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Background Late-onset infections (LOI) are a major cause of morbidity and mortality among patients in the neonatal intensive care unit (NICU). Gloving after hand hygiene may be a pragmatic approach to prevent infections that arise when healthcare workers’ hands transmit pathogens to neonates. Objective To determine the feasibility of conducting a multicenter, open-labeled randomized controlled trial (RCT) to determine whether a protocol that requires healthcare workers (HCWs) in a level 3 NICU to wear non-sterile gloves plus hand hygiene reduces the occurrence of a late-onset infection, compared to hand hygiene alone. Methods In this single-center pilot study, we recruited neonates admitted to the McMaster Children’s Hospital NICU from June 2017 to May 2018. The NICU was randomized to begin with the standard (control) arm for 6 months (June 2017 to Dec 2017), followed by the gloving (GloveCare) arm for 6 months (Jan 2018 to July 2018), with a 2-week washout period in-between to educate healthcare workers about gloving. We measured numerous feasibility outcomes including enrollment, event rate, and compliance with hand hygiene (Moment 1: before patient contact, Moment 2: before clean procedure, Moment 3: after body fluid contact, Moment 4: after patient contact) and gloving compliance. Results We enrolled 750 neonates (390 Standard care, 360 GloveCare) and achieved 100% enrollment. We found higher hand hygiene compliance during the standard care arm compared to the GloveCare for all four moments of hand hygiene (Moment 1: 87% vs 79%, OR=1.86 (1.34, 2.59); Moment 2: OR=1.73 (1.00, 3.01); Moment 3: OR=1.11 (0.62, 1.98); Moment 4: OR=1.65 (1.27, 2.14)). We developed and validated a method to calculate glove compliance, which ranged from 48 to 85%, and was highest for moment 3 (doffing after a procedure or body fluid exposure risk). No adverse events were documented for patients or staff. Discussion Reduction in hand hygiene compliance in the GloveCare arm presents a pragmatic challenge in ascertaining the effectiveness of gloving to prevent LOI. Most LOIs were non-sterile-site infections, which is considered a less patient-important or clinically relevant outcome compared to sterile-site LOI. Ensuring efficient collection and validation of hand hygiene and gloving data is imperative. Conclusion The pilot study demonstrated the feasibility of this intervention though modifications to improve hand hygiene compliance during GloveCare will be important prior to a multicenter cluster RCT to assess the efficacy of non-sterile glove-based care in preventing LOI in the NICU. Trial registration Clinicaltrials.gov, NCT03078335

Effective collaboration and mentorship are essential to success in a career of health research. We summarize our conversation with Dr. John Ioannidis, professor at Stanford University, author of the most accessed manuscript in the history of the Public Library of Science, and one of the most cited scientists in history. Dr. Ioannidis was invited for a question and answer session as part of a graduate-level course on biostatistical collaboration hosted at McMaster University in December 2020. This text provides insight into the experiences and pearls he shared, that we hope will inspire and guide other researchers early or junior in their careers. He emphasized the importance of passion, enthusiasm and a sincere pursuit for high quality research as being the cornerstones to success and continued productivity in this field.

Background The Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT) found improved health outcomes for mothers and their infants among those randomized to self-monitoring of blood glucose (SMBG) with continuous glucose monitoring (CGM) compared with SMBG alone. In this study, we evaluated whether CGM or standard SMBG was more or less costly from the perspective of a third-party payer. Methods We conducted a posthoc analysis of data from the CONCEPTT trial (Mar. 25, 2013, to Mar. 22, 2016). Health care resource data from 215 pregnant women, randomized to CGM or SMBG, were collected from 31 hospitals in 7 countries. We determined resource costs posthoc based on prices from hospitals in 3 Canadian provinces (Ontario, British Columbia, Alberta). The primary outcome was the difference between groups in the mean total cost of care for mother and infant dyads, paid by each government (i.e., the third-party payer) from randomization to hospital discharge (time horizon). The secondary outcome included CGM and SMBG costs not paid by governments (e.g., glucose monitoring devices and supplies). Results The mean total cost of care was lower in the CGM group compared with the SMBG group in each province (Ontario: $13 270.25 v. $18 465.21, difference in mean total cost [DMT] -$5194.96, 95% confidence interval [CI] -$9841 to -$1395; BC: $13 480.57 v. $18 762.17, DMT -$5281.60, 95% CI -$9964 to -$1382; Alberta: $13 294.39 v. $18 674.45, DMT -$5380.06, 95% CI -$10 216 to -$1490). There was no difference in the secondary outcome. Interpretation Government health care costs are lower when CGM is paid by the patient, driven by lower costs from reduced use of the neonatal intensive care unit in the CGM group; however, when governments pay for CGM equipment, there is no overall cost difference between CGM and SMBG. Governments should consider paying for CGM, as it results in improved maternal and neonatal outcomes with no added overall cost. Trial registration ClinicalTrials.gov, no. NCT01788527.

