Original Research

Even when depression is properly diagnosed and treatment is prescribed, the rate of patient adherence to regimens can drop to as low as 33% within the first 3 months of therapy¹—far short of the universally recommended 4 to 9 months of treatment (see Minimum duration of treatment). The rate is even lower when lifestyle and other more behaviorally demanding regimens are instituted.⁹

This study demonstrated that use of a management flow sheet, in conjunction with suitable instructions to physicians and education of patients, overcame the usual causes of discontinuance and enabled far more patients to adhere to a prescribed medical regimen than is reported by other current research, ultimately alleviating depressive symptoms regardless of cause.

Methods

Setting

The study was conducted during 2003 to 2004 in a private suburban/urban family medicine group in the Midwestern United States. Fifteen family physicians practice in the group, which cares for about 55,000 patients, most of whom are insured.

Subjects

One-hundred three patients at the clinic were newly diagnosed with varying degrees of depression by 3 doctors in the practice. All were included in the study.

Diagnoses were confirmed by patient history, physical examination, interview, and responses to a 9-item diagnostic survey (Patient Health Questionnaire [PHQ-9]—APPENDIX 1, available online at www.jfponline.com, and in our February 2003 issue [J Fam Pract 2003; 52:126]). The survey has a sensitivity of 73% and a specificity of 98% when compared with a Structured Clinical Interview administered by a mental health clinician.^10,11

No exclusion criteria were applied. Subjects were included regardless of age, gender, race, severity of depression, associated medical conditions, or insurance status. No patients refused to participate. However, of the 103 enrolled patients, 1 was later imprisoned, 2 died, and 3 transferred from the practice. Of the remaining 97, 36 were identified too late in the study to meet the 9-month protocol at the time of final analysis. Therefore, though their comorbidity and depression level data are included in this research, final conclusions relative to “measurement of adherence” were not.

The database for this study, therefore, is 97 subjects for whom data were secured, and 61 for whom adherence or nonadherence was measured. The practice continues to monitor all enrolled patients, and other enrollees for the purposes described in this project.

Experimental design

The point of this study was to determine whether a flow sheet (FIGURE 1) incorporating a checklist for comorbid disorders, medication reference guide, and a major depression reference guide (FIGURE 2), combined with patient education, would improve patient adherence with a pharmacologic regimen and reduce or eliminate depression symptoms without a subsequent relapse.

Doctors in the practice were informed of the project and educated by the author regarding its purpose, protocol, intended outcomes, and methodology.

Though a substantial number of illnesses could be considered comorbid with depression, it would be unrealistic and unwieldy to include them all. Nine conditions were included as sample characteristics, for 2 reasons. First, experience has shown that these particular comorbidities are prevalent among patients presenting to the family physicians. Second, a set of symptoms associated with each of these selected comorbidities often overlaps those of depression, and may therefore cloud the final diagnosis. The prevalence of diagnosed and documented comorbidities, which may interfere with a diagnosis of depression, is summarized in TABLE 1.

All patients who were thought to be depressed or who exhibited depressive symptoms were asked to complete a PHQ-9. None declined. All were educated by the attending physician during the initial office appointment, and given informational material to explain the disease and the necessity of adhering to a prescribed regimen for a period of no less than 9 months. A flow sheet, containing information relative to office calls, follow-up PHQ-9s, and other summaries of medication, comorbidities, and treatment regimens was inserted into their respective charts.

Following the initial appointment, patients were encouraged to schedule other visits at 4 weeks, within 4 to 9 months, and at one year. During these follow-up appointments, physicians stressed the need for continuing medication for no less than 9 months. Every patient who did not return for a follow-up appointment after 6 months, as indicated by a systematic chart review, was contacted by phone by a registered nurse employed by the practice. All of these patients subsequently scheduled an appointment, confirmed they were still following the regimen, or informed the nurse that they had discontinued their medication(s).

TABLE 1
Comorbidity summary of depression patients (n=91)

Data collection and analysis

Periodically throughout the study period of 1½ years, patient charts were audited to collect data on demographics and comorbidities, to quantify the number of patients adhering to prescribed medications for a minimum 9 months, and to compile results of the 2 PHQ-9 surveys. These data were then contrasted with existing clinical research data to demonstrate that the procedure significantly improved patient adherence to a prescribed regimen.

Results

Data from this study indicate that 61 of the 103 patients enrolled in the study completed at least 9 months’ follow-up. Based on patients’ verbal input, a second PHQ-9, notations in charts, subsequent appointments, phone follow-ups, and chart medication reviews, 40 of these 61 patients (66%) adhered to prescribed daily drug therapy for depression for at least 9 months—double the 33% adherence rate described in clinical literature.¹

Seventy-one (78%) of the patients followed in this study had 1 or more significant comorbid illnesses; 54 (76%) had 2 or more. The most common comorbidities included anxiety, migraine, and irritable bowel syndrome, with rates of 54%, 48%, and 32%, respectively (TABLE 1).

TABLE 2 summarizes the comparison of initial and follow-up PHQ-9 data after medication was begun and after an interval of at least 4 weeks. Based on the initial PHQ-9 score, 80% of patients presented with moderate, moderate-severe, or severe depressive symptoms. The average initial PHQ-9 score was 14.2±5.1 (SD).

On follow-up, only 40% of patients were documented to have the same range of severity of symptoms. The average follow-up PHQ-9 score was 8.3±6.2 (SD) (P<.001) vs initial score. Thirty-six of these 40 patients (90%) remained on their initially prescribed medications.

TABLE 2
Distribution of PHQ-9 scores

Discussion

Patients discontinue their medications many reasons (TABLE 3).^1,6,13-16 These obstacles to drug therapy often result in therapeutic failure. Given we now have better-tolerated medications, nonadherence may result more from poor patient commitment to treatment than from adverse drug effects.¹⁴

Communicate with patients. The literature also provides insight into persuasions likely to increase patient compliance. TABLE 4 lists indicative factors.^1,6,9,17

Explicit communication with patients regarding the expected duration of antidepressant therapy may reduce premature discontinuation of medication use.¹⁷

Better communication between patients and physicians about antidepressant treatment, both before and during treatment, may promote adherence.¹

Another study showed that a strong alliance between physicians and patients that involves discussions about adverse drug effects may alleviate patients’ concerns and help them continue treatment.¹

Moreover, intolerance to one antidepressant is not necessarily indicative of intolerance to another, even within the same drug class. Therefore, patients who respond poorly to one drug or who experience adverse effects may benefit by switching to another antidepressant medication.¹ This medication shift, however, necessitates good communication between patients and clinicians about treatment experiences.¹

Adherence can be improved. This study showed that patient adherence to a prescribed medical regimen significantly improved over the life of the study. The 9-month medication adherence rate of 66% dramatically exceeds the 33% rate chronicled in the literature. Over time, the use of the process outlined was associated with significant reductions in the severity of depressive symptoms.

A few caveats. One limitation of this study is its small number of subjects, and the deficiency of data for subjects who had died, transferred out of the practice, or were otherwise lost to contact.

The lack of a control group is also acknowledged. However, comparisons were made between this study and the adherence rates documented in other studies.

Though the PHQ-9 diagnostic tool is reliable and valid, it is self-administered. Likewise, data collection—ie, whether they discontinued medications, and, if so, for what reason—depended on patients’ responses.

Even though the project stressed patient adherence, the use of the flow sheet may very well have contributed to increased physician awareness and physician education, which therefore, in itself, may have resulted in improved patient compliance.

The results of this project can be generalized only to practices similar to its setting. Other practices with different methods or types of information systems may not achieve the same results when using a flow sheet. Further research in a wider area using a larger number of subjects with broader demographics is necessary to corroborate these findings.

TABLE 3
Reasons for discontinuing medications

TABLE 4
Factors conducive to regimen compliance

CORRESPONDING AUTHOR
Gary Ruoff, MD, Westside Family Medical Center, 6565 West Main Street, Kalamazooo, MI 49009. E-mail: [email protected]

Even when depression is properly diagnosed and treatment is prescribed, the rate of patient adherence to regimens can drop to as low as 33% within the first 3 months of therapy¹—far short of the universally recommended 4 to 9 months of treatment (see Minimum duration of treatment). The rate is even lower when lifestyle and other more behaviorally demanding regimens are instituted.⁹

This study demonstrated that use of a management flow sheet, in conjunction with suitable instructions to physicians and education of patients, overcame the usual causes of discontinuance and enabled far more patients to adhere to a prescribed medical regimen than is reported by other current research, ultimately alleviating depressive symptoms regardless of cause.

Methods

Setting

The study was conducted during 2003 to 2004 in a private suburban/urban family medicine group in the Midwestern United States. Fifteen family physicians practice in the group, which cares for about 55,000 patients, most of whom are insured.

Subjects

One-hundred three patients at the clinic were newly diagnosed with varying degrees of depression by 3 doctors in the practice. All were included in the study.

Diagnoses were confirmed by patient history, physical examination, interview, and responses to a 9-item diagnostic survey (Patient Health Questionnaire [PHQ-9]—APPENDIX 1, available online at www.jfponline.com, and in our February 2003 issue [J Fam Pract 2003; 52:126]). The survey has a sensitivity of 73% and a specificity of 98% when compared with a Structured Clinical Interview administered by a mental health clinician.^10,11

No exclusion criteria were applied. Subjects were included regardless of age, gender, race, severity of depression, associated medical conditions, or insurance status. No patients refused to participate. However, of the 103 enrolled patients, 1 was later imprisoned, 2 died, and 3 transferred from the practice. Of the remaining 97, 36 were identified too late in the study to meet the 9-month protocol at the time of final analysis. Therefore, though their comorbidity and depression level data are included in this research, final conclusions relative to “measurement of adherence” were not.

The database for this study, therefore, is 97 subjects for whom data were secured, and 61 for whom adherence or nonadherence was measured. The practice continues to monitor all enrolled patients, and other enrollees for the purposes described in this project.

Experimental design

The point of this study was to determine whether a flow sheet (FIGURE 1) incorporating a checklist for comorbid disorders, medication reference guide, and a major depression reference guide (FIGURE 2), combined with patient education, would improve patient adherence with a pharmacologic regimen and reduce or eliminate depression symptoms without a subsequent relapse.

Doctors in the practice were informed of the project and educated by the author regarding its purpose, protocol, intended outcomes, and methodology.

