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Background Human factors (HF) integration can improve patient safety in the operating room (OR), but the depth of current knowledge remains unknown. This study aimed to explore the content of HF training for the operative environment. Methods We searched six bibliographic databases for studies describing HF interventions for the OR. Skills taught were classified using the Chartered Institute of Ergonomics and Human Factors (CIEHF) framework, consisting of 67 knowledge areas belonging to five categories: psychology; people and systems; methods and tools; anatomy and physiology; and work environment. Results Of 1851 results, 28 studies were included, representing 27 unique interventions. HF training was mostly delivered to interdisciplinary groups (n = 19; 70 per cent) of surgeons (n = 16; 59 per cent), nurses (n = 15; 56 per cent), and postgraduate surgical trainees (n = 11; 41 per cent). Interactive methods (multimedia, simulation) were used for teaching in all studies. Of the CIEHF knowledge areas, all 27 interventions taught ‘behaviours and attitudes’ (psychology) and ‘team work’ (people and systems). Other skills included ‘communication’ (n = 25; 93 per cent), ‘situation awareness’ (n = 23; 85 per cent), and ‘leadership’ (n = 20; 74 per cent). Anatomy and physiology were taught by one intervention, while none taught knowledge areas under work environment. Conclusion Expanding HF education requires a broader inclusion of the entirety of sociotechnical factors such as contributions of the work environment, technology, and broader organizational culture on OR safety to a wider range of stakeholders.

BACKGROUND Evidence to guide treatment of pediatric medium-chain acyl-coenzyme A dehydrogenase (MCAD) deficiency and phenylketonuria (PKU) is fragmented because of large variability in outcome selection and measurement. Our goal was to develop core outcome sets (COSs) for these diseases to facilitate meaningful future evidence generation and enhance the capacity to compare and synthesize findings across studies. METHODS Parents and/or caregivers, health professionals, and health policy advisors completed a Delphi survey and participated in a consensus workshop to select core outcomes from candidate lists of outcomes for MCAD deficiency and PKU. Delphi participants rated the importance of outcomes on a nine-point scale (1–3: not important, 4–6: important but not critical, 7–9: critical). Candidate outcomes were progressively narrowed down over 3 survey rounds. At the workshop, participants evaluated the remaining candidate outcomes using an adapted nominal technique, open discussion, and voting. After the workshop, we finalized the COSs and recommended measurement instruments for each outcome. RESULTS There were 85, 61, and 53 participants across 3 Delphi rounds, respectively. The candidate core outcome lists were narrowed down to 20 outcomes per disease to be discussed at the consensus workshop. Voting by 18 workshop participants led to COSs composed of 8 and 9 outcomes for MCAD deficiency and PKU, respectively, with measurement recommendations. CONCLUSIONS These are the first known pediatric COSs for MCAD deficiency and PKU. Adoption in future studies will help to ensure best use of limited research resources to ultimately improve care for children with these rare diseases.

Background Inherited metabolic diseases (IMDs) are a group of individually rare single-gene diseases. For many IMDs, there is a paucity of high-quality evidence that evaluates the effectiveness of clinical interventions. Clinical effectiveness trials of IMD interventions could be supported through the development of core outcome sets (COSs), a recommended minimum set of standardized, high-quality outcomes and associated outcome measurement instruments to be incorporated by all trials in an area of study. We began the process of establishing pediatric COSs for two IMDs, medium-chain acyl-CoA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU), by reviewing published literature to describe outcomes reported by authors, identify heterogeneity in outcomes across studies, and assemble a candidate list of outcomes. Methods We used a comprehensive search strategy to identify primary studies and guidelines relevant to children with MCAD deficiency and PKU, extracting study characteristics and outcome information from eligible studies including outcome measurement instruments for select outcomes. Informed by an established framework and a previously published pediatric COS, outcomes were grouped into five, mutually-exclusive, a priori core areas: growth and development, life impact, pathophysiological manifestations, resource use, and death. Results For MCAD deficiency, we identified 83 outcomes from 52 articles. The most frequently represented core area was pathophysiological manifestations, with 33 outcomes reported in 29/52 articles (56%). Death was the most frequently reported outcome. One-third of outcomes were reported by a single study. The most diversely measured outcome was cognition and intelligence/IQ for which eight unique measurement instruments were reported among 14 articles. For PKU, we identified 97 outcomes from 343 articles. The most frequently represented core area was pathophysiological manifestations with 31 outcomes reported in 281/343 articles (82%). Phenylalanine concentration was the most frequently reported outcome. Sixteen percent of outcomes were reported by a single study. Similar to MCAD deficiency, the most diversely measured PKU outcome was cognition and intelligence/IQ with 39 different instruments reported among 82 articles. Conclusions Heterogeneity of reported outcomes and outcome measurement instruments across published studies for both MCAD deficiency and PKU highlights the need for COSs for these diseases, to promote the use of meaningful outcomes and facilitate comparisons across studies.

