Publications by authors named "Rasheda Rabbani"

38 Publications

Impact of Undergraduate Research Experience on Professional Career Outcomes of Nurses.

J Nurs Educ 2021 Oct 1;60(10):570-576. Epub 2021 Oct 1.

Background: The benefits of engaging undergraduate nursing students in research have been well-identified; however, little research has documented the long-term outcomes of this research assistant (RA) experience on nurses' professional careers. This study evaluated the impact of undergraduate research experience on participants' nursing professional career outcomes.

Method: A comparative cross-sectional study was conducted with a purposive sample of two groups ( = 94; R = 32 and non-R = 62). The questionnaire was administered online.

Results: A comparison of participants' responses revealed statistically significant differences regarding scholarship activities and attitudes toward evidence-based practice. RAs had a greater likelihood of involvement in professional development and higher educational aspirations than non-RAs.

Conclusion: Undergraduate nursing research experience appears to have a positive impact on evidence-based practice, professional involvement, continuing education, and scholarship activities. These findings support future investment in undergraduate nursing research experiences to build a knowledge-based workforce and advanced nursing scholarship. .
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http://dx.doi.org/10.3928/01484834-20210729-05DOI Listing
October 2021

Antiviral drugs for coronavirus disease 2019 (COVID-19): a systematic review with network meta-analysis.

Expert Rev Anti Infect Ther 2021 Aug 17:1-12. Epub 2021 Aug 17.

George & Fay Yee Centre for Healthcare Innovation, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.

Background: To better inform clinical practice, we summarized the findings from randomized controlled trials (RCTs) of antivirals for COVID-19.

Methods: We systematically searched for literature up to September 2020, and included English-language publications of RCTs among hospitalized COVID-19 patients. We conducted network meta-analysis combining results of both the direct and indirect comparisons of interventions. The efficacy outcomes were clinical progression, all-cause mortality, and viral clearance, and safety outcomes were diarrhea, nausea, and vomiting. We generated treatment rankings (best to worst) and summarized rank probabilities using rankogram.

Results: We included 15 RCTs (14,418 patients) from 7,237 retrieved citations. There was no evidence for efficacy of the assessed antivirals compared with placebo/no treatment or with another antiviral for all efficacy outcomes. Lopinavir (400 mg)/ritonavir (100 mg) significantly increased diarrhea, nausea, and vomiting compared with placebo/no treatment and other antivirals, and was ranked worst for these outcomes, while triazavirin (250 mg), baloxavir marboxil (80 mg), and remdesivir (100 mg - 10 days) ranked best, respectively.

Conclusions And Relevance: The available evidence does not support the use of any antiviral drugs for COVID-19. Cautious interpretations of the findings are, however, advised considering the paucity of the evidence. More RCTs are needed for a stronger evidence base.
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http://dx.doi.org/10.1080/14787210.2021.1961579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8477589PMC
August 2021

Evaluating the impact of an arts-based multimedia knowledge translation assignment on undergraduate nursing students.

Nurse Educ Today 2021 Oct 19;105:105030. Epub 2021 Jun 19.

College of Nursing, Rady Faculty of Health Sciences, University of Manitoba, Canada.

Background: Despite the expectation that nurses utilize research to provide excellent patient care, students often fail to recognize the value of learning about evidence-informed practice. Experiential, creative pedagogical approaches are needed to engage undergraduate nursing students in evidence-informed practice. In two undergraduate courses, we implemented an innovative assignment in which students created an arts-based multimedia knowledge translation presentation to communicate systematic review findings to patients.

Objective: To evaluate how the assignment affected nursing students' satisfaction, learning, and anticipated behaviour changes regarding evidence-informed practice and to assess what factors influenced their evaluation of the assignment.

Design And Methods: Kirkpatrick's Evaluation Model and Groff's Theory of Whole-Mindedness informed our study, incorporating an observational cross-sectional survey design. We recruited a convenience sample of nursing students (N = 242) from two baccalaureate programs. We collected data with an online survey comprised of closed- and open-ended questions. Quantitative data were analyzed with descriptive statistics, univariate analysis, and general linear models, and qualitative data with content analysis.

Results: Most students were satisfied (68%) and reported learning (77%) and benefits for their future practice (75%). Age, enjoyment of and experience with the arts, type of motivation, and valuing evidence-informed practice were significant predictors (p < 0.01) and the model predicted 59% of the variance in positive student perceptions of the assignment. Students reported experiencing relational and engaged learning, translating research findings creatively and clearly, understanding complex research concepts through experiential learning, and having frustrations and pragmatic concerns.

Conclusion: Creative approaches that contextualize research findings hold potential to deepen students' understanding of evidence-informed practice. This study identified key factors that influenced students' evaluation and experience of the assignment. These results provide valuable insights to inform effective implementation of arts-based assignments in nursing education.
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http://dx.doi.org/10.1016/j.nedt.2021.105030DOI Listing
October 2021

Customized guidance/training improved the psychometric properties of methodologically rigorous risk of bias instruments for non-randomized studies.

J Clin Epidemiol 2021 08 9;136:157-167. Epub 2021 May 9.

George & Fay Yee Center for Healthcare Innovation, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba. R3E 0T6, Canada; Department of Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, R3E 0T6, Canada.

Objectives: To evaluate the impact of guidance and training on the inter-rater reliability (IRR), inter-consensus reliability (ICR) and evaluator burden of the Risk of Bias (RoB) in Non-randomized Studies (NRS) of Interventions (ROBINS-I) tool, and the RoB instrument for NRS of Exposures (ROB-NRSE).

Study Design And Setting: In a before-and-after study, seven reviewers appraised the RoB using ROBINS-I (n = 44) and ROB-NRSE (n = 44), before and after guidance and training. We used Gwet's AC statistic to calculate IRR and ICR.

Results: After guidance and training, the IRR and ICR of the overall bias domain of ROBINS-I and ROB-NRSE improved significantly; with many individual domains showing either a significant (IRR and ICR of ROB-NRSE; ICR of ROBINS-I), or nonsignificant improvement (IRR of ROBINS-I). Evaluator burden significantly decreased after guidance and training for ROBINS-I, whereas for ROB-NRSE there was a slight nonsignificant increase.

Conclusion: Overall, there was benefit for guidance and training for both tools. We highly recommend guidance and training to reviewers prior to RoB assessments and that future research investigate aspects of guidance and training that are most effective.
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http://dx.doi.org/10.1016/j.jclinepi.2021.04.017DOI Listing
August 2021

Remdesivir for coronavirus disease 2019 (COVID-19): a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials.

Infect Dis (Lond) 2021 09 11;53(9):691-699. Epub 2021 May 11.

George and Fay Yee Centre for Healthcare Innovation, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.

Background: In view of many unanswered clinical questions regarding treatment of COVID-19 with remdesivir, we systematically identified, critically appraised and summarized the findings from randomized controlled trials (RCTs) of remdesivir for COVID-19.

Methods: We searched relevant databases/websites (up to September 2020) and selected English-language RCT publications of remdesivir for COVID-19. We conducted meta-analysis using an inverse variance, random-effects model in addition to trial sequential analysis (TSA) for the efficacy outcomes: all-cause mortality, viral burden and clinical progression. Safety outcomes were diarrhoea, nausea, and vomiting. We calculated the relative risk (RR) and 95% confidence interval (CI) for all outcomes. Statistical heterogeneity was calculated using the statistic.

Results: We included five RCTs (7540 participants) from 7237 citations. Most (80%) were of an unclear to high risk of bias. There was no evidence of a significant improvement with remdesivir (100 mg, 10 days) regarding all-cause mortality (RR 0.94, CI 0.82-1.07; = 0%; 4 RCTs; 7143 patients), clinical progression (RR 1.08, CI 0.99-1.18; = 70.4%; 3 RCTs; 1692 patients), or diarrhoea (RR 0.82, CI 0.40-1.66; = 0%; 2 RCTs; 630 patients). Nausea occurred more often with remdesivir (RR 2.77, CI 1.28-6.03; = 0%; 2 RCTs; 630 patients). TSA showed that the required information size was not reached for firm conclusions to be drawn.