Though a substantial number of illnesses could be considered comorbid with depression, it would be unrealistic and unwieldy to include them all. Nine conditions were included as sample characteristics, for 2 reasons. First, experience has shown that these particular comorbidities are prevalent among patients presenting to the family physicians. Second, a set of symptoms associated with each of these selected comorbidities often overlaps those of depression, and may therefore cloud the final diagnosis. The prevalence of diagnosed and documented comorbidities, which may interfere with a diagnosis of depression, is summarized in TABLE 1.

All patients who were thought to be depressed or who exhibited depressive symptoms were asked to complete a PHQ-9. None declined. All were educated by the attending physician during the initial office appointment, and given informational material to explain the disease and the necessity of adhering to a prescribed regimen for a period of no less than 9 months. A flow sheet, containing information relative to office calls, follow-up PHQ-9s, and other summaries of medication, comorbidities, and treatment regimens was inserted into their respective charts.

Following the initial appointment, patients were encouraged to schedule other visits at 4 weeks, within 4 to 9 months, and at one year. During these follow-up appointments, physicians stressed the need for continuing medication for no less than 9 months. Every patient who did not return for a follow-up appointment after 6 months, as indicated by a systematic chart review, was contacted by phone by a registered nurse employed by the practice. All of these patients subsequently scheduled an appointment, confirmed they were still following the regimen, or informed the nurse that they had discontinued their medication(s).

TABLE 1
Comorbidity summary of depression patients (n=91)

Data collection and analysis

Periodically throughout the study period of 1½ years, patient charts were audited to collect data on demographics and comorbidities, to quantify the number of patients adhering to prescribed medications for a minimum 9 months, and to compile results of the 2 PHQ-9 surveys. These data were then contrasted with existing clinical research data to demonstrate that the procedure significantly improved patient adherence to a prescribed regimen.

Results

Data from this study indicate that 61 of the 103 patients enrolled in the study completed at least 9 months’ follow-up. Based on patients’ verbal input, a second PHQ-9, notations in charts, subsequent appointments, phone follow-ups, and chart medication reviews, 40 of these 61 patients (66%) adhered to prescribed daily drug therapy for depression for at least 9 months—double the 33% adherence rate described in clinical literature.¹

Seventy-one (78%) of the patients followed in this study had 1 or more significant comorbid illnesses; 54 (76%) had 2 or more. The most common comorbidities included anxiety, migraine, and irritable bowel syndrome, with rates of 54%, 48%, and 32%, respectively (TABLE 1).

TABLE 2 summarizes the comparison of initial and follow-up PHQ-9 data after medication was begun and after an interval of at least 4 weeks. Based on the initial PHQ-9 score, 80% of patients presented with moderate, moderate-severe, or severe depressive symptoms. The average initial PHQ-9 score was 14.2±5.1 (SD).

On follow-up, only 40% of patients were documented to have the same range of severity of symptoms. The average follow-up PHQ-9 score was 8.3±6.2 (SD) (P<.001) vs initial score. Thirty-six of these 40 patients (90%) remained on their initially prescribed medications.

TABLE 2
Distribution of PHQ-9 scores

Discussion

Patients discontinue their medications many reasons (TABLE 3).^1,6,13-16 These obstacles to drug therapy often result in therapeutic failure. Given we now have better-tolerated medications, nonadherence may result more from poor patient commitment to treatment than from adverse drug effects.¹⁴

Communicate with patients. The literature also provides insight into persuasions likely to increase patient compliance. TABLE 4 lists indicative factors.^1,6,9,17

Explicit communication with patients regarding the expected duration of antidepressant therapy may reduce premature discontinuation of medication use.¹⁷

Better communication between patients and physicians about antidepressant treatment, both before and during treatment, may promote adherence.¹

Another study showed that a strong alliance between physicians and patients that involves discussions about adverse drug effects may alleviate patients’ concerns and help them continue treatment.¹

Moreover, intolerance to one antidepressant is not necessarily indicative of intolerance to another, even within the same drug class. Therefore, patients who respond poorly to one drug or who experience adverse effects may benefit by switching to another antidepressant medication.¹ This medication shift, however, necessitates good communication between patients and clinicians about treatment experiences.¹

Adherence can be improved. This study showed that patient adherence to a prescribed medical regimen significantly improved over the life of the study. The 9-month medication adherence rate of 66% dramatically exceeds the 33% rate chronicled in the literature. Over time, the use of the process outlined was associated with significant reductions in the severity of depressive symptoms.

A few caveats. One limitation of this study is its small number of subjects, and the deficiency of data for subjects who had died, transferred out of the practice, or were otherwise lost to contact.

The lack of a control group is also acknowledged. However, comparisons were made between this study and the adherence rates documented in other studies.

Though the PHQ-9 diagnostic tool is reliable and valid, it is self-administered. Likewise, data collection—ie, whether they discontinued medications, and, if so, for what reason—depended on patients’ responses.

Even though the project stressed patient adherence, the use of the flow sheet may very well have contributed to increased physician awareness and physician education, which therefore, in itself, may have resulted in improved patient compliance.

The results of this project can be generalized only to practices similar to its setting. Other practices with different methods or types of information systems may not achieve the same results when using a flow sheet. Further research in a wider area using a larger number of subjects with broader demographics is necessary to corroborate these findings.

TABLE 3
Reasons for discontinuing medications

TABLE 4
Factors conducive to regimen compliance

CORRESPONDING AUTHOR
Gary Ruoff, MD, Westside Family Medical Center, 6565 West Main Street, Kalamazooo, MI 49009. E-mail: [email protected]

Even when depression is properly diagnosed and treatment is prescribed, the rate of patient adherence to regimens can drop to as low as 33% within the first 3 months of therapy¹—far short of the universally recommended 4 to 9 months of treatment (see Minimum duration of treatment). The rate is even lower when lifestyle and other more behaviorally demanding regimens are instituted.⁹

This study demonstrated that use of a management flow sheet, in conjunction with suitable instructions to physicians and education of patients, overcame the usual causes of discontinuance and enabled far more patients to adhere to a prescribed medical regimen than is reported by other current research, ultimately alleviating depressive symptoms regardless of cause.

Methods

Setting

The study was conducted during 2003 to 2004 in a private suburban/urban family medicine group in the Midwestern United States. Fifteen family physicians practice in the group, which cares for about 55,000 patients, most of whom are insured.

Subjects

One-hundred three patients at the clinic were newly diagnosed with varying degrees of depression by 3 doctors in the practice. All were included in the study.

Diagnoses were confirmed by patient history, physical examination, interview, and responses to a 9-item diagnostic survey (Patient Health Questionnaire [PHQ-9]—APPENDIX 1, available online at www.jfponline.com, and in our February 2003 issue [J Fam Pract 2003; 52:126]). The survey has a sensitivity of 73% and a specificity of 98% when compared with a Structured Clinical Interview administered by a mental health clinician.^10,11

No exclusion criteria were applied. Subjects were included regardless of age, gender, race, severity of depression, associated medical conditions, or insurance status. No patients refused to participate. However, of the 103 enrolled patients, 1 was later imprisoned, 2 died, and 3 transferred from the practice. Of the remaining 97, 36 were identified too late in the study to meet the 9-month protocol at the time of final analysis. Therefore, though their comorbidity and depression level data are included in this research, final conclusions relative to “measurement of adherence” were not.

The database for this study, therefore, is 97 subjects for whom data were secured, and 61 for whom adherence or nonadherence was measured. The practice continues to monitor all enrolled patients, and other enrollees for the purposes described in this project.

Experimental design

The point of this study was to determine whether a flow sheet (FIGURE 1) incorporating a checklist for comorbid disorders, medication reference guide, and a major depression reference guide (FIGURE 2), combined with patient education, would improve patient adherence with a pharmacologic regimen and reduce or eliminate depression symptoms without a subsequent relapse.

Doctors in the practice were informed of the project and educated by the author regarding its purpose, protocol, intended outcomes, and methodology.

Though a substantial number of illnesses could be considered comorbid with depression, it would be unrealistic and unwieldy to include them all. Nine conditions were included as sample characteristics, for 2 reasons. First, experience has shown that these particular comorbidities are prevalent among patients presenting to the family physicians. Second, a set of symptoms associated with each of these selected comorbidities often overlaps those of depression, and may therefore cloud the final diagnosis. The prevalence of diagnosed and documented comorbidities, which may interfere with a diagnosis of depression, is summarized in TABLE 1.

All patients who were thought to be depressed or who exhibited depressive symptoms were asked to complete a PHQ-9. None declined. All were educated by the attending physician during the initial office appointment, and given informational material to explain the disease and the necessity of adhering to a prescribed regimen for a period of no less than 9 months. A flow sheet, containing information relative to office calls, follow-up PHQ-9s, and other summaries of medication, comorbidities, and treatment regimens was inserted into their respective charts.

Following the initial appointment, patients were encouraged to schedule other visits at 4 weeks, within 4 to 9 months, and at one year. During these follow-up appointments, physicians stressed the need for continuing medication for no less than 9 months. Every patient who did not return for a follow-up appointment after 6 months, as indicated by a systematic chart review, was contacted by phone by a registered nurse employed by the practice. All of these patients subsequently scheduled an appointment, confirmed they were still following the regimen, or informed the nurse that they had discontinued their medication(s).

TABLE 1
Comorbidity summary of depression patients (n=91)

Data collection and analysis

Periodically throughout the study period of 1½ years, patient charts were audited to collect data on demographics and comorbidities, to quantify the number of patients adhering to prescribed medications for a minimum 9 months, and to compile results of the 2 PHQ-9 surveys. These data were then contrasted with existing clinical research data to demonstrate that the procedure significantly improved patient adherence to a prescribed regimen.

Results

Data from this study indicate that 61 of the 103 patients enrolled in the study completed at least 9 months’ follow-up. Based on patients’ verbal input, a second PHQ-9, notations in charts, subsequent appointments, phone follow-ups, and chart medication reviews, 40 of these 61 patients (66%) adhered to prescribed daily drug therapy for depression for at least 9 months—double the 33% adherence rate described in clinical literature.¹

Seventy-one (78%) of the patients followed in this study had 1 or more significant comorbid illnesses; 54 (76%) had 2 or more. The most common comorbidities included anxiety, migraine, and irritable bowel syndrome, with rates of 54%, 48%, and 32%, respectively (TABLE 1).

