A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events

Faillie, Jean‐Luc; Ferrer, Pili; Gouverneur, Amandine; Driot, Damien; Berkemeyer, Shoma; Vidal, Xavier; Martinez‐Zapata, Maria José; Huerta, Consuelo; Castells, Xavier; Rottenkolber, Marietta; Schmiedl, Sven; Sabaté, Mònica; Ballarín, Elena; Ibáñez, Luisa

doi:10.1016/j.jclinepi.2017.04.023

Cited by 30 publications

(27 citation statements)

References 37 publications

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“…All statistical analyses and data visualisation were done in R [14] version 3.5.0. Bayesian regression was done using the brms [15] The risk of bias of individual studies at the outcome level was assessed using the PROTECT [17] checklist for systematic reviews on adverse drug events.…”

Section: Discussionmentioning

confidence: 99%

Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data

et al. 2020

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Section: Discussionmentioning

confidence: 99%

Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data

et al. 2020

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“… 22 , 23 , 24 Risk of bias of individual studies at the outcome level was assessed using the PROTECT checklist for systematic reviews of drug adverse events. 25 …”

Section: Methodsmentioning

confidence: 99%

Risk of sudden unexplained death after use of dihydroartemisinin–piperaquine for malaria: a systematic review and Bayesian meta-analysis

Chan

Win

Mawer

et al. 2018

The Lancet Infectious Diseases

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SummaryBackgroundDihydroartemisinin–piperaquine is an effective and well tolerated artemisinin-based combination therapy that has been assessed extensively for the prevention and treatment of malaria. Piperaquine, similar to several structurally related antimalarials currently used, can prolong cardiac ventricular repolarisation duration and the electrocardiographic QT interval, leading to concerns about its proarrhythmic potential. We aimed to assess the risk of potentially lethal iatrogenic ventricular arrhythmias in individuals receiving dihydroartemisinin–piperaquine.MethodsWe did a systematic review and Bayesian meta-analysis. We searched clinical bibliographic databases (last on May 24, 2017) for studies of dihydroartemisinin–piperaquine in human beings. Further unpublished studies were identified with the WHO Evidence Review Group on the Cardiotoxicity of Antimalarials. We searched for articles containing “dihydroartemisinin-piperaquine” as title, abstract, or subject heading keywords, with synonyms and variant spellings as additional search terms. We excluded animal studies, but did not apply limits on language or publication date. Eligible studies were prospective, randomised, controlled trials or cohort studies in which individuals received at least one 3-day treatment course of dihydroartemisinin–piperaquine for mass drug administration, preventive therapy, or case management of uncomplicated malaria, with follow-up over at least 3 days. At least two independent reviewers screened titles, abstracts, and full texts, agreed study eligibility, and extracted information about study and participant characteristics, adverse event surveillance methodology, dihydroartemisinin–piperaquine exposures, loss-to-follow up, and any deaths after dihydroartemisinin–piperaquine treatment into a standardised database. The risk of sudden unexplained death after dihydroartemisinin–piperaquine with 95% credible intervals (CI) generated by Bayesian meta-analysis was compared with the baseline rate of sudden cardiac death.FindingsOur search identified 94 eligible primary studies including data for 197 867 individuals who had received dihydroartemisinin–piperaquine: 154 505 in mass drug administration programmes; 15 188 in 14 studies of repeated courses in preventive therapies and case management of uncomplicated malaria; and 28 174 as single-course treatments of uncomplicated malaria in 76 case-management studies. There was one potentially drug-related sudden unexplained death: a healthy woman aged 16 in Mozambique who developed heart palpitations several hours after the second dose of dihydroartemisinin–piperaquine and collapsed and died on the way to hospital (no autopsy or ECG was done). The median pooled risk estimate of sudden unexplained death after dihydroartemisinin–piperaquine was 1 in 757 950 (95% CI 1 in 2 854 490 to 1 in 209 114). This risk estimate was not higher than the baseline rate of sudden cardiac death (0·7–11·9 per 100 000 person-years or 1 in 1 714 280 to 1 in 100 835 over a 30-day risk period). The risk...

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“…Since a hierarchy of evidence is not yet defined to assess drug’s safety, several studies questioned the usefulness of these tools once a combination of several types of studies is included in a systematic review and an evaluation of all is not possible [21]. In addition, the majority of the available risk of bias tools are not prepared to assess studies on adverse drug reactions [22]. A systematic review evaluating the quality of reporting in systematic reviews of drug’s safety studies found that a large proportion of the analyzed systematic reviews failed in reporting risk of bias assessment [23].…”

Section: Discussionmentioning

confidence: 99%

“…Nevertheless, some efforts are being made to improve the methodological quality assessment of studies reporting drug’s safety. In addition, a recent study has described a new risk of bias tool to use when conducting systematic reviews of randomized controlled trials, cohort studies, case-control studies, and nested case-control studies describing adverse drug reactions [22].…”

Section: Discussionmentioning

confidence: 99%

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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A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events

Cited by 30 publications

References 37 publications

Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data

Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data

Risk of sudden unexplained death after use of dihydroartemisinin–piperaquine for malaria: a systematic review and Bayesian meta-analysis

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

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