Randomized controlled trials in surgery: Issues and problems

McLeod, Robin S.; Wright, James G.; Solomon, Michael J.; Hu, Xiheng; Walters, Beverly C.; Lossing, Alan G.

doi:10.1016/s0039-6060(96)80254-6

Cited by 129 publications

(73 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Designed properly, the randomized clinical trial (RCT) is a powerful tool to evaluate medical treatments [1,2]. However, RCTs evaluating surgical treatments are challenging to design and conduct.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment

Frobell

Lohmander

Roos

2007

Contemporary Clinical Trials

View full text Add to dashboard Cite

This is an author produced version of a paper published Contemporary clinical trials. This paper has been peerreviewed but does not include the final publisher proofcorrections or journal pagination. 2 AbstractAims --To determine the number of patients needed to be screened (NNS) and allocated (NNA) to include one participant into a randomized clinical trial (RCT), and to compare the characteristics of patients accepting or declining participation in the RCT.Methods --The recruitment process of an ongoing multicenter RCT, comparing surgical and nonsurgical interventions after acute anterior cruciate ligament (ACL) injury of the knee is described. We use the known concept Number Needed to Screen (NNS) and introduce the new concept NumberNeeded to Allocate (NNA) as variables to support a priori sample size calculations of future investigations.Results --560 patients were screened to identify 162 patients (29%) eligible for inclusion in the RCT. 41of those declined participation for various reasons, the most common being unwillingness to undergo surgery (n=23) or unwillingness to risk conservative treatment (n=8). 19 patients were excluded after MRI assessment or arthroscopy. Thus, 102 (18%) patients were allocated to one of the two treatments in the RCT. The NNS was 5.5 individuals with an acute knee injury, and the NNA was 1.6 individuals eligible for inclusion, to include 1 patient in the RCT. Patients declining to participate in the RCT were more frequently self-employed and less frequently injured in sports activities than those accepting RCT participation.Conclusions --We suggest that the a priori sample size calculation needs to be multiplied by at least 5.5to provide an estimate of the number needed to screen, or 1.6 to provide an estimate of the number needed to allocate in order to include the desired number of patients in a trial comparing surgical and non-surgical treatment of the ACL injured patient.

show abstract

Section: Introductionmentioning

confidence: 99%

“…However, RCTs evaluating surgical treatments are challenging to design and conduct. In particular, the recruitment of patients has been described as difficult and time-consuming [2][3][4]. Possibly, the greatest threat to the success of a randomized clinical trial is the inability to recruit an adequate number of subjects.…”

Section: Introductionmentioning

confidence: 99%

The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment

Frobell

Lohmander

Roos

2007

Contemporary Clinical Trials

View full text Add to dashboard Cite

show abstract

“…The most of the included studies have a short follow-up and the outcome measures are still unclear. Systematic reviews with meta-analysis are limited by the data included in the RCTs, and the difficulties in the conduction of these kinds of studies, makes that, sometimes, they have poor methology, especially in the surgical area (23) . At last, we can not make the meta-analysis in some continuous outcomes, as the post-operative measure of lower esophageal sphincter tonus, because the lack of data.…”

Section: Discussionmentioning

confidence: 99%

Surgical treatment of gastroesophageal reflux disease: total or partial fundoplication? Systematic review and meta-analysis

Ramos

Lustosa²,

Almeida

et al. 2011

Arq. Gastroenterol.

View full text Add to dashboard Cite

-Context -Although the high incidence of gastroesophageal reflux disease (GERD) in the population, there is much controversy in this topic, especially in the surgical treatment. The decision to use of a total or partial fundoplication in the treatment of GERD is still a challenge to many surgeons because the few evidence found in the literature. Objective -To bring more clear evidence in the comparison between total and partial fundoplication. Data sources -A systematic review of the literature and metaanalysis with randomized controlled trials accessed from MEDLINE, LILACS, Cochrane Controlled Trials Database was done. The outcomes remarked were: dysphagia, inability to belch, bloating, recurrence of acid reflux, heartburn and esophagitis. For data analysis the odds ratio was used with corresponding 95% confidence interval. Statistical heterogeneity in the results of the metaanalysis was assessed by calculating a test of heterogeneity. The software Review Manager 5 (Cochrane Collaboration) was utilized for the data gathered and the statistical analysis. Sensitive analysis was applied using only trials that included follow-up over 2 years. Results -Ten trials were included with 1003 patients: 502 to total fundoplication group and 501 to partial fundoplication group. The outcomes dysphagia and inability to belch had statistical significant difference (P = 0.00001) in favor of partial fundoplication. There was not statistical difference in outcomes related with treatment failure. There were no heterogeneity in the outcomes dysphagia and recurrence of the acid reflux. Conclusion -The partial fundoplication has lower incidence of obstructive side effects.

show abstract

“…The broader use of pragmatic rcts 44-46 -which recruit typical participants from heterogeneous practice settings, use a broad range of outcome measures, and select clinically relevant comparators-may help to alleviate concerns about the applicability of rcts to everyday practice [47][48][49][50] , provide evidence that is more relevant to patients and clinicians, and thus be better equipped to inform real-world clinical decisions. For the areas of care in which rct designs have been widely criticized (surgery, for instance 51,52 ), research designs have to be refined and innovative tools developed to address specific shortcomings in methodology (single-institution studies and difficulty in standardizing procedures, for example). Overcoming such concerns and designing more relevant, pragmatic trials will undoubtedly require crossdisciplinary dialogue and participation.…”

Section: E514mentioning

confidence: 99%

Cross-Disciplinary Research in Cancer: An Opportunity to Narrow the Knowledge–Practice Gap

et al. 2013

View full text Add to dashboard Cite

Health services researchers have consistently identified a gap between what is identified as “best practice” and what actually happens in clinical care. Despite nearly two decades of a growing evidence-based practice movement, narrowing the knowledge–practice gap continues to be a slow, complex, and poorly understood process. Here, we contend that cross-disciplinary research is increasingly relevant and important to reducing that gap, particularly research that encompasses the notion of transdisciplinarity, wherein multiple academic disciplines and non-academic individuals and groups are integrated into the research process. The assimilation of diverse perspectives, research approaches, and types of knowledge is potentially effective in helping research teams tackle real-world patient care issues, create more practice-based evidence, and translate the results to clinical and community care settings. The goals of this paper are to present and discuss cross-disciplinary approaches to health research and to provide two examples of how engaging in such research may optimize the use of research in cancer care.

show abstract

Randomized controlled trials in surgery: Issues and problems

Cited by 129 publications

References 10 publications

The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment

The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment

Surgical treatment of gastroesophageal reflux disease: total or partial fundoplication? Systematic review and meta-analysis

Cross-Disciplinary Research in Cancer: An Opportunity to Narrow the Knowledge–Practice Gap

Contact Info

Product

Resources

About