Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

Autor:	Beard DJ; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Campbell MK; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Blazeby JM; Centre for Surgical Research, NIHR Bristol and Weston Biomedical Research Centre, Population Health Sciences, University of Bristol, Bristol, UK., Carr AJ; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Weijer C; Departments of Medicine, Epidemiology and Biostatistics, and Philosophy, Western University, London, ON, Canada., Cuthbertson BH; Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada., Buchbinder R; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia., Pinkney T; Academic Department of Surgery, University of Birmingham, Queen Elizabeth Hospital Birmingham, Birmingham, UK., Bishop FL; Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK., Pugh J; The Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK., Cousins S; Centre for Surgical Research, NIHR Bristol and Weston Biomedical Research Centre, Population Health Sciences, University of Bristol, Bristol, UK., Harris I; Faculty of Medicine, South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia., Lohmander LS; Department of Clinical Sciences Lund, Orthopedics, Clinical Epidemiology Unit, Lund University, Lund, Sweden., Blencowe N; Centre for Surgical Research, NIHR Bristol and Weston Biomedical Research Centre, Population Health Sciences, University of Bristol, Bristol, UK., Gillies K; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Probst P; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany., Brennan C; Patient representative, Oxford, UK., Cook A; Wessex Institute, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Farrar-Hockley D; Patient representative, Oxford, UK., Savulescu J; The Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK., Huxtable R; Centre for Surgical Research, NIHR Bristol and Weston Biomedical Research Centre, Population Health Sciences, University of Bristol, Bristol, UK., Rangan A; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.; Department of Health Sciences, University of York, York, UK., Tracey I; Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK., Brocklehurst P; Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Ferreira ML; Faculty of Medicine and Health, Institute of Bone and Joint Research, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia., Nicholl J; School of Health and Related Research, University of Sheffield, Sheffield, UK., Reeves BC; Clinical Trials Evaluation Unit Bristol Medical School, University of Bristol, Bristol Royal Infirmary, Bristol, UK., Hamdy F; Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK., Rowley SC; Medical Research Council, London, UK., Lee N; Editorial Department, The Lancet, London, UK., Cook JA; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Jazyk:	angličtina
Zdroj:	Health technology assessment (Winchester, England) [Health Technol Assess] 2021 Sep; Vol. 25 (53), pp. 1-52.
DOI:	10.3310/hta25530
Abstrakt:	Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future Work: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funding: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.
Databáze:	MEDLINE
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