Physicians Should Be Critical of Adverse Event Reporting in Clinical Trials

MedicalResearch.com Interview with:

Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department  IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy

Dr. Paolo Bossi

Paolo Bossi MD
Medical Oncologist
Head and Neck Cancer Department
IRCCS Istituto Nazionale dei Tumori Foundation
Milan, Italy

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

Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs.

It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs.
However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities.

This line of reasoning is particularly true for new or “relatively new” drugs, such as immunotherapy (IT) and targeted agents (TT).

So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database.

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Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions May Differ

MedicalResearch.com Interview with:

Dr Su Golder PhD Research Fellow Department of Health Sciences University of York

Dr. Su Golder

Dr Su Golder PhD
Research Fellow
Department of Health Sciences
University of York

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

Response: Serious concerns have emerged regarding publication bias or selective omission of outcomes data, whereby negative results are less likely to be published than positive results. There remains considerable uncertainty about the extent of unpublished data on adverse events beyond that reported in the published literature. We aimed to estimate the potential impact of additional data sources and the extent of unpublished information when conducting syntheses of adverse events.

We found that less published papers contain adverse events information. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies.

We also found even when adverse events are reported in the published and unpublished versions of the same study that the numbers of adverse events do not always match The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%.
Lastly we found that inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in three-quarters of pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases.

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Family Members Can Help Patients Understand Hospital Discharge Instructions

Dennis Tsilimingras, M.D., M.P.H. Assistant Professor, Co-Director of Michigan AHEC (Area Health Education Center), Director of Patient Safety, Department of Family Medicine and Public Health Sciences Wayne State University School of Medicine Detroit, MichiganMedicalResearch.com Interview with:
Dennis Tsilimingras, M.D., M.P.H.
Assistant Professor,
Co-Director of Michigan AHEC (Area Health Education Center),
Director of Patient Safety,
Department of Family Medicine and Public Health Sciences
Wayne State University School of Medicine
Detroit, Michigan

Medical Research: What is the background for this study?

Dr. Tsilimingras: There has been little research to examine post-discharge adverse events (AEs) in rural patients discharged from community hospitals.

Medical Research: What are the main findings?

Dr. Tsilimingras: Over 28 % of 684 patients experienced postdischarge AEs, most of which were either preventable or ameliorable. There was no difference in the incidence of post-discharge AEs in urban versus rural patients, but post-discharge adverse events were associated with hypertension, type 2 diabetes mellitus, and number of secondary discharge diagnoses only in urban patients.

Medical Research: What should clinicians and patients take away from your report?

Dr. Tsilimingras: Post-discharge adverse events were common in both urban and rural patients and many were preventable or ameliorable. Potentially different risk factors for AEs in urban versus rural patients suggests the need for further research into the underlying causes. Patients should be accompanied by family members at the time of discharge to better understand post-discharge instructions.  Patients and family members should not be afraid to ask as many questions as possible regarding follow-up care in their community.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Tsilimingras: Potentially different risk factors for adverse events in urban versus rural patients suggests the need for further research into

the underlying causes. Different interventions may be required in urban versus rural patients to improve patient safety during transitions in care.

Citation:

Post-Discharge Adverse Events Among Urban and Rural Patients of an Urban Community Hospital: A Prospective Cohort Study.

Tsilimingras D1, Schnipper J, Duke A, Agens J, Quintero S, Bellamy G, Janisse J, Helmkamp L, Bates DW.

J Gen Intern Med. 2015 Mar 31. [Epub ahead of print]

 

MedicalResearch.com Interview with: Dennis Tsilimingras, M.D., M.P.H. (2015). Family Members Can Help Patients Understand Hospital Discharge Instructions 

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.
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