Re-Exposure to Culprit Medication Following Adverse Drug Event Diagnosis in Canadian Emergency Department Patients: A Cohort Study.

PURPOSE: The magnitude of repeat exposures to culprit medications after hospital discharge is not well studied. We combined prospective cohort data with administrative health data to understand the frequency of repeat exposures to culprit medications after discharge and the risk factors for their occurrence. METHODS: This was a retrospective analysis of three prospective cohorts of patients who presented to the hospital with an adverse drug event in British Columbia, from 2008 to 2015 (n = 849). We linked prospectively identified adverse drug events to administrative data to examine patterns of redispensing of culprit medications. We used Cox regression to assess risk factors for re-exposure, and conducted subgroup analyses for essential vs. nonessential medications. RESULTS: Among 849 diagnosed adverse drug events, 45.2% had subsequent culprit medication redispensing within a year of hospital discharge. The factors associated with re-exposures included atrial fibrillation, adverse drug event type (e.g. adverse reaction), culprit medication type, and longer historical duration of medication use. CONCLUSIONS: Re-exposures to culprit medications occurred in almost half of the adverse drug events diagnosed in emergency departments. Many of these were appropriate re-exposures to essential medications for indications in which the risk of uncontrolled disease likely outweighed the risk of a repeat adverse event. More research is needed to understand re-exposures to nonessential medications or medications with safer alternatives.

The Impact of Eliminating Out-of-Pocket Payments on Asthma Medication Use.

BACKGROUND: High costs of controller therapies may be a barrier to guideline-recommended asthma treatment. We determined whether eliminating out-of-pocket (OOP) payments among low-income patients with asthma impacted controller medication use. METHODS: We applied a controlled interrupted time series design to administrative claims data in British Columbia, Canada from 2017-2020. Cases were individuals with an annual household income <$13,750 in whom copays were eliminated on January 2019; there was no change in public coverage for the control group with annual income >$45,000. We evaluated trends in asthma medication costs, use, the ratio of inhaled corticosteroid (ICS)-containing medications to all asthma medications, excessive use of short-acting ß-agonists (SABA) (>1 canister/month), and the proportion of days (PDC) covered by controller therapies. RESULTS: There were 12,940 cases (62% female, mean age 30.3 years, SD 14.9), and 71,331 controls (55% female, mean age of 31.3 years, SD 16.3). Removal of OOP payments increased monthly mean medication costs by $3.32 (95% CI $0.08 - $6.56, 2020 Canadian dollars), days supply of controller medications by 1.50 days (95% CI 0.61 - 2.40), and the ratio of ICS-containing medications to total medications by 4.20% (95% CI 0.73% - 7.66%) compared to the control group. The policy had no effect on PDC by controller therapies (0.01, 95% CI -0.01 - 0.04), but non-significantly decreased the percentage of patients with excessive SABA use (-6.37%; 95% CI -12.90% - 0.16%). INTERPRETATION: Removal of OOP payments increased the dispensation of controller therapies, suggesting cost-related non-adherence could impair optimal asthma management.

Understanding the factors related to how East and Southeast Asian immigrant youth and families access mental health and substance use services: A scoping review.

