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Logo of nihpaAbout Author manuscriptsSubmit a manuscriptHHS Public Access; Author Manuscript; Accepted for publication in peer reviewed journal;
 
Arch Intern Med. Author manuscript; available in PMC 2012 June 1.
Published in final edited form as:
PMCID: PMC3365537
NIHMSID: NIHMS351280

Effectiveness of a Barber-Based Intervention for Improving Hypertension Control in Black Men

The BARBER-1 Study: A Cluster Randomized Trial

Abstract

Context

Barbershop-based hypertension (HTN) outreach programs for black men are becoming increasingly common, but whether they are an effective approach for improving HTN control remains uncertain.

Objective

To evaluate whether a continuous high blood pressure (BP) monitoring and referral program conducted by barbers will motivate male patrons with elevated BP to pursue physician follow-up, leading to improved HTN control.

Design, Setting, and Participants

Cluster randomized trial (Barber-Assisted Reduction in Blood Pressure in Ethnic Residents [BARBER-1]) of HTN control among black male patrons of 17 black-owned barbershops in Dallas County, Texas (March 2006-December 2008).

Intervention

Black male patrons of participating barbershops underwent 10-week baseline BP screening. Study sites were then randomized to a comparison group (8 shops, 77 hypertensives/shop) that received standard BP pamphlets or an intervention group (9 shops, 75 hypertensives/shop) in which barbers continually offered BP checks with haircuts and promoted physician follow-up with gender-specific peer-based health messaging. After 10 months, follow-up data were obtained.

Primary Outcome Measure

Change in HTN control rate for each barbershop.

Results

The HTN control rate increased more in intervention-arm barbershops than in comparison-arm barbershops (absolute group difference, 8.8%; 95% confidence interval [CI], 0.8 to 16.9%; P=0.036); the intervention effect persisted after adjustment for covariates (P=0.031). A marginal intervention effect was found for systolic BP change (absolute group difference: −2.5 mmHg; 95% CI, −5.3 to 0.3 mmHg; P=0.08).

Conclusion

The effect of BP screening on HTN control among black male barbershop patrons was improved when barbers were enabled to become health educators, monitor BP, and promote physician referral. Further research is warranted.

Trial registration clinicalTrials.gov Identifier NCT00325533

Uncontrolled hypertension (HTN) is one of the most important causes of premature disability and death among non-Hispanic black men.1;2 Indeed, black men have the highest death rate from HTN of any race, ethnic, and gender group in the United States.2 The age-adjusted HTN-related death rate is three-times higher among black men than white men,2 with blood pressure (BP) remaining above recommended levels in 70% of the 4.4 million adult black men with HTN3—a chronic medical condition that requires frequent physician interaction for initiation and adjustment of prescription BP medication. Compared with black women, men have less frequent physician contact for preventive care and thus substantially lower rates of HTN detection, medical treatment, and control.3;4 Accordingly, the Centers for Disease Control and Prevention has issued a new priority to develop novel HTN outreach programs with community partners and deliver intervention messages that resonate with black men.1 Existing community-level health promotion research specific to black men and HTN is scarce, with most work having considered blacks as a group.1;5

Black churches are conventional community partners for medical outreach, but regular church attendance is less common among black men than women.6;7 Thus, popular secular sites—sporting events and barbershops—have been approached for HTN outreach to a larger segment of the at-risk male population.8;9 Black-owned barbershops hold special appeal for community-based intervention trials, as they are a cultural institution that draws a large and loyal male clientele and provides an open forum for discussion of numerous topics, including health, with influential peers.10-12 Barbershop-based HTN outreach programs are becoming common nationwide,1;13-17 but whether they are an effective approach for improving HTN control among black men is unknown due to a dearth of evaluation research. Interventions described in the peer-reviewed literature previously had no evaluation component.

In recent nonrandomized feasibility studies, we found that a program of continuous BP monitoring and peer-based health messaging in a barbershop can: (1) increase physician referrals and lower BP among long-term patrons with uncontrolled HTN, and (2) be implemented by barbers rather than research personnel.11 Based on the encouraging pilot data, we designed and conducted a cluster-randomized trial18—the Barber-Assisted Reduction in Blood Pressure in Ethnic Residents (BARBER-1) study.

