Original Research

As healthcare system use and costs continue to rise, increased importance has been placed on identifying the small subgroup of patients that drive this trend.¹ It is estimated that 5% of healthcare users account for over 60% of healthcare spending.^2-6 Furthermore, care for these “high users” is expensive due to an over-reliance on inpatient services. Approximately 40% of all health spending is for inpatient care, the largest single category of health spending, which is similarly skewed toward high users.^1,3,5 Improving our understanding of this population may provide an opportunity to direct improvement efforts to a select group of patients with a potentially high benefit, as well as move care away from the costly inpatient setting.

 

However, the development of effective interventions to improve patient experience and outcomes while decreasing costs (referred to as the “Triple Aim” by the Institute for Health Improvement) for high users of inpatient services hinges on the methodology used to identify this high-risk population.⁷ There is substantial variability in definitions of high users; the most common definitions are based on the number of hospital encounters, days spent in the hospital, and hospital costs.^8-15 Definitions have intrinsic differences in their implications around appropriateness, efficiency, and financial sustainability of inpatient resource use. Though the constructs underlying these definitions are highly variable, direct comparisons of differences in patient capture are limited.

A recent study from a single US center explored the clinical characteristics of hospital patients based on definitions of use vs cost and observed important differences in patients’ profiles and outcomes.¹² While this suggests that the choice of definition may have major implications for whom to target (and the efficacy of any proposed interventions), this concept has not been explored at the population level. Therefore, we used population-based administrative data from a single-payer healthcare system to compare 3 common definitions of high inpatient service use and their influence on patient capture, health outcomes, and inpatient system burden.

METHODS

Data Sources and Study Population

We conducted a retrospective population-based study using administrative and clinical data for the province of Alberta, including the discharge abstracts database, physician claims, ambulatory care records, population health registry file, and aggregated data from the Canadian census.¹⁶ We identified all adults who had 1 or more hospitalizations with a discharge date between April 1, 2012, and March 31, 2013, though the admission date could be prior to April 1, 2012.

Definition of High-Inpatient Use

High-inpatient use was defined using 3 metrics: number of inpatient episodes, length of stay, and cost. As in prior studies, for each definition, individuals in the upper5th percentile of the relevant distribution were designated “high users,”^2,15 while patients in the lower 95th percentile were considered “nonhigh users.” Patients could be defined as a high user in more than 1 definition.

Patients with 3 or more hospital episodes were defined as high users for the “number of inpatient episodes” definition. A hospital episode of care was defined as an event that resulted in discharge (or death) from an inpatient facility. If an individual was admitted to a hospital and transferred to another facility within 1 day of discharge, the hospitalizations were considered part of the same episode of care.

The “length of stay” definition refers to the cumulative number of days spent in an inpatient facility for all eligible episodes of care. Patients with 56 or more days in hospital during the study period were considered high users. Day of admission and discharge were considered full inpatient days, regardless of the time of admission and discharge.

The “cost” definition considered the cumulative estimated cost of every eligible episode of care. We estimated costs for each hospitalization using resource intensity weights (RIW). This is a relative weighted value for the average inpatient case after taking factors such as age, comorbidity, and procedures into account. The RIW for each episode was multiplied by the national average inpatient cost.¹⁷ Based on this definition, patients with a cumulative hospital cost of ≥ $63,597 were deemed high users. All costs were calculated in Canadian Dollars (CAD, $) and adjusted to 2013 dollars based on Statistics Canada’s Consumer Price Index.¹⁸

 

Demographic, Clinical, and Encounter Characteristics

Individual characteristics were measured using a combination of provincial administrative data sources. All measures were recorded as of the admission date of the first eligible hospitalization. Demographic characteristics included age, sex, First Nations status, urban/rural status (based on the individual’s residential postal code), and median neighborhood income quintile. Clinical characteristics included 28 comorbid conditions defined based on separate validated International Statistical Classification of Disease and Health Related Problems, Tenth Revision, Canada (ICD-10-CA) coding algorithms reported individually and cumulatively (categorized as 0, 1, 2–3, and 4+).¹⁹ Primary care attachment was defined as the percentage of all outpatient primary care visits made to a single practitioner in the 2-year period prior to their first hospitalization (among those with ≥3 visits). Attachment was categorized as 75%-100% (good attachment), 50%-74% (moderate attachment), or <50% (low attachment).^20,21

We also identified hospital encounter-level characteristics. These included the most responsible diagnosis, admission category (elective or urgent/emergent), and discharge disposition for each hospital episode. Reported health outcomes included the proportion of patients with in-hospital mortality and those with at least one 30-day, all-cause readmission to hospital.

Analysis

Patient characteristics were described using proportions and means (standard deviation) as appropriate for high users and nonhigh users within and across each definition. Encounter characteristics were also described and stratified by age category (18-64 or 65+ years). Comparison of patient capture was then analyzed among patients who were high use by at least 1 definition. The overlap and agreement of the 3 definitions were compared using a Venn diagram and kappa statistic. The 10 most responsible diagnoses (based on frequency) were also compared across definitions and stratified by age.

Finally, the percentage of system burden accounted for by each measure was calculated as the amount used by high users divided by the total amount used by the entire study population (x 100). To assess the potential modifying effect of age, results were stratified by age category for each definition.

All analyses were conducted using Stata 11.2 (StataCorp LP, College Station, TX).²² The Conjoint Health Research Ethics Board of the University of Calgary approved this study and granted waiver of patient consent. This manuscript is written in accordance with reporting guidelines for studies conducted using observational routinely collected health data (RECORD statement).²³

RESULTS

Comparison of Patient and Encounter-level Characterist

ics

A total of 219,106 adults had 283,204 inpatient episodes of care within the study timeframe. There were 12,707 (5.8%), 11,095 (5.1%), and 10,956 (5.0%) patients defined as high users based on number of inpatient episodes, length of stay, and cost, respectively (supplementary Figure 1). Regardless of definition, when compared to their non–high use counterparts, patients classified as high use were more likely to be male, older, in a lower median neighborhood income quintile, and have a higher level of comorbidity. Comparing across definitions of high use, those defined by number of inpatient episodes were more likely to be younger, live in rural areas, have better primary care attachment, and have fewer comorbidities, compared to the other definitions. High users by length of stay were more likely to be older and had a higher proportion of mental health–related comorbidities, including dementia and depression, as compared with the other definitions. Results were largely similar for those defined by cost (Table 1).

Encounter-level analyses

showed that high users were more likely to die within hospital (range 3.6%-9.3%) or be discharged to a long-term care setting (range 4.2%-15.2%) ,compared with nonhigh users. High users were also more likely to be readmitted within 30 days during the study period. Comparing across definitions, those defined by number of inpatient episodes were more often discharged home. High users defined by length of stay were more likely to have been discharged to a long-term care facility, while those defined by cost were more likely to have died in hospital (Table 2). Similar trends were observed across definitions when stratified by age with proportions increasing with advancing age (supplementary Table 1).

Comparison of Patient Capture and Inpatient Burden

Of the 22,691 individuals who were defined as high use by at least 1 definition, 2,331 (10.3%) were consistently high use across all 3 definitions (kappa = 0.38; Figure 1). Of the 13,682 individuals classified as high use by at least 1 of length of stay or cost, 8369 (61.2%) were defined as high use by both definitions (kappa = 0.75). However, of the 12,707 defined as high use by the number of inpatient episodes, only 3698 (29.1%) were also defined as high use by another definition. Exploration of the most responsible diagnoses across definitions showed that congestive heart failure (2.8%-3.5%), chronic obstructive pulmonary disease (1.6%-3.2%), and dementia (0.6%-2.2%) were the most frequent. Acute medical conditions (eg, pneumonia [1.8%] or gastroenteritis [0.7%]) that may result in multiple shorter hospitalizations were observed at higher frequencies among high users defined by inpatient episodes, while conditions commonly requiring rehabilitation (eg, fracture [1.8%] and stroke [1.7%]) were more common among high users defined by length of stay and cost (supplementary Table 2). Stratification by age showed marked differences in the diagnoses across high-use definitions. Among hi

gh users defined by inpatient episodes, patients aged 18-64 years had a wide range of medical diagnoses, including several for complications of childbirth. Major diagnoses among high users by length of stay aged 18-64 years were dominated by mental health–related conditions. Diagnoses among older adults (65+) were often related to degenerative neurological conditions (dementia and Alzheimer’s disease). Diagnoses among high users by cost showed similar trends to length of stay (supplementary Table 3).

 

When assessing inpatient system burden, high users by number of inpatient episodes accounted for 47,044 (16.6%) of the 283,204 episodes. High users defined by length of stay accounted for 1,286,539 (46.4%) days of 2,773,561 total days, while high users defined by cost accumulated $1.4 billion (38.9%) of the estimated $3.7 billion in inpatient expenditures. High users defined by cost and length of stay each accounted for comparatively few episode

s (8.5% and 8.2%, respectively), while high-cost individuals accounted for 42.8% of length of stay, and high length of stay individuals accounted for 35.8% of cost. High users by number of inpatient episodes accounted for a lower burden of the other definitions (Figure 2). High-user system burden was higher among elderly patients (65+) for all definitions.

DISCUSSION

Using a large population-based cohort of all adults with at least 1 hospitalization in the province of Alberta, Canada, within a 12-month period, we compared 3 commonly used definitions of high inpatient use. The choice of definition had a substantial influence on the types of patients categorized as high use, as well as the proportion of total inpatient utilization that was associated with high users. The definition based on number of inpatient episodes captured a distinct population of high users, while the populations identified using cumulative length of stay or cost were similar.

Differences within and between definitions were especially apparent in age-stratified analyses: Greater length of stay or higher cost among patients aged 18-64 years identifies a large proportion of psychological conditions, while a greater number of inpatient episodes identifies acute conditions and childbirth or labor-related complications. Conversely, definitions based on length of stay and cost in the elderly (65+) identified groups with chronic conditions that result in progressive functional decline (often requiring increasing supportive services upon discharge) or conditions that require significant rehabilitation prior to discharge. Regarding inpatient system burden, high users defined by number of inpatient episodes accounted for a small proportion of total inpatient episodes, while high users defined by length of stay and cost accounted for nearly half of the accumulated hospital days and cost for each. These findings highlight the need for careful consideration of how high use is defined when studying high-user populations and implications for targeting subpopulations for intervention.

Our results add to those from previous studies. A US-based, single-center study of 2566 individuals compared definitions of high inpatient use based on cost and frequency of admission and found that patients defined by cost were predominantly hospitalized for surgical conditions, while those fulfilling the episode-based definition were often hospitalized for medical conditions.¹² The most responsible diagnoses for patient hospitalizations in our study reflect this. We extended this comparison to consider the impact of age on outcomes and inpatient system burden and found that older age was also linked to poorer outcomes and increased burden. We also considered a third definition (cumulative length of stay), which provided another opportunity for comparison. The presence of chronic conditions requiring rehabilitation and possible alternate level of care days within our cohort highlights the utility of this length of stay-based approach when considering definitions. Although there were similarities between patients defined by length of stay and cost, partly due to cost being largely a function of length of stay, there were also important differences in their patient profiles. Those defined by cost tended to have conditions requiring surgical procedures not requiring extended in-hospital rehabilitation. Furthermore, the higher proportion of in-hospital mortality among those defined by cost may also reflect the fact that patients tend to accrue the majority of their healthcare expenditures during the final 120 days of life.²⁴

Each definition of high use identified complex patients; however, the differences between the various types of high users identified by these definitions suggest that they are not interchangeable. Arguably, selection of the most appropriate definition should depend on the objective of measuring high users, particularly if an intervention is planned. Interventions for high users are complex, requiring both medical and nonmedical components. The current literature in this area has often focused on case management programs, collaboration with community-based social support programs, and improving coordination and transitions of care.^25-27 While many of these approaches require considerable involvement outside of the inpatient setting, these interventions can be informed by defining who high users of inpatient services are. Our findings show several possible subgroups of high users, which could be targeted for intervention. For example, an inpatient episode-based definition, which identifies patients with frequent encounters for acute conditions (eg, pneumonia and urinary tract infections), would be informative if an intervention targeted reductions in inpatient use and readmission rates. Alternatively, an intervention designed to improve community-based mental health programs would best be informed by a definition based on length of stay in which high users with underlying mental health conditions were prevalent. Such interventions are rarely mutually exclusive and require multiple perspectives to inform their objectives. A well-designed intervention will not only address the medical characteristics of high users but also the social determinants of health that place patients at risk of high inpatient use.

Our study should be interpreted in light of its limitations. First, measures of disease severity were not available to further characterize similarities and differences across high-use groups. Furthermore, we were unable to account for other social determinants of health that may be relevant to inpatient system usage. Second, direct cost of hospitalizations was estimated based on RIW and is thus reflective of expected rather than actual costs. However, this will have minimal impact on capture, as patients defined by this metric require substantial costs to be included in the top fifth percentile, and thus deviations in individual hospitalization costs will have minimal influence on the cumulative cost. Finally, while inpatient spending makes up a large proportion of healthcare spending, there is likely a number of different high-use profiles found outside of the acute care setting. Despite these limitations, our study includes several key strengths. The use of population-level data allows for analysis that is robust and more generalizable than studies from single centers. Additionally, the comparison of 3 independent definitions allows for a greater comparison of the nuances of each definition. Our study also considers the important impact of age as an effect modifier of inpatient use in the general population and identifies distinct patient profiles that exist across each definition.

 

CONCLUSIONS

Definitions of high use of inpatient services based on number of inpatient episodes, days spent in hospital, and total hospital costs identify patient populations with different characteristics and differ substantially in their impact on health outcomes and inpatient burden. These results highlight the need for careful consideration of the context of the study or intervention and the implications of selecting a specific definition of high inpatient use at study conception. Ultimately, the performance of an intervention in high-use populations is likely to be conditional on the fit of the patient population generated by the chosen definition of high inpatient use to the objectives of a study.

Acknowledgments

This study is based in part on data provided by Alberta Health and Alberta Health Services. The interpretation and conclusions are those of the researchers and do not represent the views of the Government of Alberta. Neither the Government of Alberta nor Alberta Health express any opinion in relation to this study.

Disclosure

Dr. Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. Dr. Manns is supported by the Svare Professorship in Health Economics and by a Health Scholar Award by Alberta Innovates Health Solutions (AIHS). Dr. Tonelli is supported by the David Freeze chair in Health Services Research. The Interdisciplinary Chronic Disease Collaboration is funded by AIHS—Collaborative Research and Innovation Opportunity (CRIO) Team Grants Program.

 

As healthcare system use and costs continue to rise, increased importance has been placed on identifying the small subgroup of patients that drive this trend.¹ It is estimated that 5% of healthcare users account for over 60% of healthcare spending.^2-6 Furthermore, care for these “high users” is expensive due to an over-reliance on inpatient services. Approximately 40% of all health spending is for inpatient care, the largest single category of health spending, which is similarly skewed toward high users.^1,3,5 Improving our understanding of this population may provide an opportunity to direct improvement efforts to a select group of patients with a potentially high benefit, as well as move care away from the costly inpatient setting.

 

However, the development of effective interventions to improve patient experience and outcomes while decreasing costs (referred to as the “Triple Aim” by the Institute for Health Improvement) for high users of inpatient services hinges on the methodology used to identify this high-risk population.⁷ There is substantial variability in definitions of high users; the most common definitions are based on the number of hospital encounters, days spent in the hospital, and hospital costs.^8-15 Definitions have intrinsic differences in their implications around appropriateness, efficiency, and financial sustainability of inpatient resource use. Though the constructs underlying these definitions are highly variable, direct comparisons of differences in patient capture are limited.

A recent study from a single US center explored the clinical characteristics of hospital patients based on definitions of use vs cost and observed important differences in patients’ profiles and outcomes.¹² While this suggests that the choice of definition may have major implications for whom to target (and the efficacy of any proposed interventions), this concept has not been explored at the population level. Therefore, we used population-based administrative data from a single-payer healthcare system to compare 3 common definitions of high inpatient service use and their influence on patient capture, health outcomes, and inpatient system burden.

METHODS

Data Sources and Study Population

We conducted a retrospective population-based study using administrative and clinical data for the province of Alberta, including the discharge abstracts database, physician claims, ambulatory care records, population health registry file, and aggregated data from the Canadian census.¹⁶ We identified all adults who had 1 or more hospitalizations with a discharge date between April 1, 2012, and March 31, 2013, though the admission date could be prior to April 1, 2012.

Definition of High-Inpatient Use

High-inpatient use was defined using 3 metrics: number of inpatient episodes, length of stay, and cost. As in prior studies, for each definition, individuals in the upper5th percentile of the relevant distribution were designated “high users,”^2,15 while patients in the lower 95th percentile were considered “nonhigh users.” Patients could be defined as a high user in more than 1 definition.

Patients with 3 or more hospital episodes were defined as high users for the “number of inpatient episodes” definition. A hospital episode of care was defined as an event that resulted in discharge (or death) from an inpatient facility. If an individual was admitted to a hospital and transferred to another facility within 1 day of discharge, the hospitalizations were considered part of the same episode of care.

The “length of stay” definition refers to the cumulative number of days spent in an inpatient facility for all eligible episodes of care. Patients with 56 or more days in hospital during the study period were considered high users. Day of admission and discharge were considered full inpatient days, regardless of the time of admission and discharge.

The “cost” definition considered the cumulative estimated cost of every eligible episode of care. We estimated costs for each hospitalization using resource intensity weights (RIW). This is a relative weighted value for the average inpatient case after taking factors such as age, comorbidity, and procedures into account. The RIW for each episode was multiplied by the national average inpatient cost.¹⁷ Based on this definition, patients with a cumulative hospital cost of ≥ $63,597 were deemed high users. All costs were calculated in Canadian Dollars (CAD, $) and adjusted to 2013 dollars based on Statistics Canada’s Consumer Price Index.¹⁸

 

Demographic, Clinical, and Encounter Characteristics

Individual characteristics were measured using a combination of provincial administrative data sources. All measures were recorded as of the admission date of the first eligible hospitalization. Demographic characteristics included age, sex, First Nations status, urban/rural status (based on the individual’s residential postal code), and median neighborhood income quintile. Clinical characteristics included 28 comorbid conditions defined based on separate validated International Statistical Classification of Disease and Health Related Problems, Tenth Revision, Canada (ICD-10-CA) coding algorithms reported individually and cumulatively (categorized as 0, 1, 2–3, and 4+).¹⁹ Primary care attachment was defined as the percentage of all outpatient primary care visits made to a single practitioner in the 2-year period prior to their first hospitalization (among those with ≥3 visits). Attachment was categorized as 75%-100% (good attachment), 50%-74% (moderate attachment), or <50% (low attachment).^20,21

We also identified hospital encounter-level characteristics. These included the most responsible diagnosis, admission category (elective or urgent/emergent), and discharge disposition for each hospital episode. Reported health outcomes included the proportion of patients with in-hospital mortality and those with at least one 30-day, all-cause readmission to hospital.

Analysis

Patient characteristics were described using proportions and means (standard deviation) as appropriate for high users and nonhigh users within and across each definition. Encounter characteristics were also described and stratified by age category (18-64 or 65+ years). Comparison of patient capture was then analyzed among patients who were high use by at least 1 definition. The overlap and agreement of the 3 definitions were compared using a Venn diagram and kappa statistic. The 10 most responsible diagnoses (based on frequency) were also compared across definitions and stratified by age.

Finally, the percentage of system burden accounted for by each measure was calculated as the amount used by high users divided by the total amount used by the entire study population (x 100). To assess the potential modifying effect of age, results were stratified by age category for each definition.

All analyses were conducted using Stata 11.2 (StataCorp LP, College Station, TX).²² The Conjoint Health Research Ethics Board of the University of Calgary approved this study and granted waiver of patient consent. This manuscript is written in accordance with reporting guidelines for studies conducted using observational routinely collected health data (RECORD statement).²³

RESULTS

Comparison of Patient and Encounter-level Characterist

ics

A total of 219,106 adults had 283,204 inpatient episodes of care within the study timeframe. There were 12,707 (5.8%), 11,095 (5.1%), and 10,956 (5.0%) patients defined as high users based on number of inpatient episodes, length of stay, and cost, respectively (supplementary Figure 1). Regardless of definition, when compared to their non–high use counterparts, patients classified as high use were more likely to be male, older, in a lower median neighborhood income quintile, and have a higher level of comorbidity. Comparing across definitions of high use, those defined by number of inpatient episodes were more likely to be younger, live in rural areas, have better primary care attachment, and have fewer comorbidities, compared to the other definitions. High users by length of stay were more likely to be older and had a higher proportion of mental health–related comorbidities, including dementia and depression, as compared with the other definitions. Results were largely similar for those defined by cost (Table 1).

Encounter-level analyses

showed that high users were more likely to die within hospital (range 3.6%-9.3%) or be discharged to a long-term care setting (range 4.2%-15.2%) ,compared with nonhigh users. High users were also more likely to be readmitted within 30 days during the study period. Comparing across definitions, those defined by number of inpatient episodes were more often discharged home. High users defined by length of stay were more likely to have been discharged to a long-term care facility, while those defined by cost were more likely to have died in hospital (Table 2). Similar trends were observed across definitions when stratified by age with proportions increasing with advancing age (supplementary Table 1).

Comparison of Patient Capture and Inpatient Burden

Of the 22,691 individuals who were defined as high use by at least 1 definition, 2,331 (10.3%) were consistently high use across all 3 definitions (kappa = 0.38; Figure 1). Of the 13,682 individuals classified as high use by at least 1 of length of stay or cost, 8369 (61.2%) were defined as high use by both definitions (kappa = 0.75). However, of the 12,707 defined as high use by the number of inpatient episodes, only 3698 (29.1%) were also defined as high use by another definition. Exploration of the most responsible diagnoses across definitions showed that congestive heart failure (2.8%-3.5%), chronic obstructive pulmonary disease (1.6%-3.2%), and dementia (0.6%-2.2%) were the most frequent. Acute medical conditions (eg, pneumonia [1.8%] or gastroenteritis [0.7%]) that may result in multiple shorter hospitalizations were observed at higher frequencies among high users defined by inpatient episodes, while conditions commonly requiring rehabilitation (eg, fracture [1.8%] and stroke [1.7%]) were more common among high users defined by length of stay and cost (supplementary Table 2). Stratification by age showed marked differences in the diagnoses across high-use definitions. Among hi

gh users defined by inpatient episodes, patients aged 18-64 years had a wide range of medical diagnoses, including several for complications of childbirth. Major diagnoses among high users by length of stay aged 18-64 years were dominated by mental health–related conditions. Diagnoses among older adults (65+) were often related to degenerative neurological conditions (dementia and Alzheimer’s disease). Diagnoses among high users by cost showed similar trends to length of stay (supplementary Table 3).

 

When assessing inpatient system burden, high users by number of inpatient episodes accounted for 47,044 (16.6%) of the 283,204 episodes. High users defined by length of stay accounted for 1,286,539 (46.4%) days of 2,773,561 total days, while high users defined by cost accumulated $1.4 billion (38.9%) of the estimated $3.7 billion in inpatient expenditures. High users defined by cost and length of stay each accounted for comparatively few episode

s (8.5% and 8.2%, respectively), while high-cost individuals accounted for 42.8% of length of stay, and high length of stay individuals accounted for 35.8% of cost. High users by number of inpatient episodes accounted for a lower burden of the other definitions (Figure 2). High-user system burden was higher among elderly patients (65+) for all definitions.

DISCUSSION

Using a large population-based cohort of all adults with at least 1 hospitalization in the province of Alberta, Canada, within a 12-month period, we compared 3 commonly used definitions of high inpatient use. The choice of definition had a substantial influence on the types of patients categorized as high use, as well as the proportion of total inpatient utilization that was associated with high users. The definition based on number of inpatient episodes captured a distinct population of high users, while the populations identified using cumulative length of stay or cost were similar.

Differences within and between definitions were especially apparent in age-stratified analyses: Greater length of stay or higher cost among patients aged 18-64 years identifies a large proportion of psychological conditions, while a greater number of inpatient episodes identifies acute conditions and childbirth or labor-related complications. Conversely, definitions based on length of stay and cost in the elderly (65+) identified groups with chronic conditions that result in progressive functional decline (often requiring increasing supportive services upon discharge) or conditions that require significant rehabilitation prior to discharge. Regarding inpatient system burden, high users defined by number of inpatient episodes accounted for a small proportion of total inpatient episodes, while high users defined by length of stay and cost accounted for nearly half of the accumulated hospital days and cost for each. These findings highlight the need for careful consideration of how high use is defined when studying high-user populations and implications for targeting subpopulations for intervention.

Our results add to those from previous studies. A US-based, single-center study of 2566 individuals compared definitions of high inpatient use based on cost and frequency of admission and found that patients defined by cost were predominantly hospitalized for surgical conditions, while those fulfilling the episode-based definition were often hospitalized for medical conditions.¹² The most responsible diagnoses for patient hospitalizations in our study reflect this. We extended this comparison to consider the impact of age on outcomes and inpatient system burden and found that older age was also linked to poorer outcomes and increased burden. We also considered a third definition (cumulative length of stay), which provided another opportunity for comparison. The presence of chronic conditions requiring rehabilitation and possible alternate level of care days within our cohort highlights the utility of this length of stay-based approach when considering definitions. Although there were similarities between patients defined by length of stay and cost, partly due to cost being largely a function of length of stay, there were also important differences in their patient profiles. Those defined by cost tended to have conditions requiring surgical procedures not requiring extended in-hospital rehabilitation. Furthermore, the higher proportion of in-hospital mortality among those defined by cost may also reflect the fact that patients tend to accrue the majority of their healthcare expenditures during the final 120 days of life.²⁴

Each definition of high use identified complex patients; however, the differences between the various types of high users identified by these definitions suggest that they are not interchangeable. Arguably, selection of the most appropriate definition should depend on the objective of measuring high users, particularly if an intervention is planned. Interventions for high users are complex, requiring both medical and nonmedical components. The current literature in this area has often focused on case management programs, collaboration with community-based social support programs, and improving coordination and transitions of care.^25-27 While many of these approaches require considerable involvement outside of the inpatient setting, these interventions can be informed by defining who high users of inpatient services are. Our findings show several possible subgroups of high users, which could be targeted for intervention. For example, an inpatient episode-based definition, which identifies patients with frequent encounters for acute conditions (eg, pneumonia and urinary tract infections), would be informative if an intervention targeted reductions in inpatient use and readmission rates. Alternatively, an intervention designed to improve community-based mental health programs would best be informed by a definition based on length of stay in which high users with underlying mental health conditions were prevalent. Such interventions are rarely mutually exclusive and require multiple perspectives to inform their objectives. A well-designed intervention will not only address the medical characteristics of high users but also the social determinants of health that place patients at risk of high inpatient use.

Our study should be interpreted in light of its limitations. First, measures of disease severity were not available to further characterize similarities and differences across high-use groups. Furthermore, we were unable to account for other social determinants of health that may be relevant to inpatient system usage. Second, direct cost of hospitalizations was estimated based on RIW and is thus reflective of expected rather than actual costs. However, this will have minimal impact on capture, as patients defined by this metric require substantial costs to be included in the top fifth percentile, and thus deviations in individual hospitalization costs will have minimal influence on the cumulative cost. Finally, while inpatient spending makes up a large proportion of healthcare spending, there is likely a number of different high-use profiles found outside of the acute care setting. Despite these limitations, our study includes several key strengths. The use of population-level data allows for analysis that is robust and more generalizable than studies from single centers. Additionally, the comparison of 3 independent definitions allows for a greater comparison of the nuances of each definition. Our study also considers the important impact of age as an effect modifier of inpatient use in the general population and identifies distinct patient profiles that exist across each definition.

 

CONCLUSIONS

Definitions of high use of inpatient services based on number of inpatient episodes, days spent in hospital, and total hospital costs identify patient populations with different characteristics and differ substantially in their impact on health outcomes and inpatient burden. These results highlight the need for careful consideration of the context of the study or intervention and the implications of selecting a specific definition of high inpatient use at study conception. Ultimately, the performance of an intervention in high-use populations is likely to be conditional on the fit of the patient population generated by the chosen definition of high inpatient use to the objectives of a study.

Acknowledgments

This study is based in part on data provided by Alberta Health and Alberta Health Services. The interpretation and conclusions are those of the researchers and do not represent the views of the Government of Alberta. Neither the Government of Alberta nor Alberta Health express any opinion in relation to this study.

Disclosure

Dr. Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. Dr. Manns is supported by the Svare Professorship in Health Economics and by a Health Scholar Award by Alberta Innovates Health Solutions (AIHS). Dr. Tonelli is supported by the David Freeze chair in Health Services Research. The Interdisciplinary Chronic Disease Collaboration is funded by AIHS—Collaborative Research and Innovation Opportunity (CRIO) Team Grants Program.

 

As healthcare system use and costs continue to rise, increased importance has been placed on identifying the small subgroup of patients that drive this trend.¹ It is estimated that 5% of healthcare users account for over 60% of healthcare spending.^2-6 Furthermore, care for these “high users” is expensive due to an over-reliance on inpatient services. Approximately 40% of all health spending is for inpatient care, the largest single category of health spending, which is similarly skewed toward high users.^1,3,5 Improving our understanding of this population may provide an opportunity to direct improvement efforts to a select group of patients with a potentially high benefit, as well as move care away from the costly inpatient setting.

 

However, the development of effective interventions to improve patient experience and outcomes while decreasing costs (referred to as the “Triple Aim” by the Institute for Health Improvement) for high users of inpatient services hinges on the methodology used to identify this high-risk population.⁷ There is substantial variability in definitions of high users; the most common definitions are based on the number of hospital encounters, days spent in the hospital, and hospital costs.^8-15 Definitions have intrinsic differences in their implications around appropriateness, efficiency, and financial sustainability of inpatient resource use. Though the constructs underlying these definitions are highly variable, direct comparisons of differences in patient capture are limited.

A recent study from a single US center explored the clinical characteristics of hospital patients based on definitions of use vs cost and observed important differences in patients’ profiles and outcomes.¹² While this suggests that the choice of definition may have major implications for whom to target (and the efficacy of any proposed interventions), this concept has not been explored at the population level. Therefore, we used population-based administrative data from a single-payer healthcare system to compare 3 common definitions of high inpatient service use and their influence on patient capture, health outcomes, and inpatient system burden.

METHODS

Data Sources and Study Population

We conducted a retrospective population-based study using administrative and clinical data for the province of Alberta, including the discharge abstracts database, physician claims, ambulatory care records, population health registry file, and aggregated data from the Canadian census.¹⁶ We identified all adults who had 1 or more hospitalizations with a discharge date between April 1, 2012, and March 31, 2013, though the admission date could be prior to April 1, 2012.

Definition of High-Inpatient Use

High-inpatient use was defined using 3 metrics: number of inpatient episodes, length of stay, and cost. As in prior studies, for each definition, individuals in the upper5th percentile of the relevant distribution were designated “high users,”^2,15 while patients in the lower 95th percentile were considered “nonhigh users.” Patients could be defined as a high user in more than 1 definition.

Patients with 3 or more hospital episodes were defined as high users for the “number of inpatient episodes” definition. A hospital episode of care was defined as an event that resulted in discharge (or death) from an inpatient facility. If an individual was admitted to a hospital and transferred to another facility within 1 day of discharge, the hospitalizations were considered part of the same episode of care.

The “length of stay” definition refers to the cumulative number of days spent in an inpatient facility for all eligible episodes of care. Patients with 56 or more days in hospital during the study period were considered high users. Day of admission and discharge were considered full inpatient days, regardless of the time of admission and discharge.

The “cost” definition considered the cumulative estimated cost of every eligible episode of care. We estimated costs for each hospitalization using resource intensity weights (RIW). This is a relative weighted value for the average inpatient case after taking factors such as age, comorbidity, and procedures into account. The RIW for each episode was multiplied by the national average inpatient cost.¹⁷ Based on this definition, patients with a cumulative hospital cost of ≥ $63,597 were deemed high users. All costs were calculated in Canadian Dollars (CAD, $) and adjusted to 2013 dollars based on Statistics Canada’s Consumer Price Index.¹⁸

 

Demographic, Clinical, and Encounter Characteristics

Individual characteristics were measured using a combination of provincial administrative data sources. All measures were recorded as of the admission date of the first eligible hospitalization. Demographic characteristics included age, sex, First Nations status, urban/rural status (based on the individual’s residential postal code), and median neighborhood income quintile. Clinical characteristics included 28 comorbid conditions defined based on separate validated International Statistical Classification of Disease and Health Related Problems, Tenth Revision, Canada (ICD-10-CA) coding algorithms reported individually and cumulatively (categorized as 0, 1, 2–3, and 4+).¹⁹ Primary care attachment was defined as the percentage of all outpatient primary care visits made to a single practitioner in the 2-year period prior to their first hospitalization (among those with ≥3 visits). Attachment was categorized as 75%-100% (good attachment), 50%-74% (moderate attachment), or <50% (low attachment).^20,21

We also identified hospital encounter-level characteristics. These included the most responsible diagnosis, admission category (elective or urgent/emergent), and discharge disposition for each hospital episode. Reported health outcomes included the proportion of patients with in-hospital mortality and those with at least one 30-day, all-cause readmission to hospital.

Analysis

Patient characteristics were described using proportions and means (standard deviation) as appropriate for high users and nonhigh users within and across each definition. Encounter characteristics were also described and stratified by age category (18-64 or 65+ years). Comparison of patient capture was then analyzed among patients who were high use by at least 1 definition. The overlap and agreement of the 3 definitions were compared using a Venn diagram and kappa statistic. The 10 most responsible diagnoses (based on frequency) were also compared across definitions and stratified by age.

Finally, the percentage of system burden accounted for by each measure was calculated as the amount used by high users divided by the total amount used by the entire study population (x 100). To assess the potential modifying effect of age, results were stratified by age category for each definition.

All analyses were conducted using Stata 11.2 (StataCorp LP, College Station, TX).²² The Conjoint Health Research Ethics Board of the University of Calgary approved this study and granted waiver of patient consent. This manuscript is written in accordance with reporting guidelines for studies conducted using observational routinely collected health data (RECORD statement).²³

RESULTS

Comparison of Patient and Encounter-level Characterist

ics

A total of 219,106 adults had 283,204 inpatient episodes of care within the study timeframe. There were 12,707 (5.8%), 11,095 (5.1%), and 10,956 (5.0%) patients defined as high users based on number of inpatient episodes, length of stay, and cost, respectively (supplementary Figure 1). Regardless of definition, when compared to their non–high use counterparts, patients classified as high use were more likely to be male, older, in a lower median neighborhood income quintile, and have a higher level of comorbidity. Comparing across definitions of high use, those defined by number of inpatient episodes were more likely to be younger, live in rural areas, have better primary care attachment, and have fewer comorbidities, compared to the other definitions. High users by length of stay were more likely to be older and had a higher proportion of mental health–related comorbidities, including dementia and depression, as compared with the other definitions. Results were largely similar for those defined by cost (Table 1).

Encounter-level analyses

showed that high users were more likely to die within hospital (range 3.6%-9.3%) or be discharged to a long-term care setting (range 4.2%-15.2%) ,compared with nonhigh users. High users were also more likely to be readmitted within 30 days during the study period. Comparing across definitions, those defined by number of inpatient episodes were more often discharged home. High users defined by length of stay were more likely to have been discharged to a long-term care facility, while those defined by cost were more likely to have died in hospital (Table 2). Similar trends were observed across definitions when stratified by age with proportions increasing with advancing age (supplementary Table 1).

Comparison of Patient Capture and Inpatient Burden

Of the 22,691 individuals who were defined as high use by at least 1 definition, 2,331 (10.3%) were consistently high use across all 3 definitions (kappa = 0.38; Figure 1). Of the 13,682 individuals classified as high use by at least 1 of length of stay or cost, 8369 (61.2%) were defined as high use by both definitions (kappa = 0.75). However, of the 12,707 defined as high use by the number of inpatient episodes, only 3698 (29.1%) were also defined as high use by another definition. Exploration of the most responsible diagnoses across definitions showed that congestive heart failure (2.8%-3.5%), chronic obstructive pulmonary disease (1.6%-3.2%), and dementia (0.6%-2.2%) were the most frequent. Acute medical conditions (eg, pneumonia [1.8%] or gastroenteritis [0.7%]) that may result in multiple shorter hospitalizations were observed at higher frequencies among high users defined by inpatient episodes, while conditions commonly requiring rehabilitation (eg, fracture [1.8%] and stroke [1.7%]) were more common among high users defined by length of stay and cost (supplementary Table 2). Stratification by age showed marked differences in the diagnoses across high-use definitions. Among hi

gh users defined by inpatient episodes, patients aged 18-64 years had a wide range of medical diagnoses, including several for complications of childbirth. Major diagnoses among high users by length of stay aged 18-64 years were dominated by mental health–related conditions. Diagnoses among older adults (65+) were often related to degenerative neurological conditions (dementia and Alzheimer’s disease). Diagnoses among high users by cost showed similar trends to length of stay (supplementary Table 3).

 

When assessing inpatient system burden, high users by number of inpatient episodes accounted for 47,044 (16.6%) of the 283,204 episodes. High users defined by length of stay accounted for 1,286,539 (46.4%) days of 2,773,561 total days, while high users defined by cost accumulated $1.4 billion (38.9%) of the estimated $3.7 billion in inpatient expenditures. High users defined by cost and length of stay each accounted for comparatively few episode

s (8.5% and 8.2%, respectively), while high-cost individuals accounted for 42.8% of length of stay, and high length of stay individuals accounted for 35.8% of cost. High users by number of inpatient episodes accounted for a lower burden of the other definitions (Figure 2). High-user system burden was higher among elderly patients (65+) for all definitions.

DISCUSSION

Using a large population-based cohort of all adults with at least 1 hospitalization in the province of Alberta, Canada, within a 12-month period, we compared 3 commonly used definitions of high inpatient use. The choice of definition had a substantial influence on the types of patients categorized as high use, as well as the proportion of total inpatient utilization that was associated with high users. The definition based on number of inpatient episodes captured a distinct population of high users, while the populations identified using cumulative length of stay or cost were similar.

Differences within and between definitions were especially apparent in age-stratified analyses: Greater length of stay or higher cost among patients aged 18-64 years identifies a large proportion of psychological conditions, while a greater number of inpatient episodes identifies acute conditions and childbirth or labor-related complications. Conversely, definitions based on length of stay and cost in the elderly (65+) identified groups with chronic conditions that result in progressive functional decline (often requiring increasing supportive services upon discharge) or conditions that require significant rehabilitation prior to discharge. Regarding inpatient system burden, high users defined by number of inpatient episodes accounted for a small proportion of total inpatient episodes, while high users defined by length of stay and cost accounted for nearly half of the accumulated hospital days and cost for each. These findings highlight the need for careful consideration of how high use is defined when studying high-user populations and implications for targeting subpopulations for intervention.

Our results add to those from previous studies. A US-based, single-center study of 2566 individuals compared definitions of high inpatient use based on cost and frequency of admission and found that patients defined by cost were predominantly hospitalized for surgical conditions, while those fulfilling the episode-based definition were often hospitalized for medical conditions.¹² The most responsible diagnoses for patient hospitalizations in our study reflect this. We extended this comparison to consider the impact of age on outcomes and inpatient system burden and found that older age was also linked to poorer outcomes and increased burden. We also considered a third definition (cumulative length of stay), which provided another opportunity for comparison. The presence of chronic conditions requiring rehabilitation and possible alternate level of care days within our cohort highlights the utility of this length of stay-based approach when considering definitions. Although there were similarities between patients defined by length of stay and cost, partly due to cost being largely a function of length of stay, there were also important differences in their patient profiles. Those defined by cost tended to have conditions requiring surgical procedures not requiring extended in-hospital rehabilitation. Furthermore, the higher proportion of in-hospital mortality among those defined by cost may also reflect the fact that patients tend to accrue the majority of their healthcare expenditures during the final 120 days of life.²⁴

Each definition of high use identified complex patients; however, the differences between the various types of high users identified by these definitions suggest that they are not interchangeable. Arguably, selection of the most appropriate definition should depend on the objective of measuring high users, particularly if an intervention is planned. Interventions for high users are complex, requiring both medical and nonmedical components. The current literature in this area has often focused on case management programs, collaboration with community-based social support programs, and improving coordination and transitions of care.^25-27 While many of these approaches require considerable involvement outside of the inpatient setting, these interventions can be informed by defining who high users of inpatient services are. Our findings show several possible subgroups of high users, which could be targeted for intervention. For example, an inpatient episode-based definition, which identifies patients with frequent encounters for acute conditions (eg, pneumonia and urinary tract infections), would be informative if an intervention targeted reductions in inpatient use and readmission rates. Alternatively, an intervention designed to improve community-based mental health programs would best be informed by a definition based on length of stay in which high users with underlying mental health conditions were prevalent. Such interventions are rarely mutually exclusive and require multiple perspectives to inform their objectives. A well-designed intervention will not only address the medical characteristics of high users but also the social determinants of health that place patients at risk of high inpatient use.

Our study should be interpreted in light of its limitations. First, measures of disease severity were not available to further characterize similarities and differences across high-use groups. Furthermore, we were unable to account for other social determinants of health that may be relevant to inpatient system usage. Second, direct cost of hospitalizations was estimated based on RIW and is thus reflective of expected rather than actual costs. However, this will have minimal impact on capture, as patients defined by this metric require substantial costs to be included in the top fifth percentile, and thus deviations in individual hospitalization costs will have minimal influence on the cumulative cost. Finally, while inpatient spending makes up a large proportion of healthcare spending, there is likely a number of different high-use profiles found outside of the acute care setting. Despite these limitations, our study includes several key strengths. The use of population-level data allows for analysis that is robust and more generalizable than studies from single centers. Additionally, the comparison of 3 independent definitions allows for a greater comparison of the nuances of each definition. Our study also considers the important impact of age as an effect modifier of inpatient use in the general population and identifies distinct patient profiles that exist across each definition.

 

CONCLUSIONS

Definitions of high use of inpatient services based on number of inpatient episodes, days spent in hospital, and total hospital costs identify patient populations with different characteristics and differ substantially in their impact on health outcomes and inpatient burden. These results highlight the need for careful consideration of the context of the study or intervention and the implications of selecting a specific definition of high inpatient use at study conception. Ultimately, the performance of an intervention in high-use populations is likely to be conditional on the fit of the patient population generated by the chosen definition of high inpatient use to the objectives of a study.

Acknowledgments

This study is based in part on data provided by Alberta Health and Alberta Health Services. The interpretation and conclusions are those of the researchers and do not represent the views of the Government of Alberta. Neither the Government of Alberta nor Alberta Health express any opinion in relation to this study.

Disclosure

Dr. Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. Dr. Manns is supported by the Svare Professorship in Health Economics and by a Health Scholar Award by Alberta Innovates Health Solutions (AIHS). Dr. Tonelli is supported by the David Freeze chair in Health Services Research. The Interdisciplinary Chronic Disease Collaboration is funded by AIHS—Collaborative Research and Innovation Opportunity (CRIO) Team Grants Program.

 

Take-Home Points

• Complication rates did not statistically significantly differ between simultaneous and staged TKA.
• Length of stay of 2 TKA admissions was greater than 1 BTKA admission.
• Transfusion requirements were greater in BTKA.
• Avoid bilateral procedures in ASA 3 patients.
• Develop institutional protocols for BTKA with multidisciplinary input.

In the United States, osteoarthritis is the most common cause of knee pain and one of the leading causes of disability.¹ Total knee arthroplasty (TKA) is an effective treatment for end-stage osteoarthritis of the knee.² Whether patients with severe, debilitating bilateral disease should undergo simultaneous bilateral TKA (BTKA) or staged BTKA (2 separate procedures during separate hospital admissions) continues to be debated. The relative risks and benefits of simultaneous BTKA relative to staged BTKA or unilateral TKA are controversial.^3-6 Proponents of simultaneous BTKA have argued that this surgery results in shorter hospital length of stay (LOS) and higher patient satisfaction without increased risk of perioperative complications,^7-9 and opponents have argued that it leads to increased perioperative mortality and complications and should not be performed routinely.^10,11

The safety of simultaneous BTKA cannot necessarily be extrapolated from data on unilateral TKA. Authors have argued that the complication rate for simultaneous BTKA is not comparable to the rate for unilateral TKA but instead is double the rate.¹² Although a doubled rate may more closely approximate the true risk of simultaneous BTKA, it still does not account for the increased surgical impact of 2 procedures (vs 1 procedure) on a patient. In this regard, comparing simultaneous and staged BTKA provides a more accurate assessment of risk, as long as the interval between surgeries is not excessive. The major stress experienced during TKA affects the cardiovascular, pulmonary, and musculoskeletal systems, and full recovery may take up to 6 months.^13-15 Outcome studies have found significant improvement in validated measures of function and pain up to but not past 6 months.^13,15 Furthermore, a large study comparing American Society of Anesthesiologists (ASA) scores with morbidity and mortality rates recorded in the New Zealand Total Joint Database established 6 months as a best approximation of postoperative mortality and morbidity risk.¹⁴ Given these data, we propose that the most accurate analysis of postoperative morbidity and mortality would be a comparison of simultaneous BTKA with BTKA staged <6 months apart. The staged procedures fall within the crucial postoperative period when increased morbidity and mortality would more likely be present. A between-surgeries interval >6 months would effectively separate the 2 procedures, rendering their risks not truly representative.

We retrospectively analyzed all simultaneous BTKA and staged BTKA (<6 months apart) surgeries performed at our orthopedic specialty hospital between 2005 and 2009. We hypothesized there would be no significant difference in perioperative morbidity or mortality between the groups.

Methods and Materials

Our institution’s Institutional Review Board approved this study. All patients who underwent either simultaneous BTKA or staged BTKA (<6 months apart) at a single orthopedic specialty hospital between 2005 and 2009 were retrospectively identified. Twenty-five surgeons performed the procedures. Which procedure to perform (simultaneous or staged) was decided by the attending surgeon in consultation with an anesthesiologist. Preoperative medical diagnostic testing was determined by the internist, who provided medical clearance, and was subject to review by the anesthesiologist. A patient was excluded from simultaneous BTKA only if the medical or anesthesiology consultant deemed the patient too high risk for bilateral procedures. Revision TKAs were excluded from the study.

Implant, approach, tourniquet use, and TKA technique were selected by the individual surgeons. Strategies for the simultaneous procedures were (1) single surgeon, single team, sequential, start second knee after closure of first, and (2) single surgeon, single team, sequential, start second knee after implantation of first but before closure. The decision to proceed with the second knee was confirmed in consultation with the anesthesiologist after implantation and deflation of the tourniquet on the first knee.

Individual electronic patient charts were reviewed for information on demographics, comorbidities, anesthesia type, antibiotics, and postoperative venous thromboembolism prophylaxis. Demographic variables included age, sex, height, weight, and body mass index (BMI). Comorbidities recorded were diabetes mellitus, coronary artery disease, prior myocardial infarction, stroke, and endocrinopathies. In addition, available ASA scores were recorded. The primary outcome was perioperative complications, defined as any complications that occurred within 6 months after surgery. These included death, pulmonary embolism (PE), and deep surgical-site infections (SSIs). Secondary outcome measures were LOS, discharge location (rehabilitation or home), and blood transfusion requirements.

The 2 groups (simultaneous BTKA, staged BTKA) were compared using Student t test for continuous variables and χ² test for categorical variables. Subgroup analysis was performed to compare healthier patients (ASA score 1 or 2) with patients who had more severe comorbidities (ASA score 3). Statistical significance was set at P < .05.

Results

Between 2005 and 2009, 371 patients had simultaneous BTKA, and 67 had staged BTKA (134 procedures) <6 months apart (Table 1).

Mean recovery interval between staged procedures was 4.3 months (range, 2-6 months). Mean age was 63.9 years (range, 44-88 years) for the simultaneous BTKA patients and 63.1 years (range, 35-81 years) for the staged BTKA patients (P = .105). Both groups had proportionately more female patients (69.8% in the simultaneous BTKA group, 64.2% in the staged BTKA group), but there was no sex difference between the groups (P = .359). There were 71 (19.1%) morbidly obese patients (body mass index [BMI], ≥40 kg/m²) in the simultaneous group and 14 (20.9%) in the staged group (P = .739). The groups had statistically similar proportions of diabetes mellitus and coronary artery disease (P = .283).

Most surgeries (84.4% simultaneous, 90.3% staged) were performed with the patient under spinal anesthesia, and there was a trend (P = .167) toward more frequent use of general anesthesia in the simultaneous group relative to the staged group (Table 2).

Intraoperative antibiotics were given in all cases, and there were no significant differences in antibiotic type between the groups. Postoperative chemical venous thromboembolism prophylaxis was administered to all patients, depending on surgeon preference, and there were no significant differences between the groups.

The 2 cohorts’ perioperative complication rates were not statistically significantly different (P = .97) (Table 3).

The simultaneous BTKA group had 13 complications: 7 PEs (1.9%), 5 deep SSIs (1.08%), and 1 respiratory arrest (0.27%). The staged BTKA group had only 1 complication, a deep SSI (0.75%). There were no significant differences in rates of individual complications (deep vein thrombosis, PE, SSI; P = .697) or intensive care unit admission (P = .312). Mean number of transfusion units was 1.39 for simultaneous BTKA and 0.66 for both staged TKAs combined (P = .042). Mean aggregated LOS for both procedures in the staged BTKA was 8.93 days per patient, and mean LOS for simultaneous BTKA was 4.94 days per patient, significantly shorter (P = .0001). The percentage of postoperative discharges from hospital to an inpatient acute rehabilitation center was significantly higher (P = .0001) in the simultaneous BTKA group (92.7%) than in the staged BTKA group (50.7%).

