5
Depressive Symptoms and Hospital Readmission in Older Adults Jennifer S. Albrecht, PhD, a,b Ann L. Gruber-Baldini, PhD, a Jon M. Hirshon, MD, MPH, PhD, a,c Clayton H. Brown, PhD, a,d Richard Goldberg, PhD, d,e Joseph H. Rosenberg, BS, a Angela C. Comer, MPH, a and Jon P. Furuno, PhD f OBJECTIVES: To quantify the risk of 30-day unplanned hospital readmission in adults aged 65 and older with depressive symptoms. DESIGN: Prospective cohort study. SETTING: University of Maryland Medical Center. PARTICIPANTS: Individuals aged 65 and older admitted between July 1, 2011, and August 9, 2012, to the general medical and surgical units and followed for 31 days after hospital discharge (N = 750). MEASUREMENTS: Primary exposure was depressive symptoms at admission, defined as a score of 6 or more on the 15-item Geriatric Depression Scale. Primary outcome was unplanned 30-day hospital readmission, defined as an unscheduled overnight stay at any inpatient facility not occurring in the emergency department. RESULTS: Prevalence of depressive symptoms was 19% and incidence of 30-day unplanned hospital readmission was 19%. Depressive symptoms were not significantly associated with hospital readmission (relative risk (RR) = 1.20, 95% confidence interval (CI) = 0.831.72). Age, Charlson Comorbidity Index score, and number of hospitalizations within the past 6 months were significant predictors of unplanned 30-day hospital readmission. CONCLUSION: Although not associated with hospital readmission, depressive symptoms were associated with other poor outcomes and may be underdiagnosed in hospitalized older adults. Hospitals interested in reducing readmission should focus on older adults with more co- morbid illness and recent hospitalizations. J Am Geriatr Soc 62:495–499, 2014. Key words: hospital readmission; depressive symptoms; older adults U nplanned hospital readmission has been targeted for quality improvement initiatives to reduce healthcare costs and improve outcomes. Previous research has sug- gested that 20% of Medicare beneficiaries are readmitted to the hospital within 30 days of discharge and that 34% are readmitted within 90 days. 1 Hospital readmissions are costly as well, accounting for $15 billion in Medicare spending in 2007. 2 The Medicare Payment Advisory Commission tied 30-day readmission rates to Medicare reimbursements in 2013 with three diagnoses-related groups initially targeted, but the number of targeted diagnoses groups will expand in 2014. 3 Interventions to reduce hospital readmissions have been observed to be effective, but cost efficiency dictates that they be targeted toward individuals at highest risk of readmission. 46 Risk factors for readmission include older age, male sex, recent previous hospital admission, longer hospital stay, and greater comorbidity, 1,7,8 but these characteristics provide few targets for anything other than broad-based interventions. Depression may affect hospital readmissions in Medicare beneficiaries. 911 Research examining the effect of depressive symptoms on hospital readmission has found a positive association. 1216 Nonetheless, a focus on illnesses such as heart failure, age groups that included much youn- ger individuals (18), and variable readmission outcomes limits the generalizability of previous results to an older, more-general population that may be more consistent with current hospital initiatives to reduce readmissions. This article reports results from a prospective cohort study on the association between depressive symptoms at baseline and unplanned 30-day hospital readmission in individuals aged 65 and older. It was hypothesized that From the a Department of Epidemiology and Public Health, School of Medicine, University of Maryland, b Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, c Department of Emergency Medicine, School of Medicine, University of Maryland, d Veterans Affairs Capitol Healthcare Network, Mental Illness Research, Education, and Clinical Center, e Department of Psychiatry, School of Medicine, University of Maryland, Baltimore, Mayland; and f Department of Pharmacy Practice, College of Pharmacy, Oregon State University/Oregon Health & Science University, Portland, Oregon. Address correspondence to Jennifer S. Albrecht, PhD, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, 220 Arch Street, 12th floor, Room 01234, Baltimore, MD 21201. E-mail: [email protected] DOI: 10.1111/jgs.12686 JAGS 62:495–499, 2014 © 2014, Copyright the Authors Journal compilation © 2014, The American Geriatrics Society 0002-8614/14/$15.00

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Page 1: Depressive Symptoms and Hospital Readmission in Older Adults

Depressive Symptoms and Hospital Readmission in OlderAdults

Jennifer S. Albrecht, PhD,a,b Ann L. Gruber-Baldini, PhD,a Jon M. Hirshon, MD, MPH, PhD,a,c

Clayton H. Brown, PhD,a,d Richard Goldberg, PhD,d,e Joseph H. Rosenberg, BS,a

Angela C. Comer, MPH,a and Jon P. Furuno, PhDf

OBJECTIVES: To quantify the risk of 30-day unplannedhospital readmission in adults aged 65 and older withdepressive symptoms.

