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1.
Can J Cardiol ; 36(5): 775-779, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32389347

RESUMO

The Hypertension Canada 2018 clinical guidance for pregnancy hypertension recommends antihypertensive therapy for raised blood pressure in pregnancy to a target diastolic blood pressure (BP) of 85 mm Hg (ie, "tight" control). Although evidence shows this approach reduces the incidence of severe maternal hypertension without increasing risk to the baby, we do not know how pregnant women feel about this approach, particularly as they are generally medication averse. An online survey assessed pregnant women's preferences for management of pregnancy hypertension and explored decisional needs. The survey included information provision and knowledge assessment, a preference elicitation task, and a decisional needs assessment. Survey responses were analysed descriptively, by latent class analysis to identify treatment priority subgroups, and by logistic regression to assess predictors of treatment preference. For the 183 pregnant respondents, 3 treatment priority subgroups were identified, with most respondents expressing equal prioritization of treatment outcomes and components (eg, taking medication). Participants who preferred tight control (49%) were more often white (odds ratio [OR]: 2.38; 95% confidence interval [CI]: 1.18-4.55), with a university education/professional qualification (OR 1.95; 95% CI: 1.02-3.7), and had greater knowledge about pregnancy hypertension and pregnancy complications (OR 1.37; 95% CI: 1.15-1.65). Participants reported diverse decisional needs, but most preferred to make final treatment decisions themselves (70%), with (48%) or without (22%) physician input. The diversity of priorities, preferences, and decisional needs for management of pregnancy hypertension identified in this study emphasises the importance of an individualized approach to treatment recommendations.

2.
Spinal Cord ; 2020 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-32409778

RESUMO

STUDY DESIGN: Protocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial). PRIMARY OBJECTIVES: To test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI. SECONDARY OBJECTIVES: To investigate: (1) the effects of exercise on musculoskeletal and neuropathic chronic pain; (2) if reduced inflammation and increased descending inhibitory control are viable pathways by which exercise reduces pain; (3) the effects of chronic pain reductions on subjective well-being; and (4) efficiency of a home-/community-based exercise intervention. SETTING: Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada. METHOD: Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines, will be recruited and randomized to a 6-month Exercise or Wait-List Control condition. Exercise will occur in home/community settings and will be supported through behavioral counseling. All measures will be taken at baseline, 3-months and 6-months. Analyses will consist of linear mixed effect models, multiple regression analyses and a cost-utility analysis. The economic evaluation will examine the incremental costs and health benefits generated by the intervention compared with usual care. ETHICS AND DISSEMINATION: The University of British Columbia Clinical Research Ethics Board approved the protocol (#H19-01650). Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.

3.
Drug Alcohol Depend ; : 108005, 2020 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-32370932

RESUMO

BACKGROUND: Although previous studies have shown that opioid agonist therapy (OAT) is linked to reductions in illicit opioid use, less is known about how OAT impacts the use of other psychoactive substances. We aimed to examine the changes in use of different substances by comparing patterns before and after initiating OAT. METHODS: Data for this study was derived from three ongoing prospective cohorts involving people who use drugs in Vancouver, Canada from 1996 to 2018. We assessed use patterns for heroin, illicit prescription opioid, cocaine, crack cocaine, crystal methamphetamine, cannabis, daily alcohol use, and benzodiazepines. Segmented regression was conducted to compare the trends of substance use between pre-treatment and post-treatment periods. RESULTS: The study included 1107 participants. After OAT engagement, we observed an immediate decline in the proportion as well as a decreasing trend for heroin (Adjusted Odds Ratio (AOR): 0.80, 95% confidence interval (CI): 0.77, 0.83), illicit prescription opioid (AOR: 0.87, 95% CI: 0.83, 0.90), and benzodiazepines (AOR: 0.73, 95 % CI: 0.67, 0.80). There was no significant difference comparing the pre-treatment and post-treatment trends for cocaine, crack cocaine, crystal methamphetamine, and cannabis. However, higher growth slope was noted during the post-treatment period for daily alcohol use (P = 0.016). CONCLUSIONS: We observed significant reduction in illicit opioids use following OAT initiation, but not for stimulant and cannabis. The increasing problematic use of alcohol may pose challenges to the safety and effectiveness of OAT. Development of comprehensive and tailored treatment strategies is needed for poly-substance users accessing OAT.

