Original Research

The incidence of melanoma is increasing at a rate greater than any other cancer,¹ possibly due to the increasing use of indoor tanning devices. These devices emit unnaturally high levels of UVA and low levels of UVA and UVB rays.² The risks of using these devices include increased incidence of melanoma (3438 cases attributed to indoor tanning in 2008) and keratinocytes cancer (increased risk of squamous cell carcinoma by 67% and basal cell carcinoma by 29%), severe sunburns (61.1% of female users and 44.6% of male users have reported sunburns), and aggravation of underlying disorders such as systemic lupus erythematosus.^3-5

The literature varies in its explanation of how indoor tanning increases the risk of developing melanoma. Some authors suggest it is due to increased frequency of use, duration of sessions, and years of using tanning devices.^1,6 Others suggest the increased cancer risk is the result of starting to tan at an earlier age.^2,3,6-10 There is conflicting literature on the level of increased risk of melanoma in those who tan indoors at a young age (<35 years). Although the estimated rate of increased skin cancer risk varies, with rates up to 75% compared to nonusers, nearly all sources support an increased rate.⁶ Despite the growing body of knowledge that indoor tanning is dangerous, as well as the academic publication of these risks (eg, carcinogenesis, short-term and long-term eye injury, burns, UV sensitivity when combined with certain medications), teenagers in the United States and affluent countries appear to disregard the risks of tanning.¹¹

Tanning companies have promoted the misconception that only UVB rays cause cell damage and UVA rays, which the devices emit, result in “damage-free” or “safe” tans.^2,3 Until 2013, indoor tanning devices were classified by the US Food and Drug Administration (FDA) as class I, indicating that they are safe in terms of electrical shock. Many indoor tanning facilities have promoted the FDA “safe” label without clarifying that the safety indications only referred to electrical-shock potential. Nonetheless, it is known now that these devices, which emit high UVA and low UVB rays, promote melanoma, nonmelanoma skin cancers, and severe sunburns, as well as aggravate existing conditions (eg, systemic lupus erythematosus).⁴ As a result of an unacceptably high incidence of these disease complications, a 2014 FDA regulation categorized tanning beds as class II, requiring that tanning bed users be informed of the risk of skin cancer in an effort to reverse the growing trend of indoor tanning.¹² Despite these regulatory interventions, it is not clear if this knowledge of cancer risk deters patients from indoor tanning.

The purpose of this study was to investigate the patients’ perspective on indoor tanning behaviors as associated with the severity of their melanoma and the time frame in which they were diagnosed as well as their perceived views on the safety of indoor tanning and the frequency in which they continue to tan indoors. This information is highly relevant in helping to determine if requiring a warning of the risk of skin cancer will deter patients from this unhealthy habit, especially given recent reclassification of sunbeds as class II by the FDA. Additional insights from these data may clarify if indoor tanning decreases the time frame in which melanoma is diagnosed or increases the severity of the resulting melanoma. Moreover, it will help elucidate whether or not the age at which indoor tanning is initiated affects the time frame to melanoma onset and corresponding severity.

Methods

An original unvalidated online survey was conducted worldwide via a link distributed to the following supporting institutions: Advanced Dermatology & Cosmetic Surgery, Ameriderm Research, Melanoma Research Foundation (a melanoma patient advocacy group), Florida State University Department of Dermatology, Moffitt Cancer Center Cutaneous Oncology Program, Cleveland Clinic, Ohio State University Division of Medical Oncology, Harvard Medical School Department of Dermatology, The University of Texas MD Anderson Cancer Center Department of Dermatology, University of Colorado Department of Dermatology, and Northwestern University Department of Dermatology. However, there was not confirmation that all of these institutions promoted the survey. Additionally, respondents were recruited through patient advocacy groups and social media sites including Facebook, Twitter, LinkedIn, Tumblr, and Instagram. The patient advocacy groups and social media sites invited participation through recruitment announcements, including DermNetNZ (a global dermatology patient information site), with additional help from the International Federation of Dermatology Clinical Trial Network.

The survey was restricted to those who were self-identified as 18 years or older and who self-reported a diagnosis of melanoma following the use of indoor tanning devices. The survey was hosted by SurveyMonkey, which allowed consent to be obtained and responses to remain anonymous. Access to the survey was sponsored by the Basal Cell Carcinoma Nevus Syndrome Life Support Network. The University of Central Florida (Orlando, Florida) institutional review board reviewed and approved this study as exempt human research.

Survey responses collected from January 2014 to June 2015 were analyzed herein. The survey contained 58 questions and was divided into different topics including indoor tanning background (eg, states/countries in which participants tanned indoors, age when they first tanned, frequency of tanning), consenting process (eg, length, did someone review the consent with participants, what was contained in the consent), indoor tanning and melanoma (eg, how long after tanning did melanoma develop, age at development, location of melanoma), indoor tanning postmelanoma (eg, did participants tan after diagnosis and why), and other risk factors (eg, did participants smoke or drink pre- or postmelanoma).

Statistical Analysis
The data consist of both categorical and continuous variables. The categorical variables included age (<35 years or ≥35 years), frequency of indoor tanning (≤1 time weekly or >1 time weekly), and onset of melanoma diagnosis (within or after 5 years of indoor tanning). The continuous variables consisted of current age, age at start of indoor tanning, age at melanoma diagnosis, Breslow depth, and Clark level. Frequency of indoor tanning and warning of the risk of skin cancer were converted to be used as both categorical and continuous variables. For frequency of indoor tanning, the variables less than or equal to once weekly and more than once weekly were used as categorical variables, whereas less than monthly, 1 time monthly, 4 times monthly, 2 times weekly, and more than 2 times weekly were used as continuous variables. For warning of the risk of skin cancer, no and yes were converted to 0 and 1 for use in the Spearman correlations, which allowed for greater analyses among other variables. Spearman correlation was used to determine if a significant relationship existed among the age at melanoma diagnosis, age at start of indoor tanning, Breslow depth, Clark level, frequency of indoor and outdoor tanning, and knowledge and warning of the risk of skin cancer. All data were analyzed by use of IBM SPSS Statistics (version 21.0).

Difference in proportions among groups, age, frequency of tanning, onset of melanoma diagnosis within or after 5 years of starting indoor tanning, and knowledge of cancer risks was tested for significance using the χ² test. Reported P values were 2-tailed, corresponding with a significance level of P<.05. All data were analyzed using SPSS (version 21.0). All statistical analyses were conducted independent of the participants’ sex.

 

Results

Of the 454 participants who accessed the survey, 448 were analyzed in this study; 6 participants did not complete the questionnaire. Both males and females were analyzed: 289 females, 12 males, and 153 who did not report gender. The age range of participants was 18 to 69 years. The age at start of indoor tanning ranged from 8 to 54 years, with a mean of 22 years. Additional participant characteristics are described in Table 1. The mean frequency of indoor tanning was reported as 2 times weekly. When participants were asked if they were warned of the risk of skin cancer, 21.5% reported yes while 78.4% reported not being told of the risk. This knowledge was compared to their frequency of indoor tanning. Having the knowledge of the risk of skin cancer had no influence on their frequency of indoor tanning (Table 2).

Among responders, those who perceived indoor tanning as safer than outdoor tanning tanned indoors more frequently than those who do not (Spearman r=−0.224; P<.05)(Table 3). The frequency of indoor tanning was divided into those who tanned indoors more than once weekly and those who tanned indoors once a week or less. This study showed that the frequency of indoor tanning had no effect on the latency time between the commencement of indoor tanning and diagnosis of melanoma (Table 4). The time frame from the onset of melanoma diagnosis also was compared to the age at which the participants started to tan indoors. Age was divided into those younger than 35 years and those 35 years and older. There was no correlation between the age when indoor tanning began and the time frame in which the melanoma was diagnosed (eTable).

Table 5 shows the correlations between indoor tanning behaviors and melanoma characteristics. Those who started indoor tanning at an earlier age were diagnosed with melanoma at an earlier age compared to those who started indoor tanning later in life (r=0.549; P<.01). Moreover, those who started indoor tanning at a later age reported being diagnosed with a melanoma of greater Breslow depth (r=0.173; P<.01). Those who reported being diagnosed with a greater Breslow depth also reported a higher Clark level (r=0.608; P<.01). Among responders, those who more frequently tanned indoors also reported greater frequency of outdoor tanning (r=0.197; P<.01). This study showed no correlation between the age at melanoma diagnosis and the frequency of indoor (r=0.004; P>.05 not significant) or outdoor (r=0.093; P>.05 not significant) tanning. Having the knowledge of the risk of skin cancer had no relationship on the frequency of indoor tanning (r=−0.04; P>.05 not significant).

 

Comment

Thirty million Americans utilize indoor tanning devices at least once a year.¹³ UVA light comprises the majority of the spectrum used by indoor tanning devices, with a fraction (<5%) being UVB light. Until recently, UVB light was the only solar spectrum considered carcinogenic. In 2009, the International Agency for Research on Cancer classified the whole spectrum as carcinogenic to humans.^5,11 Despite this evidence, indoor tanning facilities have promoted indoor tanning as damage free.³ The goal of this study was to collect the patient perspective on the safety of indoor tanning, indoor tanning behaviors, time frame of onset of melanoma, and the severity (ie, Breslow depth) of those melanomas.

Melanoma is the most prevalent cancer in females aged 25 to 29 years.³ The median age of diagnosis of melanoma (with and without the use of indoor tanning devices) is approximately 60 years¹⁴ versus our study, which found the average age at diagnosis was 37.6 years. Our findings are consistent with other literature in that those who start indoor tanning earlier (<35 years of age) develop melanoma at an earlier age.^14,15 Cust et al¹⁴ also promoted the idea that patients develop melanoma earlier because younger individuals are more biologically susceptible to the carcinogenic effects of artificial UV light. However, our study found that those who started indoor tanning at an older age reported being diagnosed with a melanoma of greater Breslow depth, seemingly incongruent with the aforementioned hypothesis. One limitation is the age range for this research sample (18–69 years). The young age range may be attributable to the recruitment through social media, which is geared toward a younger population. Additionally, indoor tanning is a relatively new phenomenon practiced since the 1980s,² which may contribute to the younger sample size. However, 2.7 billion individuals use social media worldwide with 40% of those older than 65 years on social media.¹⁶

Prior research has shown that those who start indoor tanning before the age of 35 years have a 75% increased risk of developing melanoma.¹⁴ Another study also has suggested that UVA-rich sunlamps may shorten the latency period for induction of melanoma and nonmelanoma skin cancers.³ Our study used similar age cutoffs in concluding that there was no earlier onset of melanoma diagnosis between those who started indoor tanning before the age of 35 years and those who started at the age of 35 years or older. Limitations include that our study is cross-sectional, and therefore time course cannot be established. Also, survey responses were self-reported, allowing the possibility of recall bias.

A plethora of research has been conducted to determine if there is a connection between the use of indoor tanning devices and developing melanoma. Cust et al¹⁴ suggested the risk of melanoma was 41% higher for those who had ever used a sunbed in comparison to those who had not. Other studies describe the difficulty in making the connection between indoor tanning and melanoma, as those who more frequently tan indoors also more frequently tan outdoors,¹¹ as suggested by this study. However, there is a paucity of literature on the patients’ perspectives on the safety of indoor tanning. This study determined that those who more frequently tan indoors believed that indoor tanning is safer than outdoor tanning. With this altered perception promoted by the indoor tanning industry, the FDA has added a warning label to all indoor tanning devices about the risk of skin cancer. Our study revealed that having the knowledge of the risk of skin cancer had no influence on the frequency of indoor tanning. This concerning finding highlights a pressing need for an alternative approach to increase awareness of the harmful consequences that accompany indoor tanning. Further studies may elaborate on potential effective methods and messages to relate to an indoor tanning population comprised mostly of young females.

Acknowledgments
Supported and funded by the Basal Cell Carcinoma Nevus Syndrome Life Support Network. This research project was completed as part of the FIRE Module at the University of Central Florida, College of Medicine. We thank the FIRE Module faculty and staff for their assistance with this project.

The incidence of melanoma is increasing at a rate greater than any other cancer,¹ possibly due to the increasing use of indoor tanning devices. These devices emit unnaturally high levels of UVA and low levels of UVA and UVB rays.² The risks of using these devices include increased incidence of melanoma (3438 cases attributed to indoor tanning in 2008) and keratinocytes cancer (increased risk of squamous cell carcinoma by 67% and basal cell carcinoma by 29%), severe sunburns (61.1% of female users and 44.6% of male users have reported sunburns), and aggravation of underlying disorders such as systemic lupus erythematosus.^3-5

The literature varies in its explanation of how indoor tanning increases the risk of developing melanoma. Some authors suggest it is due to increased frequency of use, duration of sessions, and years of using tanning devices.^1,6 Others suggest the increased cancer risk is the result of starting to tan at an earlier age.^2,3,6-10 There is conflicting literature on the level of increased risk of melanoma in those who tan indoors at a young age (<35 years). Although the estimated rate of increased skin cancer risk varies, with rates up to 75% compared to nonusers, nearly all sources support an increased rate.⁶ Despite the growing body of knowledge that indoor tanning is dangerous, as well as the academic publication of these risks (eg, carcinogenesis, short-term and long-term eye injury, burns, UV sensitivity when combined with certain medications), teenagers in the United States and affluent countries appear to disregard the risks of tanning.¹¹

Tanning companies have promoted the misconception that only UVB rays cause cell damage and UVA rays, which the devices emit, result in “damage-free” or “safe” tans.^2,3 Until 2013, indoor tanning devices were classified by the US Food and Drug Administration (FDA) as class I, indicating that they are safe in terms of electrical shock. Many indoor tanning facilities have promoted the FDA “safe” label without clarifying that the safety indications only referred to electrical-shock potential. Nonetheless, it is known now that these devices, which emit high UVA and low UVB rays, promote melanoma, nonmelanoma skin cancers, and severe sunburns, as well as aggravate existing conditions (eg, systemic lupus erythematosus).⁴ As a result of an unacceptably high incidence of these disease complications, a 2014 FDA regulation categorized tanning beds as class II, requiring that tanning bed users be informed of the risk of skin cancer in an effort to reverse the growing trend of indoor tanning.¹² Despite these regulatory interventions, it is not clear if this knowledge of cancer risk deters patients from indoor tanning.

The purpose of this study was to investigate the patients’ perspective on indoor tanning behaviors as associated with the severity of their melanoma and the time frame in which they were diagnosed as well as their perceived views on the safety of indoor tanning and the frequency in which they continue to tan indoors. This information is highly relevant in helping to determine if requiring a warning of the risk of skin cancer will deter patients from this unhealthy habit, especially given recent reclassification of sunbeds as class II by the FDA. Additional insights from these data may clarify if indoor tanning decreases the time frame in which melanoma is diagnosed or increases the severity of the resulting melanoma. Moreover, it will help elucidate whether or not the age at which indoor tanning is initiated affects the time frame to melanoma onset and corresponding severity.

Methods

An original unvalidated online survey was conducted worldwide via a link distributed to the following supporting institutions: Advanced Dermatology & Cosmetic Surgery, Ameriderm Research, Melanoma Research Foundation (a melanoma patient advocacy group), Florida State University Department of Dermatology, Moffitt Cancer Center Cutaneous Oncology Program, Cleveland Clinic, Ohio State University Division of Medical Oncology, Harvard Medical School Department of Dermatology, The University of Texas MD Anderson Cancer Center Department of Dermatology, University of Colorado Department of Dermatology, and Northwestern University Department of Dermatology. However, there was not confirmation that all of these institutions promoted the survey. Additionally, respondents were recruited through patient advocacy groups and social media sites including Facebook, Twitter, LinkedIn, Tumblr, and Instagram. The patient advocacy groups and social media sites invited participation through recruitment announcements, including DermNetNZ (a global dermatology patient information site), with additional help from the International Federation of Dermatology Clinical Trial Network.

The survey was restricted to those who were self-identified as 18 years or older and who self-reported a diagnosis of melanoma following the use of indoor tanning devices. The survey was hosted by SurveyMonkey, which allowed consent to be obtained and responses to remain anonymous. Access to the survey was sponsored by the Basal Cell Carcinoma Nevus Syndrome Life Support Network. The University of Central Florida (Orlando, Florida) institutional review board reviewed and approved this study as exempt human research.

Survey responses collected from January 2014 to June 2015 were analyzed herein. The survey contained 58 questions and was divided into different topics including indoor tanning background (eg, states/countries in which participants tanned indoors, age when they first tanned, frequency of tanning), consenting process (eg, length, did someone review the consent with participants, what was contained in the consent), indoor tanning and melanoma (eg, how long after tanning did melanoma develop, age at development, location of melanoma), indoor tanning postmelanoma (eg, did participants tan after diagnosis and why), and other risk factors (eg, did participants smoke or drink pre- or postmelanoma).

Statistical Analysis
The data consist of both categorical and continuous variables. The categorical variables included age (<35 years or ≥35 years), frequency of indoor tanning (≤1 time weekly or >1 time weekly), and onset of melanoma diagnosis (within or after 5 years of indoor tanning). The continuous variables consisted of current age, age at start of indoor tanning, age at melanoma diagnosis, Breslow depth, and Clark level. Frequency of indoor tanning and warning of the risk of skin cancer were converted to be used as both categorical and continuous variables. For frequency of indoor tanning, the variables less than or equal to once weekly and more than once weekly were used as categorical variables, whereas less than monthly, 1 time monthly, 4 times monthly, 2 times weekly, and more than 2 times weekly were used as continuous variables. For warning of the risk of skin cancer, no and yes were converted to 0 and 1 for use in the Spearman correlations, which allowed for greater analyses among other variables. Spearman correlation was used to determine if a significant relationship existed among the age at melanoma diagnosis, age at start of indoor tanning, Breslow depth, Clark level, frequency of indoor and outdoor tanning, and knowledge and warning of the risk of skin cancer. All data were analyzed by use of IBM SPSS Statistics (version 21.0).

Difference in proportions among groups, age, frequency of tanning, onset of melanoma diagnosis within or after 5 years of starting indoor tanning, and knowledge of cancer risks was tested for significance using the χ² test. Reported P values were 2-tailed, corresponding with a significance level of P<.05. All data were analyzed using SPSS (version 21.0). All statistical analyses were conducted independent of the participants’ sex.

 

Results

Of the 454 participants who accessed the survey, 448 were analyzed in this study; 6 participants did not complete the questionnaire. Both males and females were analyzed: 289 females, 12 males, and 153 who did not report gender. The age range of participants was 18 to 69 years. The age at start of indoor tanning ranged from 8 to 54 years, with a mean of 22 years. Additional participant characteristics are described in Table 1. The mean frequency of indoor tanning was reported as 2 times weekly. When participants were asked if they were warned of the risk of skin cancer, 21.5% reported yes while 78.4% reported not being told of the risk. This knowledge was compared to their frequency of indoor tanning. Having the knowledge of the risk of skin cancer had no influence on their frequency of indoor tanning (Table 2).

Among responders, those who perceived indoor tanning as safer than outdoor tanning tanned indoors more frequently than those who do not (Spearman r=−0.224; P<.05)(Table 3). The frequency of indoor tanning was divided into those who tanned indoors more than once weekly and those who tanned indoors once a week or less. This study showed that the frequency of indoor tanning had no effect on the latency time between the commencement of indoor tanning and diagnosis of melanoma (Table 4). The time frame from the onset of melanoma diagnosis also was compared to the age at which the participants started to tan indoors. Age was divided into those younger than 35 years and those 35 years and older. There was no correlation between the age when indoor tanning began and the time frame in which the melanoma was diagnosed (eTable).

Table 5 shows the correlations between indoor tanning behaviors and melanoma characteristics. Those who started indoor tanning at an earlier age were diagnosed with melanoma at an earlier age compared to those who started indoor tanning later in life (r=0.549; P<.01). Moreover, those who started indoor tanning at a later age reported being diagnosed with a melanoma of greater Breslow depth (r=0.173; P<.01). Those who reported being diagnosed with a greater Breslow depth also reported a higher Clark level (r=0.608; P<.01). Among responders, those who more frequently tanned indoors also reported greater frequency of outdoor tanning (r=0.197; P<.01). This study showed no correlation between the age at melanoma diagnosis and the frequency of indoor (r=0.004; P>.05 not significant) or outdoor (r=0.093; P>.05 not significant) tanning. Having the knowledge of the risk of skin cancer had no relationship on the frequency of indoor tanning (r=−0.04; P>.05 not significant).

 

Comment

Thirty million Americans utilize indoor tanning devices at least once a year.¹³ UVA light comprises the majority of the spectrum used by indoor tanning devices, with a fraction (<5%) being UVB light. Until recently, UVB light was the only solar spectrum considered carcinogenic. In 2009, the International Agency for Research on Cancer classified the whole spectrum as carcinogenic to humans.^5,11 Despite this evidence, indoor tanning facilities have promoted indoor tanning as damage free.³ The goal of this study was to collect the patient perspective on the safety of indoor tanning, indoor tanning behaviors, time frame of onset of melanoma, and the severity (ie, Breslow depth) of those melanomas.

Melanoma is the most prevalent cancer in females aged 25 to 29 years.³ The median age of diagnosis of melanoma (with and without the use of indoor tanning devices) is approximately 60 years¹⁴ versus our study, which found the average age at diagnosis was 37.6 years. Our findings are consistent with other literature in that those who start indoor tanning earlier (<35 years of age) develop melanoma at an earlier age.^14,15 Cust et al¹⁴ also promoted the idea that patients develop melanoma earlier because younger individuals are more biologically susceptible to the carcinogenic effects of artificial UV light. However, our study found that those who started indoor tanning at an older age reported being diagnosed with a melanoma of greater Breslow depth, seemingly incongruent with the aforementioned hypothesis. One limitation is the age range for this research sample (18–69 years). The young age range may be attributable to the recruitment through social media, which is geared toward a younger population. Additionally, indoor tanning is a relatively new phenomenon practiced since the 1980s,² which may contribute to the younger sample size. However, 2.7 billion individuals use social media worldwide with 40% of those older than 65 years on social media.¹⁶

Prior research has shown that those who start indoor tanning before the age of 35 years have a 75% increased risk of developing melanoma.¹⁴ Another study also has suggested that UVA-rich sunlamps may shorten the latency period for induction of melanoma and nonmelanoma skin cancers.³ Our study used similar age cutoffs in concluding that there was no earlier onset of melanoma diagnosis between those who started indoor tanning before the age of 35 years and those who started at the age of 35 years or older. Limitations include that our study is cross-sectional, and therefore time course cannot be established. Also, survey responses were self-reported, allowing the possibility of recall bias.

A plethora of research has been conducted to determine if there is a connection between the use of indoor tanning devices and developing melanoma. Cust et al¹⁴ suggested the risk of melanoma was 41% higher for those who had ever used a sunbed in comparison to those who had not. Other studies describe the difficulty in making the connection between indoor tanning and melanoma, as those who more frequently tan indoors also more frequently tan outdoors,¹¹ as suggested by this study. However, there is a paucity of literature on the patients’ perspectives on the safety of indoor tanning. This study determined that those who more frequently tan indoors believed that indoor tanning is safer than outdoor tanning. With this altered perception promoted by the indoor tanning industry, the FDA has added a warning label to all indoor tanning devices about the risk of skin cancer. Our study revealed that having the knowledge of the risk of skin cancer had no influence on the frequency of indoor tanning. This concerning finding highlights a pressing need for an alternative approach to increase awareness of the harmful consequences that accompany indoor tanning. Further studies may elaborate on potential effective methods and messages to relate to an indoor tanning population comprised mostly of young females.

Acknowledgments
Supported and funded by the Basal Cell Carcinoma Nevus Syndrome Life Support Network. This research project was completed as part of the FIRE Module at the University of Central Florida, College of Medicine. We thank the FIRE Module faculty and staff for their assistance with this project.

The incidence of melanoma is increasing at a rate greater than any other cancer,¹ possibly due to the increasing use of indoor tanning devices. These devices emit unnaturally high levels of UVA and low levels of UVA and UVB rays.² The risks of using these devices include increased incidence of melanoma (3438 cases attributed to indoor tanning in 2008) and keratinocytes cancer (increased risk of squamous cell carcinoma by 67% and basal cell carcinoma by 29%), severe sunburns (61.1% of female users and 44.6% of male users have reported sunburns), and aggravation of underlying disorders such as systemic lupus erythematosus.^3-5

The literature varies in its explanation of how indoor tanning increases the risk of developing melanoma. Some authors suggest it is due to increased frequency of use, duration of sessions, and years of using tanning devices.^1,6 Others suggest the increased cancer risk is the result of starting to tan at an earlier age.^2,3,6-10 There is conflicting literature on the level of increased risk of melanoma in those who tan indoors at a young age (<35 years). Although the estimated rate of increased skin cancer risk varies, with rates up to 75% compared to nonusers, nearly all sources support an increased rate.⁶ Despite the growing body of knowledge that indoor tanning is dangerous, as well as the academic publication of these risks (eg, carcinogenesis, short-term and long-term eye injury, burns, UV sensitivity when combined with certain medications), teenagers in the United States and affluent countries appear to disregard the risks of tanning.¹¹

Tanning companies have promoted the misconception that only UVB rays cause cell damage and UVA rays, which the devices emit, result in “damage-free” or “safe” tans.^2,3 Until 2013, indoor tanning devices were classified by the US Food and Drug Administration (FDA) as class I, indicating that they are safe in terms of electrical shock. Many indoor tanning facilities have promoted the FDA “safe” label without clarifying that the safety indications only referred to electrical-shock potential. Nonetheless, it is known now that these devices, which emit high UVA and low UVB rays, promote melanoma, nonmelanoma skin cancers, and severe sunburns, as well as aggravate existing conditions (eg, systemic lupus erythematosus).⁴ As a result of an unacceptably high incidence of these disease complications, a 2014 FDA regulation categorized tanning beds as class II, requiring that tanning bed users be informed of the risk of skin cancer in an effort to reverse the growing trend of indoor tanning.¹² Despite these regulatory interventions, it is not clear if this knowledge of cancer risk deters patients from indoor tanning.

The purpose of this study was to investigate the patients’ perspective on indoor tanning behaviors as associated with the severity of their melanoma and the time frame in which they were diagnosed as well as their perceived views on the safety of indoor tanning and the frequency in which they continue to tan indoors. This information is highly relevant in helping to determine if requiring a warning of the risk of skin cancer will deter patients from this unhealthy habit, especially given recent reclassification of sunbeds as class II by the FDA. Additional insights from these data may clarify if indoor tanning decreases the time frame in which melanoma is diagnosed or increases the severity of the resulting melanoma. Moreover, it will help elucidate whether or not the age at which indoor tanning is initiated affects the time frame to melanoma onset and corresponding severity.

Methods

An original unvalidated online survey was conducted worldwide via a link distributed to the following supporting institutions: Advanced Dermatology & Cosmetic Surgery, Ameriderm Research, Melanoma Research Foundation (a melanoma patient advocacy group), Florida State University Department of Dermatology, Moffitt Cancer Center Cutaneous Oncology Program, Cleveland Clinic, Ohio State University Division of Medical Oncology, Harvard Medical School Department of Dermatology, The University of Texas MD Anderson Cancer Center Department of Dermatology, University of Colorado Department of Dermatology, and Northwestern University Department of Dermatology. However, there was not confirmation that all of these institutions promoted the survey. Additionally, respondents were recruited through patient advocacy groups and social media sites including Facebook, Twitter, LinkedIn, Tumblr, and Instagram. The patient advocacy groups and social media sites invited participation through recruitment announcements, including DermNetNZ (a global dermatology patient information site), with additional help from the International Federation of Dermatology Clinical Trial Network.

The survey was restricted to those who were self-identified as 18 years or older and who self-reported a diagnosis of melanoma following the use of indoor tanning devices. The survey was hosted by SurveyMonkey, which allowed consent to be obtained and responses to remain anonymous. Access to the survey was sponsored by the Basal Cell Carcinoma Nevus Syndrome Life Support Network. The University of Central Florida (Orlando, Florida) institutional review board reviewed and approved this study as exempt human research.

Survey responses collected from January 2014 to June 2015 were analyzed herein. The survey contained 58 questions and was divided into different topics including indoor tanning background (eg, states/countries in which participants tanned indoors, age when they first tanned, frequency of tanning), consenting process (eg, length, did someone review the consent with participants, what was contained in the consent), indoor tanning and melanoma (eg, how long after tanning did melanoma develop, age at development, location of melanoma), indoor tanning postmelanoma (eg, did participants tan after diagnosis and why), and other risk factors (eg, did participants smoke or drink pre- or postmelanoma).

Statistical Analysis
The data consist of both categorical and continuous variables. The categorical variables included age (<35 years or ≥35 years), frequency of indoor tanning (≤1 time weekly or >1 time weekly), and onset of melanoma diagnosis (within or after 5 years of indoor tanning). The continuous variables consisted of current age, age at start of indoor tanning, age at melanoma diagnosis, Breslow depth, and Clark level. Frequency of indoor tanning and warning of the risk of skin cancer were converted to be used as both categorical and continuous variables. For frequency of indoor tanning, the variables less than or equal to once weekly and more than once weekly were used as categorical variables, whereas less than monthly, 1 time monthly, 4 times monthly, 2 times weekly, and more than 2 times weekly were used as continuous variables. For warning of the risk of skin cancer, no and yes were converted to 0 and 1 for use in the Spearman correlations, which allowed for greater analyses among other variables. Spearman correlation was used to determine if a significant relationship existed among the age at melanoma diagnosis, age at start of indoor tanning, Breslow depth, Clark level, frequency of indoor and outdoor tanning, and knowledge and warning of the risk of skin cancer. All data were analyzed by use of IBM SPSS Statistics (version 21.0).

Difference in proportions among groups, age, frequency of tanning, onset of melanoma diagnosis within or after 5 years of starting indoor tanning, and knowledge of cancer risks was tested for significance using the χ² test. Reported P values were 2-tailed, corresponding with a significance level of P<.05. All data were analyzed using SPSS (version 21.0). All statistical analyses were conducted independent of the participants’ sex.

 

Results

Of the 454 participants who accessed the survey, 448 were analyzed in this study; 6 participants did not complete the questionnaire. Both males and females were analyzed: 289 females, 12 males, and 153 who did not report gender. The age range of participants was 18 to 69 years. The age at start of indoor tanning ranged from 8 to 54 years, with a mean of 22 years. Additional participant characteristics are described in Table 1. The mean frequency of indoor tanning was reported as 2 times weekly. When participants were asked if they were warned of the risk of skin cancer, 21.5% reported yes while 78.4% reported not being told of the risk. This knowledge was compared to their frequency of indoor tanning. Having the knowledge of the risk of skin cancer had no influence on their frequency of indoor tanning (Table 2).

Among responders, those who perceived indoor tanning as safer than outdoor tanning tanned indoors more frequently than those who do not (Spearman r=−0.224; P<.05)(Table 3). The frequency of indoor tanning was divided into those who tanned indoors more than once weekly and those who tanned indoors once a week or less. This study showed that the frequency of indoor tanning had no effect on the latency time between the commencement of indoor tanning and diagnosis of melanoma (Table 4). The time frame from the onset of melanoma diagnosis also was compared to the age at which the participants started to tan indoors. Age was divided into those younger than 35 years and those 35 years and older. There was no correlation between the age when indoor tanning began and the time frame in which the melanoma was diagnosed (eTable).

Table 5 shows the correlations between indoor tanning behaviors and melanoma characteristics. Those who started indoor tanning at an earlier age were diagnosed with melanoma at an earlier age compared to those who started indoor tanning later in life (r=0.549; P<.01). Moreover, those who started indoor tanning at a later age reported being diagnosed with a melanoma of greater Breslow depth (r=0.173; P<.01). Those who reported being diagnosed with a greater Breslow depth also reported a higher Clark level (r=0.608; P<.01). Among responders, those who more frequently tanned indoors also reported greater frequency of outdoor tanning (r=0.197; P<.01). This study showed no correlation between the age at melanoma diagnosis and the frequency of indoor (r=0.004; P>.05 not significant) or outdoor (r=0.093; P>.05 not significant) tanning. Having the knowledge of the risk of skin cancer had no relationship on the frequency of indoor tanning (r=−0.04; P>.05 not significant).

 

Comment

Thirty million Americans utilize indoor tanning devices at least once a year.¹³ UVA light comprises the majority of the spectrum used by indoor tanning devices, with a fraction (<5%) being UVB light. Until recently, UVB light was the only solar spectrum considered carcinogenic. In 2009, the International Agency for Research on Cancer classified the whole spectrum as carcinogenic to humans.^5,11 Despite this evidence, indoor tanning facilities have promoted indoor tanning as damage free.³ The goal of this study was to collect the patient perspective on the safety of indoor tanning, indoor tanning behaviors, time frame of onset of melanoma, and the severity (ie, Breslow depth) of those melanomas.

Melanoma is the most prevalent cancer in females aged 25 to 29 years.³ The median age of diagnosis of melanoma (with and without the use of indoor tanning devices) is approximately 60 years¹⁴ versus our study, which found the average age at diagnosis was 37.6 years. Our findings are consistent with other literature in that those who start indoor tanning earlier (<35 years of age) develop melanoma at an earlier age.^14,15 Cust et al¹⁴ also promoted the idea that patients develop melanoma earlier because younger individuals are more biologically susceptible to the carcinogenic effects of artificial UV light. However, our study found that those who started indoor tanning at an older age reported being diagnosed with a melanoma of greater Breslow depth, seemingly incongruent with the aforementioned hypothesis. One limitation is the age range for this research sample (18–69 years). The young age range may be attributable to the recruitment through social media, which is geared toward a younger population. Additionally, indoor tanning is a relatively new phenomenon practiced since the 1980s,² which may contribute to the younger sample size. However, 2.7 billion individuals use social media worldwide with 40% of those older than 65 years on social media.¹⁶

Prior research has shown that those who start indoor tanning before the age of 35 years have a 75% increased risk of developing melanoma.¹⁴ Another study also has suggested that UVA-rich sunlamps may shorten the latency period for induction of melanoma and nonmelanoma skin cancers.³ Our study used similar age cutoffs in concluding that there was no earlier onset of melanoma diagnosis between those who started indoor tanning before the age of 35 years and those who started at the age of 35 years or older. Limitations include that our study is cross-sectional, and therefore time course cannot be established. Also, survey responses were self-reported, allowing the possibility of recall bias.

A plethora of research has been conducted to determine if there is a connection between the use of indoor tanning devices and developing melanoma. Cust et al¹⁴ suggested the risk of melanoma was 41% higher for those who had ever used a sunbed in comparison to those who had not. Other studies describe the difficulty in making the connection between indoor tanning and melanoma, as those who more frequently tan indoors also more frequently tan outdoors,¹¹ as suggested by this study. However, there is a paucity of literature on the patients’ perspectives on the safety of indoor tanning. This study determined that those who more frequently tan indoors believed that indoor tanning is safer than outdoor tanning. With this altered perception promoted by the indoor tanning industry, the FDA has added a warning label to all indoor tanning devices about the risk of skin cancer. Our study revealed that having the knowledge of the risk of skin cancer had no influence on the frequency of indoor tanning. This concerning finding highlights a pressing need for an alternative approach to increase awareness of the harmful consequences that accompany indoor tanning. Further studies may elaborate on potential effective methods and messages to relate to an indoor tanning population comprised mostly of young females.

Acknowledgments
Supported and funded by the Basal Cell Carcinoma Nevus Syndrome Life Support Network. This research project was completed as part of the FIRE Module at the University of Central Florida, College of Medicine. We thank the FIRE Module faculty and staff for their assistance with this project.

Take-Home Points

• Suture augmentation improves construct strength for patella fixation.
• Krackow sutures may be placed in the quadriceps and patella tendons, then secured over the anterior patella (much like an anterior tension band).
• The Krackow technique described was superior to the suture cerclage technique based on mean load values, but did not reach statistical significance.
• The Krackow suture technique is a viable and easily applied technique for suture augmentation of patella fixation constructs.

Patella fractures are relatively uncommon, accounting for only 1% of skeletal injuries.¹ Restoration of the function of the patella and the extensor mechanism is vital for knee extension and gait. However, patella fractures have an inherently high rate of complications, making these injuries challenging to treat.^2-4 In patients with intact extensor function, displacement of <4 mm, and articular step-off of <3 mm, nonoperative management is extremely effective, with 99% of patients reporting favorable results.⁵ However, for fractures in which the extensor mechanism is disrupted, surgical intervention typically is indicated.⁶

Authors have reported various surgical interventions, one of the most commonly used being the anterior tension band (ATB) technique, first described by the AO (Arbeitsgemeinschaft für Osteosynthesefragen) group in the 1950s.⁷ By converting distractive anterior force during knee flexion to compressive force at the fracture site, the ATB technique provides a repair stronger than the previously used cerclage repair.⁸ Although initially considered standard of care, the ATB technique was soon found to be associated with implant failure and subcutaneous irritation prompting implant removal.⁹

To address these issues, Berg¹⁰ and Carpenter and colleagues¹¹ evaluated an ATB technique that used cannulated screws instead of Kirschner wires (K-wires). This variation on the ATB technique reduced the implant-related issues while maintaining the mechanical advantage of the tension band. The more rigid design also permitted earlier postoperative rehabilitation, which significantly reduced development of arthrofibrosis.^6,7,10 This modified ATB (MATB) technique has since been investigated for additional augments, mainly focusing on use of different tension band materials, including polyester suture and braided composite suture.^12-14

However, there is little research on augments that incorporate the surrounding soft tissue, specifically the quadriceps and patellar tendons. In a recent retrospective clinical study, Oh and colleagues¹⁵ found positive clinical results with use of Krackow sutures, though 2 or 3 vertically oriented stainless steel wires were used instead of cannulated screws.

We conducted a study to determine the biomechanical efficacy of using a cerclage suture augment and a Krackow suture augment coupled with and compared with conventional MATB repair. If effective, this technique may represent another strategy for increasing repair strength and thereby improve postoperative outcomes.

 

 

Materials and Methods

Specimen Preparation

Fresh-frozen cadaver extensor mechanisms (quadriceps tendon, patella, surrounding retinaculum, patellar tendon) were kept frozen at –4°C until preparation. Fifteen specimens were selected. Mean (SD) age at death was 68 (10) years (range, 51-85 years). One specimen was excluded for a short patella tendon, which precluded adequate attachment for testing. All specimens were free of overt osseous pathology.

After specimens were thawed overnight, the patellae were transversely osteotomized with an osteotome at the junction of the middle and distal thirds of the patella. Sharp dissection was performed to carry the division through the medial and lateral retinaculum at the same level. All 14 specimens were then repaired using the MATB technique. First, the transverse fracture was reduced with a reduction clamp. Then, two 4-mm cannulated screws (DePuy Synthes) were inserted parallel to each other and perpendicular to the fracture. An 18-gauge stainless steel wire was then passed through each screw, crossed anteriorly, and tightened to create a figure-of-8 ATB. The specimens were then randomly divided into 3 groups—MATB; MATB with cerclage suture augment; MATB with Krackow suture augment—while ensuring specimens from a single cadaver were placed in different groups to avoid confounding based on bone density differences.

A braided composite suture (No. 5 FiberWire; Arthrex) was used for the cerclage augment on 4 specimens, and a Krackow augment was used for 5 specimens (Figures 1A-1C). The cerclage augment was placed by circumferentially passing the suture at 8 points in the surrounding retinaculum. For the Krackow augment, 4 locking passes were made on both the medial and the lateral sides of the quadriceps and patella tendon, yielding a total of 4 free suture ends (Figure 2). Free ends were then crossed anteriorly in a fashion similar to that used for the 18-gauge wires and tied. Last, overlying subcutaneous tissue and paratenon were stripped from the quadriceps and patellar tendons to maximize friction during clamping for testing. After completion of all repairs, specimens were biomechanically tested.

Experimental Setup

Repaired specimens were secured with tissue clamps at the quadriceps and patellar tendons on an MTS Bionix 858 (MTS Systems) hydraulic arm.

Anatomical conditions were simulated by using a bracket to connect a distal femur sawbone model to the MTS machine and orienting the model on the posterior surface of the patella to produce a flexion angle of 45° (Figure 3), which maximizes tensile forces.¹⁶

Each patella was secured for cyclic testing. Initially it was placed under 10 N of tension. Then it underwent tensile loading from 10 N to 300 N at 50 N/s for 10 cycles. These parameters were based on previous biomechanical patella studies.^10,11 Load was measured with the MTS load cell and displacement with the displacement transducer. Fracture displacement associated with 300-N cyclic tension was recorded. Displacement was calculated as the difference between 10th cycle and 2nd cycle values, which accounted for any degree of initial tissue slippage. After cyclic testing, the patella was placed back in 10 N of tensile loading and subjected to maximum force loading to determine ultimate repair strength. For maximum loading, the patella was stretched progressively at 50 N/s until failure. Again, load and displacement were measured with MTS.

Statistical Analysis

After testing, fracture displacement and maximum load force data were compiled for analysis. One-way analysis of variance with Bonferroni correction was used to determine if there were significant differences between groups. Significance level was set at P < .05.

 

 

Results

For cyclic testing, mean total displacement was measured over 10 cycles for each group. Again, displacement was determined by taking the difference between 10th cycle and 2nd cycle values, allowing for system stabilization.

Mean (SD) displacement was 3.57 (1.63) mm with MATB repair, 2.50 (0.80) mm with cerclage augment repair, and 2.17 (0.77) mm with Krackow augment repair (Figure 4). Among all specimens, displacement followed a hyperbolic arrangement, with the majority of total displacement occurring during initial cycles and tapering off during later cycles (Figure 5). Mean displacement was 30% lower with cerclage repair (vs MATB repair) and 40% lower with Krackow repair (vs MATB repair). However, this trend was not statistically significant (P > .05), owing to sample size and presence of an outlier in all 3 groups.

After cyclic loading, load-to-failure testing was performed by applying increasing tension until repair failure. None of our 14 specimens showed significant failure after cyclic testing, so all were subjected to load-to-failure testing. Mean (SD) maximum tension force was found to be 753 (16) N for MATB, 793 (177) N for cerclage, and 863 (104) N for Krackow (Figure 6). Similar to the cyclic testing findings, maximum load strength was 5% higher with cerclage repair (vs MATB repair) and 14% higher with Krackow repair (vs MATB repair). Again, with the small sample size and the presence of outliers (and other variation among data), the trend was not statistically significant (P > .05). In addition, pairwise comparisons of the 3 groups revealed no statistically significant differences.

Discussion

Our main objective was to compare the efficacy of a novel suture augment technique with that of other patella fracture repair techniques. Our hypothesis—that adding a Krackow suture augment would increase strength in both cyclic and maximum loading—was supported. Although testing results were not statistically significant because of the small sample size, we think this novel technique has clinically relevant descriptive significance and warrants further investigation.

Proper anatomical reduction and postoperative stabilization are of utmost importance in clinical approaches to patella fractures. In addition, regardless of which technical procedure is used, open reduction should also allow for early range of motion to prevent joint arthrofibrosis. Ever since the ATB technique was first described by the AO group, postoperative outcomes have improved significantly. In a retrospective study by Levack and colleagues,¹⁷ 30 of 64 patients with patella fractures underwent internal fixation. Mean follow-up was 6.2 years. By both objective and subjective measures, the best functional outcomes were associated with internal tension band fixation (vs cerclage repair). Lotke and Ecker¹⁸ also documented the efficacy of the tension band technique. Sixteen patients with patella fractures underwent anterior tension banding; those with a comminuted fracture also underwent cerclage repair for patella stabilization during tension banding. At 6-week follow-up, all patients had good range of motion (≥90° flexion), relatively few symptoms, and no implant failures. Results were similar to those of Levack and colleagues.¹⁷

Although it improves stability and functional outcomes over conventional patellectomy and cerclage wiring, the ATB technique has been associated with subcutaneous irritation caused by the K-wires used to secure the band. Hung and colleagues⁹ followed up 68 patients with patellar fractures. Five of these patients underwent tension banding. Although there was a high level of adequate functional outcomes, implant irritation was found to be “quite frequent.”

To address this issue, Carpenter and colleagues¹¹ evaluated an ATB technique that uses K-wires instead of cannulated screws. Biomechanical testing in a cadaver model revealed less fracture displacement and overall more repair strength through cyclic and maximum load testing. Clinically, these results were supported by Berg,¹⁰ who followed up 10 patients with transverse patella fractures repaired with the MATB technique. At a mean follow-up of 24 months, 7 of the 10 patients had good to excellent outcomes, and there were no implant failures.

 

Further investigation into patella repairs has mainly focused on improving the MATB technique and experimenting with different tension band materials. Rabalais and colleagues¹³ biomechanically tested high-strength polyethylene suture as a replacement for standard 18-gauge wire, and Bryant and colleagues¹⁴ tested a braided composite suture (FiberWire; Arthrex) as a replacement for standard 18-gauge stainless steel wire. Both found no significant difference with use of augmented tension band material, but Rabalais and colleagues¹³ did find more advantages with a parallel tension band construct than with a standard figure-of-8 arrangement.

