Assessing the Compliance of Randomized Controlled Trials Published in Craniofacial Surgery Journals With the CONSORT Statement.

BACKGROUND: Randomized controlled trials (RCTs) are gold standard assessments for healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) statement was published to maximize RCT reporting transparency. The authors conducted a systematic review to assess current compliance of RCTs published within craniofacial surgery with the CONSORT statement. METHODS: The Thomson Reuters Impact Factor Report 2016 was consulted to identify craniofacial surgery journals. PubMed was used to search for recent RCTs published within the 5 journals identified. Two independent researchers assessed each study for inclusion and performed data extraction. The primary outcome was compliance of each RCT with the CONSORT statement. Secondary outcomes were the pathology and interventions examined, impact factor, multi-versus-single center, number of authors, and publication date. RESULTS: Eighty-six studies met the inclusion criteria, across which a median of 56% (range 33%-94%) applicable CONSORT items were reported. The 5 least reported items were: trial design (3a); registration number and name of trial registry (23); who generated random allocation sequences, enrolled participants, and assigned participants to interventions (10); sample size determination (7a); mentioning "randomized trial" in the title (1a). CONCLUSION: The compliance of craniofacial surgery RCTs with the CONSORT statement requires improvement. Areas in need are identified, and methods to improve reporting transparency, are discussed.

Analysis of the first 2645 registrations at the research registry®: A global repository for all study types involving human participants.

BACKGROUND: The Declaration of Helsinki has called for the registration of all research studies involving human participants. Despite this, prior registries did not allow registration certain study types, or retrospective registration. The Research Registry® (www.researchregistry.com) was established in 2015 to provide a venue of registration for any study involving human participants. METHODS: and analysis: This retrospective database analysis describes the first 3000 registrations received by the Research Registry®. Since the launch of the Registry in 2015, we have collected data on each registration and excluded inappropriate registrations through a weekly curation process. The characteristics of all studies registered is presented. Each registration was marked against a quality score by two researchers acting independently, and we describe how this has changed over time. No ethical approval was required for this data only study including no human participants. RESULTS: Of 3000 registrations, we included 2645 that were submitted to the registry between February 2015 and October 2017. The number of registrations increased year on year, and we now receive between 60 and 80 registrations per month. One fifth of registrations were from China (537 [20.3%]). Retrospective observational studies were most commonly registered (1125 [42.5%]), and studies included in excess of 20 million patients (median 80 [IQR:25-200]). The quality score of registrations improved over the time (Kruskal-Wallis p < 0.05), and the 'control/comparator' component of the quality score was most poorly completed (completed by 1199 [54%]). CONCLUSION: The Research Registry® has received registrations on over 2500 registrations, including in excess of 20 million patients, with the quality of registrations improving over time. Retrospective observational studies and case series are the most commonly registered.

The Academic Surgical Collaborative: A three-year review of a trainee research collaborative.

INTRODUCTION: The Academic Surgical Collaborative (ASC) is a trainee research collaborative (TRC) formed in the UK in October 2014. Three years on, the achievements are presented along with advice for emerging and established TRCs. Methods: A retrospective review of internal, member-maintained ASC records was conducted. Membership numbers, PubMed indexed publications, presentations and prizes awarded were all calculated over time. Google Scholar was used to calculate citations per ASC publication. An online survey was distributed to members to ascertain member satisfaction. RESULTS: With 62 active members (predominantly medical students) the ASC has published 33 PubMed indexed papers over three years, with a mean of 21 citations per paper (SD 89, range 0-491). 54 presentations have been delivered and eight prizes have been awarded for ASC research projects. 60% of ASC members believe the ASC delivers research that improves patient care. Key learning points for the ASC have been the use of a set of resources distributed to new members, the value of regular meetings, close mentoring throughout research projects to develop the skills of junior researchers, encouragement for junior members to present at conferences, and an ongoing focus on research conduct and improving evidence based medicine. CONCLUSIONS: The ASC has fulfilled many of its goals set out at its inception. The ASCs subsequent aims are to enhance existing research training for junior members, advances in the field of core outcome development and also multi-collaborative research.

A narrative synthesis of research evidence for tinnitus-related complaints as reported by patients and their significant others.

