Publications by authors named "Lehana Thabane"

826 Publications

Sensitivity and specificity of self-reported psychiatric diagnoses amongst patients treated for opioid use disorder.

BMC Psychiatry 2021 10 21;21(1):520. Epub 2021 Oct 21.

Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada.

Background: Patients with opioid use disorder (OUD) frequently present with comorbid psychiatric illnesses which have significant implications for their treatment outcomes. Notably, these are often identified by self-report. Our study examined the sensitivity and specificity of self-reported psychiatric diagnoses against a structured diagnostic interview in a cohort of patients receiving outpatient pharmacological treatment for OUD.

Methods: Using cross-sectional data from adults receiving outpatient opioid agonist treatment for OUD in clinics across Ontario, Canada, we compared participants' self-reported psychiatric diagnoses with those identified by the Mini Neuropsychiatric Interview (MINI) Version 6.0 administered at the time of study entry. Sensitivity and specificity were calculated for self-report of psychiatric diagnoses.

Results: Amongst a sample of 683 participants, 24% (n = 162) reported having a comorbid psychiatric disorder. Only 104 of these 162 individuals (64%) reporting a comorbidity met criteria for a psychiatric disorder as per the MINI; meanwhile, 304 (75%) participants who self-reported no psychiatric comorbidity were in fact identified to meet MINI criteria for a psychiatric disorder. The sensitivity and specificity for any self-reported psychiatric diagnoses were 25.5% (95% CI 21.3, 30.0) and 78.9% (95% CI 73.6, 83.6), respectively.

Conclusions: Our findings raise questions about the utility of self-reported psychiatric comorbidity in patients with OUD, particularly in the context of low sensitivity of self-reported diagnoses. Several factors may contribute to this including remittance and relapse of some psychiatric illnesses, underdiagnosis, and the challenge of differentiating psychiatric and substance-induced disorders. These findings highlight that other methods should be considered in order to identify comorbid psychiatric disorders in patients with OUD.
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http://dx.doi.org/10.1186/s12888-021-03489-4DOI Listing
October 2021

Relationship between hormonal contraceptives and sleep among women of reproductive age: a systematic review protocol.

BMJ Open 2021 Oct 8;11(10):e045819. Epub 2021 Oct 8.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

Introduction: The aetiology of sleep disruptions is unknown, but hormonal fluctuations during the menstrual cycle, pregnancy and menopause have been shown to potentially affect how well a woman sleeps. The aim of this systematic review was to investigate whether hormonal contraceptives are associated with a decreased quality of sleep and increased sleep duration in women of reproductive age.

Methods: This review will analyse data from randomised controlled trials or non-randomised comparative studies investigating the association between hormonal contraceptives and sleep outcomes among women of reproductive age. Reviews addressing the same research question with similar eligibility criteria will be included. A literature search will be performed using the MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases from inception to 7 March 2021. The Cochrane Collaboration's Risk of Bias for Randomised Trials V.2.0 and The Risk of Bias for Non-randomised Studies of Interventions tool will be used to assess risk of bias for each outcome in eligible studies. Two reviewers will independently assess eligibility of studies and risk of bias and extract the data. All extracted data will be presented in tables and narrative form. For sleep measures investigated by two or more studies with low heterogeneity, we will conduct random-effects meta-analysis to estimate the magnitude of the overall effect of hormonal contraceptives. If studies included in this systematic review form a connected network, a network meta-analysis will be conducted to estimate the comparative effect of different contraceptives. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to summarise the quality of evidence. Our protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015 guidelines.

Ethics And Dissemination: Ethics approval is not required as data were sourced from previously reported studies. The findings of this review will be published in a peer-reviewed journal and presented at relevant conferences.

Prospero Registration Number: CRD42020199958.
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http://dx.doi.org/10.1136/bmjopen-2020-045819DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8504351PMC
October 2021

Quantifying the impacts of human mobility restriction on the spread of coronavirus disease 2019: an empirical analysis from 344 cities of China.

Chin Med J (Engl) 2021 Oct 7;134(20):2438-2446. Epub 2021 Oct 7.

Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.

Background: Since the outbreak of coronavirus disease 2019 (COVID-19), human mobility restriction measures have raised controversies, partly because of the inconsistent findings. An empirical study is promptly needed to reliably assess the causal effects of the mobility restriction. The purpose of this study was to quantify the causal effects of human mobility restriction on the spread of COVID-19.

Methods: Our study applied the difference-in-difference (DID) model to assess the declines of population mobility at the city level, and used the log-log regression model to examine the effects of population mobility declines on the disease spread measured by cumulative or new cases of COVID-19 over time after adjusting for confounders.

Results: The DID model showed that a continual expansion of the relative declines over time in 2020. After 4 weeks, population mobility declined by -54.81% (interquartile range, -65.50% to -43.56%). The accrued population mobility declines were associated with the significant reduction of cumulative COVID-19 cases throughout 6 weeks (ie, 1% decline of population mobility was associated with 0.72% [95% CI: 0.50%-0.93%] reduction of cumulative cases for 1 week, 1.42% 2 weeks, 1.69% 3 weeks, 1.72% 4 weeks, 1.64% 5 weeks, and 1.52% 6 weeks). The impact on the weekly new cases seemed greater in the first 4 weeks but faded thereafter. The effects on cumulative cases differed by cities of different population sizes, with greater effects seen in larger cities.

Conclusions: Persistent population mobility restrictions are well deserved. Implementation of mobility restrictions in major cities with large population sizes may be even more important.
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http://dx.doi.org/10.1097/CM9.0000000000001763DOI Listing
October 2021

Metabolically healthy obesity in children enrolled in the CANadian Pediatric Weight management Registry (CANPWR): An exploratory secondary analysis of baseline data.

Clin Obes 2021 Oct 7:e12490. Epub 2021 Oct 7.

Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.

