Abstract
BackgroundMusculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations.MethodsThe design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making.ResultsGPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved “complete success”.ConclusionsA future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.Trial registrationName of the registry: ISRCTN. Trial registration number: 15366334.Date of registration: 06/04/2016.
Highlights
Musculoskeletal (MSK) pain from the five most common presentations to primary care, where the majority of patients are managed, is a costly global health challenge
There were 3063 potentially eligible patients screened by General Practitioner (GP) at the point-of-consultation, the electronic medical record (EMR) participant identification screen was completed in 1281 with confirmed eligibility, of whom 1237 were invited by postal letter to participate in data collection, 567 initial questionnaires returned with written consent to participate in data collection, and 524 responses were received within the 4-week eligibility time-period (231 intervention and 293 controls)
We identified that some GPs rarely coded MSK pain consultations and that others tended to use ‘Synonym’ codes, which are set of diagnostic codes that needed to be removed from the list of codes used to activate the EMR participant identification screen, as they caused it to activate in error for a range of non-MSK pain problems
Summary
Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. First-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-ofconsultation for these five most common MSK pain presentations. Musculoskeletal (MSK) pain from common conditions such as back pain and osteoarthritis are costly global health challenges, for primary care where the majority of patients are managed. Finding ways to better identify which patients to de-medicalise by limiting care primarily to reassurance and selfmanagement whilst identifying which patients should be offered more intensive and expensive healthcare treatments, is an international priority [14, 17, 23]
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