Assessment of guidelines for bariatric and metabolic surgery: a systematic review and evaluation using appraisal of guidelines for research and evaluation II (AGREE II).

BACKGROUND: In recent years, multiple guidelines on bariatric and metabolic surgery were published, however, their quality remains unknown, leaving providers with uncertainty when using them to make perioperative decisions. This study aims to evaluate the quality of existing guidelines for perioperative bariatric surgery care. METHODS: A comprehensive search of MEDLINE and EMBASE were conducted from January 2010 to October 2022 for bariatric clinical practice guidelines. Guideline evaluation was carried out using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) framework. RESULTS: The initial search yielded 1483 citations, of which, 26 were included in final analysis. The overall median domain scores for guidelines were: (1) scope and purpose: 87.5% (IQR: 57-94%), (2) stakeholder involvement: 49% (IQR: 40-64%), (3) rigor of development: 42.5% (IQR: 22-68%), (4) clarity of presentation: 85% (IQR: 81-90%), (5) applicability: 6% (IQR: 3-16%), (6) editorial independence: 50% (IQR: 48-67%), (7) overall impressions: 48% (IQR: 33-67%). Only six guidelines achieved an overall score >70%. CONCLUSIONS: Bariatric surgery guidelines effectively outlined their aim and presented recommendations. However, many did not adequately seek patient input, state search criteria, use evidence rating tools, and consider resource implications. Future guidelines should reference the AGREE II framework in study design.

Measuring waning protection from seasonal influenza vaccination during nine influenza seasons, Ontario, Canada, 2010/11 to 2018/19.

BackgroundWaning immunity from seasonal influenza vaccination can cause suboptimal protection during peak influenza activity. However, vaccine effectiveness studies assessing waning immunity using vaccinated and unvaccinated individuals are subject to biases.AimWe examined the association between time since vaccination and laboratory-confirmed influenza to assess the change in influenza vaccine protection over time.MethodsUsing linked laboratory and health administrative databases in Ontario, Canada, we identified community-dwelling individuals aged ≥ 6 months who received an influenza vaccine before being tested for influenza by RT-PCR during the 2010/11 to 2018/19 influenza seasons. We estimated the adjusted odds ratio (aOR) for laboratory-confirmed influenza by time since vaccination (categorised into intervals) and for every 28 days.ResultsThere were 53,065 individuals who were vaccinated before testing for influenza, with 10,264 (19%) influenza-positive cases. The odds of influenza increased from 1.05 (95% CI: 0.91-1.22) at 42-69 days after vaccination and peaked at 1.27 (95% CI: 1.04-1.55) at 126-153 days when compared with the reference interval (14-41 days). This corresponded to 1.09-times increased odds of influenza every 28 days (aOR = 1.09; 95% CI: 1.04-1.15). Individuals aged 18-64 years showed the greatest decline in protection against influenza A(H1N1) (aORper 28 days = 1.26; 95% CI: 0.97-1.64), whereas for individuals aged ≥ 65 years, it was against influenza A(H3N2) (aORper 28 days = 1.20; 95% CI: 1.08-1.33). We did not observe evidence of waning vaccine protection for individuals aged < 18 years.ConclusionsInfluenza vaccine protection wanes during an influenza season. Understanding the optimal timing of vaccination could ensure robust protection during seasonal influenza activity.

Severity Grading Systems for Intraoperative Adverse Events. A Systematic Review of the Literature and Citation Analysis.

INTRODUCTION: The accurate assessment and grading of adverse events (AE) is essential to ensure comparisons between surgical procedures and outcomes. The current lack of a standardized severity grading system may limit our understanding of the true morbidity attributed to AEs in surgery. The aim of this study is to review the prevalence in which intraoperative adverse event (iAE) severity grading systems are used in the literature, evaluate the strengths and limitations of these systems, and appraise their applicability in clinical studies. METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. PubMed, Web of Science, and Scopus were queried to yield all clinical studies reporting the proposal and/or the validation of iAE severity grading systems. Google Scholar, Web of Science, and Scopus were searched separately to identify the articles citing the systems to grade iAEs identified in the first search. RESULTS: Our search yielded 2957 studies, with 7 studies considered for the qualitative synthesis. Five studies considered only surgical/interventional iAEs, while 2 considered both surgical/interventional and anesthesiologic iAEs. Two included studies validated the iAE severity grading system prospectively. A total of 357 citations were retrieved, with an overall self/nonself-citation ratio of 0.17 (53/304). The majority of citing articles were clinical studies (44.1%). The average number of citations per year was 6.7 citations for each classification/severity system, with only 2.05 citations/year for clinical studies. Of the 158 clinical studies citing the severity grading systems, only 90 (56.9%) used them to grade the iAEs. The appraisal of applicability (mean%/median%) was below the 70% threshold in 3 domains: stakeholder involvement (46/47), clarity of presentation (65/67), and applicability (57/56). CONCLUSION: Seven severity grading systems for iAEs have been published in the last decade. Despite the importance of collecting and grading the iAEs, these systems are poorly adopted, with only a few studies per year using them. A uniform globally implemented severity grading system is needed to produce comparable data across studies and develop strategies to decrease iAEs, further improving patient safety.

