Dunn 2005.
Methods | A 2‐part multi‐centre randomized trial (part B included patients for whom the clinician perceived he/she was unable to select a potent regimen with a resistance test; part A included patients for whom the clinician perceived he/she was able to select a potent regimen of 3 or more drugs without a resistance test ‐ only data from part A used here | |
Participants | Inclusion: decision had been made to switch ART as a consequence of virological failure, provided the most recent HIV‐1 RNA plasma viral load (VL) exceeded 2000 copies/mL Exclusion: not reported |
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Interventions | Intervention: centralized genotypic resistance testing (i.e. a report that showed key drug‐associated mutations and classified each drug as “no evidence of resistance”, “resistance possible”, or “evidence of resistance") Control: no genotypic resistance testing |
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Outcomes | Change in viral load, virological success (< 50 copies/mL), change in CD4 cell count Follow‐up: 52 weeks |
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Notes | All participants provided informed consent. This study was funded by the NHS London Regional Office, Research and Development Programme. VIRCO (Mechelen, Belgium) provided resistance testing and transport of plasma samples to Belgium. Trial acronym: ERA (Evaluation of Resistance Assays) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization was not reported. |
Allocation concealment (selection bias) | Unclear risk | Trial authors did not report this information. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Trial authors did not report this information (knowledge of allocation is unlikely to introduce bias). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Trial authors did not report this information (knowledge of allocation is unlikely to introduce bias). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up was balanced between groups. Trial authors performed ITT analyses. |
Selective reporting (reporting bias) | Low risk | Trial authors reported all outcomes of interest. |
Other bias | Low risk | We found no other sources of bias. |
Overall risk assessment | Unclear risk | Risk is due to the uncertainties raised above. |