Conclusions And Relevance: There is insufficient evidence to support the use of remdesivir for treatment of COVID-19. More high-quality RCTs are needed for a stronger evidence. Until then, remdesivir should remain an experimental drug for COVID-19.
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http://dx.doi.org/10.1080/23744235.2021.1923799DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127173PMC
September 2021

Interventions and strategies involving primary healthcare professionals to manage emergency department overcrowding: a scoping review.

BMJ Open 2021 05 10;11(5):e048613. Epub 2021 May 10.

George and Fay Yee Center for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada.

Objectives: To conduct a scoping review to identify and summarise the existing literature on interventions involving primary healthcare professionals to manage emergency department (ED) overcrowding.

Design: A scoping review.

Data Sources: A comprehensive database search of Medline (Ovid), EMBASE (Ovid), Cochrane Library (Wiley) and CINAHL (EBSCO) databases was conducted (inception until January 2020) using peer-reviewed search strategies, complemented by a search of grey literature sources.

Eligibility Criteria: Interventions and strategies involving primary healthcare professionals (PHCPs: general practitioners (GPs), nurse practitioners (NPs) or nurses with expanded role) to manage ED overcrowding.

Methods: We engaged and collaborated, with 13 patient partners during the design and conduct stages of this review. We conducted this review using the JBI guidelines. Two reviewers independently selected studies and extracted data. We conducted descriptive analysis of the included studies (frequencies and percentages).

Results: From 23 947 records identified, we included 268 studies published between 1981 and 2020. The majority (58%) of studies were conducted in North America and were predominantly cohort studies (42%). The reported interventions were either 'within ED' (48%) interventions (eg, PHCP-led ED triage or fast track) or 'outside ED' interventions (52%) (eg, after-hours GP clinic and GP cooperatives). PHCPs involved in the interventions were: GP (32%), NP (26%), nurses with expanded role (16%) and combinations of the PHCPs (42%). The 'within ED' and 'outside ED' interventions reported outcomes on patient flow and ED utilisation, respectively.

Conclusions: We identified many interventions involving PHCPs that predominantly reported a positive impact on ED utilisation/patient flow metrics. Future research needs to focus on conducting well-designed randomized controlled trials (RCTs) and systematic reviews to evaluate the effectiveness of specific interventions involving PHCPs to critically appraise and summarise evidence on this topic.
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http://dx.doi.org/10.1136/bmjopen-2021-048613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112422PMC
May 2021

Methodologically rigorous risk of bias tools for nonrandomized studies had low reliability and high evaluator burden.

J Clin Epidemiol 2020 12 25;128:140-147. Epub 2020 Sep 25.

George & Fay Yee Center for Healthcare Innovation, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba R3E 0T6, Canada; Department of Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba R3E 0T6, Canada.

Objective: To assess the real-world interrater reliability (IRR), interconsensus reliability (ICR), and evaluator burden of the Risk of Bias (RoB) in Nonrandomized Studies (NRS) of Interventions (ROBINS-I), and the ROB Instrument for NRS of Exposures (ROB-NRSE) tools.

Study Design And Setting: A six-center cross-sectional study with seven reviewers (2 reviewer pairs) assessing the RoB using ROBINS-I (n = 44 NRS) or ROB-NRSE (n = 44 NRS). We used Gwet's AC statistic to calculate the IRR and ICR. To measure the evaluator burden, we assessed the total time taken to apply the tool and reach a consensus.

Results: For ROBINS-I, both IRR and ICR for individual domains ranged from poor to substantial agreement. IRR and ICR on overall RoB were poor. The evaluator burden was 48.45 min (95% CI 45.61 to 51.29). For ROB-NRSE, the IRR and ICR for the majority of domains were poor, while the rest ranged from fair to perfect agreement. IRR and ICR on overall RoB were slight and poor, respectively. The evaluator burden was 36.98 min (95% CI 34.80 to 39.16).

Conclusions: We found both tools to have low reliability, although ROBINS-I was slightly higher. Measures to increase agreement between raters (e.g., detailed training, supportive guidance material) may improve reliability and decrease evaluator burden.
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.033DOI Listing
December 2020

Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis.

JAMA Netw Open 2020 08 3;3(8):e2012598. Epub 2020 Aug 3.

Department of Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg, Manitoba, Canada.

Importance: Mindfulness-based interventions (MBIs), grounded in mindfulness, focus on purposely paying attention to experiences occurring at the present moment without judgment. MBIs are increasingly used by patients with cancer for the reduction of anxiety, but it remains unclear if MBIs reduce anxiety in patients with cancer.

Objective: To evaluate the association of MBIs with reductions in the severity of anxiety in patients with cancer.

Data Sources: Systematic searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, CINAHL, PsycINFO, and SCOPUS were conducted from database inception to May 2019 to identify relevant citations.

Study Selection: Randomized clinical trials (RCTs) that compared MBI with usual care, waitlist controls, or no intervention for the management of anxiety in cancer patients were included. Two reviewers conducted a blinded screening. Of 101 initially identified studies, 28 met the inclusion criteria.

Data Extraction And Synthesis: Two reviewers independently extracted the data. The Cochrane Collaboration risk-of-bias tool was used to assess the quality of RCTs, and the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was followed. Summary effect measures were reported as standardized mean differences (SMDs) and calculated using a random-effects model.

Main Outcomes And Measures: Our primary outcome was the measure of severity of short-term anxiety (up to 1-month postintervention); secondary outcomes were the severity of medium-term (1 to ≤6 months postintervention) and long-term (>6 to 12 months postintervention) anxiety, depression, and health-related quality of life of patients and caregivers.

Results: This meta-analysis included 28 RCTs enrolling 3053 adults with cancer. None of the trials were conducted in children. Mindfulness was associated with significant reductions in the severity of short-term anxiety (23 trials; 2339 participants; SMD, -0.51; 95% CI, -0.70 to -0.33; I2 = 76%). The association of mindfulness with short-term anxiety did not vary by evaluated patient, intervention, or study characteristics. Mindfulness was also associated with the reduction of medium-term anxiety (9 trials; 965 participants; SMD, -0.43; 95% CI, -0.68 to -0.18; I2 = 66%). No reduction in long-term anxiety was observed (2 trials; 403 participants; SMD, -0.02; 95% CI, -0.38 to 0.34; I2 = 68%). MBIs were associated with a reduction in the severity of depression in the short term (19 trials; 1874 participants; SMD, -0.73; 95% CI; -1.00 to -0.46; I2 = 86%) and the medium term (8 trials; 891 participants; SMD, -0.85; 95% CI, -1.35 to -0.35; I2 = 91%) and improved health-related quality of life in patients in the short term (9 trials; 1108 participants; SMD, 0.51; 95% CI, 0.20 to 0.82; I2 = 82%) and the medium term (5 trials; 771 participants; SMD, 0.29; 95% CI, 0.06 to 0.52; I2 = 57%).

Conclusions And Relevance: In this study, MBIs were associated with reductions in anxiety and depression up to 6 months postintervention in adults with cancer. Future trials should explore the long-term association of mindfulness with anxiety and depression in adults with cancer and determine its efficacy in more diverse cancer populations using active controls.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.12598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7414391PMC
August 2020

Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis.

Drug Saf 2020 12;43(12):1255-1266

IBD Clinical and Research Centre, University of Manitoba, 804F-715 McDermot Avenue, Winnipeg, MB, R3E3P4, Canada.

Introduction: Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury.

Objective: We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen.

Patients And Methods: We searched MEDLINE, EMBASE, CENTRAL, the World Health Organization International Clinical Trials Registry, and conference proceedings. We included: (1) randomized controlled trials comparing ipilimumab administration with placebo/standard care/other active chemotherapy regimens and (2) prospective observational studies. Separate meta-analyses were performed for randomized controlled trials and observational studies.

Results: Of 4760 records, we included ten unique randomized controlled trials (n = 5814 subjects) and 34 unique prospective observational studies (n = 3699 subjects). In randomized controlled trials, the pooled relative risk of ≥ grade 3 enterocolitis or ≥ grade 3 diarrhea associated with ipilimumab was 13.31 (95% confidence interval 6.01-29.48, I = 0%, ten trials) and 6.72 (95% confidence interval 3.30-13.65, I = 63%, ten trials), respectively. In observational studies, the 3-monthly risk of developing grade 3 or higher enteritis, colitis, or enterocolitis was 4% (95% confidence interval 3-7, I = 77.40%, 25 studies). Randomized controlled trials and observational studies did not distinguish between acute and chronic enterocolitis. Of the included observational studies, the pooled risk of incurring small bowel involvement associated with ipilimumab was 1% (95% CI 0-4, I = 0%, four studies) per every 3-month time period.