BARBER-1 is the first randomized-controlled trial of a barbershop-based health promotion program. The intent was to use the nature of black-owned barbershops—haircut service and socialization—to have barbers become promoters of physician follow-up for BP control. We chose the cluster-randomized trial, knowing that the design needed to avoid contamination between intervention and comparison conditions and analysis must allow for possible dependency of response between individual patrons within a barbershop as well as withdrawals and additonal of individual patrons over time.19-21 all black men attending the participating barbershops were offered 10-week baseline BP screenings for HTN. Study sites were then randomized to a comparison group of barbershops that received standard HTN education pamphlets written for a broad audience of black men and women or an intervention group in which barbers continually offered their entire male clientele BP checks with haircuts and used personalized gender-specific peer-based health messaging to promote physician follow-up. Intervention-shop patrons received this message repeatedly both though day-to-day conversations with their barbers (and other male patrons) and large role-model posters on the shop walls showing their own male peers (actual patrons of their barbershop) modeling specific HTN treatment-seeking behavior and using their own words to tell the story. After 10 months, follow-up data were collected to determine if barbershops randomized to the intervention arm showed a larger improvement in HTN control rates (percentage of a barbershop's hypertensive patrons with recommended BP levels).

Methods

Participating Barbershops

The trial was conducted in black-owned barbershops with ≥ 95% black male clientele in Dallas County, Texas, from March 2006 to December 2008 (Figure 1 and eFigure 1). Fifty-five of 222 shops met additional selection criteria (in business for ≥10 years, ≥ 3 barbers). We selected 18 of these to represent 4 geographic sectors with sizeable black populations; all 18 initially agreed to participate but 1 went out of business prior to randomization, 1 intervention shop dropped out before the intervention began, and 1 shop assigned to the comparison group was eliminated on safety concerns (criminal activity in the shop). Randomization was stratified by baseline HTN control rate and sector. Randomization was blinded. By the nature of the study, barbers and patrons could not be blinded after randomization; therefore, the evaluation data were collected by independently-contracted field interviewers who were not invested in the study's outcome. The study was approved by the institutional review boards of University of Texas Southwestern Medical Center and Temple University Institute for Survey Research, which conducted the evaluation. Patron consent was obtained; data were collected and stored in accordance with HIPAA guidelines.

Figure 1Figure 1
Figure 1A. Flow Diagram of the Design of the BARBER-1 Study

Intervention and Comparison Groups

Before randomization, both groups of hypertensive patrons were treated identically: they had 2 baseline BP screenings by field interviewers who provided them with written screening results and standard written recommendations for physician follow-up.

After randomization, comparison-arm shops had standard pamphlets written by the American Heart Association (High Blood Pressure in African Americans, product code 50-1466). No BPs were measured in the barbershops for 10 months.

In contrast, the intervention-arm shops had no pamphlets but for 10 months had barbers continually offering BP checking during haircuts (eFigure 2), and personalized gender-specific peer-based health messaging—both through conversations with barbers and other male patrons and through peer role-model stories.18 The latter were large posters placed on the barbershop walls depicting authentic stories of other male hypertensive patrons of the same shop modeling the desired treatment-seeking behavior and using the model's own words to tell the story (eFigure 3).

The intervention's theoretical underpinning was adapted from the successful AIDS Community Demonstration Projects that mobilized community peers to deliver intervention messages (specific action items) with role-model stories and make medical equipment available in the daily environment.22 Here we trained, equipped, and paid barbers to make BP monitoring and interpretation available to every adult black male patron with every haircut in intervention shops and to deliver the main intervention message that each patron with an elevated BP reading needs to follow-up with a physician. They encouraged patrons with an established physician to make a follow-up appointment and referred those without physicians to the project nursing staff, who facilitated insurance-appropriate referral to local community physicians and safety-net clinics including the UT Southwestern Hypertension Specialty Clinic staffed by physicians who were part of the study. The barbers also gave the patrons with elevated readings wallet-sized referral cards to give their physicians on-going feedback—accurate out-of-office BP readings—about the need to start or intensify BP medicine (eFigure 4).

In the intervention-arm shops, barbers were paid $3 per recorded BP, $10 per phone call requesting nurse-assisted physician referral, and $50 per BP card returned (by the patron to the barber) with the physician's signature (documenting physician-patient interaction—the study's major behavioral objective). Patrons received a free $12-haircut for each high BP referral card signed by their physician and returned to their barber.

