Abstract

BackgroundThere is growing interest in the use of routine patient-reported outcome measures (PROMs) to influence the care of individual patients with stroke. However, there are significant gaps in our understanding as to how PROMs influence post-stroke patient care and clinical practice. This is due to factors including the number of purported uses for PROMs and that PROMs are complex interventions, which attempt to stimulate varied actions or behaviours. Therefore, the objective of this realist synthesis is to offer theory-based explanations as to how PROMs influence post-stroke clinical practice and patient care.MethodsThis is a protocol for a realist synthesis, which involves three distinct phases: theory building (phase 1), theory testing and refinement (phase 2) and synthesis (phase 3). Phase 1 will develop initial rough programme theories (IRPTs), through literature searches (from January 2000 onwards) of MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Library and the grey literature. Only secondary sources will be included that contribute to the development of IRPTs. Only two IRPTs, prioritised by the stakeholder group, will be taken forward to be tested and refined during phase 2. Further novel searches will be employed in phase 2, utilising the same criteria as phase 1; however, phase 2 searches will not utilise grey literature searches, and only primary research studies that contribute to the refinement of programme theories under investigation will be included. Two independent reviewers will screen and select all returned results. The reviewers will code and annotate relevant sources, resulting in ‘fragments’ to be extracted and graded based on the richness of their contribution to explanation and causal insight. Further, these fragments will be organised into ‘Context-Mechanism-Outcome’ configurations. Phase 3 of the review will involve the synthesis of context-mechanism-outcome configurations to form middle-range theory-based explanations and developed logic models for stakeholders to understand how PROMs in post-stroke clinical practice and patient care work for whom, how and under what circumstances.DiscussionThe resulting realist synthesis will provide guidance on the implementation of PROMs within routine post-stroke clinical practice and patient care and act as a touchstone for further testing and refinement of PROMs programmes.Systematic review registrationPROSPERO CRD42020138649.

Highlights

  • There is growing interest in the use of routine patient-reported outcome measures (PROMs) to influence the care of individual patients with stroke

  • The need to clearly document all searches has been laid out in previous sections; it is worth stressing this novel feature of the realist synthesis methodology and the challenges it presents in relation to existing review frameworks

  • Protocol amendments will be agreed by the review team, documented clearly in a supplement of the protocol, with any important amendments resulting in an update to the review registration via PROSPERO, which maintains an accessible update history

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Summary

Methods

Aims and objectives This protocol is being reported in accordance with the reporting guidance provided in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement [12] (see checklist in Additional file 1). The second phase of this realist synthesis will search for and utilise the evidence from primary research studies for the purpose of testing and refining the prioritised programme theories relating to how PROMs influence post-stroke clinical practice and patient care. The decision to continue with iterative searches of primary studies of non-PROMs interventions with shared programme theories will be taken by the research team, based on the sufficiency of explanatory power within the existing body of evidence related directly to PROMs use. In relation to the exclusion criteria, it is possible to specify at this stage that the theory-testing criteria will exclude studies not involving stroke survivors, studies that focus solely on the development of PROMs or other patient-reported tools and their associated properties (e.g. reliability and validity), and secondary sources such as reviews will be excluded. This will serve to enhance rigour and to understand how these theories will be interpreted and taken forward during subsequent knowledge translation

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