4.
Vaccine ; 38(19): 3582-3590, 2020 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-32229052

RESUMO

BACKGROUND: Concern about adverse events following immunization is frequently cited by both those who receive or decline vaccines. Neurological adverse events are especially concerning. OBJECTIVES: Our aim was to detect associations between seasonal influenza vaccination and the occurrence of severe anesthesia/paresthesia or severe headaches. METHODS: Data were analyzed from the Canadian National Vaccine Safety network. Events occuring on days 0-7 were self-reported and prevented daily activity, led to school or work absenteeism, or required medical attention. Controls were the previous year's vaccinees; events in controls were collected prior to the start of the influenza vaccination program of each year (2012/13 through 2016/17). Multivariable logistic regression was used to determine the association between seasonal influenza vaccination and the occurrence of anesthesia/paresthesia or severe headaches. RESULTS: The total sample was 107,565 for investigating anesthesia/paresthesia and 97,420 for investigating severe headaches. Anesthesia/paresthesia was reported by 104/107,565 (0.10%) participants; 63/69,129 (0.09%) vaccinees and 41/38,436 (0.11%) controls (adjusted odds ratio (aOR) = 0.89; 95% CI = 0.60, 1.32). Severe headaches were reported by 1361/97,420 (1.40%) participants; 907/61,463 (1.48%) vaccinees and 454/35,957 (1.26%) controls (aOR = 1.21; 95% CI = 1.08, 1.36). No specific vaccine product was associated with severe headaches. CONCLUSIONS: Our study found no association between severe anesthesia/paresthesia and seasonal influenza vaccination. While there was an association with severe headaches as an adverse event following influenza vaccination, the rates of these events are similar to rates reported from clinical trials and are not a cause for additional concern.

5.
Open Heart ; 7(1): e001065, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32201581

RESUMO

Background: ST-segment elevation myocardial infarction (STEMI) outcomes are influenced by the location of the culprit vessel with worse outcomes portended with a left anterior descending (LAD) culprit lesion. However, relatively little is known about the independent association of LAD involvement with clinical outcomes of patients with STEMI with and without out-of-hospital cardiac arrest (OHCA). Methods: We identified 91 patients with and 929 without a preceding OHCA within the Vancouver Coastal Health Authority who presented with an acute STEMI and underwent primary percutaneous coronary intervention between 26 June 2007 and 31 March 2016. Results: Patients with STEMI with OHCA had higher rates of in-hospital cardiac arrest (43.3% vs 8.3%, p<0.001), heart failure (50.5% vs 11.3%, p<0.001), cardiogenic shock (49.5% vs 5.7%, p<0.001), mortality (35.2% vs 3.3%, p<0.001) and reduced left ventricular ejection fraction (LVEF; 42.9% vs 47.3%, p<0.001) compared with those without OHCA. Among patients without OHCA, LAD involvement was associated with increased heart failure (18.1% vs 5.2%, p<0.001), in-hospital cardiac arrest (10.7% vs 6.2%, p<0.014), cardiogenic shock (8.4% vs 3.3%, p<0.001), reduced LVEF (43.0% vs 51.2%, p<0.001) and mortality (5.2% vs 1.3%, p=0.003) compared with patients without LAD involvement. With the exception of LVEF, these associations were not seen among patients with STEMI with OHCA and an LAD culprit. The presence of an LAD culprit was not independently associated with increased hospital mortality among patients with OHCA after adjusting for potential confounding factors. Conclusion: Our study has demonstrated a differential impact of LAD involvement on clinical outcomes among patients with STEMI who present with and without OHCA. Our data highlight the complexity surrounding the prognostication following OHCA complicating STEMI and demonstrate that other mechanisms other than LAD involvement contribute to the high mortality associated with OHCA as a result of STEMI.

6.
Australas Psychiatry ; 28(2): 199-201, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32106697

RESUMO

OBJECTIVE: The current guidelines recommend screening all patients with first episode psychosis (FEP) for anti-NMDA receptor encephalitis. This paper explores the pitfalls of this strategy. CONCLUSION: Screening for anti-NMDA receptor encephalitis in patients with FEP when the pre-test probability based on the clinical presentation is low creates a risk of false positive results. Testing based on clinical suspicion would be preferable.