There was no statistically significant difference (P = .398) in occurrence of postoperative complications between the 2 cohorts compared on ASA scores, and the difference between patients with ASA score 1 or 2 and those with ASA score 3 was not statistically significant (P = .200) (Table 4).

There was a trend (P = .161) toward more complications in 85 patients with BMI of ≥40 kg/m² (morbidly obese), of whom 5 (5.9%) had a complication, than in 9 patients (2.6%) with BMI of <40 kg/m², but the difference was not statistically significant because of the sample size.

Discussion

Although there was no significant difference in postoperative complication rates within 6 months after surgery between the simultaneous and staged BTKA groups, the incidence of complications in the simultaneous group was notable. The disproportionate size of the 2 comparison groups limited the power of our study to analyze individual perioperative complications. This study may be underpowered to detect differences in complications occurring relatively infrequently, which may explain why the difference in number of complications (13 in simultaneous group, 1 in staged group) did not achieve statistical significance (β = 0.89). Post hoc power analysis showed 956 patients would be needed in each group to adequately power for such small complication rates. However, our results are consistent with those of other studies.^13-15 The 1.9% PE rate in our simultaneous BTKA group does not vary from the average PE rate for TKA in the literature and is actually lower than the PE rate in a previous study at our institution.¹⁶ Fat embolism traditionally is considered more of a concern in bilateral cases than in unilateral cases. Although fat embolism surely is inherent to the physiologic alterations caused by TKA, we did not find clinically significant fat embolism in either cohort.

Similarly, the 1.08% rate of deep SSIs is within the range for postoperative TKA infections at our institution and others.¹⁷ Our staged BTKA group’s complication rate, 0.75% (1 SSI), was slightly lower than expected. However, 0.75% is in keeping with institutional norms (typical rate, ~1%). We would have expected a nonzero rate for venous thromboembolism, and perhaps such a rate would have come with an inclusion period longer than 6 months. Last, the death in the simultaneous BTKA group was not an outlier, given the published rate of mortality after elective total joint surgery.¹⁸The characteristics of our simultaneous and staged BTKA groups were very similar (Table 1), though the larger number of staged-group patients with diabetes mellitus and coronary artery disease may represent selection bias. Nevertheless, the proportions of patients with each of 3 ASA scores were similar. It is also important to note that, in this context, a high percentage of patients in each group (33.6% simultaneous, 37.5% staged) received ASA score 3 from the anesthesiologist (P > .05). This may be an important factor in explaining the larger though not statistically significant number of complications in the simultaneous group (13) relative to the staged group (1).

We therefore consider ASA score 3 to be a contraindication to a bilateral procedure, and for simultaneous BTKA we have developed a set of exclusion criteria that include ASA score 3 or 4 (Table 5). These criteria reflect input from our surgeons, anesthesiologist, and medical specialists, as well as the data presented here.

Other authors have studied the safety of simultaneous vs staged BTKA and drawn conflicting conclusions.^11,19-21 Walmsley and colleagues²¹ found no differences in 90-day mortality between 3 groups: patients with simultaneous BTKA, patients with BTKA staged within 5 years, and patients with unilateral TKA. Stefánsdóttir and colleagues¹¹ found that, compared with simultaneous BTKA, BTKA staged within 1 year had a lower 30-day mortality rate. Meehan and colleagues²⁰ compared simultaneous BTKA with BTKA staged within 1 year and found a lower risk of infection and device malfunction and a higher risk of adverse cardiovascular outcomes in the simultaneous group. A recent meta-analysis found that, compared with staged BTKA, simultaneous BTKA had a higher risk of perioperative complications.¹⁹ A systematic review of retrospective studies found simultaneous BTKA had higher rates of mortality, PE, and transfusion and lower rates of deep SSI and revision.²² A survey of Medicare data found higher 90-day mortality and myocardial infarction rates for simultaneous BTKA but no difference in infection and revision rates.²³ Clearly, there is no consensus as to whether simultaneous BTKA carries higher risks relative to staged BTKA.

The amount of blood transfused in our simultaneous BTKA group was more than double that in the 2 staged TKAs combined. It is intuitive that the blood loss in 2 concurrent TKAs is always more than in 1 TKA, but the clinical relevance of this fact is unknown. Transfusions have potential complications, and this risk needs to be addressed in the preoperative discussion.

LOS for simultaneous BTKA was on average 4 days shorter than the combined LOS (2 hospitalizations) for staged BTKA. This shorter LOS has been shown to provide the healthcare system with a cost savings.⁸ However, not considered in the equation is the difference in cost of rehabilitations, 2 vs 1. In the present study, 92.7% of simultaneous BTKA patients and only 50.7% of staged BTKA patients were discharged to an inpatient acute rehabilitation unit. Interestingly, the majority of the staged patients who went to inpatient rehabilitation did so after the second surgery. At our institution at the time of this study, simultaneous BTKA patients, and staged BTKA patients with the second surgery completed, were more likely than unilateral TKA patients to qualify for inpatient acute rehabilitation. Staged BTKA patients’ higher cost for 2 rehabilitations, rather than 1, adds to the cost savings realized with simultaneous BTKA. In the context of an episode-based payment system, the cost of posthospital rehabilitation enters the overall cost equation and may lead to an increase in the number of simultaneous BTKAs being performed.

Conclusion

In this study, the incidence of postoperative complications was higher for simultaneous BTKA than for staged BTKA performed <6 months apart, but the difference was not significantly different. There were significant differences in LOS and blood transfusion rates between the groups, as expected. At present, only patients with ASA score 1 or 2 are considered for simultaneous BTKA at our institution. Patients with ASA score 3 or higher are not eligible.

Am J Orthop. 2017;46(4):E224-E229. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Complication rates did not statistically significantly differ between simultaneous and staged TKA.
• Length of stay of 2 TKA admissions was greater than 1 BTKA admission.
• Transfusion requirements were greater in BTKA.
• Avoid bilateral procedures in ASA 3 patients.
• Develop institutional protocols for BTKA with multidisciplinary input.

In the United States, osteoarthritis is the most common cause of knee pain and one of the leading causes of disability.¹ Total knee arthroplasty (TKA) is an effective treatment for end-stage osteoarthritis of the knee.² Whether patients with severe, debilitating bilateral disease should undergo simultaneous bilateral TKA (BTKA) or staged BTKA (2 separate procedures during separate hospital admissions) continues to be debated. The relative risks and benefits of simultaneous BTKA relative to staged BTKA or unilateral TKA are controversial.^3-6 Proponents of simultaneous BTKA have argued that this surgery results in shorter hospital length of stay (LOS) and higher patient satisfaction without increased risk of perioperative complications,^7-9 and opponents have argued that it leads to increased perioperative mortality and complications and should not be performed routinely.^10,11

The safety of simultaneous BTKA cannot necessarily be extrapolated from data on unilateral TKA. Authors have argued that the complication rate for simultaneous BTKA is not comparable to the rate for unilateral TKA but instead is double the rate.¹² Although a doubled rate may more closely approximate the true risk of simultaneous BTKA, it still does not account for the increased surgical impact of 2 procedures (vs 1 procedure) on a patient. In this regard, comparing simultaneous and staged BTKA provides a more accurate assessment of risk, as long as the interval between surgeries is not excessive. The major stress experienced during TKA affects the cardiovascular, pulmonary, and musculoskeletal systems, and full recovery may take up to 6 months.^13-15 Outcome studies have found significant improvement in validated measures of function and pain up to but not past 6 months.^13,15 Furthermore, a large study comparing American Society of Anesthesiologists (ASA) scores with morbidity and mortality rates recorded in the New Zealand Total Joint Database established 6 months as a best approximation of postoperative mortality and morbidity risk.¹⁴ Given these data, we propose that the most accurate analysis of postoperative morbidity and mortality would be a comparison of simultaneous BTKA with BTKA staged <6 months apart. The staged procedures fall within the crucial postoperative period when increased morbidity and mortality would more likely be present. A between-surgeries interval >6 months would effectively separate the 2 procedures, rendering their risks not truly representative.

We retrospectively analyzed all simultaneous BTKA and staged BTKA (<6 months apart) surgeries performed at our orthopedic specialty hospital between 2005 and 2009. We hypothesized there would be no significant difference in perioperative morbidity or mortality between the groups.

Methods and Materials

Our institution’s Institutional Review Board approved this study. All patients who underwent either simultaneous BTKA or staged BTKA (<6 months apart) at a single orthopedic specialty hospital between 2005 and 2009 were retrospectively identified. Twenty-five surgeons performed the procedures. Which procedure to perform (simultaneous or staged) was decided by the attending surgeon in consultation with an anesthesiologist. Preoperative medical diagnostic testing was determined by the internist, who provided medical clearance, and was subject to review by the anesthesiologist. A patient was excluded from simultaneous BTKA only if the medical or anesthesiology consultant deemed the patient too high risk for bilateral procedures. Revision TKAs were excluded from the study.

Implant, approach, tourniquet use, and TKA technique were selected by the individual surgeons. Strategies for the simultaneous procedures were (1) single surgeon, single team, sequential, start second knee after closure of first, and (2) single surgeon, single team, sequential, start second knee after implantation of first but before closure. The decision to proceed with the second knee was confirmed in consultation with the anesthesiologist after implantation and deflation of the tourniquet on the first knee.

Individual electronic patient charts were reviewed for information on demographics, comorbidities, anesthesia type, antibiotics, and postoperative venous thromboembolism prophylaxis. Demographic variables included age, sex, height, weight, and body mass index (BMI). Comorbidities recorded were diabetes mellitus, coronary artery disease, prior myocardial infarction, stroke, and endocrinopathies. In addition, available ASA scores were recorded. The primary outcome was perioperative complications, defined as any complications that occurred within 6 months after surgery. These included death, pulmonary embolism (PE), and deep surgical-site infections (SSIs). Secondary outcome measures were LOS, discharge location (rehabilitation or home), and blood transfusion requirements.

The 2 groups (simultaneous BTKA, staged BTKA) were compared using Student t test for continuous variables and χ² test for categorical variables. Subgroup analysis was performed to compare healthier patients (ASA score 1 or 2) with patients who had more severe comorbidities (ASA score 3). Statistical significance was set at P < .05.

Results

Between 2005 and 2009, 371 patients had simultaneous BTKA, and 67 had staged BTKA (134 procedures) <6 months apart (Table 1).

Mean recovery interval between staged procedures was 4.3 months (range, 2-6 months). Mean age was 63.9 years (range, 44-88 years) for the simultaneous BTKA patients and 63.1 years (range, 35-81 years) for the staged BTKA patients (P = .105). Both groups had proportionately more female patients (69.8% in the simultaneous BTKA group, 64.2% in the staged BTKA group), but there was no sex difference between the groups (P = .359). There were 71 (19.1%) morbidly obese patients (body mass index [BMI], ≥40 kg/m²) in the simultaneous group and 14 (20.9%) in the staged group (P = .739). The groups had statistically similar proportions of diabetes mellitus and coronary artery disease (P = .283).

Most surgeries (84.4% simultaneous, 90.3% staged) were performed with the patient under spinal anesthesia, and there was a trend (P = .167) toward more frequent use of general anesthesia in the simultaneous group relative to the staged group (Table 2).

Intraoperative antibiotics were given in all cases, and there were no significant differences in antibiotic type between the groups. Postoperative chemical venous thromboembolism prophylaxis was administered to all patients, depending on surgeon preference, and there were no significant differences between the groups.

The 2 cohorts’ perioperative complication rates were not statistically significantly different (P = .97) (Table 3).

The simultaneous BTKA group had 13 complications: 7 PEs (1.9%), 5 deep SSIs (1.08%), and 1 respiratory arrest (0.27%). The staged BTKA group had only 1 complication, a deep SSI (0.75%). There were no significant differences in rates of individual complications (deep vein thrombosis, PE, SSI; P = .697) or intensive care unit admission (P = .312). Mean number of transfusion units was 1.39 for simultaneous BTKA and 0.66 for both staged TKAs combined (P = .042). Mean aggregated LOS for both procedures in the staged BTKA was 8.93 days per patient, and mean LOS for simultaneous BTKA was 4.94 days per patient, significantly shorter (P = .0001). The percentage of postoperative discharges from hospital to an inpatient acute rehabilitation center was significantly higher (P = .0001) in the simultaneous BTKA group (92.7%) than in the staged BTKA group (50.7%).

There was no statistically significant difference (P = .398) in occurrence of postoperative complications between the 2 cohorts compared on ASA scores, and the difference between patients with ASA score 1 or 2 and those with ASA score 3 was not statistically significant (P = .200) (Table 4).

There was a trend (P = .161) toward more complications in 85 patients with BMI of ≥40 kg/m² (morbidly obese), of whom 5 (5.9%) had a complication, than in 9 patients (2.6%) with BMI of <40 kg/m², but the difference was not statistically significant because of the sample size.

Discussion

Although there was no significant difference in postoperative complication rates within 6 months after surgery between the simultaneous and staged BTKA groups, the incidence of complications in the simultaneous group was notable. The disproportionate size of the 2 comparison groups limited the power of our study to analyze individual perioperative complications. This study may be underpowered to detect differences in complications occurring relatively infrequently, which may explain why the difference in number of complications (13 in simultaneous group, 1 in staged group) did not achieve statistical significance (β = 0.89). Post hoc power analysis showed 956 patients would be needed in each group to adequately power for such small complication rates. However, our results are consistent with those of other studies.^13-15 The 1.9% PE rate in our simultaneous BTKA group does not vary from the average PE rate for TKA in the literature and is actually lower than the PE rate in a previous study at our institution.¹⁶ Fat embolism traditionally is considered more of a concern in bilateral cases than in unilateral cases. Although fat embolism surely is inherent to the physiologic alterations caused by TKA, we did not find clinically significant fat embolism in either cohort.

Similarly, the 1.08% rate of deep SSIs is within the range for postoperative TKA infections at our institution and others.¹⁷ Our staged BTKA group’s complication rate, 0.75% (1 SSI), was slightly lower than expected. However, 0.75% is in keeping with institutional norms (typical rate, ~1%). We would have expected a nonzero rate for venous thromboembolism, and perhaps such a rate would have come with an inclusion period longer than 6 months. Last, the death in the simultaneous BTKA group was not an outlier, given the published rate of mortality after elective total joint surgery.¹⁸The characteristics of our simultaneous and staged BTKA groups were very similar (Table 1), though the larger number of staged-group patients with diabetes mellitus and coronary artery disease may represent selection bias. Nevertheless, the proportions of patients with each of 3 ASA scores were similar. It is also important to note that, in this context, a high percentage of patients in each group (33.6% simultaneous, 37.5% staged) received ASA score 3 from the anesthesiologist (P > .05). This may be an important factor in explaining the larger though not statistically significant number of complications in the simultaneous group (13) relative to the staged group (1).

We therefore consider ASA score 3 to be a contraindication to a bilateral procedure, and for simultaneous BTKA we have developed a set of exclusion criteria that include ASA score 3 or 4 (Table 5). These criteria reflect input from our surgeons, anesthesiologist, and medical specialists, as well as the data presented here.

Other authors have studied the safety of simultaneous vs staged BTKA and drawn conflicting conclusions.^11,19-21 Walmsley and colleagues²¹ found no differences in 90-day mortality between 3 groups: patients with simultaneous BTKA, patients with BTKA staged within 5 years, and patients with unilateral TKA. Stefánsdóttir and colleagues¹¹ found that, compared with simultaneous BTKA, BTKA staged within 1 year had a lower 30-day mortality rate. Meehan and colleagues²⁰ compared simultaneous BTKA with BTKA staged within 1 year and found a lower risk of infection and device malfunction and a higher risk of adverse cardiovascular outcomes in the simultaneous group. A recent meta-analysis found that, compared with staged BTKA, simultaneous BTKA had a higher risk of perioperative complications.¹⁹ A systematic review of retrospective studies found simultaneous BTKA had higher rates of mortality, PE, and transfusion and lower rates of deep SSI and revision.²² A survey of Medicare data found higher 90-day mortality and myocardial infarction rates for simultaneous BTKA but no difference in infection and revision rates.²³ Clearly, there is no consensus as to whether simultaneous BTKA carries higher risks relative to staged BTKA.

The amount of blood transfused in our simultaneous BTKA group was more than double that in the 2 staged TKAs combined. It is intuitive that the blood loss in 2 concurrent TKAs is always more than in 1 TKA, but the clinical relevance of this fact is unknown. Transfusions have potential complications, and this risk needs to be addressed in the preoperative discussion.

LOS for simultaneous BTKA was on average 4 days shorter than the combined LOS (2 hospitalizations) for staged BTKA. This shorter LOS has been shown to provide the healthcare system with a cost savings.⁸ However, not considered in the equation is the difference in cost of rehabilitations, 2 vs 1. In the present study, 92.7% of simultaneous BTKA patients and only 50.7% of staged BTKA patients were discharged to an inpatient acute rehabilitation unit. Interestingly, the majority of the staged patients who went to inpatient rehabilitation did so after the second surgery. At our institution at the time of this study, simultaneous BTKA patients, and staged BTKA patients with the second surgery completed, were more likely than unilateral TKA patients to qualify for inpatient acute rehabilitation. Staged BTKA patients’ higher cost for 2 rehabilitations, rather than 1, adds to the cost savings realized with simultaneous BTKA. In the context of an episode-based payment system, the cost of posthospital rehabilitation enters the overall cost equation and may lead to an increase in the number of simultaneous BTKAs being performed.

Conclusion

In this study, the incidence of postoperative complications was higher for simultaneous BTKA than for staged BTKA performed <6 months apart, but the difference was not significantly different. There were significant differences in LOS and blood transfusion rates between the groups, as expected. At present, only patients with ASA score 1 or 2 are considered for simultaneous BTKA at our institution. Patients with ASA score 3 or higher are not eligible.

Am J Orthop. 2017;46(4):E224-E229. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Complication rates did not statistically significantly differ between simultaneous and staged TKA.
• Length of stay of 2 TKA admissions was greater than 1 BTKA admission.
• Transfusion requirements were greater in BTKA.
• Avoid bilateral procedures in ASA 3 patients.
• Develop institutional protocols for BTKA with multidisciplinary input.

In the United States, osteoarthritis is the most common cause of knee pain and one of the leading causes of disability.¹ Total knee arthroplasty (TKA) is an effective treatment for end-stage osteoarthritis of the knee.² Whether patients with severe, debilitating bilateral disease should undergo simultaneous bilateral TKA (BTKA) or staged BTKA (2 separate procedures during separate hospital admissions) continues to be debated. The relative risks and benefits of simultaneous BTKA relative to staged BTKA or unilateral TKA are controversial.^3-6 Proponents of simultaneous BTKA have argued that this surgery results in shorter hospital length of stay (LOS) and higher patient satisfaction without increased risk of perioperative complications,^7-9 and opponents have argued that it leads to increased perioperative mortality and complications and should not be performed routinely.^10,11

The safety of simultaneous BTKA cannot necessarily be extrapolated from data on unilateral TKA. Authors have argued that the complication rate for simultaneous BTKA is not comparable to the rate for unilateral TKA but instead is double the rate.¹² Although a doubled rate may more closely approximate the true risk of simultaneous BTKA, it still does not account for the increased surgical impact of 2 procedures (vs 1 procedure) on a patient. In this regard, comparing simultaneous and staged BTKA provides a more accurate assessment of risk, as long as the interval between surgeries is not excessive. The major stress experienced during TKA affects the cardiovascular, pulmonary, and musculoskeletal systems, and full recovery may take up to 6 months.^13-15 Outcome studies have found significant improvement in validated measures of function and pain up to but not past 6 months.^13,15 Furthermore, a large study comparing American Society of Anesthesiologists (ASA) scores with morbidity and mortality rates recorded in the New Zealand Total Joint Database established 6 months as a best approximation of postoperative mortality and morbidity risk.¹⁴ Given these data, we propose that the most accurate analysis of postoperative morbidity and mortality would be a comparison of simultaneous BTKA with BTKA staged <6 months apart. The staged procedures fall within the crucial postoperative period when increased morbidity and mortality would more likely be present. A between-surgeries interval >6 months would effectively separate the 2 procedures, rendering their risks not truly representative.

We retrospectively analyzed all simultaneous BTKA and staged BTKA (<6 months apart) surgeries performed at our orthopedic specialty hospital between 2005 and 2009. We hypothesized there would be no significant difference in perioperative morbidity or mortality between the groups.

Methods and Materials

Our institution’s Institutional Review Board approved this study. All patients who underwent either simultaneous BTKA or staged BTKA (<6 months apart) at a single orthopedic specialty hospital between 2005 and 2009 were retrospectively identified. Twenty-five surgeons performed the procedures. Which procedure to perform (simultaneous or staged) was decided by the attending surgeon in consultation with an anesthesiologist. Preoperative medical diagnostic testing was determined by the internist, who provided medical clearance, and was subject to review by the anesthesiologist. A patient was excluded from simultaneous BTKA only if the medical or anesthesiology consultant deemed the patient too high risk for bilateral procedures. Revision TKAs were excluded from the study.

Implant, approach, tourniquet use, and TKA technique were selected by the individual surgeons. Strategies for the simultaneous procedures were (1) single surgeon, single team, sequential, start second knee after closure of first, and (2) single surgeon, single team, sequential, start second knee after implantation of first but before closure. The decision to proceed with the second knee was confirmed in consultation with the anesthesiologist after implantation and deflation of the tourniquet on the first knee.

Individual electronic patient charts were reviewed for information on demographics, comorbidities, anesthesia type, antibiotics, and postoperative venous thromboembolism prophylaxis. Demographic variables included age, sex, height, weight, and body mass index (BMI). Comorbidities recorded were diabetes mellitus, coronary artery disease, prior myocardial infarction, stroke, and endocrinopathies. In addition, available ASA scores were recorded. The primary outcome was perioperative complications, defined as any complications that occurred within 6 months after surgery. These included death, pulmonary embolism (PE), and deep surgical-site infections (SSIs). Secondary outcome measures were LOS, discharge location (rehabilitation or home), and blood transfusion requirements.

The 2 groups (simultaneous BTKA, staged BTKA) were compared using Student t test for continuous variables and χ² test for categorical variables. Subgroup analysis was performed to compare healthier patients (ASA score 1 or 2) with patients who had more severe comorbidities (ASA score 3). Statistical significance was set at P < .05.

Results

Between 2005 and 2009, 371 patients had simultaneous BTKA, and 67 had staged BTKA (134 procedures) <6 months apart (Table 1).

Mean recovery interval between staged procedures was 4.3 months (range, 2-6 months). Mean age was 63.9 years (range, 44-88 years) for the simultaneous BTKA patients and 63.1 years (range, 35-81 years) for the staged BTKA patients (P = .105). Both groups had proportionately more female patients (69.8% in the simultaneous BTKA group, 64.2% in the staged BTKA group), but there was no sex difference between the groups (P = .359). There were 71 (19.1%) morbidly obese patients (body mass index [BMI], ≥40 kg/m²) in the simultaneous group and 14 (20.9%) in the staged group (P = .739). The groups had statistically similar proportions of diabetes mellitus and coronary artery disease (P = .283).

Most surgeries (84.4% simultaneous, 90.3% staged) were performed with the patient under spinal anesthesia, and there was a trend (P = .167) toward more frequent use of general anesthesia in the simultaneous group relative to the staged group (Table 2).

Intraoperative antibiotics were given in all cases, and there were no significant differences in antibiotic type between the groups. Postoperative chemical venous thromboembolism prophylaxis was administered to all patients, depending on surgeon preference, and there were no significant differences between the groups.

The 2 cohorts’ perioperative complication rates were not statistically significantly different (P = .97) (Table 3).

The simultaneous BTKA group had 13 complications: 7 PEs (1.9%), 5 deep SSIs (1.08%), and 1 respiratory arrest (0.27%). The staged BTKA group had only 1 complication, a deep SSI (0.75%). There were no significant differences in rates of individual complications (deep vein thrombosis, PE, SSI; P = .697) or intensive care unit admission (P = .312). Mean number of transfusion units was 1.39 for simultaneous BTKA and 0.66 for both staged TKAs combined (P = .042). Mean aggregated LOS for both procedures in the staged BTKA was 8.93 days per patient, and mean LOS for simultaneous BTKA was 4.94 days per patient, significantly shorter (P = .0001). The percentage of postoperative discharges from hospital to an inpatient acute rehabilitation center was significantly higher (P = .0001) in the simultaneous BTKA group (92.7%) than in the staged BTKA group (50.7%).

There was no statistically significant difference (P = .398) in occurrence of postoperative complications between the 2 cohorts compared on ASA scores, and the difference between patients with ASA score 1 or 2 and those with ASA score 3 was not statistically significant (P = .200) (Table 4).

There was a trend (P = .161) toward more complications in 85 patients with BMI of ≥40 kg/m² (morbidly obese), of whom 5 (5.9%) had a complication, than in 9 patients (2.6%) with BMI of <40 kg/m², but the difference was not statistically significant because of the sample size.

Discussion

Although there was no significant difference in postoperative complication rates within 6 months after surgery between the simultaneous and staged BTKA groups, the incidence of complications in the simultaneous group was notable. The disproportionate size of the 2 comparison groups limited the power of our study to analyze individual perioperative complications. This study may be underpowered to detect differences in complications occurring relatively infrequently, which may explain why the difference in number of complications (13 in simultaneous group, 1 in staged group) did not achieve statistical significance (β = 0.89). Post hoc power analysis showed 956 patients would be needed in each group to adequately power for such small complication rates. However, our results are consistent with those of other studies.^13-15 The 1.9% PE rate in our simultaneous BTKA group does not vary from the average PE rate for TKA in the literature and is actually lower than the PE rate in a previous study at our institution.¹⁶ Fat embolism traditionally is considered more of a concern in bilateral cases than in unilateral cases. Although fat embolism surely is inherent to the physiologic alterations caused by TKA, we did not find clinically significant fat embolism in either cohort.

Similarly, the 1.08% rate of deep SSIs is within the range for postoperative TKA infections at our institution and others.¹⁷ Our staged BTKA group’s complication rate, 0.75% (1 SSI), was slightly lower than expected. However, 0.75% is in keeping with institutional norms (typical rate, ~1%). We would have expected a nonzero rate for venous thromboembolism, and perhaps such a rate would have come with an inclusion period longer than 6 months. Last, the death in the simultaneous BTKA group was not an outlier, given the published rate of mortality after elective total joint surgery.¹⁸The characteristics of our simultaneous and staged BTKA groups were very similar (Table 1), though the larger number of staged-group patients with diabetes mellitus and coronary artery disease may represent selection bias. Nevertheless, the proportions of patients with each of 3 ASA scores were similar. It is also important to note that, in this context, a high percentage of patients in each group (33.6% simultaneous, 37.5% staged) received ASA score 3 from the anesthesiologist (P > .05). This may be an important factor in explaining the larger though not statistically significant number of complications in the simultaneous group (13) relative to the staged group (1).

We therefore consider ASA score 3 to be a contraindication to a bilateral procedure, and for simultaneous BTKA we have developed a set of exclusion criteria that include ASA score 3 or 4 (Table 5). These criteria reflect input from our surgeons, anesthesiologist, and medical specialists, as well as the data presented here.

Other authors have studied the safety of simultaneous vs staged BTKA and drawn conflicting conclusions.^11,19-21 Walmsley and colleagues²¹ found no differences in 90-day mortality between 3 groups: patients with simultaneous BTKA, patients with BTKA staged within 5 years, and patients with unilateral TKA. Stefánsdóttir and colleagues¹¹ found that, compared with simultaneous BTKA, BTKA staged within 1 year had a lower 30-day mortality rate. Meehan and colleagues²⁰ compared simultaneous BTKA with BTKA staged within 1 year and found a lower risk of infection and device malfunction and a higher risk of adverse cardiovascular outcomes in the simultaneous group. A recent meta-analysis found that, compared with staged BTKA, simultaneous BTKA had a higher risk of perioperative complications.¹⁹ A systematic review of retrospective studies found simultaneous BTKA had higher rates of mortality, PE, and transfusion and lower rates of deep SSI and revision.²² A survey of Medicare data found higher 90-day mortality and myocardial infarction rates for simultaneous BTKA but no difference in infection and revision rates.²³ Clearly, there is no consensus as to whether simultaneous BTKA carries higher risks relative to staged BTKA.

The amount of blood transfused in our simultaneous BTKA group was more than double that in the 2 staged TKAs combined. It is intuitive that the blood loss in 2 concurrent TKAs is always more than in 1 TKA, but the clinical relevance of this fact is unknown. Transfusions have potential complications, and this risk needs to be addressed in the preoperative discussion.

LOS for simultaneous BTKA was on average 4 days shorter than the combined LOS (2 hospitalizations) for staged BTKA. This shorter LOS has been shown to provide the healthcare system with a cost savings.⁸ However, not considered in the equation is the difference in cost of rehabilitations, 2 vs 1. In the present study, 92.7% of simultaneous BTKA patients and only 50.7% of staged BTKA patients were discharged to an inpatient acute rehabilitation unit. Interestingly, the majority of the staged patients who went to inpatient rehabilitation did so after the second surgery. At our institution at the time of this study, simultaneous BTKA patients, and staged BTKA patients with the second surgery completed, were more likely than unilateral TKA patients to qualify for inpatient acute rehabilitation. Staged BTKA patients’ higher cost for 2 rehabilitations, rather than 1, adds to the cost savings realized with simultaneous BTKA. In the context of an episode-based payment system, the cost of posthospital rehabilitation enters the overall cost equation and may lead to an increase in the number of simultaneous BTKAs being performed.

Conclusion

In this study, the incidence of postoperative complications was higher for simultaneous BTKA than for staged BTKA performed <6 months apart, but the difference was not significantly different. There were significant differences in LOS and blood transfusion rates between the groups, as expected. At present, only patients with ASA score 1 or 2 are considered for simultaneous BTKA at our institution. Patients with ASA score 3 or higher are not eligible.

Am J Orthop. 2017;46(4):E224-E229. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• The LHB tendon has been shown to be a significant pain generator in the shoulder.
• At our institution, the number of LHB tenodeses significantly increased from 2004 to 2014.
• The age of patients who underwent a LHB tenodesis did not change significantly over the study period.
• Furthermore, the percentage of shoulder procedures that involved a LHB tenodesis significantly increased over the study period.

• Biceps tenodesis has become a more common procedure to treat shoulder pathology.

Although the exact function of the long head of the biceps (LHB) tendon is not completely understood, it is accepted that the LHB tendon can be a significant source of pain within the shoulder.^1-4 Patients with symptoms related to biceps pathology often present with anterior shoulder pain that worsens with flexion and supination of the affected elbow and wrist.⁵ Although the sensitivity and specificity of physical examination maneuvers have been called into question, special tests have been developed to aid in the diagnosis of tendonitis of the LHB. These tests include the Speed, Yergason, bear hug, and uppercut tests as well as the O’Brien test (cross-body adduction).^6,7 Recent studies have found LHB pathology in 45% of patients who undergo rotator cuff repair and in 63% of patients with a subscapularis tear.^8,9

Pathology of the LHB tendon, including superior labrum anterior to posterior (SLAP) tears, can be treated in many ways.^5,10,11 Options include SLAP repair, biceps tenodesis, débridement, and biceps tenotomy.^11,12 Results of SLAP repairs have been less than optimal, but biceps tenodesis has been effective, and avoids the issue of cramping as can be seen with biceps tenotomy and débridement.^10,12,13 Surgical methods for biceps tenodesis include open subpectoral and all-arthroscopic.^11,12 Both methods have had good, reliable outcomes, but the all-arthroscopic technique is relatively new.^11,12,14We conducted a study to determine LHB tenodesis trends, including patient age at time of surgery. We used surgical data from fellowship-trained sports or shoulder/elbow orthopedic surgeons at a busy subspecialty-based shoulder orthopedic practice. We hypothesized that the rate of LHB tenodesis would increase significantly over time and that there would be no significant change in the age of patients who underwent LHB tenodesis.

Methods

Our Institutional Review Board exempted this study. To determine the number of LHB tenodesis procedures performed at our institution, overall and in comparison with other common arthroscopic shoulder procedures, we queried the surgical database of 4 fellowship-trained orthopedic surgeons (shoulder/elbow, Drs. Nicholson and Cole; sports, Drs. Romeo and Verma) for the period January 1, 2004 to December 31, 2014. We used Current Procedural Terminology (CPT) code 23430 to determine the number of LHB tenodesis cases, as the surgeons primarily perform an open subpectoral biceps tenodesis. Patient age at time of surgery and the date of surgery were recorded. All patients who underwent LHB tenodesis between January 1, 2004 and December 31, 2014 were included. Number of procedures performed each year by each surgeon was recorded, as were concomitant procedures performed at the same time as the LHB tenodesis. To get the denominator (and reference point) for the number of arthroscopic shoulder surgeries performed by these 4 surgeons during the study period, and thereby determine the rate of LHB tenodesis, we selected the most common shoulder arthroscopy CPT codes used in our practice: 23430, 29806, 29807, 29822, 29823, 29825, 29826, and 29827. For a patient who underwent multiple procedures on the same day (multiple CPT codes entered on the same day), only one code was counted for that day. If 23430 was among the codes, it was included, and the case was placed in the numerator; if 23430 was not among the codes, the case was placed in the denominator.

The Arthroscopy Association of North America provides descriptions for the CPT codes: 23430 (tenodesis of long tendon of biceps), 29806 (arthroscopy, shoulder, surgical; capsulorrhaphy), 29807 (arthroscopy, shoulder, surgical; repair of SLAP lesion), 29822 (arthroscopy, shoulder, surgical; débridement, limited), 29823 (arthroscopy, shoulder, surgical; débridement, extensive), 29825 (arthroscopy, shoulder, surgical; with lysis and resection of adhesions, with or without manipulation), 29826 (arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with or without coracoacromial release), and 29827 (arthroscopy, shoulder, surgical; with rotator cuff repair).

For analysis, we divided the data into total number of arthroscopic shoulder procedures performed by each surgeon each year and number of LHB tenodesis procedures performed by each surgeon each year. Total number of patients who had an arthroscopic procedure was used to create a denominator, and number of LHB tenodesis procedures showed the percentage of arthroscopic shoulder surgery patients who underwent LHB tenodesis. (All patients who undergo biceps tenodesis also have, at the least, diagnostic shoulder arthroscopy with or without tenotomy; if the tendon is ruptured, tenotomy is unnecessary.)

Descriptive statistics were calculated as means (SDs) for continuous variables and as frequencies with percentages for categorical variables. Linear regression analysis was used to determine whether the number of LHB tenodesis procedures changed during the study period and whether patient age changed over time. Significance was set at P < .05.

 

Results

Of the 7640 patients who underwent arthroscopic shoulder procedures between 2004 and 2014, 2125 had LHB tenodesis (CPT code 23430).

Mean (SD) age of the subgroup was 49.33 (13.2) years, and mean (SD) number of LHB tenodesis cases per year was 193.2 (130.5). Over time, mean age of patients who had these procedures did not change significantly (P = .934) (Figure 1), mean number of LHB tenodesis cases increased significantly (P = .0024) (Figure 2A), and percentage of LHB tenodesis cases increased significantly relative to percentage of all arthroscopic shoulder procedures (P = .0099) (Figure 2B).

The concomitant procedures performed with LHB tenodesis during the study period are listed in the Table.

Discussion

Tenodesis has become a common treatment option for several pathologic shoulder conditions involving the LHB tendon.⁵ We set out to determine trends in LHB tenodesis at a subspecialty-focused shoulder orthopedic practice and hypothesized that the rate of LHB tenodesis would increase significantly over time and that there would be no significant change in the age of patients who underwent LHB tenodesis. Our hypotheses were confirmed: The number of LHB tenodesis cases increased significantly without a significant change in patient age.

Treatment options for LHB pathology and SLAP tears include simple tenotomy, débridement, open biceps tenodesis, and arthroscopic tenodesis.^11,12,15

Several fixation options have been used in open subpectoral biceps tenodesis. In this technique, which was used by all the surgeons in this study, the biceps tendon is fixed such that the musculotendinous junction of the biceps rests at the inferior border of the pectoralis major in the bicipital groove.^16-19 Studies have found good, reliable outcomes with both the open and the arthroscopic surgical techniques.^12,18 Comparing the LHB tenodesis trends in the present study with the SLAP repair trends we found at our institution in a previous study,²⁰ we discovered that overall number of LHB tenodesis cases and percentage of LHB tenodesis cases relative to percentage of all arthroscopic shoulder procedures increased significantly more than for SLAP repairs.

Recent evidence has called into question the results of SLAP repairs and suggested biceps tenodesis may be a better treatment option for SLAP tears.^10,13,21 Studies have found excellent outcomes with open subpectoral biceps tenodesis in the treatment of SLAP tears, and others have found better restoration of pitchers’ thoracic rotation with open subpectoral biceps tenodesis than with SLAP repair.^13,14 Similarly, comparison studies have largely favored biceps tenodesis over SLAP repair, particularly in patients older than 35 years to 40 years.²² Given these results, it is not surprising that, querying the American Board of Orthopaedic Surgeons (ABOS) part II database for isolated SLAP lesions treated between 2002 and 2011, Patterson and colleagues²³ found the percentage of SLAP repairs decreased from 69.3% to 44.8% (P < .0001), whereas the percentage of biceps tenodesis procedures increased from 1.9% to 18.8% (P < .0001), indicating the realization of improved outcomes with LHB tenodesis in the treatment of SLAP tears. On the other hand, in the ABOS part II database for the period 2003 to 2008, Weber and colleagues²⁴ found that, despite a decrease in the percentage of SLAP repairs, total number of SLAP repairs increased from 9.4% to 10.1% (P = .0163). According to our study results, the number of SLAP repairs is decreasing over time, whereas the number of LHB tenodesis procedures is continuing to rise. The practice patterns seen in our study correlate with those in previous studies of the treatment of SLAP tears: good results in tenodesis groups and poor results in SLAP repair groups.^10,13Werner and colleagues²⁵ recently used the large PearlDiver database, which includes information from both private payers and Medicare, to determine overall LHB tenodesis trends in the United States for the period 2008 to 2011. Over those years, the incidence of LHB tenodesis increased 1.7-fold, and the rate of arthroscopic LHB tenodesis increased significantly more than the rate of open LHB tenodesis. These results are similar to ours in that the number of LHB tenodesis cases increased significantly over time. However, as the overwhelming majority of patients in our practice undergo open biceps tenodesis, the faster rate of growth in the arthroscopic cohort relative to the open cohort cannot be assessed. Additional randomized studies comparing biceps tenodesis, both open and arthroscopic, with SLAP repair are needed to properly determine the superiority of LHB tenodesis over SLAP repair.

One strength of this database study was the number of patients: more than 7000, 2125 of whom underwent biceps tenodesis performed by 1 of 4 fellowship-trained orthopedic surgeons. There were several study limitations. First, because the original diagnoses were not recorded, it was unclear exactly which pathologies were treated with tenodesis, limiting our ability to make recommendations regarding treatment trends for specific pathologies. Similarly, we did not assess outcome variables, which would have allowed us to draw conclusions about the effectiveness of the biceps tenodesis procedures. Furthermore, some procedures may have been coded incorrectly, and therefore some patients may have been erroneously included or excluded. In addition, using data from only one institution may have introduced bias into our conclusions, though the results are consistent with national trends. Finally, there was some variability among the 4 surgeons in the number of LHB tenodesis procedures performed, and this variability may have confounded results, though these surgeons treat biceps pathology in similar ways.

Am J Orthop. 2017;46(4):E219-E223. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• The LHB tendon has been shown to be a significant pain generator in the shoulder.
• At our institution, the number of LHB tenodeses significantly increased from 2004 to 2014.
• The age of patients who underwent a LHB tenodesis did not change significantly over the study period.
• Furthermore, the percentage of shoulder procedures that involved a LHB tenodesis significantly increased over the study period.

• Biceps tenodesis has become a more common procedure to treat shoulder pathology.

Although the exact function of the long head of the biceps (LHB) tendon is not completely understood, it is accepted that the LHB tendon can be a significant source of pain within the shoulder.^1-4 Patients with symptoms related to biceps pathology often present with anterior shoulder pain that worsens with flexion and supination of the affected elbow and wrist.⁵ Although the sensitivity and specificity of physical examination maneuvers have been called into question, special tests have been developed to aid in the diagnosis of tendonitis of the LHB. These tests include the Speed, Yergason, bear hug, and uppercut tests as well as the O’Brien test (cross-body adduction).^6,7 Recent studies have found LHB pathology in 45% of patients who undergo rotator cuff repair and in 63% of patients with a subscapularis tear.^8,9

Pathology of the LHB tendon, including superior labrum anterior to posterior (SLAP) tears, can be treated in many ways.^5,10,11 Options include SLAP repair, biceps tenodesis, débridement, and biceps tenotomy.^11,12 Results of SLAP repairs have been less than optimal, but biceps tenodesis has been effective, and avoids the issue of cramping as can be seen with biceps tenotomy and débridement.^10,12,13 Surgical methods for biceps tenodesis include open subpectoral and all-arthroscopic.^11,12 Both methods have had good, reliable outcomes, but the all-arthroscopic technique is relatively new.^11,12,14We conducted a study to determine LHB tenodesis trends, including patient age at time of surgery. We used surgical data from fellowship-trained sports or shoulder/elbow orthopedic surgeons at a busy subspecialty-based shoulder orthopedic practice. We hypothesized that the rate of LHB tenodesis would increase significantly over time and that there would be no significant change in the age of patients who underwent LHB tenodesis.

Methods

Our Institutional Review Board exempted this study. To determine the number of LHB tenodesis procedures performed at our institution, overall and in comparison with other common arthroscopic shoulder procedures, we queried the surgical database of 4 fellowship-trained orthopedic surgeons (shoulder/elbow, Drs. Nicholson and Cole; sports, Drs. Romeo and Verma) for the period January 1, 2004 to December 31, 2014. We used Current Procedural Terminology (CPT) code 23430 to determine the number of LHB tenodesis cases, as the surgeons primarily perform an open subpectoral biceps tenodesis. Patient age at time of surgery and the date of surgery were recorded. All patients who underwent LHB tenodesis between January 1, 2004 and December 31, 2014 were included. Number of procedures performed each year by each surgeon was recorded, as were concomitant procedures performed at the same time as the LHB tenodesis. To get the denominator (and reference point) for the number of arthroscopic shoulder surgeries performed by these 4 surgeons during the study period, and thereby determine the rate of LHB tenodesis, we selected the most common shoulder arthroscopy CPT codes used in our practice: 23430, 29806, 29807, 29822, 29823, 29825, 29826, and 29827. For a patient who underwent multiple procedures on the same day (multiple CPT codes entered on the same day), only one code was counted for that day. If 23430 was among the codes, it was included, and the case was placed in the numerator; if 23430 was not among the codes, the case was placed in the denominator.

The Arthroscopy Association of North America provides descriptions for the CPT codes: 23430 (tenodesis of long tendon of biceps), 29806 (arthroscopy, shoulder, surgical; capsulorrhaphy), 29807 (arthroscopy, shoulder, surgical; repair of SLAP lesion), 29822 (arthroscopy, shoulder, surgical; débridement, limited), 29823 (arthroscopy, shoulder, surgical; débridement, extensive), 29825 (arthroscopy, shoulder, surgical; with lysis and resection of adhesions, with or without manipulation), 29826 (arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with or without coracoacromial release), and 29827 (arthroscopy, shoulder, surgical; with rotator cuff repair).

For analysis, we divided the data into total number of arthroscopic shoulder procedures performed by each surgeon each year and number of LHB tenodesis procedures performed by each surgeon each year. Total number of patients who had an arthroscopic procedure was used to create a denominator, and number of LHB tenodesis procedures showed the percentage of arthroscopic shoulder surgery patients who underwent LHB tenodesis. (All patients who undergo biceps tenodesis also have, at the least, diagnostic shoulder arthroscopy with or without tenotomy; if the tendon is ruptured, tenotomy is unnecessary.)

Descriptive statistics were calculated as means (SDs) for continuous variables and as frequencies with percentages for categorical variables. Linear regression analysis was used to determine whether the number of LHB tenodesis procedures changed during the study period and whether patient age changed over time. Significance was set at P < .05.

 

Results

Of the 7640 patients who underwent arthroscopic shoulder procedures between 2004 and 2014, 2125 had LHB tenodesis (CPT code 23430).

Mean (SD) age of the subgroup was 49.33 (13.2) years, and mean (SD) number of LHB tenodesis cases per year was 193.2 (130.5). Over time, mean age of patients who had these procedures did not change significantly (P = .934) (Figure 1), mean number of LHB tenodesis cases increased significantly (P = .0024) (Figure 2A), and percentage of LHB tenodesis cases increased significantly relative to percentage of all arthroscopic shoulder procedures (P = .0099) (Figure 2B).

The concomitant procedures performed with LHB tenodesis during the study period are listed in the Table.

Discussion

Tenodesis has become a common treatment option for several pathologic shoulder conditions involving the LHB tendon.⁵ We set out to determine trends in LHB tenodesis at a subspecialty-focused shoulder orthopedic practice and hypothesized that the rate of LHB tenodesis would increase significantly over time and that there would be no significant change in the age of patients who underwent LHB tenodesis. Our hypotheses were confirmed: The number of LHB tenodesis cases increased significantly without a significant change in patient age.

Treatment options for LHB pathology and SLAP tears include simple tenotomy, débridement, open biceps tenodesis, and arthroscopic tenodesis.^11,12,15

Several fixation options have been used in open subpectoral biceps tenodesis. In this technique, which was used by all the surgeons in this study, the biceps tendon is fixed such that the musculotendinous junction of the biceps rests at the inferior border of the pectoralis major in the bicipital groove.^16-19 Studies have found good, reliable outcomes with both the open and the arthroscopic surgical techniques.^12,18 Comparing the LHB tenodesis trends in the present study with the SLAP repair trends we found at our institution in a previous study,²⁰ we discovered that overall number of LHB tenodesis cases and percentage of LHB tenodesis cases relative to percentage of all arthroscopic shoulder procedures increased significantly more than for SLAP repairs.

Recent evidence has called into question the results of SLAP repairs and suggested biceps tenodesis may be a better treatment option for SLAP tears.^10,13,21 Studies have found excellent outcomes with open subpectoral biceps tenodesis in the treatment of SLAP tears, and others have found better restoration of pitchers’ thoracic rotation with open subpectoral biceps tenodesis than with SLAP repair.^13,14 Similarly, comparison studies have largely favored biceps tenodesis over SLAP repair, particularly in patients older than 35 years to 40 years.²² Given these results, it is not surprising that, querying the American Board of Orthopaedic Surgeons (ABOS) part II database for isolated SLAP lesions treated between 2002 and 2011, Patterson and colleagues²³ found the percentage of SLAP repairs decreased from 69.3% to 44.8% (P < .0001), whereas the percentage of biceps tenodesis procedures increased from 1.9% to 18.8% (P < .0001), indicating the realization of improved outcomes with LHB tenodesis in the treatment of SLAP tears. On the other hand, in the ABOS part II database for the period 2003 to 2008, Weber and colleagues²⁴ found that, despite a decrease in the percentage of SLAP repairs, total number of SLAP repairs increased from 9.4% to 10.1% (P = .0163). According to our study results, the number of SLAP repairs is decreasing over time, whereas the number of LHB tenodesis procedures is continuing to rise. The practice patterns seen in our study correlate with those in previous studies of the treatment of SLAP tears: good results in tenodesis groups and poor results in SLAP repair groups.^10,13Werner and colleagues²⁵ recently used the large PearlDiver database, which includes information from both private payers and Medicare, to determine overall LHB tenodesis trends in the United States for the period 2008 to 2011. Over those years, the incidence of LHB tenodesis increased 1.7-fold, and the rate of arthroscopic LHB tenodesis increased significantly more than the rate of open LHB tenodesis. These results are similar to ours in that the number of LHB tenodesis cases increased significantly over time. However, as the overwhelming majority of patients in our practice undergo open biceps tenodesis, the faster rate of growth in the arthroscopic cohort relative to the open cohort cannot be assessed. Additional randomized studies comparing biceps tenodesis, both open and arthroscopic, with SLAP repair are needed to properly determine the superiority of LHB tenodesis over SLAP repair.

One strength of this database study was the number of patients: more than 7000, 2125 of whom underwent biceps tenodesis performed by 1 of 4 fellowship-trained orthopedic surgeons. There were several study limitations. First, because the original diagnoses were not recorded, it was unclear exactly which pathologies were treated with tenodesis, limiting our ability to make recommendations regarding treatment trends for specific pathologies. Similarly, we did not assess outcome variables, which would have allowed us to draw conclusions about the effectiveness of the biceps tenodesis procedures. Furthermore, some procedures may have been coded incorrectly, and therefore some patients may have been erroneously included or excluded. In addition, using data from only one institution may have introduced bias into our conclusions, though the results are consistent with national trends. Finally, there was some variability among the 4 surgeons in the number of LHB tenodesis procedures performed, and this variability may have confounded results, though these surgeons treat biceps pathology in similar ways.