Outcome Evaluation

Several steps were taken to rigorously evaluate the study's primary outcome—the change in HTN control rates for shops in each treatment arm. Baseline and 10-month follow-up BP measurements and computer-assisted health interviews were conducted by independently-contracted trained black field interviewers (not by barbers). HTN control rates were derived from a second set of multiple BP measurements and prescription pill bottle labels rather than the 1-or-2 BP measurements and subjective treatment reporting typically used in survey research.

For 10 weeks at both ends of the study, interviewers offered free BP screenings to all adult black men entering the barbershop. Men meeting screening criteria for HTN (measured BP > 135/85, > 130/80 for diabetics, or reporting BP medication) were asked to return another day to: (1) complete a second set of BP measurements and a health questionnaire, and (2) bring their pill bottles to the barbershop for interviewers to transcribe medication data. The questionnaire consisted of structured response items, from previously validated instruments, on numerous covariates, including: age (years), education beyond high school (yes/no), marital status (yes/no), and current smoking status (yes/no). An additional covariate, an indicator for participation in baseline and follow-up surveys, was constructed by merging the baseline and follow-up unique identifiers. These covariates were included in an adjusted analysis of the primary outcome because of their plausible influence on healthcare-seeking behavior and BP.

Interviewers were trained on proper BP measurement technique.23;24 They measured BPs using validated oscillometric monitors (Welch Allyn, Arden, NC),25 with patrons seated after 5 minutes of rest. For each subject, the appropriately-sized arm cuff was determined, recorded, and used for all subsequent BP measurements. For both baseline and follow-up data, field interviewers took 6 consecutive BP readings on each hypertensive subject on each of 2 days. Measurements on each first monitoring day are known to be higher and unstable and therefore were excluded, as recommended by current guidelines23;24 and substantiated by our preparatory field work.11 The final 4 readings on the second day were averaged to obtain a stable mean value,4;7 which was used to calculate BP outcomes. HTN was defined as having either a (a) documented current prescription for BP medication or, for untreated patrons (b) measured BP ≥ 135/85 mmHg for men without diabetes and ≥ 130/80 mmHg for those with diabetes (recommended cutoff values for out-of-office BP).24 HTN control was defined as BP levels below these limits. In each shop, the percentage of hypertensives having goal BP values was calculated at both ends of the study. The primary outcome, calculated for each barbershop, was the change in HTN control rate. Pre-specified secondary outcomes included shop-level changes in HTN treatment rates, HTN awareness rates, and BP levels.

The study was designed to have 80% power for detecting a 15% absolute mean difference in improvement in HTN control rate between study groups.18 Power calculations assumed 8 shops per study arm, 100 hypertensive patrons per shop, and an over-time correlation of 0.1. However, the actual over-time correlation was ~1 (as shown by the observed ICCChange of 0 in eTable 1), indicating that the study design provided more statistical power than anticipated. The power is driven mainly by the number of barbershops once the number of hypertensive individuals exceeds ~50/shop; thus, differences in the range of 70-100 had only a minor effect.

Statistical Analyses

Because of the cluster design, summary statistics are presented as the means and standard errors of barbershop means. A difference between study arms at baseline was tested with a mixed effects regression model with arm as a fixed effect and barbershop within arm as a random effect. A difference between study arms over time was tested with a mixed effects regression model with arm, time, and arm × time as fixed effects and barbershop, barbershop × time and patron within barbershop as random effects. The random effects of barbershop and barbershop × time account for the clustering of outcome levels and changes within barbershops, while the random effect of patron within barbershop accounts for repeated measures of clients present at both baseline and final assessment periods. These models simultaneously estimate the outcome measure in both study arms at both time points; the arm × time effect tests the intervention effect, thereby adjusting for baseline values.19;20 Generalized linear mixed models with logit link functions were used for binary outcome variables and linear mixed models were used for continuous outcome variables. Adjusted models were fit with centered, individual level covariates included as additional fixed effects.20 Model-based significance levels and 95% confidence intervals (CIs) were obtained. A P value less than.05 was considered statistically significant. Analyses were conducted using SAS/STAT® 9.1.3.