Our study purpose was to determine the prevalence of metabolically healthy obesity (MHO) and examine factors associated with MHO in children with obesity. This cross-sectional study was a secondary, exploratory analysis of data that included 2-17 years old with a body mass index (BMI) ≥85th percentile from the CANadian Pediatric Weight management Registry. Children were classified as having MHO or metabolically unhealthy obesity (MUO) using consensus-based criteria. Those with MHO had normal triglycerides, high-density lipoprotein cholesterol, blood pressure, and fasting glucose. Logistic regression was used to examine factors associated with MHO, which included calculating odds ratios (ORs) and 95% confidence intervals (CIs). In total, 945 children were included (mean age: 12.3 years; 51% female). The prevalence of MHO was 31% (n = 297), with lower levels across increasing age categories (2-5 years [n = 18; 43%], 6-11 years [n = 127; 35%], 12-17 years [n = 152; 28%]). Children with MHO were younger, weighed less, and had lower BMI z-scores than their peers with MUO (all p < 0.01). MHO status was positively associated with physical activity (OR: 1.18; 95% CI: 1.01-1.38), skim milk intake (OR: 1.10; 95% CI: 1.01-1.19), and fruit intake (OR: 1.12; 95% CI: 1.01-1.24) and negatively associated with BMI z-score (OR: 0.69; 95% CI: 0.60-0.79), total screen time in hours (OR: 0.79; 96% CI: 0.68-0.92), and intake of fruit flavoured drinks (OR: 0.91; 95% CI: 0.84-0.99). These findings may help guide clinical decision-making regarding obesity management by focusing on children with MUO who are at relatively high cardiometabolic risk.
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http://dx.doi.org/10.1111/cob.12490DOI Listing
October 2021

Service providers endorse integrated services model for youth with mental health and substance use challenges: findings from a discrete choice experiment.

BMC Health Serv Res 2021 Oct 1;21(1):1035. Epub 2021 Oct 1.

Centre for Addiction and Mental Health, 80 Workman Way, Toronto, Ontario, Canada.

Background: Given high rates of mental health and substance challenges among youth and substantial system access barriers, system innovation is required. Integrated youth services (IYS) models aim to transform youth mental health and substance use services by creating integrative, collaborative models of care in youth-friendly settings. This study examines service provider perspectives on the key service components to include in IYS models.

Method: A discrete choice experiment modeled service provider preferences for the service components of IYSs. The sample includes 388 service provider/agency leader participants (age 18+) from youth-serving organizations in Ontario. Importance scores and utility values were calculated for 12 attributes represented by four levels each. Latent class analysis identified subgroups of participants with different preferences.

Results: The majority of participants were direct service providers working in larger organizations in the mental health and/or substance use sectors in large urban centers. Participants strongly endorsed service models that provide rapid access to the widest variety of culturally sensitive service options, with supplementary e-health services, in youth-focused community settings with evening and weekend hours. They prefer caregiver involvement in youth services and treatment decisions and support youth and family engagement. Latent class analyses reveal three segments of service providers: a Youth-Focused Service Accessibility segment representing 62.1% (241/388) of participants, a Service Options segment representing 27.6% (107/388) of participants, and a Caregiver Integration segment representing 10.3% (40/388) of participants. Within these segments, the degree of prioritization of the various service components differ; however, the overall endorsement of the service components remains largely consistent across classes for most attributes. The segments did not differ based on demographic or agency characteristics.

Conclusions: The core characteristics of IYS settings for youth with mental health and substance use challenges, i.e., rapid access to a wide range of youth-oriented services, are strong priorities of service providers and youth-serving agency leaders. These findings confirm that youth-oriented service providers endorse the importance and relevance of IYS models as a whole; strong service provider buy-in to the model is expected to facilitate development, implementation and scaling of IYS models. Hearing stakeholder perspectives, including those of service providers, youth, and caregivers, is essential to developing, effectively implementing, and scaling effective youth services.
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http://dx.doi.org/10.1186/s12913-021-07038-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487137PMC
October 2021

Risk of bias: why measure it, and how?

Eye (Lond) 2021 Sep 30. Epub 2021 Sep 30.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

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http://dx.doi.org/10.1038/s41433-021-01759-9DOI Listing
September 2021

Telephone Administration of the Automated Self-Administered 24-hour Dietary Assessment in Older Adults: Lessons Learned.

Can J Diet Pract Res 2021 Sep 28:1-5. Epub 2021 Sep 28.

Department of Kinesiology and Health Sciences, University of Waterloo, Waterloo, ON.

Automated Self-Administered 24-hour Dietary Assessment (ASA24) is an economical method of estimating dietary intake as nutrient analysis is automated, but its use in older adults is limited. The purpose of this work was to guide dietitians and future researchers on how to use the ASA24 with older adults, considering potential barriers encountered and strategies used to support completion based on our experience using this tool in a pilot clinical trial. ASA24 was completed by phone interview with 39 older adults. Challenges included: recalling food intake in detail, recording frequent eating occasions and complicated recipes, and general problems with communication. Strategies to support collection included making morning phone calls and suggesting that seniors write down the food consumed. Phone interviews were acceptable to older adults, but sufficient time was required. Dietitians and future researchers can use these findings to obtain dietary intake data from this hard-to-reach group.
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http://dx.doi.org/10.3148/cjdpr-2021-024DOI Listing
September 2021

Telephone Administration of the Automated Self-Administered 24-hour Dietary Assessment in Older Adults: Lessons Learned.

Can J Diet Pract Res 2021 Sep 28:1-5. Epub 2021 Sep 28.

Department of Kinesiology and Health Sciences, University of Waterloo, Waterloo, ON.

Automated Self-Administered 24-hour Dietary Assessment (ASA24) is an economical method of estimating dietary intake as nutrient analysis is automated, but its use in older adults is limited. The purpose of this work was to guide dietitians and future researchers on how to use the ASA24 with older adults, considering potential barriers encountered and strategies used to support completion based on our experience using this tool in a pilot clinical trial. ASA24 was completed by phone interview with 39 older adults. Challenges included: recalling food intake in detail, recording frequent eating occasions and complicated recipes, and general problems with communication. Strategies to support collection included making morning phone calls and suggesting that seniors write down the food consumed. Phone interviews were acceptable to older adults, but sufficient time was required. Dietitians and future researchers can use these findings to obtain dietary intake data from this hard-to-reach group.
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http://dx.doi.org/10.3148/cjdpr-2021-024DOI Listing
September 2021

The MoveStrong program for promoting balance and functional strength training and adequate protein intake in pre-frail older adults: A pilot randomized controlled trial.

PLoS One 2021 24;16(9):e0257742. Epub 2021 Sep 24.

Department of Kinesiology and Health, University of Waterloo, Waterloo, ON, Canada.

Background: Balance and functional strength training can improve muscle strength and physical functioning outcomes and decrease the risk of falls in older adults. To maximize the benefits of strength training, adequate protein intake is also important. However, the number of older individuals that consume enough protein or routinely engage in strength training remains low at less than 5% and even lower for activities that challenge balance. Our primary aim was to assess the feasibility of implementing a model (MoveStrong) of service delivery to teach older adults about balance and functional strength training and methods to increase protein intake.

Methods: This study was a closed cohort stepped wedge randomized controlled trial. We recruited individuals ≥60 years considered pre-frail or frail with at least one chronic condition who were not currently engaging in regular strength training from Northern (rural) and Southern (urban) Ontario sites in Canada. The primary outcome was feasibility of implementation, defined by recruitment, retention, and adherence, and safety (defined by monitoring adverse events). We also reported participants' and providers' experience with MoveStrong, adaptations to the model based on participant's and provider's experience, and program fidelity.

