Gestational weight loss and fetal growth in uncomplicated pregnancies among women with obesity: a population-based retrospective cohort study.

OBJECTIVE: The impact of gestational weight loss (GWL) on fetal growth among women with obesity remains unclear. This study aimed to examine the association between weight loss during pregnancy among women with body mass index (BMI) ≥ 30 kg/m2 and the risk of small-for-gestational-age (SGA) and large-for-gestational-age (LGA) neonates. METHODS: We conducted a retrospective, population-based cohort study of women with pre-pregnancy obesity that resulted in a singleton live birth in 2012-2017, using birth registry data in Ontario, Canada. Women with pregnancy complications or health conditions which could cause weight loss were excluded. GWL is defined as negative gestational weight change (≤0 kg). The association between GWL and fetal growth was estimated using generalized estimating equation models and restricted cubic spline regression analysis. Stratified analysis was conducted by obesity class (I:30-34.9 kg/m2, II:35-39.9 kg/m2, and III + : ≥40 kg/m2). RESULTS: Of the 52,153 eligible women who entered pregnancy with a BMI ≥ 30 kg/m2, 5.3% had GWL. Compared to adequate gestational weight gain, GWL was associated with an increased risk of SGA neonates (aRR:1.45, 95% CI: 1.30-1.60) and a decreased risk of LGA neonates (aRR: 0.81, 95% CI:0.73-0.93). Non-linear L-shaped associations were observed between gestational weight change and SGA neonates, with an increased risk of SGA observed with increased GWL. On the contrary, non-linear S-shaped associations were observed between gestational weight change and LGA neonates, with a decreased risk of LGA observed with increased GWL. Similar findings were observed from the stratified analysis by obesity class. CONCLUSION: These findings highlight that GWL in women with obesity may increase the risk of SGA neonates but reduce the risk of LGA neonates. Recommendations of GWL for women with obesity should be interpreted with caution.

Planning and implementing practice changes in Ontario maternal-newborn hospital units: a secondary qualitative analysis.

BACKGROUND: Moving evidence into practice is complex, and pregnant and birthing people and their infants do not always receive care that aligns with the best available evidence. Implementation science can inform how to effectively move evidence into practice. While there are a growing number of examples of implementation science being studied in maternal-newborn care settings, it remains unknown how real-world teams of healthcare providers and leaders approach the overall implementation process when making practice changes. The purpose of this study was to describe maternal-newborn hospital teams' approaches to implementing practice changes. We aimed to identify what implementation steps teams take (or not) and identify strengths and potential areas for improvement based on best practices in implementation science. METHODS: We conducted a supplementary qualitative secondary analysis of 22 interviews completed in 2014-2015 with maternal-newborn nursing leaders in Ontario, Canada. We used directed content analysis to code the data to seven steps in an implementation framework (Implementation Roadmap): identify the problem and potential best practice; assemble local evidence; select and customize best practice; discover barriers and drivers; tailor implementation strategies; field-test, plan evaluation, prepare to launch; launch, evaluate, and sustain. Frequency counts are presented for each step. RESULTS: Participants reported completing a median of 4.5 of 7 Implementation Roadmap steps (range = 3-7), with the most common being identifying a practice problem. Other steps were described less frequently (e.g., selecting and adapting evidence, field-testing, outcome evaluation) or discussed frequently but not optimally (e.g., barriers assessment). Participants provided examples of how they engaged point-of-care staff throughout the implementation process, but provided fewer examples of engaging pregnant and birthing people and their families. Some participants stated they used a formal framework or process to guide their implementation process, with the most common being quality improvement approaches and tools. CONCLUSIONS: We identified variability across the 22 hospitals in the implementation steps taken. While we observed many strengths, we also identified areas where further support may be needed. Future work is needed to create opportunities and resources to support maternal-newborn healthcare providers and leaders to apply principles and tools from implementation science to their practice change initiatives.

Association between maternal marginalization and infants born with congenital heart disease in Ontario Canada.