IntroductionApplying human factors principles in surgical care has potential benefits for patient safety and care delivery. Although different theoretical frameworks of human factors exist, how providers are being trained in human factors and how human factors are being understood in vivo in the operating room (OR) remain unknown. The aim of this scoping review is to evaluate the application of human factors for the OR environment as described by education and training offerings for healthcare professionals.Methods and analysisThis scoping review will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. MEDLINE, Embase, PsycINFO, CINAHL, Health and Psychosocial Instruments and ERIC databases were searched on August 2020 from inception to identify relevant studies that describe the content, application and impact of human factors training for healthcare professionals or trainees who work in or interface with the OR environment. Titles, abstracts and full texts will be independently screened by two authors for eligible studies. Any disagreements will be resolved by discussion or by a third author when disagreement persists. Study information and training characteristics, such as the training tool used and type of learners and teachers, will be charted and summarised, and key themes in human factors training will be identified. Each training offering will be classified under the appropriate knowledge area(s) of human factors described by the Chartered Institute of Ergonomics & Human Factors (CIEHF). Themes that are not captured by the CIEHF framework will be independently recorded by two authors and included based on group discussion and consensus.Ethics and disseminationResearch ethics board approval is not required for this scoping review. The findings of this study will be disseminated at local and national conferences and will be published in a peer-reviewed journal.

Essentials Unprovoked venous thromboembolism (VTE) may be the first manifestation of an undiagnosed cancer. The rate of occult cancer detection in patients with unprovoked VTE is approximately 5%. Clinicians should keep a low threshold of suspicion for occult cancer in these patients. Patients should only undergo a limited as well as age- and gender-specific cancer screening. Unprovoked venous thromboembolism (VTE) can be the first manifestation of an undiagnosed cancer. Recently published studies have suggested that approximately 4-5% of patients with new unprovoked VTE will be diagnosed with cancer within 12 months of follow-up. Therefore, it is important for clinicians to keep a low threshold of suspicion for occult cancer in this patient population. After an unprovoked VTE diagnosis, patients should undergo a thorough medical history, physical examination, basic laboratory investigations (ie, complete blood count and liver function tests), chest X-ray, as well as age- and gender-specific cancer screening (breast, cervical, colon, and prostate). More intensive cancer screening including additional investigations (eg, computed tomography of the abdomen/pelvis) does not seem to increase the rate of occult cancer detection, decrease cancer-related morbidity, or increase survival or cost-effectiveness.

