Search

OBJECTIVE: To determine the acceptability of providing free access to only a short list of medicines used in the Carefully seLected and Easily Accessible at No charge Medications (CLEAN Meds) trial. DESIGN: A multimethod explanatory sequential design including interviews with trial participants and focus groups with prescribers. SETTING: Ontario. PARTICIPANTS: Participants in the intervention arm of the CLEAN Meds trial and primary care providers who prescribed medicines to those in the intervention arm of the trial. MAIN OUTCOME MEASURES: The number of trial participants in each prescription category (ie, prescribed no off-list medicine, prescribed 1 off-list medicine, or prescribed 2 or more off-list medicines) and the acceptability of the list to both participants and prescribers. RESULTS: There were 395 participants in the intervention group of the CLEAN Meds trial, but 16 participants withdrew consent or were not prescribed any medicines during the first 12 months of the trial, resulting in a total of 379 participants in the quantitative component of this study. Of the 2648 total prescriptions, 2349 (89%) were for medications that were on or had an equivalent covered by the list. Random sampling was used to select 5 participants to interview from each prescription category. A total of 19 prescribers participated in the focus groups. Themes from participant interviews included the following: having access to medicines on the list was a relief, participants trusted health care professionals to switch medicines and to decide which medicines should be on a publicly funded list, and a short list of essential medicines should be publicly funded. Major themes from the prescribers’ focus groups related to the process of developing the list, support for the list, and publicly funding a short list of essential medicines in Canada. CONCLUSION: The consensus among trial participants and prescribers is that the short list of medicines used in the trial is comprehensive and provides access to medicines commonly prescribed.

During the COVID-19 pandemic, home delivery of antiretrovirals for HIV treatment proved to be a feasible approach for ensuring treatment continuation amid facility closures and travel restrictions. Antiretroviral home delivery is a model warranting further consideration as an additional option for decentralized drug delivery for HIV treatment., Key Messages Across diverse contexts, home delivery of antiretroviral (ARV) medications was a feasible and acceptable approach for ensuring access to HIV treatment when COVID-19-related lockdowns and travel restrictions imposed barriers to treatment.The ARV home delivery models were rapidly designed and successfully implemented to meet emergency needs brought on by the pandemic. Home delivery of ARVs requires further attention before it can be implemented at greater scale in response to the current pandemic and when health services face future shocks. Key Implications Governments and their partners are urged to seek financing mechanisms and reinforcement to commodity management systems needed to sustain this mode of decentralized service delivery.National HIV program leaders are encouraged to advocate for official, permanent policy changes supportive of home delivery of ARVs. Health policy makers should consider the relevance of home delivery to all chronic health needs requiring long-term delivery of medication to clients., Introduction: Faced with the coronavirus disease (COVID-19) pandemic, governments worldwide instituted lockdowns to curtail virus spread. Health facility closures and travel restrictions disrupted access to antiretroviral (ARV) therapy for people living with HIV. This report describes how HIV programs in Indonesia, Laos, Nepal, and Nigeria supported treatment continuation by introducing home delivery of ARVs. Methods: Staff supporting the programs provided accounts of when and how decisions were taken to support ARV home delivery. They captured programmatic information about home delivery implementation using an intervention documentation tool. The 4 country experiences revealed lessons learned about factors favoring successful expansion of ARV home delivery. Results: Three of the countries relied on existing networks of community health workers for ARV delivery; the fourth country, Indonesia, relied on a private sector courier service. Across the 4 countries, between 19% and 51% of eligible clients were served by home delivery. The experiences showed that ARV home delivery is feasible and acceptable to health service providers, clients, and other stakeholders. Essential to success was rapid mobilization of stakeholders who led the design of the home delivery mechanisms and provided leadership support of the service innovations. Timely service adaptation was made possible by pre-existing differentiated models of care supportive of community-based ARV provision by outreach workers. Home delivery models prioritized protection of client confidentiality and prevention measures for COVID-19. Sustainability of the innovation depends on reinforcement of the commodity management infrastructure and investment in financing mechanisms. Conclusion: Home delivery of ARVs is a feasible client-centered approach to be included among the options for decentralized drug distribution. It serves as a measure for expanding access to care both when access to health services is disrupted and under routine circumstances.

POINTS CLES Le public est de plus en plus sensible a l’importance de divulguer et de gerer les conflits d’interets (CI) lies a l’elaboration des guides de pratique clinique et des directives de sante publique, en raison de dossiers recents tres mediatises au Canada et a l’e

