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Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention
Morgane Ethgen1, Isabelle Boutron, Philippe Gabriel Steg
1INSERM, U738, Paris, F-75018 France. morganeethgen@hotmail.com
Background:
The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.
Methods:
The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected.A standardized abstraction form was used to extract data.
Results:
132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke) were reported as primary or secondary outcomes in 107 reports (81%). However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22%) and a definition of expected adverse events was provided in 47 (36%). The length of follow-up was reported in 95 reports (72%). Assessment of adverse events by an adjudication committee was described in 46 reports (35%), and adverse events were described as being followed up for 6 months in 24% of reports (n = 32), between 7 to 12 months in 42% (n = 55) and for more than 1 year in 4% (n = 5). In 115 reports (87%), numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%). The causality of adverse events was reported in only 4 articles.
Conclusion:
Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention.
Trials Registration:
Trials manuscript: 5534201182098351 (T80802P).
Insights
Reporting of harm in stent trials for percutaneous coronary intervention was inconsistent. Many randomized controlled trials lacked adequate data on adverse events, impacting patient safety assessments.
Area of Science:
- Cardiovascular Medicine
- Clinical Trial Methodology
- Medical Device Safety
Background:
- Randomized controlled trials (RCTs) are crucial for evaluating medical interventions.
- Stents are widely used in percutaneous coronary intervention (PCI).
- Comprehensive reporting of harm is essential for assessing the safety of medical devices.
Purpose of the Study:
- To assess the reporting of harm in RCTs evaluating stents for PCI.
- To identify deficiencies in harm data reporting in this critical area of cardiology.
Main Methods:
- Methodological systematic review of RCTs.
- Searched MEDLINE and Cochrane Central Register of Controlled Trials.
- Included RCTs on stent treatment for coronary disease published 2003-2008.
Main Results:
- 132 articles analyzed; 81% reported major adverse cardiac events.
- 19% of articles lacked cardiac event data; only 4% reported causality.
- Inadequate reporting of data collection, definitions, follow-up, and adjudication for adverse events.
Conclusions:
- RCTs evaluating stents for PCI often inadequately report harm-related data.
- Deficiencies in reporting hinder comprehensive safety assessments.
- Improved harm reporting standards are needed for PCI stent trials.
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