Analysis of Longitudinal Outcome Data with Missing Values in Total Knee Arthroplasty.

PubMed

Kang, Yeon Gwi; Lee, Jang Taek; Kang, Jong Yeal; Kim, Ga Hye; Kim, Tae Kyun

2016-01-01

We sought to determine the influence of missing data on the statistical results, and to determine which statistical method is most appropriate for the analysis of longitudinal outcome data of TKA with missing values among repeated measures ANOVA, generalized estimating equation (GEE) and mixed effects model repeated measures (MMRM). Data sets with missing values were generated with different proportion of missing data, sample size and missing-data generation mechanism. Each data set was analyzed with three statistical methods. The influence of missing data was greater with higher proportion of missing data and smaller sample size. MMRM tended to show least changes in the statistics. When missing values were generated by 'missing not at random' mechanism, no statistical methods could fully avoid deviations in the results. Copyright © 2016 Elsevier Inc. All rights reserved.

Multivariate meta-analysis: a robust approach based on the theory of U-statistic.

PubMed

Ma, Yan; Mazumdar, Madhu

2011-10-30

Meta-analysis is the methodology for combining findings from similar research studies asking the same question. When the question of interest involves multiple outcomes, multivariate meta-analysis is used to synthesize the outcomes simultaneously taking into account the correlation between the outcomes. Likelihood-based approaches, in particular restricted maximum likelihood (REML) method, are commonly utilized in this context. REML assumes a multivariate normal distribution for the random-effects model. This assumption is difficult to verify, especially for meta-analysis with small number of component studies. The use of REML also requires iterative estimation between parameters, needing moderately high computation time, especially when the dimension of outcomes is large. A multivariate method of moments (MMM) is available and is shown to perform equally well to REML. However, there is a lack of information on the performance of these two methods when the true data distribution is far from normality. In this paper, we propose a new nonparametric and non-iterative method for multivariate meta-analysis on the basis of the theory of U-statistic and compare the properties of these three procedures under both normal and skewed data through simulation studies. It is shown that the effect on estimates from REML because of non-normal data distribution is marginal and that the estimates from MMM and U-statistic-based approaches are very similar. Therefore, we conclude that for performing multivariate meta-analysis, the U-statistic estimation procedure is a viable alternative to REML and MMM. Easy implementation of all three methods are illustrated by their application to data from two published meta-analysis from the fields of hip fracture and periodontal disease. We discuss ideas for future research based on U-statistic for testing significance of between-study heterogeneity and for extending the work to meta-regression setting. Copyright © 2011 John Wiley & Sons, Ltd.

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.

PubMed

Zhang, Ying; Sun, Jin; Zhang, Yun-Jiao; Chai, Qian-Yun; Zhang, Kang; Ma, Hong-Li; Wu, Xiao-Ke; Liu, Jian-Ping

2016-10-21

Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined. The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial. This study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.

Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement.

PubMed

Austin, Peter C; Fine, Jason P

2017-04-15

In studies with survival or time-to-event outcomes, a competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. Specialized statistical methods must be used to analyze survival data in the presence of competing risks. We conducted a review of randomized controlled trials with survival outcomes that were published in high-impact general medical journals. Of 40 studies that we identified, 31 (77.5%) were potentially susceptible to competing risks. However, in the majority of these studies, the potential presence of competing risks was not accounted for in the statistical analyses that were described. Of the 31 studies potentially susceptible to competing risks, 24 (77.4%) reported the results of a Kaplan-Meier survival analysis, while only five (16.1%) reported using cumulative incidence functions to estimate the incidence of the outcome over time in the presence of competing risks. The former approach will tend to result in an overestimate of the incidence of the outcome over time, while the latter approach will result in unbiased estimation of the incidence of the primary outcome over time. We provide recommendations on the analysis and reporting of randomized controlled trials with survival outcomes in the presence of competing risks. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

Systematic Review and Meta-Analysis of Studies Evaluating Diagnostic Test Accuracy: A Practical Review for Clinical Researchers-Part II. Statistical Methods of Meta-Analysis

PubMed Central

Lee, Juneyoung; Kim, Kyung Won; Choi, Sang Hyun; Huh, Jimi

2015-01-01

Meta-analysis of diagnostic test accuracy studies differs from the usual meta-analysis of therapeutic/interventional studies in that, it is required to simultaneously analyze a pair of two outcome measures such as sensitivity and specificity, instead of a single outcome. Since sensitivity and specificity are generally inversely correlated and could be affected by a threshold effect, more sophisticated statistical methods are required for the meta-analysis of diagnostic test accuracy. Hierarchical models including the bivariate model and the hierarchical summary receiver operating characteristic model are increasingly being accepted as standard methods for meta-analysis of diagnostic test accuracy studies. We provide a conceptual review of statistical methods currently used and recommended for meta-analysis of diagnostic test accuracy studies. This article could serve as a methodological reference for those who perform systematic review and meta-analysis of diagnostic test accuracy studies. PMID:26576107

Heads Up! a Calculation- & Jargon-Free Approach to Statistics

ERIC Educational Resources Information Center

Giese, Alan R.

2012-01-01

Evaluating the strength of evidence in noisy data is a critical step in scientific thinking that typically relies on statistics. Students without statistical training will benefit from heuristic models that highlight the logic of statistical analysis. The likelihood associated with various coin-tossing outcomes gives students such a model. There…

Microscopic saw mark analysis: an empirical approach.

PubMed

Love, Jennifer C; Derrick, Sharon M; Wiersema, Jason M; Peters, Charles

2015-01-01

Microscopic saw mark analysis is a well published and generally accepted qualitative analytical method. However, little research has focused on identifying and mitigating potential sources of error associated with the method. The presented study proposes the use of classification trees and random forest classifiers as an optimal, statistically sound approach to mitigate the potential for error of variability and outcome error in microscopic saw mark analysis. The statistical model was applied to 58 experimental saw marks created with four types of saws. The saw marks were made in fresh human femurs obtained through anatomical gift and were analyzed using a Keyence digital microscope. The statistical approach weighed the variables based on discriminatory value and produced decision trees with an associated outcome error rate of 8.62-17.82%. © 2014 American Academy of Forensic Sciences.

Handling incomplete correlated continuous and binary outcomes in meta-analysis of individual participant data.

PubMed

Gomes, Manuel; Hatfield, Laura; Normand, Sharon-Lise

2016-09-20

Meta-analysis of individual participant data (IPD) is increasingly utilised to improve the estimation of treatment effects, particularly among different participant subgroups. An important concern in IPD meta-analysis relates to partially or completely missing outcomes for some studies, a problem exacerbated when interest is on multiple discrete and continuous outcomes. When leveraging information from incomplete correlated outcomes across studies, the fully observed outcomes may provide important information about the incompleteness of the other outcomes. In this paper, we compare two models for handling incomplete continuous and binary outcomes in IPD meta-analysis: a joint hierarchical model and a sequence of full conditional mixed models. We illustrate how these approaches incorporate the correlation across the multiple outcomes and the between-study heterogeneity when addressing the missing data. Simulations characterise the performance of the methods across a range of scenarios which differ according to the proportion and type of missingness, strength of correlation between outcomes and the number of studies. The joint model provided confidence interval coverage consistently closer to nominal levels and lower mean squared error compared with the fully conditional approach across the scenarios considered. Methods are illustrated in a meta-analysis of randomised controlled trials comparing the effectiveness of implantable cardioverter-defibrillator devices alone to implantable cardioverter-defibrillator combined with cardiac resynchronisation therapy for treating patients with chronic heart failure. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Ten Ways to Improve the Use of Statistical Mediation Analysis in the Practice of Child and Adolescent Treatment Research

ERIC Educational Resources Information Center

Maric, Marija; Wiers, Reinout W.; Prins, Pier J. M.

2012-01-01

Despite guidelines and repeated calls from the literature, statistical mediation analysis in youth treatment outcome research is rare. Even more concerning is that many studies that "have" reported mediation analyses do not fulfill basic requirements for mediation analysis, providing inconclusive data and clinical implications. As a result, after…

A note about high blood pressure in childhood

NASA Astrophysics Data System (ADS)

Teodoro, M. Filomena; Simão, Carla

2017-06-01

In medical, behavioral and social sciences it is usual to get a binary outcome. In the present work is collected information where some of the outcomes are binary variables (1='yes'/ 0='no'). In [14] a preliminary study about the caregivers perception of pediatric hypertension was introduced. An experimental questionnaire was designed to be answered by the caregivers of routine pediatric consultation attendees in the Santa Maria's hospital (HSM). The collected data was statistically analyzed, where a descriptive analysis and a predictive model were performed. Significant relations between some socio-demographic variables and the assessed knowledge were obtained. In [14] can be found a statistical data analysis using partial questionnaire's information. The present article completes the statistical approach estimating a model for relevant remaining questions of questionnaire by Generalized Linear Models (GLM). Exploring the binary outcome issue, we intend to extend this approach using Generalized Linear Mixed Models (GLMM), but the process is still ongoing.

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

PubMed

Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

2016-01-01

Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009). Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency

PubMed Central

Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

2016-01-01

Background Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. Methods From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. Results 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31–0.89] (P value = 0.009). Conclusion Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies. PMID:27716793

Cost-Effectiveness Analysis: a proposal of new reporting standards in statistical analysis

PubMed Central

Bang, Heejung; Zhao, Hongwei

2014-01-01

Cost-effectiveness analysis (CEA) is a method for evaluating the outcomes and costs of competing strategies designed to improve health, and has been applied to a variety of different scientific fields. Yet, there are inherent complexities in cost estimation and CEA from statistical perspectives (e.g., skewness, bi-dimensionality, and censoring). The incremental cost-effectiveness ratio that represents the additional cost per one unit of outcome gained by a new strategy has served as the most widely accepted methodology in the CEA. In this article, we call for expanded perspectives and reporting standards reflecting a more comprehensive analysis that can elucidate different aspects of available data. Specifically, we propose that mean and median-based incremental cost-effectiveness ratios and average cost-effectiveness ratios be reported together, along with relevant summary and inferential statistics as complementary measures for informed decision making. PMID:24605979

[Analysis of efficacy of radiofrequency obliteration with due regard for the target vein's diameter].

PubMed

Shaĭdakov, E V; Grigorian, A G; Iliukhin, E A; Bulatov, V L; Gal'chenko, M I

2014-01-01

Data concerning the effect of the target vein's diameter on efficacy of radiofrequency obliteration (RFO) in the current literature are limited. To assess efficacy of RFO and stripping, peculiarities of the postoperative period course with due regard for the diameter of the target veins, to compare the outcomes of RFO and classical phlebectomy in treatment of varicose disease during 1-year follow up by a composite end point. A multicenter prospective non-randomized study based on analysing therapeutic outcomes in a total of 218 patients presenting with varicose disease (C2-C3 according to the CEAP). RFO was performed in 108 patients and phlebectomy in 110 subjects. The results were assessed by means of a composite end point including four components: technical outcome at 1-year follow-up, pain, subcutaneous haemorrhage, and paresthesias. The groups of patients who endured RFO and phlebectomy were subdivided into two subgroups according to the target vein's diameter with a border of 14 mm. Statistical analysis. We used the methods of non-parametric statistics (contingency tables, chi squared test), calculating the odds ratio (OR) for a favourable outcome with a 95% confidential interval. Pain dynamics was assessed by means of intellectual data analysis (cluster analysis). «Phelbectomy ≥ 14 mm» and «RFO ≥ 14 mm». The incidence rate of a good outcome in the subgroups amounted to 20 (30.8%) and 61 (95.3%), respectively. The odds ratio for favourable outcome between the subgroups of RFA and phlebectomy amounted to 45.8; 95% CI (44.5-47.0). "RFA ≥ 14 mm" and "RFA < 14 mm". Favourable outcome rate in the subgroups amounted to 25 (39.1%) and 17 (38.6%), respectively. The differences were not statistically significant, p=0.24. The odds ratio for a good outcome between the RFO subgroups amounted to: OR=0.98; 95% CI (0.18-1.77). Comparative analysis of RFO outcomes between the clinics. Favourable outcome rate in the first clinic was 50 (92.6%), in the second 34 (87.2%), and in the third 13 (86.6%), with the difference being statistically insignificant, p=0.7. The cluster analysis of the pain dynamics after the intervention. The clusters with moderate pain were composed of the patients after phlebectomy. These clusters showed association of pain intensity with increased BMI and greater vein diameter. 1) RFA of great-diameter veins by a favourable outcome by the composite end point (CED) turned out to be superior to the classic phlebectomy. 2) For RFA the incidence rate of a favourable outcome by the CED does not depend on the target vein's diameter. 3) A pronounced pain syndrome after phlebectomy was associated with excessive body weight or obesity and greater diameter of the vein.

Links between Characteristics of Collaborative Peer Video Analysis Events and Literacy Teachers' Outcomes

ERIC Educational Resources Information Center

Arya, Poonam; Christ, Tanya; Chiu, Ming

2015-01-01

This study examined how characteristics of Collaborative Peer Video Analysis (CPVA) events are related to teachers' pedagogical outcomes. Data included 39 transcribed literacy video events, in which 14 in-service teachers engaged in discussions of their video clips. Emergent coding and Statistical Discourse Analysis were used to analyze the data.…

Transfusion Indication Threshold Reduction (TITRe2) randomized controlled trial in cardiac surgery: statistical analysis plan.

PubMed

Pike, Katie; Nash, Rachel L; Murphy, Gavin J; Reeves, Barnaby C; Rogers, Chris A

2015-02-22

The Transfusion Indication Threshold Reduction (TITRe2) trial is the largest randomized controlled trial to date to compare red blood cell transfusion strategies following cardiac surgery. This update presents the statistical analysis plan, detailing how the study will be analyzed and presented. The statistical analysis plan has been written following recommendations from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, prior to database lock and the final analysis of trial data. Outlined analyses are in line with the Consolidated Standards of Reporting Trials (CONSORT). The study aims to randomize 2000 patients from 17 UK centres. Patients are randomized to either a restrictive (transfuse if haemoglobin concentration <7.5 g/dl) or liberal (transfuse if haemoglobin concentration <9 g/dl) transfusion strategy. The primary outcome is a binary composite outcome of any serious infectious or ischaemic event in the first 3 months following randomization. The statistical analysis plan details how non-adherence with the intervention, withdrawals from the study, and the study population will be derived and dealt with in the analysis. The planned analyses of the trial primary and secondary outcome measures are described in detail, including approaches taken to deal with multiple testing, model assumptions not being met and missing data. Details of planned subgroup and sensitivity analyses and pre-specified ancillary analyses are given, along with potential issues that have been identified with such analyses and possible approaches to overcome such issues. ISRCTN70923932 .

Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial

PubMed Central

Damiani, Lucas Petri; Berwanger, Otavio; Paisani, Denise; Laranjeira, Ligia Nasi; Suzumura, Erica Aranha; Amato, Marcelo Britto Passos; Carvalho, Carlos Roberto Ribeiro; Cavalcanti, Alexandre Biasi

2017-01-01

Background The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). Objective To describe the data management process and statistical analysis plan. Methods The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. Conclusion According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. Trial registration ClinicalTrials.gov number, NCT01374022. PMID:28977255

Confounding in statistical mediation analysis: What it is and how to address it.

PubMed

Valente, Matthew J; Pelham, William E; Smyth, Heather; MacKinnon, David P

2017-11-01

Psychology researchers are often interested in mechanisms underlying how randomized interventions affect outcomes such as substance use and mental health. Mediation analysis is a common statistical method for investigating psychological mechanisms that has benefited from exciting new methodological improvements over the last 2 decades. One of the most important new developments is methodology for estimating causal mediated effects using the potential outcomes framework for causal inference. Potential outcomes-based methods developed in epidemiology and statistics have important implications for understanding psychological mechanisms. We aim to provide a concise introduction to and illustration of these new methods and emphasize the importance of confounder adjustment. First, we review the traditional regression approach for estimating mediated effects. Second, we describe the potential outcomes framework. Third, we define what a confounder is and how the presence of a confounder can provide misleading evidence regarding mechanisms of interventions. Fourth, we describe experimental designs that can help rule out confounder bias. Fifth, we describe new statistical approaches to adjust for measured confounders of the mediator-outcome relation and sensitivity analyses to probe effects of unmeasured confounders on the mediated effect. All approaches are illustrated with application to a real counseling intervention dataset. Counseling psychologists interested in understanding the causal mechanisms of their interventions can benefit from incorporating the most up-to-date techniques into their mediation analyses. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

THE STATISTICAL ANALYSIS OF DISCRETE AND CONTINUOUS OUTCOMES USING DESIRABILITY FUNCTIONS.

EPA Science Inventory

Multiple types of outcomes are sometimes measured on each animal in toxicology dose-response experiments. In this paper we introduce a method of deriving a composite score for a dose-response experiment that combines information from discrete and continuous outcomes through the ...

Are well functioning civil registration and vital statistics systems associated with better health outcomes?

PubMed

Phillips, David E; AbouZahr, Carla; Lopez, Alan D; Mikkelsen, Lene; de Savigny, Don; Lozano, Rafael; Wilmoth, John; Setel, Philip W

2015-10-03

In this Series paper, we examine whether well functioning civil registration and vital statistics (CRVS) systems are associated with improved population health outcomes. We present a conceptual model connecting CRVS to wellbeing, and describe an ecological association between CRVS and health outcomes. The conceptual model posits that the legal identity that civil registration provides to individuals is key to access entitlements and services. Vital statistics produced by CRVS systems provide essential information for public health policy and prevention. These outcomes benefit individuals and societies, including improved health. We use marginal linear models and lag-lead analysis to measure ecological associations between a composite metric of CRVS performance and three health outcomes. Results are consistent with the conceptual model: improved CRVS performance coincides with improved health outcomes worldwide in a temporally consistent manner. Investment to strengthen CRVS systems is not only an important goal for individuals and societies, but also a development imperative that is good for health. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of standardized and applied variables in predicting treatment outcomes of polytrauma patients.

PubMed

Aksamija, Goran; Mulabdic, Adi; Rasic, Ismar; Muhovic, Samir; Gavric, Igor

2011-01-01

Polytrauma is defined as an injury where they are affected by at least two different organ systems or body, with at least one life-threatening injuries. Given the multilevel model care of polytrauma patients within KCUS are inevitable weaknesses in the management of this category of patients. To determine the dynamics of existing procedures in treatment of polytrauma patients on admission to KCUS, and based on statistical analysis of variables applied to determine and define the factors that influence the final outcome of treatment, and determine their mutual relationship, which may result in eliminating the flaws in the approach to the problem. The study was based on 263 polytrauma patients. Parametric and non-parametric statistical methods were used. Basic statistics were calculated, based on the calculated parameters for the final achievement of research objectives, multicoleration analysis, image analysis, discriminant analysis and multifactorial analysis were used. From the universe of variables for this study we selected sample of n = 25 variables, of which the first two modular, others belong to the common measurement space (n = 23) and in this paper defined as a system variable methods, procedures and assessments of polytrauma patients. After the multicoleration analysis, since the image analysis gave a reliable measurement results, we started the analysis of eigenvalues, that is defining the factors upon which they obtain information about the system solve the problem of the existing model and its correlation with treatment outcome. The study singled out the essential factors that determine the current organizational model of care, which may affect the treatment and better outcome of polytrauma patients. This analysis has shown the maximum correlative relationships between these practices and contributed to development guidelines that are defined by isolated factors.

Clinical Trials With Large Numbers of Variables: Important Advantages of Canonical Analysis.

PubMed

Cleophas, Ton J

2016-01-01

Canonical analysis assesses the combined effects of a set of predictor variables on a set of outcome variables, but it is little used in clinical trials despite the omnipresence of multiple variables. The aim of this study was to assess the performance of canonical analysis as compared with traditional multivariate methods using multivariate analysis of covariance (MANCOVA). As an example, a simulated data file with 12 gene expression levels and 4 drug efficacy scores was used. The correlation coefficient between the 12 predictor and 4 outcome variables was 0.87 (P = 0.0001) meaning that 76% of the variability in the outcome variables was explained by the 12 covariates. Repeated testing after the removal of 5 unimportant predictor and 1 outcome variable produced virtually the same overall result. The MANCOVA identified identical unimportant variables, but it was unable to provide overall statistics. (1) Canonical analysis is remarkable, because it can handle many more variables than traditional multivariate methods such as MANCOVA can. (2) At the same time, it accounts for the relative importance of the separate variables, their interactions and differences in units. (3) Canonical analysis provides overall statistics of the effects of sets of variables, whereas traditional multivariate methods only provide the statistics of the separate variables. (4) Unlike other methods for combining the effects of multiple variables such as factor analysis/partial least squares, canonical analysis is scientifically entirely rigorous. (5) Limitations include that it is less flexible than factor analysis/partial least squares, because only 2 sets of variables are used and because multiple solutions instead of one is offered. We do hope that this article will stimulate clinical investigators to start using this remarkable method.

Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions.