In developing our novel technique, we considered that Krackow sutures are routinely used in both quadriceps tendon repair and patellar tendon repair, including partial patellectomy for distal patella fracture. With a suture placed in both tendons, the augment could be expected to resist longitudinal gapping and augment the tension band across the anterior patella. First described by Krackow and colleagues,¹⁹ the Krackow suture is widely used for tendon reconstruction. In an interlocking system of sutures, the Krackow suture provides a repair that is more stable than repair with conventional suture techniques, specifically in the context of tendon repair.²⁰ Given the sesamoidal nature of the patella, its repair shares the goal of gap prevention with other tendon repairs. In theory, anchoring the supporting structures that are above and below the patella provides support for the intervening patella and ultimately improves fracture fixation strength.

Oh and colleagues¹⁵ reported on the clinical efficacy of a Krackow augment in distal pole patella repairs. Similarly, we found a Krackow augment to be efficacious, supporting its potential in clinical approaches to patella repairs. Our results indicate this augment can be a useful clinical adjunct in biomechanical evaluation. 

Limitations of this study include its use of dissected extensor mechanisms, which may have less biofidelity than whole-knee specimens. In our model, specimens were secured at the patellar tendon and the quadriceps tendons, as opposed to the quadriceps tendon and the tibia distally. Use of this model could have led to an increase in early displacement during cyclic testing as a result of tissue slippage. Furthermore, our small sample size could have affected our ability to demonstrate a difference between these techniques.

Given its increased strength as demonstrated by mean displacement during cyclic loading and mean load to failure, as well as the early clinical data recently published, the Krackow suture augment represents a feasible technique for patella fixation. It likely will be most useful in cases in which conventional techniques are prone to failure or cannot be applied, such as severe distal comminution or poor bone density. Further biomechanical testing with a larger number of specimens may be required for statistical significance.

Conclusion

In patella fracture repair strategies, the Krackow suture augment increased strength when used with a MATB technique. Failure to reach statistical significance likely resulted from our small sample size. Further biomechanical testing and clinical studies are needed for more complete evaluation of this technique. We think it will be most useful in the setting of poor bone quality or severe comminution, which can limit fixation options. As increased repair strength allows earlier postoperative rehabilitation and maintains fracture reduction, patient outcomes should improve. This novel technique represents another strategy for managing challenging patella fractures.

Take-Home Points

• Suture augmentation improves construct strength for patella fixation.
• Krackow sutures may be placed in the quadriceps and patella tendons, then secured over the anterior patella (much like an anterior tension band).
• The Krackow technique described was superior to the suture cerclage technique based on mean load values, but did not reach statistical significance.
• The Krackow suture technique is a viable and easily applied technique for suture augmentation of patella fixation constructs.

Patella fractures are relatively uncommon, accounting for only 1% of skeletal injuries.¹ Restoration of the function of the patella and the extensor mechanism is vital for knee extension and gait. However, patella fractures have an inherently high rate of complications, making these injuries challenging to treat.^2-4 In patients with intact extensor function, displacement of <4 mm, and articular step-off of <3 mm, nonoperative management is extremely effective, with 99% of patients reporting favorable results.⁵ However, for fractures in which the extensor mechanism is disrupted, surgical intervention typically is indicated.⁶

Authors have reported various surgical interventions, one of the most commonly used being the anterior tension band (ATB) technique, first described by the AO (Arbeitsgemeinschaft für Osteosynthesefragen) group in the 1950s.⁷ By converting distractive anterior force during knee flexion to compressive force at the fracture site, the ATB technique provides a repair stronger than the previously used cerclage repair.⁸ Although initially considered standard of care, the ATB technique was soon found to be associated with implant failure and subcutaneous irritation prompting implant removal.⁹

To address these issues, Berg¹⁰ and Carpenter and colleagues¹¹ evaluated an ATB technique that used cannulated screws instead of Kirschner wires (K-wires). This variation on the ATB technique reduced the implant-related issues while maintaining the mechanical advantage of the tension band. The more rigid design also permitted earlier postoperative rehabilitation, which significantly reduced development of arthrofibrosis.^6,7,10 This modified ATB (MATB) technique has since been investigated for additional augments, mainly focusing on use of different tension band materials, including polyester suture and braided composite suture.^12-14

However, there is little research on augments that incorporate the surrounding soft tissue, specifically the quadriceps and patellar tendons. In a recent retrospective clinical study, Oh and colleagues¹⁵ found positive clinical results with use of Krackow sutures, though 2 or 3 vertically oriented stainless steel wires were used instead of cannulated screws.

We conducted a study to determine the biomechanical efficacy of using a cerclage suture augment and a Krackow suture augment coupled with and compared with conventional MATB repair. If effective, this technique may represent another strategy for increasing repair strength and thereby improve postoperative outcomes.

 

 

Materials and Methods

Specimen Preparation

Fresh-frozen cadaver extensor mechanisms (quadriceps tendon, patella, surrounding retinaculum, patellar tendon) were kept frozen at –4°C until preparation. Fifteen specimens were selected. Mean (SD) age at death was 68 (10) years (range, 51-85 years). One specimen was excluded for a short patella tendon, which precluded adequate attachment for testing. All specimens were free of overt osseous pathology.

After specimens were thawed overnight, the patellae were transversely osteotomized with an osteotome at the junction of the middle and distal thirds of the patella. Sharp dissection was performed to carry the division through the medial and lateral retinaculum at the same level. All 14 specimens were then repaired using the MATB technique. First, the transverse fracture was reduced with a reduction clamp. Then, two 4-mm cannulated screws (DePuy Synthes) were inserted parallel to each other and perpendicular to the fracture. An 18-gauge stainless steel wire was then passed through each screw, crossed anteriorly, and tightened to create a figure-of-8 ATB. The specimens were then randomly divided into 3 groups—MATB; MATB with cerclage suture augment; MATB with Krackow suture augment—while ensuring specimens from a single cadaver were placed in different groups to avoid confounding based on bone density differences.

A braided composite suture (No. 5 FiberWire; Arthrex) was used for the cerclage augment on 4 specimens, and a Krackow augment was used for 5 specimens (Figures 1A-1C). The cerclage augment was placed by circumferentially passing the suture at 8 points in the surrounding retinaculum. For the Krackow augment, 4 locking passes were made on both the medial and the lateral sides of the quadriceps and patella tendon, yielding a total of 4 free suture ends (Figure 2). Free ends were then crossed anteriorly in a fashion similar to that used for the 18-gauge wires and tied. Last, overlying subcutaneous tissue and paratenon were stripped from the quadriceps and patellar tendons to maximize friction during clamping for testing. After completion of all repairs, specimens were biomechanically tested.

Experimental Setup

Repaired specimens were secured with tissue clamps at the quadriceps and patellar tendons on an MTS Bionix 858 (MTS Systems) hydraulic arm.

Anatomical conditions were simulated by using a bracket to connect a distal femur sawbone model to the MTS machine and orienting the model on the posterior surface of the patella to produce a flexion angle of 45° (Figure 3), which maximizes tensile forces.¹⁶

Each patella was secured for cyclic testing. Initially it was placed under 10 N of tension. Then it underwent tensile loading from 10 N to 300 N at 50 N/s for 10 cycles. These parameters were based on previous biomechanical patella studies.^10,11 Load was measured with the MTS load cell and displacement with the displacement transducer. Fracture displacement associated with 300-N cyclic tension was recorded. Displacement was calculated as the difference between 10th cycle and 2nd cycle values, which accounted for any degree of initial tissue slippage. After cyclic testing, the patella was placed back in 10 N of tensile loading and subjected to maximum force loading to determine ultimate repair strength. For maximum loading, the patella was stretched progressively at 50 N/s until failure. Again, load and displacement were measured with MTS.

Statistical Analysis

After testing, fracture displacement and maximum load force data were compiled for analysis. One-way analysis of variance with Bonferroni correction was used to determine if there were significant differences between groups. Significance level was set at P < .05.

 

 

Results

For cyclic testing, mean total displacement was measured over 10 cycles for each group. Again, displacement was determined by taking the difference between 10th cycle and 2nd cycle values, allowing for system stabilization.

Mean (SD) displacement was 3.57 (1.63) mm with MATB repair, 2.50 (0.80) mm with cerclage augment repair, and 2.17 (0.77) mm with Krackow augment repair (Figure 4). Among all specimens, displacement followed a hyperbolic arrangement, with the majority of total displacement occurring during initial cycles and tapering off during later cycles (Figure 5). Mean displacement was 30% lower with cerclage repair (vs MATB repair) and 40% lower with Krackow repair (vs MATB repair). However, this trend was not statistically significant (P > .05), owing to sample size and presence of an outlier in all 3 groups.

After cyclic loading, load-to-failure testing was performed by applying increasing tension until repair failure. None of our 14 specimens showed significant failure after cyclic testing, so all were subjected to load-to-failure testing. Mean (SD) maximum tension force was found to be 753 (16) N for MATB, 793 (177) N for cerclage, and 863 (104) N for Krackow (Figure 6). Similar to the cyclic testing findings, maximum load strength was 5% higher with cerclage repair (vs MATB repair) and 14% higher with Krackow repair (vs MATB repair). Again, with the small sample size and the presence of outliers (and other variation among data), the trend was not statistically significant (P > .05). In addition, pairwise comparisons of the 3 groups revealed no statistically significant differences.

Discussion

Our main objective was to compare the efficacy of a novel suture augment technique with that of other patella fracture repair techniques. Our hypothesis—that adding a Krackow suture augment would increase strength in both cyclic and maximum loading—was supported. Although testing results were not statistically significant because of the small sample size, we think this novel technique has clinically relevant descriptive significance and warrants further investigation.

Proper anatomical reduction and postoperative stabilization are of utmost importance in clinical approaches to patella fractures. In addition, regardless of which technical procedure is used, open reduction should also allow for early range of motion to prevent joint arthrofibrosis. Ever since the ATB technique was first described by the AO group, postoperative outcomes have improved significantly. In a retrospective study by Levack and colleagues,¹⁷ 30 of 64 patients with patella fractures underwent internal fixation. Mean follow-up was 6.2 years. By both objective and subjective measures, the best functional outcomes were associated with internal tension band fixation (vs cerclage repair). Lotke and Ecker¹⁸ also documented the efficacy of the tension band technique. Sixteen patients with patella fractures underwent anterior tension banding; those with a comminuted fracture also underwent cerclage repair for patella stabilization during tension banding. At 6-week follow-up, all patients had good range of motion (≥90° flexion), relatively few symptoms, and no implant failures. Results were similar to those of Levack and colleagues.¹⁷

Although it improves stability and functional outcomes over conventional patellectomy and cerclage wiring, the ATB technique has been associated with subcutaneous irritation caused by the K-wires used to secure the band. Hung and colleagues⁹ followed up 68 patients with patellar fractures. Five of these patients underwent tension banding. Although there was a high level of adequate functional outcomes, implant irritation was found to be “quite frequent.”

To address this issue, Carpenter and colleagues¹¹ evaluated an ATB technique that uses K-wires instead of cannulated screws. Biomechanical testing in a cadaver model revealed less fracture displacement and overall more repair strength through cyclic and maximum load testing. Clinically, these results were supported by Berg,¹⁰ who followed up 10 patients with transverse patella fractures repaired with the MATB technique. At a mean follow-up of 24 months, 7 of the 10 patients had good to excellent outcomes, and there were no implant failures.

 

Further investigation into patella repairs has mainly focused on improving the MATB technique and experimenting with different tension band materials. Rabalais and colleagues¹³ biomechanically tested high-strength polyethylene suture as a replacement for standard 18-gauge wire, and Bryant and colleagues¹⁴ tested a braided composite suture (FiberWire; Arthrex) as a replacement for standard 18-gauge stainless steel wire. Both found no significant difference with use of augmented tension band material, but Rabalais and colleagues¹³ did find more advantages with a parallel tension band construct than with a standard figure-of-8 arrangement.

In developing our novel technique, we considered that Krackow sutures are routinely used in both quadriceps tendon repair and patellar tendon repair, including partial patellectomy for distal patella fracture. With a suture placed in both tendons, the augment could be expected to resist longitudinal gapping and augment the tension band across the anterior patella. First described by Krackow and colleagues,¹⁹ the Krackow suture is widely used for tendon reconstruction. In an interlocking system of sutures, the Krackow suture provides a repair that is more stable than repair with conventional suture techniques, specifically in the context of tendon repair.²⁰ Given the sesamoidal nature of the patella, its repair shares the goal of gap prevention with other tendon repairs. In theory, anchoring the supporting structures that are above and below the patella provides support for the intervening patella and ultimately improves fracture fixation strength.

Oh and colleagues¹⁵ reported on the clinical efficacy of a Krackow augment in distal pole patella repairs. Similarly, we found a Krackow augment to be efficacious, supporting its potential in clinical approaches to patella repairs. Our results indicate this augment can be a useful clinical adjunct in biomechanical evaluation. 

Limitations of this study include its use of dissected extensor mechanisms, which may have less biofidelity than whole-knee specimens. In our model, specimens were secured at the patellar tendon and the quadriceps tendons, as opposed to the quadriceps tendon and the tibia distally. Use of this model could have led to an increase in early displacement during cyclic testing as a result of tissue slippage. Furthermore, our small sample size could have affected our ability to demonstrate a difference between these techniques.

Given its increased strength as demonstrated by mean displacement during cyclic loading and mean load to failure, as well as the early clinical data recently published, the Krackow suture augment represents a feasible technique for patella fixation. It likely will be most useful in cases in which conventional techniques are prone to failure or cannot be applied, such as severe distal comminution or poor bone density. Further biomechanical testing with a larger number of specimens may be required for statistical significance.

Conclusion

In patella fracture repair strategies, the Krackow suture augment increased strength when used with a MATB technique. Failure to reach statistical significance likely resulted from our small sample size. Further biomechanical testing and clinical studies are needed for more complete evaluation of this technique. We think it will be most useful in the setting of poor bone quality or severe comminution, which can limit fixation options. As increased repair strength allows earlier postoperative rehabilitation and maintains fracture reduction, patient outcomes should improve. This novel technique represents another strategy for managing challenging patella fractures.

Take-Home Points

• Suture augmentation improves construct strength for patella fixation.
• Krackow sutures may be placed in the quadriceps and patella tendons, then secured over the anterior patella (much like an anterior tension band).
• The Krackow technique described was superior to the suture cerclage technique based on mean load values, but did not reach statistical significance.
• The Krackow suture technique is a viable and easily applied technique for suture augmentation of patella fixation constructs.

Patella fractures are relatively uncommon, accounting for only 1% of skeletal injuries.¹ Restoration of the function of the patella and the extensor mechanism is vital for knee extension and gait. However, patella fractures have an inherently high rate of complications, making these injuries challenging to treat.^2-4 In patients with intact extensor function, displacement of <4 mm, and articular step-off of <3 mm, nonoperative management is extremely effective, with 99% of patients reporting favorable results.⁵ However, for fractures in which the extensor mechanism is disrupted, surgical intervention typically is indicated.⁶

Authors have reported various surgical interventions, one of the most commonly used being the anterior tension band (ATB) technique, first described by the AO (Arbeitsgemeinschaft für Osteosynthesefragen) group in the 1950s.⁷ By converting distractive anterior force during knee flexion to compressive force at the fracture site, the ATB technique provides a repair stronger than the previously used cerclage repair.⁸ Although initially considered standard of care, the ATB technique was soon found to be associated with implant failure and subcutaneous irritation prompting implant removal.⁹

To address these issues, Berg¹⁰ and Carpenter and colleagues¹¹ evaluated an ATB technique that used cannulated screws instead of Kirschner wires (K-wires). This variation on the ATB technique reduced the implant-related issues while maintaining the mechanical advantage of the tension band. The more rigid design also permitted earlier postoperative rehabilitation, which significantly reduced development of arthrofibrosis.^6,7,10 This modified ATB (MATB) technique has since been investigated for additional augments, mainly focusing on use of different tension band materials, including polyester suture and braided composite suture.^12-14

However, there is little research on augments that incorporate the surrounding soft tissue, specifically the quadriceps and patellar tendons. In a recent retrospective clinical study, Oh and colleagues¹⁵ found positive clinical results with use of Krackow sutures, though 2 or 3 vertically oriented stainless steel wires were used instead of cannulated screws.

We conducted a study to determine the biomechanical efficacy of using a cerclage suture augment and a Krackow suture augment coupled with and compared with conventional MATB repair. If effective, this technique may represent another strategy for increasing repair strength and thereby improve postoperative outcomes.

 

 

Materials and Methods

Specimen Preparation

Fresh-frozen cadaver extensor mechanisms (quadriceps tendon, patella, surrounding retinaculum, patellar tendon) were kept frozen at –4°C until preparation. Fifteen specimens were selected. Mean (SD) age at death was 68 (10) years (range, 51-85 years). One specimen was excluded for a short patella tendon, which precluded adequate attachment for testing. All specimens were free of overt osseous pathology.

After specimens were thawed overnight, the patellae were transversely osteotomized with an osteotome at the junction of the middle and distal thirds of the patella. Sharp dissection was performed to carry the division through the medial and lateral retinaculum at the same level. All 14 specimens were then repaired using the MATB technique. First, the transverse fracture was reduced with a reduction clamp. Then, two 4-mm cannulated screws (DePuy Synthes) were inserted parallel to each other and perpendicular to the fracture. An 18-gauge stainless steel wire was then passed through each screw, crossed anteriorly, and tightened to create a figure-of-8 ATB. The specimens were then randomly divided into 3 groups—MATB; MATB with cerclage suture augment; MATB with Krackow suture augment—while ensuring specimens from a single cadaver were placed in different groups to avoid confounding based on bone density differences.

A braided composite suture (No. 5 FiberWire; Arthrex) was used for the cerclage augment on 4 specimens, and a Krackow augment was used for 5 specimens (Figures 1A-1C). The cerclage augment was placed by circumferentially passing the suture at 8 points in the surrounding retinaculum. For the Krackow augment, 4 locking passes were made on both the medial and the lateral sides of the quadriceps and patella tendon, yielding a total of 4 free suture ends (Figure 2). Free ends were then crossed anteriorly in a fashion similar to that used for the 18-gauge wires and tied. Last, overlying subcutaneous tissue and paratenon were stripped from the quadriceps and patellar tendons to maximize friction during clamping for testing. After completion of all repairs, specimens were biomechanically tested.

Experimental Setup

Repaired specimens were secured with tissue clamps at the quadriceps and patellar tendons on an MTS Bionix 858 (MTS Systems) hydraulic arm.

Anatomical conditions were simulated by using a bracket to connect a distal femur sawbone model to the MTS machine and orienting the model on the posterior surface of the patella to produce a flexion angle of 45° (Figure 3), which maximizes tensile forces.¹⁶

Each patella was secured for cyclic testing. Initially it was placed under 10 N of tension. Then it underwent tensile loading from 10 N to 300 N at 50 N/s for 10 cycles. These parameters were based on previous biomechanical patella studies.^10,11 Load was measured with the MTS load cell and displacement with the displacement transducer. Fracture displacement associated with 300-N cyclic tension was recorded. Displacement was calculated as the difference between 10th cycle and 2nd cycle values, which accounted for any degree of initial tissue slippage. After cyclic testing, the patella was placed back in 10 N of tensile loading and subjected to maximum force loading to determine ultimate repair strength. For maximum loading, the patella was stretched progressively at 50 N/s until failure. Again, load and displacement were measured with MTS.

Statistical Analysis

After testing, fracture displacement and maximum load force data were compiled for analysis. One-way analysis of variance with Bonferroni correction was used to determine if there were significant differences between groups. Significance level was set at P < .05.

 

 

Results

For cyclic testing, mean total displacement was measured over 10 cycles for each group. Again, displacement was determined by taking the difference between 10th cycle and 2nd cycle values, allowing for system stabilization.

Mean (SD) displacement was 3.57 (1.63) mm with MATB repair, 2.50 (0.80) mm with cerclage augment repair, and 2.17 (0.77) mm with Krackow augment repair (Figure 4). Among all specimens, displacement followed a hyperbolic arrangement, with the majority of total displacement occurring during initial cycles and tapering off during later cycles (Figure 5). Mean displacement was 30% lower with cerclage repair (vs MATB repair) and 40% lower with Krackow repair (vs MATB repair). However, this trend was not statistically significant (P > .05), owing to sample size and presence of an outlier in all 3 groups.

After cyclic loading, load-to-failure testing was performed by applying increasing tension until repair failure. None of our 14 specimens showed significant failure after cyclic testing, so all were subjected to load-to-failure testing. Mean (SD) maximum tension force was found to be 753 (16) N for MATB, 793 (177) N for cerclage, and 863 (104) N for Krackow (Figure 6). Similar to the cyclic testing findings, maximum load strength was 5% higher with cerclage repair (vs MATB repair) and 14% higher with Krackow repair (vs MATB repair). Again, with the small sample size and the presence of outliers (and other variation among data), the trend was not statistically significant (P > .05). In addition, pairwise comparisons of the 3 groups revealed no statistically significant differences.

Discussion

Our main objective was to compare the efficacy of a novel suture augment technique with that of other patella fracture repair techniques. Our hypothesis—that adding a Krackow suture augment would increase strength in both cyclic and maximum loading—was supported. Although testing results were not statistically significant because of the small sample size, we think this novel technique has clinically relevant descriptive significance and warrants further investigation.

Proper anatomical reduction and postoperative stabilization are of utmost importance in clinical approaches to patella fractures. In addition, regardless of which technical procedure is used, open reduction should also allow for early range of motion to prevent joint arthrofibrosis. Ever since the ATB technique was first described by the AO group, postoperative outcomes have improved significantly. In a retrospective study by Levack and colleagues,¹⁷ 30 of 64 patients with patella fractures underwent internal fixation. Mean follow-up was 6.2 years. By both objective and subjective measures, the best functional outcomes were associated with internal tension band fixation (vs cerclage repair). Lotke and Ecker¹⁸ also documented the efficacy of the tension band technique. Sixteen patients with patella fractures underwent anterior tension banding; those with a comminuted fracture also underwent cerclage repair for patella stabilization during tension banding. At 6-week follow-up, all patients had good range of motion (≥90° flexion), relatively few symptoms, and no implant failures. Results were similar to those of Levack and colleagues.¹⁷

Although it improves stability and functional outcomes over conventional patellectomy and cerclage wiring, the ATB technique has been associated with subcutaneous irritation caused by the K-wires used to secure the band. Hung and colleagues⁹ followed up 68 patients with patellar fractures. Five of these patients underwent tension banding. Although there was a high level of adequate functional outcomes, implant irritation was found to be “quite frequent.”

To address this issue, Carpenter and colleagues¹¹ evaluated an ATB technique that uses K-wires instead of cannulated screws. Biomechanical testing in a cadaver model revealed less fracture displacement and overall more repair strength through cyclic and maximum load testing. Clinically, these results were supported by Berg,¹⁰ who followed up 10 patients with transverse patella fractures repaired with the MATB technique. At a mean follow-up of 24 months, 7 of the 10 patients had good to excellent outcomes, and there were no implant failures.

 

Further investigation into patella repairs has mainly focused on improving the MATB technique and experimenting with different tension band materials. Rabalais and colleagues¹³ biomechanically tested high-strength polyethylene suture as a replacement for standard 18-gauge wire, and Bryant and colleagues¹⁴ tested a braided composite suture (FiberWire; Arthrex) as a replacement for standard 18-gauge stainless steel wire. Both found no significant difference with use of augmented tension band material, but Rabalais and colleagues¹³ did find more advantages with a parallel tension band construct than with a standard figure-of-8 arrangement.

In developing our novel technique, we considered that Krackow sutures are routinely used in both quadriceps tendon repair and patellar tendon repair, including partial patellectomy for distal patella fracture. With a suture placed in both tendons, the augment could be expected to resist longitudinal gapping and augment the tension band across the anterior patella. First described by Krackow and colleagues,¹⁹ the Krackow suture is widely used for tendon reconstruction. In an interlocking system of sutures, the Krackow suture provides a repair that is more stable than repair with conventional suture techniques, specifically in the context of tendon repair.²⁰ Given the sesamoidal nature of the patella, its repair shares the goal of gap prevention with other tendon repairs. In theory, anchoring the supporting structures that are above and below the patella provides support for the intervening patella and ultimately improves fracture fixation strength.

Oh and colleagues¹⁵ reported on the clinical efficacy of a Krackow augment in distal pole patella repairs. Similarly, we found a Krackow augment to be efficacious, supporting its potential in clinical approaches to patella repairs. Our results indicate this augment can be a useful clinical adjunct in biomechanical evaluation. 

Limitations of this study include its use of dissected extensor mechanisms, which may have less biofidelity than whole-knee specimens. In our model, specimens were secured at the patellar tendon and the quadriceps tendons, as opposed to the quadriceps tendon and the tibia distally. Use of this model could have led to an increase in early displacement during cyclic testing as a result of tissue slippage. Furthermore, our small sample size could have affected our ability to demonstrate a difference between these techniques.

Given its increased strength as demonstrated by mean displacement during cyclic loading and mean load to failure, as well as the early clinical data recently published, the Krackow suture augment represents a feasible technique for patella fixation. It likely will be most useful in cases in which conventional techniques are prone to failure or cannot be applied, such as severe distal comminution or poor bone density. Further biomechanical testing with a larger number of specimens may be required for statistical significance.

Conclusion

In patella fracture repair strategies, the Krackow suture augment increased strength when used with a MATB technique. Failure to reach statistical significance likely resulted from our small sample size. Further biomechanical testing and clinical studies are needed for more complete evaluation of this technique. We think it will be most useful in the setting of poor bone quality or severe comminution, which can limit fixation options. As increased repair strength allows earlier postoperative rehabilitation and maintains fracture reduction, patient outcomes should improve. This novel technique represents another strategy for managing challenging patella fractures.

Over 90% of children with chronic diseases now survive into adulthood.^1,2 Clinical advances overcoming diseases previously fatal in childhood create new challenges for health systems with limited capacity to manage young adults with complicated and unfamiliar childhood-onset conditions. Consequently, improving the transition from pediatric to adult-oriented care has become a national priority.

Although major pediatric-adult transition initiatives—such as the Six Core Elements Framework,³ a technical brief from the Agency for Healthcare Research and Quality,⁴ and joint statements from major medical societies^5,6—outline key transition recommendations generally and for outpatients, they contain limited or no guidance specifically devoted to transitioning inpatient hospital care from pediatric to adult-oriented settings. Key unknowns include whether, when, and how to transition inpatient care from children’s to nonchildren’s hospitals and how this can be integrated into comprehensive youth-adult transition care.

Nevertheless, the number of discharges of 18- to 21-year-old patients with chronic conditions admitted to children’s hospitals is increasing at a faster rate than discharges of other age groups,⁷ suggesting both that the population is growing in size and that there are important barriers to transitioning these patients into nonchildren’s hospital settings. Spending on adult patients 18 years or older admitted to children’s hospitals has grown to $1 billion annually.⁸ Hospitalizations are a commonly proposed outcome measure of pediatric-adult transition work.^1,9,10 For example, higher rates of avoidable hospitalizations during early adulthood have been observed for 15- to 22-year-olds with kidney failure cared for exclusively in adult-oriented facilities and during the years immediately after transfer to adult care.¹¹

While research is beginning to describe outcomes of adult-aged patients with childhood-onset chronic conditions admitted to children’s hospitals,^7,12,13 there has been no comprehensive description of efforts within children’s hospitals to transition such patients into adult-oriented inpatient settings. This information is necessary to outline institutional needs, delineate opportunities for improvement, and help clinicians strategically organize services for patients requiring this transition.

We sought to characterize the current state of the transition from pediatric- to adult-oriented inpatient care across general pediatric inpatient services at US children’s hospitals. We hypothesized that only a limited and inconsistent set of activities would be practiced. We also hypothesized that institutions having formal outpatient transition processes or providers with specialization to care for this age group, such as dual-trained internal medicine–pediatrics (med–peds) physicians, would report performing more activities.

METHODS

Study Design, Setting, Participants

We conducted a national survey of leaders of inpatient general pediatrics services at US children’s hospitals from January 2016 to July 2016. Hospitals were identified using the online Children’s Hospital Association directory. Hospitals without inpatient general pediatrics services (eg, rehabilitation or subspecialty-only facilities) were excluded.

We identified a single respondent from each of the 195 remaining children’s hospitals using a structured protocol. Phone numbers and e-mail addresses of potential respondents were gathered from hospital or medical school directories. Following a standard script, study team members contacted potential respondents to describe the purpose of the study and to confirm their contact information. Hospitals were also allowed to designate a different individual with more specific expertise to participate, when relevant (eg, specific faculty member leading a related quality improvement initiative). The goal was to identify a leader of inpatient care with the most knowledge of institutional practices related to the transition to adult inpatient care. Examples of respondent roles included director of inpatient pediatrics, chief of hospital medicine or general pediatrics, medical director, and similar titles.

Survey Elements

As part of a larger quality improvement initiative at our institution, a multidisciplinary team of pediatric and internal medicine healthcare providers (physicians, nurse practitioners, nurses, case managers, social workers, child life specialists), as well as parents and patients, developed an “ideal state” with this transition and a consensus-based conceptual framework of key patient and institutional determinants of a formal inpatient transition initiative for children with chronic conditions within a children’s hospital (Figure).

Based on this model, we developed a novel survey instrument to assess the current state of inpatient transition from general services across US children’s hospitals. The instrument was refined and finalized after pilot testing with 5 pediatricians not involved in the study, at 3 institutions. Refinements centered on questionnaire formatting, ie, clarifying instructions, definitions, and question stems to minimize ambiguity and improve efficiency when completing the survey.

 

Institutional Context and Factors Influencing Inpatient Transitions

The following hospital characteristics were assessed: administrative structure (free-standing, hospital-within-hospital, or “free-leaning,” ie, separate physical structure but same administrative structure as a general hospital), urban versus rural, academic versus nonacademic, presence of an inpatient adolescent unit, presence of subspecialty admitting services, and providers with med–peds or family medicine training. The following provider group characteristics were assessed: number of full-time equivalents (FTEs), scope of practice (inpatient only, combination inpatient/outpatient), proportion of providers at a “senior” level (ie, at least 7 years posttraining or at an associate professor rank), estimated number of discharges per week, and proportion of patients cared for without resident physicians.

Inpatient Transition Initiative

Each institution was categorized as having or not having an inpatient transition initiative by whether they indicated having either (1) an institutional leader of the transition from pediatric to adult-oriented inpatient settings or (2) an inpatient transition process, for which “process” was defined as “a standard, organized, and predictable set of transition activities that may or may not be documented, but the steps are generally agreed upon.”

Specific Inpatient Transition Activities

Respondents indicated whether 22 activities occurred consistently, defined as at least 50% of the time. To facilitate description, activities were grouped into categories using the labels from the Six Core Elements framework³ (Table 1): Policy, Tracking and Monitoring, Readiness, Planning, Transfer of Care, and Transfer Completion. Respondents were also asked whether outpatient pediatric-adult transition activities existed at their institution and whether they were linked to inpatient transition activities.

Data Collection

After verifying contact information, respondents received an advanced priming phone call followed by a mailed request to participate with a printed uniform resource locator (URL) to the web survey. Two email reminders containing the URL were sent to nonresponders at 5 and 10 days after the initial mailing. Remaining nonresponders then received a reminder phone call, followed by a mailed paper copy of the survey questionnaire to be completed by hand approximately 2 weeks after the last emailed request. The survey was administered using the Qualtrics web survey platform (www.qualtrics.com). Data collection occurred between January 2016 and July 2016. Participants received a $20 incentive.

Statistical Analysis

Descriptive statistics summarized the current state of inpatient transition at general pediatrics services across US children’s hospitals. Exploratory factor analysis assessed whether individual activities were sufficiently correlated to allow grouping items and constructing scales. Differences in institutional or respondent characteristics between hospitals that did and did not report having an inpatient initiative were compared using t tests for continuous data. Fisher’s exact test was used for categorical data because some cell sizes were ≤5. Bivariate logistic regression quantified associations between presence versus absence of specific transition activities and presence versus absence of an inpatient transition initiative. Analyses were completed in STATA (SE version 14.0; StataCorp, College Station, Texas). The institutional review board at our institution approved this study.

RESULTS

Responses were received from 96 of 195 children’s hospitals (49.2% response rate). Responding institution characteristics are summarized in Table 2. Free-standing children’s hospitals made up just over one-third of the sample (36%), while the remaining were free-leaning (22%) or hospital-within-hospital (43%). Most children’s hospitals (58%) did not have a specific adult-oriented hospital identified to receive transitioning patients. Slightly more than 10% had an inpatient adolescent unit. The majority of institutions were academic medical centers (78%) in urban locations (88%). Respondents represented small (<5 FTE, 21%), medium (6-10 FTE, 36%), and large provider groups (11+ FTE, 44%). Although 70% of respondents described their groups as “hospitalist only,” meaning providers only practiced inpatient general pediatrics, nearly 30% had providers practicing inpatient and outpatient general pediatrics. Just over 40% of respondents reported having med–peds providers. Pediatric-adult transition processes for outpatient care were present at 45% of institutions.

Transition Activities

Thirty-eight percent of children’s hospitals had an inpatient transition initiative using our study definition—31% by having a set of generally agreed upon activities, 19% by having a leader, and 11% having both. Inpatient transition leaders included pediatric hospitalists (43%), pediatric subspecialists and primary care providers (14% each), med–peds providers (11%), or case managers (7%). Respondent and institutional characteristics were similar at institutions that did and did not have an inpatient transition initiative (Table 2); however, children’s hospitals with inpatient transition initiatives more often had med–peds providers (P = .04). Institutions with pediatric-adult outpatient care transition processes more often had an inpatient initiative (71% and 29%, respectively; P = .001).

Exploratory factor analysis identified 2 groups of well-correlated items, which we grouped into “preparation” and “transfer initiation” scales (supplementary Appendix). The preparation scale was composed of the following 5 items (Cronbach α = 0.84): proactive identification of patients anticipated to need transition, proactive identification of patients overdue for transition, readiness formally assessed, timing discussed with family, and patient and/or family informed that the next stay would be at the adult facility. The transfer initiation scale comprised the following 6 items (Cronbach α = 0.72): transition education provided to families, primary care–subspecialist agreement on timing, subspecialist–subspecialist agreement on timing, patient decision-making ability established, adult facility tour, and standardized handoff communication between healthcare providers. While these items were analyzed only in this scale, other activities were analyzed as independent variables. In this analysis, 40.9% of institutions had a preparation scale score of 0 (no items performed), while 13% had all 5 items performed. Transfer initiation scale scores ranged from 0 (47%) to 6 (2%).

Specific activities varied widely across institutions, and none of the activities occurred at a majority of children’s hospitals (Table 3). Only 11% of children’s hospital transition policies referenced transitions of inpatient care. The activity most commonly reported across children’s hospitals was addressing potential insurance problems (41%). The least common inpatient transition activities were having child life consult during the first adult hospital stay (6%) or having a system to track and monitor youth in the inpatient transition process (2%). Transition processes and policies were relatively new among institutions that had them—average years an inpatient transition process had been in place was 1.2 (SD 0.4), and average years with a transition policy, including inpatient care, was 1.3 (SD 0.4).

 

Transition Activities at Hospitals With and Without an Inpatient Transition Initiative

Most activities assessed in this study (both scales plus 5 of 11 individual activities) were significantly more common in children’s hospitals with an inpatient transition initiative (Table 3). The most common activity was addressing potential insurance problems (46%), and the least common activity was having a system to track and monitor youth in the inpatient transition process (3%). The majority of institutions without an inpatient transition initiative (53%) performed 0 transfer initiation scale items. Large effect sizes between hospitals with and without a transition initiative were observed for use of a checklist to complete tasks (odds ratio [OR] 9.6, P = .04) and creation of a transition care plan (OR 9.0, P = .008). Of the 6 activities performed at similarly low frequencies at institutions with and without an initiative, half involved transition planning, the essential step after readiness but before actual transfer of care.

DISCUSSION

We conducted the first national survey describing the policies and procedures of the transition of general inpatient care from children’s to adult-oriented hospitals for youth and young adults with chronic conditions. Our main findings demonstrate that a relatively small number of general inpatient services at children’s hospitals have leaders or dedicated processes to shepherd this transition, and a minority have a specific adult hospital identified to receive their patients. Even among institutions with inpatient transition initiatives, there is wide variability in the performance of activities to facilitate transitioning out of US children’s hospitals. In these institutions, performance seems to be more lacking in later links of the transition chain. Results from this work can serve as a baseline and identify organizational needs and opportunities for future work.

Children’s hospital general services with and without an inpatient pediatric-adult transition initiative had largely similar characteristics; however, the limited sample size may lack power to detect some differences. Perhaps not surprisingly, having med–peds providers and outpatient transition processes were the characteristics most associated with having an inpatient pediatric-adult transition initiative. The observation that over 70% of hospitals with an outpatient process had an inpatient transition leader or dedicated process makes us optimistic that as general transition efforts expand, more robust inpatient transition activities may be achievable.

We appreciate that the most appropriate location to care for hospitalized young adults with childhood-onset chronic conditions is neither known nor answered with this study. Both options face challenges—adult-oriented hospitals may not be equipped to care for adult manifestations of childhood-onset conditions,^14,15 while children’s hospitals may lack the resources and expertise to provide comprehensive care to adults.⁷ Although hospital charges and lengths of stay may be greater when adults with childhood-onset chronic conditions are admitted to children’s compared with adult hospitals,^12,13,16 important confounders such as severity of illness could explain why adult-aged patients may both remain in children’s hospitals at older ages and simultaneously have worse outcomes than peers. Regardless, at some point, transitioning care into an adult-oriented hospital may be in patients’ best interests. If so, families and providers need guidance on (1) the important aspects of this transition and (2) how to effectively implement the transition.

Because the most important inpatient transition care activities are not empirically known, we designed our survey to assess a broad set of desirable activities emerging from our multidisciplinary quality improvement work. We mapped these activities to the categories used by the Six Core Elements framework.³ Addressing insurance issues was one of the most commonly reported activities, although still fewer than 50% of hospitals reported addressing these problems. It was notable that the majority of institutions without a transition initiative performed none of the transfer initiation scale items. In addition, 2 features of transition efforts highlighted by advocates nationally—use of a checklist and creation of a transition care plan— were 9 times more likely when sites had transition initiatives. Such findings may be motivating for institutions that are considering establishing a transition initiative. Overall, we were not surprised with hospitals’ relatively low performance across most transition activities because only about 40% of US families of children with special healthcare needs report receiving the general services they need to transition to adult healthcare.¹⁷

We suspect that a number of the studied inpatient transition activities may be uncommon for structural reasons. For example, having child life consultation during an initial adult stay was rare. In fact, we observed post hoc that it occurred only in hospital-within-hospital systems, an expected finding because adult-only facilities are unlikely to have child life personnel. Other barriers, however, are less obviously structural. Almost no respondents indicated providing a tour of an adult facility, which was true whether the children’s hospital was free-standing or hospital-within-hospital. Given that hospitals with med–peds providers more often had inpatient transition initiatives, it would be interesting to examine whether institutions with med–peds training programs are able to overcome more of these barriers because of the bridges inherently created between departments even when at physically separated sites.

Having a system to track and/or monitor youth going through the transition process was also uncommon. This presumably valuable activity is one of the Six Core Elements³ and is reminiscent of population management strategies increasingly common in primary care.¹⁸ Pediatric hospitalists might benefit from adopting a similar philosophy for certain patient populations. Determining whether this activity would be most appropriately managed by inpatient providers versus being integrated into a comprehensive tracking and/or monitoring strategy (ie, inpatient care plus primary care, subspecialty care, school, employment, insurance, etc.) is worth continued consideration.

Although the activities we studied spanned many important dimensions, the most important transition activities in any given context may differ based on institutional resources and those of nearby adult healthcare providers.¹⁶ For example, an activity may be absent at a children’s hospital because it is already readily handled in primary care within that health system. Understanding how local resources and patient needs influence the relationship between transition activities and outcomes is an important next step in this line of work. Such research could inform how institutions adapt effective transition activities (eg, developing care plans) to most efficiently meet the needs of their patients and families.

Our findings align with and advance the limited work published on this aspect of transition. A systematic literature review of general healthcare transition interventions found that meeting adult providers prior to transitioning out of the pediatric system was associated with less concern about admission to the adult hospital floor.⁹ Formally recognizing inpatient care as a part of a comprehensive approach to transition may help adults with childhood-onset chronic conditions progress into adult-oriented hospitals. Inpatient and outpatient providers can educate one another on critical aspects of transition that span across settings. The Cystic Fibrosis (CF) Foundation has established a set of processes to facilitate the transition to adult care and specifically articulates the transfer to adult inpatient settings.^19,20 Perhaps as a result, CF is also one of few conditions with fewer adult patients being admitted to children’s hospitals⁷ despite the increasing number of adults living with the condition.¹⁹ Adapting the CF Foundation approach to other chronic conditions may be an effective approach.

Our study has important limitations. Most pertinently, the list of transition activities was developed at a single institution. Although drawing on accepted national guidelines and a diverse local quality improvement group, our listed activities could not be exhaustive. Care plan development and posttransition follow-up activities may benefit from ongoing development in subsequent work. Continuing to identify and integrate approaches taken at other children’s hospitals will also be informative. For example, some children’s hospitals have introduced adult medicine consultative services to focus on transition, attending children’s hospital safety rounds, and sharing standard care protocols for adult patients still cared for in pediatric settings (eg, stroke and myocardial infarction).¹⁶

In addition, our findings are limited to generalist teams at children’s hospitals and may not be applicable to inpatient subspecialty services. We could not compare differences in respondents versus nonrespondents to determine whether important selection bias exists. Respondent answers could not be verified. Despite our attempt to identify the most informed respondent at each hospital, responses may have differed with other hospital respondents. We used a novel instrument with unknown psychometric properties. Our data provide only the children’s hospital perspective, and perspectives of others (eg, families, primary care pediatricians or internists, subspecialists, etc.) will be valuable to explore in subsequent research. Subsequent research should investigate the relative importance and feasibility of specific inpatient transition activities, ideal timing, as well as the expected outcomes of high-quality inpatient transition. An important question for future work is to identify which patients are most likely to benefit by having inpatient care as part of their transition plan.

 

CONCLUSIONS

Nevertheless, the clinical and health services implications of this facet of transition appear to be substantial.¹⁶ To meet the Maternal and Child Health Bureau (MCHB) core outcome for children with special healthcare needs to receive “the services necessary to make transitions to adult healthcare,”²¹ development, validation, and implementation of effective inpatient-specific transition activities and a set of measurable processes and outcomes are needed. A key direction for the healthcare transitions field, with respect to inpatient care, is to determine the activities most effective at improving relevant patient and family outcomes. Ultimately, we advocate that the transition of inpatient care be integrated into comprehensive approaches to transitional care.

Disclosure: The project described was supported in part by the Clinical and Translational Science Award (CTSA) program, through the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The project was also supported by the University of Wisconsin Departments of Pediatrics and Medicine. The authors have no financial or other relationships relevant to this article to disclose.

 

Over 90% of children with chronic diseases now survive into adulthood.^1,2 Clinical advances overcoming diseases previously fatal in childhood create new challenges for health systems with limited capacity to manage young adults with complicated and unfamiliar childhood-onset conditions. Consequently, improving the transition from pediatric to adult-oriented care has become a national priority.

Although major pediatric-adult transition initiatives—such as the Six Core Elements Framework,³ a technical brief from the Agency for Healthcare Research and Quality,⁴ and joint statements from major medical societies^5,6—outline key transition recommendations generally and for outpatients, they contain limited or no guidance specifically devoted to transitioning inpatient hospital care from pediatric to adult-oriented settings. Key unknowns include whether, when, and how to transition inpatient care from children’s to nonchildren’s hospitals and how this can be integrated into comprehensive youth-adult transition care.

Nevertheless, the number of discharges of 18- to 21-year-old patients with chronic conditions admitted to children’s hospitals is increasing at a faster rate than discharges of other age groups,⁷ suggesting both that the population is growing in size and that there are important barriers to transitioning these patients into nonchildren’s hospital settings. Spending on adult patients 18 years or older admitted to children’s hospitals has grown to $1 billion annually.⁸ Hospitalizations are a commonly proposed outcome measure of pediatric-adult transition work.^1,9,10 For example, higher rates of avoidable hospitalizations during early adulthood have been observed for 15- to 22-year-olds with kidney failure cared for exclusively in adult-oriented facilities and during the years immediately after transfer to adult care.¹¹

While research is beginning to describe outcomes of adult-aged patients with childhood-onset chronic conditions admitted to children’s hospitals,^7,12,13 there has been no comprehensive description of efforts within children’s hospitals to transition such patients into adult-oriented inpatient settings. This information is necessary to outline institutional needs, delineate opportunities for improvement, and help clinicians strategically organize services for patients requiring this transition.

