Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

<p>Abstract</p> <p>Background</p> <p>The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.</p> <p>Methods</p> <p>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.</p> <p>A standardized abstraction form was used to extract data.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention.</p> <p>Trials Registration</p> <p>Trials manuscript: 5534201182098351 (T80802P)</p

Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention

<p>Abstract</p> <p>Background</p> <p>Stents are commonly used to treat patients with coronary artery disease. However, the quality of reporting internal and external validity data in published reports of randomised controlled trials (RCTs) of stents has never been assessed.</p> <p>The objective of our study was to evaluate the quality of reporting internal and external validity data in published reports of RCTs assessing the stents for percutaneous coronary interventions.</p> <p>Methods</p> <p>A systematic literature review was conducted. Reports of RCTs assessing stents for percutaneous coronary interventions indexed in MEDLINE and the Cochrane Central Register of Controlled Trials and published between January 2003 and September 2008 were selected. A standardized abstraction form was used to extract data. All analyses were adjusted for the effect of clustering articles by journal.</p> <p>Results</p> <p>132 articles were analyzed. The generation of the allocation sequence was adequate in 58.3% of the reports; treatment allocation was concealed in 34.8%. Adequate blinding was reported in one-fifth of the reports. An intention-to-treat analysis was described in 79.5%. The main outcome was a surrogate angiographic endpoint in 47.0%. The volume of interventions per center was described in two reports. Operator expertise was described in five (3.8%) reports. The quality of reporting was better in journals with high impact factors and in journals endorsing the CONSORT statement.</p> <p>Conclusion</p> <p>The current reporting of results of RCTs testing stents needs to be improved to allow readers to appraise the risk of bias and the applicability of the results.</p

Méthodes d'évaluation des traitements non pharmacologiques (l'exemple des dispositifs médicaux implantables)

Un premier travail a consisté en la comparaison des résultats de tolérance de traitements médicamenteux (TM) et non médicamenteux (TNM) en rhumatologie : 119 évaluant des TM et 74 évaluant des TNM sur 6 ans ont été analysés. Les données de tolérance sont plus souvent décrites dans les TM que dans les TNM (86,5% vs 47,3%). Ces résultats persistent après ajustement sur différents paramètres tels la pathologie, la taille de la population étudiée, le financement de l étude. Ce travail a permis de montrer que l appréciation du rapport bénéfice risque est fortement biaisée par le manque d information sur les traitements évalués. Nous nous sommes ensuite focalisés sur l évaluation (intervention et tolérance) des stents dans les essais randomisés en cardiologie (n=132). Le traitement à l étude était un stent actif dans 49 % des essais sélectionnés. Pourtant, le nombre de centres impliqués n était pas reporté dans un tiers des essais sélectionnés et le volume d activité des centres n était jamais décrit. Seul un tiers des essais rapportait le nom des centres ayant participé à l étude. L intervention était décrite dans 91,7% des essais, cependant, des composantes importantes de l intervention étaient insuffisamment décrites : la voie d abord (15,9%), l équipement utilisé (21,2%). Des données sur l expertise des médecins n étaient rapportées que dans 2 articles. L assignation était décrite et secrète dans 58,3% et l évaluation était réalisée en insu du traitement reçu dans 34,8%. Cette étude démontre la nécessité d améliorer la présentation des données permettant de juger de la validité interne et externePARIS-BIUSJ-Biologie recherche (751052107) / SudocSudocFranceF

Evaluation de la maintenance thérapeutique et des évènements indésirables dans une cohorte de104 polyarthrites rhumatoïdes traitées par infliximab (5 ans de suivi systématique)

STRASBOURG ILLKIRCH-Pharmacie (672182101) / SudocSudocFranceF