DESIGN: Prospective cohort study.

SETTING: University of Maryland Medical Center.

PARTICIPANTS: Individuals aged 65 and older admittedbetween July 1, 2011, and August 9, 2012, to the generalmedical and surgical units and followed for 31 days afterhospital discharge (N = 750).

MEASUREMENTS: Primary exposure was depressivesymptoms at admission, defined as a score of 6 or more onthe 15-item Geriatric Depression Scale. Primary outcomewas unplanned 30-day hospital readmission, defined as anunscheduled overnight stay at any inpatient facility notoccurring in the emergency department.

RESULTS: Prevalence of depressive symptoms was 19%and incidence of 30-day unplanned hospital readmissionwas 19%. Depressive symptoms were not significantlyassociated with hospital readmission (relative risk(RR) = 1.20, 95% confidence interval (CI) = 0.83–1.72).Age, Charlson Comorbidity Index score, and number ofhospitalizations within the past 6 months were significantpredictors of unplanned 30-day hospital readmission.

CONCLUSION: Although not associated with hospitalreadmission, depressive symptoms were associated withother poor outcomes and may be underdiagnosed inhospitalized older adults. Hospitals interested in reducing

readmission should focus on older adults with more co-morbid illness and recent hospitalizations. J Am GeriatrSoc 62:495–499, 2014.

Key words: hospital readmission; depressive symptoms;older adults

Unplanned hospital readmission has been targeted forquality improvement initiatives to reduce healthcare

costs and improve outcomes. Previous research has sug-gested that 20% of Medicare beneficiaries are readmittedto the hospital within 30 days of discharge and that 34%are readmitted within 90 days.1 Hospital readmissions arecostly as well, accounting for $15 billion in Medicarespending in 2007.2 The Medicare Payment AdvisoryCommission tied 30-day readmission rates to Medicarereimbursements in 2013 with three diagnoses-relatedgroups initially targeted, but the number of targeteddiagnoses groups will expand in 2014.3

Interventions to reduce hospital readmissions havebeen observed to be effective, but cost efficiency dictatesthat they be targeted toward individuals at highest risk ofreadmission.4–6 Risk factors for readmission include olderage, male sex, recent previous hospital admission, longerhospital stay, and greater comorbidity,1,7,8 but thesecharacteristics provide few targets for anything other thanbroad-based interventions.

Depression may affect hospital readmissions inMedicare beneficiaries.9–11 Research examining the effectof depressive symptoms on hospital readmission has founda positive association.12–16 Nonetheless, a focus on illnessessuch as heart failure, age groups that included much youn-ger individuals (≥18), and variable readmission outcomeslimits the generalizability of previous results to an older,more-general population that may be more consistent withcurrent hospital initiatives to reduce readmissions.

This article reports results from a prospective cohortstudy on the association between depressive symptoms atbaseline and unplanned 30-day hospital readmission inindividuals aged 65 and older. It was hypothesized that

From the aDepartment of Epidemiology and Public Health, School ofMedicine, University of Maryland, bDepartment of Pharmaceutical HealthServices Research, School of Pharmacy, University of Maryland,cDepartment of Emergency Medicine, School of Medicine, University ofMaryland, dVeterans Affairs Capitol Healthcare Network, Mental IllnessResearch, Education, and Clinical Center, eDepartment of Psychiatry,School of Medicine, University of Maryland, Baltimore, Mayland; andfDepartment of Pharmacy Practice, College of Pharmacy, Oregon StateUniversity/Oregon Health & Science University, Portland, Oregon.

