Clinical Risk Osteopathy and Management (CROaM) project
Welcome to the CROaM project
Treatment reactions to manual therapy have attracted increased interest in recent years. The distinction between adverse events and unpleasant but benign treatment reactions is unclear. The CROaM study will examine the process of treatment from both patient and practitioner perspectives and document perceived adverse events, treatment reactions and outcomes related to osteopathic interventions. This will be achieved through questionnaires to osteopaths and patients followed by in depth interviews with selected patients and osteopaths.
The project aims:
The overall aim of the project is to provide a description of UK osteopaths' risk assessment and risk management; to document reported adverse events and treatment reactions in patients; to deliver a model of practitioners' and patients' perceptions and beliefs about adverse events and treatment reactions. In addition, the short term follow up of patients' outcomes will enable a narrative evaluation of the comparative risks and benefits of osteopathic treatment. The study began in August 2009 and due to be completed in January 2012.
Methods:
A mixed methods approach will be used in three stages.
Stage 1. Cross sectional postal questionnaire survey of osteopaths.
Stage 2. Questionnaire based observational cohort study of consecutive osteopathic patients.
Stage 3. Qualitative interview study of osteopathic practitioners and patients sampled from survey responses in stages 1 and 2.
Who is conducting the research?
The research will be conducted by the research team at the British School of Osteopathy in collaboration with Warwick Medical School, Royal Holloway University of London and Bart's and the London School of Medicine and Dentistry.
The research team:
Steven Vogel (Principal Investigator)
Steven Vogel is Vice Principal (Research and Quality) at the BSO. He is a practicing osteopath and has led national surveys of the osteopathic profession and been involved in the design of both patient and community surveys. He has published service delivery and guideline related research in low back pain and has contributed to the development of a NICE back pain clinical guideline.
Thomas Mars (Research Fellow)
Thomas Mars is a practicing osteopath. Working as a research assistant at Queen Mary's Bart's and the London he has recently completed a published systematic review on adverse events in manual therapy. He is a trained Cochrane systematic reviewer and is a member of the European School of Osteopathy adverse events working group, and the Cochrane Back Pain Review and Musculoskeletal Groups.
Sam Keeping (Research Administrator)
Sam Keeping has a degree in Government and is currently studying towards a Master of Science degree in Health Policy, Planning and Financing. He was the Research Administrator and Secretary to the BSO REC and has extensive training in IT.
Co-applicants:
Dr Tamar Pincus, Royal Holloway, University of London
Dr Pincus is Associate Professor at the BSO and Reader in Psychology at RHUL. She is a member of The Cochrane Back Pain Study Group and the Medical Research Council College of Experts. Dr Pincus is trained in psychology, research methodology and epidemiology and has published widely in the field of psychological factors in pain in general and back pain specifically. Dr Pincus has led mixed methods studies involving osteopaths and other professional groups.
Professor Martin Underwood, Warwick Medical School
Professor Underwood is Professor of General Practice and Acting Dean of Warwick Medical School and a practicing GP. Professor Underwood has developed a substantial track record of community based research into the improved diagnosis and management of musculoskeletal disorders, particularly back pain and osteoarthritis. He has completed large trials of exercise and manipulation for low back pain (UK BEAM) and of anti-inflammatory ointments for knee pain (TOIB). Professor Underwood chaired the development of NICE clinical guideline on back pain and contributed to the development of clinical guidelines for osteoarthritis.
Professor Sandra Eldridge, Queen Mary, University of London
Professor Eldridge is a Professor of Biostatistics and joint centre lead at the Institute of Health Sciences Education, Barts and The London. She has a special interest in cluster randomized trials, and has extensive experience of research in primary care settings as well as an interest in the process of consent in trials.
Study collaborator:
Dr Michelle Qume
Dr Michelle Qume has wide experience of large scale data management and processing. She was the Data Manager in the Department of Primary Care and General Practice at the University of Birmingham. Dr Qume has experience of data meta-analytical approaches and extensive experience Optical Mark Recognition data capture and processing.
Funding the study:
The General Osteopathic Council called for the research and is funding the majority of the project with a small contribution from the BSO. The National Council for Osteopathic Research's Grants Committee managed the call for research and awarded the study to the British School of Osteopathy.
Quality Assurance:
Quality assurance for all stages of the project is overseen by a steering committee made up of the following members:
- Professor Alan Breen, Director Institute for Musculoskeletal Research and Clinical Implementation, Anglo European College of Chiropractic
- Mr. Roger Kerry, Associate Professor Division of Physiotherapy Education, University of Nottingham and member of the National Council of Osteopathic Research's Grants Governance Committee
- Dr Nefyn Williams, Clinical Senior Lecturer, Primary Care and Public Health Department of Primary Care and Public Health, Cardiff University
- Margaret Wolff, Lecturer in Ethics at the British School of Osteopathy and Member of the General Osteopathic Council's Statutory Professional Conduct Committee and Chair of the Health Committee.
The committee meets quarterly with the research team to discuss and oversee the progress and quality of the project. In addition the project team report quarterly to the National Council of Osteopathic Research's Grant's Governance Committee.