Community-based screening and triage connecting First Nations children and youth to local supports: a cross-sectional study.

BACKGROUND: First Nations children in Canada experience health inequities. We aimed to determine whether a self-report health app identified children's needs for support earlier in their illness than would typically occur. METHODS: Children (aged 8 to 18 yr) were recruited from a rural First Nation community. Children completed the Aaniish Naa Gegii: the Children's Health and Well-being Measure (ACHWM) and then met with a local mental health worker who determined their risk status. ACHWM Emotional Quadrant Scores (EQS) were compared between 3 groups of children: healthy peers (HP) who were not at risk, those with newly identified needs (NIN) who were at risk and not previously identified, and a typical treatment (TT) group who were at risk and already receiving support. RESULTS: We included 227 children (57.1% girls), and the mean age was 12.9 (standard deviation [SD] 2.9) years. The 134 children in the HP group had a mean EQS of 80.1 (SD 11.25), the 35 children in the NIN group had a mean EQS of 67.2 (SD 13.27) and the 58 children in the TT group had a mean EQS of 66.2 (SD 16.30). The HP group had significantly better EQS than the NIN and TT groups (p < 0.001). The EQS did not differ between the NIN and TT groups (p = 0.8). INTERPRETATION: The ACHWM screening process identified needs for support among 35 children, and the associated triage process connected them to local services; the similarity of EQS in the NIN and TT groups highlights the value of community screening to optimize access to services. Future research will examine the impact of this process over the subsequent year in these groups.

Improving health care facility birth rates in Rorya District, Tanzania: a multiple baseline trial.

BACKGROUND: Rates of maternal mortality and morbidity in Africa remain unacceptably high, as many women deliver at home, without access to skilled birth attendants and life-saving medications. In rural Tanzania, women face significant barriers accessing health care facilities for their deliveries. METHODS: From January 2017 to February 2019 we conducted a multiple baseline (interrupted time series) trial within the four divisions of Rorya District, Tanzania. We collected baseline data, then sequentially introduced a complex intervention in each of the divisions, in randomized order, over 3 month intervals. We allowed for a 6 month transition period to avoid contamination between the pre- and post-intervention periods. The intervention included using community health workers to educate about safe delivery, distribution of birth kits with misoprostol, and a transport subsidy for women living a distance from the health care facility. The primary outcome was the health facility birth rate, while the secondary outcomes were the rates of antenatal and postpartum care and postpartum hemorrhage. Outcomes were analyzed using fixed effects segmented logistic regression, adjusting for age, marital status, education, and parity. Maternal and baby morbidity/mortality were analyzed descriptively. RESULTS: We analyzed data from 9565 pregnant women (2634 before and 6913 after the intervention was implemented). Facility births increased from 1892 (71.8%) before to 5895 (85.1%) after implementation of the intervention. After accounting for the secular trend, the intervention was associated with an immediate increase in the odds of facility births (OR = 1.51, 95% CI 1.14 to 2.01, p = 0.0045) as well as a small gradual effect (OR = 1.03 per month, 95% CI 1.00 to 1.07, p = 0.0633). For the secondary outcomes, there were no statistically significant immediate changes associated with the intervention. Rates of maternal and baby morbidity/mortality were low and similar between the pre- and post-implementation periods. CONCLUSIONS: Access to health care facilities can be improved through implementation of education of the population by community health workers about the importance of a health care facility birth, provision of birth kits with misoprostol to women in late pregnancy, and access to a transport subsidy for delivery for women living at a distance from the health facility. CLINICAL TRIALS REGISTRATION: NCT03024905 19/01/2017.

Cost-effectiveness analysis of 3 months of weekly rifapentine and isoniazid compared to isoniazid monotherapy in a Canadian arctic setting.

