The reporting quality and transparency of orthopaedic studies using Bayesian analysis requires improvement: A systematic review.

Background: Bayesian methods are being used more frequently in orthopaedics. To advance the use and transparent reporting of Bayesian studies, reporting guidelines have been recommended. There is currently little known about the use or applications of Bayesian analysis in orthopedics including adherence to recommended reporting guidelines. The objective is to investigate the reporting of Bayesian analysis in orthopedic surgery studies; specifically, to evaluate if these papers adhere to reporting guidelines. Methods: We searched PUBMED to December 2nd, 2020. Two reviewers independently identified studies and full-text screening. We included studies that focused on one or more orthopaedic surgical interventions and used Bayesian methods. Results: After full-text review, 100 articles were included. The most frequent study designs were meta-analysis or network meta-analysis (56%, 95% CI 46-65) and cohort studies (25%, 95% CI 18-34). Joint replacement was the most common subspecialty (33%, 95% CI 25-43). We found that studies infrequently reported key concepts in Bayesian analysis including, specifying the prior distribution (37-39%), justifying the prior distribution (18%), the sensitivity to different priors (7-8%), and the statistical model used (22%). In contrast, general methodological items on the checklists were largely well reported. Conclusions: There is an opportunity to improve reporting quality and transparency of orthopaedic studies using Bayesian analysis by encouraging adherence to reporting guidelines such as ROBUST, JASP, and BayesWatch. There is an opportunity to better report prior distributions, sensitivity analyses, and the statistical models used.

National suicide management guidelines recommending family-based prevention, intervention and postvention and their association with suicide mortality rates: systematic review.

BACKGROUND: Suicidal behaviour remains a major public health concern and countries have responded by authoring guidelines to help mitigate death by suicide. Guidelines can include family-based recommendations, but evidence for the level and category of family-based involvement that is needed to effectively prevent suicide is unclear. AIMS: To explore the association between family-based recommendations in guidelines and countries' crude suicide rates. PROSPERO registration: CRD42019130195. METHOD: MEDLINE, Embase, PsycInfo, Web of Science and WHO MiNDbank databases and grey literature were searched within the past 20 years (1 January 2000 to 22 June 2020) for national guidelines giving family-based recommendations in any of three categories (prevention, intervention and postvention). RESULTS: We included 63 guidelines from 46 countries. All identified guidelines included at least one family-based recommendation. There were no statistically significant differences seen between mean World Health Organization crude suicide rates for countries that included only one, two or all three categories of family-based recommendations. However, a lower spread of crude suicide rates was seen when guideline recommendations included all three categories (mean crude suicide rates for one category: 11.09 (s.d. = 5.71); for two categories: 13.42 (s.d. = 7.76); for three categories: 10.68 (s.d. = 5.20); P = 0.478). CONCLUSIONS: Countries should work towards a comprehensive national suicide guideline that includes all categories of family-based recommendations. Countries with previously established guidelines should work towards the inclusion of evidence-based recommendations that have clear implementation plans to potentially help lower suicide rates.

Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study.

BACKGROUND: Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies. METHODS: Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada. RESULTS: One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms "pilot" or "feasibility" in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study. CONCLUSION: The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS.

Fragility of clinical trials across research fields: A synthesis of methodological reviews.

BACKGROUND: Randomized controlled trials (RCTs) are often used to inform clinical practice and it is desirable that their results be robust. A fragility index (FI), defined as the smallest number of participants in whom an outcome change from non-event to event would turn a statistically significant result to a non-significant result, can be computed to measure robustness. We sought to determine the distribution of fragility indices across various research areas and summarized the factors associated with fragility. METHODS: We searched PubMed between February 2014 and May 2019 and included reviews that reported on fragility indices and the associated factors. Two investigators independently screened articles for eligibility and extracted all relevant data from each review. Fragility indices were pooled using random effects meta-analysis. RESULTS: Twenty-four (24) reviews met the inclusion criteria. They contained a median of 41 trials (first quartile [Q1]-third quartile [Q3]: 17-120). The overall mean FI across different fields of research was 4 (95% confidence interval [CI] 3-5), indicating a high level of fragility. Higher journal impact factor, larger sample size, bigger effect size, more outcome events, a lower p-value, and adequate allocation concealment were reported to be associated with the higher FI. The ecological correlation between median FI and median sample size (22 studies) was 0.95 (95% CI 0.58-0.99). CONCLUSION: Trials across various fields of research are frequently fragile. We also identified some factors associated with fragility. Researchers should consider strategies to enhance the robustness of studies and minimize fragility.

National suicide management guidelines with family as an interv'ention and suicide mortality rates: a systematic review protocol.

INTRODUCTION: Suicidal behaviour remains a major public health challenge worldwide. Several countries have developed national suicide guidelines aimed at raising awareness of and preventing deaths by suicide. One of the interventions often mentioned in these national guidelines is the involvement of family members as a protective factor in suicide prevention. However, the level or type of family involvement required to reduce suicidal behaviour is not well understood. Thus, in this systematic review, we seek to determine the effectiveness of family-based interventions as a suicide prevention tool, by comparing suicide mortality rates between countries whose national suicide prevention guidelines include family-based interventions and those whose do not. METHODS AND ANALYSIS: MEDLINE, EMBASE, PsycINFO, Web of Science and WHO MiNDbank databases as well as grey literature such as National Guideline Clearinghouse will be searched. National guidelines for suicide prevention published within the last 20 years (between 1999 and 2019) will be included. Results will be analysed using thematic and qualitative analyses. ETHICS AND DISSEMINATION: The findings of the study will help improve the efficacy of national suicide prevention strategies. Findings will be disseminated using easily accessible summary reports and resources to primary end users. PROSPERO REGISTRATION NUMBER: This protocol has been registered on PROSPERO (CRD42019130195).

Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.

INTRODUCTION: Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting.The primary objective of this study is to assess whether pilot/feasibility studies submitted for ethics approval to a research ethics board transparently communicate the purpose of the study to participants through their informed consent practice. A highly transparent consent practice entails the consent documents communicate: (1) the term 'pilot' or 'feasibility' in the title; (2) the definition of a pilot/feasibility study; (3) the primary objectives of the study are to assess feasibility; (4) the specific feasibility objectives; and (5) the criteria for the study to successfully lead to the main study. The secondary objectives are to assess whether there is a difference between submitted and revised versions of the consent documents (revisions are made to obtain research ethics approval), to determine factors associated with transparent consent practices and to assess the consistency with which pilot and feasibility studies assess feasibility outcomes as their primary objectives. METHODS AND ANALYSIS: This is a retrospective review of informed consent information for pilot/feasibility studies submitted to the Hamilton integrated Research Ethics Board, Canada. We will look at submitted and revised consent documents for pilot/feasibility studies submitted over a 14-year period. We will use descriptive statistics to summarise data, reporting results as percentages with 95% CIs, and conduct logistic regression to determine characteristics associated with transparent consent practices. ETHICS AND DISSEMINATION: The study protocol was approved by the Hamilton integrated Research Ethics Board, and the results of this study will be submitted for publication in a peer-reviewed journal.