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1.
Syst Rev ; 9(1): 231, 2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33028389

RESUMO

BACKGROUND: Dextro-transposition of the great arteries (D-TGA) is the most frequent cyanotic congenital heart pathology in neonates. Surgical correction of this condition is possible using the arterial switch operation (ASO) which was first performed by Jatene in 1975. OBJECTIVES: The aim of this study was to summarise the evidence on short- (less than 1 year), medium- (1-20 years), and long-term (more than 20 years) outcomes of children with D-TGA treated with the ASO. The primary outcome was survival. Secondary outcomes were freedom from cardiac reoperations, occurrence of aortic insufficiency, pulmonary stenosis, coronary artery anomalies, neuropsychological development problems and quality of life. METHODS: We searched MEDLINE, EMBASE, CINAHL, LILACS, and reference lists of included articles for studies reporting outcomes after ASO for D-TGA. Screening, data extraction and risk of bias assessment were done independently by two reviewers. We pooled data using a random-effects meta-analysis of proportions and, where not possible, outcomes were synthesized narratively. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the certainty of the evidence for each outcome. MAIN RESULTS: Following ASO for TGA, short-term survival was 92.0% (95% CI 91.0-93.0%; I2 = 85.8%, 151 studies, 30,186 participants; moderate certainty evidence). Medium-term survival was 90.0% (95% CI 89.0-91.0%; I2 = 84.3%, 133 studies; 23,686 participants, moderate certainty evidence), while long-term survival was 87.0% (95% CI 80.0-92.0 %; I2 = 84.5%, 4 studies, 933 participants, very low certainty evidence). Evaluation of the different secondary outcomes also showed satisfactory results in the short, medium and long term. Subgroup analysis suggests slightly higher survival following ASO for TGA in the second surgical era (1998 to 2018) than in the first surgical era (1975 to 1997) in the short and medium term [93.0% (95% CI 92.0-94.0) vs 90.0% (95% CI 89.0-92.0) and 93.0% (95% CI 91.0-94.0) vs 88.0% (87.0-90.0%) respectively] but not in the long term [81.0% (95% CI 76.0-86.0%) vs 89.0% (80.0-95.0%)]. CONCLUSIONS: Pooled data from many sources suggests that the ASO for D-TGA leads to high rates of survival in the short, medium, and long term.

3.
JMIR Res Protoc ; 2020 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-33089783

RESUMO

BACKGROUND: Despite growing evidence of deleterious health outcomes associated with sedentary behaviour, prolonged static sitting in classrooms remains ubiquitous in primary school classrooms. Sedentary behaviour is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behaviour and its negative health effects may be required in a resource-constrained environment such as South Africa. OBJECTIVE: Primary: To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools. Secondary: To assess the preliminary effects of the intervention on sedentary behaviour and postural dynamism. METHODS: Participants: Eighty grade 5 or 6 learners, aged 10 and 11 years old, in mixed-gender, schools within the Cape Metro urban area are eligible to participate. Data to be collected at the schools. Intervention: The intervention will comprise multi-functional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behaviour. Usual practice is the absence of the intervention. Setting: Western Cape Metropolitan Urban Area in South Africa. Trial design: A pilot cluster stepped-wedge trial design with classrooms as the unit of randomisation. Outcome: Primary: i) adherence to the intervention, and ii) project pragmatics. Secondary: i) sedentariness measured using activPAL3 micro sensors, and ii) postural dynamism measured using Noraxon Myomotion IMUs. Randomization: We randomized the school to the first or second start of the intervention. Blinding: This is an open-label trial and therefore not possible to blind any group. Analysis: Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of effects on sedentariness and postural dynamism using mean difference and 95% confidence interval. RESULTS: At time of submission, two classrooms were recruited into the study. Baseline physical activity and postural dynamism data was collected from 10 participants from each class. CONCLUSIONS: The results of this feasibility stepped-wedge cluster randomised controlled trial will be useful in informing the design on the main trial to assess whether this multifaceted intervention of multi-functional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effects on sedentary behaviour in a low resource setting primary schools. CLINICALTRIAL: Trial registration: PACTR201811799476016.