Digital Parenting Interventions for Fathers of Infants From Conception to the Age of 12 Months: Systematic Review of Mixed Methods Studies.

BACKGROUND: Digital interventions help address barriers to traditional health care services. Fathers play an important parenting role in their families, and their involvement is beneficial for family well-being. Although digital interventions are a promising avenue to facilitate father involvement during the perinatal period, most are oriented toward maternal needs and do not address the unique needs of fathers. OBJECTIVE: This systematic review describes the digital interventions that exist or are currently being developed for fathers of infants from conception to 12 months postpartum. METHODS: A systematic search of the MEDLINE, PsycINFO, Cochrane Central Register of Controlled Trials, Embase (using Ovid), and CINAHL (using EBSCO) databases was conducted to identify articles from database inception to June 2022, of which 39 met the inclusion criteria. Articles were included if they were peer-reviewed and described a digital intervention that targeted fathers of fetuses or infants aged ≤12 months. Systematic reviews, meta-analyses, and opinion pieces were excluded. Data from these studies were extracted and themed using a narrative synthesis approach. Quality appraisal of the articles was conducted using the Mixed Methods Appraisal Tool. RESULTS: A total of 2816 articles were retrieved, of which 39 (1.38%) met the inclusion criteria for eligibility after removing duplicates and screening. Eligible articles included 29 different interventions across 13 countries. Most articles (22/29, 76%) described interventions that were exclusively digital. There were a variety of digital modalities, but interventions were most commonly designed to be delivered via a website or web-based portal (14/29, 48%). Just over half (21/39, 54%) of the articles described interventions designed to be delivered from pregnancy through the postpartum period. Only 26% (10/39) of the studies targeted fathers exclusively. A wide range of outcomes were included, with 54% (21/39) of the studies including a primary outcome related to intervention feasibility. Qualitative and mixed methods studies reported generally positive experiences with digital interventions and qualitative themes of the importance of providing support to partners, improving parenting confidence, and normalization of stress were identified. Of the 18 studies primarily examining efficacy outcomes, 13 (72%) reported a statistically significant intervention effect. The studies exhibited a moderate quality level overall. CONCLUSIONS: New and expecting fathers use digital technologies, which could be used to help address father-specific barriers to traditional health care services. However, in contrast to the current state of digital interventions for mothers, father-focused interventions lack evaluation and evidence. Among the existing studies on digital interventions for fathers, there seem to be mixed findings regarding their feasibility, acceptability, and efficacy. There is a need for more development and standardized evaluation of interventions that target father-identified priorities. This review was limited by not assessing equity-oriented outcomes (eg, race and socioeconomic status), which should also be considered in future intervention development.

Surgeon-specific factors have a larger impact on decision-making for the management of proximal humerus fractures than patient-specific factors: a prospective cohort study.