PubMed

Page, Matthew J; McKenzie, Joanne E; Kirkham, Jamie; Dwan, Kerry; Kramer, Sharon; Green, Sally; Forbes, Andrew

2014-10-01

Systematic reviews may be compromised by selective inclusion and reporting of outcomes and analyses. Selective inclusion occurs when there are multiple effect estimates in a trial report that could be included in a particular meta-analysis (e.g. from multiple measurement scales and time points) and the choice of effect estimate to include in the meta-analysis is based on the results (e.g. statistical significance, magnitude or direction of effect). Selective reporting occurs when the reporting of a subset of outcomes and analyses in the systematic review is based on the results (e.g. a protocol-defined outcome is omitted from the published systematic review). To summarise the characteristics and synthesise the results of empirical studies that have investigated the prevalence of selective inclusion or reporting in systematic reviews of randomised controlled trials (RCTs), investigated the factors (e.g. statistical significance or direction of effect) associated with the prevalence and quantified the bias. We searched the Cochrane Methodology Register (to July 2012), Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO and ISI Web of Science (each up to May 2013), and the US Agency for Healthcare Research and Quality (AHRQ) Effective Healthcare Program's Scientific Resource Center (SRC) Methods Library (to June 2013). We also searched the abstract books of the 2011 and 2012 Cochrane Colloquia and the article alerts for methodological work in research synthesis published from 2009 to 2011 and compiled in Research Synthesis Methods. We included both published and unpublished empirical studies that investigated the prevalence and factors associated with selective inclusion or reporting, or both, in systematic reviews of RCTs of healthcare interventions. We included empirical studies assessing any type of selective inclusion or reporting, such as investigations of how frequently RCT outcome data is selectively included in systematic reviews based on the results, outcomes and analyses are discrepant between protocol and published review or non-significant outcomes are partially reported in the full text or summary within systematic reviews. Two review authors independently selected empirical studies for inclusion, extracted the data and performed a risk of bias assessment. A third review author resolved any disagreements about inclusion or exclusion of empirical studies, data extraction and risk of bias. We contacted authors of included studies for additional unpublished data. Primary outcomes included overall prevalence of selective inclusion or reporting, association between selective inclusion or reporting and the statistical significance of the effect estimate, and association between selective inclusion or reporting and the direction of the effect estimate. We combined prevalence estimates and risk ratios (RRs) using a random-effects meta-analysis model. Seven studies met the inclusion criteria. No studies had investigated selective inclusion of results in systematic reviews, or discrepancies in outcomes and analyses between systematic review registry entries and published systematic reviews. Based on a meta-analysis of four studies (including 485 Cochrane Reviews), 38% (95% confidence interval (CI) 23% to 54%) of systematic reviews added, omitted, upgraded or downgraded at least one outcome between the protocol and published systematic review. The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain. The meta-analytic estimate suggested an increased risk of adding or upgrading (i.e. changing a secondary outcome to primary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.43, 95% CI 0.71 to 2.85; two studies, n = 552 meta-analyses). Also, the meta-analytic estimate suggested an increased risk of downgrading (i.e. changing a primary outcome to secondary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.26, 95% CI 0.60 to 2.62; two studies, n = 484 meta-analyses). None of the included studies had investigated whether the association between statistical significance and adding, upgrading or downgrading of outcomes was modified by the type of comparison, direction of effect or type of outcome; or whether there is an association between direction of the effect estimate and discrepant outcome reporting.Several secondary outcomes were reported in the included studies. Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic reviews (6% in one study and 22% in the other). One study (including 62 Cochrane Reviews) found that 32% (95% CI 21% to 45%) of systematic reviews did not report all primary outcomes in the abstract. Another study (including 64 Cochrane and 118 non-Cochrane reviews) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes (RR 2.66, 95% CI 1.81 to 3.90). None of the studies included systematic reviews published after 2009 when reporting standards for systematic reviews (Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, and Methodological Expectations of Cochrane Intervention Reviews (MECIR)) were disseminated, so the results might not be generalisable to more recent systematic reviews. Discrepant outcome reporting between the protocol and published systematic review is fairly common, although the association between statistical significance and discrepant outcome reporting is uncertain. Complete reporting of outcomes in systematic review abstracts is associated with statistical significance of the results for those outcomes. Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results. Modifications that occur once the review has commenced, along with their justification, should be clearly reported. Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results. The lack of research on selective inclusion of results in systematic reviews needs to be addressed and studies that avoid the methodological weaknesses of existing research are also needed.

Systematic review of learning curves for minimally invasive abdominal surgery: a review of the methodology of data collection, depiction of outcomes, and statistical analysis.

PubMed

Harrysson, Iliana J; Cook, Jonathan; Sirimanna, Pramudith; Feldman, Liane S; Darzi, Ara; Aggarwal, Rajesh

2014-07-01

To determine how minimally invasive surgical learning curves are assessed and define an ideal framework for this assessment. Learning curves have implications for training and adoption of new procedures and devices. In 2000, a review of the learning curve literature was done by Ramsay et al and it called for improved reporting and statistical evaluation of learning curves. Since then, a body of literature is emerging on learning curves but the presentation and analysis vary. A systematic search was performed of MEDLINE, EMBASE, ISI Web of Science, ERIC, and the Cochrane Library from 1985 to August 2012. The inclusion criteria are minimally invasive abdominal surgery formally analyzing the learning curve and English language. 592 (11.1%) of the identified studies met the selection criteria. Time is the most commonly used proxy for the learning curve (508, 86%). Intraoperative outcomes were used in 316 (53%) of the articles, postoperative outcomes in 306 (52%), technical skills in 102 (17%), and patient-oriented outcomes in 38 (6%) articles. Over time, there was evidence of an increase in the relative amount of laparoscopic and robotic studies (P < 0.001) without statistical evidence of a change in the complexity of analysis (P = 0.121). Assessment of learning curves is needed to inform surgical training and evaluate new clinical procedures. An ideal analysis would account for the degree of complexity of individual cases and the inherent differences between surgeons. There is no single proxy that best represents the success of surgery, and hence multiple outcomes should be collected.

Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement

PubMed Central

Fine, Jason P.

2017-01-01

In studies with survival or time‐to‐event outcomes, a competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. Specialized statistical methods must be used to analyze survival data in the presence of competing risks. We conducted a review of randomized controlled trials with survival outcomes that were published in high‐impact general medical journals. Of 40 studies that we identified, 31 (77.5%) were potentially susceptible to competing risks. However, in the majority of these studies, the potential presence of competing risks was not accounted for in the statistical analyses that were described. Of the 31 studies potentially susceptible to competing risks, 24 (77.4%) reported the results of a Kaplan–Meier survival analysis, while only five (16.1%) reported using cumulative incidence functions to estimate the incidence of the outcome over time in the presence of competing risks. The former approach will tend to result in an overestimate of the incidence of the outcome over time, while the latter approach will result in unbiased estimation of the incidence of the primary outcome over time. We provide recommendations on the analysis and reporting of randomized controlled trials with survival outcomes in the presence of competing risks. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:28102550

Evaluating Structural Equation Models for Categorical Outcomes: A New Test Statistic and a Practical Challenge of Interpretation.

PubMed

Monroe, Scott; Cai, Li

2015-01-01

This research is concerned with two topics in assessing model fit for categorical data analysis. The first topic involves the application of a limited-information overall test, introduced in the item response theory literature, to structural equation modeling (SEM) of categorical outcome variables. Most popular SEM test statistics assess how well the model reproduces estimated polychoric correlations. In contrast, limited-information test statistics assess how well the underlying categorical data are reproduced. Here, the recently introduced C2 statistic of Cai and Monroe (2014) is applied. The second topic concerns how the root mean square error of approximation (RMSEA) fit index can be affected by the number of categories in the outcome variable. This relationship creates challenges for interpreting RMSEA. While the two topics initially appear unrelated, they may conveniently be studied in tandem since RMSEA is based on an overall test statistic, such as C2. The results are illustrated with an empirical application to data from a large-scale educational survey.

Preoperative radiation and free flap outcomes for head and neck reconstruction: a systematic review and meta-analysis.

PubMed

Herle, Pradyumna; Shukla, Lipi; Morrison, Wayne A; Shayan, Ramin

2015-03-01

There is a general consensus among reconstructive surgeons that preoperative radiotherapy is associated with a higher risk of flap failure and complications in head and neck surgery. Opinion is also divided regarding the effects of radiation dose on free flap outcomes and timing of preoperative radiation to minimize adverse outcomes. Our meta-analysis will attempt to address these issues. A systematic review of the literature was conducted in concordance to PRISMA protocol. Data were combined using STATA 12 and Open Meta-Analyst software programmes. Twenty-four studies were included comparing 2842 flaps performed in irradiated fields and 3491 flaps performed in non-irradiated fields. Meta-analysis yielded statistically significant risk ratios for flap failure (RR 1.48, P = 0.004), complications (RR 1.84, P < 0.001), reoperation (RR 2.06, P < 0.001) and fistula (RR 2.05, P < 0.001). Mean radiation dose demonstrated a trend towards increased risk of flap failure, but this was not statistically significant. On subgroup analysis, flaps with >60 Gy radiation had a non-statistically significant higher risk of flap failure (RR 1.61, P = 0.145). Preoperative radiation is associated with a statistically significant increased risk of flap complications, failure and fistula. Preoperative radiation in excess of 60 Gy after radiotherapy represents a potential risk factor for increased flap loss and should be avoided where possible. © 2014 Royal Australasian College of Surgeons.

Analysis and interpretation of cost data in randomised controlled trials: review of published studies

PubMed Central

Barber, Julie A; Thompson, Simon G

1998-01-01

Objective To review critically the statistical methods used for health economic evaluations in randomised controlled trials where an estimate of cost is available for each patient in the study. Design Survey of published randomised trials including an economic evaluation with cost values suitable for statistical analysis; 45 such trials published in 1995 were identified from Medline. Main outcome measures The use of statistical methods for cost data was assessed in terms of the descriptive statistics reported, use of statistical inference, and whether the reported conclusions were justified. Results Although all 45 trials reviewed apparently had cost data for each patient, only 9 (20%) reported adequate measures of variability for these data and only 25 (56%) gave results of statistical tests or a measure of precision for the comparison of costs between the randomised groups. Only 16 (36%) of the articles gave conclusions which were justified on the basis of results presented in the paper. No paper reported sample size calculations for costs. Conclusions The analysis and interpretation of cost data from published trials reveal a lack of statistical awareness. Strong and potentially misleading conclusions about the relative costs of alternative therapies have often been reported in the absence of supporting statistical evidence. Improvements in the analysis and reporting of health economic assessments are urgently required. Health economic guidelines need to be revised to incorporate more detailed statistical advice. Key messagesHealth economic evaluations required for important healthcare policy decisions are often carried out in randomised controlled trialsA review of such published economic evaluations assessed whether statistical methods for cost outcomes have been appropriately used and interpretedFew publications presented adequate descriptive information for costs or performed appropriate statistical analysesIn at least two thirds of the papers, the main conclusions regarding costs were not justifiedThe analysis and reporting of health economic assessments within randomised controlled trials urgently need improving PMID:9794854

Neurological Outcomes Following Suicidal Hanging: A Prospective Study of 101 Patients

PubMed Central

Jawaid, Mohammed Turab; Amalnath, S. Deepak; Subrahmanyam, D. K. S.

2017-01-01

Context: Survivors of suicidal hanging can have variable neurological outcomes – from complete recovery to irreversible brain damage. Literature on the neurological outcomes in these patients is confined to retrospective studies and case series. Hence, this prospective study was carried out. Aims: The aim is to study the neurological outcomes in suicidal hanging. Settings and Design: This was a prospective observational study carried out from July 2014 to July 2016. Subjects and Methods: Consecutive patients admitted to the emergency and medicine wards were included in the study. Details of the clinical and radiological findings, course in hospital and at 1 month postdischarge were analyzed. Statistical Analysis Used: Statistical analysis was performed using IBM SPSS advanced statistics 20.0 (SPSS Inc., Chicago, USA). Univariate analysis was performed using Chi-square test for significance and Odd's ratio was calculated. Results: Of the 101 patients, 6 died and 4 had residual neuro deficits. Cervical spine injury was seen in 3 patients. Interestingly, 39 patients could not remember the act of hanging (retrograde amnesia). Hypotension, pulmonary edema, Glasgow coma scale (GCS) score <8 at admission, need for mechanical ventilation, and cerebral edema on plain computed tomography were more in those with amnesia as compared to those with normal memory and these findings were statistically significant. Conclusions: Majority of patients recovered without any sequelae. Routine imaging of cervical spine may not be warranted in all patients, even in those with poor GCS. Retrograde amnesia might be more common than previously believed and further studies are needed to analyze this peculiar feature. PMID:28584409

Clinical and Radiographic Mid-Term Outcomes After Total Shoulder Replacement: A Retrospective Study Protocol Including 400 Anatomical and Reverse Prosthetic Implants

PubMed Central

Merolla, Giovanni; Tartarone, Antonio; Porcellini, Giuseppe

2016-01-01

Objectives: To obtain outcomes data on anatomical and reverse total shoulder arthroplasty by analysis of clinical scores and standard radiographs. Subject selection and enrollment: 400 consecutive series of patients replaced with anatomical and reverse total shoulder arthroplasty (minimum 3 years follow-up). Study Design: retrospective monocenter. Preoperative assessment: Demographics, clinical scores (Constant-Murley) as available, shoulder X-ray (AP, outlet and axillary views) . Last follow-up: Postoperative radiographhs and clinical scores. Adverse events and complications to be reported as occurred since implantation. Statistical analysis: Data collected will be summarized and analyzed for statistical significance. PMID:27326389

Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

PubMed

Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

2018-01-11

Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the primary outcome, or funding source. Thirty-six percent (n = 94) of authors had been asked to include additional analyses that had not been included in the original manuscript; in 77% (n = 72) these were not pre-specified in the protocol. Twenty-three percent (n = 60) had been asked to modify their overall conclusion, usually (n = 53; 88%) to provide a more cautious conclusion. Overall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged.

Comparison of clinical outcomes in decompression and fusion versus decompression only in patients with ossification of the posterior longitudinal ligament: a meta-analysis.

PubMed

Mehdi, Syed K; Alentado, Vincent J; Lee, Bryan S; Mroz, Thomas E; Benzel, Edward C; Steinmetz, Michael P

2016-06-01

OBJECTIVE Ossification of the posterior longitudinal ligament (OPLL) is a pathological calcification or ossification of the PLL, predominantly occurring in the cervical spine. Although surgery is often necessary for patients with symptomatic neurological deterioration, there remains controversy with regard to the optimal surgical treatment. In this systematic review and meta-analysis, the authors identified differences in complications and outcomes after anterior or posterior decompression and fusion versus after decompression alone for the treatment of cervical myelopathy due to OPLL. METHODS A MEDLINE, SCOPUS, and Web of Science search was performed for studies reporting complications and outcomes after decompression and fusion or after decompression alone for patients with OPLL. A meta-analysis was performed to calculate effect summary mean values, 95% CIs, Q statistics, and I(2) values. Forest plots were constructed for each analysis group. RESULTS Of the 2630 retrieved articles, 32 met the inclusion criteria. There was no statistically significant difference in the incidence of excellent and good outcomes and of fair and poor outcomes between the decompression and fusion and the decompression-only cohorts. However, the decompression and fusion cohort had a statistically significantly higher recovery rate (63.2% vs 53.9%; p < 0.0001), a higher final Japanese Orthopaedic Association score (14.0 vs 13.5; p < 0.0001), and a lower incidence of OPLL progression (< 1% vs 6.3%; p < 0.0001) compared with the decompression-only cohort. There was no statistically significant difference in the incidence of complications between the 2 cohorts. CONCLUSIONS This study represents the only comprehensive review of outcomes and complications after decompression and fusion or after decompression alone for OPLL across a heterogeneous group of surgeons and patients. Based on these results, decompression and fusion is a superior surgical technique compared with posterior decompression alone in patients with OPLL. These results indicate that surgical decompression and fusion lead to a faster recovery, improved postoperative neurological functioning, and a lower incidence of OPLL progression compared with posterior decompression only. Furthermore, decompression and fusion did not lead to a greater incidence of complications compared with posterior decompression only.

Statistical analysis and handling of missing data in cluster randomized trials: a systematic review.

PubMed

Fiero, Mallorie H; Huang, Shuang; Oren, Eyal; Bell, Melanie L

2016-02-09

Cluster randomized trials (CRTs) randomize participants in groups, rather than as individuals and are key tools used to assess interventions in health research where treatment contamination is likely or if individual randomization is not feasible. Two potential major pitfalls exist regarding CRTs, namely handling missing data and not accounting for clustering in the primary analysis. The aim of this review was to evaluate approaches for handling missing data and statistical analysis with respect to the primary outcome in CRTs. We systematically searched for CRTs published between August 2013 and July 2014 using PubMed, Web of Science, and PsycINFO. For each trial, two independent reviewers assessed the extent of the missing data and method(s) used for handling missing data in the primary and sensitivity analyses. We evaluated the primary analysis and determined whether it was at the cluster or individual level. Of the 86 included CRTs, 80 (93%) trials reported some missing outcome data. Of those reporting missing data, the median percent of individuals with a missing outcome was 19% (range 0.5 to 90%). The most common way to handle missing data in the primary analysis was complete case analysis (44, 55%), whereas 18 (22%) used mixed models, six (8%) used single imputation, four (5%) used unweighted generalized estimating equations, and two (2%) used multiple imputation. Fourteen (16%) trials reported a sensitivity analysis for missing data, but most assumed the same missing data mechanism as in the primary analysis. Overall, 67 (78%) trials accounted for clustering in the primary analysis. High rates of missing outcome data are present in the majority of CRTs, yet handling missing data in practice remains suboptimal. Researchers and applied statisticians should carry out appropriate missing data methods, which are valid under plausible assumptions in order to increase statistical power in trials and reduce the possibility of bias. Sensitivity analysis should be performed, with weakened assumptions regarding the missing data mechanism to explore the robustness of results reported in the primary analysis.

A third of systematic reviews changed or did not specify the primary outcome: a PROSPERO register study.

PubMed

Tricco, Andrea C; Cogo, Elise; Page, Matthew J; Polisena, Julie; Booth, Alison; Dwan, Kerry; MacDonald, Heather; Clifford, Tammy J; Stewart, Lesley A; Straus, Sharon E; Moher, David

2016-11-01

To examine outcome reporting bias of systematic reviews registered in PROSPERO. Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions, or downgrades. Relative risks (RRs) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favorable and statistically significant. Ninety-six systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR, 2.14; 95% CI: 0.53, 8.63) or decreased risk of downgrading (RR, 0.76; 95% CI: 0.27, 2.17) an outcome when the meta-analysis result was favorable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR, 0.89; 95% CI: 0.31, 2.53) or decreased risk of downgrading (RR, 0.56; 95% CI: 0.29, 1.08) an outcome when the conclusion was positive. We recommend review authors carefully consider primary outcome selection, and journals are encouraged to focus acceptance on registered systematic reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effectiveness of Psychosocial Interventions Delivered by Teachers in Schools: A Systematic Review and Meta-Analysis.

PubMed

Franklin, Cynthia; Kim, Johnny S; Beretvas, Tasha S; Zhang, Anao; Guz, Samantha; Park, Sunyoung; Montgomery, Katherine; Chung, Saras; Maynard, Brandy R

2017-09-01

The growing mental health needs of students within schools have resulted in teachers increasing their involvement in the delivery of school-based, psychosocial interventions. Current research reports mixed findings concerning the effectiveness of psychosocial interventions delivered by teachers for mental health outcomes. This article presents a systematic review and meta-analysis that examined the effectiveness of school-based psychosocial interventions delivered by teachers on internalizing and externalizing outcomes and the moderating factors that influence treatment effects on these outcomes. Nine electronic databases, major journals, and gray literature (e.g., websites, conference abstract) were searched and field experts were contacted to locate additional studies. Twenty-four studies that met the study inclusion criteria were coded into internalizing or externalizing outcomes and further analyzed using robust variance estimation in meta-regression. Both publication and risk of bias of studies were further assessed. The results showed statistically significant reductions in students' internalizing outcomes (d = .133, 95% CI [.002, .263]) and no statistical significant effect for externalizing outcomes (d = .15, 95% CI [-.037, .066]). Moderator analysis with meta-regression revealed that gender (%male, b = -.017, p < .05), race (% Caucasian, b = .002, p < .05), and the tier of intervention (b = .299, p = .06) affected intervention effectiveness. This study builds on existing literature that shows that teacher-delivered Tier 1 interventions are effective interventions but also adds to this literature by showing that interventions are more effective with internalizing outcomes than on the externalizing outcomes. Moderator analysis also revealed treatments were more effective with female students for internalizing outcomes and more effective with Caucasian students for externalizing outcomes.

Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion

PubMed Central

2007-01-01

Background The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE) study led to a conclusion that clinical outcomes following lumbar arthroplasty were at least as good as outcomes from fusion. Methods The author performed a new analysis of the Visual Analog Scale pain scores and the Oswestry Disability Index scores from the Charité artificial disc IDE study and used a nonparametric statistical test, because observed data distributions were not normal. The analysis included all of the enrolled subjects in both the nonrandomized and randomized phases of the study. Results Subjects from both the treatment and control groups improved from the baseline situation (P < .001) at all follow-up times (6 weeks to 24 months). Additionally, these pain and disability levels with artificial disc replacement were superior (P < .05) to the fusion treatment at all follow-up times including 2 years. Conclusions The a priori statistical plan for an IDE study may not adequately address the final distribution of the data. Therefore, statistical analyses more appropriate to the distribution may be necessary to develop meaningful statistical conclusions from the study. A nonparametric statistical analysis of the Charité artificial disc IDE outcomes scores demonstrates superiority for lumbar arthroplasty versus fusion at all follow-up time points to 24 months. PMID:25802574

Effect and safety of early weight-bearing on the outcome after open-wedge high tibial osteotomy: a systematic review and meta-analysis.