Conclusions: Insufficient data exist to quantify or distinguish the risk of acute vs chronic enterocolitis following ipilmumab use. Because of the serious impact of chronic enterocolitis on quality of life and further cancer treatment, future trials evaluating the safety of immunotherapy should report gastrointestinal events in greater detail.
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http://dx.doi.org/10.1007/s40264-020-00979-4DOI Listing
December 2020

Layperson-Led vs Professional-Led Behavioral Interventions for Weight Loss in Pediatric Obesity: A Systematic Review and Meta-analysis.

JAMA Netw Open 2020 07 1;3(7):e2010364. Epub 2020 Jul 1.

George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.

Importance: The appropriate approach for weight loss among children and adolescents with overweight and obesity remains unclear.

Objective: To evaluate the difference in the treatment outcomes associated with behavioral weight loss interventions led by laypersons and professionals in comparison with unsupervised control arms among children and adolescents with overweight and obesity.

Data Sources: For this systematic review and meta-analysis, the Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, the Cochrane Library, and Cumulative Index of Nursing and Allied Health Literature (CINAHL) databases were searched from January 1, 1996, to June 1, 2019.

Study Selection: Included in this study were randomized clinical trials (RCTs) of behavioral interventions lasting at least 12 weeks for children and adolescents (aged 5-18 years) with overweight and obesity. Exclusion criteria included non-RCT studies, interventions lasting less than 12 weeks, adult enrollment, participants with other medical diagnoses, pharmacological treatment use, and articles not written in English. Two of 6 reviewers independently screened all citations. Of 25 586 citations, after duplicate removal, 78 RCTs (5780 participants) met eligibility criteria.

Data Extraction And Synthesis: A bayesian framework and Markov chain Monte Carlo simulation methods were used to combine direct and indirect associations. Random-effects and fixed-effect network meta-analysis models were used with the preferred model chosen by comparing the deviance information criteria. This study was registered with the International Prospective Register of Systematic Reviews (PROSPERO) and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.

Main Outcomes And Measures: The immediate and sustained changes in weight and body mass index (BMI) standardized mean difference (SMD) were primary outcomes planned before data collection began, whereas waist circumference and percent body fat were secondary outcomes. The hypothesis being tested was formulated before the data collection.

Results: Of 25 586 citations retrieved, we included 78 RCTs (5780 participants), with a follow-up of 12 to 104 weeks. Compared with the control condition, random-effects models revealed that professional-led weight loss interventions were associated with reductions in weight (mean difference [MD], -1.60 kg [95% CI, -2.30 to -0.99 kg]; 68 trials; P < .001) and BMI (SMD, -0.30 [95% CI, -0.39 to -0.20]; 59 trials; P < .001) that were not sustained long term (weight MD, -1.02 kg [95% CI, -2.20 to 0.34 kg]; 21 trials; P = .06; BMI SMD, -0.12 [95% CI, -0.46 to 0.21]; 20 trials; P < .001). There was no association between layperson-led interventions and weight loss in the short-term (MD, -1.40 kg [95% CI, -3.00 to 0.26 kg]; 5 trials; P = .05) or long-term (MD, -0.98 kg [95% CI, -3.60 to 1.80 kg]; 1 trial; P = .23) compared with standard care. No difference was found in head-to-head trials (professional vs layperson MD, -0.25 kg [95% CI -1.90 to 1.30 kg]; 5 trials; P = .38).

Conclusions And Relevance: This systematic review and meta-analysis found that professional-led weight loss interventions were associated with short-term but not sustained weight reduction among children and adolescents with overweight or obesity, and the evidence for layperson-led approaches was insufficient to draw firm conclusions.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.10364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7358915PMC
July 2020

Systematic review and meta-analysis of transoral laser microsurgery in hypopharyngeal carcinoma.

Laryngoscope Investig Otolaryngol 2020 Feb 14;5(1):66-73. Epub 2020 Jan 14.

Department of Otolaryngology - Head and Neck Surgery University of Manitoba Winnipeg Canada.

Background: Transoral laser microsurgery has been suggested as an alternative treatment modality for hypopharyngeal carcinoma. The purpose of this study is to systematically review the oncologic and functional outcomes of patients with hypopharyngeal carcinoma when treated with primary transoral laser microsurgery.

Methods: A comprehensive literature search was performed using PRISMA methodology on OVID MEDLINE and EMBASE. Meta-analysis was completed for oncological outcomes.

Results: Six studies reported quality of life outcomes five reported oncologic outcomes. A median of 95% (range 0.83-0.98) patients achieving gastrostomy independence, a median of 3% (range 0%-6%) were tracheostomy dependent, and a median of 97% (Range 0.89-1.0) were able to preserve their larynx. Pooled five-year overall survival was 54% (CI, 0.50-0.58, I = 29%), pooled disease-specific survival was 72% (CI, 0.68-0.77, I = 46%), and pooled local control rate was 78% (CI, 0.72-0.85, I = 69%).

Conclusion: Systematic review supports improvements in functional outcomes and oncologic outcomes with transoral laser microsurgery.
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http://dx.doi.org/10.1002/lio2.351DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042655PMC
February 2020

The effect of restrictive versus liberal transfusion strategies on longer-term outcomes after cardiac surgery: a systematic review and meta-analysis with trial sequential analysis.

Can J Anaesth 2020 05 28;67(5):577-587. Epub 2020 Feb 28.

Department of Anesthesiology, Perioperative and Pain Medicine, St. Boniface Hospital, University of Manitoba, CR3008-369 Tache Ave, Winnipeg, MB, R2H 2A6, Canada.

Purpose: Blood transfusions are frequently administered in cardiac surgery. Despite a large number of published studies comparing a "restrictive" strategy with a "liberal" strategy, no clear consensus has emerged to guide blood transfusion practice in cardiac surgery patients. The purpose of this study was to identify, critically appraise, and summarize the evidence on the overall effect of restrictive transfusion strategies compared with liberal transfusion strategies on mortality, other clinical outcomes, and transfusion-related outcomes in adult patients undergoing cardiac surgery.

Source: We searched MEDLINE (OvidSP), EMBASE (OvidSP) and Cochrane CENTRAL (Wiley) from inception to 1 December 2017 and queried clinical trial registries and conference proceedings for randomized-controlled trials of liberal vs restrictive transfusion strategies in cardiac surgery.

Principal Findings: From 7,908 citations, we included ten trials (9,101 patients) and eight companion publications. Overall, we found no significant difference in mortality between restrictive and liberal transfusion strategies (risk ratio [RR], 1.08; 95% confidence interval [CI], 0.76 to 1.54; I = 33%; seven trials; 8,661 patients). The use of a restrictive transfusion strategy did not appear to adversely impact any of the secondary clinical outcomes. As expected, the proportion of patients who received red blood cells (RBCs) in the restrictive group was significantly lower than in the liberal group (RR, 0.68; 95% CI, 0.64 to 0.73; I = 56%; 5 trials; 8,534 patients). Among transfused patients, a restrictive transfusion strategy was associated with fewer transfused RBC units per patient than a liberal transfusion strategy.

Conclusions: In adult patients undergoing cardiac surgery, a restrictive transfusion strategy reduces RBC transfusion without impacting mortality rate or the incidence of other perioperative complications. Nevertheless, further large trials in subgroups of patients, potentially of differing age, are needed to establish firm evidence to guide transfusion in cardiac surgery.

Trial Registration: PROSPERO (CRD42017071440); registered 20 April, 2018.
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http://dx.doi.org/10.1007/s12630-020-01592-wDOI Listing
May 2020

Inter-rater reliability and validity of risk of bias instrument for non-randomized studies of exposures: a study protocol.

Syst Rev 2020 02 12;9(1):32. Epub 2020 Feb 12.