Am J Orthop. 2017;46(4):E219-E223. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• The LHB tendon has been shown to be a significant pain generator in the shoulder.
• At our institution, the number of LHB tenodeses significantly increased from 2004 to 2014.
• The age of patients who underwent a LHB tenodesis did not change significantly over the study period.
• Furthermore, the percentage of shoulder procedures that involved a LHB tenodesis significantly increased over the study period.

• Biceps tenodesis has become a more common procedure to treat shoulder pathology.

Although the exact function of the long head of the biceps (LHB) tendon is not completely understood, it is accepted that the LHB tendon can be a significant source of pain within the shoulder.^1-4 Patients with symptoms related to biceps pathology often present with anterior shoulder pain that worsens with flexion and supination of the affected elbow and wrist.⁵ Although the sensitivity and specificity of physical examination maneuvers have been called into question, special tests have been developed to aid in the diagnosis of tendonitis of the LHB. These tests include the Speed, Yergason, bear hug, and uppercut tests as well as the O’Brien test (cross-body adduction).^6,7 Recent studies have found LHB pathology in 45% of patients who undergo rotator cuff repair and in 63% of patients with a subscapularis tear.^8,9

Pathology of the LHB tendon, including superior labrum anterior to posterior (SLAP) tears, can be treated in many ways.^5,10,11 Options include SLAP repair, biceps tenodesis, débridement, and biceps tenotomy.^11,12 Results of SLAP repairs have been less than optimal, but biceps tenodesis has been effective, and avoids the issue of cramping as can be seen with biceps tenotomy and débridement.^10,12,13 Surgical methods for biceps tenodesis include open subpectoral and all-arthroscopic.^11,12 Both methods have had good, reliable outcomes, but the all-arthroscopic technique is relatively new.^11,12,14We conducted a study to determine LHB tenodesis trends, including patient age at time of surgery. We used surgical data from fellowship-trained sports or shoulder/elbow orthopedic surgeons at a busy subspecialty-based shoulder orthopedic practice. We hypothesized that the rate of LHB tenodesis would increase significantly over time and that there would be no significant change in the age of patients who underwent LHB tenodesis.

Methods

Our Institutional Review Board exempted this study. To determine the number of LHB tenodesis procedures performed at our institution, overall and in comparison with other common arthroscopic shoulder procedures, we queried the surgical database of 4 fellowship-trained orthopedic surgeons (shoulder/elbow, Drs. Nicholson and Cole; sports, Drs. Romeo and Verma) for the period January 1, 2004 to December 31, 2014. We used Current Procedural Terminology (CPT) code 23430 to determine the number of LHB tenodesis cases, as the surgeons primarily perform an open subpectoral biceps tenodesis. Patient age at time of surgery and the date of surgery were recorded. All patients who underwent LHB tenodesis between January 1, 2004 and December 31, 2014 were included. Number of procedures performed each year by each surgeon was recorded, as were concomitant procedures performed at the same time as the LHB tenodesis. To get the denominator (and reference point) for the number of arthroscopic shoulder surgeries performed by these 4 surgeons during the study period, and thereby determine the rate of LHB tenodesis, we selected the most common shoulder arthroscopy CPT codes used in our practice: 23430, 29806, 29807, 29822, 29823, 29825, 29826, and 29827. For a patient who underwent multiple procedures on the same day (multiple CPT codes entered on the same day), only one code was counted for that day. If 23430 was among the codes, it was included, and the case was placed in the numerator; if 23430 was not among the codes, the case was placed in the denominator.

The Arthroscopy Association of North America provides descriptions for the CPT codes: 23430 (tenodesis of long tendon of biceps), 29806 (arthroscopy, shoulder, surgical; capsulorrhaphy), 29807 (arthroscopy, shoulder, surgical; repair of SLAP lesion), 29822 (arthroscopy, shoulder, surgical; débridement, limited), 29823 (arthroscopy, shoulder, surgical; débridement, extensive), 29825 (arthroscopy, shoulder, surgical; with lysis and resection of adhesions, with or without manipulation), 29826 (arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with or without coracoacromial release), and 29827 (arthroscopy, shoulder, surgical; with rotator cuff repair).

For analysis, we divided the data into total number of arthroscopic shoulder procedures performed by each surgeon each year and number of LHB tenodesis procedures performed by each surgeon each year. Total number of patients who had an arthroscopic procedure was used to create a denominator, and number of LHB tenodesis procedures showed the percentage of arthroscopic shoulder surgery patients who underwent LHB tenodesis. (All patients who undergo biceps tenodesis also have, at the least, diagnostic shoulder arthroscopy with or without tenotomy; if the tendon is ruptured, tenotomy is unnecessary.)

Descriptive statistics were calculated as means (SDs) for continuous variables and as frequencies with percentages for categorical variables. Linear regression analysis was used to determine whether the number of LHB tenodesis procedures changed during the study period and whether patient age changed over time. Significance was set at P < .05.

 

Results

Of the 7640 patients who underwent arthroscopic shoulder procedures between 2004 and 2014, 2125 had LHB tenodesis (CPT code 23430).

Mean (SD) age of the subgroup was 49.33 (13.2) years, and mean (SD) number of LHB tenodesis cases per year was 193.2 (130.5). Over time, mean age of patients who had these procedures did not change significantly (P = .934) (Figure 1), mean number of LHB tenodesis cases increased significantly (P = .0024) (Figure 2A), and percentage of LHB tenodesis cases increased significantly relative to percentage of all arthroscopic shoulder procedures (P = .0099) (Figure 2B).

The concomitant procedures performed with LHB tenodesis during the study period are listed in the Table.

Discussion

Tenodesis has become a common treatment option for several pathologic shoulder conditions involving the LHB tendon.⁵ We set out to determine trends in LHB tenodesis at a subspecialty-focused shoulder orthopedic practice and hypothesized that the rate of LHB tenodesis would increase significantly over time and that there would be no significant change in the age of patients who underwent LHB tenodesis. Our hypotheses were confirmed: The number of LHB tenodesis cases increased significantly without a significant change in patient age.

Treatment options for LHB pathology and SLAP tears include simple tenotomy, débridement, open biceps tenodesis, and arthroscopic tenodesis.^11,12,15

Several fixation options have been used in open subpectoral biceps tenodesis. In this technique, which was used by all the surgeons in this study, the biceps tendon is fixed such that the musculotendinous junction of the biceps rests at the inferior border of the pectoralis major in the bicipital groove.^16-19 Studies have found good, reliable outcomes with both the open and the arthroscopic surgical techniques.^12,18 Comparing the LHB tenodesis trends in the present study with the SLAP repair trends we found at our institution in a previous study,²⁰ we discovered that overall number of LHB tenodesis cases and percentage of LHB tenodesis cases relative to percentage of all arthroscopic shoulder procedures increased significantly more than for SLAP repairs.

Recent evidence has called into question the results of SLAP repairs and suggested biceps tenodesis may be a better treatment option for SLAP tears.^10,13,21 Studies have found excellent outcomes with open subpectoral biceps tenodesis in the treatment of SLAP tears, and others have found better restoration of pitchers’ thoracic rotation with open subpectoral biceps tenodesis than with SLAP repair.^13,14 Similarly, comparison studies have largely favored biceps tenodesis over SLAP repair, particularly in patients older than 35 years to 40 years.²² Given these results, it is not surprising that, querying the American Board of Orthopaedic Surgeons (ABOS) part II database for isolated SLAP lesions treated between 2002 and 2011, Patterson and colleagues²³ found the percentage of SLAP repairs decreased from 69.3% to 44.8% (P < .0001), whereas the percentage of biceps tenodesis procedures increased from 1.9% to 18.8% (P < .0001), indicating the realization of improved outcomes with LHB tenodesis in the treatment of SLAP tears. On the other hand, in the ABOS part II database for the period 2003 to 2008, Weber and colleagues²⁴ found that, despite a decrease in the percentage of SLAP repairs, total number of SLAP repairs increased from 9.4% to 10.1% (P = .0163). According to our study results, the number of SLAP repairs is decreasing over time, whereas the number of LHB tenodesis procedures is continuing to rise. The practice patterns seen in our study correlate with those in previous studies of the treatment of SLAP tears: good results in tenodesis groups and poor results in SLAP repair groups.^10,13Werner and colleagues²⁵ recently used the large PearlDiver database, which includes information from both private payers and Medicare, to determine overall LHB tenodesis trends in the United States for the period 2008 to 2011. Over those years, the incidence of LHB tenodesis increased 1.7-fold, and the rate of arthroscopic LHB tenodesis increased significantly more than the rate of open LHB tenodesis. These results are similar to ours in that the number of LHB tenodesis cases increased significantly over time. However, as the overwhelming majority of patients in our practice undergo open biceps tenodesis, the faster rate of growth in the arthroscopic cohort relative to the open cohort cannot be assessed. Additional randomized studies comparing biceps tenodesis, both open and arthroscopic, with SLAP repair are needed to properly determine the superiority of LHB tenodesis over SLAP repair.

One strength of this database study was the number of patients: more than 7000, 2125 of whom underwent biceps tenodesis performed by 1 of 4 fellowship-trained orthopedic surgeons. There were several study limitations. First, because the original diagnoses were not recorded, it was unclear exactly which pathologies were treated with tenodesis, limiting our ability to make recommendations regarding treatment trends for specific pathologies. Similarly, we did not assess outcome variables, which would have allowed us to draw conclusions about the effectiveness of the biceps tenodesis procedures. Furthermore, some procedures may have been coded incorrectly, and therefore some patients may have been erroneously included or excluded. In addition, using data from only one institution may have introduced bias into our conclusions, though the results are consistent with national trends. Finally, there was some variability among the 4 surgeons in the number of LHB tenodesis procedures performed, and this variability may have confounded results, though these surgeons treat biceps pathology in similar ways.

Am J Orthop. 2017;46(4):E219-E223. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Sarcopenia is an age-related loss of skeletal muscle that may result in diminished muscle strength and functional performance. The prevalence of sarcopenia varies based on the cohort and the assessment criteria. According to the Health Aging and Body Composition (ABC) study, the prevalence of sarcopenia in community-dwelling older adults is about 14% to 18%, whereas the estimate may exceed 30% for those in longterm care.^1,2 This geriatric syndrome may disproportionately affect veterans given that they are older than the civilian population and may have disabling comorbid conditions associated with military service.³

Recently, there has been a call to action to systematically address sarcopenia by interdisciplinary organizations such as the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Working Group on Sarcopenia (IWGS).^4,5 This call to action is due to the association of sarcopenia with increased health care costs, higher disability incidence, and elevated risk of mortality.^6,7 The consequences of sarcopenia may include serious complications, such as hip fracture or a loss of functional independence.^8,9 The CDC now recognizes sarcopenia as an independently reportable medical condition. Consequently, physicians, nurse practitioners (NPs), and other associated health professionals within the VA will need to better understand clinically viable and valid methods to screen and diagnose this geriatric syndrome.

The purpose of this paper is to inform practitioners how sarcopenia screening is aided by the new ICD-10-CM code and briefly review recent VA initiatives for proactive care. Additional objectives include identifying common methods used to assess sarcopenia and providing general recommendations to the VHA National Center for Health Promotion and Disease Prevention (NCP) concerning the management of sarcopenia.

Addressing Sarcopenia

While the age-related decline in muscle size and performance has long been recognized by geriatricians, sustained advocacy by several organizations was required to realize the formal recognition of sarcopenia. Aging in Motion (AIM), a coalition of organizations focused on advancing research and treatment for conditions associated with age-related muscle dysfunction, sought the formal recognition of sarcopenia. The CDC established the ICD-10-CM code for sarcopenia in October of 2016, which allowed the syndrome to be designated as a primary or secondary condition.¹⁰

The ubiquitous nature of agerelated changes in muscle and the mandate to engage in proactive care by all levels of VA leadership led to the focus on addressing sarcopenia. The recognition of sarcopenia by the CDC comes at an opportune time given recent VA efforts to transform itself from a facilitator mainly of care delivery to an active partner in fostering the health and well-being of veterans. Initiatives that are emblematic of this attempt to shift the organizational culture across the VHA include establishing the VA Center for Innovation (VACI) and issuing guidance documents, such as the Blueprint for Excellence, which was introduced in 2014 by then VA Secretary Robert McDonald.^11,12 Many of the following Blueprint themes and strategies potentially impact sarcopenia screening and treatment within the VA:

• Delivering high-quality, veteran-centered care: A major Blueprint theme is attaining the “Triple Aims” of a health care system by promoting better health among veterans, improving the provision of care, and lowering costs through operational efficiency. The management of sarcopenia has clear clinical value given the association of age-related muscle loss with fall risk and decreased mobility.¹³ Financial value also may be associated with the effort to decrease disability related to sarcopenia and the use of a team approach featuring associated health professionals to help screen for this geriatric syndrome.^14,15 (Strategy 2)
• Leveraging health care informatics to optimize individual and population health outcomes: The inclusion of the most basic muscle performance and functional status measures in the electronic medical record (EMR), such as grip strength and gait speed, would help to identify the risk factors and determinants of sarcopenia among the veteran population. (Strategy 3)
• Advancing personalized, proactive health care that fosters a high level of health and well-being: The long-term promotion of musculoskeletal health and optimal management of sarcopenia cannot be sustained through episodic medical interactions. Instead, a contemporary approach to health services marked by the continuous promotion of health education, physical activity and exercise, and proper nutrition has demonstrated value in the management of chronic conditions.^16,17 (Strategy 6)

The new sarcopenia ICD-10-CM code along with elements of the VHA Blueprint can serve to support the systematic assessment and management of veterans with age-related muscle dysfunction. Nevertheless, renewed calls for health promotion and screening programs are often counterbalanced by the need for cost containment and the cautionary tales concerning the potential harms or errors associated with some forms of medical screening. The American Board of Internal Medicine Foundation has spearheaded the Choosing Wisely campaign to raise awareness about excessive medical testing. However, the Institute of Medicine has linked the provision of quality health care to a diagnostic process that is both timely and accurate.¹⁸ Careful consideration of these health care challenges may help guide practitioners within the VA concerning the screening and diagnosis of sarcopenia.

Sarcopenia Assessment

Sarcopenia can have several underlying causes in some individuals and result in varied patterns of clinical presentation and differing degrees of severity. The European Working Group on Sarcopenia in Older People first met in 2009 and used a consensus-based decision-making process to determine operational definitions for sarcopenia and create a staging algorithm for the syndrome.¹⁹ This consensus group developed a conceptual staging model with 3 categories: presarcopenia, sarcopenia, and severe sarcopenia (Table 1). The impetus for sarcopenia staging was the emerging research findings suggesting that lean body mass (LBM) alone did not provide a high degree of clinical value in outpatient settings due to the nonlinear relationship between LBM and muscle function in older adults.^20,21 Using the consensus model approach, an individual is classified as sarcopenic on presenting with both low LBM and low muscle function.

Screening: A Place to Start

Findings from the Health ABC Study suggested that older adults who maintained high levels of LBM were less likely to become sarcopenic. Whereas, older adults in the cohort with low levels of LBM tended to remain in a sarcopenic state.⁶ Consequently, the early detection of sarcopenia may have important health promotion implications for older adults. Sarcopenia is a syndrome with a continuum of clinical features; it is not a disease with a clear or singular etiololgy. Therefore, the result of the screening examination should identify those who would most benefit from a formal diagnostic assessment.

One approach to screening for sarcopenia involves the use of questionnaires, such as the SARC-F (sluggishness, assistance in walking, rise from a chair, climb stairs, falls), which is a brief 5-item questionnaire with Likert scoring for patient responses.¹³ In a cohort of National Health and Nutrition Examination Survey (NHANES) participants, SARC-F scores ≥ 4 were associated with slower gait speed, lower strength, and an increased likelihood of hospitalization within a year of the test response.²² However, rather than stratify patients by risk, the SARC-F exhibits a high degree of test specificity regarding the major consensus-based sarcopenia classification criteria (specificity = 94.2% to 99.1%; sensitivity = 3.8% to 9.9%).¹³ Given the known limitations of screening tools with low sensitivity, organizations such as the ESCEO have recommended supplementing the SARC-F questionnaire with other forms of assessment.⁴ Supplements to the screening examination may range from the use of “red flag” questions concerning changes in nutritional status, body weight, and physical activity, to conducting standard gait speed and grip-strength testing.^4,19,23

Performance-based testing, including habitual gait speed and grip-strength dynamometry, also may be used in both the screening and classification of sarcopenia.² Although walking speed below 1.0 m/s has been used by the IWGS as a criterion to prompt further assessment, many people within the VA health care system may have gait abnormalities independent of LBM status, and others may be nonambulatory.^24,25 As a result, grip-strength testing should be considered as a supplementary or alternate screening assessment tool.^26,27

Hand-grip dynamometry is often used diagnostically given its previous test validation, low expense, and ease of use.²³ Moreover, recent evidence suggests that muscle strength surpasses gait speed as a means of identifying people with sarcopenia. Grip strength is associated with all-cause mortality, even when adjusting for age, sex, and body size,²⁸ while slow gait speed (< .82 m/s) has a reported sensitivity of 63% and specificity of 70% for mortality in population-based studies involving older adults.²⁹

 

Gait speed (in those who are ambulatory) and grip-strength values could be entered into the EMR evaluation note by the primary care provider (PCP). Elements of the VA EMR, such as the ability to review the diagnosis of sarcopenia on the Problem List or the nominal enhancement of providing LBM estimates within the Cumulative Vitals and Measurements Report would support the management of sarcopenia. See Table 2 for cutoff values for frequently used sarcopenia screening and staging tests.

The pitfalls of excessive or inappropriate screening are well documented. The efforts to screen for prostate cancer have highlighted instances when inappropriate followup tests and treatment fail to alter mortality rates and ultimately yield more harm than good.³⁰ However, there are several points of departure concerning the screening for sarcopenia vs screening for prostate cancer. The screening assessments for sarcopenia are low-cost procedures that are associated with a low patient burden. These procedures may include questionnaires, functional testing, or the assessment of muscle performance. Additionally, there is a low propensity for adverse effects stemming from treatment due to disease misclassification given the common nonpharmacologic approaches used to manage sarcopenia.³¹ Nonetheless, the best screening examination—even one that has low patient burden and cost—may prove to be a poor use of medical resources if the process is not linked to a viable intervention.

Screening people aged ≥ 65 years may strike a balance between controlling health care expenditures and identifying people with the initial signs of sarcopenia early enough to begin monitoring key outcomes and providing a formalized exercise prescription. Presuming an annual age-related decline in LBM of 1.5%, and considering the standard error measurement of the most frequently used methods of strength and LBM assessment, recurrent screening could occur every 2 years.^21,32

Earlier screening may be considered for patient populations with a higher pretest probability. These groups include those with conditions associated with accelerated muscle loss, such as chronic kidney disease, peripheral artery disease, and diabetes mellitus (DM).³² Although accelerated muscle loss characterized by an inflammatory motif (eg, cancer-related cachexia) may share some features of the sarcopenia screening and assessment approach, important differences exist regarding the etiology, medical evaluation, and ICD-10-CM code designation.

Staging and Classification

Staging criteria are generally used to denote the severity of a given disease or syndrome, whereas classification criteria are used to define homogenous patient groups based on specific pathologic or clinical features of a disorder. Although classification schemes may incorporate an element of severity, they are primarily used to characterize fairly distinct phenotypic forms of disease or specific clinical presentation patterns associated with a well-defined syndrome. Although not universally adopted, the European consensus group sarcopenia staging criteria are increasingly used to provide a staging algorithm presumably driven by the severity of the condition.¹⁹

The assessment of functional performance for use in sarcopenia staging often involves measuring habitual gait speed or completing the Short Physical Performance Battery (SPPB).²³ The SPPB involves a variety of performance-based activities for balance, gait, strength, and endurance. This test has predictive validity for the onset of disability and adverse health events, and it has been extensively used in research and clinical settings.³³ Additional tests used to characterize function during the staging or diagnostic process include the timed get up and go test (TGUG) and the timed sit to stand test.^34,35 The TGUG provides an estimate of dynamic balance, and the sit to stand test has been used as very basic proxy measure of muscular power.³⁶ The sit to stand test and habitual gait speed are items included in the SPPB.³³

Accepted methods to obtain the traditional index measure of sarcopenia—based on estimates of LBM—include bioimpedance analysis (BIA) and dual X-ray absorptiometry (DXA). The BIA uses the electrical impedance of body tissues and its 2 components, resistance and reactance, to derive its body composition estimates.³⁷ Segmental BIA allows for isolated measurements of the limbs, which may be calibrated to DXA appendicular lean body mass (ALM) or magnetic resonance imaging-based estimates of LBM. This instrument is relatively safe for use, inexpensive for medical facilities, and useful for longitudinal studies, but it can be confounded by issues, such as varying levels of hydration, which may affect measurement validity in some instances.

Despite the precision of DXA for estimating densities for whole body composition analysis, the equipment is not very portable and involves low levels of radiation exposure, which limits its utility in some clinical settings. While each body composition assessment method has its advantages and disadvantages, DXA is regarded as an acceptable form of measurement for hospital settings, and BIA is frequently used in outpatient clinics and community settings. Other methods used to estimate LBM with greater accuracy, such as peripheral quantitative computed tomography, doubly labeled water, and whole body gamma ray counting, are not viable for clinical use. Other accessible methods such as anthropometric measures and skinfold measures have not been embraced by sarcopenia classification consensus groups.^23,37

Alternative methods of estimating LBM, such as diagnostic ultrasound and multifrequency electrical impedance myography, are featured outcomes in ongoing clinical trials that involve veteran participants. These modalities may soon provide a clinically viable approach to assessing muscle quality via estimates of muscle tissue composition.^37,38 Similar to the management of other geriatric syndromes, interprofessional collaboration provides an optimal approach to the assessment of sarcopenia. Physicians and other health care providers may draw on the standardized assessment of strength and function (via the SPPB and hand-grip dynamometry) by physical therapists (PTs), questionnaires administered by nursing staff (the SARC-F), or body composition estimates from other health professionals (ranging from BIA to DXA) to aid the diagnostic process and facilitate appropriate case management (Table 2).

Competing staging and classification definitions have been cited as a primary factor behind the CDC’s delayed recognition of the sarcopenia diagnosis, which in turn posed a barrier to formal clinical recognition by geriatricians.²⁴ However, this reaction to the evolving sarcopenia staging criteria also may reveal the larger misapplication of the staging process to the diagnostic process. The application of classification and staging criteria results in a homogenous group of patients, whereas the application of diagnostic criteria results in a heterogeneous group of patients to account for variations in clinical presentation associated with a given disorder. Classification criteria may be equivalent to objective measures that are used in the diagnostic process when a given disease is characterized by a well-established biomarker.³⁹

However, this is not the case for most geriatric syndromes and other disorders marked by varied clinical presentation patterns. On considering the commonly used sarcopenia staging criteria of LBM ≤ 8.50 kg/m² or grip strength < 30 kg in men and LBM ≤ 5.75 kg/m² or grip strength < 20 kg in women, it is easy to understand that such general cutoff values are far from diagnostic.^40,41 Moreover, stringent cutoff values associated with classification and staging may not adequately capture those with an atypical presentation of the syndrome (eg, someone who exhibits age-related muscle weakness but has retained adequate LBM). Such criteria often prove to have high specificity and low sensitivity, which may yield a false negative rate that is appropriate for clinical research eligibility and group assignment but inadequate for clinical care.

Screening, staging, and classification criteria with high specificity may indeed be desirable for confirmatory imaging tests associated with radiation exposure concerns or for managing risk in experimental clinical trials involving pharmacologic treatment. For example, a SARC-F score ≥ 4 may prompt the formal assessment of LBM via a DXA examination.⁴ In contrast, those with a SARC-F score ≤ 3 with low gait speed or grip strength may benefit from consultation regarding regular physical activity and nutrition recommendations. Given the challenges of establishing sarcopenia classification criteria that perform consistently across populations and geographic regions, classification and staging criteria may be best viewed as clinical reasoning tools that supplement, but not supplant, the diagnostic process.^7,42

Diagnosis

Geriatric syndromes do not lend themselves to a simple diagnostic process. Syndromes such as frailty and sarcopenia are multifactorial and lack a single distinguishing clinical feature or biomarker. The oft-cited refrain that sarcopenia is an underdiagnosed condition is partially explained by the recent ICD-10-CM code and varied classification and diagnostic criteria^.5 This circumstance highlights the need to distinctly contrast the diagnostic process with the screening and staging classifications.

The diagnostic process involves the interpretation of the patient history, signs, and symptoms within the context of individual factors, local or regional disease prevalence, and the results of the best available and most appropriate laboratory tests. After all, a patient that presents with low LBM and a gradual loss of strength without a precipitating event would necessitate further workup to rule out many clinical possibilities under the aegis of a differential diagnosis. Clinical features, such as the magnitude of weakness and pattern of strength loss or muscle atrophy along with the determination of neurologic or autoimmune involvement, are among the key elements of the differential examination for a case involving the observation of frank muscle weakness. Older adults with low muscle strength may have additional risk factors for sarcopenia such as obesity, pain, poor nutrition, previous bone fracture, and a sedentary lifestyle. However, disease etiology with lower probabilities, such as myogenic or neurogenic conditions associated with advancing age, also may be under consideration during the clinical assessment.⁶

In many instances, the cutoff scores associated with the sarcopenia staging criteria may help to guide the diagnostic process and aid clinical decision making. Since individuals with a positive screening result based on the SARC-F questionnaire (score ≥ 4) have a high likelihood of meeting the staging criteria for severe sarcopenia, a PCP may opt to obtain a confirmatory estimate of LBM both to support the clinical assessment and to monitor change over the course of rehabilitation. Whereas people who present with a decline in strength (ie, grip strength < 30 kg for a male) without an observable loss of function or a positive SARC-F score may benefit from consultation from the physician, NP, or rehabilitation health professional regarding modifiable risk factors associated with sarcopenia.

Incorporating less frequently used sarcopenia classification schemes such as identifying those with sarcopenic obesity or secondary sarcopenia due to mitigating factors such as chronic kidney disease or DM (Table 3) may engender a more comprehensive approach to intervention that targets the primary disease while also addressing important secondary sequelae. Nevertheless, staging or classification criteria cannot be deemed equivalent to diagnostic criteria for sarcopenia due to the challenges posed by syndromes that have a heterogeneous clinical presentation.

The refinement of the staging and classification criteria along with the advances in imaging technology and mechanistic research are not unique to sarcopenia. Practitioners involved in the care of people with rheumatologic conditions or osteoporosis also have contended with continued refinements to their classification criteria and approach to risk stratification.^39,43,44 Primary care providers will now have the option to use a new ICD-10-CM code (M62.84) for sarcopenia, which will allow them to properly document the clinical distinctions between people with impaired strength or function largely due to age-related muscle changes and those who have impaired muscle function due to cachexia, inflammatory myopathies, or forms of neuromuscular disease.

 

The ability to identify and document this geriatric syndrome in veterans will help to better define the scope of the problem within the VA health care system. The median age of veterans is 62 years compared with 43 years for nonveterans.³ Consequently, there may be value in the adoption of a formal approach to screening and diagnosis for sarcopenia among veterans who receive their primary care from VA facilities.⁷ Indeed, the exchange between the patient and the health professional regarding the screening and diagnostic process will provide valuable opportunities to promote exercise interventions before patients incur significant impairments.

One of the biggest threats burdening global health is noncommunicable diseases, and many chronic conditions, such as sarcopenia, can be prevented and managed with appropriate levels of physical activity.¹⁷ Increased physician involvement may prove to be critical given the identification of physical inactivity as a top 5 risk factor for general morbidity and mortality by World Health Organization and consensus group recommendations calling for physicians to serve a more prominent role in the provision of exercise and physical activity recommendations.^16,17

This developing health care role should include NPs, PTs, physician assistants, and other associated health professionals. It also should include collaborative efforts between physicians and rehabilitation practitioners concerning provision of the formal exercise prescriptionprescription and monitoring of patient outcomes.

Individuals with severe forms of sarcopenia rarely improve without intervention.⁶ Although no pharmacologic treatment exists to specifically address sarcopenia, strengthening exercise has been shown to be an effective mode of prevention and conservative management.⁸ Progressive resistance exercise cannot abate the expected age-related changes in skeletal muscle, but it can significantly reverse the loss of LBM and strength in untrained older adults and slow the age-related decline in muscle performance in older adult athletes and trained individuals.⁴⁵

Local senior centers and community organizations may prove to be valuable resources concerning group exercise options, and they provide the added benefit of social engagement and peer group accountability. Federal resources include the Go4Life exercise guide and online videos provided by the National Institute on Aging and the MOVE! Weight Management and Health Program provided at select VA community-based outpatient clinics. Ultimately, collaborative efforts with exercise specialists may serve to reduce the PCP burden during the provision of health services, minimize diagnostic errors associated with sarcopenia assessment and help to connect patients to valuable health promotion resources.^17,18

Conclusion

While practitioners should remain keenly aware of the pernicious effects of overdiagnosis, sarcopenia has long existed as a known, but undiagnosed, condition. Of course, geriatricians have traditionally managed poor muscle performance and mobility limitations by addressing treatable symptoms and providing referrals to physical medicine specialists when warranted. Nevertheless, the advent of ICD-10-CM code M62.⁸⁴ provides the VA with an opportunity to take a leading role in systematically addressing this geriatric syndrome within an aging veteran population.

The following items should be considered by NCP for the development of guidelines and recommendations concerning sarcopenia screening:

1. Consider screening veterans aged > 65 years for sarcopenia every 2 years. Those with mitigating systemic conditions (eg, chronic kidney disease, DM, or malnutrition) or significant mobility limitations may be screened at any age.
2. Sarcopenia screening procedures should include at a minimum the SARC-F questionnaire and gait speed (when appropriate). Including gait speed or grip strength testing in the screening exam is recommended given the low sensitivity of the SARC-F questionnaire.
3. Veterans with positive SARC-F results (≥ 4) merit a physical therapy referral. In addition, these veterans should obtain confirmatory standardized assessments for LBM and functional status.
4. Veterans at risk for sarcopenia based on patient age, medical history, and the physical examination (eg, obesity, sedentary lifestyle, a previous fracture, self-reported physical decline), but with negative SARC-F results should receive a formal exercise prescription from their PCP. Baseline assessment measures may be used for comparison with serial measures obtained during subsequent screening visits to support long-term case management.
5. Interprofessional collaboration involving geriatricians, PTs, nurses, radiologists, and other health care professionals should be involved in the screening, diagnosis, and case management of veterans with sarcopenia.
6. The VA EMR should be systematically documented with sarcopenia assessment data obtained from the gait speed tests, SARCF, SPPB, grip strength tests, and LBM estimates to better characterize this condition within the veteran population.

Any expansion in the provision of health care comes with anticipated benefits and potential costs. Broad guidance from NCP may encourage veterans to pursue selected screening tests, promote the appropriate use of preventative services, and facilitate timely treatment when needed.³¹ Clinicians who are informed about the screening, staging, classification, and diagnostic process for sarcopenia may partner with patients to make reasoned decisions about how to best manage this syndrome within the VA medical center environment.

Sarcopenia is an age-related loss of skeletal muscle that may result in diminished muscle strength and functional performance. The prevalence of sarcopenia varies based on the cohort and the assessment criteria. According to the Health Aging and Body Composition (ABC) study, the prevalence of sarcopenia in community-dwelling older adults is about 14% to 18%, whereas the estimate may exceed 30% for those in longterm care.^1,2 This geriatric syndrome may disproportionately affect veterans given that they are older than the civilian population and may have disabling comorbid conditions associated with military service.³

Recently, there has been a call to action to systematically address sarcopenia by interdisciplinary organizations such as the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Working Group on Sarcopenia (IWGS).^4,5 This call to action is due to the association of sarcopenia with increased health care costs, higher disability incidence, and elevated risk of mortality.^6,7 The consequences of sarcopenia may include serious complications, such as hip fracture or a loss of functional independence.^8,9 The CDC now recognizes sarcopenia as an independently reportable medical condition. Consequently, physicians, nurse practitioners (NPs), and other associated health professionals within the VA will need to better understand clinically viable and valid methods to screen and diagnose this geriatric syndrome.

The purpose of this paper is to inform practitioners how sarcopenia screening is aided by the new ICD-10-CM code and briefly review recent VA initiatives for proactive care. Additional objectives include identifying common methods used to assess sarcopenia and providing general recommendations to the VHA National Center for Health Promotion and Disease Prevention (NCP) concerning the management of sarcopenia.

Addressing Sarcopenia

While the age-related decline in muscle size and performance has long been recognized by geriatricians, sustained advocacy by several organizations was required to realize the formal recognition of sarcopenia. Aging in Motion (AIM), a coalition of organizations focused on advancing research and treatment for conditions associated with age-related muscle dysfunction, sought the formal recognition of sarcopenia. The CDC established the ICD-10-CM code for sarcopenia in October of 2016, which allowed the syndrome to be designated as a primary or secondary condition.¹⁰

The ubiquitous nature of agerelated changes in muscle and the mandate to engage in proactive care by all levels of VA leadership led to the focus on addressing sarcopenia. The recognition of sarcopenia by the CDC comes at an opportune time given recent VA efforts to transform itself from a facilitator mainly of care delivery to an active partner in fostering the health and well-being of veterans. Initiatives that are emblematic of this attempt to shift the organizational culture across the VHA include establishing the VA Center for Innovation (VACI) and issuing guidance documents, such as the Blueprint for Excellence, which was introduced in 2014 by then VA Secretary Robert McDonald.^11,12 Many of the following Blueprint themes and strategies potentially impact sarcopenia screening and treatment within the VA:

• Delivering high-quality, veteran-centered care: A major Blueprint theme is attaining the “Triple Aims” of a health care system by promoting better health among veterans, improving the provision of care, and lowering costs through operational efficiency. The management of sarcopenia has clear clinical value given the association of age-related muscle loss with fall risk and decreased mobility.¹³ Financial value also may be associated with the effort to decrease disability related to sarcopenia and the use of a team approach featuring associated health professionals to help screen for this geriatric syndrome.^14,15 (Strategy 2)
• Leveraging health care informatics to optimize individual and population health outcomes: The inclusion of the most basic muscle performance and functional status measures in the electronic medical record (EMR), such as grip strength and gait speed, would help to identify the risk factors and determinants of sarcopenia among the veteran population. (Strategy 3)
• Advancing personalized, proactive health care that fosters a high level of health and well-being: The long-term promotion of musculoskeletal health and optimal management of sarcopenia cannot be sustained through episodic medical interactions. Instead, a contemporary approach to health services marked by the continuous promotion of health education, physical activity and exercise, and proper nutrition has demonstrated value in the management of chronic conditions.^16,17 (Strategy 6)

The new sarcopenia ICD-10-CM code along with elements of the VHA Blueprint can serve to support the systematic assessment and management of veterans with age-related muscle dysfunction. Nevertheless, renewed calls for health promotion and screening programs are often counterbalanced by the need for cost containment and the cautionary tales concerning the potential harms or errors associated with some forms of medical screening. The American Board of Internal Medicine Foundation has spearheaded the Choosing Wisely campaign to raise awareness about excessive medical testing. However, the Institute of Medicine has linked the provision of quality health care to a diagnostic process that is both timely and accurate.¹⁸ Careful consideration of these health care challenges may help guide practitioners within the VA concerning the screening and diagnosis of sarcopenia.

Sarcopenia Assessment

Sarcopenia can have several underlying causes in some individuals and result in varied patterns of clinical presentation and differing degrees of severity. The European Working Group on Sarcopenia in Older People first met in 2009 and used a consensus-based decision-making process to determine operational definitions for sarcopenia and create a staging algorithm for the syndrome.¹⁹ This consensus group developed a conceptual staging model with 3 categories: presarcopenia, sarcopenia, and severe sarcopenia (Table 1). The impetus for sarcopenia staging was the emerging research findings suggesting that lean body mass (LBM) alone did not provide a high degree of clinical value in outpatient settings due to the nonlinear relationship between LBM and muscle function in older adults.^20,21 Using the consensus model approach, an individual is classified as sarcopenic on presenting with both low LBM and low muscle function.

Screening: A Place to Start

Findings from the Health ABC Study suggested that older adults who maintained high levels of LBM were less likely to become sarcopenic. Whereas, older adults in the cohort with low levels of LBM tended to remain in a sarcopenic state.⁶ Consequently, the early detection of sarcopenia may have important health promotion implications for older adults. Sarcopenia is a syndrome with a continuum of clinical features; it is not a disease with a clear or singular etiololgy. Therefore, the result of the screening examination should identify those who would most benefit from a formal diagnostic assessment.

One approach to screening for sarcopenia involves the use of questionnaires, such as the SARC-F (sluggishness, assistance in walking, rise from a chair, climb stairs, falls), which is a brief 5-item questionnaire with Likert scoring for patient responses.¹³ In a cohort of National Health and Nutrition Examination Survey (NHANES) participants, SARC-F scores ≥ 4 were associated with slower gait speed, lower strength, and an increased likelihood of hospitalization within a year of the test response.²² However, rather than stratify patients by risk, the SARC-F exhibits a high degree of test specificity regarding the major consensus-based sarcopenia classification criteria (specificity = 94.2% to 99.1%; sensitivity = 3.8% to 9.9%).¹³ Given the known limitations of screening tools with low sensitivity, organizations such as the ESCEO have recommended supplementing the SARC-F questionnaire with other forms of assessment.⁴ Supplements to the screening examination may range from the use of “red flag” questions concerning changes in nutritional status, body weight, and physical activity, to conducting standard gait speed and grip-strength testing.^4,19,23

Performance-based testing, including habitual gait speed and grip-strength dynamometry, also may be used in both the screening and classification of sarcopenia.² Although walking speed below 1.0 m/s has been used by the IWGS as a criterion to prompt further assessment, many people within the VA health care system may have gait abnormalities independent of LBM status, and others may be nonambulatory.^24,25 As a result, grip-strength testing should be considered as a supplementary or alternate screening assessment tool.^26,27

Hand-grip dynamometry is often used diagnostically given its previous test validation, low expense, and ease of use.²³ Moreover, recent evidence suggests that muscle strength surpasses gait speed as a means of identifying people with sarcopenia. Grip strength is associated with all-cause mortality, even when adjusting for age, sex, and body size,²⁸ while slow gait speed (< .82 m/s) has a reported sensitivity of 63% and specificity of 70% for mortality in population-based studies involving older adults.²⁹

 

Gait speed (in those who are ambulatory) and grip-strength values could be entered into the EMR evaluation note by the primary care provider (PCP). Elements of the VA EMR, such as the ability to review the diagnosis of sarcopenia on the Problem List or the nominal enhancement of providing LBM estimates within the Cumulative Vitals and Measurements Report would support the management of sarcopenia. See Table 2 for cutoff values for frequently used sarcopenia screening and staging tests.

The pitfalls of excessive or inappropriate screening are well documented. The efforts to screen for prostate cancer have highlighted instances when inappropriate followup tests and treatment fail to alter mortality rates and ultimately yield more harm than good.³⁰ However, there are several points of departure concerning the screening for sarcopenia vs screening for prostate cancer. The screening assessments for sarcopenia are low-cost procedures that are associated with a low patient burden. These procedures may include questionnaires, functional testing, or the assessment of muscle performance. Additionally, there is a low propensity for adverse effects stemming from treatment due to disease misclassification given the common nonpharmacologic approaches used to manage sarcopenia.³¹ Nonetheless, the best screening examination—even one that has low patient burden and cost—may prove to be a poor use of medical resources if the process is not linked to a viable intervention.

Screening people aged ≥ 65 years may strike a balance between controlling health care expenditures and identifying people with the initial signs of sarcopenia early enough to begin monitoring key outcomes and providing a formalized exercise prescription. Presuming an annual age-related decline in LBM of 1.5%, and considering the standard error measurement of the most frequently used methods of strength and LBM assessment, recurrent screening could occur every 2 years.^21,32

Earlier screening may be considered for patient populations with a higher pretest probability. These groups include those with conditions associated with accelerated muscle loss, such as chronic kidney disease, peripheral artery disease, and diabetes mellitus (DM).³² Although accelerated muscle loss characterized by an inflammatory motif (eg, cancer-related cachexia) may share some features of the sarcopenia screening and assessment approach, important differences exist regarding the etiology, medical evaluation, and ICD-10-CM code designation.

Staging and Classification

Staging criteria are generally used to denote the severity of a given disease or syndrome, whereas classification criteria are used to define homogenous patient groups based on specific pathologic or clinical features of a disorder. Although classification schemes may incorporate an element of severity, they are primarily used to characterize fairly distinct phenotypic forms of disease or specific clinical presentation patterns associated with a well-defined syndrome. Although not universally adopted, the European consensus group sarcopenia staging criteria are increasingly used to provide a staging algorithm presumably driven by the severity of the condition.¹⁹

The assessment of functional performance for use in sarcopenia staging often involves measuring habitual gait speed or completing the Short Physical Performance Battery (SPPB).²³ The SPPB involves a variety of performance-based activities for balance, gait, strength, and endurance. This test has predictive validity for the onset of disability and adverse health events, and it has been extensively used in research and clinical settings.³³ Additional tests used to characterize function during the staging or diagnostic process include the timed get up and go test (TGUG) and the timed sit to stand test.^34,35 The TGUG provides an estimate of dynamic balance, and the sit to stand test has been used as very basic proxy measure of muscular power.³⁶ The sit to stand test and habitual gait speed are items included in the SPPB.³³

Accepted methods to obtain the traditional index measure of sarcopenia—based on estimates of LBM—include bioimpedance analysis (BIA) and dual X-ray absorptiometry (DXA). The BIA uses the electrical impedance of body tissues and its 2 components, resistance and reactance, to derive its body composition estimates.³⁷ Segmental BIA allows for isolated measurements of the limbs, which may be calibrated to DXA appendicular lean body mass (ALM) or magnetic resonance imaging-based estimates of LBM. This instrument is relatively safe for use, inexpensive for medical facilities, and useful for longitudinal studies, but it can be confounded by issues, such as varying levels of hydration, which may affect measurement validity in some instances.

Despite the precision of DXA for estimating densities for whole body composition analysis, the equipment is not very portable and involves low levels of radiation exposure, which limits its utility in some clinical settings. While each body composition assessment method has its advantages and disadvantages, DXA is regarded as an acceptable form of measurement for hospital settings, and BIA is frequently used in outpatient clinics and community settings. Other methods used to estimate LBM with greater accuracy, such as peripheral quantitative computed tomography, doubly labeled water, and whole body gamma ray counting, are not viable for clinical use. Other accessible methods such as anthropometric measures and skinfold measures have not been embraced by sarcopenia classification consensus groups.^23,37

Alternative methods of estimating LBM, such as diagnostic ultrasound and multifrequency electrical impedance myography, are featured outcomes in ongoing clinical trials that involve veteran participants. These modalities may soon provide a clinically viable approach to assessing muscle quality via estimates of muscle tissue composition.^37,38 Similar to the management of other geriatric syndromes, interprofessional collaboration provides an optimal approach to the assessment of sarcopenia. Physicians and other health care providers may draw on the standardized assessment of strength and function (via the SPPB and hand-grip dynamometry) by physical therapists (PTs), questionnaires administered by nursing staff (the SARC-F), or body composition estimates from other health professionals (ranging from BIA to DXA) to aid the diagnostic process and facilitate appropriate case management (Table 2).

Competing staging and classification definitions have been cited as a primary factor behind the CDC’s delayed recognition of the sarcopenia diagnosis, which in turn posed a barrier to formal clinical recognition by geriatricians.²⁴ However, this reaction to the evolving sarcopenia staging criteria also may reveal the larger misapplication of the staging process to the diagnostic process. The application of classification and staging criteria results in a homogenous group of patients, whereas the application of diagnostic criteria results in a heterogeneous group of patients to account for variations in clinical presentation associated with a given disorder. Classification criteria may be equivalent to objective measures that are used in the diagnostic process when a given disease is characterized by a well-established biomarker.³⁹

However, this is not the case for most geriatric syndromes and other disorders marked by varied clinical presentation patterns. On considering the commonly used sarcopenia staging criteria of LBM ≤ 8.50 kg/m² or grip strength < 30 kg in men and LBM ≤ 5.75 kg/m² or grip strength < 20 kg in women, it is easy to understand that such general cutoff values are far from diagnostic.^40,41 Moreover, stringent cutoff values associated with classification and staging may not adequately capture those with an atypical presentation of the syndrome (eg, someone who exhibits age-related muscle weakness but has retained adequate LBM). Such criteria often prove to have high specificity and low sensitivity, which may yield a false negative rate that is appropriate for clinical research eligibility and group assignment but inadequate for clinical care.

Screening, staging, and classification criteria with high specificity may indeed be desirable for confirmatory imaging tests associated with radiation exposure concerns or for managing risk in experimental clinical trials involving pharmacologic treatment. For example, a SARC-F score ≥ 4 may prompt the formal assessment of LBM via a DXA examination.⁴ In contrast, those with a SARC-F score ≤ 3 with low gait speed or grip strength may benefit from consultation regarding regular physical activity and nutrition recommendations. Given the challenges of establishing sarcopenia classification criteria that perform consistently across populations and geographic regions, classification and staging criteria may be best viewed as clinical reasoning tools that supplement, but not supplant, the diagnostic process.^7,42

Diagnosis

Geriatric syndromes do not lend themselves to a simple diagnostic process. Syndromes such as frailty and sarcopenia are multifactorial and lack a single distinguishing clinical feature or biomarker. The oft-cited refrain that sarcopenia is an underdiagnosed condition is partially explained by the recent ICD-10-CM code and varied classification and diagnostic criteria^.5 This circumstance highlights the need to distinctly contrast the diagnostic process with the screening and staging classifications.

The diagnostic process involves the interpretation of the patient history, signs, and symptoms within the context of individual factors, local or regional disease prevalence, and the results of the best available and most appropriate laboratory tests. After all, a patient that presents with low LBM and a gradual loss of strength without a precipitating event would necessitate further workup to rule out many clinical possibilities under the aegis of a differential diagnosis. Clinical features, such as the magnitude of weakness and pattern of strength loss or muscle atrophy along with the determination of neurologic or autoimmune involvement, are among the key elements of the differential examination for a case involving the observation of frank muscle weakness. Older adults with low muscle strength may have additional risk factors for sarcopenia such as obesity, pain, poor nutrition, previous bone fracture, and a sedentary lifestyle. However, disease etiology with lower probabilities, such as myogenic or neurogenic conditions associated with advancing age, also may be under consideration during the clinical assessment.⁶

In many instances, the cutoff scores associated with the sarcopenia staging criteria may help to guide the diagnostic process and aid clinical decision making. Since individuals with a positive screening result based on the SARC-F questionnaire (score ≥ 4) have a high likelihood of meeting the staging criteria for severe sarcopenia, a PCP may opt to obtain a confirmatory estimate of LBM both to support the clinical assessment and to monitor change over the course of rehabilitation. Whereas people who present with a decline in strength (ie, grip strength < 30 kg for a male) without an observable loss of function or a positive SARC-F score may benefit from consultation from the physician, NP, or rehabilitation health professional regarding modifiable risk factors associated with sarcopenia.

Incorporating less frequently used sarcopenia classification schemes such as identifying those with sarcopenic obesity or secondary sarcopenia due to mitigating factors such as chronic kidney disease or DM (Table 3) may engender a more comprehensive approach to intervention that targets the primary disease while also addressing important secondary sequelae. Nevertheless, staging or classification criteria cannot be deemed equivalent to diagnostic criteria for sarcopenia due to the challenges posed by syndromes that have a heterogeneous clinical presentation.

The refinement of the staging and classification criteria along with the advances in imaging technology and mechanistic research are not unique to sarcopenia. Practitioners involved in the care of people with rheumatologic conditions or osteoporosis also have contended with continued refinements to their classification criteria and approach to risk stratification.^39,43,44 Primary care providers will now have the option to use a new ICD-10-CM code (M62.84) for sarcopenia, which will allow them to properly document the clinical distinctions between people with impaired strength or function largely due to age-related muscle changes and those who have impaired muscle function due to cachexia, inflammatory myopathies, or forms of neuromuscular disease.

 

The ability to identify and document this geriatric syndrome in veterans will help to better define the scope of the problem within the VA health care system. The median age of veterans is 62 years compared with 43 years for nonveterans.³ Consequently, there may be value in the adoption of a formal approach to screening and diagnosis for sarcopenia among veterans who receive their primary care from VA facilities.⁷ Indeed, the exchange between the patient and the health professional regarding the screening and diagnostic process will provide valuable opportunities to promote exercise interventions before patients incur significant impairments.

One of the biggest threats burdening global health is noncommunicable diseases, and many chronic conditions, such as sarcopenia, can be prevented and managed with appropriate levels of physical activity.¹⁷ Increased physician involvement may prove to be critical given the identification of physical inactivity as a top 5 risk factor for general morbidity and mortality by World Health Organization and consensus group recommendations calling for physicians to serve a more prominent role in the provision of exercise and physical activity recommendations.^16,17

This developing health care role should include NPs, PTs, physician assistants, and other associated health professionals. It also should include collaborative efforts between physicians and rehabilitation practitioners concerning provision of the formal exercise prescriptionprescription and monitoring of patient outcomes.