Results: We recruited 44 participants to the study and the average adherence rate was 72% with a retention of 71%. The program had a high-fidelity score. One person experienced a fall-related injury during exercise, while two other participants reported pain during certain activities. Five individuals experienced injuries or health problems that were not related to the program. Suggestions for future trials include modifying some exercises, exploring volunteer assistance, increasing the diversity of participants enrolled, and considering a different study design.

Conclusions: Our pilot trial demonstrates the feasibility of recruitment and adherence for a larger multisite RCT of balance and functional strength training with attention to protein intake in pre-frail and frail older adults.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0257742PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8462677PMC
September 2021

Effect of Probiotics on Incident Ventilator-Associated Pneumonia in Critically Ill Patients: A Randomized Clinical Trial.

JAMA 2021 09;326(11):1024-1033

Université de Sherbrooke, Sherbrooke, Canada.

Importance: Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported.

Objective: To evaluate the effect of Lactobacillus rhamnosus GG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU).

Design, Setting, And Participants: Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020).

Interventions: Enteral L rhamnosus GG (1 × 1010 colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU.

Main Outcomes And Measures: The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections including Clostridioides difficile infection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality.

Results: Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22; P = .73, absolute difference, 0.6%, 95% CI, -2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event of L rhamnosus in a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58; P < .001).

Conclusions And Relevance: Among critically ill patients requiring mechanical ventilation, administration of the probiotic L rhamnosus GG compared with placebo, resulted in no significant difference in the development of ventilator-associated pneumonia. These findings do not support the use of L rhamnosus GG in critically ill patients.

Trial Registration: ClinicalTrials.gov Identifier: NCT02462590.
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http://dx.doi.org/10.1001/jama.2021.13355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8456390PMC
September 2021

Evaluation of the sexual health in people living with hemophilia.

Haemophilia 2021 Sep 19. Epub 2021 Sep 19.

Department of Medicine, McMaster University, Hamilton, ON, Canada.

Background: Knowledge about sexual health, difficulty with sexual activity and intimacy (sexual difficulty), in people with hemophilia is little understood.

Objectives: The objectives were to determine the prevalence of sexual difficulty in people living with hemophilia (PWH) compared to people with no bleeding disorders (PWNoBD), and to determine factors associated with it.

Methods: This was an analysis of the PROBE study. We recruited individuals who had hemophilia A or B (PWH) and PWNoBD who were 18 years old or older. We calculated proportions of participants with sexual difficulty and odds ratios (ORs) adjusted for sex and age with 95% confidence intervals.

Results: There were 2007 PWH and 1972 PWNoBD. Mean (standard deviation) age was 41 (15) years in PWH and 42 (13) years in PWNoBD. Sexual difficulty was reported in 302 (15.1%) PWH and 79 (4.0%) PWNoBD. The odds of sexual difficulty were significantly higher in PWH (OR 3.82, 95% CI 2.85, 5.11). Among PWH, older age, experiencing acute or chronic pain in the past 12 months, bleeds within the past two weeks, ≥3 spontaneous joint bleeds (past six months), limitation of range of motion of any joints, and any life- or limb-threatening bleeds in the past 12 months were associated with sexual difficulty.

Conclusions: Sexual difficulty is more prevalent in people living with hemophilia and associated with markers of disease severity. Sexual health issues should be incorporated in comprehensive hemophilia care, future research, and hemophilia related health policy.
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http://dx.doi.org/10.1111/hae.14410DOI Listing
September 2021

Simple compared to covariate-constrained randomization methods in balancing baseline characteristics: a case study of randomly allocating 72 hemodialysis centers in a cluster trial.

Trials 2021 Sep 15;22(1):626. Epub 2021 Sep 15.

Lawson Health Research Institute, London, Ontario, Canada.

Background And Aim: Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization. This is done to increase the chance of balancing the groups on cluster- and patient-level baseline characteristics. This study assessed how well two covariate-constrained randomization methods balanced baseline characteristics compared with simple randomization.

Methods: We conducted a mock 3-year cluster-randomized trial, with no active intervention, that started April 1, 2014, and ended March 31, 2017. We included a total of 11,832 patients from 72 hemodialysis centers (clusters) in Ontario, Canada. We randomly allocated the 72 clusters into two groups in a 1:1 ratio on a single date using individual- and cluster-level data available until April 1, 2013. Initially, we generated 1000 allocation schemes using simple randomization. Then, as an alternative, we performed covariate-constrained randomization based on historical data from these centers. In one analysis, we restricted on a set of 11 individual-level prognostic variables; in the other, we restricted on principal components generated using 29 baseline historical variables. We created 300,000 different allocations for the covariate-constrained randomizations, and we restricted our analysis to the 30,000 best allocations based on the smallest sum of the penalized standardized differences. We then randomly sampled 1000 schemes from the 30,000 best allocations. We summarized our results with each randomization approach as the median (25th and 75th percentile) number of balanced baseline characteristics. There were 156 baseline characteristics, and a variable was balanced when the between-group standardized difference was ≤ 10%.

Results: The three randomization techniques had at least 125 of 156 balanced baseline characteristics in 90% of sampled allocations. The median number of balanced baseline characteristics using simple randomization was 147 (142, 150). The corresponding value for covariate-constrained randomization using 11 prognostic characteristics was 149 (146, 151), while for principal components, the value was 150 (147, 151).

Conclusion: In this setting with 72 clusters, constraining the randomization using historical information achieved better balance on baseline characteristics compared with simple randomization; however, the magnitude of benefit was modest.
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http://dx.doi.org/10.1186/s13063-021-05590-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444397PMC
September 2021

Individual and family characteristics associated with health indicators at entry into multidisciplinary pediatric weight management: findings from the CANadian Pediatric Weight management Registry (CANPWR).

Int J Obes (Lond) 2021 Sep 9. Epub 2021 Sep 9.

Department of Pediatrics, McMaster University, Hamilton, ON, Canada.

Objectives: (1) To explore individual and family characteristics related to anthropometric and cardiometabolic health indicators and (2) examine whether characteristics that correlate with cardiometabolic health indicators differ across severity of obesity at time of entry to Canadian pediatric weight management clinics.

Methods: We conducted a cross-sectional analysis of 2-17 year olds with overweight or obesity who registered in the CANadian Pediatric Weight Management Registry (CANPWR) between May 2013 and October 2017 prior to their first clinic visit. Individual modifiable health behaviors included dietary intake, physical activity, screen time, and sleep. Family characteristics included parental BMI, family medical history, socioeconomic status and family structure. Linear mixed effects stepwise regression analysis was performed to determine which characteristics were related to each health indicator: BMI z-score; waist circumference; waist to height ratio; blood pressure; glycemia; HDL cholesterol; non-HDL cholesterol; triglycerides.

