Finley 2003b.

Methods	Design: RCT, parallel design Country: USA Setting: Kaiser Permanente Medical Center, San Rafael, CA, US
Participants	Inclusion criteria: people referred by their PCP immediately after starting AD therapy for the expressed purpose of treating depressive symptoms. Exclusion criteria: evidence that participants had received an AD during the preceding 6 months; concurrent psychiatric or psychological treatment; current symptoms of mania or bipolar disorder; psychotic symptoms; eminent suicidality; and active substance abuse or dependence. Mean age (years): intervention group: 54.4 (SD 14.1); control group: 54.1 (SD 17.3) Sex: 106 women; 19 men Severity of depression: mean score using BIDS: intervention group: 18.7 (SD 5.8); control group: 18.3 (SD 5.8) AD use status: participants were required to not have received an AD during the preceding 6 months. Comorbidities: chronic disease score, mean: intervention group: 606.5 (SD 363.8); control group: 664.3 (SD 428.4)
Interventions	Sample size (total): 125 Length of trial: 6 months Intervention: collaborative care treatment – remotely delivered intervention that involved care managers, clinical pharmacists, and psychiatrists. Medical, psychiatric, and drug therapy histories were taken. Patient education was delivered involving discussion on symptoms, aetiology, prognosis of depression, and detailed description of ADs' therapeutic and adverse effects provided. Clinical pharmacists were permitted to titrate doses in line with practice and prescribing guidelines; pharmacists could prescribe ancillary drugs (e.g. for insomnia), but PCP approval was needed to change AD medication. Pharmacists made telephone calls to participants on weeks 1, 2, 4, 10, and 16 to assess drug adherence, therapeutic effects, adverse effects, and other social/medical factors. Pharmacists were trained to detect activities that participants neglected during their illness and provided encouragement to resume these activities. Pharmacists also provided brief clinic visits on weeks 6 and 24 to assess clinical progress face‐to‐face. A psychiatrist provided supervision and mentoring to the pharmacists approximately 1 hour per week, and was available for consultation with the pharmacists during clinic hours, n = 75. Control: usual care – involved brief counselling on the prescribed drug, therapeutic endpoints, and adverse effects in a manner consistent with patient education routinely delivered to members receiving prescriptions from the outpatient pharmacy, n = 50.
Outcomes	Adherence (measured by computerised prescription refill records on an ITT basis); clinical and functional severity (using BIDS, patient‐rated survey ranking symptoms on a per‐protocol basis); resource utilisation (measured by change in all clinic visits between the 12 months preceding randomisation and the 12 months immediately after; work and social functioning. Acceptability (as measured by number of participants failing to return surveys at follow‐up at 6 months). Depression remission (score < 9 using BIDS) on a per‐protocol basis. Outcomes not used: patient satisfaction (not prespecified in our protocol); service utilisation (only reported by percentage increase, not usable data).
Notes	Sponsorship source: funded in part by a grant from the Sidney Garfield Memorial Fund (as part of the Interregional Depression Initiative) and by an unrestricted educational grant from Pfizer Inc., New York, NY. Trial registration identifier: not specified Date of recruitment: not specified Declarations of interest from primary researchers: none stated Correspondence: contacted authors to clarify their methods, who provided further details as to data collection and potential sources of bias (this has been included in the risk of bias assessment).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "subjects were randomly assigned to the collaborative care model or back to usual care in a 3:2 ratio" (p. 1177).
Allocation concealment (selection bias)	Low risk	Quote: "After the patients completed a brief survey to assess baseline depression severity (Brief Inventory for Depressive Symptoms [BIDS]) and functional impairment (Work and Social Disability Scale [WSDS]), the investigators opened a sealed envelope that determined study group assignment (intervention vs usual care)" (p. 1177).
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "the study was not double‐blinded (i.e., subjects and providers were presumably aware of study group assignments after randomization)" (p. 1183). Comment: due to the nature of the intervention, it was unclear how this may have effected any results.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	See above.
Incomplete outcome data (attrition bias) All outcomes	High risk	Many surveys on outcomes not returned, with more than half not accounted for in the control group on depression symptoms using BIDS and the Work and Social Disability Scale. ITT used for the outcome of adherence only. See author correspondence below on missing data.
Selective reporting (reporting bias)	Low risk	None detected.
Other bias	High risk	Quote: "Our primary outcome was Medication Adherence. While we did plan on looking at clinical outcomes... there were comparatively few surveys returned by the control group and the subjects who did return their survey from this cohort appeared to be those who were doing well. In other words, there was a substantial selection bias at work here, rendering any comparison of these clinical outcomes meaningless." – from P. Finley, email communication, 5 March 2019.