Individuals with severe forms of sarcopenia rarely improve without intervention.⁶ Although no pharmacologic treatment exists to specifically address sarcopenia, strengthening exercise has been shown to be an effective mode of prevention and conservative management.⁸ Progressive resistance exercise cannot abate the expected age-related changes in skeletal muscle, but it can significantly reverse the loss of LBM and strength in untrained older adults and slow the age-related decline in muscle performance in older adult athletes and trained individuals.⁴⁵

Local senior centers and community organizations may prove to be valuable resources concerning group exercise options, and they provide the added benefit of social engagement and peer group accountability. Federal resources include the Go4Life exercise guide and online videos provided by the National Institute on Aging and the MOVE! Weight Management and Health Program provided at select VA community-based outpatient clinics. Ultimately, collaborative efforts with exercise specialists may serve to reduce the PCP burden during the provision of health services, minimize diagnostic errors associated with sarcopenia assessment and help to connect patients to valuable health promotion resources.^17,18

Conclusion

While practitioners should remain keenly aware of the pernicious effects of overdiagnosis, sarcopenia has long existed as a known, but undiagnosed, condition. Of course, geriatricians have traditionally managed poor muscle performance and mobility limitations by addressing treatable symptoms and providing referrals to physical medicine specialists when warranted. Nevertheless, the advent of ICD-10-CM code M62.⁸⁴ provides the VA with an opportunity to take a leading role in systematically addressing this geriatric syndrome within an aging veteran population.

The following items should be considered by NCP for the development of guidelines and recommendations concerning sarcopenia screening:

1. Consider screening veterans aged > 65 years for sarcopenia every 2 years. Those with mitigating systemic conditions (eg, chronic kidney disease, DM, or malnutrition) or significant mobility limitations may be screened at any age.
2. Sarcopenia screening procedures should include at a minimum the SARC-F questionnaire and gait speed (when appropriate). Including gait speed or grip strength testing in the screening exam is recommended given the low sensitivity of the SARC-F questionnaire.
3. Veterans with positive SARC-F results (≥ 4) merit a physical therapy referral. In addition, these veterans should obtain confirmatory standardized assessments for LBM and functional status.
4. Veterans at risk for sarcopenia based on patient age, medical history, and the physical examination (eg, obesity, sedentary lifestyle, a previous fracture, self-reported physical decline), but with negative SARC-F results should receive a formal exercise prescription from their PCP. Baseline assessment measures may be used for comparison with serial measures obtained during subsequent screening visits to support long-term case management.
5. Interprofessional collaboration involving geriatricians, PTs, nurses, radiologists, and other health care professionals should be involved in the screening, diagnosis, and case management of veterans with sarcopenia.
6. The VA EMR should be systematically documented with sarcopenia assessment data obtained from the gait speed tests, SARCF, SPPB, grip strength tests, and LBM estimates to better characterize this condition within the veteran population.

Any expansion in the provision of health care comes with anticipated benefits and potential costs. Broad guidance from NCP may encourage veterans to pursue selected screening tests, promote the appropriate use of preventative services, and facilitate timely treatment when needed.³¹ Clinicians who are informed about the screening, staging, classification, and diagnostic process for sarcopenia may partner with patients to make reasoned decisions about how to best manage this syndrome within the VA medical center environment.

Sarcopenia is an age-related loss of skeletal muscle that may result in diminished muscle strength and functional performance. The prevalence of sarcopenia varies based on the cohort and the assessment criteria. According to the Health Aging and Body Composition (ABC) study, the prevalence of sarcopenia in community-dwelling older adults is about 14% to 18%, whereas the estimate may exceed 30% for those in longterm care.^1,2 This geriatric syndrome may disproportionately affect veterans given that they are older than the civilian population and may have disabling comorbid conditions associated with military service.³

Recently, there has been a call to action to systematically address sarcopenia by interdisciplinary organizations such as the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Working Group on Sarcopenia (IWGS).^4,5 This call to action is due to the association of sarcopenia with increased health care costs, higher disability incidence, and elevated risk of mortality.^6,7 The consequences of sarcopenia may include serious complications, such as hip fracture or a loss of functional independence.^8,9 The CDC now recognizes sarcopenia as an independently reportable medical condition. Consequently, physicians, nurse practitioners (NPs), and other associated health professionals within the VA will need to better understand clinically viable and valid methods to screen and diagnose this geriatric syndrome.

The purpose of this paper is to inform practitioners how sarcopenia screening is aided by the new ICD-10-CM code and briefly review recent VA initiatives for proactive care. Additional objectives include identifying common methods used to assess sarcopenia and providing general recommendations to the VHA National Center for Health Promotion and Disease Prevention (NCP) concerning the management of sarcopenia.

Addressing Sarcopenia

While the age-related decline in muscle size and performance has long been recognized by geriatricians, sustained advocacy by several organizations was required to realize the formal recognition of sarcopenia. Aging in Motion (AIM), a coalition of organizations focused on advancing research and treatment for conditions associated with age-related muscle dysfunction, sought the formal recognition of sarcopenia. The CDC established the ICD-10-CM code for sarcopenia in October of 2016, which allowed the syndrome to be designated as a primary or secondary condition.¹⁰

The ubiquitous nature of agerelated changes in muscle and the mandate to engage in proactive care by all levels of VA leadership led to the focus on addressing sarcopenia. The recognition of sarcopenia by the CDC comes at an opportune time given recent VA efforts to transform itself from a facilitator mainly of care delivery to an active partner in fostering the health and well-being of veterans. Initiatives that are emblematic of this attempt to shift the organizational culture across the VHA include establishing the VA Center for Innovation (VACI) and issuing guidance documents, such as the Blueprint for Excellence, which was introduced in 2014 by then VA Secretary Robert McDonald.^11,12 Many of the following Blueprint themes and strategies potentially impact sarcopenia screening and treatment within the VA:

• Delivering high-quality, veteran-centered care: A major Blueprint theme is attaining the “Triple Aims” of a health care system by promoting better health among veterans, improving the provision of care, and lowering costs through operational efficiency. The management of sarcopenia has clear clinical value given the association of age-related muscle loss with fall risk and decreased mobility.¹³ Financial value also may be associated with the effort to decrease disability related to sarcopenia and the use of a team approach featuring associated health professionals to help screen for this geriatric syndrome.^14,15 (Strategy 2)
• Leveraging health care informatics to optimize individual and population health outcomes: The inclusion of the most basic muscle performance and functional status measures in the electronic medical record (EMR), such as grip strength and gait speed, would help to identify the risk factors and determinants of sarcopenia among the veteran population. (Strategy 3)
• Advancing personalized, proactive health care that fosters a high level of health and well-being: The long-term promotion of musculoskeletal health and optimal management of sarcopenia cannot be sustained through episodic medical interactions. Instead, a contemporary approach to health services marked by the continuous promotion of health education, physical activity and exercise, and proper nutrition has demonstrated value in the management of chronic conditions.^16,17 (Strategy 6)

The new sarcopenia ICD-10-CM code along with elements of the VHA Blueprint can serve to support the systematic assessment and management of veterans with age-related muscle dysfunction. Nevertheless, renewed calls for health promotion and screening programs are often counterbalanced by the need for cost containment and the cautionary tales concerning the potential harms or errors associated with some forms of medical screening. The American Board of Internal Medicine Foundation has spearheaded the Choosing Wisely campaign to raise awareness about excessive medical testing. However, the Institute of Medicine has linked the provision of quality health care to a diagnostic process that is both timely and accurate.¹⁸ Careful consideration of these health care challenges may help guide practitioners within the VA concerning the screening and diagnosis of sarcopenia.

Sarcopenia Assessment

Sarcopenia can have several underlying causes in some individuals and result in varied patterns of clinical presentation and differing degrees of severity. The European Working Group on Sarcopenia in Older People first met in 2009 and used a consensus-based decision-making process to determine operational definitions for sarcopenia and create a staging algorithm for the syndrome.¹⁹ This consensus group developed a conceptual staging model with 3 categories: presarcopenia, sarcopenia, and severe sarcopenia (Table 1). The impetus for sarcopenia staging was the emerging research findings suggesting that lean body mass (LBM) alone did not provide a high degree of clinical value in outpatient settings due to the nonlinear relationship between LBM and muscle function in older adults.^20,21 Using the consensus model approach, an individual is classified as sarcopenic on presenting with both low LBM and low muscle function.

Screening: A Place to Start

Findings from the Health ABC Study suggested that older adults who maintained high levels of LBM were less likely to become sarcopenic. Whereas, older adults in the cohort with low levels of LBM tended to remain in a sarcopenic state.⁶ Consequently, the early detection of sarcopenia may have important health promotion implications for older adults. Sarcopenia is a syndrome with a continuum of clinical features; it is not a disease with a clear or singular etiololgy. Therefore, the result of the screening examination should identify those who would most benefit from a formal diagnostic assessment.

One approach to screening for sarcopenia involves the use of questionnaires, such as the SARC-F (sluggishness, assistance in walking, rise from a chair, climb stairs, falls), which is a brief 5-item questionnaire with Likert scoring for patient responses.¹³ In a cohort of National Health and Nutrition Examination Survey (NHANES) participants, SARC-F scores ≥ 4 were associated with slower gait speed, lower strength, and an increased likelihood of hospitalization within a year of the test response.²² However, rather than stratify patients by risk, the SARC-F exhibits a high degree of test specificity regarding the major consensus-based sarcopenia classification criteria (specificity = 94.2% to 99.1%; sensitivity = 3.8% to 9.9%).¹³ Given the known limitations of screening tools with low sensitivity, organizations such as the ESCEO have recommended supplementing the SARC-F questionnaire with other forms of assessment.⁴ Supplements to the screening examination may range from the use of “red flag” questions concerning changes in nutritional status, body weight, and physical activity, to conducting standard gait speed and grip-strength testing.^4,19,23

Performance-based testing, including habitual gait speed and grip-strength dynamometry, also may be used in both the screening and classification of sarcopenia.² Although walking speed below 1.0 m/s has been used by the IWGS as a criterion to prompt further assessment, many people within the VA health care system may have gait abnormalities independent of LBM status, and others may be nonambulatory.^24,25 As a result, grip-strength testing should be considered as a supplementary or alternate screening assessment tool.^26,27

Hand-grip dynamometry is often used diagnostically given its previous test validation, low expense, and ease of use.²³ Moreover, recent evidence suggests that muscle strength surpasses gait speed as a means of identifying people with sarcopenia. Grip strength is associated with all-cause mortality, even when adjusting for age, sex, and body size,²⁸ while slow gait speed (< .82 m/s) has a reported sensitivity of 63% and specificity of 70% for mortality in population-based studies involving older adults.²⁹

 

Gait speed (in those who are ambulatory) and grip-strength values could be entered into the EMR evaluation note by the primary care provider (PCP). Elements of the VA EMR, such as the ability to review the diagnosis of sarcopenia on the Problem List or the nominal enhancement of providing LBM estimates within the Cumulative Vitals and Measurements Report would support the management of sarcopenia. See Table 2 for cutoff values for frequently used sarcopenia screening and staging tests.

The pitfalls of excessive or inappropriate screening are well documented. The efforts to screen for prostate cancer have highlighted instances when inappropriate followup tests and treatment fail to alter mortality rates and ultimately yield more harm than good.³⁰ However, there are several points of departure concerning the screening for sarcopenia vs screening for prostate cancer. The screening assessments for sarcopenia are low-cost procedures that are associated with a low patient burden. These procedures may include questionnaires, functional testing, or the assessment of muscle performance. Additionally, there is a low propensity for adverse effects stemming from treatment due to disease misclassification given the common nonpharmacologic approaches used to manage sarcopenia.³¹ Nonetheless, the best screening examination—even one that has low patient burden and cost—may prove to be a poor use of medical resources if the process is not linked to a viable intervention.

Screening people aged ≥ 65 years may strike a balance between controlling health care expenditures and identifying people with the initial signs of sarcopenia early enough to begin monitoring key outcomes and providing a formalized exercise prescription. Presuming an annual age-related decline in LBM of 1.5%, and considering the standard error measurement of the most frequently used methods of strength and LBM assessment, recurrent screening could occur every 2 years.^21,32

Earlier screening may be considered for patient populations with a higher pretest probability. These groups include those with conditions associated with accelerated muscle loss, such as chronic kidney disease, peripheral artery disease, and diabetes mellitus (DM).³² Although accelerated muscle loss characterized by an inflammatory motif (eg, cancer-related cachexia) may share some features of the sarcopenia screening and assessment approach, important differences exist regarding the etiology, medical evaluation, and ICD-10-CM code designation.

Staging and Classification

Staging criteria are generally used to denote the severity of a given disease or syndrome, whereas classification criteria are used to define homogenous patient groups based on specific pathologic or clinical features of a disorder. Although classification schemes may incorporate an element of severity, they are primarily used to characterize fairly distinct phenotypic forms of disease or specific clinical presentation patterns associated with a well-defined syndrome. Although not universally adopted, the European consensus group sarcopenia staging criteria are increasingly used to provide a staging algorithm presumably driven by the severity of the condition.¹⁹

The assessment of functional performance for use in sarcopenia staging often involves measuring habitual gait speed or completing the Short Physical Performance Battery (SPPB).²³ The SPPB involves a variety of performance-based activities for balance, gait, strength, and endurance. This test has predictive validity for the onset of disability and adverse health events, and it has been extensively used in research and clinical settings.³³ Additional tests used to characterize function during the staging or diagnostic process include the timed get up and go test (TGUG) and the timed sit to stand test.^34,35 The TGUG provides an estimate of dynamic balance, and the sit to stand test has been used as very basic proxy measure of muscular power.³⁶ The sit to stand test and habitual gait speed are items included in the SPPB.³³

Accepted methods to obtain the traditional index measure of sarcopenia—based on estimates of LBM—include bioimpedance analysis (BIA) and dual X-ray absorptiometry (DXA). The BIA uses the electrical impedance of body tissues and its 2 components, resistance and reactance, to derive its body composition estimates.³⁷ Segmental BIA allows for isolated measurements of the limbs, which may be calibrated to DXA appendicular lean body mass (ALM) or magnetic resonance imaging-based estimates of LBM. This instrument is relatively safe for use, inexpensive for medical facilities, and useful for longitudinal studies, but it can be confounded by issues, such as varying levels of hydration, which may affect measurement validity in some instances.

Despite the precision of DXA for estimating densities for whole body composition analysis, the equipment is not very portable and involves low levels of radiation exposure, which limits its utility in some clinical settings. While each body composition assessment method has its advantages and disadvantages, DXA is regarded as an acceptable form of measurement for hospital settings, and BIA is frequently used in outpatient clinics and community settings. Other methods used to estimate LBM with greater accuracy, such as peripheral quantitative computed tomography, doubly labeled water, and whole body gamma ray counting, are not viable for clinical use. Other accessible methods such as anthropometric measures and skinfold measures have not been embraced by sarcopenia classification consensus groups.^23,37

Alternative methods of estimating LBM, such as diagnostic ultrasound and multifrequency electrical impedance myography, are featured outcomes in ongoing clinical trials that involve veteran participants. These modalities may soon provide a clinically viable approach to assessing muscle quality via estimates of muscle tissue composition.^37,38 Similar to the management of other geriatric syndromes, interprofessional collaboration provides an optimal approach to the assessment of sarcopenia. Physicians and other health care providers may draw on the standardized assessment of strength and function (via the SPPB and hand-grip dynamometry) by physical therapists (PTs), questionnaires administered by nursing staff (the SARC-F), or body composition estimates from other health professionals (ranging from BIA to DXA) to aid the diagnostic process and facilitate appropriate case management (Table 2).

Competing staging and classification definitions have been cited as a primary factor behind the CDC’s delayed recognition of the sarcopenia diagnosis, which in turn posed a barrier to formal clinical recognition by geriatricians.²⁴ However, this reaction to the evolving sarcopenia staging criteria also may reveal the larger misapplication of the staging process to the diagnostic process. The application of classification and staging criteria results in a homogenous group of patients, whereas the application of diagnostic criteria results in a heterogeneous group of patients to account for variations in clinical presentation associated with a given disorder. Classification criteria may be equivalent to objective measures that are used in the diagnostic process when a given disease is characterized by a well-established biomarker.³⁹

However, this is not the case for most geriatric syndromes and other disorders marked by varied clinical presentation patterns. On considering the commonly used sarcopenia staging criteria of LBM ≤ 8.50 kg/m² or grip strength < 30 kg in men and LBM ≤ 5.75 kg/m² or grip strength < 20 kg in women, it is easy to understand that such general cutoff values are far from diagnostic.^40,41 Moreover, stringent cutoff values associated with classification and staging may not adequately capture those with an atypical presentation of the syndrome (eg, someone who exhibits age-related muscle weakness but has retained adequate LBM). Such criteria often prove to have high specificity and low sensitivity, which may yield a false negative rate that is appropriate for clinical research eligibility and group assignment but inadequate for clinical care.

Screening, staging, and classification criteria with high specificity may indeed be desirable for confirmatory imaging tests associated with radiation exposure concerns or for managing risk in experimental clinical trials involving pharmacologic treatment. For example, a SARC-F score ≥ 4 may prompt the formal assessment of LBM via a DXA examination.⁴ In contrast, those with a SARC-F score ≤ 3 with low gait speed or grip strength may benefit from consultation regarding regular physical activity and nutrition recommendations. Given the challenges of establishing sarcopenia classification criteria that perform consistently across populations and geographic regions, classification and staging criteria may be best viewed as clinical reasoning tools that supplement, but not supplant, the diagnostic process.^7,42

Diagnosis

Geriatric syndromes do not lend themselves to a simple diagnostic process. Syndromes such as frailty and sarcopenia are multifactorial and lack a single distinguishing clinical feature or biomarker. The oft-cited refrain that sarcopenia is an underdiagnosed condition is partially explained by the recent ICD-10-CM code and varied classification and diagnostic criteria^.5 This circumstance highlights the need to distinctly contrast the diagnostic process with the screening and staging classifications.

The diagnostic process involves the interpretation of the patient history, signs, and symptoms within the context of individual factors, local or regional disease prevalence, and the results of the best available and most appropriate laboratory tests. After all, a patient that presents with low LBM and a gradual loss of strength without a precipitating event would necessitate further workup to rule out many clinical possibilities under the aegis of a differential diagnosis. Clinical features, such as the magnitude of weakness and pattern of strength loss or muscle atrophy along with the determination of neurologic or autoimmune involvement, are among the key elements of the differential examination for a case involving the observation of frank muscle weakness. Older adults with low muscle strength may have additional risk factors for sarcopenia such as obesity, pain, poor nutrition, previous bone fracture, and a sedentary lifestyle. However, disease etiology with lower probabilities, such as myogenic or neurogenic conditions associated with advancing age, also may be under consideration during the clinical assessment.⁶

In many instances, the cutoff scores associated with the sarcopenia staging criteria may help to guide the diagnostic process and aid clinical decision making. Since individuals with a positive screening result based on the SARC-F questionnaire (score ≥ 4) have a high likelihood of meeting the staging criteria for severe sarcopenia, a PCP may opt to obtain a confirmatory estimate of LBM both to support the clinical assessment and to monitor change over the course of rehabilitation. Whereas people who present with a decline in strength (ie, grip strength < 30 kg for a male) without an observable loss of function or a positive SARC-F score may benefit from consultation from the physician, NP, or rehabilitation health professional regarding modifiable risk factors associated with sarcopenia.

Incorporating less frequently used sarcopenia classification schemes such as identifying those with sarcopenic obesity or secondary sarcopenia due to mitigating factors such as chronic kidney disease or DM (Table 3) may engender a more comprehensive approach to intervention that targets the primary disease while also addressing important secondary sequelae. Nevertheless, staging or classification criteria cannot be deemed equivalent to diagnostic criteria for sarcopenia due to the challenges posed by syndromes that have a heterogeneous clinical presentation.

The refinement of the staging and classification criteria along with the advances in imaging technology and mechanistic research are not unique to sarcopenia. Practitioners involved in the care of people with rheumatologic conditions or osteoporosis also have contended with continued refinements to their classification criteria and approach to risk stratification.^39,43,44 Primary care providers will now have the option to use a new ICD-10-CM code (M62.84) for sarcopenia, which will allow them to properly document the clinical distinctions between people with impaired strength or function largely due to age-related muscle changes and those who have impaired muscle function due to cachexia, inflammatory myopathies, or forms of neuromuscular disease.

 

The ability to identify and document this geriatric syndrome in veterans will help to better define the scope of the problem within the VA health care system. The median age of veterans is 62 years compared with 43 years for nonveterans.³ Consequently, there may be value in the adoption of a formal approach to screening and diagnosis for sarcopenia among veterans who receive their primary care from VA facilities.⁷ Indeed, the exchange between the patient and the health professional regarding the screening and diagnostic process will provide valuable opportunities to promote exercise interventions before patients incur significant impairments.

One of the biggest threats burdening global health is noncommunicable diseases, and many chronic conditions, such as sarcopenia, can be prevented and managed with appropriate levels of physical activity.¹⁷ Increased physician involvement may prove to be critical given the identification of physical inactivity as a top 5 risk factor for general morbidity and mortality by World Health Organization and consensus group recommendations calling for physicians to serve a more prominent role in the provision of exercise and physical activity recommendations.^16,17

This developing health care role should include NPs, PTs, physician assistants, and other associated health professionals. It also should include collaborative efforts between physicians and rehabilitation practitioners concerning provision of the formal exercise prescriptionprescription and monitoring of patient outcomes.

Individuals with severe forms of sarcopenia rarely improve without intervention.⁶ Although no pharmacologic treatment exists to specifically address sarcopenia, strengthening exercise has been shown to be an effective mode of prevention and conservative management.⁸ Progressive resistance exercise cannot abate the expected age-related changes in skeletal muscle, but it can significantly reverse the loss of LBM and strength in untrained older adults and slow the age-related decline in muscle performance in older adult athletes and trained individuals.⁴⁵

Local senior centers and community organizations may prove to be valuable resources concerning group exercise options, and they provide the added benefit of social engagement and peer group accountability. Federal resources include the Go4Life exercise guide and online videos provided by the National Institute on Aging and the MOVE! Weight Management and Health Program provided at select VA community-based outpatient clinics. Ultimately, collaborative efforts with exercise specialists may serve to reduce the PCP burden during the provision of health services, minimize diagnostic errors associated with sarcopenia assessment and help to connect patients to valuable health promotion resources.^17,18

Conclusion

While practitioners should remain keenly aware of the pernicious effects of overdiagnosis, sarcopenia has long existed as a known, but undiagnosed, condition. Of course, geriatricians have traditionally managed poor muscle performance and mobility limitations by addressing treatable symptoms and providing referrals to physical medicine specialists when warranted. Nevertheless, the advent of ICD-10-CM code M62.⁸⁴ provides the VA with an opportunity to take a leading role in systematically addressing this geriatric syndrome within an aging veteran population.

The following items should be considered by NCP for the development of guidelines and recommendations concerning sarcopenia screening:

1. Consider screening veterans aged > 65 years for sarcopenia every 2 years. Those with mitigating systemic conditions (eg, chronic kidney disease, DM, or malnutrition) or significant mobility limitations may be screened at any age.
2. Sarcopenia screening procedures should include at a minimum the SARC-F questionnaire and gait speed (when appropriate). Including gait speed or grip strength testing in the screening exam is recommended given the low sensitivity of the SARC-F questionnaire.
3. Veterans with positive SARC-F results (≥ 4) merit a physical therapy referral. In addition, these veterans should obtain confirmatory standardized assessments for LBM and functional status.
4. Veterans at risk for sarcopenia based on patient age, medical history, and the physical examination (eg, obesity, sedentary lifestyle, a previous fracture, self-reported physical decline), but with negative SARC-F results should receive a formal exercise prescription from their PCP. Baseline assessment measures may be used for comparison with serial measures obtained during subsequent screening visits to support long-term case management.
5. Interprofessional collaboration involving geriatricians, PTs, nurses, radiologists, and other health care professionals should be involved in the screening, diagnosis, and case management of veterans with sarcopenia.
6. The VA EMR should be systematically documented with sarcopenia assessment data obtained from the gait speed tests, SARCF, SPPB, grip strength tests, and LBM estimates to better characterize this condition within the veteran population.

Any expansion in the provision of health care comes with anticipated benefits and potential costs. Broad guidance from NCP may encourage veterans to pursue selected screening tests, promote the appropriate use of preventative services, and facilitate timely treatment when needed.³¹ Clinicians who are informed about the screening, staging, classification, and diagnostic process for sarcopenia may partner with patients to make reasoned decisions about how to best manage this syndrome within the VA medical center environment.

Rosacea is a chronic inflammatory skin disease characterized by central facial erythema with or without intermittent papules and pustules (described as the inflammatory lesions of rosacea). Although twice-daily clindamycin 1% solution or gel has been used in the treatment of acne, few studies have investigated the use of clindamycin in rosacea.^1,2 In one study comparing twice-daily clindamycin lotion 1% with oral tetracycline in 43 rosacea patients, clindamycin was found to be superior in the eradication of pustules.³ A combination therapy of clindamycin 1% and benzoyl peroxide 5% was found to be more effective than the vehicle in inflammatory lesions and erythema of rosacea in a 12-week randomized controlled trial; however, a definitive advantage over US Food and Drug Administration-approved topical agents used to treat papulopustular rosacea was not established.^4,5 Two further studies evaluated clindamycin phosphate 1.2%-tretinoin 0.025% combination gel in the treatment of rosacea, but only 1 showed any effect on papulopustular lesions.^6-8 The objective of the studies reported here was to evaluate the efficacy and safety of clindamycin in the treatment of patients with moderate to severe rosacea.

Methods

Study Design

Two multicenter (study A, 20 centers; study B, 10 centers), randomized, investigator-blinded, vehicle-controlled studies were conducted in the United States between 1999 and 2002 in accordance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The studies were reviewed and approved by the respective institutional review boards, and all participants provided written informed consent.

In study A, moderate to severe rosacea patients with erythema, telangiectasia, and at least 8 inflammatory lesions were randomized to receive clindamycin cream 1% or vehicle cream once (in the evening) or twice daily (in the morning and evening) or clindamycin cream 0.3% once daily (in the evening) for 12 weeks (1:1:1:1:1 ratio). All study treatments were supplied in identical tubes with blinded labels.

In study B, patients with moderate to severe rosacea and at least 8 inflammatory lesions were randomized in a 1:1 ratio with instructions to apply clindamycin gel 1% or vehicle gel to the affected areas twice daily (morning and evening) for 12 weeks.

Efficacy Evaluation

Evaluations were performed at baseline and weeks 2, 4, 8, and 12 on the intention-to-treat population with the last observation carried forward.

Efficacy assessments in both studies included inflammatory lesion counts (papules and pustules) of 5 facial regions--forehead, chin, nose, right cheek, left cheek--counted separately and then combined to give the total inflammatory lesion count (both studies), as well as improvement in the investigator global rosacea severity score (0=none/clear; 1=mild, detectable erythema with ≤7 papules/pustules; 2=moderate, prominent erythema with ≥8 papules/pustules; 3=severe, intense erythema with ≥10 to <50 papules/pustules; 3.5 [study A] or 4 [study B]=very severe, intense erythema with >50 papules/pustules). In study B, the proportion of participants dichotomized to success (a score of 0 [none/clear] or 1 [mild/almost clear]) or failure (a score of ≥2) on the 5-point investigator global rosacea severity scale at week 12 was evaluated. In study A, investigator global improvement assessment at week 12, based on photographs taken at baseline, was graded on a 7-point scale (from -1 [worse], 0 [no change], and 1 [minimal improvement] to 5 [clear]). In both studies, erythema severity was graded on a 7-point scale in increments of 0.5 (from 0=no erythema to 3.5=very severe redness, very intense redness). Skin irritation also was graded as none, mild, moderate, or severe. 

Safety Evaluation

Safety was assessed by the incidence of adverse events (AEs).

Statistical Analysis

Studies were powered assuming 60% reduction in inflammatory lesion counts with active and 40% with vehicle, based on historical data from a prior study with metronidazole cream 0.75% versus vehicle; 64 participants were required in each treatment group to detect this effect using a 2-sided t test (&#945;=.017). Pairwise comparisons (clindamycin vs respective vehicle) were performed using the Cochran-Mantel-Haenszel test for combined lesion count percentage change.

 

Results

Participant Disposition and Baseline Characteristics

Overall, a total of 629 participants were randomized across both studies. In study A, a total of 416 participants were randomized into 5 treatment arms, with 369 participants (88.7%) completing the study; 47 (11.3%) participants discontinued study A, mainly due to participant request (19/47 [40.4%]) or lost to follow-up (11/47 [23.4%]). In study B, a total of 213 participants were randomized to receive either clindamycin gel 1% (n=109 [51.2%]) twice daily or vehicle gel (n=104 [48.8%]) twice daily, with 193 participants (90.6%) completing the study; 20 (9.4%) participants discontinued study B, mainly due to participant request (6/20 [30%]) or lost to follow-up (4/20 [20%]). Participants in studies A and B were similar in demographics and baseline disease characteristics (Table). The majority of participants were white females. 

Efficacy

No statistically significant difference was observed in all pairwise comparisons (clindamycin cream twice daily vs vehicle twice daily, clindamycin cream once daily vs vehicle once daily, clindamycin gel vs vehicle gel) for the primary end point of mean percentage change from baseline in inflammatory lesion counts at week 12 (Figure 1; P>.5 for all pairwise comparisons). 

At week 12, the proportion of participants in study B deemed as a success (none/clear or mild/almost clear [investigator global rosacea severity score of 0 or 1]) in the clindamycin gel 1% and vehicle gel groups were 45% versus 38%, respectively (P=.347) (Figure 2). 

For the secondary end point of mean investigator global rosacea severity assessment at week 12 (study A), there were no significant differences between the active and vehicle control groups (P>.5 for all pairwise comparisons)(Figure 3). Also, the proportion of participants with at least a moderate investigator global improvement assessment from baseline to week 12 ranged from 45% for clindamycin cream 1% twice daily to 56% for clindamycin cream 0.3% cream once daily and from 45% for vehicle cream once daily to 51% for vehicle cream twice daily (P>.5 for all pairwise comparisons).

There were no significant differences in the mean total erythema severity scores at week 12 for clindamycin cream 1% twice daily versus vehicle cream twice daily (6.3 vs 6.0; P>.5), clindamycin cream 1% once daily versus vehicle cream once daily (6.2 vs 6.0; P>.5), clindamycin cream 0.3% once daily versus vehicle cream once daily (5.9 vs 6.0; P>.5), and clindamycin gel 1% twice daily versus vehicle gel twice daily (6.7 vs 6.2; P>.5). 

There were no relevant differences between any of the clindamycin cream groups and their respective vehicle group at week 12 for skin irritation, including desquamation, edema, dryness, pruritus, and stinging/burning.

Safety

In study A, the majority of AEs in all 5 treatment arms were nondermatologic, mild in intensity, and not considered to be related to the study treatment by the investigator. Overall, 12 participants had AEs considered by the investigator as possibly or probably related to the study treatment: 4.9% in the clindamycin cream 1% twice daily group, 4.6% in the clindamycin cream 1% once daily group, 3.7% in the vehicle cream twice daily group, 1.2% in the clindamycin cream 0.3% once daily group, and 0% in the vehicle cream once daily group. Two treatment-related AEs led to treatment discontinuation, including dermatitis in 1 participant from the clindamycin cream 1% once daily group and contact dermatitis in 1 participant from the clindamycin cream 1% twice daily group.

Comment

No evidence of increased efficacy over the respective vehicles was observed with clindamycin cream or gel, whatever the regimen, in the treatment of rosacea patients in either of these well-designed and well-powered, blinded studies. Slight improvements in the various efficacy criteria were observed, even in the vehicle groups, highlighting the importance of using a good basic skin care regimen in the management of rosacea.⁹ In contrast to our observations of lack of efficacy in the treatment of rosacea, clinical efficacy of clindamycin has been demonstrated in acne,^10-12 albeit with low efficacy for clindamycin monotherapy.¹³ It is noteworthy that oral or topical antibiotics are no longer recommended as monotherapy for acne to prevent and minimize antibiotic resistance and to preserve the therapeutic value of antibiotics.¹⁴

Acne and rosacea are both chronic inflammatory disorders of the skin associated with papules and pustules, and they share some common inflammatory patterns.^15-19 Furthermore, the intrinsic anti-inflammatory activity of clindamycin in addition to its antibiotic effects has been suggested by some authors as the main reason for treating acne with clindamycin.²⁰ However, the relative contributions of antibacterial and/or anti-inflammatory properties remain to be fully elucidated, and evidence for direct anti-inflammatory effects of clindamycin remains heterogeneous.^21,22 Several pathophysiological factors have been implicated in acne, including hormonal effects, abnormal keratinocyte function, increased sebum production, and microbial components (eg, hypercolonization of the skin follicles by Propionibacterium acnes).^23,24 The antibiotic activity of clindamycin against P acnes may be the key factor responsible for the clinical effects in acne.^25,26 Although clindamycin may have anti-inflammatory effects in acne via a different inflammatory pathway not shared by rosacea, a purely antibiotic mechanism of action of clindamycin also could explain why we observed no evidence of efficacy in the treatment of rosacea, as no causative bacterial component has been clearly demonstrated in rosacea.²⁷

Conclusion

In these studies, clindamycin cream 0.3% once daily, clindamycin cream 1% once or twice daily, and clindamycin gel 1% twice daily were all well tolerated; however, they were no more effective than the vehicles in the treatment of moderate to severe rosacea.  

Acknowledgment

The authors would like to thank Helen Simpson, PhD, of Galderma R&D (Sophia Antipolis, France), for editorial and medical writing assistance.

Rosacea is a chronic inflammatory skin disease characterized by central facial erythema with or without intermittent papules and pustules (described as the inflammatory lesions of rosacea). Although twice-daily clindamycin 1% solution or gel has been used in the treatment of acne, few studies have investigated the use of clindamycin in rosacea.^1,2 In one study comparing twice-daily clindamycin lotion 1% with oral tetracycline in 43 rosacea patients, clindamycin was found to be superior in the eradication of pustules.³ A combination therapy of clindamycin 1% and benzoyl peroxide 5% was found to be more effective than the vehicle in inflammatory lesions and erythema of rosacea in a 12-week randomized controlled trial; however, a definitive advantage over US Food and Drug Administration-approved topical agents used to treat papulopustular rosacea was not established.^4,5 Two further studies evaluated clindamycin phosphate 1.2%-tretinoin 0.025% combination gel in the treatment of rosacea, but only 1 showed any effect on papulopustular lesions.^6-8 The objective of the studies reported here was to evaluate the efficacy and safety of clindamycin in the treatment of patients with moderate to severe rosacea.

Methods

Study Design

Two multicenter (study A, 20 centers; study B, 10 centers), randomized, investigator-blinded, vehicle-controlled studies were conducted in the United States between 1999 and 2002 in accordance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The studies were reviewed and approved by the respective institutional review boards, and all participants provided written informed consent.

In study A, moderate to severe rosacea patients with erythema, telangiectasia, and at least 8 inflammatory lesions were randomized to receive clindamycin cream 1% or vehicle cream once (in the evening) or twice daily (in the morning and evening) or clindamycin cream 0.3% once daily (in the evening) for 12 weeks (1:1:1:1:1 ratio). All study treatments were supplied in identical tubes with blinded labels.

In study B, patients with moderate to severe rosacea and at least 8 inflammatory lesions were randomized in a 1:1 ratio with instructions to apply clindamycin gel 1% or vehicle gel to the affected areas twice daily (morning and evening) for 12 weeks.

Efficacy Evaluation

Evaluations were performed at baseline and weeks 2, 4, 8, and 12 on the intention-to-treat population with the last observation carried forward.

Efficacy assessments in both studies included inflammatory lesion counts (papules and pustules) of 5 facial regions--forehead, chin, nose, right cheek, left cheek--counted separately and then combined to give the total inflammatory lesion count (both studies), as well as improvement in the investigator global rosacea severity score (0=none/clear; 1=mild, detectable erythema with ≤7 papules/pustules; 2=moderate, prominent erythema with ≥8 papules/pustules; 3=severe, intense erythema with ≥10 to <50 papules/pustules; 3.5 [study A] or 4 [study B]=very severe, intense erythema with >50 papules/pustules). In study B, the proportion of participants dichotomized to success (a score of 0 [none/clear] or 1 [mild/almost clear]) or failure (a score of ≥2) on the 5-point investigator global rosacea severity scale at week 12 was evaluated. In study A, investigator global improvement assessment at week 12, based on photographs taken at baseline, was graded on a 7-point scale (from -1 [worse], 0 [no change], and 1 [minimal improvement] to 5 [clear]). In both studies, erythema severity was graded on a 7-point scale in increments of 0.5 (from 0=no erythema to 3.5=very severe redness, very intense redness). Skin irritation also was graded as none, mild, moderate, or severe. 

Safety Evaluation

Safety was assessed by the incidence of adverse events (AEs).

Statistical Analysis

Studies were powered assuming 60% reduction in inflammatory lesion counts with active and 40% with vehicle, based on historical data from a prior study with metronidazole cream 0.75% versus vehicle; 64 participants were required in each treatment group to detect this effect using a 2-sided t test (&#945;=.017). Pairwise comparisons (clindamycin vs respective vehicle) were performed using the Cochran-Mantel-Haenszel test for combined lesion count percentage change.

 

Results

Participant Disposition and Baseline Characteristics

Overall, a total of 629 participants were randomized across both studies. In study A, a total of 416 participants were randomized into 5 treatment arms, with 369 participants (88.7%) completing the study; 47 (11.3%) participants discontinued study A, mainly due to participant request (19/47 [40.4%]) or lost to follow-up (11/47 [23.4%]). In study B, a total of 213 participants were randomized to receive either clindamycin gel 1% (n=109 [51.2%]) twice daily or vehicle gel (n=104 [48.8%]) twice daily, with 193 participants (90.6%) completing the study; 20 (9.4%) participants discontinued study B, mainly due to participant request (6/20 [30%]) or lost to follow-up (4/20 [20%]). Participants in studies A and B were similar in demographics and baseline disease characteristics (Table). The majority of participants were white females. 

Efficacy

No statistically significant difference was observed in all pairwise comparisons (clindamycin cream twice daily vs vehicle twice daily, clindamycin cream once daily vs vehicle once daily, clindamycin gel vs vehicle gel) for the primary end point of mean percentage change from baseline in inflammatory lesion counts at week 12 (Figure 1; P>.5 for all pairwise comparisons). 

At week 12, the proportion of participants in study B deemed as a success (none/clear or mild/almost clear [investigator global rosacea severity score of 0 or 1]) in the clindamycin gel 1% and vehicle gel groups were 45% versus 38%, respectively (P=.347) (Figure 2). 

For the secondary end point of mean investigator global rosacea severity assessment at week 12 (study A), there were no significant differences between the active and vehicle control groups (P>.5 for all pairwise comparisons)(Figure 3). Also, the proportion of participants with at least a moderate investigator global improvement assessment from baseline to week 12 ranged from 45% for clindamycin cream 1% twice daily to 56% for clindamycin cream 0.3% cream once daily and from 45% for vehicle cream once daily to 51% for vehicle cream twice daily (P>.5 for all pairwise comparisons).

There were no significant differences in the mean total erythema severity scores at week 12 for clindamycin cream 1% twice daily versus vehicle cream twice daily (6.3 vs 6.0; P>.5), clindamycin cream 1% once daily versus vehicle cream once daily (6.2 vs 6.0; P>.5), clindamycin cream 0.3% once daily versus vehicle cream once daily (5.9 vs 6.0; P>.5), and clindamycin gel 1% twice daily versus vehicle gel twice daily (6.7 vs 6.2; P>.5). 

There were no relevant differences between any of the clindamycin cream groups and their respective vehicle group at week 12 for skin irritation, including desquamation, edema, dryness, pruritus, and stinging/burning.

Safety

In study A, the majority of AEs in all 5 treatment arms were nondermatologic, mild in intensity, and not considered to be related to the study treatment by the investigator. Overall, 12 participants had AEs considered by the investigator as possibly or probably related to the study treatment: 4.9% in the clindamycin cream 1% twice daily group, 4.6% in the clindamycin cream 1% once daily group, 3.7% in the vehicle cream twice daily group, 1.2% in the clindamycin cream 0.3% once daily group, and 0% in the vehicle cream once daily group. Two treatment-related AEs led to treatment discontinuation, including dermatitis in 1 participant from the clindamycin cream 1% once daily group and contact dermatitis in 1 participant from the clindamycin cream 1% twice daily group.

Comment

No evidence of increased efficacy over the respective vehicles was observed with clindamycin cream or gel, whatever the regimen, in the treatment of rosacea patients in either of these well-designed and well-powered, blinded studies. Slight improvements in the various efficacy criteria were observed, even in the vehicle groups, highlighting the importance of using a good basic skin care regimen in the management of rosacea.⁹ In contrast to our observations of lack of efficacy in the treatment of rosacea, clinical efficacy of clindamycin has been demonstrated in acne,^10-12 albeit with low efficacy for clindamycin monotherapy.¹³ It is noteworthy that oral or topical antibiotics are no longer recommended as monotherapy for acne to prevent and minimize antibiotic resistance and to preserve the therapeutic value of antibiotics.¹⁴

Acne and rosacea are both chronic inflammatory disorders of the skin associated with papules and pustules, and they share some common inflammatory patterns.^15-19 Furthermore, the intrinsic anti-inflammatory activity of clindamycin in addition to its antibiotic effects has been suggested by some authors as the main reason for treating acne with clindamycin.²⁰ However, the relative contributions of antibacterial and/or anti-inflammatory properties remain to be fully elucidated, and evidence for direct anti-inflammatory effects of clindamycin remains heterogeneous.^21,22 Several pathophysiological factors have been implicated in acne, including hormonal effects, abnormal keratinocyte function, increased sebum production, and microbial components (eg, hypercolonization of the skin follicles by Propionibacterium acnes).^23,24 The antibiotic activity of clindamycin against P acnes may be the key factor responsible for the clinical effects in acne.^25,26 Although clindamycin may have anti-inflammatory effects in acne via a different inflammatory pathway not shared by rosacea, a purely antibiotic mechanism of action of clindamycin also could explain why we observed no evidence of efficacy in the treatment of rosacea, as no causative bacterial component has been clearly demonstrated in rosacea.²⁷

Conclusion

In these studies, clindamycin cream 0.3% once daily, clindamycin cream 1% once or twice daily, and clindamycin gel 1% twice daily were all well tolerated; however, they were no more effective than the vehicles in the treatment of moderate to severe rosacea.  

Acknowledgment

The authors would like to thank Helen Simpson, PhD, of Galderma R&D (Sophia Antipolis, France), for editorial and medical writing assistance.

Rosacea is a chronic inflammatory skin disease characterized by central facial erythema with or without intermittent papules and pustules (described as the inflammatory lesions of rosacea). Although twice-daily clindamycin 1% solution or gel has been used in the treatment of acne, few studies have investigated the use of clindamycin in rosacea.^1,2 In one study comparing twice-daily clindamycin lotion 1% with oral tetracycline in 43 rosacea patients, clindamycin was found to be superior in the eradication of pustules.³ A combination therapy of clindamycin 1% and benzoyl peroxide 5% was found to be more effective than the vehicle in inflammatory lesions and erythema of rosacea in a 12-week randomized controlled trial; however, a definitive advantage over US Food and Drug Administration-approved topical agents used to treat papulopustular rosacea was not established.^4,5 Two further studies evaluated clindamycin phosphate 1.2%-tretinoin 0.025% combination gel in the treatment of rosacea, but only 1 showed any effect on papulopustular lesions.^6-8 The objective of the studies reported here was to evaluate the efficacy and safety of clindamycin in the treatment of patients with moderate to severe rosacea.

Methods

Study Design

Two multicenter (study A, 20 centers; study B, 10 centers), randomized, investigator-blinded, vehicle-controlled studies were conducted in the United States between 1999 and 2002 in accordance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The studies were reviewed and approved by the respective institutional review boards, and all participants provided written informed consent.

In study A, moderate to severe rosacea patients with erythema, telangiectasia, and at least 8 inflammatory lesions were randomized to receive clindamycin cream 1% or vehicle cream once (in the evening) or twice daily (in the morning and evening) or clindamycin cream 0.3% once daily (in the evening) for 12 weeks (1:1:1:1:1 ratio). All study treatments were supplied in identical tubes with blinded labels.

In study B, patients with moderate to severe rosacea and at least 8 inflammatory lesions were randomized in a 1:1 ratio with instructions to apply clindamycin gel 1% or vehicle gel to the affected areas twice daily (morning and evening) for 12 weeks.

Efficacy Evaluation

Evaluations were performed at baseline and weeks 2, 4, 8, and 12 on the intention-to-treat population with the last observation carried forward.

Efficacy assessments in both studies included inflammatory lesion counts (papules and pustules) of 5 facial regions--forehead, chin, nose, right cheek, left cheek--counted separately and then combined to give the total inflammatory lesion count (both studies), as well as improvement in the investigator global rosacea severity score (0=none/clear; 1=mild, detectable erythema with ≤7 papules/pustules; 2=moderate, prominent erythema with ≥8 papules/pustules; 3=severe, intense erythema with ≥10 to <50 papules/pustules; 3.5 [study A] or 4 [study B]=very severe, intense erythema with >50 papules/pustules). In study B, the proportion of participants dichotomized to success (a score of 0 [none/clear] or 1 [mild/almost clear]) or failure (a score of ≥2) on the 5-point investigator global rosacea severity scale at week 12 was evaluated. In study A, investigator global improvement assessment at week 12, based on photographs taken at baseline, was graded on a 7-point scale (from -1 [worse], 0 [no change], and 1 [minimal improvement] to 5 [clear]). In both studies, erythema severity was graded on a 7-point scale in increments of 0.5 (from 0=no erythema to 3.5=very severe redness, very intense redness). Skin irritation also was graded as none, mild, moderate, or severe. 

Safety Evaluation

Safety was assessed by the incidence of adverse events (AEs).

Statistical Analysis

Studies were powered assuming 60% reduction in inflammatory lesion counts with active and 40% with vehicle, based on historical data from a prior study with metronidazole cream 0.75% versus vehicle; 64 participants were required in each treatment group to detect this effect using a 2-sided t test (&#945;=.017). Pairwise comparisons (clindamycin vs respective vehicle) were performed using the Cochran-Mantel-Haenszel test for combined lesion count percentage change.

 

Results

Participant Disposition and Baseline Characteristics

Overall, a total of 629 participants were randomized across both studies. In study A, a total of 416 participants were randomized into 5 treatment arms, with 369 participants (88.7%) completing the study; 47 (11.3%) participants discontinued study A, mainly due to participant request (19/47 [40.4%]) or lost to follow-up (11/47 [23.4%]). In study B, a total of 213 participants were randomized to receive either clindamycin gel 1% (n=109 [51.2%]) twice daily or vehicle gel (n=104 [48.8%]) twice daily, with 193 participants (90.6%) completing the study; 20 (9.4%) participants discontinued study B, mainly due to participant request (6/20 [30%]) or lost to follow-up (4/20 [20%]). Participants in studies A and B were similar in demographics and baseline disease characteristics (Table). The majority of participants were white females. 

Efficacy

No statistically significant difference was observed in all pairwise comparisons (clindamycin cream twice daily vs vehicle twice daily, clindamycin cream once daily vs vehicle once daily, clindamycin gel vs vehicle gel) for the primary end point of mean percentage change from baseline in inflammatory lesion counts at week 12 (Figure 1; P>.5 for all pairwise comparisons). 

At week 12, the proportion of participants in study B deemed as a success (none/clear or mild/almost clear [investigator global rosacea severity score of 0 or 1]) in the clindamycin gel 1% and vehicle gel groups were 45% versus 38%, respectively (P=.347) (Figure 2). 

For the secondary end point of mean investigator global rosacea severity assessment at week 12 (study A), there were no significant differences between the active and vehicle control groups (P>.5 for all pairwise comparisons)(Figure 3). Also, the proportion of participants with at least a moderate investigator global improvement assessment from baseline to week 12 ranged from 45% for clindamycin cream 1% twice daily to 56% for clindamycin cream 0.3% cream once daily and from 45% for vehicle cream once daily to 51% for vehicle cream twice daily (P>.5 for all pairwise comparisons).

There were no significant differences in the mean total erythema severity scores at week 12 for clindamycin cream 1% twice daily versus vehicle cream twice daily (6.3 vs 6.0; P>.5), clindamycin cream 1% once daily versus vehicle cream once daily (6.2 vs 6.0; P>.5), clindamycin cream 0.3% once daily versus vehicle cream once daily (5.9 vs 6.0; P>.5), and clindamycin gel 1% twice daily versus vehicle gel twice daily (6.7 vs 6.2; P>.5). 

There were no relevant differences between any of the clindamycin cream groups and their respective vehicle group at week 12 for skin irritation, including desquamation, edema, dryness, pruritus, and stinging/burning.

Safety

In study A, the majority of AEs in all 5 treatment arms were nondermatologic, mild in intensity, and not considered to be related to the study treatment by the investigator. Overall, 12 participants had AEs considered by the investigator as possibly or probably related to the study treatment: 4.9% in the clindamycin cream 1% twice daily group, 4.6% in the clindamycin cream 1% once daily group, 3.7% in the vehicle cream twice daily group, 1.2% in the clindamycin cream 0.3% once daily group, and 0% in the vehicle cream once daily group. Two treatment-related AEs led to treatment discontinuation, including dermatitis in 1 participant from the clindamycin cream 1% once daily group and contact dermatitis in 1 participant from the clindamycin cream 1% twice daily group.