7.
Pregnancy Hypertens ; 19: 87-93, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31927325

RESUMO

OBJECTIVE: To examine the relationship between pregnancy outcomes and BP level and variability. DESIGN: Secondary analysis of CHIPS trial data (Control of Hypertension In Pregnancy Study, NCT01192412). SETTING: International. POPULATION OR SAMPLE: Women with chronic or gestational hypertension. METHODS: BP measurement was standardised in outpatient clinics. Adjusted (including for allocated group) mixed effects logistic regression was used to assess relationships between major CHIPS outcomes and both BP level (mean of clinic readings) and visit-to-visit within-participant BP variability (standard deviation and average real variability of absolute successive difference of BP values). BP values 7-28 days prior to outcomes (or birth for perinatal outcomes) were excluded in sensitivity analyses. MAIN OUTCOME MEASURES: Major CHIPS outcomes. RESULTS: Among 961 (97.4%) women, higher BP level was associated with more adverse maternal and perinatal outcomes (usually at p < 0.001) except for serious maternal complications. Among 913 (92.5%) women with at least two post-randomisation outpatient visits, higher BP variability was associated with increased odds of severe hypertension and pre-eclampsia (usually at p < 0.01). Sensitivity analyses suggested reverse causality for these maternal outcomes, but greater diastolic BP variability may have been associated with fewer adverse perinatal outcomes. CONCLUSIONS: Higher BP is an adverse prognostic marker, regardless of target BP. While the association between higher BP variability and severe hypertension and pre-eclampsia may be related to higher BP at diagnosis, our results suggest a possible advantage of BP variability for the fetus, through undefined mechanisms. TWEETABLE ABSTRACT: Higher blood pressure (BP) is associated with more adverse pregnancy outcomes, but higher BP variability may be good for the baby.

8.
Clin Infect Dis ; 70(5): 859-866, 2020 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-30919879

RESUMO

BACKGROUND: The Early Pediatric Initiation Canada Child Cure Cohort (EPIC4) study is a prospective, multicenter, Canadian cohort study investigating human immunodeficiency virus-1 (HIV-1) reservoirs, chronic inflammation, and immune responses in children with perinatally acquired HIV-1 infection. The focus of this report is HIV-1 reservoirs and correlates in the peripheral blood of children who achieved sustained virologic suppression (SVS) for ≥5 years. METHODS: HIV-1 reservoirs were determined by measuring HIV-1 DNA in peripheral blood mononuclear cells and inducible cell-free HIV-1 RNA in CD4+ T-cells by a prostratin analogue stimulation assay. HIV serology was quantified by signal-to-cutoff ratio (S/CO). RESULTS: Of 228 enrolled participants, 69 achieved SVS for ≥5 years. HIV-1 DNA, inducible cell-free HIV-1 RNA, and S/COs correlated directly with the age of effective combination antiretroviral therapy (cART) initiation (P < .001, P = .036, and P < .001, respectively) and age when SVS was achieved (P = .002, P = .038, and P < .001, respectively) and inversely with the proportion of life spent on effective cART (P < .001, P = .01, and P < .001, respectively) and proportion of life spent with SVS (P < .001, P = .079, and P < .001, respectively). Inducible cell-free HIV-1 RNA correlated with HIV-1 DNA, most particularly in children with SVS, without virologic blips, that was achieved with the first cART regimen initiated prior to 6 months of age (rho = 0.74; P = .037) or later (rho = 0.87; P < .001). S/COs correlated with HIV-1 DNA (P = .003), but less so with inducible cell-free HIV-1 RNA (P = .09). CONCLUSIONS: The prostratin analogue stimulation assay, with its lower blood volume requirement, could be a valuable method for evaluating inducible HIV-1 reservoirs in children. Standard commercial HIV serology may be a practical initial indirect measure of reservoir size in the peripheral blood of children with perinatally acquired HIV-1 infection.

