Peri-Operative Wearables in Elder Recover after Surgery (POWERS) study: a protocol for a multicentre, prospective cohort study to evaluate perioperative activity with postoperative disability in older adults after non-cardiac surgery.

INTRODUCTION: The ageing population has led to an increasing proportion of surgical patients with greater frailty and comorbidity. Complications and mortality within 30 days of a surgical procedure are often used to evaluate success in the perioperative period however these measures can potentially underestimate a substantial level of morbidity associated with surgery. Personal wearable technologies are now readily available and can offer detailed information on activity intensity, sedentary behaviour and sleeping patterns. These devices may provide important information perioperatively by acting as a non-invasive, and cost-efficient means to risk stratify patients. METHODS AND ANALYSIS: The Peri-Operative Wearables in Elder Recover After Surgery (POWERS) study is a multicentre observational study of 200 older adults (≥65 years) having major elective non-cardiac surgery. The objectives are to characterise the association between preoperative and postoperative activity monitor measurements with postoperative disability and recovery, as well as characterise trajectories of activity and sleep in the perioperative period. Activity will be monitored with the ActiGraph GT3X device and measured for 7-day increments, preoperatively, and at 1 week, 1 month and 3 months postoperatively. Disability will be assessed using the WHO Disability Assessment Schedule 2.0 assessed at 1 week, 1 month and 3 months postoperatively. ETHICS AND DISSEMINATION: The POWERS study received research ethics board approval at all participating sites on 1 August 2019 (REB # 19-121 (CTO 1849)). Renewal was granted on 19 May 2022.

Clinical tools to assess functional capacity before elective non-cardiac surgery: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to map the evidence on clinical tools to assess functional capacity prior to elective non-cardiac surgery. INTRODUCTION: Functional capacity is a strong prognostic indicator before surgery, which can be used to identify patients at elevated risk of postoperative complications, yet, there is no consensus on which clinical tools should be used to assess functional capacity in patients prior to non-cardiac surgery. INCLUSION CRITERIA: This review will consider any randomized or non-randomized studies that evaluate the performance of a functional capacity assessment tool in adults (≥18 years) prior to non-cardiac surgery. For studies to be included, the tool must be used clinically for risk stratification. We will exclude studies on lung and liver transplant surgery, as well as ambulatory procedures performed under local anesthesia. METHODS: The review will be conducted in line with the JBI methodology for scoping reviews. A peer-reviewed search strategy will be used to query relevant databases (ie, MEDLINE, Embase, EBM Reviews). Additional sources of evidence will include databases of non-peer-reviewed literature and the reference lists of included studies. Two independent reviewers will identify eligible studies in 2 stages: stage 1, based on titles and abstracts; and stage 2, based on full texts. Information on study details, measurement properties, pragmatic qualities, and/or clinical utility metrics will be charted in duplicate onto standardized data collection forms. The results will be presented using descriptive summaries, frequency tables, and visual plots that highlight the extent of evidence and remaining gaps in the validation process of each tool. REVIEW REGISTRATION: Open Science Framework https://osf.io/6nfht.

In-hospital mortality for aspiration pneumonia in a tertiary teaching hospital: A retrospective cohort review from 2008 to 2018.

BACKGROUND: Aspiration pneumonia is a preventable condition that has higher rates of recurrence and mortality compared to non-aspiration pneumonia. The primary objective of the study was to examine independent patient factors that are associated with mortality in those requiring acute admission for aspiration pneumonia at a tertiary institution. Secondary goals of the study were to review whether factors such as mechanical ventilation and speech language pathology intervention can impact patient mortality, length of stay (LOS), and costs relating to hospitalization. METHODS: Patients older than 18 years of age who were admitted with a primary diagnosis of aspiration pneumonia from January 1, 2008 to December 31, 2018 at Unity Health Toronto-St. Michael's hospital in Toronto, Canada, were included in the study. Descriptive analyses were performed on patient characteristics using age as a continuous variable as well as a dichotomous variable with age 65 as a cut-off. Multivariable logistic regression was used to identify independent factors that contributed to in-hospital mortality and Cox proportional-hazard regression was used to identify independent factors that affected LOS. RESULTS: A total of 634 patients were included in this study. 134 (21.1%) patients died during hospitalization with an average age of 80.3 ± 13.4. The in-hospital mortality did not change significantly over the ten-year period (p = 0.718). Patients who died had longer LOS with a median length of 10.5 days (p = 0.012). Age [Odds Ratio (OR) 1.72, 95% Confidence Interval (95% CI) 1.47-2.02, p < 0.05] and invasive mechanical ventilation (OR 2.57, 95% CI 1.54-4.31, p < 0.05) were independent predictors of mortality while female gender was found to be a protective factor (OR 0.60, 95% CI 0.38-0.92, p = 0.02). Elderly patients had five times higher risk of dying during their hospital course when compared to younger patients [Hazard Ratio (HR) 5.25, 95% CI 2.99-9.23, p < 0.05). CONCLUSION: Elderly patients are a high-risk population for developing aspiration pneumonia and are at higher risk of death when hospitalized for this condition. This warrants improved preventative strategies in the community. Further studies involving other institutions and creating a Canada-wide database are required.