4.
BMJ Open ; 10(10): e038008, 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-33060083

RESUMO

INTRODUCTION: High-cost users (HCUs) account for a small proportion of the population but use a disproportionately large share of healthcare resources. Although HCUs exist in all healthcare types, acute care is the most expensive type of service and the most significant contributor to expenditures among HCUs. This study aims to determine demographic, socioeconomic and clinical factors associated with being HCUs in adult patients (≥18 years) receiving acute care in Canada. METHODS AND ANALYSIS: This is a population-based analysis using a national linked dataset. Adult patients who had at least one interaction with acute care facilities each year from 2011 to 2014 were captured in the dataset, and those living in institutions or other collective residences were not covered. The primary outcome is HCU of acute care (yes/no), which is defined as whether a patient is within the top 10% of the highest acute care cost users in his/her province. Multilevel logistic regression will be used to identify factors associated with HCU and to examine the provincial variations of these identified risk factors. Sensitivity analyses investigating the influences of different high user definitions and missing data on the study results will also be performed. ETHICS AND DISSEMINATION: All researchers will follow the codes and rules set by Statistics Canada and the Research Data Centre and give priority to the confidentiality of the data during and after this study. The study findings will be published in peer-review journals and disseminated at academic conferences.

5.
J Am Coll Cardiol ; 76(17): 1919-1930, 2020 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-33092727

RESUMO

BACKGROUND: Clinical trials change practice in cardiology, and leading them requires research training, mentorship, sponsorship, and networking. Women report challenges in obtaining these opportunities. OBJECTIVES: The purpose of this review was to evaluate temporal trends in representation of women as authors in heart failure (HF) randomized controlled trials (RCTs) published in high-impact medical journals and explore RCT characteristics associated with women as lead authors. METHODS: We searched MEDLINE, EMBASE, and CINAHL for HF RCTs published in journals with an impact factor ≥10 between January 1, 2000, and May 7, 2019. We assessed temporal trends in the gender distribution of authors, and used multivariable logistic regression to determine characteristics associated with women as lead authors. RESULTS: We identified 10,596 unique articles, of which 403 RCTs met inclusion criteria. Women represented 15.6% (95% confidence interval [CI]: 12.2% to 19.6%), 12.9% (95% CI: 9.8% to 16.6%), and 11.4% (95% CI: 8.5% to 14.9%) of lead, senior, and corresponding authors, respectively. The proportion of women authors has not changed over time. Women had lower odds of lead authorship in RCTs that were multicenter (odds ratio [OR]: 0.58; 95% CI: 0.18 to 0.96; p = 0.037), were coordinated in North America (OR: 0.21; 95% CI: 0.08 to 0.70; p = 0.011) or Europe (OR: 0.33; 95% CI: 0.09 to 0.91; p = 0.039), tested drug interventions (OR: 0.42; 95% CI: 0.16 to 0.97; p = 0.043), or had men as the senior author (OR: 0.50; 95% CI: 0.21 to 0.93; p = 0.043). CONCLUSIONS: Women are under-represented as authors of HF RCTs, with no change in temporal trends. Women had lower odds of lead authorship in RCTs that were multicenter, were coordinated in North America or Europe, tested drug interventions, or had men as senior authors.

6.
BMJ Open ; 10(9): e039650, 2020 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-32988951

RESUMO

INTRODUCTION: This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres. METHODS AND ANALYSIS: Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. ETHICS AND DISSEMINATION: All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319.

7.
Sci Rep ; 10(1): 15590, 2020 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-32973289

RESUMO

Pre-eclampsia is a severe hypertensive disorder of pregnancy and could lead to severe maternal morbidities and death. Our study aimed to develop and validate a prognostic prediction model for severe maternal outcomes among Chinese population with pre-eclampsia. We conducted a 10-year cohort study in a referral center by collecting all pregnant women who diagnosed as pre-eclampsia and delivered from 2005 to 2014. A composite of severe maternal outcomes, including maternal near-miss defined by World Health Organization, cortical blindness/retinal detachment, temporary facial paralysis and maternal death, were adopted. We used logistic regression model to develop Model 1 by retaining the predictors of p < 0.05, and further conducted Model 2 by adding quadratic terms and interaction terms to Model 1. We undertook a bootstrapping validation and estimated the model performance. A total of 397 pregnant women suffered from severe maternal outcomes among 2,793 eligible participants, with an incidence of 14.21% (95% confidence interval (CI) 12.91%-15.51%). Of 13 predictors were finally selected in Model 1. Combined with quadratic and interactive terms, the Model 2 showed higher area under the ROC curve (82.2%, 95% CI 79.6%-84.7%) and good calibration. By the bootstrapping validation, similar model performances were present.

