Allison Hirst

A UK multicentre retrospective cohort study comparing hysterectomy and uterine artery embolisation for the treatment of symptomatic uterine fibroids (HOPEFUL study): main results on medium‐term safety and efficacy

Objectives  Comparison of medium‐term safety and efficacy of hysterectomy and uterine artery embolisation (UAE) for symptomatic uterine fibroids.

Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.

Objective To assess whether the completeness of reporting of health research is related to journals’ endorsement of reporting guidelines. Design Systematic review. Data sources Reporting guidelines from a published systematic review and the EQUATOR Network (October 2011). Studies assessing the completeness of reporting by using an included reporting guideline (termed “evaluations”) (1990 to October 2011; addendum searches in January 2012) from searches of either Medline, Embase, and the Cochrane Methodology Register or Scopus, depending on reporting guideline name. Study selection English language reporting guidelines that provided explicit guidance for reporting, described the guidance development process, and indicated use of a consensus development process were included. The CONSORT statement was excluded, as evaluations of adherence to CONSORT had previously been reviewed. English or French language evaluations of included reporting guidelines were eligible if they assessed the completeness of reporting of studies as a primary intent and those included studies enabled the comparisons of interest (that is, after versus before journal endorsement and/or endorsing versus non-endorsing journals). Data extraction Potentially eligible evaluations of included guidelines were screened initially by title and abstract and then as full text reports. If eligibility was unclear, authors of evaluations were contacted; journals’ websites were consulted for endorsement information where needed. The completeness of reporting of reporting guidelines was analyzed in relation to endorsement by item and, where consistent with the authors’ analysis, a mean summed score. Results 101 reporting guidelines were included. Of 15 249 records retrieved from the search for evaluations, 26 evaluations that assessed completeness of reporting in relation to endorsement for nine reporting guidelines were identified. Of those, 13 evaluations assessing seven reporting guidelines (BMJ economic checklist, CONSORT for harms, PRISMA, QUOROM, STARD, STRICTA, and STROBE) could be analyzed. Reporting guideline items were assessed by few evaluations. Conclusions The completeness of reporting of only nine of 101 health research reporting guidelines (excluding CONSORT) has been evaluated in relation to journals’ endorsement. Items from seven reporting guidelines were quantitatively analyzed, by few evaluations each. Insufficient evidence exists to determine the relation between journals’ endorsement of reporting guidelines and the completeness of reporting of published health research reports. Journal editors and researchers should consider collaborative prospectively designed, controlled studies to provide more robust evidence. Systematic review registration Not registered; no known register currently accepts protocols for methodology systematic reviews.

IDEAL-D: a rational framework for evaluating and regulating the use of medical devices.

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

Uterine artery embolisation or hysterectomy for the treatment of symptomatic uterine fibroids: a cost-utility analysis of the HOPEFUL study.

Objectives  To evaluate the relative cost‐effectiveness of uterine artery embolisation (UAE) and hysterectomy in women with symptomatic uterine fibroids from the perspective of the UK NHS.

Reporting of participant flow diagrams in published reports of randomized trials

BackgroundReporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials.MethodsA cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram.ResultsOf 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis.ConclusionsOver half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.

Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol

BackgroundReporting of health research is often inadequate and incomplete. Complete and transparent reporting is imperative to enable readers to assess the validity of research findings for use in healthcare and policy decision-making. To this end, many guidelines, aimed at improving the quality of health research reports, have been developed for reporting a variety of research types. Despite efforts, many reporting guidelines are underused. In order to increase their uptake, evidence of their effectiveness is important and will provide authors, peer reviewers and editors with an important resource for use and implementation of pertinent guidance. The objective of this study was to assess whether endorsement of reporting guidelines by journals influences the completeness of reporting of health studies.MethodsGuidelines providing a minimum set of items to guide authors in reporting a specific type of research, developed with explicit methodology, and using a consensus process will be identified from an earlier systematic review and from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network’s reporting guidelines library. MEDLINE, EMBASE, the Cochrane Methodology Register and Scopus will be searched for evaluations of those reporting guidelines; relevant evaluations from the recently conducted CONSORT systematic review will also be included. Single data extraction with 10% verification of study characteristics, 20% of outcomes and complete verification of aspects of study validity will be carried out. We will include evaluations of reporting guidelines that assess the completeness of reporting: (1) before and after journal endorsement, and/or (2) between endorsing and non-endorsing journals. For a given guideline, analyses will be conducted for individual and the total sum of items. When possible, standard, pooled effects with 99% confidence intervals using random effects models will be calculated.DiscussionEvidence on which guidelines have been evaluated and which are associated with improved completeness of reporting is important for various stakeholders, including editors who consider which guidelines to endorse in their journal editorial policies.