We sought to characterize the current state of the transition from pediatric- to adult-oriented inpatient care across general pediatric inpatient services at US children’s hospitals. We hypothesized that only a limited and inconsistent set of activities would be practiced. We also hypothesized that institutions having formal outpatient transition processes or providers with specialization to care for this age group, such as dual-trained internal medicine–pediatrics (med–peds) physicians, would report performing more activities.

METHODS

Study Design, Setting, Participants

We conducted a national survey of leaders of inpatient general pediatrics services at US children’s hospitals from January 2016 to July 2016. Hospitals were identified using the online Children’s Hospital Association directory. Hospitals without inpatient general pediatrics services (eg, rehabilitation or subspecialty-only facilities) were excluded.

We identified a single respondent from each of the 195 remaining children’s hospitals using a structured protocol. Phone numbers and e-mail addresses of potential respondents were gathered from hospital or medical school directories. Following a standard script, study team members contacted potential respondents to describe the purpose of the study and to confirm their contact information. Hospitals were also allowed to designate a different individual with more specific expertise to participate, when relevant (eg, specific faculty member leading a related quality improvement initiative). The goal was to identify a leader of inpatient care with the most knowledge of institutional practices related to the transition to adult inpatient care. Examples of respondent roles included director of inpatient pediatrics, chief of hospital medicine or general pediatrics, medical director, and similar titles.

Survey Elements

As part of a larger quality improvement initiative at our institution, a multidisciplinary team of pediatric and internal medicine healthcare providers (physicians, nurse practitioners, nurses, case managers, social workers, child life specialists), as well as parents and patients, developed an “ideal state” with this transition and a consensus-based conceptual framework of key patient and institutional determinants of a formal inpatient transition initiative for children with chronic conditions within a children’s hospital (Figure).

Based on this model, we developed a novel survey instrument to assess the current state of inpatient transition from general services across US children’s hospitals. The instrument was refined and finalized after pilot testing with 5 pediatricians not involved in the study, at 3 institutions. Refinements centered on questionnaire formatting, ie, clarifying instructions, definitions, and question stems to minimize ambiguity and improve efficiency when completing the survey.

 

Institutional Context and Factors Influencing Inpatient Transitions

The following hospital characteristics were assessed: administrative structure (free-standing, hospital-within-hospital, or “free-leaning,” ie, separate physical structure but same administrative structure as a general hospital), urban versus rural, academic versus nonacademic, presence of an inpatient adolescent unit, presence of subspecialty admitting services, and providers with med–peds or family medicine training. The following provider group characteristics were assessed: number of full-time equivalents (FTEs), scope of practice (inpatient only, combination inpatient/outpatient), proportion of providers at a “senior” level (ie, at least 7 years posttraining or at an associate professor rank), estimated number of discharges per week, and proportion of patients cared for without resident physicians.

Inpatient Transition Initiative

Each institution was categorized as having or not having an inpatient transition initiative by whether they indicated having either (1) an institutional leader of the transition from pediatric to adult-oriented inpatient settings or (2) an inpatient transition process, for which “process” was defined as “a standard, organized, and predictable set of transition activities that may or may not be documented, but the steps are generally agreed upon.”

Specific Inpatient Transition Activities

Respondents indicated whether 22 activities occurred consistently, defined as at least 50% of the time. To facilitate description, activities were grouped into categories using the labels from the Six Core Elements framework³ (Table 1): Policy, Tracking and Monitoring, Readiness, Planning, Transfer of Care, and Transfer Completion. Respondents were also asked whether outpatient pediatric-adult transition activities existed at their institution and whether they were linked to inpatient transition activities.

Data Collection

After verifying contact information, respondents received an advanced priming phone call followed by a mailed request to participate with a printed uniform resource locator (URL) to the web survey. Two email reminders containing the URL were sent to nonresponders at 5 and 10 days after the initial mailing. Remaining nonresponders then received a reminder phone call, followed by a mailed paper copy of the survey questionnaire to be completed by hand approximately 2 weeks after the last emailed request. The survey was administered using the Qualtrics web survey platform (www.qualtrics.com). Data collection occurred between January 2016 and July 2016. Participants received a $20 incentive.

Statistical Analysis

Descriptive statistics summarized the current state of inpatient transition at general pediatrics services across US children’s hospitals. Exploratory factor analysis assessed whether individual activities were sufficiently correlated to allow grouping items and constructing scales. Differences in institutional or respondent characteristics between hospitals that did and did not report having an inpatient initiative were compared using t tests for continuous data. Fisher’s exact test was used for categorical data because some cell sizes were ≤5. Bivariate logistic regression quantified associations between presence versus absence of specific transition activities and presence versus absence of an inpatient transition initiative. Analyses were completed in STATA (SE version 14.0; StataCorp, College Station, Texas). The institutional review board at our institution approved this study.

RESULTS

Responses were received from 96 of 195 children’s hospitals (49.2% response rate). Responding institution characteristics are summarized in Table 2. Free-standing children’s hospitals made up just over one-third of the sample (36%), while the remaining were free-leaning (22%) or hospital-within-hospital (43%). Most children’s hospitals (58%) did not have a specific adult-oriented hospital identified to receive transitioning patients. Slightly more than 10% had an inpatient adolescent unit. The majority of institutions were academic medical centers (78%) in urban locations (88%). Respondents represented small (<5 FTE, 21%), medium (6-10 FTE, 36%), and large provider groups (11+ FTE, 44%). Although 70% of respondents described their groups as “hospitalist only,” meaning providers only practiced inpatient general pediatrics, nearly 30% had providers practicing inpatient and outpatient general pediatrics. Just over 40% of respondents reported having med–peds providers. Pediatric-adult transition processes for outpatient care were present at 45% of institutions.

Transition Activities

Thirty-eight percent of children’s hospitals had an inpatient transition initiative using our study definition—31% by having a set of generally agreed upon activities, 19% by having a leader, and 11% having both. Inpatient transition leaders included pediatric hospitalists (43%), pediatric subspecialists and primary care providers (14% each), med–peds providers (11%), or case managers (7%). Respondent and institutional characteristics were similar at institutions that did and did not have an inpatient transition initiative (Table 2); however, children’s hospitals with inpatient transition initiatives more often had med–peds providers (P = .04). Institutions with pediatric-adult outpatient care transition processes more often had an inpatient initiative (71% and 29%, respectively; P = .001).

Exploratory factor analysis identified 2 groups of well-correlated items, which we grouped into “preparation” and “transfer initiation” scales (supplementary Appendix). The preparation scale was composed of the following 5 items (Cronbach α = 0.84): proactive identification of patients anticipated to need transition, proactive identification of patients overdue for transition, readiness formally assessed, timing discussed with family, and patient and/or family informed that the next stay would be at the adult facility. The transfer initiation scale comprised the following 6 items (Cronbach α = 0.72): transition education provided to families, primary care–subspecialist agreement on timing, subspecialist–subspecialist agreement on timing, patient decision-making ability established, adult facility tour, and standardized handoff communication between healthcare providers. While these items were analyzed only in this scale, other activities were analyzed as independent variables. In this analysis, 40.9% of institutions had a preparation scale score of 0 (no items performed), while 13% had all 5 items performed. Transfer initiation scale scores ranged from 0 (47%) to 6 (2%).

Specific activities varied widely across institutions, and none of the activities occurred at a majority of children’s hospitals (Table 3). Only 11% of children’s hospital transition policies referenced transitions of inpatient care. The activity most commonly reported across children’s hospitals was addressing potential insurance problems (41%). The least common inpatient transition activities were having child life consult during the first adult hospital stay (6%) or having a system to track and monitor youth in the inpatient transition process (2%). Transition processes and policies were relatively new among institutions that had them—average years an inpatient transition process had been in place was 1.2 (SD 0.4), and average years with a transition policy, including inpatient care, was 1.3 (SD 0.4).

 

Transition Activities at Hospitals With and Without an Inpatient Transition Initiative

Most activities assessed in this study (both scales plus 5 of 11 individual activities) were significantly more common in children’s hospitals with an inpatient transition initiative (Table 3). The most common activity was addressing potential insurance problems (46%), and the least common activity was having a system to track and monitor youth in the inpatient transition process (3%). The majority of institutions without an inpatient transition initiative (53%) performed 0 transfer initiation scale items. Large effect sizes between hospitals with and without a transition initiative were observed for use of a checklist to complete tasks (odds ratio [OR] 9.6, P = .04) and creation of a transition care plan (OR 9.0, P = .008). Of the 6 activities performed at similarly low frequencies at institutions with and without an initiative, half involved transition planning, the essential step after readiness but before actual transfer of care.

DISCUSSION

We conducted the first national survey describing the policies and procedures of the transition of general inpatient care from children’s to adult-oriented hospitals for youth and young adults with chronic conditions. Our main findings demonstrate that a relatively small number of general inpatient services at children’s hospitals have leaders or dedicated processes to shepherd this transition, and a minority have a specific adult hospital identified to receive their patients. Even among institutions with inpatient transition initiatives, there is wide variability in the performance of activities to facilitate transitioning out of US children’s hospitals. In these institutions, performance seems to be more lacking in later links of the transition chain. Results from this work can serve as a baseline and identify organizational needs and opportunities for future work.

Children’s hospital general services with and without an inpatient pediatric-adult transition initiative had largely similar characteristics; however, the limited sample size may lack power to detect some differences. Perhaps not surprisingly, having med–peds providers and outpatient transition processes were the characteristics most associated with having an inpatient pediatric-adult transition initiative. The observation that over 70% of hospitals with an outpatient process had an inpatient transition leader or dedicated process makes us optimistic that as general transition efforts expand, more robust inpatient transition activities may be achievable.

We appreciate that the most appropriate location to care for hospitalized young adults with childhood-onset chronic conditions is neither known nor answered with this study. Both options face challenges—adult-oriented hospitals may not be equipped to care for adult manifestations of childhood-onset conditions,^14,15 while children’s hospitals may lack the resources and expertise to provide comprehensive care to adults.⁷ Although hospital charges and lengths of stay may be greater when adults with childhood-onset chronic conditions are admitted to children’s compared with adult hospitals,^12,13,16 important confounders such as severity of illness could explain why adult-aged patients may both remain in children’s hospitals at older ages and simultaneously have worse outcomes than peers. Regardless, at some point, transitioning care into an adult-oriented hospital may be in patients’ best interests. If so, families and providers need guidance on (1) the important aspects of this transition and (2) how to effectively implement the transition.

Because the most important inpatient transition care activities are not empirically known, we designed our survey to assess a broad set of desirable activities emerging from our multidisciplinary quality improvement work. We mapped these activities to the categories used by the Six Core Elements framework.³ Addressing insurance issues was one of the most commonly reported activities, although still fewer than 50% of hospitals reported addressing these problems. It was notable that the majority of institutions without a transition initiative performed none of the transfer initiation scale items. In addition, 2 features of transition efforts highlighted by advocates nationally—use of a checklist and creation of a transition care plan— were 9 times more likely when sites had transition initiatives. Such findings may be motivating for institutions that are considering establishing a transition initiative. Overall, we were not surprised with hospitals’ relatively low performance across most transition activities because only about 40% of US families of children with special healthcare needs report receiving the general services they need to transition to adult healthcare.¹⁷

We suspect that a number of the studied inpatient transition activities may be uncommon for structural reasons. For example, having child life consultation during an initial adult stay was rare. In fact, we observed post hoc that it occurred only in hospital-within-hospital systems, an expected finding because adult-only facilities are unlikely to have child life personnel. Other barriers, however, are less obviously structural. Almost no respondents indicated providing a tour of an adult facility, which was true whether the children’s hospital was free-standing or hospital-within-hospital. Given that hospitals with med–peds providers more often had inpatient transition initiatives, it would be interesting to examine whether institutions with med–peds training programs are able to overcome more of these barriers because of the bridges inherently created between departments even when at physically separated sites.

Having a system to track and/or monitor youth going through the transition process was also uncommon. This presumably valuable activity is one of the Six Core Elements³ and is reminiscent of population management strategies increasingly common in primary care.¹⁸ Pediatric hospitalists might benefit from adopting a similar philosophy for certain patient populations. Determining whether this activity would be most appropriately managed by inpatient providers versus being integrated into a comprehensive tracking and/or monitoring strategy (ie, inpatient care plus primary care, subspecialty care, school, employment, insurance, etc.) is worth continued consideration.

Although the activities we studied spanned many important dimensions, the most important transition activities in any given context may differ based on institutional resources and those of nearby adult healthcare providers.¹⁶ For example, an activity may be absent at a children’s hospital because it is already readily handled in primary care within that health system. Understanding how local resources and patient needs influence the relationship between transition activities and outcomes is an important next step in this line of work. Such research could inform how institutions adapt effective transition activities (eg, developing care plans) to most efficiently meet the needs of their patients and families.

Our findings align with and advance the limited work published on this aspect of transition. A systematic literature review of general healthcare transition interventions found that meeting adult providers prior to transitioning out of the pediatric system was associated with less concern about admission to the adult hospital floor.⁹ Formally recognizing inpatient care as a part of a comprehensive approach to transition may help adults with childhood-onset chronic conditions progress into adult-oriented hospitals. Inpatient and outpatient providers can educate one another on critical aspects of transition that span across settings. The Cystic Fibrosis (CF) Foundation has established a set of processes to facilitate the transition to adult care and specifically articulates the transfer to adult inpatient settings.^19,20 Perhaps as a result, CF is also one of few conditions with fewer adult patients being admitted to children’s hospitals⁷ despite the increasing number of adults living with the condition.¹⁹ Adapting the CF Foundation approach to other chronic conditions may be an effective approach.

Our study has important limitations. Most pertinently, the list of transition activities was developed at a single institution. Although drawing on accepted national guidelines and a diverse local quality improvement group, our listed activities could not be exhaustive. Care plan development and posttransition follow-up activities may benefit from ongoing development in subsequent work. Continuing to identify and integrate approaches taken at other children’s hospitals will also be informative. For example, some children’s hospitals have introduced adult medicine consultative services to focus on transition, attending children’s hospital safety rounds, and sharing standard care protocols for adult patients still cared for in pediatric settings (eg, stroke and myocardial infarction).¹⁶

In addition, our findings are limited to generalist teams at children’s hospitals and may not be applicable to inpatient subspecialty services. We could not compare differences in respondents versus nonrespondents to determine whether important selection bias exists. Respondent answers could not be verified. Despite our attempt to identify the most informed respondent at each hospital, responses may have differed with other hospital respondents. We used a novel instrument with unknown psychometric properties. Our data provide only the children’s hospital perspective, and perspectives of others (eg, families, primary care pediatricians or internists, subspecialists, etc.) will be valuable to explore in subsequent research. Subsequent research should investigate the relative importance and feasibility of specific inpatient transition activities, ideal timing, as well as the expected outcomes of high-quality inpatient transition. An important question for future work is to identify which patients are most likely to benefit by having inpatient care as part of their transition plan.

 

CONCLUSIONS

Nevertheless, the clinical and health services implications of this facet of transition appear to be substantial.¹⁶ To meet the Maternal and Child Health Bureau (MCHB) core outcome for children with special healthcare needs to receive “the services necessary to make transitions to adult healthcare,”²¹ development, validation, and implementation of effective inpatient-specific transition activities and a set of measurable processes and outcomes are needed. A key direction for the healthcare transitions field, with respect to inpatient care, is to determine the activities most effective at improving relevant patient and family outcomes. Ultimately, we advocate that the transition of inpatient care be integrated into comprehensive approaches to transitional care.

Disclosure: The project described was supported in part by the Clinical and Translational Science Award (CTSA) program, through the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The project was also supported by the University of Wisconsin Departments of Pediatrics and Medicine. The authors have no financial or other relationships relevant to this article to disclose.

 

Over 90% of children with chronic diseases now survive into adulthood.^1,2 Clinical advances overcoming diseases previously fatal in childhood create new challenges for health systems with limited capacity to manage young adults with complicated and unfamiliar childhood-onset conditions. Consequently, improving the transition from pediatric to adult-oriented care has become a national priority.

Although major pediatric-adult transition initiatives—such as the Six Core Elements Framework,³ a technical brief from the Agency for Healthcare Research and Quality,⁴ and joint statements from major medical societies^5,6—outline key transition recommendations generally and for outpatients, they contain limited or no guidance specifically devoted to transitioning inpatient hospital care from pediatric to adult-oriented settings. Key unknowns include whether, when, and how to transition inpatient care from children’s to nonchildren’s hospitals and how this can be integrated into comprehensive youth-adult transition care.

Nevertheless, the number of discharges of 18- to 21-year-old patients with chronic conditions admitted to children’s hospitals is increasing at a faster rate than discharges of other age groups,⁷ suggesting both that the population is growing in size and that there are important barriers to transitioning these patients into nonchildren’s hospital settings. Spending on adult patients 18 years or older admitted to children’s hospitals has grown to $1 billion annually.⁸ Hospitalizations are a commonly proposed outcome measure of pediatric-adult transition work.^1,9,10 For example, higher rates of avoidable hospitalizations during early adulthood have been observed for 15- to 22-year-olds with kidney failure cared for exclusively in adult-oriented facilities and during the years immediately after transfer to adult care.¹¹

While research is beginning to describe outcomes of adult-aged patients with childhood-onset chronic conditions admitted to children’s hospitals,^7,12,13 there has been no comprehensive description of efforts within children’s hospitals to transition such patients into adult-oriented inpatient settings. This information is necessary to outline institutional needs, delineate opportunities for improvement, and help clinicians strategically organize services for patients requiring this transition.

We sought to characterize the current state of the transition from pediatric- to adult-oriented inpatient care across general pediatric inpatient services at US children’s hospitals. We hypothesized that only a limited and inconsistent set of activities would be practiced. We also hypothesized that institutions having formal outpatient transition processes or providers with specialization to care for this age group, such as dual-trained internal medicine–pediatrics (med–peds) physicians, would report performing more activities.

METHODS

Study Design, Setting, Participants

We conducted a national survey of leaders of inpatient general pediatrics services at US children’s hospitals from January 2016 to July 2016. Hospitals were identified using the online Children’s Hospital Association directory. Hospitals without inpatient general pediatrics services (eg, rehabilitation or subspecialty-only facilities) were excluded.

We identified a single respondent from each of the 195 remaining children’s hospitals using a structured protocol. Phone numbers and e-mail addresses of potential respondents were gathered from hospital or medical school directories. Following a standard script, study team members contacted potential respondents to describe the purpose of the study and to confirm their contact information. Hospitals were also allowed to designate a different individual with more specific expertise to participate, when relevant (eg, specific faculty member leading a related quality improvement initiative). The goal was to identify a leader of inpatient care with the most knowledge of institutional practices related to the transition to adult inpatient care. Examples of respondent roles included director of inpatient pediatrics, chief of hospital medicine or general pediatrics, medical director, and similar titles.

Survey Elements

As part of a larger quality improvement initiative at our institution, a multidisciplinary team of pediatric and internal medicine healthcare providers (physicians, nurse practitioners, nurses, case managers, social workers, child life specialists), as well as parents and patients, developed an “ideal state” with this transition and a consensus-based conceptual framework of key patient and institutional determinants of a formal inpatient transition initiative for children with chronic conditions within a children’s hospital (Figure).

Based on this model, we developed a novel survey instrument to assess the current state of inpatient transition from general services across US children’s hospitals. The instrument was refined and finalized after pilot testing with 5 pediatricians not involved in the study, at 3 institutions. Refinements centered on questionnaire formatting, ie, clarifying instructions, definitions, and question stems to minimize ambiguity and improve efficiency when completing the survey.

 

Institutional Context and Factors Influencing Inpatient Transitions

The following hospital characteristics were assessed: administrative structure (free-standing, hospital-within-hospital, or “free-leaning,” ie, separate physical structure but same administrative structure as a general hospital), urban versus rural, academic versus nonacademic, presence of an inpatient adolescent unit, presence of subspecialty admitting services, and providers with med–peds or family medicine training. The following provider group characteristics were assessed: number of full-time equivalents (FTEs), scope of practice (inpatient only, combination inpatient/outpatient), proportion of providers at a “senior” level (ie, at least 7 years posttraining or at an associate professor rank), estimated number of discharges per week, and proportion of patients cared for without resident physicians.

Inpatient Transition Initiative

Each institution was categorized as having or not having an inpatient transition initiative by whether they indicated having either (1) an institutional leader of the transition from pediatric to adult-oriented inpatient settings or (2) an inpatient transition process, for which “process” was defined as “a standard, organized, and predictable set of transition activities that may or may not be documented, but the steps are generally agreed upon.”

Specific Inpatient Transition Activities

Respondents indicated whether 22 activities occurred consistently, defined as at least 50% of the time. To facilitate description, activities were grouped into categories using the labels from the Six Core Elements framework³ (Table 1): Policy, Tracking and Monitoring, Readiness, Planning, Transfer of Care, and Transfer Completion. Respondents were also asked whether outpatient pediatric-adult transition activities existed at their institution and whether they were linked to inpatient transition activities.

Data Collection

After verifying contact information, respondents received an advanced priming phone call followed by a mailed request to participate with a printed uniform resource locator (URL) to the web survey. Two email reminders containing the URL were sent to nonresponders at 5 and 10 days after the initial mailing. Remaining nonresponders then received a reminder phone call, followed by a mailed paper copy of the survey questionnaire to be completed by hand approximately 2 weeks after the last emailed request. The survey was administered using the Qualtrics web survey platform (www.qualtrics.com). Data collection occurred between January 2016 and July 2016. Participants received a $20 incentive.

Statistical Analysis

Descriptive statistics summarized the current state of inpatient transition at general pediatrics services across US children’s hospitals. Exploratory factor analysis assessed whether individual activities were sufficiently correlated to allow grouping items and constructing scales. Differences in institutional or respondent characteristics between hospitals that did and did not report having an inpatient initiative were compared using t tests for continuous data. Fisher’s exact test was used for categorical data because some cell sizes were ≤5. Bivariate logistic regression quantified associations between presence versus absence of specific transition activities and presence versus absence of an inpatient transition initiative. Analyses were completed in STATA (SE version 14.0; StataCorp, College Station, Texas). The institutional review board at our institution approved this study.

RESULTS

Responses were received from 96 of 195 children’s hospitals (49.2% response rate). Responding institution characteristics are summarized in Table 2. Free-standing children’s hospitals made up just over one-third of the sample (36%), while the remaining were free-leaning (22%) or hospital-within-hospital (43%). Most children’s hospitals (58%) did not have a specific adult-oriented hospital identified to receive transitioning patients. Slightly more than 10% had an inpatient adolescent unit. The majority of institutions were academic medical centers (78%) in urban locations (88%). Respondents represented small (<5 FTE, 21%), medium (6-10 FTE, 36%), and large provider groups (11+ FTE, 44%). Although 70% of respondents described their groups as “hospitalist only,” meaning providers only practiced inpatient general pediatrics, nearly 30% had providers practicing inpatient and outpatient general pediatrics. Just over 40% of respondents reported having med–peds providers. Pediatric-adult transition processes for outpatient care were present at 45% of institutions.

Transition Activities

Thirty-eight percent of children’s hospitals had an inpatient transition initiative using our study definition—31% by having a set of generally agreed upon activities, 19% by having a leader, and 11% having both. Inpatient transition leaders included pediatric hospitalists (43%), pediatric subspecialists and primary care providers (14% each), med–peds providers (11%), or case managers (7%). Respondent and institutional characteristics were similar at institutions that did and did not have an inpatient transition initiative (Table 2); however, children’s hospitals with inpatient transition initiatives more often had med–peds providers (P = .04). Institutions with pediatric-adult outpatient care transition processes more often had an inpatient initiative (71% and 29%, respectively; P = .001).

Exploratory factor analysis identified 2 groups of well-correlated items, which we grouped into “preparation” and “transfer initiation” scales (supplementary Appendix). The preparation scale was composed of the following 5 items (Cronbach α = 0.84): proactive identification of patients anticipated to need transition, proactive identification of patients overdue for transition, readiness formally assessed, timing discussed with family, and patient and/or family informed that the next stay would be at the adult facility. The transfer initiation scale comprised the following 6 items (Cronbach α = 0.72): transition education provided to families, primary care–subspecialist agreement on timing, subspecialist–subspecialist agreement on timing, patient decision-making ability established, adult facility tour, and standardized handoff communication between healthcare providers. While these items were analyzed only in this scale, other activities were analyzed as independent variables. In this analysis, 40.9% of institutions had a preparation scale score of 0 (no items performed), while 13% had all 5 items performed. Transfer initiation scale scores ranged from 0 (47%) to 6 (2%).

Specific activities varied widely across institutions, and none of the activities occurred at a majority of children’s hospitals (Table 3). Only 11% of children’s hospital transition policies referenced transitions of inpatient care. The activity most commonly reported across children’s hospitals was addressing potential insurance problems (41%). The least common inpatient transition activities were having child life consult during the first adult hospital stay (6%) or having a system to track and monitor youth in the inpatient transition process (2%). Transition processes and policies were relatively new among institutions that had them—average years an inpatient transition process had been in place was 1.2 (SD 0.4), and average years with a transition policy, including inpatient care, was 1.3 (SD 0.4).

 

Transition Activities at Hospitals With and Without an Inpatient Transition Initiative

Most activities assessed in this study (both scales plus 5 of 11 individual activities) were significantly more common in children’s hospitals with an inpatient transition initiative (Table 3). The most common activity was addressing potential insurance problems (46%), and the least common activity was having a system to track and monitor youth in the inpatient transition process (3%). The majority of institutions without an inpatient transition initiative (53%) performed 0 transfer initiation scale items. Large effect sizes between hospitals with and without a transition initiative were observed for use of a checklist to complete tasks (odds ratio [OR] 9.6, P = .04) and creation of a transition care plan (OR 9.0, P = .008). Of the 6 activities performed at similarly low frequencies at institutions with and without an initiative, half involved transition planning, the essential step after readiness but before actual transfer of care.

DISCUSSION

We conducted the first national survey describing the policies and procedures of the transition of general inpatient care from children’s to adult-oriented hospitals for youth and young adults with chronic conditions. Our main findings demonstrate that a relatively small number of general inpatient services at children’s hospitals have leaders or dedicated processes to shepherd this transition, and a minority have a specific adult hospital identified to receive their patients. Even among institutions with inpatient transition initiatives, there is wide variability in the performance of activities to facilitate transitioning out of US children’s hospitals. In these institutions, performance seems to be more lacking in later links of the transition chain. Results from this work can serve as a baseline and identify organizational needs and opportunities for future work.

Children’s hospital general services with and without an inpatient pediatric-adult transition initiative had largely similar characteristics; however, the limited sample size may lack power to detect some differences. Perhaps not surprisingly, having med–peds providers and outpatient transition processes were the characteristics most associated with having an inpatient pediatric-adult transition initiative. The observation that over 70% of hospitals with an outpatient process had an inpatient transition leader or dedicated process makes us optimistic that as general transition efforts expand, more robust inpatient transition activities may be achievable.

We appreciate that the most appropriate location to care for hospitalized young adults with childhood-onset chronic conditions is neither known nor answered with this study. Both options face challenges—adult-oriented hospitals may not be equipped to care for adult manifestations of childhood-onset conditions,^14,15 while children’s hospitals may lack the resources and expertise to provide comprehensive care to adults.⁷ Although hospital charges and lengths of stay may be greater when adults with childhood-onset chronic conditions are admitted to children’s compared with adult hospitals,^12,13,16 important confounders such as severity of illness could explain why adult-aged patients may both remain in children’s hospitals at older ages and simultaneously have worse outcomes than peers. Regardless, at some point, transitioning care into an adult-oriented hospital may be in patients’ best interests. If so, families and providers need guidance on (1) the important aspects of this transition and (2) how to effectively implement the transition.

Because the most important inpatient transition care activities are not empirically known, we designed our survey to assess a broad set of desirable activities emerging from our multidisciplinary quality improvement work. We mapped these activities to the categories used by the Six Core Elements framework.³ Addressing insurance issues was one of the most commonly reported activities, although still fewer than 50% of hospitals reported addressing these problems. It was notable that the majority of institutions without a transition initiative performed none of the transfer initiation scale items. In addition, 2 features of transition efforts highlighted by advocates nationally—use of a checklist and creation of a transition care plan— were 9 times more likely when sites had transition initiatives. Such findings may be motivating for institutions that are considering establishing a transition initiative. Overall, we were not surprised with hospitals’ relatively low performance across most transition activities because only about 40% of US families of children with special healthcare needs report receiving the general services they need to transition to adult healthcare.¹⁷

We suspect that a number of the studied inpatient transition activities may be uncommon for structural reasons. For example, having child life consultation during an initial adult stay was rare. In fact, we observed post hoc that it occurred only in hospital-within-hospital systems, an expected finding because adult-only facilities are unlikely to have child life personnel. Other barriers, however, are less obviously structural. Almost no respondents indicated providing a tour of an adult facility, which was true whether the children’s hospital was free-standing or hospital-within-hospital. Given that hospitals with med–peds providers more often had inpatient transition initiatives, it would be interesting to examine whether institutions with med–peds training programs are able to overcome more of these barriers because of the bridges inherently created between departments even when at physically separated sites.

Having a system to track and/or monitor youth going through the transition process was also uncommon. This presumably valuable activity is one of the Six Core Elements³ and is reminiscent of population management strategies increasingly common in primary care.¹⁸ Pediatric hospitalists might benefit from adopting a similar philosophy for certain patient populations. Determining whether this activity would be most appropriately managed by inpatient providers versus being integrated into a comprehensive tracking and/or monitoring strategy (ie, inpatient care plus primary care, subspecialty care, school, employment, insurance, etc.) is worth continued consideration.

Although the activities we studied spanned many important dimensions, the most important transition activities in any given context may differ based on institutional resources and those of nearby adult healthcare providers.¹⁶ For example, an activity may be absent at a children’s hospital because it is already readily handled in primary care within that health system. Understanding how local resources and patient needs influence the relationship between transition activities and outcomes is an important next step in this line of work. Such research could inform how institutions adapt effective transition activities (eg, developing care plans) to most efficiently meet the needs of their patients and families.

Our findings align with and advance the limited work published on this aspect of transition. A systematic literature review of general healthcare transition interventions found that meeting adult providers prior to transitioning out of the pediatric system was associated with less concern about admission to the adult hospital floor.⁹ Formally recognizing inpatient care as a part of a comprehensive approach to transition may help adults with childhood-onset chronic conditions progress into adult-oriented hospitals. Inpatient and outpatient providers can educate one another on critical aspects of transition that span across settings. The Cystic Fibrosis (CF) Foundation has established a set of processes to facilitate the transition to adult care and specifically articulates the transfer to adult inpatient settings.^19,20 Perhaps as a result, CF is also one of few conditions with fewer adult patients being admitted to children’s hospitals⁷ despite the increasing number of adults living with the condition.¹⁹ Adapting the CF Foundation approach to other chronic conditions may be an effective approach.

Our study has important limitations. Most pertinently, the list of transition activities was developed at a single institution. Although drawing on accepted national guidelines and a diverse local quality improvement group, our listed activities could not be exhaustive. Care plan development and posttransition follow-up activities may benefit from ongoing development in subsequent work. Continuing to identify and integrate approaches taken at other children’s hospitals will also be informative. For example, some children’s hospitals have introduced adult medicine consultative services to focus on transition, attending children’s hospital safety rounds, and sharing standard care protocols for adult patients still cared for in pediatric settings (eg, stroke and myocardial infarction).¹⁶

In addition, our findings are limited to generalist teams at children’s hospitals and may not be applicable to inpatient subspecialty services. We could not compare differences in respondents versus nonrespondents to determine whether important selection bias exists. Respondent answers could not be verified. Despite our attempt to identify the most informed respondent at each hospital, responses may have differed with other hospital respondents. We used a novel instrument with unknown psychometric properties. Our data provide only the children’s hospital perspective, and perspectives of others (eg, families, primary care pediatricians or internists, subspecialists, etc.) will be valuable to explore in subsequent research. Subsequent research should investigate the relative importance and feasibility of specific inpatient transition activities, ideal timing, as well as the expected outcomes of high-quality inpatient transition. An important question for future work is to identify which patients are most likely to benefit by having inpatient care as part of their transition plan.

 

CONCLUSIONS

Nevertheless, the clinical and health services implications of this facet of transition appear to be substantial.¹⁶ To meet the Maternal and Child Health Bureau (MCHB) core outcome for children with special healthcare needs to receive “the services necessary to make transitions to adult healthcare,”²¹ development, validation, and implementation of effective inpatient-specific transition activities and a set of measurable processes and outcomes are needed. A key direction for the healthcare transitions field, with respect to inpatient care, is to determine the activities most effective at improving relevant patient and family outcomes. Ultimately, we advocate that the transition of inpatient care be integrated into comprehensive approaches to transitional care.

Disclosure: The project described was supported in part by the Clinical and Translational Science Award (CTSA) program, through the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The project was also supported by the University of Wisconsin Departments of Pediatrics and Medicine. The authors have no financial or other relationships relevant to this article to disclose.

 

Despite calls for board-certified intensivist physicians to lead critical care delivery,^1-3 the intensivist shortage in the United States continues to worsen,⁴ with projected shortfalls of 22% by 2020 and 35% by 2030.⁵ Many hospitals currently have inadequate or no board-certified intensivist support.⁶ The intensivist shortage has necessitated the development of alternative intensive care unit (ICU) staffing models, including engagement in telemedicine,⁷ the utilization of advanced practice providers,⁸ and dependence on hospitalists⁹ to deliver critical care services to ICU patients. Presently, research does not clearly show consistent differences in clinical outcomes based on the training of the clinical provider, although optimized teamwork and team rounds in the ICU do seem to be associated with improved outcomes.^10-12

In its 2016 annual survey of hospital medicine (HM) leaders, the Society of Hospital Medicine (SHM) documented that most HM groups care for ICU patients, with up to 80% of hospitalist groups in some regions delivering critical care.¹³ In many United States hospitals, hospitalists serve as the primary if not lone physician providers of critical care.^6,14 HM, with its team-based approach and on-site presence, shares many of the key attributes and values that define high-functioning critical care teams, and many hospitalists likely capably deliver some critical care services.⁹ However, hospitalists are also a highly heterogeneous work force with varied exposure to and comfort with critical care medicine, making it difficult to generalize hospitalists’ scope of practice in the ICU.

Because hospitalists render a significant amount of critical care in the United States, we surveyed practicing hospitalists to understand their demographics and practice roles in the ICU setting and to ascertain how they are supported when doing so. Additionally, we sought to identify mismatches between the ICU services that hospitalists provide and what they feel prepared and supported to deliver. Finally, we attempted to elucidate how hospitalists who practice in the ICU might respond to novel educational offerings targeted to mitigate cognitive or procedural gaps.

METHODS

We developed and deployed a survey to address the aforementioned questions. The survey content was developed iteratively by the Critical Care Task Force of SHM’s Education Committee and subsequently approved by SHM’s Education Committee and Board of Directors. Members of the Critical Care Task Force include critical care physicians and hospitalists. The survey included 25 items (supplemental Appendix A). Seventeen questions addressed the demographics and practice roles of hospitalists in the ICU, 5 addressed cognitive and procedural practice gaps, and 3 addressed how hospitalists would respond to educational opportunities in critical care. We used conditional formatting to ensure that only respondents who deliver ICU care could answer questions related to ICU practice. The survey was delivered by using an online survey platform (Survey Monkey, San Mateo, CA).

The survey was deployed in 3 phases from March to October of 2016. Initially, we distributed a pilot survey to professional contacts of the Critical Care Task Force to solicit feedback and refine the survey’s format and content. These contacts were largely academic hospitalists from our local institutions. We then distributed the survey to hospitalists via professional networks with instructions to forward the link to interested hospitalists. Finally, we distributed the survey to approximately 4000 hospitalists randomly selected from SHM’s national listserv of approximately 12,000 hospitalists. Respondents could enter a drawing for a monetary prize upon completion of the survey.

None of the survey questions changed during the 3 phases of survey deployment, and the data reported herein were compiled from all 3 phases of the survey deployment. Frequency tables were created using Tableau (version 10.0; Tableau Software, Seattle, WA). Comparisons between categorical questions were made by using χ² and Fischer exact tests to calculate P values for associations by using SAS (version 9.3; SAS Institute, Cary, NC). Associations with P values below .05 were considered statistically significant.

 

RESULTS

Objective 1: Demographics and Practice Role

Four hundred and twenty-five hospitalists responded to the survey. The first 2 phases (pilot survey and distribution via professional networks) generated 101 responses, and the third phase (via SHM’s listserv) generated an additional 324 responses. As the survey was anonymous, we could not determine which hospitals or geographic regions were represented. Three hundred and twenty-five of the 425 hospitalists who completed the survey (77%) reported that they delivered care in the ICU. Of these 325 hospitalists, 45 served only as consultants, while the remaining 280 (66% of the total sample) served as the primary attending physician in the ICU. Among these primary providers of care in the ICU, 60 (21%) practiced in rural settings and 220 (79%) practiced in nonrural settings (Figure 1).

The demographics of our respondents were similar to those of the SHM annual survey,¹³ in which 66% of respondents delivered ICU care. Forty-one percent of our respondents worked in critical access or small community hospitals, 24% in academic medical centers, and 34% in large community centers with an academic affiliation. The SHM annual survey cohort included more physicians from nonteaching hospitals (58.7%) and fewer from academic medical centers (14.8%).¹³

Hospitalists’ presence in the ICU varied by practice setting (Table 1).

Seventy-eight percent of respondents practicing outside of academic medical centers served as primary ICU physicians, compared with less than 30% of hospitalists practicing at an academic medical center. Hospitalists reported substantial variability in their volumes of ICU procedures (eg, central lines, intubation), the number of mechanically ventilated patients for whom they delivered care, and who was responsible for making ventilator management decisions (Table 1).

Hospitalists were significantly more prevalent in rural ICUs than in nonrural settings (96% vs 73%; Table 2).

Rural hospitalists were also more likely to serve as primary physicians for ICU patients (85% vs 62%) and were more likely to deliver all critical care services (55% vs 10%). Seventy-five percent of respondents from rural settings reported that hospitalists manage all or most ICU patients in their hospital as opposed to 36% for nonrural respondents. The associations between hospitalist roles in the ICU care and practice setting were significantly different for rural and nonrural hospitalists (χ²P value for association <.001). Intensivist availability (measured both in hours per day and by perception of whether such support was sufficient) was significantly lower in rural ICUs (Table 2).

We found similar results when comparing academic hospitalists (those working in an academic medical center or academic-affiliated hospital) with nonacademic hospitalists (those working in critical access or small community centers). Specifically, hospitalists in nonacademic settings were significantly more prevalent in ICUs (90% vs 67%; Table 2), more likely to serve as the primary attending (81% vs 55%), and more likely to deliver all critical care services (64% vs 25%). Sixty-four percent of respondents from nonacademic settings reported that hospitalists manage all or most ICU patients in their hospital as opposed to 25% for academic respondents (χ²P value for association <.001). Intensivist availability was also significantly lower in nonacademic ICUs (Table 2).

We also sought to determine whether the ability to transfer critically ill patients to higher levels of care effectively mitigated shortfalls in intensivist staffing. When restricted to hospitalists who served as primary providers for ICU patients, 28% of all respondents and 51% of rural hospitalists reported transferring patients to a higher level of care.

Sixty-seven percent of hospitalists who served as primary physicians for ICU patients in any setting reported at least moderate difficulty arranging transfers to higher levels of care.

Objective 2: Identifying the Practice Gap

Hospitalists’ perceptions of practicing critical care beyond their skill level and without sufficient board-certified intensivist support varied by both practice location and practice type (Table 3).

In marked contrast to nonrural hospitalists, 43% of rural hospitalists reported feeling expected to practice beyond their perceived scope of expertise at least some of the time, and 31% reported never having sufficient board-certified intensivist support. Both these results were statistically significantly different when compared with nonrural hospitalists. When restricted to rural hospitalists who are primary providers for ICU patients, 90% reported that board-certified intensivist support was at least occasionally insufficient.

There were similar discrepancies between academic and nonacademic respondents. Forty-two percent of respondents practicing in nonacademic settings reported being expected to practice beyond their scope at least some of the time, and 18% reported that intensivist support was never sufficient. This contrasts with academic hospitalists, of whom 35% reported feeling expected to practice outside their scope, and less than 4% reported the available support from intensivists was never sufficient. For comparisons of academic and nonacademic respondents, only perceptions of sufficient board-certified intensivist support reached statistical significance (Table 3).

The role of intensivists in making management decisions and the strategy for ventilator management decisions correlated significantly with perception of intensivist support (P < .001) but not with the perception of practicing beyond one’s scope. The number of ventilated patients did not correlate significantly with either perception of intensivist support or of being expected to practice beyond scope.

Difficulty transferring patients to a higher level of care was the only attribute that significantly correlated with hospitalists’ perceptions of having to practice beyond their skill level (P < .05; Table 3). Difficulty of transfer was also significantly associated with perceived adequacy of board-certified intensivist support (P < .001). Total hours of intensivist coverage, intensivist role in decision making, and ventilator management arrangements also correlated significantly with the perceived adequacy of board-certified intensivist support (P < .001 for all; Table 3).

 

Objective 3: Assessing Interest in Critical Care Education

More than 85% of respondents indicated interest in obtaining additional critical care training and some form of certification short of fellowship training. Preferred modes of content delivery included courses or precourses at national meetings, academies, or online modules. Hospitalists in smaller communities indicated preference for online resources.

DISCUSSION

This survey of a large national cohort of hospitalists from diverse practice settings validates previous studies suggesting that hospitalists deliver critical care services, most notably in community and rural hospitals.¹³ A substantial subset of our respondents represented rural practice settings, which allowed us to compare rural and nonrural hospitalists as well as those practicing in academic and nonacademic settings. In assessing both the objective services that hospitalists provided as well as their subjective perceptions of how they practiced, we could correlate factors associated with the sense of practicing beyond one’s skill or feeling inadequately supported by board-certified intensivists.

More than a third of responding hospitalists who practiced in the ICU reported that they practiced beyond their self-perceived skill level, and almost three-fourths indicated that they practiced without consistent or adequate board-certified intensivist support. Rural and nonacademic hospitalists were far more likely to report delivering critical care beyond their comfort level and having insufficient board-certified intensivist support.

Calls for board-certified intensivists to deliver critical care to all critically ill patients do not reflect the reality in many American hospitals and, either by intent or by default, hospitalists have become the major and often sole providers of critical care services in many hospitals without robust intensivist support. We suspect that this phenomenon has been consistently underreported in the literature because academic hospitalists generally do not practice critical care.¹⁵

Many potential solutions to the intensivist shortage have been explored. Prior efforts in the United States have focused largely on care standardization and the recruitment of more trainees into existing critical care training pathways.¹⁶ Other countries have created multidisciplinary critical care training pathways that delink critical care from specific subspecialty training programs.¹⁷ Another potential solution to ensure that critically ill patients receive care from board-certified intensivists is to regionalize critical care such that the sickest patients are consistently transferred to referral centers with robust intensivist staffing.^1,18 While such an approach has been effectively implemented for trauma patients⁷, it has yet to materialize on a systemic basis for other critically ill cohorts. Moreover, our data suggest that hospitalists who attempt to transfer patients to higher levels of critical care find doing so burdensome and difficult.

Our surveyed hospitalists overwhelmingly expressed interest in augmenting their critical care skills and knowledge. However, most existing critical care educational offerings are not optimized for hospitalists, either focusing on very specific skills or knowledge (eg, procedural techniques or point-of-care ultrasound) or providing entry-level or very foundational education. None of these offerings provide comprehensive, structured training schemas for hospitalists who need to evolve beyond basic critical care skills to manage critically ill patients competently and consistently for extended periods of time.

Our study has several limitations. First, we estimate that about 10% of invited participants responded to this survey, but as respondents could forward the survey via professional networks, this is only an estimate. It is possible but unlikely that some respondents could have completed the survey more than once. Second, because our analysis identified only associations, we cannot infer causality for any of our findings. Third, the questionnaire was not designed to capture the acuity threshold at which point each respondent would prefer to transfer their patients into an ICU setting or to another institution for assistance in critical care management. We recognize that definitions and perceptions of patient acuity vary markedly from one hospital to the next, and a patient who can be comfortably managed in a floor setting in one hospital may require ICU care in a smaller or less well-resourced hospital. Practice patterns relating to acuity thresholds could have a substantial impact both on critical care patient volumes and on provider perceptions and, as such, warrant further study.

Finally, as respondents participated voluntarily, our sample may have overrepresented hospitalists who practice or are interested in critical care, thereby overestimating the scope of the problem and hospitalists’ interest in nonfellowship critical care training and certification. However, this seems unlikely given that, relative to SHM’s annual survey, we overrepresented hospitalists from academic and large community medical centers who generally provide less critical care than other hospitalists.¹³ Provided that roughly 85% of the estimated 50,000 American hospitalists practice outside of academic medical centers,¹³ perhaps as many as 37,000 hospitalists regularly deliver care to critically ill patients in ICUs. In light of the evolving intensivist shortage,^4,5 this number seems likely to continue to grow. Whatever biases may exist in our sample, it is evident that a substantial number of ICU patients are managed by hospitalists who feel unprepared and undersupported to perform the task.