Address correspondence to Jennifer S. Albrecht, PhD, Department ofPharmaceutical Health Services Research, University of Maryland Schoolof Pharmacy, 220 Arch Street, 12th floor, Room 01–234, Baltimore, MD21201. E-mail: [email protected]

DOI: 10.1111/jgs.12686

JAGS 62:495–499, 2014

© 2014, Copyright the Authors

Journal compilation © 2014, The American Geriatrics Society 0002-8614/14/$15.00

Page 2: Depressive Symptoms and Hospital Readmission in Older Adults

depressive symptoms would be associated with greater riskof 30-day hospital readmission. If this is the case, screen-ing for and treating depression in this population mayprovide an additional means of reducing hospital readmis-sion, as well as furnishing a target population for currentinitiatives.

METHODS

Study Design and Study Population

This was a prospective cohort study of adults aged 65 andolder admitted to the hospital. Study participants wereenrolled within 72 hours of admission. After hospitaldischarge, participants were followed up by telephone atthree time points (5, 15, and 31 days) after discharge toascertain deaths and unplanned readmission events.

The study population consisted of community-dwell-ing adults aged 65 and older admitted to the generalmedical and surgical services of the University of Mary-land Medical Center (UMMC), a 757-bed, tertiary-carehospital in Baltimore, Maryland, between July 1, 2011,and August 9, 2012. Individuals admitted to psychiatric,obstetrical, and intensive care units; residing in a nursinghome; unable to speak English; or with a Mini-MentalState Examination (MMSE) score of 15 less or wereexcluded.17 The institutional review board at the Univer-sity of Maryland Baltimore approved this study, and allparticipants provided written informed consent beforeparticipating.

Admission and discharge data on individuals meetingthe inclusion criteria were collected daily from the UMMCClinical Data Repository (CDR), a relational databaseincluding administrative, demographic, and outcome infor-mation.

Necessary sample size was calculated a priori basedupon the assumptions of 13% incidence of hospital read-mission, 20% prevalence of depressive symptoms, and10% loss to follow-up. The 13% incidence rate in adultsaged 65 and older was obtained from 5 years of data on30-day hospital readmission to UMMC from the CDR.Based on these assumptions, a sample size of 750 wouldallow 80% power to detect twice the risk of 30-dayunplanned readmission (relative risk = 2) in study partici-pants with depressive symptoms.

Measures

Study participants were administered a baseline question-naire. Prevalent clinically significant depressive symptoms,the primary exposure, were assessed using the 15-itemGeriatric Depression Scale (GDS-15) and defined as ascore of 6 or greater.18 This cut-point has been observedto have a sensitivity of 83% and a specificity of 69% todetect depression in elderly inpatients.19 Disabilities inactivities of daily living were assessed using the Katzscale (range 0–5, 5 indicating the highest level of disabil-ity); cognitive impairment using the 30-item MMSE;and social isolation using the 6-item Lubben Social Net-work Scale,17,18,20,21 which has been validated as a mea-sure of social isolation risk in community-dwellingadults. A score of <12 has been suggested to define

social isolation, which was used in this study.20 Demo-graphic information on race, sex, and education wasself-reported.

In addition to the questionnaire, data on admissionand discharge diagnoses (including the primary diagnosisand up to 15 comorbid medical conditions), number ofmedications prescribed at discharge, discharge instructions,and readmissions to UMMC were collected from partici-pants’ medical charts. Data on Charlson ComorbidityIndex score, a measure of aggregate comorbidity, andmedications prescribed at discharge were collected fromthe CDR.22

Disease categories were created based on participantdischarge diagnosis International Classification of Diseases,Ninth Revision codes.23,24 The following categories werecreated: cancer (140–208, 230–234), heart disease (391–392.0, 393–398, 402, 404, 410–416, 420–429), diseases ofthe digestive system (520–579), diseases of the musculoskel-etal system (710–739), and complications of surgical andmedical care (996–999). The remaining diagnoses weregrouped as “other.”

Study participants were contacted over the telephone 5,15, and 31 days after discharge from the index hospitaladmission to determine the incidence of 30-day unplannedhospital readmission. During these telephone calls, datawere collected on any hospital readmissions that occurredafter discharge, including date, place, reason for readmis-sion, and whether the readmission was planned orunplanned. An unplanned hospital readmission was definedas an overnight stay at any inpatient facility that didnot occur in the emergency department and was not previ-ously scheduled. If the participant was unavailable at thefollow-up call, outcome information was obtained fromthe contact person that the participant had indicated atenrollment.

