A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: A modified Delphi approach.
Victoria PalinTjeerd P Van StaaStephanie SteelsAndrea B TroxelRolf H H GroenwoldTom M MacDonaldDavid TorgersonDouglas FariesPierre ManciniMario OuwensLucy J FrithKate TsirtsonisGraham MacLennanClementine Nordonnull nullPublished in: British journal of clinical pharmacology (2022)
A set of important statistical issues in PCTs was identified and approaches were suggested to anticipate and/or minimize these through data analysis. Any impact of choosing a pragmatic design feature should be gauged in the light of the trial estimand.