Side effects are incompletely reported among systematic reviews in gastroenterology

Mahady, Suzanne E.; Schlub, Timothy E.; Bero, Lisa; Moher, David; Tovey, David; George, Jacob; Craig, Jonathan C.

doi:10.1016/j.jclinepi.2014.06.016

Cited by 17 publications

(21 citation statements)

References 53 publications

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“…Research topics include reviews of time trends in the nature and quality of publications; the development of tools and strategies to improve the planning, design, conduct, management and reporting of biomedical research; investigating strategies to help journals to improve the quality of manuscripts; and so on (e.g. Hopewell et al, 79 Stevens et al, 80 Barnes et al, 81 Mahady et al 82 ).…”

Section: Further Development Of the Equator Networkmentioning

confidence: 99%

A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

2016

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Section: Further Development Of the Equator Networkmentioning

confidence: 99%

A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

2016

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“…9 Also, selectively reporting outcomes that favor the intervention or omitting outcomes such as adverse events may be misleading and can potentially cause harm. 13–15 A systematic review found that only 2% of trials of immunosuppressive agents in kidney disease reported a quality of life outcome and almost all reported effect estimates that favored the intervention. 16…”

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confidence: 99%

Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop

Pecoits-Filho

Craig

Tong

et al. 2018

Kidney International

Self Cite

153

144

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There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes.

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“…Some studies assessed the quality of systematic reviews reporting adverse drug reactions. In general, systematic reviews reporting adverse drug reactions failed methodologically [23–25]. Definition of adverse drug reaction, design of literature search, bibliographic database choice, and assessment of methodological quality of the included studies are the main divergent steps [23–25].…”

Section: Discussionmentioning

confidence: 99%

“…In general, systematic reviews reporting adverse drug reactions failed methodologically [23–25]. Definition of adverse drug reaction, design of literature search, bibliographic database choice, and assessment of methodological quality of the included studies are the main divergent steps [23–25]. In most of the studies, only a small proportion has good reporting [23–25].…”

Section: Discussionmentioning

confidence: 99%

“…Definition of adverse drug reaction, design of literature search, bibliographic database choice, and assessment of methodological quality of the included studies are the main divergent steps [23–25]. In most of the studies, only a small proportion has good reporting [23–25]. In a previous work, we analyzed the methodology used in systematic reviews reporting ophthalmic adverse drug reactions and found the same methodological issues [26].…”

Section: Discussionmentioning

confidence: 99%

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A comparison between two recommendations to conduct and report systematic reviews on drug’s safety

Penedones

Marques

2019

Syst Rev

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Background Several recommendations are available to conduct and report a systematic review of adverse drug reactions. This study is aimed at identifying and comparing the methodologies of the two most commonly used recommendations to conduct and report systematic reviews on drug’s safety. Methods Two systematic reviews were conducted following the recommendations “Cochrane Handbook for Systematic Reviews of Interventions” and “Systematic Reviews’ Centre for Reviews and Dissemination guidance for undertaking reviews in healthcare.” The methods of each recommendation were characterized, and the results and the discussion of each systematic review were also evaluated. Results The methodologies of both recommendations are similar. The review question was structured. Both recommendations suggest to include pre- and post-marketing data. The recommended data sources differed and, consequently, the results of the systematic reviews (37 vs. 35 studies). Other aspects of search literature were identical. Different tools are suggested to evaluate the methodological quality of the included studies. For case reports, both recommendations only report some questions that may be helpful to assess risk of bias. The reporting of the results and discussion is also identical for both recommendations. Conclusions Few methodological differences were observed between the analyzed recommendations to conduct a systematic review on drug’s safety. Combining their methods into a single and recognized recommendation could be of great value.

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Side effects are incompletely reported among systematic reviews in gastroenterology

Cited by 17 publications

References 53 publications

A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network

Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop

A comparison between two recommendations to conduct and report systematic reviews on drug’s safety

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