Background Inherited metabolic diseases (IMD) are a large group of rare single-gene disorders that are typically diagnosed early in life. There are important evidence gaps related to the comparative effectiveness of therapies for IMD, which are in part due to challenges in conducting randomized controlled trials (RCTs) for rare diseases. Registry-based RCTs present a unique opportunity to address these challenges provided the registries implement standardized collection of outcomes that are important to patients and their caregivers and to clinical providers and healthcare systems. Currently there is no core outcome set (COS) for studies evaluating interventions for paediatric IMD. This protocol outlines a study that will establish COS for each of two relatively common IMD in children, phenylketonuria (PKU) and medium-chain acyl-CoA dehydrogenase (MCAD) deficiency. Methods This two-part study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative. Part 1 includes a rapid review and development of an evidence map to identify a comprehensive listing of outcomes reported in past studies of PKU and MCAD deficiency. The review follows established methods for knowledge synthesis, including a comprehensive search strategy, two stages of screening citations against inclusion/exclusion criteria by two reviewers working independently, and extraction of important data elements from eligible studies, including details of the outcomes collected and outcome measurement instruments. The review findings will inform part 2 of our study, a set of Delphi surveys to establish consensus on the highest priority outcomes for each condition. Healthcare providers, families of children with PKU or MCAD deficiency, and health system decision-makers will be invited to participate in two to three rounds of Delphi surveys. The design of the surveys will involve parents of children with IMD who are part of a family advisory forum. Discussion This protocol is a crucial step in developing the capacity to launch RCTs with meaningful outcomes that address comparative effectiveness questions in the field of paediatric IMD. Such trials will contribute high-quality evidence to inform decision-making by patients and their family members, clinicians, and policy-makers. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2327-3) contains supplementary material, which is available to authorized users.

Background: The optimal duration of anticoagulation after a first unprovoked venous thromboembolism (VTE) is uncertain. Anticoagulant therapy is highly effective at reducing the risk of recurrent VTE, but this clinical benefit is not maintained once anticoagulation is stopped. Current guidelines suggest considering indefinite anticoagulation in all patients with unprovoked who have a non-high bleeding risk. However, this is a weak recommendation based on limited evidence. Deciding whether patients with a first unprovoked VTE should be considered for indefinite anticoagulant therapy requires estimation of the long-term risk of recurrent VTE after stopping anticoagulation. This risk however, is poorly established, hindering decision making. Methods: We performed a systematic review and meta-analysis of randomized clinical trials and prospective observational studies to determine the rate of recurrent VTE in the first year, in the second year, between years 2 and 5, and years 5 and 10; and the cumulative incidence for recurrent VTE at 2, 5 and 10 years after stopping anticoagulation in men and women with first unprovoked VTE, who had completed at least 3 months of initial treatment. Studies were identified through a comprehensive literature search using MEDLINE, EMBASE and the Cochrane CENTRAL databases. Data clarifications were requested from authors of eligible studies. Rates of recurrent VTE were calculated for each study from the total number of recurrent VTE events divided by the person-years of follow-up, and then pooled using random-effects meta-analysis. Results: Fourteen studies involving 6, 446 patients were included in the analysis. Among men with a first unprovoked VTE, the pooled rate of recurrent VTE per 100 person-years after stopping anticoagulation was 11.2 events (95% CI, 9.0-13.6) in the first year; 7.4 events (95% CI, 5.5-9.5) in the second year; 4.4 events/year (95% CI, 3.2-5.7) between years 2 and 5, and 3.8 events/year (95% CI, 1.6-6.9) between years 5 and 10 [Table 1]. Among women with a first unprovoked VTE, the pooled rate of recurrent VTE per 100 person-years after stopping anticoagulation was 8.6 events (95% CI, 6.5-11.0) within the first year; 5.2 events (95% CI, 3.5-7.2) in the second year; 3.0 events/year (95% CI, 1.6-4.7) between years 2 and 5, and 2.0 events/year (95% CI, 1.3-2.9) between years 5 and 10 [Table 1]. In men and women respectively, the cumulative incidence for recurrent VTE was 17.8% (95% CI, 14.0%-21.9%) and 13.4% (95% CI, 9.8%-17.4%) at 2 years, 28.2% (95% CI, 22.0%-34.4%) and 20.9% (95% CI, 14.0%-28.5%) at 5 years, and 40.8% (95% CI, 28.0%-53.9%) and 28.5% (95% CI, 19.5%-38.3%) at 10 years after stopping anticoagulant therapy [Table 2]. Conclusions: Among patients with a first unprovoked VTE who have completed at least 3 months of initial treatment, men have a higher long-term risk of recurrent VTE after stopping anticoagulation, and may be given greater consideration for indefinite anticoagulant therapy. Our findings affirm the importance of considering patient's sex in deciding the optimal duration of anticoagulation, and as such, emphasize the need for individualized, patient-centered approach for the long-term management of unprovoked VTE. Disclosures Carrier: BMS: Honoraria, Research Funding; Leo Pharma: Research Funding; Pfizer: Honoraria; Bayer: Honoraria. Weitz:Bristol-Myers Squibb: Honoraria; Daiichi-Sankyo: Honoraria; Ionis: Consultancy, Honoraria; Janssen: Honoraria; Servier: Honoraria; Novartis: Honoraria; Bayer: Honoraria; Boehringer Ingelheim: Honoraria, Research Funding. Schulman:Boehringer-Ingelheim: Honoraria, Research Funding; Daiichi-Sankyo: Honoraria; Sanofi: Honoraria; Bayer: Honoraria. Couturaud:Pfizer: Research Funding; Bayer: Honoraria, Other: Travel Support; AstraZeneca: Honoraria; Actelion: Other: Travel Support; Intermune: Other: Travel Support; Leo Pharma: Other: Travel Support; Daiichi Sankyo: Other: Travel Support. Becattini:Bayer HealthCare: Other: Lecture Fees; Boehringer Ingelheim: Other: Lecture Fees; Bristol Meyer Squibb: Other: Lecture Fees. Agnelli:Daiichi Sankyo: Other: Personal Fees; Boehringer Ingelheim: Other: Personal Fees; Bayer Healthcare: Other: Personal Fees; Pfizer: Other: Personal Fees; Bristol-Myers-Squibb: Other: Personal Fees. Brighton:Glaxo Smith Klein: Other: Personal Fees; Novo Nordisk: Other: Personal Fees; Bayer: Other: Personal Fees. Lensing:Bayer: Employment. Prins:Pfizer: Consultancy; Daiichi Sankyo: Consultancy. Hutton:Cornerstone Research Group: Honoraria. Palareti:Roche: Membership on an entity's Board of Directors or advisory committees; Werfen: Speakers Bureau; Alfa-Wassermann: Membership on an entity's Board of Directors or advisory committees; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees. Prandoni:Pfizer: Consultancy; Daiichi-Sankyo: Consultancy; Sanofi: Consultancy; Bayer: Consultancy. Büller:Pfizer: Consultancy, Research Funding; Daiichi-Sankyo: Consultancy, Research Funding; Roche: Consultancy, Research Funding; Sanofi-Aventis: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Bayer: Consultancy, Research Funding; Boehringer Ingelheim: Consultancy, Research Funding; Thrombogenics: Consultancy, Research Funding; Isis: Consultancy, Research Funding; GlaxoSmithKline: Consultancy, Research Funding. Rodger:Biomerieux: Research Funding.