Results: This study included 1296 children (mean age ± standard deviation: 12.1 ± 3.5 years; BMI z-score: 3.55 ± 1.29; 95.3% with obesity). Hours spent sleeping (estimated β = -0.10; 95% CI [-0.15, -0.05], p = 0.0001), hours per week of organized physical activity (estimated β = -0.32; 95% CI [-0.53, -0.11], p = 0.0026), daily sugared drink intake (estimated β = 0.06; 95% CI [0.01, 0.10], p = 0.0136) and maternal BMI (estimated β = 0.03; 95% CI [0.02, 0.04], p < 0.0001) were associated with BMI z-score (adj. R = 0.2084), independent of other individual and family characteristics. Physical activity, total sugared drink intake and sleep duration were associated with glycemia and non-HDL cholesterol, independent of child BMI z-score. However, irrespective of obesity severity, little of the variance (0.86-11.1%) in cardiometabolic health indicators was explained by individual modifiable health behaviors.

Conclusions: Physical activity, total sugared drink intake and hours spent sleeping were related to anthropometric and some cardiometabolic health indicators in children entering pediatric weight management programs. This highlights the importance of these modifiable health behaviors on multiple health indicators in children with obesity.
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http://dx.doi.org/10.1038/s41366-021-00959-3DOI Listing
September 2021

Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey.

RMD Open 2021 09;7(3)

Medicine, Division of Rheumatology, University of Washington, Seattle, Washington, USA.

Background: We describe the early experiences of adults with systemic rheumatic disease who received the COVID-19 vaccine.

Methods: From 2 April to 30 April 2021, we conducted an online, international survey of adults with systemic rheumatic disease who received COVID-19 vaccination. We collected patient-reported data on clinician communication, beliefs and intent about discontinuing disease-modifying antirheumatic drugs (DMARDs) around the time of vaccination, and patient-reported adverse events after vaccination.

Results: We analysed 2860 adults with systemic rheumatic diseases who received COVID-19 vaccination (mean age 55.3 years, 86.7% female, 86.3% white). Types of COVID-19 vaccines were Pfizer-BioNTech (53.2%), Oxford/AstraZeneca (22.6%), Moderna (21.3%), Janssen/Johnson & Johnson (1.7%) and others (1.2%). The most common rheumatic disease was rheumatoid arthritis (42.3%), and 81.2% of respondents were on a DMARD. The majority (81.9%) reported communicating with clinicians about vaccination. Most (66.9%) were willing to temporarily discontinue DMARDs to improve vaccine efficacy, although many (44.3%) were concerned about rheumatic disease flares. After vaccination, the most reported patient-reported adverse events were fatigue/somnolence (33.4%), headache (27.7%), muscle/joint pains (22.8%) and fever/chills (19.9%). Rheumatic disease flares that required medication changes occurred in 4.6%.

Conclusion: Among adults with systemic rheumatic disease who received COVID-19 vaccination, patient-reported adverse events were typical of those reported in the general population. Most patients were willing to temporarily discontinue DMARDs to improve vaccine efficacy. The relatively low frequency of rheumatic disease flare requiring medications was reassuring.
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http://dx.doi.org/10.1136/rmdopen-2021-001814DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424419PMC
September 2021

Investigating and addressing the immediate and long-term consequences of the COVID-19 pandemic on patients with substance use disorders: a scoping review and evidence map protocol.

BMJ Open 2021 09 7;11(9):e045946. Epub 2021 Sep 7.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Introduction: The COVID-19 pandemic has driven unprecedented social and economic reform in efforts to curb the impact of disease. Governments worldwide have legislated non-essential service shutdowns and adapted essential service provision in order to minimise face-to-face contact. We anticipate major consequences resulting from such policies, with marginalised populations expected to bear the greatest burden of such measures, especially those with substance use disorders (SUDs).

Methods And Analysis: We aim to conduct (1) a scoping review to summarise the available evidence evaluating the impact of the COVID-19 pandemic on patients with SUDs, and (2) an evidence map to visually plot and categorise the current available evidence evaluating the impact of COVID-19 on patients with SUDs to identify gaps in addressing high-risk populations.

Ethics And Dissemination: Ethics approval is not required for this scoping review as we plan to review publicly available data. This is part of a multistep project, whereby we intend to use the findings generated from this review in combination with data from an ongoing prospective cohort study our team is leading, encompassing over 2000 patients with SUDs receiving medication-assisted therapy in Ontario prior to and during the COVID-19 pandemic.
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http://dx.doi.org/10.1136/bmjopen-2020-045946DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424417PMC
September 2021

An improved method for analysis of interrupted time series (ITS) data: accounting for patient heterogeneity using weighted analysis.

Int J Biostat 2021 Sep 2. Epub 2021 Sep 2.

School of Epidemiology and Public Health, University of Ottawa Faculty of Medicine, Ottawa, ON, Canada.

Interrupted time series (ITS) design is commonly used to evaluate the impact of interventions in healthcare settings. Segmented regression (SR) is the most commonly used statistical method and has been shown to be useful in practical applications involving ITS designs. Nevertheless, SR is prone to aggregation bias, which leads to imprecision and loss of power to detect clinically meaningful differences. The objective of this article is to present a weighted SR method, where variability across patients within the healthcare facility and across time points is incorporated through weights. We present the methodological framework, provide optimal weights associated with data at each time point and discuss relevant statistical inference. We conduct extensive simulations to evaluate performance of our method and provide comparative analysis with the traditional SR using established performance criteria such as bias, mean square error and statistical power. Illustrations using real data is also provided. In most simulation scenarios considered, the weighted SR method produced estimators that are uniformly more precise and relatively less biased compared to the traditional SR. The weighted approach also associated with higher statistical power in the scenarios considered. The performance difference is much larger for data with high variability across patients within healthcare facilities. The weighted method proposed here allows us to account for the heterogeneity in the patient population, leading to increased accuracy and power across all scenarios. We recommend researchers to carefully design their studies and determine their sample size by incorporating heterogeneity in the patient population.
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http://dx.doi.org/10.1515/ijb-2020-0046DOI Listing
September 2021

Gait Kinematic and Kinetic Characteristics of Older Adults With Mild Cognitive Impairment and Subjective Cognitive Decline: A Cross-Sectional Study.

Front Aging Neurosci 2021 3;13:664558. Epub 2021 Aug 3.

Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Background: Older adults with mild cognitive impairment (MCI) have slower gait speed and poor gait performance under dual-task conditions. However, gait kinematic and kinetic characteristics in older adults with MCI or subjective cognitive decline (SCD) remain unknown. This study was designed to explore the difference in gait kinematics and kinetics during level walking among older people with MCI, SCD, and normal cognition (NC).