Without a massive and sustained increase in the number of board-certified intensivists or a systemic national plan to regionalize critical care delivery, hospitalists will continue to practice critical care, frequently with inadequate knowledge, skills, or intensivist support. Fortunately, these same hospitalists appear to be highly interested in augmenting their skills to care for their critically ill patients. The HM and critical care communities must rise to this challenge and help these providers deliver safe, appropriate, and high-quality care to their critically ill patients.

 

Disclosure

Mark V. Williams, MD, FACP, MHM, receives funding from the Patient Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Centers for Medicare & Medicaid Services, and Society of Hospital Medicine honoraria.

Society of Hospital Medicine Resources

• SHM Offerings on Critical Care
• Critical Care for the Hospitalist Series on the SHM Learning Portal

Despite calls for board-certified intensivist physicians to lead critical care delivery,^1-3 the intensivist shortage in the United States continues to worsen,⁴ with projected shortfalls of 22% by 2020 and 35% by 2030.⁵ Many hospitals currently have inadequate or no board-certified intensivist support.⁶ The intensivist shortage has necessitated the development of alternative intensive care unit (ICU) staffing models, including engagement in telemedicine,⁷ the utilization of advanced practice providers,⁸ and dependence on hospitalists⁹ to deliver critical care services to ICU patients. Presently, research does not clearly show consistent differences in clinical outcomes based on the training of the clinical provider, although optimized teamwork and team rounds in the ICU do seem to be associated with improved outcomes.^10-12

In its 2016 annual survey of hospital medicine (HM) leaders, the Society of Hospital Medicine (SHM) documented that most HM groups care for ICU patients, with up to 80% of hospitalist groups in some regions delivering critical care.¹³ In many United States hospitals, hospitalists serve as the primary if not lone physician providers of critical care.^6,14 HM, with its team-based approach and on-site presence, shares many of the key attributes and values that define high-functioning critical care teams, and many hospitalists likely capably deliver some critical care services.⁹ However, hospitalists are also a highly heterogeneous work force with varied exposure to and comfort with critical care medicine, making it difficult to generalize hospitalists’ scope of practice in the ICU.

Because hospitalists render a significant amount of critical care in the United States, we surveyed practicing hospitalists to understand their demographics and practice roles in the ICU setting and to ascertain how they are supported when doing so. Additionally, we sought to identify mismatches between the ICU services that hospitalists provide and what they feel prepared and supported to deliver. Finally, we attempted to elucidate how hospitalists who practice in the ICU might respond to novel educational offerings targeted to mitigate cognitive or procedural gaps.

METHODS

We developed and deployed a survey to address the aforementioned questions. The survey content was developed iteratively by the Critical Care Task Force of SHM’s Education Committee and subsequently approved by SHM’s Education Committee and Board of Directors. Members of the Critical Care Task Force include critical care physicians and hospitalists. The survey included 25 items (supplemental Appendix A). Seventeen questions addressed the demographics and practice roles of hospitalists in the ICU, 5 addressed cognitive and procedural practice gaps, and 3 addressed how hospitalists would respond to educational opportunities in critical care. We used conditional formatting to ensure that only respondents who deliver ICU care could answer questions related to ICU practice. The survey was delivered by using an online survey platform (Survey Monkey, San Mateo, CA).

The survey was deployed in 3 phases from March to October of 2016. Initially, we distributed a pilot survey to professional contacts of the Critical Care Task Force to solicit feedback and refine the survey’s format and content. These contacts were largely academic hospitalists from our local institutions. We then distributed the survey to hospitalists via professional networks with instructions to forward the link to interested hospitalists. Finally, we distributed the survey to approximately 4000 hospitalists randomly selected from SHM’s national listserv of approximately 12,000 hospitalists. Respondents could enter a drawing for a monetary prize upon completion of the survey.

None of the survey questions changed during the 3 phases of survey deployment, and the data reported herein were compiled from all 3 phases of the survey deployment. Frequency tables were created using Tableau (version 10.0; Tableau Software, Seattle, WA). Comparisons between categorical questions were made by using χ² and Fischer exact tests to calculate P values for associations by using SAS (version 9.3; SAS Institute, Cary, NC). Associations with P values below .05 were considered statistically significant.

 

RESULTS

Objective 1: Demographics and Practice Role

Four hundred and twenty-five hospitalists responded to the survey. The first 2 phases (pilot survey and distribution via professional networks) generated 101 responses, and the third phase (via SHM’s listserv) generated an additional 324 responses. As the survey was anonymous, we could not determine which hospitals or geographic regions were represented. Three hundred and twenty-five of the 425 hospitalists who completed the survey (77%) reported that they delivered care in the ICU. Of these 325 hospitalists, 45 served only as consultants, while the remaining 280 (66% of the total sample) served as the primary attending physician in the ICU. Among these primary providers of care in the ICU, 60 (21%) practiced in rural settings and 220 (79%) practiced in nonrural settings (Figure 1).

The demographics of our respondents were similar to those of the SHM annual survey,¹³ in which 66% of respondents delivered ICU care. Forty-one percent of our respondents worked in critical access or small community hospitals, 24% in academic medical centers, and 34% in large community centers with an academic affiliation. The SHM annual survey cohort included more physicians from nonteaching hospitals (58.7%) and fewer from academic medical centers (14.8%).¹³

Hospitalists’ presence in the ICU varied by practice setting (Table 1).

Seventy-eight percent of respondents practicing outside of academic medical centers served as primary ICU physicians, compared with less than 30% of hospitalists practicing at an academic medical center. Hospitalists reported substantial variability in their volumes of ICU procedures (eg, central lines, intubation), the number of mechanically ventilated patients for whom they delivered care, and who was responsible for making ventilator management decisions (Table 1).

Hospitalists were significantly more prevalent in rural ICUs than in nonrural settings (96% vs 73%; Table 2).

Rural hospitalists were also more likely to serve as primary physicians for ICU patients (85% vs 62%) and were more likely to deliver all critical care services (55% vs 10%). Seventy-five percent of respondents from rural settings reported that hospitalists manage all or most ICU patients in their hospital as opposed to 36% for nonrural respondents. The associations between hospitalist roles in the ICU care and practice setting were significantly different for rural and nonrural hospitalists (χ²P value for association <.001). Intensivist availability (measured both in hours per day and by perception of whether such support was sufficient) was significantly lower in rural ICUs (Table 2).

We found similar results when comparing academic hospitalists (those working in an academic medical center or academic-affiliated hospital) with nonacademic hospitalists (those working in critical access or small community centers). Specifically, hospitalists in nonacademic settings were significantly more prevalent in ICUs (90% vs 67%; Table 2), more likely to serve as the primary attending (81% vs 55%), and more likely to deliver all critical care services (64% vs 25%). Sixty-four percent of respondents from nonacademic settings reported that hospitalists manage all or most ICU patients in their hospital as opposed to 25% for academic respondents (χ²P value for association <.001). Intensivist availability was also significantly lower in nonacademic ICUs (Table 2).

We also sought to determine whether the ability to transfer critically ill patients to higher levels of care effectively mitigated shortfalls in intensivist staffing. When restricted to hospitalists who served as primary providers for ICU patients, 28% of all respondents and 51% of rural hospitalists reported transferring patients to a higher level of care.

Sixty-seven percent of hospitalists who served as primary physicians for ICU patients in any setting reported at least moderate difficulty arranging transfers to higher levels of care.

Objective 2: Identifying the Practice Gap

Hospitalists’ perceptions of practicing critical care beyond their skill level and without sufficient board-certified intensivist support varied by both practice location and practice type (Table 3).

In marked contrast to nonrural hospitalists, 43% of rural hospitalists reported feeling expected to practice beyond their perceived scope of expertise at least some of the time, and 31% reported never having sufficient board-certified intensivist support. Both these results were statistically significantly different when compared with nonrural hospitalists. When restricted to rural hospitalists who are primary providers for ICU patients, 90% reported that board-certified intensivist support was at least occasionally insufficient.

There were similar discrepancies between academic and nonacademic respondents. Forty-two percent of respondents practicing in nonacademic settings reported being expected to practice beyond their scope at least some of the time, and 18% reported that intensivist support was never sufficient. This contrasts with academic hospitalists, of whom 35% reported feeling expected to practice outside their scope, and less than 4% reported the available support from intensivists was never sufficient. For comparisons of academic and nonacademic respondents, only perceptions of sufficient board-certified intensivist support reached statistical significance (Table 3).

The role of intensivists in making management decisions and the strategy for ventilator management decisions correlated significantly with perception of intensivist support (P < .001) but not with the perception of practicing beyond one’s scope. The number of ventilated patients did not correlate significantly with either perception of intensivist support or of being expected to practice beyond scope.

Difficulty transferring patients to a higher level of care was the only attribute that significantly correlated with hospitalists’ perceptions of having to practice beyond their skill level (P < .05; Table 3). Difficulty of transfer was also significantly associated with perceived adequacy of board-certified intensivist support (P < .001). Total hours of intensivist coverage, intensivist role in decision making, and ventilator management arrangements also correlated significantly with the perceived adequacy of board-certified intensivist support (P < .001 for all; Table 3).

 

Objective 3: Assessing Interest in Critical Care Education

More than 85% of respondents indicated interest in obtaining additional critical care training and some form of certification short of fellowship training. Preferred modes of content delivery included courses or precourses at national meetings, academies, or online modules. Hospitalists in smaller communities indicated preference for online resources.

DISCUSSION

This survey of a large national cohort of hospitalists from diverse practice settings validates previous studies suggesting that hospitalists deliver critical care services, most notably in community and rural hospitals.¹³ A substantial subset of our respondents represented rural practice settings, which allowed us to compare rural and nonrural hospitalists as well as those practicing in academic and nonacademic settings. In assessing both the objective services that hospitalists provided as well as their subjective perceptions of how they practiced, we could correlate factors associated with the sense of practicing beyond one’s skill or feeling inadequately supported by board-certified intensivists.

More than a third of responding hospitalists who practiced in the ICU reported that they practiced beyond their self-perceived skill level, and almost three-fourths indicated that they practiced without consistent or adequate board-certified intensivist support. Rural and nonacademic hospitalists were far more likely to report delivering critical care beyond their comfort level and having insufficient board-certified intensivist support.

Calls for board-certified intensivists to deliver critical care to all critically ill patients do not reflect the reality in many American hospitals and, either by intent or by default, hospitalists have become the major and often sole providers of critical care services in many hospitals without robust intensivist support. We suspect that this phenomenon has been consistently underreported in the literature because academic hospitalists generally do not practice critical care.¹⁵

Many potential solutions to the intensivist shortage have been explored. Prior efforts in the United States have focused largely on care standardization and the recruitment of more trainees into existing critical care training pathways.¹⁶ Other countries have created multidisciplinary critical care training pathways that delink critical care from specific subspecialty training programs.¹⁷ Another potential solution to ensure that critically ill patients receive care from board-certified intensivists is to regionalize critical care such that the sickest patients are consistently transferred to referral centers with robust intensivist staffing.^1,18 While such an approach has been effectively implemented for trauma patients⁷, it has yet to materialize on a systemic basis for other critically ill cohorts. Moreover, our data suggest that hospitalists who attempt to transfer patients to higher levels of critical care find doing so burdensome and difficult.

Our surveyed hospitalists overwhelmingly expressed interest in augmenting their critical care skills and knowledge. However, most existing critical care educational offerings are not optimized for hospitalists, either focusing on very specific skills or knowledge (eg, procedural techniques or point-of-care ultrasound) or providing entry-level or very foundational education. None of these offerings provide comprehensive, structured training schemas for hospitalists who need to evolve beyond basic critical care skills to manage critically ill patients competently and consistently for extended periods of time.

Our study has several limitations. First, we estimate that about 10% of invited participants responded to this survey, but as respondents could forward the survey via professional networks, this is only an estimate. It is possible but unlikely that some respondents could have completed the survey more than once. Second, because our analysis identified only associations, we cannot infer causality for any of our findings. Third, the questionnaire was not designed to capture the acuity threshold at which point each respondent would prefer to transfer their patients into an ICU setting or to another institution for assistance in critical care management. We recognize that definitions and perceptions of patient acuity vary markedly from one hospital to the next, and a patient who can be comfortably managed in a floor setting in one hospital may require ICU care in a smaller or less well-resourced hospital. Practice patterns relating to acuity thresholds could have a substantial impact both on critical care patient volumes and on provider perceptions and, as such, warrant further study.

Finally, as respondents participated voluntarily, our sample may have overrepresented hospitalists who practice or are interested in critical care, thereby overestimating the scope of the problem and hospitalists’ interest in nonfellowship critical care training and certification. However, this seems unlikely given that, relative to SHM’s annual survey, we overrepresented hospitalists from academic and large community medical centers who generally provide less critical care than other hospitalists.¹³ Provided that roughly 85% of the estimated 50,000 American hospitalists practice outside of academic medical centers,¹³ perhaps as many as 37,000 hospitalists regularly deliver care to critically ill patients in ICUs. In light of the evolving intensivist shortage,^4,5 this number seems likely to continue to grow. Whatever biases may exist in our sample, it is evident that a substantial number of ICU patients are managed by hospitalists who feel unprepared and undersupported to perform the task.

Without a massive and sustained increase in the number of board-certified intensivists or a systemic national plan to regionalize critical care delivery, hospitalists will continue to practice critical care, frequently with inadequate knowledge, skills, or intensivist support. Fortunately, these same hospitalists appear to be highly interested in augmenting their skills to care for their critically ill patients. The HM and critical care communities must rise to this challenge and help these providers deliver safe, appropriate, and high-quality care to their critically ill patients.

 

Disclosure

Mark V. Williams, MD, FACP, MHM, receives funding from the Patient Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Centers for Medicare & Medicaid Services, and Society of Hospital Medicine honoraria.

Society of Hospital Medicine Resources

• SHM Offerings on Critical Care
• Critical Care for the Hospitalist Series on the SHM Learning Portal

Despite calls for board-certified intensivist physicians to lead critical care delivery,^1-3 the intensivist shortage in the United States continues to worsen,⁴ with projected shortfalls of 22% by 2020 and 35% by 2030.⁵ Many hospitals currently have inadequate or no board-certified intensivist support.⁶ The intensivist shortage has necessitated the development of alternative intensive care unit (ICU) staffing models, including engagement in telemedicine,⁷ the utilization of advanced practice providers,⁸ and dependence on hospitalists⁹ to deliver critical care services to ICU patients. Presently, research does not clearly show consistent differences in clinical outcomes based on the training of the clinical provider, although optimized teamwork and team rounds in the ICU do seem to be associated with improved outcomes.^10-12

In its 2016 annual survey of hospital medicine (HM) leaders, the Society of Hospital Medicine (SHM) documented that most HM groups care for ICU patients, with up to 80% of hospitalist groups in some regions delivering critical care.¹³ In many United States hospitals, hospitalists serve as the primary if not lone physician providers of critical care.^6,14 HM, with its team-based approach and on-site presence, shares many of the key attributes and values that define high-functioning critical care teams, and many hospitalists likely capably deliver some critical care services.⁹ However, hospitalists are also a highly heterogeneous work force with varied exposure to and comfort with critical care medicine, making it difficult to generalize hospitalists’ scope of practice in the ICU.

Because hospitalists render a significant amount of critical care in the United States, we surveyed practicing hospitalists to understand their demographics and practice roles in the ICU setting and to ascertain how they are supported when doing so. Additionally, we sought to identify mismatches between the ICU services that hospitalists provide and what they feel prepared and supported to deliver. Finally, we attempted to elucidate how hospitalists who practice in the ICU might respond to novel educational offerings targeted to mitigate cognitive or procedural gaps.

METHODS

We developed and deployed a survey to address the aforementioned questions. The survey content was developed iteratively by the Critical Care Task Force of SHM’s Education Committee and subsequently approved by SHM’s Education Committee and Board of Directors. Members of the Critical Care Task Force include critical care physicians and hospitalists. The survey included 25 items (supplemental Appendix A). Seventeen questions addressed the demographics and practice roles of hospitalists in the ICU, 5 addressed cognitive and procedural practice gaps, and 3 addressed how hospitalists would respond to educational opportunities in critical care. We used conditional formatting to ensure that only respondents who deliver ICU care could answer questions related to ICU practice. The survey was delivered by using an online survey platform (Survey Monkey, San Mateo, CA).

The survey was deployed in 3 phases from March to October of 2016. Initially, we distributed a pilot survey to professional contacts of the Critical Care Task Force to solicit feedback and refine the survey’s format and content. These contacts were largely academic hospitalists from our local institutions. We then distributed the survey to hospitalists via professional networks with instructions to forward the link to interested hospitalists. Finally, we distributed the survey to approximately 4000 hospitalists randomly selected from SHM’s national listserv of approximately 12,000 hospitalists. Respondents could enter a drawing for a monetary prize upon completion of the survey.

None of the survey questions changed during the 3 phases of survey deployment, and the data reported herein were compiled from all 3 phases of the survey deployment. Frequency tables were created using Tableau (version 10.0; Tableau Software, Seattle, WA). Comparisons between categorical questions were made by using χ² and Fischer exact tests to calculate P values for associations by using SAS (version 9.3; SAS Institute, Cary, NC). Associations with P values below .05 were considered statistically significant.

 

RESULTS

Objective 1: Demographics and Practice Role

Four hundred and twenty-five hospitalists responded to the survey. The first 2 phases (pilot survey and distribution via professional networks) generated 101 responses, and the third phase (via SHM’s listserv) generated an additional 324 responses. As the survey was anonymous, we could not determine which hospitals or geographic regions were represented. Three hundred and twenty-five of the 425 hospitalists who completed the survey (77%) reported that they delivered care in the ICU. Of these 325 hospitalists, 45 served only as consultants, while the remaining 280 (66% of the total sample) served as the primary attending physician in the ICU. Among these primary providers of care in the ICU, 60 (21%) practiced in rural settings and 220 (79%) practiced in nonrural settings (Figure 1).

The demographics of our respondents were similar to those of the SHM annual survey,¹³ in which 66% of respondents delivered ICU care. Forty-one percent of our respondents worked in critical access or small community hospitals, 24% in academic medical centers, and 34% in large community centers with an academic affiliation. The SHM annual survey cohort included more physicians from nonteaching hospitals (58.7%) and fewer from academic medical centers (14.8%).¹³

Hospitalists’ presence in the ICU varied by practice setting (Table 1).

Seventy-eight percent of respondents practicing outside of academic medical centers served as primary ICU physicians, compared with less than 30% of hospitalists practicing at an academic medical center. Hospitalists reported substantial variability in their volumes of ICU procedures (eg, central lines, intubation), the number of mechanically ventilated patients for whom they delivered care, and who was responsible for making ventilator management decisions (Table 1).

Hospitalists were significantly more prevalent in rural ICUs than in nonrural settings (96% vs 73%; Table 2).

Rural hospitalists were also more likely to serve as primary physicians for ICU patients (85% vs 62%) and were more likely to deliver all critical care services (55% vs 10%). Seventy-five percent of respondents from rural settings reported that hospitalists manage all or most ICU patients in their hospital as opposed to 36% for nonrural respondents. The associations between hospitalist roles in the ICU care and practice setting were significantly different for rural and nonrural hospitalists (χ²P value for association <.001). Intensivist availability (measured both in hours per day and by perception of whether such support was sufficient) was significantly lower in rural ICUs (Table 2).

We found similar results when comparing academic hospitalists (those working in an academic medical center or academic-affiliated hospital) with nonacademic hospitalists (those working in critical access or small community centers). Specifically, hospitalists in nonacademic settings were significantly more prevalent in ICUs (90% vs 67%; Table 2), more likely to serve as the primary attending (81% vs 55%), and more likely to deliver all critical care services (64% vs 25%). Sixty-four percent of respondents from nonacademic settings reported that hospitalists manage all or most ICU patients in their hospital as opposed to 25% for academic respondents (χ²P value for association <.001). Intensivist availability was also significantly lower in nonacademic ICUs (Table 2).

We also sought to determine whether the ability to transfer critically ill patients to higher levels of care effectively mitigated shortfalls in intensivist staffing. When restricted to hospitalists who served as primary providers for ICU patients, 28% of all respondents and 51% of rural hospitalists reported transferring patients to a higher level of care.

Sixty-seven percent of hospitalists who served as primary physicians for ICU patients in any setting reported at least moderate difficulty arranging transfers to higher levels of care.

Objective 2: Identifying the Practice Gap

Hospitalists’ perceptions of practicing critical care beyond their skill level and without sufficient board-certified intensivist support varied by both practice location and practice type (Table 3).

In marked contrast to nonrural hospitalists, 43% of rural hospitalists reported feeling expected to practice beyond their perceived scope of expertise at least some of the time, and 31% reported never having sufficient board-certified intensivist support. Both these results were statistically significantly different when compared with nonrural hospitalists. When restricted to rural hospitalists who are primary providers for ICU patients, 90% reported that board-certified intensivist support was at least occasionally insufficient.

There were similar discrepancies between academic and nonacademic respondents. Forty-two percent of respondents practicing in nonacademic settings reported being expected to practice beyond their scope at least some of the time, and 18% reported that intensivist support was never sufficient. This contrasts with academic hospitalists, of whom 35% reported feeling expected to practice outside their scope, and less than 4% reported the available support from intensivists was never sufficient. For comparisons of academic and nonacademic respondents, only perceptions of sufficient board-certified intensivist support reached statistical significance (Table 3).

The role of intensivists in making management decisions and the strategy for ventilator management decisions correlated significantly with perception of intensivist support (P < .001) but not with the perception of practicing beyond one’s scope. The number of ventilated patients did not correlate significantly with either perception of intensivist support or of being expected to practice beyond scope.

Difficulty transferring patients to a higher level of care was the only attribute that significantly correlated with hospitalists’ perceptions of having to practice beyond their skill level (P < .05; Table 3). Difficulty of transfer was also significantly associated with perceived adequacy of board-certified intensivist support (P < .001). Total hours of intensivist coverage, intensivist role in decision making, and ventilator management arrangements also correlated significantly with the perceived adequacy of board-certified intensivist support (P < .001 for all; Table 3).

 

Objective 3: Assessing Interest in Critical Care Education

More than 85% of respondents indicated interest in obtaining additional critical care training and some form of certification short of fellowship training. Preferred modes of content delivery included courses or precourses at national meetings, academies, or online modules. Hospitalists in smaller communities indicated preference for online resources.

DISCUSSION

This survey of a large national cohort of hospitalists from diverse practice settings validates previous studies suggesting that hospitalists deliver critical care services, most notably in community and rural hospitals.¹³ A substantial subset of our respondents represented rural practice settings, which allowed us to compare rural and nonrural hospitalists as well as those practicing in academic and nonacademic settings. In assessing both the objective services that hospitalists provided as well as their subjective perceptions of how they practiced, we could correlate factors associated with the sense of practicing beyond one’s skill or feeling inadequately supported by board-certified intensivists.

More than a third of responding hospitalists who practiced in the ICU reported that they practiced beyond their self-perceived skill level, and almost three-fourths indicated that they practiced without consistent or adequate board-certified intensivist support. Rural and nonacademic hospitalists were far more likely to report delivering critical care beyond their comfort level and having insufficient board-certified intensivist support.

Calls for board-certified intensivists to deliver critical care to all critically ill patients do not reflect the reality in many American hospitals and, either by intent or by default, hospitalists have become the major and often sole providers of critical care services in many hospitals without robust intensivist support. We suspect that this phenomenon has been consistently underreported in the literature because academic hospitalists generally do not practice critical care.¹⁵

Many potential solutions to the intensivist shortage have been explored. Prior efforts in the United States have focused largely on care standardization and the recruitment of more trainees into existing critical care training pathways.¹⁶ Other countries have created multidisciplinary critical care training pathways that delink critical care from specific subspecialty training programs.¹⁷ Another potential solution to ensure that critically ill patients receive care from board-certified intensivists is to regionalize critical care such that the sickest patients are consistently transferred to referral centers with robust intensivist staffing.^1,18 While such an approach has been effectively implemented for trauma patients⁷, it has yet to materialize on a systemic basis for other critically ill cohorts. Moreover, our data suggest that hospitalists who attempt to transfer patients to higher levels of critical care find doing so burdensome and difficult.

Our surveyed hospitalists overwhelmingly expressed interest in augmenting their critical care skills and knowledge. However, most existing critical care educational offerings are not optimized for hospitalists, either focusing on very specific skills or knowledge (eg, procedural techniques or point-of-care ultrasound) or providing entry-level or very foundational education. None of these offerings provide comprehensive, structured training schemas for hospitalists who need to evolve beyond basic critical care skills to manage critically ill patients competently and consistently for extended periods of time.

Our study has several limitations. First, we estimate that about 10% of invited participants responded to this survey, but as respondents could forward the survey via professional networks, this is only an estimate. It is possible but unlikely that some respondents could have completed the survey more than once. Second, because our analysis identified only associations, we cannot infer causality for any of our findings. Third, the questionnaire was not designed to capture the acuity threshold at which point each respondent would prefer to transfer their patients into an ICU setting or to another institution for assistance in critical care management. We recognize that definitions and perceptions of patient acuity vary markedly from one hospital to the next, and a patient who can be comfortably managed in a floor setting in one hospital may require ICU care in a smaller or less well-resourced hospital. Practice patterns relating to acuity thresholds could have a substantial impact both on critical care patient volumes and on provider perceptions and, as such, warrant further study.

Finally, as respondents participated voluntarily, our sample may have overrepresented hospitalists who practice or are interested in critical care, thereby overestimating the scope of the problem and hospitalists’ interest in nonfellowship critical care training and certification. However, this seems unlikely given that, relative to SHM’s annual survey, we overrepresented hospitalists from academic and large community medical centers who generally provide less critical care than other hospitalists.¹³ Provided that roughly 85% of the estimated 50,000 American hospitalists practice outside of academic medical centers,¹³ perhaps as many as 37,000 hospitalists regularly deliver care to critically ill patients in ICUs. In light of the evolving intensivist shortage,^4,5 this number seems likely to continue to grow. Whatever biases may exist in our sample, it is evident that a substantial number of ICU patients are managed by hospitalists who feel unprepared and undersupported to perform the task.

Without a massive and sustained increase in the number of board-certified intensivists or a systemic national plan to regionalize critical care delivery, hospitalists will continue to practice critical care, frequently with inadequate knowledge, skills, or intensivist support. Fortunately, these same hospitalists appear to be highly interested in augmenting their skills to care for their critically ill patients. The HM and critical care communities must rise to this challenge and help these providers deliver safe, appropriate, and high-quality care to their critically ill patients.

 

Disclosure

Mark V. Williams, MD, FACP, MHM, receives funding from the Patient Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Centers for Medicare & Medicaid Services, and Society of Hospital Medicine honoraria.

Society of Hospital Medicine Resources

• SHM Offerings on Critical Care
• Critical Care for the Hospitalist Series on the SHM Learning Portal

The value placed on bedside clinical observation in the decision-making process of a patient’s illness has been diminished by today’s armamentarium of sophisticated technology. Increasing reliance is now placed on the result of nonspecific tests in preference to bedside clinical judgement in the diagnostic and management process. While diagnostic investigations have undoubtedly provided great advancements in medical care, they come at time and financial costs. Physicians should therefore continue to be encouraged to make clinical decisions based on their bedside assessment.

With hospital overcrowding a significant problem within the healthcare system and the expectation that it will worsen with an ageing population, identifying factors that predict patient suitability for discharge has become an important focus for clinicians.^1,2 There exists a paucity of literature predicting discharge suitability of general surgical patients admitted through the emergency department (ED). Furthermore, despite the extensive research into the effectiveness of discharge planning,³ little research has been conducted to describe positive predictive indicators for discharge. Observations made during surgical rounds have led the authors to consider that individuals who are using a smartphone during their bedside assessment may be clinically well enough for discharge.

The aim of this study was to assess whether the clinical assessment of an acute surgical patient could be usefully augmented by the observation of the active use of smartphones (the smartphone sign) and whether this could be used as a surrogate marker to indicate a patient’s well-being and suitability for same-day discharge from the hospital in acute surgical patients.

METHODS

Design and Setting

This was a prospective observational study performed over 2 periods at a tertiary hospital in South Australia, Australia. At our institution, acute surgical patients are admitted to the acute surgical unit (ASU) from the ED by junior surgical doctors. Patients are then reviewed by the on-call surgical consultant, who implements management plans or advises discharge on 2 occasions per day.

Participants

All patients admitted under the ASU were considered eligible for the study. Exclusion criteria included patients that (i) required immediate surgical intervention (defined as time of review to theatre of less than 4 hours) and (ii) had immediate admission to the intensive care unit.

Consultant surgeons are employed within a general surgical subspecialty, including upper gastrointestinal, hepatobiliary, breast and endocrine, and colorectal. All surgeons from each team partake in the general surgery on-call roster. Each surgeon was included at least once within the observation periods. Experience of consultant surgeons ranged from 5 years of postfellowship experience to surgeons with more than 30 years of experience, with the majority having more than 10 years of postfellowship experience.

Patients were stratified into 2 distinct cohorts upon consultant review: smartphone positive (spP) was defined as a patient who was using a smartphone or who had their phone on their bed; a patient was classified as smartphone negative (spN) if they did not fulfil these criteria. The presence or absence of a smartphone was recorded by the authors, who were present on consultant ward rounds but not involved in the decision-making process of patient care. In order to minimize bias, only 1 surgeon (PGD) was aware that the study was being conducted and all patients were blinded to the study. Additional information that was collected included patient demographics, requirement for surgery, and length of stay (LOS). A patient who was discharged on the same day as the consultant review was considered to be discharged on day 1, all other patients were considered to have LOS greater than 1 day. Requirement for surgery was defined as a patient who underwent a surgical procedure in an operating suite. Thirty-day unplanned readmission rates for all patients were examined. Readmission to another public hospital within the state was also included within the readmission data.

Observation Periods

An initial 4-week pilot study was conducted to assess for a possible association between spP and same-day discharge. A second 8-week study period was undertaken 1 year later accounting for the employment of the authors at the study’s institution. Unless stated, the results described are the accumulation of both study periods.

Statistical Analysis

As this is the first study of its kind, no prior estimates of numbers were known. After 2 weeks of data collection, data were analyzed in order to provide an estimate of the total number of patients required to provide a statistically valid result (α = 0.05; power = 0.80). Sample size was calculated to be 40 subjects. It was agreed that in order to make the study as robust as possible, data should be collected for the 2 observation periods.

 

Demographic data are presented as means with standard deviations (SDs) or frequencies with percentages. A 2-sample Student t test was used to compare the age of spP and spN patients. A χ² test and logistic regressions were used to assess the association between smartphone status and patient demographics, LOS, and requirement for surgery. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value of <0.05 was considered significant. All data were analyzed by using R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

RESULTS

During the 2 observation periods, a total of 227 eligible surgical admissions were observed with complete data for 221 patients. Six patients were excluded as their smartphone status was not recorded. The study sample represents our population of interest within an ASU, and we had complete data for 97.4% of participants with a 100% follow-up. There was no significant effect of study between the 2 observation periods (χ² = 140.19; P = 0.10). The mean age of patients was 50.24 years. Further demographic data are presented in Table 1. Twenty-five (11.3%) patients were spP and 196 (88.7%) were spN. Fifty-two (23.5%) patients were discharged home on day 1, and 169 (76.5%) had admissions longer than 1 day (see Figure). Sixty (27%) patients underwent surgery during their admission. Twenty-two patients had unplanned readmissions; only 1 of these patients had been observed to be spP.

There was a statistically significant difference in ages between the spP and spN groups (t = 8.40; P < 0.0005), with the average age of spP patients being 31.84 years compared with 52.58 years for spN patients. There was no statistical difference between gender and smartphone status (χ² = 1.78; P = 0.18; Table 2).

For those patients discharged home on day 1, there was a statistically significant association with being spP (χ² = 14.55, P = 0.0001). Patients who were spP were 5.29 times more likely to be discharged on day 1 (95% CI, 2.24-12.84). Of the variables analyzed, only gender failed to demonstrate an effect on discharge home on day 1 (Table 3). Overall, the presence of a smartphone was found to have a sensitivity of 56.0% (95% CI, 34.93-75.60) and a specificity of 80.6% (95% CI, 74.37-85.90) in regard to same-day discharge. However, it was found to have a negative predictive value of 93.49% (95% CI, 88.65-96.71).

When examining readmission rates, only 4% of spP patients were readmitted versus 10.7% of spN patients. Accounting for variables, spP patients were 4 times less likely to be readmitted, though this was not statistically significant (OR 4.02; 95% CI, 0.43-37.2; P = 0.22). Furthermore, when examining only those patients discharged on day 1, smartphone status was not a predictor of readmission (OR 0.94; 95% CI, 0.06-15.2; P = 0 .97).

To mitigate the effect of age, analysis was conducted excluding those aged over 55 years (the previous retirement age in Australia), leaving 131 patients for analysis. The average age of spP patients was 31.8 years (SD 10.0) compared with 36.7 years (SD 10.9) for spN patients, representing a significant difference (t = 2.14; P = 0.04); 51.1% of patients were male, 19.1% of patients were spP, 26.0% of patients proceeded to an operation, the oldest spP was 51 years, and 29.0% of patients were discharged home on day 1. There was no difference in gender and smartphone status (χ² = 0.33; P = 0.6). When analyzing those discharged on day 1, again spP patients were more likely to be discharged home (χ² = 9.4; P = 0.002), and spP patients were 3.6 times more likely to be discharged home on day 1.

There were 4 spP patients who underwent an operation. Two patients had an incision and drainage of a perianal abscess, 1 patient underwent a laparotomy for an internal hernia after recently undergoing a Roux-en-Y gastric bypass at another hospital, and the final patient underwent a laparoscopic appendicectomy. One of these patients was still discharged home on day 1.

DISCUSSION

As J. A. Lindsay⁴ said, “For one mistake made for not knowing, ten mistakes are made for not looking.” At medical school, we are taught the finer techniques of the physical examination in order to support our diagnosis made from the history. It is not until we are experienced clinicians do we develop the clinical acumen and ability to tell an unwell patient from a well patient at a glance—colloquially known as the “end of the bed” assessment. In the pretechnology era, a well patient could frequently be seen reading their book, eg, the “novel-sign.” With the advent of the smartphone and electronic devices upon which novels can be read, statuses updated, and locations “checked into” (ie, the modern “vital signs”), the book sign may be a thing of the past. However, the ability for the clinician to assess a patient’s wellness is still crucial, and the value of any additional “physical signs” need to be estimated.

 

We observed a cohort of patients through a busy ASU in a tertiary hospital in South Australia, Australia. Acute surgical patients admitted to the hospital who were observed to be on their phones upon consultant review were more than 5 times likely to be discharged that same day. To the best of our knowledge, this is the first study to prospectively collect data to assess a frequently used but unevaluated clinical observation.

The use of a smartphone can tell us a lot about an individual’s physiology. We can assume the individual’s airway and breathing are adequate, allowing enough oxygen to reach the lungs and subsequently circulate. The individual is usually sitting up in bed and thus has an adequate blood pressure and blood oxygenation that can maintain cerebral perfusion. They have the cognitive and cerebral processing in place to function the device, and we can examine their cerebellar function by looking for fine-motor movements.

Mobile phone ownership is pervasive within Australia,⁵ with a conservative estimated 85.7% of the population (20.57 million people of a total population of approximately 24 million) owning a mobile phone and an estimated 50% to 79% of mobile phone ownership being of a smartphone.^6,7 This ownership is not just limited to the young, with 74% of Australians over 65 owning or using a mobile phone.⁸ Despite this high phone ownership among those over 65, it is still significantly less than their younger counterparts and may be one reason for the absence of spP in those older than 51 years. A key point in the study is that overall phone ownership was not known, and, thus, it is not possible to determine the proportion of spN patients who were negative because they did not own a phone. However, based on general population data, the incidence of spP patients was well below that seen in the community (11.3%)⁵ and even when excluding those over 55, the percentage of spP patients only rose to 19.1%. Unsurprisingly, increasing age was associated with a decreased likelihood of being spP (P < 0.0005), as younger people are more likely to own a phone.⁸ There was no association with gender (P = 0.18). There are a number of explanations that may explain the lower than expected percentage of spP patients, including the inability for the patient to gather their possessions during a medical emergency, patients storing their phones prior to doctor review (72%-85% of Australians report talking on phones in public places to be rude or intrusive⁵), but more importantly, that our hypothesis that patients were too unwell to use their device appears to hold true.

There are potential alternate reasons other than smartphone status that may account for patients being discharged home on day 1. While there was no association seen with gender, the need for an operation prolonged a patient’s stay (OR 1.64; 95% CI, 0.046-0.46), and there was a trend seen with increasing age (OR 0.98; 95% CI, 0.96-1.00). Neither of these 2 demographics are unsurprising: increasing age is associated with increasing medical comorbidities and thus complexity; even the simplest of operations require a postprocedure observation period, automatically increasing their LOS. Additionally, measured demographics are limited and there may be further unmeasured reasons that account for earlier discharge.

The other key component to this study is the value of the physical examination, albeit only assessing 1 component: the general inspection. In their review of the value of the physical examination of the cardiovascular system, Elder et al. highlight an important point: in traditional teaching, the value of a physical sign is compared with a diagnostic reference, typically imaging or an invasive test.⁹ They argue that this definition undervalues the physical examination and list other values aside from accuracy including accessibility, contribution to clinical care beyond diagnoses, cost effectiveness, patients’ safety, patients’ perceptions, and pedagogic value; and they argue that the physical examination should always be considered in regard to the clinical context—in this case, the newly admitted general surgical patient.

The assessment of the presence or absence of a smartphone is readily performed upon general inspection and is easily visible; general inspection of the patient and failure to observe the clinical sign when present are 2 of the greatest errors associated with physical examination.¹⁰ Furthermore, given its unique status as a physical sign, the authors’ opinion and experience is that it is readily teachable. McGee states, “…a fundamental lesson [in regards to teaching] is that the diagnosis of many clinical problems, despite modern testing, still depends primarily on what the clinician sees, hears, and feels.”¹¹ In their article, Paley et al. found that more than 80% of patients admitted from the ED under internal medicine could be accurately diagnosed based largely on history and examination alone and concluded that basic clinical skills are sufficient for achieving an accurate diagnosis in most cases.¹² Although Paley et al. were assisted with basic tests (such as electrocardiogram and basic haematological and biochemistry results), the point of clinical skills is not lost. Furthermore, this assessment was made in a group of patients generally considered to be complex in contrast to the “standard” appendicitis or cholecystitis patient that makes up a significant proportion of general surgical patients.

There are a number of limitations to this study, however, including smartphones that may have been missed during the observational period. Potential confounding variables such as socioeconomic status and the overall smartphone ownership of our subjects were not known. We did not ask all admitted patients whether they owned a phone or whether they had a phone in their possession. Knowledge of those who owned phones but were not in possession of them could strengthen our argument that spN patients were not using their phone because they were unwell, rather than just not having access to it.

However, this study has a number of strengths, including a large sample size and data that were prospectively collected by a method and in a setting that was the same for all participants. Clear and appropriate definitions were used, which minimizes misclassification bias. Participants and decision makers were blinded to the study, and potentially confounding variables such as age and sex were accounted for.

Assessing the suitability for discharge from the hospital is a decision encountered by hospital-based clinicians every day. These skills are not taught, but are rather learned as a junior doctor acquires experience. It is unlikely that protocols will be developed to aid identification of potential discharges from an acute surgical ward; acute surgical conditions are too varied and dynamic to be able to pool all data. We continue to rely on our own and fellow colleagues’ (doctors, nurses, and other staff) input and assessment. However, our study has shown that it is possible to identify and quantify clinical findings that are already regularly used, albeit potentially subconsciously, to assess suitability for discharge. We have shown in this large, prospectively collected observational study that if a surgical patient is seen using their electronic device, they are more likely to be safe to go home. Thus, surgeons can reliably use this observation as a trigger to consider discharging the patient following a more thorough assessment.

 

CONCLUSION

While these observations might appear to be rather a simplistic way of trying to quantify whether or not a patient is fit for discharge, any clues that hint towards a patient’s well-being should be taken into account when making an overall assessment. The active use of a smartphone is one such measure.

Acknowledgments

The authors thank Emma Knight and Nancy Briggs from the Data Management & Analysis Centre, Discipline of Public Health, University of Adelaide.

Disclosure

No author nor the institution received any payment or services from a third party for any aspect of the submitted work and report no conflict of interest. There are no reported financial relationships with any entities by any of the authors. There are no patents pending based upon this publication. There are no relationships or activities that readers could perceive to have influenced, or give the appearance of influencing, the submitted work. The corresponding author is not in receipt of a research scholarship. The paper is not based on a previous communication.

 

The value placed on bedside clinical observation in the decision-making process of a patient’s illness has been diminished by today’s armamentarium of sophisticated technology. Increasing reliance is now placed on the result of nonspecific tests in preference to bedside clinical judgement in the diagnostic and management process. While diagnostic investigations have undoubtedly provided great advancements in medical care, they come at time and financial costs. Physicians should therefore continue to be encouraged to make clinical decisions based on their bedside assessment.

With hospital overcrowding a significant problem within the healthcare system and the expectation that it will worsen with an ageing population, identifying factors that predict patient suitability for discharge has become an important focus for clinicians.^1,2 There exists a paucity of literature predicting discharge suitability of general surgical patients admitted through the emergency department (ED). Furthermore, despite the extensive research into the effectiveness of discharge planning,³ little research has been conducted to describe positive predictive indicators for discharge. Observations made during surgical rounds have led the authors to consider that individuals who are using a smartphone during their bedside assessment may be clinically well enough for discharge.

The aim of this study was to assess whether the clinical assessment of an acute surgical patient could be usefully augmented by the observation of the active use of smartphones (the smartphone sign) and whether this could be used as a surrogate marker to indicate a patient’s well-being and suitability for same-day discharge from the hospital in acute surgical patients.

METHODS

Design and Setting

This was a prospective observational study performed over 2 periods at a tertiary hospital in South Australia, Australia. At our institution, acute surgical patients are admitted to the acute surgical unit (ASU) from the ED by junior surgical doctors. Patients are then reviewed by the on-call surgical consultant, who implements management plans or advises discharge on 2 occasions per day.

Participants

All patients admitted under the ASU were considered eligible for the study. Exclusion criteria included patients that (i) required immediate surgical intervention (defined as time of review to theatre of less than 4 hours) and (ii) had immediate admission to the intensive care unit.

Consultant surgeons are employed within a general surgical subspecialty, including upper gastrointestinal, hepatobiliary, breast and endocrine, and colorectal. All surgeons from each team partake in the general surgery on-call roster. Each surgeon was included at least once within the observation periods. Experience of consultant surgeons ranged from 5 years of postfellowship experience to surgeons with more than 30 years of experience, with the majority having more than 10 years of postfellowship experience.

Patients were stratified into 2 distinct cohorts upon consultant review: smartphone positive (spP) was defined as a patient who was using a smartphone or who had their phone on their bed; a patient was classified as smartphone negative (spN) if they did not fulfil these criteria. The presence or absence of a smartphone was recorded by the authors, who were present on consultant ward rounds but not involved in the decision-making process of patient care. In order to minimize bias, only 1 surgeon (PGD) was aware that the study was being conducted and all patients were blinded to the study. Additional information that was collected included patient demographics, requirement for surgery, and length of stay (LOS). A patient who was discharged on the same day as the consultant review was considered to be discharged on day 1, all other patients were considered to have LOS greater than 1 day. Requirement for surgery was defined as a patient who underwent a surgical procedure in an operating suite. Thirty-day unplanned readmission rates for all patients were examined. Readmission to another public hospital within the state was also included within the readmission data.

Observation Periods

An initial 4-week pilot study was conducted to assess for a possible association between spP and same-day discharge. A second 8-week study period was undertaken 1 year later accounting for the employment of the authors at the study’s institution. Unless stated, the results described are the accumulation of both study periods.

Statistical Analysis

As this is the first study of its kind, no prior estimates of numbers were known. After 2 weeks of data collection, data were analyzed in order to provide an estimate of the total number of patients required to provide a statistically valid result (α = 0.05; power = 0.80). Sample size was calculated to be 40 subjects. It was agreed that in order to make the study as robust as possible, data should be collected for the 2 observation periods.

