Impact of providing patients access to electronic health records on quality and safety of care: a systematic review and meta-analysis

ObjectiveTo evaluate the impact of sharing electronic health records (EHRs) with patients and map it across six domains of quality of care (ie, patient-centredness, effectiveness, efficiency, timeliness, equity and safety).DesignSystematic review and meta-analysis.Data sourcesCINAHL, Cochrane, Embase, HMIC, Medline/PubMed and PsycINFO, from 1997 to 2017.Eligibility criteriaRandomised trials focusing on adult subjects, testing an intervention consisting of sharing EHRs with patients, and with an outcome in one of the six domains of quality of care.Data analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Title and abstract screening were performed by two pairs of investigators and assessed using the Cochrane Risk of Bias Tool. For each domain, a narrative synthesis of the results was performed, and significant differences in results between low risk and high/unclear risk of bias studies were tested (t-test, p<0.05). Continuous outcomes evaluated in four studies or more (glycated haemoglobin (HbA1c), systolic blood pressure (SBP) and diastolic blood pressure (DBP)) were pooled as weighted mean difference (WMD) using random effects meta-analysis. Sensitivity analyses were performed for low risk of bias studies, and long-term interventions only (lasting more than 12 months).ResultsTwenty studies were included (17 387 participants). The domain most frequently assessed was effectiveness (n=14), and the least were timeliness and equity (n=0). Inconsistent results were found for patient-centredness outcomes (ie, satisfaction, activation, self-efficacy, empowerment or health literacy), with 54.5% of the studies (n=6) demonstrating a beneficial effect. Meta-analyses showed a beneficial effect in effectiveness by reducing absolute values of HbA1c (unit: %; WMD=−0.316; 95% CI −0.540 to −0.093, p=0.005, I2=0%), which remained significant in the sensitivity analyses for low risk of bias studies (WMD= −0.405; 95% CI −0.711 to −0.099), and long-term interventions only (WMD=−0.272; 95% CI −0.482 to −0.062). A significant reduction of absolute values of SBP (unit: mm Hg) was found but lost in sensitivity analysis for studies with low risk of bias (WMD= −1.375; 95% CI −2.791 to 0.041). No significant effect was found for DBP (unit: mm Hg; WMD=−0.918; 95% CI −2.078 to 0.242, p=0.121, I2=0%). Concerning efficiency, most studies (80%, n=4) found either a reduction of healthcare usage or no change. A beneficial effect was observed in a range of safety outcomes (ie, general adherence, medication safety), but not in medication adherence. The proportion of studies reporting a beneficial effect did not differ between low risk and high/unclear risk studies, for the domains evaluated.DiscussionOur analysis supports that sharing EHRs with patients is effective in reducing HbA1c levels, a major predictor of mortality in type 2 diabetes (mean decrease of −0.405, unit: %) and could improve patient safety. More studies are necessary to enhance meta-analytical power and assess the impact in other domains of care.Protocol registrationhttp://www.crd.york.ac.uk/PROSPERO (CRD42017070092).

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Methodological Quality Assessment of Systematic Review or Meta-Analysis Using AMSTAR-2: the Long-Term Effectiveness or Efficacy of Opioids for Chronic Non-Cancer Pain

10.21203/rs.2.12469/v1 ◽

2019 ◽

Author(s):

Qian Li ◽

Ke Deng ◽

Xiaoyuan Jiang ◽

Huan Tao ◽

Hui Liu ◽

...

Keyword(s):