Background Despite progress in improving antiretroviral therapy (ART) for people with HIV in Malawi, the burden of HIV infections and HIV treatment outcomes among key populations is suboptimal. Client-centered differentiated service delivery approaches may facilitate addressing HIV prevention and treatment needs of key populations in Malawi. Methods De-identified program data routinely collected as part of the LINKAGES project–Malawi were assembled from October 2017 to September 2019. HIV case finding was compared across different testing modalities for each population. Poisson regression was used to estimate the association between testing modalities and ART initiation. Results Of the 18 397 people included in analyses, 10 627 (58%) were female sex workers (FSWs), 2219 (12%) were men who have sex with men (MSM), and 4970 (27%) were clients of FSWs. HIV case finding varied by modality and population, with index testing and enhanced peer outreach demonstrating high yield despite reaching relatively few individuals. FSWs who tested positive through risk network referral testing were more likely to initiate ART within 30 days compared with those who tested positive through clinic-based testing (adjusted risk ratio [aRR], 1.50; 95% CI, 1.23–1.82). For MSM, index testing (aRR, 1.45; 95% CI, 1.06–2.00) and testing through a drop-in center (aRR, 1.82; 95% CI, 1.19–2.78) were associated with 30-day ART initiation. Conclusions These data suggest that differentiated HIV testing and outreach approaches tailored to the needs of different key populations may facilitate improved ART initiation in Malawi. Achieving 0 new infections by 2030 suggests the need to adapt treatment strategies given individual and structural barriers to treatment for key populations with HIV in high-prevalence settings.

ObjectiveTo evaluate the effect of a one-time cash transfer of $C1000 in people who are unable to physically distance due to insufficient income.DesignOpen-label, multi-centre, randomised superiority trial.SettingSeven primary care sites in Ontario, Canada; six urban sites associated with St. Michael’s Hospital in Toronto and one in Manitoulin Island.Participants392 individuals who reported trouble affording basic necessities due to disruptions related to COVID-19.InterventionAfter random allocation, participants either received the cash transfer of $C1000 (n=196) or physical distancing guidelines alone (n=196).Main outcome measuresThe primary outcome was the maximum number of symptoms consistent with COVID-19 over 14 days. Secondary outcomes were meeting clinical criteria for COVID-19, SARS-CoV-2 presence, number of close contacts, general health and ability to afford basic necessities.ResultsThe primary outcome of number of symptoms reported by participants did not differ between groups after 2 weeks (cash transfer, mean 1.6 vs 1.9, ratio of means 0.83; 95% CI 0.56 to 1.24). There were no statistically significant effects on secondary outcomes of the meeting COVID-19 clinical criteria (7.9% vs 12.8%; risk difference −0.05; 95% CI −0.11 to 0.01), SARS-CoV-2 presence (0.5% vs 0.6%; risk difference 0.00 95% CI −0.02 to 0.02), mean number of close contacts (3.5 vs 3.7; rate ratio 1.10; 95% CI 0.83 to 1.46), general health very good or excellent (60% vs 63%; risk difference −0.03 95% CI −0.14 to 0.08) and ability to make ends meet (52% vs 51%; risk difference 0.01 95% CI −0.10 to 0.12).ConclusionsA single cash transfer did not reduce the COVID-19 symptoms or improve the ability to afford necessities. Further studies are needed to determine whether some groups may benefit from financial supports and to determine if a higher level of support is beneficial.Trial registration numberNCT04359264.

Purpose To inform recommendations by the Canadian Task Force on Preventive Health Care on potentially inappropriate prescribing and over-the-counter (OTC) medication use among adults aged 65 years and older in primary care settings. This protocol outlines the planned scope and methods for a systematic review of the benefits and harms and acceptability of interventions to reduce potentially inappropriate prescriptions and OTC medication use. Methods De novo systematic reviews will be conducted to synthesize the available evidence on (a) the benefits and harms of interventions to reduce potentially inappropriate prescriptions and OTC medications compared to no intervention, usual care, or non- or minimally active intervention among adults aged 65 years and older and (b) the acceptability of these interventions or attributes among patients. Outcomes of interest for the benefits and harms review are all-cause mortality, hospitalization, non-serious adverse drug reactions, quality of life, emergency department visits, injurious falls, medical visits, and the number of medications (and number of pills). Outcomes for the acceptability review are the preference for and relative importance of different interventions or their attributes. For the benefits and harms review, we will search MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for randomized controlled trials. For the acceptability review, we will search MEDLINE, Embase, PsycInfo, Cochrane Central Register of Controlled Trials, and the NHS Economic Evaluation Database for experimental and observational studies with a comparator. Websites of relevant organizations, other grey literature sources, and reference lists of included studies and reviews will be searched. Title and abstract screening will be completed by two independent reviewers using the liberal accelerated approach. Full-text review, data extraction, risk of bias assessments, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will be completed independently by two reviewers, with any disagreements resolved by consensus or by consulting with a third reviewer. The GRADE approach will be used to assess the certainty of the evidence for outcomes. Discussion The results of this systematic review will be used by the Canadian Task Force on Preventive Health Care to inform their recommendation on potentially inappropriate prescribing and OTC medication use among adults aged 65 years and older. Systematic review registration PROSPERO (KQ1: CRD42022302313; KQ2: CRD42022302324); Open Science Framework (https://osf.io/urj4b/).