 

Demographic data are presented as means with standard deviations (SDs) or frequencies with percentages. A 2-sample Student t test was used to compare the age of spP and spN patients. A χ² test and logistic regressions were used to assess the association between smartphone status and patient demographics, LOS, and requirement for surgery. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value of <0.05 was considered significant. All data were analyzed by using R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

RESULTS

During the 2 observation periods, a total of 227 eligible surgical admissions were observed with complete data for 221 patients. Six patients were excluded as their smartphone status was not recorded. The study sample represents our population of interest within an ASU, and we had complete data for 97.4% of participants with a 100% follow-up. There was no significant effect of study between the 2 observation periods (χ² = 140.19; P = 0.10). The mean age of patients was 50.24 years. Further demographic data are presented in Table 1. Twenty-five (11.3%) patients were spP and 196 (88.7%) were spN. Fifty-two (23.5%) patients were discharged home on day 1, and 169 (76.5%) had admissions longer than 1 day (see Figure). Sixty (27%) patients underwent surgery during their admission. Twenty-two patients had unplanned readmissions; only 1 of these patients had been observed to be spP.

There was a statistically significant difference in ages between the spP and spN groups (t = 8.40; P < 0.0005), with the average age of spP patients being 31.84 years compared with 52.58 years for spN patients. There was no statistical difference between gender and smartphone status (χ² = 1.78; P = 0.18; Table 2).

For those patients discharged home on day 1, there was a statistically significant association with being spP (χ² = 14.55, P = 0.0001). Patients who were spP were 5.29 times more likely to be discharged on day 1 (95% CI, 2.24-12.84). Of the variables analyzed, only gender failed to demonstrate an effect on discharge home on day 1 (Table 3). Overall, the presence of a smartphone was found to have a sensitivity of 56.0% (95% CI, 34.93-75.60) and a specificity of 80.6% (95% CI, 74.37-85.90) in regard to same-day discharge. However, it was found to have a negative predictive value of 93.49% (95% CI, 88.65-96.71).

When examining readmission rates, only 4% of spP patients were readmitted versus 10.7% of spN patients. Accounting for variables, spP patients were 4 times less likely to be readmitted, though this was not statistically significant (OR 4.02; 95% CI, 0.43-37.2; P = 0.22). Furthermore, when examining only those patients discharged on day 1, smartphone status was not a predictor of readmission (OR 0.94; 95% CI, 0.06-15.2; P = 0 .97).

To mitigate the effect of age, analysis was conducted excluding those aged over 55 years (the previous retirement age in Australia), leaving 131 patients for analysis. The average age of spP patients was 31.8 years (SD 10.0) compared with 36.7 years (SD 10.9) for spN patients, representing a significant difference (t = 2.14; P = 0.04); 51.1% of patients were male, 19.1% of patients were spP, 26.0% of patients proceeded to an operation, the oldest spP was 51 years, and 29.0% of patients were discharged home on day 1. There was no difference in gender and smartphone status (χ² = 0.33; P = 0.6). When analyzing those discharged on day 1, again spP patients were more likely to be discharged home (χ² = 9.4; P = 0.002), and spP patients were 3.6 times more likely to be discharged home on day 1.

There were 4 spP patients who underwent an operation. Two patients had an incision and drainage of a perianal abscess, 1 patient underwent a laparotomy for an internal hernia after recently undergoing a Roux-en-Y gastric bypass at another hospital, and the final patient underwent a laparoscopic appendicectomy. One of these patients was still discharged home on day 1.

DISCUSSION

As J. A. Lindsay⁴ said, “For one mistake made for not knowing, ten mistakes are made for not looking.” At medical school, we are taught the finer techniques of the physical examination in order to support our diagnosis made from the history. It is not until we are experienced clinicians do we develop the clinical acumen and ability to tell an unwell patient from a well patient at a glance—colloquially known as the “end of the bed” assessment. In the pretechnology era, a well patient could frequently be seen reading their book, eg, the “novel-sign.” With the advent of the smartphone and electronic devices upon which novels can be read, statuses updated, and locations “checked into” (ie, the modern “vital signs”), the book sign may be a thing of the past. However, the ability for the clinician to assess a patient’s wellness is still crucial, and the value of any additional “physical signs” need to be estimated.

 

We observed a cohort of patients through a busy ASU in a tertiary hospital in South Australia, Australia. Acute surgical patients admitted to the hospital who were observed to be on their phones upon consultant review were more than 5 times likely to be discharged that same day. To the best of our knowledge, this is the first study to prospectively collect data to assess a frequently used but unevaluated clinical observation.

The use of a smartphone can tell us a lot about an individual’s physiology. We can assume the individual’s airway and breathing are adequate, allowing enough oxygen to reach the lungs and subsequently circulate. The individual is usually sitting up in bed and thus has an adequate blood pressure and blood oxygenation that can maintain cerebral perfusion. They have the cognitive and cerebral processing in place to function the device, and we can examine their cerebellar function by looking for fine-motor movements.

Mobile phone ownership is pervasive within Australia,⁵ with a conservative estimated 85.7% of the population (20.57 million people of a total population of approximately 24 million) owning a mobile phone and an estimated 50% to 79% of mobile phone ownership being of a smartphone.^6,7 This ownership is not just limited to the young, with 74% of Australians over 65 owning or using a mobile phone.⁸ Despite this high phone ownership among those over 65, it is still significantly less than their younger counterparts and may be one reason for the absence of spP in those older than 51 years. A key point in the study is that overall phone ownership was not known, and, thus, it is not possible to determine the proportion of spN patients who were negative because they did not own a phone. However, based on general population data, the incidence of spP patients was well below that seen in the community (11.3%)⁵ and even when excluding those over 55, the percentage of spP patients only rose to 19.1%. Unsurprisingly, increasing age was associated with a decreased likelihood of being spP (P < 0.0005), as younger people are more likely to own a phone.⁸ There was no association with gender (P = 0.18). There are a number of explanations that may explain the lower than expected percentage of spP patients, including the inability for the patient to gather their possessions during a medical emergency, patients storing their phones prior to doctor review (72%-85% of Australians report talking on phones in public places to be rude or intrusive⁵), but more importantly, that our hypothesis that patients were too unwell to use their device appears to hold true.

There are potential alternate reasons other than smartphone status that may account for patients being discharged home on day 1. While there was no association seen with gender, the need for an operation prolonged a patient’s stay (OR 1.64; 95% CI, 0.046-0.46), and there was a trend seen with increasing age (OR 0.98; 95% CI, 0.96-1.00). Neither of these 2 demographics are unsurprising: increasing age is associated with increasing medical comorbidities and thus complexity; even the simplest of operations require a postprocedure observation period, automatically increasing their LOS. Additionally, measured demographics are limited and there may be further unmeasured reasons that account for earlier discharge.

The other key component to this study is the value of the physical examination, albeit only assessing 1 component: the general inspection. In their review of the value of the physical examination of the cardiovascular system, Elder et al. highlight an important point: in traditional teaching, the value of a physical sign is compared with a diagnostic reference, typically imaging or an invasive test.⁹ They argue that this definition undervalues the physical examination and list other values aside from accuracy including accessibility, contribution to clinical care beyond diagnoses, cost effectiveness, patients’ safety, patients’ perceptions, and pedagogic value; and they argue that the physical examination should always be considered in regard to the clinical context—in this case, the newly admitted general surgical patient.

The assessment of the presence or absence of a smartphone is readily performed upon general inspection and is easily visible; general inspection of the patient and failure to observe the clinical sign when present are 2 of the greatest errors associated with physical examination.¹⁰ Furthermore, given its unique status as a physical sign, the authors’ opinion and experience is that it is readily teachable. McGee states, “…a fundamental lesson [in regards to teaching] is that the diagnosis of many clinical problems, despite modern testing, still depends primarily on what the clinician sees, hears, and feels.”¹¹ In their article, Paley et al. found that more than 80% of patients admitted from the ED under internal medicine could be accurately diagnosed based largely on history and examination alone and concluded that basic clinical skills are sufficient for achieving an accurate diagnosis in most cases.¹² Although Paley et al. were assisted with basic tests (such as electrocardiogram and basic haematological and biochemistry results), the point of clinical skills is not lost. Furthermore, this assessment was made in a group of patients generally considered to be complex in contrast to the “standard” appendicitis or cholecystitis patient that makes up a significant proportion of general surgical patients.

There are a number of limitations to this study, however, including smartphones that may have been missed during the observational period. Potential confounding variables such as socioeconomic status and the overall smartphone ownership of our subjects were not known. We did not ask all admitted patients whether they owned a phone or whether they had a phone in their possession. Knowledge of those who owned phones but were not in possession of them could strengthen our argument that spN patients were not using their phone because they were unwell, rather than just not having access to it.

However, this study has a number of strengths, including a large sample size and data that were prospectively collected by a method and in a setting that was the same for all participants. Clear and appropriate definitions were used, which minimizes misclassification bias. Participants and decision makers were blinded to the study, and potentially confounding variables such as age and sex were accounted for.

Assessing the suitability for discharge from the hospital is a decision encountered by hospital-based clinicians every day. These skills are not taught, but are rather learned as a junior doctor acquires experience. It is unlikely that protocols will be developed to aid identification of potential discharges from an acute surgical ward; acute surgical conditions are too varied and dynamic to be able to pool all data. We continue to rely on our own and fellow colleagues’ (doctors, nurses, and other staff) input and assessment. However, our study has shown that it is possible to identify and quantify clinical findings that are already regularly used, albeit potentially subconsciously, to assess suitability for discharge. We have shown in this large, prospectively collected observational study that if a surgical patient is seen using their electronic device, they are more likely to be safe to go home. Thus, surgeons can reliably use this observation as a trigger to consider discharging the patient following a more thorough assessment.

 

CONCLUSION

While these observations might appear to be rather a simplistic way of trying to quantify whether or not a patient is fit for discharge, any clues that hint towards a patient’s well-being should be taken into account when making an overall assessment. The active use of a smartphone is one such measure.

Acknowledgments

The authors thank Emma Knight and Nancy Briggs from the Data Management & Analysis Centre, Discipline of Public Health, University of Adelaide.

Disclosure

No author nor the institution received any payment or services from a third party for any aspect of the submitted work and report no conflict of interest. There are no reported financial relationships with any entities by any of the authors. There are no patents pending based upon this publication. There are no relationships or activities that readers could perceive to have influenced, or give the appearance of influencing, the submitted work. The corresponding author is not in receipt of a research scholarship. The paper is not based on a previous communication.

 

The value placed on bedside clinical observation in the decision-making process of a patient’s illness has been diminished by today’s armamentarium of sophisticated technology. Increasing reliance is now placed on the result of nonspecific tests in preference to bedside clinical judgement in the diagnostic and management process. While diagnostic investigations have undoubtedly provided great advancements in medical care, they come at time and financial costs. Physicians should therefore continue to be encouraged to make clinical decisions based on their bedside assessment.

With hospital overcrowding a significant problem within the healthcare system and the expectation that it will worsen with an ageing population, identifying factors that predict patient suitability for discharge has become an important focus for clinicians.^1,2 There exists a paucity of literature predicting discharge suitability of general surgical patients admitted through the emergency department (ED). Furthermore, despite the extensive research into the effectiveness of discharge planning,³ little research has been conducted to describe positive predictive indicators for discharge. Observations made during surgical rounds have led the authors to consider that individuals who are using a smartphone during their bedside assessment may be clinically well enough for discharge.

The aim of this study was to assess whether the clinical assessment of an acute surgical patient could be usefully augmented by the observation of the active use of smartphones (the smartphone sign) and whether this could be used as a surrogate marker to indicate a patient’s well-being and suitability for same-day discharge from the hospital in acute surgical patients.

METHODS

Design and Setting

This was a prospective observational study performed over 2 periods at a tertiary hospital in South Australia, Australia. At our institution, acute surgical patients are admitted to the acute surgical unit (ASU) from the ED by junior surgical doctors. Patients are then reviewed by the on-call surgical consultant, who implements management plans or advises discharge on 2 occasions per day.

Participants

All patients admitted under the ASU were considered eligible for the study. Exclusion criteria included patients that (i) required immediate surgical intervention (defined as time of review to theatre of less than 4 hours) and (ii) had immediate admission to the intensive care unit.

Consultant surgeons are employed within a general surgical subspecialty, including upper gastrointestinal, hepatobiliary, breast and endocrine, and colorectal. All surgeons from each team partake in the general surgery on-call roster. Each surgeon was included at least once within the observation periods. Experience of consultant surgeons ranged from 5 years of postfellowship experience to surgeons with more than 30 years of experience, with the majority having more than 10 years of postfellowship experience.

Patients were stratified into 2 distinct cohorts upon consultant review: smartphone positive (spP) was defined as a patient who was using a smartphone or who had their phone on their bed; a patient was classified as smartphone negative (spN) if they did not fulfil these criteria. The presence or absence of a smartphone was recorded by the authors, who were present on consultant ward rounds but not involved in the decision-making process of patient care. In order to minimize bias, only 1 surgeon (PGD) was aware that the study was being conducted and all patients were blinded to the study. Additional information that was collected included patient demographics, requirement for surgery, and length of stay (LOS). A patient who was discharged on the same day as the consultant review was considered to be discharged on day 1, all other patients were considered to have LOS greater than 1 day. Requirement for surgery was defined as a patient who underwent a surgical procedure in an operating suite. Thirty-day unplanned readmission rates for all patients were examined. Readmission to another public hospital within the state was also included within the readmission data.

Observation Periods

An initial 4-week pilot study was conducted to assess for a possible association between spP and same-day discharge. A second 8-week study period was undertaken 1 year later accounting for the employment of the authors at the study’s institution. Unless stated, the results described are the accumulation of both study periods.

Statistical Analysis

As this is the first study of its kind, no prior estimates of numbers were known. After 2 weeks of data collection, data were analyzed in order to provide an estimate of the total number of patients required to provide a statistically valid result (α = 0.05; power = 0.80). Sample size was calculated to be 40 subjects. It was agreed that in order to make the study as robust as possible, data should be collected for the 2 observation periods.

 

Demographic data are presented as means with standard deviations (SDs) or frequencies with percentages. A 2-sample Student t test was used to compare the age of spP and spN patients. A χ² test and logistic regressions were used to assess the association between smartphone status and patient demographics, LOS, and requirement for surgery. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value of <0.05 was considered significant. All data were analyzed by using R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

RESULTS

During the 2 observation periods, a total of 227 eligible surgical admissions were observed with complete data for 221 patients. Six patients were excluded as their smartphone status was not recorded. The study sample represents our population of interest within an ASU, and we had complete data for 97.4% of participants with a 100% follow-up. There was no significant effect of study between the 2 observation periods (χ² = 140.19; P = 0.10). The mean age of patients was 50.24 years. Further demographic data are presented in Table 1. Twenty-five (11.3%) patients were spP and 196 (88.7%) were spN. Fifty-two (23.5%) patients were discharged home on day 1, and 169 (76.5%) had admissions longer than 1 day (see Figure). Sixty (27%) patients underwent surgery during their admission. Twenty-two patients had unplanned readmissions; only 1 of these patients had been observed to be spP.

There was a statistically significant difference in ages between the spP and spN groups (t = 8.40; P < 0.0005), with the average age of spP patients being 31.84 years compared with 52.58 years for spN patients. There was no statistical difference between gender and smartphone status (χ² = 1.78; P = 0.18; Table 2).

For those patients discharged home on day 1, there was a statistically significant association with being spP (χ² = 14.55, P = 0.0001). Patients who were spP were 5.29 times more likely to be discharged on day 1 (95% CI, 2.24-12.84). Of the variables analyzed, only gender failed to demonstrate an effect on discharge home on day 1 (Table 3). Overall, the presence of a smartphone was found to have a sensitivity of 56.0% (95% CI, 34.93-75.60) and a specificity of 80.6% (95% CI, 74.37-85.90) in regard to same-day discharge. However, it was found to have a negative predictive value of 93.49% (95% CI, 88.65-96.71).

When examining readmission rates, only 4% of spP patients were readmitted versus 10.7% of spN patients. Accounting for variables, spP patients were 4 times less likely to be readmitted, though this was not statistically significant (OR 4.02; 95% CI, 0.43-37.2; P = 0.22). Furthermore, when examining only those patients discharged on day 1, smartphone status was not a predictor of readmission (OR 0.94; 95% CI, 0.06-15.2; P = 0 .97).

To mitigate the effect of age, analysis was conducted excluding those aged over 55 years (the previous retirement age in Australia), leaving 131 patients for analysis. The average age of spP patients was 31.8 years (SD 10.0) compared with 36.7 years (SD 10.9) for spN patients, representing a significant difference (t = 2.14; P = 0.04); 51.1% of patients were male, 19.1% of patients were spP, 26.0% of patients proceeded to an operation, the oldest spP was 51 years, and 29.0% of patients were discharged home on day 1. There was no difference in gender and smartphone status (χ² = 0.33; P = 0.6). When analyzing those discharged on day 1, again spP patients were more likely to be discharged home (χ² = 9.4; P = 0.002), and spP patients were 3.6 times more likely to be discharged home on day 1.

There were 4 spP patients who underwent an operation. Two patients had an incision and drainage of a perianal abscess, 1 patient underwent a laparotomy for an internal hernia after recently undergoing a Roux-en-Y gastric bypass at another hospital, and the final patient underwent a laparoscopic appendicectomy. One of these patients was still discharged home on day 1.

DISCUSSION

As J. A. Lindsay⁴ said, “For one mistake made for not knowing, ten mistakes are made for not looking.” At medical school, we are taught the finer techniques of the physical examination in order to support our diagnosis made from the history. It is not until we are experienced clinicians do we develop the clinical acumen and ability to tell an unwell patient from a well patient at a glance—colloquially known as the “end of the bed” assessment. In the pretechnology era, a well patient could frequently be seen reading their book, eg, the “novel-sign.” With the advent of the smartphone and electronic devices upon which novels can be read, statuses updated, and locations “checked into” (ie, the modern “vital signs”), the book sign may be a thing of the past. However, the ability for the clinician to assess a patient’s wellness is still crucial, and the value of any additional “physical signs” need to be estimated.

 

We observed a cohort of patients through a busy ASU in a tertiary hospital in South Australia, Australia. Acute surgical patients admitted to the hospital who were observed to be on their phones upon consultant review were more than 5 times likely to be discharged that same day. To the best of our knowledge, this is the first study to prospectively collect data to assess a frequently used but unevaluated clinical observation.

The use of a smartphone can tell us a lot about an individual’s physiology. We can assume the individual’s airway and breathing are adequate, allowing enough oxygen to reach the lungs and subsequently circulate. The individual is usually sitting up in bed and thus has an adequate blood pressure and blood oxygenation that can maintain cerebral perfusion. They have the cognitive and cerebral processing in place to function the device, and we can examine their cerebellar function by looking for fine-motor movements.

Mobile phone ownership is pervasive within Australia,⁵ with a conservative estimated 85.7% of the population (20.57 million people of a total population of approximately 24 million) owning a mobile phone and an estimated 50% to 79% of mobile phone ownership being of a smartphone.^6,7 This ownership is not just limited to the young, with 74% of Australians over 65 owning or using a mobile phone.⁸ Despite this high phone ownership among those over 65, it is still significantly less than their younger counterparts and may be one reason for the absence of spP in those older than 51 years. A key point in the study is that overall phone ownership was not known, and, thus, it is not possible to determine the proportion of spN patients who were negative because they did not own a phone. However, based on general population data, the incidence of spP patients was well below that seen in the community (11.3%)⁵ and even when excluding those over 55, the percentage of spP patients only rose to 19.1%. Unsurprisingly, increasing age was associated with a decreased likelihood of being spP (P < 0.0005), as younger people are more likely to own a phone.⁸ There was no association with gender (P = 0.18). There are a number of explanations that may explain the lower than expected percentage of spP patients, including the inability for the patient to gather their possessions during a medical emergency, patients storing their phones prior to doctor review (72%-85% of Australians report talking on phones in public places to be rude or intrusive⁵), but more importantly, that our hypothesis that patients were too unwell to use their device appears to hold true.

There are potential alternate reasons other than smartphone status that may account for patients being discharged home on day 1. While there was no association seen with gender, the need for an operation prolonged a patient’s stay (OR 1.64; 95% CI, 0.046-0.46), and there was a trend seen with increasing age (OR 0.98; 95% CI, 0.96-1.00). Neither of these 2 demographics are unsurprising: increasing age is associated with increasing medical comorbidities and thus complexity; even the simplest of operations require a postprocedure observation period, automatically increasing their LOS. Additionally, measured demographics are limited and there may be further unmeasured reasons that account for earlier discharge.

The other key component to this study is the value of the physical examination, albeit only assessing 1 component: the general inspection. In their review of the value of the physical examination of the cardiovascular system, Elder et al. highlight an important point: in traditional teaching, the value of a physical sign is compared with a diagnostic reference, typically imaging or an invasive test.⁹ They argue that this definition undervalues the physical examination and list other values aside from accuracy including accessibility, contribution to clinical care beyond diagnoses, cost effectiveness, patients’ safety, patients’ perceptions, and pedagogic value; and they argue that the physical examination should always be considered in regard to the clinical context—in this case, the newly admitted general surgical patient.

The assessment of the presence or absence of a smartphone is readily performed upon general inspection and is easily visible; general inspection of the patient and failure to observe the clinical sign when present are 2 of the greatest errors associated with physical examination.¹⁰ Furthermore, given its unique status as a physical sign, the authors’ opinion and experience is that it is readily teachable. McGee states, “…a fundamental lesson [in regards to teaching] is that the diagnosis of many clinical problems, despite modern testing, still depends primarily on what the clinician sees, hears, and feels.”¹¹ In their article, Paley et al. found that more than 80% of patients admitted from the ED under internal medicine could be accurately diagnosed based largely on history and examination alone and concluded that basic clinical skills are sufficient for achieving an accurate diagnosis in most cases.¹² Although Paley et al. were assisted with basic tests (such as electrocardiogram and basic haematological and biochemistry results), the point of clinical skills is not lost. Furthermore, this assessment was made in a group of patients generally considered to be complex in contrast to the “standard” appendicitis or cholecystitis patient that makes up a significant proportion of general surgical patients.

There are a number of limitations to this study, however, including smartphones that may have been missed during the observational period. Potential confounding variables such as socioeconomic status and the overall smartphone ownership of our subjects were not known. We did not ask all admitted patients whether they owned a phone or whether they had a phone in their possession. Knowledge of those who owned phones but were not in possession of them could strengthen our argument that spN patients were not using their phone because they were unwell, rather than just not having access to it.

However, this study has a number of strengths, including a large sample size and data that were prospectively collected by a method and in a setting that was the same for all participants. Clear and appropriate definitions were used, which minimizes misclassification bias. Participants and decision makers were blinded to the study, and potentially confounding variables such as age and sex were accounted for.

Assessing the suitability for discharge from the hospital is a decision encountered by hospital-based clinicians every day. These skills are not taught, but are rather learned as a junior doctor acquires experience. It is unlikely that protocols will be developed to aid identification of potential discharges from an acute surgical ward; acute surgical conditions are too varied and dynamic to be able to pool all data. We continue to rely on our own and fellow colleagues’ (doctors, nurses, and other staff) input and assessment. However, our study has shown that it is possible to identify and quantify clinical findings that are already regularly used, albeit potentially subconsciously, to assess suitability for discharge. We have shown in this large, prospectively collected observational study that if a surgical patient is seen using their electronic device, they are more likely to be safe to go home. Thus, surgeons can reliably use this observation as a trigger to consider discharging the patient following a more thorough assessment.

 

CONCLUSION

While these observations might appear to be rather a simplistic way of trying to quantify whether or not a patient is fit for discharge, any clues that hint towards a patient’s well-being should be taken into account when making an overall assessment. The active use of a smartphone is one such measure.

Acknowledgments

The authors thank Emma Knight and Nancy Briggs from the Data Management & Analysis Centre, Discipline of Public Health, University of Adelaide.

Disclosure

No author nor the institution received any payment or services from a third party for any aspect of the submitted work and report no conflict of interest. There are no reported financial relationships with any entities by any of the authors. There are no patents pending based upon this publication. There are no relationships or activities that readers could perceive to have influenced, or give the appearance of influencing, the submitted work. The corresponding author is not in receipt of a research scholarship. The paper is not based on a previous communication.

 

Take-Home Points

• An increasing number of THAs and HAs were performed over time for FNF.
• HA patients tended to be older.
• Hospitalization and blood transfusion rates were higher for THA.
• Hospital size affected the rate of HAs, while hospital location affected the rate of THAs.
• A larger proportion of THA patients had private insurance.

Femoral neck fractures (FNFs) are a common source of morbidity and mortality worldwide. The increasing number of FNFs in the United States is attributed to increases in number of US residents >65 years old, the average life span, and the incidence of osteoporosis.¹ Three hundred forty thousand hip fractures occurred in the United States in 1996, and the number is expected to double by 2050.² By that year, an estimated 6.3 million hip fractures will occur worldwide.³ Given the 1-year mortality rate of 14% to 36%, optimizing the management of these fractures is an important public health issue that must be addressed.⁴

Treatment is based on preoperative ambulatory status, cognitive function, comorbidities, fracture type and displacement, and other factors. In physiologically elderly patients with displaced fractures, surgical treatment usually involves either hemiarthroplasty (HA) or total hip arthroplasty (THA). There is controversy regarding which modality is the preferred treatment.

Proponents of HA point to a higher rate of dislocation for FNFs treated with THAs,^5,6 attributed to increased range of motion.⁷ Proponents of THA point to superior short-term clinical results and fewer complications, especially in mobile, independent patients.⁸

We conducted a study to assess recent US national trends in performing THA and HA for FNFs and to evaluate perioperative outcomes for each treatment group. 

Materials and Methods

Data for this study were obtained from the National Center for Health Statistics (NCHS) National Hospital Discharge Survey (NHDS) and were imported into Microsoft Office Excel 2010.⁹ The NHDS examines patient discharges from various hospitals across the US, including federal, military, and Veterans Administration hospitals.⁹ Only short-stay hospitals (mean stay, <30 days) and hospitals with a general specialty are included in the survey. Each year, about 1% of all hospital admissions from across the US are abstracted and weighted to provide nationwide estimates. The information collected from each hospital record includes age, sex, race, marital status, discharge month, discharge status, days of care, hospital location, hospital size (number of beds), hospital type (proprietary or for-profit, government, nonprofit/church), and up to 15 discharge diagnoses and 8 procedures performed during admission.⁹

International Classification of Diseases, Ninth Revision (ICD-9) procedure codes were used to search the NHDS for patients admitted after FNF for each year from 2001 through 2010. These codes were then used to identify patients within this group who underwent THA or HA. We also collected data on patient demographics, hospitalization duration, discharge disposition, in-hospital adverse events (deep vein thrombosis [DVT], pulmonary embolism [PE], blood transfusion, mortality), form of primary medical insurance, number of hospital beds (0-99, 100-199, 200-299, 300-499, ≥500), hospital type (proprietary, government, nonprofit/church), and hospital region (Northeast, Midwest, South, West). 

 

Trends were evaluated by linear regression with the Pearson correlation coefficient (r). Statistical comparisons were made using the Student t test for continuous data, and both the Fisher exact test and the χ² test for categorical variables. Significance level was set at P < .05. All analyses were performed with IBM SPSS Statistics 22. 

Results

Of the 12,757 patients identified as having FNFs (Figure 1), 582 (4.6%) underwent THA, 6697 (52.5%) underwent HA, 3453 (27.1%) received internal fixation, and 1809 (14.2%) did not have their surgery documented. There were 164 men (28.2%) in the THA group and 1744 (26.0%) in the HA group (P = .27). Mean age was significantly (P < .01) higher for HA patients (81.1 years; range, 18-99 years) than for THA patients (76.9 years; range, 19-99 years), and there were significantly (P < .01) more medical comorbidities for HA patients (6.4 diagnoses; range, 1-7+ diagnoses) than for THA patients (6.1 diagnoses; range, 1-7 diagnoses).

There was no clear trend in prevalence of FNFs between 2001 and 2010 (r = 0.25; Figure 2). During this period, fracture prevalence ranged from 406 to 477 per 100,000 admissions. However, there was increased frequency in use of both surgical techniques for FNFs over time: THA (r = 0.82; Figure 3) and HA (r = 0.80; Figure 4).

The rate of THAs for FNFs increased from 4.2% for 2001 to 2005 to 5.0% for 2006 to 2010 (P = .04); similarly, the rate of HAs for FNFs increased from 51.0% for 2001 to 2005 to 54.7% for 2006 to 2010 (P < .01).

Hospital stay was longer (P < .01) for THA patients (7.7 days; range, 1-312 days) than for HA patients (6.7 days; range, 1-118 days), and blood transfusion rate was higher (P = .02) for THA patients (30.4%) than for HA patients (25.7%), but the groups did not differ in their rates of DVT (THA, 1.2%; HA, 0.80%, P = .50), PE (THA, 0.52%; HA, 0.72%, P = .52), or mortality (THA, 1.8%; HA, 2.9%; P = .16). Discharge disposition varied with surgical status (P < .01): 23.2% of THA patients and 11.6% of HA patients were discharged directly home after their inpatient stay, and 76.8% of THA patients and 88.4% of HA patients were discharged or transferred to a short- or long-term care facility.

Hospital size (number of beds) affected the number of HAs performed (P < .01) but not the number of THAs performed (P = .10; Table). Hospital location (Northeast, Midwest, South, West) affected THA frequency (P = .01), but not HA frequency (P = .07; Figure 5). In contrast, hospital type (proprietary, government, nonprofit/church) affected the HA rate (P < .01) but not the THA rate (P = .12; Table). 

Private medical insurance provided coverage for 14.3% of THAs and 9.1% of HAs, and Medicare provided coverage for 80.9% of THAs and 86.0% of HAs (P < .01).

 

 

Discussion

The NHDS data showed a preference for HA over THA in the treatment of FNFs and suggested THA was favored for younger, healthier patients while HA was reserved for older patients with more comorbidities. Despite being younger and healthier, the THA group had higher transfusion rates and longer hospitalizations, possibly because of the increased complexity of THA procedures, which generally involve more operative time and increased blood loss. The resultant higher transfusion rate for THAs likely contributed to longer hospitalizations for FNFs. However, the THA and HA groups did not differ in their rates of DVT, PE, or mortality.

Multiple studies have noted no differences in mortality, infection, or general complications between THA and HA for FNF.^8,10,11 THA patients have better functional outcomes, including Harris and Oxford hip scores and walking distance, but higher dislocation rates,^8,10-12 and HA patients are at higher risk for reoperation because of progressive acetabular erosion.^8,10,11

We noted an increase in use of both THA and HA for FNF over the study period (2001-2010). In a review of operative treatment for FNF by surgeons applying for the American Board of Orthopaedic Surgery certification between 1999 and 2011, Miller and colleagues¹³ found a similar increase in the THA rate over time, but decreases in the HA and internal fixation rates, with candidates in the “adult reconstruction” subspecialty showing a particularly strong trend toward THA use.

These findings reflect a general propensity toward femoral head replacement rather than preservation through open reduction and internal fixation (ORIF). Recent studies have found that ORIF carries a 39% to 43% rate of fixation failure and need for secondary revision, as well as risks of avascular necrosis, malunion, and nonunion.^1,14-16 This need for secondary surgery makes ORIF ultimately less cost-effective than either THA or HA.16,17 Most authors would recommend arthroplasty for FNF in elderly patients with normal mental function^1,16,18 and would reserve ORIF for young patients with good bone stock, joint space preservation, and reducible noncomminuted fractures.^1,19

Our study results suggest that smaller hospitals (<100 beds) tend to have lower rates of HA (P < .01, significant) and THA (P = .10, not significant; Table), possibly because FNF patients who present to these hospitals may be referred elsewhere because of regional differences in the availability of orthopedic traumatologists and arthroplasty subspecialists. Surgeon volume affects postoperative outcomes and may play a role in referral patterns.²⁰ Ames and colleagues²⁰ found that HA performed for FNF by surgeons with high-volume THA experience (vs non-hip-arthroplasty surgeons) had lower rates of dislocation, superficial infection, and mortality.

Regional differences were significant for THA alone, with the highest THA rates in the South (5.2%) and the lowest in the West (3.3%; Figure 5). There were no clear regional trends for HA. Possible explanations include a propensity toward a more aggressive approach in these regions, increased regional prevalence of acetabular disease, regional surgeon preferences, and regional differences in patient characteristics (eg, increased prevalence of obesity in the South).²¹

 

HA rates were highest for nonprofit/church hospitals and lowest for proprietary hospitals, whereas THA rates did not differ by hospital type. Possible explanations include an older, less mobile nonprofit/church patient cohort that is more amenable to HA, and surgeon preference. 

THA patients were more likely to be covered by private medical insurance than by Medicare—a finding in agreement with Hochfelder and colleagues,²² who found that, compared with federal insurance and self-pay patients, private insurance patients were 41% more likely to undergo THA than HA or internal fixation for FNF. We think that the age difference between our THA and HA groups contributed to the insurance variability in our study.

Our study had several limitations. It was conducted to examine the rates of THA and HA after FNF, not to survey treatment types, including ORIF and nonoperative management. The NHDS database does not provide information on HA implant type (unipolar, bipolar), use or nonuse of cement with HA, or surgical approach. Surgical approach could influence the rate of postoperative dislocation, an outcome measure that was not examined in this study. Last, the NHDS database tracks admissions and discharges, not patients. When a patient is discharged, collection of information on the patient’s postoperative course stops; a patient who returns even only 1 day later is recorded as a new or unique patient. Therefore, intermediate or long-term outcome information is unavailable, which likely led to an underrepresentation of DVT, PE, and mortality after these THA and HA procedures.

There was a trend toward femoral head replacement rather than ORIF in the treatment of FNF. Cognitively functional and independent elderly patients, and patients with osteoarthritis or rheumatoid arthritis, may benefit from THA, whereas HA may be better suited to cognitively dysfunctional patients.^23,24 The NHDS reflects an increasing trend toward arthroplasty over ORIF, but the exact treatment choice is affected by hospital type, size,  location and surgeon preference, training, and subspecialization.

Take-Home Points

• An increasing number of THAs and HAs were performed over time for FNF.
• HA patients tended to be older.
• Hospitalization and blood transfusion rates were higher for THA.
• Hospital size affected the rate of HAs, while hospital location affected the rate of THAs.
• A larger proportion of THA patients had private insurance.

Femoral neck fractures (FNFs) are a common source of morbidity and mortality worldwide. The increasing number of FNFs in the United States is attributed to increases in number of US residents >65 years old, the average life span, and the incidence of osteoporosis.¹ Three hundred forty thousand hip fractures occurred in the United States in 1996, and the number is expected to double by 2050.² By that year, an estimated 6.3 million hip fractures will occur worldwide.³ Given the 1-year mortality rate of 14% to 36%, optimizing the management of these fractures is an important public health issue that must be addressed.⁴

Treatment is based on preoperative ambulatory status, cognitive function, comorbidities, fracture type and displacement, and other factors. In physiologically elderly patients with displaced fractures, surgical treatment usually involves either hemiarthroplasty (HA) or total hip arthroplasty (THA). There is controversy regarding which modality is the preferred treatment.

Proponents of HA point to a higher rate of dislocation for FNFs treated with THAs,^5,6 attributed to increased range of motion.⁷ Proponents of THA point to superior short-term clinical results and fewer complications, especially in mobile, independent patients.⁸

We conducted a study to assess recent US national trends in performing THA and HA for FNFs and to evaluate perioperative outcomes for each treatment group. 

Materials and Methods

Data for this study were obtained from the National Center for Health Statistics (NCHS) National Hospital Discharge Survey (NHDS) and were imported into Microsoft Office Excel 2010.⁹ The NHDS examines patient discharges from various hospitals across the US, including federal, military, and Veterans Administration hospitals.⁹ Only short-stay hospitals (mean stay, <30 days) and hospitals with a general specialty are included in the survey. Each year, about 1% of all hospital admissions from across the US are abstracted and weighted to provide nationwide estimates. The information collected from each hospital record includes age, sex, race, marital status, discharge month, discharge status, days of care, hospital location, hospital size (number of beds), hospital type (proprietary or for-profit, government, nonprofit/church), and up to 15 discharge diagnoses and 8 procedures performed during admission.⁹

International Classification of Diseases, Ninth Revision (ICD-9) procedure codes were used to search the NHDS for patients admitted after FNF for each year from 2001 through 2010. These codes were then used to identify patients within this group who underwent THA or HA. We also collected data on patient demographics, hospitalization duration, discharge disposition, in-hospital adverse events (deep vein thrombosis [DVT], pulmonary embolism [PE], blood transfusion, mortality), form of primary medical insurance, number of hospital beds (0-99, 100-199, 200-299, 300-499, ≥500), hospital type (proprietary, government, nonprofit/church), and hospital region (Northeast, Midwest, South, West). 

 

Trends were evaluated by linear regression with the Pearson correlation coefficient (r). Statistical comparisons were made using the Student t test for continuous data, and both the Fisher exact test and the χ² test for categorical variables. Significance level was set at P < .05. All analyses were performed with IBM SPSS Statistics 22. 

Results

Of the 12,757 patients identified as having FNFs (Figure 1), 582 (4.6%) underwent THA, 6697 (52.5%) underwent HA, 3453 (27.1%) received internal fixation, and 1809 (14.2%) did not have their surgery documented. There were 164 men (28.2%) in the THA group and 1744 (26.0%) in the HA group (P = .27). Mean age was significantly (P < .01) higher for HA patients (81.1 years; range, 18-99 years) than for THA patients (76.9 years; range, 19-99 years), and there were significantly (P < .01) more medical comorbidities for HA patients (6.4 diagnoses; range, 1-7+ diagnoses) than for THA patients (6.1 diagnoses; range, 1-7 diagnoses).

There was no clear trend in prevalence of FNFs between 2001 and 2010 (r = 0.25; Figure 2). During this period, fracture prevalence ranged from 406 to 477 per 100,000 admissions. However, there was increased frequency in use of both surgical techniques for FNFs over time: THA (r = 0.82; Figure 3) and HA (r = 0.80; Figure 4).

The rate of THAs for FNFs increased from 4.2% for 2001 to 2005 to 5.0% for 2006 to 2010 (P = .04); similarly, the rate of HAs for FNFs increased from 51.0% for 2001 to 2005 to 54.7% for 2006 to 2010 (P < .01).

Hospital stay was longer (P < .01) for THA patients (7.7 days; range, 1-312 days) than for HA patients (6.7 days; range, 1-118 days), and blood transfusion rate was higher (P = .02) for THA patients (30.4%) than for HA patients (25.7%), but the groups did not differ in their rates of DVT (THA, 1.2%; HA, 0.80%, P = .50), PE (THA, 0.52%; HA, 0.72%, P = .52), or mortality (THA, 1.8%; HA, 2.9%; P = .16). Discharge disposition varied with surgical status (P < .01): 23.2% of THA patients and 11.6% of HA patients were discharged directly home after their inpatient stay, and 76.8% of THA patients and 88.4% of HA patients were discharged or transferred to a short- or long-term care facility.

Hospital size (number of beds) affected the number of HAs performed (P < .01) but not the number of THAs performed (P = .10; Table). Hospital location (Northeast, Midwest, South, West) affected THA frequency (P = .01), but not HA frequency (P = .07; Figure 5). In contrast, hospital type (proprietary, government, nonprofit/church) affected the HA rate (P < .01) but not the THA rate (P = .12; Table). 

Private medical insurance provided coverage for 14.3% of THAs and 9.1% of HAs, and Medicare provided coverage for 80.9% of THAs and 86.0% of HAs (P < .01).

 

 

Discussion

The NHDS data showed a preference for HA over THA in the treatment of FNFs and suggested THA was favored for younger, healthier patients while HA was reserved for older patients with more comorbidities. Despite being younger and healthier, the THA group had higher transfusion rates and longer hospitalizations, possibly because of the increased complexity of THA procedures, which generally involve more operative time and increased blood loss. The resultant higher transfusion rate for THAs likely contributed to longer hospitalizations for FNFs. However, the THA and HA groups did not differ in their rates of DVT, PE, or mortality.

Multiple studies have noted no differences in mortality, infection, or general complications between THA and HA for FNF.^8,10,11 THA patients have better functional outcomes, including Harris and Oxford hip scores and walking distance, but higher dislocation rates,^8,10-12 and HA patients are at higher risk for reoperation because of progressive acetabular erosion.^8,10,11

We noted an increase in use of both THA and HA for FNF over the study period (2001-2010). In a review of operative treatment for FNF by surgeons applying for the American Board of Orthopaedic Surgery certification between 1999 and 2011, Miller and colleagues¹³ found a similar increase in the THA rate over time, but decreases in the HA and internal fixation rates, with candidates in the “adult reconstruction” subspecialty showing a particularly strong trend toward THA use.

These findings reflect a general propensity toward femoral head replacement rather than preservation through open reduction and internal fixation (ORIF). Recent studies have found that ORIF carries a 39% to 43% rate of fixation failure and need for secondary revision, as well as risks of avascular necrosis, malunion, and nonunion.^1,14-16 This need for secondary surgery makes ORIF ultimately less cost-effective than either THA or HA.16,17 Most authors would recommend arthroplasty for FNF in elderly patients with normal mental function^1,16,18 and would reserve ORIF for young patients with good bone stock, joint space preservation, and reducible noncomminuted fractures.^1,19

Our study results suggest that smaller hospitals (<100 beds) tend to have lower rates of HA (P < .01, significant) and THA (P = .10, not significant; Table), possibly because FNF patients who present to these hospitals may be referred elsewhere because of regional differences in the availability of orthopedic traumatologists and arthroplasty subspecialists. Surgeon volume affects postoperative outcomes and may play a role in referral patterns.²⁰ Ames and colleagues²⁰ found that HA performed for FNF by surgeons with high-volume THA experience (vs non-hip-arthroplasty surgeons) had lower rates of dislocation, superficial infection, and mortality.

Regional differences were significant for THA alone, with the highest THA rates in the South (5.2%) and the lowest in the West (3.3%; Figure 5). There were no clear regional trends for HA. Possible explanations include a propensity toward a more aggressive approach in these regions, increased regional prevalence of acetabular disease, regional surgeon preferences, and regional differences in patient characteristics (eg, increased prevalence of obesity in the South).²¹

 

HA rates were highest for nonprofit/church hospitals and lowest for proprietary hospitals, whereas THA rates did not differ by hospital type. Possible explanations include an older, less mobile nonprofit/church patient cohort that is more amenable to HA, and surgeon preference. 

THA patients were more likely to be covered by private medical insurance than by Medicare—a finding in agreement with Hochfelder and colleagues,²² who found that, compared with federal insurance and self-pay patients, private insurance patients were 41% more likely to undergo THA than HA or internal fixation for FNF. We think that the age difference between our THA and HA groups contributed to the insurance variability in our study.

Our study had several limitations. It was conducted to examine the rates of THA and HA after FNF, not to survey treatment types, including ORIF and nonoperative management. The NHDS database does not provide information on HA implant type (unipolar, bipolar), use or nonuse of cement with HA, or surgical approach. Surgical approach could influence the rate of postoperative dislocation, an outcome measure that was not examined in this study. Last, the NHDS database tracks admissions and discharges, not patients. When a patient is discharged, collection of information on the patient’s postoperative course stops; a patient who returns even only 1 day later is recorded as a new or unique patient. Therefore, intermediate or long-term outcome information is unavailable, which likely led to an underrepresentation of DVT, PE, and mortality after these THA and HA procedures.

There was a trend toward femoral head replacement rather than ORIF in the treatment of FNF. Cognitively functional and independent elderly patients, and patients with osteoarthritis or rheumatoid arthritis, may benefit from THA, whereas HA may be better suited to cognitively dysfunctional patients.^23,24 The NHDS reflects an increasing trend toward arthroplasty over ORIF, but the exact treatment choice is affected by hospital type, size,  location and surgeon preference, training, and subspecialization.

Take-Home Points

• An increasing number of THAs and HAs were performed over time for FNF.
• HA patients tended to be older.
• Hospitalization and blood transfusion rates were higher for THA.
• Hospital size affected the rate of HAs, while hospital location affected the rate of THAs.
• A larger proportion of THA patients had private insurance.

Femoral neck fractures (FNFs) are a common source of morbidity and mortality worldwide. The increasing number of FNFs in the United States is attributed to increases in number of US residents >65 years old, the average life span, and the incidence of osteoporosis.¹ Three hundred forty thousand hip fractures occurred in the United States in 1996, and the number is expected to double by 2050.² By that year, an estimated 6.3 million hip fractures will occur worldwide.³ Given the 1-year mortality rate of 14% to 36%, optimizing the management of these fractures is an important public health issue that must be addressed.⁴

Treatment is based on preoperative ambulatory status, cognitive function, comorbidities, fracture type and displacement, and other factors. In physiologically elderly patients with displaced fractures, surgical treatment usually involves either hemiarthroplasty (HA) or total hip arthroplasty (THA). There is controversy regarding which modality is the preferred treatment.

Proponents of HA point to a higher rate of dislocation for FNFs treated with THAs,^5,6 attributed to increased range of motion.⁷ Proponents of THA point to superior short-term clinical results and fewer complications, especially in mobile, independent patients.⁸

We conducted a study to assess recent US national trends in performing THA and HA for FNFs and to evaluate perioperative outcomes for each treatment group. 

