Meta-analysis Of Outcome Data Research Articles

Impact of Bilingualism on the Cognitive Outcomes in Stroke Survivors: A Systematic Review (P4-12.005)

<h3>Objective:</h3> To examine existing evidence on the effect of bilingualism on cognitive outcomes in the stroke population. <h3>Background:</h3> Stroke is associated with an increased risk of vascular cognitive impairment. Bilingualism promotes cognitive reserve and resilience through the effect of language switching on the cognitive control systems and is suggested to delay cognitive impairment and dementia in non-stroke populations. However, the impact of bilingualism on cognitive outcomes in stroke patients has not been thoroughly examined. <h3>Design/Methods:</h3> We systematically reviewed published literature in medical databases that compared the cognitive assessment scores between mono-and bilingual stroke patients using cognitive assessment tool(s). We planned (1) a meta-analysis of outcome data using the subdomains of cognitive assessment tool(s); (2) a qualitative comparison if a meta-analysis was impossible. We assessed the study quality using the Joanna Briggs Institute tool. <h3>Results:</h3> Our literature search yielded 348 articles, and six were eligible for our systematic review (N=528 bilinguals; 737 monolinguals). One study was of good quality (Hope, 2015), and five were of moderate quality. We could not perform a meta-analysis because of disparate cohort characteristics and study methods, choice of cognitive tests, outcome measures, and lack of common data elements. Studies used one cognition and three language assessment batteries as cognitive assessment tools. In two studies, bilinguals performed better than monolinguals on cognitive tests (Paplikar, 2019; Alladi, 2016). On language assessment batteries, bilinguals performed better than monolinguals in four studies (Paplikar, 2019; Lahiri, 2020; Ardila, 2021; deLetter, 2021) and poorly in one study (Hope et al., 2015). ACE-R was significantly greater in bilinguals than monolinguals (Paplikar, 2019; Alladi, 2016). <h3>Conclusions:</h3> The current literature on the relationship between bilingualism and cognitive outcomes in stroke patients is sparse and insufficient. Harmonization of study methods (e.g., cognitive assessment tools) and common-data elements are critically needed to advance bilingualism research. <b>Disclosure:</b> Ms. Eldem has nothing to disclose. Mr. Misra has nothing to disclose. Dr. Quinn has nothing to disclose. Dr. Driskell has nothing to disclose. Dr. Perez has nothing to disclose. Dr. Carrión has nothing to disclose. Todd Constable has nothing to disclose. Dr. Schindler has received personal compensation for serving as an employee of Aeromics. Dr. Schindler has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Aeromics. Dr. Schindler has received stock or an ownership interest from Aeromics. Dr. Schindler has received publishing royalties from a publication relating to health care. Dr. Zhao has nothing to disclose. Dr. Sico has nothing to disclose. Dr. Hinman has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Bertoldo, Baker, Carter &amp; Smith. Dr. Hinman has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Koskoff, Koskoff &amp; Bieder. Dr. Hinman has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Matthew Millea, PC. Dr. Hinman has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Popham Law Firm PC. Dr. Hinman has received stock or an ownership interest from Sage Cerebrovascular Diagnostics, Inc.. Dr. Hinman has received research support from NIH. Dr. Hinman has received research support from American Heart Association. Dr. Hinman has received research support from Reneuron. Dr. Hinman has received intellectual property interests from a discovery or technology relating to health care. Prof. Allore has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American College of Rheumatology. The institution of Prof. Allore has received research support from NIH. Prof. Allore has received personal compensation in the range of $500-$4,999 for serving as a DSMB member with NIH. An immediate family member of Prof. Kiran has received personal compensation for serving as an employee of Constant Therapy. Prof. Kiran has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Academy of Aphasia. Prof. Kiran has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Prof. Kiran has stock in Constant Therapy Health. The institution of Prof. Kiran has received research support from NIH. Jubin Abutalebi has nothing to disclose. Dr. Annoni has received personal compensation for serving as an employee of OMPharma, Switzerland . The institution of Dr. Annoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CERC European Cardiovascular Research Centre . Dr. Mishra has nothing to disclose.

