| Methods |
Immediately after referral patients were individually randomized in blocks of 8 to one of 4 treatment groups by prearranged random number sequence, stratified by drug type, in a factorial design. Patients were unaware of their allocation at first interview and were asked not to reveal drug‐counseling sessions to the interviewer subsequently |
| Participants |
Patients were included if they were aged 18 or over and starting new courses of treatment with dothiepin or amitriptyline. Inclusion was based on clinical diagnosis of depressive illness. Patients were excluded if they had received either drug within 3 months, had a contraindication (allergy, heart disease, glaucoma, or pregnancy) or were receiving other incompatible drugs. Any patients at high risk of suicide were also excluded |
| Interventions |
The 4 treatment groups were as follows: treatment as usual, leaflet, drug counseling, or both interventions. The information leaflet contained information about the drug, unwanted side effects, and what to do in the event of a missing dose. Patients were given drug counseling by a nurse at weeks 2 and 8, according to a written protocol. Sessions included assessment of daily routine and lifestyle, attitudes to treatment, and understanding of the reasons for treatment. Education was given about depressive illness and related problems, self help, and local resources. The importance of drug treatment was emphasized, and side effects and their management discussed. Advice was given about the use of reminders and cues, the need to continue treatment for up to 6 months, and what to do in the event of forgetting a dose, and the feasibility of involving family or friends with medicine taking was explored |
| Outcomes |
Measurement of compliance: at 6 weeks, self reported adherence was assessed and was reassessed at the final visit. To check the reliability of self reported adherence, adherence was measured in a subgroup using a Medication Event Monitoring System (MEMS) monitor. Patients were seen at 3 weeks to resupply drugs and pills were counted. At 6 weeks the container was collected and the cap data were downloaded
Measurement of clinical health outcomes: depressive symptoms were measured by the hospital anxiety and depression scale and functional status was measured by the SF‐36 health survey. Interviews were conducted at baseline, 6 weeks, and when drugs were discontinued at 12 weeks (whichever was sooner). Also, at 6 weeks depressive symptoms and unwanted effects of treatment were assessed. At the final visit, satisfaction with treatment and unwanted effects were reassessed and the SF‐36 repeated |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Immediately after referral, patients were individually randomised in blocks of eight to one of four treatment groups (treatment as usual, leaflet, drug counselling, or both interventions) by prearranged random number sequence, stratified by drug type, in a factorial design." (pg 612) |
| Allocation concealment (selection bias) |
Low risk |
"To maintain blinding the randomisation key was concealed from interviewers. Leaflets were included in an opaque sealed envelope with study information. Patients were unaware of their allocation at first interview and asked not to reveal drug counselling sessions to the interviewer subsequently." (pg 613) |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
High risk |
The authors admit and try to account for patient selection bias by general practitioners. "The main weakness of this design is that it is important to know whether there was significant bias in patient selection by general physicians. Our attempt to evaluate bias retrospectively suggests that patients with chronic depression, concurrent physical illness or postnatal depression may have been under represented." (pg 615) |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT QUESTIONNAIRE ‐ Although patients were asked not to reveal drug counseling session to the interviewer, there was no formal test of blindness conducted and so it possible that the blinding was not effective. A randomization key was concealed from interviewers to maintain blinding, however. "To maintain blinding the randomisation key was concealed from interviewers. Leaflets were included in an opaque sealed envelope with study information. Patients were unaware of their allocation at first interview and asked not to reveal drug counselling sessions to the interviewer subsequently." (pg 613) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) DEPRESSION SYMPTOMS ‐ "To maintain blinding the randomisation key was concealed from interviewers. Leaflets were included in an opaque sealed envelope with study information. Patients were unaware of their allocation at first interview and asked not to reveal drug counselling sessions to the interviewer subsequently." (pg 613) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT QUESTIONNAIRE ‐ This is a subjective measure; blinding could have been broken |
| Blinding of participants (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) DEPRESSION SYMPTOMS ‐ This is a subjective measure. To maintain blinding the randomization key was concealed from interviewers. Leaflets were included in an opaque sealed envelope with study information. Patients were unaware of their allocation at first interview and asked not to reveal drug counseling sessions to the interviewer subsequently." (pg 613); "Depressive symptoms were measured by the hospital anxiety and depression scale and functional status was measured by the SF 36 health survey. Interviews were conducted at baseline, 6 weeks, and when drugs were discontinued or at12 weeks, whichever was sooner. A postal questionnaire was sent at 12 weeks to all those who discontinued. At 6 weeks self reported adherence depressive symptoms and unwanted effects of treatment were assessed. At the final visit, reported adherence, satisfaction with treatment and unwanted effects were reassessed and the depression scale and SF 36 repeated." (pg 613) |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) DEPRESSION SYMPTOMS ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT QUESTIONNAIRE ‐ Reasons for missing data were not provided |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) DEPRESSION SYMPTOMS ‐ Reasons for missing data were unclear |