The objective of the review is to identify factors related to how East and Southeast Asian immigrant youth aged 12-24 and their families access mental health and substance use (MHSU) services. To address how East and Southeast Asian youth and their families access mental health and substance use services, a scoping review was conducted to identify studies in these databases: PubMed, MEDLINE (Ovid), EMBASE (Ovid), PsychINFO, CINAHL, and Sociology Collection. Qualitative content analysis was used to deductively identify themes and was guided by Bronfenbrenner's Ecological Systems Theory, the process-person-context-time (PPCT) model, and the five dimensions of care accessibility (approachability, acceptability, availability and accommodation, appropriateness, affordability). Seventy-three studies met the inclusion criteria. The dimensions of healthcare accessibility shaped the following themes: 1) Acceptability; 2) Appropriateness; 3) Approachability; 4) Availability and Accommodation. Bronfenbrenner's Ecological Systems Theory and the PPCT model informed the development of the following themes: 1) Immediate Environment/Proximal Processes (Familial Factors, Relationships with Peers; 2) Context (School-Based Services/Community Resources, Discrimination, Prevention, Virtual Care); 3) Person (Engagement in Services/Treatment/Research, Self-management); 4) Time (Immigration Status). The study suggests that there is a growing body of research (21 studies) focused on identifying acceptability factors, including Asian cultural values and the model minority stereotype impacting how East and Southeast Asian immigrant youth access MHSU services. This review also highlighted familial factors (16 studies), including family conflict, lack of MHSU literacy, reliance on family as support, and family-based interventions, as factors affecting how East and Southeast Asian immigrant youth access MHSU care. However, the study also highlighted a dearth of research examining how East and Southeast Asian youth with diverse identities access MHSU services. This review emphasizes the factors related to the access to MHSU services by East and Southeast Asian immigrant youth and families while providing insights that will improve cultural safety.

Validating use of diagnostic codes in Canadian administrative data for identification of adverse drug events.

AIMS: While diagnostic codes from administrative health data might be a valuable source to identify adverse drug events (ADEs), their ability to identify unintended harms remains unclear. We validated claims-based diagnosis codes for ADEs based on events identified in a prospective cohort study and assessed whether key attributes predicted their documentation in administrative data. METHODS: This was a retrospective analysis of 3 prospective cohorts in British Columbia, from 2008 to 2015 (n = 13 969). We linked prospectively identified ADEs to administrative insurance data to examine the sensitivity and specificity of different diagnostic code schemes. We used logistic regression to assess which key attributes (e.g., type of event, symptoms and culprit medications) were associated with better documentation of ADEs in administrative data. RESULTS: Among 1178 diagnosed events, the sensitivity of the diagnostic codes in administrative data ranged from 3.4 to 52.6%, depending on the database and codes used. We found that documentation was worse for certain types of ADEs (dose-related: odds ratio [OR]: 0.32, 95% confidence interval [CI]: 0.15, 0.69; nonadherence events (OR: 0.35, 95% CI: 0.20, 0.62), and better for those experiencing arrhythmias (OR: 4.19, 95% CI: 0.96, 18.28). CONCLUSION: ADEs were not well documented in administrative data. Alternative methods should be explored to capture ADEs for health research.

The Impact of reference pricing on prescribing patterns, costs, and health services utilization of proton pump inhibitors: A quasi-experimental study in British Columbia, Canada.

INTRODUCTION: The Reference Drug Program (RDP) was established to steer patients toward equally safe and cost-effective medication under British Columbia's public drug coverage. Each RDP class covers at least one reference drug, and non-reference drugs are reimbursed up to the cost of the reference drug. In 2016, the RDP updated to include proton pump inhibitors (PPIs). This study evaluated the impact on drug expenditures, prescription patterns, and health services utilization. METHODS: We identified a cohort of individuals covered by Fair Pharmacare who used PPIs, and a control group of H2 Blockers users. We used interrupted time series analysis on administrative data from June 2014 to December 2019 on the following outcomes: new users, day supply, expenditures, drug costs, reference drug use, and physician visits and costs. RESULTS: The RDP had little impact on overall PPI use patterns. We did not observe any changes in reference drug uptake, new users, physician visits, cost-savings, or significant changes to days supplied post-policy. Cost expenditure results were likely biased due to co-occurring changes to drug prices. CONCLUSION: Inclusion of PPIs to the RDP saw no cost-savings for the provincial drug program and had little impact on prescribing patterns. Overall, our findings are consistent with existing evidence that the RDP is safe for similar therapeutic alternatives, but the impact on PPI costs remains unclear.

Effect of a Billing Code to Reimburse Nurse-Supported Rheumatology Care on Health Care Costs and Access: An Interrupted Time Series Analysis.