Antibiotic prophylaxis in transurethral resection of bladder tumours: study protocol for a systematic review and meta-analysis

BackgroundThe necessity of antibiotic prophylaxis for postoperative urinary tract infections (UTIs) after transurethral resection of bladder tumours is controversial. This potentially leads to the overuse of antibiotic prophylaxis and rising antimicrobial resistance rates. The objective of this systematic review and meta-analysis is to compare the impact of different antimicrobial prophylaxis schemes versus placebo on the prevention of postoperative UTI and asymptomatic bacteriuria.MethodsWe designed and registered a study protocol for a systematic review and meta-analysis of randomized controlled trials and non-randomized (e.g. cohort, case-control) studies examining any form of antibiotic prophylaxis in patients with transurethral resection of bladder tumours. Literature searches will be conducted in several electronic databases (from inception onwards), including MEDLINE (Ovid), EMBASE (Ovid), and the Cochrane Central Register of Controlled Trials (CENTRAL). Grey literature will be identified through searching conference abstracts. The primary outcome will be postoperative urinary tract infections. The secondary outcome will be asymptomatic bacteriuria. Two reviewers will independently screen all citations, full-text articles, and abstract data. Potential conflicts will be resolved through discussion. The study methodological quality (or bias) will be appraised using appropriate tools (e.g. Risk of Bias 2.0 tool and Newcastle-Ottawa Scale). If feasible, we will conduct random-effects meta-analysis of outcome data. Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g. study design, publication year, the setting of the study, and antibiotics regimen).We will also search, identify, and discuss potential risk factors for urinary tract infections following transurethral resection of bladder tumours. This may serve as basis for a scoping review.DiscussionIn times of rising antimicrobial resistance rates, sound evidence on the necessity of antibiotic prophylaxis is essential for implementation into guideline recommendations and for decision-making in clinical practice.Systematic review registrationPROSPERO, CRD42019131733

Prognostic Role of Pre-Operative Symptom Status in Carotid Endarterectomy: A Systematic Review and Meta-Analysis

Objective This study investigates the prognostic significance of pre-operative symptom status and type of symptom in outcomes after carotid endarterectomy (CEA). Methods This review was conducted and reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) to identify studies reporting peri-operative outcomes of CEA in symptomatic and asymptomatic patients. The last search was conducted in August 2019 and a methodological assessment was performed using the Newcastle Ottawa Scale. A meta-analysis of outcome data using the odds ratio (OR) as the summary statistic was conducted, and the precision of the effect was reported as 95% confidence interval (CI). Fixed effect or random effects models were used to calculate the pooled estimates. Results Eighteen studies reporting a total of 91 895 patients were included in the meta-analysis. Asymptomatic patients had a lower peri-operative risk of stroke (OR 0.5, 95% CI 0.45–0.54; p Conclusion Patients undergoing CEA after a stroke have worse peri-operative outcomes in terms of stroke and death. Further research needs to be performed to ascertain the value of this finding in risk stratification systems and to investigate potential aetiological associations between pre-operative symptom status and peri-operative risk following a CEA.

Dealing with missing outcome data in meta-analysis.

Missing data result in less precise and possibly biased effect estimates in single studies. Bias arising from studies with incomplete outcome data is naturally propagated in a meta‐analysis. Conventional analysis using only individuals with available data is adequate when the meta‐analyst can be confident that the data are missing at random (MAR) in every study—that is, that the probability of missing data does not depend on unobserved variables, conditional on observed variables. Usually, such confidence is unjustified as participants may drop out due to lack of improvement or adverse effects. The MAR assumption cannot be tested, and a sensitivity analysis to assess how robust results are to reasonable deviations from the MAR assumption is important. Two methods may be used based on plausible alternative assumptions about the missing data. Firstly, the distribution of reasons for missing data may be used to impute the missing values. Secondly, the analyst may specify the magnitude and uncertainty of possible departures from the missing at random assumption, and these may be used to correct bias and reweight the studies. This is achieved by employing a pattern mixture model and describing how the outcome in the missing participants is related to the outcome in the completers. Ideally, this relationship is informed using expert opinion. The methods are illustrated in two examples with binary and continuous outcomes. We provide recommendations on what trial investigators and systematic reviewers should do to minimize the problem of missing outcome data in meta‐analysis.