The George & Fay Yee Center for Healthcare Innovation, University of Manitoba, 363-753 McDermot Avenue, Winnipeg, Manitoba, R3E 0 T6, Canada.

Background: A new tool, "risk of bias (ROB) instrument for non-randomized studies of exposures (ROB-NRSE)," was recently developed. It is important to establish consistency in its application and interpretation across review teams. In addition, it is important to understand if specialized training and guidance will improve the reliability in the results of the assessments. Therefore, the objective of this cross-sectional study is to establish the inter-rater reliability (IRR), inter-consensus reliability (ICR), and concurrent validity of the new ROB-NRSE tool. Furthermore, as this is a relatively new tool, it is important to understand the barriers to using this tool (e.g., time to conduct assessments and reach consensus-evaluator burden).

Methods: Reviewers from four participating centers will apprise the ROB of a sample of NRSE publications using ROB-NRSE tool in two stages. For IRR and ICR, two pairs of reviewers will assess the ROB for each NRSE publication. In the first stage, reviewers will assess the ROB without any formal guidance. In the second stage, reviewers will be provided customized training and guidance. At each stage, each pair of reviewers will resolve conflicts and arrive at a consensus. To calculate the IRR and ICR, we will use Gwet's AC statistic. For concurrent validity, reviewers will appraise a sample of NRSE publications using both the Newcastle-Ottawa Scale (NOS) and ROB-NRSE tool. We will analyze the concordance between the two tools for similar domains and for the overall judgments using Kendall's tau coefficient. To measure evaluator burden, we will assess the time taken to apply ROB-NRSE tool (without and with guidance), and the NOS. To assess the impact of customized training and guidance on the evaluator burden, we will use the generalized linear models. We will use Microsoft Excel and SAS 9.4, to manage and analyze study data, respectively.

Discussion: The quality of evidence from systematic reviews that include NRSE depends partly on the study-level ROB assessments. The findings of this study will contribute to an improved understanding of ROB-NRSE and how best to use it.
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http://dx.doi.org/10.1186/s13643-020-01291-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017505PMC
February 2020

Efficacy and Safety of Tranexamic Acid in Major Non-Cardiac Surgeries at High Risk for Transfusion: A Systematic Review and Meta-Analysis.

Transfus Med Rev 2020 01 23;34(1):51-62. Epub 2019 Oct 23.

Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba; Department of Medical Oncology and Haematology, CancerCare Manitoba, Winnipeg, Manitoba; Rady Faculty of Health Sciences, College of Pharmacy, University of Manitoba, Winnipeg, Manitoba.

Tranexamic acid (TXA) reduces transfusion requirements in cardiac surgery and total hip and knee arthroplasty, where it has become standard of care. Our objective is to determine the efficacy and safety of TXA in other surgeries associated with a high risk for red blood cell (RBC) transfusion. We identified randomized controlled trials in Medline, Embase, CENTRAL, and CAB abstracts from inception to June 2019. We included trials evaluating intraoperative IV TXA in adult patients undergoing a non-cardiac and non-hip and knee arthroplasty surgeries at high-risk for RBC transfusion, defined as a baseline transfusion rate ≥5% in comparator arm. We assessed risk of bias using the Cochrane Risk of Bias tool. We used GRADE methodology to assess certainty of evidence. From 8565 citations identified, we included 69 unique trials, enrolling 6157 patients. TXA reduces both the proportion of patients transfused RBCs (relative risk (RR) 0.59; 95% confidence interval (CI) 0.48 to 0.72; low certainty evidence) and the volume of RBC transfused (MD -0.51 RBC units; 95%CI -0.13 to -0.9 units; low certainty evidence) when compared to placebo or usual care. TXA was not associated with differences in deep vein thrombosis, pulmonary embolism, all-cause mortality, hospital length of stay, need for re-operation due to hemorrhage, myocardial infarction, stroke or seizure. In patients undergoing a broad range of non-cardiac and non-hip and knee arthroplasty surgeries at high risk for RBC transfusion, perioperative TXA reduced exposure to RBC transfusion. No differences in thrombotic outcomes were identified; however, summary effect estimates were limited by lack of systemic screening and short duration of follow-up.
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http://dx.doi.org/10.1016/j.tmrv.2019.10.001DOI Listing
January 2020

Resveratrol for adults with type 2 diabetes mellitus.

Cochrane Database Syst Rev 2020 Jan 17;1:CD011919. Epub 2020 Jan 17.

University of Manitoba, Knowledge Synthesis Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada, R3A 1R9.

Background: Type 2 diabetes mellitus (T2DM) is a chronic disorder that is characterised by insulin resistance and hyperglycaemia, which over time may give rise to vascular complications. Resveratrol is a plant-derived nutritional supplement shown to have anti-diabetic properties in many animal models. Less evidence is available on its safety and efficacy in the management of T2DM in humans.

Objectives: To assess the efficacy and safety of resveratrol formulations for adults with type 2 diabetes mellitus.

Search Methods: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and International Pharmaceutical Abstracts, as well as the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov. The date of the last search was December 2018 for all databases. No language restrictions were applied.

Selection Criteria: All randomised controlled trials (RCTs) comparing effects of oral resveratrol (any dose or formulation, duration, or frequency of administration) with placebo, no treatment, other anti-diabetic medications, or diet or exercise, in adults with a diagnosis of T2DM.

Data Collection And Analysis: Two review authors independently identified and included RCTs, assessed risk of bias, and extracted study-level data. Study authors were contacted for any missing information or for clarification of reported data. We assessed studies for certainty of the evidence using the GRADE instrument.

Main Results: We identified three RCTs with a total of 50 participants. Oral resveratrol not combined with other plant polyphenols was administered at 10 mg, 150 mg, or 1000 mg daily for a period ranging from four weeks to five weeks. The comparator intervention was placebo. Overall, all three included studies had low risk of bias. None of the three included studies reported long-term, patient-relevant outcomes such as all-cause mortality, diabetes-related complications, diabetes-related mortality, health-related quality of life, or socioeconomic effects. All three included studies reported that no adverse events were observed, indicating that no deaths occurred (very low-quality evidence for adverse events, all-cause mortality, and diabetes-related mortality). Resveratrol versus placebo showed neutral effects for glycosylated haemoglobin A1c (HbA1c) levels (mean difference (MD) 0.1%, 95% confidence interval (CI) -0.02 to 0.2; P = 0.09; 2 studies; 31 participants; very low-certainty evidence). Due to the short follow-up period, HbA1c results have to be interpreted cautiously. Similarly, resveratrol versus placebo showed neutral effects for fasting blood glucose levels (MD 2 mg/dL, 95% CI -2 to 7; P = 0.29; 2 studies; 31 participants), and resveratrol versus placebo showed neutral effects for insulin resistance (MD -0.35, 95% CI -0.99 to 0.28; P = 0.27; 2 studies; 36 participants). We found eight ongoing RCTs with approximately 800 participants and two studies awaiting assessment, which, when published, could contribute to the findings of this review.

Authors' Conclusions: Currently, research is insufficient for review authors to evaluate the safety and efficacy of resveratrol supplementation for treatment of adults with T2DM. The limited available research does not provide sufficient evidence to support any effect, beneficial or adverse, of four to five weeks of 10 mg to 1000 mg of resveratrol in adults with T2DM. Adequately powered RCTs reporting patient-relevant outcomes with long-term follow-up periods are needed to further evaluate the efficacy and safety of resveratrol supplementation in the treatment of T2DM.
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http://dx.doi.org/10.1002/14651858.CD011919.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6984411PMC
January 2020

Inter-rater reliability and concurrent validity of ROBINS-I: protocol for a cross-sectional study.

Syst Rev 2020 01 13;9(1):12. Epub 2020 Jan 13.

The George and Fay Yee Center for Healthcare Innovation, University of Manitoba, 753 McDermot Avenue, Winnipeg, MB, R3E 0T6, Canada.

Background: The Cochrane Bias Methods Group recently developed the "Risk of Bias (ROB) in Non-randomized Studies of Interventions" (ROBINS-I) tool to assess ROB for non-randomized studies of interventions (NRSI). It is important to establish consistency in its application and interpretation across review teams. In addition, it is important to understand if specialized training and guidance will improve the reliability of the results of the assessments. Therefore, the objective of this cross-sectional study is to establish the inter-rater reliability (IRR), inter-consensus reliability (ICR), and concurrent validity of ROBINS-I. Furthermore, as this is a relatively new tool, it is important to understand the barriers to using this tool (e.g., time to conduct assessments and reach consensus-evaluator burden).