OBJECTIVE: To assess the cost effectiveness of once weekly rifapentine and isoniazid for 12 weeks (3HP) to the current standard care for latent tuberculosis (TB) infection (LTBI) in Iqaluit, Nunavut. DESIGN: A cost-effectiveness analysis using a Markov model reflecting local practices for LTBI treatment. SETTING: A remote Canadian arctic community with a high incidence of TB. PARTICIPANTS: Hypothetical patients with LTBI. INTERVENTIONS: The cost effectiveness of 3HP was compared with the existing standard of care in the study region which consists of 9 months of twice weekly isoniazid (9H) given by directly observed therapy. OUTCOME MEASURES: Effectiveness was measured in quality-adjusted life years (QALYs) with model parameters were derived from historical programmatic data, a local implementation study of 3HP and published literature. Costs from the perspective of the Nunavut healthcare system were measured in 2019 US dollars and were obtained primarily from local, empirically collected data. Secondary health outcomes included estimated TB cases and TB deaths averted using 3HP versus 9H. One way and probabilistic sensitivity analyses were performed. RESULTS: The 3HP regimen was dominant over 9H: costs were lower (US$628 vs US$924/person) and health outcomes slightly improved (20.14 vs 20.13 QALYs/person). In comparison to 9H, 3HP treatment resulted in fewer TB cases (27.89 vs 30.16/1000 persons) and TB deaths (2.29 vs 2.48/1000 persons). 3HP completion, initiation and risk of fatal adverse events were the primary drivers of cost effectiveness. CONCLUSION: In a remote Canadian arctic setting, using 3HP instead of 9H for LTBI treatment may result in cost savings and similar or improved health outcomes.

Potential Life-Years Lost: The Impact of the Cancer Drug Regulatory and Funding Process in Canada.

BACKGROUND: Canada has an established publicly funded health care system with a complex drug approval and funding process. After proof of efficacy (POE; key publication/presentation) and before becoming publicly accessible, each drug undergoes a Health Canada approval process, a health technology assessment (HTA), a pricing negotiation, and finally individual provincial funding agreements. We quantified potential life-years lost during this process. METHODS: We analyzed drugs for advanced lung, breast, and colorectal cancer that underwent the HTA process between 2011 and 2016. Life-years lost were calculated by multiplying documented improvement in progression-free and overall survival, number of eligible patients, and time from POE to first public funding. For conservative calculation, we assumed all eligible patients in Canada had access at the time of first public funding, whereas in reality provinces fund at different time points. RESULTS: We analyzed 21 drugs. Of these, 15 have been funded publicly. The time from POE to first public funding ranged from 14.0 to 99.2 months (median 26.6 months). Total overall life-years lost from POE to first public funding were 39,067 (lung 32,367; breast 6,691). Progression-free life-years lost from POE to first public funding were 48,037 (lung 9,139, breast 15,827, colorectal 23,071). CONCLUSION: The number of potential life-years lost during the drug regulatory and funding process in Canada is substantial, largely driven by delays to funding of colorectal cancer drugs. Recognizing that interprovincial differences exist and that eligible patients may not all receive a given drug, if even a fraction does so, the impact of delays remains substantive. Collaborative national initiatives are required to address this major barrier to treatment access. IMPLICATIONS FOR PRACTICE: Patients may spend lengthy periods of time awaiting access to new and effective cancer drugs. Patients with private drug insurance or personal funds or who reside in certain Canadian provinces may obtain some drugs sooner than others, potentially creating a two-tiered access system. The cancer drug access and public funding system must be expedited to improve equity.

A multi-center pragmatic, randomized, feasibility trial comparing standard of care schedules of filgrastim administration for primary febrile neutropenia prophylaxis in early-stage breast cancer.

INTRODUCTION: The most effective duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer (EBC) patients is unknown. Despite significant differences in cost and toxicity, no prospective trial has been performed to optimize practice. We assessed the feasibility of using a novel pragmatic trial model to compare the most commonly used schedules of filgrastim. METHODS: Early breast cancer patients receiving chemotherapy were randomized to 5, 7, or 10 days of filgrastim as primary FN prophylaxis. The trial methodology integrated broad eligibility criteria, simply defined endpoints, an integrated consent model incorporating oral consent, and web-based randomization in the clinic. Feasibility was reflected through a combination of primary endpoints including patient and physician engagement (if > 50% of appropriate patients approached agree to participate, and if > 50% of physicians approached patients for the study). Secondary endpoints included the first occurrence rates of FN, treatment-related hospital admission, or chemotherapy dose reductions/delays/discontinuation. RESULTS: From May 2015 to August 2016, 142/149 (95.3%) patients approached agreed to participate and were randomized. Seventeen of 24 (70.8%) medical oncologists approached and randomized patients. The 142 patients received a total of 495 cycles of chemotherapy. Aggregate incidences of a first event by patient were FN (8/142, 5.6%), treatment-related hospitalization (6/142, 4.2%), chemotherapy discontinuation (7/142, 4.9%), chemotherapy delays (5/142, 3.5%), and chemotherapy dose reduction (18/142, 12.7%). Overall, 31.7% (45/142) of patients and 9.0% (45/495) of chemotherapy cycles were associated with one of these first events. CONCLUSION: This study met its feasibility endpoints. This novel pragmatic trial approach offers a means of comparing standard of care treatments in a practical and cost-effective manner. The trial will now be expanded to compare rates of FN between the three filgrastim schedules. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02428114.