Cancer Pain ◽

Systematic Reviews ◽

Methodological Quality ◽

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Central Register ◽

Cochrane Reviews ◽

Meta Analyses

Abstract Background：Systematic review or meta-analysis, the strong study design of high quality evidence, give inconsistent conclusion of long-term effectiveness or efficacy of opioids for chronic non-cancer pain. We appraised the methodological quality of systematic reviews or meta-analyses. Methods: We found the relevant systematic reviews or meta-analyses by searching Medline, EMBASE, the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, the International prospective register of systematic reviews, Psyc ARTICLES/OVID, the Chinese Bio-Medical Literature Database, the China National Knowledge Infrastructure, and the Wan Fang Data and VIP Database on March 1st, 2019. The methodological quality was assessed by A Measurement Tool to Assess Systematic Reviews-2(AMSTAR-2). Spearman correlation analysis and non-parametric tests were used to assess the association between quality and factors. Results: Twenty-one systematic reviews or meta-analyses were included in our study. One has no individual study. In terms of methodological quality, twelve reviews were critically low in overall confidence, four reviews were low, two reviews were moderate, two reviews were high. When referring to the systematic reviews or meta-analyses of relatively better methodological quality with more credible results and conclusions, the effectiveness or efficacy of opioids was small to questionable. Cochrane reviews performed better than non-Cochrane reviews in establishing prior protocol (100% vs 17%, P<0.05), providing an excluded studies list (100% vs 50%, P<0.05) and taking risk of bias into account when interpreting the results of the review (100% vs 75%, P<0.05). There was a strong correlation (ρ=0.526, P<0.05) between the impact factor of systematic reviews or meta-analyses in published journals and methodological quality. Conclusion The methodological quality of the included systematic reviews or meta-analyses is far from satisfactory and needs improvement, especially in establishing prior protocol and justifying significant deviations from the protocol, providing an excluded primary studies list, reporting the funding information of primary studies, and assessing the potential impact of risk of bias on individual studies.

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ROB-MEN: a tool to assess risk of bias due to missing evidence in network meta-analysis

BMC Medicine ◽

10.1186/s12916-021-02166-3 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Virginia Chiocchia ◽

Adriani Nikolakopoulou ◽

Julian P. T. Higgins ◽

Matthew J. Page ◽

Theodoros Papakonstantinou ◽

...

Keyword(s):

Web Application ◽

Clinical Decision Making ◽

Meta Analysis ◽

Pairwise Comparison ◽

Risk Of Bias ◽

Low Risk ◽

Pairwise Comparisons ◽

Coronary Syndrome ◽

Meta Analyses ◽

The Impact

Abstract Background Selective outcome reporting and publication bias threaten the validity of systematic reviews and meta-analyses and can affect clinical decision-making. A rigorous method to evaluate the impact of this bias on the results of network meta-analyses of interventions is lacking. We present a tool to assess the Risk Of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN). Methods ROB-MEN first evaluates the risk of bias due to missing evidence for each of the possible pairwise comparison that can be made between the interventions in the network. This step considers possible bias due to the presence of studies with unavailable results (within-study assessment of bias) and the potential for unpublished studies (across-study assessment of bias). The second step combines the judgements about the risk of bias due to missing evidence in pairwise comparisons with (i) the contribution of direct comparisons to the network meta-analysis estimates, (ii) possible small-study effects evaluated by network meta-regression, and (iii) any bias from unobserved comparisons. Then, a level of “low risk”, “some concerns”, or “high risk” for the bias due to missing evidence is assigned to each estimate, which is our tool’s final output. Results We describe the methodology of ROB-MEN step-by-step using an illustrative example from a published NMA of non-diagnostic modalities for the detection of coronary artery disease in patients with low risk acute coronary syndrome. We also report a full application of the tool on a larger and more complex published network of 18 drugs from head-to-head studies for the acute treatment of adults with major depressive disorder. Conclusions ROB-MEN is the first tool for evaluating the risk of bias due to missing evidence in network meta-analysis and applies to networks of all sizes and geometry. The use of ROB-MEN is facilitated by an R Shiny web application that produces the Pairwise Comparisons and ROB-MEN Table and is incorporated in the reporting bias domain of the CINeMA framework and software.

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Differentiating PSP from MSA using MR planimetric measurements: a systematic review and meta-analysis

Journal of Neural Transmission ◽

10.1007/s00702-021-02362-8 ◽

2021 ◽

Author(s):

Beatrice Heim ◽

Florian Krismer ◽

Klaus Seppi

Keyword(s):

