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Table 4 Included process evaluation studies

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

Reference(s) Description of process evaluation Methodology and data collection methods Intervention or trial processes Process evaluation components Labelled as process evaluation
Ball 2018 [22] Investigated the effect of mild cognitive impairment in participants on intervention outcome Quantitative
Trial dataset
Intervention Contextual moderators No
Clark 2015 [23] Explored patient perceptions of the acceptability of intervention in both groups, and motivations for agreeing or refusing to participate in the trial Qualitative
Interviews
Intervention and trial Participant responses
Reach
Contextual moderators
Unintended consequences
Causal mechanisms in context
No
Grubbs 2015 [24] Investigated which factors predicted patient uptake of an element of the intervention found to mediate the primary outcome Quantitative
Medical record review
Intervention Contextual moderators No
Handoll 2016 [25] Described how the intended fracture population was practically achieved in pragmatic RCT, including results of formal independent assessment and classification of trial fractures Quantitative
Detailed author description
Trial dataset
Intervention and trial Reach No
Handoll 2015 [26]
Handoll 2014 [27] Described processes undertaken to ensure usual care received by both groups in trial was good quality and comparable, including results of methods described Quantitative
Detailed author description
Deliverer self-report
Intervention and trial How delivery is achieved
Fidelity
No
Handoll 2015 [26]
Hall 2017 [28] Investigated mediators of intervention outcome Quantitative
Trial dataset
Intervention Mediators No
Hill 2016 [29] Explored perceptions of ward staff about how intervention contributed to outcome, and experience of intervention being delivered on their ward Qualitative
Focus groups
Intervention How delivery is achieved
Participant responses
Contextual moderators
Causal mechanisms in context
Contextual factors shaping intervention theory
No
Hill 2016 [30] Explored patient experiences of intervention and perceived barriers to engagement Qualitative
Semi-structured questionnaires
Intervention Participant responses
Causal mechanisms in context
Contextual factors shaping intervention theory
Yes
Hill 2015 [31] Explored perceptions of intervention deliverers of delivering intervention and how the intervention worked Qualitative
Focus groups, interview, field notes, intervention notes
Intervention How delivery is achieved
Contextual factors shaping intervention theory
Participant responses
Causal mechanisms in context
Yes
Keding 2019 [32] Explored how patient and surgeon treatment preferences impacted recruitment, trial conduct, and patient outcomes Quantitative
Trial dataset
Intervention and trial Reach
Participant responses
Contextual moderators
No
Handoll 2015 [26]
Knowles 2015 [33] Explored patient experiences of the intervention, including acceptability, ease of use, barriers to engagement, content, accessibility, and support. Also explored healthcare professional perceptions of feasibility and which patients’ intervention most suited to. Qualitative
Interviews
Intervention Participant responses
How delivery is achieved
Reach
Causal mechanisms in context
Contextual moderators
Unintended consequences
Contextual factors shaping intervention theory
Yes
Littlewood 2015 [34]
Nichols 2017 [35] Explored experiences of patients about intervention, with focus on patient adherence, and how changed over time Qualitative
Interviews (longitudinal)
Intervention Participant responses
Causal mechanisms in context
Contextual moderators
How delivery is achieved
No
Williams 2015 [36]
Novak 2015 [37] Investigated whether and how trial sites supplied thawed plasma in a timely manner Quantitative
Detailed author description
Observation, reports from sites
Intervention and trial Fidelity
How delivery is achieved
No
Sands 2016 [38] Explored how the flexible complex intervention was delivered in real-world complex settings Qualitative
Trial dataset
Intervention How delivery is achieved
Adaptations
Contextual moderators
Participant responses
Unintended consequences
Contextual factors shaping intervention theory
Fidelity
No
Saville 2016 [39] Explored preferences and experiences of intervention deliverers about various aspects of intervention Quantitative
Questionnaire
Intervention How delivery is achieved No
Tjia 2017 [40] Investigated patients’ perceptions of benefits and drawbacks of intervention Quantitative
Questionnaire
Intervention Participant responses No
Vennik 2019 [41] Explored views and experiences of parents and practice nurses of intervention and usual care Qualitative
Interviews
Intervention Participant responses
How delivery is achieved
Contextual factors shaping intervention theory
Causal mechanisms in context
Unintended consequences
No
Williamson 2016 [42]