Subjective and objective evaluation of corneal haze after accelerated corneal crosslinking for corneal ectasias.

PURPOSE: To evaluate the relationship between subjective (slit lamp examination [SLE]) and objective (densitometry) measurements of corneal haze after accelerated corneal crosslinking (aCXL), assess the relationship between densitometry and corrected distance visual acuity (CDVA), and determine the effect of baseline characteristics on densitometry after aCXL in eyes with progressive keratoconus and other ectasias. SETTING: Kensington Eye Institute and Bochner Eye Institute, Toronto, Canada. DESIGN: Retrospective analysis of a prospective interventional cohort study. METHODS: Scheimpflug-derived corneal densitometry, CDVA, maximum keratometry (Kmax ), and central corneal thickness were measured preoperatively and up to 1 year after aCXL, and post-operative haze was estimated with SLE (n = 483 eyes). A random effect model was used to examine the relationship between post-operative subjective haze with SLE and densitometry. Linear mixed models were used to examine the relationship between densitometry, pre-operative baseline characteristics, and CDVA. RESULTS: There was a significant association between subjective haze with SLE and densitometry (p < 0.001). There was a significant relationship between CDVA and densitometry: for every 10 GSUs of increased densitometry in the 0-2 mm zone, CDVA worsened by approximately half a Snellen line (p < 0.001). Age and pre-operative Kmax were significant predictors of densitometry. For every 10 years of age, densitometry increased by 0.68 GSUs (95% CI [0.27 to 1.07], p < 0.001). For every 10 D of increased preoperative Kmax , densitometry increased by 0.69 GSUs (95% CI [0.41 to 0.98], p < 0.001). CONCLUSIONS: Subjective haze after aCXL estimated with SLE, is significantly associated with densitometry. Increased densitometry after aCXL is associated with a reduction in CDVA.

Ontario Cataract Quality Outcome Initiative: appropriateness and prioritization of cataract surgery.

OBJECTIVE: To explore the utility of the Catquest 9SF visual function (VF) questionnaire along with visual acuity (VA) for determining appropriateness and priority for cataract surgery. To evaluate the feasibility of administering the Catquest-9SF in a clinical setting using web-based electronic data capture and interpretation. DESIGN: Prospective multicentred interventional observational study. PARTICIPANTS: Subjects undergoing sequential cataract surgery in both eyes at 4 sites in Ontario. METHODS: We recorded best-corrected VA (BCVA) and VA with current correction (CCVA) in each eye and both eyes (OU) and Catquest-9SF responses on a tablet before and after cataract surgery. Linear regression models were employed to test for associations between VA and visual function (VF). RESULTS: Preoperative BCVA and CCVA in the worse eye were significant predictors of change in VF (p = 0.006 and p = 0.008, respectively); subjects with worse VA had a greater improvement in VF after surgery. There was a significant association between improvement in VF and improvement in CCVA OU (p = 0.001). Fourteen of 151 subjects (9%) had no improvement or worse VF scores after surgery. Within this group, 10 of 14 subjects had a preoperative score ≤-3, which is suggestive of minimal visual disability. Within this subset, 4 of 14 subjects (2.6%) had a preoperative BCVA of 20/30 or better in their worse eye. CONCLUSIONS: For patient groups with equal VA, the Catquest-9SF score can help determine priority for surgery. Web-based data capture and interpretation allow for efficient virtual assessments of VF. A BCVA in the worse eye of 20/30 or better combined with a Catquest-9SF score <-3 can be used as a guideline for lowest priority.

