Parienti 2007.
| Methods | Randomized controlled trial | |
| Participants | The study location was 4 French academic medical centers, France 31 participants were randomized to the intervention group and 31 participants were randomized to the control group The inclusion criteria were chronically HIV‐1‐infected adults, receiving nevirapine‐based antiretroviral therapy with RNA‐HIV levels less than 400 copies/ml for more than 6 months and without liver enzyme abnormality (aspartate aminotransferase or alanine aminotransferase > 2.5 N and > 1.25 N if hepatitis virus B or C were negative and positive, respectively) |
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| Interventions | Intervention: ONCE A DAY DOSING
Patients were switched from 2 a day nevirapine to a 1 a day formula Control: TWICE A DAY DOSAGE Control participants continued to take nevirapine twice a day |
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| Outcomes | The measures of adherence were Medication Event Monitoring System (MEMS) and nevirapine plasma level at the end of each phase. MEMS is a electronic monitoring device. Electronic adherence data showing no event within the 14 preceding days of a plasma sample with detectable nevirapine levels were considered invalid and the overall phase was suppressed. In addition, electronic data were validated by patient's self report to detect pocket‐dose and box‐filling in order to adjust events. The patient outcomes were viral control (RNA‐HIV level < 400 copies/ml), measured at the end of the RCT portion of the trial |
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| Notes | It is not clear what the patient clinical outcomes were and how they were measured | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The author stated that permutated blocks of size 4 stratified by centers were used in randomization |
| Allocation concealment (selection bias) | Unclear risk | No information was provided about how allocation was handled. "At the end of month 3, patients were 1 : 1 randomly allocated to continue nevirapine twice a day or switch to nevirapine once‐daily for a 4‐month period (phase 2, randomized controlled trial)." (pg 2218) |
| Selective reporting (reporting bias) | Unclear risk | The efficacy data only given in total, not between groups |
| Other bias | Low risk | The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) MEMS ‐ As data were adjusted based on patient self report, the objectivity of the MEMS measure is somewhat questionable. No information given about the personnel or the methods that were used to collect the patient self reports |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) VIRAL CONTROL ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) MEMS ‐ As data were adjusted based on patient self report, the objectively of the MEMS measure is somewhat questionable |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) VIRAL CONTROL ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) MEMS ‐ As data were adjusted based on patient self report, the objectively of the MEMS measure is somewhat questionable. Not enough detail given on how the patient's MEMS records were adjusted based on their self report |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) VIRAL CONTROL ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) MEMS ‐ No detail given about which dropouts were in which group |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) VIRAL CONTROL ‐ Not enough information was given on which missing data are from which groups |