Background Men who have sex with men (MSM) are a key group for HIV interventions in Malawi considering their high HIV prevalence (17.5% compared to 8.4% among men in the general population). The use of oral preexposure prophylaxis (PrEP) presents a new opportunity for MSM to be protected. We present the findings from a qualitative assessment designed to assess awareness of and willingness and barriers to using PrEP among MSM in Malawi. Objective The 3 main objectives of this assessment were to determine: (1) awareness of PrEP, (2) factors that influence willingness to use PrEP, and (3) potential barriers to PrEP use and adherence among MSM in order to guide the design and implementation of a PrEP program in Malawi. Methods Ahead of the introduction of PrEP in Malawi, a qualitative study using in-depth interviews (IDIs) and focus group discussions (FGDs) was conducted in October 2018 in Blantyre, Lilongwe, and rural districts of Mzimba North and Mangochi. With support of members of the population, study participants were purposively recruited from 4 MSM-friendly drop-in centers where MSM receive a range of health services to ensure representativeness across sites and age. Participants were asked what they had heard about PrEP, their willingness to use PrEP, their barriers to PrEP use, and their preferences for service delivery. The data were analyzed using a thematic content analysis framework that was predetermined in line with objectives. Results A total of 109 MSM were interviewed—13 through IDIs and 96 through FGDs. Most participants were aware of PrEP as a new HIV intervention but had limited knowledge related to its use. However, the majority were willing to use it and were looking forward to having access to it. IDI participants indicated that they will be more willing to take PrEP if the dosing frequency were appropriate and MSM were involved in information giving and distribution of the drug. FGD participants emphasized that places of distribution and characteristics of the service provider are the key factors that will affect use. Knowing the benefits of PrEP emerged as a key theme in both the IDIs and FGDs. Participants highlighted barriers that would hinder them from taking PrEP such as side effects which were cited in IDIs and FGDs. Key factors from FGDs include cost, fear of being outed, drug stockouts, fear of being known as MSMs by wives, and lack of relevant information. FGDs cited stigma from health care workers, forgetfulness, and community associated factors. Conclusions Despite having inadequate knowledge about PrEP, study participants were largely willing to use PrEP if available. Programs should include an effective information, education, and communication component around their preferences and provide PrEP in MSM-friendly sites.

Introduction The rapid increase in the number of people living with HIV (PLHIV) on antiretroviral therapy (ART) in Akwa Ibom and Cross River states in Nigeria led to overcrowding at clinics. Patients were devolved to receive ART refills through five differentiated service delivery (DSD) models: fast‐track (FT), adolescent refill clubs (ARCs), community pharmacy ART refill programs (CPARPs), community ART refill clubs (CARCs) and community ART refill groups (CARGs) designed to meet the needs of different groups of PLHIV. In the context of COVID‐19‐related travel restrictions, out‐of‐facility models offered critical mechanisms for continuity of treatment. We compared retention and viral suppression among those devolved to DSD with those who continued standard care at facilities. Methods A retrospective cohort study was conducted among patients devolved to DSD from January 2018 to December 2020. Bivariate analyses were conducted to assess differences in retention and viral suppression by socio‐demographic characteristics. Kaplan–Meier assessed retention at 3, 6, 9 and 12 months. Differences in proportions were compared using the chi‐square test; a p‐value of

This cross-sectional study assesses the frequency and thoroughness of reporting of sociodemographic variables in randomized clinical trials published in 5 high-impact health journals from January 2014 to July 2020.

Objective To evaluate the relationship between the timing of infant cereal introduction between 4 and 6 months of age and growth and dietary intake in later childhood. Study design A longitudinal cohort study was conducted among healthy children 0-10 years of age participating in The Applied Research Group for Kids cohort study between June 2008 and August 2019 in Toronto, Canada. Results Of 8943 children included, the mean (SD) age of infant cereal introduction was 5.7 (2.1) months. In the primary analysis, children who were introduced to infant cereal at 4 vs 6 months had 0.17 greater body mass index z score (95% CI 0.06-0.28; P = .002) and greater odds of obesity (OR 1.82; 95% CI 1.18-2.80; P = .006) at 10 years of age. In the secondary analysis, children who were introduced to infant cereal at 4 vs 6 months had 0.09 greater height-for-age z score (95% CI 0.04-0.15; P = .002) at 1 year of age, an association that was not observed at 5 or 10 years of age. Children who were introduced to infant cereal at 4 vs 6 months had greater nutrition risk which was primarily determined by a less-favorable eating behavior score at 18 months to 5 years of age (0.18 units higher; 95% CI 0.07-0.29; P = .001). Conclusions Introduction of infant cereal at 4 vs 6 months was associated with greater body mass index z score, greater odds of obesity, similar height-for-age z score, and less favorable eating behavior. These findings support recommendations for introducing solid food around 6 months of age.

KEY POINTS Public awareness regarding the importance of disclosing and managing conflicts of interest (COIs) during the development of clinical practice and public health guidelines is growing, owing to recent high-profile news stories within and outside Canada.[1][1]–[9][2] Despite the existence