BACKGROUND: There is significant variability both in how proximal humerus fractures (PHFs) are treated and the ensuing patient outcomes. The purpose of this study was to investigate which surgeon- and patient-specific factors contribute to decision-making in the treatment of adult PHFs. We hypothesized that orthopedic sub-specialty training creates inherent bias and plays an important role in management algorithms for PHFs. METHODS: We performed a prospective cohort investigation in 2 groups of surgeons-traumatologists (N = 25) and shoulder & elbow/sports surgeons (SES) (N = 26)-and asked them to provide treatment recommendations for 30 distinct clinical cases with standardized radiographic and clinical data. This is a population-based sample of surgeons who take trauma call and treat PHFs with different sub-specializations and practice settings including academic, hospital-employed, and private. Surgeons characterized based on subspecialty (trauma vs. SES), experience level (>10 vs. ≤10-years), and employment type (hospital- vs. non-hospital-employed). Chi-square analyses, logistic mixed-effects modeling, and relative importance analysis were used to evaluate the data. RESULTS: Of the patient-specific factors, we found that the management of PHFs is largely dependent on initial radiographs obtained. Traumatologists were more likely to offer open reduction internal fixation (ORIF) and less likely to offer arthroplasty: 69% ORIF (traumatologists) vs. 51% ORIF (SES, P < .001), 8% arthroplasty (traumatologists) vs. 17% (SES, P < .001). Traumatologists were less likely to change from operative (either ORIF or arthroplasty) to non-operative management compared to SES surgeons when presented with additional patient demographic data. Surgeon-specific factors contributed to more than one-half of the variability in decision-making of PHF management while patient-specific factors contributed to about one-third of the variability in decision-making. CONCLUSIONS: As physicians strive to advance the treatment for PHFs and optimize patient outcomes, our findings highlight the complex overlap between surgeon-, fracture-, and patient-specific factors in the final decision-making process.

Intraoperative leak test is associated with lower postoperative bleed rate in primary sleeve gastrectomy: a propensity matched analysis of primary and revision bariatric surgery using the MBSAQIP database.

BACKGROUND: Gastrointestinal leaks after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) occur infrequently but lead to clinical and socioeconomic burden on patients. Surgeons perform intraoperative leak test (IOLT) via gastric tube or endoscopy to help prevent postoperative leaks. However, there is knowledge gap in the literature on effectiveness of IOLT during bariatric surgery. METHODS: In this observational cohort study using the 2015-2017 MBSAQIP database, we compared the outcomes in patients who received IOLT with those who did not during primary or revision RYGB and SG. The primary outcome was 30-day postoperative leak. Secondary outcomes were procedure duration and the rates of 30-day postoperative bleed, readmission, reoperation and intervention. Propensity score matching was used to assemble cohorts of patients with similar baseline characteristics. RESULTS: Among 363,042 patients, 82% underwent IOLT. Four subgroups of patients who underwent operations with or without IOLT during primary RYGB (n = 13,756), primary SG (n = 110,810), revision RYGB (n = 1140), and revision SG (n = 5576) had similar propensity scores and were matched 1:1. Patients who underwent IOLT had similar postoperative leak rates compared to those who did not (Primary RYGB with IOLT 0.7% v. without IOLT 0.6%; Primary SG 0.4% v. 0.3%; Revision RYGB 2.3% v. 1.0%; Revision SG 1.1% v. 0.7%). In primary SG subgroup, patients who underwent IOLT had lower postoperative bleed rates (0.6% v. 0.8%, p = 0.002). In primary RYGB and SG subgroups, operations with IOLT were slightly longer. CONCLUSION: Postoperative leak rates after primary and revision bariatric surgery were low and similar irrespective of IOLT. Patients who had IOLT during primary SG had lower postoperative bleed rates. Current judgment as to whether to perform an IOLT leads to excellent outcomes, and thus, current practices should continue. However, one should consider an IOLT during primary SG, not necessarily to reduce leak rates but to help reduce postoperative bleeding occurrences.

High-resolution cryo-EM structures of outbreak strain human norovirus shells reveal size variations.

Noroviruses are a leading cause of foodborne illnesses worldwide. Although GII.4 strains have been responsible for most norovirus outbreaks, the assembled virus shell structures have been available in detail for only a single strain (GI.1). We present high-resolution (2.6- to 4.1-Å) cryoelectron microscopy (cryo-EM) structures of GII.4, GII.2, GI.7, and GI.1 human norovirus outbreak strain virus-like particles (VLPs). Although norovirus VLPs have been thought to exist in a single-sized assembly, our structures reveal polymorphism between and within genogroups, with small, medium, and large particle sizes observed. Using asymmetric reconstruction, we were able to resolve a Zn2+ metal ion adjacent to the coreceptor binding site, which affected the structural stability of the shell. Our structures serve as valuable templates for facilitating vaccine formulations.

Onboard cone-beam CT-based replan evaluation for head and neck proton therapy.