This text builds on a conversation with Dr. Gordon Guyatt who provided guidance to trainees on interdisciplinary collaboration and work-life balance as part of a graduate-level biostatistics course in September 2020. The participants in the conversation comprised a group of clinicians, methodologists and biostatisticians, ranging from junior trainees to world-renowned established researchers. Biostatisticians, methodologists and clinicians often collaborate in conducting clinical research, calling upon interpersonal soft skills that are rarely explicitly addressed in undergraduate and graduate coursework. Acquiring such skills are essential for allowing seamless collaboration and communication within a multidisciplinary team and are therefore key to career advancement for young researchers, which was the focus of this session. As an invited guest, Dr. Guyatt shares his experiences after decades of leadership and successful international collaborations. He emphasizes the importance finding the right mentor, forming productive collaborations, developing self-awareness, and strategies for achieving a work-life balance.

Background: Early classroom communication supports are critical in influencing oral language development and emergent literacy skills. It is both support from peers and adults, as well as the environment that impacts the quality and efficacy of language learning. Schools in particular play a key role in communication development, which will be further explored in this article.Objectives: To describe how communication was being supported in the classroom by teachers in the areas of language-learning environment (LLE), language-learning interactions (LLIs) and language-learning opportunities (LLOs) to focus on classroom communication supports to strengthen literacy outcomes for Grade R learners.Method: A cross-sectional descriptive survey of classrooms was conducted using a structured observation method in 136 classrooms. The Communication Supporting Classroom Observation Tool was used to make 223 observations across classrooms of LLE (19 items), LLI (20 items) and LLO (5 items). A descriptive analysis of frequency of occurrence of items was conducted for each domain.Results: Language-learning environment had more frequently occurring observations, with 12 out of 19 items being observed with a frequency of occurrence greater than 65%, indicating that the environment had adequate basic resources (e.g. good light). Language-learning interactions scores indicated that 3 out of 20 items were observed frequently, while 17 out of 20 items were observed less frequently (56.5%), including interactive strategies (e.g. turn-taking). Language Learning Opportunities scores indicated that teacher-led behaviours (e.g. including children in small group activities) were infrequently observed on all items.Conclusion: While the physical environment was generally supportive, the behaviours in the interactive domains of LLI and LLO were observed less frequently. There is potential for speech–language therapists to work collaboratively with teachers to develop communication supporting classrooms as a critical primary-level intervention for language-literacy learning.

IntroductionQuality improvement (QI) is a growing field of inquiry in healthcare, including neonatology. However, there is limited information on the study setting, and the methodologic approaches used to develop, implement and evaluate QI interventions in neonatology studies. In this study, we describe these intervention characteristics and approaches.MethodsArticles were taken from a previous publication. There, we searched MEDLINE for publications of QI studies from 2016 to 16 April 2020. We retrieved all relevant full-text publications and sampled 100 of these articles for data abstraction, stratified by the year of publication. For each QI study, we described several methodological characteristics that included: the clinical topic of QI, setting, whether the study was multicentre, stakeholder engagement, root cause analysis and related problem identification methods, implementation techniques for QI interventions, types of outcomes and statistical analysis methods used.ResultsWe assessed 100 studies; most were conducted in the USA (56%). Academic settings and multicentre settings comprised 44% and 24% of studies, respectively. Most studies reported stakeholder engagement (81%), but infrequently reported engagement with leadership (32%) and caregivers (10%). Frequently used techniques for implementing interventions include provider education (82%), formal QI methods (42%) and audit, feedback and benchmarking (40%). Both patient-important clinical outcomes (78%) and process outcomes (89%) were frequently reported. P values were frequently reported (80%), but other statistical techniques were infrequently used.ConclusionQI studies in neonatology use diverse multicomponent interventions. Reporting of these methodologic details can be useful in designing, implementing and evaluating QI studies in clinical practice.