Sensitivity And Specificity ◽

Meta Analysis ◽

Risk Of Bias ◽

Index Test ◽

Study Quality ◽

Parkinsonian Syndromes ◽

Quantitative Mr ◽

Meta Analyses ◽

Planimetric Measurements

AbstractDifferential diagnosis of parkinsonian syndromes is considered one of the most challenging in neurology. Quantitative MR planimetric measurements were reported to discriminate between progressive supranuclear palsy (PSP) and non-PSP-parkinsonism. Several studies have used midbrain to pons ratio (M/P) and the Magnetic Resonance Parkinsonism Index (MRPI) in distinguishing PSP patients from those with Parkinson's disease. The current meta-analysis aimed to compare the performance of these measures in discriminating PSP from multiple system atrophy (MSA). A systematic MEDLINE review identified 59 out of 2984 studies allowing a calculation of sensitivity and specificity using the MRPI or M/P. Meta-analyses of results were carried out using random effects modelling. To assess study quality and risk of bias, the QUADAS-2 tool was used. Eight studies were suitable for analysis. The meta‐analysis showed a pooled sensitivity and specificity for the MRPI of PSP versus MSA of 79.2% (95% CI 72.7–84.4%) and 91.2% (95% CI 79.5–96.5%), and 84.1% (95% CI 77.2–89.2%) and 89.2% (95% CI 81.8–93.8%), respectively, for the M/P. The QUADAS-2 toolbox revealed a high risk of bias regarding the methodological quality of patient selection and index test, as all patients were seen in a specialized outpatient department without avoiding case control design and no predefined threshold was given regarding MRPI or M/P cut-offs. Planimetric brainstem measurements, in special the MRPI and M/P, yield high diagnostic accuracy for the discrimination of PSP from MSA. However, there is an urgent need for well-designed, prospective validation studies to ameliorate the concerns regarding the risk of bias.

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Predictability of rotational tooth movement with orthodontic aligners comparing software-based and achieved data: A systematic review and meta-analysis of observational studies

Journal of Orthodontics ◽

10.1177/14653125211027266 ◽

2021 ◽

pp. 146531252110272

Author(s):

Despina Koletsi ◽

Anna Iliadi ◽

Theodore Eliades

Keyword(s):

Effect Size ◽

Tooth Movement ◽

Data Extraction ◽

Meta Analysis ◽

Risk Of Bias ◽

Patient Treatment ◽

Qualitative Synthesis ◽

Meta Analyses ◽

Enamel Reduction

Objective: To evaluate all available evidence on the prediction of rotational tooth movements with aligners. Data sources: Seven databases of published and unpublished literature were searched up to 4 August 2020 for eligible studies. Data selection: Studies were deemed eligible if they included evaluation of rotational tooth movement with any type of aligner, through the comparison of software-based and actually achieved data after patient treatment. Data extraction and data synthesis: Data extraction was done independently and in duplicate and risk of bias assessment was performed with the use of the QUADAS-2 tool. Random effects meta-analyses with effect sizes and their 95% confidence intervals (CIs) were performed and the quality of the evidence was assessed through GRADE. Results: Seven articles were included in the qualitative synthesis, of which three contributed to meta-analyses. Overall results revealed a non-accurate prediction of the outcome for the software-based data, irrespective of the use of attachments or interproximal enamel reduction (IPR). Maxillary canines demonstrated the lowest percentage accuracy for rotational tooth movement (three studies: effect size = 47.9%; 95% CI = 27.2–69.5; P < 0.001), although high levels of heterogeneity were identified (I2: 86.9%; P < 0.001). Contrary, mandibular incisors presented the highest percentage accuracy for predicted rotational movement (two studies: effect size = 70.7%; 95% CI = 58.9–82.5; P < 0.001; I2: 0.0%; P = 0.48). Risk of bias was unclear to low overall, while quality of the evidence ranged from low to moderate. Conclusion: Allowing for all identified caveats, prediction of rotational tooth movements with aligner treatment does not appear accurate, especially for canines. Careful selection of patients and malocclusions for aligner treatment decisions remain challenging.

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Fuke Qianjin Combined with Antibiotic Therapy for Pelvic Inflammatory Disease: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/5372839 ◽

2020 ◽

Vol 2020 ◽

pp. 1-10

Author(s):

Yu Chen ◽

Shaobin Wei ◽

Li Huang ◽

Mei Luo ◽

Yang Wu ◽

...

Keyword(s):

