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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]