OBJECTIVE: This study was undertaken to evaluate the impact of a Multidisciplinary Care Assessment (MCA) billing code on health system costs and access to care in British Columbia (BC). METHODS: Data on all people treated by rheumatologists in BC were obtained from five linked health administrative databases held by Population Data BC from April 1, 2006, to March 31, 2020. Rheumatologists were allocated to either the intervention (ever-billers) or control groups (never-billers). For the intervention group, the index date was the month of the first MCA code billing. For the control group the index dates were imputed from intervention index dates. Our analysis focused on a 48-month period (24 months before and after the index date). We evaluated the impact on two cost (costs related to rheumatoid arthritis [RA]; total health care costs) and access outcomes (rheumatology-related visits per rheumatologist; days between rheumatology visits for patients with RA) using an interrupted time series analysis. RESULTS: A total of 46 rheumatologists (31 intervention and 15 control) met our inclusion criteria. Introduction of the MCA was associated with a small but significant increase in RA-related costs that, at 2 years, translates to a net absolute change of $9.66 per patient per month, but no statistically significant changes in total health care costs. There was no statistically significant change in the number of rheumatology-related visits, but at 2 years there was a net absolute reduction in the median days between rheumatologist visits for patients with RA (6.3 days). CONCLUSION: The introduction of the MCA code was associated with a negligible increase in the RA-related costs and an improvement in access to ongoing care for patients.

Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data.

AIMS: Medication non-adherence is a type of adverse drug event that can lead to untreated and exacerbated chronic illness, and that drives healthcare utilization. Research using medication claims data has attempted to identify instances of medication non-adherence using the proportion of days covered or by examining gaps between medication refills. We sought to validate these measures compared to a gold standard diagnosis of non-adherence made in hospital. METHODS: This was a retrospective analysis of adverse drug events diagnosed during three prospective cohorts in British Columbia between 2008 and 2015 (n = 976). We linked prospectively identified adverse drug events to medication claims data to examine the sensitivity and specificity of typical non-adherence measures. RESULTS: The sensitivity of the non-adherence measures ranged from 22.4% to 37.5%, with a proportion of days covered threshold of 95% performing the best; the non-persistence measures had sensitivities ranging from 10.4% to 58.3%. While a 7-day gap was most sensitive, it classified 61.2% of the sample as non-adherent, whereas only 19.6% were diagnosed as such in hospital. CONCLUSIONS: The methods used to identify non-adherence in administrative databases are not accurate when compared to a gold standard diagnosis by healthcare providers. Research that has relied on administrative data to identify non-adherent patients both underestimates the magnitude of the problem and may label patients as non-adherent who were in fact adherent.

Impact of income-based public drug coverage deductibles on adherence to asthma medications.

BACKGROUND: Cost-related nonadherence to medications can be a barrier to asthma management. OBJECTIVE: To quantify the impact of public drug plan deductibles on adherence to asthma medications. METHODS: We used a quasi-experimental regression discontinuity analysis to determine whether thresholds in deductibles for public drug coverage, determined on the basis of annual household income, decreased medication use among lower-income children and adults with asthma in British Columbia from 2013 to 2018. Using dispensed medication records, we evaluated deductible thresholds at annual household incomes of $15,000 (a deductible increase from 0% to 2% of annual household income), and $30,000 (a deductible increase from 2% to 3% annual household income). We evaluated medication costs, use, the ratio of inhaled corticosteroids-containing controller medications to total medications, excessive use of short-acting ß-agonists, and the proportion of days covered by controller therapies. All costs are reported in 2020 Canadian dollars. RESULTS: Overall, 88,935 individuals contributed 443,847 person-years of follow-up (57% of female sex, mean age 31 years). Public drug subsidy decreased by -$41.74 (95% CI, -$28.34 to -$55.13) at the $15,000-deductible threshold, a 28% reduction, and patient costs increased by $48.45 (95% CI, $35.37-$61.53). The $30,000 deductible threshold did not affect public drug costs (P = .31), but patient costs increased by $27.65 (95% CI, $15.22-$40.09), which is an 11% increase. Asthma-related medication use, inhaled corticosteroids-to-total medication ratio, excessive use of short-acting ß-agonists, and proportion of days covered by controller therapies were not impacted by deductible thresholds. CONCLUSION: Income-based deductibles reduced public drug costs with no effect on asthma-related medication use, adherence to controller therapies, or excessive reliever therapy use in lower-income individuals with asthma.