Effect of a tailored sepsis treatment protocol on patient outcomes in the Tikur Anbessa Specialized Hospital, Ethiopia: results of an interrupted time series analysis.

BACKGROUND: Despite improvement, sepsis mortality rates remain high, with an estimated 11 million sepsis-related deaths globally in 2017 (Rudd et. al, Lancet 395:200-211, 2020). Low- and middle-income countries (LMICs) are estimated to account for 85% of global sepsis mortality; however, evidence for improved sepsis mortality in LMICs is lacking. We aimed to improve sepsis care and outcomes through development and evaluation of a sepsis treatment protocol tailored to the Tikur Anbessa Specialized Hospital Emergency Department, Ethiopia, context. METHODS: We employed a mixed methods design, including an interrupted times series study, pre-post knowledge testing, and process evaluation. The primary outcome was the proportion of patients receiving appropriate sepsis care (blood culture collection before antibiotics and initiation of appropriate antibiotics within 1 h of assessment). Secondary outcomes included time to antibiotic administration, 72-h sepsis mortality, and 90-day all-cause mortality. Due to poor documentation, we were unable to assess our primary outcome and time to antibiotic administration. We used segmented regression with outcomes as binomial proportions to assess the impact of the intervention on mortality. Pre-post knowledge test scores were analyzed using the Student's t-test to compare group means for percentage of scenarios with correct diagnosis. RESULTS: A total of 113 and 300 patients were enrolled in the pre-implementation and post-implementation phases respectively. While age and gender were similar across the phases, a higher proportion (31 vs. 57%) of patients had malignancies in the post-implementation phase. We found a significant change in trend between the phases, with a trend for increasing odds of survival in the pre-implementation phase (OR 1.24, 95% CI 0.98-1.56), and a shift down, with odds of survival virtually flat (OR 0.95, 95% CI. 0.88-1.03) in the post-implementation phases for 72-h mortality, and trends for survival pre- and post-implementation are virtually flat for 90-day mortality. We found no significant difference in pre-post knowledge test scores, with interpretation limited by response rate. Implementation quality was negatively impacted by resource challenges. CONCLUSION: We found no improvement in sepsis outcomes, with a trend for increasing odds of survival lost post-implementation and no significant change in knowledge pre- and post-implementation. Variable availability of resources was the principal barrier to implementation. TRIAL REGISTRATION: Open Science Framework osf.io/ju4ga . Registered June 28, 2017.

Introducing the Safety Threats and Adverse events in Trauma (STAT) taxonomy: standardized classification system for evaluating safety during trauma resuscitation.

PURPOSE: Adverse events (AEs) during trauma resuscitation are common and heterogeneity in reporting limits comparisons between hospitals and systems. A recent modified Delphi study established a taxonomy of AEs that occur during trauma resuscitation. This tool was further refined to yield the Safety Threats and Adverse events in Trauma (STAT) taxonomy. The objective of this study was to evaluate the inter-rater reliability of the STAT taxonomy using in-situ simulation resuscitations. METHODS: Two reviewers utilized the STAT taxonomy to score 12 in-situ simulated trauma resuscitations. AEs were reported for each simulation and timestamped in the case of multiple occurrences of a single AE. Inter-rater reliability was assessed using Gwet's AC1. RESULTS: The agreement on all AEs between reviewers was 90.1% (973/1080). The Gwet's AC1 across AE categories were: EMS handover (median 0.72, IQR [0.54, 0.82]), airway and breathing (median 0.91, IQR [0.60, 1.0]), circulation (median 0.91, IQR [0.72, 1.0]), assessment of injuries (median 0.80, IQR [0.24, 0.91]), management of injuries (median 1.00, IQR [1.00, 1.00]), procedure related (median 1.00, IQR [81, 1.00]), patient monitoring and IV access (median 1.00, IQR [1.00, 1.00]), disposition (median 1.00, IQR [1.00, 1.00]), team communication and dynamics (median 0.80, IQR [0.62, 1.00]). CONCLUSIONS: The STAT taxonomy yielded 90.1% agreement and demonstrated excellent inter-rater reliability between reviewers in the in-situ simulation scenario. The STAT taxonomy may serve as a standardized evaluation tool of latent safety threats and adverse events in the trauma bay. Future work should focus on applying this tool to live trauma patients.