PURPOSE: Quality assurance computed tomography (QACT) is the current clinical practice in proton therapy to evaluate the needs for replan. QACT could falsely indicate replan because of setup issues that would be solved on the treatment machine. Deforming the treatment planning CT (TPCT) to the pretreatment CBCT may eliminate this issue. We investigated the performance of replan evaluation based on deformed TPCT (TPCTdir) for proton head and neck (H&N) therapy. METHODS AND MATERIALS: Twenty-eight H&N datasets along with pretreatment CBCT and QACT were used to validate the method. The changes in body volume were analyzed between the no-replan and replan groups. The dose on the TPCTdir, the deformed QACT (QACTdir), and the QACT were calculated by applying the clinical plans to these image sets. Dosimetric parameters' changes, including ΔD95, ΔDmean, and ΔD1 for the clinical target volumes (CTVs) were calculated. Receiver operating characteristic curves for replan evaluation based on ΔD95 on QACT and TPCTdir were calculated, using ΔD95 on QACTdir as the reference. A threshold for replan based on ΔD95 on TPCTdir is proposed. The specificities for the proposed method were calculated. RESULTS: The changes in the body contour were 95.8 ± 83.8 cc versus 305.0 ± 235.0 cc (p < 0.01) for the no-replan and replan groups, respectively. The ΔD95, ΔDmean, and ΔD1 are all comparable for all the evaluations. The differences between TPCTdir and QACTdir evaluations were 0.30% ± 0.86%, 0.00 ± 0.22 Gy, and -0.17 ± 0.61 Gy for CTV ΔD95, ΔDmean, and ΔD1, respectively. The corresponding differences between the QACT and QACTdir were 0.12% ± 1.1%, 0.02 ± 0.32 Gy, and -0.01 ± 0.71 Gy. CTV ΔD95 > 2.6% in TPCTdir was chosen as the threshold to trigger QACT/replan. The corresponding specificity was 94% and 98% for the clinical practice and the proposed method, respectively. CONCLUSIONS: The replan evaluation based on TPCTdir provides better specificity than that based on the QACT.

System Factors Affecting Patient Safety in the OR: An Analysis of Safety Threats and Resiliency.

OBJECTIVE: The objective of this study is to determine the characteristics and frequency of intraoperative safety threats and resilience supports using a human factors measurement tool. BACKGROUND: Human factors analysis can provide insight into how system elements contribute to intraoperative adverse events. Empiric evidence on safety threats and resilience in surgical practice is lacking. METHODS: A cross-sectional study of 24 patients undergoing elective laparoscopic general surgery at a single center in the Netherlands from May to November, 2017 was conducted. Video, audio, and patient physiologic data from all included procedures were obtained through a multichannel synchronized recording device. Trained analysts reviewed the recordings and coded safety threats and resilience supports. The codes were categorized into 1 of 6 categories (person, task, tools and technology, physical environment, organization, and external environment). RESULTS: A median of 14 safety threats [interquartile range (IQR) 11-16] and 12 resilience supports (IQR 11-16) were identified per case. Most safety threat codes (median 9, IQR 7-12) and resilience support codes (median 10, IQR 7-12) were classified in the person category. The organization category contained a median of 2 (IQR 1-2) safety threat codes and 2 (IQR 2-3) resilience support codes per case. The tools and technology category contributed a small number of safety threats (median 1 per case, IQR 0-1), but rarely provided resilience support. CONCLUSIONS: Through a detailed human factors analysis of elective laparoscopic general surgery cases, this study provided a quantitative analysis of the existing safety threats and resilience supports in a modern endoscopic operating room.

Non-technical skills and device-related interruptions in minimally invasive surgery.

BACKGROUND: Device-related interruptions in the operating room (OR) may create stress among health care providers and delays. Although non-technical skills (NTS) of the OR teams, such as situational awareness and communication, are expected to influence device-related interruptions, empirical data on this relationship are limited. METHODS: We performed a prospective cohort study of 144 consecutive elective laparoscopic operations during 13 months. A data capture system called the OR Black Box® was used to characterize device-related interruptions, NTS, and distractions. Device-related interruptions were classified according to a priori established categories. Positive and negative NTS instances were identified according to validated measurement tools specific for nurses and surgeons. We assessed the relationship between NTS and device-related interruptions after adjusting for potential confounders. RESULTS: A total of 86 device-related interruptions occurred in 48 of 144 operations (33%). They were most frequently classified as device failure (54%) followed by improper assembly (19%) and disconnection (14%). Medians of 1 [interquartile range (IQR) 0-3] and 1 (IQR 0-2) negative NTS instance per operation were demonstrated by nurses and surgeons, respectively. Medians of 28 (IQR 15-38) and 40 (IQR 28-118) positive NTS instances per operation were demonstrated by nurses and surgeons. In a multivariable analysis, a higher frequency of negative NTS instances demonstrated by nurses was associated with device-related interruptions after risk adjustment (Odds Ratio 1.33, p = 0.02). CONCLUSIONS: In elective laparoscopic operations, an increased likelihood of device-related interruptions in the OR was associated with more frequent negative NTS demonstrations by nursing teams.