An assessment of Prostate Cancer Research International: Active Surveillance (PRIAS) criteria for active surveillance of clinically low-risk prostate cancer patients.

INTRODUCTION: Active surveillance is a strategy to delay or prevent treatment of indolent prostate cancer. The Prostate Cancer Research International: Active Surveillance (PRIAS) criteria were developed to select patients for prostate cancer active surveillance. The objective of this study was to compare pathological findings from PRIAS-eligible and PRIAS-ineligible clinically low-risk prostate cancer patients. METHODS: A D'Amico low-risk cohort of 1512 radical prostatectomy patients treated at The Ottawa Hospital or Memorial Sloan Kettering Cancer Centre between January 1995 and December 2007 was reviewed. Pathological outcomes (pT3 tumours, Gleason sum ≥7, lymph node metastases, or a composite) and clinical outcomes (prostate-specific antigen [PSA] recurrence, secondary cancer treatments, and death) were compared between PRIAS-eligible and PRIAS-ineligible cohorts. RESULTS: The PRIAS-eligible cohort (n=945) was less likely to have Gleason score ≥7 (odds ratio [OR] 0.61; 95% confidence interval [CI] 0.49-0.75), pT3 (OR 0.41; 95% CI 0.31-0.55), nodal metastases (OR 0.37; 95% CI 0.10-1.31), or any adverse feature (OR 0.56; 95% CI 0.45-0.69) compared to the PRIAS-ineligible cohort. The probability of any adverse pathology in the PRIAS-eligible cohort was 41% vs. 56% in the PRIAS-ineligible cohort. At median follow-up of 3.7 years, 72 (4.8%) patients had a PSA recurrence, 24 (1.6%) received pelvic radiation, and 13 (0.9%) received androgen deprivation. No difference was detected for recurrence-free and overall survival between groups (recurrence hazard ratio [HR] 0.71; 95% CI 0.46-1.09 and survival HR 0.72; 95% CI 0.36-1.47). CONCLUSIONS: Low-risk prostate cancer patients who met PRIAS eligibility criteria are less likely to have higher-risk cancer compared to those who did not meet at least one of these criteria.

BEST-TEST2: assessment of hematology trainee knowledge of transfusion medicine.

BACKGROUND: As transfusion is a common therapy and key component in every hematologist's practice, hematology training programs should dedicate significant time and effort to delivering high-quality transfusion medicine education to their trainees. The current state of hematology trainee knowledge of transfusion medicine is not known. STUDY DESIGN AND METHODS: A validated assessment tool developed by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative was used to assess prior transfusion medicine education, attitudes, perceived ability, and transfusion medicine knowledge of hematology trainees. RESULTS: A total of 149 hematology trainees at 17 international sites were assessed. The overall mean exam score was 61.6% (standard deviation, 13.4%; range, 30%-100%) with no correlation in exam scores with postgraduate year or previous transfusion medicine education in medical school or internal medicine residency. However, better scores correlated with 3 or more hours of transfusion medicine education (p = 0.0003) and perceived higher-quality education during hematology training (p = 0.03). Hematology trainees at US sites, where hematology is often combined with oncology training, had statistically lower scores than trainees at non-US sites (56.2% vs. 67.4%; p < 0.0001). In terms of topic areas, although 93% of participants had obtained consent for transfusion, the lowest scores were on transfusion reaction-related questions. CONCLUSION: Given the overall poor performance, this study serves as an impetus for all hematology training programs to reevaluate the quality and quantity of transfusion medicine training and can assist in the development of targeted curricula.

Temporal variability and sources of triclosan exposure in pregnancy.

