Table 3 Characteristics of randomized controlled trials described in CTFPHC, UKNSC, and USPSTF guidelines
Condition/guideline | First author Year Country | Number of patients randomized | Eligibility and randomization | Determined eligibility and randomized patients prior to screening? | Diagnostic/treatment status | Excluded already diagnosed and already treated patients? | Management | Similar management options for screened and unscreened trial arms? |
|---|---|---|---|---|---|---|---|---|
Alcohol Misuse | ||||||||
UKNSC | Fleming 1997 USA [20] | 774 | Adult primary care practice patients who screened positive for problem drinking (men > 14 drinks per week, women > 11 drinks per week) were eligible and randomized | No | Patients with alcohol treatment program in the previous year or advice from physician to change alcohol use in previous 3 months were excluded | Yes | Intervention arm: general health booklet, 15-minute brief intervention and reinforcement session 1 month later; Control arm: general health booklet only | No |
Wutzke 2002 Australia [21] | 554 | Adult general practice patients who screened positive for problem drinking (men ≥ 300 g weekly, women ≥ 180 g weekly; two or more episodes of intoxication a month; or experiencing alcohol-related harm in the previous 6 months) were eligible and randomized | No | Patients with a history of hospital admission for an alcohol-related disorder or who had received advice from a health professional to abstain from alcohol were excluded | Yes | Intervention arm 1: 5 minutes of brief advice and a leaflet plus 15 minutes of counseling Intervention arm 2: 15 minutes of counseling with 2 additional counseling sessions; Control arm: 5 minutes of brief advice and a leaflet | No | |
Crawford 2004 UK [22] | 599 | Adult emergency department patients who screened positive for alcohol misuse (men > 8 units of alcohol in any one session at least once a week, women > 6 units of alcohol in any one session at least once a week; patient believed their attendance in the emergency department could be related to alcohol) were eligible and randomized | No | Patients already in contact with alcohol services or who requested help with alcohol problems were excluded | Yes | Intervention arm: patients given an informational leaflet and offered a follow-up appointment with an alcohol health worker; Control arm: informational leaflet only | No | |
Beich 2007 Denmark [23] | 906 | Adult primary care patients who screened positive on the AUDIT (score > 8 and < 21) with a maximum weekly consumption of 35 drinks were eligible and randomized | No | Patients receiving treatment for an alcohol use disorder at the time of enrollment were excluded | Yes | Intervention arm: patients offered feedback on present drinking, advice on reducing drinking, a self-help booklet, and an invitation for follow-up consultation; Control arm: no intervention received | No | |
Depression | ||||||||
USPSTF | Callahan 1994 USA [24] | 175 | Adult primary care patients with CES-D ≥ 16 and HAMD ≥ 15 were eligible and randomized | No | 21% of enrolled patients already diagnosed and 12% already on antidepressants (overlap not specified) | No | Intervention arm: enhanced depression care; Control arm: usual care | No |
Williams 1999 USA [13] | 969a | Adult medical patients eligible and randomized to (1) screening with single mood question, (2) screening with the CES-D, or (3) usual care; depression outcomes only assessed for 97 patients with major depression at baseline and a random sample of 119 other patients | Yesa | Only 11 of 41 physician diagnoses of depression 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 yearsb | No | Both groups received usual care | Yes | |
Wells 2004 USA [25] | 1356 | Primary care clinics randomized; adult patients with probable depressive disorder were eligible | No | In the 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; Control arm: usual care | No | |
Whooley 2000 USA [32] | 2346c | Primary care patients ≥ 65 years were eligible and randomized to screening with GDS and seven educational sessions versus usual care; only 331 patients with GDS ≥ 6 at baseline were included in depression outcome analysis | Yesc | In the 12 months prior to trial, 20% of patients in outcome analysis prescribed antidepressant medication | No | Intervention arm: patients offered 6 weekly educational sessions on depression plus 1 booster session; Control arm: usual care | No | |
Rost 2001 USA [26] | 479 | Primary care practices randomized; adult patients with five or more symptoms of current major depressive disorder were eligible | No | In the 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; Control arm: usual care | No | |
MacArthur 2002 UK [33] | 2064 | Midwife practices randomized; women receiving postnatal care in participating midwife practices were eligible Midwives used a symptom checklist and the EPDS to inform care plans and visit scheduling in intervention group, but not for screening | Yes | Existing depression diagnosis or treatment not in exclusion criteria; no information on depression diagnosis or treatment provided at time of enrollment | No | Intervention arm: multifaceted care enhancement, including training of midwives to implement new model of care and use of symptom checklist; Control arm: usual care | No | |
Jarjoura 2004 USA [27] | 61 | Adult internal medicine patients positive for depression on PRIME-MD were eligible and randomized | No | Patients receiving intervention for mental health problems or seeking help for depression or other emotional problems were excluded | Yes | Intervention arm: nurse-supported depression management and referral program; Control arm: usual care | No | |