Data Analysis

The primary exposure (clinically significant depressivesymptoms) and outcome (unplanned 30-day hospitalreadmission) were treated as dichotomous variables.Association between the exposure and outcome variablesand covariates was examined using chi-square tests fordichotomous covariates and Student t-tests for normallydistributed continuous covariates to assess potential con-founding. The Wilcoxon rank sum test was used to assessassociations between nonnormally distributed variables.Statistical significance was defined as P < .05. Covariatesthat were significantly associated with the exposure andthe outcome and covariates known to be associated witheither from the literature were considered for inclusion inthe regression model.

A log-binomial regression model was used to estimatethe relative risk of 30-day unplanned hospital readmissionin the study population. The primary log-binomial regres-sion model contained an indicator variable for prevalentdepressive symptoms and modeled the log relative risk of30-day unplanned hospital readmission. Effect modifiersidentified using the Breslow-Day test (with P ≤ .05) andtheir main effects were also examined in the model. Alldata analysis was performed using SAS version 9.2 (SASInstitute, Inc., Cary, NC).

496 ALBRECHT ET AL. MARCH 2014–VOL. 62, NO. 3 JAGS

Page 3: Depressive Symptoms and Hospital Readmission in Older Adults

RESULTS

During the study period, 3,699 participants aged 65 andolder were admitted to the general medical and surgicalunits at UMMC; 146 of these (4%) were not competent toparticipate, and 61 (2%) did not speak English. Of theremaining 3,492, 750 (21%) were enrolled in the study.Reasons for nonparticipation included refusal (21%);already discharged from hospital (16%); already partici-pating in study (6%); and inaccessibility of the participantbecause of procedures, therapy, or sleep (25%). Individu-als who enrolled in the study were slightly younger, with amean age � standard deviation of 73.2 � 6.5 (vs73.9 � 6.9, P = .01), and more likely to be Caucasian(70% vs 60%, P < .001). Participants did not differ fromnonparticipants according to sex (49% vs 52% female,P = .08) or Charlson Comorbidity Index (2.5 � 2.3 vs2.6 � 2.4, P = .70).

Of the 750 participants enrolled in the study, 13(1.7%) died during their hospital stay, four (0.5%) with-drew from the study, and 17 (2.3%) were lost to follow-up at 31 days. This left 716 (95%) individuals for whomdata on the primary outcome were ascertained.

Mean age was 73.2 � 6.5, and mean MMSE scorewas 27.9 � 8.1 (Table 1). Length of hospital stay wasskewed, with a median of 4 days (interquartile range0–9 days). Nineteen percent of the sample had depressive

symptoms (mean GDS-15 score 3.2 � 2.8). The most-pre-valent discharge diagnosis was heart disease (20%). The“other” category comprised 35% of discharge diagnosesand included (as a percentage of “other”) chronic kidneydisease (17%), diseases of the respiratory system (11%),stroke or transient ischemic attack (7%), septicemia (3%),fracture (3%), diseases of the nervous system (3%), and“symptoms” (15%).

One hundred forty-two (19%) study participantsexperienced an unplanned 30-day hospital readmission; 68of these (48%) were readmitted to UMMC. Prevalentreadmission diagnoses were heart failure (13%), complica-tions (13%), “symptoms” (13%), and digestive problems(6%). Myocardial infarction and respiratory problemsaccounted for 3% and 2% of readmission diagnoses,respectively. Thirty-five percent of readmission diagnosesfell into the “other” category.

Participants with depressive symptoms had greaterbaseline morbidity than those without. Differences in self-rated health of good or better (30% vs 65%, P < .001),one or more ADL disabilities (31% vs 16%, P < .001),two or more hospital admissions in the past 6 months(36% vs 22%, P < .001), two or more falls in the last6 months (25% vs 12%, P < .001), number of medica-tions prescribed at discharge (11.2 vs 10.0, P = .01), andmean Charlson Comorbidity Index score (3.1 vs 2.4,P = .004) reflected this. A doctor had previously told 48%

Table 1. Characteristics of the Study Population of Hospitalized Individuals at University of Maryland MedicalCenter, 2011–2012 According to Depressive Symptom Status

Characteristic

Total,

N = 750

Depressive Symptoms,

n = 140aNo Depressive

Symptoms, n = 610 P-Valueb

Age, mean � SD 73.2 � 6.5 72.8 � 6.5 73.4 � 6.6 .35Mini-Mental State Examination score,mean � SD (range 0–30)