Measuring the teamwork performance of operating room teams: a systematic review of assessment tools and their measurement properties.

Teamwork is fundamental to surgical patient safety but is inconsistently measured. While many tools have been developed for elective intraoperative situations, it is unclear which is the most robust. This systematic review aimed to identify tools to measure the teamwork of operating room teams. Studies were included if they examined the measurement properties of these tools. PsycINFO, Embase (via OVID), CINAHL, ERIC, Medline and Medline in Process (via OVID) were searched through to May 3, 2019, as were reference lists of included studies and previously published relevant reviews. Retrieved articles were screened and data extracted in duplicate by two independent reviewers. Quality was assessed using the COSMIN checklist. Of the 2121 references identified, 14 studies of six assessment tools were included. Tools were validated across various specialties, mostly in clinical rather than simulated settings. The Observational Teamwork Assessment for Surgery (OTAS) and Operating Theater Team Non-Technical Skills Assessment Tool (NOTECHS) were the most frequently investigated tools. Though acceptable for assessing teamwork, both NOTECHS and OTAS rely on the questionable assumption that the teamwork of a team is equivalent to the sum of individual performances. Future studies may investigate other assessment tools that assess the whole team as the unit of analysis along with the potential of these tools to provide healthcare providers with meaningful feedback in clinical practice.

Health and service use of newcomers and other adults with intellectual and developmental disabilities: A population-based study.

BACKGROUND: This study examines newcomers with intellectual and developmental disabilities compared to other adults with intellectual and developmental disabilities in Ontario, Canada. METHODS: This population-based retrospective cohort study used linked health and social services administrative data to identify adults with intellectual and developmental disabilities as newcomers, or non-newcomers, and compared their health status and health service outcomes. RESULTS: Among those with intellectual and developmental disabilities, compared to non-newcomers, newcomers generally had lower or similar rates of health issues, except for higher rates of psychosis. Newcomers also had slightly greater use of community-based health services, but less hospital use. CONCLUSION: Trends among those with the intellectual and developmental disabilities were consistent with general population trends; newcomers had lower rates of many health issues and lower hospital use. It also underscores the value of understanding drivers of heterogeneity within newcomers, such as the circumstances of admission and settlement in their new country.

First-year Analysis of the Operating Room Black Box Study.

OBJECTIVE: To characterize intraoperative errors, events, and distractions, and measure technical skills of surgeons in minimally invasive surgery practice. BACKGROUND: Adverse events in the operating room (OR) are common contributors of morbidity and mortality in surgical patients. Adverse events often occur due to deviations in performance and environmental factors. Although comprehensive intraoperative data analysis and transparent disclosure have been advocated to better understand how to improve surgical safety, they have rarely been done. METHODS: We conducted a prospective cohort study in 132 consecutive patients undergoing elective laparoscopic general surgery at an academic hospital during the first year after the definite implementation of a multiport data capture system called the OR Black Box to identify intraoperative errors, events, and distractions. Expert analysts characterized intraoperative distractions, errors, and events, and measured trainee involvement as main operator. Technical skills were compared, crude and risk-adjusted, among the attending surgeon and trainees. RESULTS: Auditory distractions occurred a median of 138 times per case [interquartile range (IQR) 96-190]. At least 1 cognitive distraction appeared in 84 cases (64%). Medians of 20 errors (IQR 14-36) and 8 events (IQR 4-12) were identified per case. Both errors and events occurred often in dissection and reconstruction phases of operation. Technical skills of residents were lower than those of the attending surgeon (P = 0.015). CONCLUSIONS: During elective laparoscopic operations, frequent intraoperative errors and events, variation in surgeons' technical skills, and a high amount of environmental distractions were identified using the OR Black Box.