9.
AIDS ; 2019 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-31794519

RESUMO

OBJECTIVES: The objective of this study was to determine the time to, and durability of, viral suppression, among Canadian children living with HIV after initiation of combination antiretroviral therapy (cART). DESIGN: Prospective, multicenter Canadian cohort study (Early Pediatric Initiation Canada Child Cure Cohort), using both prospective and retrospectively collected data. METHODS: Kaplan-Meir survival estimates with Cox regression were used to determine the time to and risk factors for viral suppression, defined as two consecutive undetectable viral loads (<50 copies/ml) at least 30 days apart after initiation of cART. RESULTS: A total of 228 children were enrolled between December 2014 and December 2018. The time to viral suppression was significantly shorter among children initiating cART after 5 vs. 5 years or less of age [adjusted hazard ratio (aHR) 1.57, 95% confidence interval (CI) 1.13-2.20], among those born after 2010 vs. prior (aHR 1.71, 95% CI 1.04-2.79), and among those without child protection services involvement (aHR 1.44, 95% CI 1.03-2.01). Overall, 27% of children had a viral rebound within 3 years of achieving viral suppression; the risk of viral rebound was significantly lower among children initiating cART after 5 vs. 5 years or less of age [adjusted odds ratio (aOR): 0.32, 95% CI 0.13-0.81], those whose families had not received social assistance (aOR 0.16, 95% CI 0.06-0.46), and females vs. males (aOR 0.51, 95% CI 0.26-0.99). CONCLUSION: Only 73% of the children in the Early Pediatric Initiation Canada Child Cure Cohort had maintained viral suppression 3 years after it was first achieved. Age at cART initiation, and socioeconomic factors were predictors of both time to viral suppression and risk of viral rebound in this cohort.

10.
Trials ; 20(1): 781, 2019 Dec 27.
Artigo em Inglês | MEDLINE | ID: mdl-31881991

RESUMO

BACKGROUND: The current treatment paradigm for type 2 diabetes mellitus (T2D) typically involves use of multiple medications to lower glucose levels in hope of reducing long-term complications. However, such treatment does not necessarily address the underlying pathophysiology of the disease and very few patients achieve partial, complete, or prolonged remission of T2D after diagnosis. The therapeutic potential of nutrition has been highlighted recently based on results of clinical trials reporting remission of T2D with targeted dietary approaches. During the initial phase of such interventions that restrict carbohydrates and/or induce rapid weight loss, hypoglycemia presents a notable risk to patients. We therefore hypothesized that delivering very low-carbohydrate, low-calorie therapeutic nutrition through community pharmacies would be an innovative strategy to facilitate lowering of glycated hemoglobin (A1C) while safely reducing the use of glucose-lowering medications in T2D. METHODS: A community-based randomized controlled trial that is pragmatic in nature, following a parallel-group design will be conducted (N = 200). Participants will have an equal chance of being randomized to either a pharmacist-led, therapeutic carbohydrate restricted (Pharm-TCR) diet or guideline-based treatment as usual (TAU). Pharm-TCR involves a 12-week very low carbohydrate, calorie-restricted commercial diet plan led by pharmacists and lifestyle coaches with pharmacists responsible for managing medications in collaboration with the participants' family physicians. Main inclusion criteria are diagnosis of T2D, currently treated with glucose-lowering medications, age 30-75 years, and body mass index ≥ 30. The primary outcome is a binary measure of use of glucose-lowering medication. Secondary outcomes include A1C, anthropometrics and clinical blood markers. DISCUSSION: There are inherent risks involved if patients with T2D who take glucose-lowering medications follow very low carbohydrate diets. This randomized controlled trial aims to determine whether engaging community pharmacists is a safe and effective way to deliver therapeutic carbohydrate restriction and reduce/eliminate the need for glucose-lowering medications in people with T2D. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03181165. Registered on 8 June 2017.

11.
Clin Infect Dis ; 2019 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-31617568

RESUMO

BACKGROUND: Several countries have implemented a 2-dose (2D) human papillomavirus (HPV) vaccination schedule for adolescents based on immunobridging studies. We compared immunogenicity of 2D vs 3-dose (3D) schedules of the quadrivalent vaccine (4vHPV) up to 10 years after the first dose. METHODS: Girls aged 9-13 years were randomized to receive 2D or 3D and were compared with women aged 16-26 receiving 3D at day 1 and months 7, 24, and 120 after the first dose. Antibody levels for HPV6/11/16/18 were evaluated using the competitive Luminex immunoassay (cLIA) and total immunoglobulin G assay. Geometric mean titers (GMTs) and seropositivity rates were compared between the different groups at different time points. Noninferiority of GMT ratios was defined as the lower bound of the 2-sided 95% confidence interval (CI) being greater than 0.5. Kinetics of antibody titers over time among study groups were examined. RESULTS: At 120 months, data from 35 2D girls, 38 3D girls, and 30 3D women were used for analyses. cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%). GMT ratios (cLIA) for both 2D and 3D girls were noninferior to 3 doses in women for HPV6/11/16/18. Trends were comparable between assays. CONCLUSIONS: GMTs for HPV6/11/16/18 after 2D or 3D of 4vHPV in girls were noninferior to 3D in adult women up to 120 months postvaccination. This study demonstrates long-term immunogenicity of the 2D HPV vaccine schedule.

