Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?—a systematic review

C French, H Pinnock, G Forbes, I Skene, SJC Taylor - Trials, 2020 - Springer
Background Process evaluations are increasingly conducted within pragmatic randomised
controlled trials (RCTs) of health services interventions and provide vital information to …

Designing process evaluations using case study to explore the context of complex interventions evaluated in trials

A Grant, C Bugge, M Wells - Trials, 2020 - Springer
Background Process evaluations are an important component of an effectiveness evaluation
as they focus on understanding the relationship between interventions and context to …

Use of PRECIS ratings in the National Institutes of Health (NIH) health care systems research Collaboratory

KE Johnson, G Neta, LM Dember, GD Coronado… - Trials, 2016 - Springer
Abstract Background The National Institutes of Health (NIH) Health Care Systems Research
Collaboratory (NIH Collaboratory) seeks to produce generalizable knowledge about the …

The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders

SG Nicholls, K Carroll, M Zwarenstein, JC Brehaut… - Trials, 2019 - Springer
Background There is a concern that the apparent effectiveness of interventions tested in
clinical trials may not be an accurate reflection of their actual effectiveness in usual practice …

Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial

RR Baier, E Jutkowitz, SL Mitchell, E McCreedy… - BMC Medical Research …, 2019 - Springer
Background Pragmatic randomized, controlled trials (PCTs) test the effectiveness of
interventions implemented in routine clinical practice. Because PCT findings are …

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

PD Lipman, K Loudon, L Dluzak, R Moloney… - Trials, 2017 - Springer
Background There continues to be debate about what constitutes a pragmatic trial and how
it is distinguished from more traditional explanatory trials. The NIH Pragmatic Trials …

Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials. gov: A cross-sectional analysis

S Vanderhout, DA Fergusson, JA Cook… - PLoS Medicine, 2022 - journals.plos.org
Background Use of patient-reported outcomes (PROs) and patient and public engagement
are critical ingredients of pragmatic trials, which are intended to be patient centered …

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

H Bruhn, EJ Cowan, MK Campbell, L Constable… - Trials, 2021 - Springer
Background There is an ethical imperative to offer the results of trials to those who
participated. Existing research highlights that less than a third of trials do so, despite the …

Process Evaluation of Complex Interventions Guidance: UK Medical Research Council (MRC) Guidance

G Moore, S Audrey, M Barker, L Bond, C Bonell… - 2014 - eprints.gla.ac.uk
Updated MRC guidance for evaluation of complex interventions published in 2008 (Craig et
al. 2008) highlighted the value of process evaluation within trials of complex interventions in …

Process evaluation of complex interventions: Medical Research Council guidance

GF Moore, S Audrey, M Barker, L Bond, C Bonell… - bmj, 2015 - bmj.com
Process evaluation of complex interventions: Medical Research Council guidance Page 1
ReseaRch Methods & RepoRting 1 the bmj | BMJ 2015;350:h1258 | doi: 10.1136/bmj.h1258 …