Sirey 2010.
| Methods | Randomized controlled trial | |
| Participants | The study location was New York City, New York, USA 33 participants were randomized to the intervention group and 37 participants were randomized to the control group The inclusion criteria were adults aged 60 diagnosed with major depression; newly recommended antidepressant treatment by their primary care physicians; confirmed diagnosis via a structured diagnostic interview (Structured Clinical Interview for DSM Disroders [SCID] IV); and score of 14 or greater on the Hamilton Depression Rating Scale The exclusion criteria were active suicidal ideation; psychotic depression; a history of mania; cognitive impairment (MMSE < 24); or unable to communicate in English |
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| Interventions | Intervention: TREATMENT INITIATION AND PARTICIPATION PROGRAM (TIP)
The Treatment Initiation and Participation Program (TIP) included 3 30‐minute individual meetings between the TIP Counselor and older adult patient during the first 6 weeks of pharmacotherapy, followed by 2 follow‐up telephone calls at 8 and 10 weeks after study entry. During these sessions the TIP Counselor and older adult would review symptoms and antidepressant therapy regimen, and conduct a barriers assessment, define a personal goal that could be achieved with adherence, provide education about depression and antidepressant therapy, collaborate to address barriers to treatment participation, create an adherence strategy and facilitate and empower the older adult to talk directly with the primary care physician (PCP) about the treatment. A "contact sheet" listed barriers in each domain and specific intervention techniques and served as the guide for sessions and a record of the interventions administered Control: TREATMENT AS USUAL (TAU) Patients in the control group continued with treatment as usual |
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| Outcomes | The measure of adherence was the Medication and Nonmedication Treatment Compliance Data form, completed at entry, 6 weeks, 12 weeks, and 24 weeks after entry. It was assessed by trained Research Assistants. At study completion, a chart review recorded the duration of antidepressant treatment and verified a prescription was on record The patient outcome was depression severity, measured by the Hamilton Depression Rating Scale at entry, 6 weeks, 12 weeks, and 24 weeks. Self report assessment administered by research associates |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization was not described in detail. "Participants who met study criteria were randomly assigned to either pharmacotherapy as usual (TAU) or pharmacotherapy with the Treatment Initiation and Participation (TIP) program." (pg 3) |
| Allocation concealment (selection bias) | Unclear risk | No information was provided about how allocation was handled |
| Selective reporting (reporting bias) | High risk | Aside from adherence and HDRS, the WHODAS and use of mental health services was assessed, but not reported in results and neither was chart verification. "Overall functioning was assessed using the World Health Organization Disability Assessment Schedule (WHODAS). At study completion, a chart review recorded the duration of antidepressant treatment and verified a prescription was on record for those clients who indicated they were taking antidepressant medication. Use of mental health services was recorded at 12 and 24 weeks using the Cornell Services Index. [32]" (pg 3) |
| Other bias | High risk | No co‐intervention or sham intervention for TAU group. The attention alone could have an effect |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Article indicates staff were blind to group. "Assessments were conducted by trained Research Assistants who were unaware of group assignment." (pg 3) |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) DEPRESSIVE SYMPTOMS ‐ Assessments were conducted by trained Research Assistants who were unaware of group assignment |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) DEPRESSIVE SYMPTOMS ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Unclear who did the comparisons with the charts/prescription records and how those might have influenced the scoring of the self report, especially if those personnel were not blinded. Possible source of bias, but not described in article so it is unclear |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) DEPRESSIVE 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 ‐ No reasons given for why the patients dropped out |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) DEPRESSIVE SYMPTOMS ‐ No information given on the reasons for dropout |