The Intersectional Impact of Cost-Related Non-Adherence and Depression: A Cross-Sectional Analysis of the Canadian Community Health Survey by Sex, Race, and Indigeneity.

We evaluated the relationship between cost-related non-adherence (CRNA) and depressive symptoms. Pooling data from the 2015, 2016, 2018, and 2019 annual Canadian Community Health Survey, we analyzed the relationship between CRNA and moderate to severe depressive symptoms, assessed by the Patient Health Questionnaire (PHQ-9). Among the sample, 4.9% experienced CRNA and 6.8% experienced moderate to severe depressive symptoms. Respondents who reported CRNA had 1.51 (95% confidence interval [CI], 1.51-1.52) greater odds of experiencing moderate to severe depressive symptoms. Stratified analysis by sex and race showed the association between CRNA and depressive symptoms was greatest among racialized males (aOR: 1.83, 95% CI: 1.81- 1.85). Stratified analysis by sex and Indigeneity showed this association was greatest for Indigenous males (aOR: 2.16, 95% CI: 2.10-2.22). Forgoing prescribed medications due to cost is associated with more severe depressive symptoms among Canadians, particularly racialized and Indigenous males.

The Impact of Blood Glucose Test Strips Reimbursement Limits on Utilization, Costs, and Health-care Utilization in British Columbia.

OBJECTIVE: People living with diabetes and not using insulin may not derive clinically significant benefit from routine glucose self-monitoring. As a result, in 2015, British Columbia (BC) introduced quantity restrictions for blood glucose test strips (BGTS) coverage in public plans. We studied the impact of this policy on utilization, costs, and health-care utilization. METHODS: We identified a cohort of adults (≥18 years old) with diabetes between 2013 and 2019. Using BC's administrative data, we studied utilization and costs among individuals with at least one PharmaCare-eligible BGTS claim. Using interrupted time-series analysis, we studied cost savings and determined the level of policy adherence. In addition, we investigated longitudinal changes in all-cause and diabetes-specific physician visits, all-cause hospitalizations, and health-care spending in the 3 to 5 years after policy implementation. RESULTS: Over the study period, 279.7 million BGTS were eligible for PharmaCare coverage, on which the government spent $124.3 million. After policy implementation, we observed an immediate decline in average utilization and PharmaCare expenditure on BGTS, leading to an estimated $44.6 million in savings between 2015 and 2019 (95% confidence interval $16.9 to $72.3 million). We found no association between the policy's implementation and health services utilization or overall health-care spending over the long term. CONCLUSIONS: Restricting reimbursement for BGTS in BC resulted in significant cost savings without any attendant increase in health services utilization over the subsequent 5 years. This disinvestment freed up resources that could be channeled toward other interventions.

Prevalence and predictors of primary nonadherence to medications prescribed in primary care.

