Tuldra 2000.
| Methods | 116 patients were randomly allocated (no statement of allocation concealment) to 1 of 2 arms. 61 patients were randomized to the control group and 55 were randomized to the "psychoeducative intervention" group. There is no statement in the report about blinding of physicians. Patients and psychologists were not blinded and, if there was a separate outcome assessor, it is not stated | |
| Participants | 116 patients who initiated their first or second‐line highly active antiretroviral treatment (HAART) at a general university hospital's HIV‐outpatient unit were included. Exclusion criteria were not specified | |
| Interventions | The experimental group received a psychoeducative assessment in addition to the regular clinical follow‐up. The individual(s) who delivered the intervention is not identified, but is apparently, a psychologist, rather than the treating physician. The intervention was intended "primarily to improve patients' knowledge and customs in handling medication to increase self efficacy". Patients in this arm received explanations about the reasons for starting treatment and the relevance of appropriate adherence to prevent replication of viral mutations and the development of antiretroviral drug resistance. Patients' doubts about medication intake were solved and a dosage schedule was developed with the patients' input. Study subjects were also taught to manage medication and tackle problems such as forgetting, delays, side effects and changes in the daily routine. A phone number was also given should any questions arise before the next interview. During follow‐up visits, adherence was verbally reinforced and strategies were developed to deal with problems that had appeared to that point, including rescheduling dose schedules to overcome adherence problems, providing skills to deal with minor adverse effects. Patients in the control group received a standard assessment consisting of an interview with a psychologist following the regular medical visit, in which only variables related to adherence were recorded. The control group received only normal clinical follow‐up. Both groups were interviewed for data collection at 0, 4, 24, and 48 weeks of follow‐up | |
| Outcomes | Measurement of compliance: self reported adherence was registered at each visit. The proportion of compliance was calculated by dividing the number of pills taken during the month before by the number of pills prescribed during the same period. Patients who consumed more than 95% of medication prescribed were considered "adherent patients". Randomized blood analyses were also performed without warning in 40% of the patients to measure plasma levels of protease inhibitors (PI). Plasma levels of PI > 0.01mg/L indicated adequate compliance, PI levels < 0.01 mg/dl indicated noncompliance Measurement for clinical health outcomes: HIV‐1 RNA levels (copies/ml) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No mention of randomization process. "...prospective, two‐arm randomized controlled study was designed" (pg 222) |
| Allocation concealment (selection bias) | Unclear risk | No information was provided about how allocation was handled. "...prospective, two‐arm randomized controlled study was designed" (pg 222) |
| 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 | Low risk | The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) PLASMA RNA COUNT ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) PLASMA RNA COUNT ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) PLASMA RNA COUNT ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Only at 48 weeks groups differed in adherence in as‐treated analysis. In ITT the difference was less significant, again at 48 weeks only. 16% did not complete the 48‐week follow‐up. It is also reported that 11% discontinued therapy due to toxicity, 4 patients abandoned medication, 5% interrupted medical follow‐up, 2 patients in control group were switched to other therapies |
| Incomplete outcome data (attrition bias) Patient outcome | High risk | (PRIMARY) PLASMA RNA COUNT ‐ Only at 48 weeks groups differed in adherence in as‐treated analysis. In ITT the difference was less significant, again at 48 weeks only. 16% did not complete the 48‐week follow‐up. It is also reported that 11% discontinued therapy due to toxicity, 4 patients abandoned medication, 5% interrupted medical follow‐up, 2 patients in control group were switched to other therapies |