TABLE 2 summarizes the comparison of initial and follow-up PHQ-9 data after medication was begun and after an interval of at least 4 weeks. Based on the initial PHQ-9 score, 80% of patients presented with moderate, moderate-severe, or severe depressive symptoms. The average initial PHQ-9 score was 14.2±5.1 (SD).

On follow-up, only 40% of patients were documented to have the same range of severity of symptoms. The average follow-up PHQ-9 score was 8.3±6.2 (SD) (P<.001) vs initial score. Thirty-six of these 40 patients (90%) remained on their initially prescribed medications.

TABLE 2
Distribution of PHQ-9 scores

Discussion

Patients discontinue their medications many reasons (TABLE 3).^1,6,13-16 These obstacles to drug therapy often result in therapeutic failure. Given we now have better-tolerated medications, nonadherence may result more from poor patient commitment to treatment than from adverse drug effects.¹⁴

Communicate with patients. The literature also provides insight into persuasions likely to increase patient compliance. TABLE 4 lists indicative factors.^1,6,9,17

Explicit communication with patients regarding the expected duration of antidepressant therapy may reduce premature discontinuation of medication use.¹⁷

Better communication between patients and physicians about antidepressant treatment, both before and during treatment, may promote adherence.¹

Another study showed that a strong alliance between physicians and patients that involves discussions about adverse drug effects may alleviate patients’ concerns and help them continue treatment.¹

Moreover, intolerance to one antidepressant is not necessarily indicative of intolerance to another, even within the same drug class. Therefore, patients who respond poorly to one drug or who experience adverse effects may benefit by switching to another antidepressant medication.¹ This medication shift, however, necessitates good communication between patients and clinicians about treatment experiences.¹

Adherence can be improved. This study showed that patient adherence to a prescribed medical regimen significantly improved over the life of the study. The 9-month medication adherence rate of 66% dramatically exceeds the 33% rate chronicled in the literature. Over time, the use of the process outlined was associated with significant reductions in the severity of depressive symptoms.

A few caveats. One limitation of this study is its small number of subjects, and the deficiency of data for subjects who had died, transferred out of the practice, or were otherwise lost to contact.

The lack of a control group is also acknowledged. However, comparisons were made between this study and the adherence rates documented in other studies.

Though the PHQ-9 diagnostic tool is reliable and valid, it is self-administered. Likewise, data collection—ie, whether they discontinued medications, and, if so, for what reason—depended on patients’ responses.

Even though the project stressed patient adherence, the use of the flow sheet may very well have contributed to increased physician awareness and physician education, which therefore, in itself, may have resulted in improved patient compliance.

The results of this project can be generalized only to practices similar to its setting. Other practices with different methods or types of information systems may not achieve the same results when using a flow sheet. Further research in a wider area using a larger number of subjects with broader demographics is necessary to corroborate these findings.

TABLE 3
Reasons for discontinuing medications

TABLE 4
Factors conducive to regimen compliance

CORRESPONDING AUTHOR
Gary Ruoff, MD, Westside Family Medical Center, 6565 West Main Street, Kalamazooo, MI 49009. E-mail: [email protected]

Despite its potential importance, the problem of wasted medication has been studied little. Some previous research has concerned inpatient hospital and nursing facility drug discards.^1-5 However, a pharmacy-based initiative for collecting wasted medications in Alberta, Canada, accumulated 204 tons of medicines over a 7-year period, suggesting the need for further research on outpatient drug waste.⁶

The specific aim of our study was to assess the occurrence, costs, and reasons for medication waste in a population of older adults by doing in-home surveys and counts of leftover medications. We also sought to determine why patients do not always finish their full prescriptions.

Methods

Our study, conducted from May 1999 to November 1999, was a cross-sectional survey describing medication use and nonuse in older adults in a retirement community. To minimize recall bias, researchers both used questionnaires and visited participants’ homes to sort pills according to active use or waste. Any medication prescribed within the past year that the study participant did not intend to use before its expiration date was considered wasted. If subjects recalled medications that had been thrown away, these were recorded. Questionnaire data included name, date of birth, sex, length of time in the residence, current medications, type and amount of medication discarded in the past year, and reasons for nonuse of medications.

All community residents in the study population had full prescription drug benefits without co-payments. In general, residents of this community have relatively high levels of education (78% had a bachelor’s degree or higher) and yearly income (only 4% were receiving less than $20,000).⁷ Primary care was largely obtained from an academic family physician and an internist, both with certificates of added qualification in geriatrics, and 2 geriatric nurse practitioners. To promote full disclosure of waste, data were kept confidential from the providers who cared for the study subjects. As a result, no clinical consequences of waste could be determined. The criteria for entry were age 65 years or older, voluntary response to study recruitment advertisements, residence in the facility for at least 1 year, and contact with a licensed health care provider within the past year. No volunteer subject was found ineligible. The Committee for Protection of Human Subjects at Dartmouth Medical School approved the study protocol.

The researchers coded medications by pharmaceutical class and calculated totals for each drug, including the costs of current medication use and total annual costs due to waste, using 1999 Red Book⁸ median wholesale drug cost estimates for a 3 months’ supply when exact prescription quantities were unknown.

Results

A total of 73 subjects received in-home pharmacy evaluations and completed questionnaires. Of these, 49 were women (67%), and 24 were men (33%). All were white, and all were older than 65 years. The mean age was 81.2 ± 6.0 (standard deviation [SD]) years. The mean number of years in residence was 5.4 ± 2.5 (SD).

The sum of all costs of wasted medication was $2011 in the study group (n=66). Mean per-person annual cost of wasted medication was $30.47 (range = $0-$131.56) based on the 66 subjects for whom complete data on pill counts were available. Pill counts were missing or incomplete on 7 questionnaires, which were not counted. Median annual waste was only $12.32, because 32 of the subjects (48%) wasted no medications. A total of 2078 wasted pills were found for the 66 subjects, yielding a mean of 31.5 pills wasted per subject (range = 0 to 208).

Mean waste represented 2.3% of total annual medication costs, which were $1302.78 per subject (interquartile range = $584.61-$1773.90). Increasing age was correlated with a higher number of pills wasted (r=0.35; P=.03) and a higher total cost of waste (r=0.20; P=.10). Total waste did not represent a fixed percentage of total annual medication costs. As yearly medication costs rose, waste as a percentage of yearly costs (ie, inefficient medication use) decreased significantly (r = -0.32; P=.02).

The most frequently wasted medication classes were antibiotics, benzodiazepines, and antihypertensives Table 1. Many of the medications listed as frequently wasted are taken episodically rather than in a stable daily pattern. Table 1 also shows that the most frequently wasted medications (eg, antibiotics) are not necessarily the most prescribed or the costliest.

Table 1 also shows the total annual relative costs of wasted medication by pharmaceutical class. Benzodiazepines, antidepressants, and antihypertensive medications combined accounted for a third of the total annual costs due to waste. The reasons for waste of medications and the relative contribution of each to total waste are presented in Table 2. The perception by subjects that a medical condition had resolved or that a medication was ineffective accounted for more than half of the cost due to waste. Physician and geriatric nurse practitioner perspectives are not captured by these data.

Discussion

On the basis of comprehensive home assessments, our study provides an estimate of wasted medication and the reasons for it in an outpatient population of older adults.

Most waste derived from 2 factors: the resolution of the condition for which the medication was prescribed and perceived ineffectiveness of a medication for its purpose. Together these 2 reasons accounted for more than half of the costs. This finding implies that acute conditions are central to waste, especially when medications for such conditions have high unit costs. Further support for the importance of acute conditions was that higher yearly drug expenditures were associated with lower percentage waste. Thus, high annual drug costs reflected stable, efficient patterns of medication use.

Although it may be difficult for clinicians to estimate how many pills to dispense, efforts should be made to determine the effectiveness and tolerability of medications before prescribing full quantities. Judicious use of samples is a possible remedy for this problem. Small prescriptions requiring multiple pharmacy visits would not help, but research on optimal prescribing quantities might lend some insight. Physicians should encourage patients to finish prescribed antibiotics if tolerated and not needlessly change prescriptions when previous pills remain. Further suggestions for promoting medication compliance in older adults are available in the medical literature.⁹

Limitations

We emphasize that our pilot study was small and not necessarily generalizable, yet it has made progress in a neglected area of research. As employees of the retirement community, the physicians caring for these patients are motivated to be fiscally responsible, and for this reason the mean annual waste detected in our study may, if anything, have been a substantial underestimate. Also, some subjects may have been overly optimistic in concluding that they intended to use all of a prescription medication on an as-needed basis. The lack of drug co-payments in this population, however, may predispose to more waste.

Based on our interviews, we found it uncharacteristic of most subjects to throw any pills away, but further underestimation could have occurred because of forgotten disposal of medicines. Researchers were motivated to find waste but could find none for 48% of subjects. Those subjects seemed sure that waste was absent.

Even though we counted more than 2000 wasted pills, numbers of specific medications were small. Thus, our analysis was confined to broad pharmaceutical classes and overall reasons for waste. This limitation could be overcome in more focused studies of specific wasted medications.

Conclusions

If, as we found in our study, average medication waste of $30 per person-year represents a conservative estimate, given that there are nearly 35 million individuals older than 65 years in the United States,¹⁰ the total national costs due to medication waste would not be less than $1 billion per year. Clearly, further studies in varied populations are required to confirm our waste estimate, and more research is needed to find effective waste reduction strategies. Despite the limitations of our study, physicians should begin to take note of what happens to prescribed medicines. That may serve as the most immediate basis for waste reduction.

Related resources

The Drugs and Devices Information Line Contains links to pharmacoepidemiology resources, maintained by the Pharmacoepidemiology Program, Harvard School of Public Health. http://www.hsph.harvard.edu/Organizations/DDIL/ddilhpge.html

Topics of Pharmacoepidemiology and Pharmacoeconomics A listserv for discussions related to these areas. http://www.findmail.com/list/pharmacoepidemiology/

ISPE—International Society for Pharmacoepidemiology A non-profit international professional organization dedicated to promoting pharmacoepidemiology. http://www.pharmacoepi.org/index.htm

Pharmacoepidemiology and Drug Safety The official journal of the International Society for Pharmacoepidemiology http://www.interscience.wiley.com/jpages/1053-8569/

Acknowledgment

The author acknowledges the assistance of the following undergraduate research assistants: Allison Robbins, Barbara Jones, Eva Liu, Karen Walp, Cynthia Oberto, Amanda Cook, John Raser, Sarah Hamilton, Anjali Godambe, and Michelle Anatone. Allen Dietrich, MD, provided guidance in the planning and execution of the study. Harlan Krumholz, MD, and Jerome Kassirer, MD, of the Yale University Robert Wood Johnson Clinical Scholars Program provided critical review of the manuscript.