Methods: Reviewers from four participating centers will appraise the ROB of a sample of NRSI publications using the ROBINS-I tool in two stages. For IRR and ICR, two pairs of reviewers will assess the ROB for each NRSI publication. In the first stage, reviewers will assess the ROB without any formal guidance. In the second stage, reviewers will be provided customized training and guidance. At each stage, each pair of reviewers will resolve conflicts and arrive at a consensus. To calculate the IRR and ICR, we will use Gwet's AC statistic. For concurrent validity, reviewers will appraise a sample of NRSI publications using both the New-castle Ottawa Scale (NOS) and ROBINS-I. We will analyze the concordance between the two tools for similar domains and for the overall judgments using Kendall's tau coefficient. To measure the evaluator burden, we will assess the time taken to apply the ROBINS-I (without and with guidance), and the NOS. To assess the impact of customized training and guidance on the evaluator burden, we will use the generalized linear models. We will use Microsoft Excel and SAS 9.4 to manage and analyze study data, respectively.

Discussion: The quality of evidence from systematic reviews that include NRS depends partly on the study-level ROB assessments. The findings of this study will contribute to an improved understanding of the ROBINS-I tool and how best to use it.
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http://dx.doi.org/10.1186/s13643-020-1271-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6958722PMC
January 2020

Does a Delay in Anterior Cruciate Ligament Reconstruction Increase the Incidence of Secondary Pathology in the Knee? A Systematic Review and Meta-Analysis.

Clin J Sport Med 2021 May;31(3):313-320

Pan Am Clinic, University of Manitoba, Winnipeg, MB, Canada.

Objective: Previous systematic reviews looking at timing of anterior cruciate ligament reconstruction (ACLR) examined the functional outcomes and range of motion; however, few have quantified the effect of timing of surgery on secondary pathology. The goal of this study was to analyze the effects of early ACLRs versus delayed ACLR on the incidence of meniscal and chondral lesions.

Data Sources: We searched MEDLINE, EMBASE, and CINAHL on March 20, 2018, for randomized control trials (RCTs) that compared early and delayed ACLR in a skeletally mature population. Two reviewers independently identified trials, extracted trial-level data, performed risk-of-bias assessments using the Cochrane Risk of Bias tool, and evaluated the study methodology using the Detsky scale. A meta-analysis was performed using a random-effects model with the primary outcome being the total number of meniscal and chondral lesions per group.

Results: Of 1887 citations identified from electronic and hand searches, we included 4 unique RCTs (303 patients). We considered early reconstruction as <3 weeks and delayed reconstruction as >4 weeks after injury. There was no evidence of a difference between early and late ACLR regarding the incidence of meniscal [relative risk (RR), 0.98; 95% confidence interval (CI), 0.74-1.29] or chondral lesions (RR, 0.88; 95% CI, 0.59-1.29), postoperative infection, graft rupture, functional outcomes, or range of motion.

Conclusions: We found no evidence of benefit of early ACLR. Further studies may consider delaying surgery even further (eg, >3 months) to determine whether there are any real benefits to earlier reconstruction.
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http://dx.doi.org/10.1097/JSM.0000000000000762DOI Listing
May 2021

Training interventions to improve adenoma detection rates during colonoscopy: a systematic review and meta-analysis.

Surg Endosc 2020 09 8;34(9):3870-3882. Epub 2019 Oct 8.

Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.

Background: Colonoscopies are effective means of detecting and removing precancerous adenomatous polyps. The adenoma detection rate (ADR) is a marker of colonoscopy quality and an independent predictor of colorectal cancer incidence. Focused training interventions may improve an endoscopist's ADR, but the supporting research is limited. This systematic review and meta-analysis identified, critically appraised, and meta-analyzed data from randomized trials (RCTs) evaluating the effect of training interventions on ADRs.

Methods: Ovid Medline, EMBASE, CENTRAL, Eric, CINAHL, Scopus, Web of Science, and ClinicalTrials.gov were searched for RCTs investigating the effect of an educational intervention on ADRs. Two reviewers independently screened, identified, and extracted trial-level data. Internal validity was assessed in duplicate using the Risk of Bias tool. Our primary outcome was the ADR. Secondary outcomes were advanced ADR, adenocarcinoma detection rate, polyp detection rate, and withdrawal times. Safety outcomes were post-polypectomy bleeding rate and colonoscopy-related perforation rate.

Results: From 2837 screened citations, we identified 3 trials (119 endoscopists) meeting our inclusion criteria. Training interventions were associated with a trend toward increased ADRs (odds ratio 1.16, 95% confidence interval (CI) 1.00-1.34; I 83%; 3 trials; 119 endoscopists). When limited to screening colonoscopies, the odds ratio for ADRs associated with training interventions was 1.17 (95% CI 1.00-1.36; I 80%; 3 trials; 119 endoscopists). There was a high level of heterogeneity between the trials' training interventions. Training intervention improved the advanced ADR, adenocarcinoma detection rate, polyp detection rate, and withdrawal times. Safety outcomes were not reported.

Conclusions: A focused training intervention was associated with a strong trend toward increased ADRs among certified endoscopists. While the described training interventions definitely show promise, further efforts around continuing professional developments activities are needed to more consistently improve ADRS among certified endoscopists.
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http://dx.doi.org/10.1007/s00464-019-07153-7DOI Listing
September 2020

Combining population-based administrative health records and electronic medical records for disease surveillance.

BMC Med Inform Decis Mak 2019 07 2;19(1):120. Epub 2019 Jul 2.

Department of Community Health Sciences, University of Manitoba, S113-750 Bannatyne Avenue, Winnipeg, MB, R3E 0W3, Canada.

Background: Administrative health records (AHRs) and electronic medical records (EMRs) are two key sources of population-based data for disease surveillance, but misclassification errors in the data can bias disease estimates. Methods that combine information from error-prone data sources can build on the strengths of AHRs and EMRs. We compared bias and error for four data-combining methods and applied them to estimate hypertension prevalence.

Methods: Our study included rule-based OR and AND methods that identify disease cases from either or both data sources, respectively, rule-based sensitivity-specificity adjusted (RSSA) method that corrects for inaccuracies using a deterministic rule, and probabilistic-based sensitivity-specificity adjusted (PSSA) method that corrects for error using a statistical model. Computer simulation was used to estimate relative bias (RB) and mean square error (MSE) under varying conditions of population disease prevalence, correlation amongst data sources, and amount of misclassification error. AHRs and EMRs for Manitoba, Canada were used to estimate hypertension prevalence using validated case definitions and multiple disease markers.

Results: The OR method had the lowest RB and MSE when population disease prevalence was 10%, and the RSSA method had the lowest RB and MSE when population prevalence increased to 20%. As the correlation between data sources increased, the OR method resulted in the lowest RB and MSE. Estimates of hypertension prevalence for AHRs and EMRs alone were 30.9% (95% CI: 30.6-31.2) and 24.9% (95% CI: 24.6-25.2), respectively. The estimates were 21.4% (95% CI: 21.1-21.7), for the AND method, 34.4% (95% CI: 34.1-34.8) for the OR method, 32.2% (95% CI: 31.8-32.6) for the RSSA method, and ranged from 34.3% (95% CI: 34.1-34.5) to 35.9% (95% CI, 35.7-36.1) for the PSSA method, depending on the statistical model.

Conclusions: The OR and AND methods are influenced by correlation amongst the data sources, while the RSSA method is dependent on the accuracy of prior sensitivity and specificity estimates. The PSSA method performed well when population prevalence was high and average correlations amongst disease markers was low. This study will guide researchers to select a data-combining method that best suits their data characteristics.
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http://dx.doi.org/10.1186/s12911-019-0845-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6604278PMC
July 2019

The Relation Between Periodontal Disease and Vitamin D.

J Can Dent Assoc 2019 Mar;84:j4

Background: There is conflicting evidence regarding the association between vitamin D and periodontal disease. The purpose of this study was to explore that relation.