IntroductionQuality improvement (QI) is a growing field of inquiry in healthcare, but the reporting quality of QI studies in neonatology remains unclear. We conducted a systematic survey of the literature to assess the reporting quality of QI studies and factors associated with reporting quality.MethodsWe searched Medline for publications of QI studies from 2016 to 16 April 2020. Pairs of reviewers independently screened citations and assessed reporting quality using a 31-item modified Standards for Quality Improvement Reporting Excellence, 2nd edition (SQUIRE 2.0) checklist. We reported the number (percentage) of studies that reported each item and their corresponding 95% CIs. We used Poisson regression to explore factors associated with reporting quality, namely, journal endorsement of SQUIRE 2.0, declaration of funding sources, year of publication and number of authors. The results were reported as incidence rate ratio (IRR) and 95% CI.ResultsOf 1921 citations, 336 were eligible; among them, we randomly selected 100 articles to assess reporting quality. The mean (standard deviation) number of SQUIRE 2.0 items adhered to was 22.0 (4.5). Percentage of articles reporting each item varied from 26% to 100%. Journal endorsement of SQUIRE 2.0 (IRR=1.11, 95% CI 1.02 to 1.21, p=0.015), declaration of funding sources and increasing number of authors were significantly associated with better reporting.ConclusionsReporting quality of QI studies in neonatology is inadequate. Endorsing the SQUIRE 2.0 guideline is a step that journals can implement to enhance the completeness of reporting.

Primary Subject area Physician Wellness Background Physician burnout is a psychological phenomenon with serious and pervasive consequences on physicians’ mental health, patient safety, and quality of care. Burnout is multifactorial, originating from systemic issues, organizational culture and individual coping skills. Burnout is more common in residency training. Residents experience burnout more intensely due to lack of autonomy, self-efficacy and exposure to mistreatment. Residents are also frontline workers and the future healthcare givers. Organization-led interventions mostly focus on building resilience and mindfulness without addressing systems-level issues. In our study, we attempted to shift the paradigm to address system-level concerns first. We aimed to adapt Joy-in-Work: a quality improvement framework developed by the Institute for Healthcare Improvement (IHI). This program allows residents to identify system problems that are meaningful to them and empower them to work as a team, taking back their autonomy and self-efficacy. Objectives To demonstrate that Joy-in-Work can be adapted effectively into a residency training program to reduce burnout and improve psychological safety among residents. Design/Methods The four steps of Joy-in-Work were implemented for residents in a level 3 neonatal intensive care unit. Residents engaged in “what matters” conversations through survey and group meetings, and identified impediments to Joy-in-Work. By applying QI methodology, residents identified priority interventions to eliminate impediments. Finally, the effectiveness of interventions was evaluated. Primary outcomes included prevalence of burnout and psychological safety; secondary outcomes assessed control over workload, and organizational culture. An IHI 12-item questionnaire was administered at baseline and after the interventions. To assess sustainability, a survey was also conducted one year after the implementation. We assessed adherence to interventions, nurse practitioners’ satisfaction and residents’ workload indicators. Results Through the implementation of Joy-in-Work, residents identified autonomy and work life integration as priorities. Stakeholders developed two interventions: change call schedule according to residents’ preferences and earlier afternoon handover time. Burnout was 77.8%, 50% and 75% for three survey periods respectively. Psychological safety increased consistently from 16.7% to 37.5% to 43.8%. Lack of control over workload dropped sharply from 72.2% to 12.5%, with a rebound to 56.3%. Most secondary outcomes demonstrated a similar pattern of positive change initially with reversion to baseline. Conclusion We demonstrated that Joy-in-Work is successfully adaptable into a residency setting. Implementation through residents’ engagement and empowerment can decrease burnout and improve psychological safety significantly. The process itself was likely the key driver for achieving positive outcomes rather than the actual interventions. Sustainability remains a key issue that requires systems support.