Despite its potential importance, the problem of wasted medication has been studied little. Some previous research has concerned inpatient hospital and nursing facility drug discards.^1-5 However, a pharmacy-based initiative for collecting wasted medications in Alberta, Canada, accumulated 204 tons of medicines over a 7-year period, suggesting the need for further research on outpatient drug waste.⁶

The specific aim of our study was to assess the occurrence, costs, and reasons for medication waste in a population of older adults by doing in-home surveys and counts of leftover medications. We also sought to determine why patients do not always finish their full prescriptions.

Methods

Our study, conducted from May 1999 to November 1999, was a cross-sectional survey describing medication use and nonuse in older adults in a retirement community. To minimize recall bias, researchers both used questionnaires and visited participants’ homes to sort pills according to active use or waste. Any medication prescribed within the past year that the study participant did not intend to use before its expiration date was considered wasted. If subjects recalled medications that had been thrown away, these were recorded. Questionnaire data included name, date of birth, sex, length of time in the residence, current medications, type and amount of medication discarded in the past year, and reasons for nonuse of medications.

All community residents in the study population had full prescription drug benefits without co-payments. In general, residents of this community have relatively high levels of education (78% had a bachelor’s degree or higher) and yearly income (only 4% were receiving less than $20,000).⁷ Primary care was largely obtained from an academic family physician and an internist, both with certificates of added qualification in geriatrics, and 2 geriatric nurse practitioners. To promote full disclosure of waste, data were kept confidential from the providers who cared for the study subjects. As a result, no clinical consequences of waste could be determined. The criteria for entry were age 65 years or older, voluntary response to study recruitment advertisements, residence in the facility for at least 1 year, and contact with a licensed health care provider within the past year. No volunteer subject was found ineligible. The Committee for Protection of Human Subjects at Dartmouth Medical School approved the study protocol.

The researchers coded medications by pharmaceutical class and calculated totals for each drug, including the costs of current medication use and total annual costs due to waste, using 1999 Red Book⁸ median wholesale drug cost estimates for a 3 months’ supply when exact prescription quantities were unknown.

Results

A total of 73 subjects received in-home pharmacy evaluations and completed questionnaires. Of these, 49 were women (67%), and 24 were men (33%). All were white, and all were older than 65 years. The mean age was 81.2 ± 6.0 (standard deviation [SD]) years. The mean number of years in residence was 5.4 ± 2.5 (SD).

The sum of all costs of wasted medication was $2011 in the study group (n=66). Mean per-person annual cost of wasted medication was $30.47 (range = $0-$131.56) based on the 66 subjects for whom complete data on pill counts were available. Pill counts were missing or incomplete on 7 questionnaires, which were not counted. Median annual waste was only $12.32, because 32 of the subjects (48%) wasted no medications. A total of 2078 wasted pills were found for the 66 subjects, yielding a mean of 31.5 pills wasted per subject (range = 0 to 208).

Mean waste represented 2.3% of total annual medication costs, which were $1302.78 per subject (interquartile range = $584.61-$1773.90). Increasing age was correlated with a higher number of pills wasted (r=0.35; P=.03) and a higher total cost of waste (r=0.20; P=.10). Total waste did not represent a fixed percentage of total annual medication costs. As yearly medication costs rose, waste as a percentage of yearly costs (ie, inefficient medication use) decreased significantly (r = -0.32; P=.02).

The most frequently wasted medication classes were antibiotics, benzodiazepines, and antihypertensives Table 1. Many of the medications listed as frequently wasted are taken episodically rather than in a stable daily pattern. Table 1 also shows that the most frequently wasted medications (eg, antibiotics) are not necessarily the most prescribed or the costliest.

Table 1 also shows the total annual relative costs of wasted medication by pharmaceutical class. Benzodiazepines, antidepressants, and antihypertensive medications combined accounted for a third of the total annual costs due to waste. The reasons for waste of medications and the relative contribution of each to total waste are presented in Table 2. The perception by subjects that a medical condition had resolved or that a medication was ineffective accounted for more than half of the cost due to waste. Physician and geriatric nurse practitioner perspectives are not captured by these data.

Discussion

On the basis of comprehensive home assessments, our study provides an estimate of wasted medication and the reasons for it in an outpatient population of older adults.

Most waste derived from 2 factors: the resolution of the condition for which the medication was prescribed and perceived ineffectiveness of a medication for its purpose. Together these 2 reasons accounted for more than half of the costs. This finding implies that acute conditions are central to waste, especially when medications for such conditions have high unit costs. Further support for the importance of acute conditions was that higher yearly drug expenditures were associated with lower percentage waste. Thus, high annual drug costs reflected stable, efficient patterns of medication use.

Although it may be difficult for clinicians to estimate how many pills to dispense, efforts should be made to determine the effectiveness and tolerability of medications before prescribing full quantities. Judicious use of samples is a possible remedy for this problem. Small prescriptions requiring multiple pharmacy visits would not help, but research on optimal prescribing quantities might lend some insight. Physicians should encourage patients to finish prescribed antibiotics if tolerated and not needlessly change prescriptions when previous pills remain. Further suggestions for promoting medication compliance in older adults are available in the medical literature.⁹

Limitations

We emphasize that our pilot study was small and not necessarily generalizable, yet it has made progress in a neglected area of research. As employees of the retirement community, the physicians caring for these patients are motivated to be fiscally responsible, and for this reason the mean annual waste detected in our study may, if anything, have been a substantial underestimate. Also, some subjects may have been overly optimistic in concluding that they intended to use all of a prescription medication on an as-needed basis. The lack of drug co-payments in this population, however, may predispose to more waste.

Based on our interviews, we found it uncharacteristic of most subjects to throw any pills away, but further underestimation could have occurred because of forgotten disposal of medicines. Researchers were motivated to find waste but could find none for 48% of subjects. Those subjects seemed sure that waste was absent.

Even though we counted more than 2000 wasted pills, numbers of specific medications were small. Thus, our analysis was confined to broad pharmaceutical classes and overall reasons for waste. This limitation could be overcome in more focused studies of specific wasted medications.

Conclusions

If, as we found in our study, average medication waste of $30 per person-year represents a conservative estimate, given that there are nearly 35 million individuals older than 65 years in the United States,¹⁰ the total national costs due to medication waste would not be less than $1 billion per year. Clearly, further studies in varied populations are required to confirm our waste estimate, and more research is needed to find effective waste reduction strategies. Despite the limitations of our study, physicians should begin to take note of what happens to prescribed medicines. That may serve as the most immediate basis for waste reduction.

Related resources

The Drugs and Devices Information Line Contains links to pharmacoepidemiology resources, maintained by the Pharmacoepidemiology Program, Harvard School of Public Health. http://www.hsph.harvard.edu/Organizations/DDIL/ddilhpge.html

Topics of Pharmacoepidemiology and Pharmacoeconomics A listserv for discussions related to these areas. http://www.findmail.com/list/pharmacoepidemiology/

ISPE—International Society for Pharmacoepidemiology A non-profit international professional organization dedicated to promoting pharmacoepidemiology. http://www.pharmacoepi.org/index.htm

Pharmacoepidemiology and Drug Safety The official journal of the International Society for Pharmacoepidemiology http://www.interscience.wiley.com/jpages/1053-8569/

Acknowledgment

The author acknowledges the assistance of the following undergraduate research assistants: Allison Robbins, Barbara Jones, Eva Liu, Karen Walp, Cynthia Oberto, Amanda Cook, John Raser, Sarah Hamilton, Anjali Godambe, and Michelle Anatone. Allen Dietrich, MD, provided guidance in the planning and execution of the study. Harlan Krumholz, MD, and Jerome Kassirer, MD, of the Yale University Robert Wood Johnson Clinical Scholars Program provided critical review of the manuscript.

Despite its potential importance, the problem of wasted medication has been studied little. Some previous research has concerned inpatient hospital and nursing facility drug discards.^1-5 However, a pharmacy-based initiative for collecting wasted medications in Alberta, Canada, accumulated 204 tons of medicines over a 7-year period, suggesting the need for further research on outpatient drug waste.⁶

The specific aim of our study was to assess the occurrence, costs, and reasons for medication waste in a population of older adults by doing in-home surveys and counts of leftover medications. We also sought to determine why patients do not always finish their full prescriptions.

Methods

Our study, conducted from May 1999 to November 1999, was a cross-sectional survey describing medication use and nonuse in older adults in a retirement community. To minimize recall bias, researchers both used questionnaires and visited participants’ homes to sort pills according to active use or waste. Any medication prescribed within the past year that the study participant did not intend to use before its expiration date was considered wasted. If subjects recalled medications that had been thrown away, these were recorded. Questionnaire data included name, date of birth, sex, length of time in the residence, current medications, type and amount of medication discarded in the past year, and reasons for nonuse of medications.

All community residents in the study population had full prescription drug benefits without co-payments. In general, residents of this community have relatively high levels of education (78% had a bachelor’s degree or higher) and yearly income (only 4% were receiving less than $20,000).⁷ Primary care was largely obtained from an academic family physician and an internist, both with certificates of added qualification in geriatrics, and 2 geriatric nurse practitioners. To promote full disclosure of waste, data were kept confidential from the providers who cared for the study subjects. As a result, no clinical consequences of waste could be determined. The criteria for entry were age 65 years or older, voluntary response to study recruitment advertisements, residence in the facility for at least 1 year, and contact with a licensed health care provider within the past year. No volunteer subject was found ineligible. The Committee for Protection of Human Subjects at Dartmouth Medical School approved the study protocol.

The researchers coded medications by pharmaceutical class and calculated totals for each drug, including the costs of current medication use and total annual costs due to waste, using 1999 Red Book⁸ median wholesale drug cost estimates for a 3 months’ supply when exact prescription quantities were unknown.

