Antenatal corticosteroids and newborn respiratory outcomes in twins: A regression discontinuity study.

OBJECTIVE: To estimate the effect of antenatal corticosteroids on newborn respiratory morbidity in twins. DESIGN: Regression discontinuity applied to population-based birth registry data. SETTING: British Columbia, Canada, 2008-2018. POPULATION: Twin pregnancies admitted for birth between 31+0 and 36+6 weeks of gestation. METHODS: During our study period, Canadian clinical practice guidelines recommended antenatal corticosteroid administration for imminent preterm birth up to 33+6 weeks. We used a logistic model to compare the predicted risks of our outcomes among pregnancies admitted for birth immediately before this clinical cut-point (higher probability of exposure to antenatal corticosteroids) versus immediately after it (lower probability). MAIN OUTCOME MEASURES: Our primary outcome was a composite of newborn respiratory distress or in-hospital death. Our secondary outcome was a composite of newborn respiratory intervention or in-hospital death. RESULTS: Among 2524 pregnancies (5035 liveborn twins), 47% of admissions before 34+0 weeks of gestation were exposed to antenatal corticosteroids but only 4.2% of admissions after this cut-point were exposed. The risk of newborn respiratory distress or in-hospital mortality increased abruptly at 34+0 weeks, corresponding to a protective effect of treatment (risk ratio [RR] 0.69, 95% CI 0.53-0.90; risk difference [RD] -12 cases per 100 births, 95% CI -20 to -4.1). There was no clear evidence for or against an effect on newborn respiratory intervention or in-hospital death (RR 0.89, 95% CI 0.70-1.13; RD -4.2 per 100, 95% CI -13 to +4.2). CONCLUSIONS: Our findings provide evidence for the effectiveness of antenatal corticosteroids in preventing adverse newborn respiratory outcomes in twins.

Cost modelling incorporating procalcitonin for the risk stratification of febrile infants ≤60 days old.

Objectives: Procalcitonin testing is recommended to discriminate febrile young infants at risk of serious bacterial infections (SBI). However, this test is not available in many clinical settings, limited largely by cost. This study sought to evaluate contemporary real-world costs associated with the usual care of febrile young infants, and estimate impact on clinical trajectory and costs when incorporating procalcitonin testing. Methods: We assessed hospital-level door-to-discharge costs of all well-appearing febrile infants aged ≤60 days, evaluated at a tertiary paediatric hospital between April/2016 and March/2019. Emergency Department and inpatient expense data for usual care were obtained from the institutional general ledger, validated by the provincial Ministry of Health. These costs were then incorporated into a probabilistic model of risk stratification for an equivalent simulated cohort, with the addition of procalcitonin. Results: During the 3-year study period, 1168 index visits were included for analysis. Real-world median costs-per-infant were the following: $3266 (IQR $2468 to $4317, n=93) for hospitalized infants with SBIs; $2476 (IQR $1974 to $3236, n=530) for hospitalized infants without SBIs; $323 (IQR $286 to $393, n=538) for discharged infants without SBIs; and, $3879 (IQR $3263 to $5297, n=7) for discharged infants subsequently hospitalized for missed SBIs. Overall median cost-per-infant of usual care was $1555 (IQR $1244 to $2025), compared to a modelled cost of $1389 (IQR $1118 to $1797) with the addition of procalcitonin (10.7% overall cost savings; $1,816,733 versus $1,622,483). Under pessimistic and optimistic model assumptions, savings were 5.9% and 14.9%, respectively. Conclusions: Usual care of febrile young infants is variable and resource intensive. Increased access to procalcitonin testing could improve risk stratification at lower overall costs.

Health care services use, stillbirth, and neonatal and infant survival following implementation of the Maternal Health Voucher Scheme in Bangladesh: A difference-in-differences analysis of Bangladesh Demographic and Health Survey data, 2000 to 2016.