BACKGROUND: This study aims to evaluate the impact of socioeconomic status (SES) on the risk of congenital heart disease (CHD) since previous studies have yielded inconsistent results. METHODS: We conducted a population-based retrospective cohort study, including all singleton live and still births in Ontario hospitals from April 1, 2012, to March 31, 2018. We used linked records from the Better Outcomes Registry & Network Information System, the Canadian Institute for Health Information databases, and the Ontario Marginalization Index (ON_Marg). ON_Marg was estimated at a dissemination area level using Canadian Census 2016 data and categorized into quintiles. Multivariable logistic regression models were performed to examine the relationships between four ON_Marg indices (material deprivation, dependency, ethnic concentration, residential instability), as proxies for maternal SES and the risk of infant CHD. We adjusted for maternal age at birth, assisted reproductive technology, obesity, pre-existing health conditions, substance use during pregnancy, mental health conditions before and during pregnancy, rural residence, and infant's sex in the analysis. RESULTS: Among the cohort of 776,799 singletons, 9,359 infants had a diagnosis of CHD. Of those, 3,069 were severe CHD and 493 cases were single ventricle CHD. The prevalence of all infant CHD types was higher for males relative to females. Compared to mothers living in neighbourhoods with the lowest material deprivation, mothers with highest material deprivation had a 27% (adjusted OR = 1.27; 95% CI: 1.18-1.37) higher odds of having an infant diagnosed with CHD. Mothers living in neighbourhoods with the highest minority ethnic and immigrant concentration tend to have infants with 11% lower odds of CHD (adjusted OR = 0.89; 95% CI: 0.82-0.97) as compared to those living in the least ethnically diverse communities. Maternal dependency and residential stability quintiles were not significantly associated with the risk of CHD. CONCLUSION: Higher maternal material deprivation was associated with increasing odds of infant CHD, whereas neighbourhood minority ethnic concentration was inversely associated with the odds of infant CHD. Our study further confirms that poverty is associated with CHD development. Future investigations might focus on the causal pathways between social deprivation, immigrant status, ethnicity, and the risk of infant CHD.

Worries, beliefs and factors influencing perinatal COVID-19 vaccination: a cross-sectional survey of preconception, pregnant and lactating individuals.

BACKGROUND: COVID-19 vaccines are recommended for pregnant and lactating individuals, and there is substantial evidence for their safety and effectiveness. As the pandemic continues, information on worries and beliefs surrounding perinatal COVID-19 vaccination remains important to inform efforts aimed at improving vaccine uptake. Our objectives were to assess factors associated with COVID-19 vaccination among perinatal individuals; and to explore motivational factors associated with willingness to be vaccinated among unvaccinated perinatal individuals. METHODS: This was a cross-sectional web-based survey of preconception, pregnant, and lactating individuals in Canada. The outcomes of interest were vaccination with at least one dose of any COVID-19 vaccine and willingness to be vaccinated among unvaccinated individuals. Sample characteristics were summarized using frequencies and percentages. The association between eight prespecified risk factors and two outcomes (vaccination status and willingness to be vaccinated) was assessed by logistic regression. Odds ratios (OR) and 95% confidence intervals (CI) were calculated for the total sample, and across perinatal sub-groups. RESULTS: Among 3446 survey respondents, there were 447 (13.0%) preconception, 1832 (53.2%) pregnant, and 1167 (42.4%) lactating. There were 1460 (42.4%) and 1982 (57.5%) who were vaccinated and unvaccinated, respectively. Factors positively associated with COVID-19 vaccine status were speaking to a healthcare provider about vaccination during the perinatal period (aOR:2.35, 95% CI:1.97-2.80) and believing that the COVID-19 vaccine is effective (aOR:1.91, 95% CI:1.46-2.48). Factors negatively associated with vaccine status included worries about fetal growth and development (aOR:0.55, 95% CI:0.43-0.70) and future child behavioral/neurodevelopmental problems (aOR:0.59, 95% CI:0.46-0.75). Among unvaccinated individuals specifically, characteristics positively associated with willingness to vaccinate were speaking to a healthcare provider (aOR:1.67, 95% CI:1.32-2.12) and believing the COVID-19 vaccine is effective (aOR:3.56, 95% CI:2.70-4.69). Factors negatively associated with willingness were concerns over infertility (aOR:0.66, 95% CI:0.49-0.88), fetal growth and development (aOR:0.33, 95% CI:0.24-0.46), and future child behavioral/neurodevelopmental problems (aOR:0.64, 95% CI:0.48-0.84). CONCLUSIONS: In this Canadian perinatal population, approximately 42% reported COVID-19 vaccination. Among unvaccinated individuals, willingness to receive vaccination was high (73%). Factors enhancing vaccine willingness included discussions with healthcare providers and believing the vaccine was effective. Concerns regarding vaccine safety, particularly with respect to fetal/child development, were the greatest barriers to vaccine uptake.

Associations of congenital heart disease with deprivation index by rural-urban maternal residence: a population-based retrospective cohort study in Ontario, Canada.