Bergus 2005 USA [31] | 51 | Adult family practice patients with low mood or anhedonia in last 2 weeks based on PHQ-9 were eligible and randomized to have their PHQ-9 scores disclosed or not to their physician | No | 38% of enrolled patients on medication for depression or anxiety at time of enrollment and 60% had a history of depression treatment | No | Both groups received usual care | Yes | |
145 | General practices randomized; patients with GDS ≥ 5 and positive for depression on PRIME-MD were eligible | No | Patients using antidepressants at time of trial enrollment were excluded | Yes | Intervention arm: enhanced depression care; Control arm: usual care | No | ||
Morrell 2009 UK [34] | 4084 | General practices randomized; only women with EPDS ≥ 12 at 6 weeks postpartum were included in outcome analyses | Yesd | Excluded women with severe mental health problems, but existing depression diagnosis or treatment not part of exclusion criteria; no information on depression diagnosis or treatment provided at time of enrollment | No | Intervention arm: home visits from health visitors with training in psychological approaches, along with screening and psychological interventions; Control arm: usual care | No | |
Leung 2011 Hong Kong [14] | 462 | Women attending maternal and child health centers for routine child health services were eligible and randomized to screening with the EPDS versus usual care | Yes | Patients receiving psychiatric treatment were excluded | Yes | Both groups eligible to receive nurse counseling or a community psychiatry referral | Yes | |
van der Weele 2012 Netherlands [30] | 239 | Primary care practices randomized; patients ≥ 75 years with GDS-15 scores ≥ 5 were eligible | No | Patients receiving treatment for depression at the time of enrollment were excluded | Yes | Intervention arm: stepped-care consisting of individual counseling, coping with depression course, and possible referral to general practitioner to discuss further treatment; Control arm: usual care | No | |
Yawn 2012 USA [35] | 2343d | Primary care practices were randomized to a complex depression care intervention, including screening with EPDS and PHQ-9, versus usual care; women 5 to 12 weeks postpartum were eligible; only 408 patients with positive depression screen at baseline were included in depression outcome analysis | Yese | Existing depression diagnosis or treatment not in exclusion criteria; no information on depression diagnosis or treatment provided at time of enrollment | No | Intervention arm: enhanced depression care; Control arm: usual care | No | |
Developmental Delay (CTFPHC) and Speech and Language Delay (USPSTF) | ||||||||
CTFPHC | Guevara 2013 USA [15] | 2103 | Pediatric patients < 30 months old, > 36 weeks’ estimated gestational age, with no major congenital anomalies or genetic syndromes, not in home foster care, and not currently receiving early intervention services were eligible and randomized to (1) screening with office assistance, (2) screening without office assistance, or (3) standard developmental surveillance without screening | Yes | Children receiving early intervention at the time of enrollment were excluded | Yes | Both groups eligible for referrals to early intervention services | Yes |
CTFPHC USPSTF | 10,355 | Child healthcare physicians randomized to screening with the VTO Language Screening Instrument versus standard developmental surveillance without screening; children aged 15 to 18 months were eligible | Yes | Existing developmental delay diagnosis or treatment not in exclusion criteria; no information on developmental delay diagnosis or treatment provided at time of enrollment | No | Both groups eligible for standard speech and language assessments and early intervention | Yes | |
Domestic Violence (UKNSC) and Intimate Partner Violence (USPSTF) | ||||||||
UKNSC USPSTF | MacMillan 2009 Canada [18] | 6743 | Female primary care, emergency department, or obstetrics/gynecology patients who had a male partner at some point in the last 12 months were eligible and randomized to be screened with the WAST versus usual care | Yes | Already receiving treatment or help for domestic violence not in exclusion criteria; no information provided on how many women were receiving help for partner violence at time of enrollment | No | Both groups eligible to receive an information card with contact details for locally available resources for women exposed to violence | Yes |
UKNSC | Klevens 2012 USA [36] | 2708 | Female primary care patients eligible and randomized to (1) screening with the Partner Violence Screen instrument, (2) no screening (all receive a partner violence resource list), or (3) no screening (no list) | Yes | Already receiving treatment or help for domestic violence not in exclusion criteria; no information provided on how many women were receiving help for partner violence at time of enrollment | No | Intervention arm 1: women with positive screens receive informational video about hospital-based partner advocacy program, plus a partner violence resources list and a general resource list; Women with negative screen receive general resources list only; Intervention arm 2: partner violence resource list and general resource list to all women; Control arm: general resource list only to all women | No |
Suicide Risk | ||||||||
USPSTF | Crawford 2011 UK [19] | 443 | Adult primary care patients with signs of depression (“yes” to two-item screener) were eligible and randomized to be screened or not for suicide risk | Yes | Already receiving treatment or help for suicide risk not in exclusion criteria; no information provided on how many patients receiving treatment at time of enrollment | No | Intervention arm: patients with positive screens encouraged to use resources already available to them; Control arm: not described, but assumed to be same usual care as in intervention arm | Yes |