Predicting pain and function outcomes in people consulting with shoulder pain: The PANDA-S clinical cohort and qualitative study protocol (ISRCTN 46948079)

Abstract

AbstractIntroductionShoulder pain is common in primary care but achieving definitive diagnosis is contentious leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (i) to investigate the short- and long-term outcomes (overall prognosis) of shoulder pain, (ii) estimate costs of care, (iii) develop a prognostic model for predicting individuals’ level and risk of pain and disability at 6 months, (iv) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis, and management of shoulder pain.Methods and analysisPANDA-S is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via SMS text or software application (App). Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (GP or physiotherapist).Short and long-term trajectories of shoulder pain and disability (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6-months using penalisation methods to adjust for overfitting. The added predictive value of pre-specified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making and perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options.Ethics and disseminationThe PANDA-S study has ethical approval from Yorkshire and The Humber – Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites.Registration detailsThe PANDA-S Study is registered at ISRCTN Number: 46948079Article summaryStrengths and limitations of this study▪ This cohort study will offer a detailed characterisation of patients presenting with a new episode of shoulder pain in primary care, including short and long-term outcomes.▪ Detailed, weekly data collection will offer unique insights into the impact of shoulder pain on everyday activity, mood, and work during the first 3 months after presentation.▪ Clinical assessment will investigate the added predictive value of physical examination tests and ultrasound scan findings, over and beyond self-reported prognostic information.▪ The use of ‘dyad’ interviews allows for a rich understanding of the views and experiences of clinicians and patients towards shoulder pain management.▪ The COVID-19 pandemic has impacted on recruitment and data collection, but the study allows an investigation of the pandemic and related (lockdown) measures restrictions on the experience and management of shoulder pain.