BACKGROUND: The risk of congenital heart disease (CHD) has been found to vary by maternal socioeconomic status (SES) and rural-urban residence. In this study, we examined associations of CHD with two maternal SES indicators and stratified the analysis by maternal rural-urban residence. METHODS: This was a population-based retrospective cohort study. We included all singleton stillbirths and live hospital births from April 1, 2012 to March 31, 2018 in Ontario, Canada. We linked the BORN Information System and Canadian Institute for Health Information databases. Multivariable logistic regression models were used to examine associations of CHD with material deprivation index (MDI), social deprivation index (SDI), and maternal residence while adjusting for maternal age at birth, assisted reproductive technology, obesity, pre-pregnancy maternal health conditions, mental health illness before and during pregnancy, substance use during pregnancy, and infant's sex. MDI and SDI were estimated at a dissemination area level in Ontario and were categorized into quintiles (Q1-Q5). RESULTS: This cohort study included 798,173 singletons. In maternal urban residence, the p trend (Cochran-Armitage test) was less than 0.0001 for both MDI and SDI; while for rural residence, it was 0.002 and 0.98, respectively. Infants living in the most materially deprived neighbourhoods (MDI Q5) had higher odds of CHD (aOR: 1.21, 95% CI: 1.12-1.29) compared to Q1. Similarly, infants living in the most socially deprived neighbourhoods (SDI Q5) had an 18% increase in the odds of CHD (aOR: 1.18, 95% CI: 1.1-1.26) compared to Q1. Rural infants had a 13% increase in the odds of CHD compared to their urban counterparts. After stratifying by maternal rural-urban residence, we still detected higher odds of CHD with two indices in urban residence but only MDI in rural residence. CONCLUSION: Higher material and social deprivation and rural residence were associated with higher odds of CHD. Health interventions and policies should reinforce the need for optimal care for all families, particularly underprivileged families in both rural and urban regions. Future studies should further investigate the effect of social deprivation on the risk of CHD development.

Understanding how and under what circumstances decision coaching works for people making healthcare decisions: a realist review.

BACKGROUND: Decision coaching is non-directive support delivered by a trained healthcare provider to help people prepare to actively participate in making healthcare decisions. This study aimed to understand how and under what circumstances decision coaching works for people making healthcare decisions. METHODS: We followed the realist review methodology for this study. This study was built on a Cochrane systematic review of the effectiveness of decision coaching interventions for people facing healthcare decisions. It involved six iterative steps: (1) develop the initial program theory; (2) search for evidence; (3) select, appraise, and prioritize studies; (4) extract and organize data; (5) synthesize evidence; and (6) consult stakeholders and draw conclusions. RESULTS: We developed an initial program theory based on decision coaching theories and stakeholder feedback. Of the 2594 citations screened, we prioritized 27 papers for synthesis based on their relevance rating. To refine the program theory, we identified 12 context-mechanism-outcome (CMO) configurations. Essential mechanisms for decision coaching to be initiated include decision coaches', patients', and clinicians' commitments to patients' involvement in decision making and decision coaches' knowledge and skills (four CMOs). CMOs during decision coaching are related to the patient (i.e., willing to confide, perceiving their decisional needs are recognized, acquiring knowledge, feeling supported), and the patient-decision coach interaction (i.e., exchanging information, sharing a common understanding of patient's values) (five CMOs). After decision coaching, the patient's progress in making or implementing a values-based preferred decision can be facilitated by the decision coach's advocacy for the patient, and the patient's deliberation upon options (two CMOs). Leadership support enables decision coaches to have access to essential resources to fulfill their role (one CMOs). DISCUSSION: In the refined program theory, decision coaching works when there is strong leadership support and commitment from decision coaches, clinicians, and patients. Decision coaches need to be capable in coaching, encourage patients' participation, build a trusting relationship with patients, and act as a liaison between patients and clinicians to facilitate patients' progress in making or implementing an informed values-based preferred option. More empirical studies, especially qualitative and process evaluation studies, are needed to further refine the program theory.

Association of COVID-19 Vaccination in Pregnancy With Adverse Peripartum Outcomes.