PubMed

Lee, O-Sung; Ahn, Soyeon; Lee, Yong Seuk

2017-07-01

The purpose of this systematic review and meta-analysis was to evaluate the effectiveness and safety of early weight-bearing by comparing clinical and radiological outcomes between early and traditional delayed weight-bearing after OWHTO. A rigorous and systematic approach was used. The methodological quality was also assessed. Results that are possible to be compared in two or more than two articles were presented as forest plots. A 95% confidence interval was calculated for each effect size, and we calculated the I 2 statistic, which presents the percentage of total variation attributable to the heterogeneity among studies. The random-effects model was used to calculate the effect size. Six articles were included in the final analysis. All case groups were composed of early full weight-bearing within 2 weeks. All control groups were composed of late full weight-bearing between 6 weeks and 2 months. Pooled analysis was possible for the improvement in Lysholm score, but there was no statistically significant difference shown between groups. Other clinical results were also similar between groups. Four studies reported mechanical femorotibial angle (mFTA) and this result showed no statistically significant difference between groups in the pooled analysis. Furthermore, early weight-bearing showed more favorable results in some radiologic results (osseointegration and patellar height) and complications (thrombophlebitis and recurrence). Our analysis supports that early full weight-bearing after OWHTO using a locking plate leads to improvement in outcomes and was comparable to the delayed weight-bearing in terms of clinical and radiological outcomes. On the contrary, early weight-bearing was more favorable with respect to some radiologic parameters and complications compared with delayed weight-bearing.

Mediation analysis in nursing research: a methodological review.

PubMed

Liu, Jianghong; Ulrich, Connie

2016-12-01

Mediation statistical models help clarify the relationship between independent predictor variables and dependent outcomes of interest by assessing the impact of third variables. This type of statistical analysis is applicable for many clinical nursing research questions, yet its use within nursing remains low. Indeed, mediational analyses may help nurse researchers develop more effective and accurate prevention and treatment programs as well as help bridge the gap between scientific knowledge and clinical practice. In addition, this statistical approach allows nurse researchers to ask - and answer - more meaningful and nuanced questions that extend beyond merely determining whether an outcome occurs. Therefore, the goal of this paper is to provide a brief tutorial on the use of mediational analyses in clinical nursing research by briefly introducing the technique and, through selected empirical examples from the nursing literature, demonstrating its applicability in advancing nursing science.

The Ontology of Biological and Clinical Statistics (OBCS) for standardized and reproducible statistical analysis.

PubMed

Zheng, Jie; Harris, Marcelline R; Masci, Anna Maria; Lin, Yu; Hero, Alfred; Smith, Barry; He, Yongqun

2016-09-14

Statistics play a critical role in biological and clinical research. However, most reports of scientific results in the published literature make it difficult for the reader to reproduce the statistical analyses performed in achieving those results because they provide inadequate documentation of the statistical tests and algorithms applied. The Ontology of Biological and Clinical Statistics (OBCS) is put forward here as a step towards solving this problem. The terms in OBCS including 'data collection', 'data transformation in statistics', 'data visualization', 'statistical data analysis', and 'drawing a conclusion based on data', cover the major types of statistical processes used in basic biological research and clinical outcome studies. OBCS is aligned with the Basic Formal Ontology (BFO) and extends the Ontology of Biomedical Investigations (OBI), an OBO (Open Biological and Biomedical Ontologies) Foundry ontology supported by over 20 research communities. Currently, OBCS comprehends 878 terms, representing 20 BFO classes, 403 OBI classes, 229 OBCS specific classes, and 122 classes imported from ten other OBO ontologies. We discuss two examples illustrating how the ontology is being applied. In the first (biological) use case, we describe how OBCS was applied to represent the high throughput microarray data analysis of immunological transcriptional profiles in human subjects vaccinated with an influenza vaccine. In the second (clinical outcomes) use case, we applied OBCS to represent the processing of electronic health care data to determine the associations between hospital staffing levels and patient mortality. Our case studies were designed to show how OBCS can be used for the consistent representation of statistical analysis pipelines under two different research paradigms. Other ongoing projects using OBCS for statistical data processing are also discussed. The OBCS source code and documentation are available at: https://github.com/obcs/obcs . The Ontology of Biological and Clinical Statistics (OBCS) is a community-based open source ontology in the domain of biological and clinical statistics. OBCS is a timely ontology that represents statistics-related terms and their relations in a rigorous fashion, facilitates standard data analysis and integration, and supports reproducible biological and clinical research.

Twenty Years of MALL Project Implementation: A Meta-Analysis of Learning Outcomes

ERIC Educational Resources Information Center

Burston, Jack

2015-01-01

Despite the hundreds of Mobile-Assisted Language Learning (MALL) publications over the past twenty years, statistically reliable measures of learning outcomes are few and far between. In part, this is due to the fact that well over half of all MALL-related studies report no objectively quantifiable learning outcomes, either because they did not…

Common pitfalls in statistical analysis: Absolute risk reduction, relative risk reduction, and number needed to treat

PubMed Central

Ranganathan, Priya; Pramesh, C. S.; Aggarwal, Rakesh

2016-01-01

In the previous article in this series on common pitfalls in statistical analysis, we looked at the difference between risk and odds. Risk, which refers to the probability of occurrence of an event or outcome, can be defined in absolute or relative terms. Understanding what these measures represent is essential for the accurate interpretation of study results. PMID:26952180

Dysphagia management: an analysis of patient outcomes using VitalStim therapy compared to traditional swallow therapy.

PubMed

Kiger, Mary; Brown, Catherine S; Watkins, Lynn

2006-10-01

This study compares the outcomes using VitalStim therapy to outcomes using traditional swallowing therapy for deglutition disorders. Twenty-two patients had an initial and a followup videofluoroscopic swallowing study or fiberoptic endoscopic evaluation of swallowing and were divided into an experimental group that received VitalStim treatments and a control group that received traditional swallowing therapy. Outcomes were analyzed for changes in oral and pharyngeal phase dysphagia severity, dietary consistency restrictions, and progression from nonoral to oral intake. Results of chi(2) analysis showed no statistically significant difference in outcomes between the experimental and control groups.

Markov chains and semi-Markov models in time-to-event analysis.

PubMed

Abner, Erin L; Charnigo, Richard J; Kryscio, Richard J

2013-10-25

A variety of statistical methods are available to investigators for analysis of time-to-event data, often referred to as survival analysis. Kaplan-Meier estimation and Cox proportional hazards regression are commonly employed tools but are not appropriate for all studies, particularly in the presence of competing risks and when multiple or recurrent outcomes are of interest. Markov chain models can accommodate censored data, competing risks (informative censoring), multiple outcomes, recurrent outcomes, frailty, and non-constant survival probabilities. Markov chain models, though often overlooked by investigators in time-to-event analysis, have long been used in clinical studies and have widespread application in other fields.

Markov chains and semi-Markov models in time-to-event analysis

PubMed Central

Abner, Erin L.; Charnigo, Richard J.; Kryscio, Richard J.

2014-01-01

A variety of statistical methods are available to investigators for analysis of time-to-event data, often referred to as survival analysis. Kaplan-Meier estimation and Cox proportional hazards regression are commonly employed tools but are not appropriate for all studies, particularly in the presence of competing risks and when multiple or recurrent outcomes are of interest. Markov chain models can accommodate censored data, competing risks (informative censoring), multiple outcomes, recurrent outcomes, frailty, and non-constant survival probabilities. Markov chain models, though often overlooked by investigators in time-to-event analysis, have long been used in clinical studies and have widespread application in other fields. PMID:24818062

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).

PubMed

Olavarría, Verónica V; Arima, Hisatomi; Anderson, Craig S; Brunser, Alejandro; Muñoz-Venturelli, Paula; Billot, Laurent; Lavados, Pablo M

2017-02-01

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis.

PubMed

Kent, David M; Dahabreh, Issa J; Ruthazer, Robin; Furlan, Anthony J; Weimar, Christian; Serena, Joaquín; Meier, Bernhard; Mattle, Heinrich P; Di Angelantonio, Emanuele; Paciaroni, Maurizio; Schuchlenz, Herwig; Homma, Shunichi; Lutz, Jennifer S; Thaler, David E

2015-09-14

The preferred antithrombotic strategy for secondary prevention in patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) is unknown. We pooled multiple observational studies and used propensity score-based methods to estimate the comparative effectiveness of oral anticoagulation (OAC) compared with antiplatelet therapy (APT). Individual participant data from 12 databases of medically treated patients with CS and PFO were analysed with Cox regression models, to estimate database-specific hazard ratios (HRs) comparing OAC with APT, for both the primary composite outcome [recurrent stroke, transient ischaemic attack (TIA), or death] and stroke alone. Propensity scores were applied via inverse probability of treatment weighting to control for confounding. We synthesized database-specific HRs using random-effects meta-analysis models. This analysis included 2385 (OAC = 804 and APT = 1581) patients with 227 composite endpoints (stroke/TIA/death). The difference between OAC and APT was not statistically significant for the primary composite outcome [adjusted HR = 0.76, 95% confidence interval (CI) 0.52-1.12] or for the secondary outcome of stroke alone (adjusted HR = 0.75, 95% CI 0.44-1.27). Results were consistent in analyses applying alternative weighting schemes, with the exception that OAC had a statistically significant beneficial effect on the composite outcome in analyses standardized to the patient population who actually received APT (adjusted HR = 0.64, 95% CI 0.42-0.99). Subgroup analyses did not detect statistically significant heterogeneity of treatment effects across clinically important patient groups. We did not find a statistically significant difference comparing OAC with APT; our results justify randomized trials comparing different antithrombotic approaches in these patients. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Statistical analysis of arthroplasty data

PubMed Central

2011-01-01

It is envisaged that guidelines for statistical analysis and presentation of results will improve the quality and value of research. The Nordic Arthroplasty Register Association (NARA) has therefore developed guidelines for the statistical analysis of arthroplasty register data. The guidelines are divided into two parts, one with an introduction and a discussion of the background to the guidelines (Ranstam et al. 2011a, see pages x-y in this issue), and this one with a more technical statistical discussion on how specific problems can be handled. This second part contains (1) recommendations for the interpretation of methods used to calculate survival, (2) recommendations on howto deal with bilateral observations, and (3) a discussion of problems and pitfalls associated with analysis of factors that influence survival or comparisons between outcomes extracted from different hospitals. PMID:21619500

Effects of music therapy for children and adolescents with psychopathology: a meta-analysis.

PubMed

Gold, Christian; Voracek, Martin; Wigram, Tony

2004-09-01

The objectives of this review were to examine the overall efficacy of music therapy for children and adolescents with psychopathology, and to examine how the size of the effect of music therapy is influenced by the type of pathology, client's age, music therapy approach, and type of outcome. Eleven studies were included for analysis, which resulted in a total of 188 subjects for the meta-analysis. Effect sizes from these studies were combined, with weighting for sample size, and their distribution was examined. After exclusion of an extreme positive outlying value, the analysis revealed that music therapy has a medium to large positive effect (ES =.61) on clinically relevant outcomes that was statistically highly significant (p <.001) and statistically homogeneous. No evidence of a publication bias was identified. Effects tended to be greater for behavioural and developmental disorders than for emotional disorders; greater for eclectic, psychodynamic, and humanistic approaches than for behavioural models; and greater for behavioural and developmental outcomes than for social skills and self-concept. Implications for clinical practice and research are discussed.

A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan.

PubMed

Traeger, Adrian C; Skinner, Ian W; Hübscher, Markus; Lee, Hopin; Moseley, G Lorimer; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; Lo, Serigne; McAuley, James H

Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain. We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures. Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808). Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Mediation analysis in nursing research: a methodological review

PubMed Central

Liu, Jianghong; Ulrich, Connie

2017-01-01

Mediation statistical models help clarify the relationship between independent predictor variables and dependent outcomes of interest by assessing the impact of third variables. This type of statistical analysis is applicable for many clinical nursing research questions, yet its use within nursing remains low. Indeed, mediational analyses may help nurse researchers develop more effective and accurate prevention and treatment programs as well as help bridge the gap between scientific knowledge and clinical practice. In addition, this statistical approach allows nurse researchers to ask – and answer – more meaningful and nuanced questions that extend beyond merely determining whether an outcome occurs. Therefore, the goal of this paper is to provide a brief tutorial on the use of mediational analyses in clinical nursing research by briefly introducing the technique and, through selected empirical examples from the nursing literature, demonstrating its applicability in advancing nursing science. PMID:26176804

Outcome of temporal lobe epilepsy surgery predicted by statistical parametric PET imaging.

PubMed

Wong, C Y; Geller, E B; Chen, E Q; MacIntyre, W J; Morris, H H; Raja, S; Saha, G B; Lüders, H O; Cook, S A; Go, R T

1996-07-01

PET is useful in the presurgical evaluation of temporal lobe epilepsy. The purpose of this retrospective study is to assess the clinical use of statistical parametric imaging in predicting surgical outcome. Interictal 18FDG-PET scans in 17 patients with surgically-treated temporal lobe epilepsy (Group A-13 seizure-free, group B = 4 not seizure-free at 6 mo) were transformed into statistical parametric imaging, with each pixel representing a z-score value by using the mean and s.d. of count distribution in each individual patient, for both visual and quantitative analysis. Mean z-scores were significantly more negative in anterolateral (AL) and mesial (M) regions on the operated side than the nonoperated side in group A (AL: p < 0.00005, M: p = 0.0097), but not in group B (AL: p = 0.46, M: p = 0.08). Statistical parametric imaging correctly lateralized 16 out of 17 patients. Only the AL region, however, was significant in predicting surgical outcome (F = 29.03, p < 0.00005). Using a cut-off z-score value of -1.5, statistical parametric imaging correctly classified 92% of temporal lobes from group A and 88% of those from Group B. The preliminary results indicate that statistical parametric imaging provides both clinically useful information for lateralization in temporal lobe epilepsy and a reliable predictive indicator of clinical outcome following surgical treatment.

Reporting quality of statistical methods in surgical observational studies: protocol for systematic review.

PubMed

Wu, Robert; Glen, Peter; Ramsay, Tim; Martel, Guillaume

2014-06-28

Observational studies dominate the surgical literature. Statistical adjustment is an important strategy to account for confounders in observational studies. Research has shown that published articles are often poor in statistical quality, which may jeopardize their conclusions. The Statistical Analyses and Methods in the Published Literature (SAMPL) guidelines have been published to help establish standards for statistical reporting.This study will seek to determine whether the quality of statistical adjustment and the reporting of these methods are adequate in surgical observational studies. We hypothesize that incomplete reporting will be found in all surgical observational studies, and that the quality and reporting of these methods will be of lower quality in surgical journals when compared with medical journals. Finally, this work will seek to identify predictors of high-quality reporting. This work will examine the top five general surgical and medical journals, based on a 5-year impact factor (2007-2012). All observational studies investigating an intervention related to an essential component area of general surgery (defined by the American Board of Surgery), with an exposure, outcome, and comparator, will be included in this systematic review. Essential elements related to statistical reporting and quality were extracted from the SAMPL guidelines and include domains such as intent of analysis, primary analysis, multiple comparisons, numbers and descriptive statistics, association and correlation analyses, linear regression, logistic regression, Cox proportional hazard analysis, analysis of variance, survival analysis, propensity analysis, and independent and correlated analyses. Each article will be scored as a proportion based on fulfilling criteria in relevant analyses used in the study. A logistic regression model will be built to identify variables associated with high-quality reporting. A comparison will be made between the scores of surgical observational studies published in medical versus surgical journals. Secondary outcomes will pertain to individual domains of analysis. Sensitivity analyses will be conducted. This study will explore the reporting and quality of statistical analyses in surgical observational studies published in the most referenced surgical and medical journals in 2013 and examine whether variables (including the type of journal) can predict high-quality reporting.

Dealing with missing standard deviation and mean values in meta-analysis of continuous outcomes: a systematic review.

PubMed

Weir, Christopher J; Butcher, Isabella; Assi, Valentina; Lewis, Stephanie C; Murray, Gordon D; Langhorne, Peter; Brady, Marian C

2018-03-07

Rigorous, informative meta-analyses rely on availability of appropriate summary statistics or individual participant data. For continuous outcomes, especially those with naturally skewed distributions, summary information on the mean or variability often goes unreported. While full reporting of original trial data is the ideal, we sought to identify methods for handling unreported mean or variability summary statistics in meta-analysis. We undertook two systematic literature reviews to identify methodological approaches used to deal with missing mean or variability summary statistics. Five electronic databases were searched, in addition to the Cochrane Colloquium abstract books and the Cochrane Statistics Methods Group mailing list archive. We also conducted cited reference searching and emailed topic experts to identify recent methodological developments. Details recorded included the description of the method, the information required to implement the method, any underlying assumptions and whether the method could be readily applied in standard statistical software. We provided a summary description of the methods identified, illustrating selected methods in example meta-analysis scenarios. For missing standard deviations (SDs), following screening of 503 articles, fifteen methods were identified in addition to those reported in a previous review. These included Bayesian hierarchical modelling at the meta-analysis level; summary statistic level imputation based on observed SD values from other trials in the meta-analysis; a practical approximation based on the range; and algebraic estimation of the SD based on other summary statistics. Following screening of 1124 articles for methods estimating the mean, one approximate Bayesian computation approach and three papers based on alternative summary statistics were identified. Illustrative meta-analyses showed that when replacing a missing SD the approximation using the range minimised loss of precision and generally performed better than omitting trials. When estimating missing means, a formula using the median, lower quartile and upper quartile performed best in preserving the precision of the meta-analysis findings, although in some scenarios, omitting trials gave superior results. Methods based on summary statistics (minimum, maximum, lower quartile, upper quartile, median) reported in the literature facilitate more comprehensive inclusion of randomised controlled trials with missing mean or variability summary statistics within meta-analyses.

Common pitfalls in statistical analysis: Odds versus risk

PubMed Central

Ranganathan, Priya; Aggarwal, Rakesh; Pramesh, C. S.

2015-01-01

In biomedical research, we are often interested in quantifying the relationship between an exposure and an outcome. “Odds” and “Risk” are the most common terms which are used as measures of association between variables. In this article, which is the fourth in the series of common pitfalls in statistical analysis, we explain the meaning of risk and odds and the difference between the two. PMID:26623395

Variations and inter-relationship in outcome from emergency admissions in England: a retrospective analysis of Hospital Episode Statistics from 2005-2010.

PubMed

Holt, Peter James Edward; Sinha, Sidhartha; Ozdemir, Baris Ata; Karthikesalingam, Alan; Poloniecki, Jan Dominik; Thompson, Matt Merfyn

2014-06-19

The quality of care delivered and clinical outcomes of care are of paramount importance. Wide variations in the outcome of emergency care have been suggested, but the scale of variation, and the way in which outcomes are inter-related are poorly defined and are critical to understand how best to improve services. This study quantifies the scale of variation in three outcomes for a contemporary cohort of patients undergoing emergency medical and surgical admissions. The way in which the outcomes of different diagnoses relate to each other is investigated. A retrospective study using the English Hospital Episode Statistics 2005-2010 with one-year follow-up for all patients with one of 20 of the commonest and highest-risk emergency medical or surgical conditions. The primary outcome was in-hospital all-cause risk-standardised mortality rate (in-RSMR). Secondary outcomes were 1-year all-cause risk-standardised mortality rate (1 yr-RSMR) and 28-day all-cause emergency readmission rate (RSRR). 2,406,709 adult patients underwent emergency medical or surgical admissions in the groups of interest. Clinically and statistically significant variations in outcome were observed between providers for all three outcomes (p < 0.001). For some diagnoses including heart failure, acute myocardial infarction, stroke and fractured neck of femur, more than 20% of hospitals lay above the upper 95% control limit and were statistical outliers. The risk-standardised outcomes within a given hospital for an individual diagnostic group were significantly associated with the aggregated outcome of the other clinical groups. Hospital-level risk-standardised outcomes for emergency admissions across a range of specialties vary considerably and cross traditional speciality boundaries. This suggests that global institutional infra-structure and processes of care influence outcomes. The implications are far reaching, both in terms of investigating performance at individual hospitals and in understanding how hospitals can learn from the best performers to improve outcomes.

Statistical Methods for the Analysis of Discrete Choice Experiments: A Report of the ISPOR Conjoint Analysis Good Research Practices Task Force.

PubMed

Hauber, A Brett; González, Juan Marcos; Groothuis-Oudshoorn, Catharina G M; Prior, Thomas; Marshall, Deborah A; Cunningham, Charles; IJzerman, Maarten J; Bridges, John F P

2016-06-01

Conjoint analysis is a stated-preference survey method that can be used to elicit responses that reveal preferences, priorities, and the relative importance of individual features associated with health care interventions or services. Conjoint analysis methods, particularly discrete choice experiments (DCEs), have been increasingly used to quantify preferences of patients, caregivers, physicians, and other stakeholders. Recent consensus-based guidance on good research practices, including two recent task force reports from the International Society for Pharmacoeconomics and Outcomes Research, has aided in improving the quality of conjoint analyses and DCEs in outcomes research. Nevertheless, uncertainty regarding good research practices for the statistical analysis of data from DCEs persists. There are multiple methods for analyzing DCE data. Understanding the characteristics and appropriate use of different analysis methods is critical to conducting a well-designed DCE study. This report will assist researchers in evaluating and selecting among alternative approaches to conducting statistical analysis of DCE data. We first present a simplistic DCE example and a simple method for using the resulting data. We then present a pedagogical example of a DCE and one of the most common approaches to analyzing data from such a question format-conditional logit. We then describe some common alternative methods for analyzing these data and the strengths and weaknesses of each alternative. We present the ESTIMATE checklist, which includes a list of questions to consider when justifying the choice of analysis method, describing the analysis, and interpreting the results. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan.