8.
PLoS Med ; 17(9): e1003293, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32941437

RESUMO

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly spreading disease that has caused extensive burden to individuals, families, countries, and the world. Effective treatments of COVID-19 are urgently needed. METHODS AND FINDINGS: This is the first edition of a living systematic review of randomized clinical trials comparing the effects of all treatment interventions for participants in all age groups with COVID-19. We planned to conduct aggregate data meta-analyses, trial sequential analyses, network meta-analysis, and individual patient data meta-analyses. Our systematic review is based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and Cochrane guidelines, and our 8-step procedure for better validation of clinical significance of meta-analysis results. We performed both fixed-effect and random-effects meta-analyses. Primary outcomes were all-cause mortality and serious adverse events. Secondary outcomes were admission to intensive care, mechanical ventilation, renal replacement therapy, quality of life, and nonserious adverse events. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the certainty of evidence. We searched relevant databases and websites for published and unpublished trials until August 7, 2020. Two reviewers independently extracted data and assessed trial methodology. We included 33 randomized clinical trials enrolling a total of 13,312 participants. All trials were at overall high risk of bias. We identified one trial randomizing 6,425 participants to dexamethasone versus standard care. This trial showed evidence of a beneficial effect of dexamethasone on all-cause mortality (rate ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001; low certainty) and on mechanical ventilation (risk ratio [RR] 0.77; 95% CI 0.62-0.95; p = 0.021; low certainty). It was possible to perform meta-analysis of 10 comparisons. Meta-analysis showed no evidence of a difference between remdesivir versus placebo on all-cause mortality (RR 0.74; 95% CI 0.40-1.37; p = 0.34, I2 = 58%; 2 trials; very low certainty) or nonserious adverse events (RR 0.94; 95% CI 0.80-1.11; p = 0.48, I2 = 29%; 2 trials; low certainty). Meta-analysis showed evidence of a beneficial effect of remdesivir versus placebo on serious adverse events (RR 0.77; 95% CI 0.63-0.94; p = 0.009, I2 = 0%; 2 trials; very low certainty) mainly driven by respiratory failure in one trial. Meta-analyses and trial sequential analyses showed that we could exclude the possibility that hydroxychloroquine versus standard care reduced the risk of all-cause mortality (RR 1.07; 95% CI 0.97-1.19; p = 0.17; I2 = 0%; 7 trials; low certainty) and serious adverse events (RR 1.07; 95% CI 0.96-1.18; p = 0.21; I2 = 0%; 7 trials; low certainty) by 20% or more, and meta-analysis showed evidence of a harmful effect on nonserious adverse events (RR 2.40; 95% CI 2.01-2.87; p < 0.00001; I2 = 90%; 6 trials; very low certainty). Meta-analysis showed no evidence of a difference between lopinavir-ritonavir versus standard care on serious adverse events (RR 0.64; 95% CI 0.39-1.04; p = 0.07, I2 = 0%; 2 trials; very low certainty) or nonserious adverse events (RR 1.14; 95% CI 0.85-1.53; p = 0.38, I2 = 75%; 2 trials; very low certainty). Meta-analysis showed no evidence of a difference between convalescent plasma versus standard care on all-cause mortality (RR 0.60; 95% CI 0.33-1.10; p = 0.10, I2 = 0%; 2 trials; very low certainty). Five single trials showed statistically significant results but were underpowered to confirm or reject realistic intervention effects. None of the remaining trials showed evidence of a difference on our predefined outcomes. Because of the lack of relevant data, it was not possible to perform other meta-analyses, network meta-analysis, or individual patient data meta-analyses. The main limitation of this living review is the paucity of data currently available. Furthermore, the included trials were all at risks of systematic errors and random errors. CONCLUSIONS: Our results show that dexamethasone and remdesivir might be beneficial for COVID-19 patients, but the certainty of the evidence was low to very low, so more trials are needed. We can exclude the possibility of hydroxychloroquine versus standard care reducing the risk of death and serious adverse events by 20% or more. Otherwise, no evidence-based treatment for COVID-19 currently exists. This review will continuously inform best practice in treatment and clinical research of COVID-19.