Importance: There is limited comparative epidemiological evidence on outcomes associated with COVID-19 vaccination during pregnancy; monitoring pregnancy outcomes in large populations is required. Objective: To evaluate peripartum outcomes following COVID-19 vaccination during pregnancy. Design, Setting, and Participants: Population-based retrospective cohort study in Ontario, Canada, using a birth registry linked with the provincial COVID-19 immunization database. All births between December 14, 2020, and September 30, 2021, were included. Exposures: COVID-19 vaccination during pregnancy, COVID-19 vaccination after pregnancy, and no vaccination. Main Outcomes and Measures: Postpartum hemorrhage, chorioamnionitis, cesarean delivery (overall and emergency cesarean delivery), admission to neonatal intensive care unit (NICU), and low newborn 5-minute Apgar score (<7). Linear and robust Poisson regression was used to generate adjusted risk differences (aRDs) and risk ratios (aRRs), respectively, comparing cumulative incidence of outcomes in those who received COVID-19 vaccination during pregnancy with those vaccinated after pregnancy and those with no record of COVID-19 vaccination at any point. Inverse probability of treatment weights were used to adjust for confounding. Results: Among 97 590 individuals (mean [SD] age, 31.9 [4.9] years), 22 660 (23%) received at least 1 dose of COVID-19 vaccine during pregnancy (63.6% received dose 1 in the third trimester; 99.8% received an mRNA vaccine). Comparing those vaccinated during vs after pregnancy (n = 44 815), there were no significantly increased risks of postpartum hemorrhage (incidence: 3.0% vs 3.0%; aRD, -0.28 per 100 individuals [95% CI, -0.59 to 0.03]; aRR, 0.91 [95% CI, 0.82-1.02]), chorioamnionitis (0.5% vs 0.5%; aRD, -0.04 per 100 individuals [95% CI, -0.17 to 0.09]; aRR, 0.92 [95% CI, 0.70-1.21]), cesarean delivery (30.8% vs 32.2%; aRD, -2.73 per 100 individuals [95% CI, -3.59 to -1.88]; aRR, 0.92 [95% CI, 0.89-0.95]), NICU admission (11.0% vs 13.3%; aRD, -1.89 per 100 newborns [95% CI, -2.49 to -1.30]; aRR, 0.85 [95% CI, 0.80-0.90]), or low Apgar score (1.8% vs 2.0%; aRD, -0.31 per 100 newborns [95% CI, -0.56 to -0.06]; aRR, 0.84 [95% CI, 0.73-0.97]). Findings were qualitatively similar when compared with individuals who did not receive COVID-19 vaccination at any point (n = 30 115). Conclusions and Relevance: In this population-based cohort study in Ontario, Canada, COVID-19 vaccination during pregnancy, compared with vaccination after pregnancy and with no vaccination, was not significantly associated with increased risk of adverse peripartum outcomes. Study interpretation should consider that the vaccinations received during pregnancy were primarily mRNA vaccines administered in the second and third trimester.

Histologic Correlates of Molecular Group 4 Pediatric Medulloblastoma: A Retrospective Canadian Review.

INTRODUCTION: The World Health Organization currently classifies medulloblastoma (MB) into four molecular groups (WNT, SHH, Group 3 and Group 4) and four histologic subtypes (classic, desmoplastic nodular, MB with extensive nodularity, and large cell/anaplastic). "Classic" MB is the most frequent histology, but unfortunately it does not predict molecular group or patient outcome. While MB may exhibit additional histologic features outside of the traditional WHO subtypes, the clinical significance of such features, in a molecular context, is unclear. METHODS: The clinicopathologic features of 120 pediatric MB were reviewed in the context of NanoString molecular grouping. Each case was evaluated for five ancillary histologic features, including: nodularity without desmoplasia (i.e., "biphasic", B-MB), rhythmic palisades, and focal anaplasia. Molecular and histological features were statistically correlated to clinical outcome using Chi-square, log-rank, and multivariate Cox regression analysis. RESULTS: While B-MB (N = 32) and rhythmic palisades (N = 12) were enriched amongst non-WNT/SHH MB (especially Group 4), they were not statistically associated with outcome. In contrast, focal anaplasia (N = 12) was not associated with any molecular group, but did predict unfavorable outcome. CONCLUSION: These data nominate B-MB as a surrogate marker of Groups 3 and particularly 4 MB, which may earmark a clinically significant subset of cases.

Decision coaching for people making healthcare decisions.