PubMed

Westendorp, Willeke F; Vermeij, Jan-Dirk; Dippel, Diederik W J; Dijkgraaf, Marcel G W; van der Poll, Tom; Prins, Jan M; Vermeij, Frederique H; Roos, Yvo B W E M; Brouwer, Matthijs C; Zwinderman, Aeilko H; van de Beek, Diederik; Nederkoorn, Paul J

2014-10-01

Infections occur in 30% of stroke patients and are associated with unfavorable outcomes. Preventive antibiotic therapy lowers the infection rate after stroke, but the effect of preventive antibiotic treatment on functional outcome in patients with stroke is unknown. The PASS is a multicenter, prospective, phase three, randomized, open-label, blinded end-point (PROBE) trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to standard stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. The aim of this study is to assess whether preventive antibiotic treatment improves functional outcome at 3 months by preventing infections. This paper presents in detail the statistical analysis plan (SAP) of the Preventive Antibiotics in Stroke Study (PASS) and was submitted while the investigators were still blinded for all outcomes. The primary outcome is the score on the modified Rankin Scale (mRS), assessed by ordinal logistic regression analysis according to a proportional odds model. Secondary analysis of the primary outcome is the score on the mRS dichotomized as a favorable outcome (mRS 0 to 2) versus unfavorable outcome (mRS 3 to 6). Secondary outcome measures are death rate at discharge and 3 months, infection rate during hospital admission, length of hospital admission, volume of post-stroke care, use of antibiotics during hospital stay, quality-adjusted life years and costs. Complications of treatment, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) are reported as safety outcomes. The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection and will be analyzed according to this pre-specified SAP. Current controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.

Effects of lifestyle change interventions for people with intellectual disabilities: Systematic review and meta-analysis of randomized controlled trials.

PubMed

Willems, Mariël; Waninge, Aly; Hilgenkamp, Thessa I M; van Empelen, Pepijn; Krijnen, Wim P; van der Schans, Cees P; Melville, Craig A

2018-05-08

Promotion of a healthy lifestyle for people with intellectual disabilities is important; however, the effectiveness of lifestyle change interventions is unclear. This research will examine the effectiveness of lifestyle change interventions for people with intellectual disabilities. Randomized controlled trials (RCTs) of lifestyle change interventions for people with intellectual disabilities were included in a systematic review and meta-analysis. Data on study and intervention characteristics were extracted, as well as data on outcome measures and results. Internal validity of the selected papers was assessed using the Cochrane Collaboration's risk bias tool. Eight RCTs were included. Multiple outcome measures were used, whereby outcome measures targeting environmental factors and participation were lacking and personal outcome measures were mostly used by a single study. Risks of bias were found for all studies. Meta-analysis showed some effectiveness for lifestyle change interventions, and a statistically significant decrease was found for waist circumference. Some effectiveness was found for lifestyle change interventions for people with intellectual disabilities. However, the effects were only statistically significant for waist circumference, so current lifestyle change interventions may not be optimally tailored to meet the needs of people with intellectual disabilities. © 2018 John Wiley & Sons Ltd.

Schools and Labor Market Outcomes. EQW Working Papers WP33.

ERIC Educational Resources Information Center

Crawford, David L.; And Others

The relationship between school characteristics and labor market outcomes was examined through a literature review and an econometric analysis of the effects of various characteristics of the schooling experience on students' labor market performance after high school. Data from the National Center on Education Statistics' longitudinal survey of…

Educational Achievement and Black-White Inequality. Statistical Analysis Report.

ERIC Educational Resources Information Center

Jacobson, Jonathan; Olsen, Cara; Rice, Jennifer King; Sweetland, Stephen

This study explored relationships between black-white differences in educational achievement and black-white differences in various educational and economic outcomes. Three data sets examined the extent to which black-white differences in labor market outcomes, in educational attainment, and in mathematics and reading achievement were present for…

A Bayesian Missing Data Framework for Generalized Multiple Outcome Mixed Treatment Comparisons

ERIC Educational Resources Information Center

Hong, Hwanhee; Chu, Haitao; Zhang, Jing; Carlin, Bradley P.

2016-01-01

Bayesian statistical approaches to mixed treatment comparisons (MTCs) are becoming more popular because of their flexibility and interpretability. Many randomized clinical trials report multiple outcomes with possible inherent correlations. Moreover, MTC data are typically sparse (although richer than standard meta-analysis, comparing only two…

Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs.

PubMed

Thorlund, Kristian; Druyts, Eric; Toor, Kabirraaj; Mills, Edward J

2015-05-01

To conduct a network meta-analysis (NMA) to establish the comparative efficacy of infliximab, adalimumab and golimumab for the treatment of moderately to severely active ulcerative colitis (UC). A systematic literature search identified five randomized controlled trials for inclusion in the NMA. One trial assessed golimumab, two assessed infliximab and two assessed adalimumab. Outcomes included clinical response, clinical remission, mucosal healing, sustained clinical response and sustained clinical remission. Innovative methods were used to allow inclusion of the golimumab trial data given the alternative design of this trial (i.e., two-stage re-randomization). After induction, no statistically significant differences were found between golimumab and adalimumab or between golimumab and infliximab. Infliximab was statistically superior to adalimumab after induction for all outcomes and treatment ranking suggested infliximab as the superior treatment for induction. Golimumab and infliximab were associated with similar efficacy for achieving maintained clinical remission and sustained clinical remission, whereas adalimumab was not significantly better than placebo for sustained clinical remission. Golimumab and infliximab were also associated with similar efficacy for achieving maintained clinical response, sustained clinical response and mucosal healing. Finally, golimumab 50 and 100 mg was statistically superior to adalimumab for clinical response and sustained clinical response, and golimumab 100 mg was also statistically superior to adalimumab for mucosal healing. The results of our NMA suggest that infliximab was statistically superior to adalimumab after induction, and that golimumab was statistically superior to adalimumab for sustained outcomes. Golimumab and infliximab appeared comparable in efficacy.

Water Polo Game-Related Statistics in Women’s International Championships: Differences and Discriminatory Power

PubMed Central

Escalante, Yolanda; Saavedra, Jose M.; Tella, Victor; Mansilla, Mirella; García-Hermoso, Antonio; Dominguez, Ana M.

2012-01-01

The aims of this study were (i) to compare women’s water polo game-related statistics by match outcome (winning and losing teams) and phase (preliminary, classificatory, and semi-final/bronze medal/gold medal), and (ii) identify characteristics that discriminate performances for each phase. The game-related statistics of the 124 women’s matches played in five International Championships (World and European Championships) were analyzed. Differences between winning and losing teams in each phase were determined using the chi-squared. A discriminant analysis was then performed according to context in each of the three phases. It was found that the game-related statistics differentiate the winning from the losing teams in each phase of an international championship. The differentiating variables were both offensive (centre goals, power-play goals, counterattack goal, assists, offensive fouls, steals, blocked shots, and won sprints) and defensive (goalkeeper-blocked shots, goalkeeper-blocked inferiority shots, and goalkeeper-blocked 5-m shots). The discriminant analysis showed the game-related statistics to discriminate performance in all phases: preliminary, classificatory, and final phases (92%, 90%, and 83%, respectively). Two variables were discriminatory by match outcome (winning or losing teams) in all three phases: goals and goalkeeper-blocked shots. Key pointsThe preliminary phase that more than one variable was involved in this differentiation, including both offensive and defensive aspects of the game.The game-related statistics were found to have a high discriminatory power in predicting the result of matches with shots and goalkeeper-blocked shots being discriminatory variables in all three phases.Knowledge of the characteristics of women’s water polo game-related statistics of the winning teams and their power to predict match outcomes will allow coaches to take these characteristics into account when planning training and match preparation. PMID:24149356

A Systematic Review of Clinical Functional Outcomes After Medial Stabilized Versus Non-Medial Stabilized Total Knee Joint Replacement

PubMed Central

Young, Tony; Dowsey, Michelle M.; Pandy, Marcus; Choong, Peter F.

2018-01-01

Background Medial stabilized total knee joint replacement (TKJR) construct is designed to closely replicate the kinematics of the knee. Little is known regarding comparison of clinical functional outcomes of patients utilising validated patient reported outcome measures (PROM) after medial stabilized TKJR and other construct designs. Purpose To perform a systematic review of the available literature related to the assessment of clinical functional outcomes following a TKJR employing a medial stabilized construct design. Methods The review was performed with a Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) algorithm. The literature search was performed using variouscombinations of keywords. The statistical analysis was completed using Review Manager (RevMan), Version 5.3. Results In the nineteen unique studies identified, there were 2,448 medial stabilized TKJRs implanted in 2,195 participants, there were 1,777 TKJRs with non-medial stabilized design constructs implanted in 1,734 subjects. The final mean Knee Society Score (KSS) value in the medial stabilized group was 89.92 compared to 90.76 in the non-medial stabilized group, with the final KSS mean value difference between the two groups was statistically significant and favored the non-medial stabilized group (SMD 0.21; 95% CI: 0.01 to 0.41; p = 004). The mean difference in the final WOMAC values between the two groups was also statistically significant and favored the medial stabilized group (SMD: −0.27; 95% CI: −0.47 to −0.07; p = 0.009). Moderate to high values (I2) of heterogeneity were observed during the statistical comparison of these functional outcomes. Conclusion Based on the small number of studies with appropriate statistical analysis, we are unable to reach a clear conclusion in the clinical performance of medial stabilized knee replacement construct. Level of Evidence Level II PMID:29696144

A Systematic Review of Clinical Functional Outcomes After Medial Stabilized Versus Non-Medial Stabilized Total Knee Joint Replacement.

PubMed

Young, Tony; Dowsey, Michelle M; Pandy, Marcus; Choong, Peter F

2018-01-01

Medial stabilized total knee joint replacement (TKJR) construct is designed to closely replicate the kinematics of the knee. Little is known regarding comparison of clinical functional outcomes of patients utilising validated patient reported outcome measures (PROM) after medial stabilized TKJR and other construct designs. To perform a systematic review of the available literature related to the assessment of clinical functional outcomes following a TKJR employing a medial stabilized construct design. The review was performed with a Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) algorithm. The literature search was performed using variouscombinations of keywords. The statistical analysis was completed using Review Manager (RevMan), Version 5.3. In the nineteen unique studies identified, there were 2,448 medial stabilized TKJRs implanted in 2,195 participants, there were 1,777 TKJRs with non-medial stabilized design constructs implanted in 1,734 subjects. The final mean Knee Society Score (KSS) value in the medial stabilized group was 89.92 compared to 90.76 in the non-medial stabilized group, with the final KSS mean value difference between the two groups was statistically significant and favored the non-medial stabilized group (SMD 0.21; 95% CI: 0.01 to 0.41; p = 004). The mean difference in the final WOMAC values between the two groups was also statistically significant and favored the medial stabilized group (SMD: -0.27; 95% CI: -0.47 to -0.07; p = 0.009). Moderate to high values ( I 2 ) of heterogeneity were observed during the statistical comparison of these functional outcomes. Based on the small number of studies with appropriate statistical analysis, we are unable to reach a clear conclusion in the clinical performance of medial stabilized knee replacement construct. Level II.

Optical zone centration: a retrospective analysis of the excimer laser after three years

NASA Astrophysics Data System (ADS)

Vervecken, Filip; Trau, Rene; Mertens, Erik L.; Vanhorenbeeck, R.; Van Aerde, F.; Zen, J.; Haustrate, F.; Tassignon, Marie J.

1996-12-01

The aim of this study was to evaluate the implication of the mechanical factor 'decentration' on the visual outcome after PRK. 100 eyes of 70 patients were included. The mean decentration was 0.27 mm +/- 0.18. Decentration was less than 0.5 mm in 84 percent of the cases. The importance of the decentration was investigated by the statistical correlation of decentration from the pupilcenter and the visual outcome. We did not find any statistical significant association for decentrations less than 1 mm. Our conclusion is that decentration, if less than 1 mm, does not play an important role in the final visual outcome after PRK.

Cluster analysis as a prediction tool for pregnancy outcomes.

PubMed

Banjari, Ines; Kenjerić, Daniela; Šolić, Krešimir; Mandić, Milena L

2015-03-01

Considering specific physiology changes during gestation and thinking of pregnancy as a "critical window", classification of pregnant women at early pregnancy can be considered as crucial. The paper demonstrates the use of a method based on an approach from intelligent data mining, cluster analysis. Cluster analysis method is a statistical method which makes possible to group individuals based on sets of identifying variables. The method was chosen in order to determine possibility for classification of pregnant women at early pregnancy to analyze unknown correlations between different variables so that the certain outcomes could be predicted. 222 pregnant women from two general obstetric offices' were recruited. The main orient was set on characteristics of these pregnant women: their age, pre-pregnancy body mass index (BMI) and haemoglobin value. Cluster analysis gained a 94.1% classification accuracy rate with three branch- es or groups of pregnant women showing statistically significant correlations with pregnancy outcomes. The results are showing that pregnant women both of older age and higher pre-pregnancy BMI have a significantly higher incidence of delivering baby of higher birth weight but they gain significantly less weight during pregnancy. Their babies are also longer, and these women have significantly higher probability for complications during pregnancy (gestosis) and higher probability of induced or caesarean delivery. We can conclude that the cluster analysis method can appropriately classify pregnant women at early pregnancy to predict certain outcomes.

Dealing with the Conflicting Results of Psycholinguistic Experiments: How to Resolve Them with the Help of Statistical Meta-analysis.

PubMed

Rákosi, Csilla

2018-01-22

This paper proposes the use of the tools of statistical meta-analysis as a method of conflict resolution with respect to experiments in cognitive linguistics. With the help of statistical meta-analysis, the effect size of similar experiments can be compared, a well-founded and robust synthesis of the experimental data can be achieved, and possible causes of any divergence(s) in the outcomes can be revealed. This application of statistical meta-analysis offers a novel method of how diverging evidence can be dealt with. The workability of this idea is exemplified by a case study dealing with a series of experiments conducted as non-exact replications of Thibodeau and Boroditsky (PLoS ONE 6(2):e16782, 2011. https://doi.org/10.1371/journal.pone.0016782 ).

Longitudinal Assessment of Self-Reported Recent Back Pain and Combat Deployment in the Millennium Cohort Study

DTIC Science & Technology

2016-11-15

participants who were followed for the development of back pain for an average of 3.9 years. Methods. Descriptive statistics and longitudinal...health, military personnel, occupational health, outcome assessment, statistics, survey methodology . Level of Evidence: 3 Spine 2016;41:1754–1763ack...based on the National Health and Nutrition Examination Survey.21 Statistical Analysis Descriptive and univariate analyses compared character- istics

The effectiveness and safety of antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis.

PubMed

Ker, Katharine; Prieto-Merino, David; Sprigg, Nikola; Mahmood, Abda; Bath, Philip; Kang Law, Zhe; Flaherty, Katie; Roberts, Ian

2017-01-01

Introduction : The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of antifibrinolytics for acute intracranial haemorrhage. Methods : The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) death in hospital at end of trial follow-up, and 2) death in hospital or dependency at end of trial follow-up. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions : This IPD meta-analysis will examine important clinical questions about the effects of antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice.

Major bleeding after percutaneous coronary intervention and risk of subsequent mortality: a systematic review and meta-analysis

PubMed Central

Kwok, Chun Shing; Rao, Sunil V; Myint, Phyo K; Keavney, Bernard; Nolan, James; Ludman, Peter F; de Belder, Mark A; Loke, Yoon K; Mamas, Mamas A

2014-01-01

Objectives To examine the relationship between periprocedural bleeding complications and major adverse cardiovascular events (MACEs) and mortality outcomes following percutaneous coronary intervention (PCI) and study differences in the prognostic impact of different bleeding definitions. Methods We conducted a systematic review and meta-analysis of PCI studies that evaluated periprocedural bleeding complications and their impact on MACEs and mortality outcomes. A systematic search of MEDLINE and EMBASE was conducted to identify relevant studies. Data from relevant studies were extracted and random effects meta-analysis was used to estimate the risk of adverse outcomes with periprocedural bleeding. Statistical heterogeneity was assessed by considering the I2 statistic. Results 42 relevant studies were identified including 533 333 patients. Meta-analysis demonstrated that periprocedural major bleeding complications was independently associated with increased risk of mortality (OR 3.31 (2.86 to 3.82), I2=80%) and MACEs (OR 3.89 (3.26 to 4.64), I2=42%). A differential impact of major bleeding as defined by different bleeding definitions on mortality outcomes was observed, in which the REPLACE-2 (OR 6.69, 95% CI 2.26 to 19.81), STEEPLE (OR 6.59, 95% CI 3.89 to 11.16) and BARC (OR 5.40, 95% CI 1.74 to 16.74) had the worst prognostic impacts while HORIZONS-AMI (OR 1.51, 95% CI 1.11 to 2.05) had the least impact on mortality outcomes. Conclusions Major bleeding after PCI is independently associated with a threefold increase in mortality and MACEs outcomes. Different contemporary bleeding definitions have differential impacts on mortality outcomes, with 1.5–6.7-fold increases in mortality observed depending on the definition of major bleeding used. PMID:25332786

Inactive Hepatitis B Carrier and Pregnancy Outcomes: A Systematic Review and Meta-analysis.

PubMed

Keramat, Afsaneh; Younesian, Masud; Gholami Fesharaki, Mohammad; Hasani, Maryam; Mirzaei, Samaneh; Ebrahimi, Elham; Alavian, Seyed Moaed; Mohammadi, Fatemeh

2017-04-01

We aimed to explore whether maternal asymptomatic hepatitis B (HB) infection effects on pre-term rupture of membranous (PROM), stillbirth, preeclampsia, eclampsia, gestational hypertension, or antepartum hemorrhage. We searched the PubMed, Scopus, and ISI web of science from 1990 to Feb 2015. In addition, electronic literature searches supplemented by searching the gray literature (e.g., conference abstracts thesis and the result of technical reports) and scanning the reference lists of included studies and relevant systematic reviews. We explored statistical heterogeneity using the, I2 and tau-squared (Tau2) statistical tests. Eighteen studies were included. Preterm rupture of membranous (PROM), stillbirth, preeclampsia, eclampsia, gestational hypertension and antepartum hemorrhage were considerable outcomes in this survey. The results showed no significant association between inactive HB and these complications in pregnancy. The small amounts of P -value and chi-square and large amount of I2 suggested the probable heterogeneity in this part, which we tried to modify with statistical methods such as subgroup analysis. Inactive HB infection did not increase the risk of adversely mentioned outcomes in this study. Further, well-designed studies should be performed to confirm the results.

A review of empirical research related to the use of small quantitative samples in clinical outcome scale development.

PubMed

Houts, Carrie R; Edwards, Michael C; Wirth, R J; Deal, Linda S

2016-11-01

There has been a notable increase in the advocacy of using small-sample designs as an initial quantitative assessment of item and scale performance during the scale development process. This is particularly true in the development of clinical outcome assessments (COAs), where Rasch analysis has been advanced as an appropriate statistical tool for evaluating the developing COAs using a small sample. We review the benefits such methods are purported to offer from both a practical and statistical standpoint and detail several problematic areas, including both practical and statistical theory concerns, with respect to the use of quantitative methods, including Rasch-consistent methods, with small samples. The feasibility of obtaining accurate information and the potential negative impacts of misusing large-sample statistical methods with small samples during COA development are discussed.

Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair

PubMed Central

Perser, Karen; Godfrey, David; Bisson, Leslie

2011-01-01

Context: Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. Objective: To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Data Sources: Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. Study Selection: The literature was systematically searched, and 5 level I and II studies were found comparing clinical outcomes of single-row and double-row rotator cuff repair. Coleman methodology scores were calculated for each article. Data Extraction: Meta-analysis was performed, with treatment effect between single row and double row for clinical outcomes and with odds ratios for radiographic results. The sample size necessary to detect a given difference in clinical outcome between the 2 methods was calculated. Results: Three level I studies had Coleman scores of 80, 74, and 81, and two level II studies had scores of 78 and 73. There were 156 patients with single-row repairs and 147 patients with double-row repairs, both with an average follow-up of 23 months (range, 12-40 months). Double-row repairs resulted in a greater treatment effect for each validated outcome measure in 4 studies, but the differences were not clinically or statistically significant (range, 0.4-2.2 points; 95% confidence interval, –0.19, 4.68 points). Double-row repairs had better radiographic results, but the differences were also not statistically significant (P = 0.13). Two studies had adequate power to detect a 10-point difference between repair methods using the Constant score, and 1 study had power to detect a 5-point difference using the UCLA (University of California, Los Angeles) score. Conclusions: Double-row rotator cuff repair does not show a statistically significant improvement in clinical outcome or radiographic healing with short-term follow-up. PMID:23016017

Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair.