Background In the context of the mostly generalized HIV epidemic in Côte d’Ivoire, key populations bear a higher burden of HIV than that borne by the general reproductive-aged population. Mathematical models have demonstrated the significant potential impact and cost-effectiveness of improving the coverage of HIV prevention and treatment services for key populations in Côte d’Ivoire. However, in 2019, coverage of these services remained limited by multiple intersecting stigmas affecting key populations, necessitating the study of innovative implementation strategies to better meet the needs of those most marginalized. Here, we leverage programmatic data to compare the effectiveness of the enhanced and traditional peer outreach approaches in reaching and providing community HIV testing to female sex workers not readily engaged in HIV prevention and treatment services in Côte d’Ivoire. Objective The aim of this study was to describe the characteristics of female sex workers reached by the LINKAGES project in Côte d’Ivoire with enhanced peer outreach and traditional peer outreach and to compare HIV-related outcomes between the women reached by both strategies. Methods Deidentified routine programmatic data collected as part of LINKAGES Côte d’Ivoire between October 2017 and April 2018 were used in these analyses. Demographic characteristics and HIV indicators including HIV testing history, HIV case-finding, linkage to HIV treatment, and treatment initiation were assessed using descriptive statistics. Differences in these indicators were compared by outreach strategy using Pearson chi-square tests. Results There were 9761 women reached with enhanced peer outreach and routine peer outreach included in these analyses. The overall case-finding rate in the sample was 7.8% (698/8851). Compared with women reached by routine outreach, those reached by enhanced peer outreach were more likely to have previously been tested for HIV (enhanced: 1695/2509, 67.6%; routine: 4302/7252, 60.0%; χ21=43.8; P=.001). The enhanced peer outreach approach was associated with a higher HIV case-finding rate (enhanced: 269/2507 10.7%; routine: 429/6344, 6.8%; χ21=32.3; P=.001), higher proportion of linkage to treatment (enhanced: 258/269, 95.9%; routine: 306/429, 71.3%; χ21=64.4; P=.001), and higher proportion of treatment initiation (enhanced: 212/269, 78.8%; routine: 315/429, 73.3%; χ21=2.6; P=.11). Women reached by both approaches were categorized as high risk for HIV-related behaviors such as condomless sex and number of sex acts in the previous week. Conclusions These analyses suggest that the novel peer-referral strategy, the enhanced peer outreach approach, was effective in reaching female sex workeres in Côte d’Ivoire with demonstrated acquisition risks for HIV and who had not been effectively engaged by routine outreach approaches. Scaling up novel strategies such as enhanced peer outreach in the context of differentiated service models may be needed to optimize HIV prevention and treatment outcomes for key populations in Côte d’Ivoire.

BACKGROUND In Burundi, given the low testing numbers among key populations (KPs), peer-assisted HIV self-testing (HIVST) was initiated for female sex workers (FSWs), men who have sex with men (MSM), and transgender people to provide another testing option. HIVST was provided by existing peer outreach workers who were trained to provide support before, during, and after the administration of the test. People who screened reactive were referred and actively linked to confirmatory testing, and those confirmed positive were linked to treatment. Standard testing included HIV testing by clinical staff either at mobile clinics in the community or in facilities. OBJECTIVE This study aims to improve access to HIV testing for underserved KPs, improve diagnoses of HIV serostatus among key populations, and link those who were confirmed HIV positive to life-saving treatment for epidemic control. METHODS A descriptive analysis was conducted using routine programmatic data that were collected during a 9-month implementation period (June 2018 to March 2019) for peer-assisted HIVST among FSWs, MSM, and transgender people in 6 provinces where the US Agency for International Development–and US President’s Emergency Plan for AIDS Relief–funded LINKAGES (Linkage across the Continuum of HIV Services for KP Affected by HIV) Burundi project was being implemented. Chi-square tests were used to compare case-finding rates among individuals who were tested through HIVST versus standard testing. Multivariable logistic regression was performed to assess factors that were independently associated with HIV seropositivity among FSWs and MSM who used HIVST kits. RESULTS A total of 2198 HIVST kits were administered (FSWs: 1791/2198, 81.48%; MSM: 363/2198, 16.52%; transgender people: 44/2198, 2%). HIV seropositivity rates from HIVST were significantly higher than those from standard testing for FSWs and MEM and nonsignificantly higher than those from standard testing for transgender people (FSWs: 257/1791, 14.35% vs 890/9609, 9.26%; PPP=.50). Antiretroviral therapy initiation rates were significantly lower among MSM who were confirmed to be HIV positive through HIVST compared to those among MSM who were confirmed to be HIV positive through standard testing (40/47, 85% vs 89/90, 99%; P8 clients per week (adjusted odds ratio 1.3, 95% CI 1.0-1.8) were independently associated with HIV seropositivity. CONCLUSIONS The results demonstrate the potential effectiveness of HIVST in newly diagnosing underserved KPs and linking them to treatment. CLINICALTRIAL