BACKGROUND: Starting in 2006 to 2007, the Government of Bangladesh implemented the Maternal Health Voucher Scheme (MHVS). This program provides pregnant women with vouchers that can be exchanged for health services from eligible public and private sector providers. In this study, we examined whether access to the MHVS was associated with maternal health services utilization, stillbirth, and neonatal and infant mortality. METHODS AND FINDINGS: We used information on pregnancies and live births between 2000 to 2016 reported by women 15 to 49 years of age surveyed as part of the Bangladesh Demographic and Health Surveys. Our analytic sample included 23,275 pregnancies lasting at least 7 months for analyses of stillbirth and between 15,125 and 21,668 live births for analyses of health services use, neonatal, and infant mortality. With respect to live births occurring prior to the introduction of the MHVS, 31.3%, 14.1%, and 18.0% of women, respectively, reported receiving at least 3 antenatal care visits, delivering in a health institution, and having a skilled birth attendant at delivery. Rates of neonatal and infant mortality during this period were 40 and 63 per 1,000 live births, respectively, and there were 32 stillbirths per 1,000 pregnancies lasting at least 7 months. We applied a difference-in-differences design to estimate the effect of providing subdistrict-level access to the MHVS program, with inverse probability of treatment weights to address selection into the program. The introduction of the MHVS program was associated with a lagged improvement in the probability of delivering in a health facility, one of the primary targets of the program, although associations with other health services were less evident. After 6 years of access to the MHVS, the probabilities of reporting at least 3 antenatal care visits, delivering in a health facility, and having a skilled birth attendant present increased by 3.0 [95% confidence interval (95% CI) = -4.8, 10.7], 6.5 (95% CI = -0.6, 13.6), and 5.8 (95% CI = -1.8, 13.3) percentage points, respectively. We did not observe evidence consistent with the program improving health outcomes, with probabilities of stillbirth, neonatal mortality, and infant mortality decreasing by 0.7 (95% CI = -1.3, 2.6), 0.8 (95% CI = -1.7, 3.4), and 1.3 (95% CI = -2.5, 5.1) percentage points, respectively, after 6 years of access to the MHVS. The sample size was insufficient to detect smaller associations with adequate precision. Additionally, we cannot rule out the possibility of measurement error, although it was likely nondifferential by treatment group, or unmeasured confounding by concomitant interventions that were implemented differentially in treated and control areas. CONCLUSIONS: In this study, we found that the introduction of the MHVS was positively associated with the probability of delivering in a health facility, but despite a longer period of follow-up than most extant evaluations, we did not observe attendant reductions in stillbirth, neonatal mortality, or infant mortality. Further work and engagement with stakeholders is needed to assess if the MHVS has affected the quality of care and health inequalities and whether the design and eligibility of the program should be modified to improve maternal and neonatal health outcomes.

Antenatal corticosteroid administration and attention-deficit/hyperactivity disorder in childhood: a regression discontinuity study.

BACKGROUND: Antenatal corticosteroids reduce respiratory morbidity in preterm infants, but their use during late preterm gestation (34-36 weeks) is limited because their safety for longer-term child neurodevelopment is unclear. We sought to determine if fetuses with higher probability of exposure to antenatal corticosteroids had increased rates of prescriptions for attention-deficit/hyperactivity disorder (ADHD) medication in childhood, using a quasiexperimental design that better controls for confounding than existing observational studies. METHODS: We identified 16 358 children whose birthing parents were admitted for delivery between 31 + 0 (31 weeks, 0 days) and 36 + 6 weeks' gestation in 2000-2013, using a perinatal data registry from British Columbia, Canada, and linked their records with population-based child ADHD medication data (2000-2018). We used a regression discontinuity design to capitalize on the fact that pregnancies presenting for delivery immediately before and immediately after the clinical cut-off for antenatal corticosteroid administration of 34 + 0 weeks' gestation have very different levels of exposure to corticosteroids, but are otherwise similar with respect to confounders. RESULTS: Over a median follow-up period of 9 years, 892 (5.5%) children had 1 or more dispensations of ADHD medication. Children whose birthing parents were admitted for delivery just before the corticosteroid clinical cut-off of 34 + 0 weeks' gestation did not appear to be more likely to be prescribed ADHD medication than those admitted just after the cut-off (rate ratio 1.1, 95% confidence interval [CI] 0.8 to 1.6; 1.3 excess cases per 100 children, 95% CI -2.5 to 5.7). INTERPRETATION: We found little evidence that children with higher probability of exposure to antenatal corticosteroids have higher rates of ADHD prescriptions in childhood, supporting the safety of antenatal corticosteroids for this neurodevelopmental outcome.

Addressing Competing Risks When Assessing the Impact of Health Services Interventions on Hospital Length of Stay.