Nontechnical Skill Assessment of the Collective Surgical Team Using the Non-Technical Skills for Surgeons (NOTSS) System.

OBJECTIVE: To validate the Non-Technical Skills for Surgeons (NOTSS) system for assessment of the collective surgical teams' nontechnical skills after observing recordings of actual OR environment. BACKGROUND: The NOTSS system is a widely accepted tool to measure nontechnical skills of individual surgeons, and has mostly been used in the simulated setting. Surgical procedures are rarely performed by a single surgeon, but by a surgical team of attending surgeons, surgical assistants, and surgical trainees. Therefore, assessment of nontechnical skills may benefit from holistic assessment of the collective surgical teams. METHODS: Five trained participants assessed surgical team and attending surgeon using the NOTSS system after watching ten 20-minute long videos obtained from live OR. A set of reference ratings was provided by a multidisciplinary expert committee. We performed analyses to assess system sensitivity; examine inter-rater reliability of ratings; investigate concurrent construct validity; and assess feasibility and acceptability of using the NOTSS system to measure surgical team performance. RESULTS: There was adequate system sensitivity when comparing participants' and reference ratings. Inter-rater reliability among the participants' ratings was good except for decision-making category. The level of inter-rater reliability was similar when rating teams and attending surgeons. There was strong positive correlation between teams' and attending surgeons' NOTSS ratings at category [Pearson coefficient 0.86, 95% confidence interval (CI) 0.82-0.89] and element levels (0.83, 95% CI 0.80-0.85), demonstrating evidence of concurrent construct validity. The participants felt that the use of NOTSS system to measure teams' nontechnical skills was acceptable and feasible to a fair extent. CONCLUSION: The NOTSS system, although developed for assessment of individual surgeons, is a useful tool for observing and rating surgical teams.

Development and Evaluation of a Novel Instrument to Measure Severity of Intraoperative Events Using Video Data.

OBJECTIVE: To develop and evaluate a novel instrument to measure SEVERE processes using video data. BACKGROUND: Surgical video data can serve an important role in understanding the relationship between intraoperative events and postoperative outcomes. However, a standard tool to measure severity of intraoperative events is not yet available. METHODS: Items to be included in the instrument were identified through literature and video reviews. A committee of experts guided item reduction, including pilot tests and revisions, and determined weighted scores. Content validity was evaluated using a validated sensibility questionnaire. Inter-rater reliability was assessed by calculating intraclass correlation coefficient. Construct validity was evaluated on a sample of 120 patients who underwent laparoscopic Roux-en-Y gastric bypass procedure, in which comprehensive video data was obtained. RESULTS: SEVERE index measures severity of 5 event types using ordinal scales. Each intraoperative event is given a weighted score out of 10. Inter-rater reliability was excellent [0.87 (95%-confidence interval, 0.77-0.92)]. In a sample of consecutive 120 patients undergoing gastric bypass procedures, a median of 12 events [interquartile range (IQR) 9-18] occurred per patient and bleeding was the most frequent type (median 10, IQR 7-14). The median SEVERE score per case was 11.3 (IQR 8.3-16.9). In risk-adjusted multivariable regression models, history of previous abdominal surgery (P = 0.02) and body mass index (P = 0.005) were associated with SEVERE scores, demonstrating construct validity evidence. CONCLUSION: The SEVERE index may prove to be a useful instrument in identifying patients with high risk of developing postoperative complications.

Factors associated with surgeon's perception of distraction in the operating room.

BACKGROUND: Distractions in the operating room (OR) can create stress among surgeons and lead to higher chances of errors and adverse events. The objective is to determine intraoperative factors that are associated with surgeons' perception of distraction. METHODS: We conducted a prospective cohort study in 265 consecutive patients undergoing elective laparoscopic general surgery during the 2 years after the implementation of a data capture system called the OR Black Box to identify intraoperative sources of distraction. At the end of each operation, human-factor surveys were administered to assess whether surgeons felt distracted. Using a multivariable logistic model, we determined which intraoperative sources of distraction were associated with the surgeons feeling distracted in the OR. RESULTS: The attending surgeon reported feeling distracted in 120 of 265 operations (45%). Auditory sources of distraction, such as the OR door opening occurred at a median of 41 times per case (interquartile range (IQR), 32-54). Cognitive distractions such as teaching (142 cases (54%)), device malfunction (91 (34%)), irrelevant conversations (72 (27%)), management of the next case (41 (15%)), and time pressure (22 (8%)) occurred in a significant number of operations. In a multivariable analysis, presence of irrelevant conversations (odds ratio 2.14, 95% confidence interval (CI) 1.16-3.94, p = 0.015) and patient history of previous abdominal surgery (odds ratio 2.2, 95% CI 1.18-4.1, p = 0.013) were independently associated with increased likelihood of the surgeons feeling distracted. CONCLUSIONS: Irrelevant conversation in the OR is a modifiable factor that was independently associated with surgeon's perception of distraction.