BACKGROUND In the context of the mostly generalized HIV epidemic in Côte d’Ivoire, key populations bear a higher burden of HIV than that borne by the general reproductive-aged population. Mathematical models have demonstrated the significant potential impact and cost-effectiveness of improving the coverage of HIV prevention and treatment services for key populations in Côte d’Ivoire. However, in 2019, coverage of these services remained limited by multiple intersecting stigmas affecting key populations, necessitating the study of innovative implementation strategies to better meet the needs of those most marginalized. Here, we leverage programmatic data to compare the effectiveness of the enhanced and traditional peer outreach approaches in reaching and providing community HIV testing to female sex workers not readily engaged in HIV prevention and treatment services in Côte d’Ivoire. OBJECTIVE The aim of this study was to describe the characteristics of female sex workers reached by the LINKAGES project in Côte d’Ivoire with enhanced peer outreach and traditional peer outreach and to compare HIV-related outcomes between the women reached by both strategies. METHODS Deidentified routine programmatic data collected as part of LINKAGES Côte d’Ivoire between October 2017 and April 2018 were used in these analyses. Demographic characteristics and HIV indicators including HIV testing history, HIV case-finding, linkage to HIV treatment, and treatment initiation were assessed using descriptive statistics. Differences in these indicators were compared by outreach strategy using Pearson chi-square tests. RESULTS There were 9761 women reached with enhanced peer outreach and routine peer outreach included in these analyses. The overall case-finding rate in the sample was 7.8% (698/8851). Compared with women reached by routine outreach, those reached by enhanced peer outreach were more likely to have previously been tested for HIV (enhanced: 1695/2509, 67.6%; routine: 4302/7252, 60.0%; χ21=43.8; P=.001). The enhanced peer outreach approach was associated with a higher HIV case-finding rate (enhanced: 269/2507 10.7%; routine: 429/6344, 6.8%; χ21=32.3; P=.001), higher proportion of linkage to treatment (enhanced: 258/269, 95.9%; routine: 306/429, 71.3%; χ21=64.4; P=.001), and higher proportion of treatment initiation (enhanced: 212/269, 78.8%; routine: 315/429, 73.3%; χ21=2.6; P=.11). Women reached by both approaches were categorized as high risk for HIV-related behaviors such as condomless sex and number of sex acts in the previous week. CONCLUSIONS These analyses suggest that the novel peer-referral strategy, the enhanced peer outreach approach, was effective in reaching female sex workeres in Côte d’Ivoire with demonstrated acquisition risks for HIV and who had not been effectively engaged by routine outreach approaches. Scaling up novel strategies such as enhanced peer outreach in the context of differentiated service models may be needed to optimize HIV prevention and treatment outcomes for key populations in Côte d’Ivoire.

ContextOpioid related deaths are at epidemic levels in many developed nations globally. Concerns about the contribution of prescribed opioids, and particularly high-dose opioids, continue to mount as do initiatives to reduce prescribing. Evidence around opioid tapering, which can be challenging and potentially hazardous, is not well developed. A recent national guideline has recognized this and recommended referral to multidisciplinary care for challenging cases of opioid tapering. However, multidisciplinary care for opioid tapering is not well understood or defined.ObjectiveIdentify the existing literature on any multidisciplinary care programs that evaluate impact on opioid use, synthesize how these programs work and clarify whom they benefit.Study designSystematic rapid realist review.DatasetBibliographic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Library), grey literature, reference hand search and formal expert consultation.Results95 studies were identified. 75% of the programs were from the United States and the majority (n = 62) were published after 2000. A minority (n = 23) of programs reported on >12 month opioid use outcomes. There were three necessary but insufficient mechanisms common to all programs: pain relief, behavior change and active medication management. Programs that did not include a combination of all three mechanisms did not result in opioid dose reductions. A concerning 20-40% of subjects resumed opioid use within one year of program completion.ConclusionsProviding alternative analgesia is insufficient for reducing opioid doses. Even high quality primary care multidisciplinary care programs do not reduce prescribed opioid use unless there is active medication management accomplished by changing the primary opioid prescriber. Rates of return to use of opioids from these programs are very concerning in the current context of a highly potent and lethal street drug supply. This contextual factor may be powerful enough to undermine the modest benefits of opioid dose reduction via multidisciplinary care.

Objective Outdoor free play is important for preschoolers' physical activity, health, and development. Certain temperamental characteristics are associated with obesity, nutrition, and sedentary behaviors in preschoolers, but the relationship between temperament and outdoor play has not been examined. This study examined whether there is an association between temperament and outdoor play in young children. Methods Healthy children aged 1 to 5 years recruited to The Applied Research Group for Kids (TARGet Kids!), a community-based primary care research network, from July 2008 to September 2013 were included. Parent-reported child temperament was assessed using the Childhood Behavior Questionnaire. Outdoor free play and other potential confounding variables were assessed through validated questionnaires. Multivariable linear regression was used to determine the association between temperament and outdoor play, adjusted for potential confounders. Results There were 3393 children with data on outdoor play. The association between negative affectivity and outdoor play was moderated by sex; in boys, for every 1-point increase in negative affectivity score, mean outdoor play decreased by 4.7 minutes per day. There was no significant association in girls. Surgency was associated with outdoor play; for every 1-point increase in surgency/extraversion, outdoor play increased by 4.6 minutes per day. Conclusions Young children's temperamental characteristics were associated with their participation in outdoor free play. Consideration of temperament could enhance interventions and strategies to increase outdoor play in young children. Longitudinal studies are needed to elucidate the relationship between children's early temperament and physical activity.