BACKGROUND: Although hospital length of stay is generally modeled continuously, it is increasingly recommended that length of stay should be considered a time-to-event outcome (i.e., time to discharge). Additionally, in-hospital mortality is a competing risk that makes it impossible for a patient to be discharged alive. We estimated the effect of trauma center accreditation on risk of being discharged alive while considering in-hospital mortality as a competing risk. We also compared these results with those from the "naive" approach, with length of stay modeled continuously. METHODS: Data include admissions to a level I trauma center in Quebec, Canada, between 2008 and 2017. We computed standardized risk of being discharged alive at specific days by combining inverse probability weighting and the Aalen-Johansen estimator of the cumulative incidence function. We estimated effect of accreditation using pre-post, interrupted time series (ITS) analyses, and the "naive" approach. RESULTS: Among 5,300 admissions, 12% died, and 83% were discharged alive within 60 days. Following accreditation, we observed increases in risk of discharge between the 7th day (4.5% [95% CI = 2.3, 6.6]) and 30th day since admission 3.8% (95% CI = 1.5, 6.2). We also observed a stable decrease in hospital mortality, -1.9% (95% CI = -3.6, -0.11) at the 14th day. Although pre-post and ITS produced similar results, we observed contradictory associations with the naive approach. CONCLUSIONS: Treating length of stay as time to discharge allows for estimation of risk of being discharged alive at specific days after admission while accounting for competing risk of death.

Development and Validation of an Instrument to Measure Health-Related Out-of-Pocket Costs: The Cost for Patients Questionnaire.

OBJECTIVE: The growth of healthcare spending is a major concern for insurers and governments but also for patients whose health problems may result in costs going beyond direct medical costs. To develop a comprehensive tool to measure direct and indirect costs of a health condition for patients and their families to various outpatient contexts. METHODS: We conducted a content and face validation including results of a systematic review to identify the items related to direct and indirect costs for patients or their families and an online Delphi to determine the cost items to retain. We conducted a pilot test-retest with 18 naive participants and analyzed data calculating intraclass correlation and kappa coefficients. RESULTS: An initial list of 34 items was established from the systematic review. Each round of the Delphi panel incorporated feedback from the previous round until a strong consensus was achieved. After 4 rounds of the Delphi to reach consensus on items to be included and wording, the questionnaire had a total of 32 cost items. For the test-retest, kappa coefficients ranged from -0.11 to 1.00 (median = 0.86), and intraclass correlation ranged from -0.02 to 0.99 (median = 0.62). CONCLUSIONS: A rigorous process of content and face development was implemented for the Cost for Patients Questionnaire, and this study allowed to set a list of cost elements to be considered from the patient's perspective. Additional research including a test-retest with a larger sample will be part of a subsequent validation strategy.

Prevalence and clinical, social, and health care predictors of miscarriage.

BACKGROUND: Pregnancy loss is common and several factors (e.g. chromosomal anomalies, parental age) are known to increase the risk of occurrence. However, much existing research focuses on recurrent loss; comparatively little is known about the predictors of a first miscarriage. Our objective was to estimate the population-level prevalence of miscarriages and to assess the contributions of clinical, social, and health care use factors as predictors of the first detected occurrence of these losses. METHODS: In this population-based cohort study, we used linked administrative health data to estimate annual rates of miscarriage in the Manitoba population from 2003 to 2014, as a share of identified pregnancies. We compared the unadjusted associations between clinical, social, and health care use factors and first detected miscarriage compared with a live birth. We estimated multivariable generalized linear models to assess whether risk factors were associated with first detected miscarriage controlling for other predictors. RESULTS: We estimated an average annual miscarriage rate of 11.3%. In our final sample (n = 79,978 women), the fully-adjusted model indicated that use of infertility drugs was associated with a 4 percentage point higher risk of miscarriage (95% CI 0.02, 0.06) and a past suicide attempt with a 3 percentage point higher risk (95% CI -0.002, 0.07). Women with high morbidity were twice as likely to experience a miscarriage compared to women with low morbidity (RD = 0.12, 95% CI 0.09, 0.15). Women on income assistance had a 3 percentage point lower risk (95% CI -0.04, -0.02). CONCLUSIONS: We estimate that 1 in 9 pregnant women in Manitoba experience and seek care for a miscarriage. After adjusting for clinical factors, past health care use and morbidity contribute important additional information about the risk of first detected miscarriage. Social factors may also be informative.

Eliminating Structural Barriers: The Impact of Unrestricted Access on Hepatitis C Treatment Uptake Among People Living With Human Immunodeficiency Virus.

