Article Text
Abstract
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.
- ICP, informed consent from patients
- RCT, randomised controlled trial
- REC, research ethics committee
- clinical trials
- ethics
- method
- randomised
- quality
Statistics from Altmetric.com
Footnotes
Read the full text or download the PDF:
Other content recommended for you
- Reporting guidelines for health care simulation research: Extensions to the CONSORT and STROBE statements
- Assessment of the quality of reporting in randomised controlled trials of acupuncture in the Korean literature using the CONSORT statement and STRICTA guidelines
- Adherence in leading medical journals to the CONSORT 2010 statement for reporting of binary outcomes in randomised controlled trials: cross-sectional analysis
- Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review
- Statistical testing of baseline differences in sports medicine RCTs: a systematic evaluation
- CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
- Quality of reporting in sports injury prevention abstracts according to the CONSORT and STROBE criteria: an analysis of the World Congress of Sports Injury Prevention in 2005 and 2008
- Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
- Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review
- Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis