Journal Article

PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations (the PERISCOPE trial) – a study protocol for a pragmatic, UK multicentre, superiority randomised controlled trial with an internal pilot, economic evaluation and nested qualitative study

Ronaldson, Sarah, Parkinson, Gillian, Taylor, Johanna, Abhishek, Abhishek, Goodman, Susan Marion, Mott, Andrew, Li, Jinshuo, Pandit, Hemant, Marzo-Ortega, Helena, Maxwell, James, Nanchahal, Jagdeep, Adamson, Joy, van Duren, Bernard, Hewitt, Catherine, Mankia, Kulveer Singh, Shepherd, Susan, Brady, Samantha, Carlisle, Katie, Richards, Duncan, Mandefield, Laura, Rangan, Amar, Wilkinson, Jeremy Mark, Coates, Laura, Emery, Paul

2024

Overview

IntroductionBiological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT).Methods and analysisPERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients’ and clinicians’ acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively.Ethics and disseminationEthical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period.Trial registration numberISRCTN17691638.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Antirheumatic Agents - economics / Antirheumatic Agents - therapeutic use / Biological products / Biological Products - economics / Biological Products - therapeutic use / Clinical outcomes / Cost-Benefit Analysis / Disease control / Drug dosages / Equivalence Trials as Topic / Health services / Humans / Infections / Information systems / Informed consent / Intervention / Multicenter Studies as Topic / orthopaedic & trauma surgery / Orthopedic Procedures / Orthopedics / Patient satisfaction / Perioperative Care - economics / Perioperative Care - methods / Pilot Projects / Pragmatic Clinical Trials as Topic / Psoriatic arthritis / Qualitative Research / Quality of life / Questionnaires / randomized controlled trial / Rehabilitation / Rheumatoid arthritis / Rheumatology / Steroids / Surgery / Surgical outcomes / Sutures / United Kingdom / Wound healing