La définition des moments critiques et non critiques en salle d'opération : une étude de consensus Delphi modifiée.

BACKGROUND: While the operating room (OR) has significantly benefited from aviation strategies to improve safety, the rate of avoidable human errors remains relatively high. One key aviation strategy that has yet to be formally established in the OR is the "sterile cockpit" rule, which prohibits all non-essential behaviours during critical moments of a flight. Applying this rule to the OR may enhance patient safety, but the critical moments of surgery need to be defined first. METHODS: This study used a modified Delphi methodology to determine critical moments during surgery according to OR team members across institutions, professions, and specialties. Analysis occurred after each round. The stopping criterion was consensus on 80% of survey items or no change in the mean score for any individual item between two consecutive rounds. RESULTS: The first round included 304 respondents. Of these, 115 completed the second-round survey, and 75 completed all three rounds (27 nurses, 29 anesthesiologists, 19 surgeons). Critical moments obtained by consensus were: induction of anesthesia; emergence from anesthesia; preoperative briefing; final counts at the end of the procedure; anesthesiologist- or surgeon-relevant intraoperative event; handovers; procedure-specific high-risk surgical moments; crisis resource management situations; medication and equipment preparation; and key medication administration. CONCLUSIONS: By defining the most critical moments of surgery, future research can determine the relative importance of behaviour and actions at each stage and target interventions to these stages.

RéSUMé: CONTEXTE: Alors que la salle d'opération (SOP) bénéficie considérablement des stratégies de l'aviation pour améliorer la sécurité, le taux d'erreurs humaines évitables y demeure relativement élevé. L'une des stratégies clés de l'aviation qui doit encore être mise en place de manière formelle en SOP est la règle de la « cabine de pilotage stérile ¼, qui interdit tout comportement non essentiel pendant les moments critiques d'un vol. L'application de cette règle à la SOP pourrait améliorer la sécurité des patients, mais les moments critiques d'une chirurgie doivent d'abord être définis. MéTHODE: Cette étude a utilisé une méthodologie Delphi modifiée afin de déterminer les moments critiques pendant une chirurgie selon les membres des équipes de SOP en provenance de différentes institutions, professions et spécialités. Une analyse a eu lieu après chaque itération. Le critère d'arrêt était un consensus sur 80 % des items du sondage ou aucun changement dans la note moyenne obtenue pour n'importe quel item individuel entre deux itérations consécutives. RéSULTATS: La première série a inclus 304 répondants. Parmi ceux-ci, 115 ont complété le deuxième sondage, et 75 ont complété les trois séries de questions (27 infirmiers/infirmières, 29 anesthésiologistes, 19 chirurgiens/chirurgiennes). Les moments critiques retenus par consensus étaient : l'induction de l'anesthésie; l'émergence de l'anesthésie; le temps d'arrêt préopératoire; les décomptes finaux à la fin de l'intervention; les événements peropératoires importants pour l'anesthésiologiste ou le chirurgien; les transferts; les moments chirurgicaux à risque élevé spécifiques à l'intervention; les situations de gestion de crise des ressources; la préparation des médicaments et du matériel; et l'administration de médicaments clés. CONCLUSION: En définissant les moments les plus critiques de la chirurgie, les recherches futures pourront déterminer l'importance relative des comportements et des actes à chaque étape et cibler les interventions en fonction de ces étapes.

The impact of repeated vaccination using 10-year vaccination history on protection against influenza in older adults: a test-negative design study across the 2010/11 to 2015/16 influenza seasons in Ontario, Canada.