Functional Improvement Trajectories After Surgery (FIT After Surgery) study: protocol for a multicentre prospective cohort study to evaluate significant new disability after major surgery in older adults.

INTRODUCTION: Older adults prioritise surviving surgery, but also preservation of their functional status and quality of life. Current approaches to measure postoperative recovery, which focus on death, complications and length of hospitalisation, may miss key relevant domains. We propose that postoperative disability is an important patient-centred outcome to measure intermediate-to-long recovery after major surgery in older adults. METHODS AND ANALYSIS: The Functional Improvement Trajectories After Surgery (FIT After Surgery) study is a multicentre cohort study of 2000 older adults (≥65 years) having major non-cardiac surgery. Its objectives are to characterise the incidence, trajectories, risk factors and impact of new significant disability after non-cardiac surgery. Disability is assessed using WHO Disability Assessment Schedule (WHODAS) 2.0 instrument and participants' level-of-care needs. Disability assessments occur before surgery, and at 1, 3, 6, 9 and 12 months after surgery. The primary outcome is significantly worse WHODAS score or death at 6 months after surgery. Secondary outcomes are (1) significantly worse WHODAS score or death at 1 year after surgery, (2) increased care needs or death at 6 months after surgery and (3) increased care needs or death at 1 year after surgery. We will use multivariable logistic regression models to determine the association of preoperative characteristics and surgery type with outcomes, joint modelling to characterise longitudinal time trends in WHODAS scores over 12 months after surgery, and longitudinal latent class mixture models to identify clusters following similar trajectories of disability. ETHICS AND DISSEMINATION: The FIT After Surgery study has received research ethics board approval at all sites. Recruitment began in December 2019 but was placed on hold in March 2020 because of the COVID-19 pandemic. Recruitment was gradually restarted in October 2020, with 1-year follow-up expected to finish in 2023. Publication of the primary results is anticipated to occur in 2024.

Earlier Surgery Reduces Complications in Acute Traumatic Thoracolumbar Spinal Cord Injury: Analysis of a Multi-Center Cohort of 4108 Patients.

Early surgical intervention to decompress the spinal cord and stabilize the spinal column in patients with acute traumatic thoracolumbar spinal cord injury (TLSCI) may lessen the risk of developing complications and improve outcomes. However, there has yet to be agreement on what constitutes "early" surgery; reported thresholds range from 8 to 72 h. To address this knowledge gap, we conducted an observational cohort study using data from the American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP) from 2010 to 2016. The association between time from hospital arrival to surgical intervention and risk of major complications was assessed using restricted cubic splines. Propensity score matching was then used to assess the association between delayed surgery and risk of complications. Across 354 trauma centers 4108 adult TLSCI patients who underwent surgery were included. Median time-to-surgery was 18.8 h (interquartile range [IQR]: 7.4-40.9 h). The spline model suggests the risk of major complication rises consistently after a 12-h surgical wait-time. After propensity score matching, the odds of major complication were significantly lower for those receiving surgery within 12 h (odds ratio [OR] 0.77, 95% confidence interval [CI]: 0.64 to 0.94). This was also true for immobility-related complications (OR 0.79, 95% CI: 0.64 to 0.97). Patients in the early group spent 1.5 fewer days in the critical care unit on average (95% CI: -2.09 to -0.88). Although surgery within 12 h may not always be feasible, these data suggest that whenever possible surgeons should strive to reduce the amount of time between hospital arrival and surgical intervention, and health care systems should support this endeavor.

Reproducibility of Symptom Sequences Across Episodes of Recurrent Anaphylaxis.