Comment

No evidence of increased efficacy over the respective vehicles was observed with clindamycin cream or gel, whatever the regimen, in the treatment of rosacea patients in either of these well-designed and well-powered, blinded studies. Slight improvements in the various efficacy criteria were observed, even in the vehicle groups, highlighting the importance of using a good basic skin care regimen in the management of rosacea.⁹ In contrast to our observations of lack of efficacy in the treatment of rosacea, clinical efficacy of clindamycin has been demonstrated in acne,^10-12 albeit with low efficacy for clindamycin monotherapy.¹³ It is noteworthy that oral or topical antibiotics are no longer recommended as monotherapy for acne to prevent and minimize antibiotic resistance and to preserve the therapeutic value of antibiotics.¹⁴

Acne and rosacea are both chronic inflammatory disorders of the skin associated with papules and pustules, and they share some common inflammatory patterns.^15-19 Furthermore, the intrinsic anti-inflammatory activity of clindamycin in addition to its antibiotic effects has been suggested by some authors as the main reason for treating acne with clindamycin.²⁰ However, the relative contributions of antibacterial and/or anti-inflammatory properties remain to be fully elucidated, and evidence for direct anti-inflammatory effects of clindamycin remains heterogeneous.^21,22 Several pathophysiological factors have been implicated in acne, including hormonal effects, abnormal keratinocyte function, increased sebum production, and microbial components (eg, hypercolonization of the skin follicles by Propionibacterium acnes).^23,24 The antibiotic activity of clindamycin against P acnes may be the key factor responsible for the clinical effects in acne.^25,26 Although clindamycin may have anti-inflammatory effects in acne via a different inflammatory pathway not shared by rosacea, a purely antibiotic mechanism of action of clindamycin also could explain why we observed no evidence of efficacy in the treatment of rosacea, as no causative bacterial component has been clearly demonstrated in rosacea.²⁷

Conclusion

In these studies, clindamycin cream 0.3% once daily, clindamycin cream 1% once or twice daily, and clindamycin gel 1% twice daily were all well tolerated; however, they were no more effective than the vehicles in the treatment of moderate to severe rosacea.  

Acknowledgment

The authors would like to thank Helen Simpson, PhD, of Galderma R&D (Sophia Antipolis, France), for editorial and medical writing assistance.

Facial acne vulgaris is a common skin disease among teenagers and adolescents that may negatively affect self-esteem, perceived facial attractiveness, and social participation.¹ Treatments for acne often are multimodal and require the utmost adherence. For these reasons, acne treatments have been challenging to clinicians and patients alike, as patient compliance in maintaining the use of prescribed topical and oral medications remains essential to attain improvement in quality of life (QOL).

Salicylic acid is a popular medicament for acne treatment that frequently is used as monotherapy or as an adjuvant for other acne treatments, especially in patients with oily skin.² Salicylic acid has a keratolytic effect, causing corneocyte discohesion in clogged pores or congested follicles,² and it is effective in treating both inflammatory and noninflammatory acne.^3,4

Light therapy, particularly with visible light, has been demonstrated to improve acne outcomes.⁵ Pneumatic broadband light (PBBL) is a therapeutic light treatment in the broadband range (400–1200 nm) that is combined with vacuum suction, which creates a mechanical lysis of thin-walled pustules and dislodges pore impaction. Additionally, the blue light portion of the PBBL spectrum targets endogenous porphyrins in Propionibacterium acnes, resulting in bacterial destruction.^6-8

The purpose of this study was to compare the efficacy, tolerability, and safety of salicylic acid 30% peel versus PBBL in the treatment of mild to moderately severe facial acne vulgaris.

METHODS

Study Design

This single-blind, randomized, split-face pilot study was approved by the institutional review board of the University of Pennsylvania (Philadelphia, Pennsylvania). All patients provided informed consent before entering the study. The single-blind evaluation was performed by one dermatologist (C.T.) who examined the participants on every visit prior to PBBL treatment.

Before the study started, participants were randomized for which side of the face was to be treated with PBBL using a number assigned to each participant. Participants received both treatments—salicylic acid 30% peel on one side of the face and PBBL treatment on the other side of the face—once weekly for a total of 6 treatments. They were then asked to return for 2 follow-up evaluations at weeks 3 and 6 following the last treatment session and were instructed not to use any topical or oral acne medications during these follow-up periods.

Inclusion and Exclusion Criteria

Patients aged 18 years and older of any race and sex with noninflammatory papules, some inflammatory papules, and no more than 1 nodule (considered as mild to moderately severe facial acne) were included in the study. Participants had not been on any topical acne medications for at least 1 month and/or oral retinoids for at least 1 year prior to the study period. All women completed urine pregnancy tests prior to the study and were advised to utilize birth control during the study period.

Study Treatments

Salicylic Acid 30% Peel

The participant’s face was cleansed thoroughly before application of salicylic acid 30% (1.5 g/2.5 mL) to half of the face and left on for 5 minutes before being carefully rinsed off by spraying with spring water. Prior to initiating PBBL therapy, the peeled side of the participant’s face was covered with a towel.

Pneumatic Broadband Light

On the other side of the face, PBBL was performed to deliver broadband light within the spectrum range of 400 to 1200 nm at a setting approximately equivalent to a fluence of 4 to 6 J/cm² and a vacuum setting approximately equivalent to a negative pressure of 3 lb/in². The power setting was increased on each subsequent visit depending on each participant’s tolerability.

Participants were required to apply a moisturizer and sunscreen to the face and avoid excessive sun exposure between study visits.

Efficacy Evaluation

A comparison of the efficacy of the treatments was determined by clinical evaluation and examining the results of the outcome measurements with the modified Global Acne Grading Score (mGAGS) and Acne QOL Scale during each treatment visit. Facial photographs were taken at each visit.

Modified Global Acne Grading Score

The mGAGS is a modification of the Global Acne Grading Scale (GAGS) that has been used to evaluate acne severity in many studies.^9-11 The GAGS considers 6 locations on the face with a grading factor for each location. The local score is obtained by multiplying the factor rated by location with the factor of clinical assessment: local score = factor rated by location × factor rated by clinical assessment. The total score is the sum of the individual local scores (Table 1).

Although the original GAGS incorporated the type and location of the lesions in its calculation, we felt that the number of lesions also was important to add to our grading score. Therefore, we modified the GAGS by adding a factor rated by the number of lesions to improve the accuracy of the test. Accordingly, the local mGAGS scores were calculated by multiplying the location factor by the lesion type and number of lesions factors: local score = location factor × lesion type factor × number of lesions factor.

Acne QOL Questionnaire

Acne QOL was assessed during each visit to demonstrate if the treatment results affected participants’ socialization due to appearance.¹² Participants were asked to complete the questionnaire, which consisted of 9 questions with 4 rating answers (0=not affected; 1=mildly affected; 2=moderately affected; 3=markedly affected). A total score of 9 or higher (high score) indicated that acne had a substantial negative impact on the participant, while a total score below 9 (low score) meant acne scarcely impacted social aspects and daily activities of the patient.

Safety Evaluation

The safety of the treatments was evaluated by clinical inspection and by comparing the results of the Wong-Baker FACES Pain Rating Scale (WBPRS)¹³ after treatment. The WBPRS is used worldwide among researchers to assess pain, particularly in children.^14,15 It is composed of 6 faces expressing pain with word descriptions with a corresponding number range reflecting pain severity from 0 to 5 (0=no hurt; 1=hurts little bit; 2=hurts little more; 3=hurts even more; 4=hurts whole lot; 5=hurts worst).¹³

Statistical Analysis

All variables were presented as the median (range). A Wilcoxon signed rank test was used to compare clinical responses between the salicylic acid 30% peel and PBBL therapies. SPSS software version 12.0 was used for all statistical analysis. A 2-tailed P value of ≤.05 was considered statistically significant.

 

RESULTS

Study Population

Twelve participants (2 males, 10 females) aged 17 to 36 years (median age, 22 years; mean age [SD], 23.33 [1.65] years) with both comedonal and inflammatory acne were enrolled into this study for 6 split-face treatments of salicylic acid 30% peel and PBBL at 1-week intervals for 6 weeks, with 2 subsequent follow-up sessions at weeks 3 and 6 posttreatment. Of the 12 participants, 11 were white and 1 was Asian American, with Fitzpatrick skin types II to IV. Nine participants (75%) completed the study. One participant dropped out of the study after the fourth treatment due to a scheduling conflict, and the other 2 participants did not return for follow-up. No participants withdrew from the study because of adverse therapeutic events.

Efficacy Evaluation

Comparisons between the salicylic acid 30% peel and PBBL procedures for mGAGS at each visit are shown in Table 2. There was no significant difference in treatment efficacy between the salicylic acid 30% peel and PBBL therapies during the study’s treatment and follow-up events; however, both procedures contributed to a major improvement in acne symptoms by the third treatment session and through to the last follow-up session (P≤.05). Clinical photographs at baseline, at last treatment visit (week 6), and at last follow-up (week 12) are shown in Figures 1 and 2.

The results of the acne QOL questionnaire are shown in Table 2. Lower scores reflect a higher QOL. Median QOL scores at each visit ranged from 0.5 to 4.5. There was no significant difference found between the peel agent or PBBL based on the baseline QOL and subsequent visit assessments; however, the differences between the 2 treatments were significant at weeks 3 (P=.05) and 5 (P=.03) of treatment as well as at the last follow-up visit (P=.05).

According to the QOL scores, by the third treatment session participants were more satisfied with their improved acne condition from the PBBL procedure than the salicylic acid 30% peel as demonstrated by a positive range of the QOL assessments between PBBL and salicylic acid 30% peel (as shown in the difference in QOL in Table 2: week 3, 0–6; week 4, 0–3; week 5, 0–7). On the other hand, participants saw more improvement from the salicylic acid 30% peel than from PBBL by the last follow-up evaluation, as the differences in QOL scores between the 2 treatments resulted in a negative range (−5–0).

Safety

Pain assessment by the WBPRS at every visit showed a low pain rating associated with both salicylic acid 30% peel (range, 0–0.5) and PBBL (range, 1.0–1.5) treatments. The median pain score of the salicylic acid 30% peel appeared higher compared to the PBBL treatment, yet a significant difference between both treatments was seen only at weeks 1, 3, and 6 of treatment (P≤.05).

There were no unexpected therapeutic reactions reported in our study, and no participants withdrew from the study due to adverse events. Most participants experienced only mild adverse reactions, including redness, stinging, and a burning sensation on the salicylic acid 30% peel side, which were transient and disappeared in minutes; only redness occurred on the PBBL-treated side.

Comment

Facial acne treatment is challenging, as prolonged and/or severe acne contributes to scarring, declining self-confidence, and undesirable financial consequences. Even though salicylic acid peel is a commonly used acne treatment choice, the PBBL methodology was approved by the US Food and Drug Administration⁶ and has become an alternative procedure for acne treatment.

The pharmacological effects of salicylic acid are related to its corneocyte desquamation and exfoliative actions, thereby reducing corneocyte cohesion and unclogging follicular pores.¹⁶ Salicylic acid has been demonstrated to ameliorate inflammatory acne by its effects on the arachidonic acid cascade.^2,4,17 In our study, salicylic acid 30% peel met participants’ satisfaction in acne improvement similar to a study showing a 50% improvement in acne scores after just 2 treatments.¹⁸ Our data support and corroborate that salicylic acid 30% peel renders an improvement in acne sequelae reported in several other studies.^2,17,18

Pneumatic broadband light has been known to treat acne by the mechanism of pneumatic suction combined with photodynamic therapy using broadband-pulsed light (400–1200 nm).^6-8 By applying the pneumatic device, a vacuum is created on the skin to remove sebum contents from follicles, whereas broadband light is emitted simultaneously to destroy bacteria and decrease the inflammatory process.⁷ During the vacuum process, the skin is stretched to reduce pain and avoid competitive chromophores (eg, hemoglobin), while the broadband light is administered.⁷ Broadband light encompasses 2 main light spectrums: blue light (415 nm) activates coproporphyrin III, which induces reactive free radicals and singlet oxygen species and has been reported to be the cause of bacterial cell death,¹⁹ and red light (633 nm), which renders an increase of fibroblast growth factors to work against the inflammatory processes.²⁰ There are numerous studies showing a reduction of acne lesions after photopneumatic therapy with minimal side effects.^6-8

In our study, we compared the efficacy of salicylic acid 30% peel with PBBL in the treatment of acne. Both treatments showed significant reduction of mGAGS compared to baseline starting from week 3 and lasting until week 12. Remarkably, although there were some participants who reported acne recurrence after completing all treatments at week 6, which could have happened when the treatments were ended, the final acne score at week 12 was still significantly lower than baseline. It is clear that the participants continued their acne improvement up to the 6-week follow-up period without any topical or oral medication. We do not propose that either salicylic acid peel or PBBL treatment is a solitary option but speculate that the combination of both treatments may initiate a faster resolution in the disappearance of acne.

Although there was no statistically significant difference in efficacy between salicylic acid 30% peel and PBBL procedures at each visit, QOL assessments related to treatment satisfaction did yield significant differences between baseline and the end of treatment. We noticed that participants had more positive attitudes toward the PBBL side at week 3 and week 5 but only mild satisfaction at week 4, as the differences in QOL scores between both treatments showed positive ranging values. This finding is most likely related to the immediate reduction of acne pustules by the PBBL vacuum lysis of these lesions. The differences in the QOL scores between both treatments at week 12 (the last follow-up evaluation) provided opposite findings, which meant patients had nearly even improvement in both PBBL method and salicylic acid 30% peel. Therefore, according to QOL data, acne disappeared quickly with the application of PBBL therapy but reappeared on the PBBL-treated side by the follow-up evaluations, though the acne score between both sides showed no statistically significant difference.

We reason that the PBBL therapy works better than salicylic acid 30% peel because the pneumatic system may help to unclog the pores through mechanical debridement via suctioning versus desquamation from salicylic acid 30% peel. Nonetheless, salicylic acid 30% peel sustained improvement when compared to PBBL through the follow-up periods. Both salicylic acid 30% peel and PBBL treatments are well tolerated and may initiate a faster resolution in the improvement of acne when incorporated with a medical program.

Because of the recurrence of acne after treatments were stopped, additional medical therapies are advised to be used along with this study’s clinical treatments to help mitigate the acne symptoms. These treatments should be considered in patients concerned about antibiotic resistance or those who cannot take oral antibiotics or retinoids. Salicylic acid peel is more accessible and affordable than PBBL, whereas PBBL is slightly more tolerable and less irritating than salicylic acid peel. Nevertheless, the cost of investment in PBBL is quite high—as much as $70,000—and does not include disposable, single-use tips, which cost $30 each. The machine is easy to set up, weighs about 40 lb, and requires little space to store. The average cost per visit of PBBL treatment in office is $150.00 and $75.00 for salicylic acid peel (unpublished data, Hospital of the University of Pennsylvania, 2010). Most patients may select salicylic acid peel over PBBL due to the cost and convenience of the treatment. Neither procedure should be considered as a solitary treatment option but rather as adjunctive procedures combined with oral and/or topical acne medications. After this study’s treatments were stopped and without other medications to maintain treatment effectiveness, the lesions reappeared, trending back toward baseline.

 

Conclusion

Both salicylic acid 30% peel and PBBL procedures are effective, safe, and well tolerated in treating acne. Although there was no significant difference in the efficacy between both treatments in this study, the small sample size and short follow-up intervals warrant further studies to support the observed outstanding outcomes and should be considered in combination with other medical treatment options. These procedures may be beneficial in holding the patient compliant until their medical therapies have an opportunity to work.

Acknowledgment

The authors would like to thank Joyce Okawa, RN (Philadelphia, Pennsylvania), for her assistance in the submission to the institutional review board of the University of Pennsylvania.

Facial acne vulgaris is a common skin disease among teenagers and adolescents that may negatively affect self-esteem, perceived facial attractiveness, and social participation.¹ Treatments for acne often are multimodal and require the utmost adherence. For these reasons, acne treatments have been challenging to clinicians and patients alike, as patient compliance in maintaining the use of prescribed topical and oral medications remains essential to attain improvement in quality of life (QOL).

Salicylic acid is a popular medicament for acne treatment that frequently is used as monotherapy or as an adjuvant for other acne treatments, especially in patients with oily skin.² Salicylic acid has a keratolytic effect, causing corneocyte discohesion in clogged pores or congested follicles,² and it is effective in treating both inflammatory and noninflammatory acne.^3,4

Light therapy, particularly with visible light, has been demonstrated to improve acne outcomes.⁵ Pneumatic broadband light (PBBL) is a therapeutic light treatment in the broadband range (400–1200 nm) that is combined with vacuum suction, which creates a mechanical lysis of thin-walled pustules and dislodges pore impaction. Additionally, the blue light portion of the PBBL spectrum targets endogenous porphyrins in Propionibacterium acnes, resulting in bacterial destruction.^6-8

The purpose of this study was to compare the efficacy, tolerability, and safety of salicylic acid 30% peel versus PBBL in the treatment of mild to moderately severe facial acne vulgaris.

METHODS

Study Design

This single-blind, randomized, split-face pilot study was approved by the institutional review board of the University of Pennsylvania (Philadelphia, Pennsylvania). All patients provided informed consent before entering the study. The single-blind evaluation was performed by one dermatologist (C.T.) who examined the participants on every visit prior to PBBL treatment.

Before the study started, participants were randomized for which side of the face was to be treated with PBBL using a number assigned to each participant. Participants received both treatments—salicylic acid 30% peel on one side of the face and PBBL treatment on the other side of the face—once weekly for a total of 6 treatments. They were then asked to return for 2 follow-up evaluations at weeks 3 and 6 following the last treatment session and were instructed not to use any topical or oral acne medications during these follow-up periods.

Inclusion and Exclusion Criteria

Patients aged 18 years and older of any race and sex with noninflammatory papules, some inflammatory papules, and no more than 1 nodule (considered as mild to moderately severe facial acne) were included in the study. Participants had not been on any topical acne medications for at least 1 month and/or oral retinoids for at least 1 year prior to the study period. All women completed urine pregnancy tests prior to the study and were advised to utilize birth control during the study period.

Study Treatments

Salicylic Acid 30% Peel

The participant’s face was cleansed thoroughly before application of salicylic acid 30% (1.5 g/2.5 mL) to half of the face and left on for 5 minutes before being carefully rinsed off by spraying with spring water. Prior to initiating PBBL therapy, the peeled side of the participant’s face was covered with a towel.

Pneumatic Broadband Light

On the other side of the face, PBBL was performed to deliver broadband light within the spectrum range of 400 to 1200 nm at a setting approximately equivalent to a fluence of 4 to 6 J/cm² and a vacuum setting approximately equivalent to a negative pressure of 3 lb/in². The power setting was increased on each subsequent visit depending on each participant’s tolerability.

Participants were required to apply a moisturizer and sunscreen to the face and avoid excessive sun exposure between study visits.

Efficacy Evaluation

A comparison of the efficacy of the treatments was determined by clinical evaluation and examining the results of the outcome measurements with the modified Global Acne Grading Score (mGAGS) and Acne QOL Scale during each treatment visit. Facial photographs were taken at each visit.

Modified Global Acne Grading Score

The mGAGS is a modification of the Global Acne Grading Scale (GAGS) that has been used to evaluate acne severity in many studies.^9-11 The GAGS considers 6 locations on the face with a grading factor for each location. The local score is obtained by multiplying the factor rated by location with the factor of clinical assessment: local score = factor rated by location × factor rated by clinical assessment. The total score is the sum of the individual local scores (Table 1).

Although the original GAGS incorporated the type and location of the lesions in its calculation, we felt that the number of lesions also was important to add to our grading score. Therefore, we modified the GAGS by adding a factor rated by the number of lesions to improve the accuracy of the test. Accordingly, the local mGAGS scores were calculated by multiplying the location factor by the lesion type and number of lesions factors: local score = location factor × lesion type factor × number of lesions factor.

Acne QOL Questionnaire

Acne QOL was assessed during each visit to demonstrate if the treatment results affected participants’ socialization due to appearance.¹² Participants were asked to complete the questionnaire, which consisted of 9 questions with 4 rating answers (0=not affected; 1=mildly affected; 2=moderately affected; 3=markedly affected). A total score of 9 or higher (high score) indicated that acne had a substantial negative impact on the participant, while a total score below 9 (low score) meant acne scarcely impacted social aspects and daily activities of the patient.

Safety Evaluation

The safety of the treatments was evaluated by clinical inspection and by comparing the results of the Wong-Baker FACES Pain Rating Scale (WBPRS)¹³ after treatment. The WBPRS is used worldwide among researchers to assess pain, particularly in children.^14,15 It is composed of 6 faces expressing pain with word descriptions with a corresponding number range reflecting pain severity from 0 to 5 (0=no hurt; 1=hurts little bit; 2=hurts little more; 3=hurts even more; 4=hurts whole lot; 5=hurts worst).¹³

Statistical Analysis

All variables were presented as the median (range). A Wilcoxon signed rank test was used to compare clinical responses between the salicylic acid 30% peel and PBBL therapies. SPSS software version 12.0 was used for all statistical analysis. A 2-tailed P value of ≤.05 was considered statistically significant.

 

RESULTS

Study Population

Twelve participants (2 males, 10 females) aged 17 to 36 years (median age, 22 years; mean age [SD], 23.33 [1.65] years) with both comedonal and inflammatory acne were enrolled into this study for 6 split-face treatments of salicylic acid 30% peel and PBBL at 1-week intervals for 6 weeks, with 2 subsequent follow-up sessions at weeks 3 and 6 posttreatment. Of the 12 participants, 11 were white and 1 was Asian American, with Fitzpatrick skin types II to IV. Nine participants (75%) completed the study. One participant dropped out of the study after the fourth treatment due to a scheduling conflict, and the other 2 participants did not return for follow-up. No participants withdrew from the study because of adverse therapeutic events.

Efficacy Evaluation

Comparisons between the salicylic acid 30% peel and PBBL procedures for mGAGS at each visit are shown in Table 2. There was no significant difference in treatment efficacy between the salicylic acid 30% peel and PBBL therapies during the study’s treatment and follow-up events; however, both procedures contributed to a major improvement in acne symptoms by the third treatment session and through to the last follow-up session (P≤.05). Clinical photographs at baseline, at last treatment visit (week 6), and at last follow-up (week 12) are shown in Figures 1 and 2.

The results of the acne QOL questionnaire are shown in Table 2. Lower scores reflect a higher QOL. Median QOL scores at each visit ranged from 0.5 to 4.5. There was no significant difference found between the peel agent or PBBL based on the baseline QOL and subsequent visit assessments; however, the differences between the 2 treatments were significant at weeks 3 (P=.05) and 5 (P=.03) of treatment as well as at the last follow-up visit (P=.05).

According to the QOL scores, by the third treatment session participants were more satisfied with their improved acne condition from the PBBL procedure than the salicylic acid 30% peel as demonstrated by a positive range of the QOL assessments between PBBL and salicylic acid 30% peel (as shown in the difference in QOL in Table 2: week 3, 0–6; week 4, 0–3; week 5, 0–7). On the other hand, participants saw more improvement from the salicylic acid 30% peel than from PBBL by the last follow-up evaluation, as the differences in QOL scores between the 2 treatments resulted in a negative range (−5–0).

Safety

Pain assessment by the WBPRS at every visit showed a low pain rating associated with both salicylic acid 30% peel (range, 0–0.5) and PBBL (range, 1.0–1.5) treatments. The median pain score of the salicylic acid 30% peel appeared higher compared to the PBBL treatment, yet a significant difference between both treatments was seen only at weeks 1, 3, and 6 of treatment (P≤.05).

There were no unexpected therapeutic reactions reported in our study, and no participants withdrew from the study due to adverse events. Most participants experienced only mild adverse reactions, including redness, stinging, and a burning sensation on the salicylic acid 30% peel side, which were transient and disappeared in minutes; only redness occurred on the PBBL-treated side.

Comment

Facial acne treatment is challenging, as prolonged and/or severe acne contributes to scarring, declining self-confidence, and undesirable financial consequences. Even though salicylic acid peel is a commonly used acne treatment choice, the PBBL methodology was approved by the US Food and Drug Administration⁶ and has become an alternative procedure for acne treatment.

The pharmacological effects of salicylic acid are related to its corneocyte desquamation and exfoliative actions, thereby reducing corneocyte cohesion and unclogging follicular pores.¹⁶ Salicylic acid has been demonstrated to ameliorate inflammatory acne by its effects on the arachidonic acid cascade.^2,4,17 In our study, salicylic acid 30% peel met participants’ satisfaction in acne improvement similar to a study showing a 50% improvement in acne scores after just 2 treatments.¹⁸ Our data support and corroborate that salicylic acid 30% peel renders an improvement in acne sequelae reported in several other studies.^2,17,18

Pneumatic broadband light has been known to treat acne by the mechanism of pneumatic suction combined with photodynamic therapy using broadband-pulsed light (400–1200 nm).^6-8 By applying the pneumatic device, a vacuum is created on the skin to remove sebum contents from follicles, whereas broadband light is emitted simultaneously to destroy bacteria and decrease the inflammatory process.⁷ During the vacuum process, the skin is stretched to reduce pain and avoid competitive chromophores (eg, hemoglobin), while the broadband light is administered.⁷ Broadband light encompasses 2 main light spectrums: blue light (415 nm) activates coproporphyrin III, which induces reactive free radicals and singlet oxygen species and has been reported to be the cause of bacterial cell death,¹⁹ and red light (633 nm), which renders an increase of fibroblast growth factors to work against the inflammatory processes.²⁰ There are numerous studies showing a reduction of acne lesions after photopneumatic therapy with minimal side effects.^6-8

In our study, we compared the efficacy of salicylic acid 30% peel with PBBL in the treatment of acne. Both treatments showed significant reduction of mGAGS compared to baseline starting from week 3 and lasting until week 12. Remarkably, although there were some participants who reported acne recurrence after completing all treatments at week 6, which could have happened when the treatments were ended, the final acne score at week 12 was still significantly lower than baseline. It is clear that the participants continued their acne improvement up to the 6-week follow-up period without any topical or oral medication. We do not propose that either salicylic acid peel or PBBL treatment is a solitary option but speculate that the combination of both treatments may initiate a faster resolution in the disappearance of acne.

Although there was no statistically significant difference in efficacy between salicylic acid 30% peel and PBBL procedures at each visit, QOL assessments related to treatment satisfaction did yield significant differences between baseline and the end of treatment. We noticed that participants had more positive attitudes toward the PBBL side at week 3 and week 5 but only mild satisfaction at week 4, as the differences in QOL scores between both treatments showed positive ranging values. This finding is most likely related to the immediate reduction of acne pustules by the PBBL vacuum lysis of these lesions. The differences in the QOL scores between both treatments at week 12 (the last follow-up evaluation) provided opposite findings, which meant patients had nearly even improvement in both PBBL method and salicylic acid 30% peel. Therefore, according to QOL data, acne disappeared quickly with the application of PBBL therapy but reappeared on the PBBL-treated side by the follow-up evaluations, though the acne score between both sides showed no statistically significant difference.

We reason that the PBBL therapy works better than salicylic acid 30% peel because the pneumatic system may help to unclog the pores through mechanical debridement via suctioning versus desquamation from salicylic acid 30% peel. Nonetheless, salicylic acid 30% peel sustained improvement when compared to PBBL through the follow-up periods. Both salicylic acid 30% peel and PBBL treatments are well tolerated and may initiate a faster resolution in the improvement of acne when incorporated with a medical program.

Because of the recurrence of acne after treatments were stopped, additional medical therapies are advised to be used along with this study’s clinical treatments to help mitigate the acne symptoms. These treatments should be considered in patients concerned about antibiotic resistance or those who cannot take oral antibiotics or retinoids. Salicylic acid peel is more accessible and affordable than PBBL, whereas PBBL is slightly more tolerable and less irritating than salicylic acid peel. Nevertheless, the cost of investment in PBBL is quite high—as much as $70,000—and does not include disposable, single-use tips, which cost $30 each. The machine is easy to set up, weighs about 40 lb, and requires little space to store. The average cost per visit of PBBL treatment in office is $150.00 and $75.00 for salicylic acid peel (unpublished data, Hospital of the University of Pennsylvania, 2010). Most patients may select salicylic acid peel over PBBL due to the cost and convenience of the treatment. Neither procedure should be considered as a solitary treatment option but rather as adjunctive procedures combined with oral and/or topical acne medications. After this study’s treatments were stopped and without other medications to maintain treatment effectiveness, the lesions reappeared, trending back toward baseline.

 

Conclusion

Both salicylic acid 30% peel and PBBL procedures are effective, safe, and well tolerated in treating acne. Although there was no significant difference in the efficacy between both treatments in this study, the small sample size and short follow-up intervals warrant further studies to support the observed outstanding outcomes and should be considered in combination with other medical treatment options. These procedures may be beneficial in holding the patient compliant until their medical therapies have an opportunity to work.

Acknowledgment

The authors would like to thank Joyce Okawa, RN (Philadelphia, Pennsylvania), for her assistance in the submission to the institutional review board of the University of Pennsylvania.

Facial acne vulgaris is a common skin disease among teenagers and adolescents that may negatively affect self-esteem, perceived facial attractiveness, and social participation.¹ Treatments for acne often are multimodal and require the utmost adherence. For these reasons, acne treatments have been challenging to clinicians and patients alike, as patient compliance in maintaining the use of prescribed topical and oral medications remains essential to attain improvement in quality of life (QOL).

Salicylic acid is a popular medicament for acne treatment that frequently is used as monotherapy or as an adjuvant for other acne treatments, especially in patients with oily skin.² Salicylic acid has a keratolytic effect, causing corneocyte discohesion in clogged pores or congested follicles,² and it is effective in treating both inflammatory and noninflammatory acne.^3,4

Light therapy, particularly with visible light, has been demonstrated to improve acne outcomes.⁵ Pneumatic broadband light (PBBL) is a therapeutic light treatment in the broadband range (400–1200 nm) that is combined with vacuum suction, which creates a mechanical lysis of thin-walled pustules and dislodges pore impaction. Additionally, the blue light portion of the PBBL spectrum targets endogenous porphyrins in Propionibacterium acnes, resulting in bacterial destruction.^6-8

The purpose of this study was to compare the efficacy, tolerability, and safety of salicylic acid 30% peel versus PBBL in the treatment of mild to moderately severe facial acne vulgaris.

METHODS

Study Design

This single-blind, randomized, split-face pilot study was approved by the institutional review board of the University of Pennsylvania (Philadelphia, Pennsylvania). All patients provided informed consent before entering the study. The single-blind evaluation was performed by one dermatologist (C.T.) who examined the participants on every visit prior to PBBL treatment.

Before the study started, participants were randomized for which side of the face was to be treated with PBBL using a number assigned to each participant. Participants received both treatments—salicylic acid 30% peel on one side of the face and PBBL treatment on the other side of the face—once weekly for a total of 6 treatments. They were then asked to return for 2 follow-up evaluations at weeks 3 and 6 following the last treatment session and were instructed not to use any topical or oral acne medications during these follow-up periods.

Inclusion and Exclusion Criteria

Patients aged 18 years and older of any race and sex with noninflammatory papules, some inflammatory papules, and no more than 1 nodule (considered as mild to moderately severe facial acne) were included in the study. Participants had not been on any topical acne medications for at least 1 month and/or oral retinoids for at least 1 year prior to the study period. All women completed urine pregnancy tests prior to the study and were advised to utilize birth control during the study period.

Study Treatments

Salicylic Acid 30% Peel

The participant’s face was cleansed thoroughly before application of salicylic acid 30% (1.5 g/2.5 mL) to half of the face and left on for 5 minutes before being carefully rinsed off by spraying with spring water. Prior to initiating PBBL therapy, the peeled side of the participant’s face was covered with a towel.

Pneumatic Broadband Light

On the other side of the face, PBBL was performed to deliver broadband light within the spectrum range of 400 to 1200 nm at a setting approximately equivalent to a fluence of 4 to 6 J/cm² and a vacuum setting approximately equivalent to a negative pressure of 3 lb/in². The power setting was increased on each subsequent visit depending on each participant’s tolerability.

Participants were required to apply a moisturizer and sunscreen to the face and avoid excessive sun exposure between study visits.

Efficacy Evaluation

A comparison of the efficacy of the treatments was determined by clinical evaluation and examining the results of the outcome measurements with the modified Global Acne Grading Score (mGAGS) and Acne QOL Scale during each treatment visit. Facial photographs were taken at each visit.

Modified Global Acne Grading Score

The mGAGS is a modification of the Global Acne Grading Scale (GAGS) that has been used to evaluate acne severity in many studies.^9-11 The GAGS considers 6 locations on the face with a grading factor for each location. The local score is obtained by multiplying the factor rated by location with the factor of clinical assessment: local score = factor rated by location × factor rated by clinical assessment. The total score is the sum of the individual local scores (Table 1).

Although the original GAGS incorporated the type and location of the lesions in its calculation, we felt that the number of lesions also was important to add to our grading score. Therefore, we modified the GAGS by adding a factor rated by the number of lesions to improve the accuracy of the test. Accordingly, the local mGAGS scores were calculated by multiplying the location factor by the lesion type and number of lesions factors: local score = location factor × lesion type factor × number of lesions factor.

Acne QOL Questionnaire

Acne QOL was assessed during each visit to demonstrate if the treatment results affected participants’ socialization due to appearance.¹² Participants were asked to complete the questionnaire, which consisted of 9 questions with 4 rating answers (0=not affected; 1=mildly affected; 2=moderately affected; 3=markedly affected). A total score of 9 or higher (high score) indicated that acne had a substantial negative impact on the participant, while a total score below 9 (low score) meant acne scarcely impacted social aspects and daily activities of the patient.

Safety Evaluation

The safety of the treatments was evaluated by clinical inspection and by comparing the results of the Wong-Baker FACES Pain Rating Scale (WBPRS)¹³ after treatment. The WBPRS is used worldwide among researchers to assess pain, particularly in children.^14,15 It is composed of 6 faces expressing pain with word descriptions with a corresponding number range reflecting pain severity from 0 to 5 (0=no hurt; 1=hurts little bit; 2=hurts little more; 3=hurts even more; 4=hurts whole lot; 5=hurts worst).¹³

Statistical Analysis

All variables were presented as the median (range). A Wilcoxon signed rank test was used to compare clinical responses between the salicylic acid 30% peel and PBBL therapies. SPSS software version 12.0 was used for all statistical analysis. A 2-tailed P value of ≤.05 was considered statistically significant.

 

RESULTS

Study Population

Twelve participants (2 males, 10 females) aged 17 to 36 years (median age, 22 years; mean age [SD], 23.33 [1.65] years) with both comedonal and inflammatory acne were enrolled into this study for 6 split-face treatments of salicylic acid 30% peel and PBBL at 1-week intervals for 6 weeks, with 2 subsequent follow-up sessions at weeks 3 and 6 posttreatment. Of the 12 participants, 11 were white and 1 was Asian American, with Fitzpatrick skin types II to IV. Nine participants (75%) completed the study. One participant dropped out of the study after the fourth treatment due to a scheduling conflict, and the other 2 participants did not return for follow-up. No participants withdrew from the study because of adverse therapeutic events.

Efficacy Evaluation

Comparisons between the salicylic acid 30% peel and PBBL procedures for mGAGS at each visit are shown in Table 2. There was no significant difference in treatment efficacy between the salicylic acid 30% peel and PBBL therapies during the study’s treatment and follow-up events; however, both procedures contributed to a major improvement in acne symptoms by the third treatment session and through to the last follow-up session (P≤.05). Clinical photographs at baseline, at last treatment visit (week 6), and at last follow-up (week 12) are shown in Figures 1 and 2.

The results of the acne QOL questionnaire are shown in Table 2. Lower scores reflect a higher QOL. Median QOL scores at each visit ranged from 0.5 to 4.5. There was no significant difference found between the peel agent or PBBL based on the baseline QOL and subsequent visit assessments; however, the differences between the 2 treatments were significant at weeks 3 (P=.05) and 5 (P=.03) of treatment as well as at the last follow-up visit (P=.05).

According to the QOL scores, by the third treatment session participants were more satisfied with their improved acne condition from the PBBL procedure than the salicylic acid 30% peel as demonstrated by a positive range of the QOL assessments between PBBL and salicylic acid 30% peel (as shown in the difference in QOL in Table 2: week 3, 0–6; week 4, 0–3; week 5, 0–7). On the other hand, participants saw more improvement from the salicylic acid 30% peel than from PBBL by the last follow-up evaluation, as the differences in QOL scores between the 2 treatments resulted in a negative range (−5–0).

Safety

Pain assessment by the WBPRS at every visit showed a low pain rating associated with both salicylic acid 30% peel (range, 0–0.5) and PBBL (range, 1.0–1.5) treatments. The median pain score of the salicylic acid 30% peel appeared higher compared to the PBBL treatment, yet a significant difference between both treatments was seen only at weeks 1, 3, and 6 of treatment (P≤.05).

There were no unexpected therapeutic reactions reported in our study, and no participants withdrew from the study due to adverse events. Most participants experienced only mild adverse reactions, including redness, stinging, and a burning sensation on the salicylic acid 30% peel side, which were transient and disappeared in minutes; only redness occurred on the PBBL-treated side.

Comment

Facial acne treatment is challenging, as prolonged and/or severe acne contributes to scarring, declining self-confidence, and undesirable financial consequences. Even though salicylic acid peel is a commonly used acne treatment choice, the PBBL methodology was approved by the US Food and Drug Administration⁶ and has become an alternative procedure for acne treatment.

The pharmacological effects of salicylic acid are related to its corneocyte desquamation and exfoliative actions, thereby reducing corneocyte cohesion and unclogging follicular pores.¹⁶ Salicylic acid has been demonstrated to ameliorate inflammatory acne by its effects on the arachidonic acid cascade.^2,4,17 In our study, salicylic acid 30% peel met participants’ satisfaction in acne improvement similar to a study showing a 50% improvement in acne scores after just 2 treatments.¹⁸ Our data support and corroborate that salicylic acid 30% peel renders an improvement in acne sequelae reported in several other studies.^2,17,18

Pneumatic broadband light has been known to treat acne by the mechanism of pneumatic suction combined with photodynamic therapy using broadband-pulsed light (400–1200 nm).^6-8 By applying the pneumatic device, a vacuum is created on the skin to remove sebum contents from follicles, whereas broadband light is emitted simultaneously to destroy bacteria and decrease the inflammatory process.⁷ During the vacuum process, the skin is stretched to reduce pain and avoid competitive chromophores (eg, hemoglobin), while the broadband light is administered.⁷ Broadband light encompasses 2 main light spectrums: blue light (415 nm) activates coproporphyrin III, which induces reactive free radicals and singlet oxygen species and has been reported to be the cause of bacterial cell death,¹⁹ and red light (633 nm), which renders an increase of fibroblast growth factors to work against the inflammatory processes.²⁰ There are numerous studies showing a reduction of acne lesions after photopneumatic therapy with minimal side effects.^6-8

In our study, we compared the efficacy of salicylic acid 30% peel with PBBL in the treatment of acne. Both treatments showed significant reduction of mGAGS compared to baseline starting from week 3 and lasting until week 12. Remarkably, although there were some participants who reported acne recurrence after completing all treatments at week 6, which could have happened when the treatments were ended, the final acne score at week 12 was still significantly lower than baseline. It is clear that the participants continued their acne improvement up to the 6-week follow-up period without any topical or oral medication. We do not propose that either salicylic acid peel or PBBL treatment is a solitary option but speculate that the combination of both treatments may initiate a faster resolution in the disappearance of acne.

Although there was no statistically significant difference in efficacy between salicylic acid 30% peel and PBBL procedures at each visit, QOL assessments related to treatment satisfaction did yield significant differences between baseline and the end of treatment. We noticed that participants had more positive attitudes toward the PBBL side at week 3 and week 5 but only mild satisfaction at week 4, as the differences in QOL scores between both treatments showed positive ranging values. This finding is most likely related to the immediate reduction of acne pustules by the PBBL vacuum lysis of these lesions. The differences in the QOL scores between both treatments at week 12 (the last follow-up evaluation) provided opposite findings, which meant patients had nearly even improvement in both PBBL method and salicylic acid 30% peel. Therefore, according to QOL data, acne disappeared quickly with the application of PBBL therapy but reappeared on the PBBL-treated side by the follow-up evaluations, though the acne score between both sides showed no statistically significant difference.

We reason that the PBBL therapy works better than salicylic acid 30% peel because the pneumatic system may help to unclog the pores through mechanical debridement via suctioning versus desquamation from salicylic acid 30% peel. Nonetheless, salicylic acid 30% peel sustained improvement when compared to PBBL through the follow-up periods. Both salicylic acid 30% peel and PBBL treatments are well tolerated and may initiate a faster resolution in the improvement of acne when incorporated with a medical program.

Because of the recurrence of acne after treatments were stopped, additional medical therapies are advised to be used along with this study’s clinical treatments to help mitigate the acne symptoms. These treatments should be considered in patients concerned about antibiotic resistance or those who cannot take oral antibiotics or retinoids. Salicylic acid peel is more accessible and affordable than PBBL, whereas PBBL is slightly more tolerable and less irritating than salicylic acid peel. Nevertheless, the cost of investment in PBBL is quite high—as much as $70,000—and does not include disposable, single-use tips, which cost $30 each. The machine is easy to set up, weighs about 40 lb, and requires little space to store. The average cost per visit of PBBL treatment in office is $150.00 and $75.00 for salicylic acid peel (unpublished data, Hospital of the University of Pennsylvania, 2010). Most patients may select salicylic acid peel over PBBL due to the cost and convenience of the treatment. Neither procedure should be considered as a solitary treatment option but rather as adjunctive procedures combined with oral and/or topical acne medications. After this study’s treatments were stopped and without other medications to maintain treatment effectiveness, the lesions reappeared, trending back toward baseline.

 

Conclusion

Both salicylic acid 30% peel and PBBL procedures are effective, safe, and well tolerated in treating acne. Although there was no significant difference in the efficacy between both treatments in this study, the small sample size and short follow-up intervals warrant further studies to support the observed outstanding outcomes and should be considered in combination with other medical treatment options. These procedures may be beneficial in holding the patient compliant until their medical therapies have an opportunity to work.

Acknowledgment

The authors would like to thank Joyce Okawa, RN (Philadelphia, Pennsylvania), for her assistance in the submission to the institutional review board of the University of Pennsylvania.

Clinician educators face numerous obstacles to their joint mission of facilitating learning while also ensuring high-quality and patient-centered care. Time constraints, including the institution of house officer duty hour limitations,¹ shorter lengths of stay for hospitalized patients,² and competing career responsibilities, combine to create a dynamic learning environment. Additionally, clinician educators must balance the autonomy of their learners with the safety of their patients. They must teach to multiple learning levels and work collaboratively with multiple disciplines to foster an effective team-based approach to patient care. Yet, many clinician educators have no formal training in pedagogical methods.³ Such challenges necessitate increased attention to the work of excellent clinician educators and their respective teaching approaches.

Many studies of clinical teaching rely primarily on survey data of attributes of good clinical teachers.^3-7 While some studies have incorporated direct observations of teaching^8,9 or interviews with clinician educators or learners,^10,11 few have incorporated multiple perspectives from the current team and from former learners in order to provide a comprehensive picture of team-based learning.¹²

The goal of this study was to gain a thorough understanding, through multiple perspectives, of the techniques and behaviors used by exemplary educators within actual clinical environments. We studied attitudes, behaviors, and approaches of 12 such inpatient clinician educators.

METHODS

Study Design and Sampling

This was a multisite study using an exploratory qualitative approach to inquiry. This approach was used to study the techniques and behaviors of excellent attendings during inpatient general medicine rounds. A modified snowball sampling approach¹³ was used, meaning individuals known to one member of the research team (SS) were initially contacted and asked to identify clinician educators (also referred to as attendings) for potential inclusion in the study. In an effort to identify attendings from a broad range of medical schools, the “2015 U.S. News and World Report Top Medical Schools: Research” rankings¹⁴ were also reviewed, with priority given to the top 25, as these are widely used to represent the best US hospitals. In an attempt to invite attendings from diverse institutions, additional medical schools not in the top 25 as well as historically black medical schools were also included. Division chiefs and chairs of internal medicine and/or directors of internal medicine residency programs at these schools were contacted and asked for recommendations of attendings, both within and outside their institutions, who they considered to be great inpatient teachers. In addition, key experts who have won teaching awards or were known to be specialists in the field of medical education were asked to nominate one or two other outstanding attendings.

 

By using this sampling method, 59 potential participants were identified. An internet search was conducted to obtain information about the potential participants and their institutions. Organizational characteristics such as geographic location, hospital size and affiliation, and patient population, as well as individual characteristics such as gender, medical education and training, and educational awards received were considered so that a diversity of organizations and backgrounds was represented. The list was narrowed down to 16 attendings who were contacted via e-mail and asked to participate. Interested participants were asked for a list of their current team members and 6 to 10 former learners to contact for interviews and focus groups. Former learners were included in an effort to better understand lasting effects on learners from their exemplary teaching attendings. A total of 12 attending physicians agreed to participate (Table 1). Literature on field methods has shown that 12 interviews are found to be adequate in accomplishing data saturation.¹⁵ Although 2 attendings were located at the same institution, we decided to include them given that both are recognized as master clinician educators and were each recommended by several individuals from various institutions. Hospitals were located throughout the US and included both university-affiliated hospitals and Veterans Affairs medical centers. Despite efforts to include physicians from historically black colleges and universities, only one attending was identified, and they declined the request to participate.

Data Collection

Observations. The one-day site visits were mainly conducted by two research team members, a physician (SS) and a medical anthropologist (MH), both of whom have extensive experience in qualitative methods. Teams were not uniform but were generally comprised of 1 attending, 1 senior medical resident, 1 to 2 interns, and approximately 2 medical students. Occasionally, a pharmacist, clinical assistant, or other health professional accompanied the team on rounds. Not infrequently, the bedside nurse would explicitly be included in the discussion regarding his or her specific patient. Each site visit began with observing attendings (N = 12) and current learners (N = 57) during rounds. Each research team member recorded their own observations via handwritten field notes, paying particular attention to group interactions, teaching approach, conversations occurring within and peripheral to the team, patient-team interactions, and the physical environment. By standing outside of the medical team circle and remaining silent during rounds, research team members remained unobtrusive to the discussion and process of rounds. Materials the attendings used during their teaching rounds were also documented and collected. Rounds generally lasted 2 to 3 hours. After each site visit, the research team met to compare and combine field notes.

Interviews and Focus Groups. The research team then conducted individual, semi-structured interviews with the attendings, focus groups with their current team (N = 46), and interviews or focus groups with their former learners (N = 26; Supplement 1). Eleven of the current team members observed during rounds were unable to participate in the focus groups due to clinical duties. Because the current learners who participated in the focus groups were also observed during rounds, the research team was able to ask them open-ended questions regarding teaching rounds and their roles as learners within this environment. Former learners who were still at the hospital participated in separate focus groups or interviews. Former learners who were no longer present at the hospital were contacted by telephone and individually interviewed by one research team member (MH). All interviews and focus groups were audio-recorded and transcribed.

This study was determined to be exempt by the University of Michigan Institutional Review Board. All participants were informed that their participation was completely voluntary and that they could terminate their involvement at any time.

Data Analysis

Data were analyzed using a thematic analysis approach.¹⁶ Thematic analysis entails reading through the data to identify patterns (and create codes) that relate to behaviors, experiences, meanings, and activities. Once patterns have been identified, they are grouped according to similarity into themes, which help to further explain the findings.¹⁷

After the first site visit was completed, the research team members that participated (SS and MH) met to develop initial ideas about meanings and possible patterns. All transcripts were read by one team member (MH) and, based on review of the data, codes were developed, defined, and documented in a codebook. This process was repeated after every site visit using the codebook to expand or combine codes and refine definitions as necessary. If a new code was added, the previously coded data were reviewed to apply the new code. NVivo® 10 software (QSR International; Melbourne, Australia) was used to manage the data.

Once all field notes and transcripts were coded (MH), the code reports, which list all data described within a specific code, were run to ensure consistency and identify relationships between codes. Once coding was verified, codes were grouped based on similarities and relationships into salient themes by 3 members of the research team (NH, MH, and SM). Themes, along with their supporting codes, were then further defined to understand how these attendings worked to facilitate excellent teaching in clinical settings.

 

RESULTS

The coded interview data and field notes were categorized into broad, overlapping themes. Three of these major themes include (1) fostering positive relationships, (2) patient-centered teaching, and (3) collaboration and coaching. Table 2 lists each theme, salient behaviors, examples, and selected quotes that further elucidate its meaning.

Fostering Positive Relationships

Attending physicians took observable steps to develop positive relationships with their team members, which in turn created a safe learning environment. For instance, attendings used learners’ first names, demonstrated interest in their well-being, deployed humor, and generally displayed informal actions—uncrossed arms, “fist bump” when recognizing learners’ success, standing outside the circle of team members and leaning in to listen—during learner interactions. Attendings also made it a priority to get to know individuals on a personal level. As one current learner put it, “He asks about where we are from. He will try to find some kind of connection that he can establish with not only each of the team members but also with each of the patients.”

Additionally, attendings built positive relationships with their learners by responding thoughtfully to their input, even when learners’ evaluations of patients required modification. In turn, learners reported feeling safe to ask questions, admit uncertainty, and respectfully disagree with their attendings. As one attending reflected, “If I can get them into a place where they feel like the learning environment is someplace where they can make a mistake and know that that mistake does not necessarily mean that it’s going to cost them in their evaluation part, then I feel like that’s why it’s important.”

