Run an applicability assessment by comparing each included trial's population, setting, and outcome definitions against the review question, then recording an indirectness judgement with supporting quotations for every trial. Cochrane's interpretation guidance and the GRADE approach both treat applicability and indirectness as judgements tied to the review question and to specific outcomes, so the assessment should be organized outcome by outcome and trial by trial.
- Write the review question as explicit elements: the target population, the care setting, the intervention and comparator, and each outcome with its definition and time point. This becomes the reference against which every trial is compared, and it fixes the criteria before you read the trials.
- Extract the matching elements from each trial using its registration record and report. ClinicalTrials.gov data element definitions cover eligibility, locations, and outcomes, so use those fields to capture who was enrolled, where the trial ran, and how each outcome was defined and measured.
- Compare each trial element with the review question and assign an indirectness judgement for that element. Record the quotation or field value that supports the judgement so a reader can see the basis for it.
- Summarize the judgements in an applicability table with one row per included trial and columns for population, setting, outcome definitions, and the indirectness judgement with its supporting quotation.
- Add a summary note stating how the recorded indirectness affects the certainty rating for each outcome, following the GRADE approach of making certainty judgements at the outcome level.
The finished artifact is the applicability table covering every included trial plus the summary note linking indirectness to certainty. Cochrane's interpretation guidance and the GRADE Working Group's criteria are the reference points for the judgements; the trial registration fields supply the population, setting, and outcome details you compare.