BACKGROUND: Anaphylactic reactions may present with varying levels of severity, ranging from mild multisystem involvement to severe, and sometimes fatal, anaphylaxis. The severity of anaphylaxis is variable from one reaction to the next within the same individuals. OBJECTIVE: To compare the temporal sequence of symptoms within individuals and between individuals across multiple anaphylactic reactions. METHODS: Patients were evaluated for recurrent anaphylaxis in a tertiary care allergy clinic between 2012 and 2018. At each visit, patients were asked to record the temporal sequence in which symptoms of anaphylaxis appeared. These data were recorded at each visit and retrieved through retrospective chart review. Patients with a history of ≥2 anaphylactic reactions were included; those with anaphylaxis due to multiple allergens were excluded. The Fleiss Kappa method was used to assess reproducibility of the order of appearance of specific symptoms during anaphylaxis within individual patients and between individuals with similar triggers. RESULTS: The mean patient age was 35.6 years (standard deviation = 13.9; range: 1-68 years); 113 of 149 (76%) patients were female. The mean Fleiss Kappa reproducibility score within individuals was 0.94, 5th percentile was 0.53, and 95th percentile was 1.0. The mean Kappa score between individuals was -0.03 (range, -0.14 to 0.05). Among the 16 of 149 patients who recorded reactions of varying severity grades, the mean within-patient Kappa score was 0.96. CONCLUSION: Individual patients experience reproducibly stereotypic anaphylactic reactions over time, which are unique to a given patient, irrespective of the cause of anaphylaxis, including foods, medications, mast cell disorders, and idiopathic anaphylaxis. In contrast, symptom sequences during anaphylaxis are not reproducible between individuals.

Reality of Accomplishing Surgery within 24 Hours for Complete Cervical Spinal Cord Injury: Clinical Practices and Safety.

Substantial clinical data support an association between superior neurological outcomes and early (within 24 h) surgical decompression for those with traumatic cervical spinal cord injury (SCI). Despite this, much discussion persists around feasibility and safety of this time threshold, particularly for those with a complete cervical SCI. This study aims to assess clinical practices and the safety profile of early surgery across a large sample of North American trauma centers. Data were derived from the Trauma Quality Improvement Program database from 2010-2016. Adult patients with a complete cervical SCI (American Spinal Injury Association [ASIA] A) who underwent surgery were included. Patients were stratified into those receiving surgery at or before 24 h and those receiving delayed intervention. Risk-adjusted variability in surgical timing across trauma centers was investigated using mixed-effects regression. In-hospital adverse events including death, major complications, and immobility-related complications were compared between groups after propensity score matching. There were 2862 patients from 353 North American trauma centers included; 1760 (61.5%) underwent surgery within 24 h. Case-mix and hospital-level characteristics explained only 6% of the variability in surgical timing both between centers and within centers. No significant differences in adverse events were identified between groups. These findings suggest a relatively large proportion of patients are not receiving surgery within the recommended time frame, despite apparent safety. Moreover, patient and hospital-level characteristics explain little of the variability in time-to-surgery. Further knowledge translation is needed to increase the proportion of patients in whom surgery is performed before the 24-h threshold so patients might reach their greatest potential for neurological recovery.

Variability in time to surgery for patients with acute thoracolumbar spinal cord injuries.

There are limited data pertaining to current practices in timing of surgical decompression for acute thoracolumbar spinal cord injury (SCI). We conducted a retrospective cohort study to evaluate variability in timing between- and within-trauma centers in North America; and to identify patient- and hospital-level factors associated with treatment delay. Adults with acute thoracolumbar SCI who underwent decompressive surgery within five days of injury at participating trauma centers in the American College of Surgeons Trauma Quality Improvement Program were included. Mixed-effects regression with a random intercept for trauma center was used to model the outcome of time to surgical decompression and assess risk-adjusted variability in surgery timeliness across centers. 3,948 patients admitted to 214 TQIP centers were eligible. 28 centers were outliers, with a significantly shorter or longer time to surgery than average. Case-mix and hospital characteristics explained < 1% of between-hospital variability in surgical timing. Moreover, only 7% of surgical timing variability within-centers was explained by case-mix characteristics. The adjusted intraclass correlation coefficient of 12% suggested poor correlation of surgical timing for patients with similar characteristics treated at the same center. These findings support the need for further research into the optimal timing of surgical intervention for thoracolumbar SCI.

Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry.

