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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.

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.

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.