BACKGROUND: High costs of direct-acting antivirals (DAAs) have led health-care insurers to limit access worldwide. Using a natural experiment, we evaluated the impact of removing fibrosis stage restrictions on hepatitis C (HCV) treatment initiation rates among people living with human immunodeficiency virus (HIV), and then examined who was left to be treated. METHODS: Using data from the Canadian HIV-HCV Coinfection Cohort, we applied a difference-in-differences approach. Changes in treatment initiation rates following the removal of fibrosis stage restrictions were assessed using a negative binomial regression with generalized estimating equations. The policy change was then specifically assessed among people who inject drugs (PWID). We then identified the characteristics of participants who remained to be treated using a modified Poisson regression. RESULTS: Between 2010-2018, there were a total of 585 HCV initiations among 1130 eligible participants. After removing fibrosis stage restrictions, DAA initiations increased by 1.8-fold (95% confidence interval [CI] 1.3-2.4) controlling for time-invariant differences and secular trends. Among PWID the impact appeared even stronger, with an adjusted incidence rate ratio of 3.6 (95% CI 1.8-7.4). However, this increased treatment uptake was not sustained. At 1 year following universal access, treatment rates declined to 0.8 (95% CI .5-1.1). Marginalized participants (PWID and those of indigenous ethnicity) and those disengaged from care were more likely to remain HCV RNA positive. CONCLUSIONS: After the removal of fibrosis restrictions, HCV treatment initiations nearly doubled immediately, but this treatment rate was not sustained. To meet the World Health Organization elimination targets, the minimization of structural barriers and adoption of tailored interventions are needed to engage and treat all vulnerable populations.

Antenatal corticosteroid administration and early school age child development: A regression discontinuity study in British Columbia, Canada.

BACKGROUND: There are growing concerns that antenatal corticosteroid administration may harm children's neurodevelopment. We investigated the safety of antenatal corticosteroid administration practices for children's overall developmental health (skills and behaviors) at early school age. METHODS AND FINDINGS: We linked population health and education databases from British Columbia (BC), Canada to identify a cohort of births admitted to hospital between 31 weeks, 0 days gestation (31+0 weeks), and 36+6 weeks, 2000 to 2013, with routine early school age child development testing. We used a regression discontinuity design to compare outcomes of infants admitted just before and just after the clinical threshold for corticosteroid administration of 34+0 weeks. We estimated the median difference in the overall Early Development Instrument (EDI) score and EDI subdomain scores, as well as risk differences (RDs) for special needs designation and developmental vulnerability (<10th percentile on 2 or more subdomains). The cohort included 5,562 births admitted between 31+0 and 36+6 weeks, with a median EDI score of 40/50. We found no evidence that antenatal corticosteroid administration practices were linked with altered child development at early school age: median EDI score difference of -0.5 [95% CI: -2.2 to 1.7] (p = 0.65), RD per 100 births for special needs designation -0.5 [-4.2 to 3.1] (p = 0.96) and for developmental vulnerability of 3.9 [95% CI:-2.2 to 10.0] (p = 0.24). A limitation of our study is that the regression discontinuity design estimates the effect of antenatal corticosteroid administration at the gestational age of the discontinuity, 34 + 0 weeks, so our results may become less generalisable as gestational age moves further away from this point. CONCLUSIONS: Our study did not find that that antenatal corticosteroid administration practices were associated with child development at early school age. Our findings may be useful for supporting clinical counseling about antenatal corticosteroids administration at late preterm gestation, when the balance of harms and benefits is less clear.

Trauma system accreditation and patient outcomes in British Columbia: an interrupted time series analysis.

OBJECTIVE: We aim to assess the impact of several accreditation cycles of trauma centers on patient outcomes, specifically in-hospital mortality, complications and hospital length of stay. DESIGN: Interrupted time series. SETTING: British Columbia, Canada. PARTICIPANTS: Trauma patients admitted to all level I and level II trauma centers between January 2008 and March 2018. EXPOSURE: Accreditation. MAIN OUTCOMES AND MEASURES: We first computed quarterly estimates of the proportions of in-hospital mortality, complications and survival to discharge standardized for change in patient case-mix using prognostic scores and the Aalen-Johansen estimator of the cumulative incidence function. Piecewise regressions were then used to estimate the change in levels and trends for patient outcomes following accreditation. RESULTS: For in-hospital mortality and major complications, the impact of accreditation seems to be associated with short- and long-term reductions after the first cycle and only short-term reductions for subsequent cycles. However, the 95% confidence intervals for these estimates were wide, and we lacked the precision to consistently conclude that accreditation is beneficial. CONCLUSIONS: Applying a quasi-experimental design to time series accounting for changes in patient case-mix, our results suggest that accreditation might reduce in-hospital mortality and major complications. However, there was uncertainty around the estimates of accreditation. Further studies looking at clinical processes of care and other outcomes such as patient or health staff satisfaction are needed.