Assuntos
Betacoronavirus , Infecções por Coronavirus/terapia , Cuidados Críticos/métodos , Gerenciamento Clínico , Pandemias , Pneumonia Viral/terapia , Qualidade de Vida , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/psicologia , Hospitalização/tendências , Humanos , Pneumonia Viral/epidemiologia , Pneumonia Viral/psicologia
9.
Am J Sports Med ; : 363546520952804, 2020 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-32970955

RESUMO

BACKGROUND: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. PURPOSE: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. RESULTS: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, -7.22 to 7.45]; P = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03]; P = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). CONCLUSION: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. REGISTRATION: NCT01623843 (ClinicalTrials.gov identifier).

10.
JBI Evid Synth ; 18(8): 1738-1750, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32898366

RESUMO

OBJECTIVE: The aim of this review is to i) evaluate the effectiveness of current rehabilitation interventions in promoting short-, moderate-, and long-term physical activity maintenance among patients post-stroke, and ii) to investigate the intervention characteristics associated with the promotion of physical activity maintenance among patients post-stroke. INTRODUCTION: Physical activity and exercise can positively impact post-stroke recovery. However, few patients participate in the recommended levels of physical activity after a stroke. To design better post-stroke programs, the characteristics of current interventions that promote physical activity maintenance need to be identified. INCLUSION CRITERIA: Randomized controlled trials including adults (age ≥ 18) post-stroke, assessing physical activity via subjective or objective measures with a minimum three-month follow-up, and published in English will be considered for inclusion. METHODS: Literature searches will be conducted using MEDLINE, Embase, PsycINFO, CINAHL, SPORTDiscus, and Cochrane Central Register of Controlled Trials. The quality of the randomized controlled trials will be assessed using Cochrane's risk of bias tool. Interventions will be coded using the Behaviour Change Technique Taxonomy version 1. Standardized mean differences of physical activity levels between intervention and control groups will be calculated using study-specific measures and interpreted as small (<0.40), medium (0.40-0.70), or large (>0.70). Meta-analysis of effect sizes will be conducted for short- (three months), moderate- (six months), and long-term (≥12 months) follow-ups. Univariable and multivariable random effects meta-regression using intervention characteristics (setting, delivery method, delivery type, duration, outcome measure, and behavior change techniques) will be conducted to identify predictors of maintenance. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42019131056.

11.
J Am Geriatr Soc ; 2020 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-32936468

RESUMO

BACKGROUND/OBJECTIVES: Sarcopenia is associated with poor health outcomes such as disability, institutionalization, and mortality. Efforts to manage sarcopenia clinically have been hindered by challenges in determining how to ascertain sarcopenia status correctly. The objective of this project was to assess the agreement between the different methods of ascertaining sarcopenia recommended by expert groups. DESIGN: Cross-sectional study of baseline data (2011-2015) from the Canadian Longitudinal Study on Aging. SETTING: Population-based multicenter study of community-dwelling participants. PARTICIPANTS: Eligible participants (n = 12,646) aged 65 to 85 living within 25 to 50 km of 11 data collection sites in Canada. The analyses included 10,820 participants with the data required to diagnose sarcopenia. MEASUREMENTS: Sarcopenia was operationalized as appendicular lean mass (ALM), ALM and grip strength, ALM and gait speed, and grip strength and gait speed. Within each combination, ALM was adjusted for height squared, weight, body mass index, and the residual of regressing lean mass on height and fat mass. The lowest 20th sex-specific percentile values were used as the cutoffs for low ALM. Low grip strength cutoffs of 35.5 kg for men and 20 kg for women and a gait speed cutoff of .8 m/s were used. RESULTS: The mean age was 73.0 ± 5.6 years, and 51.9% of the sample was male. The agreement (Cohen's κ) between the different combinations of variables used to ascertain sarcopenia status was below .50. Agreement for the different lean mass adjustment techniques ranged from .04 to .76. CONCLUSION: The combination of variables used to ascertain sarcopenia and many of the ALM adjustment techniques have insufficient agreement to be considered equivalent. This has important clinical implications for the management of sarcopenia because treatments may differ based on how sarcopenia is identified. To improve the clinical utility of sarcopenia, a unified definition of sarcopenia is required.

