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Table 1 Characteristics of randomized controlled trials in 2009 United States Preventive Services Task Force and Cochrane systematic reviews

From: There are no randomized controlled trials that support the United States Preventive Services Task Force guideline on screening for depression in primary care: a systematic review

First author, year, country Included in 2009 USPSTF, Cochrane, or both reviews or updated search Number of patients randomized Eligibility and randomization Determined eligibility and randomized of patients analyzed prior to screening? Diagnostic/treatment status Excluded already diagnosed and already treated patients? Depression management Similar depression management options for screened and unscreened trial arms?
Callahan 1994, US [19] Both 175 Patients with CES-D ≥ 16 and HAMD ≥ 15 eligible and randomized to enhanced depression care versus usual care. No 21% of enrolled patients already diagnosed and 12% already on antidepressant (overlap not specified). No Intervention arm: enhanced depression care. No
Control arm: usual care.
Dowrick 1995, UK [23, 26] Cochrane + 2002 USPSTFa 116 Patients with BDI ≥14 eligible and randomized to have their BDI scores and diagnostic interpretation disclosed to their physician or not disclosed. No Patients excluded if their physicians believed they were currently depressed, but already diagnosed and already treated patients not necessarily excluded.b No Both groups received usual care. Yes
Lewis 1996, UK [24] Cochrane + 2002 USPSTFc 454d Patients with GHQ-12 ≥2 eligible and randomized to have their GHQ-12 scores placed in their physician’s notes or not disclosed. No Existing depression diagnosis or treatment not in exclusion criteria. No information on depression diagnosis or treatment at time of enrollment provided. No Both groups received usual care. Yes
Williams 1999, US [20] Both 969e Patients randomized to screening with single mood question, with the CES-D, or to usual care. Depression outcomes only assessed for 97 patients with major depression at baseline and a sample of 119 other patients. Yese Only 11 of 41 diagnoses of depression post-screening were new diagnoses (27%). Patients classified as new diagnoses if no evidence of diagnosis in chart and patient reported that not diagnosed or treated in last 2 years.f No Both groups received usual care. Yes
Wells 2000, US [14, 27] USPSTF 1356 Patients with probable depressive disorder eligible and randomized to enhanced depression care versus usual care. No In 6 months prior to trial, 48% of patients discussed emotional issues at medical visit; 29% had specialty mental health visit; 44% getting appropriate mental health care. No Intervention arm: enhanced depression care. No
Control arm: usual care.
Whooley 2000, US [21] Both 2346g Patients randomized to screening with GDS and seven educational sessions versus usual care. Only 331 patients with GDS ≥6 at baseline included in depression outcome analysis. Yesg In 12 months prior to trial, 20% of patients in outcome analysis prescribed antidepressant medication. No Intervention arm: patients offered six weekly educational sessions on depression plus one booster session. No
Control arm: usual care.
Rost 2001, US [15, 28, 29] USPSTF 479 Patients with five or more symptoms of current MDD eligible. Practices randomized to enhanced depression care versus usual care. No In 6 months prior to trial, 44% of patients were prescribed antidepressant medication or had a specialty mental health care visit. No Intervention arm: enhanced depression care. No
Control arm: usual care.
Jarjoura 2004, US [16] USPSTF 61 Patients positive for depression on PRIME-MD eligible and randomized to nurse-supported depression management and referral program versus usual care. No Patients receiving intervention for mental health problems or seeking help for depression or other emotional problems excluded. Yes Intervention arm: nurse-supported depression management and referral program. No
Control arm: usual care.
Bergus 2005, US [22] Both 51 Patients with low mood or anhedonia in last two weeks based on PHQ-9 eligible and randomized to have their PHQ-9 scores disclosed to their physician or not disclosed. No 38% of enrolled patients on medication for depression or anxiety at time of enrollment and 60% had history of depression treatment. No Both groups received usual care. Yes
Bosmans 2006, The Netherlands [17] USPSTF 145 Patients with GDS ≥5 and positive for depression on PRIME-MD eligible and randomized to enhanced depression care versus usual care. No Patients using antidepressants at time of trial enrollment excluded. Yesh Intervention arm: enhanced depression care. No
Control arm: usual care.