Methods: This cross-sectional study recruited 181 participants from July to December 2019; only 82 met the inclusion criteria and consented to participate and only 79 completed gait analysis. Kinematic and kinetic data were obtained using three-dimensional motion capture system during level walking, and joint movements of the lower limbs in the sagittal plane were analyzed by Visual 3D software. Differences in gait kinematics and kinetics among the groups were analyzed using multivariate analysis of covariance (MANCOVA) with Bonferroni analysis. After adjusting for multiple comparisons, the significance level was < 0.002 for MANCOVA and < 0.0008 for analysis.

Results: Twenty-two participants were MCI [mean ± standard deviation (SD) age, 71.23 ± 6.65 years], 33 were SCD (age, 72.73 ± 5.25 years), and 24 were NC (age, 71.96 ± 5.30 years). MANCOVA adjusted for age, gender, body mass index (BMI), gait speed, years of education, diabetes mellitus, and Geriatric Depression Scale (GDS) revealed a significant multivariate effect of group in knee peak extension angle ( = 8.77, < 0.0001) and knee heel strike angle ( = 8.07, = 0.001) on the right side. comparisons with Bonferroni correction showed a significant increase of 5.91° in knee peak extension angle ( < 0.0001) and a noticeable decrease of 6.21°in knee heel strike angle ( = 0.001) in MCI compared with NC on the right side. However, no significant intergroup difference was found in gait kinetics, including dorsiflexion, plantar flexion, knee flexion, knee extension, hip flexion, and hip extension( > 0.002).

Conclusion: An increase of right knee peak extension angle and a decrease of right knee heel strike angle during level walking were found among older adults with MCI compared to those with NC.
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http://dx.doi.org/10.3389/fnagi.2021.664558DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8368728PMC
August 2021

Pearls on science, collaboration, and mentorship in health research: A masterclass conversation with Dr. John Ioannidis.

J Clin Epidemiol 2021 Aug 13. Epub 2021 Aug 13.

Department of Medicine, Stanford University, Stanford, CA; Department of Epidemiology and Population Health, Stanford University, Stanford, CA.

Effective collaboration and mentorship are essential to success in a career of health research. We summarize our conversation with Dr. John Ioannidis, professor at Stanford University, author of the most accessed manuscript in the history of the Public Library of Science, and one of the most cited scientists in history. Dr. Ioannidis was invited for a question and answer session as part of a graduate-level course on biostatistical collaboration hosted at McMaster University in December 2020. This text provides insight into the experiences and pearls he shared, that we hope will inspire and guide other researchers early or junior in their careers. He emphasized the importance of passion, enthusiasm and a sincere pursuit for high quality research as being the cornerstones to success and continued productivity in this field.
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http://dx.doi.org/10.1016/j.jclinepi.2021.08.009DOI Listing
August 2021

Derivation and validation of predictors of oral anticoagulant-related adverse events in seniors transitioning from hospital to home.

Thromb Res 2021 Oct 2;206:18-28. Epub 2021 Aug 2.

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, 2C Area, Hamilton, Ontario L8S 4K1, Canada; Biostatistics Unit, St Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, Ontario L8N 4A6, Canada. Electronic address:

Introduction: Oral anticoagulant (OAC)-related adverse events are high post-hospitalization. We planned to develop and validate a prediction model for OAC-related harm within 30 days of hospitalization.

Methods: We undertook a population-based study of adults aged ≥66 years who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome was a composite of time to first hospitalization or emergency department visit for a hemorrhagic or thromboembolic event, or mortality within 30 days of hospital discharge. Cox proportional hazards regression was used to build the model.

Results: We included 120,721 patients of which 5423 experienced the outcome. Most patients were aged ≥75 years (59.5%) and were female (55.6%). Sixty percent of the cohort had a follow-up visit with a healthcare provider within 7 days of discharge. Patients discharged on a direct acting OAC versus warfarin (apixaban: Hazard Ratio [HR] 0.82, 95% confidence interval [CI] 0.71-0.94; dabigatran: HR 0.73, 95% CI 0.63-0.84; rivaroxaban: HR 0.79, 95% CI 0.71-0.88), were prevalent users of the dispensed OAC versus incident users (HR 0.82, 95% CI 0.69-0.96), had a joint replacement in the past 35 days (HR 0.40, 95% CI 0.33-0.50) or major surgery during index hospital stay (HR 0.69, 95% CI 0.60-0.80) had a lower risk for the outcome. The Cox model was stable with acceptable discrimination but poor goodness-of-fit.

Conclusions: A model for OAC-related harm in the early post-discharge period was developed. External validation studies are required to understand the model's poor calibration.
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http://dx.doi.org/10.1016/j.thromres.2021.07.016DOI Listing
October 2021

Comparing and combining evidence of treatment effects in randomized and nonrandomized studies on the use of misoprostol to prevent postpartum hemorrhage.

J Evid Based Med 2021 Sep 13;14(3):198-207. Epub 2021 Aug 13.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.

Objective: Postpartum hemorrhage (PPH) is a preventable condition and the main cause of maternal death worldwide. Evidence on the effectiveness of misoprostol in the prevention of PPH has been generated from both randomized controlled trials (RCTs) and nonrandomized studies (NRS). This study aimed to compare the results of RCTs and NRS, and to compare Classical and Bayesian approaches of combining the results of RCTs and NRS on the use of misoprostol versus placebo in the prevention of PPH.

Methods: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials for appropriate studies. We pooled estimates of effects from RCTs and NRS seperately, using random-effects models, then merged them using classical and Bayesian random effects meta-analysis.

Results: A total of 34 studies (20 RCTs and 14 NRS) involving 74 204 participants were identified. The summary odds ratio (OR) from RCTs for the use of misoprostol in the prevention of PPH was 0.69 (95% confidence interval [CI]: 0.59 to 0.80). The summary OR from NRS was 0.46 (95% CI: 0.36 to 0.63). Classical and Bayesian approaches of combining the two study designs both showed benefit of misoprostol in preventing PPH, with similar effects.

Conclusions: Both RCTs and NRS show comparable significant benefit for the use of misoprostol in the prevention of PPH.
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http://dx.doi.org/10.1111/jebm.12440DOI Listing
September 2021

Genetic basis of cannabis use: a systematic review.

BMC Med Genomics 2021 08 12;14(1):203. Epub 2021 Aug 12.

Neuroscience Graduate Program, Department of Psychiatry and Behavioural Neurosciences, McMaster University, 100 West 5th St., Hamilton, ON, L8N 3K7, Canada.