12.
Artigo em Inglês | MEDLINE | ID: mdl-32945127

RESUMO

AIM: The issue of youth who are not engaged in education, employment or training has been a focus of policymakers for decades. Although interventions exist for these youth, they often measure success in ways that fail to capture what youth seek to gain. The project aims to address this gap by assessing youth-oriented outcomes for interventions targeting upcoming youth. Acknowledging the stigma attached to the deficit-based notion of not engaged in education, employment or training, hereafter we refer to 'upcoming youth', a term coined by youth partners on the project. This study asks what youth want to achieve by participating in an intervention for upcoming youth, with a view to guiding service and research design. METHODS: A mixed-methods discrete choice experiment will be conducted with youth engaged as partners. A qualitative (focus group) stage will be conducted to design discrete-choice experiment attributes and levels. The experiment will be piloted and administered online to approx. 500 youth (aged 14-29) across Canada to identify the outcomes that youth prioritize for interventions. Latent class analyses will then be conducted to explore clusters of outcomes that different groups of youth prioritize. CONCLUSIONS: From a strengths-based recovery-oriented framework, hearing the voices of the target population is important in designing and evaluating services. This youth-oriented research project will identify the intervention outcomes that are the highest priority for upcoming youth. Findings will inform the development, implementation and testing of interventions targeting relevant outcomes for youth who are not engaged in education, employment or training.

13.
BMC Med Res Methodol ; 20(1): 226, 2020 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-32894052

RESUMO

BACKGROUND: Methodological studies - studies that evaluate the design, analysis or reporting of other research-related reports - play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste. MAIN BODY: We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a "frequently asked questions" format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies? CONCLUSION: Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies.

14.
Artigo em Inglês | MEDLINE | ID: mdl-32940016

RESUMO

BACKGROUND: Sarcopenia definitions recommend different combinations of variables (lean mass, strength, and physical function) and different methods of adjusting lean mass. The purpose of this paper was to address the gaps in the literature regarding how differences in the operationalization of sarcopenia impact the association between sarcopenia and injurious falls. METHODS: Participants included 9936 individuals from the Canadian Longitudinal Study on Aging aged ≥65 years at baseline (2012-2015), with complete data for sarcopenia-related variables, injurious falls, and covariates. Sarcopenia was defined using all combinations of muscle variables (lean mass, grip strength, chair rise test, and gait speed) and methods of adjusting lean mass (height2 , weight, body mass index (BMI), and regressing on height and fat mass) recommended by the expert group sarcopenia definitions. Multiple cut off values for the measures were explored. The association between sarcopenia and injurious falls (0, 1, or 2+ falls) measured 18 months after baseline data collection were assessed using proportional odds regression models. RESULTS: In men (n = 5162, 72.9 ± 5.6 years), the odds of having a higher level of injurious falls was between 1.43 and 2.14 greater when sarcopenia was defined as (i) lean mass adjusted for weight only; (ii) grip strength (<30 or <26 kg) only; (iii) lean mass adjusted for weight and grip strength (<30 or <26 kg); (iv) lean mass adjusted for BMI and grip strength (<26 kg); and (v) lean mass adjusted using the regression technique and grip strength (<30 or <26 kg). In women (n = 4774, 72.8 ± 5.6 years), only the combination of lean mass adjusted using regression with gait speed (<0.8 m/s) was associated with a significantly higher odds (1.46, 95% confidence interval: 1.01-2.10, P = 0.04) of having a higher level of injurious falls. CONCLUSIONS: Sarcopenia definitions based on different combinations of muscle variables and methods of adjusting lean mass are not equally associated with injurious falls. In men, definitions including grip strength but not gait speed or the chair rise test, and adjusting lean mass for weight, BMI, or using the residual technique but not height2 , tended to be associated with injurious falls. In women, sarcopenia was generally not associated with injurious falls regardless of the definition used.

15.
Syst Rev ; 9(1): 200, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-32873330

RESUMO

BACKGROUND: The burden of opioid use disorder (OUD) has been increasing in North America. Administration of medication-assisted treatments (MATs) for OUD on an individual-dose basis has been shown to affect patient responses to treatment, proving to be, on occasion, dangerous. A genetic basis has been identified for some MAT responses in a candidate gene context, but consensus has not been reached for any genome-wide significant associations. This systematic review aims to identify and assess any genetic variants associated with MAT patient outcomes at genome-wide significance. METHODS: The databases searched by the authors will be: MEDLINE, Web of Science, EMBASE, CINAHL and Pre-CINAHL, GWAS Catalog, GWAS Central, and NIH Database of Genotypes and Phenotypes. A title and abstract screening, full-text screening, data extraction, and quality assessment will be completed in duplicate for each study via Covidence. Treatment outcomes of interest include continued opioid use or abstinence during treatment or at follow-up, time to relapse, treatment retention rates, opioid overdose, other substance use, comorbid psychiatric disorders, risk taking behaviors, MAT plasma concentrations, and mortality rates. Analysis methods applied, if appropriate, will include random effects meta-analysis with pooled odds ratios for all outcomes. Subgroup analyses will also be implemented, when possible. DISCUSSION: This systematic review can hopefully inform the direction of future research, aiding in the development of a safer and more patient-centered treatment. It will be able to highlight genome-wide significant variants that are replicable and associated with MAT patient outcomes. SYSTEMATIC REVIEW REGISTRATION: This systematic review protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO) (registration ID CRD42020169121).