To build rapport and create a safe learning environment, attendings used a number of strategies to position themselves as learners alongside their team members. For instance, attendings indicated that they wanted their ideas questioned because they saw it as an opportunity to learn. Moreover, in conversations with learners, attendings demonstrated humility, admitting when they did not know something. One former learner noted, “There have been times when he has asked [a] question…nobody knows and then he admits that he doesn’t know either. So everybody goes and looks it up…The whole thing turns out to be a fun learning experience.”

Attendings demonstrated respect for their team members’ time by reading about patients before rounds, identifying learning opportunities during rounds, and integrating teaching points into the daily work of patient care. Teaching was not relegated exclusively to the conference room or confined to the traditional “chalk talk” before or after rounds but rather was assimilated into daily workflow. They appeared to be responsive to the needs of individual patients and the team, which allowed attendings to both directly oversee their patients’ care and overcome the challenges of multiple competing demands for time. The importance of this approach was made clear by one current learner who stated “…she does prepare before, especially you know on call days, she does prepare for the new patients before coming in to staff, which is really appreciated… it saves a lot of time on rounds.”

Attendings also included other health professionals in team discussions. Attendings used many of the same relationship-building techniques with these professionals as they did with learners and patients. They consistently asked these professionals to provide insight and direction in patients’ plans of care. A former learner commented, “He always asks the [nurse] what is her impression of the patient...he truly values the [nurse’s] opinion of the patient.” One attending reiterated this approach, stating “I don’t want them to think that anything I have to say is more valuable than our pharmacist or the [nurse].”

Patient-Centered Teaching

Attending physicians modeled numerous teaching techniques that focused learning around the patient. Attendings knew their patients well through review of the medical records, discussion with the patient, and personal examination. This preparation allowed attendings to focus on key teaching points in the context of the patient. One former learner noted, “He tended to bring up a variety of things that really fit well into the clinical scenario. So whether that is talking about what is the differential for a new symptom that just came up for this patient or kind of here is a new paper talking about this condition or maybe some other pearl of physical exam for a patient that has a certain physical condition.”

Attendings served as effective role models by being directly involved in examining and talking with patients as well as demonstrating excellent physical examination and communication techniques. One current learner articulated the importance of learning these skills by observing them done well: “I think he teaches by example and by doing, again, those little things: being attentive to the patients and being very careful during exams…I think those are things that you teach people by doing them, not by saying you need to do this better during the patient encounter.”

 

Collaboration and Coaching

Attending physicians used varied collaboration and coaching techniques to facilitate learning across the entire care team. During rounds, attendings utilized visual aids to reinforce key concepts and simplify complex topics. They also collaborated by using discussion rather than lecture to engage with team members. For instance, attendings used Socratic questioning, asking questions that lead learners through critical thinking and allow them to solve problems themselves, to guide learners’ decision-making. One former learner reported, “He never gives you the answer, and he always asks your opinion; ‘So what are your thoughts on this?’”

Coaching for success, rather than directing the various team members, was emphasized. Attendings did not wish to be seen as the “leaders” of the team. During rounds, one attending was noted to explain his role in ensuring that the team was building connections with others: “When we have a bad outcome, if it feels like your soul has been ripped out, then you’ve done something right. You’ve made that connection with the patient. My job, as your coach, was to build communication between all of us so we feel vested in each other and our patients.”

Attendings also fostered clinical reasoning skills in their learners by encouraging them to verbalize their thought processes aloud in order to clarify and check for understanding. Attendings also placed emphasis not simply on memorizing content but rather prioritization of the patient’s problems and thinking step by step through individual medical problems. One current learner applauded an attending who could “come up with schematics of how to approach problems rather than feeding us factual information of this paper or this trial.”

Additionally, attendings facilitated learning across the entire care team by differentiating their teaching to meet the needs of multiple learning levels. While the entire team was explicitly included in the learning process, attendings encouraged learners to play various roles, execute tasks, and answer questions depending on their educational level. Attendings positioned learners as leaders of the team by allowing them to talk without interruption and by encouraging them to take ownership of their patients’ care. One former learner stated, “She set expectations…we would be the ones who would be running the team, that you know it would very much be our team and that she is there to advise us and provide supervision but also safety for the patients as well.”

CONCLUSION

This study reveals the complex ways effective attendings build rapport, create a safe learning environment, utilize patient-centered teaching strategies, and engage in collaboration and coaching with all members of the team. These findings provide a framework of shared themes and their salient behaviors that may influence the success of inpatient general medicine clinician educators (Table 3).

There is a broad and voluminous literature on the subject of outstanding clinical teaching characteristics, much of which has shaped various faculty development curricula for decades. This study sought not to identify novel approaches of inpatient teaching necessarily but rather to closely examine the techniques and behaviors of clinician educators identified as exemplary. The findings affirm and reinforce the numerous, well-documented lists of personal attributes, techniques, and behaviors that resonate with learners, including creating a positive environment, demonstrating enthusiasm and interest in the learner, reading facial expressions, being student-centered, maintaining a high level of clinical knowledge, and utilizing effective communication skills.^18-24 The strengths of this study lie within the nuanced and rich observations and discussions that move beyond learners’ Likert scale evaluations and responses.^3-7,12 Input was sought from multiple perspectives on the care team, which provided detail from key stakeholders. Out of these comprehensive data arose several conclusions that extend the research literature on medical education.

In their seminal review, Sutkin et al.¹⁸ demonstrate that two thirds of characteristics of outstanding clinical teachers are “noncognitive” and that, “Perhaps what makes a clinical educator truly great depends less on the acquisition of cognitive skills such as medical knowledge and formulating learning objectives, and more on inherent, relationship-based, noncognitive attributes. Whereas cognitive abilities generally involve skills that may be taught and learned, albeit with difficulty, noncognitive abilities represent personal attributes, such as relationship skills, personality types, and emotional states, which are more difficult to develop and teach.”¹⁸ Our study, thus, adds to the literature by (1) highlighting examples of techniques and behaviors that encompass the crucial “noncognitive” arena and (2) informing best practices in teaching clinical medicine, especially those that resonate with learners, for future faculty development.

The findings highlight the role that relationships play in the teaching and learning of team-based medicine. Building rapport and sustaining successful relationships are cornerstones of effective teaching.¹⁸ For the attendings in this study, this manifested in observable, tangible behaviors such as greeting others by name, joking, using physical touch, and actively involving all team members, regardless of role or level of education. Previous literature has highlighted the importance of showing interest in learners.^7,19,25-27 This study provides multiple and varied examples of ways in which interest might be displayed.

For patients, the critical role of relationships was evidenced through rapport building and attention to patients as people outside their acute hospitalization. For instance, attendings regularly put patients’ medical issues into context and anticipated future outpatient challenges. To the authors’ knowledge, previous scholarship has not significantly emphasized this form of contextualized medicine, which involves the mindful consideration of the ongoing needs patients may experience upon transitions of care.

Several participants highlighted humility as an important characteristic of effective clinician educators. Attendings recognized that the field produces more new knowledge than can possibly be assimilated and that uncertainty is a mainstay of modern medical care. Attendings frequently utilized self-deprecation to acknowledge doubt, a technique that created a collaborative environment in which learners also felt safe to ask questions. These findings support the viewpoints by Reilly and Beckman that humility and an appreciation for questions and push-back from learners encourage lifelong learning through role modeling.^19,23 In responding to the interviewer’s question “And what happens when [the attending] is wrong?” one learner simply stated, “He makes fun of himself.”

This study has several limitations. First, it was conducted in a limited number of US based healthcare systems. The majority of institutions represented were larger, research intensive hospitals. While these hospitals were purposefully selected to provide a range in geography, size, type, and access to resources, the findings may differ in other settings. Second, it was conducted with a limited number of attendings and learners, which may limit the study’s generalizability. However, enough interviews were conducted to reach data saturation.¹⁵ Because evidence for a causal relationship between quality teaching and student and patient outcomes is lacking,¹⁸ we must rely on imperfect proxies for teaching excellence, including awards and recognition. This study attempted to identify exemplary educators through various means, but it is recognized that bias is likely. Third, because attendings provided lists of former learners, selection and recall biases may have been introduced, as attendings may have more readily identified former learners with whom they formed strong relationships. Fourth, focus was placed exclusively on teaching and learning within general medicine rounds. This was because there would be ample opportunity for teaching on this service, the structure of the teams and the types of patients would be comparable across sites, and the principal investigator was also a general medicine attending and would have a frame of reference for these types of rounds. Due to this narrow focus, the findings may not be generalizable to other subspecialties. Fifth, attendings were selected through a nonexhaustive method. However, the multisite design, the modified snowball sampling, and the inclusion of several types of institutions in the final participant pool introduced diversity to the final list. Finally, although we cannot discount the potential role of a Hawthorne effect on our data collection, the research team did attempt to mitigate this by standing apart from the care teams and remaining unobtrusive during observations.

Using a combination of interviews, focus group discussions, and direct observation, we identified consistent techniques and behaviors of excellent teaching attendings during inpatient general medicine rounds. We hope that all levels of clinician educators may use them to elevate their own teaching.

 

Disclosure

Dr. Saint is on a medical advisory board of Doximity, a new social networking site for physicians, and receives an honorarium. He is also on the scientific advisory board of Jvion, a healthcare technology company. Drs. Houchens, Harrod, Moody, and Ms. Fowler have no conflicts of interest.

Clinician educators face numerous obstacles to their joint mission of facilitating learning while also ensuring high-quality and patient-centered care. Time constraints, including the institution of house officer duty hour limitations,¹ shorter lengths of stay for hospitalized patients,² and competing career responsibilities, combine to create a dynamic learning environment. Additionally, clinician educators must balance the autonomy of their learners with the safety of their patients. They must teach to multiple learning levels and work collaboratively with multiple disciplines to foster an effective team-based approach to patient care. Yet, many clinician educators have no formal training in pedagogical methods.³ Such challenges necessitate increased attention to the work of excellent clinician educators and their respective teaching approaches.

Many studies of clinical teaching rely primarily on survey data of attributes of good clinical teachers.^3-7 While some studies have incorporated direct observations of teaching^8,9 or interviews with clinician educators or learners,^10,11 few have incorporated multiple perspectives from the current team and from former learners in order to provide a comprehensive picture of team-based learning.¹²

The goal of this study was to gain a thorough understanding, through multiple perspectives, of the techniques and behaviors used by exemplary educators within actual clinical environments. We studied attitudes, behaviors, and approaches of 12 such inpatient clinician educators.

METHODS

Study Design and Sampling

This was a multisite study using an exploratory qualitative approach to inquiry. This approach was used to study the techniques and behaviors of excellent attendings during inpatient general medicine rounds. A modified snowball sampling approach¹³ was used, meaning individuals known to one member of the research team (SS) were initially contacted and asked to identify clinician educators (also referred to as attendings) for potential inclusion in the study. In an effort to identify attendings from a broad range of medical schools, the “2015 U.S. News and World Report Top Medical Schools: Research” rankings¹⁴ were also reviewed, with priority given to the top 25, as these are widely used to represent the best US hospitals. In an attempt to invite attendings from diverse institutions, additional medical schools not in the top 25 as well as historically black medical schools were also included. Division chiefs and chairs of internal medicine and/or directors of internal medicine residency programs at these schools were contacted and asked for recommendations of attendings, both within and outside their institutions, who they considered to be great inpatient teachers. In addition, key experts who have won teaching awards or were known to be specialists in the field of medical education were asked to nominate one or two other outstanding attendings.

 

By using this sampling method, 59 potential participants were identified. An internet search was conducted to obtain information about the potential participants and their institutions. Organizational characteristics such as geographic location, hospital size and affiliation, and patient population, as well as individual characteristics such as gender, medical education and training, and educational awards received were considered so that a diversity of organizations and backgrounds was represented. The list was narrowed down to 16 attendings who were contacted via e-mail and asked to participate. Interested participants were asked for a list of their current team members and 6 to 10 former learners to contact for interviews and focus groups. Former learners were included in an effort to better understand lasting effects on learners from their exemplary teaching attendings. A total of 12 attending physicians agreed to participate (Table 1). Literature on field methods has shown that 12 interviews are found to be adequate in accomplishing data saturation.¹⁵ Although 2 attendings were located at the same institution, we decided to include them given that both are recognized as master clinician educators and were each recommended by several individuals from various institutions. Hospitals were located throughout the US and included both university-affiliated hospitals and Veterans Affairs medical centers. Despite efforts to include physicians from historically black colleges and universities, only one attending was identified, and they declined the request to participate.

Data Collection

Observations. The one-day site visits were mainly conducted by two research team members, a physician (SS) and a medical anthropologist (MH), both of whom have extensive experience in qualitative methods. Teams were not uniform but were generally comprised of 1 attending, 1 senior medical resident, 1 to 2 interns, and approximately 2 medical students. Occasionally, a pharmacist, clinical assistant, or other health professional accompanied the team on rounds. Not infrequently, the bedside nurse would explicitly be included in the discussion regarding his or her specific patient. Each site visit began with observing attendings (N = 12) and current learners (N = 57) during rounds. Each research team member recorded their own observations via handwritten field notes, paying particular attention to group interactions, teaching approach, conversations occurring within and peripheral to the team, patient-team interactions, and the physical environment. By standing outside of the medical team circle and remaining silent during rounds, research team members remained unobtrusive to the discussion and process of rounds. Materials the attendings used during their teaching rounds were also documented and collected. Rounds generally lasted 2 to 3 hours. After each site visit, the research team met to compare and combine field notes.

Interviews and Focus Groups. The research team then conducted individual, semi-structured interviews with the attendings, focus groups with their current team (N = 46), and interviews or focus groups with their former learners (N = 26; Supplement 1). Eleven of the current team members observed during rounds were unable to participate in the focus groups due to clinical duties. Because the current learners who participated in the focus groups were also observed during rounds, the research team was able to ask them open-ended questions regarding teaching rounds and their roles as learners within this environment. Former learners who were still at the hospital participated in separate focus groups or interviews. Former learners who were no longer present at the hospital were contacted by telephone and individually interviewed by one research team member (MH). All interviews and focus groups were audio-recorded and transcribed.

This study was determined to be exempt by the University of Michigan Institutional Review Board. All participants were informed that their participation was completely voluntary and that they could terminate their involvement at any time.

Data Analysis

Data were analyzed using a thematic analysis approach.¹⁶ Thematic analysis entails reading through the data to identify patterns (and create codes) that relate to behaviors, experiences, meanings, and activities. Once patterns have been identified, they are grouped according to similarity into themes, which help to further explain the findings.¹⁷

After the first site visit was completed, the research team members that participated (SS and MH) met to develop initial ideas about meanings and possible patterns. All transcripts were read by one team member (MH) and, based on review of the data, codes were developed, defined, and documented in a codebook. This process was repeated after every site visit using the codebook to expand or combine codes and refine definitions as necessary. If a new code was added, the previously coded data were reviewed to apply the new code. NVivo® 10 software (QSR International; Melbourne, Australia) was used to manage the data.

Once all field notes and transcripts were coded (MH), the code reports, which list all data described within a specific code, were run to ensure consistency and identify relationships between codes. Once coding was verified, codes were grouped based on similarities and relationships into salient themes by 3 members of the research team (NH, MH, and SM). Themes, along with their supporting codes, were then further defined to understand how these attendings worked to facilitate excellent teaching in clinical settings.

 

RESULTS

The coded interview data and field notes were categorized into broad, overlapping themes. Three of these major themes include (1) fostering positive relationships, (2) patient-centered teaching, and (3) collaboration and coaching. Table 2 lists each theme, salient behaviors, examples, and selected quotes that further elucidate its meaning.

Fostering Positive Relationships

Attending physicians took observable steps to develop positive relationships with their team members, which in turn created a safe learning environment. For instance, attendings used learners’ first names, demonstrated interest in their well-being, deployed humor, and generally displayed informal actions—uncrossed arms, “fist bump” when recognizing learners’ success, standing outside the circle of team members and leaning in to listen—during learner interactions. Attendings also made it a priority to get to know individuals on a personal level. As one current learner put it, “He asks about where we are from. He will try to find some kind of connection that he can establish with not only each of the team members but also with each of the patients.”

Additionally, attendings built positive relationships with their learners by responding thoughtfully to their input, even when learners’ evaluations of patients required modification. In turn, learners reported feeling safe to ask questions, admit uncertainty, and respectfully disagree with their attendings. As one attending reflected, “If I can get them into a place where they feel like the learning environment is someplace where they can make a mistake and know that that mistake does not necessarily mean that it’s going to cost them in their evaluation part, then I feel like that’s why it’s important.”

To build rapport and create a safe learning environment, attendings used a number of strategies to position themselves as learners alongside their team members. For instance, attendings indicated that they wanted their ideas questioned because they saw it as an opportunity to learn. Moreover, in conversations with learners, attendings demonstrated humility, admitting when they did not know something. One former learner noted, “There have been times when he has asked [a] question…nobody knows and then he admits that he doesn’t know either. So everybody goes and looks it up…The whole thing turns out to be a fun learning experience.”

Attendings demonstrated respect for their team members’ time by reading about patients before rounds, identifying learning opportunities during rounds, and integrating teaching points into the daily work of patient care. Teaching was not relegated exclusively to the conference room or confined to the traditional “chalk talk” before or after rounds but rather was assimilated into daily workflow. They appeared to be responsive to the needs of individual patients and the team, which allowed attendings to both directly oversee their patients’ care and overcome the challenges of multiple competing demands for time. The importance of this approach was made clear by one current learner who stated “…she does prepare before, especially you know on call days, she does prepare for the new patients before coming in to staff, which is really appreciated… it saves a lot of time on rounds.”

Attendings also included other health professionals in team discussions. Attendings used many of the same relationship-building techniques with these professionals as they did with learners and patients. They consistently asked these professionals to provide insight and direction in patients’ plans of care. A former learner commented, “He always asks the [nurse] what is her impression of the patient...he truly values the [nurse’s] opinion of the patient.” One attending reiterated this approach, stating “I don’t want them to think that anything I have to say is more valuable than our pharmacist or the [nurse].”

Patient-Centered Teaching

Attending physicians modeled numerous teaching techniques that focused learning around the patient. Attendings knew their patients well through review of the medical records, discussion with the patient, and personal examination. This preparation allowed attendings to focus on key teaching points in the context of the patient. One former learner noted, “He tended to bring up a variety of things that really fit well into the clinical scenario. So whether that is talking about what is the differential for a new symptom that just came up for this patient or kind of here is a new paper talking about this condition or maybe some other pearl of physical exam for a patient that has a certain physical condition.”

Attendings served as effective role models by being directly involved in examining and talking with patients as well as demonstrating excellent physical examination and communication techniques. One current learner articulated the importance of learning these skills by observing them done well: “I think he teaches by example and by doing, again, those little things: being attentive to the patients and being very careful during exams…I think those are things that you teach people by doing them, not by saying you need to do this better during the patient encounter.”

 

Collaboration and Coaching

Attending physicians used varied collaboration and coaching techniques to facilitate learning across the entire care team. During rounds, attendings utilized visual aids to reinforce key concepts and simplify complex topics. They also collaborated by using discussion rather than lecture to engage with team members. For instance, attendings used Socratic questioning, asking questions that lead learners through critical thinking and allow them to solve problems themselves, to guide learners’ decision-making. One former learner reported, “He never gives you the answer, and he always asks your opinion; ‘So what are your thoughts on this?’”

Coaching for success, rather than directing the various team members, was emphasized. Attendings did not wish to be seen as the “leaders” of the team. During rounds, one attending was noted to explain his role in ensuring that the team was building connections with others: “When we have a bad outcome, if it feels like your soul has been ripped out, then you’ve done something right. You’ve made that connection with the patient. My job, as your coach, was to build communication between all of us so we feel vested in each other and our patients.”

Attendings also fostered clinical reasoning skills in their learners by encouraging them to verbalize their thought processes aloud in order to clarify and check for understanding. Attendings also placed emphasis not simply on memorizing content but rather prioritization of the patient’s problems and thinking step by step through individual medical problems. One current learner applauded an attending who could “come up with schematics of how to approach problems rather than feeding us factual information of this paper or this trial.”

Additionally, attendings facilitated learning across the entire care team by differentiating their teaching to meet the needs of multiple learning levels. While the entire team was explicitly included in the learning process, attendings encouraged learners to play various roles, execute tasks, and answer questions depending on their educational level. Attendings positioned learners as leaders of the team by allowing them to talk without interruption and by encouraging them to take ownership of their patients’ care. One former learner stated, “She set expectations…we would be the ones who would be running the team, that you know it would very much be our team and that she is there to advise us and provide supervision but also safety for the patients as well.”

CONCLUSION

This study reveals the complex ways effective attendings build rapport, create a safe learning environment, utilize patient-centered teaching strategies, and engage in collaboration and coaching with all members of the team. These findings provide a framework of shared themes and their salient behaviors that may influence the success of inpatient general medicine clinician educators (Table 3).

There is a broad and voluminous literature on the subject of outstanding clinical teaching characteristics, much of which has shaped various faculty development curricula for decades. This study sought not to identify novel approaches of inpatient teaching necessarily but rather to closely examine the techniques and behaviors of clinician educators identified as exemplary. The findings affirm and reinforce the numerous, well-documented lists of personal attributes, techniques, and behaviors that resonate with learners, including creating a positive environment, demonstrating enthusiasm and interest in the learner, reading facial expressions, being student-centered, maintaining a high level of clinical knowledge, and utilizing effective communication skills.^18-24 The strengths of this study lie within the nuanced and rich observations and discussions that move beyond learners’ Likert scale evaluations and responses.^3-7,12 Input was sought from multiple perspectives on the care team, which provided detail from key stakeholders. Out of these comprehensive data arose several conclusions that extend the research literature on medical education.

In their seminal review, Sutkin et al.¹⁸ demonstrate that two thirds of characteristics of outstanding clinical teachers are “noncognitive” and that, “Perhaps what makes a clinical educator truly great depends less on the acquisition of cognitive skills such as medical knowledge and formulating learning objectives, and more on inherent, relationship-based, noncognitive attributes. Whereas cognitive abilities generally involve skills that may be taught and learned, albeit with difficulty, noncognitive abilities represent personal attributes, such as relationship skills, personality types, and emotional states, which are more difficult to develop and teach.”¹⁸ Our study, thus, adds to the literature by (1) highlighting examples of techniques and behaviors that encompass the crucial “noncognitive” arena and (2) informing best practices in teaching clinical medicine, especially those that resonate with learners, for future faculty development.

The findings highlight the role that relationships play in the teaching and learning of team-based medicine. Building rapport and sustaining successful relationships are cornerstones of effective teaching.¹⁸ For the attendings in this study, this manifested in observable, tangible behaviors such as greeting others by name, joking, using physical touch, and actively involving all team members, regardless of role or level of education. Previous literature has highlighted the importance of showing interest in learners.^7,19,25-27 This study provides multiple and varied examples of ways in which interest might be displayed.

For patients, the critical role of relationships was evidenced through rapport building and attention to patients as people outside their acute hospitalization. For instance, attendings regularly put patients’ medical issues into context and anticipated future outpatient challenges. To the authors’ knowledge, previous scholarship has not significantly emphasized this form of contextualized medicine, which involves the mindful consideration of the ongoing needs patients may experience upon transitions of care.

Several participants highlighted humility as an important characteristic of effective clinician educators. Attendings recognized that the field produces more new knowledge than can possibly be assimilated and that uncertainty is a mainstay of modern medical care. Attendings frequently utilized self-deprecation to acknowledge doubt, a technique that created a collaborative environment in which learners also felt safe to ask questions. These findings support the viewpoints by Reilly and Beckman that humility and an appreciation for questions and push-back from learners encourage lifelong learning through role modeling.^19,23 In responding to the interviewer’s question “And what happens when [the attending] is wrong?” one learner simply stated, “He makes fun of himself.”

This study has several limitations. First, it was conducted in a limited number of US based healthcare systems. The majority of institutions represented were larger, research intensive hospitals. While these hospitals were purposefully selected to provide a range in geography, size, type, and access to resources, the findings may differ in other settings. Second, it was conducted with a limited number of attendings and learners, which may limit the study’s generalizability. However, enough interviews were conducted to reach data saturation.¹⁵ Because evidence for a causal relationship between quality teaching and student and patient outcomes is lacking,¹⁸ we must rely on imperfect proxies for teaching excellence, including awards and recognition. This study attempted to identify exemplary educators through various means, but it is recognized that bias is likely. Third, because attendings provided lists of former learners, selection and recall biases may have been introduced, as attendings may have more readily identified former learners with whom they formed strong relationships. Fourth, focus was placed exclusively on teaching and learning within general medicine rounds. This was because there would be ample opportunity for teaching on this service, the structure of the teams and the types of patients would be comparable across sites, and the principal investigator was also a general medicine attending and would have a frame of reference for these types of rounds. Due to this narrow focus, the findings may not be generalizable to other subspecialties. Fifth, attendings were selected through a nonexhaustive method. However, the multisite design, the modified snowball sampling, and the inclusion of several types of institutions in the final participant pool introduced diversity to the final list. Finally, although we cannot discount the potential role of a Hawthorne effect on our data collection, the research team did attempt to mitigate this by standing apart from the care teams and remaining unobtrusive during observations.

Using a combination of interviews, focus group discussions, and direct observation, we identified consistent techniques and behaviors of excellent teaching attendings during inpatient general medicine rounds. We hope that all levels of clinician educators may use them to elevate their own teaching.

 

Disclosure

Dr. Saint is on a medical advisory board of Doximity, a new social networking site for physicians, and receives an honorarium. He is also on the scientific advisory board of Jvion, a healthcare technology company. Drs. Houchens, Harrod, Moody, and Ms. Fowler have no conflicts of interest.

Clinician educators face numerous obstacles to their joint mission of facilitating learning while also ensuring high-quality and patient-centered care. Time constraints, including the institution of house officer duty hour limitations,¹ shorter lengths of stay for hospitalized patients,² and competing career responsibilities, combine to create a dynamic learning environment. Additionally, clinician educators must balance the autonomy of their learners with the safety of their patients. They must teach to multiple learning levels and work collaboratively with multiple disciplines to foster an effective team-based approach to patient care. Yet, many clinician educators have no formal training in pedagogical methods.³ Such challenges necessitate increased attention to the work of excellent clinician educators and their respective teaching approaches.

Many studies of clinical teaching rely primarily on survey data of attributes of good clinical teachers.^3-7 While some studies have incorporated direct observations of teaching^8,9 or interviews with clinician educators or learners,^10,11 few have incorporated multiple perspectives from the current team and from former learners in order to provide a comprehensive picture of team-based learning.¹²

The goal of this study was to gain a thorough understanding, through multiple perspectives, of the techniques and behaviors used by exemplary educators within actual clinical environments. We studied attitudes, behaviors, and approaches of 12 such inpatient clinician educators.

METHODS

Study Design and Sampling

This was a multisite study using an exploratory qualitative approach to inquiry. This approach was used to study the techniques and behaviors of excellent attendings during inpatient general medicine rounds. A modified snowball sampling approach¹³ was used, meaning individuals known to one member of the research team (SS) were initially contacted and asked to identify clinician educators (also referred to as attendings) for potential inclusion in the study. In an effort to identify attendings from a broad range of medical schools, the “2015 U.S. News and World Report Top Medical Schools: Research” rankings¹⁴ were also reviewed, with priority given to the top 25, as these are widely used to represent the best US hospitals. In an attempt to invite attendings from diverse institutions, additional medical schools not in the top 25 as well as historically black medical schools were also included. Division chiefs and chairs of internal medicine and/or directors of internal medicine residency programs at these schools were contacted and asked for recommendations of attendings, both within and outside their institutions, who they considered to be great inpatient teachers. In addition, key experts who have won teaching awards or were known to be specialists in the field of medical education were asked to nominate one or two other outstanding attendings.

 

By using this sampling method, 59 potential participants were identified. An internet search was conducted to obtain information about the potential participants and their institutions. Organizational characteristics such as geographic location, hospital size and affiliation, and patient population, as well as individual characteristics such as gender, medical education and training, and educational awards received were considered so that a diversity of organizations and backgrounds was represented. The list was narrowed down to 16 attendings who were contacted via e-mail and asked to participate. Interested participants were asked for a list of their current team members and 6 to 10 former learners to contact for interviews and focus groups. Former learners were included in an effort to better understand lasting effects on learners from their exemplary teaching attendings. A total of 12 attending physicians agreed to participate (Table 1). Literature on field methods has shown that 12 interviews are found to be adequate in accomplishing data saturation.¹⁵ Although 2 attendings were located at the same institution, we decided to include them given that both are recognized as master clinician educators and were each recommended by several individuals from various institutions. Hospitals were located throughout the US and included both university-affiliated hospitals and Veterans Affairs medical centers. Despite efforts to include physicians from historically black colleges and universities, only one attending was identified, and they declined the request to participate.

Data Collection

Observations. The one-day site visits were mainly conducted by two research team members, a physician (SS) and a medical anthropologist (MH), both of whom have extensive experience in qualitative methods. Teams were not uniform but were generally comprised of 1 attending, 1 senior medical resident, 1 to 2 interns, and approximately 2 medical students. Occasionally, a pharmacist, clinical assistant, or other health professional accompanied the team on rounds. Not infrequently, the bedside nurse would explicitly be included in the discussion regarding his or her specific patient. Each site visit began with observing attendings (N = 12) and current learners (N = 57) during rounds. Each research team member recorded their own observations via handwritten field notes, paying particular attention to group interactions, teaching approach, conversations occurring within and peripheral to the team, patient-team interactions, and the physical environment. By standing outside of the medical team circle and remaining silent during rounds, research team members remained unobtrusive to the discussion and process of rounds. Materials the attendings used during their teaching rounds were also documented and collected. Rounds generally lasted 2 to 3 hours. After each site visit, the research team met to compare and combine field notes.

Interviews and Focus Groups. The research team then conducted individual, semi-structured interviews with the attendings, focus groups with their current team (N = 46), and interviews or focus groups with their former learners (N = 26; Supplement 1). Eleven of the current team members observed during rounds were unable to participate in the focus groups due to clinical duties. Because the current learners who participated in the focus groups were also observed during rounds, the research team was able to ask them open-ended questions regarding teaching rounds and their roles as learners within this environment. Former learners who were still at the hospital participated in separate focus groups or interviews. Former learners who were no longer present at the hospital were contacted by telephone and individually interviewed by one research team member (MH). All interviews and focus groups were audio-recorded and transcribed.

This study was determined to be exempt by the University of Michigan Institutional Review Board. All participants were informed that their participation was completely voluntary and that they could terminate their involvement at any time.

Data Analysis

Data were analyzed using a thematic analysis approach.¹⁶ Thematic analysis entails reading through the data to identify patterns (and create codes) that relate to behaviors, experiences, meanings, and activities. Once patterns have been identified, they are grouped according to similarity into themes, which help to further explain the findings.¹⁷

After the first site visit was completed, the research team members that participated (SS and MH) met to develop initial ideas about meanings and possible patterns. All transcripts were read by one team member (MH) and, based on review of the data, codes were developed, defined, and documented in a codebook. This process was repeated after every site visit using the codebook to expand or combine codes and refine definitions as necessary. If a new code was added, the previously coded data were reviewed to apply the new code. NVivo® 10 software (QSR International; Melbourne, Australia) was used to manage the data.

Once all field notes and transcripts were coded (MH), the code reports, which list all data described within a specific code, were run to ensure consistency and identify relationships between codes. Once coding was verified, codes were grouped based on similarities and relationships into salient themes by 3 members of the research team (NH, MH, and SM). Themes, along with their supporting codes, were then further defined to understand how these attendings worked to facilitate excellent teaching in clinical settings.

 

RESULTS

The coded interview data and field notes were categorized into broad, overlapping themes. Three of these major themes include (1) fostering positive relationships, (2) patient-centered teaching, and (3) collaboration and coaching. Table 2 lists each theme, salient behaviors, examples, and selected quotes that further elucidate its meaning.

Fostering Positive Relationships

Attending physicians took observable steps to develop positive relationships with their team members, which in turn created a safe learning environment. For instance, attendings used learners’ first names, demonstrated interest in their well-being, deployed humor, and generally displayed informal actions—uncrossed arms, “fist bump” when recognizing learners’ success, standing outside the circle of team members and leaning in to listen—during learner interactions. Attendings also made it a priority to get to know individuals on a personal level. As one current learner put it, “He asks about where we are from. He will try to find some kind of connection that he can establish with not only each of the team members but also with each of the patients.”

Additionally, attendings built positive relationships with their learners by responding thoughtfully to their input, even when learners’ evaluations of patients required modification. In turn, learners reported feeling safe to ask questions, admit uncertainty, and respectfully disagree with their attendings. As one attending reflected, “If I can get them into a place where they feel like the learning environment is someplace where they can make a mistake and know that that mistake does not necessarily mean that it’s going to cost them in their evaluation part, then I feel like that’s why it’s important.”

To build rapport and create a safe learning environment, attendings used a number of strategies to position themselves as learners alongside their team members. For instance, attendings indicated that they wanted their ideas questioned because they saw it as an opportunity to learn. Moreover, in conversations with learners, attendings demonstrated humility, admitting when they did not know something. One former learner noted, “There have been times when he has asked [a] question…nobody knows and then he admits that he doesn’t know either. So everybody goes and looks it up…The whole thing turns out to be a fun learning experience.”

Attendings demonstrated respect for their team members’ time by reading about patients before rounds, identifying learning opportunities during rounds, and integrating teaching points into the daily work of patient care. Teaching was not relegated exclusively to the conference room or confined to the traditional “chalk talk” before or after rounds but rather was assimilated into daily workflow. They appeared to be responsive to the needs of individual patients and the team, which allowed attendings to both directly oversee their patients’ care and overcome the challenges of multiple competing demands for time. The importance of this approach was made clear by one current learner who stated “…she does prepare before, especially you know on call days, she does prepare for the new patients before coming in to staff, which is really appreciated… it saves a lot of time on rounds.”

Attendings also included other health professionals in team discussions. Attendings used many of the same relationship-building techniques with these professionals as they did with learners and patients. They consistently asked these professionals to provide insight and direction in patients’ plans of care. A former learner commented, “He always asks the [nurse] what is her impression of the patient...he truly values the [nurse’s] opinion of the patient.” One attending reiterated this approach, stating “I don’t want them to think that anything I have to say is more valuable than our pharmacist or the [nurse].”

Patient-Centered Teaching

Attending physicians modeled numerous teaching techniques that focused learning around the patient. Attendings knew their patients well through review of the medical records, discussion with the patient, and personal examination. This preparation allowed attendings to focus on key teaching points in the context of the patient. One former learner noted, “He tended to bring up a variety of things that really fit well into the clinical scenario. So whether that is talking about what is the differential for a new symptom that just came up for this patient or kind of here is a new paper talking about this condition or maybe some other pearl of physical exam for a patient that has a certain physical condition.”

Attendings served as effective role models by being directly involved in examining and talking with patients as well as demonstrating excellent physical examination and communication techniques. One current learner articulated the importance of learning these skills by observing them done well: “I think he teaches by example and by doing, again, those little things: being attentive to the patients and being very careful during exams…I think those are things that you teach people by doing them, not by saying you need to do this better during the patient encounter.”

 

Collaboration and Coaching

Attending physicians used varied collaboration and coaching techniques to facilitate learning across the entire care team. During rounds, attendings utilized visual aids to reinforce key concepts and simplify complex topics. They also collaborated by using discussion rather than lecture to engage with team members. For instance, attendings used Socratic questioning, asking questions that lead learners through critical thinking and allow them to solve problems themselves, to guide learners’ decision-making. One former learner reported, “He never gives you the answer, and he always asks your opinion; ‘So what are your thoughts on this?’”

Coaching for success, rather than directing the various team members, was emphasized. Attendings did not wish to be seen as the “leaders” of the team. During rounds, one attending was noted to explain his role in ensuring that the team was building connections with others: “When we have a bad outcome, if it feels like your soul has been ripped out, then you’ve done something right. You’ve made that connection with the patient. My job, as your coach, was to build communication between all of us so we feel vested in each other and our patients.”

Attendings also fostered clinical reasoning skills in their learners by encouraging them to verbalize their thought processes aloud in order to clarify and check for understanding. Attendings also placed emphasis not simply on memorizing content but rather prioritization of the patient’s problems and thinking step by step through individual medical problems. One current learner applauded an attending who could “come up with schematics of how to approach problems rather than feeding us factual information of this paper or this trial.”

Additionally, attendings facilitated learning across the entire care team by differentiating their teaching to meet the needs of multiple learning levels. While the entire team was explicitly included in the learning process, attendings encouraged learners to play various roles, execute tasks, and answer questions depending on their educational level. Attendings positioned learners as leaders of the team by allowing them to talk without interruption and by encouraging them to take ownership of their patients’ care. One former learner stated, “She set expectations…we would be the ones who would be running the team, that you know it would very much be our team and that she is there to advise us and provide supervision but also safety for the patients as well.”

CONCLUSION

This study reveals the complex ways effective attendings build rapport, create a safe learning environment, utilize patient-centered teaching strategies, and engage in collaboration and coaching with all members of the team. These findings provide a framework of shared themes and their salient behaviors that may influence the success of inpatient general medicine clinician educators (Table 3).

There is a broad and voluminous literature on the subject of outstanding clinical teaching characteristics, much of which has shaped various faculty development curricula for decades. This study sought not to identify novel approaches of inpatient teaching necessarily but rather to closely examine the techniques and behaviors of clinician educators identified as exemplary. The findings affirm and reinforce the numerous, well-documented lists of personal attributes, techniques, and behaviors that resonate with learners, including creating a positive environment, demonstrating enthusiasm and interest in the learner, reading facial expressions, being student-centered, maintaining a high level of clinical knowledge, and utilizing effective communication skills.^18-24 The strengths of this study lie within the nuanced and rich observations and discussions that move beyond learners’ Likert scale evaluations and responses.^3-7,12 Input was sought from multiple perspectives on the care team, which provided detail from key stakeholders. Out of these comprehensive data arose several conclusions that extend the research literature on medical education.

In their seminal review, Sutkin et al.¹⁸ demonstrate that two thirds of characteristics of outstanding clinical teachers are “noncognitive” and that, “Perhaps what makes a clinical educator truly great depends less on the acquisition of cognitive skills such as medical knowledge and formulating learning objectives, and more on inherent, relationship-based, noncognitive attributes. Whereas cognitive abilities generally involve skills that may be taught and learned, albeit with difficulty, noncognitive abilities represent personal attributes, such as relationship skills, personality types, and emotional states, which are more difficult to develop and teach.”¹⁸ Our study, thus, adds to the literature by (1) highlighting examples of techniques and behaviors that encompass the crucial “noncognitive” arena and (2) informing best practices in teaching clinical medicine, especially those that resonate with learners, for future faculty development.

The findings highlight the role that relationships play in the teaching and learning of team-based medicine. Building rapport and sustaining successful relationships are cornerstones of effective teaching.¹⁸ For the attendings in this study, this manifested in observable, tangible behaviors such as greeting others by name, joking, using physical touch, and actively involving all team members, regardless of role or level of education. Previous literature has highlighted the importance of showing interest in learners.^7,19,25-27 This study provides multiple and varied examples of ways in which interest might be displayed.

For patients, the critical role of relationships was evidenced through rapport building and attention to patients as people outside their acute hospitalization. For instance, attendings regularly put patients’ medical issues into context and anticipated future outpatient challenges. To the authors’ knowledge, previous scholarship has not significantly emphasized this form of contextualized medicine, which involves the mindful consideration of the ongoing needs patients may experience upon transitions of care.

Several participants highlighted humility as an important characteristic of effective clinician educators. Attendings recognized that the field produces more new knowledge than can possibly be assimilated and that uncertainty is a mainstay of modern medical care. Attendings frequently utilized self-deprecation to acknowledge doubt, a technique that created a collaborative environment in which learners also felt safe to ask questions. These findings support the viewpoints by Reilly and Beckman that humility and an appreciation for questions and push-back from learners encourage lifelong learning through role modeling.^19,23 In responding to the interviewer’s question “And what happens when [the attending] is wrong?” one learner simply stated, “He makes fun of himself.”

This study has several limitations. First, it was conducted in a limited number of US based healthcare systems. The majority of institutions represented were larger, research intensive hospitals. While these hospitals were purposefully selected to provide a range in geography, size, type, and access to resources, the findings may differ in other settings. Second, it was conducted with a limited number of attendings and learners, which may limit the study’s generalizability. However, enough interviews were conducted to reach data saturation.¹⁵ Because evidence for a causal relationship between quality teaching and student and patient outcomes is lacking,¹⁸ we must rely on imperfect proxies for teaching excellence, including awards and recognition. This study attempted to identify exemplary educators through various means, but it is recognized that bias is likely. Third, because attendings provided lists of former learners, selection and recall biases may have been introduced, as attendings may have more readily identified former learners with whom they formed strong relationships. Fourth, focus was placed exclusively on teaching and learning within general medicine rounds. This was because there would be ample opportunity for teaching on this service, the structure of the teams and the types of patients would be comparable across sites, and the principal investigator was also a general medicine attending and would have a frame of reference for these types of rounds. Due to this narrow focus, the findings may not be generalizable to other subspecialties. Fifth, attendings were selected through a nonexhaustive method. However, the multisite design, the modified snowball sampling, and the inclusion of several types of institutions in the final participant pool introduced diversity to the final list. Finally, although we cannot discount the potential role of a Hawthorne effect on our data collection, the research team did attempt to mitigate this by standing apart from the care teams and remaining unobtrusive during observations.

Using a combination of interviews, focus group discussions, and direct observation, we identified consistent techniques and behaviors of excellent teaching attendings during inpatient general medicine rounds. We hope that all levels of clinician educators may use them to elevate their own teaching.

 

Disclosure

Dr. Saint is on a medical advisory board of Doximity, a new social networking site for physicians, and receives an honorarium. He is also on the scientific advisory board of Jvion, a healthcare technology company. Drs. Houchens, Harrod, Moody, and Ms. Fowler have no conflicts of interest.

The transition from hospital to home can be overwhelming for caregivers.¹ Stress of hospitalization coupled with the expectation of families to execute postdischarge care plans make understandable discharge communication critical. Communication failures, inadequate education, absence of caregiver confidence, and lack of clarity regarding care plans may prohibit smooth transitions and lead to adverse postdischarge outcomes.^2-4

Health literacy plays a pivotal role in caregivers’ capacity to navigate the healthcare system, comprehend, and execute care plans. An estimated 90 million Americans have limited health literacy that may negatively impact the provision of safe and quality care^5,6 and be a risk factor for poor outcomes, including increased emergency department (ED) utilization and readmission rates.^7-9 Readability strongly influences the effectiveness of written materials.¹⁰ However, written medical information for patients and families are frequently between the 10^th and 12^th grade reading levels; more than 75% of all pediatric health information is written at or above 10^th grade reading level.¹¹ Government agencies recommend between a 6^th and 8^th grade reading level, for written material;^5,12,13 written discharge instructions have been identified as an important quality metric for hospital-to-home transitions.^14-16

At our center, we found that discharge instructions were commonly written at high reading levels and often incomplete.¹⁷ Poor discharge instructions may contribute to increased readmission rates and unnecessary ED visits.^9,18 Our global aim targeted improved health-literate written information, including understandability and completeness.

Our specific aim was to increase the percentage of discharge instructions written at or below the 7th grade level for hospital medicine (HM) patients on a community hospital pediatric unit from 13% to 80% in 6 months.

METHODS

Context

The improvement work took place at a 42-bed inpatient pediatric unit at a community satellite of our large, urban, academic hospital. The unit is staffed by medical providers including attendings, fellows, nurse practitioners (NPs), and senior pediatric residents, and had more than 1000 HM discharges in fiscal year 2016. Children with common general pediatric diagnoses are admitted to this service; postsurgical patients are not admitted primarily to the HM service. In Cincinnati, the neighborhood-level high school drop-out rates are as high as 64%.¹⁹ Discharge instructions are written by medical providers in the electronic health record (EHR). A printed copy is given to families and verbally reviewed by a bedside nurse prior to discharge. Quality improvement (QI) efforts focused on discharge instructions were ignited by a prior review of 200 discharge instructions that showed they were difficult to read (median reading level of 10^th grade), poorly understandable (36% of instructions met the threshold of understandability as measured by the Patient Education Materials Assessment Tool²⁰) and were missing key elements of information.¹⁷

 

Improvement Team

The improvement team consisted of 4 pediatric hospitalists, 2 NPs, 1 nurse educator with health literacy expertise, 1 pediatric resident, 1 fourth-year medical student, 1 QI consultant, and 2 parents who had first-hand experience on the HM service. The improvement team observed the discharge process, including roles of the provider, nurse and family, outlined a process map, and created a modified failure mode and effect analysis.²¹ Prior to our work, discharge instructions written by providers often occurred as a last step, and the content was created as free text or from nonstandardized templates. Key drivers that informed interventions were determined and revised over time (Figure 1). The study was reviewed by our institutional review board and deemed not human subjects research.

Improvement Activities

Key drivers were identified, and interventions were executed using Plan-Do Study-Act cycles.²² The key drivers thought to be critical for the success of the QI efforts were family engagement; standardization of discharge instructions; medical staff engagement; and audit and feedback of data. The corresponding interventions were as follows:

Family Engagement

Understanding the discharge information families desired. Prior to testing, 10 families admitted to the HM service were asked about the discharge experience. We asked families about information they wanted in written discharge instructions: 1) reasons to call your primary doctor or return to the hospital; 2) when to see your primary doctor for a follow-up visit; 3) the phone number to reach your child’s doctor; 4) more information about why your child was admitted; 5) information about new medications; and 6) what to do to help your child continue to recover at home.

Development of templates. We engaged families throughout the process of creating general and disease-specific discharge templates. After a specific template was created and reviewed by the parents on our team, it was sent to members of the institutional Patient Education Committee, which includes parents and local health literacy experts, to review and critique. Feedback from the reviewers was incorporated into the templates prior to use in the EHR.

Postdischarge phone calls.A convenience sample of families discharged from the satellite campus was called 24 to 48 hours after discharge over a 2-week period in January, 2016. A member of our improvement team solicited feedback from families about the quality of the discharge instructions. Families were asked if discharge instructions were reviewed with them prior to going home, if they were given a copy of the instructions, how they would rate the ability to read and use the information, and if there were additional pieces of information that would have improved the instructions.

Standardization of Instructions

Education. A presentation was created and shared with medical providers; it was re-disseminated monthly to new residents rotating onto the service and to the attendings, fellows, and NPs scheduled for shifts during the month. This education continued for the duration of the study. The presentation included the definition of health literacy, scope of the problem, examples of poorly written discharge instructions, and tips on how to write readable and understandable instructions. Laminated cards that included tips on how to write instructions were also placed on work stations.

Creation of discharge instruction templates in the EHR.A general discharge instruction template that was initially created and tested in the EHR (Figure 2) included text written below the 7th grade and employed 14 point font, bolded words for emphasis, and lists with bullet points. Asterisks were used to indicate where providers needed to include patient-specific information. The sections included in the general template were informed by feedback from providers and parents prior to testing, parents on the improvement team, and parents of patients admitted to our satellite campus. The sections reflect components critical to successful postdischarge care: discharge diagnosis and its brief description, postdischarge care information, new medications, signs and symptoms that would warrant escalation of care to the patient’s primary care provider or the ED, and follow-up instructions and contact information for the patent’s primary care doctor.

While the general template was an important first step, the content relied heavily on free text by providers, which could still lead to instructions written at a high reading level. Thus, disease-specific discharge instruction templates were created with prepopulated information that was written at a reading level at or below 7^th grade level (Figure 2). The diseases were prioritized based on the most common diagnoses on our HM service. Each template included information under each of the subheadings noted in the general template. Twelve disease-specific templates were tested and ultimately embedded in the EHR; the general template remained for use when the discharge diagnosis was not covered by a disease-specific template.

 

Medical Staff Engagement

Previously described tests of change also aimed to enhance staff engagement. These included frequent e-mails, discussion of the QI efforts at specific team meetings, and the creation of visual cues posted at computer work stations, which prompted staff to begin to work on discharge instructions soon after admission.

Audit and Feedback of Data

Weekly phone calls. One team updated clinicians through a regularly scheduled bi-weekly phone conference. The phone conference was established prior to our work and was designed to relay pertinent information to attendings and NPs who work at the satellite hospital. During the phone conferences, clinicians were notified of current performance on discharge instruction readability and specific tests of change for the week. Additionally, providers gave feedback about the improvement efforts. These updates continued for the first 6 months of the project until sustained improvements were observed.

E-mails. Weekly e-mails were sent to all providers scheduled for clinical time at the satellite campus. The e-mail contained information on current tests of change, a list of discharge instruction templates that were available in the EHR, and the annotated run chart illustrating readability levels over time.

Additionally, individual e-mails were sent to each provider after review of the written discharge instructions for the week. Providers were given information on the number of discharge instructions they personally composed, the percentage of those instructions that were written at or below 7^th grade level, and specific feedback on how their written instructions could be improved. We also encouraged feedback from each provider to better identify barriers to achieving our goal.

Study of the Interventions

Baseline data included a review of all instructions for patients discharged from the satellite campus from the end of April 2015 through mid-September 2015. The time period for testing of interventions during the fall and winter months allowed for rapid cycle learning due to higher patient census and predictability of admissions for specific diagnosis (ie, asthma and bronchiolitis). An automated report was generated from the EHR weekly with specific demographics and identifiers for patient discharged over the past 7 days, including patient age, gender, length of stay, discharge diagnosis, and insurance classification. Data was collected during the intervention period via structured review of the discharge instructions in the EHR by the principal investigator or a trained research coordinator. Discharge instructions for medically cleared mental health patients admitted to hospital medicine while awaiting psychiatric bed availability and patients and parents who were non-English speaking were excluded from review. All other instructions for patients discharged from the HM service at our Liberty Campus were included for review.