Results

A total of 73 subjects received in-home pharmacy evaluations and completed questionnaires. Of these, 49 were women (67%), and 24 were men (33%). All were white, and all were older than 65 years. The mean age was 81.2 ± 6.0 (standard deviation [SD]) years. The mean number of years in residence was 5.4 ± 2.5 (SD).

The sum of all costs of wasted medication was $2011 in the study group (n=66). Mean per-person annual cost of wasted medication was $30.47 (range = $0-$131.56) based on the 66 subjects for whom complete data on pill counts were available. Pill counts were missing or incomplete on 7 questionnaires, which were not counted. Median annual waste was only $12.32, because 32 of the subjects (48%) wasted no medications. A total of 2078 wasted pills were found for the 66 subjects, yielding a mean of 31.5 pills wasted per subject (range = 0 to 208).

Mean waste represented 2.3% of total annual medication costs, which were $1302.78 per subject (interquartile range = $584.61-$1773.90). Increasing age was correlated with a higher number of pills wasted (r=0.35; P=.03) and a higher total cost of waste (r=0.20; P=.10). Total waste did not represent a fixed percentage of total annual medication costs. As yearly medication costs rose, waste as a percentage of yearly costs (ie, inefficient medication use) decreased significantly (r = -0.32; P=.02).

The most frequently wasted medication classes were antibiotics, benzodiazepines, and antihypertensives Table 1. Many of the medications listed as frequently wasted are taken episodically rather than in a stable daily pattern. Table 1 also shows that the most frequently wasted medications (eg, antibiotics) are not necessarily the most prescribed or the costliest.

Table 1 also shows the total annual relative costs of wasted medication by pharmaceutical class. Benzodiazepines, antidepressants, and antihypertensive medications combined accounted for a third of the total annual costs due to waste. The reasons for waste of medications and the relative contribution of each to total waste are presented in Table 2. The perception by subjects that a medical condition had resolved or that a medication was ineffective accounted for more than half of the cost due to waste. Physician and geriatric nurse practitioner perspectives are not captured by these data.

Discussion

On the basis of comprehensive home assessments, our study provides an estimate of wasted medication and the reasons for it in an outpatient population of older adults.

Most waste derived from 2 factors: the resolution of the condition for which the medication was prescribed and perceived ineffectiveness of a medication for its purpose. Together these 2 reasons accounted for more than half of the costs. This finding implies that acute conditions are central to waste, especially when medications for such conditions have high unit costs. Further support for the importance of acute conditions was that higher yearly drug expenditures were associated with lower percentage waste. Thus, high annual drug costs reflected stable, efficient patterns of medication use.

Although it may be difficult for clinicians to estimate how many pills to dispense, efforts should be made to determine the effectiveness and tolerability of medications before prescribing full quantities. Judicious use of samples is a possible remedy for this problem. Small prescriptions requiring multiple pharmacy visits would not help, but research on optimal prescribing quantities might lend some insight. Physicians should encourage patients to finish prescribed antibiotics if tolerated and not needlessly change prescriptions when previous pills remain. Further suggestions for promoting medication compliance in older adults are available in the medical literature.⁹

Limitations

We emphasize that our pilot study was small and not necessarily generalizable, yet it has made progress in a neglected area of research. As employees of the retirement community, the physicians caring for these patients are motivated to be fiscally responsible, and for this reason the mean annual waste detected in our study may, if anything, have been a substantial underestimate. Also, some subjects may have been overly optimistic in concluding that they intended to use all of a prescription medication on an as-needed basis. The lack of drug co-payments in this population, however, may predispose to more waste.

Based on our interviews, we found it uncharacteristic of most subjects to throw any pills away, but further underestimation could have occurred because of forgotten disposal of medicines. Researchers were motivated to find waste but could find none for 48% of subjects. Those subjects seemed sure that waste was absent.

Even though we counted more than 2000 wasted pills, numbers of specific medications were small. Thus, our analysis was confined to broad pharmaceutical classes and overall reasons for waste. This limitation could be overcome in more focused studies of specific wasted medications.

Conclusions

If, as we found in our study, average medication waste of $30 per person-year represents a conservative estimate, given that there are nearly 35 million individuals older than 65 years in the United States,¹⁰ the total national costs due to medication waste would not be less than $1 billion per year. Clearly, further studies in varied populations are required to confirm our waste estimate, and more research is needed to find effective waste reduction strategies. Despite the limitations of our study, physicians should begin to take note of what happens to prescribed medicines. That may serve as the most immediate basis for waste reduction.

Related resources

The Drugs and Devices Information Line Contains links to pharmacoepidemiology resources, maintained by the Pharmacoepidemiology Program, Harvard School of Public Health. http://www.hsph.harvard.edu/Organizations/DDIL/ddilhpge.html

Topics of Pharmacoepidemiology and Pharmacoeconomics A listserv for discussions related to these areas. http://www.findmail.com/list/pharmacoepidemiology/

ISPE—International Society for Pharmacoepidemiology A non-profit international professional organization dedicated to promoting pharmacoepidemiology. http://www.pharmacoepi.org/index.htm

Pharmacoepidemiology and Drug Safety The official journal of the International Society for Pharmacoepidemiology http://www.interscience.wiley.com/jpages/1053-8569/

Acknowledgment

The author acknowledges the assistance of the following undergraduate research assistants: Allison Robbins, Barbara Jones, Eva Liu, Karen Walp, Cynthia Oberto, Amanda Cook, John Raser, Sarah Hamilton, Anjali Godambe, and Michelle Anatone. Allen Dietrich, MD, provided guidance in the planning and execution of the study. Harlan Krumholz, MD, and Jerome Kassirer, MD, of the Yale University Robert Wood Johnson Clinical Scholars Program provided critical review of the manuscript.

Six months ago I embarked on a quest to develop a health care model that would truly serve our community. I had an epiphany that involving the community in the creation of the clinic would be integral to the success of the venture.

In neighborhoods and community centers throughout the region, I facilitated public forum discussions on the “Ideal Medical Clinic.” All participants were encouraged to express their wildest dreams and most creative visions in roundtable discussions that were remarkably lively, providing fertile material for the birth of our true community-based medical practice. Just 1 month later, 90% of the community input was incorporated into a fully functioning solo “Family and Community Medicine Clinic.”

Concurrent with my venture to create the ideal medical practice locally, the Future of Family Medicine (FFM) project has spearheaded a national campaign, a call to action for family physicians to create a new model of family medicine. After substantial research, the FFM project determined the characteristics of the “New Model” of family medicine:

• a personal medical home
• patient-centered care
• whole person orientation
• team approach
• elimination of barriers to access
• advanced information systems
• redesigned offices
• care provided within a community context
• emphasis on quality/safety
• enhanced practice finance
• provide family medicine’s basket of services.

It appeared we had inadvertently stumbled on this “new model” in our co-creation of the Family and Community Medicine Clinic, which successfully embodied all 11 characteristics.

A facility designed to reassure

The clinic is housed in a wellness center tucked into a wooded residential area within walking distance of my home. The center offers yoga, massage therapy, and counseling, and features a full size, solar-heated, wheelchair-accessible indoor pool/hot tub. A covered walkway connects the pool to the cozy medical office space, which feels more like a living room with its overstuffed chairs, pillows, and muted colors.

A partial wall separates the consultation area from the exam room. The exam area has a relaxing Caribbean decor with local commissioned artwork, fun flannel gowns, and an attached bathroom. A regional hospital with a full range of specialists is located just 2 miles from the clinic, and paramedics are next door in the fire station.

Gratifying physician-patient encounters

Patients enjoy 24/7 access to their family doctor, and hospital care if needed. After-hours calls are rare because appointments run 30 to 60 minutes and are comprehensive. Appointments are scheduled for weekday afternoons and evenings so patients never have to miss work. Same day and weekend visits are available for urgent needs.

I enjoy a leisurely bicycle ride to the office on scheduled afternoons, and I reward patients who walk, bicycle, or ride public transit to their visit with a selection of gifts (local handmade soaps, lotions). Other gifts such as massage or body work honor major behavior or lifestyle changes. Generic antibiotics are dispensed on site, free of charge, so ill patients do not have to wait at a pharmacy.

Patients active in care of selves and others

Novel voluntary programs were developed by the community and include healing circles and a quality improvement team composed of patients. Disease registries have made it possible to form chronic disease support groups.

For those in support groups, group medical visits are available and allow exchange of complex information in an informal nurturing environment. There are also a variety of volunteer opportunities for skilled patients to serve other patients with special needs.

Running the center with a little creativity

Our community medical practice operates without grants or outside financing aside from the small amount I contributed to buy furniture and supplies. Rented office space is $280/month, and with no staff I have extremely low overhead. My home business office is where I handle phone calls, billing, and charting on my Apple laptop computer. Malpractice insurance is inexpensive ($1200/first year); discounted 50%, as I work part-time. Insurance is accepted, and uninsured patients are given large discounts with barter options available. Oddly enough, I will likely exceed my prior full-time salary.

The rewards of embracing this new model

My colleagues were concerned I would serve the worried well in a wellness-centered “spa” setting. On the contrary, my first patient was an uninsured, whimsical, and thin 25-year-old man with a blood pressure of 220/120 mm Hg. I diagnosed renal artery stenosis due to fibromuscular dysplasia, and accompanied him to angioplasty.

Two weeks after his initial visit, I had his blood pressure down to 118/80 mm Hg without medication. The night after his angioplasty I brought the family and patient into the radiology department to recreate the amazing scene showing the catheters, wires, and film images, which they kept as souvenirs. We all stood there silently, in awe.

In this new practice model, I now have the luxury to stand in awe with my patients marveling at life itself. I also have the luxury of accompanying my patients through all facets of their treatment, including visits with specialists. It is an honor and a privilege to attend to patients with the curiosity and freedom (lack of time constraints) of a new medical student and with the wisdom of a seasoned family physician.

I am amazed at how simple and enjoyable it is to create a solo community medical practice that conforms to the national “New Model” of family medicine as supported by the FFM project. I look forward enthusiastically to exploring the new models that other family physicians develop in their communities, each with its own regional flavor, infused with the personalities of the creative physicians involved. May we all energize and inspire each other in our collective journey to renew our beloved profession.

CORRESPONDENCE:
Pamela L. Wible, MD, Family & Community Medicine, 3575 Donald St #220, Eugene, OR 97406. E-mail: [email protected]

Six months ago I embarked on a quest to develop a health care model that would truly serve our community. I had an epiphany that involving the community in the creation of the clinic would be integral to the success of the venture.

