Fritsch 2007.
| Study characteristics | ||
| Methods |
Study design: RCT Duration of study: 6 months |
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| Participants |
Country: Chile Income classification: upper‐middle income Geographical scope: urban (Santiago) Healthcare setting: 5 PHC clinics Mental health condition: major depression Population 1. Age: 18 to 70 years 2. Gender: female 3. Socioeconomic background: about 30% employed, 8% unemployed, 5% student 4. Inclusion criteria a. As above, with depression for 3 months (screening with GHQ‐12 (≥ 5) twice, 2 weeks apart) b. At least 1 child aged 6 to 16 living with her Exclusion criteria a. Abuse/dependence on alcohol or drugs b. Bipolar disorder c. Psychotic symptoms (present or past) d. Suicidal ideation e. Pregnancy f. Physical or mental disabilities that would hamper participation in the study |
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| Interventions |
Stated purpose: to compare monitored pharmacotherapy intervention with current treatment in PC INTERVENTION (n = 143) Name: Monitored Pharmacotherapy Delivered by: PHP and LHWs Title/name of PW and number: 5 generalist doctors/GPs (1 per practice) and non‐professional trained staff from 5 clinics 1. Selection: based on practice selection 2. Educational background: qualified doctors 3. Training: for doctors: 6 hours of training by principal investigators; for non‐professional trained staff: 2 hours 4. Supervision: doctors had permanent monitoring by principal investigators. In addition, doctors participated in monthly meetings with a psychiatrist to discuss cases 5. Incentives/remuneration: not specified Intervention details 1. Duration/frequency: regular visits to GP by patients 2. Content of intervention: regular visits to GP with pharmacotherapy structured using clinical algorithms (use of available antidepressants: fluoxetine, amitriptyline, imipramine). Regular telephone contact by non‐professional, but trained personnel provided education, monitoring of drug intake and side effects, and reminders/reinforcement of the need for regular follow‐up with the doctor CONTROL: usual care (n = 131) Based on Ministry of Health programme for treatment of depression in PC: consultations with GPs, pharmacotherapy, individual or group psychotherapy with psychologists, and referral to psychiatrists CO‐INTERVENTIONS: none |
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| Outcomes |
Patients 1. Diagnosis of depression (MINI) 2. Severity of symptoms (HDRS) 3. QoL (SF‐36) Carers None Process/health workers None Economic outcomes None Time points: 3 months and 6 months |
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| Notes |
Source of funding: Fondecyt, Chile Notes on validation of instruments: all instruments were validated internationally and in Chilean setting Additional information: no protocol was provided. Declaration of interests ‐ none Handling the data: as per footnotes in data and analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: patients were assigned randomly; this took place at the individual level, using computer systems managed at a central level |
| Allocation concealment (selection bias) | Low risk | Comment: patients were assigned randomly; this took place at the individual level, using computer systems managed at a central level |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: due to the nature of the intervention, participants could not be blinded to the intervention; this is unlikely to create any bias to the results |
| Blinding of outcome assessment (detection bias) all outcomes | Low risk | Comment: assessors were not involved in the design of the study, did not know the study hypotheses, and were blinded to group assignment. No objective outcomes |
| Baseline outcome measurements similar | Low risk | Comment: the 2 study groups did not vary significantly |
| Baseline characteristics similar? | Low risk | Comment: the 2 study groups did not vary significantly |
| Incomplete outcome data (attrition bias) Efficacy data | Unclear risk | Comment: MINI scores are not reported at follow‐up. In addition, study author does not show comparative tables of results at 3 and 6 months (only individual figures per allocated group; no summary statistics) |
| Protection against contamination | Unclear risk | Comment: we have incomplete information; we are not sure if GPs in this setting may be providing both intervention and control interventions |
| Selective reporting (reporting bias) | Unclear risk | Comment: no published clinical trial available; no selective reporting based on paper alone |
| Other bias | Low risk | Comment: no other sources of bias |