Measures

Readability, our primary measure of interest, was calculated using the mean score from the following formulas: Flesch Kincaid Grade Level,²³ Simple Measure of Gobbledygook Index,²⁴ Coleman-Liau Index,²⁵ Gunning-Fog Index,²⁶ and Automated Readability Index²⁷ by means of an online platform (https://readability-score.com).²⁸ This platform was chosen because it incorporated a variety of formulas, was user-friendly, and required minimal data cleaning. Each of the readability formulas have been used to assesses readability of health information given to patients and families.^29,30 The threshold of 7th grade is in alignment with our institutional policy for educational materials and with recommendations from several government agencies.^5,12

Analysis

A statistical process control p-chart was used to analyze our primary measure of readability, dichotomized as percent discharge instructions written at or below 7th grade level. Run charts were used to follow mean reading level of discharge instructions and our process measure of percent of discharge instruction written with a general or disease-specific standardized template. Run chart and control chart rules for identifying special cause were used for midline shifts.³¹

RESULTS

The Table includes the demographic and clinical information of patients included in our analyses. Through sequential interventions, the percentage of discharge instructions written at or below 7th grade readability level increased from a mean of 13% to more than 80% in 3 months (Figure 3). Furthermore, the mean was sustained above 90% for 10 months and at 98% for the last 4 months. The use of 1 of the 13 EHR templates increased from 0% to 96% and was associated with the largest impact on the overall improvements (Supplemental Figure 1). Additionally, the average reading level of the discharge instructions decreased from 10th grade to 6th grade level (Supplemental Figure 2).

Qualitative comments from providers about the discharge instructions included:

“Are these [discharge instructions] available at base??  Great resource for interns.”
“These [discharge] instructions make the [discharge] process so easy!!! Love these...”
“Also feel like they have helped my discharge teaching in the room!”

Qualitative comments from families postdischarge included:
“I thought the instructions were very clear and easy to read. I especially thought that highlighting the important areas really helped.”
“I think this form looks great, and I really like the idea of having your child’s name on it.”

 

DISCUSSION

Through sequential Plan-Do Study-Act cycles, we increased the percentage of discharge instructions written at or below 7^th grade reading level from 13% to 98%. Our most impactful intervention was the creation and dissemination of standardized disease-specific discharge instruction templates. Our findings complement evidence in the adult and pediatric literature that the use of standardized, disease-specific discharge instruction templates may improve readability of instructions.^32,33 And, while quality improvement efforts have been employed to improve the discharge process for patients,^34-36 this is the first study in the inpatient setting that, to our knowledge, specifically addresses discharge instructions using quality improvement methods.

Our work targeted the critical intersection between individual health literacy, an individual’s capacity to acquire, interpret, and use health information, and the necessary changes needed within our healthcare system to ensure that appropriately written instructions are given to patients and families.^17,37 Our efforts focused on improving discharge instructions answer the call to consider health literacy a modifiable clinical risk factor.³⁷ Furthermore, we address the 6 aims for quality healthcare delivery: 1) safe, timely, efficient and equitable delivery of care through the creation and dissemination of standardized instructions that are written at the appropriate reading level for families to ease hospital-to-home transitions and streamline the workflow of medical providers; 2) effective education of medical providers on health literacy concepts; and 3) family-centeredness through the involvement of families in our QI efforts. While previous QI efforts to improve hospital-to-home transitions have focused on medication reconciliation, communication with primary care physicians, follow-up appointments, and timely discharges of patients, none have specifically focused on the quality of discharge instructions.^34-36

Most physicians do not receive education about how to write information that is readable and understandable; more than half of providers desired more education in this area.³⁸ Furthermore, pediatric providers may overestimate parental health literacy levels,³⁹ which may contribute to variability in the readability of written health materials. While education alone can contribute to a provider’s ability to create readable instructions, we note the improvement after the introduction of disease templates to demonstrate the importance of workflow-integrated higher reliability interventions to sustain improvements.

Our baseline poor readability rates were due to limited knowledge by frontline providers composing the instructions and a system in which an important element for successful hospital-to-home transitions was not tackled until patients were ready for discharge. Streamlining of the discharge process, including the creation of discharge instructions, may lead to improved efficiency, fewer discrepancies, more effective communication, and an enhanced family experience. Moreover, the success of our improvement work was due to key stakeholders, including parents, being a part of the team and the notable buy-in from providers.

Our work was not without limitations. We excluded non-English speaking families from the study. We were unable to measure reading level of our population directly and instead based our goals on national estimates. Our primary measure was readability, which is only 1 piece contributing to quality discharge instructions. Understandability and actionability are also important considerations; ^17,20,29,40 however, improvements in these areas were limited by our design options within the EHR. Our efforts focused on children with common general pediatric diagnoses, and it is unclear how our interventions would generalize to medically complex patients with more volume of information to communicate at discharge and with uncommon diagnoses that are less readily incorporated into standardized templates. Relatedly, our work occurred at the satellite campus of our tertiary care center and may not represent generalizable material or methods to implement templates at our main campus location or at other hospitals. To begin to better understand this, we have spread to HM patients at our main campus, including medically complex patients with technology dependence and/or neurological impairments. Standardized, disease-specific templates most relevant to this population as well as several patient specific templates, for those with frequent readmissions due to medical complexity, have been created and are actively being tested.

CONCLUSION

In conclusion, in using interventions targeted at standardization of discharge instructions and timely feedback to staff, we saw rapid, dramatic, and sustained improvement in the readability of discharge instructions. Next steps include adaptation and spread to other patient populations and care teams, collaborations with other centers, and assessing the impact of effectively written discharge instructions on patient outcomes, such as adverse drug events, readmission rates, and family experience.

Disclosure

No external funding was secured for this study. Dr. Brady is supported by a Patient-Centered Outcomes Research Mentored Clinical Investigator Award from the Agency for Healthcare Research and Quality, Award Number K08HS023827. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding organizations. The funding organization had no role in the design, preparation, review, or approval of this paper; nor the decision to submit the manuscript for publication. The authors have no financial relationships relevant to this article to disclose.

The transition from hospital to home can be overwhelming for caregivers.¹ Stress of hospitalization coupled with the expectation of families to execute postdischarge care plans make understandable discharge communication critical. Communication failures, inadequate education, absence of caregiver confidence, and lack of clarity regarding care plans may prohibit smooth transitions and lead to adverse postdischarge outcomes.^2-4

Health literacy plays a pivotal role in caregivers’ capacity to navigate the healthcare system, comprehend, and execute care plans. An estimated 90 million Americans have limited health literacy that may negatively impact the provision of safe and quality care^5,6 and be a risk factor for poor outcomes, including increased emergency department (ED) utilization and readmission rates.^7-9 Readability strongly influences the effectiveness of written materials.¹⁰ However, written medical information for patients and families are frequently between the 10^th and 12^th grade reading levels; more than 75% of all pediatric health information is written at or above 10^th grade reading level.¹¹ Government agencies recommend between a 6^th and 8^th grade reading level, for written material;^5,12,13 written discharge instructions have been identified as an important quality metric for hospital-to-home transitions.^14-16

At our center, we found that discharge instructions were commonly written at high reading levels and often incomplete.¹⁷ Poor discharge instructions may contribute to increased readmission rates and unnecessary ED visits.^9,18 Our global aim targeted improved health-literate written information, including understandability and completeness.

Our specific aim was to increase the percentage of discharge instructions written at or below the 7th grade level for hospital medicine (HM) patients on a community hospital pediatric unit from 13% to 80% in 6 months.

METHODS

Context

The improvement work took place at a 42-bed inpatient pediatric unit at a community satellite of our large, urban, academic hospital. The unit is staffed by medical providers including attendings, fellows, nurse practitioners (NPs), and senior pediatric residents, and had more than 1000 HM discharges in fiscal year 2016. Children with common general pediatric diagnoses are admitted to this service; postsurgical patients are not admitted primarily to the HM service. In Cincinnati, the neighborhood-level high school drop-out rates are as high as 64%.¹⁹ Discharge instructions are written by medical providers in the electronic health record (EHR). A printed copy is given to families and verbally reviewed by a bedside nurse prior to discharge. Quality improvement (QI) efforts focused on discharge instructions were ignited by a prior review of 200 discharge instructions that showed they were difficult to read (median reading level of 10^th grade), poorly understandable (36% of instructions met the threshold of understandability as measured by the Patient Education Materials Assessment Tool²⁰) and were missing key elements of information.¹⁷

 

Improvement Team

The improvement team consisted of 4 pediatric hospitalists, 2 NPs, 1 nurse educator with health literacy expertise, 1 pediatric resident, 1 fourth-year medical student, 1 QI consultant, and 2 parents who had first-hand experience on the HM service. The improvement team observed the discharge process, including roles of the provider, nurse and family, outlined a process map, and created a modified failure mode and effect analysis.²¹ Prior to our work, discharge instructions written by providers often occurred as a last step, and the content was created as free text or from nonstandardized templates. Key drivers that informed interventions were determined and revised over time (Figure 1). The study was reviewed by our institutional review board and deemed not human subjects research.

Improvement Activities

Key drivers were identified, and interventions were executed using Plan-Do Study-Act cycles.²² The key drivers thought to be critical for the success of the QI efforts were family engagement; standardization of discharge instructions; medical staff engagement; and audit and feedback of data. The corresponding interventions were as follows:

Family Engagement

Understanding the discharge information families desired. Prior to testing, 10 families admitted to the HM service were asked about the discharge experience. We asked families about information they wanted in written discharge instructions: 1) reasons to call your primary doctor or return to the hospital; 2) when to see your primary doctor for a follow-up visit; 3) the phone number to reach your child’s doctor; 4) more information about why your child was admitted; 5) information about new medications; and 6) what to do to help your child continue to recover at home.

Development of templates. We engaged families throughout the process of creating general and disease-specific discharge templates. After a specific template was created and reviewed by the parents on our team, it was sent to members of the institutional Patient Education Committee, which includes parents and local health literacy experts, to review and critique. Feedback from the reviewers was incorporated into the templates prior to use in the EHR.

Postdischarge phone calls.A convenience sample of families discharged from the satellite campus was called 24 to 48 hours after discharge over a 2-week period in January, 2016. A member of our improvement team solicited feedback from families about the quality of the discharge instructions. Families were asked if discharge instructions were reviewed with them prior to going home, if they were given a copy of the instructions, how they would rate the ability to read and use the information, and if there were additional pieces of information that would have improved the instructions.

Standardization of Instructions

Education. A presentation was created and shared with medical providers; it was re-disseminated monthly to new residents rotating onto the service and to the attendings, fellows, and NPs scheduled for shifts during the month. This education continued for the duration of the study. The presentation included the definition of health literacy, scope of the problem, examples of poorly written discharge instructions, and tips on how to write readable and understandable instructions. Laminated cards that included tips on how to write instructions were also placed on work stations.

Creation of discharge instruction templates in the EHR.A general discharge instruction template that was initially created and tested in the EHR (Figure 2) included text written below the 7th grade and employed 14 point font, bolded words for emphasis, and lists with bullet points. Asterisks were used to indicate where providers needed to include patient-specific information. The sections included in the general template were informed by feedback from providers and parents prior to testing, parents on the improvement team, and parents of patients admitted to our satellite campus. The sections reflect components critical to successful postdischarge care: discharge diagnosis and its brief description, postdischarge care information, new medications, signs and symptoms that would warrant escalation of care to the patient’s primary care provider or the ED, and follow-up instructions and contact information for the patent’s primary care doctor.

While the general template was an important first step, the content relied heavily on free text by providers, which could still lead to instructions written at a high reading level. Thus, disease-specific discharge instruction templates were created with prepopulated information that was written at a reading level at or below 7^th grade level (Figure 2). The diseases were prioritized based on the most common diagnoses on our HM service. Each template included information under each of the subheadings noted in the general template. Twelve disease-specific templates were tested and ultimately embedded in the EHR; the general template remained for use when the discharge diagnosis was not covered by a disease-specific template.

 

Medical Staff Engagement

Previously described tests of change also aimed to enhance staff engagement. These included frequent e-mails, discussion of the QI efforts at specific team meetings, and the creation of visual cues posted at computer work stations, which prompted staff to begin to work on discharge instructions soon after admission.

Audit and Feedback of Data

Weekly phone calls. One team updated clinicians through a regularly scheduled bi-weekly phone conference. The phone conference was established prior to our work and was designed to relay pertinent information to attendings and NPs who work at the satellite hospital. During the phone conferences, clinicians were notified of current performance on discharge instruction readability and specific tests of change for the week. Additionally, providers gave feedback about the improvement efforts. These updates continued for the first 6 months of the project until sustained improvements were observed.

E-mails. Weekly e-mails were sent to all providers scheduled for clinical time at the satellite campus. The e-mail contained information on current tests of change, a list of discharge instruction templates that were available in the EHR, and the annotated run chart illustrating readability levels over time.

Additionally, individual e-mails were sent to each provider after review of the written discharge instructions for the week. Providers were given information on the number of discharge instructions they personally composed, the percentage of those instructions that were written at or below 7^th grade level, and specific feedback on how their written instructions could be improved. We also encouraged feedback from each provider to better identify barriers to achieving our goal.

Study of the Interventions

Baseline data included a review of all instructions for patients discharged from the satellite campus from the end of April 2015 through mid-September 2015. The time period for testing of interventions during the fall and winter months allowed for rapid cycle learning due to higher patient census and predictability of admissions for specific diagnosis (ie, asthma and bronchiolitis). An automated report was generated from the EHR weekly with specific demographics and identifiers for patient discharged over the past 7 days, including patient age, gender, length of stay, discharge diagnosis, and insurance classification. Data was collected during the intervention period via structured review of the discharge instructions in the EHR by the principal investigator or a trained research coordinator. Discharge instructions for medically cleared mental health patients admitted to hospital medicine while awaiting psychiatric bed availability and patients and parents who were non-English speaking were excluded from review. All other instructions for patients discharged from the HM service at our Liberty Campus were included for review.

Measures

Readability, our primary measure of interest, was calculated using the mean score from the following formulas: Flesch Kincaid Grade Level,²³ Simple Measure of Gobbledygook Index,²⁴ Coleman-Liau Index,²⁵ Gunning-Fog Index,²⁶ and Automated Readability Index²⁷ by means of an online platform (https://readability-score.com).²⁸ This platform was chosen because it incorporated a variety of formulas, was user-friendly, and required minimal data cleaning. Each of the readability formulas have been used to assesses readability of health information given to patients and families.^29,30 The threshold of 7th grade is in alignment with our institutional policy for educational materials and with recommendations from several government agencies.^5,12

Analysis

A statistical process control p-chart was used to analyze our primary measure of readability, dichotomized as percent discharge instructions written at or below 7th grade level. Run charts were used to follow mean reading level of discharge instructions and our process measure of percent of discharge instruction written with a general or disease-specific standardized template. Run chart and control chart rules for identifying special cause were used for midline shifts.³¹

RESULTS

The Table includes the demographic and clinical information of patients included in our analyses. Through sequential interventions, the percentage of discharge instructions written at or below 7th grade readability level increased from a mean of 13% to more than 80% in 3 months (Figure 3). Furthermore, the mean was sustained above 90% for 10 months and at 98% for the last 4 months. The use of 1 of the 13 EHR templates increased from 0% to 96% and was associated with the largest impact on the overall improvements (Supplemental Figure 1). Additionally, the average reading level of the discharge instructions decreased from 10th grade to 6th grade level (Supplemental Figure 2).

Qualitative comments from providers about the discharge instructions included:

“Are these [discharge instructions] available at base??  Great resource for interns.”
“These [discharge] instructions make the [discharge] process so easy!!! Love these...”
“Also feel like they have helped my discharge teaching in the room!”

Qualitative comments from families postdischarge included:
“I thought the instructions were very clear and easy to read. I especially thought that highlighting the important areas really helped.”
“I think this form looks great, and I really like the idea of having your child’s name on it.”

 

DISCUSSION

Through sequential Plan-Do Study-Act cycles, we increased the percentage of discharge instructions written at or below 7^th grade reading level from 13% to 98%. Our most impactful intervention was the creation and dissemination of standardized disease-specific discharge instruction templates. Our findings complement evidence in the adult and pediatric literature that the use of standardized, disease-specific discharge instruction templates may improve readability of instructions.^32,33 And, while quality improvement efforts have been employed to improve the discharge process for patients,^34-36 this is the first study in the inpatient setting that, to our knowledge, specifically addresses discharge instructions using quality improvement methods.

Our work targeted the critical intersection between individual health literacy, an individual’s capacity to acquire, interpret, and use health information, and the necessary changes needed within our healthcare system to ensure that appropriately written instructions are given to patients and families.^17,37 Our efforts focused on improving discharge instructions answer the call to consider health literacy a modifiable clinical risk factor.³⁷ Furthermore, we address the 6 aims for quality healthcare delivery: 1) safe, timely, efficient and equitable delivery of care through the creation and dissemination of standardized instructions that are written at the appropriate reading level for families to ease hospital-to-home transitions and streamline the workflow of medical providers; 2) effective education of medical providers on health literacy concepts; and 3) family-centeredness through the involvement of families in our QI efforts. While previous QI efforts to improve hospital-to-home transitions have focused on medication reconciliation, communication with primary care physicians, follow-up appointments, and timely discharges of patients, none have specifically focused on the quality of discharge instructions.^34-36

Most physicians do not receive education about how to write information that is readable and understandable; more than half of providers desired more education in this area.³⁸ Furthermore, pediatric providers may overestimate parental health literacy levels,³⁹ which may contribute to variability in the readability of written health materials. While education alone can contribute to a provider’s ability to create readable instructions, we note the improvement after the introduction of disease templates to demonstrate the importance of workflow-integrated higher reliability interventions to sustain improvements.

Our baseline poor readability rates were due to limited knowledge by frontline providers composing the instructions and a system in which an important element for successful hospital-to-home transitions was not tackled until patients were ready for discharge. Streamlining of the discharge process, including the creation of discharge instructions, may lead to improved efficiency, fewer discrepancies, more effective communication, and an enhanced family experience. Moreover, the success of our improvement work was due to key stakeholders, including parents, being a part of the team and the notable buy-in from providers.

Our work was not without limitations. We excluded non-English speaking families from the study. We were unable to measure reading level of our population directly and instead based our goals on national estimates. Our primary measure was readability, which is only 1 piece contributing to quality discharge instructions. Understandability and actionability are also important considerations; ^17,20,29,40 however, improvements in these areas were limited by our design options within the EHR. Our efforts focused on children with common general pediatric diagnoses, and it is unclear how our interventions would generalize to medically complex patients with more volume of information to communicate at discharge and with uncommon diagnoses that are less readily incorporated into standardized templates. Relatedly, our work occurred at the satellite campus of our tertiary care center and may not represent generalizable material or methods to implement templates at our main campus location or at other hospitals. To begin to better understand this, we have spread to HM patients at our main campus, including medically complex patients with technology dependence and/or neurological impairments. Standardized, disease-specific templates most relevant to this population as well as several patient specific templates, for those with frequent readmissions due to medical complexity, have been created and are actively being tested.

CONCLUSION

In conclusion, in using interventions targeted at standardization of discharge instructions and timely feedback to staff, we saw rapid, dramatic, and sustained improvement in the readability of discharge instructions. Next steps include adaptation and spread to other patient populations and care teams, collaborations with other centers, and assessing the impact of effectively written discharge instructions on patient outcomes, such as adverse drug events, readmission rates, and family experience.

Disclosure

No external funding was secured for this study. Dr. Brady is supported by a Patient-Centered Outcomes Research Mentored Clinical Investigator Award from the Agency for Healthcare Research and Quality, Award Number K08HS023827. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding organizations. The funding organization had no role in the design, preparation, review, or approval of this paper; nor the decision to submit the manuscript for publication. The authors have no financial relationships relevant to this article to disclose.

The transition from hospital to home can be overwhelming for caregivers.¹ Stress of hospitalization coupled with the expectation of families to execute postdischarge care plans make understandable discharge communication critical. Communication failures, inadequate education, absence of caregiver confidence, and lack of clarity regarding care plans may prohibit smooth transitions and lead to adverse postdischarge outcomes.^2-4

Health literacy plays a pivotal role in caregivers’ capacity to navigate the healthcare system, comprehend, and execute care plans. An estimated 90 million Americans have limited health literacy that may negatively impact the provision of safe and quality care^5,6 and be a risk factor for poor outcomes, including increased emergency department (ED) utilization and readmission rates.^7-9 Readability strongly influences the effectiveness of written materials.¹⁰ However, written medical information for patients and families are frequently between the 10^th and 12^th grade reading levels; more than 75% of all pediatric health information is written at or above 10^th grade reading level.¹¹ Government agencies recommend between a 6^th and 8^th grade reading level, for written material;^5,12,13 written discharge instructions have been identified as an important quality metric for hospital-to-home transitions.^14-16

At our center, we found that discharge instructions were commonly written at high reading levels and often incomplete.¹⁷ Poor discharge instructions may contribute to increased readmission rates and unnecessary ED visits.^9,18 Our global aim targeted improved health-literate written information, including understandability and completeness.

Our specific aim was to increase the percentage of discharge instructions written at or below the 7th grade level for hospital medicine (HM) patients on a community hospital pediatric unit from 13% to 80% in 6 months.

METHODS

Context

The improvement work took place at a 42-bed inpatient pediatric unit at a community satellite of our large, urban, academic hospital. The unit is staffed by medical providers including attendings, fellows, nurse practitioners (NPs), and senior pediatric residents, and had more than 1000 HM discharges in fiscal year 2016. Children with common general pediatric diagnoses are admitted to this service; postsurgical patients are not admitted primarily to the HM service. In Cincinnati, the neighborhood-level high school drop-out rates are as high as 64%.¹⁹ Discharge instructions are written by medical providers in the electronic health record (EHR). A printed copy is given to families and verbally reviewed by a bedside nurse prior to discharge. Quality improvement (QI) efforts focused on discharge instructions were ignited by a prior review of 200 discharge instructions that showed they were difficult to read (median reading level of 10^th grade), poorly understandable (36% of instructions met the threshold of understandability as measured by the Patient Education Materials Assessment Tool²⁰) and were missing key elements of information.¹⁷

 

Improvement Team

The improvement team consisted of 4 pediatric hospitalists, 2 NPs, 1 nurse educator with health literacy expertise, 1 pediatric resident, 1 fourth-year medical student, 1 QI consultant, and 2 parents who had first-hand experience on the HM service. The improvement team observed the discharge process, including roles of the provider, nurse and family, outlined a process map, and created a modified failure mode and effect analysis.²¹ Prior to our work, discharge instructions written by providers often occurred as a last step, and the content was created as free text or from nonstandardized templates. Key drivers that informed interventions were determined and revised over time (Figure 1). The study was reviewed by our institutional review board and deemed not human subjects research.

Improvement Activities

Key drivers were identified, and interventions were executed using Plan-Do Study-Act cycles.²² The key drivers thought to be critical for the success of the QI efforts were family engagement; standardization of discharge instructions; medical staff engagement; and audit and feedback of data. The corresponding interventions were as follows:

Family Engagement

Understanding the discharge information families desired. Prior to testing, 10 families admitted to the HM service were asked about the discharge experience. We asked families about information they wanted in written discharge instructions: 1) reasons to call your primary doctor or return to the hospital; 2) when to see your primary doctor for a follow-up visit; 3) the phone number to reach your child’s doctor; 4) more information about why your child was admitted; 5) information about new medications; and 6) what to do to help your child continue to recover at home.

Development of templates. We engaged families throughout the process of creating general and disease-specific discharge templates. After a specific template was created and reviewed by the parents on our team, it was sent to members of the institutional Patient Education Committee, which includes parents and local health literacy experts, to review and critique. Feedback from the reviewers was incorporated into the templates prior to use in the EHR.

Postdischarge phone calls.A convenience sample of families discharged from the satellite campus was called 24 to 48 hours after discharge over a 2-week period in January, 2016. A member of our improvement team solicited feedback from families about the quality of the discharge instructions. Families were asked if discharge instructions were reviewed with them prior to going home, if they were given a copy of the instructions, how they would rate the ability to read and use the information, and if there were additional pieces of information that would have improved the instructions.

Standardization of Instructions

Education. A presentation was created and shared with medical providers; it was re-disseminated monthly to new residents rotating onto the service and to the attendings, fellows, and NPs scheduled for shifts during the month. This education continued for the duration of the study. The presentation included the definition of health literacy, scope of the problem, examples of poorly written discharge instructions, and tips on how to write readable and understandable instructions. Laminated cards that included tips on how to write instructions were also placed on work stations.

Creation of discharge instruction templates in the EHR.A general discharge instruction template that was initially created and tested in the EHR (Figure 2) included text written below the 7th grade and employed 14 point font, bolded words for emphasis, and lists with bullet points. Asterisks were used to indicate where providers needed to include patient-specific information. The sections included in the general template were informed by feedback from providers and parents prior to testing, parents on the improvement team, and parents of patients admitted to our satellite campus. The sections reflect components critical to successful postdischarge care: discharge diagnosis and its brief description, postdischarge care information, new medications, signs and symptoms that would warrant escalation of care to the patient’s primary care provider or the ED, and follow-up instructions and contact information for the patent’s primary care doctor.

While the general template was an important first step, the content relied heavily on free text by providers, which could still lead to instructions written at a high reading level. Thus, disease-specific discharge instruction templates were created with prepopulated information that was written at a reading level at or below 7^th grade level (Figure 2). The diseases were prioritized based on the most common diagnoses on our HM service. Each template included information under each of the subheadings noted in the general template. Twelve disease-specific templates were tested and ultimately embedded in the EHR; the general template remained for use when the discharge diagnosis was not covered by a disease-specific template.

 

Medical Staff Engagement

Previously described tests of change also aimed to enhance staff engagement. These included frequent e-mails, discussion of the QI efforts at specific team meetings, and the creation of visual cues posted at computer work stations, which prompted staff to begin to work on discharge instructions soon after admission.

Audit and Feedback of Data

Weekly phone calls. One team updated clinicians through a regularly scheduled bi-weekly phone conference. The phone conference was established prior to our work and was designed to relay pertinent information to attendings and NPs who work at the satellite hospital. During the phone conferences, clinicians were notified of current performance on discharge instruction readability and specific tests of change for the week. Additionally, providers gave feedback about the improvement efforts. These updates continued for the first 6 months of the project until sustained improvements were observed.

E-mails. Weekly e-mails were sent to all providers scheduled for clinical time at the satellite campus. The e-mail contained information on current tests of change, a list of discharge instruction templates that were available in the EHR, and the annotated run chart illustrating readability levels over time.

Additionally, individual e-mails were sent to each provider after review of the written discharge instructions for the week. Providers were given information on the number of discharge instructions they personally composed, the percentage of those instructions that were written at or below 7^th grade level, and specific feedback on how their written instructions could be improved. We also encouraged feedback from each provider to better identify barriers to achieving our goal.

Study of the Interventions

Baseline data included a review of all instructions for patients discharged from the satellite campus from the end of April 2015 through mid-September 2015. The time period for testing of interventions during the fall and winter months allowed for rapid cycle learning due to higher patient census and predictability of admissions for specific diagnosis (ie, asthma and bronchiolitis). An automated report was generated from the EHR weekly with specific demographics and identifiers for patient discharged over the past 7 days, including patient age, gender, length of stay, discharge diagnosis, and insurance classification. Data was collected during the intervention period via structured review of the discharge instructions in the EHR by the principal investigator or a trained research coordinator. Discharge instructions for medically cleared mental health patients admitted to hospital medicine while awaiting psychiatric bed availability and patients and parents who were non-English speaking were excluded from review. All other instructions for patients discharged from the HM service at our Liberty Campus were included for review.

Measures

Readability, our primary measure of interest, was calculated using the mean score from the following formulas: Flesch Kincaid Grade Level,²³ Simple Measure of Gobbledygook Index,²⁴ Coleman-Liau Index,²⁵ Gunning-Fog Index,²⁶ and Automated Readability Index²⁷ by means of an online platform (https://readability-score.com).²⁸ This platform was chosen because it incorporated a variety of formulas, was user-friendly, and required minimal data cleaning. Each of the readability formulas have been used to assesses readability of health information given to patients and families.^29,30 The threshold of 7th grade is in alignment with our institutional policy for educational materials and with recommendations from several government agencies.^5,12

Analysis

A statistical process control p-chart was used to analyze our primary measure of readability, dichotomized as percent discharge instructions written at or below 7th grade level. Run charts were used to follow mean reading level of discharge instructions and our process measure of percent of discharge instruction written with a general or disease-specific standardized template. Run chart and control chart rules for identifying special cause were used for midline shifts.³¹

RESULTS

The Table includes the demographic and clinical information of patients included in our analyses. Through sequential interventions, the percentage of discharge instructions written at or below 7th grade readability level increased from a mean of 13% to more than 80% in 3 months (Figure 3). Furthermore, the mean was sustained above 90% for 10 months and at 98% for the last 4 months. The use of 1 of the 13 EHR templates increased from 0% to 96% and was associated with the largest impact on the overall improvements (Supplemental Figure 1). Additionally, the average reading level of the discharge instructions decreased from 10th grade to 6th grade level (Supplemental Figure 2).

Qualitative comments from providers about the discharge instructions included:

“Are these [discharge instructions] available at base??  Great resource for interns.”
“These [discharge] instructions make the [discharge] process so easy!!! Love these...”
“Also feel like they have helped my discharge teaching in the room!”

Qualitative comments from families postdischarge included:
“I thought the instructions were very clear and easy to read. I especially thought that highlighting the important areas really helped.”
“I think this form looks great, and I really like the idea of having your child’s name on it.”

 

DISCUSSION

Through sequential Plan-Do Study-Act cycles, we increased the percentage of discharge instructions written at or below 7^th grade reading level from 13% to 98%. Our most impactful intervention was the creation and dissemination of standardized disease-specific discharge instruction templates. Our findings complement evidence in the adult and pediatric literature that the use of standardized, disease-specific discharge instruction templates may improve readability of instructions.^32,33 And, while quality improvement efforts have been employed to improve the discharge process for patients,^34-36 this is the first study in the inpatient setting that, to our knowledge, specifically addresses discharge instructions using quality improvement methods.

Our work targeted the critical intersection between individual health literacy, an individual’s capacity to acquire, interpret, and use health information, and the necessary changes needed within our healthcare system to ensure that appropriately written instructions are given to patients and families.^17,37 Our efforts focused on improving discharge instructions answer the call to consider health literacy a modifiable clinical risk factor.³⁷ Furthermore, we address the 6 aims for quality healthcare delivery: 1) safe, timely, efficient and equitable delivery of care through the creation and dissemination of standardized instructions that are written at the appropriate reading level for families to ease hospital-to-home transitions and streamline the workflow of medical providers; 2) effective education of medical providers on health literacy concepts; and 3) family-centeredness through the involvement of families in our QI efforts. While previous QI efforts to improve hospital-to-home transitions have focused on medication reconciliation, communication with primary care physicians, follow-up appointments, and timely discharges of patients, none have specifically focused on the quality of discharge instructions.^34-36

Most physicians do not receive education about how to write information that is readable and understandable; more than half of providers desired more education in this area.³⁸ Furthermore, pediatric providers may overestimate parental health literacy levels,³⁹ which may contribute to variability in the readability of written health materials. While education alone can contribute to a provider’s ability to create readable instructions, we note the improvement after the introduction of disease templates to demonstrate the importance of workflow-integrated higher reliability interventions to sustain improvements.

Our baseline poor readability rates were due to limited knowledge by frontline providers composing the instructions and a system in which an important element for successful hospital-to-home transitions was not tackled until patients were ready for discharge. Streamlining of the discharge process, including the creation of discharge instructions, may lead to improved efficiency, fewer discrepancies, more effective communication, and an enhanced family experience. Moreover, the success of our improvement work was due to key stakeholders, including parents, being a part of the team and the notable buy-in from providers.

Our work was not without limitations. We excluded non-English speaking families from the study. We were unable to measure reading level of our population directly and instead based our goals on national estimates. Our primary measure was readability, which is only 1 piece contributing to quality discharge instructions. Understandability and actionability are also important considerations; ^17,20,29,40 however, improvements in these areas were limited by our design options within the EHR. Our efforts focused on children with common general pediatric diagnoses, and it is unclear how our interventions would generalize to medically complex patients with more volume of information to communicate at discharge and with uncommon diagnoses that are less readily incorporated into standardized templates. Relatedly, our work occurred at the satellite campus of our tertiary care center and may not represent generalizable material or methods to implement templates at our main campus location or at other hospitals. To begin to better understand this, we have spread to HM patients at our main campus, including medically complex patients with technology dependence and/or neurological impairments. Standardized, disease-specific templates most relevant to this population as well as several patient specific templates, for those with frequent readmissions due to medical complexity, have been created and are actively being tested.

CONCLUSION

In conclusion, in using interventions targeted at standardization of discharge instructions and timely feedback to staff, we saw rapid, dramatic, and sustained improvement in the readability of discharge instructions. Next steps include adaptation and spread to other patient populations and care teams, collaborations with other centers, and assessing the impact of effectively written discharge instructions on patient outcomes, such as adverse drug events, readmission rates, and family experience.

Disclosure

No external funding was secured for this study. Dr. Brady is supported by a Patient-Centered Outcomes Research Mentored Clinical Investigator Award from the Agency for Healthcare Research and Quality, Award Number K08HS023827. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding organizations. The funding organization had no role in the design, preparation, review, or approval of this paper; nor the decision to submit the manuscript for publication. The authors have no financial relationships relevant to this article to disclose.

Direct-acting oral anticoagulants (DOACs) have been introduced into clinical use for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), prevention of venous thrombosis after hip or knee surgery, and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).^1-7 Advantages of DOACs over warfarin are often stated as fixed dosing, minor drug and food interactions, wider therapeutic index, and no need for laboratory test monitoring.^1,8 Yet, recommended DOAC dosages vary by renal function and therapeutic indications. Dosing recommendations for prevention of stroke in patients with NVAF are based on estimated creatinine clearance (dabigatran, rivaroxaban, edoxaban), age (apixaban), weight (apixaban, edoxaban), serum creatinine level (apixaban, edoxaban), and presence of cirrhosis by Child-Pugh class^9,10 (apixaban, edoxaban).^4-6,11,12 Dosing recommendations based on coadministration of strong CYP34A and P-glycoprotein inhibitors or inducers vary by DOAC. In addition, dabigatran cannot be crushed and must be stored in its original packaging, and rivaroxaban should be taken with food when the dose is over 10 mg.

We studied DOAC prescribing in adults admitted to a large academic medical center by comparing initial prescribed dosing with FDA-approved prescribing information. We hypothesized that the complexity of DOAC dosing may not be recognized by prescribers.

METHODS

Our study protocol was approved by the Committee on Human Research (Institutional Review Board) of the University of California San Francisco.

Data Collection

We used electronic medical records (EMRs) to identify adult inpatients who were prescribed a DOAC (apixaban, dabigatran, edoxaban, or rivaroxaban) at the University of California San Francisco Medical Center, a large academic hospital, between July 1, 2014 and June 30, 2015. Demographic and medical information related to therapeutic indications, contraindications, and indications for dose adjustments were collected and included diagnoses classified by International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) for venous thromboses; phlebitis or thrombophlebitis; PE or venous embolism; atrial arrhythmias; surgical procedures; cirrhosis and/or ascites or liver disease; coagulopathies; artificial heart valves or implanted devices; prior use of medications including parenteral anticoagulants; and laboratory data obtained before the first DOAC order (serum creatinine level, estimated glomerular filtration rate [eGFR] determined by Chronic Kidney Disease Epidemiology Collaboration,¹³ international normalized ratio, or, if available, activated partial thromboplastin time and bilirubin level). Creatinine clearance was calculated with the Cockcroft-Gault method¹⁴ using total body weight, per drug label recommendation. Child-Pugh class was calculated if cirrhosis was diagnosed.¹⁰ DOAC dose, frequency, dosing directions, and prescriber medical specialty were determined.

 

Accuracy of search results was confirmed by review of the first 200 patients’ records. Records were manually reviewed for encounters lacking ICD-9/10 codes and approved DOAC indications (30%) and encounters having multiple coded diagnostic indications (to identify the indication). ICD-9 codes for venous thrombosis were reviewed to differentiate acute from chronic events.

Data Analysis

The main outcome was concordance or discordance between the first DOAC prescribing order and the FDA-approved prescribing information at the time. Initial classification, performed by 2 independent reviewers (a pharmacist and a physician, or 2 pharmacists), was followed by adjudication and individual record review (by 2 independent reviewers) of all initial prescribing orders classified as discordant. A third reviewer adjudicated any disagreement. Records and notes were reviewed to identify stated or potential reasons for dosing variation and pre-admission prescriptions. Data are presented as means and standard deviations (SDs) and as raw numbers and percentages. Differences in patient characteristics by DOAC or therapeutic indication were determined by analysis of variance (ANOVA) with Bonferroni correction for post hoc comparisons. Dosing information was categorized as the same as recommended, lower than recommended, higher than recommended, or avoid drug use (drug–drug or drug–disease interaction), per FDA-approved prescribing information, and χ² tests were used to determine whether variation in dosing occurred by individual DOAC, therapeutic indication, or prescriber specialty. Relationships between dosing variation and age or renal function were tested by ANOVA with Bonferroni correction for post hoc comparisons.

RESULTS

There were 635 admissions with apixaban, dabigatran, or rivaroxaban prescribed for 508 patients (Table 1). Edoxaban was not on the formulary and not prescribed during the period studied. The therapeutic indication was prevention of embolic stroke in patients with atrial fibrillation/flutter or AF (465 admissions, or 73%, with valvular disease and/or tissue valve in 35), chronic DVT (67 admissions, or 11%, with active malignancy in 14), acute DVT (32 admissions, with malignancy in 2), chronic PE (23 admissions, with malignancy in 3), acute PE (19 admissions, with malignancy in 4), and DVT prevention after hip or knee surgery (19 admissions). DOACs were prescribed for unapproved indications in 10 admissions, and these were excluded from further analysis (mural thrombus in 3 admissions, low ejection fraction in 2, bedrest immobilization in 2, aortic aneurysm in 1, thrombocytosis in 1, and extensive superficial venous thrombosis in 1) (Table 2).

Patients with AF were older with lower creatinine clearance compared to patients with other diagnoses. Mean (SD) patient age was 72.1 (12.7) years for AF, 53.1 (10.9) years for chronic PE, 55.5 (14) years for acute PE, 56.4 (15.9) years for chronic DVT, 57.9 (18.4) years for acute DVT, and 61.4 (11.6) years for DVT prevention after hip or knee surgery (P < 0.0001 for all comparisons). Mean (SD) estimated creatinine clearance was 76.8 (43.5) mL/min for AF, 92.4 (44.4) mL/min for DVT prevention after hip or knee surgery, 111 (53) mL/min for chronic DVT, 118 (55) mL/min for acute DVT, 126 (60) mL/min for chronic PE, and 127 (54) mL/min for acute PE (P < 0.0001 for all comparisons). Differences between patient groups by therapeutic indication were not detected for weight, body mass index, or serum creatinine level.

The most frequent deviation from prescribing recommendations was omission of directions to administer rivaroxaban with food—93% (248/268) of orders—but not for DVT prevention after hip or knee surgery, for which the 10-mg dose is appropriately administered without food. Doses were the same as recommended for 82% of apixaban orders, 84% of rivaroxaban orders, and 93% of initial dabigatran orders (P < 0.05 for differences; Table 3). Dosages not concordant with FDA recommendations were prescribed in 44 (18.1%) of 243 apixaban orders, 41 (14.3%) of 286 rivaroxaban orders, and 7 (7.2%) of 89 initial dabigatran orders. Lower than recommended doses were more common than higher than recommended doses (Table 3, Figure 1): 15.2% versus 2.1% of apixaban orders, 9.4% versus 3.5% of rivaroxaban orders, and 4.2% versus 1.0% of initial dabigatran orders (P < 0.05). Failure to avoid drug use (for potential drug–drug or drug–disease interactions) was uncommon (1%-2%). There were more deviations from recommended doses for patients with AF or DVT prevention after hip or knee surgery than for patients with acute or chronic PE or acute DVT (Table 3). No significant differences were detected between prescribed and recommended doses by prescriber specialty.

In most cases, a reason for deviating from FDA dosing recommendations was not stated in the EMR. The exception was fluctuating renal function, which was cited in 8 cases.

For apixaban, patients who were prescribed lower than recommended doses were older than those prescribed recommended doses: mean (SD), 78.1 (12.2) years versus 71 (13.6) years (P = 0.003). Seventy-six percent of those prescribed lower than recommended doses were older than 75. Prescriptions for apixaban at lower than recommended doses were continuations of prior outpatient prescriptions in 20 of 37 cases (almost half), and in 12 cases (one-fourth) antiplatelet drugs were coprescribed (aspirin in 10 cases, clopidogrel in 1, prasugrel in 1). For rivaroxaban, older age was associated with both lower than recommended dosing (P = 0.003) and higher than recommended dosing (P < 0.001). Variations from prescribing recommendations were continuations of outpatient rivaroxaban doses in about two-thirds (26 of 41; 63.4 %) with 13 receiving antiplatelet drugs. For dabigatran, 6 of 7 orders not in agreement with recommendations were continuations of outpatient dosing.

The specific equation used to estimate renal function also had the potential to lead to dosing errors. Among the 41 rivaroxaban patients categorized as receiving doses discordant with recommendations, 8 would have had an inappropriate DOAC dose if eGFR were used instead of eCrCL as recommended. No relationships were detected for other patient variables/measures and dosing deviations from recommendations.

 

DISCUSSION

We examined initial hospital orders for DOACs in adults admitted to a single academic medical center during 2014-2015. Dabigatran, apixaban and rivaroxaban were prescribed for prevention of stroke in patients with atrial fibrillation/flutter (AF) in three quarters of the encounters similar to national patterns. (15) Prescribing departures from FDA-approved recommendations ranged from failure to prescribe rivaroxaban with food to failure to recognize drug-drug interactions in 1% to 2%. Unexpectedly, lower than recommended dosing was more common than higher than recommended dosing of the three DOACs.

Rivaroxaban bioavailability is dose dependent with the presence of food required to enhance absorption for doses over 10 mg that are used for prevention of stroke in patients with non-valvular AF or treatment of DVT or PE.^5,16 Peak rivaroxaban concentrations are 75% higher and the total area under the concentration vs. time curve after dosing is 40% higher when rivaroxaban is administered with high fat high calorie meals compared to the fasting state.¹⁶ If rivaroxaban is not administered with food, drug concentrations and pharmacologic effects may be less than in clinical trials that specified co-administration with food.^17-19 A small survey of outpatients receiving rivaroxaban found that 23% reported taking it without food.²⁰ With electronic pharmacy systems in almost all hospitals and electronic prescriber order entry in most, automated addition of directions for rivaroxaban administration with food for doses over 10 mg to labels or dispensing instructions could easily correct this deviation from recommended practice.

Lower than recommended doses were prescribed in 9.4% of orders for rivaroxaban and 15.2% of orders for apixaban, with dose-deviations often appearing to be a continuation of outpatient doses. Patients 75 years or older were more likely to receive lower than recommended dosing of apixaban. Reductions in apixaban doses from 5 mg twice daily to 2.5 mg twice daily are recommended in patients with non-valvular AF with two of the following criteria: age ≥80 y, weight ≤60 kg, serum creatinine ≥1.5 mg/dL or co-administration of a strong PgP inhibitor to a patient without 2 of the 3 dose reduction criteria. Our study was not designed to determine reasons for under-dosing, but we speculate that clinicians may have considered patients aged 75-79 years to be similar to those 80 years of age or older, or, older and not as healthy as those enrolled in randomized trials.^21-25 The median age of our patients with AF receiving apixaban was 75y (interquartile range of 16) vs 70y ( interquartile range 63-76) in the pivotal trial comparing warfarin to apixaban.²¹ Renal function was also lower with 37% having eCrCL below 50 mL/min compared to 17% in ARISTOTLE. (21). Twenty-six percent of our apixaban-treated AF patients qualified for the lower 2.5 mg twice daily compared to only 5% of ARISTOTLE participants,²¹ further suggesting differences between patients in our sample compared to randomized trial participants.

Concerns regarding bleeding or falls in older patients, may also have contributed to lower than recommended doses. Recent analyses of patients at risk for falls confirmed that increased risk of falling was associated with more bone fractures, bleeding and all-cause death but not stroke or systemic emboli, and with less severe bleeding with the DOAC edoxaban compared to warfarin.²⁶ While a rationale for personalized or lower than recommended dosing of apixaban may exist in very old patients and those at risk of falls and bleeding, more data are needed to determine outcomes of lower than recommended doses of DOACs before such an approach can be endorsed. Monitoring of anticoagulant effect in patients who receive doses lower than those investigated in clinical trials could provide important information. The assays that measure DOAC effects are likely to be more available because of the use of reversal agents in the setting of bleeding with DOACs.²⁷

We had anticipated higher than recommended dosing for rivaroxaban as recommendations are based on creatinine clearance while laboratories routinely report estimated glomerular filtration rate (eGFR) that can provide higher estimates of renal clearance and estimated DOAC doses in older and smaller individuals.²⁸ Higher than recommended dosing was found in only 3.5% of our sample. In half, eGFR estimates were higher than creatinine clearance estimates. An international postmarketing registry of rivaroxaban use for the prevention of stroke in patients with NVAF, which included outpatients, found that 36% of those with creatinine clearances below 50 mL/min received a dose higher than recommended, and 15% received a dose lower than expected.²⁹ A more recent outpatient registry report on patients with NVAF, in which apixaban, dabigatran, or rivaroxaban was administered, found that overall 9.4% received a dose lower than recommended, and 3.4% were overdosed, with a similar percentage (34%) of rivaroxaban patients with creatinine clearance of 15 to 50 mL/min receiving higher than recommended dosing.³⁰ The lower rate of higher-than-recommended doses that we observed may have been related to the routine measurement of serum creatinine and attention to dosing adjustments for renal function in the inpatient setting compared to the outpatient setting. In addition, renal function data may not be available to outpatient pharmacies, limiting potential input on dosing recommendations. At least one cardiac society recommends monitoring of renal function in patients treated with DOACs, annually in patients with normal estimated creatinine clearance and more frequently (at intervals in months equal to the creatinine clearance divided by 10) in patients with abnormal creatinine clearance.¹¹ A hospital encounter provides an opportunity to assess or reassess renal status to optimize DOAC dosing.

Dabigatran was the first DOAC introduced into use in the United States with the same dose recommended for prevention of stroke in patients with AF or venous thromboembolic disease with reductions for creatinine clearance below 30 mL/min or creatinine clearance between 30 and 50 mL/min and concomitant use of the potent P-glycoprotein inhibitor dronedarone or systemic ketoconazole. The relative simplicity of dosing may have been responsible for the lowest rate of prescribing outside of recommendations observed in this study, but the low dabigatran use limits analyses of contributing factors.

Failure to avoid drug use in combination with use of strong P-glycoprotein inducers or inhibitors was infrequent but should be preventable. Current prescribing recommendations refer to “strong” P-glycoprotein inhibitors and list different specific agents that interact with each DOAC without a standardized definition or classification. Standardized classifications or reference sources would be helpful.

Our primary goal in this study was to compare initial prescribed dosing of DOACs with FDA-approved prescribing directions. However, therapeutic indication data warrant discussion. In our sample, 7.5% of patients with AF had bioprosthetic valves or recent mitral valve repair or replacement. Using the NVAF definition found in the 2014 AHA/ACC/HRS (American Heart Association, American College of Cardiology, Heart Rhythm Society) AF guidelines¹—“absence of rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair”—these patients would not appear to be candidates for DOACs. However, arguments have been made that a bioprosthetic heart valve or native valve after valve repair does not have a risk profile for thromboembolism that differs from other forms of NVAF and would be equally responsive to DOAC therapy.³¹ Data are sparse, but retrospective subanalyses of limited numbers of patients with valvular disease (including bioprosthesis and mitral repair patients but excluding mechanical valve patients) enrolled in the pivotal DOAC studies support this conclusion.³² For the first months after biological valve replacement (including catheter-based valve replacement), recent European guidelines recommend vitamin K antagonists but also state, “NOACs probably deliver the same protection.”⁸ DOACs were also used for management of venous thromboembolic disease (both acute and chronic) in patients with active cancer. Our data predate the most recent American College of Chest Physician guidelines on treatment of venous thromboembolism in patients with cancer, which provide grade 2B recommendations for use of low-molecular-weight heparin (LMWH) over vitamin K antagonists and grade 2C recommendations for use of LMWH over dabigatran, rivaroxaban, apixaban, or edoxaban.³³

Our study had several limitations. First, data were from a single US academic medical center, though similar rates of prescribing deviation from recommendations have been reported for rivaroxaban and dabigatran in NVAF patients in other countries.^29,34 Second, therapeutic indications may have been misclassified because of errors, incomplete EMR data, or multiple indications. Third, we analyzed the first DOAC order and not dispensing information or subsequent corrections. Therefore, deviations from recommendations should not be interpreted as errors that reached patients. We evaluated dosing based on the measures used at the time of hospital admission, noting that, in a significant fraction of deviations from recommended doses, they represented continuations of outpatient doses when renal function or weight may have differed, and it is unknown whether patients were counseled to take rivaroxaban with food in the outpatient setting. Fourth, the number of patients with acute DVT was small, so firm conclusions cannot be drawn for this specific population. Fifth, our estimates of off-label dosing may have been underestimates, as data on cancer and cancer activity or cardiac valvular disease may not have been complete.