Methods: This cross-sectional study used data from the Canadian Health Measures Survey for respondents 13-79 years of age. Vitamin D status was determined by measuring plasma 25-hydroxyvitamin D (25(OH)D) concentrations. Periodontal disease was defined by gingival index (GI) and calculated loss of attachment (LOA). Statistical analyses included bivariate tests and multiple logistic regression.

Results: At the bivariate level, 25(OH)D concentrations below the cutoff levels of 50 nmol/L and 75 nmol/L were associated with GI. However, multiple regression analyses for GI revealed no association with mean 25(OH)D level or either concentration. Although no significant association between LOA and 25(OH)D status was identified at the bivariate level, a statistically significant association was observed between LOA and 25(OH)D levels < 75 nmol/L on multiple regression analysis. However, mean 25(OH)D concentrations and those < 50 nmol/L were not associated with LOA on multiple regression analysis.

Conclusion: Vitamin D status was inversely associated with GI at the bivariate level, but not at the multivariate level. Conversely, vitamin D status was not associated with LOA at the bivariate level, but it was inversely associated with LOA at the multivariate level. These results provide modest evidence supporting a relation between low plasma 25(OH)D concentrations and periodontal disease as measured by GI and LOA.
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March 2019

Upper limb tendon/muscle vibration in persons with subacute and chronic stroke: a systematic review and meta-analysis.

Eur J Phys Rehabil Med 2019 Oct 11;55(5):558-569. Epub 2019 Mar 11.

Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, MB, Canada.

Introduction: Results of several recent studies suggest that tendon/muscle vibration treatment may improve motor performance and reduce spasticity in individuals with stroke. We performed a systematic review and meta-analysis to assess the efficacy of tendon/muscle vibration treatment for upper limb functional movements in persons with subacute and chronic stroke.

Evidence Acquisition: We searched MEDLINE (Ovid), EMBASE (Ovid), and the Cochrane Central Register of Controlled Trials (Wiley) from inception to September 2017. We included randomized controlled trials comparing upper limb tendon/muscle vibration to sham treatment/rest or conventional interventions in persons with subacute and chronic stroke. Our primary outcome was upper limb functional movement at the end of the treatment period.

Evidence Synthesis: We included eight trials, enrolling a total of 211 participants. We found insufficient evidence to support a benefit for upper limb functional movement (standard mean difference -0.32, 95% confidence interval (CI) -0.74 to 0.10, I2 25%, 6 trials, 135 participants). Movement time for reaching tasks significantly decreased after using tendon/muscle vibration (standard mean difference -1.20, 95% CI -2.05 to -0.35, I2 65%, 2 trials, 74 participants). We also found that tendon/muscle vibration was not associated with a significant reduction in spasticity (4 trials).

Conclusions: Besides shorter movement time for reaching tasks, we did not identify evidence to support clinical improvement in upper limb functional movements after tendon/muscle vibration treatment in persons with subacute and chronic stroke. A small number of trials were identified; therefore, there is a need for larger, higher quality studies and to consider the clinical relevance of performance-based outcome measures that focus on time to complete a functional movement such as a reach.
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http://dx.doi.org/10.23736/S1973-9087.19.05605-3DOI Listing
October 2019

The Efficacy of Split-Dose Bowel Preparations for Polyp Detection: A Systematic Review and Meta-Analysis.

Am J Gastroenterol 2019 06;114(6):884-892

Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.

Introduction: Split-dose bowel preparation leads to superior colon cleansing for colonoscopy. However, the magnitude of benefit in detecting colonic polyps is uncertain. We performed a systematic review to synthesize the data on whether using a split-dose bowel preparation regimen improves the detection of polyps when compared with other dosing methods or regimen products.

Methods: We searched MEDLINE, EMBASE, and CENTRAL databases (from the inception to June 2017) for randomized controlled trials that assessed the following: split-dose vs day-before, split-dose vs same-day (as colonoscopy), or different types of split-dose regimens for patients undergoing colonoscopy. We excluded studies limited to inpatients, children, or individuals with inflammatory bowel disease. We compared the number of patients undergoing colonoscopy with recorded detection of polyps, adenomas, advanced adenomas, sessile serrated polyps (SSPs), right colonic adenomas, right colonic polyps, or right colonic SSPs.

Results: Twenty-eight trials fulfilled the inclusion criteria (8,842 participants). Of the seven trials comparing split-dose vs day-before bowel preparation regimens, there was an increased detection rate of adenomas (risk ratio (RR) 1.26, 95% confidence intervals (CIs): 1.10-1.44; 4 trials; 1,258 participants), advanced adenomas (RR 1.53, 95% CI: 1.22-1.92; 3 trials; 1,155 participants), and SSPs (RR 2.48, 95% CI: 1.21-5.09; 2 trials; 1,045 participants). Pooled estimates from 8 trials (1,587 participants) evaluating split-dose vs same-day bowel preparations yielded no evidence of statistical difference. For various split-dose vs split-dose trials, 14 fulfilled the criteria (5,496 participants) and no superior split-regimen was identified.

Conclusions: Compared with day-before bowel preparation regimens, split-dose bowel preparations regimens increase the detection of adenomas, advanced adenomas, and have the greatest benefit in SSP detection.
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http://dx.doi.org/10.14309/ajg.0000000000000155DOI Listing
June 2019

Vitamins and Minerals for Migraine Prophylaxis: A Systematic Review and Meta-analysis.

Can J Neurol Sci 2019 03 15;46(2):224-233. Epub 2019 Feb 15.

George & Fay Yee Centre for Healthcare Innovation, Max Rady College of Medicine, Rady Faculty of Health Sciences,University of Manitoba,Winnipeg,Canada.

Objective: To summarize the findings of randomized controlled trials (RCTs) on the efficacy and safety of vitamins and minerals for migraine prophylaxis.

Methods: We systematically searched bibliographic databases and relevant websites for parallel and crossover RCTs reporting efficacy and/or safety of vitamins and/or minerals for migraine prophylaxis. Our primary outcomes were migraine frequency (number of attacks) and duration (hours). Secondary outcomes were severity (intensity), days with migraine, and adverse events. Meta-analysis was conducted when analyzable data were available from at least two trials.

Results: Eighteen placebo-controlled trials met our eligibility criteria. Only coenzyme Q10 and magnesium contributed to meta-analyses. In adults, compared with placebo, coenzyme Q10 did not significantly decrease migraine frequency (mean difference (MD) -0.44 (-2.14 to 1.26); I2 53%; 2 trials; 97 participants; moderate strength of the evidence), duration (MD -1.97 (-4.82 to 0.87); I2 0%; 2 trials; 97 participants; moderate strength of the evidence), or severity (ratio of means (RoM) -0.05 (-0.20 to 0.11); I2 0%; 2 trials; 97 participants). In adults, compared with placebo, magnesium did not significantly decrease migraine severity (RoM -0.17 (-0.36 to 0.02); I2 48%; 3 trials; 226 participants; low strength of the evidence). Meta-analysis of other vitamins and minerals, and other outcomes were not feasible due to a lack of sufficiently reported data.

Conclusions: Based on insufficient evidence, it is unknown if coenzyme Q10 and magnesium are effective for migraine prophylaxis in adults. High-quality, adequately powered RCTs are needed to fully evaluate the efficacy and safety of vitamins and minerals for migraine prophylaxis.
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http://dx.doi.org/10.1017/cjn.2018.394DOI Listing
March 2019

Can authorship bias be detected in meta-analysis?

Can J Anaesth 2019 03 6;66(3):287-292. Epub 2019 Feb 6.

George and Fay Yee Centre for Healthcare Innovation, University of Manitoba/Winnipeg Regional Health Authority, Chown Building, 367-753 McDermot Ave, Winnipeg, MB, R3A 1R9, Canada.

Purpose: Statistical approaches have been developed to detect bias in individual trials, but guidance on how to detect systematic differences at a meta-analytical level is lacking. In this paper, we elucidate whether author bias can be detected in a cohort of randomized trials included in a meta-analysis.

Methods: We utilized mortality data from 35 trials (10,880 patients) included in our previously published meta-analysis. First, we linked each author with their trial (or trials). Then we calculated author-specific odds ratios using univariate cross table methods. Finally, we tested the effect of authorship by comparing each author's estimated odds ratio with all other pooled estimated odds ratios using meta-regression.