This work is supported by grant 381409 from the Canadian Institutes for Health Research, the Ontario SPOR Support Unit that is supported by the Canadian Institutes of Health Research and the Province of Ontario, the Canada Research Chairs program, and the St Michael’s Hospital Foundation. Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients. Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence. Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle. Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391). Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines. Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL). Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines. Trial Registration: ClinicalTrials.gov identifier: NCT02744963. Publisher PDF

To determine the association between cow's milk-fat and non-high-density lipoprotein (non-HDL) cholesterol, a marker of cardiovascular disease (CVD) risk in young children, and whether this association is mediated by the typical volume of cow's milk consumed.A longitudinal study in 2- to 8-year-old children (n = 2890) was conducted through The Applied Research Group for Kids (TARGet Kids!), a practice-based research network in Toronto, Canada. Generalized estimating equations were used to examine the relationship between parent-reported cow's milk-fat percentage intake and serum non-HDL cholesterol concentrations as well as having high non-HDL cholesterol (≥3.75 mmol/L [145 mg/dL]), adjusting for covariates including age, sex, body mass index z score, breastfeeding duration, mother's ethnicity, and parental history of CVD. Bootstrap resampling (10 000 repetitions) was used to assess whether typical volume consumed mediated the association between cow's milk-fat percentage and non-HDL cholesterol.In total, 156 (5.4%) had high non-HDL cholesterol. Each percent increase in cow's milk-fat was associated with a 0.035 mmol/L (1.35 mg/dL) (P .001) and 0.024 mmol/L (0.92 mg/dL) (P = .01) increase in non-HDL cholesterol, unadjusted and adjusted for covariates respectively. Cow's milk-fat percentage was not associated with greater odds of having high non-HDL cholesterol. Volume of cow's milk partially mediated the association between cow's milk-fat percentage and non-HDL cholesterol, accounting for 28% of the relationship (P .001).Consumption of higher-fat cow's milk was associated with a small increase in non-HDL cholesterol but not greater odds of having high non-HDL cholesterol. Further research is needed to assess this relationship with other CVD risk factors in young children.ClinicalTrials.gov: NCT01869530.

Introduction: The opioid epidemic has been influenced by immense marketing campaigns produced by pharmaceutical companies. These campaigns include advertisements aimed at emergency medicine (EM) physicians, which may have influenced overprescription. This study is a part of a larger effort to systematically assess opioid ads published in major medical journals in North America. To our knowledge, this is the first study to systematically assess the volume, claims, and levels of evidence for opioid ads aimed at EM physicians. Methods: Up to two issues per year from 1996 to 2016 of ten major North American medical journals were hand-searched for opioid advertisements. Specifically, we assessed random samples of issues from five major North American emergency medicine journals, including Annals of Emergency Medicine, Emergency Medicine, Canadian Journal of Emergency Medicine, Emergency Medicine Journal, and American Journal of Emergency Medicine. Five generalist medical journals were assessed including Journal of the American Medical Association, New England Journal of Medicine, Canadian Medical Association Journal, American Family Physician, and Canadian Family Physician. The volume of advertisements, nature of the claims, and cited evidence were collected by independent reviewers. The referenced evidence was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence rubric. Results: Of the 269 issues across the ten journals, opioid ads compromised 95 of the 3392 pharmaceutical advertisements with 79 opioid ads available for analysis. When analysis was completed with two reviewers, inter-rater agreement was rated as 99.87 (Cohen's kappa of 0.976). 37/79 ads did not mention the addictive potential of opioids, with 60/79 not mentioning the possibility of death. The tamper potential of medications was mentioned in 27/79 ads. Positive claims included efficacy (47/79), fast-acting ability (16/79), patient preference (5/79), convenience (26/79) and reduced side effects (22/79). 26/79 cited references directly in their text. Citations were provided for a total of 19 available original studies, of which a majority (16/19) were Level 2 evidence. Upon examination of conflicts of interest, 100% (19/19) of the referenced studies were funded by a pharmaceutical company. Conclusion: A variety of claims were published in medical journals through opioid advertisements, which cite industry studies. Many ads did not mention key negative information, which may have influenced EM physician prescribing.

ObjectivesOpioid-related deaths continue to increase in North America, an epidemic that was initiated by high rates of opioid prescribing. We designed a multifaceted, theory-informed Opioid Self-Assessment (OSA) package, to increase adherence to the Canadian Opioid Guideline among family physicians. This study aimed to assess changes in Canadian family physicians’ knowledge and practices after completing the OSA package.DesignWe conducted a mixed-method evaluation using a pre-test and post-test design that involved the collection of both qualitative and quantitative data.SettingThis research was conducted in the primary care setting in Ontario, Canada.ParticipantsWe recruited a purposive sample of nine family physicians in Ontario who use long-term opioid therapy to treat patients with chronic pain.InterventionsThe OSA package included four components: an online knowledge test, an online learning programme, a safe medication practice self-assessment questionnaire and chart audit with feedback.Outcome measuresOur measures included changes in knowledge, opioid safety practices and physicians’ perspectives on the OSA package.ResultsWe found statistically significant improvements between pre-test and post-test knowledge scores at both baseline and 6-month follow-up. Physicians’ scores improved significantly on five of the seven core characteristics of the practice self-assessment questionnaire. On the chart audits, we observed an improvement in patient education between baseline and 6 months. Qualitative interviews showed that participants appreciated embedded resources in the OSA package. The completion of the package stimulated identification of gaps or deficits in practice and served as a useful reminder to discuss risk and safety with patients. Participants described the chart review as helpful in prompting discussions with their patients, identifying deficits and strengths and a ‘primary motivator’ for project participation.ConclusionsThe OSA package has the potential to improve medication safety practices in primary care related to opioid monitoring and adherence to current opioid guidelines.