27.7 � 2.4 27.0 � 2.7 27.8 � 2.4 .002

Length of stay, days, median (IQR) 4.0 (5.0) 4.0 (5.5) 4.0 (5.0) .20Female, n (%) 366 (49) 74 (53) 292 (48) .29White, n (%) 540 (72) 101 (72) 439 (72) .97Married, n (%) 433 (58) 72 (51) 361 (59) .09Self-rated health good or better, n (%) 439 (59) 41 (30) 398 (65) <.001≥1 activity of daily livingdisabilities in, n (%)

141 (19) 43 (31) 98 (16) <.001

≥High school education, n (%) 636 (85) 110 (79) 526 (86) .02≥2 hospital admissions inlast 6 months, n (%)

184 (25) 50 (36) 134 (22) <.001

≥2 falls in last 6 months, n (%) 108 (14) 35 (25) 73 (12) <.001Lives alone, n (%) 199 (27) 35 (25) 164 (27) .62Social isolation, n (%)c 89 (12) 34 (24) 55 (9) <.001Number of medications atdischarge, mean � SD

10.2 � 4.7 11.2 � 5.4 10.0 � 4.5 .01

Primary discharge diagnosis, n (%)Cancer 97 (13) 20 (14) 77 (13) .60Heart disease 151 (20) 27 (19) 124 (20) .78Diseases of the digestive system 93 (12) 17 (12) 76 (12) .92Complications of medical care 83 (11) 19 (14) 64 (10) .29Diseases of the musculoskeletal system 65 (9) 11 (8) 54 (9) .71Other 261 (35) 46 (33) 215 (35) .59Charlson Comorbidity Index,median (IQR) (range 0–37)

2.0 (3.0) 2.5 (3.5) 2.0 (2.0) .001

SD = Standard Deviation; IQR = Interquartile Range.aGeriatric Depression Scale-15 score ≥6.bChi-square for categorical variables, Student t-test for continuous variables, Wilcoxon for length of stay, and Charlson Comorbidity Index.cLubben Social Network Scale-6 score <12.

JAGS MARCH 2014–VOL. 62, NO. 3 DEPRESSION AND READMISSION IN OLDER ADULTS 497

Page 4: Depressive Symptoms and Hospital Readmission in Older Adults

of participants with depressive symptoms that they weredepressed.

Based on the bivariate analyses and previous research,the final regression model included terms for age, sex,Charlson Comorbidity Index, social isolation risk, hospitaladmissions in the past 6 months, and self-rated health.

In the adjusted model, an association between depres-sive symptoms and risk of hospital readmission wasobserved, although it did not achieve statistical significance(relative risk (RR) = 1.20, 95% confidence interval(CI) = 0.83–1.72) (Table 2). Age (3% increase in risk peryear of age), Charlson Comorbidity Index (7% increase inrisk for each point), and hospital admissions in the past6 months (53% increase in risk for ≥2) significantlypredicted 30-day unplanned hospital readmission.

DISCUSSION

Depressive symptoms were not significantly associatedwith risk of unplanned 30-day hospital readmission. Olderage, higher Charlson Comorbidity Index, and previoushospitalizations within the past 6 months were all associ-ated with a significantly greater risk of 30-day unplannedhospital readmission in adults aged 65 and older.

These results contrast with previous studies that havereported positive associations between depression and hos-pital readmission.12–16 There are a number of possibleexplanations for this. Although the sample size was largerthan in most previous studies, the observed effect size(20% greater risk) was smaller than has been reported. Inaddition, this study focused on general medical and surgi-cal patients aged 65 and older and 30-day unplanned read-mission and used the GDS-15, a validated measure inhospitalized elderly adults, to measure depressive symp-toms.19 The more-stringent measures, ability to follow upwith participants readmitted to non-UMMC hospitals, anddefinition of 30-day unplanned hospitalization may haveaffected the size of the effect observed. Previous researchexamining the effect of depressive symptoms on hospitalreadmission has primarily focused on individuals with spe-cific illnesses such as heart failure, age groups thatincluded much younger individuals (≥18), and readmissionoutcomes that varied from 30 days to 1 year and mayhave included planned events.12–16 Furthermore, previousinstruments used to measure depressive symptoms haveincluded somatic measures, which can be confused with

symptoms of comorbid illness in older adults. This vari-ability in previous studies may have resulted in largereffect sizes than observed in this study. Finally, a recentsystematic review concluded that readmission risk predic-tion models generally perform poorly because of the multi-factorial nature of hospital readmission.25 Depressivesymptoms may interact with facility- and individual-levelcharacteristics not found in this study to affect risk.