Results: The median number of investigators named as authors on the primary trial reports was six (interquartile range: 5-8, range: 2-32). The results showed that the slope of author effect for mortality ranged from - 1.35 to 0.71. We identified only one author team showing a marginally significant effect (- 0.39; 95% confidence interval, - 0.78 to 0.00). This author team has a history of retractions due to data manipulations and ethical violations.

Conclusion: When combining trial-level data to produce a pooled effect estimate, investigators must consider sources of potential bias. Our results suggest that systematic errors can be detected using meta-regression, although further research is needed to examine the sensitivity of this model. Systematic reviewers will benefit from the availability of methods to guard against the dissemination of results with the potential to mislead decision-making.
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http://dx.doi.org/10.1007/s12630-018-01268-6DOI Listing
March 2019

Publication of Randomized Clinical Trials in Pediatric Research: A Follow-up Study.

JAMA Netw Open 2018 05 18;1(1):e180156. Epub 2018 May 18.

George and Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.

Importance: Nonpublication of research results in considerable research waste and compromises medical evidence and the safety of interventions in child health.

Objective: To replicate, compare, and contrast the findings of a study conducted 15 years ago to determine the impact of ethical, editorial, and legislative mandates to register and publish findings.

Design, Setting, And Participants: In this cohort study, abstracts accepted to the Pediatric Academic Societies (PAS) meetings from May 2008 to May 2011 were screened in duplicate to identify phase 3 randomized clinical trials enrolling pediatric populations. Subsequent publication was ascertained through a search of electronic databases in 2017. Study internal validity was measured using the Cochrane Risk of Bias Tool, the Jadad scale, and allocation concealment, and key variables (eg, trial design and study stage) were extracted. Associations between variables and publication status, time to publication, and publication bias were examined.

Main Outcomes And Measures: Publication rate, trial registration rate, study quality, and risk of bias.

Results: A total of 177 787 abstracts were indexed in the PAS database. Of these, 3132 were clinical trials, and 129 met eligibility criteria. Of these, 93 (72.1%; 95% CI, 53.8%-79.1%) were published. Compared with the previous analysis, the current analysis showed that fewer studies remained unpublished (183 of 447 [40.9%] vs 36 of 129 [27.9%], respectively; odds ratio [OR], 0.56; 95% CI, 0.36-0.86; P = .008). Fifty-one of 129 abstracts (39.5%) were never registered. Abstracts with larger sample sizes (OR, 1.92; 95% CI, 1.15-3.18; P = .01) and those registered in ClinicalTrials.gov (OR, 13.54; 95% CI, 4.78-38.46; P < .001) were more likely to be published. There were no differences in quality measures, risk of bias, or preference for positive results (OR, 1.60; 95% CI, 0.58-4.38; P = .34) between published and unpublished studies. Mean (SE) time to publication following study presentation was 26.48 (1.97) months and did not differ between studies with significant and nonsignificant findings (25.61 vs 26.86 months; P = .93). Asymmetric distribution in the funnel plot (Egger regression, -2.77; P = .04) suggests reduced but ongoing publication bias among published studies. Overall, we observed a reduction in publication bias and in preference for positive findings and an increase in study size and publication rates over time.

Conclusions And Relevance: These results suggest a promising trend toward a reduction in publication bias and nonpublication rates over time and positive impacts of trial registration. Further efforts are needed to ensure the entirety of evidence can be accessed when assessing treatment effectiveness.
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http://dx.doi.org/10.1001/jamanetworkopen.2018.0156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324306PMC
May 2018

Point-of-care viscoelastic hemostatic testing in cardiac surgery patients: a systematic review and meta-analysis.

Can J Anaesth 2018 12 7;65(12):1333-1347. Epub 2018 Sep 7.

Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.

Purpose: Thromboelastography and rotational thromboelastometry are point-of-care (POC) viscoelastic tests used to help guide blood product administration. It is unclear whether these tests improve clinical or transfusion-related outcomes. The objective of this study was to appraise data from randomized trials evaluating the benefit of POC testing in cardiac surgery patients. Primary outcomes were the proportion of patients transfused with blood products and all-cause mortality.

Source: Medline (Ovid), EMBASE (Ovid), CENTRAL (the Cochrane Library-Wiley), Web of Science, Biosis, Scopus, and CINAHL databases, as well as clinical trial registries and conference proceedings were queried from inception to February 2018.

Principal Findings: We identified 1,917 records, 11 of which were included in our analysis (8,294 patients). Point-of-care testing was not associated with a difference in the proportion of patients transfused with any blood product (risk ratio [RR], 0.90; 95% confidence interval [CI], 0.79 to 1.02; I = 51%; four trials, 7,623 patients), or all-cause mortality (RR, 0.73; 95% CI, 0.47 to 1.13; I = 5%; six trials, 7,931 patients). Nevertheless, POC testing was weakly associated with a decrease in the proportion of patients receiving red blood cells (RBC) (RR, 0.91; 95% CI, 0.85 to 0.96; I = 0%; seven trials, 8,029 patients), and heterogeneous reductions in frozen plasma (FP) (RR, 0.58; 95% CI, 0.34 to 0.99; I = 87%; six trials, 7,989 patients) and platelets (RR, 0.66; 95% CI, 0.49 to 0.90; I = 65%; seven trials, 8,029 patients). Meta-analysis of the number of units of RBCs and FP was not possible due to heterogeneity in reporting, however POC testing significantly reduced the units of platelets transfused (standard mean difference, -0.09; 95% CI, -0.18 to 0.00; four trials, 7,643 patients).

Conclusion: Our review indicates that in cardiac surgery patients, POC viscoelastic hemostatic testing is not associated with a reduction in the proportion of patients receiving any blood product or all-cause mortality. However, viscoelastic testing is weakly associated with a reduction in proportion of patients transfused with specific blood products. Presently, the benefits associated with viscoelastic testing in cardiac surgery patients are insufficiently robust to recommend routine implementation of this technology.

Trial Registration: PROSPERO (CRD4201706577). Registered 11 May 2017.
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http://dx.doi.org/10.1007/s12630-018-1217-9DOI Listing
December 2018

Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomised controlled trials.

BMJ Open 2018 04 5;8(4):e019240. Epub 2018 Apr 5.

Department of Internal Medicine, Section of Medical Oncology and Haematology, University of Manitoba, Winnipeg, Manitoba, Canada.

Objective: Iron supplementation in iron-deficiency anaemia is standard practice, but the benefits of iron supplementation in iron-deficient non-anaemic (IDNA) individuals remains controversial. Our objective is to identify the effects of iron therapy on fatigue and physical capacity in IDNA adults.

Design: Systematic review and meta-analysis of randomised controlled trials (RCTs).

Setting: Primary care.

Participants: Adults (≥18 years) who were iron deficient but non-anaemic.

Interventions: Oral, intramuscular or intravenous iron supplementation; all therapy doses, frequencies and durations were included.

Comparators: Placebo or active therapy.

Results: We identified RCTs in Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health, SportDiscus and CAB Abstracts from inception to 31 October 2016. We searched the WHO's International Clinical Trials Registry Platform for relevant ongoing trials and performed forward searches of included trials and relevant reviews in Web of Science. We assessed internal validity of included trials using the Cochrane Risk of Bias tool and the external validity using the Grading of Recommendations Assessment, Development and Evaluation methodology. From 11 580 citations, we included 18 unique trials and 2 companion papers enrolling 1170 patients. Using a Mantel-Haenszel random-effects model, iron supplementation was associated with reduced self-reported fatigue (standardised mean difference (SMD) -0.38; 95% CI -0.52 to -0.23; I 0%; 4 trials; 714 participants) but was not associated with differences in objective measures of physical capacity, including maximal oxygen consumption (SMD 0.11; 95% CI -0.15 to 0.37; I 0%; 9 trials; 235 participants) and timed methods of exercise testing. Iron supplementation significantly increased serum haemoglobin concentration (MD 4.01 g/L; 95% CI 1.22 to 6.81; I 48%; 12 trials; 298 participants) and serum ferritin (MD 9.23 µmol/L; 95% CI 6.48 to 11.97; I 58%; 14 trials; 616 participants).