Abdominal Pain ◽

Pelvic Inflammatory Disease ◽

Inflammatory Disease ◽

Meta Analysis ◽

Lower Abdominal Pain ◽

Effective Rate ◽

Chinese Patent ◽

Meta Analyses

Background. Pelvic inflammatory disease (PID) without timely and proper treatment can cause long-term sequelae; meanwhile, patients will be confronted with the antimicrobial resistance and side effects. Chinese patent medicine as a supplement is used to treat PID with satisfactory clinical efficacy. This study evaluated the efficacy and safety of Fuke Qianjin (FKQJ) combined with antibiotics in the treatment of PID. Methods. Eight electronic databases and other resources were searched to make a collection of the randomized controlled trials (RCTs) from 1990 to 2019. The RCTs contrasting the effect of FKQJ combined with antibiotics regimens and antibiotics alone in reproductive women with PID were included. The antibiotics regimens are all recommended by the guidelines. Two reviewers independently screened the studies, extracted the data, and assessed the methodological quality of the included studies. Then, the meta-analyses were performed by RevMan 5. 3 software if appropriate. Results. Twenty-three RCTs (2527 women) were included in this review. The evidence showed that FKQJ combined with antibiotics improved the markedly effective rate compared to antibiotics alone group (RR = 1.38, 95% CI 1.27 to 1.49, I2 = 42%), shortened the improvement time of low abdominal pain (MD = −1.11, 95% CI −1.39 to −0.84, I2 = 38%), and increased the rate of lower abdominal pain improvement (RR = 1.35, 95% CI 1.19 to 1.55, I2 = 0). The implementation of adjuvant reduced the recurrent rate compared with antibiotics alone (RR = 0.27, 95% CI 0.13 to 0.56, I2 = 0%). Conclusions. Based on available evidence, FKQJ combined with antibiotics therapy have certain outcomes on increasing the markedly effective rate, decreasing the recurrent rate compared with antibiotics alone group. This therapy appears to improve lower abdominal pain and curtail the relief time. Due to the low quality and the risk of bias, any high-quality evidence or longer follow-up period should be advisable and necessary in the future.

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Comparative efficacy and safety of oral or transdermal opioids in the treatment of knee or hip osteoarthritis: a systematic review and Bayesian network meta-analysis protocol

BMJ Open ◽

10.1136/bmjopen-2018-022142 ◽

2018 ◽

Vol 8 (10) ◽

pp. e022142

Author(s):

Jun Wang ◽

Yin Wang ◽

Hui Zhang ◽

Ming Lu ◽

Weilu Gao ◽

...

Keyword(s):

Bayesian Network ◽

Meta Analysis ◽

Hip Osteoarthritis ◽

Sensitivity Analyses ◽

Cochrane Library ◽

Efficacy And Safety ◽

Meta Analyses ◽

Transdermal Opioids ◽

And Function

IntroductionOsteoarthritis is a common degenerative joint disease that eventually leads to disability and poor quality of life. The main symptoms are joint pain and mobility disorders. If the patient has severe pain or other analgesics are contraindicated, opioids may be a viable treatment option. To evaluate and compare the efficacy and safety of opioids in the treatment of knee or hip osteoarthritis, we will integrate direct and indirect evidence using a Bayesian network meta-analysis to establish hierarchies of these drugs.Methods and analysisWe will search the Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and PsycINFO databases as well as published and unpublished research in international registries and regulatory agency websites for osteoarthritis reports published prior to 5 January 2018. There will be no restrictions on the language. Randomised clinical trials that compare oral or transdermal opioids with other various opioids, placebo or no treatment for patients with knee or hip osteoarthritis will be included. The primary outcomes of efficacy will be pain and function. We will use pain and function scales to evaluate the main outcomes. The secondary outcomes of safety will be defined as the proportion of patients who have stopped treatment due to side effects. Pairwise meta-analyses and Bayesian network meta-analyses will be performed for all related outcome measures. We will conduct subgroup analyses and sensitivity analyses to assess the robustness of our findings. The Grading of Recommendations, Assessment, Development and Evaluations framework will be used to assess the quality of the evidence contributing to each network assessment.Ethics and disseminationThis study does not require formal ethical approval because individual patient data will not be included. The findings will be disseminated through peer-reviewed publications or conference presentations.PROSPERO registration numberCRD42018085503.

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Risk of malignancies in patients with spondyloarthritis treated with biologics compared with those treated with non-biologics: a systematic review and meta-analysis

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x20925696 ◽

2020 ◽

Vol 12 ◽

pp. 1759720X2092569

Author(s):

Yu Heng Kwan ◽

Ka Keat Lim ◽

Warren Fong ◽

Hendra Goh ◽

Linkai Ng ◽

...