BACKGROUND: Decision coaching is non-directive support delivered by a healthcare provider to help patients prepare to actively participate in making a health decision. 'Healthcare providers' are considered to be all people who are engaged in actions whose primary intent is to protect and improve health (e.g. nurses, doctors, pharmacists, social workers, health support workers such as peer health workers). Little is known about the effectiveness of decision coaching. OBJECTIVES: To determine the effects of decision coaching (I) for people facing healthcare decisions for themselves or a family member (P) compared to (C) usual care or evidence-based intervention only, on outcomes (O) related to preparation for decision making, decisional needs and potential adverse effects. SEARCH METHODS: We searched the Cochrane Library (Wiley), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), CINAHL (Ebsco), Nursing and Allied Health Source (ProQuest), and Web of Science from database inception to June 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) where the intervention was provided to adults or children preparing to make a treatment or screening healthcare decision for themselves or a family member. Decision coaching was defined as: a) delivered individually by a healthcare provider who is trained or using a protocol; and b) providing non-directive support and preparing an adult or child to participate in a healthcare decision. Comparisons included usual care or an alternate intervention. There were no language restrictions. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations, assessed risk of bias, and extracted data on characteristics of the intervention(s) and outcomes. Any disagreements were resolved by discussion to reach consensus. We used the standardised mean difference (SMD) with 95% confidence intervals (CI) as the measures of treatment effect and, where possible, synthesised results using a random-effects model. If more than one study measured the same outcome using different tools, we used a random-effects model to calculate the standardised mean difference (SMD) and 95% CI. We presented outcomes in summary of findings tables and applied GRADE methods to rate the certainty of the evidence. MAIN RESULTS: Out of 12,984 citations screened, we included 28 studies of decision coaching interventions alone or in combination with evidence-based information, involving 5509 adult participants (aged 18 to 85 years; 64% female, 52% white, 33% African-American/Black; 68% post-secondary education). The studies evaluated decision coaching used for a range of healthcare decisions (e.g. treatment decisions for cancer, menopause, mental illness, advancing kidney disease; screening decisions for cancer, genetic testing). Four of the 28 studies included three comparator arms.  For decision coaching compared with usual care (n = 4 studies), we are uncertain if decision coaching compared with usual care improves any outcomes (i.e. preparation for decision making, decision self-confidence, knowledge, decision regret, anxiety) as the certainty of the evidence was very low.  For decision coaching compared with evidence-based information only (n = 4 studies), there is low certainty-evidence that participants exposed to decision coaching may have little or no change in knowledge (SMD -0.23, 95% CI: -0.50 to 0.04; 3 studies, 406 participants). There is low certainty-evidence that participants exposed to decision coaching may have little or no change in anxiety, compared with evidence-based information. We are uncertain if decision coaching compared with evidence-based information improves other outcomes (i.e. decision self-confidence, feeling uninformed) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with usual care (n = 17 studies), there is low certainty-evidence that participants may have improved knowledge (SMD 9.3, 95% CI: 6.6 to 12.1; 5 studies, 1073 participants). We are uncertain if decision coaching plus evidence-based information compared with usual care improves other outcomes (i.e. preparation for decision making, decision self-confidence, feeling uninformed, unclear values, feeling unsupported, decision regret, anxiety) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with evidence-based information only (n = 7 studies), we are uncertain if decision coaching plus evidence-based information compared with evidence-based information only improves any outcomes (i.e. feeling uninformed, unclear values, feeling unsupported, knowledge, anxiety) as the certainty of the evidence was very low. AUTHORS' CONCLUSIONS: Decision coaching may improve participants' knowledge when used with evidence-based information. Our findings do not indicate any significant adverse effects (e.g. decision regret, anxiety) with the use of decision coaching. It is not possible to establish strong conclusions for other outcomes. It is unclear if decision coaching always needs to be paired with evidence-informed information. Further research is needed to establish the effectiveness of decision coaching for a broader range of outcomes.

Neighbourhood maternal socioeconomic status indicators and risk of congenital heart disease.

BACKGROUND: This study aimed to examine the relationships between various maternal socioeconomic status (SES) indicators and the risk of congenital heart disease (CHD). METHODS: This was a population-based retrospective cohort study, including all singleton stillbirths and live births in Ontario hospitals from April 1, 2012 to March 31, 2018. Multivariable logistic regression models were performed to examine the relationships between maternal neighbourhood household income, poverty, education level, employment and unemployment status, immigration and minority status, and population density and the risk of CHD. All SES variables were estimated at a dissemination area level and categorized into quintiles. Adjustments were made for maternal age at birth, assisted reproductive technology, obesity, pre-existing maternal health conditions, substance use during pregnancy, rural or urban residence, and infant's sex. RESULTS: Of 804,292 singletons, 9731 (1.21%) infants with CHD were identified. Compared to infants whose mothers lived in the highest income neighbourhoods, infants whose mothers lived in the lowest income neighbourhoods had higher likelihood of developing CHD (adjusted OR: 1.29, 95% CI: 1.20-1.38). Compared to infants whose mothers lived in the neighbourhoods with the highest percentage of people with a university or higher degree, infants whose mothers lived in the neighbourhoods with the lowest percentage of people with university or higher degree had higher chance of CHD (adjusted OR: 1.34, 95% CI: 1.24-1.44). Compared to infants whose mothers lived in the neighbourhoods with the highest employment rate, the odds of infants whose mothers resided in areas with the lowest employment having CHD was 18% higher (adjusted OR: 1.18, 95% CI: 1.10-1.26). Compared to infants whose mothers lived in the neighbourhoods with the lowest proportion of immigrants or minorities, infants whose mothers resided in areas with the highest proportions of immigrants or minorities had 18% lower odds (adjusted OR: 0.82, 95% CI: 0.77-0.88) and 16% lower odds (adjusted OR: 0.84, 95% CI: 0.78-0.91) of CHD, respectively. CONCLUSION: Lower maternal neighbourhood household income, poverty, lower educational level and unemployment status had positive associations with CHD, highlighting a significant social inequity in Ontario. The findings of lower CHD risk in immigrant and minority neighbourhoods require further investigation.

Targeted Polo-like Kinase Inhibition Combined With Aurora Kinase Inhibition in Pediatric Acute Leukemia Cells.

