Adverse Events Reporting: Room for Improvement

Sunita Vohra MD MSc FRCPC FCAHS Director, CARE Program Director, PedCAM Network, AIHS Health Scholar Professor, Dept of Pediatrics Faculty of Medicine & Dentistry University of Alberta Edmonton Continuing Care Centre, Edmonton, Alberta CanadaMedicalResearch.com Interview with:
Sunita Vohra MD MSc FRCPC FCAHS
Director, CARE Program
Director, PedCAM Network, AIHS Health Scholar
Professor, Dept of Pediatrics Faculty of Medicine & Dentistry
University of Alberta
Edmonton Continuing Care Centre, Edmonton, Alberta Canada

MedicalResearch.com: What are the main findings of the study?

Dr. Vohra: Our main findings were: (i) relative to how often systematic reviews
evaluate the effectiveness of health interventions, the systematic review
of harms is quite neglected; and (ii) even when systematic reviews do aim
to evaluate harms, there is considerable room for improvement in reporting.

MedicalResearch.com: Were any of the findings unexpected?

Dr. Vohra: All health interventions have the potential for benefit and the potential
for harm. It is surprising that even though clinicians and patients need
information about both, there are so few systematic reviews that evaluate
harms. It is worrying that harms are under-studied, under-reported, and
that this is compounded by the lack of synthesis of harms data in
systematic reviews (and the poor reporting we found in those reviews). This
suggests that decision-makers don’t have the information they need, in
order to choose the best therapy.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Vohra: Clinicians and patients need to demand better quality evidence with which to make decisions, and they need to ask this of all parties: e.g. funders
(who often spend taxpayer money on evaluating therapies), journal editors
(who publish health research), and researchers (who conduct/report health
research). At every stage, an equal emphasis on the investigation and
reporting of harms is warranted, so that high quality data about benefits
and harms are available to decision-makers.

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

Dr. Vohra:  We think reporting guidelines to improve the reporting of harms in
systematic reviews are warranted (e.g. PRISMA harms extension). Hopefully
it will have the same positive impact to improve the quality of reporting
that PRISMA has had on systematic reviews.

Citation:

Quality of reporting in systematic reviews of adverse events: systematic
review

Zorzela L ,Golder S ,Liu Y ,Pilkington K ,Hartling L ,Joffe A ,et al.
Quality of reporting in systematic reviews of adverse events: systematic review.
BMJ 2014;348:f7668