PubMed

Perser, Karen; Godfrey, David; Bisson, Leslie

2011-05-01

Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. The literature was systematically searched, and 5 level I and II studies were found comparing clinical outcomes of single-row and double-row rotator cuff repair. Coleman methodology scores were calculated for each article. Meta-analysis was performed, with treatment effect between single row and double row for clinical outcomes and with odds ratios for radiographic results. The sample size necessary to detect a given difference in clinical outcome between the 2 methods was calculated. Three level I studies had Coleman scores of 80, 74, and 81, and two level II studies had scores of 78 and 73. There were 156 patients with single-row repairs and 147 patients with double-row repairs, both with an average follow-up of 23 months (range, 12-40 months). Double-row repairs resulted in a greater treatment effect for each validated outcome measure in 4 studies, but the differences were not clinically or statistically significant (range, 0.4-2.2 points; 95% confidence interval, -0.19, 4.68 points). Double-row repairs had better radiographic results, but the differences were also not statistically significant (P = 0.13). Two studies had adequate power to detect a 10-point difference between repair methods using the Constant score, and 1 study had power to detect a 5-point difference using the UCLA (University of California, Los Angeles) score. Double-row rotator cuff repair does not show a statistically significant improvement in clinical outcome or radiographic healing with short-term follow-up.

The Effectiveness of Computer-Assisted Instruction to Teach Physical Examination to Students and Trainees in the Health Sciences Professions: A Systematic Review and Meta-Analysis.

PubMed

Tomesko, Jennifer; Touger-Decker, Riva; Dreker, Margaret; Zelig, Rena; Parrott, James Scott

2017-01-01

To explore knowledge and skill acquisition outcomes related to learning physical examination (PE) through computer-assisted instruction (CAI) compared with a face-to-face (F2F) approach. A systematic literature review and meta-analysis published between January 2001 and December 2016 was conducted. Databases searched included Medline, Cochrane, CINAHL, ERIC, Ebsco, Scopus, and Web of Science. Studies were synthesized by study design, intervention, and outcomes. Statistical analyses included DerSimonian-Laird random-effects model. In total, 7 studies were included in the review, and 5 in the meta-analysis. There were no statistically significant differences for knowledge (mean difference [MD] = 5.39, 95% confidence interval [CI]: -2.05 to 12.84) or skill acquisition (MD = 0.35, 95% CI: -5.30 to 6.01). The evidence does not suggest a strong consistent preference for either CAI or F2F instruction to teach students/trainees PE. Further research is needed to identify conditions which examine knowledge and skill acquisition outcomes that favor one mode of instruction over the other.

Diagnosis of students' ability in a statistical course based on Rasch probabilistic outcome

NASA Astrophysics Data System (ADS)

Mahmud, Zamalia; Ramli, Wan Syahira Wan; Sapri, Shamsiah; Ahmad, Sanizah

2017-06-01

Measuring students' ability and performance are important in assessing how well students have learned and mastered the statistical courses. Any improvement in learning will depend on the student's approaches to learning, which are relevant to some factors of learning, namely assessment methods carrying out tasks consisting of quizzes, tests, assignment and final examination. This study has attempted an alternative approach to measure students' ability in an undergraduate statistical course based on the Rasch probabilistic model. Firstly, this study aims to explore the learning outcome patterns of students in a statistics course (Applied Probability and Statistics) based on an Entrance-Exit survey. This is followed by investigating students' perceived learning ability based on four Course Learning Outcomes (CLOs) and students' actual learning ability based on their final examination scores. Rasch analysis revealed that students perceived themselves as lacking the ability to understand about 95% of the statistics concepts at the beginning of the class but eventually they had a good understanding at the end of the 14 weeks class. In terms of students' performance in their final examination, their ability in understanding the topics varies at different probability values given the ability of the students and difficulty of the questions. Majority found the probability and counting rules topic to be the most difficult to learn.

Cigarette smoking impairs clinical outcomes of assisted reproduction technologies: a meta-analysis of the literature.

PubMed

Budani, Maria Cristina; Fensore, Stefania; Di Marzio, Marco; Tiboni, Gian Mario

2018-06-12

There is convincing evidence that cigarette smoking can impair female reproductive potential. This meta-analysis updates the knowledge regarding the effects of cigarette smoking on clinical outcomes of assisted reproductive technologies (ART). Twenty-six studies were included in this meta-analysis. Results were expressed as odds ratios (OR) with 95% confidence intervals (CI) and statistical heterogeneity between the studies was evaluated with Higgins (I 2 ), Breslow (τ 2 ), Birge's ratio (H 2 ) indices and Chi-square test (χ 2 ). A P-value < 0.05 was considered statistically significant. The analysis showed a significant decrease in live birth rate per cycle for smoking patients (OR 0.59, 95% CI 0.44-0.79; P = 0.0005), a significant lower clinical pregnancy rate per cycle for smoking women (OR 0.53, 95% CI 0.41-0.68; P < 0.0001), and a significant increase in terms of spontaneous miscarriage rate (OR 2.22, 95% CI 1.10-4.48; P = 0.025) for smokers. These findings demonstrate clear negative effects of cigarette smoking on the outcome of ART programs. Copyright © 2018 Elsevier Inc. All rights reserved.

Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial.

PubMed

Vickerstaff, Victoria; Ambler, Gareth; Bunce, Catey; Xing, Wen; Gazzard, Gus

2015-11-11

The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study. The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses. The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 .

Advances in Statistical Methods for Substance Abuse Prevention Research

PubMed Central

MacKinnon, David P.; Lockwood, Chondra M.

2010-01-01

The paper describes advances in statistical methods for prevention research with a particular focus on substance abuse prevention. Standard analysis methods are extended to the typical research designs and characteristics of the data collected in prevention research. Prevention research often includes longitudinal measurement, clustering of data in units such as schools or clinics, missing data, and categorical as well as continuous outcome variables. Statistical methods to handle these features of prevention data are outlined. Developments in mediation, moderation, and implementation analysis allow for the extraction of more detailed information from a prevention study. Advancements in the interpretation of prevention research results include more widespread calculation of effect size and statistical power, the use of confidence intervals as well as hypothesis testing, detailed causal analysis of research findings, and meta-analysis. The increased availability of statistical software has contributed greatly to the use of new methods in prevention research. It is likely that the Internet will continue to stimulate the development and application of new methods. PMID:12940467

Evaluation of trauma care using TRISS method: the role of adjusted misclassification rate and adjusted w-statistic.

PubMed

Llullaku, Sadik S; Hyseni, Nexhmi Sh; Bytyçi, Cen I; Rexhepi, Sylejman K

2009-01-15

Major trauma is a leading cause of death worldwide. Evaluation of trauma care using Trauma Injury and Injury Severity Score (TRISS) method is focused in trauma outcome (deaths and survivors). For testing TRISS method TRISS misclassification rate is used. Calculating w-statistic, as a difference between observed and TRISS expected survivors, we compare our trauma care results with the TRISS standard. The aim of this study is to analyze interaction between misclassification rate and w-statistic and to adjust these parameters to be closer to the truth. Analysis of components of TRISS misclassification rate and w-statistic and actual trauma outcome. The component of false negative (FN) (by TRISS method unexpected deaths) has two parts: preventable (Pd) and non-preventable (nonPd) trauma deaths. Pd represents inappropriate trauma care of an institution; otherwise nonpreventable trauma deaths represents errors in TRISS method. Removing patients with preventable trauma deaths we get an Adjusted misclassification rate: (FP + FN - Pd)/N or (b+c-Pd)/N. Substracting nonPd from FN value in w-statistic formula we get an Adjusted w-statistic: [FP-(FN - nonPd)]/N, respectively (FP-Pd)/N, or (b-Pd)/N). Because adjusted formulas clean method from inappropriate trauma care, and clean trauma care from the methods error, TRISS adjusted misclassification rate and adjusted w-statistic gives more realistic results and may be used in researches of trauma outcome.

Quantifying the impact of between-study heterogeneity in multivariate meta-analyses

PubMed Central

Jackson, Dan; White, Ian R; Riley, Richard D

2012-01-01

Measures that quantify the impact of heterogeneity in univariate meta-analysis, including the very popular I2 statistic, are now well established. Multivariate meta-analysis, where studies provide multiple outcomes that are pooled in a single analysis, is also becoming more commonly used. The question of how to quantify heterogeneity in the multivariate setting is therefore raised. It is the univariate R2 statistic, the ratio of the variance of the estimated treatment effect under the random and fixed effects models, that generalises most naturally, so this statistic provides our basis. This statistic is then used to derive a multivariate analogue of I2, which we call . We also provide a multivariate H2 statistic, the ratio of a generalisation of Cochran's heterogeneity statistic and its associated degrees of freedom, with an accompanying generalisation of the usual I2 statistic, . Our proposed heterogeneity statistics can be used alongside all the usual estimates and inferential procedures used in multivariate meta-analysis. We apply our methods to some real datasets and show how our statistics are equally appropriate in the context of multivariate meta-regression, where study level covariate effects are included in the model. Our heterogeneity statistics may be used when applying any procedure for fitting the multivariate random effects model. Copyright © 2012 John Wiley & Sons, Ltd. PMID:22763950

Improving Our Ability to Evaluate Underlying Mechanisms of Behavioral Onset and Other Event Occurrence Outcomes: A Discrete-Time Survival Mediation Model

PubMed Central

Fairchild, Amanda J.; Abara, Winston E.; Gottschall, Amanda C.; Tein, Jenn-Yun; Prinz, Ronald J.

2015-01-01

The purpose of this article is to introduce and describe a statistical model that researchers can use to evaluate underlying mechanisms of behavioral onset and other event occurrence outcomes. Specifically, the article develops a framework for estimating mediation effects with outcomes measured in discrete-time epochs by integrating the statistical mediation model with discrete-time survival analysis. The methodology has the potential to help strengthen health research by targeting prevention and intervention work more effectively as well as by improving our understanding of discretized periods of risk. The model is applied to an existing longitudinal data set to demonstrate its use, and programming code is provided to facilitate its implementation. PMID:24296470

Antiviral treatment of Bell's palsy based on baseline severity: a systematic review and meta-analysis.

PubMed

Turgeon, Ricky D; Wilby, Kyle J; Ensom, Mary H H

2015-06-01

We conducted a systematic review with meta-analysis to evaluate the efficacy of antiviral agents on complete recovery of Bell's palsy. We searched CENTRAL, Embase, MEDLINE, International Pharmaceutical Abstracts, and sources of unpublished literature to November 1, 2014. Primary and secondary outcomes were complete and satisfactory recovery, respectively. To evaluate statistical heterogeneity, we performed subgroup analysis of baseline severity of Bell's palsy and between-study sensitivity analyses based on risk of allocation and detection bias. The 10 included randomized controlled trials (2419 patients; 807 with severe Bell's palsy at onset) had variable risk of bias, with 9 trials having a high risk of bias in at least 1 domain. Complete recovery was not statistically significantly greater with antiviral use versus no antiviral use in the random-effects meta-analysis of 6 trials (relative risk, 1.06; 95% confidence interval, 0.97-1.16; I(2) = 65%). Conversely, random-effects meta-analysis of 9 trials showed a statistically significant difference in satisfactory recovery (relative risk, 1.10; 95% confidence interval, 1.02-1.18; I(2) = 63%). Response to antiviral agents did not differ visually or statistically between patients with severe symptoms at baseline and those with milder disease (test for interaction, P = .11). Sensitivity analyses did not show a clear effect of bias on outcomes. Antiviral agents are not efficacious in increasing the proportion of patients with Bell's palsy who achieved complete recovery, regardless of baseline symptom severity. Copyright © 2015 Elsevier Inc. All rights reserved.

HIV self-care practices during pregnancy and maternal health outcomes among HIV-positive postnatal mothers aged 18-35 years at Mbuya Nehanda maternity hospital.

PubMed

Dodzo, Lilian Gertrude; Mahaka, Hilda Tandazani; Mukona, Doreen; Zvinavashe, Mathilda; Haruzivishe, Clara

2017-06-01

HIV-related conditions are one of the indirect causes of maternal deaths in Zimbabwe and the prevalence rate was estimated to be 13.63% in 2009. The study utilised a descriptive correlational design on 80 pregnant women who were HIV positive at Mbuya Nehanda maternity hospital in Harare, Zimbabwe. Participants comprised a random sample of 80 postnatal mothers. Permission to carry out the study was obtained from the respective review boards. Participants signed an informed consent. Data were collected using a structured questionnaire and record review from 1 to 20 March 2012. Interviews were done in a private room and code numbers were used to identify the participants. Completed questionnaires were kept in a lockable cupboard and the researcher had sole access to them. Data were analysed using the Statistical Package for Social Sciences (SPSS) version 12. Descriptive statistics were used to analyse data on demographics, maternal health outcomes and self-care practices. Inferential statistics (Pearson's correlation and regression analysis) were used to analyse the relationship between self-care practices and maternal health outcomes. Self-care practices were good with a mean score of 8 out of 16. Majority (71.3%) fell within the good category. Maternal outcomes were poor with a mean score of 28 out of 62 and 67.5% falling in the poor category. Pearson's correlation indicated a weak significant positive relationship (r = .317, p = <.01). Regression analysis (R 2 ) was .10 implying that self-care practices explained 10% of the variance observed in maternal health outcomes. More research needs to be carried out to identify other variables affecting maternal outcomes in HIV-positive pregnant women.

[How to fit and interpret multilevel models using SPSS].

PubMed

Pardo, Antonio; Ruiz, Miguel A; San Martín, Rafael

2007-05-01

Hierarchic or multilevel models are used to analyse data when cases belong to known groups and sample units are selected both from the individual level and from the group level. In this work, the multilevel models most commonly discussed in the statistic literature are described, explaining how to fit these models using the SPSS program (any version as of the 11 th ) and how to interpret the outcomes of the analysis. Five particular models are described, fitted, and interpreted: (1) one-way analysis of variance with random effects, (2) regression analysis with means-as-outcomes, (3) one-way analysis of covariance with random effects, (4) regression analysis with random coefficients, and (5) regression analysis with means- and slopes-as-outcomes. All models are explained, trying to make them understandable to researchers in health and behaviour sciences.

Are Student Evaluations of Teaching Effectiveness Valid for Measuring Student Learning Outcomes in Business Related Classes? A Neural Network and Bayesian Analyses

ERIC Educational Resources Information Center

Galbraith, Craig S.; Merrill, Gregory B.; Kline, Doug M.

2012-01-01

In this study we investigate the underlying relational structure between student evaluations of teaching effectiveness (SETEs) and achievement of student learning outcomes in 116 business related courses. Utilizing traditional statistical techniques, a neural network analysis and a Bayesian data reduction and classification algorithm, we find…

Modeling Outcomes with Floor or Ceiling Effects: An Introduction to the Tobit Model

ERIC Educational Resources Information Center

McBee, Matthew

2010-01-01

In gifted education research, it is common for outcome variables to exhibit strong floor or ceiling effects due to insufficient range of measurement of many instruments when used with gifted populations. Common statistical methods (e.g., analysis of variance, linear regression) produce biased estimates when such effects are present. In practice,…

Cognitive and Socio-Affective Outcomes of Project-Based Learning: Perceptions of Greek Second Chance School Students

ERIC Educational Resources Information Center

Koutrouba, Konstantina; Karageorgou, Elissavet

2013-01-01

The present questionnaire-based study was conducted in 2010 in order to examine 677 Greek Second Chance School (SCS) students' perceptions about the cognitive and socio-affective outcomes of project-based learning. Data elaboration, statistical and factor analysis showed that the participants found that project-based learning offered a second…

The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan.

PubMed

Delaney, Anthony P; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

2013-09-01

The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis. In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies. Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials.

Statistics 101 for Radiologists.

PubMed

Anvari, Arash; Halpern, Elkan F; Samir, Anthony E

2015-10-01

Diagnostic tests have wide clinical applications, including screening, diagnosis, measuring treatment effect, and determining prognosis. Interpreting diagnostic test results requires an understanding of key statistical concepts used to evaluate test efficacy. This review explains descriptive statistics and discusses probability, including mutually exclusive and independent events and conditional probability. In the inferential statistics section, a statistical perspective on study design is provided, together with an explanation of how to select appropriate statistical tests. Key concepts in recruiting study samples are discussed, including representativeness and random sampling. Variable types are defined, including predictor, outcome, and covariate variables, and the relationship of these variables to one another. In the hypothesis testing section, we explain how to determine if observed differences between groups are likely to be due to chance. We explain type I and II errors, statistical significance, and study power, followed by an explanation of effect sizes and how confidence intervals can be used to generalize observed effect sizes to the larger population. Statistical tests are explained in four categories: t tests and analysis of variance, proportion analysis tests, nonparametric tests, and regression techniques. We discuss sensitivity, specificity, accuracy, receiver operating characteristic analysis, and likelihood ratios. Measures of reliability and agreement, including κ statistics, intraclass correlation coefficients, and Bland-Altman graphs and analysis, are introduced. © RSNA, 2015.

Use of multiple cluster analysis methods to explore the validity of a community outcomes concept map.

PubMed

Orsi, Rebecca

2017-02-01

Concept mapping is now a commonly-used technique for articulating and evaluating programmatic outcomes. However, research regarding validity of knowledge and outcomes produced with concept mapping is sparse. The current study describes quantitative validity analyses using a concept mapping dataset. We sought to increase the validity of concept mapping evaluation results by running multiple cluster analysis methods and then using several metrics to choose from among solutions. We present four different clustering methods based on analyses using the R statistical software package: partitioning around medoids (PAM), fuzzy analysis (FANNY), agglomerative nesting (AGNES) and divisive analysis (DIANA). We then used the Dunn and Davies-Bouldin indices to assist in choosing a valid cluster solution for a concept mapping outcomes evaluation. We conclude that the validity of the outcomes map is high, based on the analyses described. Finally, we discuss areas for further concept mapping methods research. Copyright © 2016 Elsevier Ltd. All rights reserved.

A double-blind placebo-controlled cross-over clinical trial of DONepezil In Posterior cortical atrophy due to underlying Alzheimer's Disease: DONIPAD study.

PubMed

Ridha, Basil H; Crutch, Sebastian; Cutler, Dawn; Frost, Christopher; Knight, William; Barker, Suzie; Epie, Norah; Warrington, Elizabeth K; Kukkastenvehmas, Riitta; Douglas, Jane; Rossor, Martin N

2018-05-01

The study investigated whether donepezil exerts symptomatic benefit in patients with posterior cortical atrophy (PCA), an atypical variant of Alzheimer's disease. A single-centre, double-blind, placebo-controlled, cross-over clinical trial was performed to assess the efficacy of donepezil in patients with PCA. Each patient received either donepezil (5 mg once daily in the first 6 weeks and 10 mg once daily in the second 6 weeks) or placebo for 12 weeks. After a 2-week washout period, each patient received the other treatment arm during the following 12 weeks followed by another 2-week washout period. The primary outcome was the Mini-Mental State Examination (MMSE) at 12 weeks. Secondary outcome measures were five neuropsychological tests reflecting parieto-occipital function. Intention-to-treat analysis was used. For each outcome measure, carry-over effects were first assessed. If present, then analysis was restricted to the first 12-week period. Otherwise, the standard approach to the analysis of a 2 × 2 cross-over trial was used. Eighteen patients (13 females) were recruited (mean age 61.6 years). There was a protocol violation in one patient, who subsequently withdrew from the study due to gastrointestinal side effects. There was statistically significant (p < 0.05) evidence of a carry-over effect on MMSE. Therefore, the analysis of treatment effect on MMSE was restricted to the first 12-week period. Treatment effect at 6 weeks was statistically significant (difference = 2.5 in favour of donepezil, 95% CI 0.1 to 5.0, p < 0.05). Treatment effect at 12 weeks was close, but not statistically significant (difference = 2.0 in favour of donepezil, 95% CI -0.1 to 4.5, p > 0.05). There were no statistically significant treatment effects on any of the five neuropsychological tests, except for digit span at 12 weeks (higher by 0.5 digits in favour of placebo, 95% CI 0.1 to 0.9). Gastrointestinal side effects occurred most frequently, affecting 13/18 subjects (72%), and were the cause of study discontinuation in one subject. Nightmares and vivid dreams occurred in 8/18 subjects (44%), and were statistically more frequent during treatment with donepezil. In this small study, there was no statistically significant treatment effect of donepezil on the primary outcome measure (MMSE score at 12 weeks) in PCA patients, who appear to be particularly susceptible to the development of nightmares and vivid dreams when treated. Trial registration: Current Controlled Trials ISRCTN22636071 . Retrospectively registered 19 May 2010.

The role of empirical Bayes methodology as a leading principle in modern medical statistics.

PubMed

van Houwelingen, Hans C

2014-11-01

This paper reviews and discusses the role of Empirical Bayes methodology in medical statistics in the last 50 years. It gives some background on the origin of the empirical Bayes approach and its link with the famous Stein estimator. The paper describes the application in four important areas in medical statistics: disease mapping, health care monitoring, meta-analysis, and multiple testing. It ends with a warning that the application of the outcome of an empirical Bayes analysis to the individual "subjects" is a delicate matter that should be handled with prudence and care. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A Guerilla Guide to Common Problems in ‘Neurostatistics’: Essential Statistical Topics in Neuroscience

PubMed Central

Smith, Paul F.