Cost-Effectiveness Simulation

We used the CHD (Coronary Heart Disease) Policy Model—an established computer-simulation, state-transition (Markov cohort) model of CHD incidence, prevalence, mortality, and costs in the U.S. population26-28 –to simulate the average benefits of the observed systolic BP reduction in BARBER-1 on the numbers of adverse events prevented, and associated healthcare cost savings, during a 1-year intervention. The total cost savings provides an estimate of how much could be spent on intervention implementation plus antihypertensive treatment for the program to be cost-neutral in the first year. Details on methodology and model population characteristics are in eTables 2 & 3.

Results

The characteristics of the participating barbershops and the patrons with HTN are shown in Table 1. The groups were well-balanced at baseline across most characteristics. However, at baseline, a higher percentage of patrons in the comparison group reported being married (P<0.05).

Table 1
Characteristics of Black Barbershops and Black Male Patrons with HTNa

Although at baseline 85% of the hypertensive patrons in both groups reported having health insurance (mostly private insurance) and middle-income levels (Table 1), HTN was uncontrolled in the majority of affected patrons. Overall, 45% of the subjects screened had HTN, and, of these, 78% were aware of their diagnosis, 69% were being treated for it, and only 38% had their BP controlled; these rates are all slightly higher than recent national estimates (eTable 4). Baseline HTN control rates were not significantly different between study groups (P=0.22) but tended to be lower in the intervention group (33.8% vs. 40.0%) (Table 2 and Figure 2).

Figure 2
Baseline and Follow-up HTN Control Rates for Individual Barbershops in Intervention and Comparison Groups
Table 2
Mean Change in Hypertension (HTN) Control Ratea and Its Components in Barbershops Randomized to Intervention and Comparison Conditions

Primary Outcome

Table 2 shows the change over time in the primary and secondary outcomes. Figure 2 shows the barbershop-specific changes over time in HTN control rates. In unadjusted analysis that used all available data (17 barbershops at baseline, 15 at follow-up), the enhanced barber-based intervention resulted in a greater improvement in the primary outcome of HTN control rate than the comparison treatment: (absolute group difference, 8.8%; 95% confidence interval [CI], 0.8 to 16.9%; P=0.036); the intervention effect persisted after adjustment for covariates (P=0.031). Additionally, in a conservative intention-to-treat analysis, which assumed that the 2 barbershops lost to follow-up (one per arm) both followed the lesser trajectory of the comparison-arm shops, the resultant intervention effect was 7.8%; 95% confidence interval [CI], 0.4 to 15.3%; P=0.041.

Secondary Outcomes

Borderline intervention effects were observed for several secondary outcomes (Table 2), including systolic BP reduction (absolute group difference: −2.5 mmHg; 95% CI, −5.3 to 0.3 mmHg; P=0.08). However, there was no evidence for an intervention effect on HTN awareness.

Process Data on Intervention Implementation, Penetration, Incentive Payments, and Acceptability

In the intervention group, follow-up data were collected on 539 patrons with HTN served by 29 participating barbers in 8 barbershops completing the study. Of the 539 patrons, 275 (51%) reported that during the intervention their barbers discussed a model story during every haircut, 175 (32%) reported that their barbers discussed a story during half of their haircuts, and 89 (17%) reported that their barbers never discussed one. The barbers measured BP on 417 of the 539 hypertensive patrons (77%), recording 3,350 sets of BPs (8 sets per patron), and successfully counseled 180 of 350 patrons with elevated BP readings (51%) to have documented physician visits (including 36 documented nurse-assisted referrals).

The mean total incentive payment was estimated at $133 per hypertensive patron as follows: barbers were paid $60,474 in total for intervention activities on the above 539 hypertensive patrons ($112/ patron). These patrons returned 939 signed physician-referral cards to the barbers and received one free $12-haircut per card ($21 value/patron).

With the intervention group, 530 of the 539 hypertensive patrons (98%) completing the study and all 29 participating barbers reported that they would like the barber-based intervention program continued indefinitely.

Cost-Effectiveness Simulation

If the intervention could be implemented in the ~18,000 black-owned barbershops in the U.S. (see eTable2 legend) to reduce systolic BP by 2.5 mmHg in the ~50% of hypertensive U.S. black men who patronize these barbershops (N=2.2 million persons), we project that about 800 fewer myocardial infarctions, 550 fewer strokes, and 900 fewer deaths would occur in the first year alone, saving ~$98 million in CHD care and $13 million in stroke care (but offset by $6 million in additional non-CHD costs contributed by persons who would otherwise have died). For this intervention to be cost-neutral from a healthcare system perspective, therefore, the program costs (including performance incentives, medication and other healthcare delivery costs) could be ~$5,800 per barbershop or ~$50 per hypertensive barbershop patron.