In neighborhoods and community centers throughout the region, I facilitated public forum discussions on the “Ideal Medical Clinic.” All participants were encouraged to express their wildest dreams and most creative visions in roundtable discussions that were remarkably lively, providing fertile material for the birth of our true community-based medical practice. Just 1 month later, 90% of the community input was incorporated into a fully functioning solo “Family and Community Medicine Clinic.”

Concurrent with my venture to create the ideal medical practice locally, the Future of Family Medicine (FFM) project has spearheaded a national campaign, a call to action for family physicians to create a new model of family medicine. After substantial research, the FFM project determined the characteristics of the “New Model” of family medicine:

• a personal medical home
• patient-centered care
• whole person orientation
• team approach
• elimination of barriers to access
• advanced information systems
• redesigned offices
• care provided within a community context
• emphasis on quality/safety
• enhanced practice finance
• provide family medicine’s basket of services.

It appeared we had inadvertently stumbled on this “new model” in our co-creation of the Family and Community Medicine Clinic, which successfully embodied all 11 characteristics.

A facility designed to reassure

The clinic is housed in a wellness center tucked into a wooded residential area within walking distance of my home. The center offers yoga, massage therapy, and counseling, and features a full size, solar-heated, wheelchair-accessible indoor pool/hot tub. A covered walkway connects the pool to the cozy medical office space, which feels more like a living room with its overstuffed chairs, pillows, and muted colors.

A partial wall separates the consultation area from the exam room. The exam area has a relaxing Caribbean decor with local commissioned artwork, fun flannel gowns, and an attached bathroom. A regional hospital with a full range of specialists is located just 2 miles from the clinic, and paramedics are next door in the fire station.

Gratifying physician-patient encounters

Patients enjoy 24/7 access to their family doctor, and hospital care if needed. After-hours calls are rare because appointments run 30 to 60 minutes and are comprehensive. Appointments are scheduled for weekday afternoons and evenings so patients never have to miss work. Same day and weekend visits are available for urgent needs.

I enjoy a leisurely bicycle ride to the office on scheduled afternoons, and I reward patients who walk, bicycle, or ride public transit to their visit with a selection of gifts (local handmade soaps, lotions). Other gifts such as massage or body work honor major behavior or lifestyle changes. Generic antibiotics are dispensed on site, free of charge, so ill patients do not have to wait at a pharmacy.

Patients active in care of selves and others

Novel voluntary programs were developed by the community and include healing circles and a quality improvement team composed of patients. Disease registries have made it possible to form chronic disease support groups.

For those in support groups, group medical visits are available and allow exchange of complex information in an informal nurturing environment. There are also a variety of volunteer opportunities for skilled patients to serve other patients with special needs.

Running the center with a little creativity

Our community medical practice operates without grants or outside financing aside from the small amount I contributed to buy furniture and supplies. Rented office space is $280/month, and with no staff I have extremely low overhead. My home business office is where I handle phone calls, billing, and charting on my Apple laptop computer. Malpractice insurance is inexpensive ($1200/first year); discounted 50%, as I work part-time. Insurance is accepted, and uninsured patients are given large discounts with barter options available. Oddly enough, I will likely exceed my prior full-time salary.

The rewards of embracing this new model

My colleagues were concerned I would serve the worried well in a wellness-centered “spa” setting. On the contrary, my first patient was an uninsured, whimsical, and thin 25-year-old man with a blood pressure of 220/120 mm Hg. I diagnosed renal artery stenosis due to fibromuscular dysplasia, and accompanied him to angioplasty.

Two weeks after his initial visit, I had his blood pressure down to 118/80 mm Hg without medication. The night after his angioplasty I brought the family and patient into the radiology department to recreate the amazing scene showing the catheters, wires, and film images, which they kept as souvenirs. We all stood there silently, in awe.

In this new practice model, I now have the luxury to stand in awe with my patients marveling at life itself. I also have the luxury of accompanying my patients through all facets of their treatment, including visits with specialists. It is an honor and a privilege to attend to patients with the curiosity and freedom (lack of time constraints) of a new medical student and with the wisdom of a seasoned family physician.

I am amazed at how simple and enjoyable it is to create a solo community medical practice that conforms to the national “New Model” of family medicine as supported by the FFM project. I look forward enthusiastically to exploring the new models that other family physicians develop in their communities, each with its own regional flavor, infused with the personalities of the creative physicians involved. May we all energize and inspire each other in our collective journey to renew our beloved profession.

CORRESPONDENCE:
Pamela L. Wible, MD, Family & Community Medicine, 3575 Donald St #220, Eugene, OR 97406. E-mail: [email protected]

Six months ago I embarked on a quest to develop a health care model that would truly serve our community. I had an epiphany that involving the community in the creation of the clinic would be integral to the success of the venture.

In neighborhoods and community centers throughout the region, I facilitated public forum discussions on the “Ideal Medical Clinic.” All participants were encouraged to express their wildest dreams and most creative visions in roundtable discussions that were remarkably lively, providing fertile material for the birth of our true community-based medical practice. Just 1 month later, 90% of the community input was incorporated into a fully functioning solo “Family and Community Medicine Clinic.”

Concurrent with my venture to create the ideal medical practice locally, the Future of Family Medicine (FFM) project has spearheaded a national campaign, a call to action for family physicians to create a new model of family medicine. After substantial research, the FFM project determined the characteristics of the “New Model” of family medicine:

• a personal medical home
• patient-centered care
• whole person orientation
• team approach
• elimination of barriers to access
• advanced information systems
• redesigned offices
• care provided within a community context
• emphasis on quality/safety
• enhanced practice finance
• provide family medicine’s basket of services.

It appeared we had inadvertently stumbled on this “new model” in our co-creation of the Family and Community Medicine Clinic, which successfully embodied all 11 characteristics.

A facility designed to reassure

The clinic is housed in a wellness center tucked into a wooded residential area within walking distance of my home. The center offers yoga, massage therapy, and counseling, and features a full size, solar-heated, wheelchair-accessible indoor pool/hot tub. A covered walkway connects the pool to the cozy medical office space, which feels more like a living room with its overstuffed chairs, pillows, and muted colors.

A partial wall separates the consultation area from the exam room. The exam area has a relaxing Caribbean decor with local commissioned artwork, fun flannel gowns, and an attached bathroom. A regional hospital with a full range of specialists is located just 2 miles from the clinic, and paramedics are next door in the fire station.

Gratifying physician-patient encounters

Patients enjoy 24/7 access to their family doctor, and hospital care if needed. After-hours calls are rare because appointments run 30 to 60 minutes and are comprehensive. Appointments are scheduled for weekday afternoons and evenings so patients never have to miss work. Same day and weekend visits are available for urgent needs.

I enjoy a leisurely bicycle ride to the office on scheduled afternoons, and I reward patients who walk, bicycle, or ride public transit to their visit with a selection of gifts (local handmade soaps, lotions). Other gifts such as massage or body work honor major behavior or lifestyle changes. Generic antibiotics are dispensed on site, free of charge, so ill patients do not have to wait at a pharmacy.

Patients active in care of selves and others

Novel voluntary programs were developed by the community and include healing circles and a quality improvement team composed of patients. Disease registries have made it possible to form chronic disease support groups.

For those in support groups, group medical visits are available and allow exchange of complex information in an informal nurturing environment. There are also a variety of volunteer opportunities for skilled patients to serve other patients with special needs.

Running the center with a little creativity

Our community medical practice operates without grants or outside financing aside from the small amount I contributed to buy furniture and supplies. Rented office space is $280/month, and with no staff I have extremely low overhead. My home business office is where I handle phone calls, billing, and charting on my Apple laptop computer. Malpractice insurance is inexpensive ($1200/first year); discounted 50%, as I work part-time. Insurance is accepted, and uninsured patients are given large discounts with barter options available. Oddly enough, I will likely exceed my prior full-time salary.

The rewards of embracing this new model

My colleagues were concerned I would serve the worried well in a wellness-centered “spa” setting. On the contrary, my first patient was an uninsured, whimsical, and thin 25-year-old man with a blood pressure of 220/120 mm Hg. I diagnosed renal artery stenosis due to fibromuscular dysplasia, and accompanied him to angioplasty.

Two weeks after his initial visit, I had his blood pressure down to 118/80 mm Hg without medication. The night after his angioplasty I brought the family and patient into the radiology department to recreate the amazing scene showing the catheters, wires, and film images, which they kept as souvenirs. We all stood there silently, in awe.

In this new practice model, I now have the luxury to stand in awe with my patients marveling at life itself. I also have the luxury of accompanying my patients through all facets of their treatment, including visits with specialists. It is an honor and a privilege to attend to patients with the curiosity and freedom (lack of time constraints) of a new medical student and with the wisdom of a seasoned family physician.

I am amazed at how simple and enjoyable it is to create a solo community medical practice that conforms to the national “New Model” of family medicine as supported by the FFM project. I look forward enthusiastically to exploring the new models that other family physicians develop in their communities, each with its own regional flavor, infused with the personalities of the creative physicians involved. May we all energize and inspire each other in our collective journey to renew our beloved profession.

CORRESPONDENCE:
Pamela L. Wible, MD, Family & Community Medicine, 3575 Donald St #220, Eugene, OR 97406. E-mail: [email protected]

One day a residency program decided to put its evidence-based medicine (EBM) curriculum to good use. A group of faculty and residents conducted a thorough review of the evidence regarding liquid-based cytoloutilizegy vs conventional Pap smears. They identified the key national recommendations and reviewed the supporting evidence behind each recommendation, tracing back to the individual studies themselves.^1-3

Based on the review, the group concluded that there was insufficient evidence to recommend one method of screening over another, but that there were situations in which one method might be preferred. They presented the evidence and their conclusions to the majority of faculty and residents at grand rounds. Following the presentation, the larger group discussed the relative merits of each screening method and decided the elements of evidence that supported the liquid test were more relevant to the practice than the conventional Pap smear. As a result, a decision was made by the group to stop carrying supplies for the conventional Pap smear. While the decision seemed reasonable on the level of an individual practitioner, several faculty and residents were unhappy with the “evidence-based” decision.