Rubenstein 2007, US [18] USPSTF 792 Patients were randomized to practices in a Veterans Administration healthcare system that provided enhanced geriatric care versus usual care. Patients positive on ≥4 of 10 GPSS items related to falls/balance, urinary incontinence, depression, memory loss, pain, weight loss, polypharmacy and general health were eligible.i Nog Existing depression diagnosis or treatment not in exclusion criteria. No information on depression diagnosis or treatment at time of enrollment provided. No Intervention arm: enhanced geriatric care. No
Control arm: usual care.
Yeung 2010, US [30] Updated Search 100 Patients with confirmed MDD randomized to enhanced depression care versus usual care. No Patients already receiving treatment for MDD were excluded. Yes Intervention arm: enhanced depression care. No
Control arm: usual care.
Yawn 2012, US [31] Updated Search 2343j Primary care practices were randomized to a complex depression care intervention, including screening with EPSD and PHQ-9, versus usual care. Women 5 to 12 weeks postpartum were eligible. Only 408 patients with positive depression screen at baseline included in depression outcome analysis. Yesj Existing depression diagnosis or treatment not in exclusion criteria. No information on depression diagnosis or treatment at time of enrollment provided. No Intervention arm: enhanced depression care. No
Control arm: usual care.
Romera 2013, Spain [32] Updated Search 3737 Primary care physician practices were randomized to training on screening with 2 questions and usual depression care versus usual care. After 6 months, 3737 patients randomly selected for depression assessment. Yes Existing depression diagnosis or treatment not in exclusion criteria. No information on depression diagnosis or treatment at time of enrollment provided. No Both groups received usual care. Yes
  1. aDowrick et al. trial was included in the 2002 USPSTF review, but excluded from the 2009 USPSTF review with note, ‘Does not report included outcomes’. The exclusion note referenced only one of the published trial reports [23], which did not provide depression outcomes, but did not cite another published report [26] that did provide depression outcomes. bBased on published articles and clarification provided by corresponding author. cLewis et al. trial was included in the 2002 USPSTF review, but excluded from the 2009 USPSTF review with note, ‘Missing both depression-specific screener and depression-specific outcomes’. The GHQ-12 appears to have been considered a depression screening and depression outcome in the 2002 review, but not in the 2009 review. dThe trial included three arms with 227 in each arm. One arm, however, included screening with a short questionnaire and a 15- to 45-minute computerized diagnostic interview for depression. Consistent with the Cochrane review [7] and because the diagnostic interview is not screening, we evaluated only two trial arms. eEligibility was determined and randomization occurred pre-screening. However, only 216 of 969 patients randomized (23%) were assessed for depression outcomes. fBased on published article and clarification provided by corresponding author. gEligibility was determined and randomization occurred pre-screening. However, only 331 of 2,346 patients randomized (14%) were include in depression outcome analysis. hPatients receiving other forms of depression treatment were not excluded, but the number of patients receiving other forms of treatment was not reported. iScreening was done based on many problems faced by elderly patients. Only 46% of patients in the trial screened positive on a single item related to depression. jEligibility was determined and randomization occurred pre-screening. However, only 408 of 2,343 patients randomized (17%) were assessed for depression outcomes. BDI, Beck Depression Inventory; CES-D, Center for Epidemiological Studies Depression Scale; GDS, Geriatric Depression Scale; GHQ-12, General Health Questionnaire, 12-item version; GPSS, Geriatric Postal Screening Survey; HAMD, 21-item Hamilton Depression Rating Scale; MDD, major depressive disorder; PHQ-9; 9-item Patient Health Questionnaire; PRIME-MD, Primary Care Evaluation of Mental Disorders; USPSTF, United States Preventive Services Task Force.