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  • Predicting pain and function outcomes in people consulting with shoulder pain: the PANDA-S clinical cohort and qualitative study protocol

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General practice / Family practice
Protocol
Predicting pain and function outcomes in people consulting with shoulder pain: the PANDA-S clinical cohort and qualitative study protocol
  1. Gwenllian Wynne-Jones1,
  2. Helen Myers2,
  3. Alison Hall1,
  4. Chris Littlewood1,3,
  5. S Hennings2,
  6. Benjamin Saunders1,
  7. Milica Bucknall1,
  8. Sue Jowett4,
  9. Richard Riley1,
  10. Simon Wathall2,
  11. Carl Heneghan5,
  12. Johanna Cook5,
  13. Tamar Pincus6,
  14. Christian Mallen1,
  15. Edward Roddy1,
  16. Nadine Foster1,7,
  17. David Beard8,
  18. Jeremy Lewis9,10,
  19. J L Rees8,
  20. Adele Higginbottom1,
  21. Danielle van der Windt1
  1. 1School of Medicine, Keele University, Keele, UK
  2. 2Clinical Trials Unit, Keele University, Keele, UK
  3. 3Department of Health Professions, Manchester Metropolitan University, Manchester, UK
  4. 4Health Economics Unit, University of Birmingham, Birmingham, UK
  5. 5Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK
  6. 6Psychology, Royal Hollaway University of London, London, UK
  7. 7STARS Education and Research Alliance, The University of Queensland, Saint Lucia, Queensland, Australia
  8. 8Nuffield Dept of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  9. 9School of Health and Social Work, University of Hertfordshire, Hatfield, UK
  10. 10Central London Community Healthcare NHS Trust, London, UK
  1. Correspondence to Dr Gwenllian Wynne-Jones; g.wynne-jones{at}keele.ac.uk

Abstract

Introduction People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals’ level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain.

Methods and analysis The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study 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 Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).

Short-term and long-term trajectories of Shoulder Pain and Disability Index (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 prespecified 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, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options.

Ethics and dissemination The 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.

Trial registration number ISRCTN46948079.

  • shoulder
  • musculoskeletal disorders
  • primary care
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-052758

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    Footnotes

    • Contributors Design: DvdW, GW-J, CL, AHa, HM, SH, BS, MB, SJ, RR, SW, CH, JC, TP, CM, ER, NF, DB, JL, JLR and AHi. Data collection and project administration: DvdW, GW-J, AHa, HM, SH, SW and JC. Writing original draft: GW-J, DvdW, HM, BS, MB and SJ. Writing-review and editing, and review of final draft: DvdW, GW-J, CL, AHa, HM, SH, BS, MB, SJ, RR, SW, CH, JC, TP, CM, ER, NF, DB, JL, JLR and AHi.

    • Funding NIHR Programme Grants for Applied Research (RP-PG-0615-20002). This study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme in collaboration with Versus Arthritis (RP-PG-0615-20002). CM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, and the National Institute for Health Research (NIHR) School for Primary Care Research. The cohort study is co-funded by Versus Arthritis.

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.