Reconceptualising patient-reported outcome measures for back pain

INTERVENTION: The cRCT aims to evaluate the outcome of the intervention (study objective A). The process evaluation aims to understand the processes by which an intervention functions, by examining its implementation, mechanisms and context (study objectives B ‐ E). 1. Cluster randomised controlled trial Patients will be asked to complete PROMs at various stages during their treatment. The PROMs will be the Musculoskeletal Health Questionnaire (MSK‐HQ) and the Patient Global Impression of Change Scale (PGIC). The chiropractors recruited into the study will be randomly allocated to one of the three groups using a randomisation generator. Patients booking in with these chiropractors will be asked if they would like to take part in the study and those who consent to take part to the study will be allocated to that chiropractor’s group in the trial. Depending whether patients have booked in with chiropractors in the routine PROM group or the intensive PROM group, they will be asked to complete PROMs at various stages during their treatment. Patients in the routine PROM group will be asked to complete PROMs three times. Patients in the intensive PROM group will be asked to complete PROMs seven times. Those in the control group will not complete PROMs. Chiropractors in the routine and intensive PROM groups will be asked to discuss PROMs with their patients at every session after a PROM has been completed. The follow up will be 90 days. Some participants in the trial will be invited to also take part in the nested mixed methods study. 2. The qualitative phase aims to understand the processes by which the intervention functions and help explain the results from the trial. CONDITION: Back pain management by chiropractors in private settings ; Musculoskeletal Diseases PRIMARY OUTCOME: Back pain (physical functioning and disability) measured with the Roland‐Morris Questionnaire at baseline and 90 days INCLUSION CRITERIA: Chiropractors: 1. Be registered with the General Chiropractic Council 2. Speak and read English fluently, as the PROM used within this study has not been translated into other languages and independently assessed for validity and reliability 3. Be able to comply with all study procedures Patients: 1. Be at least 16 years old. Due to the biological and psychological differences between children, adolescents and adults, children and adolescents have been excluded from the scope of this project 2. Speak and read English fluently. As with the chiropractors, the inclusion criteria of speaking and reading English fluently has been set so study participants may coherently understand the questions in the PROMs used in the study 3. Be a private patient presenting to the musculoskeletal clinic 4. Present to the clinic with self‐reported back pain SECONDARY OUTCOME: Quantitative secondary outcome measures measured at 90 days: ; 1. Health‐related quality of life (HRQoL), measured using the EQ‐5D thermometer; 2. Pain‐related fear, measured using the fear subscale of the pain anxiety symptoms scale (PASS‐20); 3. Pain catastrophising, measured using the catastrophising subscale of the coping strategies questionnaire (CSQ‐CAT); 4. Fear‐avoidance behaviours, measured using the fear‐avoidance beliefs questionnaire physical activity subscale (FABPA); 5. Self‐efficacy for self‐management, measured using the self‐efficacy beliefs in patients with chronic pain subscale ‐ self‐efficacy for pain management (PSE); 6. Self‐management behaviours, measured using the maintenance subscale of the pain stages of change questionnaire (PSOCQ); 7. Treatment perceptions, measured using four‐item low back pain treatment beliefs questionnaire; 8. Patient‐centered communication, measured using patient perception of patient centeredness questionnaire; 9. Therapeutic alliance, measured using working alliance inventory ‐ short‐revised (WAI_SR); 10. Patient satisfaction, measured using a one‐item question: “Over the course of chiropractic treatment for your low back pain how would you rate your overall care?”, scored on a five‐point scale from ‘very dissatisfied’ to ‘very satisfied’; 11. Intervention fidelity, measured using a one‐item question: “Did you and your chiropractor discuss the questionnaires that you filled in before, during and after your treatment?”, scored on a seven point scale from ‘never’ to ‘always'; ; Nested qualitative study:; 1. Audio recordings ‐ one participant per cluster will be randomly sampled to have their treatment sessions audio recorded. The audio recordings will allow researchers to explore and understand the behaviour and activities of participants in relation to discussion of PROMs within treatment sessions; 2. Qualitative interviews ‐ within one month following participants’ completion of the 90‐day PROMs, qualitative semi‐structured interviews will be conducted individually with a subset of participants (n = 35) and chiropractors (n = 15). Purposive sampling will be used to intentionally recruit participants from the groups who have had clinically meaningful changes in pain scores and HRQoL and participants who have no changes in pain scores and HRQoL. Using qualitative interviews allows for exploration into patients’ and practitioners’ subjective evaluations of how PROMs may have an effect when used in the treatment of low back pain