Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.

BACKGROUND: 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. 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. METHODS: The 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. RESULTS: GPs 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". CONCLUSIONS: A 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 REGISTRATION: Name of the registry: ISRCTN. TRIAL REGISTRATION NUMBER: 15366334. Date of registration: 06/04/2016.

The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol.

INTRODUCTION: This pilot trial will inform the design and methods of a future full-scale randomized controlled trial (RCT) and examine the feasibility, acceptability and fidelity of the Increasing Physical activity in Older People with chronic Pain (iPOPP) intervention, a healthcare assistant (HCA)-supported intervention to promote walking in older adults with chronic musculoskeletal pain in a primary care setting. METHODS AND ANALYSIS: The iPOPP study is an individually randomized, multicentre, three-parallel-arm pilot RCT. A total of 150 participants aged ≥65 years with chronic pain in one or more index sites will be recruited and randomized using random permuted blocks, stratified by general practice, to: (i) usual care plus written information; (ii) pedometer plus usual care and written information; or (iii) the iPOPP intervention. A theoretically informed mixed-methods approach will be employed using semi-structured interviews, audio recordings of the HCA consultations, self-reported questionnaires, case report forms and objective physical activity data collection (accelerometry). Follow-up will be conducted 12 weeks post-randomization. Collection of the quantitative data and statistical analysis will be performed blinded to treatment allocation, and analysis will be exploratory to inform the design and methods of a future RCT. Analysis of the HCA consultation recordings will focus on the use of a checklist to determine the fidelity of the iPOPP intervention delivery, and the interview data will be analysed using a constant comparison approach in order to generate conceptual themes focused around the acceptability and feasibility of the trial, and then mapped to the Theoretical Domains Framework to understand barriers and facilitators to behaviour change. A triangulation protocol will be used to integrate quantitative and qualitative data and findings.

Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?

PURPOSE: Back pain is a common problem and has significant societal impact. Sickness certification is commonly issued to patients consulting their general practitioner with low back pain. The aim of this study was to investigate the association of certification for low back pain with clinical outcomes and cost consequences. METHODS: A prospective cohort study using linked questionnaire and medical record data from 806 low back pain patients in 8 UK general practices: comparison of 116 (14.4%) who received a sickness certificate versus 690 who did not receive certification. The primary clinical measure was the Roland and Morris Disability Questionnaire (RMDQ). Data on back pain consultation and work absenteeism were used to calculate healthcare and societal costs. RESULTS: Participants issued a sickness certificate had higher back-related disability at baseline consultation and 6-month follow-up [mean difference 3.1 (95% CI 1.8, 4.4) on the RMDQ], indicating worse health status. After fully adjusting for baseline differences, most changes in clinical outcomes at 6 months were not significantly different between study groups. Productivity losses were significantly higher for the certification group, with most absence occurring after the expected end of certification; mean difference in costs due to absenteeism over 6 months was £1,956 (95% CI £941, £3040). CONCLUSIONS: There was no clear evidence of a difference in clinical outcomes between individuals issued a sickness certificate and those not issued a certification for their back pain. With little overall contrast in clinical outcomes, policy makers and care providers may wish to draw on the likely difference in societal costs alongside issues in ethical and moral care in their consideration of patient care for low back pain.