Materials and Methods

Data for this study were obtained from the National Center for Health Statistics (NCHS) National Hospital Discharge Survey (NHDS) and were imported into Microsoft Office Excel 2010.⁹ The NHDS examines patient discharges from various hospitals across the US, including federal, military, and Veterans Administration hospitals.⁹ Only short-stay hospitals (mean stay, <30 days) and hospitals with a general specialty are included in the survey. Each year, about 1% of all hospital admissions from across the US are abstracted and weighted to provide nationwide estimates. The information collected from each hospital record includes age, sex, race, marital status, discharge month, discharge status, days of care, hospital location, hospital size (number of beds), hospital type (proprietary or for-profit, government, nonprofit/church), and up to 15 discharge diagnoses and 8 procedures performed during admission.⁹

International Classification of Diseases, Ninth Revision (ICD-9) procedure codes were used to search the NHDS for patients admitted after FNF for each year from 2001 through 2010. These codes were then used to identify patients within this group who underwent THA or HA. We also collected data on patient demographics, hospitalization duration, discharge disposition, in-hospital adverse events (deep vein thrombosis [DVT], pulmonary embolism [PE], blood transfusion, mortality), form of primary medical insurance, number of hospital beds (0-99, 100-199, 200-299, 300-499, ≥500), hospital type (proprietary, government, nonprofit/church), and hospital region (Northeast, Midwest, South, West). 

 

Trends were evaluated by linear regression with the Pearson correlation coefficient (r). Statistical comparisons were made using the Student t test for continuous data, and both the Fisher exact test and the χ² test for categorical variables. Significance level was set at P < .05. All analyses were performed with IBM SPSS Statistics 22. 

Results

Of the 12,757 patients identified as having FNFs (Figure 1), 582 (4.6%) underwent THA, 6697 (52.5%) underwent HA, 3453 (27.1%) received internal fixation, and 1809 (14.2%) did not have their surgery documented. There were 164 men (28.2%) in the THA group and 1744 (26.0%) in the HA group (P = .27). Mean age was significantly (P < .01) higher for HA patients (81.1 years; range, 18-99 years) than for THA patients (76.9 years; range, 19-99 years), and there were significantly (P < .01) more medical comorbidities for HA patients (6.4 diagnoses; range, 1-7+ diagnoses) than for THA patients (6.1 diagnoses; range, 1-7 diagnoses).

There was no clear trend in prevalence of FNFs between 2001 and 2010 (r = 0.25; Figure 2). During this period, fracture prevalence ranged from 406 to 477 per 100,000 admissions. However, there was increased frequency in use of both surgical techniques for FNFs over time: THA (r = 0.82; Figure 3) and HA (r = 0.80; Figure 4).

The rate of THAs for FNFs increased from 4.2% for 2001 to 2005 to 5.0% for 2006 to 2010 (P = .04); similarly, the rate of HAs for FNFs increased from 51.0% for 2001 to 2005 to 54.7% for 2006 to 2010 (P < .01).

Hospital stay was longer (P < .01) for THA patients (7.7 days; range, 1-312 days) than for HA patients (6.7 days; range, 1-118 days), and blood transfusion rate was higher (P = .02) for THA patients (30.4%) than for HA patients (25.7%), but the groups did not differ in their rates of DVT (THA, 1.2%; HA, 0.80%, P = .50), PE (THA, 0.52%; HA, 0.72%, P = .52), or mortality (THA, 1.8%; HA, 2.9%; P = .16). Discharge disposition varied with surgical status (P < .01): 23.2% of THA patients and 11.6% of HA patients were discharged directly home after their inpatient stay, and 76.8% of THA patients and 88.4% of HA patients were discharged or transferred to a short- or long-term care facility.

Hospital size (number of beds) affected the number of HAs performed (P < .01) but not the number of THAs performed (P = .10; Table). Hospital location (Northeast, Midwest, South, West) affected THA frequency (P = .01), but not HA frequency (P = .07; Figure 5). In contrast, hospital type (proprietary, government, nonprofit/church) affected the HA rate (P < .01) but not the THA rate (P = .12; Table). 

Private medical insurance provided coverage for 14.3% of THAs and 9.1% of HAs, and Medicare provided coverage for 80.9% of THAs and 86.0% of HAs (P < .01).

 

 

Discussion

The NHDS data showed a preference for HA over THA in the treatment of FNFs and suggested THA was favored for younger, healthier patients while HA was reserved for older patients with more comorbidities. Despite being younger and healthier, the THA group had higher transfusion rates and longer hospitalizations, possibly because of the increased complexity of THA procedures, which generally involve more operative time and increased blood loss. The resultant higher transfusion rate for THAs likely contributed to longer hospitalizations for FNFs. However, the THA and HA groups did not differ in their rates of DVT, PE, or mortality.

Multiple studies have noted no differences in mortality, infection, or general complications between THA and HA for FNF.^8,10,11 THA patients have better functional outcomes, including Harris and Oxford hip scores and walking distance, but higher dislocation rates,^8,10-12 and HA patients are at higher risk for reoperation because of progressive acetabular erosion.^8,10,11

We noted an increase in use of both THA and HA for FNF over the study period (2001-2010). In a review of operative treatment for FNF by surgeons applying for the American Board of Orthopaedic Surgery certification between 1999 and 2011, Miller and colleagues¹³ found a similar increase in the THA rate over time, but decreases in the HA and internal fixation rates, with candidates in the “adult reconstruction” subspecialty showing a particularly strong trend toward THA use.

These findings reflect a general propensity toward femoral head replacement rather than preservation through open reduction and internal fixation (ORIF). Recent studies have found that ORIF carries a 39% to 43% rate of fixation failure and need for secondary revision, as well as risks of avascular necrosis, malunion, and nonunion.^1,14-16 This need for secondary surgery makes ORIF ultimately less cost-effective than either THA or HA.16,17 Most authors would recommend arthroplasty for FNF in elderly patients with normal mental function^1,16,18 and would reserve ORIF for young patients with good bone stock, joint space preservation, and reducible noncomminuted fractures.^1,19

Our study results suggest that smaller hospitals (<100 beds) tend to have lower rates of HA (P < .01, significant) and THA (P = .10, not significant; Table), possibly because FNF patients who present to these hospitals may be referred elsewhere because of regional differences in the availability of orthopedic traumatologists and arthroplasty subspecialists. Surgeon volume affects postoperative outcomes and may play a role in referral patterns.²⁰ Ames and colleagues²⁰ found that HA performed for FNF by surgeons with high-volume THA experience (vs non-hip-arthroplasty surgeons) had lower rates of dislocation, superficial infection, and mortality.

Regional differences were significant for THA alone, with the highest THA rates in the South (5.2%) and the lowest in the West (3.3%; Figure 5). There were no clear regional trends for HA. Possible explanations include a propensity toward a more aggressive approach in these regions, increased regional prevalence of acetabular disease, regional surgeon preferences, and regional differences in patient characteristics (eg, increased prevalence of obesity in the South).²¹

 

HA rates were highest for nonprofit/church hospitals and lowest for proprietary hospitals, whereas THA rates did not differ by hospital type. Possible explanations include an older, less mobile nonprofit/church patient cohort that is more amenable to HA, and surgeon preference. 

THA patients were more likely to be covered by private medical insurance than by Medicare—a finding in agreement with Hochfelder and colleagues,²² who found that, compared with federal insurance and self-pay patients, private insurance patients were 41% more likely to undergo THA than HA or internal fixation for FNF. We think that the age difference between our THA and HA groups contributed to the insurance variability in our study.

Our study had several limitations. It was conducted to examine the rates of THA and HA after FNF, not to survey treatment types, including ORIF and nonoperative management. The NHDS database does not provide information on HA implant type (unipolar, bipolar), use or nonuse of cement with HA, or surgical approach. Surgical approach could influence the rate of postoperative dislocation, an outcome measure that was not examined in this study. Last, the NHDS database tracks admissions and discharges, not patients. When a patient is discharged, collection of information on the patient’s postoperative course stops; a patient who returns even only 1 day later is recorded as a new or unique patient. Therefore, intermediate or long-term outcome information is unavailable, which likely led to an underrepresentation of DVT, PE, and mortality after these THA and HA procedures.

There was a trend toward femoral head replacement rather than ORIF in the treatment of FNF. Cognitively functional and independent elderly patients, and patients with osteoarthritis or rheumatoid arthritis, may benefit from THA, whereas HA may be better suited to cognitively dysfunctional patients.^23,24 The NHDS reflects an increasing trend toward arthroplasty over ORIF, but the exact treatment choice is affected by hospital type, size,  location and surgeon preference, training, and subspecialization.

Take-Home Points

• Fractures of the greater tuberosity are often mismanaged.
• Comprehension of greater tuberosity fractures involves classification into nonoperative and operative treatment, displacement >5mm or <5 mm, and open vs arthroscopic surgery.
• Nearly a third of patients may suffer concomitant anterior glenohumeral instability.
• Stiffness is the most common postoperative complication.
• Surgery is associated with high patient satisfaction and low rates of complications and reoperations.

Although proximal humerus fractures are common in the elderly, isolated fractures of the greater tuberosity occur less often. Management depends on several factors, including fracture pattern and displacement.^1,2 Nondisplaced fractures are often successfully managed with sling immobilization and early range of motion.^3,4 Although surgical intervention improves outcomes in displaced greater tuberosity fractures, the ideal surgical treatment is less clear.⁵

Displaced greater tuberosity fractures may require surgery for prevention of subacromial impingement and range-of-motion deficits.² Superior fracture displacement results in decreased shoulder abduction, and posterior displacement can limit external rotation.⁶ Although the greater tuberosity can displace in any direction, posterosuperior displacement has the worst outcomes.¹ The exact surgery-warranting displacement amount ranges from 3 mm to 10 mm but is yet to be clearly elucidated.^5,6 Less displacement is tolerated by young overhead athletes, and more displacement by older less active patients.^5,7,8 Surgical options for isolated greater tuberosity fractures include fragment excision, open reduction and internal fixation (ORIF), closed reduction with percutaneous fixation, and arthroscopically assisted reduction with internal fixation.^3,9,10

We conducted a study to determine the management patterns for isolated greater tuberosity fractures. We hypothesized that greater tuberosity fractures displaced <5 mm may be managed nonoperatively and that greater tuberosity fractures displaced >5 mm require surgical fixation.

Methods

Search Strategy

We performed this systematic review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist¹¹ and registered it (CRD42014010691) with the PROSPERO international prospective register of systematic reviews. Literature searches using the PubMed/Medline database and the Cochrane Central Register of Clinical Trials were completed in August 2014. There were no date or year restrictions. Key words were used to capture all English- language studies with level I to IV evidence (Oxford Centre for Evidence-Based Medicine) and reported clinical or radiographic outcomes. Initial exclusion criteria were cadaveric, biomechanical, histologic, and kinematic results. An electronic search algorithm with key words and a series of NOT phrases was designed to match our exclusion criteria: 

((((((((((((((((((((((((((((((((((((((((((((((((((greater[Title/Abstract]) AND tuberosity [Title/Abstract] OR tubercle [Title/Abstract]) AND fracture[Title/Abstract]) AND proximal[Title/Abstract] AND (English[lang]))) NOT intramedullary[Title] AND (English[lang]))) NOT nonunion[Title] AND (English[lang]))) NOT malunion[Title] AND (English[lang]))) NOT biomechanical[Title/Abstract] AND (English[lang]))) NOT cadaveric[Title/Abstract] AND (English[lang]))) NOT cadaver[Title/Abstract] AND (English[lang]))) NOT ((basic[Title/Abstract]) AND science[Title/Abstract] AND (English[lang])) AND (English[lang]))) NOT revision[Title] AND (English[lang]))) NOT pediatric[Title] AND (English[lang]))) NOT physeal[Title] AND (English[lang]))) NOT children[Title] AND (English[lang]))) NOT instability[Title] AND (English[lang]))) NOT imaging[Title])) NOT salter[Title])) NOT physis[Title])) NOT shaft[Title])) NOT distal[Title])) NOT clavicle[Title])) NOT scapula[Title])) NOT ((diaphysis[Title]) AND diaphyseal[Title]))) NOT infection[Title])) NOT laboratory[Title/Abstract])) NOT metastatic[Title/Abstract])) NOT (((((((malignancy[Title/Abstract]) OR malignant[Title/Abstract]) OR tumor[Title/Abstract]) OR oncologic[Title/Abstract]) OR cyst[Title/Abstract]) OR aneurysmal[Title/Abstract]) OR unicameral[Title/Abstract]).

Study Selection

We obtained 135 search results and reviewed them for further differentiation. All the references in these studies were cross-referenced for inclusion (if missed by the initial search), which added another 15 studies. Technical notes, letters to the editor, and level V evidence reviews were excluded. Double-counting of patients was avoided by comparing each study’s authors, data collection period, and ethnic population with those of the other studies. In cases of overlapping authorship, period, or place, only the study with the longer follow-up, more patients, or more comprehensive data was included. For studies separating outcomes by diagnosis, only outcomes of isolated greater tuberosity fractures were included. Data on 3- or 4-part proximal humerus fractures and isolated lesser tuberosity fractures were excluded. Studies that could not be deconstructed as such or that were devoted solely to one of our exclusion criteria were excluded. Minimum follow-up was 2 years. After all inclusion and exclusion criteria were accounted for, 13 studies with 429 patients (429 shoulders) were selected for inclusion (Figure, Table 1).^2,5,12-22

 

 

Data Extraction

We extracted data from the 13 studies that met the eligibility criteria. Details of study design, sample size, and patient demographics, including age, sex, and hand dominance, were recorded, as were mechanism of injury and concomitant anterior shoulder instability. To capture the most patients, we noted radiographic fracture displacement categorically rather than continuously; patients were divided into 2 displacement groups (<5 mm, >5 mm). Most studies did not define degree of comminution or specific direction of displacement per fracture, so these variables were not included in the data analysis. Nonoperative management and operative management were studied. We abstracted surgical factors, such as approach, method, fixation type (screws or sutures), and technique (suture anchors or transosseous tunnels). Clinical outcomes included physical examination findings, functional assessment results (patient satisfaction; Constant and University of California Los Angeles [UCLA] shoulder scores), and the number of revisions. Radiologic outcomes, retrieved from radiographs or computed tomography scans, focused on loss of reduction (as determined by the respective authors), malunion, nonunion, and heterotopic ossification. Each study’s methodologic quality and bias were evaluated with the 15-item Modified Coleman Methodology Score (MCMS), which was described by Cowan and colleagues.²³ The MCMS has been used to assess randomized and nonrandomized patient trials.^24,25 Its scaled potential score ranges from 0 to 100 (85-100, excellent; 70-84, good; 55-69, fair; <55, poor).

Statistical Analysis

We report our data as weighted means (SDs). A mean was calculated for each study that reported a respective data point, and each mean was then weighed according to its study sample size. This calculation was performed by multiplying a study’s individual mean by the number of patients enrolled in that study and dividing the sum of these weighted data points by the number of eligible patients in all relevant studies. The result was that the nonweighted means from studies with smaller sample sizes did not carry as much weight as the nonweighted means from larger studies. We compared 3 paired groups: treatment type (nonoperative vs operative), fracture displacement amount (<5 mm vs >5 mm), and surgery type (open vs arthroscopic). Regarding all patient, surgery, and outcomes data, unpaired Student t tests were used for continuous variables and 2-tailed Fisher exact tests for categorical variables with α = 0.05 (SPSS Version 18; IBM).

Results

Demographic information and treatment strategies are listed in Table 2. Fifty-eight percent of patients were male, 59.0% of dominant shoulders were affected, and 59.2% of fractures were displaced <5 mm. Concomitant shoulder instability was reported in 28.1% of patients. Mechanism of injury was not reported in all studies but most commonly (n = 75; 49.3%) involved a fall on an outstretched hand; 31 patients (20.4%) had a sports-related injury, and another 37 (24.3%) were injured in a motor vehicle collision. Of the 429 patients, 217 (50.6%) were treated nonoperatively, and 212 (49.4%) underwent surgery. Open, arthroscopic, and percutaneous approaches were reported. No studies presented outcomes of fragment excision.

Postoperative physical examination findings were underreported so that surgical groups could be compared. Of all the surgical studies, 4 reported postoperative forward elevation (mean, 160°; SD, 9.8°) and external rotation (mean, 46.4°; SD 26.3°).^14,15,18,22 No malunions and only 1 nonunion were reported in all 13 studies. No deaths or other serious medical complications were reported. Patients with anterior instability more often underwent surgery than were treated nonoperatively (39.2% vs 12.0%; P < .01) and more often had fractures displaced >5 mm than <5 mm (44.3% vs 14.5%; P < .01).

 

Comparisons of treatment type are listed in Table 3. Compared with nonoperative patients, operative patients had significantly fewer radiographic losses of reduction (P < .01) and better patient satisfaction (P < .01). Operative patients had a significantly higher rate of shoulder stiffness (P < .01). Eight operative patients (3.8%) and no nonoperative patients required reoperation during clinical follow-up (P < .01). All 12 reported cases of stiffness were in the operative group, and 3 required revision surgery. One patient required revision ORIF. There were 2 cases of postoperative superficial infection (0.9%) and 4 neurologic injuries (1.9%).

Comparisons of displacement amount are listed in Table 4. Compared with fractures displaced >5 mm, those displaced <5 mm had more radiographic losses of reduction (P < .01) but fewer instances of heterotopic ossification (P < .01). Fractures displaced >5 mm were significantly more likely than not to be managed with surgery (P < .01) and significantly more likely to develop stiffness after treatment (P = .01). One patient (0.4%) with a fracture displaced <5 mm eventually underwent surgery for stiffness, and 6 patients (3.6%) with fractures displaced >5 mm required reoperation (P = .02).

Comparisons of surgery type are listed in Table 5. All open procedures were performed with a deltoid-splitting approach. Screw fixation was used in 4 cases: 2 percutaneous^5,21 and 2 open.^2,5 The other open and arthroscopic studies described suture fixation, half with anchors (77/156 patients; 49.4%) and half with transosseous tunnels (79/156; 50.6%). There were no statistically significant differences between open/percutaneous and arthroscopic techniques in terms of stiffness, superficial infection, neurologic injury, or reoperation rate.

Fisher exact tests were used to perform isolated comparisons of screws and sutures as well as suture anchors and transosseous tunnels. Patients with screw fixation were significantly (P = .051) less likely to require reoperation (0/56; 0%) than patients with suture fixation (8/100; 8.0%). Screw fixation also led to significantly less stiffness (0% vs 12.0%; P < .01) but trended toward a higher rate of superficial infection (3.6% vs 0%; P = .13). There was no statistical difference in nerve injury rates between screws and sutures (1.8% vs 3.0%; P = 1.0). There were no significant differences in reoperations, stiffness, superficial infections, or nerve injuries between suture anchor and transosseous tunnel constructs.

 

For all 13 studies, mean (SD) MCMS was 41.1 (8.6).

Discussion

Five percent of all fractures involve the proximal humerus, and 20% of proximal humerus fractures are isolated greater tuberosity fractures.^26,27 In his classic 1970 article, Neer⁶ formulated the 4-part proximal humerus fracture classification and defined greater tuberosity fracture “parts” using the same criteria as for other fracture “parts.” Neer⁶ recommended nonoperative management for isolated greater tuberosity fractures displaced <1 cm but did not present evidence corroborating his recommendation. More recent cutoffs for nonoperative management include 5 mm (general population) and 3 mm (athletes).^7,17

In the present systematic review of greater tuberosity fractures, 3 separate comparisons were made: treatment type (nonoperative vs operative), fracture displacement amount (<5 mm vs >5 mm), and surgery type (open vs arthroscopic).

Treatment Type. Only 4 studies reported data on nonoperative treatment outcomes.^5,12,16,17 Of these 4 studies, 2 found successful outcomes for fractures displaced <5 mm.^12,17 Platzer and colleagues¹⁷ found good or excellent results in 97% of 135 shoulders after 4 years. Good results were defined with shoulder scores of ≥80 (Constant), <8 (Vienna), and >28 (UCLA), and excellent results were defined with maximum scores on 2 of the 3 systems. Platzer and colleagues¹⁷ also found nonsignificantly worse shoulder scores with superior displacement of 3 mm to 5 mm and recommended surgery for overhead athletes in this group. Rath and colleagues¹² described a successful 3-phase rehabilitation protocol of sling immobilization for 3 weeks, pendulum exercises for 3 weeks, and active exercises thereafter. By an average of 31 months, patient satisfaction scores improved to 9.5 from 4.2 (10-point scale), though the authors cautioned that pain and decreased motion lasted 8 months on average. Conservative treatment was far less successful in the 2 studies of fractures displaced >5 mm.^5,16 Keene and colleagues¹⁶ reported unsatisfactory results in all 4 patients with fractures displaced >1.5 cm. In a study separate from their 2005 analysis,¹⁷ Platzer and colleagues⁵ in 2008 evaluated displaced fractures and found function and patient satisfaction were inferior after nonoperative treatment than after surgery. The studies by Keene and colleagues¹⁶ and Platzer and colleagues⁵ support the finding of an overall lower patient satisfaction rate in nonoperative patients.

Fracture Displacement Amount. Only 2 arthroscopic studies and no open studies addressed surgery for fractures displaced <5 mm. Fewer than 16% of these fractures were managed operatively, and <1% required reoperation. By contrast, almost all fractures displaced >5 mm were managed operatively, and 3.6% required reoperation. Radiographic loss of reduction was more common in fractures displaced <5 mm, primarily because they were managed without fixation. Radiographic loss of reduction was reported in only 9 operatively treated patients, none of whom was symptomatic enough to require another surgery.⁵ Reoperations were most commonly performed for stiffness, which itself was significantly more common in fractures displaced >5 mm. Bhatia and colleagues¹⁴ reported the highest reoperation rate (14.3%; 3/21), but they studied more complex, comminuted fractures of the greater tuberosity. Two of their 3 reoperations were biceps tenodeses for inflamed, stiff tenosynovitis, and the third patient had a foreign body giant cell reaction to suture material. Fewer than 1% of patients with operatively managed displaced fractures required revision ORIF, and <2% developed a superficial infection or postoperative nerve palsy.^19,22 For displaced greater tuberosity fractures, surgery is highly successful overall, complication rates are very low, and 90% of patients report being satisfied.

Surgery Type. Patients were divided into 2 groups. In the nonarthroscopic group, open and percutaneous approaches were used. All studies that described a percutaneous approach used screw fixation^5,21; in addition, 32 patients were treated with screws through an open approach.^2,5 The other open and arthroscopic studies used suture fixation. Interestingly, no studies reported on clinical outcomes of fragment excision. There were no statistically significant differences in rates of reoperation, stiffness, infection, or neurologic injury between the arthroscopic and nonarthroscopic groups. Patient satisfaction scores were slightly higher in the nonarthroscopic group (91.0% vs 87.8%), but the difference was not statistically significant.

 

With surgical techniques isolated, there were no significant differences between suture anchors and transosseous tunnel constructs, but screws performed significantly better than suture techniques. Compared with suture fixation, screw fixation led to significantly fewer cases of stiffness and reoperation, which suggests surgeons need to give screws more consideration in the operative management of these fractures. However, the number of patients treated with screws was smaller than the number treated with suture fixation; it is possible the differences between these cohorts would be eliminated if there were more patients in the screw cohort. In addition, screw fixation was universally performed with an open or percutaneous approach and trended toward a higher infection rate. As screw and suture techniques have low rates of complications and reoperations, we recommend leaving fixation choice to the surgeon.

Anterior shoulder instability has been associated with greater tuberosity fractures.^1,8,19 The supraspinatus, infraspinatus, and teres minor muscles all insert into the greater tuberosity and resist anterior translation of the proximal humerus. Loss of this dynamic muscle stabilization is amplified by tuberosity fracture displacement: Anterior shoulder instability was significantly more common in fractures displaced >5 mm (44.3%) vs <5 mm (14.5%). In turn, glenohumeral instability was more common in patients treated with surgery, specifically open surgery, because displaced fractures may not be as easily accessed with arthroscopic techniques. No studies reported concomitant labral repair or capsular plication techniques.

This systematic review was limited by the studies analyzed. All but 1 study⁵ had level IV evidence. Mean (SD) MCMS was 41.8 (8.6). Any MCMS score <54 indicates a poor methodology level, but this scoring system is designed for randomized controlled trials,²³ and there were none in this study. Physical examination findings, such as range of motion, were underreported. In addition, radiographic parameters were not consistently described but rather were determined by the respective authors’ subjective interpretations of malunion, nonunion, and loss of reduction. Publication bias is present in that we excluded non- English language studies and medical conference abstracts and may have omitted potentially eligible studies not discoverable with our search methodology. Performance bias is a factor in any systematic review with multiple surgeons and wide variation in surgical technique.

Conclusion

Greater tuberosity fractures displaced <5 mm may be safely managed nonoperatively, as there are no reports of nonoperatively managed fractures that subsequently required surgery. Nonoperative treatment was initially associated with low patient satisfaction, but only because displaced fractures were conservatively managed in early studies.^5,16 Fractures displaced >5 mm respond well to operative fixation with screws, suture anchors, or transosseous suture tunnels. Stiffness is the most common postoperative complication (<6%), followed by heterotopic ossification, transient neurapraxias, and superficial infection. There are no discernible differences in outcome between open and arthroscopic techniques, but screw fixation may lead to significantly fewer cases of stiffness and reoperation in comparison with suture constructs.

Take-Home Points

• Fractures of the greater tuberosity are often mismanaged.
• Comprehension of greater tuberosity fractures involves classification into nonoperative and operative treatment, displacement >5mm or <5 mm, and open vs arthroscopic surgery.
• Nearly a third of patients may suffer concomitant anterior glenohumeral instability.
• Stiffness is the most common postoperative complication.
• Surgery is associated with high patient satisfaction and low rates of complications and reoperations.

Although proximal humerus fractures are common in the elderly, isolated fractures of the greater tuberosity occur less often. Management depends on several factors, including fracture pattern and displacement.^1,2 Nondisplaced fractures are often successfully managed with sling immobilization and early range of motion.^3,4 Although surgical intervention improves outcomes in displaced greater tuberosity fractures, the ideal surgical treatment is less clear.⁵

Displaced greater tuberosity fractures may require surgery for prevention of subacromial impingement and range-of-motion deficits.² Superior fracture displacement results in decreased shoulder abduction, and posterior displacement can limit external rotation.⁶ Although the greater tuberosity can displace in any direction, posterosuperior displacement has the worst outcomes.¹ The exact surgery-warranting displacement amount ranges from 3 mm to 10 mm but is yet to be clearly elucidated.^5,6 Less displacement is tolerated by young overhead athletes, and more displacement by older less active patients.^5,7,8 Surgical options for isolated greater tuberosity fractures include fragment excision, open reduction and internal fixation (ORIF), closed reduction with percutaneous fixation, and arthroscopically assisted reduction with internal fixation.^3,9,10

We conducted a study to determine the management patterns for isolated greater tuberosity fractures. We hypothesized that greater tuberosity fractures displaced <5 mm may be managed nonoperatively and that greater tuberosity fractures displaced >5 mm require surgical fixation.

Methods

Search Strategy

We performed this systematic review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist¹¹ and registered it (CRD42014010691) with the PROSPERO international prospective register of systematic reviews. Literature searches using the PubMed/Medline database and the Cochrane Central Register of Clinical Trials were completed in August 2014. There were no date or year restrictions. Key words were used to capture all English- language studies with level I to IV evidence (Oxford Centre for Evidence-Based Medicine) and reported clinical or radiographic outcomes. Initial exclusion criteria were cadaveric, biomechanical, histologic, and kinematic results. An electronic search algorithm with key words and a series of NOT phrases was designed to match our exclusion criteria: 

((((((((((((((((((((((((((((((((((((((((((((((((((greater[Title/Abstract]) AND tuberosity [Title/Abstract] OR tubercle [Title/Abstract]) AND fracture[Title/Abstract]) AND proximal[Title/Abstract] AND (English[lang]))) NOT intramedullary[Title] AND (English[lang]))) NOT nonunion[Title] AND (English[lang]))) NOT malunion[Title] AND (English[lang]))) NOT biomechanical[Title/Abstract] AND (English[lang]))) NOT cadaveric[Title/Abstract] AND (English[lang]))) NOT cadaver[Title/Abstract] AND (English[lang]))) NOT ((basic[Title/Abstract]) AND science[Title/Abstract] AND (English[lang])) AND (English[lang]))) NOT revision[Title] AND (English[lang]))) NOT pediatric[Title] AND (English[lang]))) NOT physeal[Title] AND (English[lang]))) NOT children[Title] AND (English[lang]))) NOT instability[Title] AND (English[lang]))) NOT imaging[Title])) NOT salter[Title])) NOT physis[Title])) NOT shaft[Title])) NOT distal[Title])) NOT clavicle[Title])) NOT scapula[Title])) NOT ((diaphysis[Title]) AND diaphyseal[Title]))) NOT infection[Title])) NOT laboratory[Title/Abstract])) NOT metastatic[Title/Abstract])) NOT (((((((malignancy[Title/Abstract]) OR malignant[Title/Abstract]) OR tumor[Title/Abstract]) OR oncologic[Title/Abstract]) OR cyst[Title/Abstract]) OR aneurysmal[Title/Abstract]) OR unicameral[Title/Abstract]).

Study Selection

We obtained 135 search results and reviewed them for further differentiation. All the references in these studies were cross-referenced for inclusion (if missed by the initial search), which added another 15 studies. Technical notes, letters to the editor, and level V evidence reviews were excluded. Double-counting of patients was avoided by comparing each study’s authors, data collection period, and ethnic population with those of the other studies. In cases of overlapping authorship, period, or place, only the study with the longer follow-up, more patients, or more comprehensive data was included. For studies separating outcomes by diagnosis, only outcomes of isolated greater tuberosity fractures were included. Data on 3- or 4-part proximal humerus fractures and isolated lesser tuberosity fractures were excluded. Studies that could not be deconstructed as such or that were devoted solely to one of our exclusion criteria were excluded. Minimum follow-up was 2 years. After all inclusion and exclusion criteria were accounted for, 13 studies with 429 patients (429 shoulders) were selected for inclusion (Figure, Table 1).^2,5,12-22

 

 

Data Extraction

We extracted data from the 13 studies that met the eligibility criteria. Details of study design, sample size, and patient demographics, including age, sex, and hand dominance, were recorded, as were mechanism of injury and concomitant anterior shoulder instability. To capture the most patients, we noted radiographic fracture displacement categorically rather than continuously; patients were divided into 2 displacement groups (<5 mm, >5 mm). Most studies did not define degree of comminution or specific direction of displacement per fracture, so these variables were not included in the data analysis. Nonoperative management and operative management were studied. We abstracted surgical factors, such as approach, method, fixation type (screws or sutures), and technique (suture anchors or transosseous tunnels). Clinical outcomes included physical examination findings, functional assessment results (patient satisfaction; Constant and University of California Los Angeles [UCLA] shoulder scores), and the number of revisions. Radiologic outcomes, retrieved from radiographs or computed tomography scans, focused on loss of reduction (as determined by the respective authors), malunion, nonunion, and heterotopic ossification. Each study’s methodologic quality and bias were evaluated with the 15-item Modified Coleman Methodology Score (MCMS), which was described by Cowan and colleagues.²³ The MCMS has been used to assess randomized and nonrandomized patient trials.^24,25 Its scaled potential score ranges from 0 to 100 (85-100, excellent; 70-84, good; 55-69, fair; <55, poor).

Statistical Analysis

We report our data as weighted means (SDs). A mean was calculated for each study that reported a respective data point, and each mean was then weighed according to its study sample size. This calculation was performed by multiplying a study’s individual mean by the number of patients enrolled in that study and dividing the sum of these weighted data points by the number of eligible patients in all relevant studies. The result was that the nonweighted means from studies with smaller sample sizes did not carry as much weight as the nonweighted means from larger studies. We compared 3 paired groups: treatment type (nonoperative vs operative), fracture displacement amount (<5 mm vs >5 mm), and surgery type (open vs arthroscopic). Regarding all patient, surgery, and outcomes data, unpaired Student t tests were used for continuous variables and 2-tailed Fisher exact tests for categorical variables with α = 0.05 (SPSS Version 18; IBM).

Results

Demographic information and treatment strategies are listed in Table 2. Fifty-eight percent of patients were male, 59.0% of dominant shoulders were affected, and 59.2% of fractures were displaced <5 mm. Concomitant shoulder instability was reported in 28.1% of patients. Mechanism of injury was not reported in all studies but most commonly (n = 75; 49.3%) involved a fall on an outstretched hand; 31 patients (20.4%) had a sports-related injury, and another 37 (24.3%) were injured in a motor vehicle collision. Of the 429 patients, 217 (50.6%) were treated nonoperatively, and 212 (49.4%) underwent surgery. Open, arthroscopic, and percutaneous approaches were reported. No studies presented outcomes of fragment excision.

Postoperative physical examination findings were underreported so that surgical groups could be compared. Of all the surgical studies, 4 reported postoperative forward elevation (mean, 160°; SD, 9.8°) and external rotation (mean, 46.4°; SD 26.3°).^14,15,18,22 No malunions and only 1 nonunion were reported in all 13 studies. No deaths or other serious medical complications were reported. Patients with anterior instability more often underwent surgery than were treated nonoperatively (39.2% vs 12.0%; P < .01) and more often had fractures displaced >5 mm than <5 mm (44.3% vs 14.5%; P < .01).

 

Comparisons of treatment type are listed in Table 3. Compared with nonoperative patients, operative patients had significantly fewer radiographic losses of reduction (P < .01) and better patient satisfaction (P < .01). Operative patients had a significantly higher rate of shoulder stiffness (P < .01). Eight operative patients (3.8%) and no nonoperative patients required reoperation during clinical follow-up (P < .01). All 12 reported cases of stiffness were in the operative group, and 3 required revision surgery. One patient required revision ORIF. There were 2 cases of postoperative superficial infection (0.9%) and 4 neurologic injuries (1.9%).

Comparisons of displacement amount are listed in Table 4. Compared with fractures displaced >5 mm, those displaced <5 mm had more radiographic losses of reduction (P < .01) but fewer instances of heterotopic ossification (P < .01). Fractures displaced >5 mm were significantly more likely than not to be managed with surgery (P < .01) and significantly more likely to develop stiffness after treatment (P = .01). One patient (0.4%) with a fracture displaced <5 mm eventually underwent surgery for stiffness, and 6 patients (3.6%) with fractures displaced >5 mm required reoperation (P = .02).

Comparisons of surgery type are listed in Table 5. All open procedures were performed with a deltoid-splitting approach. Screw fixation was used in 4 cases: 2 percutaneous^5,21 and 2 open.^2,5 The other open and arthroscopic studies described suture fixation, half with anchors (77/156 patients; 49.4%) and half with transosseous tunnels (79/156; 50.6%). There were no statistically significant differences between open/percutaneous and arthroscopic techniques in terms of stiffness, superficial infection, neurologic injury, or reoperation rate.

Fisher exact tests were used to perform isolated comparisons of screws and sutures as well as suture anchors and transosseous tunnels. Patients with screw fixation were significantly (P = .051) less likely to require reoperation (0/56; 0%) than patients with suture fixation (8/100; 8.0%). Screw fixation also led to significantly less stiffness (0% vs 12.0%; P < .01) but trended toward a higher rate of superficial infection (3.6% vs 0%; P = .13). There was no statistical difference in nerve injury rates between screws and sutures (1.8% vs 3.0%; P = 1.0). There were no significant differences in reoperations, stiffness, superficial infections, or nerve injuries between suture anchor and transosseous tunnel constructs.

 

For all 13 studies, mean (SD) MCMS was 41.1 (8.6).

Discussion

Five percent of all fractures involve the proximal humerus, and 20% of proximal humerus fractures are isolated greater tuberosity fractures.^26,27 In his classic 1970 article, Neer⁶ formulated the 4-part proximal humerus fracture classification and defined greater tuberosity fracture “parts” using the same criteria as for other fracture “parts.” Neer⁶ recommended nonoperative management for isolated greater tuberosity fractures displaced <1 cm but did not present evidence corroborating his recommendation. More recent cutoffs for nonoperative management include 5 mm (general population) and 3 mm (athletes).^7,17

In the present systematic review of greater tuberosity fractures, 3 separate comparisons were made: treatment type (nonoperative vs operative), fracture displacement amount (<5 mm vs >5 mm), and surgery type (open vs arthroscopic).

Treatment Type. Only 4 studies reported data on nonoperative treatment outcomes.^5,12,16,17 Of these 4 studies, 2 found successful outcomes for fractures displaced <5 mm.^12,17 Platzer and colleagues¹⁷ found good or excellent results in 97% of 135 shoulders after 4 years. Good results were defined with shoulder scores of ≥80 (Constant), <8 (Vienna), and >28 (UCLA), and excellent results were defined with maximum scores on 2 of the 3 systems. Platzer and colleagues¹⁷ also found nonsignificantly worse shoulder scores with superior displacement of 3 mm to 5 mm and recommended surgery for overhead athletes in this group. Rath and colleagues¹² described a successful 3-phase rehabilitation protocol of sling immobilization for 3 weeks, pendulum exercises for 3 weeks, and active exercises thereafter. By an average of 31 months, patient satisfaction scores improved to 9.5 from 4.2 (10-point scale), though the authors cautioned that pain and decreased motion lasted 8 months on average. Conservative treatment was far less successful in the 2 studies of fractures displaced >5 mm.^5,16 Keene and colleagues¹⁶ reported unsatisfactory results in all 4 patients with fractures displaced >1.5 cm. In a study separate from their 2005 analysis,¹⁷ Platzer and colleagues⁵ in 2008 evaluated displaced fractures and found function and patient satisfaction were inferior after nonoperative treatment than after surgery. The studies by Keene and colleagues¹⁶ and Platzer and colleagues⁵ support the finding of an overall lower patient satisfaction rate in nonoperative patients.

Fracture Displacement Amount. Only 2 arthroscopic studies and no open studies addressed surgery for fractures displaced <5 mm. Fewer than 16% of these fractures were managed operatively, and <1% required reoperation. By contrast, almost all fractures displaced >5 mm were managed operatively, and 3.6% required reoperation. Radiographic loss of reduction was more common in fractures displaced <5 mm, primarily because they were managed without fixation. Radiographic loss of reduction was reported in only 9 operatively treated patients, none of whom was symptomatic enough to require another surgery.⁵ Reoperations were most commonly performed for stiffness, which itself was significantly more common in fractures displaced >5 mm. Bhatia and colleagues¹⁴ reported the highest reoperation rate (14.3%; 3/21), but they studied more complex, comminuted fractures of the greater tuberosity. Two of their 3 reoperations were biceps tenodeses for inflamed, stiff tenosynovitis, and the third patient had a foreign body giant cell reaction to suture material. Fewer than 1% of patients with operatively managed displaced fractures required revision ORIF, and <2% developed a superficial infection or postoperative nerve palsy.^19,22 For displaced greater tuberosity fractures, surgery is highly successful overall, complication rates are very low, and 90% of patients report being satisfied.

Surgery Type. Patients were divided into 2 groups. In the nonarthroscopic group, open and percutaneous approaches were used. All studies that described a percutaneous approach used screw fixation^5,21; in addition, 32 patients were treated with screws through an open approach.^2,5 The other open and arthroscopic studies used suture fixation. Interestingly, no studies reported on clinical outcomes of fragment excision. There were no statistically significant differences in rates of reoperation, stiffness, infection, or neurologic injury between the arthroscopic and nonarthroscopic groups. Patient satisfaction scores were slightly higher in the nonarthroscopic group (91.0% vs 87.8%), but the difference was not statistically significant.

 

With surgical techniques isolated, there were no significant differences between suture anchors and transosseous tunnel constructs, but screws performed significantly better than suture techniques. Compared with suture fixation, screw fixation led to significantly fewer cases of stiffness and reoperation, which suggests surgeons need to give screws more consideration in the operative management of these fractures. However, the number of patients treated with screws was smaller than the number treated with suture fixation; it is possible the differences between these cohorts would be eliminated if there were more patients in the screw cohort. In addition, screw fixation was universally performed with an open or percutaneous approach and trended toward a higher infection rate. As screw and suture techniques have low rates of complications and reoperations, we recommend leaving fixation choice to the surgeon.

Anterior shoulder instability has been associated with greater tuberosity fractures.^1,8,19 The supraspinatus, infraspinatus, and teres minor muscles all insert into the greater tuberosity and resist anterior translation of the proximal humerus. Loss of this dynamic muscle stabilization is amplified by tuberosity fracture displacement: Anterior shoulder instability was significantly more common in fractures displaced >5 mm (44.3%) vs <5 mm (14.5%). In turn, glenohumeral instability was more common in patients treated with surgery, specifically open surgery, because displaced fractures may not be as easily accessed with arthroscopic techniques. No studies reported concomitant labral repair or capsular plication techniques.

This systematic review was limited by the studies analyzed. All but 1 study⁵ had level IV evidence. Mean (SD) MCMS was 41.8 (8.6). Any MCMS score <54 indicates a poor methodology level, but this scoring system is designed for randomized controlled trials,²³ and there were none in this study. Physical examination findings, such as range of motion, were underreported. In addition, radiographic parameters were not consistently described but rather were determined by the respective authors’ subjective interpretations of malunion, nonunion, and loss of reduction. Publication bias is present in that we excluded non- English language studies and medical conference abstracts and may have omitted potentially eligible studies not discoverable with our search methodology. Performance bias is a factor in any systematic review with multiple surgeons and wide variation in surgical technique.

Conclusion

Greater tuberosity fractures displaced <5 mm may be safely managed nonoperatively, as there are no reports of nonoperatively managed fractures that subsequently required surgery. Nonoperative treatment was initially associated with low patient satisfaction, but only because displaced fractures were conservatively managed in early studies.^5,16 Fractures displaced >5 mm respond well to operative fixation with screws, suture anchors, or transosseous suture tunnels. Stiffness is the most common postoperative complication (<6%), followed by heterotopic ossification, transient neurapraxias, and superficial infection. There are no discernible differences in outcome between open and arthroscopic techniques, but screw fixation may lead to significantly fewer cases of stiffness and reoperation in comparison with suture constructs.

Take-Home Points

• Fractures of the greater tuberosity are often mismanaged.
• Comprehension of greater tuberosity fractures involves classification into nonoperative and operative treatment, displacement >5mm or <5 mm, and open vs arthroscopic surgery.
• Nearly a third of patients may suffer concomitant anterior glenohumeral instability.
• Stiffness is the most common postoperative complication.
• Surgery is associated with high patient satisfaction and low rates of complications and reoperations.

Although proximal humerus fractures are common in the elderly, isolated fractures of the greater tuberosity occur less often. Management depends on several factors, including fracture pattern and displacement.^1,2 Nondisplaced fractures are often successfully managed with sling immobilization and early range of motion.^3,4 Although surgical intervention improves outcomes in displaced greater tuberosity fractures, the ideal surgical treatment is less clear.⁵

Displaced greater tuberosity fractures may require surgery for prevention of subacromial impingement and range-of-motion deficits.² Superior fracture displacement results in decreased shoulder abduction, and posterior displacement can limit external rotation.⁶ Although the greater tuberosity can displace in any direction, posterosuperior displacement has the worst outcomes.¹ The exact surgery-warranting displacement amount ranges from 3 mm to 10 mm but is yet to be clearly elucidated.^5,6 Less displacement is tolerated by young overhead athletes, and more displacement by older less active patients.^5,7,8 Surgical options for isolated greater tuberosity fractures include fragment excision, open reduction and internal fixation (ORIF), closed reduction with percutaneous fixation, and arthroscopically assisted reduction with internal fixation.^3,9,10

We conducted a study to determine the management patterns for isolated greater tuberosity fractures. We hypothesized that greater tuberosity fractures displaced <5 mm may be managed nonoperatively and that greater tuberosity fractures displaced >5 mm require surgical fixation.

