Multicentre randomised controlled trials in obstetrics and gynaecology: an analysis of trends over three decades (original) (raw)
Related papers
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2020
To describe the characteristics of obstetrical and gynecological randomized clinical trials (RCTs) that were registered at a national database, and to identify factors associated with the publication among the completed trials. Study Design: This was a cross-sectional study using data from ClinicalTrials.gov which was queried for all obstetrical and gynecological RCTs that were registered between January 1, 2009 and December 31, 2013. Poisson regression models were used to examine the factors associated with publication among the completed trials (using relative risk [RR] and 95 % confidence interval [CI]). Results: During the 5-year study period, 1389 obstetrical and gynecological RCTs were registered at ClinicalTrials.gov: 31 % (n = 538) in obstetrics and 69 % (n = 851) in gynecology. Among all registered RCTs in obstetrics-gynecology, 59 % (n = 816) were completed and 29 % (n = 406) were published. Compared to registered trials that were unpublished, those that were published were more likely to be funded by NIH/ US Federal Government (RR = 3.36, 95 % CI = 1.46À7.74) or other non-industry organizations (RR = 2.41, 95 % CI = 1.07À5.38), have a procedural intervention (RR = 1.52, 95 % CI = 1.12À2.06), or an enrollment of >150 (RR = 2.73, 95 % CI = 1.57À4.75). Conclusion: Among the obstetrical and gynecological randomized controlled trials registered at ClinicalTrials.gov, less than two-third were completed, and only one-third were published.
Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology
American Journal of Obstetrics and Gynecology, 1996
OBJECTIVES: Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references. STUDY DESIGN: We performed a hand search of the AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria. RESULTS: Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.
Royal College of Obstetricians and Gynaecologists guidelines: How evidence-based are they?
Journal of Obstetrics and Gynaecology, 2014
Evidence-based medicine aims to translate scientifi c research into good medical practice. The Royal College of Obstetricians and Gynaecologists publishes recommendations and guidelines to guide clinicians in decision-making. In this study, the evidence base underlying the ' Green-top Guidelines ' has been analysed in order to establish the quality of research underlying recommendations. During this descriptive study of 1,682 individual recommendations, the authors found that only 9-12% of the guidelines were based on the best quality (Grade A) evidence. The authors believe that this type of analysis serves to provide greater clarity for clinicians and patients using guidelines and recommendations in the fi eld of obstetrics and gynaecology to make collaborative clinical decisions.
Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov
The Journal of Clinical Pharmacology, 2013
Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007-2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured
Obstetrics & Gynecology, 2011
Clinical guidelines are an important source of guidance for clinicians. Few studies have examined the quality of scientific data underlying evidence-based guidelines. We examined the quality of evidence that underlies the recommendations made by the American College of Obstetricians and Gynecologists (the College). METHODS: The current practice bulletins of the College were examined. Each bulletin makes multiple recommendations. Each recommendation is categorized based on the quality and quantity of evidence that underlies the recommendation into one of three levels of evidence: A (good and consistent evidence), B (limited or inconsistent evidence), or C (consensus and opinion). We analyzed the distribution of levels of evidence for obstetrics and gynecology recommendations. RESULTS: A total of 84 practice bulletins that offered 717 individual recommendations were identified. Forty-eight (57.1%) of the guidelines were obstetric and 36 (42.9%) were gynecologic. When all recommendations were considered, 215 (30.0%) provided level A evidence, 270 (37.7%) level B, and 232 (32.3%) level C. Among obstetric recommendations, 93 (25.5%) were level A, 145 (39.7%) level B, and 117 (34.8%) level C. For the gynecologic recommendations, 122 (34.7%) were level A, 125 (35.5%) level B, and 105 (29.8%) level C. The gynecology recommendations were more likely to be of level A evidence than the obstetrics recommendations (P.)940.؍ CONCLUSION: One third of the recommendations put forth by the College in its practice bulletins are based on good and consistent scientific evidence.
Obstetric medicine, 2009
In this study, 65% (132/195) of level B/C obstetric recommendations are amenable to randomized clinical trials (RCTs) and seven were identified as most needed. The purpose of the survey was to evaluate levels B and C recommendations in obstetric practice bulletins (PBs) regarding the feasibility of performing RCT to elevate each subject to level A evidence. Eleven geographically dispersed physicians with experience in research reviewed levels B and C recommendations for the ethical and logistical feasibility of performing an RCT. In the 35 obstetric PBs, 195 level B/C recommendations were reviewed. The majority considered 47 (24%) topics unethical for an RCT and thought 16 (11%) did not need an RCT, thus leaving 132 (67%) levels B and C recommendations available for an RCT. Two-thirds of levels B and C recommendations in obstetric PB are amenable to RCTs and potentially becoming level A evidence.
The CROWN Initiative: journal editors invite researchers to develop core outcomes in women’s health*
Hypertension in Pregnancy, 2014
Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes -a "core outcomes set" -for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women's health have come together to support The CROWN (CoRe Outcomes in WomeN's health) Initiative.
BMC women's health, 2006
To examine the rates of evidence-supported care provided in an obstetrics-gynaecology unit. The main diagnosis-intervention set was established for a sample of 325 consecutive inpatient admissions in 1998-99 in a prospective study in a UK tertiary care centre. A comprehensive literature search was conducted to obtain the evidence supporting the intervention categorised according to the following hierarchy: Grade A, care supported by evidence from randomised controlled trials; Grade B, care supported by evidence from controlled observational studies and convincing non-randomised evidence; and Grade C, care without substantial research evidence. Of the 325 admissions, in 135 (42%) the quality of care was based on Grade A evidence, in 157 (48%) it was based on Grade B evidence, and in 33 (10%) it was based on Grade C evidence. The patterns of care were not different amongst patients sampled in 1998 and 1999. A significant majority (90%) of obstetric and gynaecological care was found to...