KAP theory and EBM

KAP theory identifies Knowledge, Attitudes, and Practice beliefs as key elements that drive healthcare providers’ decisions about medical care. In a sense EBM represents knowledge.⁴ There is a collective body of medical knowledge in the form of research, which represents “the evidence.” And there is what the healthcare provider himself “knows.” A major purpose of healthcare recommendations, point of care information systems, and best practice guidelines is to help the healthcare provider’s individual medical knowledge reflect the collective body of evidence.

For the purposes of this example, evidence will be considered absolute, inadequate, conditional, or relative. Absolute evidence occurs when there is clearly a correct answer. For example, the net benefits of aspirin for the treatment of myocardial infarction are clear. However, for most topics the evidence is not absolute; rather, it is inconclusive.⁵ The evidence may be inconclusive because it is inadequate—eg, insufficient research, conflicting studies, or research on peripheral topics. As an example, studies have demonstrated that aspirin decreases colorectal polyps, which may or may not be peripheral to the question of whether aspirin prevents colorectal cancer.

The evidence can also be conditional, meaning that in some defined instances the net benefit is clear. However, extending this net benefit beyond these instances is less clear. For example, patients at high risk for cardiovascular disease have a clear net benefit in taking aspirin for myocardial infarction prevention. Finally, the evidence may be relative, with a balance of known benefits and known risks.⁶ Using the aspirin example for cardiovascular disease prevention, patients at moderate risk receive benefit from aspirin in preventing myocardial infarction but at a risk cost of increased bleeding.

When the evidence is inconclusive, the second and third aspects of KAP theory—attitudes and practice beliefs—become very important. Healthcare providers and patients may arrive at different conclusions based on different viewpoints. On an individual level, healthcare practitioners use tools such as shared decision-making and patient-centered care to reach decisions.^6,7 However, inconclusive evidence provides a unique challenge when trying to develop local, regional, or national standards.

Evidence heresy

EBM frequently has negative connotations. In a room full of healthcare providers, some will believe that EBM should revolutionize the practice of medicine,⁸ and some that EBM has limited utility.⁹ How does this happen? The above scenario serves as a useful example, highlighting 3 misuses of the term “evidence” that frequently give EBM a bad name.

First, inconclusive evidence should not be stated in absolute terms; rather, it is more helpful to explicitly state what we know and the limits of what we know. Shaughnessy and Slawson wrote, “Absolute certainty is absolutely impossible, and we do not have to wait for that, of course.”¹⁰ This reflects the paucity of topics with certain evidence and highlights the need for clinicians to act on the available information. Every clinician necessarily utilizes this skill on a daily basis. The clinician has to become an Information Master¹¹ and know not only the end result of what the evidence indicates but also the facts supporting the end results and how those facts apply to the care of an unique individual.¹² However, taking this a step further and stating that one answer or option is absolutely correct in all cases ventures into dangerous ground. During the residency’s discussion of cervical cancer screening tests, the group recognized the merits of both options verbally but, the act of removing all conventional Pap smear supplies implied the nonverbal judgment that liquid-based technology was an absolute correct answer.

Second, while attitudes and practice beliefs can be used to weigh elements of evidence to reach a final conclusion, the conclusion should not negate other perspectives. An important skill of an adept clinician is the ability to interweave the healthcare provider’s and the patient’s attitudes and practice beliefs into the body of existing evidence to determine the appropriate intervention.¹³ However, attitudes and practice beliefs vary from individual to individual and from community to community. When these factors play a critical role in defining the appropriate action based on the evidence, how attitudes and practice beliefs are used should be explicitly stated. In the Pap smear example, the pivotal issue of contention was the belief about whether individual practitioners should act as stewards of limited healthcare resources. Proponents of using solely the liquid-based Pap smear felt the cost problem was a national issue and that the actions of the individual clinician had little impact on global healthcare costs. Others felt their local actions affected insurance premiums, leading directly to decreased healthcare access.¹¹ For cervical cancer, the key impact on mortality is getting any form of screening.¹ Using the liquid-based method for low-risk women may increase cervical cancer mortality by increasing costs and decreasing healthcare access. Removing conventional Pap smears disempowered the latter group of clinicians from implementing their practice beliefs and attitudes.

Finally, a conclusion should not be labeled as “evidence-based” when it is really made on other grounds such as economics, law, ethics, convenience, social values, or policy. Certainly, reviewing medical evidence is an important step in making decisions. However, the process for making decisions on these factors should be held to the same standards as making medical evidence decisions. This includes defining the process and explicitly stating the basis by which final decision will be made. The US is very conflicted when it comes to dealing with these non-evidence issues. We have no national standard for incorporating costs into healthcare decisions.^14,15 With respect to healthcare delivery, we have a wide range of social values that are sometimes disproportionate to logical expectations.¹⁶ Few effective systems are in place to incorporate these elements in healthcare decisions and, as a result, “evidence” is often used as a code word to focus on other issues.

For the Pap smear example, the decision factors were really economics, law, and systems of care. Proponents of the liquid-based method cited the community standard of care, fear of malpractice, patient expectations of receiving the latest technology, and the ease of adopting one screening method for the entire office. Others felt these issues, although important, were secondary to the lack of evidence supporting a liquid-based system as a sole screening method. For lowrisk women, adopting the liquid-based method only makes economic sense if screening is done every 2 or 3 years.¹⁷ However, many low-risk women still favor performing a Pap smear annually.¹⁸ As a result a decision-making process other than the strict EBM method, focusing on other factors would be necessary to change the practice standard.

Conclusions: Recognize the limitations of EBM

Cervical cancer screening serves as a common example of a difficult decision healthcare providers are faced with on a daily basis—what to do when evidence, based on patient oriented outcomes, is inconclusive. Providers do not have the luxury of merely stating the evidence is inconclusive; they must act. Frequently decisions are based on attitudes and practice beliefs in a broader context of unique economic, legal, and practice environments.

EBM is one tool in the decision-making armamentarium. It is a very powerful tool and has had a very positive impact on healthcare. Its methods have been well defined and explicitly stated. However, failing to recognize its limitations and making a decision under the rubric of EBM, when other variables are clearly playing a role, perpetuates the perception of its limited utility. Advocates of EBM need to wield this instrument carefully and judiciously.

CORRESPONDENCE
Alex Krist, MD, 3825 Charles Stewart Drive, Fairfax VA 22033. E-mail: [email protected]

One day a residency program decided to put its evidence-based medicine (EBM) curriculum to good use. A group of faculty and residents conducted a thorough review of the evidence regarding liquid-based cytoloutilizegy vs conventional Pap smears. They identified the key national recommendations and reviewed the supporting evidence behind each recommendation, tracing back to the individual studies themselves.^1-3

Based on the review, the group concluded that there was insufficient evidence to recommend one method of screening over another, but that there were situations in which one method might be preferred. They presented the evidence and their conclusions to the majority of faculty and residents at grand rounds. Following the presentation, the larger group discussed the relative merits of each screening method and decided the elements of evidence that supported the liquid test were more relevant to the practice than the conventional Pap smear. As a result, a decision was made by the group to stop carrying supplies for the conventional Pap smear. While the decision seemed reasonable on the level of an individual practitioner, several faculty and residents were unhappy with the “evidence-based” decision.

KAP theory and EBM

KAP theory identifies Knowledge, Attitudes, and Practice beliefs as key elements that drive healthcare providers’ decisions about medical care. In a sense EBM represents knowledge.⁴ There is a collective body of medical knowledge in the form of research, which represents “the evidence.” And there is what the healthcare provider himself “knows.” A major purpose of healthcare recommendations, point of care information systems, and best practice guidelines is to help the healthcare provider’s individual medical knowledge reflect the collective body of evidence.

For the purposes of this example, evidence will be considered absolute, inadequate, conditional, or relative. Absolute evidence occurs when there is clearly a correct answer. For example, the net benefits of aspirin for the treatment of myocardial infarction are clear. However, for most topics the evidence is not absolute; rather, it is inconclusive.⁵ The evidence may be inconclusive because it is inadequate—eg, insufficient research, conflicting studies, or research on peripheral topics. As an example, studies have demonstrated that aspirin decreases colorectal polyps, which may or may not be peripheral to the question of whether aspirin prevents colorectal cancer.

The evidence can also be conditional, meaning that in some defined instances the net benefit is clear. However, extending this net benefit beyond these instances is less clear. For example, patients at high risk for cardiovascular disease have a clear net benefit in taking aspirin for myocardial infarction prevention. Finally, the evidence may be relative, with a balance of known benefits and known risks.⁶ Using the aspirin example for cardiovascular disease prevention, patients at moderate risk receive benefit from aspirin in preventing myocardial infarction but at a risk cost of increased bleeding.

When the evidence is inconclusive, the second and third aspects of KAP theory—attitudes and practice beliefs—become very important. Healthcare providers and patients may arrive at different conclusions based on different viewpoints. On an individual level, healthcare practitioners use tools such as shared decision-making and patient-centered care to reach decisions.^6,7 However, inconclusive evidence provides a unique challenge when trying to develop local, regional, or national standards.

Evidence heresy

EBM frequently has negative connotations. In a room full of healthcare providers, some will believe that EBM should revolutionize the practice of medicine,⁸ and some that EBM has limited utility.⁹ How does this happen? The above scenario serves as a useful example, highlighting 3 misuses of the term “evidence” that frequently give EBM a bad name.

First, inconclusive evidence should not be stated in absolute terms; rather, it is more helpful to explicitly state what we know and the limits of what we know. Shaughnessy and Slawson wrote, “Absolute certainty is absolutely impossible, and we do not have to wait for that, of course.”¹⁰ This reflects the paucity of topics with certain evidence and highlights the need for clinicians to act on the available information. Every clinician necessarily utilizes this skill on a daily basis. The clinician has to become an Information Master¹¹ and know not only the end result of what the evidence indicates but also the facts supporting the end results and how those facts apply to the care of an unique individual.¹² However, taking this a step further and stating that one answer or option is absolutely correct in all cases ventures into dangerous ground. During the residency’s discussion of cervical cancer screening tests, the group recognized the merits of both options verbally but, the act of removing all conventional Pap smear supplies implied the nonverbal judgment that liquid-based technology was an absolute correct answer.