12.
Pregnancy Hypertens ; 18: 156-162, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31627057

RESUMO

The international CHIPS Trial (Control of Hypertension In Pregnancy Study) enrolled 987 women with chronic (75%) or gestational (25%) hypertension. Pre-eclampsia developed in 48%; women remained on their allocated BP control and delivered an average of two weeks later. 'Less tight' control (target diastolic BP 100 mmHg) achieved BP that was 6/5mmHg higher (p < 0.001) than 'tight' control (target diastolic 85 mmHg, BP achieved 133/85 mmHg). 'Less tight' (vs. 'tight') control resulted in similar adverse perinatal outcomes (31.5% vs. 30.7%; p = 0.84) that balanced birthweight < 10th percentile (16.1% vs. 19.8%; p = 0.14) against preterm birth (35.6% vs. 31.5%; p = 0.18). 12-month follow-up revealed no compelling evidence for developmental programming of child growth. However, 'less tight' (vs. 'tight') control resulted in more severe maternal hypertension (40.6% vs. 27.5%; p < 0.001), and more women with platelets < 100 × 109/L (4.3% vs. 1.6%; p = 0.02) or symptomatic elevated liver enzymes (4.3% vs. 1.8%; p = 0.03), with no difference in serious maternal complications (3.7% vs. 2.0%; p = 0.17). Labetalol was the drug of choice. Methyldopa did not result in inferior outcomes. Post-hoc, severe hypertension, independent of pre-eclampsia, was associated with heightened increased risk of adverse outcomes, and in 'less tight' control, of serious maternal complications. At no gestational age at initiation of BP control was 'less tight' superior to 'tight'. Women in both groups were equally satisfied with care. 'Less tight' control tended to be more expensive by CAD$6000 (p =0.07) based on neonatal care costs. Collectively, CHIPS publications have provided evidence that women with non-severe pregnancy hypertension should receive 'tight' BP control achieved by a simple algorithm.

13.
Trials ; 20(1): 572, 2019 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533793

RESUMO

BACKGROUND: Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populations or that allow adding/removing arms during the trial), offering enhanced efficiency and a more ethical approach to trial evaluation. Despite the many advantages of these designs, they are infrequently used. METHODS: We conducted a landscape analysis of master protocols using a systematic literature search to determine what trials have been conducted and proposed for an overall goal of improving the literacy in this emerging concept. On July 8, 2019, English-language studies were identified from MEDLINE, EMBASE, and CENTRAL databases and hand searches of published reviews and registries. RESULTS: We identified 83 master protocols (49 basket, 18 umbrella, and 16 platform trials). The number of master protocols has increased rapidly over the last five years. Most have been conducted in the US (n = 44/83) and investigated experimental drugs (n = 82/83) in the field of oncology (n = 76/83). The majority of basket trials were exploratory (i.e., phase I/II; n = 47/49) and not randomized (n = 44/49), and more than half (n = 28/48) investigated only a single intervention. The median sample size of basket trials was 205 participants (interquartile range, Q3-Q1 [IQR]: 500-90 = 410), and the median study duration was 22.3 (IQR: 74.1-42.9 = 31.1) months. Similar to basket trials, most umbrella trials were exploratory (n = 16/18), but the use of randomization was more common (n = 8/18). The median sample size of umbrella trials was 346 participants (IQR: 565-252 = 313), and the median study duration was 60.9 (IQR: 81.3-46.9 = 34.4) months. The median number of interventions investigated in umbrella trials was 5 (IQR: 6-4 = 2). The majority of platform trials were randomized (n = 15/16), and phase III investigation (n = 7/15; one did not report information on phase) was more common in platform trials with four of them using seamless II/III design. The median sample size was 892 (IQR: 1835-255 = 1580), and the median study duration was 58.9 (IQR: 101.3-36.9 = 64.4) months. CONCLUSIONS: We anticipate that the number of master protocols will continue to increase at a rapid pace over the upcoming decades. More efforts to improve awareness and training are needed to apply these innovative trial design methods to fields outside of oncology.

