Al‐Saffar 2005.

Methods	Design: RCT, parallel group Country: Kuwait Setting: hospital outpatient clinic
Participants	Inclusion criteria: people with a diagnosis of depressive or persistent mood affective disorder, aged ≥ 17 years; in receipt of a prescription for a single AD; fluent in Arabic; and willing to commit their time so that follow‐up questionnaires on treatment could be completed. Exclusion criteria: people with suicidal tendencies and those with a limited mental capacity, psychotic disorders, deafness, addiction, or organic brain disease. Age range (years): 17–70 Sex: 92 women; 186 men Severity of depression: as measured by HAMD‐17 subclinical: n = 22 (score 10–17); mild: n = 152 (score 18–25); moderate: n = 88 (score 26–38). AD use status: n = 207 'newly treated' participants (i.e. receiving a new prescription for AD medication, not taken within 1 month before entering the study); n = 71 receiving 'ongoing' treatment (i.e. had been taking the AD continuously for ≥ 1 month before entering the study). n = 163 prescribed TCAs for the trial; n = 115 prescribed SSRIs for the trial. Comorbidities: not detailed
Interventions	Sample size: n = 300 (total originally randomised); n = 22 withdrew after randomisation but before treatment began. Length of trial: 18 months Intervention: in‐person intervention (pharmacist counselling + participant information leaflet (PIL)). Counselling protocol: it was emphasised that the counselling was not intended to replace, but rather to strengthen, the advice previously given by the doctor. Quote: "The pharmacist wished: to make sure the patient knew why their medication had been prescribed; to make sure the patient understood how they were meant to take their medication; to give the patient an opportunity to talk freely about any concerns they might have about their illness or their medication." "The pharmacist then made the following observations: the depression was neither the patient's fault, nor was it a weakness of character but it would not go away of it [its] own accord; the patient needed to take the medication because they were suffering from an illness; the medication they had been prescribed would help their problem if they took it as directed and for a sufficient period of time." PIL sheet: using non‐medical terms the leaflet detailed: "why the medicine has been prescribed; how an antidepressant works; the time required for symptoms to improve; how long treatment should be continued to prevent relapse; why patients should not vary the dose of their own accord; what to do if a dose is missed; common side‐effects that might occur and how they should be managed; how medicine should be stored; when patients should inform their doctor of concurrent disease or medication. The content of the leaflets went through a quality assessment process to gauge suitability by 20 patients with participants and 20 health volunteers. The pharmacist would hold discussions with the participant specifically regarding: dosing regimen; individual patient concerns (e.g. their thoughts about taking the medication, concerns of adverse effects); storage of medication; when to report allergies and side effects to a doctor. For each patient, the mean length of the first counselling session was 17 (SD 3) minutes. No session lasted longer than 23 minute," n = 98. Active control (PIL only): participants received the same PIL as the intervention group, n = 93. Control: TAU. Members of the control group received advice from the dispensing pharmacist that merely reinforced the labelling instructions on the medication, n = 87.
Outcomes	Acceptability of intervention (defined as participants attending follow‐up clinics); non‐adherence to medication (defined as participants who took their tablets exactly as prescribed and whose 'tablet‐count ratio' was 80–100% inclusive on an ITT basis); any adverse event (as listed) at 2 and 5 months. Outcomes not used: participant knowledge of therapy (not an outcome defined in our protocol).
Notes	Sponsorship source: the study was funded by the Kuwait Foundation for the Advancement of Sciences (KFAS) and a postgraduate scholarship from the Government of the State of Kuwait. Trial registration identifier: not detailed; "protocol written in Arabic" (p. 124). Date of recruitment: not stated Declarations of interest from primary researchers: not stated Correspondence: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "recruited patients were randomised sequentially by day of recruitment into a control and two treatment groups" (p. 125).
Allocation concealment (selection bias)	Unclear risk	No details provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details provided.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details provided.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: after randomisation, "100 patients were allocated to the control group and to each of the intervention groups. Because of the time necessary to complete the attitudinal survey, 22 patients withdrew after this stage had been completed. There remained 87 patients in the control group, 93 in the 'leaflet‐only' group and 98 in the counselling plus patient information leaflet group" (p. 126). Comment: 22 who withdrew did not receive any intervention/control. Authors stated that not all participants provided data on outcome of adherence (p. 128, Table 3). Only 152 participants attending follow‐up provided adverse event data.
Selective reporting (reporting bias)	Unclear risk	Study reported outcomes at 2 and 5 months. Trial ran for 18 months. Unclear why longer‐term outcomes were not reported.
Other bias	Low risk	None detected.