BACKGROUND: Most research on medication adherence has focused on secondary nonadherence and persistence to therapy. Medication prescriptions that are never filled by patients (primary nonadherence) remain understudied in the general population. METHODS: We linked prescribing data from primary care electronic medical records to comprehensive pharmacy dispensing claims between January 2013 and April 2019 in British Columbia (BC) to estimate primary nonadherence, defined as failure to dispense a new medication or its equivalent within 6 months of the prescription date. We used hierarchical multivariable logistic regression to determine prescriber, patient and medication factors associated with primary nonadherence among community-dwelling patients in primary care. RESULTS: Among 150 565 new prescriptions to 34 243 patients, 17% of prescriptions were never filled. Primary nonadherence was highest for drugs prescribed mostly on an as-needed basis, including topical corticosteroids (35.1%) and antihistamines (23.4%). In multivariable analysis, primary nonadherence was lower for prescriptions issued by male prescribers (odds ratio [OR] 0.66, 95% confidence interval [CI] 0.50-0.88). Primary nonadherence decreased with patient age (OR 0.91, 95% CI 0.90-0.92 for each additional 10 years) but increased with polypharmacy among patients aged 65 years or older. Patients filled more than 82% of their medication prescriptions within 2 weeks after their primary care provider visit. INTERPRETATION: The prevalence of primary nonadherence to new prescriptions was 17%. Interventions to address primary nonadherence could target older patients with multiple medication use and within the first 2 weeks of the prescription issue date.

Effect of Free Medicine Distribution on Health Care Costs in Canada Over 3 Years: A Secondary Analysis of the CLEAN Meds Randomized Clinical Trial.

Importance: Few interventions are proven to reduce total health care costs, and addressing cost-related nonadherence has the potential to do so. Objective: To determine the effect of eliminating out-of-pocket medication fees on total health care costs. Design, Setting, and Participants: This secondary analysis of a multicenter randomized clinical trial using a prespecified outcome took place across 9 primary care sites in Ontario, Canada (6 in Toronto and 3 in rural areas), where health care services are generally publicly funded. Adult patients (≥18 years old) reporting cost-related nonadherence to medicines in the past 12 months were recruited between June 1, 2016, and April 28, 2017, and followed up until April 28, 2020. Data analysis was completed in 2021. Interventions: Access to a comprehensive list of 128 medicines commonly prescribed in ambulatory care with no out-of-pocket costs for 3 years vs usual medicine access. Main Outcome and Measures: Total publicly funded health care costs over 3 years, including costs of hospitalizations. Health care costs were determined using administrative data from Ontario's single-payer health care system, and all costs are reported in Canadian dollars with adjustments for inflation. Results: A total of 747 participants from 9 primary care sites were included in the analysis (mean [SD] age, 51 [14] years; 421 [56.4%] female). Free medicine distribution was associated with a lower median total health care spending over 3 years of $1641 (95% CI, $454-$2792; P = .006). Mean total spending was $4465 (95% CI, -$944 to $9874) lower over the 3-year period. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, eliminating out-of-pocket medication expenses for patients with cost-related nonadherence in primary care was associated with lower health care spending over 3 years. These findings suggest that eliminating out-of-pocket medication costs for patients could reduce overall costs of health care. Trial Registration: ClinicalTrials.gov Identifier: NCT02744963.

Healthcare Utilization After Respiratory Tuberculosis: A Controlled Interrupted Time Series Analysis.

BACKGROUND: Despite data suggesting elevated morbidity and mortality among people who have survived tuberculosis disease, the impact of respiratory tuberculosis on healthcare utilization in the years following diagnosis and treatment remains unclear. METHODS: Using linked health administrative data from British Columbia, Canada, we identified foreign-born individuals treated for respiratory tuberculosis between 1990 and 2019. We matched each person with up to four people without a tuberculosis diagnosis from the same source cohort using propensity score matching. Then, using a controlled interrupted time series analysis, we measured outpatient physician encounters and inpatient hospital admissions in the 5 years following respiratory tuberculosis diagnosis and treatment. RESULTS: We matched 1216 individuals treated for respiratory tuberculosis to 4864 non-tuberculosis controls. Immediately following the tuberculosis diagnostic and treatment period, the monthly rate of outpatient encounters in the tuberculosis group was 34.0% (95% confidence interval [CI]: 30.7%, 37.2%) higher than expected, and this trend was sustained for the duration of the post-tuberculosis period. The excess utilization represented an additional 12.2 (95% CI: 10.6, 14.9) outpatient encounters per person over the post-tuberculosis period, with respiratory morbidity a large contributor to the excess healthcare utilization. Results were similar for hospital admissions, with an additional 0.4 (95% CI: .3, .5) hospital admissions per person over the post-tuberculosis period. CONCLUSIONS: Respiratory tuberculosis appears to have long-term impacts on healthcare utilization beyond treatment. These findings underscore the need for screening, assessment, and treatment of post-tuberculosis sequelae, as it may provide an opportunity to improve health and reduce resource use.