SU88 - AN OPRD1 VARIANT PREDICTS CONTINUED OPIOID USE IN AFRICAN-AMERICANS UNDERGOING BUPRENORPHINE TREATMENT

Background Opioid Use Disorder (OUD) is a significant public health issue in the United States and globally. FDA-approved treatment for OUD includes Opioid Substitution Therapy (OST) with medications such as methadone and buprenorphine. While OST has been shown to be effective, a meta-analysis of outcome data from OST studies indicated that a significant percentage of opioid dependent patients treated with OST do not sustain abstinence or reduce their illicit opioid use. Understanding the factors that predict reductions in illicit opioid use during treatment would allow clinicians to make more informed therapeutic decisions, selecting medications that are most likely to benefit individual patients. Methods The START trial was a 24-week open-label randomized trial of methadone and buprenorphine for the treatment of OUD. Weekly urine drug screens were performed. Treatment efficacy was defined by the proportion of opioid positive urine tests. A Generalized Estimating Equation (GEE) was used to determine if variants in the OPRD1 gene were associated with treatment efficacy in African-Americans (AA; n=77). A replication population (n=75) was collected from AA patients who had previously participated in OST trials in Baltimore. Urine drug screens were performed three times per week. For a meta-analysis, weeks 21–24 were analyzed since they represent the last month of data available for both data sets. Responders were defined as patients who a) were retained in treatment until at least week 21 and b) were opioid positive for less than 50% of their urine drug screens in weeks 21–24. For in vitro analysis, 15 bp regions surrounding the C or T allele of rs678849 were cloned into luciferase vectors and transfected into neuroblastoma cells. Luciferase activity was measured by dual-luciferase reporter assay system. Results In the START trial, rs678849 was associated with the efficacy of methadone (p=0.001) and buprenorphine (p=0.008) in treating OUD in AA patients. The pharmacogenetic effect on buprenorphine (p=0.01), but not methadone (p=0.23), was replicated in the independent AA population from Baltimore. In a meta-analysis of weeks 21–24 of both data sets, patients with the C/C genotype had a significantly higher proportion of opioid positive urine drug screens (59%) than T allele carriers (26%, p Discussion These data suggest that a variant in the OPRD1 gene has a large pharmacogenetic effect on buprenorphine efficacy in the AA population and that the variant may have effects on expression. We hypothesize that the C allele of rs678849 functions as a silencer element, binding transcriptional repressors and downregulating OPRD1 expression. We also hypothesize that the T allele of the variant is an enhancer element and upregulates OPRD1 expression through interactions with a unique group of transcription factors. Further in vitro studies will be needed to dissect the complete mechanism and a prospective clinical trial that confirms this pharmacogenetic effect will be necessary before rs678849 can be used to guide treatment decisions.

Multifactorial e- and mHealth interventions for cardiovascular disease primary prevention: Protocol for a systematic review and meta-analysis of randomised controlled trials.

ObjectiveCardiovascular diseases (CVD) are a leading cause of mortality and disease burden. Preventative interventions to augment the population-level adoption of health lifestyle behaviours that reduce CVD risk are a priority. Face-to-face interventions afford individualisation and are effective for improving health-related behaviours and outcomes, but they are costly and resource intensive. Electronic and mobile health (e- and mHealth) approaches aimed at modifying lifestyle risk factors may be an effective and scalable approach to reach many individuals while preserving individualisation. This systematic review aims to (a) determine the effectiveness of multifactorial e- and mHealth interventions on CVD risk and on lifestyle-related cardiometabolic risk factors and self-management behaviours among adults without CVD; and (b) describe the evidence on adverse events and on the cost-effectiveness of these interventions.MethodsMethods were detailed prior to the start of the review in order to improve conduct and prevent inconsistent decision making throughout the review. This protocol was prepared following the PRISMA-P 2015 statement. MEDLINE, CINAHL, Embase, PsycINFO, Web of Science, Cochrane Public Health Group Specialised Register and CENTRAL electronic databases will be searched between 1991 and September 2019. Eligibility criteria are: (a) population: community-dwelling adults; (b) intervention/comparison: randomised controlled trials comparing e- or mHealth CVD risk preventative interventions with usual care; and (c) outcomes: modifiable CVD risk factors. Selection of study reports will involve two authors independently screening titles and abstracts, followed by a full-text review of potentially eligible reports. Two authors will independently undertake data extraction and assess risk of bias. Where appropriate, meta-analysis of outcome data will be performed.DiscussionThis protocol describes the pre-specified methods for a systematic review that will provide quantitative and narrative syntheses of current multifactorial e- and mHealth CVD preventative interventions. A systematic review and meta-analysis will be conducted following the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions and reported according to PRISMA guidelines.

