Systematic Reviews May Not Address Adverse Side Effects

MedicalResearch.com Interview with:

Dr Su Golder, PhD Department of Health Sciences University of York

Dr. Golder

Dr. Su Golder, PhD
Department of Health Sciences
University of York

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  Patients and providers need to know about the relative benefits and harms of an intervention. It is not just those adverse events deemed to be serious that are important but also those categorized as minor.

Systematic reviews are summaries of the evidence, often used in to inform guidelines and decision-making. It is common for systematic reviews to focus on the potential benefits of an intervention without addressing the adverse effects. This leads to bias and an incomplete picture of the evidence.

To aid transparency in systematic reviews, authors should published a protocol, describing what they intend to do. We look at protocols with a completed systematic review published in 2017 or 2018. We found that only 38% said that they would record adverse effects.

Equally worrying of those authors that stated in their protocol that they intended to look at adverse effects – only 65% fully reported the adverse outcome exactly as they set out to do. 

MedicalResearch.com: What should readers take away from your report?

Response: Decision makers should be wary that evidence that they use from systematic reviews may be biased. In particular, evidence may not incorporate a complete picture of the harms profile of an intervention. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Authors of systematic reviews should be encouraged to include harms outcomes in their protocols and then fully report them in their published systematic reviews. Guideline producers and policy makers need to be aware that systematic reviews may not provide enough information to undertake a full benefit:harm evaluation.

Future research, should be undertaken to identify the barriers to including harms outcomes in systematic reviews, particularly in the protocol and published article. In addition, evaluations should be undertaken of any potentially useful interventions to address these barriers.

Disclosures: Disclosures: None of the authors have any conflicts of interest or financial relationships to disclose. Dr Su Golder is funded by a post-doctoral fellowship (PDF-2014-07-04) through the National Institute for Health Research (NIHR) (and Health Education England if applicable). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Citation:

Rachael Parsons, Su Golder, Ian Watt. More than one-third of systematic reviews did not fully report the adverse events outcome. Journal of Clinical Epidemiology, 2019; 108: 95 DOI: 1016/j.jclinepi.2018.12.007 

Feb 8, 2019 @ 1:20 pm

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