2017-01-01

Effective inferential statistical analysis is essential for high quality studies in neuroscience. However, recently, neuroscience has been criticised for the poor use of experimental design and statistical analysis. Many of the statistical issues confronting neuroscience are similar to other areas of biology; however, there are some that occur more regularly in neuroscience studies. This review attempts to provide a succinct overview of some of the major issues that arise commonly in the analyses of neuroscience data. These include: the non-normal distribution of the data; inequality of variance between groups; extensive correlation in data for repeated measurements across time or space; excessive multiple testing; inadequate statistical power due to small sample sizes; pseudo-replication; and an over-emphasis on binary conclusions about statistical significance as opposed to effect sizes. Statistical analysis should be viewed as just another neuroscience tool, which is critical to the final outcome of the study. Therefore, it needs to be done well and it is a good idea to be proactive and seek help early, preferably before the study even begins. PMID:29371855

A Guerilla Guide to Common Problems in 'Neurostatistics': Essential Statistical Topics in Neuroscience.

PubMed

Smith, Paul F

2017-01-01

Effective inferential statistical analysis is essential for high quality studies in neuroscience. However, recently, neuroscience has been criticised for the poor use of experimental design and statistical analysis. Many of the statistical issues confronting neuroscience are similar to other areas of biology; however, there are some that occur more regularly in neuroscience studies. This review attempts to provide a succinct overview of some of the major issues that arise commonly in the analyses of neuroscience data. These include: the non-normal distribution of the data; inequality of variance between groups; extensive correlation in data for repeated measurements across time or space; excessive multiple testing; inadequate statistical power due to small sample sizes; pseudo-replication; and an over-emphasis on binary conclusions about statistical significance as opposed to effect sizes. Statistical analysis should be viewed as just another neuroscience tool, which is critical to the final outcome of the study. Therefore, it needs to be done well and it is a good idea to be proactive and seek help early, preferably before the study even begins.

Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

PubMed Central

Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

2016-01-01

Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to statistically significant midterm improvement in ROM and satisfactory midterm subjective outcome scores with low complication/failure rates in patients with average medium-sized rotator cuff tears with minimal fatty infiltration. Further work is required to evaluate radiographic healing rates with this technique and to compare outcomes following suture anchor repair. Level of Evidence: Level IV PMID:26980983

The outcome of the seminal fluid parameters collected via coitus interruptus versus masturbation.

PubMed

Bahyah, M Kamarul; Murad, Z Ahmad; Ghazali, I; Roszaman, R; Noraziana, A W; Mokhtar, A; Omar, M H

2010-03-01

A one year study was carried out to determine the outcome of the seminal fluid parameters collected via masturbation and coitus interruptus in 151 patients who were undergoing intrauterine insemination (IUI) and patients who came for seminal analysis. There were no statistically significant differences in terms of volume, concentration, progressive motility and normal morphology from specimens collected via coitus interruptus compared to specimens collected via masturbation. Pregnancy outcomes were also comparable.

Cost analysis and outcomes of simple elbow dislocations

PubMed Central

Panteli, Michalis; Pountos, Ippokratis; Kanakaris, Nikolaos K; Tosounidis, Theodoros H; Giannoudis, Peter V

2015-01-01

AIM: To evaluate the management, clinical outcome and cost implications of three different treatment regimes for simple elbow dislocations. METHODS: Following institutional board approval, we performed a retrospective review of all consecutive patients treated for simple elbow dislocations in a Level I trauma centre between January 2008 and December 2010. Based on the length of elbow immobilisation (LOI), patients were divided in three groups (Group I, < 2 wk; Group II, 2-3 wk; and Group III, > 3 wk). Outcome was considered satisfactory when a patient could achieve a pain-free range of motion ≥ 100° (from 30° to 130°). The associated direct medical costs for the treatment of each patient were then calculated and analysed. RESULTS: We identified 80 patients who met the inclusion criteria. Due to loss to follow up, 13 patients were excluded from further analysis, leaving 67 patients for the final analysis. The mean LOI was 14 d (median 15 d; range 3-43 d) with a mean duration of hospital engagement of 67 d (median 57 d; range 10-351 d). Group III (prolonged immobilisation) had a statistically significant worse outcome in comparison to Group I and II (P = 0.04 and P = 0.01 respectively); however, there was no significant difference in the outcome between groups I and II (P = 0.30). No statistically significant difference in the direct medical costs between the groups was identified. CONCLUSION: The length of elbow immobilization doesn’t influence the medical cost; however immobilisation longer than three weeks is associated with persistent stiffness and a less satisfactory clinical outcome. PMID:26301180

Comparison of Scrub Typhus Meningitis with Acute Bacterial Meningitis and Tuberculous Meningitis.

PubMed

Kakarlapudi, Svas Raju; Chacko, Anila; Samuel, Prasanna; Verghese, Valsan Philip; Rose, Winsley

2018-01-15

To compare scrub typhus meningitis with bacterial and tuberculous meningitis. Children aged <15 years admitted with meningitis were screened and those who fit criteria for diagnosis of scrub typhus meningitis (n=48), bacterial meningitis (n=44) and tuberculous meningitis (n=31) were included for analysis. Clinical features, investigations and outcomes were compared between the three types of meningitis. Mean age, duration of fever at presentation, presence of headache and, altered sensorium and presence of hepatomegaly/splenomegaly were statistically significantly different between the groups. Scrub typhus had statistically significant thrombocytopenia, shorter hospital stay and a better neurological and mortality outcome. Sub-acute presentation of meningitis in older age group children, and good outcome is associated with scrub typhus when compared to bacterial and tuberculous meningitis.

Compositional data analysis for physical activity, sedentary time and sleep research.

PubMed

Dumuid, Dorothea; Stanford, Tyman E; Martin-Fernández, Josep-Antoni; Pedišić, Željko; Maher, Carol A; Lewis, Lucy K; Hron, Karel; Katzmarzyk, Peter T; Chaput, Jean-Philippe; Fogelholm, Mikael; Hu, Gang; Lambert, Estelle V; Maia, José; Sarmiento, Olga L; Standage, Martyn; Barreira, Tiago V; Broyles, Stephanie T; Tudor-Locke, Catrine; Tremblay, Mark S; Olds, Timothy

2017-01-01

The health effects of daily activity behaviours (physical activity, sedentary time and sleep) are widely studied. While previous research has largely examined activity behaviours in isolation, recent studies have adjusted for multiple behaviours. However, the inclusion of all activity behaviours in traditional multivariate analyses has not been possible due to the perfect multicollinearity of 24-h time budget data. The ensuing lack of adjustment for known effects on the outcome undermines the validity of study findings. We describe a statistical approach that enables the inclusion of all daily activity behaviours, based on the principles of compositional data analysis. Using data from the International Study of Childhood Obesity, Lifestyle and the Environment, we demonstrate the application of compositional multiple linear regression to estimate adiposity from children's daily activity behaviours expressed as isometric log-ratio coordinates. We present a novel method for predicting change in a continuous outcome based on relative changes within a composition, and for calculating associated confidence intervals to allow for statistical inference. The compositional data analysis presented overcomes the lack of adjustment that has plagued traditional statistical methods in the field, and provides robust and reliable insights into the health effects of daily activity behaviours.

Education, Training, and Employment Outcomes: Analysis of a National Survey of Employers. Final Technical Report.

ERIC Educational Resources Information Center

Hollenbeck, Kevin

A study examined the effect of education and training on the economy and on employment outcomes. Data collected during a 1982 nationwide telephone survey of 3,500 employers were used as the basis for statistical models of voluntary and involuntary job separations and job promotions. Four major conclusions resulted from the modeling process…

The Effectiveness of Computer-Assisted Instruction to Teach Physical Examination to Students and Trainees in the Health Sciences Professions: A Systematic Review and Meta-Analysis

PubMed Central

Tomesko, Jennifer; Touger-Decker, Riva; Dreker, Margaret; Zelig, Rena; Parrott, James Scott

2017-01-01

Purpose: To explore knowledge and skill acquisition outcomes related to learning physical examination (PE) through computer-assisted instruction (CAI) compared with a face-to-face (F2F) approach. Method: A systematic literature review and meta-analysis published between January 2001 and December 2016 was conducted. Databases searched included Medline, Cochrane, CINAHL, ERIC, Ebsco, Scopus, and Web of Science. Studies were synthesized by study design, intervention, and outcomes. Statistical analyses included DerSimonian-Laird random-effects model. Results: In total, 7 studies were included in the review, and 5 in the meta-analysis. There were no statistically significant differences for knowledge (mean difference [MD] = 5.39, 95% confidence interval [CI]: −2.05 to 12.84) or skill acquisition (MD = 0.35, 95% CI: −5.30 to 6.01). Conclusions: The evidence does not suggest a strong consistent preference for either CAI or F2F instruction to teach students/trainees PE. Further research is needed to identify conditions which examine knowledge and skill acquisition outcomes that favor one mode of instruction over the other. PMID:29349338

Comparison of suprapatellar and infrapatellar intramedullary nailing for tibial shaft fractures: a systematic review and meta-analysis.

PubMed

Yang, Liqing; Sun, Yuefeng; Li, Ge

2018-06-14

Optimal surgical approach for tibial shaft fractures remains controversial. We perform a meta-analysis from randomized controlled trials (RCTs) to compare the clinical efficacy and prognosis between infrapatellar and suprapatellar intramedullary nail in the treatment of tibial shaft fractures. PubMed, OVID, Embase, ScienceDirect, and Web of Science were searched up to December 2017 for comparative RCTs involving infrapatellar and suprapatellar intramedullary nail in the treatment of tibial shaft fractures. Primary outcomes were blood loss, visual analog scale (VAS) score, range of motion, Lysholm knee scores, and fluoroscopy times. Secondary outcomes were length of hospital stay and postoperative complications. We assessed statistical heterogeneity for each outcome with the use of a standard χ 2 test and the I 2 statistic. The meta-analysis was undertaken using Stata 14.0. Four RCTs involving 293 participants were included in our study. The present meta-analysis indicated that there were significant differences between infrapatellar and suprapatellar intramedullary nail regarding the total blood loss, VAS scores, Lysholm knee scores, and fluoroscopy times. Suprapatellar intramedullary nailing could significantly reduce total blood loss, postoperative knee pain, and fluoroscopy times compared to infrapatellar approach. Additionally, it was associated with an improved Lysholm knee scores. High-quality RCTs were still required for further investigation.

Power analysis on the time effect for the longitudinal Rasch model.

PubMed

Feddag, M L; Blanchin, M; Hardouin, J B; Sebille, V

2014-01-01

Statistics literature in the social, behavioral, and biomedical sciences typically stress the importance of power analysis. Patient Reported Outcomes (PRO) such as quality of life and other perceived health measures (pain, fatigue, stress,...) are increasingly used as important health outcomes in clinical trials or in epidemiological studies. They cannot be directly observed nor measured as other clinical or biological data and they are often collected through questionnaires with binary or polytomous items. The Rasch model is the well known model in the item response theory (IRT) for binary data. The article proposes an approach to evaluate the statistical power of the time effect for the longitudinal Rasch model with two time points. The performance of this method is compared to the one obtained by simulation study. Finally, the proposed approach is illustrated on one subscale of the SF-36 questionnaire.

The Hard but Necessary Task of Gathering Order-One Effect Size Indices in Meta-Analysis

ERIC Educational Resources Information Center

Ortego, Carmen; Botella, Juan

2010-01-01

Meta-analysis of studies with two groups and two measurement occasions must employ order-one effect size indices to represent study outcomes. Especially with non-random assignment, non-equivalent control group designs, a statistical analysis restricted to post-treatment scores can lead to severely biased conclusions. The 109 primary studies…

Modeling longitudinal data, I: principles of multivariate analysis.

PubMed

Ravani, Pietro; Barrett, Brendan; Parfrey, Patrick

2009-01-01

Statistical models are used to study the relationship between exposure and disease while accounting for the potential role of other factors' impact on outcomes. This adjustment is useful to obtain unbiased estimates of true effects or to predict future outcomes. Statistical models include a systematic component and an error component. The systematic component explains the variability of the response variable as a function of the predictors and is summarized in the effect estimates (model coefficients). The error element of the model represents the variability in the data unexplained by the model and is used to build measures of precision around the point estimates (confidence intervals).

Single-Level and Multilevel Mediation Analysis

ERIC Educational Resources Information Center

Tofighi, Davood; Thoemmes, Felix

2014-01-01

Mediation analysis is a statistical approach used to examine how the effect of an independent variable on an outcome is transmitted through an intervening variable (mediator). In this article, we provide a gentle introduction to single-level and multilevel mediation analyses. Using single-level data, we demonstrate an application of structural…

Evidence of selective reporting bias in hematology journals: A systematic review

PubMed Central

Scheckel, Caleb; Hicks, Chandler; Nissen, Timothy; Leduc, Linda; Som, Mousumi; Vassar, Matt

2017-01-01

Introduction Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored. Methods Our primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included. Results Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes. Conclusion Our results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making. PMID:28570573

Single-case research design in pediatric psychology: considerations regarding data analysis.

PubMed

Cohen, Lindsey L; Feinstein, Amanda; Masuda, Akihiko; Vowles, Kevin E

2014-03-01

Single-case research allows for an examination of behavior and can demonstrate the functional relation between intervention and outcome in pediatric psychology. This review highlights key assumptions, methodological and design considerations, and options for data analysis. Single-case methodology and guidelines are reviewed with an in-depth focus on visual and statistical analyses. Guidelines allow for the careful evaluation of design quality and visual analysis. A number of statistical techniques have been introduced to supplement visual analysis, but to date, there is no consensus on their recommended use in single-case research design. Single-case methodology is invaluable for advancing pediatric psychology science and practice, and guidelines have been introduced to enhance the consistency, validity, and reliability of these studies. Experts generally agree that visual inspection is the optimal method of analysis in single-case design; however, statistical approaches are becoming increasingly evaluated and used to augment data interpretation.

Cost-effectiveness research in cancer therapy: a systematic review of literature trends, methods and the influence of funding

PubMed Central

Al-Badriyeh, Daoud; Alameri, Marwah; Al-Okka, Randa

2017-01-01

Objective To perform a first-time analysis of the cost-effectiveness (CE) literature on chemotherapies, of all types, in cancer, in terms of trends and change over time, including the influence of industry funding. Design Systematic review. Setting A wide range of cancer-related research settings within healthcare, including health systems, hospitals and medical centres. Participants All literature comparative CE research of drug-based cancer therapies in the period 1986 to 2015. Primary and secondary outcome measures Primary outcomes are the literature trends in relation to journal subject category, authorship, research design, data sources, funds and consultation involvement. An additional outcome measure is the association between industry funding and study outcomes. Analysis Descriptive statistics and the χ2, Fisher exact or Somer's D tests were used to perform non-parametric statistics, with a p value of <0.05 as the statistical significance measure. Results Total 574 publications were analysed. The drug-related CE literature expands over time, with increased publishing in the healthcare sciences and services journal subject category (p<0.001). The retrospective data collection in studies increased over time (p<0.001). The usage of prospective data, however, has been decreasing (p<0.001) in relation to randomised clinical trials (RCTs), but is unchanging for non-RCT studies. The industry-sponsored CE studies have especially been increasing (p<0.001), in contrast to those sponsored by other sources. While paid consultation involvement grew throughout the years, the declaration of funding for this is relatively limited. Importantly, there is evidence that industry funding is associated with favourable result to the sponsor (p<0.001). Conclusions This analysis demonstrates clear trends in how the CE cancer research is presented to the practicing community, including in relation to journals, study designs, authorship and consultation, together with increased financial sponsorship by pharmaceutical industries, which may be more influencing study outcomes than other funding sources. PMID:28131999

Is using multiple imputation better than complete case analysis for estimating a prevalence (risk) difference in randomized controlled trials when binary outcome observations are missing?

PubMed

Mukaka, Mavuto; White, Sarah A; Terlouw, Dianne J; Mwapasa, Victor; Kalilani-Phiri, Linda; Faragher, E Brian

2016-07-22

Missing outcomes can seriously impair the ability to make correct inferences from randomized controlled trials (RCTs). Complete case (CC) analysis is commonly used, but it reduces sample size and is perceived to lead to reduced statistical efficiency of estimates while increasing the potential for bias. As multiple imputation (MI) methods preserve sample size, they are generally viewed as the preferred analytical approach. We examined this assumption, comparing the performance of CC and MI methods to determine risk difference (RD) estimates in the presence of missing binary outcomes. We conducted simulation studies of 5000 simulated data sets with 50 imputations of RCTs with one primary follow-up endpoint at different underlying levels of RD (3-25 %) and missing outcomes (5-30 %). For missing at random (MAR) or missing completely at random (MCAR) outcomes, CC method estimates generally remained unbiased and achieved precision similar to or better than MI methods, and high statistical coverage. Missing not at random (MNAR) scenarios yielded invalid inferences with both methods. Effect size estimate bias was reduced in MI methods by always including group membership even if this was unrelated to missingness. Surprisingly, under MAR and MCAR conditions in the assessed scenarios, MI offered no statistical advantage over CC methods. While MI must inherently accompany CC methods for intention-to-treat analyses, these findings endorse CC methods for per protocol risk difference analyses in these conditions. These findings provide an argument for the use of the CC approach to always complement MI analyses, with the usual caveat that the validity of the mechanism for missingness be thoroughly discussed. More importantly, researchers should strive to collect as much data as possible.

Statistical issues on the analysis of change in follow-up studies in dental research.

PubMed

Blance, Andrew; Tu, Yu-Kang; Baelum, Vibeke; Gilthorpe, Mark S

2007-12-01

To provide an overview to the problems in study design and associated analyses of follow-up studies in dental research, particularly addressing three issues: treatment-baselineinteractions; statistical power; and nonrandomization. Our previous work has shown that many studies purport an interacion between change (from baseline) and baseline values, which is often based on inappropriate statistical analyses. A priori power calculations are essential for randomized controlled trials (RCTs), but in the pre-test/post-test RCT design it is not well known to dental researchers that the choice of statistical method affects power, and that power is affected by treatment-baseline interactions. A common (good) practice in the analysis of RCT data is to adjust for baseline outcome values using ancova, thereby increasing statistical power. However, an important requirement for ancova is there to be no interaction between the groups and baseline outcome (i.e. effective randomization); the patient-selection process should not cause differences in mean baseline values across groups. This assumption is often violated for nonrandomized (observational) studies and the use of ancova is thus problematic, potentially giving biased estimates, invoking Lord's paradox and leading to difficulties in the interpretation of results. Baseline interaction issues can be overcome by use of statistical methods; not widely practiced in dental research: Oldham's method and multilevel modelling; the latter is preferred for its greater flexibility to deal with more than one follow-up occasion as well as additional covariates To illustrate these three key issues, hypothetical examples are considered from the fields of periodontology, orthodontics, and oral implantology. Caution needs to be exercised when considering the design and analysis of follow-up studies. ancova is generally inappropriate for nonrandomized studies and causal inferences from observational data should be avoided.

Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

PubMed

Billot, Laurent; Lindley, Richard I; Harvey, Lisa A; Maulik, Pallab K; Hackett, Maree L; Murthy, Gudlavalleti Vs; Anderson, Craig S; Shamanna, Bindiganavale R; Jan, Stephen; Walker, Marion; Forster, Anne; Langhorne, Peter; Verma, Shweta J; Felix, Cynthia; Alim, Mohammed; Gandhi, Dorcas Bc; Pandian, Jeyaraj Durai

2017-02-01

Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.

Outcome predictors in the management of intramedullary classic ependymoma: An integrative survival analysis.

PubMed

Wang, Yinqing; Cai, Ranze; Wang, Rui; Wang, Chunhua; Chen, Chunmei

2018-06-01

This is a retrospective study.The aim of this study was to illustrate the survival outcomes of patients with classic ependymoma (CE) and identify potential prognostic factors.CE is the most common category of spinal ependymomas, but few published studies have discussed predictors of the survival outcome.A Boolean search of the PubMed, Embase, and OVID databases was conducted by 2 investigators independently. The objects were intramedullary grade II ependymoma according to 2007 WHO classification. Univariate Kaplan-Meier analysis and Log-Rank tests were performed to identify variables associated with progression-free survival (PFS) or overall survival (OS). Multivariate Cox regression was performed to assess hazard ratios (HRs) with 95% confidence intervals (95% CIs). Statistical analysis was performed by SPSS version 23.0 (IBM Corp.) with statistical significance defined as P < .05.A total of 35 studies were identified, including 169 cases of CE. The mean follow-up time across cases was 64.2 ± 51.5 months. Univariate analysis showed that patients who had undergone total resection (TR) had better PFS and OS than those with subtotal resection (STR) and biopsy (P = .002, P = .004, respectively). Within either univariate or multivariate analysis (P = .000, P = .07, respectively), histological type was an independent prognostic factor for PFS of CE [papillary type: HR 0.002, 95% CI (0.000-0.073), P = .001, tanycytic type: HR 0.010, 95% CI (0.000-0.218), P = .003].It was the first integrative analysis of CE to elucidate the correlation between kinds of factors and prognostic outcomes. Definite histological type and safely TR were foundation of CE's management. 4.

[Use of the methods of mathematical modeling for evaluation of the data of cerebrospinal fluid examination in patients with bacterial meningoencephalitis].

PubMed

Iarosh, O A; Iarosh, A A

1991-01-01

As many as 300 patients of different age groups underwent a probability statistical analysis of cytosis and CSF protein depending on the outcome of bacterial meningoencephalitis. The clinical and CSF interrelations discovered reflect the function of the blood-brain barrier and can be used as an additional test for predicting the disease outcome.

Measuring outcome from vestibular rehabilitation, part II: refinement and validation of a new self-report measure.