14.
Open Forum Infect Dis ; 6(7)2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31363776

RESUMO

BACKGROUND: We conducted a pilot study assessing the feasibility, efficacy, and safety of a simplified combination HIV antiretroviral and hepatitis C virus (HCV) antiviral regimen in HIV-HCV coinfection. METHODS: Participants on suppressive antiretrovirals and HCV genotype 1 infection were switched to single-tablet daily-dosed elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and 1 month later initiated single-tablet-regimen daily-dosed ledipasvir-sofosbuvir for 12 weeks. E/C/F/TAF was continued during HCV treatment and for 12 weeks after. RESULTS: Twenty-six individuals were screened, 25 enrolled, and 23 completed all HIV and HCV treatment. Participants were predominantly male, with a mean age (SD) of 55 (7.5) years. The median transient elastography score (interquartile range [IQR]) was 5.9 (5.3 to 7.6) kPa, and the mean CD4 count (SD) was 579 (223) cells/µL. The median adherence to HCV medications, assessed by pill count, was 100% (95% confidence interval [CI], 100%-100%), and HIV ranged from 99% to 100% (100%; 95% CI, 90%-100%) over the 7-month study duration. HIV undetectability was maintained in all but 1 participant enrolled with unsuspected multiclass resistance. Treatment was well tolerated, with no study medication modification due to adverse events and no serious adverse event related to the study drug. All participants achieved sustained virological response. The mean CD4 count (SD) increased to 673 (361) cells/µL, and the fibrosis score (IQR) declined to 5.2 (4.4 to 7.4) kPa by week 12 after HCV treatment. There was no treatment effect on glucose metabolism. Cholesterol increased during and after treatment. CONCLUSIONS: Provision of this 2-tablet daily HIV-HCV regimen is feasible, well tolerated, and safe, avoids drug-drug interactions between HIV and HCV medications, maintains HIV suppression in the absence of drug resistance, and is highly curative of HCV.

15.
Addiction ; 114(12): 2173-2186, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31328354

RESUMO

BACKGROUND AND AIMS: Injection drug use patterns are known to change over time, although such long-term changes have not been well described. We sought to characterize longitudinal trajectories of injection drug use and identify associated factors. DESIGN: Data were derived from the Vancouver Injection Drug Users Study and AIDS Care Cohort to evaluate the Exposure to Survival Services study, two prospective cohorts involving people who inject drugs in Vancouver, Canada between 1996 and 2017. Growth mixture modeling was applied to identify distinct injection drug use trajectories. Multinomial logistic regression was used to identify baseline factors associated with each trajectory. SETTING: Canada. PARTICIPANTS: A total of 2057 participants who reported having used illicit drugs via injection in the past 6 months at the baseline visit were included in the study. The median time since first injection drug use at baseline was 14.8 years (quartile 1-quartile 3: 6.5-24.3). MEASUREMENTS: Information regarding self-reported injection drug use during the past 6 months was collected at baseline and semi-annually thereafter via interviewer-administered questionnaires. FINDINGS: Participants were followed for a median of 113.4 months (quartile 1-quartile 3: 63.4-161.7). Five trajectories were identified: persistent high frequency injection (507, 24.6%); high frequency injection with late decrease (374, 18.2%); gradual cessation (662, 32.2%); early cessation with late relapse (227, 11.0%); and early cessation (287, 14.0%). Factors found to be associated with distinct trajectories included: daily heroin injection, binge injection drug use, age, not being in a stable relationship and year of study enrollment. CONCLUSIONS: People who used drugs in Vancouver, Canada from 1996 to 2017 appeared to follow five drug use trajectories, ranging from persistent high frequency use to early cessation. Almost 25% of participants remained high-frequency injectors over the study period.