Real-world impact of direct acting antiviral therapy on health-related quality of life in HIV/Hepatitis C co-infected individuals.

Clinical trial results of direct acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) have shown improvements in health-related quality of life (HR-QoL). However, the extent to which these results are broadly generalizable to real-world settings is unknown. We investigated the real-world impact of oral DAA therapy on HR-QoL among individuals coinfected with HIV/HCV. We used data from the Canadian HIV/HCV Co-Infection Cohort Study that prospectively follows 1795 participants from 18 centres. Since 2007, clinical, lifestyle, and HR-QoL data have been collected biannually through self-administered questionnaires and chart review. HR-QoL was measured using the EQ-5D instrument. Participants initiating oral DAAs, having at least one visit before treatment initiation and at least one visit after DAA treatment response was ascertained, were included. Successful treatment response was defined as a sustained viral response (SVR). Segmented multivariate linear mixed models were used to evaluate the impact of SVR on HR-QoL, controlling for pretreatment trends. 227 participants met our eligibility criteria, 93% of whom achieved SVR. Before treatment, the EQ-5D utility index decreased 0.6 percentage-point/y (95% CI, -0.9, -0.3) and health state was constant over time. The immediate effect of SVR resulted in an increase of 2.3-units (-0.1, 4.7) in patients' health state and 2.0 percentage-point increase (-0.2, 4.0) in utility index. Health state continued to increase post-SVR by 1.4 units/y (-0.9, 3.7), while utility trends post-SVR plateaued over the observation period. Overall using real-world data, we found modest improvements in HR-QoL following SVR, compared to previously published clinical trials.

The Impact of Parental and Medical Leave Policies on Socioeconomic and Health Outcomes in OECD Countries: A Systematic Review of the Empirical Literature.

Policy Points: Historically, reforms that have increased the duration of job-protected paid parental leave have improved women's economic outcomes. By targeting the period around childbirth, access to paid parental leave also appears to reduce rates of infant mortality, with breastfeeding representing one potential mechanism. The provision of more generous paid leave entitlements in countries that offer unpaid or short durations of paid leave could help families strike a balance between the competing demands of earning income and attending to personal and family well-being. CONTEXT: Policies legislating paid leave from work for new parents, and to attend to individual and family illness, are common across Organisation for Economic Co-operation and Development (OECD) countries. However, there exists no comprehensive review of their potential impacts on economic, social, and health outcomes. METHODS: We conducted a systematic review of the peer-reviewed literature on paid leave and socioeconomic and health outcomes. We reviewed 5,538 abstracts and selected 85 published papers on the impact of parental leave policies, 22 papers on the impact of medical leave policies, and 2 papers that evaluated both types of policies. We synthesized the main findings through a narrative description; a meta-analysis was precluded by heterogeneity in policy attributes, policy changes, outcomes, and study designs. FINDINGS: We were able to draw several conclusions about the impact of parental leave policies. First, extensions in the duration of paid parental leave to between 6 and 12 months were accompanied by attendant increases in leave-taking and longer durations of leave. Second, there was little evidence that extending the duration of paid leave had negative employment or economic consequences. Third, unpaid leave does not appear to confer the same benefits as paid leave. Fourth, from a population health perspective, increases in paid parental leave were consistently associated with better infant and child health, particularly in terms of lower mortality rates. Fifth, paid paternal leave policies of adequate length and generosity have induced fathers to take additional time off from work following the birth of a child. How medical leave policies for personal or family illness influence health has not been widely studied. CONCLUSIONS: There is substantial quasi-experimental evidence to support expansions in the duration of job-protected paid parental leave as an instrument for supporting women's labor force participation, safeguarding women's incomes and earnings, and improving child survival. This has implications, in particular, for countries that offer shorter durations of job-protected paid leave or lack a national paid leave entitlement altogether.

Measuring colorectal cancer incidence: the performance of an algorithm using administrative health data.