Background: With the increase in cannabis use rates, cannabis use disorder is being reported as one of the most common drug use disorders globally. Cannabis use has several known physical, psychological, and social adverse events, such as altered judgement, poor educational outcomes, and respiratory symptoms. The propensity for taking cannabis and the development of a cannabis use disorder may be genetically influenced for some individuals. Heritability estimates suggest a genetic basis for cannabis use, and several genome-wide association studies (GWASs) have identified possible regions of association, albeit with inconsistent findings. This systematic review aims to summarize the findings from GWASs investigating cannabis use and cannabis use disorder.

Methods: This systematic review incorporates articles that have performed a GWAS investigating cannabis use or cannabis use disorder. MEDLINE, Web of Science, EMBASE, CINAHL, GWAS Catalog, GWAS Central, and NIH Database of Genotype and Phenotype were searched using a comprehensive search strategy. All studies were screened in duplicate, and the quality of evidence was assessed using the quality of genetic association studies (Q-Genie) tool. All studies underwent qualitative synthesis; however, quantitative analysis was not feasible.

Results: Our search identified 5984 articles. Six studies met our eligibility criteria and were included in this review. All six studies reported results that met our significance threshold of p ≤ 1.0 × 10. In total 96 genetic variants were identified. While meta-analysis was not possible, this review identified the following genes, ANKFN1, INTS7, PI4K2B, CSMD1, CST7, ACSS1, and SCN9A, to be associated with cannabis use. These regions were previously reported in different mental health conditions, however not in relation to cannabis use.

Conclusion: This systematic review summarized GWAS findings within the field of cannabis research. While a meta-analysis was not possible, the summary of findings serves to inform future candidate gene studies and replication efforts. Systematic Review Registration PROSPERO CRD42020176016.
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http://dx.doi.org/10.1186/s12920-021-01035-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359088PMC
August 2021

Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal pharyngitis in children: study protocol.

BMJ Open 2021 08 11;11(8):e047271. Epub 2021 Aug 11.

Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada.

Introduction: Streptococcal pharyngitis, which commonly occurs in children, should be treated with antibiotics. Clinical prediction rules to differentiate streptococcal pharyngitis from viral infection are not recommended in children. Rapid point-of-care (POC) antigen tests have limited sensitivity and so are not often used in Canadian paediatric emergency departments (EDs). Standard paediatric practice is to rely on laboratory-based testing, which often results in a delay before the results can be communicated to the patient; this may impede appropriate prescribing, decrease caregiver satisfaction and delay recovery. The objective of this study is to determine whether a novel rapid molecular POC assay for streptococcal pharyngitis leads to more appropriate antibiotic use in children seeking care in a paediatric ED than standard laboratory-based testing.

Methods And Analysis: A randomised, superiority, open-label, trial with two parallel groups. Children presenting to a tertiary paediatric ED at least 3 years of age who have a throat swab ordered for diagnosis of streptococcal pharyngitis will be eligible; those who have taken antibiotics within 72 hours prior to presentation and those with additional active infections will be excluded. The primary study outcome will be appropriate antibiotic treatment at 3-5 days postenrolment. Secondary outcomes include time to symptom resolution, caregiver satisfaction, caregiver/child absenteeism, number of subsequent healthcare visits, clinician satisfaction and incremental cost-effectiveness of POC testing. A total of 352 participants will be needed.

Ethics And Dissemination: All study documentation has been approved by the Hamilton Integrated Research Ethics board and informed consent will be obtained from all participants. Data from this trial will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines.

Trial Registration Number: NCT04247243.
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http://dx.doi.org/10.1136/bmjopen-2020-047271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359528PMC
August 2021

Lessons learned from Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): a pragmatic clinical trial of computerized decision support in primary care.

Trials 2021 Aug 11;22(1):531. Epub 2021 Aug 11.

Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

Background: Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) was a pragmatic, cluster randomized trial assessing the effectiveness of a clinical decision support (CDS) tool in primary care, Nova Scotia, Canada. We evaluated if CDS software versus Usual Care could help primary care providers (PCPs) deliver individualized guideline-based AF patient care.

Methods: Key study challenges including CDS development and implementation, recruitment, and data integration documented over the trial duration are presented as lessons learned.

Results: Adequate resources must be allocated for software development, updates and feasibility testing. Development took longer than projected. End-user feedback suggested network access and broadband speeds impeded uptake; they felt further that the CDS was not sufficiently user-friendly or efficient in supporting AF care (i.e., repetitive alerts). Integration across e-platforms is crucial. Intellectual property and other issues prohibited CDS integration within electronic medical records and provincial e-health platforms. Double login and data entry were impediments to participation or reasons for provider withdrawal. Data integration challenges prevented easy and timely data access, analysis, and reporting. Primary care study recruitment is resource intensive. Altogether, 203 PCPs and 1145 of their patients participated, representing 25% of eligible providers and 12% of AF patients in Nova Scotia, respectively. The most effective provider recruitment strategy was in-office, small group lunch-and-learns. PCPs with past research experience or who led patient consent were top recruiters. The study office played a pivotal role in achieving patient recruitment targets.

Conclusions: A rapid growth in healthcare data is leading to widespread development of CDS. Our experience found practical issues to address for such applications to succeed. Feasibility testing to assess the utility of any healthcare CDS prior to implementation is recommended. Adequate resources are necessary to support successful recruitment for future pragmatic trials. CDS tools that integrate multiple co-morbid guidelines across eHealth platforms should be pursued.

Trial Registration: ClinicalTrials.gov NCT01927367. Registered on August 22, 2013.
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http://dx.doi.org/10.1186/s13063-021-05488-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359062PMC
August 2021

Patient-Reported Goals of Youths in Canada Receiving Medication-Assisted Treatment for Opioid Use Disorder.

JAMA Netw Open 2021 Aug 2;4(8):e2119600. Epub 2021 Aug 2.

Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada.

Importance: In the literature on opioid use disorder (OUD), opioid abstinence is used as an outcome measure for individuals receiving medication-assisted treatment (MAT), without consideration of patient-reported goals (PRGs).

Objectives: To identify common PRGs for youths receiving MAT for OUD and assess whether these patients achieve their stated goals.

Design, Setting, And Participants: This prospective cohort study examined data from 152 individuals aged 16 to 25 years (noninclusive) recruited between May 22, 2018, and March 11, 2020, from 45 outpatient MAT clinics in the Pharmacogenetics of Opioid Substitution Treatment Response study. Youths receiving MAT for OUD were included and were followed up for 3 months.

Exposures: Medication-assisted treatment for OUD.

Main Outcomes And Measures: The frequency of each PRG; the success of goal attainment, compared between those who reported specific PRGs and those who did not; and associations between reporting certain goals and achieving them.