16.
Acta Diabetol ; 56(7): 755-765, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31093764

RESUMO

AIM: To examine the effect of walking before dinner on 24-h glycemic control in individuals with type 2 diabetes using the standardized multi-site Exercise-Physical Activity and Diabetes Glucose Monitoring (E-PAraDiGM) Protocol. METHODS: Eighty participants were studied under two conditions (exercise vs. non-exercise control) separated by 72 h in a randomized crossover design. Each condition lasted 2 days during which standardized meals were provided. Exercise consisted of 50 min of treadmill walking at 5.0 km/h before the evening meal, while control involved 50 min of sitting. The primary outcome measure was mean glucose during the 24-h period following exercise (or sitting) measured by continuous glucose monitoring. RESULTS: Of the 80 participants who were initially randomized, 73 completed both exercise and control. Sixty-three participants [29 males, 34 females; age = 64 ± 8 years, body mass index = 30.5 ± 6.5 kg/m2 and HbA1c = 51 ± 8 mmol/mol (6.8 ± 0.7%), mean ± SD] complied with the standardized diets and had complete continuous glucose monitoring data. Exercise did not affect mean 24-h glucose compared to control (0.03 mmol/L; 95% CI - 0.17, 0.22, P = 0.778) but individual differences between conditions ranged from - 2.8 to +1.8 mmol/L. Exercise did not affect fasting glucose, postprandial glucose or glucose variability. Glucose concentrations measured by continuous glucose monitoring were reduced during the 50 min of walking in exercise compared to sitting in control (- 1.56 mmol/L; 95% CI - 2.18, - 0.95, p < 0.001). CONCLUSION: Contrary to previous acute exercise studies, 50 min of walking before dinner in the E-PAraDiGM protocol did not affect 24-h glucose profiles. However, highly heterogeneous responses to exercise were observed. TRIAL REGISTRATION: NCT02834689.


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/terapia , Refeições , Caminhada/fisiologia , Adulto , Idoso , Automonitorização da Glicemia , Estudos Cross-Over , Diabetes Mellitus Tipo 2/diagnóstico , Exercício Físico/fisiologia , Teste de Esforço , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Prandial/fisiologia , Fatores de Tempo
17.
JMIR Res Protoc ; 8(3): e11226, 2019 Mar 26.
Artigo em Inglês | MEDLINE | ID: mdl-30912761

RESUMO

BACKGROUND: Worldwide incidence of type 2 diabetes (T2D) is rapidly increasing. Given the numerous negative health consequences associated with T2D, prevention of this disease has become a priority. Lifestyle changes, including regular exercise, can reduce the onset of T2D in those at elevated risk. However, long-term adherence to exercise is often poor in this population. Existing lifestyle interventions targeting exercise are labor intensive and costly for staff and participants. Evidence-informed counseling delivered in a manner that reduces dependence on staff and facilitates self-regulatory skills could alleviate time and financial barriers while promoting independent exercise. OBJECTIVE: This protocol outlines the design, recruitment, and proposed analysis of a brief, 2-week evidence-informed exercise counseling intervention combined with either high-intensity interval training (HIIT) or traditional moderate-intensity continuous training (MICT). METHODS: Small Steps for Big Changes is a 2-arm randomized controlled trial that will examine the effectiveness of combining brief exercise counseling with HIIT or MICT on adherence to moderate and vigorous exercise over 1 year. Cardiorespiratory fitness will be assessed at baseline, post intervention (2 weeks), and at 6- and 12-month follow-up. Physical activity behavior will be examined at baseline, post intervention, and 3-, 6-, 9-, and 12-month follow-up. The impact of the intervention on psychosocial outcomes pertinent to exercise adherence will be examined. RESULTS: Data collection was complete in March 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. CONCLUSIONS: The results of this brief intervention have the potential to inform future public health efforts designed to increase exercise in individuals at risk of T2D. TRIAL REGISTRATION: ClinicalTrials.gov NCT02164474; https://clinicaltrials.gov/ct2/show/NCT02164474 (Archived by WebCite at http://www.webcitation.org/74Hx1ipj6). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11226.