Physical frailty and functional status in patients with advanced kidney disease: a protocol for a systematic review

BackgroundPredicting outcomes in those with chronic kidney disease or following transplantation is challenging, and current models lack detailed patient-level information. Frailty and poor functional status are risk factors for adverse patient outcomes that may be useful additions to prognostic tools in patients with chronic kidney disease. The purpose of this systematic review is to examine whether frailty or functional status are associated with increased risk of mortality or adverse clinical outcomes in patients with advanced kidney disease.Methods/designWe will conduct a systematic review to identify and evaluate studies linking frailty and functional status with patient outcomes in populations with advanced kidney disease. We will search MEDLINE, Embase, and the Cochrane Central Register for Controlled Trials. Two reviewers will conduct all screening and data extraction independently. A modified version of the Quality In Prognosis Studies tool will be used to evaluate the quality of the studies. If meta-analysis of outcome data is possible, a random effects model will be used.DiscussionThe results of this review will inform the development, selection, and validation of appropriate metrics needed to improve prognostication in patients with chronic kidney disease.Systematic review registrationPROSPERO CRD42016045251

Pain and disability following first-time lumbar fusion surgery for degenerative disorders: a systematic review protocol.

BackgroundLumbar spinal fusion for degenerative disorders of the lumbar spine is frequently used, despite current research presenting inconclusive evidence. This study aims to systematically review and meta-analyse the natural course of pain and disability in patients with degenerative disorders of the lumbar spine such as spinal stenosis, spondylolisthesis, disc herniation, or discogenic low back pain to improve lumbar spinal fusion management.Methods/designAn electronic database search will be conducted up to 30 September 2015 using MEDLINE, EMBASE, CINAHL, and ZETOC database. In addition, a search for articles in press and published ahead of print, British National Bibliography for Report Literature, and OpenGrey will be conducted. Prospective cohort studies using outcome measures of pain and disability will be eligible for inclusion. Two reviewers will screen titles, abstracts, and full-text independently using predetermined inclusion and exclusion criteria. The risk of bias of included studies will be assessed with the modified version of the Quality in Prognostic Studies tool. If meta-analysis of outcome data is deemed appropriate, variance-weighted pooled means will be calculated.DiscussionThe results of this systematic review and meta-analysis may improve understanding of recovery after lumbar spinal fusion and improve lumbar spinal fusion management.Systematic review registrationPROSPERO CRD42015026922Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0252-2) contains supplementary material, which is available to authorized users.

Clinical outcomes of immunoglobulin use in solid organ transplant recipients: protocol for a systematic review and meta-analysis.

BackgroundTransplantation improves survival and the quality of life of patients with end-stage organ failure. Infection, due to surgical issues, host factors such as diabetes, immunosuppression, and hypogammaglobulinemia, is a major post-transplant complication. Clinical outcomes of prophylaxis or treatment of hypogammaglobulinemia in solid organ transplant recipients are not well established and are in need of further study.Methods/designWe will conduct a systematic review of studies investigating clinically relevant outcomes of immunoglobulin use either as prophylaxis or treatment of hypogammaglobulinemia after solid organ transplantation. Both randomized and non-randomized studies (excluding case reports and case series of less than 20 subjects) will be included. Outcomes of interest will include the overall rate of infection, hospital admission, hospital length of stay, intensive care unit admission, 1-year all-cause mortality, incidence of acute organ rejection, allograft survival within 1 year, and adverse events. We will search MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Transplant library, and the International Clinical Trials Registry Platform for randomized and non-randomized studies on adult solid organ transplant patients who received prophylactic immunoglobulin or immunoglobulin treatment. Two reviewers will conduct all screening and data collection independently. We will assess study level of risk of bias using the Cochrane Risk of Bias Assessment Tool for randomized controlled trials and for non-randomized studies. If meta-analysis of outcome data is deemed appropriate, we will use random effects models to combine data for continuous and dichotomous measures.DiscussionThe results of this systematic review may inform guideline development for measuring immunoglobulin level and use of immunoglobulin in solid organ transplant patients and highlight areas for further research.Systematic review registrationPROSPERO CRD42015017620Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0156-6) contains supplementary material, which is available to authorized users.

A Bayesian framework to account for uncertainty due to missing binary outcome data in pairwise meta-analysis.

