Trials we cannot trust? Assessing trustworthiness of randomised controlled trials
Investigating the trustworthiness of clinical trials in pain research, and how the INSPECT SR tool can improve reliability
In this talk, Neil O'Connell will discuss an investigation into the trustworthiness of a group of clinical trials in the field of back pain, and an exploration of the impact that those trials have had on the evidence base and on international clinical guidelines. He will also introduce the ENTRUST-PE framework for more trustworthy evidence in pain.
He will then pass over to Jack Wilkinson, who will introduce the problem of untrustworthy data entering systematic reviews. Many systematic reviews contain problematic randomised controlled trials (RCTs). These are studies with false data or results, which could be caused by research misconduct (i.e. data fabrication) or by critical errors in study conduct. Risk of bias tools are not designed to detect problems of this nature. This prompts the question of how problematic RCTs may be detected by systematic reviewers.
The INSPECT-SR (INveStigating ProblEmatic Clinical Trials in Systematic Reviews) tool has been developed in partnership with Cochrane for this purpose. In this talk, Jack will introduce the INSPECT-SR tool by describing its development and illustrating its use with an example. The session will also provide details on how to access further resources, including free online training workshops.
Speakers
Neil O'Connell
Neil O'Connell is Professor of Evidence-Based Healthcare in the Physiotherapy Division of the Department of Health Sciences at Brunel University.
Neil's research interests focus on the evidence-based management of persistent pain. He was the Co-ordinating Editor for the Cochrane Pain, Palliative and Supportive Care (PaPaS) group from 2020-23 and is a member of Cochrane's central editorial board. He was a member of the Guideline Development Group for the UK's National Institute of Health and Care Excellence (NICE) 2016 clinical guideline on the management of low back pain and sciatica.
He is the current Chair of the International Association for the Study of Pain (IASP) Methods, Evidence Synthesis and Implementation Special Interest Group (MESIGIG) and the Scientific Co-ordinator ENhancing TRUST in Pain Evidence (ENTRUST-PE) network.
Jack Wilkinson
Jack Wilkinson is a Senior Lecturer in the Centre for Biostatistics at the University of Manchester, UK.
His research interests cover both the application, development, and criticism of methods for the evaluation of health interventions, with a particular interest in interventions for the treatment of subfertility, including assisted reproductive technologies (ART). He is a statistical editor for Cochrane Gynaecology and Fertility.
Jack has a background in undertaking integrity investigations for scientific journals and publishers. He also leads the NIHR-funded INSPECT-SR project, which has developed a tool for identifying ‘problematic’ randomised controlled trials including those subject to data fabrication or falsification.
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