Keyword(s):

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Library ◽

Interleukin 17 ◽

Randomized Controlled ◽

Risk Of Malignancy ◽

Meta Analyses ◽

Analytical Approaches

Background: The aim of our study was to synthesize evidence on the occurrence of malignancy in spondyloarthritis (SpA), from randomized controlled trials (RCTs) comparing biologics with non-biologics and biologics to each other. Methods: We systematically searched Medline, Cochrane Library, EMBASE, Scopus and ClinicalTrials.gov from inception until 31 October 2018. RCTs with ⩾24-week follow-up were included. We extracted data using standardized forms and assessed the risk of bias using the Cochrane Risk of Bias Tool. We performed pair-wise meta-analyses and network meta-analyses to compare the risk of malignancy for each biologics class and SpA type. We reported the Peto odds ratio (OR) of any malignancy along with 95% confidence intervals (95% CI). Bayesian posterior probabilities comparing risk of malignancy of each biologic class with non-biologics were computed as supplementary measures. Results: Fifty-four trials were included; most (44/54) had follow-up <1 year. Among 14,245 patients, 63 developed a malignancy. While most Peto ORs were >1, they had wide 95% CI and p >0.05. The overall Peto OR comparing biologics with non-biologics was 1.42 (95% CI 0.80–2.53). Only interleukin-17 inhibitors in peripheral SpA had p <0.05 (Peto OR 2.77, 95% CI 1.07–7.13); the posterior probability that the risk was higher than non-biologics was 98%. Stratified analyses revealed no consistent trend by prior exposure to biologics, duration of follow-up, study quality, study-arm crossover, analytical approaches and type of malignancy. Conclusions: Our findings indicate no overall elevated risk of malignancy with biologics in SpA. As our meta-analyses are unable to conclude on the long-term risk, long-term pharmacovigilance of biologics in SpA may still be warranted.

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Considering the methodological limitations in the evidence base of antidepressants for depression: a reanalysis of a network meta-analysis

BMJ Open ◽

10.1136/bmjopen-2018-024886 ◽

2019 ◽

Vol 9 (6) ◽

pp. e024886 ◽

Cited By ~ 24

Author(s):

Klaus Munkholm ◽

Asger Sand Paludan-Müller ◽

Kim Boesen

Keyword(s):

Systematic Review ◽

Clinical Study ◽

Effect Size ◽

Meta Analysis ◽

Evidence Base ◽

Risk Of Bias ◽

Depression Symptom ◽

Meta Analyses ◽

The Impact ◽

Clinical Study Reports

ObjectivesTo investigate whether the conclusion of a recent systematic review and network meta-analysis (Ciprianiet al) that antidepressants are more efficacious than placebo for adult depression was supported by the evidence.DesignReanalysis of a systematic review, with meta-analyses.Data sources522 trials (116 477 participants) as reported in the systematic review by Ciprianiet aland clinical study reports for 19 of these trials.AnalysisWe used the Cochrane Handbook’s risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to evaluate the risk of bias and the certainty of evidence, respectively. The impact of several study characteristics and publication status was estimated using pairwise subgroup meta-analyses.ResultsSeveral methodological limitations in the evidence base of antidepressants were either unrecognised or underestimated in the systematic review by Ciprianiet al. The effect size for antidepressants versus placebo on investigator-rated depression symptom scales was higher in trials with a ‘placebo run-in’ study design compared with trials without a placebo run-in design (p=0.05). The effect size of antidepressants was higher in published trials compared with unpublished trials (p<0.0001). The outcome data reported by Ciprianiet aldiffered from the clinical study reports in 12 (63%) of 19 trials. The certainty of the evidence for the placebo-controlled comparisons should be very low according to GRADE due to a high risk of bias, indirectness of the evidence and publication bias. The mean difference between antidepressants and placebo on the 17-item Hamilton depression rating scale (range 0–52 points) was 1.97 points (95% CI 1.74 to 2.21).ConclusionsThe evidence does not support definitive conclusions regarding the benefits of antidepressants for depression in adults. It is unclear whether antidepressants are more efficacious than placebo.

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An individual patient data (IPD) meta-analysis of the impact of thrombocytosis (?plts) on overall survival (OS) whilst using an intermittent chemotherapy (iCTx) strategy in advanced colorectal cancer (aCRC).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15044 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15044-e15044

Author(s):

Richard Adams ◽

Kaitlyn Goey ◽

Benoist Chibaudel ◽

Miriam Koopman ◽

Cornelis J. A. Punt ◽

...