"What's Sex and Gender Got to Do With It?" A Scoping Review of Sex- and Gender-Based Analysis in Pharmacoepidemiologic Studies of Medication Adherence.

OBJECTIVES: Medication taking is a complex multidimensional behavior that may be impeded by a range of biological and psychosocial factors, including sex and gender. We aimed to synthesize how sex and gender have been reported and analyzed in pharmacoepidemiologic studies of medication. METHODS: We searched for English-language peer-reviewed articles of observational studies (eg, cross-sectional, cohort, and case-control) that examined medication adherence among adults and included sex or gender in their reporting. RESULTS: We included 937 studies among 530 537 287 participants published between the year 1979 and 2021. Most studies were cross-sectional (47%), lasted ≤ 1 year (35%), examined self-reported adherence (53%), did not assess specific adherence problem(s) (40%), and included medications for cardiovascular conditions (24%) or systemic infections (24%). A quarter of studies (25%) used sex and gender interchangeably, more than one third of studies (36%) that reported gender data likely collected data on sex, and < 1% of studies described sex and gender as distinct variables. Studies of cisgender participants more often reported that females/women experienced greater adherence problems often than males/men (31% vs 20%), particularly discontinuation and cost-related nonadherence. Only 21 studies (2%) reported on transgender individuals, and these predominantly examined antiretroviral medications for HIV. CONCLUSIONS: Our review revealed substantial conflation of sex and gender in studies of medication adherence and a paucity of research among transgender individuals. Moreover, our synthesis showed sex/gender disparities in medication taking with studies reporting greater medication adherence problems among cisgender women and transgender participants than cisgender men.

The effect of changing screening practices and demographics on the incidence of gestational diabetes in British Columbia, 2005-2019.

BACKGROUND: Rates of gestational diabetes are reported to be increasing in many jurisdictions, but the reasons for this are poorly understood. We sought to evaluate the relative contribution of screening practices for gestational diabetes (including completion and methods of screening) and population characteristics to risk of gestational diabetes in British Columbia, Canada, from 2005 to 2019. METHODS: We used a population-based cohort from a provincial registry of perinatal data, linked to laboratory billing records. We used data on screening completion, screening method (1-step 75-g glucose test or 2-step approach of 50-g glucose screening test, followed by a diagnostic test for patients who screen positive) and demographic risk factors. We modelled predicted annual risk for gestational diabetes, sequentially adjusted for screening completion, screening method and risk factors. RESULTS: We included 551 457 pregnancies in the study cohort. The incidence of gestational diabetes more than doubled over the study period, from 7.2% in 2005 to 14.7% in 2019. Screening completion increased from 87.2% in 2005 to 95.5% in 2019. Use of 1-step screening methods increased from 0.0% in 2005 to 39.5% in 2019 among those who were screened. Unadjusted models estimated a 2.04 (95% confidence interval [CI] 1.94-2.13) increased risk of gestational diabetes in 2019 (v. 2005). This increase was 1.89 (95% CI 1.81-1.98) after accounting for the rise in screening completion and 1.34 (95% CI 1.28-1.40) after accounting for changes in screening methods. Further accounting for demographic risk factors (e.g., age, body mass index, prenatal care) had a small impact (increase of 1.25, 95% CI 1.19-1.31). INTERPRETATION: Most of the observed increase in the incidence of gestational diabetes was attributable to changes in screening practices (primarily changes in screening methods) rather than changing population factors. Our findings highlight the importance of understanding variation in screening practices when monitoring incidence rates for gestational diabetes.