BACKGROUND: Triclosan (TCS) is an antibacterial agent commonly added to personal care products. Some animal research studies have associated TCS exposure with androgenic and thyroid effects, as well as endocrine disruption, contact dermatitis and skin irritation. Limited Canadian data exist on exposure levels, temporal variability and sources of exposure to TCS, especially among pregnant women. METHODS: Single and serial spot urine samples (n=1249), as well as consumer product use information were collected over 5 study visits across pregnancy and post-partum from 80 healthy pregnant women in Ottawa, Canada. Urine samples were analyzed for TCS by GC-MS-MS. Summary statistics, linear mixed effects models, and surrogate category analysis were used to describe the results. RESULTS: Triclosan was detected in 87% of maternal urine samples (LOD=3.0µg/L). The geometric mean TCS concentration of all urine samples was 21.6µg/L (95% CI 18.2-25.7). Triclosan concentrations were significantly higher when the urine was collected before 16:00, in the autumn, and more than 90min since last void, and in nulliparous women with household incomes greater than $100,000. A significant correlation was observed between maternal urinary TCS concentrations and number of reported uses of TCS-containing products. The ability of a single spot urine sample collected at any time during or post-pregnancy to predict an individual's geometric mean urinary TCS level corresponding to low, medium, or high exposure was 86.7%. Intraclass correlation coefficients indicated high reproducibility within a week-day (0.77) and week-end day (0.79) and moderate reproducibility across the study period (0.50). CONCLUSIONS: This study provided the first data on temporal variability of urinary TCS concentrations and predictors of exposure in Canadian pregnant women. These results can inform exposure assessments in pregnant women and justify collection of single spot urine samples in epidemiologic studies, especially for women with higher exposures.

Internal medicine resident knowledge of transfusion medicine: results from the BEST-TEST international education needs assessment.

BACKGROUND: Blood transfusion is the most common hospital procedure performed in the United States. While inadequate physician transfusion medicine knowledge may lead to inappropriate practice, such an educational deficit has not been investigated on an international scale using a validated assessment tool. Identifying specific deficiencies is critical for developing curricula to improve patient care. STUDY DESIGN AND METHODS: Rasch analysis, a method used in high-stakes testing, was used to validate an assessment tool consisting of a 23-question survey and a 20-question examination. The assessment tool was administered to internal medicine residents to determine prior training, attitudes, perceived ability, and actual knowledge related to transfusion medicine. RESULTS: A total of 474 residents at 23 programs in nine countries completed the examination. The overall mean score of correct responses was 45.7% (site range, 32%-56%). The mean score for Postgraduate Year (PGY)1 (43.9%) was significantly lower than for PGY3 (47.1%) and PGY4 (50.6%) residents. Although 89% of residents had participated in obtaining informed consent from a patient for transfusion, residents scored poorly (<25% correct) on questions related to transfusion reactions. The majority of residents (65%) would find additional transfusion medicine training "very" or "extremely" helpful. CONCLUSION: Internationally, internal medicine residents have poor transfusion medicine knowledge and would welcome additional training. The especially limited knowledge of transfusion reactions suggests an initial area for focused training. This study not only represents the largest international assessment of transfusion medicine knowledge, but also serves as a model for rigorous, collaborative research in medical education.

Achieving a climate for patient safety by focusing on relationships.

OBJECTIVE: Despite many initiatives, advances in patient safety remain uneven in part because poor relationships among health professionals have not been addressed. The purpose of this study was to determine whether relationships between health professionals contributed to a patient safety climate, after implementation of an intervention to improve inter-professional collaboration. DESIGN/SETTING: This was a secondary analysis of data collected to evaluate the Interprofessional Model of Patient Care (IPMPC) at The Ottawa Hospital in Ontario, Canada, which consists of five sites. A series of generalized estimating equation models were generated, accounting for the clustering of responses by site. PARTICIPANTS: Thirteen health professionals including physicians, nurses, physiotherapists and others (n = 1896) completed anonymous surveys about 1 year after the IPMPC was introduced. INTERVENTION: The IPMPC was implemented to improve interdisciplinary collaboration. MAIN OUTCOME MEASURES: Reliable instruments were used to measure collaboration, respect, inter-professional conflict and patient safety climate. RESULTS: Collaboration (ß = 0.13; P = 0.002) and respect (ß = 1.07; P = 0.03) were significant independent predictors of patient safety climate. Conflict was an independent and significant inverse predictor of patient safety climate (ß = -0.29; P = 0.03), but did not moderate linkages between collaboration and patient safety climate or between respect and patient safety climate. CONCLUSIONS: Through the IPMPC, all health professionals learned how to collaborate and build a patient safety climate, even in the presence of inter-professional conflict. Efforts by others to foster better work relationships may yield similar improvements in patient safety climate.