The National COVID Cohort Collaborative (N3C): Rationale, design, infrastructure, and deployment.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) poses societal challenges that require expeditious data and knowledge sharing. Though organizational clinical data are abundant, these are largely inaccessible to outside researchers. Statistical, machine learning, and causal analyses are most successful with large-scale data beyond what is available in any given organization. Here, we introduce the National COVID Cohort Collaborative (N3C), an open science community focused on analyzing patient-level data from many centers. MATERIALS AND METHODS: The Clinical and Translational Science Award Program and scientific community created N3C to overcome technical, regulatory, policy, and governance barriers to sharing and harmonizing individual-level clinical data. We developed solutions to extract, aggregate, and harmonize data across organizations and data models, and created a secure data enclave to enable efficient, transparent, and reproducible collaborative analytics. RESULTS: Organized in inclusive workstreams, we created legal agreements and governance for organizations and researchers; data extraction scripts to identify and ingest positive, negative, and possible COVID-19 cases; a data quality assurance and harmonization pipeline to create a single harmonized dataset; population of the secure data enclave with data, machine learning, and statistical analytics tools; dissemination mechanisms; and a synthetic data pilot to democratize data access. CONCLUSIONS: The N3C has demonstrated that a multisite collaborative learning health network can overcome barriers to rapidly build a scalable infrastructure incorporating multiorganizational clinical data for COVID-19 analytics. We expect this effort to save lives by enabling rapid collaboration among clinicians, researchers, and data scientists to identify treatments and specialized care and thereby reduce the immediate and long-term impacts of COVID-19.

Is team-based perception of safety in the operating room associated with self-reported wrong-site surgery? An exploratory cross-sectional survey among physicians.

AIMS: Participation in wrong-site surgery may negatively influence the perception of safety by the health care professionals in the operating room (OR). The objective was to explore if perception of safety in the OR was seen as a team-based or individualist concern and whether having participated in wrong-site surgery was associated with perception of safety. METHOD AND RESULTS: Cross-sectional survey at 2 annual meetings of surgery, in Switzerland, 2010. We used multivariate generalized models to assess the association of perception of safety in the OR (1 item) with self-reported participation in wrong-site surgery-overall, past (more than 3 y ago), or recent (last 3 y) participations-controlling for sociodemographic characteristics and opinion of the surgical safety checklist. One hundred ninety respondents answered the questionnaire (participation rate of 22.6%). Respondents mostly had a team-based, rather than an individualistic, perception of safety in the OR. In multivariate analyses, the influence of ever participation in wrong-site surgery was not significant. However, past participation in wrong-site surgery (more than 3 y ago) was associated with perception of safety as team based, whereas recent participation (last 3 y) was associated-despite not significant at α ≤ 5%-with perception of safety as individualistic. CONCLUSION: In this sample, safety in the OR is most often seen as team based rather than individualistic. Perceiving safety in the OR as team based varies according to recent or past participation in wrong-site surgery. Longitudinal research is needed to assess causality between participation in wrong-site surgery and change in perception of safety.

Does the patient's inherent rating tendency influence reported satisfaction scores and affect division ranking?

OBJECTIVE: To determine the impact of adjusting for rating tendency (RT) on patient satisfaction scores in a large teaching hospital and to assess the impact of adjustment on the ranking of divisions. DESIGN: Cross-sectional survey. SETTING: Large 2200-bed university teaching hospital. PARTICIPANTS: All adult patients hospitalized during a 1-month period in one of 20 medical divisions. INTERVENTION: None. MAIN OUTCOME MEASURES: Patient experience of care measured by the Picker Patient Experience questionnaire and RT scores. RESULTS: Problem scores were weakly but significantly associated with RT. Division ranking was slightly modified in RT adjusted models. Division ranking changed substantially in case-mix adjusted models. CONCLUSIONS: Adjusting patient self-reported problem scores for RT did impact ranking of divisions, although marginally. Further studies are needed to determine the impact of RT when comparing different institutions, particularly across inter-cultural settings, where the difference in RT may be more substantial.

Proximal opening wedge osteotomy with wedge-plate fixation compared with proximal chevron osteotomy for the treatment of hallux valgus: a prospective, randomized study.

BACKGROUND: Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy. The proximal chevron osteotomy is commonly used but is technically difficult. This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle. METHODS: This prospective, randomized multicenter (three-center) study was based on the clinical outcome scores of the Short Form-36, the American Orthopaedic Foot & Ankle Society forefoot questionnaire, and the visual analog scale for pain, activity, and patient satisfaction. Subjects were assessed prior to surgery and at three, six, and twelve months postoperatively. Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure. RESULTS: No significant differences were found for any of the patients' clinical outcome measurements between the two procedures. The proximal opening wedge osteotomy was found to lengthen, and the proximal chevron osteotomy was found to shorten, the first metatarsal. The intermetatarsal angles improved (decreased) significantly, from 14.8° ± 3.2° to 9.1° ± 2.9 (mean and standard deviation) after a proximal opening wedge osteotomy and from 14.6° ± 3.9° to 11.3° ± 4.0° after a proximal chevron osteotomy (p < 0.05 for both). Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy (mean and standard deviation, 67.1 ± 16.5 minutes compared with 69.9 ± 18.6 minutes; p = 0.510). CONCLUSIONS: Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain, satisfaction, and function. The proximal opening wedge osteotomy lengthens, and the proximal chevron osteotomy shortens, the first metatarsal. The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Implementation of the surgical safety checklist in Switzerland and perceptions of its benefits: cross-sectional survey.