UNSTRUCTURED Programmatic mapping (PM) is a rapid and efficient mechanism to develop size estimates of key populations including female sex workers (FSWs) and geolocate them at physical locations in a systematic and scientific manner. At the macro level, this information forms the basis for allocating program resources, setting performance targets, and assess coverage. At a micro level, PM data provide specific information on hot spots, estimates of FSWs at those spots, and hot spot typology and days and times of operation, all of which provides targeted service delivery strategies. This information can provide a reliable platform to plan HIV prevention and treatment services to considerable scale and intensity. Above all, the entire PM process requires deep involvement of FSWs, which increases community ownership of the data and can lead to an increased uptake of services. Despite a few limitations, the approach is versatile and can be used in varied country contexts to generate important information about sex work and its dynamics. In this paper, we describe experiences and lessons learned from using evidence generated from PM of FSWs in multiple countries to develop HIV prevention programs at scale.

Programmatic mapping (PM) is a rapid and efficient mechanism to develop size estimates of key populations including female sex workers (FSWs) and geolocate them at physical locations in a systematic and scientific manner. At the macro level, this information forms the basis for allocating program resources, setting performance targets, and assess coverage. At a micro level, PM data provide specific information on hot spots, estimates of FSWs at those spots, and hot spot typology and days and times of operation, all of which provides targeted service delivery strategies. This information can provide a reliable platform to plan HIV prevention and treatment services to considerable scale and intensity. Above all, the entire PM process requires deep involvement of FSWs, which increases community ownership of the data and can lead to an increased uptake of services. Despite a few limitations, the approach is versatile and can be used in varied country contexts to generate important information about sex work and its dynamics. In this paper, we describe experiences and lessons learned from using evidence generated from PM of FSWs in multiple countries to develop HIV prevention programs at scale.

OBJECTIVES: The American Academy of Pediatrics recommends universal screening for anemia using hemoglobin at 12 months. However, hemoglobin lacks diagnostic accuracy for iron deficiency, and the optimal age for screening has not been determined. Our objective was to assess a screening strategy for iron deficiency using serum ferritin. METHODS: We conducted a cross-sectional study of children 1 to 3 years old attending a health supervision visit. We examined the relationship between child age and serum ferritin, age and hemoglobin, hemoglobin and serum ferritin, and the prevalence of elevated C-reactive protein (CRP). RESULTS: Restricted cubic spline analysis (n = 1735) revealed a nonlinear relationship between age and serum ferritin (P < .0001). A linear spline model revealed that from 12 to 15 months, for each 1-month increase in age, serum ferritin levels decreased by 9% (95% confidence interval [CI]: 5 to 13). From 15 to 24 months, the rate of change was nonsignificant. From 24 to 38 months, for each month increase in age, serum ferritin increased by 2% (95% CI: 1 to 2). For hemoglobin, from 12 to 24 months, the rate of change was nonsignificant. From 24 to 38 months, for each 1-month increase in age, hemoglobin increased by 20% (95% CI: 9 to 32). Compared with the serum ferritin cutoff of CONCLUSIONS: Screening for iron deficiency using serum ferritin at 15 or 18 months may be a promising strategy. For children at low risk for acute inflammation, concurrent measurement of CRP may not be necessary.

Chronic noncancer pain includes any painful condition that persists for at least three months and is not associated with malignant disease.[1][1] According to seven national surveys conducted between 1994 and 2008, 15%–19% of Canadian adults live with chronic noncancer pain.[2][2] Chronic

Doxylamine-pyridoxine is the first-line agent for the treatment of nausea and vomiting of pregnancy (NVP) according to Canadian guidelines, and this combination is commonly prescribed to pregnant women. There is limited evidence that doxylamine-pyridoxine is more effective than pyridoxine alone. There is stronger support for the safety of pyridoxine monotherapy than for the combination of doxylamine-pyridoxine during pregnancy, and some conflicting evidence links doxylamine-pyridoxine use to pyloric stenosis and childhood malignancies. The role of doxylamine-pyridoxine as the first-line pharmacological treatment for NVP in Canada should be reconsidered.La combinaison doxylamine-pyridoxine constitue l’agent de première intention à utiliser pour la prise en charge de la nausée et des vomissements de la grossesse (NVG), selon les lignes directrices canadiennes traitant de la question, et cette combinaison est couramment prescrite aux femmes enceintes. Les données qui indiquent que la combinaison doxylamine-pyridoxine est plus efficace que la pyridoxine utilisée seule sont limitées. En fait, les données qui soutiennent l’innocuité de la monothérapie à la pyridoxine pendant la grossesse sont plus solides que les données qui soutiennent celle de la combinaison doxylamine-pyridoxine; de plus, certaines données contradictoires établissent des liens entre la combinaison doxylamine-pyridoxine et les tumeurs malignes de l’enfance et la sténose du pylore. Le rôle de la combinaison doxylamine-pyridoxine à titre de traitement pharmacologique de première intention pour contrer la nausée et les vomissements de la grossesse au Canada devrait être remis en question.