BACKGROUND: Uterine fibroids are common in women and their management is heavily influenced by information gathered through imaging. We aimed to evaluate the type and quality of imaging performed for assessment of uterine fibroids in Canada. METHODS: Starting in July 2015, premenopausal women with symptomatic fibroids were enrolled in a prospective, noninterventional, observational registry (Canadian Women With Uterine Fibroids Registry [CAPTURE]) that included 19 Canadian sites. Clinical characteristics were extracted from the baseline visit. We evaluated the association between demographic and clinical variables of interest with regard to imaging type using unadjusted and adjusted logistic regression models. RESULTS: Of 1493 women, 1148 had ultrasonography, 135 had magnetic resonance imaging (MRI), 80 had other types of imaging and 130 did not have imaging reported within 12 months of the baseline visit. After adjusting for demographic and clinical characteristics, patients who underwent MRI had larger fibroids (odds ratio [OR] per 1-cm increase 1.11, 95% confidence interval [CI] 1.05-1.17) and more numerous fibroids (1 v. > 1; OR 1.74, 95% CI 1.14-2.64) compared with those who underwent ultrasonography only. For ultrasonography reporting, quality criteria were met for 268 of 1148 patients (23.3%). There was a difference in the quality of reporting among the 19 sites (p < 0.001). Logistic regression model accounting for within-site variability showed that reporting results from ultrasonography in the province of Quebec were less likely to meet all quality criteria (OR 0.20, 95% CI 0.06-0.66) and those from sites in more populated cities (≥ 400 000 inhabitants) were more likely to do so (OR 6.15, 95% CI 2.20-17.18). INTERPRETATION: We determined that imaging modality for fibroids is associated with patient characteristics. The quality of reporting results for ultrasonography of fibroids in Canada falls short of internationally endorsed guidelines and needs improvement. STUDY REGISTRATION: ClinicalTrials.gov, no. NCT02580578.

Paediatric reference values for total psoas muscle area.

BACKGROUND: Sarcopenia, the unintentional loss of skeletal muscle mass, is associated with poor outcomes in adult patient populations. In adults, sarcopenia is often ascertained by cross-sectional imaging of the psoas muscle area (PMA). Although children with chronic medical illnesses may be at increased risk for muscle loss because of nutritional deficiencies, physical deconditioning, endocrine anomalies, and systemic inflammation, consistent quantitative definitions for sarcopenia in children are lacking. We aimed to generate paediatric reference values for PMA at two intervertebral lumbar levels, L3-4 and L4-5. METHODS: In this cross-sectional study, we analysed abdominal computed tomography scans of consecutive children presenting to the emergency department. Participants were children 1-16 years who required abdominal cross-sectional imaging after paediatric trauma between January 1, 2005 and December 31, 2015 in a large Canadian quaternary care centre. Children with a documented chronic medical illness or an acute spinal trauma at presentation were excluded. Total PMA (tPMA) at levels L3-4 and L4-5 were measured in square millimetres (mm2 ) as the sum of left and right PMA. Age-specific and sex-specific tPMA percentile curves were modelled using quantile regression. RESULTS: Computed tomography images from 779 children were included. Values of tPMA at L4-5 were significantly larger than at L3-4 at all ages, but their correlation was high for both girls (r = 0.95) and boys (r = 0.98). Amongst girls, tPMA 50th percentile values ranged from 365 to 2336 mm2 at L3-4 and from 447 to 2704 mm2 for L4-5. Amongst boys, 50th percentile values for tPMA ranged between 394 and 3050 mm2 at L3-4 and from 498 to 3513 mm2 at L4-5. Intraclass correlation coefficients were excellent at L3-4 (0.97, 95% CI 0.94 to 0.981) and L4-5 (0.99, 95% CI 0.986 to 0.995). Weight and tPMA were correlated, stratified by sex for boys (L3-4 r = 0.90; L4-5 r = 0.90) and for girls (L3-4 r = 0.87; L4-5 r = 0.87). An online application was subsequently developed to easily calculate age-specific and sex-specific z-scores and percentiles. CONCLUSIONS: We provide novel paediatric age-specific and sex-specific growth curves for tPMA at intervertebral L3-4 and L4-5 levels for children between the ages of 1-16 years. Together with an online tool (https://ahrc-apps.shinyapps.io/sarcopenia/), these tPMA curves should serve as a reference enabling earlier identification and targeted intervention of sarcopenia in children with chronic medical conditions.