Results: Among the 152 youths in the study, 82 were male (53.9%), and the mean (SD) age was 22.8 (1.8) years. Ten overarching goals were identified, with the most common being to taper the dose of or stop MAT (96 [63.2%]), avoid use of recreational substances (71 [46.7%]), manage OUD symptoms (25 [16.4%]), live a normal life (14 [9.2%]), improve mental health (11 [7.2%]), and gain employment (8 [5.3%]). Overall, individuals who reported PRGs had similar odds of achieving them as those who did not for the goals of taper dose of or stop MAT (OR, 1.98; 95% CI, 0.88-4.46; P = .10), avoid recreational substances (OR, 1.34; 95% CI, 0.65-2.74; P = .43), manage OUD symptoms (β coefficient, -0.93; 95% CI, -4.24 to 2.38; P = .58), and improve mental health (β coefficient, -0.76; 95% CI, -6.31 to 4.78; P = .79). Furthermore, multivariable logistic regression showed that goals to taper the dose of or stop MAT (odds ratio, 1.90; 95% CI, 0.78-4.63; P = .16) or avoid recreational substances (odds ratio, 1.27; 95% CI, 0.60-2.67; P = .53) were not associated with achieving these respective outcomes.

Conclusions And Relevance: This study suggests that youths have highly variable PRGs regarding MAT for OUD and that reporting a goal may not mean one is at higher odds of achieving it. There is a need to develop treatment plans that effectively incorporate PRGs. In addition, the finding that most youths aim to minimize or stop their MAT dose warrants the creation of a tapering protocol to guide clinicians. Because a diagnosis of OUD has substantial psychosocial implications in this population, clinicians must ensure that these dimensions of care are part of routine clinical practice.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.19600DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343465PMC
August 2021

Standardized Assessment of Global activities in the Elderly scale in adult cardiac surgery patients.

Br J Anaesth 2021 Oct 28;127(4):539-546. Epub 2021 Jul 28.

Department of Health Research Methods, Evaluation, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.

Background: Different instruments have been used to assess ability to perform everyday functional activities, such as activities of daily living (ADL) and instrumental activities of daily living (IADL). No measures of functional activity have been validated in cardiac surgery. We assessed the reliability and validity of the Standardized Assessment of Global activities in the Elderly (SAGE) scale.

Methods: We undertook an observational sub-study of VISION Cardiac Surgery. Patients were assessed post-discharge after cardiac surgery using SAGE and comparator measures to determine convergent validity. A blinded independent assessor administered SAGE by phone within 7 days to determine test-retest reliability. We sought to demonstrate a correlation of ≥0.5 between SAGE and each corresponding measure. We also sought to define the SAGE score corresponding to severe functional disability, defined using the World Health Organisation Disability Assessment Schedule (WHODAS).

Results: There were 152 patients included. Inter-rater reliability was excellent (intra-class correlation coefficient=0.99; 95% confidence interval [CI], 0.98-0.99). Convergent validity was evident, ranging from adequate for the overall SAGE score (0.54; 95% CI, 0.42-0.65) to very good for the SAGE mobility sub-score (0.80; 95% CI, 0.73-0.85). SAGE was initially poorly correlated with the IADL index (-0.24) but increased to -0.60 after post-hoc adjustment of SAGE scoring. A SAGE score ≥7 was associated with severe functional disability and occurred in 42/152 (27.6%) of patients.

Conclusion: These results demonstrate the reliability and validity of the SAGE scale as a measure of global function in patients discharged home after cardiac surgery.

Clinical Trial Registration: NCT01842568.
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http://dx.doi.org/10.1016/j.bja.2021.05.037DOI Listing
October 2021

Errors in the implementation, analysis, and reporting of randomization within obesity and nutrition research: a guide to their avoidance.

Int J Obes (Lond) 2021 Nov 29;45(11):2335-2346. Epub 2021 Jul 29.

Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.

Randomization is an important tool used to establish causal inferences in studies designed to further our understanding of questions related to obesity and nutrition. To take advantage of the inferences afforded by randomization, scientific standards must be upheld during the planning, execution, analysis, and reporting of such studies. We discuss ten errors in randomized experiments from real-world examples from the literature and outline best practices for their avoidance. These ten errors include: representing nonrandom allocation as random, failing to adequately conceal allocation, not accounting for changing allocation ratios, replacing subjects in nonrandom ways, failing to account for non-independence, drawing inferences by comparing statistical significance from within-group comparisons instead of between-groups, pooling data and breaking the randomized design, failing to account for missing data, failing to report sufficient information to understand study methods, and failing to frame the causal question as testing the randomized assignment per se. We hope that these examples will aid researchers, reviewers, journal editors, and other readers to endeavor to a high standard of scientific rigor in randomized experiments within obesity and nutrition research.
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http://dx.doi.org/10.1038/s41366-021-00909-zDOI Listing
November 2021

Relationship between glucosamine use and the risk of lung cancer: data from a nationwide prospective cohort study.

Eur Respir J 2021 Jul 29. Epub 2021 Jul 29.

Liverpool Centre for Cardiovascular Science, University of Liverpool, United Kingdom.

Background: Research on glucosamine shows anti-inflammatory and anti-cancer benefits with a minimal adverse effects. We aimed to explore the relationship between use of glucosamine and risk of lung cancer and lung cancer mortality based on data from the large-scale nationwide prospective UK Biobank cohort study.

Methods: Participants were enrolled between the year 2006 and 2010 and followed up to 2020. Cox proportion hazards model were used to assess the relationship between glucosamine use and risk of lung cancer and lung cancer mortality. Subgroup analyses and sensitivity analyses were performed to explore the potential effect modifications and the robustness of main findings.

Results: A total of 439,393 participants (mean age: 56 years; 53% females) with a mean follow-up of 11 years were included for analyses. There were 82,603 (18.80%) participants reporting regular use of glucosamine at baseline. During follow-up, there were 1,971 (0.45%) lung cancer events documented. Glucosamine use was significantly associated with a decreased risk of lung cancer (hazard ratio=0.84, 95% CI: 0.75-0.92, p<0.001) and lung cancer mortality (hazard ratio=0.88, 95% CI: 0.81-0.96, p=0.002) in fully-adjusted models. A stronger association between glucosamine use and decreased lung cancer risk was observed in participants with a family history of lung cancer when compared to those without a family history.

Conclusion: Regular use of glucosamine was significantly related with decreased risk of lung cancer and lung cancer mortality, based on data from this nationwide prospective cohort study.
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http://dx.doi.org/10.1183/13993003.01399-2021DOI Listing
July 2021

Opioid-sparing effects of medical cannabis or cannabinoids for chronic pain: a systematic review and meta-analysis of randomised and observational studies.