Keyword(s):

Meta Analysis ◽

Sensitivity Analyses ◽

First Line Therapy ◽

Initial Regimen ◽

Intermittent Chemotherapy ◽

Baseline Factors ◽

Central Database ◽

Continuous Strategies ◽

Meta Analyses ◽

The Impact

e15044 Background: iCTx in pts with aCRC offers potential for improvement in QoL. The COIN trial is the largest study to compare iCTx v. continuous strategies in aCRC, a pre-specified subgroup analysis of 16 baseline factors was undertaken among pts with stable or responding disease after 3 mths of first-line therapy to see if the relative treatment effect differed by subgroup. Baseline ⇡plts alone identified a group of pts with significantly worse OS when an iCTx strategy was applied. Here we seek to validate this finding in other intermittent strategy trials. Methods: Published RCTs of iCTx in aCRC were identified via literature review. Eligible trials could allow one or more re-introductions of “full” initial regimen either upon progression or after a set period of time. Outcome and platelet data were requested and collated into a central database. The COIN trial was declared the discovery dataset and other eligible trials the validating datasets. Two co-primary hypotheses were agreed based upon the COIN trial results: Hypothesis 1: In pts with baseline ⇡plts, any planned complete stop of all therapyis detrimental to OS when compared to any maintenance strategy. Hypothesis 2: In pts with baseline ⇡plts, any planned stop of oxaliplatin(Ox) therapy is detrimental to OS when compared to any equivalent strategy where Ox is maintained. Unadjusted IPD meta-analysis was performed according to a pre-specified statistical plan. Results: All trials had broadly similar inclusion criteria . Incidence of ⇡plts range 17-32%. ⇡plts was a poor prognostic marker. Combining IPD from all trials, iCTx was not detrimental to OS. Hypothesis 1 included AIO-0207, CAIRO3, COIN B, OPTIMOX 2 and GISCAD with 1622 pts, HR for interaction of ⇡plts with treatment strategy 0.97 (0.66-1.40), p = 0.78. Hypothesis 2 included TTD MACRO, NORDIC VII and OPTIMOX I, with 1268 pts, HR for interaction 1.36 (0.71-2.62), p = 0.18. Conclusions: These IPD meta-analyses do not validate COIN trial findings that showed reduced OS in pts with baseline ⇡plts who are given a planned treatment break. Sensitivity analyses will be presented, including impact of RAS mut status.

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Incidence of sudden cardiac arrest and death in young athletes and military members: a systematic review and meta-analysis

Journal of Athletic Training ◽

10.4085/1062-6050-0748.20 ◽

2021 ◽

Author(s):

Aaron Lear ◽

Niraj Patel ◽

Chanda Mullen ◽

Marian Simonson ◽

Vince Leone ◽

...

Keyword(s):

Cardiac Arrest ◽

Incidence Rate ◽

Meta Analysis ◽

National Level ◽

Sudden Cardiac Arrest ◽

Rare Event ◽

Risk Of Bias ◽

Low Risk ◽

Military Members

Abstract Objectives: The goals of this review are to evaluate the quality of the evidence on the incidence of sudden cardiac arrest and death (SCA/D) in athletes and military members; and to estimate annual incidence of SCA/D. Data Sources: MEDLINE, Embase, Cochrane CENTRAL, Web of Science, BIOSIS, Scopus, SPORT discus, PEDro, and clinicaltrials.gov were searched from inception to dates between 2/21/19–7/29/19. Study Selection: Studies which reported incidence of SCA/D or both in athletes, or military members under age 40 were eligible for inclusion. 40 studies were identified for inclusion Data Extraction: Risk of bias was assessed using a validated, customized tool for prevalence studies in all included studies. 12 were found to be low ROB, with the remaining 28 moderate or high ROB. Data was extracted for narrative review, and meta-analysis. Data Synthesis: Random-effects meta-analysis was performed in studies judged to be low risk of bias in two separate categories: 5 studies on regional or national level data including athletes at all levels, and both sexes included 130 events of SCD, with a total of 11,272,560 athlete years showing a cumulative incidence rate of 0.98 [95%CI: 0.62, 1.53] per 100,000 athlete years, with high heterogeneity with I2 of 78%; 3 Studies on competitive athletes aged 14 to 25 were combined, and included 183 events, and 17,798758 athlete years showing an incidence rate of 1.91[95%CI: 0.71; 5.14] per 100,000 athlete years with high heterogeneity with I2 of 97%. The remaining low risk of bias studies were in military members, and were not synthesized. Conclusion: The worldwide incidence of SCD is a rare event. Low risk of bias studies indicate incidence to be below 2 per 100,000 athlete years. Overall, the quality of the evidence available is low, but there are high quality individual studies to inform the question of incidence levels. PROSPERO Registration: CRD42019125560

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