Accelerated Corneal Cross-Linking: Efficacy, Risk of Progression, and Characteristics Affecting Outcomes. A Large, Single-Center Prospective Study.

PURPOSE: We examined the efficacy and preoperative characteristics that affect outcomes of accelerated (9 mW/cm2 for 10 minutes) corneal cross-linking (CXL). DESIGN: Prospective single-center observational cohort study. METHODS: We enrolled 612 eyes of 391 subjects with progressive keratoconus (n = 589), pellucid marginal degeneration (n = 11), and laser in situ keratomileusis-induced ectasia (n = 12). We evaluated best spectacle-corrected visual acuity (BSCVA), topography, refraction, endothelial cell density, corneal thickness, haze, intraocular pressure, and visual function before and 12 months after the CXL procedure. We tabulated the proportion of those with progression of maximum keratometry (Kmax). We included participant's race, age, sex, and the presence of preoperative apical scarring and environmental allergies in a multivariable linear regression model to determine the effect of these characteristics on outcomes. RESULTS: At 1 year there was no significant change in mean Kmax (n = 569). Progression of Kmax was higher in subgroups with a baseline Kmax >58 diopters (n = 191) and those 14-18 years of age (n = 53). Preoperative BSCVA, Kmax, refraction, corneal cylinder, coma, central corneal thickness, and vision function were statistically and clinically significant predictors of outcomes (P < .001). Preoperative apical scarring led to worsening haze (P = .0001), more astigmatism (P = .002), more central corneal thinning (P = .002), and was protective to the endothelium (P = .008). Race, age, and sex affected some outcomes. CONCLUSION: Mean Kmax was stable at 1 year after accelerated CXL. Younger patients and those with a higher preoperative Kmax need to be monitored closely for progression. Preoperative BSCVA, topography, refraction, CCT, and apical scarring were significant predictors of outcomes.

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.

Fit for School Study protocol: early child growth, health behaviours, nutrition, cardiometabolic risk and developmental determinants of a child's school readiness, a prospective cohort.

INTRODUCTION: School readiness is a multidimensional construct that includes cognitive, behavioural and emotional aspects of a child's development. School readiness is strongly associated with a child's future school success and well-being. The Early Development Instrument (EDI) is a reliable and valid teacher-completed tool for assessing school readiness in children at kindergarten age. A substantial knowledge gap exists in understanding how early child growth, health behaviours, nutrition, cardiometabolic risk and development impact school readiness. The primary objective was to determine if growth patterns, measured by body mass index trajectories in healthy children aged 0-5 years, are associated with school readiness at ages 4-6 years (kindergarten age). Secondary objectives were to determine if other health trajectories, including health behaviours, nutrition, cardiometabolic risk and development, are associated with school readiness at ages 4-6 years. This paper presents the Fit for School Study protocol. METHODS AND ANALYSIS: This is an ongoing prospective cohort study. Parents of children enrolled in the The Applied Health Research Group for Kids (TARGet Kids!) practice-based research network are invited to participate in the Fit for School Study. Child growth, health behaviours, nutrition, cardiometabolic risk and development data are collected annually at health supervision visits and linked to EDI data collected by schools. The primary and secondary analyses will use a two-stage process: (1) latent class growth models will be used to first determine trajectory groups, and (2) generalised linear mixed models will be used to examine the relationship between exposures and EDI results. ETHICS AND DISSEMINATION: The research ethics boards at The Hospital for Sick Children, Unity Health Toronto and McMaster University approved this study, and research ethics approval was obtained from each school board with a student participating in the study. The findings will be presented locally, nationally and internationally and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT01869530.

Temporomandibular joint total replacement using the Zimmer Biomet Microfixation patient-matched prosthesis results in reduced pain and improved function.