BMJ Open 2021 07 28;11(7):e047717. Epub 2021 Jul 28.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

Objective: To assess the efficacy and harms of adding medical cannabis to prescription opioids among people living with chronic pain.

Design: Systematic review.

Data Sources: CENTRAL, EMBASE and MEDLINE.

Main Outcomes And Measures: Opioid dose reduction, pain relief, sleep disturbance, physical and emotional functioning and adverse events.

Study Selection Criteria And Methods: We included studies that enrolled patients with chronic pain receiving prescription opioids and explored the impact of adding medical cannabis. We used Grading of Recommendations Assessment, Development and Evaluation to assess the certainty of evidence for each outcome.

Results: Eligible studies included five randomised trials (all enrolling chronic cancer-pain patients) and 12 observational studies. All randomised trials instructed participants to maintain their opioid dose, which resulted in a very low certainty evidence that adding cannabis has little or no impact on opioid use (weighted mean difference (WMD) -3.4 milligram morphine equivalent (MME); 95% CI (CI) -12.7 to 5.8). Randomised trials provided high certainty evidence that cannabis addition had little or no effect on pain relief (WMD -0.18 cm; 95% CI -0.38 to 0.02; on a 10 cm Visual Analogue Scale (VAS) for pain) or sleep disturbance (WMD -0.22 cm; 95% CI -0.4 to -0.06; on a 10 cm VAS for sleep disturbance; minimally important difference is 1 cm) among chronic cancer pain patients. Addition of cannabis likely increases nausea (relative risk (RR) 1.43; 95% CI 1.04 to 1.96; risk difference (RD) 4%, 95% CI 0% to 7%) and vomiting (RR 1.5; 95% CI 1.01 to 2.24; RD 3%; 95% CI 0% to 6%) (both moderate certainty) and may have no effect on constipation (RR 0.85; 95% CI 0.54 to 1.35; RD -1%; 95% CI -4% to 2%) (low certainty). Eight observational studies provided very low certainty evidence that adding cannabis reduced opioid use (WMD -22.5 MME; 95% CI -43.06 to -1.97).

Conclusion: Opioid-sparing effects of medical cannabis for chronic pain remain uncertain due to very low certainty evidence.CRD42018091098.
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http://dx.doi.org/10.1136/bmjopen-2020-047717DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8319983PMC
July 2021

Immediate effect of the COVID-19 pandemic on patient health, health-care use, and behaviours: results from an international survey of people with rheumatic diseases.

Lancet Rheumatol 2021 Oct 22;3(10):e707-e714. Epub 2021 Jul 22.

Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Background: The impact and consequences of the COVID-19 pandemic on people with rheumatic disease are unclear. We developed the COVID-19 Global Rheumatology Alliance Patient Experience Survey to assess the effects of the COVID-19 pandemic on people with rheumatic disease worldwide.

Methods: Survey questions were developed by key stakeholder groups and disseminated worldwide through social media, websites, and patient support organisations. Questions included demographics, rheumatic disease diagnosis, COVID-19 diagnosis, adoption of protective behaviours to mitigate COVID-19 exposure, medication access and changes, health-care access and communication with rheumatologists, and changes in employment or schooling. Adults age 18 years and older with inflammatory or autoimmune rheumatic diseases were eligible for inclusion. We included participants with and without a COVID-19 diagnosis. We excluded participants reporting only non-inflammatory rheumatic diseases such as fibromyalgia or osteoarthritis.

Findings: 12 117 responses to the survey were received between April 3 and May 8, 2020, and of these, 10 407 respondents had included appropriate age data. We included complete responses from 9300 adults with rheumatic disease (mean age 46·1 years; 8375 [90·1%] women, 893 [9·6%] men, and 32 [0·3%] participants who identified as non-binary). 6273 (67·5%) of respondents identified as White, 1565 (16·8%) as Latin American, 198 (2·1%) as Black, 190 (2·0%) as Asian, and 42 (0·5%) as Native American or Aboriginal or First Nation. The most common rheumatic disease diagnoses included rheumatoid arthritis (3636 [39·1%] of 9300), systemic lupus erythematosus (2882 [31·0%]), and Sjögren's syndrome (1290 [13·9%]). Most respondents (6921 [82·0%] of 8441) continued their antirheumatic medications as prescribed. Almost all (9266 [99·7%] of 9297) respondents adopted protective behaviours to limit SARS-CoV-2 exposure. A change in employment status occurred in 2524 (27·1%) of 9300) of respondents, with a 13·6% decrease in the number in full-time employment (from 4066 to 3514).

Interpretation: People with rheumatic disease maintained therapy and followed public health advice to mitigate the risks of COVID-19. Substantial employment status changes occurred, with potential implications for health-care access, medication affordability, mental health, and rheumatic disease activity.

Funding: American College of Rheumatology.
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http://dx.doi.org/10.1016/S2665-9913(21)00175-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8298011PMC
October 2021

Patient-Reported Outcomes and Patient-Reported Experience of Patients With Atrial Fibrillation in the IMPACT-AF Clinical Trial.

J Am Heart Assoc 2021 08 28;10(15):e019783. Epub 2021 Jul 28.

Department of Health Research Methods, Evidence and Impact McMaster University Hamilton ON Canada.

Background The IMPACT-AF (Integrated Management Program Advancing Community Treatment of Atrial Fibrillation) trial is a prospective, randomized, cluster design trial comparing atrial fibrillation management with a computerized clinical decision support system with usual care (control) in the primary care setting of Nova Scotia, Canada. The objective of this analysis was to assess and compare patient-reported health-related quality of life and patient-reported experience with atrial fibrillation care between clinical decision support and control groups. Methods and Results Health-related quality of life was measured using the EuroQol 5-dimensional 5-level scale, whereas patient-reported experience was assessed using a self-administered satisfaction questionnaire, both assessed at baseline and 12 months. Health utilities were calculated using the Canadian EuroQol 5-dimensional 5-level value set. Descriptive statistics and generalized estimating equations were used to compare between groups. Among 1145 patients enrolled in the trial, 717 had complete EuroQol 5-dimensional 5-level data at baseline. The mean age of patients was 73.53 years, and 61.87% were men. Mean utilities at baseline were 0.809 (SD, 0.157) and 0.814 (SD, 0.157) for clinical decision support and control groups, respectively. At baseline, most patients in both groups reported being "very satisfied" with the care received for their atrial fibrillation. There were no statistically significant differences in utility scores or patient satisfaction between groups at 12 months. Conclusions Health-related quality of life of patients remained stable over 12 months, and there was no significant difference in patient satisfaction or utility scores between clinical decision support and control groups. Registration information clinicaltrials.gov. Identifier: NCT01927367.
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http://dx.doi.org/10.1161/JAHA.120.019783DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8475702PMC
August 2021
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