BACKGROUND: There are a large number of assessment tools for tinnitus, with little consensus on what it is important to measure and no preference for a minimum reporting standard. The item content of tinnitus assessment tools should seek to capture relevant impacts of tinnitus on everyday life, but no-one has yet synthesised information about the range of tinnitus complaints. This review is thus the first comprehensive and authoritative collection and synthesis of what adults with tinnitus and their significant others report as problems in their everyday lives caused by tinnitus. METHODS: Electronic searches were conducted in PubMed, Embase, CINAHL, as well as grey literature sources to identify publications from January 1980 to June 2015 in which participants were enrolled because tinnitus was their primary complaint. A manual search of seven relevant journals updated the search to December 2017. Of the 3699 titles identified overall, 84 records (reporting 86 studies) met our inclusion criteria and were taken through to data collection. Coders collated generic and tinnitus-specific complaints reported by people with tinnitus. All relevant data items were then analyzed using an iterative approach to narrative synthesis to form domain groupings representing complaints of tinnitus, which were compared patients and significant others. RESULTS: From the 86 studies analyzed using data collected from 16,381 patients, 42 discrete complaints were identified spanning physical and psychological health, quality of life and negative attributes of the tinnitus sound. This diversity was not captured by any individual study alone. There was good convergence between complaints collected using open- and closed-format questions, with the exception of general moods and perceptual attributes of tinnitus (location, loudness, pitch and unpleasantness); reported only using closed questions. Just two studies addressed data from the perspective of significant others (n = 79), but there was substantial correspondence with the patient framework, especially regarding relationships and social life. CONCLUSIONS: Our findings contribute fundamental new knowledge and a unique resource that enables investigators to appreciate the broad impacts of tinnitus on an individual. Our findings can also be used to guide questions during diagnostic assessment, to evaluate existing tinnitus-specific HR-QoL questionnaires and develop new ones, where necessary. TRIAL REGISTRATION: PROSPERO registration number: CRD42015020629 . Protocol published in BMJ Open. 2016;6e009171.

The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery.

INTRODUCTION: The development of reporting guidelines over the past 20 years represents a major advance in scholarly publishing with recent evidence showing positive impacts. Whilst over 350 reporting guidelines exist, there are few that are specific to surgery. Here we describe the development of the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS: We published our protocol apriori. Current guidelines for case series (PROCESS), cohort studies (STROBE) and randomised controlled trials (CONSORT) were analysed to compile a list of items which were used as baseline material for developing a suitable checklist for surgical cohort guidelines. These were then put forward in a Delphi consensus exercise to an expert panel of 74 surgeons and academics via Google Forms. RESULTS: The Delphi exercise was completed by 62% (46/74) of the participants. All the items were passed in a single round to create a STROCSS guideline consisting of 17 items. CONCLUSION: We present the STROCSS guideline for surgical cohort, cross-sectional and case-control studies consisting of a 17-item checklist. We hope its use will increase the transparency and reporting quality of such studies. This guideline is also suitable for cross-sectional and case control studies. We encourage authors, reviewers, journal editors and publishers to adopt these guidelines.

A protocol for the development of the STROCSS guideline: Strengthening the Reporting of Cohort Studies in Surgery.

INTRODUCTION: Strengthening the reporting of observational studies in epidemiology (STROBE) coined in 2007, highlighted the importance of improving the quality of observational research by providing an item checklist in order to avoid inadequate reporting of research. However, currently there are no reporting guidelines specific to surgical cohort studies, which have an extremely important role within the surgical literature. The recent development of surgery specific guidelines has underscored how surgical and procedural interventions require additional detail for readers to have a complete, clear, transparent and reproducible understanding. The objective of this research is to conduct a Delphi consensus exercise to develop the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS: Current guidelines for case series (PROCESS), Cohort Studies (STROBE) and randomised controlled trials (CONSORT) will be analysed to compile items to form baseline material for developing cohort guidelines in the Delphi consensus exercise. The Delphi questionnaire will be administered via Google Forms and conducted using standard Delphi Methodology. Surgeons and individuals with significant experience of reviewing cohort studies as well as those with experience in developing reporting guidelines will be invited to participate. In the first round, existing items from PROCESS and STROBE will be put forward and participants will be invited to augment them or contribute further items for consideration. The provisional guidelines will then be updated in successive rounds using the nine-point Likert scale as proposed by the Grading Recommendations, Assessment, Development, and Evaluations (GRADE) working group. This process will be used to agree Standard definitions for the outcomes. DISSEMINATION: The work will be published in a peer-reviewed journal and presented at national and international meetings. Findings will be disseminated to interested parties, and journals will be encouraged to endorse the reporting guidelines.