543: Designing acceptability and feasibility testing for RCTs: Lessons from the NHMRC AUSMODIC study

Topic: Clinical Science
Subtopic: Pain category (ICD-11), Chronic secondary musculoskeletal pain, Developing methodology/technology, Pharmacological treatments, Treatment/management

Background and Aims: Feasibility and acceptability studies are essential for optimising the design and implementation of randomised controlled trials (RCTs), particularly for novel or complex interventions. However, there is limited practical guidance on how to systematically design and integrate these processes prior to a definitive trial. This NHMRC-funded study aims to illustrate a structured, theory-informed approach to designing and conducting acceptability and feasibility testing, using the AUSMODIC trial as an example. The AUSMODIC trial investigates antibiotic therapy for chronic low back pain associated with Modic type 1 changes, a condition with ongoing scientific debate and clinical uncertainty. The aim of this study is to describe the design and methodological approach used to develop and optimise trial processes prior to a definitive RCT.

Methods: We developed a multi-phase feasibility program informed by National Institute for Health and Care Research guidance and contemporary literature on feasibility and acceptability studies. The program integrates two components. First, a qualitative workplan using semi-structured interviews and focus groups with patients and clinicians to explore perceptions of recruitment, randomisation, telehealth delivery, treatment regimen, and data collection. Data are guided by the Theoretical Framework of Acceptability to explore constructs such as burden, intervention coherence, and perceived effectiveness. Second, a pilot RCT will evaluate recruitment rates, retention, adherence, and feasibility of trial procedures in a real-world setting. The study is designed by a multidisciplinary team with expertise in clinical trials, qualitative research, musculoskeletal health, and infectious diseases. Consumer involvement is embedded throughout the design process to enhance relevance and acceptability.

Results: This framework outlines a structured approach to identifying and addressing potential barriers to trial participation and delivery. Integrating qualitative insights with pilot trial data is expected to inform recruitment strategies, refine intervention delivery, and optimise trial processes. The qualitative component will provide in-depth understanding of participant and clinician perspectives, while the pilot trial will generate key feasibility metrics. Together, these components are expected to strengthen the overall trial design and improve the likelihood of successful implementation of the definitive RCT.

Conclusions: This study provides a practical, theory-informed example of how acceptability and feasibility testing can be systematically integrated into the design of complex RCTs. By combining qualitative methods with pilot trial evaluation, the approach enables early identification and mitigation of potential barriers to recruitment, intervention delivery, and trial implementation. This structured framework may inform future trial design, particularly for novel or potentially controversial interventions, by enhancing feasibility, improving participant and clinician acceptability, and increasing the likelihood of successful delivery of definitive trials.

References: ١. Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88
2. Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016;11(3):e0150205.
3. National Institute for Health and Care Research (NIHR). Feasibility and pilot studies guidance. Available from: https://www.nihr.ac.uk

Presenting Author: Abdulaziz Albhlal
Submitting Author: Abdulaziz Albhlal

Senior Author: Abdulaziz Albhlal

IASP 2026 Global Year theme of Neuropathic Pain: No

• Abdulaziz Albhlal: BSc (Physiotherapy), MSc (Clinical Musculoskeletal Physiotherapy), PhD candidate - 1. School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia 2. Institute for Musculoskeletal Health, Sydney Local Health District, Australia
• Caitlin Jones - 1. School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia 2. Institute for Musculoskeletal Health, Sydney Local Health District, Australia
• Chung-Wei Christine Lin - 1. School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia 2. Institute for Musculoskeletal Health, Sydney Local Health District, Australia
• Kristen Pickles - 1. School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia 2. Institute for Musculoskeletal Health, Sydney Local Health District, Australia
• Abby Haynes - 1. School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia 2. Institute for Musculoskeletal Health, Sydney Local Health District, Australia
• Chris Maher - 1. School of Public Health, Faculty of Medicine and Health, The University of Sydney, Australia 2. Institute for Musculoskeletal Health, Sydney Local Health District, Australia