PubMed

Morris, Anna E; Lutman, Mark E; Yardley, Lucy

2009-01-01

A prototype self-report measure of vestibular rehabilitation outcome is described in a previous paper. The objectives of the present work were to identify the most useful items and assess their psychometric properties. Stage 1: One hundred fifty-five participants completed a prototype 36-item Vestibular Rehabilitation Benefit Questionnaire (VRBQ). Statistical analysis demonstrated its subscale structure and identified redundant items. Stage 2: One hundred twenty-four participants completed a refined 22-item VRBQ and three established questionnaires (Dizziness Handicap Inventory, DHI; Vertigo Symptom Scale short form, VSS-sf; Medical Outcomes Study short form 36, SF-36) in a longitudinal study. Statistical analysis revealed four internally consistent subscales of the VRBQ: Dizziness, Anxiety, Motion-Provoked Dizziness, and Quality of Life. Correlations with the DHI, VSS-sf, and SF-36 support the validity of the VRBQ, and effect size estimates suggest that the VRBQ is more responsive than comparable questionnaires. Twenty participants completed the VRBQ twice in a 24-hour period, indicating excellent test-retest reliability. The VRBQ appears to be a concise and psychometrically robust questionnaire that addresses the main aspects of dizziness impact.

Antiplatelet therapy for aneurysmal subarachnoid haemorrhage.

PubMed

Dorhout Mees, S M; van den Bergh, W M; Algra, A; Rinkel, G J E

2007-10-17

Secondary ischaemia is a frequent cause of poor outcome in patients with aneurysmal subarachnoid haemorrhage (SAH). Besides vasospasm, platelet aggregation seems to play a role in the pathogenesis of secondary ischaemia. Experimental studies have suggested that antiplatelet agents can prevent secondary ischaemia. To determine whether antiplatelet agents change outcome in patients with aneurysmal SAH. We searched the Cochrane Stroke Group Trials Register (last searched August 2006), MEDLINE (1966 to August 2006) and EMBASE databases (1980 to August 2006). We also searched reference lists of identified trials. All randomised controlled trials (RCTs) comparing any antiplatelet agent with control in patients with aneurysmal SAH. Two review authors independently extracted the data and assessed trial quality. Relative risks (RR) were calculated with regard to poor outcome, case fatality, secondary ischaemia, haemorrhagic intracranial complications and aneurysmal rebleeding according to the intention-to-treat principle. In case of a statistically significant primary analysis, a worst case analysis was performed. Seven RCTs were included in the review, totalling 1385 patients. Four of these trials met the criteria for good quality studies. For any antiplatelet agent there were reductions of a poor outcome (RR 0.79, 95% confidence interval (CI) 0.62 to 1.01) and secondary brain ischaemia (RR 0.79, 95% CI 0.56 to 1.22) and more intracranial haemorrhagic complications (RR 1.36, 95% CI 0.59 to 3.12), but none of these differences were statistically significant. There was no effect on case fatality (RR 1.01, 95% CI 0.74 to 1.37) or aneurysmal rebleeding (RR 0.98, 95% CI 0.78 to 1.38). For individual antiplatelet agents, only ticlopidine was associated with statistically significant fewer occurrences of a poor outcome (RR 0.37, 95% CI 95% CI 0.14 to 0.98) but this estimate was based on only one small RCT. This review shows a trend towards better outcome in patients treated with antiplatelet agents, possibly due to a reduction in secondary ischaemia. However, results were not statistically significant, thus no definite conclusions can be drawn. Also, antiplatelet agents could increase the risk of haemorrhagic complications. On the basis of the current evidence treatment with antiplatelet agents in order to prevent secondary ischaemia or poor outcome cannot be recommended.

Is Quality/Effectiveness An Empirically Demonstrable School Attribute? Statistical Aids for Determining Appropriate Levels of Analysis.

ERIC Educational Resources Information Center

Griffith, James

2002-01-01

Describes and demonstrates analytical techniques used in organizational psychology and contemporary multilevel analysis. Using these analytic techniques, examines the relationship between educational outcomes and the school environment. Finds that at least some indicators might be represented as school-level phenomena. Results imply that the…

A Meta-Analysis: The Relationship between Father Involvement and Student Academic Achievement

ERIC Educational Resources Information Center

Jeynes, William H.

2015-01-01

A meta-analysis was undertaken, including 66 studies, to determine the relationship between father involvement and the educational outcomes of urban school children. Statistical analyses were done to determine the overall impact and specific components of father involvement. The possible differing effects of paternal involvement by race were also…

What Happens to Students Placed into Developmental Education? A Meta-Analysis of Regression Discontinuity Studies

ERIC Educational Resources Information Center

Valentine, Jeffrey C.; Konstantopoulos, Spyros; Goldrick-Rab, Sara

2017-01-01

This article reports a systematic review and meta-analysis of studies that use regression discontinuity to examine the effects of placement into developmental education. Results suggest that placement into developmental education is associated with effects that are negative, statistically significant, and substantively large for three outcomes:…

The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis.

PubMed

Linkevicius, Tomas; Vaitelis, Julius

2015-09-01

The objective of this review was to analyze research with regard to the effect of zirconia or titanium as abutment material on soft peri-implant tissues. Clinical studies were selected via electronic and hand searches in English language journals until December 1, 2014. Only randomized clinical trials (RCTs) and prospective controlled clinical trials (CCTs) showing direct comparison between zirconia (Zr) and titanium (Ti) abutments in the same patient were considered. The outcome measures were (1) soft tissue color, (2) soft tissue recession, (3) peri-implant probing, (4) bleeding on probing, (5) esthetic indexes, (6) patient-reported outcome, (7) marginal bone level, and (8) biological complications. Nine relevant studies (11 papers) were identified: 4 RCTs and 5 CCTs. Due to heterogeneity in the study design, statistical methods, and reported results, a meta-analysis of the data was feasible only for soft tissue color. The outcome was found to be significantly superior for Zr abutments. For the other outcome measures, a qualitative analysis of the selected articles was performed. The studies did not show any statistically significant differences between Zr and Ti abutments on soft tissue recession, probing depths, bleeding on probing, marginal bone level, and patient-reported outcome. One study reported significantly higher pink esthetic score (PES) scores at Zr implants with Zr abutments, compared to metal implants and Ti abutments. Overall, the research does not support any obvious advantage of Ti or Zr abutments over each other. However, there is a significant tendency in Zr abutments evoking better color response of peri-implant mucosa and superior esthetic outcome measured by PES score. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Preparing systems engineering and computing science students in disciplined methods, quantitative, and advanced statistical techniques to improve process performance

NASA Astrophysics Data System (ADS)

McCray, Wilmon Wil L., Jr.

The research was prompted by a need to conduct a study that assesses process improvement, quality management and analytical techniques taught to students in U.S. colleges and universities undergraduate and graduate systems engineering and the computing science discipline (e.g., software engineering, computer science, and information technology) degree programs during their academic training that can be applied to quantitatively manage processes for performance. Everyone involved in executing repeatable processes in the software and systems development lifecycle processes needs to become familiar with the concepts of quantitative management, statistical thinking, process improvement methods and how they relate to process-performance. Organizations are starting to embrace the de facto Software Engineering Institute (SEI) Capability Maturity Model Integration (CMMI RTM) Models as process improvement frameworks to improve business processes performance. High maturity process areas in the CMMI model imply the use of analytical, statistical, quantitative management techniques, and process performance modeling to identify and eliminate sources of variation, continually improve process-performance; reduce cost and predict future outcomes. The research study identifies and provides a detail discussion of the gap analysis findings of process improvement and quantitative analysis techniques taught in U.S. universities systems engineering and computing science degree programs, gaps that exist in the literature, and a comparison analysis which identifies the gaps that exist between the SEI's "healthy ingredients " of a process performance model and courses taught in U.S. universities degree program. The research also heightens awareness that academicians have conducted little research on applicable statistics and quantitative techniques that can be used to demonstrate high maturity as implied in the CMMI models. The research also includes a Monte Carlo simulation optimization model and dashboard that demonstrates the use of statistical methods, statistical process control, sensitivity analysis, quantitative and optimization techniques to establish a baseline and predict future customer satisfaction index scores (outcomes). The American Customer Satisfaction Index (ACSI) model and industry benchmarks were used as a framework for the simulation model.

Five-Year Outcomes of Surgically Treated Symptomatic Epiretinal Membranes With and Without Internal Limiting Membrane Peeling.

PubMed

Sultan, Harris; Wykoff, Charles C; Shah, Ankoor R

2018-05-01

The authors evaluated long-term postoperative visual outcomes and recurrence rates following surgery for symptomatic epiretinal membrane (ERM) ± internal limiting membrane (ILM) peeling. This was a retrospective, consecutive case series of 78 patients undergoing vitrectomy for symptomatic ERM between 1/2010 and 4/2012 with follow-up through at least postoperative year 5 (POY5). Outcomes included visual acuity (VA) (Snellen VA converted to logMAR), central retinal thickness (CRT; μm), and ERM recurrence. Subgroup analysis evaluated outcomes related to ILM peeling. Subgroup analysis based on ILM peeling did not find VA (20/50 [0.430 logMAR ± 0.061 logMAR; mean ± SD] vs. 20/60 [0.518 logMAR ± 0.128 logMAR] for ILM vs. non-ILM peeling respectively; P = .513) nor macular thickness (355 μm ± 13 μm vs. 360 μm ± 42 μm; P = .410) to be significantly different at POY5. Recurrence requiring surgery with and without ILM peeling was not statistically significantly different at POY5 (1.6% and 11.8%; P = .118). Vitrectomy for symptomatic ERM led to improved visual and anatomic outcomes with sustained benefit through 5 years. ILM peeling was was associated with reduced ERM recurrence, but this benefit was not statistically significant at POY5. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:296-302.]. Copyright 2018, SLACK Incorporated.

Surviving and Thriving: The Adaptive Responses of U.S. Four-Year Colleges and Universities during the Great Recession

ERIC Educational Resources Information Center

Brint, Steven; Yoshikawa, Sarah R. K.; Rotondi, Matthew B.; Viggiano, Tiffany; Maldonado, John

2016-01-01

Press reports and industry statistics both give incomplete pictures of the outcomes of the Great Recession for U.S. four-year colleges and universities. To address these gaps, we conducted a statistical analysis of all articles that appeared in Lexis-Nexis on a sample of more than 300 U.S. colleges and universities during the Recession years. We…

Robot-assisted walking training for individuals with Parkinson’s disease: a pilot randomized controlled trial

PubMed Central

2013-01-01

Background Over the last years, the introduction of robotic technologies into Parkinson’s disease rehabilitation settings has progressed from concept to reality. However, the benefit of robotic training remains elusive. This pilot randomized controlled observer trial is aimed at investigating the feasibility, the effectiveness and the efficacy of new end-effector robot training in people with mild Parkinson’s disease. Methods Design. Pilot randomized controlled trial. Setting. Robot assisted gait training (EG) compared to treadmill training (CG). Participants. Twenty cognitively intact participants with mild Parkinson’s disease and gait disturbance. Interventions. The EG underwent a rehabilitation programme of robot assisted walking for 40 minutes, 5 times a week for 4 weeks. The CG received a treadmill training programme for 40 minutes, 5 times a week for 4 weeks. Main outcome measures. The outcome measure of efficacy was recorded by gait analysis laboratory. The assessments were performed at the beginning (T0) and at the end of the treatment (T1). The main outcome was the change in velocity. The feasibility of the intervention was assessed by recording exercise adherence and acceptability by specific test. Results Robot training was feasible, acceptable, safe, and the participants completed 100% of the prescribed training sessions. A statistically significant improvement in gait index was found in favour of the EG (T0 versus T1). In particular, the statistical analysis of primary outcome (gait speed) using the Friedman test showed statistically significant improvements for the EG (p = 0,0195). The statistical analysis performed by Friedman test of Step length left (p = 0,0195) and right (p = 0,0195) and Stride length left (p = 0,0078) and right (p = 0,0195) showed a significant statistical gain. No statistically significant improvements on the CG were found. Conclusions Robot training is a feasible and safe form of rehabilitative exercise for cognitively intact people with mild PD. This original approach can contribute to increase a short time lower limb motor recovery in idiopathic PD patients. The focus on the gait recovery is a further characteristic that makes this research relevant to clinical practice. On the whole, the simplicity of treatment, the lack of side effects, and the positive results from patients support the recommendation to extend the use of this treatment. Further investigation regarding the long-time effectiveness of robot training is warranted. Trial registration ClinicalTrials.gov NCT01668407 PMID:23706025

Treatment of missing data in follow-up studies of randomised controlled trials: A systematic review of the literature.

PubMed

Sullivan, Thomas R; Yelland, Lisa N; Lee, Katherine J; Ryan, Philip; Salter, Amy B

2017-08-01

After completion of a randomised controlled trial, an extended follow-up period may be initiated to learn about longer term impacts of the intervention. Since extended follow-up studies often involve additional eligibility restrictions and consent processes for participation, and a longer duration of follow-up entails a greater risk of participant attrition, missing data can be a considerable threat in this setting. As a potential source of bias, it is critical that missing data are appropriately handled in the statistical analysis, yet little is known about the treatment of missing data in extended follow-up studies. The aims of this review were to summarise the extent of missing data in extended follow-up studies and the use of statistical approaches to address this potentially serious problem. We performed a systematic literature search in PubMed to identify extended follow-up studies published from January to June 2015. Studies were eligible for inclusion if the original randomised controlled trial results were also published and if the main objective of extended follow-up was to compare the original randomised groups. We recorded information on the extent of missing data and the approach used to treat missing data in the statistical analysis of the primary outcome of the extended follow-up study. Of the 81 studies included in the review, 36 (44%) reported additional eligibility restrictions and 24 (30%) consent processes for entry into extended follow-up. Data were collected at a median of 7 years after randomisation. Excluding 28 studies with a time to event primary outcome, 51/53 studies (96%) reported missing data on the primary outcome. The median percentage of randomised participants with complete data on the primary outcome was just 66% in these studies. The most common statistical approach to address missing data was complete case analysis (51% of studies), while likelihood-based analyses were also well represented (25%). Sensitivity analyses around the missing data mechanism were rarely performed (25% of studies), and when they were, they often involved unrealistic assumptions about the mechanism. Despite missing data being a serious problem in extended follow-up studies, statistical approaches to addressing missing data were often inadequate. We recommend researchers clearly specify all sources of missing data in follow-up studies and use statistical methods that are valid under a plausible assumption about the missing data mechanism. Sensitivity analyses should also be undertaken to assess the robustness of findings to assumptions about the missing data mechanism.

The Effects of Child Abuse and Exposure to Domestic Violence on Adolescent Internalizing and Externalizing Behavior Problems.

PubMed

Moylan, Carrie A; Herrenkohl, Todd I; Sousa, Cindy; Tajima, Emiko A; Herrenkohl, Roy C; Russo, M Jean

2010-01-01

This study examines the effects of child abuse and domestic violence exposure in childhood on adolescent internalizing and externalizing behaviors. Data for this analysis are from the Lehigh Longitudinal Study, a prospective study of 457 youth addressing outcomes of family violence and resilience in individuals and families. Results show that child abuse, domestic violence, and both in combination (i.e., dual exposure) increase a child's risk for internalizing and externalizing outcomes in adolescence. When accounting for risk factors associated with additional stressors in the family and surrounding environment, only those children with dual exposure had an elevated risk of the tested outcomes compared to non-exposed youth. However, while there were some observable differences in the prediction of outcomes for children with dual exposure compared to those with single exposure (i.e., abuse only or exposure to domestic violence only), these difference were not statistically significant. Analyses showed that the effects of exposure for boys and girls are statistically comparable.

Progress of statistical analysis in biomedical research through the historical review of the development of the Framingham score.

PubMed

Ignjatović, Aleksandra; Stojanović, Miodrag; Milošević, Zoran; Anđelković Apostolović, Marija

2017-12-02

The interest in developing risk models in medicine not only is appealing, but also associated with many obstacles in different aspects of predictive model development. Initially, the association of biomarkers or the association of more markers with the specific outcome was proven by statistical significance, but novel and demanding questions required the development of new and more complex statistical techniques. Progress of statistical analysis in biomedical research can be observed the best through the history of the Framingham study and development of the Framingham score. Evaluation of predictive models comes from a combination of the facts which are results of several metrics. Using logistic regression and Cox proportional hazards regression analysis, the calibration test, and the ROC curve analysis should be mandatory and eliminatory, and the central place should be taken by some new statistical techniques. In order to obtain complete information related to the new marker in the model, recently, there is a recommendation to use the reclassification tables by calculating the net reclassification index and the integrated discrimination improvement. Decision curve analysis is a novel method for evaluating the clinical usefulness of a predictive model. It may be noted that customizing and fine-tuning of the Framingham risk score initiated the development of statistical analysis. Clinically applicable predictive model should be a trade-off between all abovementioned statistical metrics, a trade-off between calibration and discrimination, accuracy and decision-making, costs and benefits, and quality and quantity of patient's life.

Application of a faith-based integration tool to assess mental and physical health interventions.

PubMed

Saunders, Donna M; Leak, Jean; Carver, Monique E; Smith, Selina A

2017-01-01

To build on current research involving faith-based interventions (FBIs) for addressing mental and physical health, this study a) reviewed the extent to which relevant publications integrate faith concepts with health and b) initiated analysis of the degree of FBI integration with intervention outcomes. Derived from a systematic search of articles published between 2007 and 2017, 36 studies were assessed with a Faith-Based Integration Assessment Tool (FIAT) to quantify faith-health integration. Basic statistical procedures were employed to determine the association of faith-based integration with intervention outcomes. The assessed studies possessed (on average) moderate, inconsistent integration because of poor use of faith measures, and moderate, inconsistent use of faith practices. Analysis procedures for determining the effect of FBI integration on intervention outcomes were inadequate for formulating practical conclusions. Regardless of integration, interventions were associated with beneficial outcomes. To determine the link between FBI integration and intervention outcomes, additional analyses are needed.

Knot positioning during McDonald cervical cerclage, does it make a difference? A cohort study.

PubMed

Atia, Hytham; Ellaithy, Mohamed; Altraigey, Ahmed; Ibrahim, Heba

2018-05-15

To study the effect of McDonald cerclage knot position on the different maternal and neonatal outcomes. This historical cohort study included women with singleton pregnancy who had a prophylactic McDonald cervical cerclage between 1 May 2010 and 31 September 2017. Maternal and neonatal outcome parameters were compared between the anterior and posterior knot cerclage procedures. The primary outcome measure was the rate of term birth. 550 Women had a prophylactic McDonald cervical cerclage, 306 with anterior knot (Group A) and 244 with posterior knot (Group B). There were no statistically significant differences regarding gestational age (GA) at delivery (36.3 ± 4.2 versus 35.8 ± 5.3 for groups A and B respectively), term birth rate, post-cerclage cervical length, symptomatic vaginitis, urinary tract infection, difficult cerclage removal and cervical lacerations. Similarly, there were no statistically significant differences as regards the studied neonatal outcomes including take home babies, neonatal intensive care admission, respiratory distress syndrome and neonatal sepsis. Survival analysis on GA at delivery demonstrated no statistically significant difference as regards the proportion of term deliveries in the anterior and posterior knot cerclage groups (log-rank test p-value = .478). Knot positioning during McDonald cervical cerclage, anteriorly or posteriorly, didn't significantly impact the studied maternal and neonatal outcomes.

A behavior-analytic view of psychological health

PubMed Central

Follette, William C.; Bach, Patricia A.; Follette, Victoria M.

1993-01-01

This paper argues that a behavioral analysis of psychological health is useful and appropriate. Such an analysis will allow us to better evaluate intervention outcomes without resorting only to the assessment of pathological behavior, thus providing an alternative to the Diagnostic and Statistical Manual system of conceptualizing behavior. The goals of such an analysis are to distinguish between people and outcomes using each term of the three-term contingency as a dimension to consider. A brief review of other efforts to define psychological health is provided. Laboratory approaches to a behavioral analysis of healthy behavior are presented along with shortcomings in our science that impede our analysis. Finally, we present some of the functional characteristics of psychological health that we value. PMID:22478160

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz

2018-03-15

The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.

PubMed

Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

2013-10-01

The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Gender-related analysis of the clinical presentation, treatment response and outcome in patients with immune thrombocytopenia.