BACKGROUND: Certain cancer case ascertainment methods used in Quebec and elsewhere are known to underestimate the burden of cancer, particularly for some subgroups. Algorithms using claims data are a low-cost option to improve the quality of cancer surveillance, but have not frequently been implemented at the population-level. Our objectives were to 1) develop a colorectal cancer (CRC) case ascertainment algorithm using population-level hospitalization and physician billing data, 2) validate the algorithm, and 3) describe the characteristics of cases. METHODS: We linked physician billing, hospitalization, and tumor registry data for 2,013,430 Montreal residents age 20+ (2000-2010). We compared the performance of three algorithms based on diagnosis and treatment codes from different data sources. We described identified cases according to age, sex, socioeconomic status, treatment patterns, site distribution, and time trends. All statistical tests were two-sided. RESULTS: Our algorithm based on diagnosis and treatment codes identified 11,476 of the 12,933 incident CRC cases contained in the tumor registry as well as 2317 newly-captured cases. Our cases share similar overall time trends and site distributions to existing data, which increases our confidence in the algorithm. Our algorithm captured proportionally 35% more individuals age 50 and younger among CRC cases: 8.2% vs. 5.3%. The newly captured cases were also more likely to be living in socioeconomically advantaged areas. CONCLUSIONS: Our algorithm provides a more complete picture of population-wide CRC incidence than existing case ascertainment methods. It could be used to estimate long-term incidence trends, aid in timely surveillance, and to inform interventions, in both Quebec and other jurisdictions.

Team-based versus traditional primary care models and short-term outcomes after hospital discharge.

BACKGROUND: Strategies to reduce hospital readmission have been studied mainly at the local level. We assessed associations between population-wide policies supporting team-based primary care delivery models and short-term outcomes after hospital discharge. METHODS: We extracted claims data on hospital admissions for any cause from 2002 to 2009 in the province of Quebec. We included older or chronically ill patients enrolled in team-based or traditional primary care practices. Outcomes were rates of readmission, emergency department visits and mortality in the 90 days following hospital discharge. We used inverse probability weighting to balance exposure groups on covariates and used marginal structural survival models to estimate rate differences and hazard ratios. RESULTS: We included 620 656 index admissions involving 312 377 patients. Readmission rates at any point in the 90-day post-discharge period were similar between primary care models. Patients enrolled in team-based primary care practices had lower 30-day rates of emergency department visits not associated with readmission (adjusted difference 7.5 per 1000 discharges, 95% confidence interval [CI] 4.2 to 10.8) and lower 30-day mortality (adjusted difference 3.8 deaths per 1000 discharges, 95% CI 1.7 to 5.9). The 30-day difference for mortality differed according to morbidity level (moderate morbidity: 1.0 fewer deaths per 1000 discharges in team-based practices, 95% CI 0.3 more to 2.3 fewer deaths; very high morbidity: 4.2 fewer deaths per 1000 discharges, 95% CI 3.0 to 5.3; p < 0.001). INTERPRETATION: Our study showed that enrolment in the newer team-based primary care practices was associated with lower rates of postdischarge emergency department visits and death. We did not observe differences in readmission rates, which suggests that more targeted or intensive efforts may be needed to affect this outcome.

Safety of labour and delivery following closures of obstetric services in small community hospitals.

BACKGROUND: In recent decades, many smaller hospitals in British Columbia, Canada, have stopped providing planned obstetric services. We examined the effect of these service closures on the labour and delivery outcomes of pregnant women living in affected communities. METHODS: We used maternal postal codes to identify delivery records (1998-2014) of women residing in a community affected by service closure. The records were obtained from the British Columbia Perinatal Data Registry. We examined the effect of the closures using a within-communities fixed-effects framework and included similar-sized communities without service closures to control for underlying time trends. The primary outcome was a previously published composite measure of labour and delivery safety, the Adverse Outcome Index, which includes adverse events such as birth injury and unanticipated operative procedures, and includes weights for severity of adverse events. Secondary outcomes included maternal or newborn transfer, and use of obstetric interventions. RESULTS: We found little evidence that closure of planned obstetric services affected the risk of composite adverse maternal-newborn outcome (-0.4 excess adverse events per 100 deliveries, 95% confidence interval [CI] -2.0 to 1.1), or most other secondary outcomes. The severity of composite outcome events decreased following the closures (rate ratio 0.58, 95% CI 0.36 to 0.89). Closures were associated with increases in use of epidural analgesia (3.4 excess events per 100 deliveries, 95% CI 0.4 to 6.3) and length of antepartum stay (0.6 h, 95% CI 0.1 to 1.0 h). INTERPRETATION: Closure of planned obstetric services in low-volume hospitals was not associated with an increase or decrease in frequency of adverse events during labour and delivery.

Inter-institutional Variation in Use of Caesarean Delivery for Labour Dystocia.

