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Animal Ethics Biosafety Human Research Ethics Research Integrity

Trials we cannot trust: investigating their impact on systematic reviews and clinical guidelines in spinal pain (Papers: N.E. O’Connell et. al. | July 2023)

Posted by Dr Gary Allen in Human Research Ethics, Research Integrity on July 31, 2023
Keywords: Breaches, Clinical trial, Journal, Medical research, Research Misconduct, Research results

The Linked Original Item was Posted On July, 13 2023 04:48:27

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Highlights

  • A group of trials with trust concerns had major impacts on the results of systematic reviews and clinical guidelines.
  • They substantially impacted effect sizes and influenced the conclusions and recommendations drawn.
  • There is a need for a greater focus on the trustworthiness of studies in evidence appraisal.

The damage done by compromised can clinical trials is not marginal or theoretical, especially when their results make it into systematic reviews, clinical texts or clinical practice.  They can cause serious harm, suffering and even death. Institutions, funding bodies, registers and publishes have a clear role.  Retractions must be promptly and clearly reported.  Researchers and authors must take care never to cite retracted work.  Anything that undermines the reliability of the scientific record, especially in relation to medical/professional practice is a series form of misconduct and should be treated as such.

We previously conducted an exploration of the trustworthiness of a group of clinical trials of cognitive behavioural therapy (CBT) and exercise in spinal pain. We identified multiple concerns in eight trials, judging them untrustworthy. In this study, we systematically explored the impact of these trials (“index trials”) on results, conclusions and recommendations of systematic reviews and clinical practice guidelines (CPGs). We conducted forward citation tracking using Google Scholar and the citation chaser tool, searched the Guidelines International Network (GIN) library and National Institute of Health and Care Excellence (NICE) archive to June 2022 to identify systematic reviews and CPGs. We explored how index trials impacted their findings. Where reviews presented meta-analyses, we extracted or conducted sensitivity analyses for the outcomes pain and disability, to explore how exclusion of index trials affected effect estimates. We developed and applied an ’Impact Index’ to categorise the extent to which index studies impacted their results. We included 32 unique reviews and 10 CPGs. None directly raised concerns regarding the veracity of the trials. Across meta-analyses (55 comparisons), removal of index trials reduced effect sizes by a median 58% (IQR 40 to 74). 85% of comparisons were classified as highly, 3% as moderately, and 11% as minimally impacted. Nine out 10 reviews conducting narrative synthesis drew positive conclusions regarding the intervention tested. Nine out of 10 CPGs made positive recommendations for the intervention(s) evaluated. This cohort of trials, with concerns regarding trustworthiness, has substantially impacted the results of systematic reviews and guideline recommendations.

Perspective

We found that a group of trials of CBT for spinal pain with concerns relating to their trustworthiness have had substantial impacts on the analyses and conclusions of systematic reviews and clinical practice guidelines. This highlights the need for a greater focus on the trustworthiness of studies in evidence appraisal.

Keywords

Clinical trials, spinal pain, trustworthiness, systematic reviews, clinical practice guidelines

O’Connell, N. E., Moore, R. A., Stewart, G., Fisher, E., Hearn, L., Eccleston, C., Wewege, M., & de C Williams, A. C. (2023). Trials we cannot trust: investigating their impact on systematic reviews and clinical guidelines in spinal pain. The journal of pain, S1526-5900(23)00467-4. Advance online publication. https://doi.org/10.1016/j.jpain.2023.07.003
Publisher (Open Access): https://www.jpain.org/article/S1526-5900(23)00467-4/fulltext

Trials we cannot trust: investigating their impact on systematic reviews and clinical guidelines in spinal pain
We previously conducted an exploration of the trustworthiness of a group of clinical
trials of cognitive behavioural therapy (CBT) and exercise in spinal pain. We identified
multiple concerns in eight trials, judging them untrustworthy. In this study, we systematically
explored the impact of these t…

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