16.
BMJ Open ; 10(9): e036537, 2020 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-32963065

RESUMO

INTRODUCTION: Oral anticoagulants (OACs) are widely prescribed in older adults. High OAC-related adverse event rates in the early period following hospital discharge argue for an analysis to identify predictors. Our objective is to identify and validate clinical and continuity of care variables among seniors discharged from hospital on an OAC, which are independently associated with OAC-related adverse events within 30 days. METHODS AND ANALYSIS: We propose a population-based retrospective cohort study of all adults aged 66 years or older who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome is a composite of the first hospitalisation or emergency department visit for a haemorrhage or thromboembolic event or mortality within 30 days of hospital discharge. A Cox proportional hazards model will be used to determine the association between the composite outcome and a set of prespecified covariates. A split sample method will be adopted to validate the variables associated with OAC-related adverse events. ETHICS AND DISSEMINATION: The use of data in this project was authorised under section 45 of Ontario's Personal Health Information Protection Act, which does not require review by a research ethics board. Results will be disseminated via peer-reviewed publications and presentations at conferences and will determine intervention targets to improve OAC management in upcoming randomised trials. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02777047; Pre-results.

17.
BMJ Open ; 10(9): e034793, 2020 09 23.
Artigo em Inglês | MEDLINE | ID: mdl-32967868

RESUMO

OBJECTIVES: We sought to map the evidence and identify interventions that increase initiation of antiretroviral therapy, adherence to antiretroviral therapy and retention in care for people living with HIV at high risk for poor engagement in care. METHODS: We conducted an overview of systematic reviews and sought for evidence on vulnerable populations (men who have sex with men (MSM), African, Caribbean and Black (ACB) people, sex workers (SWs), people who inject drugs (PWID) and indigenous people). We searched PubMed, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science and the Cochrane Library in November 2018. We screened, extracted data and assessed methodological quality in duplicate and present a narrative synthesis. RESULTS: We identified 2420 records of which only 98 systematic reviews were eligible. Overall, 65/98 (66.3%) were at low risk of bias. Systematic reviews focused on ACB (66/98; 67.3%), MSM (32/98; 32.7%), PWID (6/98; 6.1%), SWs and prisoners (both 4/98; 4.1%). Interventions were: mixed (37/98; 37.8%), digital (22/98; 22.4%), behavioural or educational (9/98; 9.2%), peer or community based (8/98; 8.2%), health system (7/98; 7.1%), medication modification (6/98; 6.1%), economic (4/98; 4.1%), pharmacy based (3/98; 3.1%) or task-shifting (2/98; 2.0%). Most of the reviews concluded that the interventions effective (69/98; 70.4%), 17.3% (17/98) were neutral or were indeterminate 12.2% (12/98). Knowledge gaps were the types of participants included in primary studies (vulnerable populations not included), poor research quality of primary studies and poorly tailored interventions (not designed for vulnerable populations). Digital, mixed and peer/community-based interventions were reported to be effective across the continuum of care. CONCLUSIONS: Interventions along the care cascade are mostly focused on adherence and do not sufficiently address all vulnerable populations.