Methods

Search Strategy

We performed this systematic review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist¹¹ and registered it (CRD42014010691) with the PROSPERO international prospective register of systematic reviews. Literature searches using the PubMed/Medline database and the Cochrane Central Register of Clinical Trials were completed in August 2014. There were no date or year restrictions. Key words were used to capture all English- language studies with level I to IV evidence (Oxford Centre for Evidence-Based Medicine) and reported clinical or radiographic outcomes. Initial exclusion criteria were cadaveric, biomechanical, histologic, and kinematic results. An electronic search algorithm with key words and a series of NOT phrases was designed to match our exclusion criteria: 

((((((((((((((((((((((((((((((((((((((((((((((((((greater[Title/Abstract]) AND tuberosity [Title/Abstract] OR tubercle [Title/Abstract]) AND fracture[Title/Abstract]) AND proximal[Title/Abstract] AND (English[lang]))) NOT intramedullary[Title] AND (English[lang]))) NOT nonunion[Title] AND (English[lang]))) NOT malunion[Title] AND (English[lang]))) NOT biomechanical[Title/Abstract] AND (English[lang]))) NOT cadaveric[Title/Abstract] AND (English[lang]))) NOT cadaver[Title/Abstract] AND (English[lang]))) NOT ((basic[Title/Abstract]) AND science[Title/Abstract] AND (English[lang])) AND (English[lang]))) NOT revision[Title] AND (English[lang]))) NOT pediatric[Title] AND (English[lang]))) NOT physeal[Title] AND (English[lang]))) NOT children[Title] AND (English[lang]))) NOT instability[Title] AND (English[lang]))) NOT imaging[Title])) NOT salter[Title])) NOT physis[Title])) NOT shaft[Title])) NOT distal[Title])) NOT clavicle[Title])) NOT scapula[Title])) NOT ((diaphysis[Title]) AND diaphyseal[Title]))) NOT infection[Title])) NOT laboratory[Title/Abstract])) NOT metastatic[Title/Abstract])) NOT (((((((malignancy[Title/Abstract]) OR malignant[Title/Abstract]) OR tumor[Title/Abstract]) OR oncologic[Title/Abstract]) OR cyst[Title/Abstract]) OR aneurysmal[Title/Abstract]) OR unicameral[Title/Abstract]).

Study Selection

We obtained 135 search results and reviewed them for further differentiation. All the references in these studies were cross-referenced for inclusion (if missed by the initial search), which added another 15 studies. Technical notes, letters to the editor, and level V evidence reviews were excluded. Double-counting of patients was avoided by comparing each study’s authors, data collection period, and ethnic population with those of the other studies. In cases of overlapping authorship, period, or place, only the study with the longer follow-up, more patients, or more comprehensive data was included. For studies separating outcomes by diagnosis, only outcomes of isolated greater tuberosity fractures were included. Data on 3- or 4-part proximal humerus fractures and isolated lesser tuberosity fractures were excluded. Studies that could not be deconstructed as such or that were devoted solely to one of our exclusion criteria were excluded. Minimum follow-up was 2 years. After all inclusion and exclusion criteria were accounted for, 13 studies with 429 patients (429 shoulders) were selected for inclusion (Figure, Table 1).^2,5,12-22

 

 

Data Extraction

We extracted data from the 13 studies that met the eligibility criteria. Details of study design, sample size, and patient demographics, including age, sex, and hand dominance, were recorded, as were mechanism of injury and concomitant anterior shoulder instability. To capture the most patients, we noted radiographic fracture displacement categorically rather than continuously; patients were divided into 2 displacement groups (<5 mm, >5 mm). Most studies did not define degree of comminution or specific direction of displacement per fracture, so these variables were not included in the data analysis. Nonoperative management and operative management were studied. We abstracted surgical factors, such as approach, method, fixation type (screws or sutures), and technique (suture anchors or transosseous tunnels). Clinical outcomes included physical examination findings, functional assessment results (patient satisfaction; Constant and University of California Los Angeles [UCLA] shoulder scores), and the number of revisions. Radiologic outcomes, retrieved from radiographs or computed tomography scans, focused on loss of reduction (as determined by the respective authors), malunion, nonunion, and heterotopic ossification. Each study’s methodologic quality and bias were evaluated with the 15-item Modified Coleman Methodology Score (MCMS), which was described by Cowan and colleagues.²³ The MCMS has been used to assess randomized and nonrandomized patient trials.^24,25 Its scaled potential score ranges from 0 to 100 (85-100, excellent; 70-84, good; 55-69, fair; <55, poor).

Statistical Analysis

We report our data as weighted means (SDs). A mean was calculated for each study that reported a respective data point, and each mean was then weighed according to its study sample size. This calculation was performed by multiplying a study’s individual mean by the number of patients enrolled in that study and dividing the sum of these weighted data points by the number of eligible patients in all relevant studies. The result was that the nonweighted means from studies with smaller sample sizes did not carry as much weight as the nonweighted means from larger studies. We compared 3 paired groups: treatment type (nonoperative vs operative), fracture displacement amount (<5 mm vs >5 mm), and surgery type (open vs arthroscopic). Regarding all patient, surgery, and outcomes data, unpaired Student t tests were used for continuous variables and 2-tailed Fisher exact tests for categorical variables with α = 0.05 (SPSS Version 18; IBM).

Results

Demographic information and treatment strategies are listed in Table 2. Fifty-eight percent of patients were male, 59.0% of dominant shoulders were affected, and 59.2% of fractures were displaced <5 mm. Concomitant shoulder instability was reported in 28.1% of patients. Mechanism of injury was not reported in all studies but most commonly (n = 75; 49.3%) involved a fall on an outstretched hand; 31 patients (20.4%) had a sports-related injury, and another 37 (24.3%) were injured in a motor vehicle collision. Of the 429 patients, 217 (50.6%) were treated nonoperatively, and 212 (49.4%) underwent surgery. Open, arthroscopic, and percutaneous approaches were reported. No studies presented outcomes of fragment excision.

Postoperative physical examination findings were underreported so that surgical groups could be compared. Of all the surgical studies, 4 reported postoperative forward elevation (mean, 160°; SD, 9.8°) and external rotation (mean, 46.4°; SD 26.3°).^14,15,18,22 No malunions and only 1 nonunion were reported in all 13 studies. No deaths or other serious medical complications were reported. Patients with anterior instability more often underwent surgery than were treated nonoperatively (39.2% vs 12.0%; P < .01) and more often had fractures displaced >5 mm than <5 mm (44.3% vs 14.5%; P < .01).

 

Comparisons of treatment type are listed in Table 3. Compared with nonoperative patients, operative patients had significantly fewer radiographic losses of reduction (P < .01) and better patient satisfaction (P < .01). Operative patients had a significantly higher rate of shoulder stiffness (P < .01). Eight operative patients (3.8%) and no nonoperative patients required reoperation during clinical follow-up (P < .01). All 12 reported cases of stiffness were in the operative group, and 3 required revision surgery. One patient required revision ORIF. There were 2 cases of postoperative superficial infection (0.9%) and 4 neurologic injuries (1.9%).

Comparisons of displacement amount are listed in Table 4. Compared with fractures displaced >5 mm, those displaced <5 mm had more radiographic losses of reduction (P < .01) but fewer instances of heterotopic ossification (P < .01). Fractures displaced >5 mm were significantly more likely than not to be managed with surgery (P < .01) and significantly more likely to develop stiffness after treatment (P = .01). One patient (0.4%) with a fracture displaced <5 mm eventually underwent surgery for stiffness, and 6 patients (3.6%) with fractures displaced >5 mm required reoperation (P = .02).

Comparisons of surgery type are listed in Table 5. All open procedures were performed with a deltoid-splitting approach. Screw fixation was used in 4 cases: 2 percutaneous^5,21 and 2 open.^2,5 The other open and arthroscopic studies described suture fixation, half with anchors (77/156 patients; 49.4%) and half with transosseous tunnels (79/156; 50.6%). There were no statistically significant differences between open/percutaneous and arthroscopic techniques in terms of stiffness, superficial infection, neurologic injury, or reoperation rate.

Fisher exact tests were used to perform isolated comparisons of screws and sutures as well as suture anchors and transosseous tunnels. Patients with screw fixation were significantly (P = .051) less likely to require reoperation (0/56; 0%) than patients with suture fixation (8/100; 8.0%). Screw fixation also led to significantly less stiffness (0% vs 12.0%; P < .01) but trended toward a higher rate of superficial infection (3.6% vs 0%; P = .13). There was no statistical difference in nerve injury rates between screws and sutures (1.8% vs 3.0%; P = 1.0). There were no significant differences in reoperations, stiffness, superficial infections, or nerve injuries between suture anchor and transosseous tunnel constructs.

 

For all 13 studies, mean (SD) MCMS was 41.1 (8.6).

Discussion

Five percent of all fractures involve the proximal humerus, and 20% of proximal humerus fractures are isolated greater tuberosity fractures.^26,27 In his classic 1970 article, Neer⁶ formulated the 4-part proximal humerus fracture classification and defined greater tuberosity fracture “parts” using the same criteria as for other fracture “parts.” Neer⁶ recommended nonoperative management for isolated greater tuberosity fractures displaced <1 cm but did not present evidence corroborating his recommendation. More recent cutoffs for nonoperative management include 5 mm (general population) and 3 mm (athletes).^7,17

In the present systematic review of greater tuberosity fractures, 3 separate comparisons were made: treatment type (nonoperative vs operative), fracture displacement amount (<5 mm vs >5 mm), and surgery type (open vs arthroscopic).

Treatment Type. Only 4 studies reported data on nonoperative treatment outcomes.^5,12,16,17 Of these 4 studies, 2 found successful outcomes for fractures displaced <5 mm.^12,17 Platzer and colleagues¹⁷ found good or excellent results in 97% of 135 shoulders after 4 years. Good results were defined with shoulder scores of ≥80 (Constant), <8 (Vienna), and >28 (UCLA), and excellent results were defined with maximum scores on 2 of the 3 systems. Platzer and colleagues¹⁷ also found nonsignificantly worse shoulder scores with superior displacement of 3 mm to 5 mm and recommended surgery for overhead athletes in this group. Rath and colleagues¹² described a successful 3-phase rehabilitation protocol of sling immobilization for 3 weeks, pendulum exercises for 3 weeks, and active exercises thereafter. By an average of 31 months, patient satisfaction scores improved to 9.5 from 4.2 (10-point scale), though the authors cautioned that pain and decreased motion lasted 8 months on average. Conservative treatment was far less successful in the 2 studies of fractures displaced >5 mm.^5,16 Keene and colleagues¹⁶ reported unsatisfactory results in all 4 patients with fractures displaced >1.5 cm. In a study separate from their 2005 analysis,¹⁷ Platzer and colleagues⁵ in 2008 evaluated displaced fractures and found function and patient satisfaction were inferior after nonoperative treatment than after surgery. The studies by Keene and colleagues¹⁶ and Platzer and colleagues⁵ support the finding of an overall lower patient satisfaction rate in nonoperative patients.

Fracture Displacement Amount. Only 2 arthroscopic studies and no open studies addressed surgery for fractures displaced <5 mm. Fewer than 16% of these fractures were managed operatively, and <1% required reoperation. By contrast, almost all fractures displaced >5 mm were managed operatively, and 3.6% required reoperation. Radiographic loss of reduction was more common in fractures displaced <5 mm, primarily because they were managed without fixation. Radiographic loss of reduction was reported in only 9 operatively treated patients, none of whom was symptomatic enough to require another surgery.⁵ Reoperations were most commonly performed for stiffness, which itself was significantly more common in fractures displaced >5 mm. Bhatia and colleagues¹⁴ reported the highest reoperation rate (14.3%; 3/21), but they studied more complex, comminuted fractures of the greater tuberosity. Two of their 3 reoperations were biceps tenodeses for inflamed, stiff tenosynovitis, and the third patient had a foreign body giant cell reaction to suture material. Fewer than 1% of patients with operatively managed displaced fractures required revision ORIF, and <2% developed a superficial infection or postoperative nerve palsy.^19,22 For displaced greater tuberosity fractures, surgery is highly successful overall, complication rates are very low, and 90% of patients report being satisfied.

Surgery Type. Patients were divided into 2 groups. In the nonarthroscopic group, open and percutaneous approaches were used. All studies that described a percutaneous approach used screw fixation^5,21; in addition, 32 patients were treated with screws through an open approach.^2,5 The other open and arthroscopic studies used suture fixation. Interestingly, no studies reported on clinical outcomes of fragment excision. There were no statistically significant differences in rates of reoperation, stiffness, infection, or neurologic injury between the arthroscopic and nonarthroscopic groups. Patient satisfaction scores were slightly higher in the nonarthroscopic group (91.0% vs 87.8%), but the difference was not statistically significant.

 

With surgical techniques isolated, there were no significant differences between suture anchors and transosseous tunnel constructs, but screws performed significantly better than suture techniques. Compared with suture fixation, screw fixation led to significantly fewer cases of stiffness and reoperation, which suggests surgeons need to give screws more consideration in the operative management of these fractures. However, the number of patients treated with screws was smaller than the number treated with suture fixation; it is possible the differences between these cohorts would be eliminated if there were more patients in the screw cohort. In addition, screw fixation was universally performed with an open or percutaneous approach and trended toward a higher infection rate. As screw and suture techniques have low rates of complications and reoperations, we recommend leaving fixation choice to the surgeon.

Anterior shoulder instability has been associated with greater tuberosity fractures.^1,8,19 The supraspinatus, infraspinatus, and teres minor muscles all insert into the greater tuberosity and resist anterior translation of the proximal humerus. Loss of this dynamic muscle stabilization is amplified by tuberosity fracture displacement: Anterior shoulder instability was significantly more common in fractures displaced >5 mm (44.3%) vs <5 mm (14.5%). In turn, glenohumeral instability was more common in patients treated with surgery, specifically open surgery, because displaced fractures may not be as easily accessed with arthroscopic techniques. No studies reported concomitant labral repair or capsular plication techniques.

This systematic review was limited by the studies analyzed. All but 1 study⁵ had level IV evidence. Mean (SD) MCMS was 41.8 (8.6). Any MCMS score <54 indicates a poor methodology level, but this scoring system is designed for randomized controlled trials,²³ and there were none in this study. Physical examination findings, such as range of motion, were underreported. In addition, radiographic parameters were not consistently described but rather were determined by the respective authors’ subjective interpretations of malunion, nonunion, and loss of reduction. Publication bias is present in that we excluded non- English language studies and medical conference abstracts and may have omitted potentially eligible studies not discoverable with our search methodology. Performance bias is a factor in any systematic review with multiple surgeons and wide variation in surgical technique.

Conclusion

Greater tuberosity fractures displaced <5 mm may be safely managed nonoperatively, as there are no reports of nonoperatively managed fractures that subsequently required surgery. Nonoperative treatment was initially associated with low patient satisfaction, but only because displaced fractures were conservatively managed in early studies.^5,16 Fractures displaced >5 mm respond well to operative fixation with screws, suture anchors, or transosseous suture tunnels. Stiffness is the most common postoperative complication (<6%), followed by heterotopic ossification, transient neurapraxias, and superficial infection. There are no discernible differences in outcome between open and arthroscopic techniques, but screw fixation may lead to significantly fewer cases of stiffness and reoperation in comparison with suture constructs.

Take-Home Points

• Gorham disease is a rare condition that manifests as an acute, spontaneous osteolysis.
• There is no clear hereditary pattern of transmission. Bones of any type or location can be affected.
• Imaging studies are nonspecific, but show permeative osteolysis involving the subcortical and intramedullary regions and typically affect regional, contiguous bones, without adjacent sclerosis, somewhat resembling osteoporosis.
• Tissue biopsy is indicated to rule out other potential etiologies of osteolysis, and the histologic findings help confirm a diagnosis of Gorham disease.
• There is no single or combined treatment modality that is considered as the gold standard. Surgical treatment includes resection of the lesion and reconstruction. Also, antiosteoclastic medication can be used.

Gorham disease, a rare condition of unknown etiology, manifests as acute, spontaneous osteolysis associated with benign hemangiomatosis or lymphangiomatosis, which presents as skeletal lucency on radiographs, prompting the classic eponym of vanishing bone disease.^1-6 There is no evidence supporting the idea that osteoclasts are present in any meaningful amount in the resorption areas or that local reparative osteogenesis occurs.^4,6

Jackson and colleagues first described idiopathic osteolysis in 1838,^1,2 and Gorham and Stout³ introduced the syndrome to the orthopedic community in 1955. Since then, few strides have been made in identifying the disease origin.^1,2,4 Diagnosis is possible only after meticulous work-up has excluded neoplastic and infectious etiologies.^7,8

Clinical Presentation

Gorham disease affects patients ranging widely in age, from 2 months to 78 years, but typically presents in those under 40 years. There is a questionable predilection for males but no correlation with ethnicity or geographic region. There is no clear hereditary pattern of transmission.⁷ Although the bones of the head, neck, and upper extremities are involved in most cases, bone of any type or location can be affected.⁶ Pelvic bones seem to be involved least often.^6,7

Initial clinical presentation varies considerably but typically involves prolonged soreness in the affected region and, rarely, acute pathologic fracture.^1,2,4 The nonspecific nature of complaints, lack of markers of systemic illness, and rarity of the disease contribute to delayed diagnosis.^1,2

Imaging

Plain radiographs show permeative osteolysis involving the subcortical and intramedullary regions and typically affecting regional, contiguous bones, without adjacent sclerosis, and somewhat resembling heterogeneous osteoporosis (Figure 1).^8-10

Computed tomography (CT) better defines the severity and extent of these changes.

Progression can result in osseous tapering, or “pointing” at lytic margins, forming cone-shaped spicules. In progressive cases, there is an “extraosseous” stage characterized by frank cortical destruction and true “disappearance” of bone, with extensive soft-tissue edema^8-10 (Figures 2A, 2B).

Magnetic resonance imaging shows an infiltrative and irregular T2 hyperintense signal throughout regions of bone affected by osteolysis, but this finding is not characteristic. There is heterogeneous enhancement on postcontrast sequences, and, though masslike enhancement is absent, signal abnormalities may extend into adjacent soft tissues.

These changes indicate inflammation and hemorrhage of various degrees interspersed with scant fibrous tissue^8-10 (Figures 3A, 3B).

Bone scintigraphy using technetium-99m is similarly nonspecific, typically revealing radiotracer uptake that is consistent with bony reaction to an underlying osteolytic process (Figure 4) but turning negative with ongoing resorption.

In some cases of Gorham disease, bone scintigraphy did not reveal a significant increase in activity, such as would be expected in a vascular malformation or purely angiomatous neoplasm. Similar findings could be attributed to a variety of pathologies, including primary bone tumor, metastasis, or even osteomyelitis.^8-10

Positron emission tomography/CT typically shows foci of increased metabolic activity in the areas of osteolysis.¹⁰

 

Diagnosis

There have been 8 histologic and clinical criteria described to diagnose Gorham disease: (1) biopsy positive for presence of angiomatous tissue, (2) complete absence of any cellular atypia, (3) lack of osteoclastic response and lack of dystrophic calcifications, (4) evidence of progressive resorption of native bone, (5) no evidence of expansive or ulcerative lesion, (6) lack of visceral involvement, (7) osteolytic radiographic pattern, and (8) no concrete diagnosis after hereditary, metabolic, neoplastic, immunologic, and infectious work-up.^4-6 These criteria confirm that the diagnosis can be rendered only after exclusion of neoplastic and infectious etiologies through clinical and laboratory work-up, imaging studies, and tissue sampling.

Tissue biopsy is indicated to rule out other potential etiologies of osteolysis, and the histologic findings help confirm a diagnosis of Gorham disease.

Biopsies typically show a progressive osteolysis that is consistently associated with a benign but abnormal vascular proliferation that in many cases has characteristics of lymphatic endothelium. The apparent bony destruction is largely attributed to this process (Figures 5A-5D).^11,12

The differential diagnosis includes infection (osteomyelitis, Brodie abscess), benign tumors (eosinophilic granuloma/Langerhans cell histiocytosis), malignant tumors (Ewing sarcoma and angiosarcoma), inflammatory conditions (eg, apatite- associated destructive arthritis), endocrine disorders (eg, osteolytic hyperparathyroidism), benign non-neoplastic conditions (venous or venolymphatic malformation), and other syndromes that present with osteolysis.^1,2 Nevertheless, progressive and unusually substantial bone destruction without evidence of repair is almost pathognomonic for Gorham disease.⁹

Treatment

Although no single or combined treatment modality is considered the gold standard (Table),^1,2,4,13-23 management of Gorham disease generally centers on radiation therapy for local control of large and painful lesions and on surgical intervention for pathologic progression that would otherwise result in substantial functional limitations.² Also described for treatment are antiosteoclastic medications (bisphosphonates), which are often used in conjunction with radiation and/or surgical intervention.^2,4 The newer literature cites some benefit of using various experimental modalities, including a combination of interferon alfa-2b and low-molecular-weight heparin,¹³ and even propranolol.¹⁴

Surgical treatment usually includes lesion resection and subsequent reconstruction using combinations of bone grafts (allogenic) and prostheses. Bone graft alone is quickly resorbed and has not been found to be beneficial.^1,2,4,20

Take-Home Points

• Gorham disease is a rare condition that manifests as an acute, spontaneous osteolysis.
• There is no clear hereditary pattern of transmission. Bones of any type or location can be affected.
• Imaging studies are nonspecific, but show permeative osteolysis involving the subcortical and intramedullary regions and typically affect regional, contiguous bones, without adjacent sclerosis, somewhat resembling osteoporosis.
• Tissue biopsy is indicated to rule out other potential etiologies of osteolysis, and the histologic findings help confirm a diagnosis of Gorham disease.
• There is no single or combined treatment modality that is considered as the gold standard. Surgical treatment includes resection of the lesion and reconstruction. Also, antiosteoclastic medication can be used.

Gorham disease, a rare condition of unknown etiology, manifests as acute, spontaneous osteolysis associated with benign hemangiomatosis or lymphangiomatosis, which presents as skeletal lucency on radiographs, prompting the classic eponym of vanishing bone disease.^1-6 There is no evidence supporting the idea that osteoclasts are present in any meaningful amount in the resorption areas or that local reparative osteogenesis occurs.^4,6

Jackson and colleagues first described idiopathic osteolysis in 1838,^1,2 and Gorham and Stout³ introduced the syndrome to the orthopedic community in 1955. Since then, few strides have been made in identifying the disease origin.^1,2,4 Diagnosis is possible only after meticulous work-up has excluded neoplastic and infectious etiologies.^7,8

Clinical Presentation

Gorham disease affects patients ranging widely in age, from 2 months to 78 years, but typically presents in those under 40 years. There is a questionable predilection for males but no correlation with ethnicity or geographic region. There is no clear hereditary pattern of transmission.⁷ Although the bones of the head, neck, and upper extremities are involved in most cases, bone of any type or location can be affected.⁶ Pelvic bones seem to be involved least often.^6,7

Initial clinical presentation varies considerably but typically involves prolonged soreness in the affected region and, rarely, acute pathologic fracture.^1,2,4 The nonspecific nature of complaints, lack of markers of systemic illness, and rarity of the disease contribute to delayed diagnosis.^1,2

Imaging

Plain radiographs show permeative osteolysis involving the subcortical and intramedullary regions and typically affecting regional, contiguous bones, without adjacent sclerosis, and somewhat resembling heterogeneous osteoporosis (Figure 1).^8-10

Computed tomography (CT) better defines the severity and extent of these changes.

Progression can result in osseous tapering, or “pointing” at lytic margins, forming cone-shaped spicules. In progressive cases, there is an “extraosseous” stage characterized by frank cortical destruction and true “disappearance” of bone, with extensive soft-tissue edema^8-10 (Figures 2A, 2B).

Magnetic resonance imaging shows an infiltrative and irregular T2 hyperintense signal throughout regions of bone affected by osteolysis, but this finding is not characteristic. There is heterogeneous enhancement on postcontrast sequences, and, though masslike enhancement is absent, signal abnormalities may extend into adjacent soft tissues.

These changes indicate inflammation and hemorrhage of various degrees interspersed with scant fibrous tissue^8-10 (Figures 3A, 3B).

Bone scintigraphy using technetium-99m is similarly nonspecific, typically revealing radiotracer uptake that is consistent with bony reaction to an underlying osteolytic process (Figure 4) but turning negative with ongoing resorption.

In some cases of Gorham disease, bone scintigraphy did not reveal a significant increase in activity, such as would be expected in a vascular malformation or purely angiomatous neoplasm. Similar findings could be attributed to a variety of pathologies, including primary bone tumor, metastasis, or even osteomyelitis.^8-10

Positron emission tomography/CT typically shows foci of increased metabolic activity in the areas of osteolysis.¹⁰

 

Diagnosis

There have been 8 histologic and clinical criteria described to diagnose Gorham disease: (1) biopsy positive for presence of angiomatous tissue, (2) complete absence of any cellular atypia, (3) lack of osteoclastic response and lack of dystrophic calcifications, (4) evidence of progressive resorption of native bone, (5) no evidence of expansive or ulcerative lesion, (6) lack of visceral involvement, (7) osteolytic radiographic pattern, and (8) no concrete diagnosis after hereditary, metabolic, neoplastic, immunologic, and infectious work-up.^4-6 These criteria confirm that the diagnosis can be rendered only after exclusion of neoplastic and infectious etiologies through clinical and laboratory work-up, imaging studies, and tissue sampling.

Tissue biopsy is indicated to rule out other potential etiologies of osteolysis, and the histologic findings help confirm a diagnosis of Gorham disease.

Biopsies typically show a progressive osteolysis that is consistently associated with a benign but abnormal vascular proliferation that in many cases has characteristics of lymphatic endothelium. The apparent bony destruction is largely attributed to this process (Figures 5A-5D).^11,12

The differential diagnosis includes infection (osteomyelitis, Brodie abscess), benign tumors (eosinophilic granuloma/Langerhans cell histiocytosis), malignant tumors (Ewing sarcoma and angiosarcoma), inflammatory conditions (eg, apatite- associated destructive arthritis), endocrine disorders (eg, osteolytic hyperparathyroidism), benign non-neoplastic conditions (venous or venolymphatic malformation), and other syndromes that present with osteolysis.^1,2 Nevertheless, progressive and unusually substantial bone destruction without evidence of repair is almost pathognomonic for Gorham disease.⁹

Treatment

Although no single or combined treatment modality is considered the gold standard (Table),^1,2,4,13-23 management of Gorham disease generally centers on radiation therapy for local control of large and painful lesions and on surgical intervention for pathologic progression that would otherwise result in substantial functional limitations.² Also described for treatment are antiosteoclastic medications (bisphosphonates), which are often used in conjunction with radiation and/or surgical intervention.^2,4 The newer literature cites some benefit of using various experimental modalities, including a combination of interferon alfa-2b and low-molecular-weight heparin,¹³ and even propranolol.¹⁴

Surgical treatment usually includes lesion resection and subsequent reconstruction using combinations of bone grafts (allogenic) and prostheses. Bone graft alone is quickly resorbed and has not been found to be beneficial.^1,2,4,20

Take-Home Points

• Gorham disease is a rare condition that manifests as an acute, spontaneous osteolysis.
• There is no clear hereditary pattern of transmission. Bones of any type or location can be affected.
• Imaging studies are nonspecific, but show permeative osteolysis involving the subcortical and intramedullary regions and typically affect regional, contiguous bones, without adjacent sclerosis, somewhat resembling osteoporosis.
• Tissue biopsy is indicated to rule out other potential etiologies of osteolysis, and the histologic findings help confirm a diagnosis of Gorham disease.
• There is no single or combined treatment modality that is considered as the gold standard. Surgical treatment includes resection of the lesion and reconstruction. Also, antiosteoclastic medication can be used.

Gorham disease, a rare condition of unknown etiology, manifests as acute, spontaneous osteolysis associated with benign hemangiomatosis or lymphangiomatosis, which presents as skeletal lucency on radiographs, prompting the classic eponym of vanishing bone disease.^1-6 There is no evidence supporting the idea that osteoclasts are present in any meaningful amount in the resorption areas or that local reparative osteogenesis occurs.^4,6

Jackson and colleagues first described idiopathic osteolysis in 1838,^1,2 and Gorham and Stout³ introduced the syndrome to the orthopedic community in 1955. Since then, few strides have been made in identifying the disease origin.^1,2,4 Diagnosis is possible only after meticulous work-up has excluded neoplastic and infectious etiologies.^7,8

Clinical Presentation

Gorham disease affects patients ranging widely in age, from 2 months to 78 years, but typically presents in those under 40 years. There is a questionable predilection for males but no correlation with ethnicity or geographic region. There is no clear hereditary pattern of transmission.⁷ Although the bones of the head, neck, and upper extremities are involved in most cases, bone of any type or location can be affected.⁶ Pelvic bones seem to be involved least often.^6,7

Initial clinical presentation varies considerably but typically involves prolonged soreness in the affected region and, rarely, acute pathologic fracture.^1,2,4 The nonspecific nature of complaints, lack of markers of systemic illness, and rarity of the disease contribute to delayed diagnosis.^1,2

Imaging

Plain radiographs show permeative osteolysis involving the subcortical and intramedullary regions and typically affecting regional, contiguous bones, without adjacent sclerosis, and somewhat resembling heterogeneous osteoporosis (Figure 1).^8-10

Computed tomography (CT) better defines the severity and extent of these changes.

Progression can result in osseous tapering, or “pointing” at lytic margins, forming cone-shaped spicules. In progressive cases, there is an “extraosseous” stage characterized by frank cortical destruction and true “disappearance” of bone, with extensive soft-tissue edema^8-10 (Figures 2A, 2B).

Magnetic resonance imaging shows an infiltrative and irregular T2 hyperintense signal throughout regions of bone affected by osteolysis, but this finding is not characteristic. There is heterogeneous enhancement on postcontrast sequences, and, though masslike enhancement is absent, signal abnormalities may extend into adjacent soft tissues.

These changes indicate inflammation and hemorrhage of various degrees interspersed with scant fibrous tissue^8-10 (Figures 3A, 3B).

Bone scintigraphy using technetium-99m is similarly nonspecific, typically revealing radiotracer uptake that is consistent with bony reaction to an underlying osteolytic process (Figure 4) but turning negative with ongoing resorption.

In some cases of Gorham disease, bone scintigraphy did not reveal a significant increase in activity, such as would be expected in a vascular malformation or purely angiomatous neoplasm. Similar findings could be attributed to a variety of pathologies, including primary bone tumor, metastasis, or even osteomyelitis.^8-10

Positron emission tomography/CT typically shows foci of increased metabolic activity in the areas of osteolysis.¹⁰

 

Diagnosis

There have been 8 histologic and clinical criteria described to diagnose Gorham disease: (1) biopsy positive for presence of angiomatous tissue, (2) complete absence of any cellular atypia, (3) lack of osteoclastic response and lack of dystrophic calcifications, (4) evidence of progressive resorption of native bone, (5) no evidence of expansive or ulcerative lesion, (6) lack of visceral involvement, (7) osteolytic radiographic pattern, and (8) no concrete diagnosis after hereditary, metabolic, neoplastic, immunologic, and infectious work-up.^4-6 These criteria confirm that the diagnosis can be rendered only after exclusion of neoplastic and infectious etiologies through clinical and laboratory work-up, imaging studies, and tissue sampling.

Tissue biopsy is indicated to rule out other potential etiologies of osteolysis, and the histologic findings help confirm a diagnosis of Gorham disease.

Biopsies typically show a progressive osteolysis that is consistently associated with a benign but abnormal vascular proliferation that in many cases has characteristics of lymphatic endothelium. The apparent bony destruction is largely attributed to this process (Figures 5A-5D).^11,12

The differential diagnosis includes infection (osteomyelitis, Brodie abscess), benign tumors (eosinophilic granuloma/Langerhans cell histiocytosis), malignant tumors (Ewing sarcoma and angiosarcoma), inflammatory conditions (eg, apatite- associated destructive arthritis), endocrine disorders (eg, osteolytic hyperparathyroidism), benign non-neoplastic conditions (venous or venolymphatic malformation), and other syndromes that present with osteolysis.^1,2 Nevertheless, progressive and unusually substantial bone destruction without evidence of repair is almost pathognomonic for Gorham disease.⁹

Treatment

Although no single or combined treatment modality is considered the gold standard (Table),^1,2,4,13-23 management of Gorham disease generally centers on radiation therapy for local control of large and painful lesions and on surgical intervention for pathologic progression that would otherwise result in substantial functional limitations.² Also described for treatment are antiosteoclastic medications (bisphosphonates), which are often used in conjunction with radiation and/or surgical intervention.^2,4 The newer literature cites some benefit of using various experimental modalities, including a combination of interferon alfa-2b and low-molecular-weight heparin,¹³ and even propranolol.¹⁴

Surgical treatment usually includes lesion resection and subsequent reconstruction using combinations of bone grafts (allogenic) and prostheses. Bone graft alone is quickly resorbed and has not been found to be beneficial.^1,2,4,20

Traumatic brain injury (TBI) is a health concern for the U.S. Military Health System (MHS) as well as the VHA. It occurs in both deployed and nondeployed settings; however, Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) and improved reporting mechanisms have dramatically increased TBI diagnoses in active-duty service members. According to the Defense and Veterans Brain Injury Center (DVBIC), more than 370,000 service members have been diagnosed with a TBI since 2000 (Figure).¹

Background

The DoD and the VA are collaborating on clinical research studies to identify, understand, and treat the long-term effects of TBI that can affect patients and their families. Most TBIs are mild (mTBIs), also called concussions, and patients typically recover within a few weeks (Table 1). However, some individuals with mTBI experience symptoms that may persist for months or years. A meta-analysis by Perry and colleagues showed that the prevalence or risk of a neurologic disorder, depression, or other mental health issue following mTBI was 67% higher compared with that in uninjured controls.²

Patients with any severity of TBI may require assistance with activities of daily living (ADLs), such as bathing, dressing, managing medications, and feeding. Patients also may need help with instrumental ADLs, such as meal preparation, grocery shopping, household chores, child care, getting to appointments or activities, coordination of educational and vocational services, financial and benefits management, and supportive listening.

Increased injuries have spurred the DoD and VA to coordinate health care to provide a seamless transition for patients between the 2 agencies. However, individuals who sustained a TBI may need various levels of caregiver assistance over time.

TBI and Caregivers

Despite better agency coordination for patients, caregivers can experience stress. Griffin and colleagues found that caregiving responsibilities can compete with other demands on the caregiver, such as work and family, and may negatively impact their health and finances.^3,4

Lou and colleagues studied the factors associated with caring for chronically ill family members that may result in stress for the caregivers.⁵ Along with an unaccounted for economic contribution, caregivers may face lost work time and pay and limitations on work travel and work advancement. Additionally, lost time for leisure, travel, social activities, family obligations, and retirement could result in physical and mental drain on the caregiver. Stress may reach a level at which the caregivers risk psychological distress. The study also noted that families with perceived high stress experience disrupted family functioning. Some TBI caregiver studies sought to understand how best to evaluate and determine the level of caregiver burden, and other studies investigated appropriate interventions.^6-9

Health care practitioners within the federal health care system may benefit from a greater awareness of caregiver needs and caregiver resources. Caregiver support can improve outcomes for both the caregiver and care recipient, and many organizations and resources already exist to assist the caregiver. This article reviews recent published literature on TBI caregivers of patients with TBI across civilian, military, and veteran populations and lists caregiver resources for additional information, assistance, and support.

Literature Review

The DVBIC defines the term caregiver as “any family or support person(s) relied upon by the service member or veteran with traumatic brain injury (TBI) who assumes primary responsibility for ensuring the needed level of care and overall well-being of that service member or veteran. A family or family caregiver may include spouse, parents, children, other extended family members, as well as significant others and friends.”³

In the following discussion, findings from military and veteran literature are separated from civilian population findings to highlight similarities and differences between these 2 bodies of research. Several of the studies in the military/veteran cohorts include polytrauma patients with comorbid physical and mental health issues not necessarily found in civilian literature.

Civilian Literature

A 2015 systematic review by Anderson and colleagues on coping and psychological adjustment in TBI caregivers indicated no Class I or Class II studies.¹⁰ Four Class III and 3 Class IV studies were found. The authors suggest that more rigorous studies (ie, Class I and II) are needed.

Despite these limitations, peer-reviewed literature indicates that the levels of stress and distress in TBI caregivers are consistent with reports for other diseases. In a civilian population, Carlozzi and colleagues found that TBI caregivers who reported stress, distress, anxiety, and feeling overwhelmed often had concerns for their social, emotional, physical, cognitive health, as well as feelings of loss.⁵ In addition, caregivers may need to take leaves of absence or leave the workforce entirely to provide for a family member or friend who had a TBI—often leading to financial strain (eg, depleting assets, accumulating debt). These challenges may occur during prime earning years, and the caregiver may lose the ability to resume work if the care receiver requires care for extended periods.¹¹

Kratz and colleagues showed that caregivers of individuals with moderate-to-severe TBI: (1) felt overburdened with responsibilities; (2) lacked personal time and time for self-care; (3) felt their lives were interrupted or lost; (4) grieved the loss of the person with TBI; and (5) endorsed anger, guilt, anxiety, and sadness.¹²

Perceptions differed between caregiver parents and caregiver partners. Parents expressed feelings of grief and sadness related to the “loss of the person before the TBI.” Parents also reported a sense of guilt and responsibility for their child’s TBI and feelings of being tied down to the individual with TBI. Parents experienced a greater level of stress if the son or daughter with TBI still lived at home. Partners expressed frustration and despair related to their role as sole decision maker and care provider. Partners’ distress also related to the partner relationship and the relationship between children and the individual with TBI.

Verhasghe and colleagues found that partners experience a greater degree of stress than do parents.¹³ Young families with minimal social support for coping with financial, psychiatric, and medical problems were the most vulnerable to stress. A systematic review by Ennis and colleagues evaluated depression and anxiety in caregiver parents vs spouses.¹⁴ Although methods and quality differed in the studies, findings indicated high levels of distress regardless of the type of caregiver.

Anderson and colleagues used the Ways of Coping Questionnaire to evaluate the association between coping and psychological adjustment in caregivers of TBI individuals.¹⁰ The use of emotion-focused coping and problem solving was possibly associated with psychological adjustment in caregivers. Verhasghe and colleagues indicated that the nature of the injuries more than the severity of TBI determined the level of stress up to 15 years after the TBI.¹³ Gender and social and professional support also influenced coping. The review identified the need to develop models of long-term support and care.

An Australian cohort of 79 family caregivers participated in a study by Perlesz and colleagues.¹⁵ Participants’ caregiving responsibilities averaged 19.3 months posttrauma. The Family Satisfaction Scale, Beck Depression Inventory, State Anxiety Inventory, and Profile of Mood States were used in this analysis. Male caregivers reported distress in terms of anger and fatigue; female caregivers were at greatest risk of poor psychosocial outcomes. Although findings from primary caregivers indicated that 35% to 49% displayed enough distress to warrant clinical intervention, between 51% and 80% were not psychologically distressed and were satisfied with their families. Data supported previous reports suggesting caregivers are “not universally distressed.”¹⁵

Manskow and colleagues followed patients with severe TBI and assessed caregiver burden 1 year later. Using the Caregiver Burden Scale, caregivers reported the highest scores (N = 92) on the General Strain Index followed by the Disappointment Index.¹⁶ Bayen and colleagues also studied caregivers of severe TBI patients.¹⁷ Objective and subjective caregiver burden data 4 years later indicated 44% of caregivers (N = 98) reported multidimensional burden. Greater burden was associated in caring for individuals who had poorer Glasgow Outcome Scale Extended scores and more severe cognitive disorders.

 

Military and Veteran Literature

Griffin and colleagues conducted the Family and Caregiver Experience Study (FACES) with caregivers (N = 564) of service members who incurred a TBI.³ According to the caregivers, two-thirds of the patients lost consciousness for more than 30 minutes, which was followed by inpatient rehabilitation care at a VA polytrauma center between 2001 and 2009. The majority of caregivers of TBI patients were female (79%) and aged < 60 years (84%). Parents comprised 62% and spouses 32% of the cohort. Caregivers tended to have some level of education beyond high school (73%), were married (77%), either worked or were enrolled in school (55%), and earned less than $40,000 a year (70%). Common characteristics of the care receivers were male gender (95%), average age 30, high school educated (52%), married (almost 50%), and employed (50%). Forty-five percent of the care receivers were injured 4 to 6 years prior, and 12% were injured 7 or more years prior. The study determined the caregivers’ perception of intensity of care needed and indicated that families as well as clinicians need to plan for some level of long-term support and services.

In addition to the TBI-related caregiving needs, Griffin and colleagues found in a military population that other medical conditions impacted the level of caregiving and strained a marriage.¹⁸ Their study found that in a military population between 30% and 50% of marriages of patients with TBI dissolved within the first 10 years after injury. Caregivers may need to learn nursing activities, such as tube feedings, tracheostomy and stoma care, catheter care, wound care, and medication administration. Family stress with caregiving may interfere with the ability to understand information related to the care receivers’ medical care and may require multiple formats to explain care needs. Sander and colleagues associated better emotional functioning in caregivers with greater social integration and occupation outcomes in patients at the postacute rehabilitation program phase (within 6 months of injury).¹⁹ However, these outcomes did not continue more than 6 months postinjury.

Intervention and Research Studies

Powell and colleagues used a telephone-based, individualized TBI education intervention along with problem-solving mentoring (10 phone calls at 2-week intervals following patient discharge for moderate-to-severe TBI from a level 1 trauma center) to determine which programs, activities, and coping strategies could decrease caregiver challenges.²⁰ The telephone interventions resulted in better caregiver outcomes than usual care as measured by composite scores on the Bakas Caregiving Outcomes Scale (BCOS) and the Brief Symptom Inventory (BSI-18) at 6 months post-TBI survivor discharge. Dyer and colleagues explored Internet approaches and mobile applications to provide support for caregivers. ¹⁸ In a small sample of 10 caregivers, Damianakis and colleagues conducted a 10-session pilot videoconferencing support-group intervention program led by a clinician. Results indicated that the intervention enhanced caregiver coping and problem-solving skills.⁷

Petranovich and colleagues examined the efficacy of counselor-assisted problem-solving interventions in improving long-term caregiver psychological functioning following TBI in adolescents.²¹ Their findings support the utility of online interventions in improving long-term caregiver psychological distress, particularly for lower income families. Although this study focused on adolescents, research may indicate merit in an adult population. In relatives of patients with severe TBI, Norup and colleagues associated improvements in health-related quality of life (HRQOL) with improvements in symptoms of anxiety and depression without specific intervention.²²

Moriarty and colleagues conducted a randomized controlled trial for veterans who received care at a VA polytrauma center and their family members who participated in a veteran’s in-home program (VIP) intervention.⁹ The study aimed to evaluate how VIP affected family members’ caregiver burden, depressive symptoms, satisfaction with caregiving, and the program’s acceptability. Eighty-one veterans with a key family member were randomized. Of those, 63 veterans completed a follow-up interview. The intervention consisted of 6 home visits of 1 to 2 hours each and 2 telephone calls from an occupational therapist over 3 to 4 months. Family members were invited to participate during the home visits. The control group received usual clinic care with 2 telephone calls during the study period. All participants received the follow-up interview 3 to 4 months after baseline interviews. The severity of TBI was determined by a review of the electronic medical record using the VA/DoD Clinical Practice Guidelines. Findings of this study indicated that family members in the intervention group showed significantly lower depressive symptom scores and caregiver burden scores.⁹ Additionally, the veterans in the intervention group exhibited higher community integration and ability to manage their targeted outcomes. Further research may indicate that VIP could assist patients with TBI and caregivers in an active-duty population.

The DVBIC is the executive agent for a congressionally mandated 15-year longitudinal study on TBI incurred by members of the armed services in OEF and OIF. The John Warner National Defense Authorization Act for Fiscal Year 2007 outlined the study. An initial finding identified the need for an HRQOL outcomes assessment specific to TBI caregivers.²³ Having these data will allow investigators to fully determine the comprehensive impact of caring for a person who sustained a mild, moderate, severe, or penetrating TBI and to evaluate the effectiveness of interventions designed to address caregivers’ needs. To date, the study has identified the following HRQOL themes generated among caregivers: social health, emotional health, physical/medical health, cognitive functioning, and feelings of loss (related to changing social roles). Carlozzi and colleagues noted that the study also aimed to identify a sensitive outcome measure to evaluate quality of life in the caregivers over time.⁷

 

Knowledge Gaps

Ongoing studies focus on caregiving for individuals with various illnesses and needs. Some of the information in each study may be beneficial to TBI caregivers who are not fully aware of resources and interventions. For example, Fortune and colleagues, Hirano and colleagues, and Grover and colleagues are studying caregiver activities involving other diseases to determine, more generally, which programs, activities, and coping strategies can decrease caregiver challenges.^24-26 Further, understanding and addressing the needs of these families over many years will provide data that could inform policy, benefits, resources, and needed services (such as the Caregivers and Veterans Omnibus Health Services Act of 2010) and assist with family resilience efforts, including understanding and enhancing family protective and recovery factors.

As studies have indicated, some families do not report family distress when providing care to an individual with TBI. Understanding the factors that influence positive family adjustment is important to capture and perhaps replicate in future studies so that they can lead to effective treatment interventions. Although this review does not discuss caregiver needs for patients with TBI with disorders of consciousness that require more care than most caregivers can provide in the home setting, caregiving for this population deserves attention in future studies. Furthermore, an area that has not received much attention is the impact on children in the household. Children aged < 18 years can assist not only in the care of a disabled adult, but also of younger siblings; also they can help with household activities from housekeeping to meal preparation. Children also may provide physical and emotional support.