Additional file 5. Microsoft Word document (.docx). Title: Measurement instruments for typically self-reported or neuropsychological PKU outcomes. Description: Includes frequency data and references for listed measurement instruments

Additional details on the methods for the rapid review and evidence map. (PDF 174 kb)

Additional file 4. Microsoft Word document (.docx). Title: Measurement instruments for typically self-reported or neuropsychological MCAD deficiency outcomes. Description: Includes frequency data and references for listed measurement instruments

Additional file 2. Microsoft Word document (.docx). Title: List of eligible studies excluded from data synthesis. Description: A table listing the references for eligible PKU and COMET database articles that were excluded from data synthesis

Additional file 1. Microsoft Word document (.docx). Title: Supplemental Materials and Methods: Description: Includes PRISMA checklist, search strategies, screening forms, and data extraction fields

Additional details on the methods for the rapid review and evidence map. (PDF 174 kb)

Additional file 2. Microsoft Word document (.docx). Title: List of eligible studies excluded from data synthesis. Description: A table listing the references for eligible PKU and COMET database articles that were excluded from data synthesis

List of Research Ethics Board: Delphi surveys for families. (DOCX 16 kb)

Additional file 1. Microsoft Word document (.docx). Title: Supplemental Materials and Methods: Description: Includes PRISMA checklist, search strategies, screening forms, and data extraction fields

Additional file 5. Microsoft Word document (.docx). Title: Measurement instruments for typically self-reported or neuropsychological PKU outcomes. Description: Includes frequency data and references for listed measurement instruments