CONSORT Compliance in Surgical Randomized Trials

Adie, Sam; Harris, Ian A.; Naylor, Justine M.; Mittal, Rajat

doi:10.1097/sla.0b013e31829664b9

Cited by 60 publications

(44 citation statements)

References 50 publications

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“…Although this finding concurs with the paradigm of general surgical RCTs, the proportion of industry-sponsored laparoscopic studies (5%) is significantly less than the reported proportion in general surgery (25%) [17]. This might have two possible explanations; either the reported percentages are pragmatic and medical industry preferably sponsors general surgical trials rather than laparoscopic trials, or the results are biased by the proportion of laparoscopic RCTs published in different journals, several of which may or may not presuppose declaration of the source of funding.…”

Section: Discussionmentioning

confidence: 43%

“…Although 40% of RCTs in general surgery were multicentric in 2009, the respective proportion in laparoscopic RCTs was only 18% in 2012 [24]. Collaborative works have been recently endorsed by associations of endoscopic surgery worldwide and are expected to improve quality of novel evidence, considering that power calculation and sample size have also been identified as factors predicting reported methodological quality [17]. …”

Section: Discussionmentioning

confidence: 99%

“…Several tools have been developed with the objective to improve these parameters and to provide a platform for the production of high-quality RCTs, such as the Jadad scale, the CONSORT checklist and the Balas scale [14,15,16]. A recent systematic review of the surgical literature has identified variables associated with reporting quality, such as power calculation, random sequence and length of article [17]. Similar reports are available in the fields of oncology, intensive care medicine, orthopedics and anesthesia, among others [18,19,20,21].…”

Section: Introductionmentioning

confidence: 99%

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A Systematic Review and Analysis of Factors Associated with Methodological Quality in Laparoscopic Randomized Controlled Trials

et al. 2015

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Several methods for assessment of methodological quality in randomized controlled trials (RCTs) have been developed during the past few years. Factors associated with quality in laparoscopic surgery have not been defined till date. The aim of this study was to investigate the relationship between bibliometric and the methodological quality of laparoscopic RCTs. The PubMed search engine was queried to identify RCTs on minimally invasive surgery published in 2012 in the 10 highest impact factor surgery journals and the 5 highest impact factor laparoscopic journals. Eligible studies were blindly assessed by two independent investigators using the Scottish Intercollegiate Guidelines Network (SIGN) tool for RCTs. Univariate and multivariate analyses were performed to identify potential associations with methodological quality. A total of 114 relevant RCTs were identified. More than half of the trials were of high or acceptable quality. Half of the reports provided information on comparative demographic data and only 21% performed intention-to-treat analysis. RCTs with sample size of at least 60 patients presented higher methodological quality (p = 0.025). Upon multiple regression, reporting on preoperative care and the experience level of surgeons were independent factors of quality.

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Section: Discussionmentioning

confidence: 43%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Systematic Review and Analysis of Factors Associated with Methodological Quality in Laparoscopic Randomized Controlled Trials

et al. 2015

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“…One study exploring the reporting quality in 150 RCTs of surgical interventions found a low level of guideline adherence, with only 55% of the CONSORT checklist items adequately reported (16). Most included trials did not satisfactorily report sequence generation for randomization (57%), allocation concealment (55%), blinding (63%), or sample-size calculation (55%).…”

Section: Lack Of Adherence To Reporting Guidelines For Rctsmentioning

confidence: 99%

Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions

Bhatt

Wang

et al. 2018

Proc. Natl. Acad. Sci. U.S.A.

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Evidence from a well-designed randomized controlled trial (RCT) is generally considered to be the gold standard that can inform clinical practice and guide decision-making. However, several deficiencies in the reporting of RCTs have frequently been identified, including incomplete, selective, and biased or inconsistent reporting. Such suboptimal reporting may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct. In this article, we present an overview of the reporting of RCTs in the biomedical literature with a focus on the three most common reporting problems: (i) lack of adherence to reporting guidelines, (ii) inconsistencies between trial protocols or registrations and full reports, and (iii) inconsistencies between abstracts and their corresponding full reports. Unsatisfactory levels of adherence to guidelines and frequent inconsistencies between protocols or registrations and full reports, and between abstracts and full reports, were consistently found in various biomedical research fields. A variety of factors were found to be associated with these reporting challenges. Improved reporting can build public trust and credibility of science, save resources, and enhance the ethical integrity of research. Therefore, joint efforts from the various sectors of the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers) are needed to reduce and reverse the current suboptimal state of RCT reporting in the literature.randomized controlled trial | reporting quality | transparency | guideline adherence | inconsistent reporting I n evidence-based medicine, evidence from well-designed randomized controlled trials (RCTs) is generally considered to be the gold standard to inform clinical practice and guide decisionmaking (1). However, several deficiencies in the reporting of RCTs have been frequently identified, including incomplete, selective, and biased or inconsistent reporting. For example, it was found that only about 60% of RCT reports provided adequate information on interventions (2). This suboptimal reporting of clinical trials may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct mainly due to the potential consequence of patients suffering and dying unnecessarily (3). Moreover, enhancing the quality and transparency of reporting is an ethical and scientific obligation in order to avoid wasting research resources, minimize risk of harms and maximize benefits of therapies, and enhance research integrity (4-6). Therefore, improving reporting of health research is an imperative that requires a variety of efforts by the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers). In this article, we highlight and provide some insights into the three most co...

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“…Recently, Adie et al [10] have scrutinized 150 RCTs of surgical interventions published mainly in surgical journals. They found that less than half of these trials described essential methodological details such as sample size calculation (45%), random sequence generation (43%), allocation concealment (45%), or blinding (37%).…”

Section: The Current Clinical Research Landscape In Surgerymentioning

confidence: 99%

Clinical Research in Surgery: Threats and Opportunities

Ceelen¹

2014

Eur Surg Res

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Surgery is a discipline which profoundly affects human integrity. Therefore, there is an ethical and scientific imperative that surgical practice depends on the best possible trial-based evidence. Traditionally, the quality and quantity of clinical research have been lagging behind other disciplines in clinical medicine. However, recent collaborative initiatives, such as the IDEAL framework which tests surgical innovation, international registries, and quality assurance platforms, the development of modified randomized controlled trials and alternative trial designs as well as the impending reforms of the regulatory framework surrounding nonpharmaceutical interventions and devices offer significant and timely opportunities to enhance the relevance of clinical research in surgery. Here, we provide an overview of the current state of clinical research in surgery, identify possible obstacles, and discuss realistic and emerging solutions that have the potential to change the way surgical research is organized, funded, and translated to the patient's benefit.

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CONSORT Compliance in Surgical Randomized Trials

Abstract: There remains much room for improvement for the reporting of surgical intervention trials. Authors and journal editors should apply existing reporting guidelines, and guidelines specific to the reporting of surgical interventions should be developed.

Cited by 60 publications

References 50 publications

A Systematic Review and Analysis of Factors Associated with Methodological Quality in Laparoscopic Randomized Controlled Trials

A Systematic Review and Analysis of Factors Associated with Methodological Quality in Laparoscopic Randomized Controlled Trials

Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions

Clinical Research in Surgery: Threats and Opportunities

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