Comment

Black-owned barbershops are rapidly gaining traction as potential community partners for health promotion programs targeting HTN as well as diabetes, prostate cancer, and other diseases that disproportionately affect black men.1;11;13-17;29 Yet the effectiveness of barbershop-based HTN screening and referral programs on BP control previously has not been evaluated by a randomized trial. In this cluster-randomized controlled trial, we found that an enhanced intervention program—in which barbers continuously monitored BP and actively promoted physician-follow-up with personalized gender-specific messages—resulted in improved BP control among black male barbershop patrons with HTN. Although BP control also improved in a comparison group, which received standard written information about high BP, the improvement was greater with the enhanced intervention. A statistically borderline intervention effect was seen for medication treatment rates, BP levels, and other secondary outcomes. Thus, the results of this study provide the first evidence for the effectiveness of a barber-based intervention for controlling HTN in black men and indicate that more research is needed to develop a highly effective and sustainable intervention model prior to large-scale program implementation.

We detected a positive intervention effect despite an unexpectedly large improvement in BP control in the comparison group, which was not an inactive comparator. In collecting thorough baseline BP data, we unavoidably intervened in both groups: patrons with HTN in all participating barbershops were repeatedly exposed to research staff measuring their BP at two baseline haircut visits, and due to ethical reasoning, gave those with elevated BP readings detailed written recommendations for physician follow-up. In addition to this Hawthorne effect, educational pamphlets written for black individuals were distributed only to comparison shops.

The larger improvement in HTN control seen in the intervention group is not explained by baseline values, which were taken into account by the mixed-effects model. Moreover, within either group, shops with lower baseline values did not show larger increments in HTN control and there was no ceiling effect.

The new data confirm and extend our earlier pilot data11 by indicating that the characteristic long-term patronage in black-owned barbershops (almost a decade) and frequent haircut visits (1 every 3-to-4 weeks) provided much opportunity for barbers to repeatedly monitor BP and deliver intervention messages. The process data indicate that, in general, the intervention was implemented as intended. That barbers measured BP on 3 of every 4 patrons with HTN and that each of the participating patrons averaged 8 barber BP checks in 10 months shows reasonably high levels of intervention implementation and penetration. That the barbers motivated 50% of their patrons with elevated BP readings to visit a physician supports the theoretical underpinning of the behavior theory-based intervention, namely, that barbers, as influential peers, can increase HTN treatment-seeking behavior. The intervention effect on primary and secondary BP outcomes may have been larger than observed if barbers had motivated the other 50% of high BP patrons to see a physician.

A salient finding is the middle-income status of the barbershop clientele. Although most participating barbershops were in low-income areas, patrons need financial resources to afford frequent haircuts. Because socioeconomic status and affordability of health insurance are major determinants of HTN control,1 the low baseline HTN control rates among the barbershop patrons may seem disproportionate to income level and healthcare access. However, for reasons that require more study, middle-income status alone does not protect black men from many poor health indicators, including under-utilization of available medical services to control HTN and prevent its complications.30 For example, socio-cultural factors related to masculinity (such as a desire to avoid showing vulnerability) also can deter men from fully utilizing available preventive medical services.4;30 Our data suggest that barbers can deliver health messages which resonate with men and, more broadly that the barbershop constitutes a unique opportunity for further research on improving the health status of this particularly vulnerable and under-studied group of men—middle-income black men.1;30

Our study has several important limitations. The impact of the barber-based intervention was less than optimal because not all barbers participated fully and not all patrons agreed to have their BP monitored and be referred for physician follow-up. Because study sites were confined to one county, the results cannot be generalized to other geographic areas without further study. Because the barbershops' clientele were predominately middle-income, the intervention had limited ability to reach very low-income individuals who will require other types of intervention. The evaluation strategy provided a snapshot of BP improvement at one point in time and does not demonstrate whether the outcomes are sustainable, particularly because financial incentives were paid to barbers for conducting the intervention and to patrons for following their advice in seeking medical attention. However, the $112 incentive paid per barber per hypertensive patron and the $21 paid per patron in free haircuts for HTN-related physician visits is far less than the $750 cash incentive per patient used in a recent smoking-cessation study.31

