Brook 2003.
Methods | Randomised trial | |
Participants | Patients with depression: 135 (intervention 64; control 71)
Health professional (delivering intervention): 19
Practice: not clear Community pharmacy The Netherlands Year of study: April 2000 to April 2001. |
|
Interventions | Pharmacist coaching patients and take‐home video, vs usual care Length of the intervention: not clear Number of interventions: 3 during 6 months | |
Outcomes | Disease control assessed by self‐rating 90‐item (Hopkins) Symptom Checklist (SCL‐90) | |
Notes | Required 75 patients in arm to detect 13% difference in depression at significance level of 0.05. No useable quantitative data. Funding source: Organon unconditionally sponsors International Health Foundation. The study received an unconditional grant from GlaxoSmithKline Conflict of interest: The study was carried out without interference of either of the companies. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation occurred at patient level and with a 1:1 ratio, using block randomisation to ensure equal numbers of intervention and control patients by pharmacy. |
Allocation concealment (selection bias) | Low risk | Randomisation used "block randomization". The whole sample was randomised before delivery to the pharmacies. These forms were precoded and delivered in sealed envelopes. |
Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | High risk | Quote: "Neither patients, nor pharmacists were blinded for group assignment" Unclear if this influenced intervention. Same pharmacists delivered both arms, therefore potential for contamination |
Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | High risk | Subjective outcome in an unblinded trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Between group attrition < 10%. |
Selective reporting (reporting bias) | Low risk | 1 outcome, appropriately reported |
Other bias | Low risk | None |