OBJECTIVES: To examine the implementation of the Surgical Safety Checklist (SSC) among surgeons and anaesthetists working in Swiss hospitals and clinics and their perceptions of the SSC. METHODS: Cross-sectional survey at the 97th Annual Meeting of the Swiss Society of Surgery, Switzerland, 2010. Opinions of the SSC were assessed with a 6-item questionnaire. RESULTS: 152 respondents answered the questionnaire (participation rate 35.1%). 64.7% respondents acknowledged having a checklist in their hospital or their clinic. Median implementation year was 2009. More than 8 out of 10 respondents reported their team applied the Sign In and the Time Out very often or quasi systematically, whereas almost half of respondents acknowledged the Sign Out was applied never or rarely. The majority of respondents agreed that the checklist improves safety and team communication, and helps to develop a safety culture. However, they were less supportive about the opinion that the checklist facilitates teamwork and eliminates social hierarchy between caregivers. CONCLUSIONS: This survey indicates that the SSC has been largely implemented in many Swiss hospitals and clinics. Both surgeons and anaesthetists perceived the SSC as a valuable tool in improving intraoperative patient safety and communication among health care professionals, with lesser importance in facilitating teamwork (and eliminating hierarchical categories).

Longitudinal migration and inducible displacement of the Mobility Total Ankle System.

BACKGROUND AND PURPOSE: RSA can be used for early detection of unstable implants. We assessed the micromotion of the Mobility Total Ankle System over 2 years, to evaluate the stability of the bone-implant interface using radiostereometric analysis measurements of longitudinal migration and inducible displacement. PATIENTS AND METHODS: 23 patients were implanted with the Mobility system. Median age was 62 (28-75) years and median BMI was 28.8 (26.0-34.5). Supine radiostereometric analysis examinations were done from postoperatively to the 2-year follow-up. Standing examinations were taken from the 3-month to the 2-year follow-up. Migrations and displacements were assessed using model-based RSA software (v. 3.2). RESULTS: The median maximum total point motion (MTPM) for the implants at 2 years was 1.19 (0.39-1.95) mm for the talar component and 0.90 (0.17-2.28) mm for the spherical tip of the tibial component. The general pattern for all patients was that the slope of the migration curves decreased over time. The main direction of motion for both components was that of subsidence. The median 2-year MTPM inducible displacement for the talar component was 0.49 (0.27-1.15) mm, and it was 0.07 (0.03-0.68) mm for the tibial component tip. INTERPRETATION: The implants subside into the bone over time and under load. This corresponds to the direction of primary loading during standing or walking. This statistically significant motion may become a clinically significant finding that would correspond with premature implant failure.

Promoting clinical competence: using scaffolded instruction for practice-based learning.

Competency-based education is essential for bridging the gap between education and practice. The attributes of competency-based education include an outcomes focus, allowance for increasing levels of competency, learner accountability, practice-based learning, self-assessment, and individualized learning experiences. One solution to this challenge is scaffolded instruction, where collaboration and knowledge facilitate learning. Collaboration refers to the role of clinical faculty who model desired clinical skills then gradually shift responsibility for nursing activity to the student. This article describes scaffolded instruction as applied in a Web-based second-degree bachelor of science in nursing (BSN) program. This second-degree BSN program uses innovative approaches to education, including a clinical component that relies on clinical coaches. Students in the program remain in their home community and complete their clinical hours with an assigned coach. The method will be described first, followed by a description of how the method was applied.

Ability of the objective structured clinical examination to differentiate surgical residents, medical students, and physician assistant students.

BACKGROUND: The Objective Structured Clinical Examination (OSCE) has been used extensively to evaluate the clinical abilities of medical students and residents. The purpose of this study was to investigate whether the standard OSCE would differentiate performance of subjects with different levels and/or types of training. METHODS: We conducted a blinded OSCE, during which we simultaneously evaluated surgical residents from all 5 years of the general surgery training program, third-year medical students, and second-year physician assistant students. All examinees went through the same clinical evaluation stations, which consisted of history-taking, physical examination, technical skills, trauma management, and X-ray interpretation. The students and residents were rated at each station by a trained standardized patient evaluator or a faculty evaluator using a checklist for performance evaluation. All subjects wore surgical scrubs without name tags or identification of program or year of training. RESULTS: Overall mean performance scores (P = 0.09, NS) were for surgical residents 71.2% (+/-9.7); for medical students 66.9% (+/-5.7); for physician assistant students 64.7% (+/-5.8). This shows a significant trend toward higher scores with more training. Surgical residents scored higher on technical stations, history-taking, and X-ray interpretation. Medical students scored higher in performance of physical examination. Physician assistant students scored quite close to the other two groups. CONCLUSIONS: The differences among group performance appeared to reflect the level of experience of the learners. Some components of the OSCE appear to better differentiate levels of training.