BACKGROUND Pharmaceutical companies are prohibited from marketing medications for off-label uses in both the United States and Canada. In the United States, there have been several recent multi-billion dollar settlements with pharmaceutical companies based, partly, on off-label promotion. Health Canada has not publicized any investigations into, or prosecutions of, pharmaceutical companies for off-label promotion in Canada even though many of the same medications are marketed here. The prohibition on off-label promotion is largely directed at preventing pharmaceutical companies from circumventing the drug licensing process and attendant safety checks. OBJECTIVE To determine if sanctions for off-label pharmaceutical promotion in one jurisdiction can be used to regulate marketing in another. METHODS We reviewed and compared the laws and regulatory bodies in Canada and the United States to determine if Canadian regulators could use the findings of American regulators. RESULTS There were no important differences in the laws and regulatory bodies in Canada and the United States related to off-label promotion. CONCLUSIONS Canadian regulators can use the findings of American regulators to investigate off-label promotion in Canada. All countries should consider using sanctions in other jurisdictions to direct the deployment of limited regulatory resources.

Finding new HIV-positive cases remains a priority to achieve the UNAIDS goals. An enhanced peer outreach approach (EPOA) was implemented to expand the delivery of HIV services to female sex workers (FSWs) and men who have sex with men (MSM) in three countries in West and Central Africa. The aim of EPOA is to identify new HIV-positive cases. EPOA was implemented in Burundi among FSWs, and in Cote d'Ivoire and Democratic Republic of the Congo (DRC) among both FSWs and MSM. Implementation ranged from five to nine weeks and was nested within a three-month reporting period. Standard outreach was suspended for the duration of EPOA implementation but was resumed thereafter. Summary service statistics were used to compare HIV seropositivity during standard outreach and EPOA. Trends were analyzed during the quarter in which EPOA was implemented, and these were compared with the two preceding quarters. Differences in proportions of HIV seropositivity were tested using Pearson's chi-square test; p-values of less than 0.05 were considered statistically significant. Overall, EPOA resulted in a higher proportion of new HIV-positive cases being found, both within and between quarters. In Burundi, HIV seropositivity among FSWs was significantly higher during EPOA than during standard outreach (10.8% vs. 4.1%, p

To examine the association between body mass index (BMI) and iron deficiency in early childhood, while considering the influence of low-grade systemic inflammation.Healthy children ages 1-3 years were included in a cross-sectional analysis. Age- and sex-standardized World Health Organization BMI z score (zBMI) was calculated using height/length and weight measurements; iron status was assessed by serum ferritin; inflammation was assessed by C-reactive protein (CRP). Children with CRP ≥10 mg/L were excluded because this may indicate acute systemic inflammation. Adjusted multivariable regression analyses were used to investigate the association between zBMI and both serum ferritin (µg/L), and iron deficiency (serum ferritin12 µg/L). We performed prespecified subgroup analyses according to CRP level (normal [≤1.0 mg/L] and low-grade inflammation [1.0 mg/L to10.0 mg/L]).Of 1607 children included, 20% were categorized as with zBMI1, 13% had iron deficiency, and 18% had low-grade inflammation. Higher zBMI was associated with lower serum ferritin (-1.51 µg/L, 95% CI -2.23, -0.76, P .0001) and increased odds of iron deficiency (OR 1.28, 95% CI 1.10, 1.50, P = .002). Though there was no interaction between zBMI and CRP for the adjusted linear regression model (P = .79) or logistic regression model (P = .43), children with low-grade inflammation had a higher serum ferritin (P .0001).Higher zBMI is associated with increased risk for iron deficiency in children between 1 and 3 years, and should be considered as a risk factor in targeted screening. Further research is needed to better understand the relationship between serum ferritin and CRP for children in all weight categories.ClinicalTrials.gov: NCT01869530.

Background: Modifiable behaviours during early childhood may provide opportunities to prevent disease processes before adverse outcomes occur. Our objective was to determine whether young children’s eating behaviours were associated with increased risk of cardiovascular disease in later life. Methods: In this cross-sectional study involving children aged 3–5 years recruited from 7 primary care practices in Toronto, Ontario, we assessed the relation between eating behaviours as assessed by the NutriSTEP (Nutritional Screening Tool for Every Preschooler) questionnaire (completed by parents) and serum levels of non–high-density lipoprotein (HDL) cholesterol, a surrogate marker of cardiovascular risk. We also assessed the relation between dietary intake and serum non-HDL cholesterol, and between eating behaviours and other laboratory indices of cardiovascular risk (low-density lipoprotein [LDL] cholesterol, apolipoprotein B, HDL cholesterol and apoliprotein A1). Results: A total of 1856 children were recruited from primary care practices in Toronto. Of these children, we included 1076 in our study for whom complete data and blood samples were available for analysis. The eating behaviours subscore of the NutriSTEP tool was significantly associated with serum non-HDL cholesterol ( p = 0.03); for each unit increase in the eating behaviours subscore suggesting greater nutritional risk, we saw an increase of 0.02 mmol/L (95% confidence interval [CI] 0.002 to 0.05) in serum non-HDL cholesterol. The eating behaviours subscore was also associated with LDL cholesterol and apolipoprotein B, but not with HDL cholesterol or apolipoprotein A1. The dietary intake subscore was not associated with non-HDL cholesterol. Interpretation: Eating behaviours in preschool-aged children are important potentially modifiable determinants of cardiovascular risk and should be a focus for future studies of screening and behavioural interventions.