This study was powered at 80% to detect a doublingof the risk of 30-day unplanned hospital readmission inindividuals with depression based on a sample size of 750and the assumptions described in the methods, but theobserved association suggests a smaller population effectthan assumed in the sample size calculations, leading to aloss of statistical power. Nevertheless, the outcome wasassessed in more than 97% of study participants, and anincidence of 30-day unplanned hospital readmission con-sistent with that reported in a national study of Medicareenrollees was observed, lending validity to the results.1

Individuals with greater depressive symptoms mayhave been less likely to enroll in the study. Nonetheless,the reported prevalence of depressive symptoms (19%) isconsistent with prior research in older hospitalized popula-tions (range 14–25%).26,27 Individuals with a MMSE score<15 and those residing in nursing homes were not eligibleto participate in this study, although it was not thoughtthat these exclusions greatly affect generalizability becausenursing home residents represent only a small percentageof hospitalized older adults, and cognitive impairment hasnot been reported to be a risk factor for hospital readmis-sion.

This single-site study reports incidence of 30-dayunplanned hospital readmission and prevalence of depressivesymptoms consistent with national samples, helping to sup-port its generalizability.1,26,27 Furthermore, this study con-firmed previously observed associations between unplanned30-day hospital readmission and older age, greater comor-bidity, and prior hospital admissions.1,7,8,13,28–30 Only 48%of readmissions were to the index facility. This may haveled to an underestimation of 30-day hospital readmissionrates in the sample size calculations and has implicationsfor institutions attempting to reduce readmissions.

In this large prospective cohort study, a 20% increasein the risk of 30-day unplanned hospital readmission inadults aged 65 and older with depressive symptoms wasobserved but was not statistically significant. Hospitalsinterested in effectively using limited funds to reducehospital readmission in older adults should focus on olderadults with a greater burden of comorbid illness and priorhospital admissions. Nonetheless, the low prevalenceof doctor-recognized depression in people exhibitingdepressive symptoms presents an opportunity for a publichealth intervention to increase screening for depression inolder adults. Further research is needed to determine thecost effectiveness of screening for depression and the effi-cacy of interventions to reduce hospital readmission in thispopulation.

ACKNOWLEDGMENTS

Conflict of Interest: The authors declare no conflicts ofinterest.

Table 2. Risk of 30-Day Unplanned Hospital Readmis-sion (N = 716)

Characteristic

Unadjusted Adjusted

Relative Risk (95% Confidence

Interval)

Depressive symptoms 1.31 (0.93–1.84) 1.20 (0.83–1.72)Age, per year 1.03 (1.00–1.05)Female 0.88 (0.65–1.18)Charlson Comorbidity Index 1.07 (1.01–1.14)≥2 admissions in last 6 months 1.53 (1.12–2.09)Self-rated health good or better 0.90 (0.65–1.24)Social isolation 0.72 (0.43–1.21)

498 ALBRECHT ET AL. MARCH 2014–VOL. 62, NO. 3 JAGS

Page 5: Depressive Symptoms and Hospital Readmission in Older Adults

This work was supported by Agency for HealthcareResearch and Quality (AHRQ) Grant R36HS021068–01(JSA); National Institutes of Health GrantsT32AG000262–14 (JSA), K01AI071015–05 (JPF); andNational Heart, Lung, and Blood Institute Grant R01HL085706 (ALG-B).

Author Contributions: Albrecht: study concept anddesign, acquisition of subjects and data, analysis and inter-pretation of data, preparation of manuscript. Gruber-Baldini,Hirshon, Goldberg, Furuno: study concept and design, inter-pretation of data, preparation of manuscript. Brown: studyconcept and design, analysis and interpretation of data,preparation of manuscript. Rosenberg, Comer: studyconcept and design, acquisition of subjects and data, prep-aration of manuscript.

Sponsor’s Role: The AHRQ had no direct role in thedesign, methods, subject recruitment, data collections,analysis, or preparation of manuscript. No other sponsorshad a direct role in design, methods, subject recruitment,data collections, analysis, or preparation of manuscript.

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