The impact of COVID-19 and national pandemic responses on health service utilisation in seven low- and middle-income countries.

BACKGROUND: The COVID-19 pandemic has disrupted health services worldwide, which may have led to increased mortality and secondary disease outbreaks. Disruptions vary by patient population, geographic area, and service. While many reasons have been put forward to explain disruptions, few studies have empirically investigated their causes. OBJECTIVE: We quantify disruptions to outpatient services, facility-based deliveries, and family planning in seven low- and middle-income countries during the COVID-19 pandemic and quantify relationships between disruptions and the intensity of national pandemic responses. METHODS: We leveraged routine data from 104 Partners In Health-supported facilities from January 2016 to December 2021. We first quantified COVID-19-related disruptions in each country by month using negative binomial time series models. We then modelled the relationship between disruptions and the intensity of national pandemic responses, as measured by the stringency index from the Oxford COVID-19 Government Response Tracker. RESULTS: For all the studied countries, we observed at least one month with a significant decline in outpatient visits during the COVID-19 pandemic. We also observed significant cumulative drops in outpatient visits across all months in Lesotho, Liberia, Malawi, Rwanda, and Sierra Leone. A significant cumulative decrease in facility-based deliveries was observed in Haiti, Lesotho, Mexico, and Sierra Leone. No country had significant cumulative drops in family planning visits. For a 10-unit increase in the average monthly stringency index, the proportion deviation in monthly facility outpatient visits compared to expected fell by 3.9% (95% CI: -5.1%, -1.6%). No relationship between stringency of pandemic responses and utilisation was observed for facility-based deliveries or family planning. CONCLUSIONS: Context-specific strategies show the ability of health systems to sustain essential health services during the pandemic. The link between pandemic responses and healthcare utilisation can inform purposeful strategies to ensure communities have access to care and provide lessons for promoting the utilisation of health services elsewhere.

Weight gain in pregnancy and infant birthweight after the onset of the COVID-19 pandemic: an interrupted time series analysis.

BACKGROUND: Increased weight gain and decreased physical activity have been reported in some populations since the coronavirus disease 2019 (COVID-19) pandemic, but this has not been well characterized in pregnant populations. OBJECTIVES: Our objective was to characterize the impact of the COVID-19 pandemic and associated countermeasures on pregnancy weight gain and infant birthweight in a US cohort. METHODS: Washington State pregnancies and births (1 January, 2016 to 28 December, 2020) from a multihospital quality improvement organization were examined for pregnancy weight gain, pregnancy weight gain z-score adjusted for pregestational BMI and gestational age, and infant birthweight z-score, using an interrupted time series design that controls for underlying time trends. We used mixed-effect linear regression models, controlled for seasonality and clustered at the hospital level, to model the weekly time trends and changes on 23 March, 2020, the onset of local COVID-19 countermeasures. RESULTS: Our analysis included 77,411 pregnant people and 104,936 infants with complete outcome data. The mean pregnancy weight gain was 12.1 kg (z-score: -0.14) during the prepandemic time period (March to December 2019) and increased to 12.4 kg (z-score: -0.09) after the onset of the pandemic (March to December 2020). Our time series analysis found that after the pandemic onset, the mean weight gain increased by 0.49 kg (95% CI: 0.25, 0.73 kg) and weight gain z-score increased by 0.080 (95% CI: 0.03, 0.13), with no changes in the baseline yearly trend. Infant birthweight z-scores were unchanged (-0.004; 95% CI: -0.04, 0.03). Overall, the results were unchanged in analyses stratified by pregestational BMI categories. CONCLUSIONS: We observed a modest increase in weight gain after the onset of the pandemic among pregnant people but no changes in infant birthweights. This weight change could be more important in high BMI subgroups.

Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study.