 

CONCLUSION

Healthcare professionals are prescribing DOACs in ways that differ from recommendations. These differences may reflect the older ages and reduced renal function of clinical populations relative to randomized clinical trial groups, but they could also potentially alter clinical efficacy. Our findings support the need to evaluate the appropriateness and dosing of DOACs at each encounter and to determine the outcomes of patients treated with lower than recommended doses of DOACs and the outcomes of DOAC-treated patients with bioprostheses or active malignancies.

Acknowledgment

The authors thank Tobias Schmelzinger for electronic data extraction and compilation and University of California San Francisco students Eduardo De La Torre Cruz (School of Pharmacy) and Carlos Mikell (School of Medicine) for assistance with data review.

Disclosure

Dr. Schwartz reports receiving personal fees from Bristol-Myers Squibb and Amgen and grants from Bristol-Myers Squibb and Pfizer, outside the submitted work. The other authors have nothing to report.

 

Direct-acting oral anticoagulants (DOACs) have been introduced into clinical use for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), prevention of venous thrombosis after hip or knee surgery, and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).^1-7 Advantages of DOACs over warfarin are often stated as fixed dosing, minor drug and food interactions, wider therapeutic index, and no need for laboratory test monitoring.^1,8 Yet, recommended DOAC dosages vary by renal function and therapeutic indications. Dosing recommendations for prevention of stroke in patients with NVAF are based on estimated creatinine clearance (dabigatran, rivaroxaban, edoxaban), age (apixaban), weight (apixaban, edoxaban), serum creatinine level (apixaban, edoxaban), and presence of cirrhosis by Child-Pugh class^9,10 (apixaban, edoxaban).^4-6,11,12 Dosing recommendations based on coadministration of strong CYP34A and P-glycoprotein inhibitors or inducers vary by DOAC. In addition, dabigatran cannot be crushed and must be stored in its original packaging, and rivaroxaban should be taken with food when the dose is over 10 mg.

We studied DOAC prescribing in adults admitted to a large academic medical center by comparing initial prescribed dosing with FDA-approved prescribing information. We hypothesized that the complexity of DOAC dosing may not be recognized by prescribers.

METHODS

Our study protocol was approved by the Committee on Human Research (Institutional Review Board) of the University of California San Francisco.

Data Collection

We used electronic medical records (EMRs) to identify adult inpatients who were prescribed a DOAC (apixaban, dabigatran, edoxaban, or rivaroxaban) at the University of California San Francisco Medical Center, a large academic hospital, between July 1, 2014 and June 30, 2015. Demographic and medical information related to therapeutic indications, contraindications, and indications for dose adjustments were collected and included diagnoses classified by International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) for venous thromboses; phlebitis or thrombophlebitis; PE or venous embolism; atrial arrhythmias; surgical procedures; cirrhosis and/or ascites or liver disease; coagulopathies; artificial heart valves or implanted devices; prior use of medications including parenteral anticoagulants; and laboratory data obtained before the first DOAC order (serum creatinine level, estimated glomerular filtration rate [eGFR] determined by Chronic Kidney Disease Epidemiology Collaboration,¹³ international normalized ratio, or, if available, activated partial thromboplastin time and bilirubin level). Creatinine clearance was calculated with the Cockcroft-Gault method¹⁴ using total body weight, per drug label recommendation. Child-Pugh class was calculated if cirrhosis was diagnosed.¹⁰ DOAC dose, frequency, dosing directions, and prescriber medical specialty were determined.

 

Accuracy of search results was confirmed by review of the first 200 patients’ records. Records were manually reviewed for encounters lacking ICD-9/10 codes and approved DOAC indications (30%) and encounters having multiple coded diagnostic indications (to identify the indication). ICD-9 codes for venous thrombosis were reviewed to differentiate acute from chronic events.

Data Analysis

The main outcome was concordance or discordance between the first DOAC prescribing order and the FDA-approved prescribing information at the time. Initial classification, performed by 2 independent reviewers (a pharmacist and a physician, or 2 pharmacists), was followed by adjudication and individual record review (by 2 independent reviewers) of all initial prescribing orders classified as discordant. A third reviewer adjudicated any disagreement. Records and notes were reviewed to identify stated or potential reasons for dosing variation and pre-admission prescriptions. Data are presented as means and standard deviations (SDs) and as raw numbers and percentages. Differences in patient characteristics by DOAC or therapeutic indication were determined by analysis of variance (ANOVA) with Bonferroni correction for post hoc comparisons. Dosing information was categorized as the same as recommended, lower than recommended, higher than recommended, or avoid drug use (drug–drug or drug–disease interaction), per FDA-approved prescribing information, and χ² tests were used to determine whether variation in dosing occurred by individual DOAC, therapeutic indication, or prescriber specialty. Relationships between dosing variation and age or renal function were tested by ANOVA with Bonferroni correction for post hoc comparisons.

RESULTS

There were 635 admissions with apixaban, dabigatran, or rivaroxaban prescribed for 508 patients (Table 1). Edoxaban was not on the formulary and not prescribed during the period studied. The therapeutic indication was prevention of embolic stroke in patients with atrial fibrillation/flutter or AF (465 admissions, or 73%, with valvular disease and/or tissue valve in 35), chronic DVT (67 admissions, or 11%, with active malignancy in 14), acute DVT (32 admissions, with malignancy in 2), chronic PE (23 admissions, with malignancy in 3), acute PE (19 admissions, with malignancy in 4), and DVT prevention after hip or knee surgery (19 admissions). DOACs were prescribed for unapproved indications in 10 admissions, and these were excluded from further analysis (mural thrombus in 3 admissions, low ejection fraction in 2, bedrest immobilization in 2, aortic aneurysm in 1, thrombocytosis in 1, and extensive superficial venous thrombosis in 1) (Table 2).

Patients with AF were older with lower creatinine clearance compared to patients with other diagnoses. Mean (SD) patient age was 72.1 (12.7) years for AF, 53.1 (10.9) years for chronic PE, 55.5 (14) years for acute PE, 56.4 (15.9) years for chronic DVT, 57.9 (18.4) years for acute DVT, and 61.4 (11.6) years for DVT prevention after hip or knee surgery (P < 0.0001 for all comparisons). Mean (SD) estimated creatinine clearance was 76.8 (43.5) mL/min for AF, 92.4 (44.4) mL/min for DVT prevention after hip or knee surgery, 111 (53) mL/min for chronic DVT, 118 (55) mL/min for acute DVT, 126 (60) mL/min for chronic PE, and 127 (54) mL/min for acute PE (P < 0.0001 for all comparisons). Differences between patient groups by therapeutic indication were not detected for weight, body mass index, or serum creatinine level.

The most frequent deviation from prescribing recommendations was omission of directions to administer rivaroxaban with food—93% (248/268) of orders—but not for DVT prevention after hip or knee surgery, for which the 10-mg dose is appropriately administered without food. Doses were the same as recommended for 82% of apixaban orders, 84% of rivaroxaban orders, and 93% of initial dabigatran orders (P < 0.05 for differences; Table 3). Dosages not concordant with FDA recommendations were prescribed in 44 (18.1%) of 243 apixaban orders, 41 (14.3%) of 286 rivaroxaban orders, and 7 (7.2%) of 89 initial dabigatran orders. Lower than recommended doses were more common than higher than recommended doses (Table 3, Figure 1): 15.2% versus 2.1% of apixaban orders, 9.4% versus 3.5% of rivaroxaban orders, and 4.2% versus 1.0% of initial dabigatran orders (P < 0.05). Failure to avoid drug use (for potential drug–drug or drug–disease interactions) was uncommon (1%-2%). There were more deviations from recommended doses for patients with AF or DVT prevention after hip or knee surgery than for patients with acute or chronic PE or acute DVT (Table 3). No significant differences were detected between prescribed and recommended doses by prescriber specialty.

In most cases, a reason for deviating from FDA dosing recommendations was not stated in the EMR. The exception was fluctuating renal function, which was cited in 8 cases.

For apixaban, patients who were prescribed lower than recommended doses were older than those prescribed recommended doses: mean (SD), 78.1 (12.2) years versus 71 (13.6) years (P = 0.003). Seventy-six percent of those prescribed lower than recommended doses were older than 75. Prescriptions for apixaban at lower than recommended doses were continuations of prior outpatient prescriptions in 20 of 37 cases (almost half), and in 12 cases (one-fourth) antiplatelet drugs were coprescribed (aspirin in 10 cases, clopidogrel in 1, prasugrel in 1). For rivaroxaban, older age was associated with both lower than recommended dosing (P = 0.003) and higher than recommended dosing (P < 0.001). Variations from prescribing recommendations were continuations of outpatient rivaroxaban doses in about two-thirds (26 of 41; 63.4 %) with 13 receiving antiplatelet drugs. For dabigatran, 6 of 7 orders not in agreement with recommendations were continuations of outpatient dosing.

The specific equation used to estimate renal function also had the potential to lead to dosing errors. Among the 41 rivaroxaban patients categorized as receiving doses discordant with recommendations, 8 would have had an inappropriate DOAC dose if eGFR were used instead of eCrCL as recommended. No relationships were detected for other patient variables/measures and dosing deviations from recommendations.

 

DISCUSSION

We examined initial hospital orders for DOACs in adults admitted to a single academic medical center during 2014-2015. Dabigatran, apixaban and rivaroxaban were prescribed for prevention of stroke in patients with atrial fibrillation/flutter (AF) in three quarters of the encounters similar to national patterns. (15) Prescribing departures from FDA-approved recommendations ranged from failure to prescribe rivaroxaban with food to failure to recognize drug-drug interactions in 1% to 2%. Unexpectedly, lower than recommended dosing was more common than higher than recommended dosing of the three DOACs.

Rivaroxaban bioavailability is dose dependent with the presence of food required to enhance absorption for doses over 10 mg that are used for prevention of stroke in patients with non-valvular AF or treatment of DVT or PE.^5,16 Peak rivaroxaban concentrations are 75% higher and the total area under the concentration vs. time curve after dosing is 40% higher when rivaroxaban is administered with high fat high calorie meals compared to the fasting state.¹⁶ If rivaroxaban is not administered with food, drug concentrations and pharmacologic effects may be less than in clinical trials that specified co-administration with food.^17-19 A small survey of outpatients receiving rivaroxaban found that 23% reported taking it without food.²⁰ With electronic pharmacy systems in almost all hospitals and electronic prescriber order entry in most, automated addition of directions for rivaroxaban administration with food for doses over 10 mg to labels or dispensing instructions could easily correct this deviation from recommended practice.

Lower than recommended doses were prescribed in 9.4% of orders for rivaroxaban and 15.2% of orders for apixaban, with dose-deviations often appearing to be a continuation of outpatient doses. Patients 75 years or older were more likely to receive lower than recommended dosing of apixaban. Reductions in apixaban doses from 5 mg twice daily to 2.5 mg twice daily are recommended in patients with non-valvular AF with two of the following criteria: age ≥80 y, weight ≤60 kg, serum creatinine ≥1.5 mg/dL or co-administration of a strong PgP inhibitor to a patient without 2 of the 3 dose reduction criteria. Our study was not designed to determine reasons for under-dosing, but we speculate that clinicians may have considered patients aged 75-79 years to be similar to those 80 years of age or older, or, older and not as healthy as those enrolled in randomized trials.^21-25 The median age of our patients with AF receiving apixaban was 75y (interquartile range of 16) vs 70y ( interquartile range 63-76) in the pivotal trial comparing warfarin to apixaban.²¹ Renal function was also lower with 37% having eCrCL below 50 mL/min compared to 17% in ARISTOTLE. (21). Twenty-six percent of our apixaban-treated AF patients qualified for the lower 2.5 mg twice daily compared to only 5% of ARISTOTLE participants,²¹ further suggesting differences between patients in our sample compared to randomized trial participants.

Concerns regarding bleeding or falls in older patients, may also have contributed to lower than recommended doses. Recent analyses of patients at risk for falls confirmed that increased risk of falling was associated with more bone fractures, bleeding and all-cause death but not stroke or systemic emboli, and with less severe bleeding with the DOAC edoxaban compared to warfarin.²⁶ While a rationale for personalized or lower than recommended dosing of apixaban may exist in very old patients and those at risk of falls and bleeding, more data are needed to determine outcomes of lower than recommended doses of DOACs before such an approach can be endorsed. Monitoring of anticoagulant effect in patients who receive doses lower than those investigated in clinical trials could provide important information. The assays that measure DOAC effects are likely to be more available because of the use of reversal agents in the setting of bleeding with DOACs.²⁷

We had anticipated higher than recommended dosing for rivaroxaban as recommendations are based on creatinine clearance while laboratories routinely report estimated glomerular filtration rate (eGFR) that can provide higher estimates of renal clearance and estimated DOAC doses in older and smaller individuals.²⁸ Higher than recommended dosing was found in only 3.5% of our sample. In half, eGFR estimates were higher than creatinine clearance estimates. An international postmarketing registry of rivaroxaban use for the prevention of stroke in patients with NVAF, which included outpatients, found that 36% of those with creatinine clearances below 50 mL/min received a dose higher than recommended, and 15% received a dose lower than expected.²⁹ A more recent outpatient registry report on patients with NVAF, in which apixaban, dabigatran, or rivaroxaban was administered, found that overall 9.4% received a dose lower than recommended, and 3.4% were overdosed, with a similar percentage (34%) of rivaroxaban patients with creatinine clearance of 15 to 50 mL/min receiving higher than recommended dosing.³⁰ The lower rate of higher-than-recommended doses that we observed may have been related to the routine measurement of serum creatinine and attention to dosing adjustments for renal function in the inpatient setting compared to the outpatient setting. In addition, renal function data may not be available to outpatient pharmacies, limiting potential input on dosing recommendations. At least one cardiac society recommends monitoring of renal function in patients treated with DOACs, annually in patients with normal estimated creatinine clearance and more frequently (at intervals in months equal to the creatinine clearance divided by 10) in patients with abnormal creatinine clearance.¹¹ A hospital encounter provides an opportunity to assess or reassess renal status to optimize DOAC dosing.

Dabigatran was the first DOAC introduced into use in the United States with the same dose recommended for prevention of stroke in patients with AF or venous thromboembolic disease with reductions for creatinine clearance below 30 mL/min or creatinine clearance between 30 and 50 mL/min and concomitant use of the potent P-glycoprotein inhibitor dronedarone or systemic ketoconazole. The relative simplicity of dosing may have been responsible for the lowest rate of prescribing outside of recommendations observed in this study, but the low dabigatran use limits analyses of contributing factors.

Failure to avoid drug use in combination with use of strong P-glycoprotein inducers or inhibitors was infrequent but should be preventable. Current prescribing recommendations refer to “strong” P-glycoprotein inhibitors and list different specific agents that interact with each DOAC without a standardized definition or classification. Standardized classifications or reference sources would be helpful.

Our primary goal in this study was to compare initial prescribed dosing of DOACs with FDA-approved prescribing directions. However, therapeutic indication data warrant discussion. In our sample, 7.5% of patients with AF had bioprosthetic valves or recent mitral valve repair or replacement. Using the NVAF definition found in the 2014 AHA/ACC/HRS (American Heart Association, American College of Cardiology, Heart Rhythm Society) AF guidelines¹—“absence of rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair”—these patients would not appear to be candidates for DOACs. However, arguments have been made that a bioprosthetic heart valve or native valve after valve repair does not have a risk profile for thromboembolism that differs from other forms of NVAF and would be equally responsive to DOAC therapy.³¹ Data are sparse, but retrospective subanalyses of limited numbers of patients with valvular disease (including bioprosthesis and mitral repair patients but excluding mechanical valve patients) enrolled in the pivotal DOAC studies support this conclusion.³² For the first months after biological valve replacement (including catheter-based valve replacement), recent European guidelines recommend vitamin K antagonists but also state, “NOACs probably deliver the same protection.”⁸ DOACs were also used for management of venous thromboembolic disease (both acute and chronic) in patients with active cancer. Our data predate the most recent American College of Chest Physician guidelines on treatment of venous thromboembolism in patients with cancer, which provide grade 2B recommendations for use of low-molecular-weight heparin (LMWH) over vitamin K antagonists and grade 2C recommendations for use of LMWH over dabigatran, rivaroxaban, apixaban, or edoxaban.³³

Our study had several limitations. First, data were from a single US academic medical center, though similar rates of prescribing deviation from recommendations have been reported for rivaroxaban and dabigatran in NVAF patients in other countries.^29,34 Second, therapeutic indications may have been misclassified because of errors, incomplete EMR data, or multiple indications. Third, we analyzed the first DOAC order and not dispensing information or subsequent corrections. Therefore, deviations from recommendations should not be interpreted as errors that reached patients. We evaluated dosing based on the measures used at the time of hospital admission, noting that, in a significant fraction of deviations from recommended doses, they represented continuations of outpatient doses when renal function or weight may have differed, and it is unknown whether patients were counseled to take rivaroxaban with food in the outpatient setting. Fourth, the number of patients with acute DVT was small, so firm conclusions cannot be drawn for this specific population. Fifth, our estimates of off-label dosing may have been underestimates, as data on cancer and cancer activity or cardiac valvular disease may not have been complete.

 

CONCLUSION

Healthcare professionals are prescribing DOACs in ways that differ from recommendations. These differences may reflect the older ages and reduced renal function of clinical populations relative to randomized clinical trial groups, but they could also potentially alter clinical efficacy. Our findings support the need to evaluate the appropriateness and dosing of DOACs at each encounter and to determine the outcomes of patients treated with lower than recommended doses of DOACs and the outcomes of DOAC-treated patients with bioprostheses or active malignancies.

Acknowledgment

The authors thank Tobias Schmelzinger for electronic data extraction and compilation and University of California San Francisco students Eduardo De La Torre Cruz (School of Pharmacy) and Carlos Mikell (School of Medicine) for assistance with data review.

Disclosure

Dr. Schwartz reports receiving personal fees from Bristol-Myers Squibb and Amgen and grants from Bristol-Myers Squibb and Pfizer, outside the submitted work. The other authors have nothing to report.

 

Direct-acting oral anticoagulants (DOACs) have been introduced into clinical use for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), prevention of venous thrombosis after hip or knee surgery, and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).^1-7 Advantages of DOACs over warfarin are often stated as fixed dosing, minor drug and food interactions, wider therapeutic index, and no need for laboratory test monitoring.^1,8 Yet, recommended DOAC dosages vary by renal function and therapeutic indications. Dosing recommendations for prevention of stroke in patients with NVAF are based on estimated creatinine clearance (dabigatran, rivaroxaban, edoxaban), age (apixaban), weight (apixaban, edoxaban), serum creatinine level (apixaban, edoxaban), and presence of cirrhosis by Child-Pugh class^9,10 (apixaban, edoxaban).^4-6,11,12 Dosing recommendations based on coadministration of strong CYP34A and P-glycoprotein inhibitors or inducers vary by DOAC. In addition, dabigatran cannot be crushed and must be stored in its original packaging, and rivaroxaban should be taken with food when the dose is over 10 mg.

We studied DOAC prescribing in adults admitted to a large academic medical center by comparing initial prescribed dosing with FDA-approved prescribing information. We hypothesized that the complexity of DOAC dosing may not be recognized by prescribers.

METHODS

Our study protocol was approved by the Committee on Human Research (Institutional Review Board) of the University of California San Francisco.

Data Collection

We used electronic medical records (EMRs) to identify adult inpatients who were prescribed a DOAC (apixaban, dabigatran, edoxaban, or rivaroxaban) at the University of California San Francisco Medical Center, a large academic hospital, between July 1, 2014 and June 30, 2015. Demographic and medical information related to therapeutic indications, contraindications, and indications for dose adjustments were collected and included diagnoses classified by International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) for venous thromboses; phlebitis or thrombophlebitis; PE or venous embolism; atrial arrhythmias; surgical procedures; cirrhosis and/or ascites or liver disease; coagulopathies; artificial heart valves or implanted devices; prior use of medications including parenteral anticoagulants; and laboratory data obtained before the first DOAC order (serum creatinine level, estimated glomerular filtration rate [eGFR] determined by Chronic Kidney Disease Epidemiology Collaboration,¹³ international normalized ratio, or, if available, activated partial thromboplastin time and bilirubin level). Creatinine clearance was calculated with the Cockcroft-Gault method¹⁴ using total body weight, per drug label recommendation. Child-Pugh class was calculated if cirrhosis was diagnosed.¹⁰ DOAC dose, frequency, dosing directions, and prescriber medical specialty were determined.

 

Accuracy of search results was confirmed by review of the first 200 patients’ records. Records were manually reviewed for encounters lacking ICD-9/10 codes and approved DOAC indications (30%) and encounters having multiple coded diagnostic indications (to identify the indication). ICD-9 codes for venous thrombosis were reviewed to differentiate acute from chronic events.

Data Analysis

The main outcome was concordance or discordance between the first DOAC prescribing order and the FDA-approved prescribing information at the time. Initial classification, performed by 2 independent reviewers (a pharmacist and a physician, or 2 pharmacists), was followed by adjudication and individual record review (by 2 independent reviewers) of all initial prescribing orders classified as discordant. A third reviewer adjudicated any disagreement. Records and notes were reviewed to identify stated or potential reasons for dosing variation and pre-admission prescriptions. Data are presented as means and standard deviations (SDs) and as raw numbers and percentages. Differences in patient characteristics by DOAC or therapeutic indication were determined by analysis of variance (ANOVA) with Bonferroni correction for post hoc comparisons. Dosing information was categorized as the same as recommended, lower than recommended, higher than recommended, or avoid drug use (drug–drug or drug–disease interaction), per FDA-approved prescribing information, and χ² tests were used to determine whether variation in dosing occurred by individual DOAC, therapeutic indication, or prescriber specialty. Relationships between dosing variation and age or renal function were tested by ANOVA with Bonferroni correction for post hoc comparisons.

RESULTS

There were 635 admissions with apixaban, dabigatran, or rivaroxaban prescribed for 508 patients (Table 1). Edoxaban was not on the formulary and not prescribed during the period studied. The therapeutic indication was prevention of embolic stroke in patients with atrial fibrillation/flutter or AF (465 admissions, or 73%, with valvular disease and/or tissue valve in 35), chronic DVT (67 admissions, or 11%, with active malignancy in 14), acute DVT (32 admissions, with malignancy in 2), chronic PE (23 admissions, with malignancy in 3), acute PE (19 admissions, with malignancy in 4), and DVT prevention after hip or knee surgery (19 admissions). DOACs were prescribed for unapproved indications in 10 admissions, and these were excluded from further analysis (mural thrombus in 3 admissions, low ejection fraction in 2, bedrest immobilization in 2, aortic aneurysm in 1, thrombocytosis in 1, and extensive superficial venous thrombosis in 1) (Table 2).

Patients with AF were older with lower creatinine clearance compared to patients with other diagnoses. Mean (SD) patient age was 72.1 (12.7) years for AF, 53.1 (10.9) years for chronic PE, 55.5 (14) years for acute PE, 56.4 (15.9) years for chronic DVT, 57.9 (18.4) years for acute DVT, and 61.4 (11.6) years for DVT prevention after hip or knee surgery (P < 0.0001 for all comparisons). Mean (SD) estimated creatinine clearance was 76.8 (43.5) mL/min for AF, 92.4 (44.4) mL/min for DVT prevention after hip or knee surgery, 111 (53) mL/min for chronic DVT, 118 (55) mL/min for acute DVT, 126 (60) mL/min for chronic PE, and 127 (54) mL/min for acute PE (P < 0.0001 for all comparisons). Differences between patient groups by therapeutic indication were not detected for weight, body mass index, or serum creatinine level.

The most frequent deviation from prescribing recommendations was omission of directions to administer rivaroxaban with food—93% (248/268) of orders—but not for DVT prevention after hip or knee surgery, for which the 10-mg dose is appropriately administered without food. Doses were the same as recommended for 82% of apixaban orders, 84% of rivaroxaban orders, and 93% of initial dabigatran orders (P < 0.05 for differences; Table 3). Dosages not concordant with FDA recommendations were prescribed in 44 (18.1%) of 243 apixaban orders, 41 (14.3%) of 286 rivaroxaban orders, and 7 (7.2%) of 89 initial dabigatran orders. Lower than recommended doses were more common than higher than recommended doses (Table 3, Figure 1): 15.2% versus 2.1% of apixaban orders, 9.4% versus 3.5% of rivaroxaban orders, and 4.2% versus 1.0% of initial dabigatran orders (P < 0.05). Failure to avoid drug use (for potential drug–drug or drug–disease interactions) was uncommon (1%-2%). There were more deviations from recommended doses for patients with AF or DVT prevention after hip or knee surgery than for patients with acute or chronic PE or acute DVT (Table 3). No significant differences were detected between prescribed and recommended doses by prescriber specialty.

In most cases, a reason for deviating from FDA dosing recommendations was not stated in the EMR. The exception was fluctuating renal function, which was cited in 8 cases.

For apixaban, patients who were prescribed lower than recommended doses were older than those prescribed recommended doses: mean (SD), 78.1 (12.2) years versus 71 (13.6) years (P = 0.003). Seventy-six percent of those prescribed lower than recommended doses were older than 75. Prescriptions for apixaban at lower than recommended doses were continuations of prior outpatient prescriptions in 20 of 37 cases (almost half), and in 12 cases (one-fourth) antiplatelet drugs were coprescribed (aspirin in 10 cases, clopidogrel in 1, prasugrel in 1). For rivaroxaban, older age was associated with both lower than recommended dosing (P = 0.003) and higher than recommended dosing (P < 0.001). Variations from prescribing recommendations were continuations of outpatient rivaroxaban doses in about two-thirds (26 of 41; 63.4 %) with 13 receiving antiplatelet drugs. For dabigatran, 6 of 7 orders not in agreement with recommendations were continuations of outpatient dosing.

The specific equation used to estimate renal function also had the potential to lead to dosing errors. Among the 41 rivaroxaban patients categorized as receiving doses discordant with recommendations, 8 would have had an inappropriate DOAC dose if eGFR were used instead of eCrCL as recommended. No relationships were detected for other patient variables/measures and dosing deviations from recommendations.

 

DISCUSSION

We examined initial hospital orders for DOACs in adults admitted to a single academic medical center during 2014-2015. Dabigatran, apixaban and rivaroxaban were prescribed for prevention of stroke in patients with atrial fibrillation/flutter (AF) in three quarters of the encounters similar to national patterns. (15) Prescribing departures from FDA-approved recommendations ranged from failure to prescribe rivaroxaban with food to failure to recognize drug-drug interactions in 1% to 2%. Unexpectedly, lower than recommended dosing was more common than higher than recommended dosing of the three DOACs.

Rivaroxaban bioavailability is dose dependent with the presence of food required to enhance absorption for doses over 10 mg that are used for prevention of stroke in patients with non-valvular AF or treatment of DVT or PE.^5,16 Peak rivaroxaban concentrations are 75% higher and the total area under the concentration vs. time curve after dosing is 40% higher when rivaroxaban is administered with high fat high calorie meals compared to the fasting state.¹⁶ If rivaroxaban is not administered with food, drug concentrations and pharmacologic effects may be less than in clinical trials that specified co-administration with food.^17-19 A small survey of outpatients receiving rivaroxaban found that 23% reported taking it without food.²⁰ With electronic pharmacy systems in almost all hospitals and electronic prescriber order entry in most, automated addition of directions for rivaroxaban administration with food for doses over 10 mg to labels or dispensing instructions could easily correct this deviation from recommended practice.

Lower than recommended doses were prescribed in 9.4% of orders for rivaroxaban and 15.2% of orders for apixaban, with dose-deviations often appearing to be a continuation of outpatient doses. Patients 75 years or older were more likely to receive lower than recommended dosing of apixaban. Reductions in apixaban doses from 5 mg twice daily to 2.5 mg twice daily are recommended in patients with non-valvular AF with two of the following criteria: age ≥80 y, weight ≤60 kg, serum creatinine ≥1.5 mg/dL or co-administration of a strong PgP inhibitor to a patient without 2 of the 3 dose reduction criteria. Our study was not designed to determine reasons for under-dosing, but we speculate that clinicians may have considered patients aged 75-79 years to be similar to those 80 years of age or older, or, older and not as healthy as those enrolled in randomized trials.^21-25 The median age of our patients with AF receiving apixaban was 75y (interquartile range of 16) vs 70y ( interquartile range 63-76) in the pivotal trial comparing warfarin to apixaban.²¹ Renal function was also lower with 37% having eCrCL below 50 mL/min compared to 17% in ARISTOTLE. (21). Twenty-six percent of our apixaban-treated AF patients qualified for the lower 2.5 mg twice daily compared to only 5% of ARISTOTLE participants,²¹ further suggesting differences between patients in our sample compared to randomized trial participants.

Concerns regarding bleeding or falls in older patients, may also have contributed to lower than recommended doses. Recent analyses of patients at risk for falls confirmed that increased risk of falling was associated with more bone fractures, bleeding and all-cause death but not stroke or systemic emboli, and with less severe bleeding with the DOAC edoxaban compared to warfarin.²⁶ While a rationale for personalized or lower than recommended dosing of apixaban may exist in very old patients and those at risk of falls and bleeding, more data are needed to determine outcomes of lower than recommended doses of DOACs before such an approach can be endorsed. Monitoring of anticoagulant effect in patients who receive doses lower than those investigated in clinical trials could provide important information. The assays that measure DOAC effects are likely to be more available because of the use of reversal agents in the setting of bleeding with DOACs.²⁷

We had anticipated higher than recommended dosing for rivaroxaban as recommendations are based on creatinine clearance while laboratories routinely report estimated glomerular filtration rate (eGFR) that can provide higher estimates of renal clearance and estimated DOAC doses in older and smaller individuals.²⁸ Higher than recommended dosing was found in only 3.5% of our sample. In half, eGFR estimates were higher than creatinine clearance estimates. An international postmarketing registry of rivaroxaban use for the prevention of stroke in patients with NVAF, which included outpatients, found that 36% of those with creatinine clearances below 50 mL/min received a dose higher than recommended, and 15% received a dose lower than expected.²⁹ A more recent outpatient registry report on patients with NVAF, in which apixaban, dabigatran, or rivaroxaban was administered, found that overall 9.4% received a dose lower than recommended, and 3.4% were overdosed, with a similar percentage (34%) of rivaroxaban patients with creatinine clearance of 15 to 50 mL/min receiving higher than recommended dosing.³⁰ The lower rate of higher-than-recommended doses that we observed may have been related to the routine measurement of serum creatinine and attention to dosing adjustments for renal function in the inpatient setting compared to the outpatient setting. In addition, renal function data may not be available to outpatient pharmacies, limiting potential input on dosing recommendations. At least one cardiac society recommends monitoring of renal function in patients treated with DOACs, annually in patients with normal estimated creatinine clearance and more frequently (at intervals in months equal to the creatinine clearance divided by 10) in patients with abnormal creatinine clearance.¹¹ A hospital encounter provides an opportunity to assess or reassess renal status to optimize DOAC dosing.

Dabigatran was the first DOAC introduced into use in the United States with the same dose recommended for prevention of stroke in patients with AF or venous thromboembolic disease with reductions for creatinine clearance below 30 mL/min or creatinine clearance between 30 and 50 mL/min and concomitant use of the potent P-glycoprotein inhibitor dronedarone or systemic ketoconazole. The relative simplicity of dosing may have been responsible for the lowest rate of prescribing outside of recommendations observed in this study, but the low dabigatran use limits analyses of contributing factors.

Failure to avoid drug use in combination with use of strong P-glycoprotein inducers or inhibitors was infrequent but should be preventable. Current prescribing recommendations refer to “strong” P-glycoprotein inhibitors and list different specific agents that interact with each DOAC without a standardized definition or classification. Standardized classifications or reference sources would be helpful.

Our primary goal in this study was to compare initial prescribed dosing of DOACs with FDA-approved prescribing directions. However, therapeutic indication data warrant discussion. In our sample, 7.5% of patients with AF had bioprosthetic valves or recent mitral valve repair or replacement. Using the NVAF definition found in the 2014 AHA/ACC/HRS (American Heart Association, American College of Cardiology, Heart Rhythm Society) AF guidelines¹—“absence of rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair”—these patients would not appear to be candidates for DOACs. However, arguments have been made that a bioprosthetic heart valve or native valve after valve repair does not have a risk profile for thromboembolism that differs from other forms of NVAF and would be equally responsive to DOAC therapy.³¹ Data are sparse, but retrospective subanalyses of limited numbers of patients with valvular disease (including bioprosthesis and mitral repair patients but excluding mechanical valve patients) enrolled in the pivotal DOAC studies support this conclusion.³² For the first months after biological valve replacement (including catheter-based valve replacement), recent European guidelines recommend vitamin K antagonists but also state, “NOACs probably deliver the same protection.”⁸ DOACs were also used for management of venous thromboembolic disease (both acute and chronic) in patients with active cancer. Our data predate the most recent American College of Chest Physician guidelines on treatment of venous thromboembolism in patients with cancer, which provide grade 2B recommendations for use of low-molecular-weight heparin (LMWH) over vitamin K antagonists and grade 2C recommendations for use of LMWH over dabigatran, rivaroxaban, apixaban, or edoxaban.³³

Our study had several limitations. First, data were from a single US academic medical center, though similar rates of prescribing deviation from recommendations have been reported for rivaroxaban and dabigatran in NVAF patients in other countries.^29,34 Second, therapeutic indications may have been misclassified because of errors, incomplete EMR data, or multiple indications. Third, we analyzed the first DOAC order and not dispensing information or subsequent corrections. Therefore, deviations from recommendations should not be interpreted as errors that reached patients. We evaluated dosing based on the measures used at the time of hospital admission, noting that, in a significant fraction of deviations from recommended doses, they represented continuations of outpatient doses when renal function or weight may have differed, and it is unknown whether patients were counseled to take rivaroxaban with food in the outpatient setting. Fourth, the number of patients with acute DVT was small, so firm conclusions cannot be drawn for this specific population. Fifth, our estimates of off-label dosing may have been underestimates, as data on cancer and cancer activity or cardiac valvular disease may not have been complete.

 

CONCLUSION

Healthcare professionals are prescribing DOACs in ways that differ from recommendations. These differences may reflect the older ages and reduced renal function of clinical populations relative to randomized clinical trial groups, but they could also potentially alter clinical efficacy. Our findings support the need to evaluate the appropriateness and dosing of DOACs at each encounter and to determine the outcomes of patients treated with lower than recommended doses of DOACs and the outcomes of DOAC-treated patients with bioprostheses or active malignancies.

Acknowledgment

The authors thank Tobias Schmelzinger for electronic data extraction and compilation and University of California San Francisco students Eduardo De La Torre Cruz (School of Pharmacy) and Carlos Mikell (School of Medicine) for assistance with data review.

Disclosure

Dr. Schwartz reports receiving personal fees from Bristol-Myers Squibb and Amgen and grants from Bristol-Myers Squibb and Pfizer, outside the submitted work. The other authors have nothing to report.

 

Return visit (RV) rate is a quality measure commonly used in the emergency department (ED) setting. This metric may represent suboptimal care at the index ED visit.^1-5 Although patient- and visit-level factors affecting ED RVs have been evaluated,^1,3,4,6-9 hospital-level factors and factors of a hospital’s patient population that may play roles in ED RV rates have not been examined. Identifying the factors associated with increased RVs may allow resources to be designated to areas that improve emergent care for children.¹⁰

Hospital readmission rates are a closely followed quality measure and are linked to reimbursement by the federal government, but a recent study found the influence a hospital can have on this marker may be mitigated by the impact of the social determinates of health (SDHs) of the hospital’s patient population.¹¹ That study and others have prompted an ongoing debate about adjusting quality measures for SDHs.^12,13 A clearer understanding of these interactions may permit us to focus on factors that can truly lead to improvement in care instead of penalizing practitioners or hospitals that provide care to those most in need.

Prior work has identified several SDHs associated with higher ED RV rates in patient- or visit-level analyses.^3,11,14 We conducted a study of hospital-level characteristics and characteristics of a hospital’s patient population to identify potentially mutable factors associated with increased ED RV rates that, once recognized, may allow for improvement in this quality measure.

PATIENTS AND METHODS

This study was not considered human subjects research in accordance with Common Rule 45 CFR§46.104(f) and was evaluated by the Ann and Robert H. Lurie Children’s Hospital and Northwestern University Feinberg School of Medicine Institutional Review Boards and deemed exempt from review.

Study Population and Protocol

Our study had 2 data sources (to be described in detail): the Pediatric Health Information System (PHIS) and a survey of ED medical directors of the hospitals represented within PHIS. Hospitals were eligible for inclusion in the study if their data (1) met PHIS quality control standards for ED patient visits as determined by internal data assurance processes incorporated in PHIS,^3,14,15 (2) included data only from an identifiable single main ED, and (3) completed the ED medical director’s survey.

 

PHIS Database

PHIS, an administrative database managed by Truven Health Analytics, includes data from ED, ambulatory surgery, observation, and inpatient encounters across Children’s Hospital Association member children’s hospitals in North America. Data are subjected to validity checks before being included in the database.¹⁶ PHIS assigns unique patient identifiers to track individual patient visits within participating institutions over time.

Hospitals were described by percentages of ED patients in several groups: age (<1, 1-4, 5-9, 10-14, and 15-18 years)¹⁷; sex; race/ethnicity; insurance type (commercial, government, other); ED International Classification of Diseases, Ninth Edition (ICD-9) diagnosis code–based severity classification system score (1-2, low severity; 3-5, high severity)¹⁸; complex chronic condition presence at ED visits in prior year^14,19-21; home postal (Zip) code median household income from 2010 US Census data compared with Federal Poverty Level (<1.5, 1.5-2, 2-3, and >3 × FPL)¹⁷; and primary care physician (PCP) density in Federal Health Service Area of patient’s home address as reported by Dartmouth Atlas of Health Care modeled by quartiles.²² Density of PCPs—general pediatricians, family practitioners, general practitioners, and general internists—is calculated as number of PCPs per 100,000 residents. We used PCP density to account for potential care provided by any of the PCPs mentioned. We also assessed, at hospital level, index visit arrival time (8:01 am to 4:00 pm; 4:01 pm to 12:00 am; 12:01 am to 8:00 am) and index visit season.²³

ED Medical Director Survey

A web-based survey was constructed in an iterative process based on literature review and expert opinion to assess hospital-level factors that may impact ED RV rates.^3,7,24-26 The survey was piloted at 3 institutions to refine its structure and content.

The survey included 15 close-ended or multiple-choice questions on ED environment and operations and 2 open-ended questions, “What is the largest barrier to reducing the number of return visits within 72 hours of discharge from a previous ED visit?” and “In your opinion, what is the best way of reducing the number of the return visits within 72 hours of previous ED visit ?” (questionnaire in Supplemental material). Hospital characteristics from the survey included total clinical time allotment, or full-time equivalent (FTE), among all physicians, pediatric emergency medicine (PEM) fellowship-trained physicians, and all other (non-PEM) physicians. The data were standardized across sites by calculating FTE-per-10,000-visits values for each hospital; median duration of ED visit for admitted and discharged patients; median time from arrival to ED physician evaluation; rate of leaving without being seen; discharge educational material authorship and age specificity; follow-up visit scheduling procedure; and percentage of ED patients for whom English was a second language.

Responses to the 2 open-ended questions were independently categorized by Drs. Pittsenbarger and Alpern. Responses could be placed in more than 1 category if multiple answers to the question were included in the response. Categorizations were compared for consistency, and any inconsistencies were resolved by the consensus of the study investigators.

Outcome Measures From PHIS Database

All ED visits within a 12-month period (July 1, 2013–June 30, 2014) by patients younger than 18 years at time of index ED visit were eligible for inclusion in the study. An index visit was defined as any ED visit without another ED visit within the preceding 72 hours. The 72-hour time frame was used because it is the most widely studied time frame for ED RVs.⁵ Index ED visits that led to admission, observation status, death, or transfer were excluded.

The 2 primary outcomes of interest were (1) RVs within 72 hours of index ED visit discharge and (2) RVs within 72 hours that resulted in hospital admission or observation status at the next ED visit (RVA).^7,9,27-30 For patients with multiple ED revisits within 72 hours, only the first was assessed. There was a 72-hour minimum between index visits for the same patient.

Statistical Analyses

To determine hospital groups based on RV and RVA rates, we adjusted RV and RVA rates using generalized linear mixed-effects models, controlling for clustering and allowing for correlated data (within hospitals), nonconstant variability (across hospitals), and non-normally distributed data, as we did in a study of patient-level factors associated with ED RV and RVA.³ For each calculated rate (RV, RVA), the hospitals were then classified into 3 groups based on whether the hospital’s adjusted RV and RVA rates were outside 2 SDs from the mean, below the 5th or above the 95th percentile, or within that range. These groups were labeled lowest outliers, highest outliers, and average-performing hospitals.

After the groups of hospitals were determined, we returned to using unadjusted data to statistically analyze them. We summarized continuous variables using minimum and maximum values, medians, and interquartile ranges (IQRs). We present categorical variables using counts and percentages. To identify hospital characteristics with the most potential to gain from improvement, we also analyzed associations using 2 collapsed groups: hospitals with RV (or RVA) rates included in the average-performing and lowest outlier groups and hospitals within the highest outlier group. Hospital characteristics and hospital’s patient population characteristics from the surveys are summarized based on RV and RVA rate groups. Differences in distributions among continuous variables were assessed by Kruskal-Wallis 1-way analysis of variance. Chi-square tests were used to evaluate differences in proportions among categorical variables. All statistical analyses were performed with SAS Version 9.4 (SAS Institute); 2-sided P < 0.05 was considered statistically significant.

 

RESULTS

Return Visit Rates and Hospital ED Site Population Characteristics

Twenty-four of 35 (68%) eligible hospitals that met PHIS quality control standards for ED patient visits responded to the ED medical director survey. The included hospitals that both met quality control standards and completed the survey had a total of 1,456,377 patient visits during the study period. Individual sites had annual volumes ranging from 26,627 to 96,637 ED encounters. The mean RV rate across the institutions was 3.7% (range, 3.0%-4.8%), and the mean RVA rate across the hospitals was 0.7% (range, 0.5%-1.1%) (Figure).

There were 5 hospitals with RV rates less than 2 SDs of the mean rate, placing them in the lowest outlier group for RV; 13 hospitals with RV rates within 2 SDs of the mean RV rate, placing them in the average-performing group; and 6 hospitals with RV rates above 2 SDs of the mean, placing them in the highest outlier group. Table 1 lists the hospital ED site population characteristics among the 3 RV rate groups. Hospitals in the highest outlier group served populations with higher proportions of patients with insurance from a government payer, lower proportions of patients covered by a commercial insurance plan, and higher proportion of patients with lower median household incomes.

In the RVA analysis, there were 6 hospitals with RVA rates less than 2 SDs of the mean RVA rate (lowest outliers); 14 hospitals with RVA rates within 2 SDs of the mean RVA rate (average performers); and 4 hospitals with RVA rates above 2 SDs of the mean RVA rate (highest outliers). When using these groups based on RVA rate, there were no statistically significant differences in hospital ED site population characteristics (Supplemental Table 1).

RV Rates and Hospital-Level Factors Survey Characteristics

Table 2 lists the ED medical director survey hospital-level data among the 3 RV rate groups. There were fewer FTEs by PEM fellowship-trained physicians per 10,000 patient visits at sites with higher RV rates (Table 2). Hospital-level characteristics assessed by the survey were not associated with RVA rates (Supplemental Table 2).

Evaluating characteristics of hospitals with the most potential to gain from improvement, hospitals with the highest RV rates (highest outlier group), compared with hospitals in the lowest outlier and average-performing groups collapsed together, persisted in having fewer PEM fellowship-trained physician FTEs per patient visit (Table 3). A similar collapsed analysis of RVA rates demonstrated that hospitals in the highest outlier group had longer-wait-to-physician time (81 minutes; IQR, 51-105 minutes) compared with hospitals in the other 2 groups (30 minutes; IQR, 19-42.5 minutes) (Table 3).

In response to the first qualitative question on the ED medial director survey, “In your opinion, what is the largest barrier to reducing the number of return visits within 72 hours of discharge from a previous ED visit?”, 15 directors (62.5%) reported limited access to primary care, 4 (16.6%) reported inadequate discharge instructions and/or education provided, and 3 (12.5%) reported lack of access to specialist care. To the second question, “In your opinion, what is the best way of reducing the number of the return visits within 72 hours of previous ED visit for the same condition?”, they responded that RVs could be reduced by innovations in scheduling primary care or specialty follow-up visits (19, 79%), improving discharge education and instructions (6, 25%), and identifying more case management or care coordination (4, 16.6%).

DISCUSSION

Other studies have identified patient- and visit-level characteristics associated with higher ED RV and RVA rates.^3,8,9,31 However, as our goal was to identify possible modifiable institutional features, our study examined factors at hospital and population-served levels (instead of patient or visit level) that may impact ED RV and RVA rates. Interestingly, our sample of tertiary-care pediatric center EDs provided evidence of variability in RV and RVA rates. We identified factors associated with RV rates related to the SDHs of the populations served by the ED, which suggests these factors are not modifiable at an institution level. In addition, we found that the increased availability of PEM providers per patient visit correlated with fewer ED RVs.

Hospitals serving ED populations with more government-insured and fewer commercially insured patients had higher rates of return to the ED. Similarly, hospitals with larger proportions of patients from areas with lower median household incomes had higher RV rates. These factors may indicate that patients with limited resources may have more frequent ED RVs,^3,6,32,33 and hospitals that serve them have higher ED RV rates. Our findings complement those of a recent study by Sills et al.,¹¹ who evaluated hospital readmissions and proposed risk adjustment for performance reimbursement. This study found that hospital population-level race, ethnicity, insurance status, and household income were predictors of hospital readmission after discharge.

Of note, our data did not identify similar site-level attributes related to the population served that correlated with RVA rates. We postulate that the need for admission on RV may indicate an inherent clinical urgency or medical need associated with the return to the ED, whereas RV without admission may be related more to patient- or population-level sociodemographic factors than to quality of care and clinical course, which influence ED utilization.^1,3,30 EDs treating higher proportions of patients of minority race or ethnicity, those with fewer financial resources, and those in more need of government health insurance are at higher risk for ED revisits.

We observed that increased PEM fellowship-trained physician staffing was associated with decreased RV rates. The availability of specialty-trained physicians in PEM may allow a larger proportion of patients treated by physicians with honed clinical skills for the patient population. Data from a single pediatric center showed PEM fellowship-trained physicians had admission rates lower than those of their counterparts without subspecialty fellowship training.³⁴ The lower RV rate for this group in our study is especially interesting in light of previously reported lower admission rates at index visit in PEM trained physicians. With lower index admission rates, it may have been assumed that visits associated with PEM trained physician care would have an increased (rather than decreased) chance of RV. In addition, we noted the increased RVA rates were associated with longer waits to see a physician. These measures may indicate the effect of institutional access to robust resources (the ability to hire and support more specialty-trained physicians). These novel findings warrant further evaluation, particularly as our sample included only pediatric centers.

Our survey data demonstrated the impact that access to care has on ED RV rates. The ED medical directors indicated that limited access to outpatient appointments with PCPs and specialists was an important factor increasing ED RVs and a potential avenue for interventions. As the 2 open-ended questions addressed barriers and potential solutions, it is interesting that the respondents cited access to care and discharge instructions as the largest barriers and identified innovations in access to care and discharge education as important potential remedies.

This study demonstrated that, at the hospital level, ED RV quality measures are influenced by complex and varied SDHs that primarily reflect the characteristics of the patient populations served. Prior work has similarly highlighted the importance of gaining a rigorous understanding of other quality measures before widespread use, reporting, and dissemination of results.^11,35-38 With this in mind, as quality measures are developed and implemented, care should be taken to ensure they accurately and appropriately reflect the quality of care provided to the patient and are not more representative of other factors not directly within institutional control. These findings call into question the usefulness of ED RVs as a quality measure for comparing institutions.

 

Study Limitations

This study had several limitations. The PHIS dataset tracks only patients within each institution and does not include RVs to other EDs, which may account for a proportion of RVs.³⁹ Our survey response rate was 68% among medical directors, excluding 11 hospitals from analysis, which decreased the study’s power to detect differences that may be present between groups. In addition, the generalizability of our findings may be limited to tertiary-care children’s hospitals, as the PHIS dataset included only these types of healthcare facilities. We also included data only from the sites’ main EDs, and therefore cannot know if our results are applicable to satellite EDs. ED staffing of PEM physicians was analyzed using FTEs. However, number of clinical hours in 1 FTE may vary among sites, leading to imprecision in this hospital characteristic.

CONCLUSION

Hospitals with the highest RV rates served populations with a larger proportion of patients with government insurance and lower household income, and these hospitals had fewer PEM trained physicians. Variation in RV rates among hospitals may be indicative of the SDHs of their unique patient populations. ED revisit rates should be used cautiously in determining the quality of care of hospitals providing care to differing populations.

Disclosure

Nothing to report.