Background: The stepped wedge trial (SWT) design is a type of the randomized clinical trial (RCT) design in which clusters or individuals are randomly and sequentially crossed over from control to intervention over a number of time periods. Trials using SWT design have become increasingly popular in medical, behavioral and social sciences research. Therefore, complete and transparent reporting of these studies is crucial. In particular, the quality of the abstracts of their reports is important because these may be the only accessible sources for their results. Objective: The aims of this survey were to evaluate the reporting quality of SWT abstracts and to identify factors contributing to better reporting quality. Methods: We performed literature searches to identify relevant articles in English published from November 1987 to October 2016 in the following electronic databases: Medline, Embase, Web of Science, CINAHL, and PsycINFO. At least two reviewers examined the quality of abstract reporting using the 17-item CONSORT (CONsolidated Standards Of Reporting Trials) Extension for Abstracts tool. Poisson regression models for incidence rate ratio (IRR) were used to identify factors associated with reporting quality (e.g., CONSORT endorsement, the number of authors, abstract format). Results: A total of 92 eligible articles were identified. Only 6 from the 17 items were reported in more than 80% of the articles (e.g., the statement of conclusions, contact details for the corresponding author). In the multivariable analysis, the year of publication since 2008 (IRR: 1.16; 95% confidence interval (CI): 1.02, 1.33), journal endorsement of the CONSORT Statement (IRR: 1.15; 95% CI: 1.01, 1.31), and multiple authorship (IRR 1.13, 95% CI: 1.01, 1.27) were significantly associated with better reporting quality. Conclusion: The quality of reporting of SWT abstracts was suboptimal, although there have been some significant improvements since 2008. Endorsement of the CONSORT Statement by journals is an essential element of improvement strategies. Also, multiple authorship is significantly associated with better quality of abstract reporting.

ObjectivesComorbidity in traumatic brain injury (TBI) has been recognised to alter the clinical course of patients and influence short-term and long-term outcomes. We synthesised the evidence on the effects of different comorbid conditions on early and late mortality post-TBI in order to (1) examine the relationship between comorbid condition(s) and all-cause mortality in TBI and (2) determine the influence of sociodemographic and clinical characteristics of patients with a TBI at baseline on all-cause mortality.DesignSystematic review.Data sourcesMedline, Central, Embase, PsycINFO and bibliographies of identified articles were searched from May 1997 to January 2019.Eligibility criteria for selecting studiesIncluded studies met the following criteria: (1) focused on comorbidity as it related to our outcome of interest in adults (ie, ≥18 years of age) diagnosed with a TBI; (2) comorbidity was detected by any means excluding self-report; (3) reported the proportion of participants without comorbidity and (4) followed participants for any period of time.Data extraction and synthesisTwo independent reviewers extracted the data and assessed risk of bias using the Quality in Prognosis Studies tool. Data were synthesised through tabulation and qualitative description.ResultsA total of 27 cohort studies were included. Among the wide range of individual comorbid conditions studied, only low blood pressure was a consistent predictors of post-TBI mortality. Other consistent predictors were traditional sociodemographic risk factors. Higher comorbidity scale, scores and the number of comorbid conditions were not consistently associated with post-TBI mortality.ConclusionsGiven the high number of comorbid conditions that were examined by the single studies, research is required to further substantiate the evidence and address conflicting findings. Finally, an enhanced set of comorbidity measures that are suited for the TBI population will allow for better risk stratification to guide TBI management and treatment.PROSPERO registration numberCRD42017070033

IntroductionReports on the association between comorbidity and functional status and risk of death in patients with traumatic brain injury (TBI) have been inconsistent; it is currently unknown which additional clinical entities (comorbidities) have an adverse influence on the evolution of outcomes across the lifespan of men and women with TBI. The current protocol outlines a strategy for a systematic review of the current evidence examining the impact of comorbidity on functional status and early-term and late-term mortality, taking into account known risk factors of these adverse outcomes (ie, demographic (age and sex) and injury-related characteristics).Methods and analysisA comprehensive search strategy for TBI prognosis, functional (cognitive and physical) status and mortality studies has been developed in collaboration with a medical information specialist of the large rehabilitation teaching hospital. All peer-reviewed English language studies with longitudinal design in adults with TBI of any severity, published from May 1997 to April 2017, found through Medline, Central, Embase, Scopus, PsycINFO and bibliographies of identified articles, will be considered eligible. Study quality will be assessed using published guidelines.Ethics and disseminationThe authors will publish findings from this review in a peer-reviewed scientific journal(s) and present the results at national and international conferences. This work aims to understand how comorbidity may contribute to adverse outcomes in TBI, to inform risk stratification of patients and guide the management of brain injury acutely and at the chronic stages postinjury on a population level.PROSPERO registration numberCRD42017070033.