The impact of aging caregivers and subsequent needs for their own care as well as the person(s) they are providing care for has not been fully addressed. Areas requiring more research include both the aging caregiver taking care of an aging spouse or relative and the aging parent taking care of a young adult or child. Along with aging, the issue of long-term caregiving needs further development. For example, how do the differences between access to services between caregivers of adults with TBI in the military and those in the civilian sector impact the family/caregiver? Further research may answer questions such as:

• Which tools are most useful in evaluating and determining caregiver stress and burden?
• Are the needs of military and veteran caregivers unique?
• Do polytrauma patients with comorbid diagnoses have unique caregiver needs and trajectories?
• Do TBI caregiver stressors differ from stressors related to other medical conditions or chronic diseases?
• Is there a need for military and veteran TBI-specific caregiver programs?
• Which interventions best help caregivers and for how long?
• Should the approach to intervention depend on variables such as age and gender of the caregivers or relationship to the patient with a TBI (eg, spouse vs parent)?

Methods or processes to inform and update caregivers about available resources also are critically needed. Also, Sabab and colleagues noted the importance of research on the effects of denial as it relates to cognitive, emotional, social impact.²⁷ Denial may impact delays in treatments.

Resource

Many national, state, local, and grassroots organizations provide information and support for persons with illness and/or disabilities. Most clinicians of neurologic, mental health, and cancer have developed various forms of support interventions for those with the disease and their caregivers (Table 2). Highlighted in this section are a few organizations that specifically provide resources for caregivers caring for active-duty service members or veterans with a TBI.

Although a caregiver generally does not receive money from an outside source for services, the DoD may consider the caregiver as a nonmedical attendant for an active-duty service member and provide a temporary stipend. The VA provides several support and service options for caregivers under the Caregiver Support Program, through which more than 300 VA health care professionals provide support to caregivers. The Caregivers and Veterans Omnibus Health Services Act of 2010 authorizes the VA to provide additional VA services for seriously injured post-9/11 veterans and their family caregivers through the Program of Comprehensive Assistance for Family Caregivers (VA Caregiver Support Program). After meeting eligibility criteria, primary caregivers of post-9/11 veterans may receive a monthly stipend (based on the level of care needed) as well as comprehensive caregiver training, referral services, access to health care insurance, mental health services, counseling, and respite care. The Caregiver Support Program offers a toll-free support line and a 24-hour crisis hot line.

In 2014, the Government Accountability Office (GAO) outlined the VA health care improvements needed to manage the demand for the Caregiver Support Program, which are established at VA medical centers.²⁸ The GAO reported that the “VA significantly underestimated caregivers’ demand for services… larger than expected workloads and …delays in approval determinations” with about 500 approved caregivers who are added to the program each month. Original estimates indicated that about 4,000 caregivers would be approved by September 2014; however, by May 2014 about 15,600 caregivers were approved.

In addition to the VA Caregiver Support Program, a variety of state, local, and nonprofit organizations offer support for caregivers. Established in 2012, the Elizabeth Dole Foundation’s program Caring for Military Families “assists caregivers by raising awareness of the caregiver role, leveraging resources and partnerships to provide support, and identifying best practices and solutions to address the challenges caregivers face.” The foundation commissioned the RAND Corporation to “describe the magnitude of military caregiving in the United States, and to identify gaps in programs, policies, and services.” The 2014 RAND report estimated that among the 5.5 million military caregivers in the U.S., 1 million (19.6%) cared for post-9/11 veterans.²⁹ The military caregivers consistently experienced poorer health outcomes, greater strains on family relationships, and more workplace problems than noncaregivers; post-9/11 military caregivers fared worse in those areas.

The Elizabeth Dole Foundation, Hidden Heroes Impact Council Forum advocates for caregiver empowerment, cultural competency awareness, and better policies, programs, and services. The council focuses its efforts on key impact: community support at home, education and training, employment and workplace support, financial and legal issues, interfaith action and ministry council, mental and physical health, and respite care. It aims to raise the money to build awareness and support for military and veterans’ caregivers. The Military and Veteran Caregiver Network is another Elizabeth Dole Foundation initiative. It is an online forum community, peer support group, and peer mentor program structure. A resource library for referrals to local services also is available.

A variety of other organizations, such as United Service Organizations; Easter Seals; Team Red, White and Blue; Operation Homefront; Blue Star Families; state Brain Injury Associations; and support groups for TBI at local hospitals and community centers provide resources to both patients and caregivers. Organizations for caregivers not exclusive to TBI patients include the Caregiver Action Network (formerly National Family Caregiver Association) and the Family Caregiver Alliance. The National Family Caregivers Support Program provides grants to states and territories to develop and provide supportive services to caregivers. Some training for caregivers could include long-term financial planning, legal issues, residential and educational planning, caregiver stress management, the benefits of utilizing support resources, and actions and behaviors that enhance coping strategies. In 2007, DVBIC developed The Traumatic Brain Injury Guide for Caregivers of Service Members and Veterans, which is intended for family caregivers assisting a service member or veteran who sustained a moderate or severe TBI.⁶ A recent assessment determined the need to update the guide. The Center of Excellence for Medical Multimedia is another source of information for caregivers.

 

Conclusion

The recent combat conflicts of OEF and OIF have resulted in a dramatic increase in the occurrence of TBI injuries in active-duty service members both in theater and stateside and have highlighted the need for some service members and veterans with a TBI to require ongoing assistance from a caregiver. The levels of assistance and length of time vary greatly, impacted by the severity of the TBI and psychosocial situations.

In response to elevated awareness, several programs and resources have been developed or enhanced to address the specific needs of caregivers. Certain programs and resources are specific for caregivers of military service members and veterans, whereas others benefit caregivers in general. Likewise, some programs are not specific to individuals with TBI.

Caregivers assume many roles in their efforts to support the person with a TBI. They may need to dramatically adjust their lives to serve as a caregiver. Providing adequate resources for the caregivers impacts their ability to continue providing care. Thus, awareness of and access to resources play a critical role in helping to reduce stress, distress, burden (eg, physical, emotional, and financial), and caregiver burnout. Programs and resources often change, making it difficult for health care practitioners to know which programs offer what or even whether they still exist. Therefore, the authors synthesized the current medical literature of the topic of TBI and their caregiver needs as well as current resources for additional information and support.

Ongoing research studies, such as the congressionally mandated 15-year longitudinal study, are examining the impact of caregiving in the military and veteran communities. Future research could identify specific needs of military caregivers, identify gaps in services or programs, and identify interventions that promote resilience. Moreover, research directed at military and veteran caregivers can promote change that will benefit the general population of caregivers. It will be important for health care practitioners to keep abreast of new findings and information to incorporate into care plans for their patients who have had a TBI and their families.

Traumatic brain injury (TBI) is a health concern for the U.S. Military Health System (MHS) as well as the VHA. It occurs in both deployed and nondeployed settings; however, Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) and improved reporting mechanisms have dramatically increased TBI diagnoses in active-duty service members. According to the Defense and Veterans Brain Injury Center (DVBIC), more than 370,000 service members have been diagnosed with a TBI since 2000 (Figure).¹

Background

The DoD and the VA are collaborating on clinical research studies to identify, understand, and treat the long-term effects of TBI that can affect patients and their families. Most TBIs are mild (mTBIs), also called concussions, and patients typically recover within a few weeks (Table 1). However, some individuals with mTBI experience symptoms that may persist for months or years. A meta-analysis by Perry and colleagues showed that the prevalence or risk of a neurologic disorder, depression, or other mental health issue following mTBI was 67% higher compared with that in uninjured controls.²

Patients with any severity of TBI may require assistance with activities of daily living (ADLs), such as bathing, dressing, managing medications, and feeding. Patients also may need help with instrumental ADLs, such as meal preparation, grocery shopping, household chores, child care, getting to appointments or activities, coordination of educational and vocational services, financial and benefits management, and supportive listening.

Increased injuries have spurred the DoD and VA to coordinate health care to provide a seamless transition for patients between the 2 agencies. However, individuals who sustained a TBI may need various levels of caregiver assistance over time.

TBI and Caregivers

Despite better agency coordination for patients, caregivers can experience stress. Griffin and colleagues found that caregiving responsibilities can compete with other demands on the caregiver, such as work and family, and may negatively impact their health and finances.^3,4

Lou and colleagues studied the factors associated with caring for chronically ill family members that may result in stress for the caregivers.⁵ Along with an unaccounted for economic contribution, caregivers may face lost work time and pay and limitations on work travel and work advancement. Additionally, lost time for leisure, travel, social activities, family obligations, and retirement could result in physical and mental drain on the caregiver. Stress may reach a level at which the caregivers risk psychological distress. The study also noted that families with perceived high stress experience disrupted family functioning. Some TBI caregiver studies sought to understand how best to evaluate and determine the level of caregiver burden, and other studies investigated appropriate interventions.^6-9

Health care practitioners within the federal health care system may benefit from a greater awareness of caregiver needs and caregiver resources. Caregiver support can improve outcomes for both the caregiver and care recipient, and many organizations and resources already exist to assist the caregiver. This article reviews recent published literature on TBI caregivers of patients with TBI across civilian, military, and veteran populations and lists caregiver resources for additional information, assistance, and support.

Literature Review

The DVBIC defines the term caregiver as “any family or support person(s) relied upon by the service member or veteran with traumatic brain injury (TBI) who assumes primary responsibility for ensuring the needed level of care and overall well-being of that service member or veteran. A family or family caregiver may include spouse, parents, children, other extended family members, as well as significant others and friends.”³

In the following discussion, findings from military and veteran literature are separated from civilian population findings to highlight similarities and differences between these 2 bodies of research. Several of the studies in the military/veteran cohorts include polytrauma patients with comorbid physical and mental health issues not necessarily found in civilian literature.

Civilian Literature

A 2015 systematic review by Anderson and colleagues on coping and psychological adjustment in TBI caregivers indicated no Class I or Class II studies.¹⁰ Four Class III and 3 Class IV studies were found. The authors suggest that more rigorous studies (ie, Class I and II) are needed.

Despite these limitations, peer-reviewed literature indicates that the levels of stress and distress in TBI caregivers are consistent with reports for other diseases. In a civilian population, Carlozzi and colleagues found that TBI caregivers who reported stress, distress, anxiety, and feeling overwhelmed often had concerns for their social, emotional, physical, cognitive health, as well as feelings of loss.⁵ In addition, caregivers may need to take leaves of absence or leave the workforce entirely to provide for a family member or friend who had a TBI—often leading to financial strain (eg, depleting assets, accumulating debt). These challenges may occur during prime earning years, and the caregiver may lose the ability to resume work if the care receiver requires care for extended periods.¹¹

Kratz and colleagues showed that caregivers of individuals with moderate-to-severe TBI: (1) felt overburdened with responsibilities; (2) lacked personal time and time for self-care; (3) felt their lives were interrupted or lost; (4) grieved the loss of the person with TBI; and (5) endorsed anger, guilt, anxiety, and sadness.¹²

Perceptions differed between caregiver parents and caregiver partners. Parents expressed feelings of grief and sadness related to the “loss of the person before the TBI.” Parents also reported a sense of guilt and responsibility for their child’s TBI and feelings of being tied down to the individual with TBI. Parents experienced a greater level of stress if the son or daughter with TBI still lived at home. Partners expressed frustration and despair related to their role as sole decision maker and care provider. Partners’ distress also related to the partner relationship and the relationship between children and the individual with TBI.

Verhasghe and colleagues found that partners experience a greater degree of stress than do parents.¹³ Young families with minimal social support for coping with financial, psychiatric, and medical problems were the most vulnerable to stress. A systematic review by Ennis and colleagues evaluated depression and anxiety in caregiver parents vs spouses.¹⁴ Although methods and quality differed in the studies, findings indicated high levels of distress regardless of the type of caregiver.

Anderson and colleagues used the Ways of Coping Questionnaire to evaluate the association between coping and psychological adjustment in caregivers of TBI individuals.¹⁰ The use of emotion-focused coping and problem solving was possibly associated with psychological adjustment in caregivers. Verhasghe and colleagues indicated that the nature of the injuries more than the severity of TBI determined the level of stress up to 15 years after the TBI.¹³ Gender and social and professional support also influenced coping. The review identified the need to develop models of long-term support and care.

An Australian cohort of 79 family caregivers participated in a study by Perlesz and colleagues.¹⁵ Participants’ caregiving responsibilities averaged 19.3 months posttrauma. The Family Satisfaction Scale, Beck Depression Inventory, State Anxiety Inventory, and Profile of Mood States were used in this analysis. Male caregivers reported distress in terms of anger and fatigue; female caregivers were at greatest risk of poor psychosocial outcomes. Although findings from primary caregivers indicated that 35% to 49% displayed enough distress to warrant clinical intervention, between 51% and 80% were not psychologically distressed and were satisfied with their families. Data supported previous reports suggesting caregivers are “not universally distressed.”¹⁵

Manskow and colleagues followed patients with severe TBI and assessed caregiver burden 1 year later. Using the Caregiver Burden Scale, caregivers reported the highest scores (N = 92) on the General Strain Index followed by the Disappointment Index.¹⁶ Bayen and colleagues also studied caregivers of severe TBI patients.¹⁷ Objective and subjective caregiver burden data 4 years later indicated 44% of caregivers (N = 98) reported multidimensional burden. Greater burden was associated in caring for individuals who had poorer Glasgow Outcome Scale Extended scores and more severe cognitive disorders.

 

Military and Veteran Literature

Griffin and colleagues conducted the Family and Caregiver Experience Study (FACES) with caregivers (N = 564) of service members who incurred a TBI.³ According to the caregivers, two-thirds of the patients lost consciousness for more than 30 minutes, which was followed by inpatient rehabilitation care at a VA polytrauma center between 2001 and 2009. The majority of caregivers of TBI patients were female (79%) and aged < 60 years (84%). Parents comprised 62% and spouses 32% of the cohort. Caregivers tended to have some level of education beyond high school (73%), were married (77%), either worked or were enrolled in school (55%), and earned less than $40,000 a year (70%). Common characteristics of the care receivers were male gender (95%), average age 30, high school educated (52%), married (almost 50%), and employed (50%). Forty-five percent of the care receivers were injured 4 to 6 years prior, and 12% were injured 7 or more years prior. The study determined the caregivers’ perception of intensity of care needed and indicated that families as well as clinicians need to plan for some level of long-term support and services.

In addition to the TBI-related caregiving needs, Griffin and colleagues found in a military population that other medical conditions impacted the level of caregiving and strained a marriage.¹⁸ Their study found that in a military population between 30% and 50% of marriages of patients with TBI dissolved within the first 10 years after injury. Caregivers may need to learn nursing activities, such as tube feedings, tracheostomy and stoma care, catheter care, wound care, and medication administration. Family stress with caregiving may interfere with the ability to understand information related to the care receivers’ medical care and may require multiple formats to explain care needs. Sander and colleagues associated better emotional functioning in caregivers with greater social integration and occupation outcomes in patients at the postacute rehabilitation program phase (within 6 months of injury).¹⁹ However, these outcomes did not continue more than 6 months postinjury.

Intervention and Research Studies

Powell and colleagues used a telephone-based, individualized TBI education intervention along with problem-solving mentoring (10 phone calls at 2-week intervals following patient discharge for moderate-to-severe TBI from a level 1 trauma center) to determine which programs, activities, and coping strategies could decrease caregiver challenges.²⁰ The telephone interventions resulted in better caregiver outcomes than usual care as measured by composite scores on the Bakas Caregiving Outcomes Scale (BCOS) and the Brief Symptom Inventory (BSI-18) at 6 months post-TBI survivor discharge. Dyer and colleagues explored Internet approaches and mobile applications to provide support for caregivers. ¹⁸ In a small sample of 10 caregivers, Damianakis and colleagues conducted a 10-session pilot videoconferencing support-group intervention program led by a clinician. Results indicated that the intervention enhanced caregiver coping and problem-solving skills.⁷

Petranovich and colleagues examined the efficacy of counselor-assisted problem-solving interventions in improving long-term caregiver psychological functioning following TBI in adolescents.²¹ Their findings support the utility of online interventions in improving long-term caregiver psychological distress, particularly for lower income families. Although this study focused on adolescents, research may indicate merit in an adult population. In relatives of patients with severe TBI, Norup and colleagues associated improvements in health-related quality of life (HRQOL) with improvements in symptoms of anxiety and depression without specific intervention.²²

Moriarty and colleagues conducted a randomized controlled trial for veterans who received care at a VA polytrauma center and their family members who participated in a veteran’s in-home program (VIP) intervention.⁹ The study aimed to evaluate how VIP affected family members’ caregiver burden, depressive symptoms, satisfaction with caregiving, and the program’s acceptability. Eighty-one veterans with a key family member were randomized. Of those, 63 veterans completed a follow-up interview. The intervention consisted of 6 home visits of 1 to 2 hours each and 2 telephone calls from an occupational therapist over 3 to 4 months. Family members were invited to participate during the home visits. The control group received usual clinic care with 2 telephone calls during the study period. All participants received the follow-up interview 3 to 4 months after baseline interviews. The severity of TBI was determined by a review of the electronic medical record using the VA/DoD Clinical Practice Guidelines. Findings of this study indicated that family members in the intervention group showed significantly lower depressive symptom scores and caregiver burden scores.⁹ Additionally, the veterans in the intervention group exhibited higher community integration and ability to manage their targeted outcomes. Further research may indicate that VIP could assist patients with TBI and caregivers in an active-duty population.

The DVBIC is the executive agent for a congressionally mandated 15-year longitudinal study on TBI incurred by members of the armed services in OEF and OIF. The John Warner National Defense Authorization Act for Fiscal Year 2007 outlined the study. An initial finding identified the need for an HRQOL outcomes assessment specific to TBI caregivers.²³ Having these data will allow investigators to fully determine the comprehensive impact of caring for a person who sustained a mild, moderate, severe, or penetrating TBI and to evaluate the effectiveness of interventions designed to address caregivers’ needs. To date, the study has identified the following HRQOL themes generated among caregivers: social health, emotional health, physical/medical health, cognitive functioning, and feelings of loss (related to changing social roles). Carlozzi and colleagues noted that the study also aimed to identify a sensitive outcome measure to evaluate quality of life in the caregivers over time.⁷

 

Knowledge Gaps

Ongoing studies focus on caregiving for individuals with various illnesses and needs. Some of the information in each study may be beneficial to TBI caregivers who are not fully aware of resources and interventions. For example, Fortune and colleagues, Hirano and colleagues, and Grover and colleagues are studying caregiver activities involving other diseases to determine, more generally, which programs, activities, and coping strategies can decrease caregiver challenges.^24-26 Further, understanding and addressing the needs of these families over many years will provide data that could inform policy, benefits, resources, and needed services (such as the Caregivers and Veterans Omnibus Health Services Act of 2010) and assist with family resilience efforts, including understanding and enhancing family protective and recovery factors.

As studies have indicated, some families do not report family distress when providing care to an individual with TBI. Understanding the factors that influence positive family adjustment is important to capture and perhaps replicate in future studies so that they can lead to effective treatment interventions. Although this review does not discuss caregiver needs for patients with TBI with disorders of consciousness that require more care than most caregivers can provide in the home setting, caregiving for this population deserves attention in future studies. Furthermore, an area that has not received much attention is the impact on children in the household. Children aged < 18 years can assist not only in the care of a disabled adult, but also of younger siblings; also they can help with household activities from housekeeping to meal preparation. Children also may provide physical and emotional support.

The impact of aging caregivers and subsequent needs for their own care as well as the person(s) they are providing care for has not been fully addressed. Areas requiring more research include both the aging caregiver taking care of an aging spouse or relative and the aging parent taking care of a young adult or child. Along with aging, the issue of long-term caregiving needs further development. For example, how do the differences between access to services between caregivers of adults with TBI in the military and those in the civilian sector impact the family/caregiver? Further research may answer questions such as:

• Which tools are most useful in evaluating and determining caregiver stress and burden?
• Are the needs of military and veteran caregivers unique?
• Do polytrauma patients with comorbid diagnoses have unique caregiver needs and trajectories?
• Do TBI caregiver stressors differ from stressors related to other medical conditions or chronic diseases?
• Is there a need for military and veteran TBI-specific caregiver programs?
• Which interventions best help caregivers and for how long?
• Should the approach to intervention depend on variables such as age and gender of the caregivers or relationship to the patient with a TBI (eg, spouse vs parent)?

Methods or processes to inform and update caregivers about available resources also are critically needed. Also, Sabab and colleagues noted the importance of research on the effects of denial as it relates to cognitive, emotional, social impact.²⁷ Denial may impact delays in treatments.

Resource

Many national, state, local, and grassroots organizations provide information and support for persons with illness and/or disabilities. Most clinicians of neurologic, mental health, and cancer have developed various forms of support interventions for those with the disease and their caregivers (Table 2). Highlighted in this section are a few organizations that specifically provide resources for caregivers caring for active-duty service members or veterans with a TBI.

Although a caregiver generally does not receive money from an outside source for services, the DoD may consider the caregiver as a nonmedical attendant for an active-duty service member and provide a temporary stipend. The VA provides several support and service options for caregivers under the Caregiver Support Program, through which more than 300 VA health care professionals provide support to caregivers. The Caregivers and Veterans Omnibus Health Services Act of 2010 authorizes the VA to provide additional VA services for seriously injured post-9/11 veterans and their family caregivers through the Program of Comprehensive Assistance for Family Caregivers (VA Caregiver Support Program). After meeting eligibility criteria, primary caregivers of post-9/11 veterans may receive a monthly stipend (based on the level of care needed) as well as comprehensive caregiver training, referral services, access to health care insurance, mental health services, counseling, and respite care. The Caregiver Support Program offers a toll-free support line and a 24-hour crisis hot line.

In 2014, the Government Accountability Office (GAO) outlined the VA health care improvements needed to manage the demand for the Caregiver Support Program, which are established at VA medical centers.²⁸ The GAO reported that the “VA significantly underestimated caregivers’ demand for services… larger than expected workloads and …delays in approval determinations” with about 500 approved caregivers who are added to the program each month. Original estimates indicated that about 4,000 caregivers would be approved by September 2014; however, by May 2014 about 15,600 caregivers were approved.

In addition to the VA Caregiver Support Program, a variety of state, local, and nonprofit organizations offer support for caregivers. Established in 2012, the Elizabeth Dole Foundation’s program Caring for Military Families “assists caregivers by raising awareness of the caregiver role, leveraging resources and partnerships to provide support, and identifying best practices and solutions to address the challenges caregivers face.” The foundation commissioned the RAND Corporation to “describe the magnitude of military caregiving in the United States, and to identify gaps in programs, policies, and services.” The 2014 RAND report estimated that among the 5.5 million military caregivers in the U.S., 1 million (19.6%) cared for post-9/11 veterans.²⁹ The military caregivers consistently experienced poorer health outcomes, greater strains on family relationships, and more workplace problems than noncaregivers; post-9/11 military caregivers fared worse in those areas.

The Elizabeth Dole Foundation, Hidden Heroes Impact Council Forum advocates for caregiver empowerment, cultural competency awareness, and better policies, programs, and services. The council focuses its efforts on key impact: community support at home, education and training, employment and workplace support, financial and legal issues, interfaith action and ministry council, mental and physical health, and respite care. It aims to raise the money to build awareness and support for military and veterans’ caregivers. The Military and Veteran Caregiver Network is another Elizabeth Dole Foundation initiative. It is an online forum community, peer support group, and peer mentor program structure. A resource library for referrals to local services also is available.

A variety of other organizations, such as United Service Organizations; Easter Seals; Team Red, White and Blue; Operation Homefront; Blue Star Families; state Brain Injury Associations; and support groups for TBI at local hospitals and community centers provide resources to both patients and caregivers. Organizations for caregivers not exclusive to TBI patients include the Caregiver Action Network (formerly National Family Caregiver Association) and the Family Caregiver Alliance. The National Family Caregivers Support Program provides grants to states and territories to develop and provide supportive services to caregivers. Some training for caregivers could include long-term financial planning, legal issues, residential and educational planning, caregiver stress management, the benefits of utilizing support resources, and actions and behaviors that enhance coping strategies. In 2007, DVBIC developed The Traumatic Brain Injury Guide for Caregivers of Service Members and Veterans, which is intended for family caregivers assisting a service member or veteran who sustained a moderate or severe TBI.⁶ A recent assessment determined the need to update the guide. The Center of Excellence for Medical Multimedia is another source of information for caregivers.

 

Conclusion

The recent combat conflicts of OEF and OIF have resulted in a dramatic increase in the occurrence of TBI injuries in active-duty service members both in theater and stateside and have highlighted the need for some service members and veterans with a TBI to require ongoing assistance from a caregiver. The levels of assistance and length of time vary greatly, impacted by the severity of the TBI and psychosocial situations.

In response to elevated awareness, several programs and resources have been developed or enhanced to address the specific needs of caregivers. Certain programs and resources are specific for caregivers of military service members and veterans, whereas others benefit caregivers in general. Likewise, some programs are not specific to individuals with TBI.

Caregivers assume many roles in their efforts to support the person with a TBI. They may need to dramatically adjust their lives to serve as a caregiver. Providing adequate resources for the caregivers impacts their ability to continue providing care. Thus, awareness of and access to resources play a critical role in helping to reduce stress, distress, burden (eg, physical, emotional, and financial), and caregiver burnout. Programs and resources often change, making it difficult for health care practitioners to know which programs offer what or even whether they still exist. Therefore, the authors synthesized the current medical literature of the topic of TBI and their caregiver needs as well as current resources for additional information and support.

Ongoing research studies, such as the congressionally mandated 15-year longitudinal study, are examining the impact of caregiving in the military and veteran communities. Future research could identify specific needs of military caregivers, identify gaps in services or programs, and identify interventions that promote resilience. Moreover, research directed at military and veteran caregivers can promote change that will benefit the general population of caregivers. It will be important for health care practitioners to keep abreast of new findings and information to incorporate into care plans for their patients who have had a TBI and their families.

Traumatic brain injury (TBI) is a health concern for the U.S. Military Health System (MHS) as well as the VHA. It occurs in both deployed and nondeployed settings; however, Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) and improved reporting mechanisms have dramatically increased TBI diagnoses in active-duty service members. According to the Defense and Veterans Brain Injury Center (DVBIC), more than 370,000 service members have been diagnosed with a TBI since 2000 (Figure).¹

Background

The DoD and the VA are collaborating on clinical research studies to identify, understand, and treat the long-term effects of TBI that can affect patients and their families. Most TBIs are mild (mTBIs), also called concussions, and patients typically recover within a few weeks (Table 1). However, some individuals with mTBI experience symptoms that may persist for months or years. A meta-analysis by Perry and colleagues showed that the prevalence or risk of a neurologic disorder, depression, or other mental health issue following mTBI was 67% higher compared with that in uninjured controls.²

Patients with any severity of TBI may require assistance with activities of daily living (ADLs), such as bathing, dressing, managing medications, and feeding. Patients also may need help with instrumental ADLs, such as meal preparation, grocery shopping, household chores, child care, getting to appointments or activities, coordination of educational and vocational services, financial and benefits management, and supportive listening.

Increased injuries have spurred the DoD and VA to coordinate health care to provide a seamless transition for patients between the 2 agencies. However, individuals who sustained a TBI may need various levels of caregiver assistance over time.

TBI and Caregivers

Despite better agency coordination for patients, caregivers can experience stress. Griffin and colleagues found that caregiving responsibilities can compete with other demands on the caregiver, such as work and family, and may negatively impact their health and finances.^3,4

Lou and colleagues studied the factors associated with caring for chronically ill family members that may result in stress for the caregivers.⁵ Along with an unaccounted for economic contribution, caregivers may face lost work time and pay and limitations on work travel and work advancement. Additionally, lost time for leisure, travel, social activities, family obligations, and retirement could result in physical and mental drain on the caregiver. Stress may reach a level at which the caregivers risk psychological distress. The study also noted that families with perceived high stress experience disrupted family functioning. Some TBI caregiver studies sought to understand how best to evaluate and determine the level of caregiver burden, and other studies investigated appropriate interventions.^6-9

Health care practitioners within the federal health care system may benefit from a greater awareness of caregiver needs and caregiver resources. Caregiver support can improve outcomes for both the caregiver and care recipient, and many organizations and resources already exist to assist the caregiver. This article reviews recent published literature on TBI caregivers of patients with TBI across civilian, military, and veteran populations and lists caregiver resources for additional information, assistance, and support.

Literature Review

The DVBIC defines the term caregiver as “any family or support person(s) relied upon by the service member or veteran with traumatic brain injury (TBI) who assumes primary responsibility for ensuring the needed level of care and overall well-being of that service member or veteran. A family or family caregiver may include spouse, parents, children, other extended family members, as well as significant others and friends.”³

In the following discussion, findings from military and veteran literature are separated from civilian population findings to highlight similarities and differences between these 2 bodies of research. Several of the studies in the military/veteran cohorts include polytrauma patients with comorbid physical and mental health issues not necessarily found in civilian literature.

Civilian Literature

A 2015 systematic review by Anderson and colleagues on coping and psychological adjustment in TBI caregivers indicated no Class I or Class II studies.¹⁰ Four Class III and 3 Class IV studies were found. The authors suggest that more rigorous studies (ie, Class I and II) are needed.

Despite these limitations, peer-reviewed literature indicates that the levels of stress and distress in TBI caregivers are consistent with reports for other diseases. In a civilian population, Carlozzi and colleagues found that TBI caregivers who reported stress, distress, anxiety, and feeling overwhelmed often had concerns for their social, emotional, physical, cognitive health, as well as feelings of loss.⁵ In addition, caregivers may need to take leaves of absence or leave the workforce entirely to provide for a family member or friend who had a TBI—often leading to financial strain (eg, depleting assets, accumulating debt). These challenges may occur during prime earning years, and the caregiver may lose the ability to resume work if the care receiver requires care for extended periods.¹¹

Kratz and colleagues showed that caregivers of individuals with moderate-to-severe TBI: (1) felt overburdened with responsibilities; (2) lacked personal time and time for self-care; (3) felt their lives were interrupted or lost; (4) grieved the loss of the person with TBI; and (5) endorsed anger, guilt, anxiety, and sadness.¹²

Perceptions differed between caregiver parents and caregiver partners. Parents expressed feelings of grief and sadness related to the “loss of the person before the TBI.” Parents also reported a sense of guilt and responsibility for their child’s TBI and feelings of being tied down to the individual with TBI. Parents experienced a greater level of stress if the son or daughter with TBI still lived at home. Partners expressed frustration and despair related to their role as sole decision maker and care provider. Partners’ distress also related to the partner relationship and the relationship between children and the individual with TBI.

Verhasghe and colleagues found that partners experience a greater degree of stress than do parents.¹³ Young families with minimal social support for coping with financial, psychiatric, and medical problems were the most vulnerable to stress. A systematic review by Ennis and colleagues evaluated depression and anxiety in caregiver parents vs spouses.¹⁴ Although methods and quality differed in the studies, findings indicated high levels of distress regardless of the type of caregiver.

Anderson and colleagues used the Ways of Coping Questionnaire to evaluate the association between coping and psychological adjustment in caregivers of TBI individuals.¹⁰ The use of emotion-focused coping and problem solving was possibly associated with psychological adjustment in caregivers. Verhasghe and colleagues indicated that the nature of the injuries more than the severity of TBI determined the level of stress up to 15 years after the TBI.¹³ Gender and social and professional support also influenced coping. The review identified the need to develop models of long-term support and care.

An Australian cohort of 79 family caregivers participated in a study by Perlesz and colleagues.¹⁵ Participants’ caregiving responsibilities averaged 19.3 months posttrauma. The Family Satisfaction Scale, Beck Depression Inventory, State Anxiety Inventory, and Profile of Mood States were used in this analysis. Male caregivers reported distress in terms of anger and fatigue; female caregivers were at greatest risk of poor psychosocial outcomes. Although findings from primary caregivers indicated that 35% to 49% displayed enough distress to warrant clinical intervention, between 51% and 80% were not psychologically distressed and were satisfied with their families. Data supported previous reports suggesting caregivers are “not universally distressed.”¹⁵

Manskow and colleagues followed patients with severe TBI and assessed caregiver burden 1 year later. Using the Caregiver Burden Scale, caregivers reported the highest scores (N = 92) on the General Strain Index followed by the Disappointment Index.¹⁶ Bayen and colleagues also studied caregivers of severe TBI patients.¹⁷ Objective and subjective caregiver burden data 4 years later indicated 44% of caregivers (N = 98) reported multidimensional burden. Greater burden was associated in caring for individuals who had poorer Glasgow Outcome Scale Extended scores and more severe cognitive disorders.

 

Military and Veteran Literature

Griffin and colleagues conducted the Family and Caregiver Experience Study (FACES) with caregivers (N = 564) of service members who incurred a TBI.³ According to the caregivers, two-thirds of the patients lost consciousness for more than 30 minutes, which was followed by inpatient rehabilitation care at a VA polytrauma center between 2001 and 2009. The majority of caregivers of TBI patients were female (79%) and aged < 60 years (84%). Parents comprised 62% and spouses 32% of the cohort. Caregivers tended to have some level of education beyond high school (73%), were married (77%), either worked or were enrolled in school (55%), and earned less than $40,000 a year (70%). Common characteristics of the care receivers were male gender (95%), average age 30, high school educated (52%), married (almost 50%), and employed (50%). Forty-five percent of the care receivers were injured 4 to 6 years prior, and 12% were injured 7 or more years prior. The study determined the caregivers’ perception of intensity of care needed and indicated that families as well as clinicians need to plan for some level of long-term support and services.

In addition to the TBI-related caregiving needs, Griffin and colleagues found in a military population that other medical conditions impacted the level of caregiving and strained a marriage.¹⁸ Their study found that in a military population between 30% and 50% of marriages of patients with TBI dissolved within the first 10 years after injury. Caregivers may need to learn nursing activities, such as tube feedings, tracheostomy and stoma care, catheter care, wound care, and medication administration. Family stress with caregiving may interfere with the ability to understand information related to the care receivers’ medical care and may require multiple formats to explain care needs. Sander and colleagues associated better emotional functioning in caregivers with greater social integration and occupation outcomes in patients at the postacute rehabilitation program phase (within 6 months of injury).¹⁹ However, these outcomes did not continue more than 6 months postinjury.

Intervention and Research Studies

Powell and colleagues used a telephone-based, individualized TBI education intervention along with problem-solving mentoring (10 phone calls at 2-week intervals following patient discharge for moderate-to-severe TBI from a level 1 trauma center) to determine which programs, activities, and coping strategies could decrease caregiver challenges.²⁰ The telephone interventions resulted in better caregiver outcomes than usual care as measured by composite scores on the Bakas Caregiving Outcomes Scale (BCOS) and the Brief Symptom Inventory (BSI-18) at 6 months post-TBI survivor discharge. Dyer and colleagues explored Internet approaches and mobile applications to provide support for caregivers. ¹⁸ In a small sample of 10 caregivers, Damianakis and colleagues conducted a 10-session pilot videoconferencing support-group intervention program led by a clinician. Results indicated that the intervention enhanced caregiver coping and problem-solving skills.⁷

Petranovich and colleagues examined the efficacy of counselor-assisted problem-solving interventions in improving long-term caregiver psychological functioning following TBI in adolescents.²¹ Their findings support the utility of online interventions in improving long-term caregiver psychological distress, particularly for lower income families. Although this study focused on adolescents, research may indicate merit in an adult population. In relatives of patients with severe TBI, Norup and colleagues associated improvements in health-related quality of life (HRQOL) with improvements in symptoms of anxiety and depression without specific intervention.²²

Moriarty and colleagues conducted a randomized controlled trial for veterans who received care at a VA polytrauma center and their family members who participated in a veteran’s in-home program (VIP) intervention.⁹ The study aimed to evaluate how VIP affected family members’ caregiver burden, depressive symptoms, satisfaction with caregiving, and the program’s acceptability. Eighty-one veterans with a key family member were randomized. Of those, 63 veterans completed a follow-up interview. The intervention consisted of 6 home visits of 1 to 2 hours each and 2 telephone calls from an occupational therapist over 3 to 4 months. Family members were invited to participate during the home visits. The control group received usual clinic care with 2 telephone calls during the study period. All participants received the follow-up interview 3 to 4 months after baseline interviews. The severity of TBI was determined by a review of the electronic medical record using the VA/DoD Clinical Practice Guidelines. Findings of this study indicated that family members in the intervention group showed significantly lower depressive symptom scores and caregiver burden scores.⁹ Additionally, the veterans in the intervention group exhibited higher community integration and ability to manage their targeted outcomes. Further research may indicate that VIP could assist patients with TBI and caregivers in an active-duty population.

The DVBIC is the executive agent for a congressionally mandated 15-year longitudinal study on TBI incurred by members of the armed services in OEF and OIF. The John Warner National Defense Authorization Act for Fiscal Year 2007 outlined the study. An initial finding identified the need for an HRQOL outcomes assessment specific to TBI caregivers.²³ Having these data will allow investigators to fully determine the comprehensive impact of caring for a person who sustained a mild, moderate, severe, or penetrating TBI and to evaluate the effectiveness of interventions designed to address caregivers’ needs. To date, the study has identified the following HRQOL themes generated among caregivers: social health, emotional health, physical/medical health, cognitive functioning, and feelings of loss (related to changing social roles). Carlozzi and colleagues noted that the study also aimed to identify a sensitive outcome measure to evaluate quality of life in the caregivers over time.⁷

 

Knowledge Gaps

Ongoing studies focus on caregiving for individuals with various illnesses and needs. Some of the information in each study may be beneficial to TBI caregivers who are not fully aware of resources and interventions. For example, Fortune and colleagues, Hirano and colleagues, and Grover and colleagues are studying caregiver activities involving other diseases to determine, more generally, which programs, activities, and coping strategies can decrease caregiver challenges.^24-26 Further, understanding and addressing the needs of these families over many years will provide data that could inform policy, benefits, resources, and needed services (such as the Caregivers and Veterans Omnibus Health Services Act of 2010) and assist with family resilience efforts, including understanding and enhancing family protective and recovery factors.

As studies have indicated, some families do not report family distress when providing care to an individual with TBI. Understanding the factors that influence positive family adjustment is important to capture and perhaps replicate in future studies so that they can lead to effective treatment interventions. Although this review does not discuss caregiver needs for patients with TBI with disorders of consciousness that require more care than most caregivers can provide in the home setting, caregiving for this population deserves attention in future studies. Furthermore, an area that has not received much attention is the impact on children in the household. Children aged < 18 years can assist not only in the care of a disabled adult, but also of younger siblings; also they can help with household activities from housekeeping to meal preparation. Children also may provide physical and emotional support.

The impact of aging caregivers and subsequent needs for their own care as well as the person(s) they are providing care for has not been fully addressed. Areas requiring more research include both the aging caregiver taking care of an aging spouse or relative and the aging parent taking care of a young adult or child. Along with aging, the issue of long-term caregiving needs further development. For example, how do the differences between access to services between caregivers of adults with TBI in the military and those in the civilian sector impact the family/caregiver? Further research may answer questions such as:

• Which tools are most useful in evaluating and determining caregiver stress and burden?
• Are the needs of military and veteran caregivers unique?
• Do polytrauma patients with comorbid diagnoses have unique caregiver needs and trajectories?
• Do TBI caregiver stressors differ from stressors related to other medical conditions or chronic diseases?
• Is there a need for military and veteran TBI-specific caregiver programs?
• Which interventions best help caregivers and for how long?
• Should the approach to intervention depend on variables such as age and gender of the caregivers or relationship to the patient with a TBI (eg, spouse vs parent)?

Methods or processes to inform and update caregivers about available resources also are critically needed. Also, Sabab and colleagues noted the importance of research on the effects of denial as it relates to cognitive, emotional, social impact.²⁷ Denial may impact delays in treatments.

Resource

Many national, state, local, and grassroots organizations provide information and support for persons with illness and/or disabilities. Most clinicians of neurologic, mental health, and cancer have developed various forms of support interventions for those with the disease and their caregivers (Table 2). Highlighted in this section are a few organizations that specifically provide resources for caregivers caring for active-duty service members or veterans with a TBI.

Although a caregiver generally does not receive money from an outside source for services, the DoD may consider the caregiver as a nonmedical attendant for an active-duty service member and provide a temporary stipend. The VA provides several support and service options for caregivers under the Caregiver Support Program, through which more than 300 VA health care professionals provide support to caregivers. The Caregivers and Veterans Omnibus Health Services Act of 2010 authorizes the VA to provide additional VA services for seriously injured post-9/11 veterans and their family caregivers through the Program of Comprehensive Assistance for Family Caregivers (VA Caregiver Support Program). After meeting eligibility criteria, primary caregivers of post-9/11 veterans may receive a monthly stipend (based on the level of care needed) as well as comprehensive caregiver training, referral services, access to health care insurance, mental health services, counseling, and respite care. The Caregiver Support Program offers a toll-free support line and a 24-hour crisis hot line.

In 2014, the Government Accountability Office (GAO) outlined the VA health care improvements needed to manage the demand for the Caregiver Support Program, which are established at VA medical centers.²⁸ The GAO reported that the “VA significantly underestimated caregivers’ demand for services… larger than expected workloads and …delays in approval determinations” with about 500 approved caregivers who are added to the program each month. Original estimates indicated that about 4,000 caregivers would be approved by September 2014; however, by May 2014 about 15,600 caregivers were approved.

In addition to the VA Caregiver Support Program, a variety of state, local, and nonprofit organizations offer support for caregivers. Established in 2012, the Elizabeth Dole Foundation’s program Caring for Military Families “assists caregivers by raising awareness of the caregiver role, leveraging resources and partnerships to provide support, and identifying best practices and solutions to address the challenges caregivers face.” The foundation commissioned the RAND Corporation to “describe the magnitude of military caregiving in the United States, and to identify gaps in programs, policies, and services.” The 2014 RAND report estimated that among the 5.5 million military caregivers in the U.S., 1 million (19.6%) cared for post-9/11 veterans.²⁹ The military caregivers consistently experienced poorer health outcomes, greater strains on family relationships, and more workplace problems than noncaregivers; post-9/11 military caregivers fared worse in those areas.

The Elizabeth Dole Foundation, Hidden Heroes Impact Council Forum advocates for caregiver empowerment, cultural competency awareness, and better policies, programs, and services. The council focuses its efforts on key impact: community support at home, education and training, employment and workplace support, financial and legal issues, interfaith action and ministry council, mental and physical health, and respite care. It aims to raise the money to build awareness and support for military and veterans’ caregivers. The Military and Veteran Caregiver Network is another Elizabeth Dole Foundation initiative. It is an online forum community, peer support group, and peer mentor program structure. A resource library for referrals to local services also is available.

A variety of other organizations, such as United Service Organizations; Easter Seals; Team Red, White and Blue; Operation Homefront; Blue Star Families; state Brain Injury Associations; and support groups for TBI at local hospitals and community centers provide resources to both patients and caregivers. Organizations for caregivers not exclusive to TBI patients include the Caregiver Action Network (formerly National Family Caregiver Association) and the Family Caregiver Alliance. The National Family Caregivers Support Program provides grants to states and territories to develop and provide supportive services to caregivers. Some training for caregivers could include long-term financial planning, legal issues, residential and educational planning, caregiver stress management, the benefits of utilizing support resources, and actions and behaviors that enhance coping strategies. In 2007, DVBIC developed The Traumatic Brain Injury Guide for Caregivers of Service Members and Veterans, which is intended for family caregivers assisting a service member or veteran who sustained a moderate or severe TBI.⁶ A recent assessment determined the need to update the guide. The Center of Excellence for Medical Multimedia is another source of information for caregivers.

 

Conclusion

The recent combat conflicts of OEF and OIF have resulted in a dramatic increase in the occurrence of TBI injuries in active-duty service members both in theater and stateside and have highlighted the need for some service members and veterans with a TBI to require ongoing assistance from a caregiver. The levels of assistance and length of time vary greatly, impacted by the severity of the TBI and psychosocial situations.

In response to elevated awareness, several programs and resources have been developed or enhanced to address the specific needs of caregivers. Certain programs and resources are specific for caregivers of military service members and veterans, whereas others benefit caregivers in general. Likewise, some programs are not specific to individuals with TBI.

Caregivers assume many roles in their efforts to support the person with a TBI. They may need to dramatically adjust their lives to serve as a caregiver. Providing adequate resources for the caregivers impacts their ability to continue providing care. Thus, awareness of and access to resources play a critical role in helping to reduce stress, distress, burden (eg, physical, emotional, and financial), and caregiver burnout. Programs and resources often change, making it difficult for health care practitioners to know which programs offer what or even whether they still exist. Therefore, the authors synthesized the current medical literature of the topic of TBI and their caregiver needs as well as current resources for additional information and support.

Ongoing research studies, such as the congressionally mandated 15-year longitudinal study, are examining the impact of caregiving in the military and veteran communities. Future research could identify specific needs of military caregivers, identify gaps in services or programs, and identify interventions that promote resilience. Moreover, research directed at military and veteran caregivers can promote change that will benefit the general population of caregivers. It will be important for health care practitioners to keep abreast of new findings and information to incorporate into care plans for their patients who have had a TBI and their families.