Second, while attitudes and practice beliefs can be used to weigh elements of evidence to reach a final conclusion, the conclusion should not negate other perspectives. An important skill of an adept clinician is the ability to interweave the healthcare provider’s and the patient’s attitudes and practice beliefs into the body of existing evidence to determine the appropriate intervention.¹³ However, attitudes and practice beliefs vary from individual to individual and from community to community. When these factors play a critical role in defining the appropriate action based on the evidence, how attitudes and practice beliefs are used should be explicitly stated. In the Pap smear example, the pivotal issue of contention was the belief about whether individual practitioners should act as stewards of limited healthcare resources. Proponents of using solely the liquid-based Pap smear felt the cost problem was a national issue and that the actions of the individual clinician had little impact on global healthcare costs. Others felt their local actions affected insurance premiums, leading directly to decreased healthcare access.¹¹ For cervical cancer, the key impact on mortality is getting any form of screening.¹ Using the liquid-based method for low-risk women may increase cervical cancer mortality by increasing costs and decreasing healthcare access. Removing conventional Pap smears disempowered the latter group of clinicians from implementing their practice beliefs and attitudes.

Finally, a conclusion should not be labeled as “evidence-based” when it is really made on other grounds such as economics, law, ethics, convenience, social values, or policy. Certainly, reviewing medical evidence is an important step in making decisions. However, the process for making decisions on these factors should be held to the same standards as making medical evidence decisions. This includes defining the process and explicitly stating the basis by which final decision will be made. The US is very conflicted when it comes to dealing with these non-evidence issues. We have no national standard for incorporating costs into healthcare decisions.^14,15 With respect to healthcare delivery, we have a wide range of social values that are sometimes disproportionate to logical expectations.¹⁶ Few effective systems are in place to incorporate these elements in healthcare decisions and, as a result, “evidence” is often used as a code word to focus on other issues.

For the Pap smear example, the decision factors were really economics, law, and systems of care. Proponents of the liquid-based method cited the community standard of care, fear of malpractice, patient expectations of receiving the latest technology, and the ease of adopting one screening method for the entire office. Others felt these issues, although important, were secondary to the lack of evidence supporting a liquid-based system as a sole screening method. For lowrisk women, adopting the liquid-based method only makes economic sense if screening is done every 2 or 3 years.¹⁷ However, many low-risk women still favor performing a Pap smear annually.¹⁸ As a result a decision-making process other than the strict EBM method, focusing on other factors would be necessary to change the practice standard.

Conclusions: Recognize the limitations of EBM

Cervical cancer screening serves as a common example of a difficult decision healthcare providers are faced with on a daily basis—what to do when evidence, based on patient oriented outcomes, is inconclusive. Providers do not have the luxury of merely stating the evidence is inconclusive; they must act. Frequently decisions are based on attitudes and practice beliefs in a broader context of unique economic, legal, and practice environments.

EBM is one tool in the decision-making armamentarium. It is a very powerful tool and has had a very positive impact on healthcare. Its methods have been well defined and explicitly stated. However, failing to recognize its limitations and making a decision under the rubric of EBM, when other variables are clearly playing a role, perpetuates the perception of its limited utility. Advocates of EBM need to wield this instrument carefully and judiciously.

CORRESPONDENCE
Alex Krist, MD, 3825 Charles Stewart Drive, Fairfax VA 22033. E-mail: [email protected]

One day a residency program decided to put its evidence-based medicine (EBM) curriculum to good use. A group of faculty and residents conducted a thorough review of the evidence regarding liquid-based cytoloutilizegy vs conventional Pap smears. They identified the key national recommendations and reviewed the supporting evidence behind each recommendation, tracing back to the individual studies themselves.^1-3

Based on the review, the group concluded that there was insufficient evidence to recommend one method of screening over another, but that there were situations in which one method might be preferred. They presented the evidence and their conclusions to the majority of faculty and residents at grand rounds. Following the presentation, the larger group discussed the relative merits of each screening method and decided the elements of evidence that supported the liquid test were more relevant to the practice than the conventional Pap smear. As a result, a decision was made by the group to stop carrying supplies for the conventional Pap smear. While the decision seemed reasonable on the level of an individual practitioner, several faculty and residents were unhappy with the “evidence-based” decision.

KAP theory and EBM

KAP theory identifies Knowledge, Attitudes, and Practice beliefs as key elements that drive healthcare providers’ decisions about medical care. In a sense EBM represents knowledge.⁴ There is a collective body of medical knowledge in the form of research, which represents “the evidence.” And there is what the healthcare provider himself “knows.” A major purpose of healthcare recommendations, point of care information systems, and best practice guidelines is to help the healthcare provider’s individual medical knowledge reflect the collective body of evidence.

For the purposes of this example, evidence will be considered absolute, inadequate, conditional, or relative. Absolute evidence occurs when there is clearly a correct answer. For example, the net benefits of aspirin for the treatment of myocardial infarction are clear. However, for most topics the evidence is not absolute; rather, it is inconclusive.⁵ The evidence may be inconclusive because it is inadequate—eg, insufficient research, conflicting studies, or research on peripheral topics. As an example, studies have demonstrated that aspirin decreases colorectal polyps, which may or may not be peripheral to the question of whether aspirin prevents colorectal cancer.

The evidence can also be conditional, meaning that in some defined instances the net benefit is clear. However, extending this net benefit beyond these instances is less clear. For example, patients at high risk for cardiovascular disease have a clear net benefit in taking aspirin for myocardial infarction prevention. Finally, the evidence may be relative, with a balance of known benefits and known risks.⁶ Using the aspirin example for cardiovascular disease prevention, patients at moderate risk receive benefit from aspirin in preventing myocardial infarction but at a risk cost of increased bleeding.

When the evidence is inconclusive, the second and third aspects of KAP theory—attitudes and practice beliefs—become very important. Healthcare providers and patients may arrive at different conclusions based on different viewpoints. On an individual level, healthcare practitioners use tools such as shared decision-making and patient-centered care to reach decisions.^6,7 However, inconclusive evidence provides a unique challenge when trying to develop local, regional, or national standards.

Evidence heresy

EBM frequently has negative connotations. In a room full of healthcare providers, some will believe that EBM should revolutionize the practice of medicine,⁸ and some that EBM has limited utility.⁹ How does this happen? The above scenario serves as a useful example, highlighting 3 misuses of the term “evidence” that frequently give EBM a bad name.

First, inconclusive evidence should not be stated in absolute terms; rather, it is more helpful to explicitly state what we know and the limits of what we know. Shaughnessy and Slawson wrote, “Absolute certainty is absolutely impossible, and we do not have to wait for that, of course.”¹⁰ This reflects the paucity of topics with certain evidence and highlights the need for clinicians to act on the available information. Every clinician necessarily utilizes this skill on a daily basis. The clinician has to become an Information Master¹¹ and know not only the end result of what the evidence indicates but also the facts supporting the end results and how those facts apply to the care of an unique individual.¹² However, taking this a step further and stating that one answer or option is absolutely correct in all cases ventures into dangerous ground. During the residency’s discussion of cervical cancer screening tests, the group recognized the merits of both options verbally but, the act of removing all conventional Pap smear supplies implied the nonverbal judgment that liquid-based technology was an absolute correct answer.

Second, while attitudes and practice beliefs can be used to weigh elements of evidence to reach a final conclusion, the conclusion should not negate other perspectives. An important skill of an adept clinician is the ability to interweave the healthcare provider’s and the patient’s attitudes and practice beliefs into the body of existing evidence to determine the appropriate intervention.¹³ However, attitudes and practice beliefs vary from individual to individual and from community to community. When these factors play a critical role in defining the appropriate action based on the evidence, how attitudes and practice beliefs are used should be explicitly stated. In the Pap smear example, the pivotal issue of contention was the belief about whether individual practitioners should act as stewards of limited healthcare resources. Proponents of using solely the liquid-based Pap smear felt the cost problem was a national issue and that the actions of the individual clinician had little impact on global healthcare costs. Others felt their local actions affected insurance premiums, leading directly to decreased healthcare access.¹¹ For cervical cancer, the key impact on mortality is getting any form of screening.¹ Using the liquid-based method for low-risk women may increase cervical cancer mortality by increasing costs and decreasing healthcare access. Removing conventional Pap smears disempowered the latter group of clinicians from implementing their practice beliefs and attitudes.

Finally, a conclusion should not be labeled as “evidence-based” when it is really made on other grounds such as economics, law, ethics, convenience, social values, or policy. Certainly, reviewing medical evidence is an important step in making decisions. However, the process for making decisions on these factors should be held to the same standards as making medical evidence decisions. This includes defining the process and explicitly stating the basis by which final decision will be made. The US is very conflicted when it comes to dealing with these non-evidence issues. We have no national standard for incorporating costs into healthcare decisions.^14,15 With respect to healthcare delivery, we have a wide range of social values that are sometimes disproportionate to logical expectations.¹⁶ Few effective systems are in place to incorporate these elements in healthcare decisions and, as a result, “evidence” is often used as a code word to focus on other issues.

For the Pap smear example, the decision factors were really economics, law, and systems of care. Proponents of the liquid-based method cited the community standard of care, fear of malpractice, patient expectations of receiving the latest technology, and the ease of adopting one screening method for the entire office. Others felt these issues, although important, were secondary to the lack of evidence supporting a liquid-based system as a sole screening method. For lowrisk women, adopting the liquid-based method only makes economic sense if screening is done every 2 or 3 years.¹⁷ However, many low-risk women still favor performing a Pap smear annually.¹⁸ As a result a decision-making process other than the strict EBM method, focusing on other factors would be necessary to change the practice standard.

Conclusions: Recognize the limitations of EBM

Cervical cancer screening serves as a common example of a difficult decision healthcare providers are faced with on a daily basis—what to do when evidence, based on patient oriented outcomes, is inconclusive. Providers do not have the luxury of merely stating the evidence is inconclusive; they must act. Frequently decisions are based on attitudes and practice beliefs in a broader context of unique economic, legal, and practice environments.

EBM is one tool in the decision-making armamentarium. It is a very powerful tool and has had a very positive impact on healthcare. Its methods have been well defined and explicitly stated. However, failing to recognize its limitations and making a decision under the rubric of EBM, when other variables are clearly playing a role, perpetuates the perception of its limited utility. Advocates of EBM need to wield this instrument carefully and judiciously.

CORRESPONDENCE
Alex Krist, MD, 3825 Charles Stewart Drive, Fairfax VA 22033. E-mail: [email protected]