Abstract
BackgroundApproximately 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.MethodsIn 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.ResultsConsensus 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.ConclusionsThis 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.
Highlights
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
Primary total knee replacement is a successful intervention for reducing pain severity for most patients, about 20% of people experience chronic pain afterwards [3]
Chronic pain after total knee replacement is associated with functional limitations, decreased satisfaction and reduced quality of life [5]
Summary
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. Current NHS service provision for people with chronic pain after knee replacement is patchy and inconsistent [7]. This reflects an absence of evidence about effective interventions for chronic post-surgical pain that could inform commissioning of services [8, 9] and emphasises the need to develop and evaluate interventions to address chronic pain after knee replacement. There is a lack of clear pathways and referral processes for patients with chronic pain after knee replacement [7] These are considered to be integral aspects of good care for chronic pain [10] and their absence hinders patients’ access to targeted and individualised care [13] indicating a pressing need for the development of new models of care delivery for this population
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