| Domain | Patient selection | Index test | Reference standard | Flow and timing |
| Description | We will describe methods of patient selection, and the intended use of the adherence measure in this setting. | We will describe the measure of adherence, and how the researchers interpreted it. | We will describe the method used to measure viral load and the lower limit of detection of the assay. | We will describe any interval between the adherence measure and the viral load measurement. |
| Signalling questions (yes, no, unclear) |
Consecutive or random sample of patients? Yes: if authors stated they used random patient sampling or consecutive enrolment. No: when patients were selected, for example, based on previously identified concerns regarding adherence. Unclear: if authors provided insufficient information. |
Index test results interpreted without knowledge of the results of reference standard? Yes: if authors clearly reported that the measures of adherence were applied and interpreted before the viral load result was available. No: if authors reported that the measures were applied or interpreted after the viral load was available. Unclear: if authors provided insufficient information. |
Reference standard likely to correctly classify the target condition? Yes: if authors clearly reported that a laboratory reference test was used at a manufacturer recommended threshold of lower limit of detection, and this was < 400 copies/mL. No: if authors reported application of a post‐hoc threshold. Unclear: if authors provided insufficient information. |
Appropriate interval between measure of adherence and viral load measurement? Yes: if the measure of adherence and the measure of viral load were made on the same day. No: if time period between measure of adherence and viral load was not made on the same day. Unclear: if authors provided insufficient information. |
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Did the study avoid inappropriate exclusions? Yes: if there were no inappropriate exclusions. No: if there was evidence that authors inappropriately excluded certain patients, e.g. those deemed to have limited ability to use electronic monitoring devices, or excluded those with literacy concerns if self‐report measures were to be self‐administered. Unclear: if authors provided insufficient information. |
Prespecified threshold used? Yes: if authors reported an a priori threshold value (or values) for adherence. No: if authors determined threshold values post hoc. Unclear: if authors provided insufficient information. |
Reference standard results interpreted without knowledge of the index test? Yes: if authors reported that viral loads were measured and recorded without a priori knowledge of the measure of adherence result. No: if authors reported that viral load was measured or recorded with knowledge of the measure of adherence result. Unclear: if authors provided insufficient information. |
Did all patients receive a viral load, using the same assay, and were all included in the analysis? Yes: if authors reported that all patients received a viral load using the same assay and all were included in the analysis. No: if only a selection of those with adherence measures have viral load measures, or different assays were used. Unclear: if authors provided insufficient information. |
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| Risk of bias (high, low, unclear) |
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| Applicability concerns (high, low, unclear) |
Are there concerns that the included patients do not match the review question? High: if some but not all included patients were concurrently receiving interventions to improve their adherence, rather than the same standard of care, and these groups cannot be separated. Low: if all patients were receiving the same standard of care. Unclear: if there was insufficient information to make a judgement. |
Are there concerns that the index test, its conduct, or interpretation differs from the review question? High: if the measure of adherence was not truly applicable in a resource‐limited setting, e.g. requiring additional remote information infrastructure or analysis. Low: if the measure of adherence could feasibly be applied in a resource‐limited setting. Unclear: if there was insufficient information to make a judgement. |
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