18.
BMJ Open ; 9(1): e024793, 2019 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-30659041

RESUMO

INTRODUCTION: Despite antiretroviral therapy (ART), people living with HIV have higher rates of non-infectious chronic diseases. These conditions are driven by relatively high levels of inflammation persisting on ART compared with uninfected individuals. Chronic inflammation also contributes to HIV persistence during ART. Cannabis when taken orally may represent a way to reduce inflammation and strengthen immune responses. Before planning large interventional studies, it is important to ensure that cannabis taken orally is safe and well tolerated in people living with HIV. We propose to conduct a pilot randomised trial to examine the safety and tolerability of cannabis oils containing tetrahydrocannabinol (THC) and cannabidiol (CBD) consumed orally in people living with HIV. We will also measure inflammatory markers, markers of HIV persistence in peripheral blood cells and changes in the gastrointestinal microbiome. METHODS AND ANALYSIS: Twenty-six people living with HIV having undetectable viral load for at least 3 years will be randomised to receive TN-TC11LM (THC:CBD in 1:1 ratio) or TN-TC19LM (THC:CBD in 1:9 ratio) capsules daily for 12 weeks. Safety and tolerability of these capsules will be assessed through haematological, hepatic and renal blood tests, face-to-face interviews and questionnaires. Proportions of participants without any signs of significant toxicity (grades 0-2 scores on the WHO toxicity scale) and who complete the study, as well as scores on quality of life and mood will be examined using descriptive statistics. The effects on inflammatory markers, markers of peripheral blood reservoir size and effect on the composition of the gastrointestinal microbiome will be assessed before and after study completion. ETHICS AND DISSEMINATION: This study has been approved by the Research Institute of the McGill University Health Centre. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open-access journal within 6 months of study completion. TRIAL REGISTRATION NUMBER: NCT03550352.


Assuntos
Antirretrovirais/uso terapêutico , Canabidiol/administração & dosagem , Dronabinol/administração & dosagem , Infecções por HIV/tratamento farmacológico , Canabidiol/efeitos adversos , Dronabinol/efeitos adversos , Quimioterapia Combinada , Microbioma Gastrointestinal/efeitos dos fármacos , Humanos , Projetos Piloto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Ann Otol Rhinol Laryngol ; 128(4): 316-322, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30614248

RESUMO

OBJECTIVES:: To determine the impact of socioeconomic status (SES) on voice outcomes for spasmodic dysphonia (SD) patients treated with botulinum toxin injections. METHODS:: This was a prospective cross-sectional study in a tertiary care, academic voice clinic in Canada. Adult SD patients returning to the voice clinic for their botulinum toxin injections were recruited from October 2017 to April 2018. Patients completed a questionnaire on demographic data, the Hollingshead Four-Factor Index for socioeconomic status (validated instrument based on education, occupation, gender, and marital status), and the Voice-Handicap Index 10 (VHI-10) (validated instrument on self-reported vocal handicap). Primary outcome was the association between VHI-10 and Hollingshead Index. Secondary variables were median household income by postal code, duration of disease, gender, age, and professional voice user. Descriptive statistics and multiple linear regression were conducted. RESULTS:: One hundred and one patients (age = 62.8 ± 13.7 years, 20.8% male) were recruited with VHI-10 of 22.1 ± 8.1 (out of 40) and Hollingshead Index of 46.3 ± 11.7 (range, 8-66). Median household income was $75 875 ± $16 393, which was above the Canadian average of $70 336. About 91.1% were Caucasian, 54.4% had university degree, 86.1% spoke English, and 43.5% were employed. In multiple linear regression, there was mild to moderate negative correlation (r = -.292, P = .004) between VHI-10 and Hollingshead Index when controlling for disease duration, age, gender, and professional voice use. CONCLUSION:: SD patients treated with botulinum toxin were mostly affluent, Caucasian, well educated, and English speakers. Lower self-perceived vocal handicap was associated with higher socioeconomic status.


Assuntos
Toxinas Botulínicas , Disfonia , Classe Social , Qualidade da Voz , Idoso , Atitude Frente a Saúde , Toxinas Botulínicas/administração & dosagem , Toxinas Botulínicas/efeitos adversos , Canadá/epidemiologia , Estudos Transversais , Avaliação da Deficiência , Disfonia/epidemiologia , Disfonia/fisiopatologia , Disfonia/psicologia , Disfonia/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neurotoxinas/administração & dosagem , Neurotoxinas/efeitos adversos , Estudos Prospectivos , Autorrelato/estatística & dados numéricos
20.
JMIR Res Protoc ; 8(1): e12322, 2019 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-30635261

RESUMO

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. OBJECTIVE: In this paper, we report on a protocol to evaluate Healing Circles-an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. METHODS: In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. RESULTS: The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. CONCLUSIONS: Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. TRIAL REGISTRATION: ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12322.

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