BACKGROUND: Recent studies have shown that cell cycle events are tightly controlled by complex and shared activities of a select group of kinases. Among these, polo-like kinases (Plks) are regulatory mitotic proteins that are overexpressed in several types of cancer and are associated with poor prognosis. MATERIALS AND METHODS: We have evaluated, in preclinical in vitro studies, the activity of a panel of Plk inhibitors against cell lines derived from refractory pediatric leukemia, as well as primary leukemia cells, in culture. Through in vitro growth inhibition studies, Western blot analysis for the expression and activation of key regulators of cell growth and survival and gene silencing studies, we specifically examined the ability of these agents to induce cytotoxicity through the activation of apoptosis and their capacity to interact and modulate the expression and phosphorylation of Aurora kinases. RESULTS: Our findings show that the various Plk-1 inhibitors in development show potential utility for the treatment of pediatric leukemia and exhibit a wide range of phosphorylation and target modulatory capabilities. Finally, we provide evidence for a complex interregulatory relationship between Plk-1 and Aurora kinases enabling the identification of synergy and biologic correlates of drug combinations targeting the 2 distinct enzyme systems. DISCUSSION: This information provide the rationale for the evaluation of Plk-1 as an effective target for therapeutics in refractory pediatric leukemia and indicate compensatory activities between Plk-1 and Aurora kinases, providing insight into some of the complex mechanisms involved in the process of cell division.

Effect of implementation of the MOREOB program on adverse maternal and neonatal birth outcomes in Ontario, Canada: a retrospective cohort study.

BACKGROUND: In 2002, the MOREOB (Managing Obstetrical Risk Efficiently) obstetrical patient safety program was phased-in across hospitals in Ontario, Canada. The purpose of our study was to evaluate the effect of the MOREOB program on rates of adverse maternal and neonatal outcomes. METHODS: A retrospective cohort study, using province-wide administrative hospitalization data. We included maternal and neonatal records between fiscal years 2002-2003 and 2013-2014, for deliveries taking place at the 67 Ontario hospitals where the MOREOB program was implemented between 2002 and 2012. After accounting for institutional mergers and excluding very small hospitals, 55 hospitals (1,447,073 deliveries) were included. Multivariable logistic and linear mixed effects regression analysis were used, accounting for secular trends, within hospital correlation and over time correlation, and adjusting for a maternal comorbidity index, hospital annual birth volume, and level of care. The main outcome measure was a composite individual-level indicator of incidence of any adverse events, and a hospital-level score, called the Weighted Adverse Outcome Score (WAOS) capturing both maternal and neonatal adverse outcomes. RESULTS: Across the 12 years of follow up, there were 98,789 adverse maternal and neonatal outcomes, a rate of 6.83 per 100 deliveries (6.66 per 100 occurring before, 6.91 per 100 during, and 6.84 per 100 after program implementation). The multivariable analysis found no statistically significant decrease in adverse events associated with program implementation (OR for adverse events after versus before =1.11 (95% CI: 1.06 to 1.17, change in mean WAOS score after minus before =0.15 (- 0.36 to 0.67)). CONCLUSIONS: We did not find a reduction in the incidence of maternal and neonatal adverse outcomes associated with the MOREOB program, and small yet statistically significant increases in some adverse events were observed.

A mixed-methods evaluation of the MOREOB program in Ontario hospitals: participant knowledge, organizational culture, and experiences.

BACKGROUND: MOREOB (Managing Obstetrical Risk Efficiently) is a patient safety program for health care providers and administrators in hospital obstetric units. MOREOB has been implemented widely in Canada and gradually spread to the United States. The main goal of MOREOB is to build a patient safety culture and improve clinical outcomes. In 2013, 26 Ontario hospitals voluntarily accepted provincial funding to participate in MOREOB. The purpose of our study was to assess the effect of MOREOB on participant knowledge, organizational culture, and experiences implementing and participating in the program at these 26 Ontario hospitals. METHODS: A convergent parallel mixed-methods study in Ontario, Canada, with MOREOB participants from 26 hospitals. The quantitative component used a descriptive pre-post repeated measures design to assess participant knowledge and perception of culture, administered pre-MOREOB and after each of the three MOREOB modules. Changes in mean scores were assessed using mixed-effects regression. The qualitative component used a qualitative descriptive design with individual semi-structured interviews. We used content analysis to code, categorize, and thematically describe data. A convergent parallel design was used to triangulate findings from data sources. RESULTS: 308 participants completed the knowledge test, and 329 completed the culture assessment at all four time points. Between baseline and post-Module 3, statistically significant increases on both scores were observed, with an increase of 7.9% (95% CI: 7.1 to 8.8) on the knowledge test and an increase of 0.45 (on a scale of 1-5, 95% CI: 0.38 to 0.52) on the culture assessment. Interview participants (n = 15) described improvements in knowledge, interprofessional communication, ability to provide safe care, and confidence in skills. Facilitators and barriers to program implementation and sustainability were identified. CONCLUSIONS: Participants were satisfied with their participation in the MOREOB program and perceived that it increased health care provider knowledge and confidence, improved safety for patients, and improved communication between team members. Additionally, mean scores on knowledge tests for obstetric content and culture assessment improved. The MOREOB program can help organizations and individuals improve care by concentrating on the human and organizational aspects of patient safety. Further work to improve program implementation and sustainability is required.