OBJECTIVE: The aim of this study was to evaluate pain and maximum interincisal opening (MIO) in patients treated with the Zimmer Biomet Microfixation patient-matched alloplastic temporomandibular joint (TMJ) prosthesis. STUDY DESIGN: We performed a retrospective cohort study of patients who had undergone bilateral or unilateral TMJ total joint replacement (TJR). The primary outcome variables were pain and MIO, which were measured at various time points between 12 and greater than 60 months. Secondary outcomes included perceived masticatory efficiency and patient satisfaction. RESULTS: A total of 33 patients (62 joints) met the inclusion criteria for the study. The relationship between time and the change in pain scores, although significant immediately after surgery in an unadjusted model, was not statistically significant in an adjusted model. A statistically significant improvement between time and MIO was noted in both adjusted and unadjusted models. The majority of patients (91%) reported subjective improvement in their diet. Similarly, 91% of patients felt that TJR was beneficial and, in retrospect, would repeat their decision to undergo TJR. CONCLUSIONS: Patients treated with the Zimmer Biomet Microfixation patient-matched TMJ prosthesis experience improvements in pain, MIO, and ability to masticate. Future studies are needed to assess long-term outcomes prospectively.

Diagnostic Value of CT in Detecting Peripheral Zone Prostate Cancer.

OBJECTIVE. The purpose of this study was to identify the sensitivity of contrast-enhanced CT in detecting high-grade prostate adenocarcinoma. MATERIALS AND METHODS. A retrospective analysis included 100 patients with prostate cancer proven by biopsy between January 2010 and December 2017 who underwent staging CT of the abdomen and pelvis within 3 months of diagnosis. The control subjects were 100 randomly selected aged-matched male outpatients with no known history of malignancy who underwent contrast-enhanced CT of the abdomen and pelvis in the same time period as the patients with cancer. Two readers, blinded to both groups, independently assessed the likelihood of prostate cancer on the basis of the CT finding of focal abnormally increased peripheral enhancement in the prostate. Binary classification of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) was used to assess the diagnostic utility of CT versus the reference standard of transrectal ultrasound-guided biopsy. RESULTS. Eighty-three of 100 patients with biopsy-proven prostate cancer and 92 of 100 control subjects were correctly identified (sensitivity, 0.83; specificity, 0.92; PPV, 0.91; NPV, 0.84). There was no significant difference in diagnostic accuracy among subjects with different Gleason scores. Interrater agreement on both the cancer and control patients was 0.76 as assessed by Cohen kappa statistic. CONCLUSION. Incidental detection of a focal area of increased enhancement in the periphery of the prostate at contrast-enhanced CT may represent a clinically significant cancer and deserves further workup with prostate-specific antigen measurement and correlation with clinical risk factors for prostate cancer.

Predictive factors for sleep apnoea in patients on opioids for chronic pain.

Background: The risk of death is elevated in patients taking opioids for chronic non-cancer pain. Respiratory depression is the main cause of death due to opioids and sleep apnoea is an important associated risk factor. Methods: In chronic pain clinics, we assessed the STOP-Bang questionnaire (a screening tool for sleep apnoea; Snoring, Tiredness, Observed apnoea, high blood Pressure, Body mass index, age, neck circumference and male gender), Epworth Sleepiness Scale, thyromental distance, Mallampati classification, daytime oxyhaemoglobin saturation (SpO2) and calculated daily morphine milligram equivalent (MME) approximations for each participant, and performed an inlaboratory polysomnogram. The primary objective was to determine the predictive factors for sleep apnoea in patients on chronic opioid therapy using multivariable logistic regression models. Results: Of 332 consented participants, 204 underwent polysomnography, and 120 (58.8%) had sleep apnoea (AHI ≥5) (72% obstructive, 20% central and 8% indeterminate sleep apnoea), with a high prevalence of moderate (23.3%) and severe (30.8%) sleep apnoea. The STOP-Bang questionnaire and SpO2 are predictive factors for sleep apnoea (AHI ≥15) in patients on opioids for chronic pain. For each one-unit increase in the STOP-Bang score, the odds of moderate-to-severe sleep apnoea (AHI ≥15) increased by 70%, and for each 1% SpO2 decrease the odds increased by 33%. For each 10 mg MME increase, the odds of Central Apnoea Index ≥5 increased by 3%, and for each 1% SpO2 decrease the odds increased by 45%. Conclusion: In patients on opioids for chronic pain, the STOP-Bang questionnaire and daytime SpO2 are predictive factors for sleep apnoea, and MME and daytime SpO2 are predictive factors for Central Apnoea Index ≥5. Trial registration number: NCT02513836.