Conclusion: In IDNA adults, iron supplementation is associated with reduced subjective measures of fatigue but not with objective improvements in physical capacity. Given the global prevalence of both iron deficiency and fatigue, patients and practitioners could consider consumption of iron-rich foods or iron supplementation to improve symptoms of fatigue in the absence of documented anaemia.

Prospero Registration Number: CRD42014007085.
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http://dx.doi.org/10.1136/bmjopen-2017-019240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5892776PMC
April 2018

Autologous Bone Marrow Stem Cell Therapy in Patients With ST-Elevation Myocardial Infarction: A Systematic Review and Meta-analysis.

Can J Cardiol 2017 12 7;33(12):1611-1623. Epub 2017 Oct 7.

The George and Fay Yee Center for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada; Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.

Background: Randomized controlled trials (RCTs) on bone marrow stem cell (BMSC) therapy in ST-elevation myocardial infarction (STEMI) patients have reported conflicting results. Our main objective was to critically appraise and meta-analyze best-available evidence on efficacy and safety of intracoronary administration of autologous BMSC therapy in STEMI patients after primary percutaneous coronary intervention.

Methods: We conducted a search of MEDLINE, PubMed, EMBASE, CENTRAL, Global Health, CINAHL, and conference proceedings in February 2017. Our primary outcome was all-cause mortality. Secondary and safety outcomes included cardiac death, heart failure, arrhythmias, repeat myocardial infarction, or target vessel revascularizations; or improved health-related quality of life, left ventricular ejection fraction, or infarct size. Summary relative and absolute risks were obtained using random effects models. We also evaluated the strength of evidence.

Results: A comprehensive database search identified 42 RCTs (3365 STEMI patients). BMSC therapy did not significantly decrease mortality (risk ratio, 0.71; 95% confidence interval, 0.45-1.11; I, 0%; absolute risk reduction, 0.1%; 95% confidence interval, -0.71 to 0.91; 40 trials; 3289 participants; I, 0%; low strength of evidence). BMSC therapy had no effect on secondary or adverse outcomes. Trial sequential analysis for all-cause mortality showed no evidence of a clinically important difference, with a very low probability that future studies can change the current conclusion.

Conclusions: On the basis of evidence from 42 RCTs published in the past 15 years, we provide conclusive evidence for a lack of beneficial effect for autologous BMSC therapy in patients with STEMI.
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http://dx.doi.org/10.1016/j.cjca.2017.10.001DOI Listing
December 2017

High-flow oxygen via nasal cannulae in patients with acute hypoxemic respiratory failure: a systematic review and meta-analysis.

Syst Rev 2017 10 16;6(1):202. Epub 2017 Oct 16.

Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada.

Background: We performed a systematic review and meta-analysis to evaluate the efficacy and safety of high-flow oxygen via nasal cannulae (HFNC) compared to non-invasive ventilation (NIV) and/or standard oxygen in patients with acute, hypoxemic respiratory failure.

Methods: We reviewed randomized controlled trials from CENTRAL, EMBASE, MEDLINE, Scopus and the International Clinical Trials Registry Platform (inception to February 2016), conference proceedings, and relevant article reference lists. Two reviewers independently screened and extracted trial-level data from trials investigating HFNC in patients with acute, hypoxemic respiratory failure. Internal validity was assessed in duplicate using the Cochrane Risk of Bias tool. The strength of evidence was assessed in duplicate using the Grading of Recommendations Assessment, Development and Evaluation framework. Our primary outcome was mortality. Secondary outcomes included dyspnea, PaO:FiO ratio, PaCO, and pH. Safety outcomes included respiratory arrest, intubation, delirium, and skin breakdown.

Results: From 2023 screened citations, we identified seven trials (1771 patients) meeting inclusion criteria. All trials were at high risk of bias due to lack of blinding. There was no evidence for a mortality difference in patients receiving HFNC vs. NIV and/or standard oxygen (RR 1.01, 95% CI 0.69 to 1.48, I  = 63%, five trials, 1629 patients). In subgroup analyses of HFNC compared to NIV or standard oxygen individually, mortality differences were not observed. Measures of patient tolerability were heterogeneous. The PaO:FiO ratio at 6-12 h was significantly lower in patients receiving oxygen via HFNC compared to NIV or standard oxygen for hypoxemic respiratory failure (MD - 53.34, 95% CI - 71.95 to - 34.72, I  = 61%, 1143 patients). There were no differences in pH, PaCO, or rates of intubation or cardio-respiratory arrest. Delirium and skin breakdown were infrequently reported in included trials.

Conclusions: In patients with acute hypoxemic respiratory failure HFNC was not associated with a difference in mortality compared to NIV or standard oxygen. Secondary outcomes including dyspnea, tolerance, and safety were not systematically reported. Residual heterogeneity and variable reporting of secondary outcomes limit the conclusions that can be made in this review. Prospective trials designed to evaluate the efficacy and safety of HFNC in patients with acute hypoxemic respiratory failure are required.
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http://dx.doi.org/10.1186/s13643-017-0593-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5644261PMC
October 2017

Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis.

Crit Care Med 2017 Sep;45(9):1538-1545

1Section of Critical Care, Department of Medicine, Max Rady College of Medicine, University of Manitoba, Health Sciences Centre, Winnipeg, MB, Canada.2Department of Anesthesia and Perioperative Medicine, Western University, University Hospital, London, ON, Canada.3Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.4George & Fay Yee Center for Healthcare Innovation, University of Manitoba/Winnipeg Regional Health Authority, Winnipeg, MB, Canada.5Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine and Population Health and Optimal Health Practices Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Center, Université Laval, Quebec City, QC, Canada.

Objective: Dynamic tests of fluid responsiveness have been developed and investigated in clinical trials of goal-directed therapy. The impact of this approach on clinically relevant outcomes is unknown. We performed a systematic review and meta-analysis to evaluate whether fluid therapy guided by dynamic assessment of fluid responsiveness compared with standard care improves clinically relevant outcomes in adults admitted to the ICU.

Data Sources: Randomized controlled trials from MEDLINE, EMBASE, CENTRAL, clinicaltrials.gov, and the International Clinical Trials Registry Platform from inception to December 2016, conference proceedings, and reference lists of relevant articles.

Study Selection: Two reviewers independently identified randomized controlled trials comparing dynamic assessment of fluid responsiveness with standard care for acute volume resuscitation in adults admitted to the ICU.

Data Extraction: Two reviewers independently abstracted trial-level data including population characteristics, interventions, clinical outcomes, and source of funding. Our primary outcome was mortality at longest duration of follow-up. Our secondary outcomes were ICU and hospital length of stay, duration of mechanical ventilation, and frequency of renal complications. The internal validity of trials was assessed in duplicate using the Cochrane Collaboration's Risk of Bias tool.

Data Synthesis: We included 13 trials enrolling 1,652 patients. Methods used to assess fluid responsiveness included stroke volume variation (nine trials), pulse pressure variation (one trial), and stroke volume change with passive leg raise/fluid challenge (three trials). In 12 trials reporting mortality, the risk ratio for death associated with dynamic assessment of fluid responsiveness was 0.59 (95% CI, 0.42-0.83; I = 0%; n = 1,586). The absolute risk reduction in mortality associated with dynamic assessment of fluid responsiveness was -2.9% (95% CI, -5.6% to -0.2%). Dynamic assessment of fluid responsiveness was associated with reduced duration of ICU length of stay (weighted mean difference, -1.16 d [95% CI, -1.97 to -0.36]; I = 74%; n = 394, six trials) and mechanical ventilation (weighted mean difference, -2.98 hr [95% CI, -5.08 to -0.89]; I = 34%; n = 334, five trials). Three trials were adjudicated at unclear risk of bias; the remaining trials were at high risk of bias.

Conclusions: In adult patients admitted to intensive care who required acute volume resuscitation, goal-directed therapy guided by assessment of fluid responsiveness appears to be associated with reduced mortality, ICU length of stay, and duration of mechanical ventilation. High-quality clinical trials in both medical and surgical ICU populations are warranted to inform routine care.
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http://dx.doi.org/10.1097/CCM.0000000000002554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5555977PMC
September 2017
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