Data accuracy in the Ontario birth Registry: a chart re-abstraction study.

BACKGROUND: Ontario's birth Registry (BORN) was established in 2009 to collect, interpret, and share critical data about pregnancy, birth and the early childhood period to facilitate and improve the provision of healthcare. Since the use of routinely-collected health data has been prioritized internationally by governments and funding agencies to improve patient care, support health system planning, and facilitate epidemiological surveillance and research, high quality data is essential. The purpose of this study was to verify the accuracy of a selection of data elements that are entered in the Registry. METHODS: Data quality was assessed by comparing data re-abstracted from patient records to data entered into the Ontario birth Registry. A purposive sample of 10 hospitals representative of hospitals in Ontario based on level of care, birth volume and geography was selected and a random sample of 100 linked mother and newborn charts were audited for each site. Data for 29 data elements were compared to the corresponding data entered in the Ontario birth Registry using percent agreement, kappa statistics for categorical data elements and intra-class correlation coefficients (ICCs) for continuous data elements. RESULTS: Agreement ranged from 56.9 to 99.8%, but 76% of the data elements (22 of 29) had greater than 90% agreement. There was almost perfect (kappa 0.81-0.99) or substantial (kappa 0.61-0.80) agreement for 12 of the categorical elements. Six elements showed fair-to-moderate agreement (kappa <0.60). We found moderate-to-excellent agreement for four continuous data elements (ICC >0.50). CONCLUSION: Overall, the data elements we evaluated in the birth Registry were found to have good agreement with data from the patients' charts. Data elements that showed moderate kappa or low ICC require further investigation.

Agreement assessment of key maternal and newborn data elements between birth registry and Clinical Administrative Hospital Databases in Ontario, Canada.

PURPOSE: Since 2012, BORN Ontario, a maternal-newborn registry, has collected data on every birth in Ontario. To ensure data quality, we assessed the reliability of key elements collected in BORN by comparing these with like data elements in the Canadian Institute for Health Information-Discharge Abstract Database (CIHI-DAD). METHODS: We used provincial health card numbers to deterministically link live or stillbirth records and their corresponding mothers' records in the BORN database to the CIHI-DAD in the fiscal years 2012-2013 to 2014-2015. Percentage agreement and Cohen Kappa statistics were used to assess agreement on main elements in both databases. RESULTS: The percentage agreement and Kappa coefficients were 99.98% and 0.740 (95% CI: 0.677-0.803) on live/stillbirth, respectively. The Kappa coefficients for infant sex, gestational age at birth, induction of labour, and caesarean birth were 0.989 (95% CI: 0.988-0.989), 0.920 (95% CI: 0.919-0.920), 0.782 (95% CI: 0.780-0.785), and 0.995 (95% CI: 0.995-0.996), respectively. Kappa agreement for the number of fetuses in a pregnancy was 0.979 (95% CI: 0.977-0.981). Percentage agreement was very high for infants' birthdates (99.9%), infant postal codes (91.8%), infants' birth weight in grams (95.5%), and mothers' dates of birth (99.1%). CONCLUSIONS: Overall, the BORN and CIHI-DAD databases had concordance on key birth and maternal data elements; however, additional work is needed to understand discrepancies identified.

A Parent-Targeted and Mediated Video Intervention to Improve Uptake of Pain Treatment for Infants During Newborn Screening: A Pilot Randomized Controlled Trial.

Most newborns undergo newborn screening blood tests. Breastfeeding, skin-to-skin care, and sweet solutions effectively reduce pain; however, these strategies are inconsistently used. We conducted a 2-armed pilot randomized controlled trial in a mother-baby unit to examine the feasibility and acceptability of a parent-targeted and -mediated video demonstrating use of these pain-reducing strategies and to obtain preliminary effectiveness data on uptake of pain management. One hundred parent-newborn dyads were randomized to view the video or receive usual care (51 intervention and 49 control arm). Consent and attrition rates were 70% and 1%, respectively. All participants in the intervention arm received the intervention as planned and reported an intention to recommend the video and to use at least 1 pain treatment with breastfeeding or skin-to-skin care preferred over sucrose. In the intervention arm, 60% of newborns received at least 1 pain treatment compared with 67% in the control arm (absolute difference, -7%; 95% confidence interval, -26 to 12). The video was well accepted and feasible to show to parents. As there was no evidence of effect on the use of pain management, major modifications are required before launching a full-scale trial. Effective means to translate evidence-based pain knowledge is warranted.