OBJECTIVE: To understand how the experiences and views of trial participants, trial investigators and others connected to clinical trial research relate to whether researchers have a duty to participants to publicly report research findings. DESIGN: Qualitative interview study. SETTING: Semistructured interviews held in person or by telephone between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia and Ontario. PARTICIPANTS: 34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators and 3 research ethics board members. ANALYSIS: We conducted a thematic analysis, including qualitative coding of interview transcripts and identification of key themes. MAIN OUTCOME MEASURES: Key themes identified through qualitative coding of interview data. RESULTS: Most clinical trial participants felt that reporting clinical trial results is important. Accounts of trial participants suggest their contributions are part of a reciprocal relationship involving the expectation that research will advance medical knowledge. Similarly, comments from trial investigators suggest that reporting trial results is part of reciprocity with trial participants and is a necessary part of honouring informed consent. Accounts of trial investigators suggest that when drug trials are not reported, this may undermine informed consent in subsequent trials by withholding information on harms or efficacy relevant to informed decisions on whether to conduct or enroll in future trials of similar drugs. CONCLUSION: The views of trial participants, trial investigators and others connected to clinical trial research in Canada suggest that researchers have an obligation to participants to publicly report clinical trial results and that reporting results is necessary for honouring informed consent.

The Cascade of Care for Hepatitis C Treatment in Rwanda: A Retrospective Cohort Study of the 2017-2019 Mass Screening and Treatment Campaign.

Access to hepatitis C (HCV) testing and treatment is still limited globally. To address this, the Government of Rwanda launched a voluntary mass screening and treatment campaign in 2017. We studied the progression of patients through the cascade of HCV care during this campaign. We conducted a retrospective cohort study and included all patients screened at 46 hospitals between April 2017 and October 2019. We used hierarchical logistic regression to assess factors associated with HCV positivity, gaps in care, and treatment failure. A total of 860,801 people attended the mass screening during the study period. Some 5.7% tested positive for anti-HCV, and 2.9% were confirmed positive. Of those who were confirmed positive, 52% initiated treatment, and 72% of those initiated treatment, completed treatment and returned for assessment 12 weeks afterward. The cure rate was 88%. HCV positivity was associated with age, socio-economic status, sex, marital status, and HIV coinfection. Treatment failure was associated with cirrhosis, baseline viral load, and a family history of HCV. Our results suggest that future HCV screening and testing interventions in Rwanda and other similar settings should target high-risk groups. High dropout rates suggest that more effort should be put into patient follow-up to increase adherence to care.

Validation of Insurance Billing Codes for Monitoring Antenatal Screening.

BACKGROUND: Prevalence statistics for pregnancy complications identified through screening such as gestational diabetes usually assume universal screening. However, rates of screening completion in pregnancy are not available in many birth registries or hospital databases. We validated screening-test completion by comparing public insurance laboratory and radiology billing records with medical records at three hospitals in British Columbia, Canada. METHODS: We abstracted a random sample of 140 delivery medical records (2014-2019), and successfully linked 127 to valid provincial insurance billings and maternal-newborn registry data. We compared billing records for gestational diabetes screening, any ultrasound before 14 weeks gestational age, and Group B streptococcus screening during each pregnancy to the gold standard of medical records by calculating sensitivity and specificity, positive predictive value, negative predictive value, and prevalence with 95% confidence intervals (CIs). RESULTS: Gestational diabetes screening (screened vs. unscreened) in billing records had a high sensitivity (98% [95% CI = 93, 100]) and specificity (>99% [95% CI = 86, 100]). The use of specific glucose screening approaches (two-step vs. one-step) were also well characterized by billing data. Other tests showed high sensitivity (ultrasound 97% [95% CI = 92, 99]; Group B streptococcus 96% [95% CI = 89, 99]) but lower negative predictive values (ultrasound 64% [95% CI = 33, 99]; Group B streptococcus 70% [95% CI = 40, 89]). Lower negative predictive values were due to the high prevalence of these screening tests in our sample. CONCLUSIONS: Laboratory and radiology insurance billing codes accurately identified those who completed routine antenatal screening tests with relatively low false-positive rates.