OBJECTIVE: To establish the degree of variation across hospitals in the use of Caesarean delivery for the indication of labour dystocia before and after accounting for maternal, fetal, and hospital characteristics. METHODS: This study was a retrospective, population-based cohort study of nulliparous women delivering term singletons in cephalic position following labour. Delivery visits were extracted from three provincial perinatal registries in the Canadian provinces of Ontario, Alberta, and British Columbia, from 2008-2012. Crude hospital-specific rates of Caesarean delivery for labour dystocia were reported, and these rates were then stabilized to account for hospitals with low delivery volumes. Rates were then adjusted for maternal, fetal, and hospital characteristics using hierarchical logistic regression. RESULTS: Among 403 205 women delivering at 170 hospitals, the overall Caesarean delivery rate was 21.0%, and the rate of Caesarean delivery for labour dystocia was 12.7%, indicating that 60% of all Caesarean deliveries were performed in part for this indication. The middle 95% of hospitals had Caesarean delivery rates for labour dystocia ranging from 4.5% to 24.7%. Differences in maternal case mix and hospital characteristics explained only a small proportion of this variation (95% central range 6.3%-21.7%). CONCLUSION: Considerable inter-hospital variation in rates of Caesarean delivery for labour dystocia remained after accounting for differences in maternal and hospital factors. Reporting systems that monitor variation in inter-institutional rates should incorporate stabilization and adjustment for case-mix differences and consider indication-specific rates of Caesarean delivery to more fairly compare hospital performance and better target interventions to reduce Caesarean delivery for specific indications.

Self-care tools to treat depressive symptoms in patients with age-related eye disease: a randomized controlled clinical trial.

BACKGROUND: Depression is very common in people with age-related eye disease. Our goal was to determine if self-care tools plus limited telephone support could reduce depressive symptoms in patients with age-related macular degeneration or diabetic retinopathy. DESIGN: A single-blind randomized controlled clinical trial was conducted at Maisonneuve-Rosemont Hospital in Montreal, Canada. PARTICIPANTS: Eighty participants were recruited. METHODS: To be eligible, participants must have had either late stage age-related macular degeneration or diabetic retinopathy, at least mild depressive symptoms, and visual acuity better than 20/200. Half were randomized to the intervention arm and half to delayed intervention/usual care. The intervention consisted of large print written and audio tools incorporating cognitive-behavioral principles plus three 10-minute telephone calls from a lay coach. Eight-week follow-up data were collected by telephone. MAIN OUTCOME MEASURES: The primary outcome was the 8-week change in depressive symptoms as measured by the Patient Health Questionnaire-9. Secondary outcomes included anxiety, life space and self-efficacy. RESULTS: The baseline mean logMAR visual acuity was 0.37 (SD = 0.20), and the baseline mean Patient Health Questionnaire-9 score was 9.5 (SD = 3.9) indicating moderate depressive symptoms. After adjusting for baseline imbalances in visual acuity, the intervention reduced depressive symptoms by 2.1 points more than usual care (P = 0.040). The intervention was not associated with the secondary outcomes (P > 0.05). CONCLUSIONS: Self-care tools plus telephone coaching led to a modest improvement in depressive symptoms in patients with age-related eye disease. Additional research on how to maximize their effect is necessary.

[The Management of Depression in Older Adults and Their Family Caregivers: Findings from a Research Program in Quebec]. / La gestion de la dépression chez les aînés et leurs aidants naturels : résultats d'un programme de recherche au Québec.

Objectives A research group based at St. Mary's Research Centre, St. Mary's Hospital, Montreal, has conducted a research program over the past two decades that aims to inform improvements in the management of depression in primary care and general medical settings, among older adults. This paper reviews the findings from this research program, discusses the findings in the context of other research, and highlights the implications for practice and health policy.Methods Narrative review and synthesis of 25 published articles, that included: 4 systematic reviews, 10 observational studies, 9 intervention trials, and 2 consensus conference reports.Results The results pertain to 4 research areas: detection of depression in primary care and general medical settings; collaborative care of depression; depression self-care interventions; and the role of family and friends in supporting depression self-care interventions.Conclusions We propose six recommendations for improving the management of depression in the target population. 1) Depression detection and treatment can be improved through collaborative care models that involve primary care physicians, mental health specialists and non-physician mental health workers who are trained to assist with the detection of depression, with the delivery of brief, low-intensity psychological interventions and with self-care support. More research and evaluation are necessary to determine the factors that enhance the effectiveness, cost-efficiency, and consumer-centeredness of these interventions. 2) Supported depression self-care (and other low-intensity interventions such as short problem-solving therapy) offered by telephone or via internet, either as part of collaborative or usual care are feasible treatment options but more research is necessary to determine their effectiveness in different clinical populations. Some populations (e.g., those aged 75 and over, with visual and/or mild cognitive impairment) are likely to need greater or face-to-face support. 3) As most family physicians are unlikely to have the necessary time or interest to support depression self-care interventions, other sustainable programmatic contexts are needed for delivery of these interventions. Options include: nurses or other mental health workers in multidisciplinary family medicine groups; regional mental health programs; and voluntary organizations dedicated to assisting in the management of chronic illnesses. Research is needed on the feasibility and effectiveness of using peer support workers or volunteers to provide coaching of depression self-care interventions. 4) Involvement of family or friends in depression self-care may improve outcomes (e.g., dyadic interventions) but further research is necessary. 5) Further research should explore the potential of depression self-care interventions to prevent major depression and in depression relapse prevention in this population.

