scholarly journals Novel ways to explore surgical interventions in randomised controlled trials: applying case study methodology in the operating theatre

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Natalie S. Blencowe ◽  
Jane M. Blazeby ◽  
Jenny L. Donovan ◽  
Nicola Mills
Keyword(s):  
Randomised Controlled Trials ◽  
Operating Theatre ◽  
Controlled Trials ◽  
Case Study Methodology ◽  
Surgical Interventions ◽  
Study Methodology ◽  
Randomised Controlled

scholarly journals Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop

2021 ◽  
Vol 25 (53) ◽  
pp. 1-52
Author(s):  
David J Beard ◽  
Marion K Campbell ◽  
Jane M Blazeby ◽  
Andrew J Carr ◽  
Charles Weijer ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Medical Research Council ◽  
Placebo Control ◽  
Controlled Trials ◽  
Surgical Trials ◽  
Surgical Interventions ◽  
Placebo Controls ◽  
Randomised Controlled ◽  
The Uk ◽  
Future Work

Background The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funding Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.

scholarly journals Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials

BMJ ◽  
2019 ◽  
pp. l1842 ◽  
Author(s):  
Mari Imamura ◽  
Jemma Hudson ◽  
Sheila A Wallace ◽  
Graeme MacLennan ◽  
Michal Shimonovich ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Surgical Interventions ◽  
Randomised Controlled ◽  
Meta Analyses

Abstract Objectives To compare the effectiveness and safety of surgical interventions for women with stress urinary incontinence. Design Systematic review and network meta-analysis. Eligibility criteria for selecting studies Randomised controlled trials evaluating surgical interventions for the treatment of stress urinary incontinence in women. Methods Identification of relevant randomised controlled trials from Cochrane reviews and the Cochrane Incontinence Specialised Register (searched May 2017), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Medline In-Process, Medline Epub Ahead of Print, CINAHL, ClinicalTrials.gov, and WHO ICTRP. The reference lists of relevant articles were also searched. Primary outcomes were “cure” and “improvement” at 12 months, analysed by means of network meta-analyses, with results presented as the surface under the cumulative ranking curve (SUCRA). Adverse events were analysed using pairwise meta-analyses. Risk of bias was assessed using the Cochrane risk of bias tool. The quality of evidence for network meta-analysis was assessed using the GRADE approach. Results 175 randomised controlled trials assessing a total of 21 598 women were included. Most studies had high or unclear risk across all risk of bias domains. Network meta-analyses were based on data from 105 trials that reported cure and 120 trials that reported improvement of incontinence symptoms. Results showed that the interventions with highest cure rates were traditional sling, retropubic midurethral sling (MUS), open colposuspension, and transobturator MUS, with rankings of 89.4%, 89.1%, 76.7%, and 64.1%, respectively. Compared with retropubic MUS, the odds ratio of cure for traditional sling was 1.06 (95% credible interval 0.62 to 1.85), for open colposuspension was 0.85 (0.54 to 1.33), and for transobtrurator MUS was 0.74 (0.59 to 0.92). Women were also more likely to experience an improvement in their incontinence symptoms after receiving retropubic MUS or transobturator MUS compared with other surgical procedures. In particular, compared with retropubic MUS, the odds ratio of improvement for transobturator MUS was 0.76 (95% credible interval 0.59 to 0.98), for traditional sling was 0.69 (0.39 to 1.26), and for open colposuspension was 0.65 (0.41 to 1.02). Quality of evidence was moderate for retropubic MUS versus transobturator MUS and low or very low for retropubic MUS versus the other two interventions. Data on adverse events were available mainly for mesh procedures, indicating a higher rate of repeat surgery and groin pain but a lower rate of suprapubic pain, vascular complications, bladder or urethral perforation, and voiding difficulties after transobturator MUS compared with retropubic MUS. Data on adverse events for non-MUS procedures were sparse and showed wide confidence intervals. Long term data were limited. Conclusions Retropubic MUS, transobturator MUS, traditional sling, and open colposuspension are more effective than other procedures for stress urinary incontinence in the short to medium term. Data on long term effectiveness and adverse events are, however, limited, especially around the comparative adverse events profiles of MUS and non-MUS procedures. A better understanding of complications after surgery for stress urinary incontinence is imperative. Systematic review registration PROSPERO CRD42016049339.

scholarly journals A systematic breakdown of the levels of evidence supporting the European Society of Cardiology guidelines

2019 ◽  
Vol 26 (18) ◽  
pp. 1944-1952 ◽  
Author(s):  
Wouter B van Dijk ◽  
Diederick E Grobbee ◽  
Martine C de Vries ◽  
Rolf H H Groenwold ◽  
Rieke van der Graaf ◽  
...  
Keyword(s):  
Expert Opinion ◽  
European Society ◽  
Randomised Controlled Trials ◽  
Class I ◽  
Controlled Trials ◽  
Specific Recommendation ◽  
Level Of Evidence ◽  
Surgical Interventions ◽  
European Society Of Cardiology ◽  
Randomised Controlled

Aims Reviews of clinical practice guidelines have repeatedly concluded that only a minority of guideline recommendations are supported by high-quality evidence from randomised controlled trials. The aim of this study is to evaluate whether these findings apply to the whole cardiovascular evidence base or specific recommendation types and actions. Methods All recommendations from current European Society of Cardiology guidelines were extracted with their class (I, treatment is beneficial; II, treatment is possibly beneficial; III, treatment is harmful) and level of evidence (A, multiple randomised controlled trials/meta-analyses; B, single randomised controlled trials/large observational studies; C, expert opinion/small studies). Recommendations were categorised by type (therapeutic, diagnostic, other) and actions (e.g. pharmaceutical intervention/non-invasive imaging/test). Results In total, 3531 recommendations (median 128, interquartile range 108–150) were extracted from 27 guidelines. Therapeutic recommendations comprised 2545 (72.1%) recommendations, 411 (16.1%) were supported by level of evidence A, 833 (32.7%) by B and 1301 (51.1%) by C. Class I/III (should/should not) recommendations on minimally invasive interventions were most supported by level of evidence A (55/183, 30.1%) (B [70/183, 38.3%], C [58/183, 31.7%]), while class I/III recommendations on open surgical interventions were least supported by level of evidence A (15/164, 9.1%) (B [34/164, 20.7%], C [115/164, 70.1%]). Of all (831, 23.5%) diagnostic recommendations, just 44/503 (8.7%) class I/III recommendations were supported by level of evidence A (B (125/503, 24.9%), C (334/503, 66.4%)). Conclusion Evidence levels supporting European Society of Cardiology guideline recommendations differ widely between recommendation types and actions. Attributing to this variability are different evidence requirements, therapeutic/diagnostic recommendations, different feasibility levels for trials (e.g. open surgical/pharmacological) and many off-topic/policy recommendations based on expert opinion.

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