18.
Contemp Clin Trials ; 97: 106151, 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32942056

RESUMO

BACKGROUND: Randomized controlled trials (RCTs) are often used to inform clinical practice and it is desirable that their results be robust. A fragility index (FI), defined as the smallest number of participants in whom an outcome change from non-event to event would turn a statistically significant result to a non-significant result, can be computed to measure robustness. We sought to determine the distribution of fragility indices across various research areas and summarized the factors associated with fragility. METHODS: We searched PubMed between February 2014 and May 2019 and included reviews that reported on fragility indices and the associated factors. Two investigators independently screened articles for eligibility and extracted all relevant data from each review. Fragility indices were pooled using random effects meta-analysis. RESULTS: Twenty-four (24) reviews met the inclusion criteria. They contained a median of 41 trials (first quartile [Q1]-third quartile [Q3]: 17-120). The overall mean FI across different fields of research was 4 (95% confidence interval [CI] 3-5), indicating a high level of fragility. Higher journal impact factor, larger sample size, bigger effect size, more outcome events, a lower p-value, and adequate allocation concealment were reported to be associated with the higher FI. The ecological correlation between median FI and median sample size (22 studies) was 0.95 (95% CI 0.58-0.99). CONCLUSION: Trials across various fields of research are frequently fragile. We also identified some factors associated with fragility. Researchers should consider strategies to enhance the robustness of studies and minimize fragility.

19.
BMJ Open ; 10(9): e040229, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32873685

RESUMO

INTRODUCTION: The current COVID-19 pandemic has resulted in high rates of infection and death, as well as widespread social disruption and a reduction in access to healthcare services and support. There is growing concern over how the pandemic, as well as measures put in place to curb the pandemic, will impact people with mental disorders. We aim to study the effect of pandemics and epidemics on mental health outcomes for people with premorbid mental disorders. METHODS AND ANALYSIS: With our predefined search strategy, we will search five databases for studies reporting on mental health outcomes in people with pre-existing mental disorders during pandemic and epidemic settings. Search dates are planned as follows: 5 May 2020 and 23 July 2020. The following databases will be searched: MEDLINE/PubMed, CINAHL, PsycINFO, MedRxiv and EMBASE. Data will be screened and extracted in duplicate by two independent reviewers. Studies involving non-clinical populations or patients diagnosed with a mental disorder during a pandemic/epidemic will be excluded. We will include data collected from all pandemics and epidemics throughout history, including the present COVID-19 pandemic. If possible, study findings will be combined in meta-analyses, and subgroup analyses will be performed. We hope that this review will shed light on the impact of pandemics and epidemics on those with pre-existing mental disorders. Knowledge generated may inform future intervention studies as well as healthcare policies. Given the potential implications of the current pandemic measures (ie, disruption of healthcare services) on mental health, we will also compile a list of existing mental health resources. ETHICS AND DISSEMINATION: No ethical approval is required for this protocol and proposed systematic review as we will only use data from previously published papers that have themselves received ethics clearance and used proper informed consent procedures. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD42020179611.


Assuntos
Infecções por Coronavirus , Transtornos Mentais , Serviços de Saúde Mental/provisão & distribução , Saúde Mental , Pandemias/estatística & dados numéricos , Pneumonia Viral , Betacoronavirus , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/organização & administração , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/psicologia , Acesso aos Serviços de Saúde , Humanos , Transtornos Mentais/epidemiologia , Transtornos Mentais/terapia , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/psicologia , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
20.
Br J Anaesth ; 125(5): 779-801, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32798067

RESUMO

BACKGROUND: Despite common use, the benefit of adding steroids to local anaesthetics (SLA) for chronic non-cancer pain (CNCP) injections is uncertain. We performed a systematic review and meta-analysis of English-language RCTs to assess the benefit and safety of adding steroids to local anaesthetics (LA) for CNCP. METHODS: We searched MEDLINE, EMBASE, and CENTRAL databases from inception to May 2019. Trial selection and data extraction were performed in duplicate. Outcomes were guided by the Initiative in Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) statement with pain improvement as the primary outcome and pooled using random effects model and reported as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CIs). RESULTS: Among 5097 abstracts, 73 trials were eligible. Although SLA increased the rate of success (42 trials, 3592 patients; RR=1.14; 95% CI, 1.03-1.25; number needed to treat [NNT], 13), the effect size decreased by nearly 50% (NNT, 22) with the removal of two intrathecal injection studies. The differences in pain scores with SLA were not clinically meaningful (54 trials, 4416 patients, MD=0.44 units; 95% CI, 0.24-0.65). No differences were observed in other outcomes or adverse events. No subgroup effects were detected based on clinical categories. Meta-regression showed no significant association with steroid dose or length of follow-up and pain relief. CONCLUSIONS: Addition of cortico steroids to local anaesthetic has only small benefits and a potential for harm. Injection of local anaesthetic alone could be therapeutic, beyond being diagnostic. A shared decision based on patient preferences should be considered. If used, one must avoid high doses and series of steroid injections. CLINICAL TRIAL REGISTRATION: PROSPERO #: CRD42015020614.

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