Because hypertensive patrons choose their individual physicians, we could not collect actual data on increased antihypertensive treatment costs associated with the intervention. Our CHD Policy Model simulation indicates that the projected cost savings from reduced HTN-related cardiovascular disease (CVD) events in the first year alone would substantially offset intervention costs. More extensive simulations are needed to project the cost savings and quality adjusted life-years from reduced CVD that would accumulate beyond the first year (including long-term care savings from prevented strokes, etc), particularly if the modest reductions in systolic BP observed in BARBER-1 could be sustained or augmented in this high-risk black male population.28;32;33

Despite these limitations, the study establishes an important precedent for future quantitative evaluation research on this and other health promotion programs in barbershops. The results provide proof-of-concept for one effective barber-based intervention, which lowered systolic BP by ~8 mmHg from baseline—2.5 mmHg more than in the comparison group. Based on the observed intervention effect of an 8.8% greater improvement in HTN control rate, we estimate that 12 hypertensive black male patrons would need to be exposed to this intervention to achieve BP control in one more patron.

The study addresses the newly recommended policy shift from traditional case-management to develop novel population-based systems and community-based support for persons with HTN.34 The data add to an emerging literature on the effectiveness of community health workers in the care of people with HTN,35 as contemporary barbers constitute a unique workforce of community health workers whose historical predecessors were barber-surgeons.36 Future studies should evaluate the potential effectiveness of the intervention in other urban centers, alternative incentive structures, comparative effectiveness of the intervention with and without certain components (e.g., model stories), and project long-term cost-effectiveness of alternative strategies (e.g., targeting barbershops with a mainly older clientele to enhance screening efficiency and prevent more HTN-related events). The public health potential is intriguing.

Supplementary Material

On-line material

Acknowledgments

Funding Support: BARBER-1 study was supported by research grants to Dr. Victor from the National Heart Lung and Blood Institute (RO-1 HL080582), the Donald W. Reynolds Foundation, the Aetna Foundation Regional Healthy Disparity Program, Pfizer, and an educational grant to Dr. Victor from Biovail. Dr. Victor was supported by the Norman and Audrey Kaplan Chair in Hypertension at UT Southwestern, and is currently supported by the Burns and Allen Chair in Cardiology Research at the Cedars-Sinai Heart Institute and by a research grant from The Lincy Foundation. Dr. Ravenell is supported by a Harold Amos Award from the Robert Wood Johnson Foundation.

Footnotes

Role of the Sponsors: The design and conduct of the study, collection, management, analysis, and interpretation of data, and preparation, review, and approval of the manuscript were conducted completely independently of the sponsors.

Additional Contributions: We thank Martin Shapiro, MD, Professor and Chief of General Internal Medicine and Professor of Medicine in the Department of Health Services at the David Geffen School of Medicine at UCLA, who was not financially compensated for helpful comments and suggestions on critical revision of the manuscript.

Author Contributions: Dr. Victor had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Victor, Haley, Freeman, Bhat, Knowles

Acquisition of data: Victor, Ravenell, Storm, Shafiq

Analysis and interpretation of data: Victor, Leonard, Bhat, Haley, Ravenell, Hannan, Adhikari, Coxson, Pletcher, Bibbins-Domingo

Drafting of the manuscript: Victor, Storm, Knowles, Shafiq, Adhikari, Bhat

Critical revision of the manuscript: Victor, Haley, Bhat, Leonard, Ravenell, Hannan, Freeman, Adhikari, Storm, Coxson, Pletcher, Bibbins-Domingo

Statistical expertise: Leonard, Bhat, Haley, Hannan

Obtained funding: Victor, Freeman

Administrative, technical, or material support: Knowles, Adhikari, Shafiq, Ravenell, Storm

Study supervision: Victor, Freeman

Other contributions: Coxson, Pletcher, Bibbins-Domingo (cost-effectiveness modeling and analysis)

Financial Disclosures: Dr. Victor reported being on the speaker's Bureau for Pfizer, Inc. and receiving an investigator initiated research grant from Pfizer and an unrestricted educational grant from Biovail. None of the other authors reported financial disclosures.

Publisher's Disclaimer: Disclaimer: The results and conclusions are those of the authors, and should not be attributed to any of the funding agencies.

Additional Information: eFigures 1-4 and eTables 1-4 are available at http://www.archinternmed.com

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