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01.12.2018 | Research | Ausgabe 1/2018 Open Access

Trials 1/2018

Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway

Trials > Ausgabe 1/2018
Vikki Wylde, Nicholas Howells, Wendy Bertram, Andrew J. Moore, Julie Bruce, Candy McCabe, Ashley W. Blom, Jane Dennis, Amanda Burston, Rachael Gooberman-Hill
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Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-017-2391-8) contains supplementary material, which is available to authorized users.



Approximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable.


In line with the UK Medical Research Council’s recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders.


Consensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial.


This work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.
Additional file 1: Schematic depiction of the draft STAR trial intervention. (DOCX 39 kb)
Additional file 2: Overview of STAR assessment clinic appointment, telephone follow-up and recommended treatment referral pathways. (DOCX 18 kb)
Additional file 3: The Template for intervention description and replication (TIDieR) checklist. (DOCX 15 kb)
Additional file 4: Schematic depiction of the final STAR intervention. (DOCX 50 kb)
Additional file 5: Summary of the STAR trial intervention using TiDIER criteria. (DOCX 15 kb)
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