IntroductionAnnual influenza vaccination is recommended for older adults, but evidence regarding the impact of repeated vaccination has been inconclusive.AimWe investigated vaccine effectiveness (VE) against laboratory-confirmed influenza and the impact of repeated vaccination over 10 previous seasons on current season VE among older adults.MethodsWe conducted an observational test-negative study in community-dwelling adults aged > 65 years in Ontario, Canada for the 2010/11 to 2015/16 seasons by linking laboratory and health administrative data. We estimated VE using multivariable logistic regression. We assessed the impact of repeated vaccination by stratifying by previous vaccination history.ResultsWe included 58,304 testing episodes for respiratory viruses, with 11,496 (20%) testing positive for influenza and 31,004 (53%) vaccinated. Adjusted VE against laboratory-confirmed influenza for the six seasons combined was 21% (95% confidence interval (CI): 18 to 24%). Patients who were vaccinated in the current season, but had received no vaccinations in the previous 10 seasons, had higher current season VE (34%; 95%CI: 9 to 52%) than patients who had received 1-3 (26%; 95%CI: 13 to 37%), 4-6 (24%; 95%CI: 15 to 33%), 7-8 (13%; 95%CI: 2 to 22%), or 9-10 (7%; 95%CI: -4 to 16%) vaccinations (trend test p = 0.001). All estimates were higher after correcting for misclassification of current season vaccination status. For patients who were not vaccinated in the current season, residual protection rose significantly with increasing numbers of vaccinations received previously.ConclusionsAlthough VE appeared to decrease with increasing numbers of previous vaccinations, current season vaccination likely provides some protection against influenza regardless of the number of vaccinations received over the previous 10 influenza seasons.

Underreporting of Veress Needle Injuries: Comparing Direct Observation and Chart Review Methods.

BACKGROUND: Adverse events in surgery occur frequently, increase likelihood of postoperative morbidity, and mostly take place in the operating rooms. Several surgeons have advocated for learning from adverse events and near misses to help improve patient safety. To do so, one must first understand how to accurately identify and report intraoperative events. MATERIALS AND METHODS: Consecutive laparoscopic cases performed in a referral center were included in the cohort. Veress needle (VN) injuries were characterized according to a priori established criteria. Two methods were used to identify VN injuries: direct observation and patient chart review. For direct observation, trained surgeon assessors identified the outcomes using a comprehensive data capture platform called the operating room black box. On the other hand, operative reports and patient charts were reviewed by trained assessors to identify reported VN injuries. RESULTS: Hundred thirty-one cases were analyzed. There were 12 (9%) VN injuries identified by direct observation compared to 3 (2%) identified in patient chart review method. Injuries to the liver and stomach were identified by both methods, whereas injuries to the omentum were not reported in patient charts even if they required rectification. There were seven VN injuries that required rectification, lasting up to 12% of the operating time. There were 47 (35%) near misses identified through direct observation, whereas none was reported in patient charts. CONCLUSIONS: Direct observation enables characterization of VN injury and near misses with far greater detail and accuracy than patient chart review.

Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies.

BACKGROUND: The burden of device-related interruptions is expected to increase as modern surgical practices adopt complex minimally invasive surgery devices. Currently, there is a paucity of empiric data that examined the nature of device-related interruptions using comprehensive intraoperative data. METHODS: We performed a cross-sectional study of consecutive elective laparoscopic general surgery cases performed in one operating room (OR) at a referral center between April 2014 and April 2016. The included cases were directly observed using a comprehensive multiport data recorder called the OR Black Box. The data were synchronized, encrypted, and reviewed by expert surgeon assessors. The assessors characterized device-related interruptions that occurred during operations. The prevalence of the cases with device-related interruptions was calculated. Device-related interruptions were classified into a priori categories of (1) absent/wrong device; (2) improper assembly; (3) loss of sterility; (4) disconnection; and (5) device failure. RESULTS: In a cohort of 210 cases, 64 (30%) had at least one device-related interruption. Sleeve gastrectomy (52%) and oncologic gastrectomy (43%) procedures experienced the highest prevalence of device-related interruptions. Device failure was the most frequently chosen category with laparoscopic staplers implicated in more than half of these failures. Three failure modes were described for laparoscopic stapler, of which stapler malfunction (46%) was the most common. CONCLUSIONS: Device-related interruptions occurred frequently in the OR and could be characterized into one of the five categories. Understanding the nature of the device-related interruptions can help guide implementation of safety interventions and user training in the future.