Missing outcome data are a common threat to the validity of the results from randomised controlled trials (RCTs), which, if not analysed appropriately, can lead to misleading treatment effect estimates. Studies with missing outcome data also threaten the validity of any meta‐analysis that includes them. A conceptually simple Bayesian framework is proposed, to account for uncertainty due to missing binary outcome data in meta‐analysis. A pattern‐mixture model is fitted, which allows the incorporation of prior information on a parameter describing the missingness mechanism. We describe several alternative parameterisations, with the simplest being a prior on the probability of an event in the missing individuals. We describe a series of structural assumptions that can be made concerning the missingness parameters. We use some artificial data scenarios to demonstrate the ability of the model to produce a bias‐adjusted estimate of treatment effect that accounts for uncertainty. A meta‐analysis of haloperidol versus placebo for schizophrenia is used to illustrate the model. We end with a discussion of elicitation of priors, issues with poor reporting and potential extensions of the framework. Our framework allows one to make the best use of evidence produced from RCTs with missing outcome data in a meta‐analysis, accounts for any uncertainty induced by missing data and fits easily into a wider evidence synthesis framework for medical decision making. © 2015 The Authors. Statistics in MedicinePublished by John Wiley & Sons Ltd.

Addressing missing outcome data in meta-analysis

ObjectiveMissing outcome data are a common problem in clinical trials and systematic reviews, as it compromises inferences by reducing precision and potentially biasing the results. Systematic reviewers often assume that...

Adult inguinoscrotal sarcomas: outcome analysis of 21 cases, systematic review of the literature and meta-analysis

Inguinoscrotal sarcomas are exceedingly rare tumors. The aim of this study was to enable clinicians an easy and rapid access to the available information on this tumor entity. An updated series of 21 men treated for sarcoma of the inguinoscrotal region at our institution between 1992 and 2012 was analyzed, and a systematic review of the literature with meta-analysis of outcome data was performed. The review was focused on demographic data, survival rates, prognostic factors, sites of relapse and complete remissions or successful treatments for metastatic disease. With only 38 %, the proportion of high-grade tumors in our sample was lower than reported in the literature and the 10-year relapse-free, disease-specific and overall survival rates were favorable with 77, 93 and 81 %. Beside our series, twelve studies including 345 patients were identified in the literature. The weighed mean 10-year relapse-free, disease-specific and overall survival rates were 63, 64 and 50 %. Only in patients with rhabdomyosarcoma, durable control of metastatic disease has been reported in more than one case (n = 4). Successful treatment in these cases consisted of a combination of complete surgical resection of metastatic lesions, subsequent chemotherapy and (optional) radiotherapy. Overall, about two-thirds of inguinoscrotal sarcomas may be cured. In series with a predominance of low-grade tumors, the long-term survival rates in completely excised inguinoscrotal sarcomas may be as favorable as in testicular germ cell tumors. Life-long surveillance is advisable to detect late recurrences.

Imputation methods for missing outcome data in meta-analysis of clinical trials

BackgroundMissing outcome data from randomized trials lead to greater uncertainty and possible bias in estimating the effect of an experimental treatment. An intention-to-treat analysis should take account of all randomized participants even if they have missing observations.PurposeTo review and develop imputation methods for missing outcome data in meta-analysis of clinical trials with binary outcomes.MethodsWe review some common strategies, such as simple imputation of positive or negative outcomes, and develop a general approach involving ‘informative missingness odds ratios’ (IMORs). We describe several choices for weighting studies in the meta-analysis, and illustrate methods using a meta-analysis of trials of haloperidol for schizophrenia.ResultsIMORs describe the relationship between the unknown risk among missing participants and the known risk among observed participants. They are allowed to differ between treatment groups and across trials. Application of IMORs and other methods to the haloperidol trials reveals the overall conclusion to be robust to different assumptions about the missing data.LimitationsThe methods are based on summary data from each trial (number of observed positive outcomes, number of observed negative outcomes and number of missing outcomes) for each intervention group. This limits the options for analysis, and greater flexibility would be available with individual participant data.ConclusionsWe propose that available reasons for missingness be used to determine appropriate IMORs. We also recommend a strategy for undertaking sensitivity analyses, in which the IMORs are varied over plausible ranges.

Nephrolithiasis Clinical Guidelines Panel Summary Report on the Management of Staghorn Calculi

The American Urological Association Nephrolithiasis Clinical Guidelines Panel recommendations for managing struvite staghorn calculi are based on a comprehensive review of the treatment literature and meta-analysis of outcome data from the 110 pertinent articles containing viable, unduplicated data. The panel concluded that the 3 most significant outcome probabilities are those of being stone-free, undergoing secondary unplanned procedures and having associated complications. Panel guideline recommendations for most standard patients are that neither shock wave lithotripsy monotherapy nor open surgery should be a first-line treatment choice but that a combination of percutaneous stone removal and shock wave lithotripsy should be used.