Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery.

Background: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. 

Method: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). 

Results: The mean Jadad score was 9.86 ± 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 ± 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 ± 0.133; it was 0.43 ± 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. 

Conclusion: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

https://jme.bmj.com/content/medethics/31/5/251.full.pdf

Methodological quality and reporting of ethical requirements in phase III cancer trials

Summary Background Ethical standards of biomedical publications are associated with editorial leadership, such as contents of instructions to authors and journal's mechanisms for research and publication ethics. Objectives To compare ethical issues in the guidelines for authors in oral-craniomaxillofacial/facial plastic surgery (OCM–FPS) journals with those in plastic surgery and otorhinolaryngology/head and neck surgery (ORL–HNS) journals, and to evaluate the relationship between journal's impact factor (IF) and ethical issues in the instructions to authors. Methods This study used a cross-sectional study design. The predictor variables were journal's speciality and IF. The outcome variable was the presence of seven ethical issues in the online versions of journal's instructions to authors in October 2009. We included only journals with identifiable IF for 2008, published in English, French, German and Thai. Appropriate descriptive and univariate statistics were computed for all study variables. The level of statistical significance was set at P  Results The sample was composed of 48 journals: seven OCM–FPS (14.6%), 14 plastic surgery (29.2%) and 27 ORL–HNS (56.2%) journals. Only four journals (8.3%) mentioned all ethical issues in their guidelines for authors. Neither journal's speciality nor IF was linked to completeness of the ethical requirements. Conclusions The results of this study suggest that ethical issues in the instructions to authors of most IF-indexed journals in OCM–FPS, plastic surgery and ORL–HNS are incomplete, regardless of speciality and IF. There is room for substantial improvement to uphold scientific integrity of these surgical specialities.

Ethical issues in instructions to authors of journals in oral-craniomaxillofacial/ facial plastic surgery and related specialities

Do all clinical research publications show strong application of ethics principles and respect for biomedical law? We examined, for the year 2009, the ethics requirements displayed on the website of 30 leading medical journals with an impact factor (IF) >10, and 30 others with an IF <10. We carried out a short study looking at the relationship between the IF of a journal and the ethics requirements in its instructions to authors. We show that the IF of a biomedical journal bears a direct relationship to its ethics requirements. Such results should improve the ethics requirements of all biomedical journals, especially those with low IF, so that they are internationally standardised to the higher standard required by journals with higher IF.

https://jme.bmj.com/content/medethics/38/4/253.full.pdf

Ethics requirements and impact factor

Objective: The mortality rate is high in some patients undergoing primary percutaneous coronary intervention (PPCI) because of ineffective epicardial and myocardial perfusion. The use of thrombus aspiration (TA) might be beneficial in this group but there is contradictory evidence in current trials. Therefore, using PRISMA statement, we performed a meta-analysis that compares PPCI+TA with PPCI alone. Methods: Sixteen studies in which PPCI (n=5262) versus PPCI+TA (n=5256) were performed, were included in this meta-analysis. We calculated the risk ratio (RR) for epicardial and myocardial perfusion, such as the Thrombolysis In myocardial Infarction (TIMI) flow, myocardial blush grade (MBG) and stent thrombosis (ST) resolution (STR), and clinical outcomes, such as all-cause death, recurrent infarction (Re-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), stent thrombosis (ST), and stroke. Results: Postprocedural TIMI-III flow frequency, postprocedural MBG II-III flow frequency, and postprocedural STR were significantly high in TA+PPCI compared with the PPCI alone group. However, neither all-cause mortality [6.6% vs. 7.4%, RR=0.903, 95% confidence interval (CI): 0.785-1.038, p=0.149] nor Re-MI (2.3% vs. 2.6%, RR=0.884, 95% CI: 0.693-1.127, p=0.319), TVR/TLR (8.2% vs. 8.0%, RR=1.028, 95% CI: 0.900-1.174, p=0.687), ST (0.93% vs. 0.90%, RR=1.029, 95% CI: 0.668-1.583, p=0.898), and stroke (0.5% vs. 0.5%, RR=1.073, 95% CI: 0.588-1.959, p=0.819) rates were comparable between the groups. Conclusion: This meta-analysis is the first updated analysis after publishing the 1-year result of the “Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction” trial, and it showed that TA did not reduce the rate of all-cause mortality, Re-MI, TVR/TLR, ST, and stroke. (Anatol J Cardiol 2015; 15: 175-87)

Thrombus aspiration in patients with ST elevation myocardial infarction: meta-analysis of 16 randomized trials.

The ethical quality of research could be improved in four ways: increasing the expertise of research committees, encouraging the popularization of research in ethics, delivering medical training in ethics, and improving the a posteriori control of editorial committees. With regard to the last point, we propose ethical guidelines that may be used as a screening device for publication. Scientific publications have a duty to contribute to the diffusion and application of ethical principles. But too often pieces of research published in these journals do not adequately demonstrate their ethical reflections and chosen ethical procedures. Only scientific procedures are extensively discussed. We think it is essential to develop an assessment of the ethical value of research that is featured in journals, in the same way that the methodological value is assessed. This paper reports what motivated our group to create an ethical scheme, how we developed this scheme and what was our process of validation. In the same way that today a study can be refused publication for methodological inadequacies, in the future publication could more likely be refused for ethical shortcomings.

Ethical assessment of clinical research publications.

En France, la recherche biomedicale a ete reglementee par une loi, appelee loi Huriet-Serusclat, du nom des deux senateurs qui l'ont proposee. Elle institue une protection des personnes qui se pretent a ces recherches, avec ou sans un benefice personnel potentiel, individuel et direct. Pour que cette protection soit effective et a l'origine d'une confiance entre la societe et les chercheurs, les auteurs pensent qu'une grille (resumant des elements ethiques a respecter durant les recherches) pourrait avoir l'avantage d'aider les chercheurs, les comites qui donnent un avis sur leurs projets de recherche et les journaux scientifiques qui integrent la qualite ethique dans leur selection des etudes publiees. Une telle grille ne peut etre elaboree sans la participation des chercheurs. C'est l'objet de cette prise de position. Une hierarchisation des criteres proposes pourra etre alors entreprise, apres debat avec les professionnels.

/pdf/qualite-ethique-des-publications-scientifiques-mythe-ou-24qm8x5zs4.pdf

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Ethical assessment of clinical research publications.

Qualité éthique des publications scientifiques : mythe ou réalité ?