How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World?

BACKGROUND: Direct-acting antivirals (DAAs) against hepatitis C virus (HCV) have been described as revolutionary. However, it remains uncertain how effective these drugs will be for individuals coinfected with human immunodeficiency virus (HIV)-HCV. Bridging this gap between efficacy and effectiveness requires a focus on the generalizability of clinical trials. METHODS: Generalizability of DAA trials was assessed by applying the eligibility criteria from 5 efficacy trials: NCT01479868, PHOTON-1 (NCT01667731), TURQUOISE-I (NCT01939197), ION-4 (NCT02073656), and ALLY-2 (NCT02032888) that evaluated simeprevir; sofosbuvir; ombitasvir, paritaprevir/ritonavir/dasabuvir; sofosbuvir/ledipasvir; and daclatasvir/sofosbuvir, respectively, to the Canadian Coinfection Cohort, representing approximately 23% of the total coinfected population in care in Canada. RESULTS: Of 874 active participants, 70% had chronic HCV, of whom 410, 26, 94, and 11 had genotypes 1, 2, 3, and 4, respectively. After applying trial eligibility criteria, only 5.9% (24/410) would have been eligible for enrollment in the simeprevir trial, 9.8% (52/530) in PHOTON-1, 6.3% (26/410) in TURQUOISE-I, and 8.1% (34/421) in ION-4. The ALLY-2 study was more inclusive; 43% (233/541) of the cohort would have been eligible. The most exclusive eligibility criteria across all trials with the exception of ALLY-2 were restriction to specific antiretroviral therapies (63%-79%) and active illicit drug use (53%-55%). CONCLUSIONS: DAA trial results may have limited generalizability, since the majority of coinfected individuals were not eligible to participate. Exclusions appeared to be related to improving treatment outcomes by not including those at higher risk of poor adherence and reinfection--individuals for whom real-world data are urgently needed.

Increased Duration of Paid Maternity Leave Lowers Infant Mortality in Low- and Middle-Income Countries: A Quasi-Experimental Study.

BACKGROUND: Maternity leave reduces neonatal and infant mortality rates in high-income countries. However, the impact of maternity leave on infant health has not been rigorously evaluated in low- and middle-income countries (LMICs). In this study, we utilized a difference-in-differences approach to evaluate whether paid maternity leave policies affect infant mortality in LMICs. METHODS AND FINDINGS: We used birth history data collected via the Demographic and Health Surveys to assemble a panel of approximately 300,000 live births in 20 countries from 2000 to 2008; these observational data were merged with longitudinal information on the duration of paid maternity leave provided by each country. We estimated the effect of an increase in maternity leave in the prior year on the probability of infant (<1 y), neonatal (<28 d), and post-neonatal (between 28 d and 1 y after birth) mortality. Fixed effects for country and year were included to control for, respectively, unobserved time-invariant confounders that varied across countries and temporal trends in mortality that were shared across countries. Average rates of infant, neonatal, and post-neonatal mortality over the study period were 55.2, 30.7, and 23.0 per 1,000 live births, respectively. Each additional month of paid maternity was associated with 7.9 fewer infant deaths per 1,000 live births (95% CI 3.7, 12.0), reflecting a 13% relative reduction. Reductions in infant mortality associated with increases in the duration of paid maternity leave were concentrated in the post-neonatal period. Estimates were robust to adjustment for individual, household, and country-level characteristics, although there may be residual confounding by unmeasured time-varying confounders, such as coincident policy changes. CONCLUSIONS: More generous paid maternity leave policies represent a potential instrument for facilitating early-life interventions and reducing infant mortality in LMICs and warrant further discussion in the post-2015 sustainable development agenda. From a policy planning perspective, further work is needed to elucidate the mechanisms that explain the benefits of paid maternity leave for infant mortality.