ArticleJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2012
Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery.
Article in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Pain-focused psychological interventions in women with endometriosis: A systematic review.Neuropsychopharmacology reports · 2023Pooled it
- The Effect of Psychological Interventions on the Quality of Life in Women with Fibromyalgia: A Systematic Review.Journal of clinical psychology in medical settings · 2021Pooled it
- Pooled it
- Quality Assessment and Relevant Clinical Impact of Randomized Controlled Trials of Varicocele: Next Step to Good-Quality Randomized Controlled Trial of Varicocele Treatment.The world journal of men's health · 2022Article
- Randomized controlled trials on erectile dysfunction: quality assessment and relevant clinical impact (2007-2018).International journal of impotence research · 2020Article
- Comparison of self-care in non-cardiac diabetic patients.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019Article
- Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.International urogynecology journal · 2018Article
- Journal impact factor and methodological quality of surgical randomized controlled trials: an empirical study.Langenbeck's archives of surgery · 2017Review
- Quality analysis of randomized controlled trials in the International Journal of Impotence Research: quality assessment and relevant clinical impact.International journal of impotence research · 2017Article
- The relationship between external and internal validity of randomized controlled trials: A sample of hypertension trials from China.Contemporary clinical trials communications · 2015Article
- Conflicts of Interest, Selective Inertia, and Research Malpractice in Randomized Clinical Trials: An Unholy Trinity.Science and engineering ethics · 2015Article
- Analysis of randomized controlled trials in Rheumatology International from 1981 to 2012: methodological assessment.Rheumatology international · 2014Article
- A note on the jadad score as an efficient tool for measuring trial quality.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness.
objectiveThe aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities. STUDY
designAll of the articles chosen for review reported on phase III randomized controlled gastrointestinal surgical trials were published in 12 international journals during 2006 and 2007. The eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. The methodological quality was evaluated using the Jadad scale, and the ethical quality was evaluated using the Berdeu score.
resultsThe mean Jadad score was 9.7 ± 1.78. The methodological quality was insufficient in 64 RCTs (37.4 %; Jadad score <9). The mean Berdeu score was 0.36 ± 0.08. The journal impact factor, number of randomized patients, and number of centers correlated with the outcome of the Jadad score, and the journal impact factor, industry funding, and year in which the trial began correlated with the outcome of the Berdeu score. Informed consent from patients was not obtained in 7 % (n = 12) of the RCTs, and research ethics committee approval was not mentioned in 14.6 % (n = 25) of the RCTs.
conclusionsThe reporting of gastrointestinal surgery RCTs is less than optimal. In our study, the trials of higher methodological quality were more likely to provide information about their ethical aspects. These results suggest the need for more attention to be paid to the conduct of clinical research and the reporting of ethical aspects. The appropriation of the ethical rules by surgeons involved in human clinical trials could improve the methodology and reporting of RCTs in gastrointestinal surgery.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.