Shared decision making during antenatal counselling for anticipated extremely preterm birth.

OBJECTIVES: To explore health care providers' (HCPs) perceptions of using shared decision making (SDM) and to identify facilitators of and barriers to its use with families facing the anticipated birth of an extremely preterm infant at 22+0 to 25+6 weeks gestational age. STUDY DESIGN: Qualitative descriptive study design: we conducted interviews with 25 HCPs involved in five cases at a tertiary care centre and completed qualitative content analysis of their responses. RESULTS: Nine facilitators and 16 barriers were identified. Facilitators included: a correct understanding of this process and how to apply it, a belief that parents should be the decision makers in these situations, and a positive outlook toward using SDM during antenatal counselling. Barriers included: HCPs' misunderstandings of how and when to apply SDM during antenatal counselling, challenges using the process for cases at the lower end of the gestational age range, fear of the negative emotions and stress parents face when making decisions, and HCPs' uncertainty about their ability to properly apply SDM. CONCLUSIONS: This study identified facilitators and barriers to use of SDM during antenatal counselling for anticipated birth of extremely preterm infants that can be used to inform development of tailored strategies to facilitate future implementation of shared decision making in this area.

Elective Repeat Caesarean Section in Low-Risk Women-Economic Evaluation Comparing Births Before vs. After 39 Weeks Gestation in Ontario, Canada.

PURPOSE: To undertake an economic analysis of repeat Caesarean births in low-risk women (LRW) not in labour in Ontario who delivered at 37-38 weeks (<39 weeks) vs. 39-40 weeks (≥39 weeks) gestation. METHODS: Data from the Better Outcomes Registry & Network (BORN) Information System for fiscal years 2012-2013 and 2013-2014 meeting the definition for elective repeat CS (ERCS) for LRW between 37 and 40 weeks gestation. Costs were obtained from the Ottawa Hospital Data Warehouse and applied through to discharge. RESULTS: For April 2012 to March 2013, we extracted 3637 ERCS dyads at <39 weeks and 3282 dyads at ≥39 weeks. There were 334 NICU admissions at <39 weeks (0.92%) and 235 at ≥39 weeks (0.72%). Average neonate cost was $1247.99 (<39 weeks) vs. $1200.77 (≥39 weeks)-a difference of $47.22. Average dyad cost was $3608.92 (<39 weeks) vs. $3577.04 (≥39 weeks)-a difference of $31.88 per birth. If these births were delayed to ≥39 weeks, net savings of $173 864 and $115 947 annually would be realized on "baby only" and "dyad" costs, respectively. For April 2013 to March 2014, we extracted 2875 ERCS dyads at ≤39 weeks and 3892 dyads at ≥39 weeks. There were 216 NICU admissions ≤39 weeks (0.75%) and 224 at ≥39 weeks (0.58%). Average neonate cost was $1268.56 (<39 weeks) vs. $1126.56 (≥39 weeks)-a difference of $142.00 per birth. Average dyad cost was $3605.70 (≤39 weeks) vs. $3456.61 (≥39 weeks)-a difference of $149.08. If these births were delayed to ≥39 weeks, net annual savings of $404 842 and $428 605 would be realized on "baby only" and "dyad" costs respectively. CONCLUSIONS: Restricting repeat CS in LRW to ≥39 weeks is a cost-effective strategy.

Roles, processes, and outcomes of interprofessional shared decision-making in a neonatal intensive care unit: A qualitative study.

Shared decision-making provides an opportunity for the knowledge and skills of care providers to synergistically influence patient care. Little is known about interprofessional shared decision-making processes in critical care settings. The aim of this study was to explore interprofessional team members' perspectives about the nature of interprofessional shared decision-making in a neonatal intensive care unit (NICU) and to determine if there are any differences in perspectives across professional groups. An exploratory qualitative approach was used consisting of semi-structured interviews with 22 members of an interprofessional team working in a tertiary care NICU in Canada. Participants identified four key roles involved in interprofessional shared decision-making: leader, clinical experts, parents, and synthesizer. Participants perceived that interprofessional shared decision-making happens through collaboration, sharing, and weighing the options, the evidence and the credibility of opinions put forward. The process of interprofessional shared decision-making leads to a well-informed decision and participants feeling valued. Findings from this study identified key concepts of interprofessional shared decision-making, increased awareness of differing professional perspectives about this process of shared decision-making, and clarified understanding of the different roles involved in the decision-making process in an NICU.