Practical guide to the Idea, Development and Exploration stages of the IDEAL Framework and Recommendations.

Evaluation of new surgical procedures is a complex process challenged by evolution of technique, operator learning curves, the possibility of variable procedural quality, and strong treatment preferences among patients and clinicians. Preliminary studies that address these issues are needed to prepare for a successful randomized trial. The IDEAL (Idea, Development, Exploration, Assessment and Long‐term follow‐up) Framework and Recommendations provide an integrated step‐by‐step evaluation pathway that can help investigators achieve this.

Enhanced quality and transparency of health research reporting can lead to improvements in public health policy decision-making: help from the EQUATOR Network

Evidence published in the scientific literature is commonly used in public health to support policy decisions. A wide variety of stakeholders consults Cadernos de Saude Publica (CSP) to assess and summarize research evidence, plan health programs, design new interventions, and identify risk factors for a particular health outcome. Thus, it is crucial that scientific articles are published transparently and accurately in order to allow evaluating the reliability of the research for future use. CSP receives more than 1,500 research manuscripts annually, and a high proportion fail to achieve acceptable quality levels for publication, either because the study was poorly conducted or reported, or both. Common flaws include lack of control of confounding in observational studies, lack of information on quality assessment for studies included in systematic reviews, and poor descriptions of clinical trial interventions. Biases due to deficiencies in the performance and reporting of health research can be dangerously misleading to policy decisions. The literature provides abundant examples, such as the erroneous belief that hormone replacement therapy protects against cardiovascular disease, a statistical relationship that was ultimately proven to be confounded by socioeconomic status (von Elm EV, Egger M. BMJ 2004; 329:868-9). CSP publishes numerous observational studies, systematic reviews, clinical trials, among others. Unfortunately, only a small portion of submitted manuscripts use appropriate reporting guidelines such as Strengthening the Reporting of Observational studies in Epidemiology (STROBE), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), or Consolidated Standards of Reporting Trials (CONSORT). Compliance with these guidelines is a great way to improve transparency and accuracy and has proven to increase the reliability and impact of health research (Simera et al. BMC Med 2010; 8:24). The EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) is “an international initiative that seeks to improve the quality of scientific publications”. EQUATOR (http://www.equator-network.org/) has compiled a vast catalogue of all available reporting guidelines in its library to help authors and peer reviewers of health research. It also provides education and training. EQUATOR works with a variety of key stakeholders in the research and publication process including journal editors, peer reviewers and developers of reporting guidelines. The Pan-American Health Organization has recently established a formal agreement with EQUATOR to disseminate the initiative in Latin America. It is already possible to browse a Spanish version of the Network’s website. Several reporting guidelines have also been translated into Spanish. In the near future, CSP may only publish articles that follow appropriate reporting guidelines. It is time to reduce wastefulness and fully realize the investment in health research by translating findings from high quality research into health benefits derived from evidenced-based policy decisions. Enhanced quality and transparency of health research reporting can lead to improvements in public health policy decision-making: help from the EQUATOR Network

No surgical innovation without evaluation : evolution and further development of the IDEAL Framework and Recommendations

Objective: To update, clarify, and extend IDEAL concepts and recommendations. Background: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. Methods: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions—Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a “Pre-IDEAL” stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. Conclusions: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.

Tailoring study design to each stage of surgical innovation: the ideal recommendations.

The pathway of surgical innovation is complex. Inherent ethical and practical characteristics make scientific evaluation of new techniques or devices by a definitive randomized controlled trial (RCT) challenging. The IDEAL Collaboration (http://www.ideal-collaboration.net) Framework for evaluating surgical innovation describes a five stage process - Idea, Development, Exploration, Assessment and Long-term study.(1) Early stage studies should be designed to facilitate and prepare the way for a rigorous evaluation by RCT. IDEAL Recommendations in the early stages (Idea/Development) emphasise prospective designs, transparency and full reporting in open registries, to provide reliable data early in the innovation development process. At the Exploration stage, prospective observational studies need to address factors such as case-mix, learning and outcomes, building co-operatively and explicitly towards a definitive evaluation study, preferably an RCT, optimising the contribution of data from non-randomised prospective evaluations (Assessment stage). The Long-term stages should be characterised by registry-based surveillance for both new procedures and devices. IDEAL proposals for high quality RCTs of surgical procedures focus on three key areas: definition of the intervention; who delivers the intervention and preferences of surgeons and patients. IDEAL Recommendations identify modifications to study design which may help address these difficult areas. We will describe examples of good practice using these suggested methods. Everyone involved in evaluating surgical innovations is invited to join the IDEAL Collaboration community and help further evolve methodology and reporting standards for robust trials in surgery.