PubMed

Andrès, Emmanuel; Mecili, Mustapha; Fothergill, Helen; Zimmer, Jacques; Vogel, Thomas; Maloisel, Frédéric

2012-09-01

Immune thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) frequently occurs in young adults, particularly women in their third or fourth decade. The female predominance suggests that sex hormones may play a role in the different aspects of ITP. In this paper, we report a gender-related analysis of patients with ITP, specifically examining the clinical manifestations, responses to treatment and overall outcomes of the patients. We included patients with "ITP" attending the departments of onco-hematology or internal medicine B (university hospital of Strasbourg, France) between 1990 and December 2010 The gender-related analysis was retrospective. We studied in 225 consecutive cases of established ITP with a follow-up period of 1.7 to 112 months The mean age of the patients was 44 years; 156 patients were female. The analysis revealed no significant statistical differences regarding patient characteristics between the female and male groups, with the exception of the following characteristics: the bleeding score, which altered in the presence of meno- and/or metrorrhagia and hematuria in female patients (P=0.03); the presence of anemia (P=0.04); and the detection of antinuclear and/or antiphospholipid antibodies (P=0.02). During the follow-up, no statistically significant difference was found regarding outcome or treatment response in relation to gender among these 225 patients (all P>0.05). Gender does not appear to affect the manifestation of immune thrombocytopenia, the outcome or response to treatment. However, further large-scale randomized trials are needed to confirm these findings. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

A pharmacogenetics study to predict outcome in patients receiving anti-VEGF therapy in age related macular degeneration

PubMed Central

Kitchens, John W; Kassem, Nawal; Wood, William; Stone, Thomas W; Isernhagen, Rick; Wood, Edward; Hancock, Brad A; Radovich, Milan; Waymire, Josh; Li, Lang; Schneider, Bryan P

2013-01-01

Purpose To ascertain whether single nucleotide polymorphisms (SNPs) in the Vascular Endothelial Growth factor (VEGFA), Complement Factor H (CFH), and LOC387715 genes could predict outcome to anti-VEGF therapy for patients with age related macular degeneration (AMD). Methods Patients with “wet” AMD were identified by chart review. Baseline optical coherence tomography (OCT) and visual acuity (VA) data, and at least 6 months of clinical follow up after 3 initial monthly injections of bevacizumab or ranibizumab were required for inclusion. Based on OCT and VA, patients were categorized into two possible clinical outcomes: (a) responders and (b) non-responders. DNA was extracted from saliva and genotyped for candidate SNPs in the VEGFA, LOC387715, and CFH genes. Clinical outcomes were statistically compared to patient genotypes. Results 101 patients were recruited, and one eye from each patient was included in the analysis. 97% of samples were successfully genotyped for all SNPs. We found a statistically significant association between the LOC387715 A69S TT genotype and outcome based on OCT. Conclusion Genetic variation may be associated with outcome in patients receiving anti-VEGF therapy. PMID:24143065

PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial.

PubMed

Thybo, Kasper Højgaard; Jakobsen, Janus Christian; Hägi-Pedersen, Daniel; Pedersen, Niels Anker; Dahl, Jørgen Berg; Schrøder, Henrik Morville; Bülow, Hans Henrik; Bjørck, Jan Gottfrid; Overgaard, Søren; Mathiesen, Ole; Wetterslev, Jørn

2017-10-10

Effective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen. This paper describes in detail the statistical analysis plan for the primary publication to prevent outcome reporting bias and data-driven analysis results. The PANSAID trial is a multicentre, randomised, controlled, parallel, four-group clinical trial comparing the beneficial and harmful effects of different doses and combinations of paracetamol and ibuprofen in patients having total hip arthroplastic surgery. Patients, caregivers, physicians, investigators, and statisticians are blinded to the intervention. The two co-primary outcomes are 24-h consumption of morphine and proportion of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and the proportion of patients with one or more adverse events within 24 h postoperatively. PANSAID will provide a large trial with low risk of bias regarding benefits and harms of the combination of paracetamol and ibuprofen used in a perioperative setting. ClinicalTrials.org identifier: NCT02571361 . Registered on 7 October 2015.

Systematic review and meta-analysis of the effect of equine assisted activities and therapies on gross motor outcome in children with cerebral palsy.

PubMed

Tseng, Sung-Hui; Chen, Hung-Chou; Tam, Ka-Wai

2013-01-01

To evaluate the literature on the efficacy of equine assisted activities and therapies (EAAT) on gross motor outcomes representing the ICF component of body functions and activity in children with cerebral palsy (CP). We conducted a systematic review and meta-analysis of randomized controlled trials and observational studies of hippotherapy (HPOT) and therapeutic horseback riding (TR) for children with spastic CP. Gross motor outcomes, assessed via muscle activity and muscle tone, gait, posture and Gross Motor Function Measures (GMFM) were evaluated. Five TR studies and nine HPOT studies were included. Our meta-analysis indicated that short-term HPOT (total riding time 8-10 min) significantly reduced asymmetrical activity of the hip adductor muscles. HPOT could improve postural control in children with spastic CP, GMFCS level < 5. However, the evidence did not show a statistically significant effect on GMFM after long-term HPOT or TR (total riding time, 8-22 h) in children with spastic CP. This systematic review found insufficient evidence to support the claim that long-term TR or HPOT provide a significant benefit to children with spastic CP. We found no statistically significant evidence of either therapeutic effect or maintenance effects on the gross motor activity status in CP children.

The predictive value of FDG-PET with 3D-SSP for surgical outcomes in patients with temporal lobe epilepsy.

PubMed

Higo, Takuma; Sugano, Hidenori; Nakajima, Madoka; Karagiozov, Kostadin; Iimura, Yasushi; Suzuki, Masaru; Sato, Kiyoshi; Arai, Hajime

2016-10-01

We retrospectively evaluated the diagnostic value of (18)F-2-fluorodeoxy-d-glucose positron emission tomography (FDG-PET) with statistical analysis for the foci detection and predictive utility for postsurgical seizure outcome of patients with mesial temporal lobe epilepsy (mTLE). We evaluated 40 patients who were diagnosed mTLE and underwent selective amygdalohippocampectomy (SAH) or anterior temporal lobectomy (ATL) in our institute. Preoperative interictal FDG-PET with statistical analysis using three-dimensional stereotactic surface projection (3D-SSP) was detected with several clinical data including seizure semiology, MRI, scalp electroencephalography, surgical procedure with SAH or ATL and postsurgical outcome. The region of interest (ROI) was defined on 'Hippocampus & Amygdala', 'Parahippocampal gyrus & Uncus', 'T1 & T2', and 'T3 & Fusiform gyrus'. We obtained the ratio of hypometabolism difference (RHD) by 3D-SSP, and evaluated the relation among hypometabolic extent, surgical outcome and surgical procedure. The RHD in each ROIs ipsilateral to operative side was significantly higher than that of contralateral side in good outcome group. Hypometabolism of 'Hippocampus & Amygdala' was most reliable prognostic factor. Patients of discordant with presurgical examinations hardly showed obvious lateralized hypometabolism. Nevertheless, when they have significantly high RHD in mesial temporal lobe, good surgical outcome was expected. There was not significant difference of RHD distribution between SAH and ATL in good outcome group. Significant hypometabolism in mesial temporal lobe on FDG-PET with 3D-SSP is useful to predict good surgical outcome for patients with mTLE, particularly in discordant patients with hypometabolism in mesial temporal structure. However, FDG-PET is not indicative of surgical procedure. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Centralized Analysis of Local Data, With Dollars and Lives on the Line: Lessons From The Home Radon Experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Price, PhillipN.; Gelman, Andrew

2014-11-24

In this chapter we elucidate four main themes. The first is that modern data analyses, including "Big Data" analyses, often rely on data from different sources, which can present challenges in constructing statistical models that can make effective use of all of the data. The second theme is that although data analysis is usually centralized, frequently the final outcome is to provide information or allow decision-making for individuals. Third, data analyses often have multiple uses by design: the outcomes of the analysis are intended to be used by more than one person or group, for more than one purpose. Finally,more » issues of privacy and confidentiality can cause problems in more subtle ways than are usually considered; we will illustrate this point by discussing a case in which there is substantial and effective political opposition to simply acknowledging the geographic distribution of a health hazard. A researcher analyzes some data and learns something important. What happens next? What does it take for the results to make a difference in people's lives? In this chapter we tell a story - a true story - about a statistical analysis that should have changed government policy, but didn't. The project was a research success that did not make its way into policy, and we think it provides some useful insights into the interplay between locally-collected data, statistical analysis, and individual decision making.« less

Does the extended Glasgow Outcome Scale add value to the conventional Glasgow Outcome Scale?

PubMed

Weir, James; Steyerberg, Ewout W; Butcher, Isabella; Lu, Juan; Lingsma, Hester F; McHugh, Gillian S; Roozenbeek, Bob; Maas, Andrew I R; Murray, Gordon D

2012-01-01

The Glasgow Outcome Scale (GOS) is firmly established as the primary outcome measure for use in Phase III trials of interventions in traumatic brain injury (TBI). However, the GOS has been criticized for its lack of sensitivity to detect small but clinically relevant changes in outcome. The Glasgow Outcome Scale-Extended (GOSE) potentially addresses this criticism, and in this study we estimate the efficiency gain associated with using the GOSE in place of the GOS in ordinal analysis of 6-month outcome. The study uses both simulation and the reanalysis of existing data from two completed TBI studies, one an observational cohort study and the other a randomized controlled trial. As expected, the results show that using an ordinal technique to analyze the GOS gives a substantial gain in efficiency relative to the conventional analysis, which collapses the GOS onto a binary scale (favorable versus unfavorable outcome). We also found that using the GOSE gave a modest but consistent increase in efficiency relative to the GOS in both studies, corresponding to a reduction in the required sample size of the order of 3-5%. We recommend that the GOSE be used in place of the GOS as the primary outcome measure in trials of TBI, with an appropriate ordinal approach being taken to the statistical analysis.

Meta-analysis of pemetrexed plus carboplatin doublet safety profile in first-line non-squamous non-small cell lung cancer studies.

PubMed

Okamoto, Isamu; Schuette, Wolfgang H W; Stinchcombe, Thomas E; Rodrigues-Pereira, José; San Antonio, Belén; Chen, Jian; Liu, Jingyi; John, William J; Zinner, Ralph G

2017-05-01

This meta-analysis compared safety profiles (selected drug-related treatment-emergent adverse events [TEAEs]) of first-line pemetrexed plus carboplatin (PCb) area under the concentration-time curve 5 mg/min•mL (PCb5) or 6 mg/min•mL (PCb6), two widely used regimens in clinical practice for advanced non-squamous non-small cell lung cancer. All patients received pemetrexed 500 mg/m 2 every 21 days with either of two carboplatin doses for up to 4-6 cycles. Safety profiles of PCb doses were compared using three statistical analysis methods: frequency table analysis (FTA), generalized linear mixed effect model (GLMM), and the propensity score method. Efficacy outcomes of PCb5 and PCb6 regimens were summarized. A total of 486 patients mainly from the US, Europe, and East Asia were included in the analysis; 22% (n = 105) received PCb5 in one trial and 78% (n = 381) received PCb6 in four trials. The FTA comparison demonstrated that PCb5 vs PCb6 was associated with a statistically significantly lower incidence of TEAEs, including all-grade thrombocytopenia, anemia, fatigue, and vomiting, and grade 3/4 thrombocytopenia. In the GLMM analysis, PCb5 patients were numerically less likely to experience all-grade and grade 3/4 neutropenia, anemia, and thrombocytopenia. The propensity score regression analysis showed PCb5 group patients were significantly less likely than PCb6 group patients to experience all-grade hematologic TEAEs and grade 3/4 thrombocytopenia and anemia. After applying propensity score 1:1 matching, FTA analysis showed that the PCb5 group had significantly less all-grade and grade 3/4 hematologic toxicities. Overall efficacy outcomes, including overall survival, progression-free survival, and response rate, were similar between the two carboplatin doses. Acknowledging the limitations of this meta-analysis of five trials, heterogeneous in patient's characteristics and trial designs, the results show that the PCb5 regimen was generally associated with a better safety profile than PCb6 across three statistical approaches, with no apparent impact on survival outcomes.

Translational Research for Occupational Therapy: Using SPRE in Hippotherapy for Children with Developmental Disabilities.

PubMed

Weissman-Miller, Deborah; Miller, Rosalie J; Shotwell, Mary P

2017-01-01

Translational research is redefined in this paper using a combination of methods in statistics and data science to enhance the understanding of outcomes and practice in occupational therapy. These new methods are applied, using larger data and smaller single-subject data, to a study in hippotherapy for children with developmental disabilities (DD). The Centers for Disease Control and Prevention estimates DD affects nearly 10 million children, aged 2-19, where diagnoses may be comorbid. Hippotherapy is defined here as a treatment strategy in occupational therapy using equine movement to achieve functional outcomes. Semiparametric ratio estimator (SPRE), a single-subject statistical and small data science model, is used to derive a "change point" indicating where the participant adapts to treatment, from which predictions are made. Data analyzed here is from an institutional review board approved pilot study using the Hippotherapy Evaluation and Assessment Tool measure, where outcomes are given separately for each of four measured domains and the total scores of each participant. Analysis with SPRE, using statistical methods to predict a "change point" and data science graphical interpretations of data, shows the translational comparisons between results from larger mean values and the very different results from smaller values for each HEAT domain in terms of relationships and statistical probabilities.

Translational Research for Occupational Therapy: Using SPRE in Hippotherapy for Children with Developmental Disabilities

PubMed Central

Miller, Rosalie J.; Shotwell, Mary P.

2017-01-01

Translational research is redefined in this paper using a combination of methods in statistics and data science to enhance the understanding of outcomes and practice in occupational therapy. These new methods are applied, using larger data and smaller single-subject data, to a study in hippotherapy for children with developmental disabilities (DD). The Centers for Disease Control and Prevention estimates DD affects nearly 10 million children, aged 2–19, where diagnoses may be comorbid. Hippotherapy is defined here as a treatment strategy in occupational therapy using equine movement to achieve functional outcomes. Semiparametric ratio estimator (SPRE), a single-subject statistical and small data science model, is used to derive a “change point” indicating where the participant adapts to treatment, from which predictions are made. Data analyzed here is from an institutional review board approved pilot study using the Hippotherapy Evaluation and Assessment Tool measure, where outcomes are given separately for each of four measured domains and the total scores of each participant. Analysis with SPRE, using statistical methods to predict a “change point” and data science graphical interpretations of data, shows the translational comparisons between results from larger mean values and the very different results from smaller values for each HEAT domain in terms of relationships and statistical probabilities. PMID:29097962

How to interpret the results of medical time series data analysis: Classical statistical approaches versus dynamic Bayesian network modeling.

PubMed

Onisko, Agnieszka; Druzdzel, Marek J; Austin, R Marshall

2016-01-01

Classical statistics is a well-established approach in the analysis of medical data. While the medical community seems to be familiar with the concept of a statistical analysis and its interpretation, the Bayesian approach, argued by many of its proponents to be superior to the classical frequentist approach, is still not well-recognized in the analysis of medical data. The goal of this study is to encourage data analysts to use the Bayesian approach, such as modeling with graphical probabilistic networks, as an insightful alternative to classical statistical analysis of medical data. This paper offers a comparison of two approaches to analysis of medical time series data: (1) classical statistical approach, such as the Kaplan-Meier estimator and the Cox proportional hazards regression model, and (2) dynamic Bayesian network modeling. Our comparison is based on time series cervical cancer screening data collected at Magee-Womens Hospital, University of Pittsburgh Medical Center over 10 years. The main outcomes of our comparison are cervical cancer risk assessments produced by the three approaches. However, our analysis discusses also several aspects of the comparison, such as modeling assumptions, model building, dealing with incomplete data, individualized risk assessment, results interpretation, and model validation. Our study shows that the Bayesian approach is (1) much more flexible in terms of modeling effort, and (2) it offers an individualized risk assessment, which is more cumbersome for classical statistical approaches.

The Relationship between Parental Involvement and Urban Secondary School Student Academic Achievement: A Meta-Analysis

ERIC Educational Resources Information Center

Jeynes, William H.

2007-01-01

A meta-analysis is undertaken, including 52 studies, to determine the influence of parental involvement on the educational outcomes of urban secondary school children. Statistical analyses are done to determine the overall impact of parental involvement as well as specific components of parental involvement. Four different measures of educational…

Multiple imputation methods for bivariate outcomes in cluster randomised trials.

PubMed

DiazOrdaz, K; Kenward, M G; Gomes, M; Grieve, R

2016-09-10

Missing observations are common in cluster randomised trials. The problem is exacerbated when modelling bivariate outcomes jointly, as the proportion of complete cases is often considerably smaller than the proportion having either of the outcomes fully observed. Approaches taken to handling such missing data include the following: complete case analysis, single-level multiple imputation that ignores the clustering, multiple imputation with a fixed effect for each cluster and multilevel multiple imputation. We contrasted the alternative approaches to handling missing data in a cost-effectiveness analysis that uses data from a cluster randomised trial to evaluate an exercise intervention for care home residents. We then conducted a simulation study to assess the performance of these approaches on bivariate continuous outcomes, in terms of confidence interval coverage and empirical bias in the estimated treatment effects. Missing-at-random clustered data scenarios were simulated following a full-factorial design. Across all the missing data mechanisms considered, the multiple imputation methods provided estimators with negligible bias, while complete case analysis resulted in biased treatment effect estimates in scenarios where the randomised treatment arm was associated with missingness. Confidence interval coverage was generally in excess of nominal levels (up to 99.8%) following fixed-effects multiple imputation and too low following single-level multiple imputation. Multilevel multiple imputation led to coverage levels of approximately 95% throughout. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Do Program Implementation Factors or Fidelity Affect Chronic Disease Self-Management Education Programs' Outcomes?

PubMed

Brady, Teresa J; Murphy, Louise B; O'Colmain, Benita J; Hobson, Reeti Desai

2017-09-01

To evaluate whether implementation factors or fidelity moderate chronic disease self-management education program outcomes. Meta-analysis of 34 Arthritis Self-Management Program and Chronic Disease Self-Management Program studies. Community. N = 10 792. Twelve implementation factors: program delivery fidelity and setting and leader and participant characteristics. Eighteen program outcomes: self-reported health behaviors, physical health status, psychological health status, and health-care utilization. Meta-analysis using pooled effect sizes. Modest to moderate statistically significant differences for 4 of 6 implementation factors; these findings were counterintuitive with better outcomes when leaders and participants were unpaid, leaders had less than minimum training, and implementation did not meet fidelity requirements. Exploratory study findings suggest that these interventions tolerate some variability in implementation factors. Further work is needed to identify key elements where fidelity is essential for intervention effectiveness.

How to take deontological concerns seriously in risk-cost-benefit analysis: a re-interpretation of the precautionary principle.

PubMed

John, S D

2007-04-01

In this paper the coherence of the precautionary principle as a guide to public health policy is considered. Two conditions that any account of the principle must meet are outlined, a condition of practicality and a condition of publicity. The principle is interpreted in terms of a tripartite division of the outcomes of action (good outcomes, normal bad outcomes and special bad outcomes). Such a division of outcomes can be justified on either "consequentialist" or "deontological" grounds. In the second half of the paper, it is argued that the precautionary principle is not necessarily opposed to risk-cost-benefit analysis, but, rather, should be interpreted as suggesting a lowering of our epistemic standards for assessing evidence that there is a link between some policy and "special bad" outcomes. This suggestion is defended against the claim that it mistakes the nature of statistical testing and against the charge that it is unscientific or antiscientific, and therefore irrational.

Empirical evidence about inconsistency among studies in a pair‐wise meta‐analysis

PubMed Central

Turner, Rebecca M.; Higgins, Julian P. T.

2015-01-01

This paper investigates how inconsistency (as measured by the I2 statistic) among studies in a meta‐analysis may differ, according to the type of outcome data and effect measure. We used hierarchical models to analyse data from 3873 binary, 5132 continuous and 880 mixed outcome meta‐analyses within the Cochrane Database of Systematic Reviews. Predictive distributions for inconsistency expected in future meta‐analyses were obtained, which can inform priors for between‐study variance. Inconsistency estimates were highest on average for binary outcome meta‐analyses of risk differences and continuous outcome meta‐analyses. For a planned binary outcome meta‐analysis in a general research setting, the predictive distribution for inconsistency among log odds ratios had median 22% and 95% CI: 12% to 39%. For a continuous outcome meta‐analysis, the predictive distribution for inconsistency among standardized mean differences had median 40% and 95% CI: 15% to 73%. Levels of inconsistency were similar for binary data measured by log odds ratios and log relative risks. Fitted distributions for inconsistency expected in continuous outcome meta‐analyses using mean differences were almost identical to those using standardized mean differences. The empirical evidence on inconsistency gives guidance on which outcome measures are most likely to be consistent in particular circumstances and facilitates Bayesian meta‐analysis with an informative prior for heterogeneity. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. PMID:26679486

Changes in patellofemoral alignment do not cause clinical impact after open-wedge high tibial osteotomy.

PubMed

Lee, Yong Seuk; Lee, Sang Bok; Oh, Won Seok; Kwon, Yong Eok; Lee, Beom Koo

2016-01-01

The objectives of this study were (1) to evaluate the clinical and radiologic outcomes of open-wedge high tibial osteotomy focusing on patellofemoral alignment and (2) to search for correlation between variables and patellofemoral malalignment. A total of 46 knees (46 patients) from 32 females and 14 males who underwent open-wedge high tibial osteotomy were included in this retrospective case series. Outcomes were evaluated using clinical scales and radiologic parameters at the last follow-up. Pre-operative and final follow-up values were compared for the outcome analysis. For the focused analysis of the patellofemoral joint, correlation analyses between patellofemoral variables and pre- and post-operative weight-bearing line (WBL), clinical score, posterior slope, Blackburn Peel ratio, lateral patellar tilt, lateral patellar shift, and congruence angle were performed. The minimum follow-up period was 2 years and median follow-up period was 44 months (range 24-88 months). The percentage of weight-bearing line was shifted from 17.2 ± 11.1 to 56.7 ± 12.7%, and it was statistically significant (p < 0.01). Regarding the clinical results, statistical significance was observed using all scores (p < 0.01). In the radiologic evaluation, patellar descent was observed with statistical significance (p < 0.01). Last follow-up lateral patellar tilt was decreased with statistical significance (p < 0.01). In correlation analysis between variables of patellofemoral malalignment, the pre-operative weight-bearing line showed an association with the change in lateral patellar tilt and lateral patellar shift (correlation coefficient: 0.3). After open-wedge high tibial osteotomy, clinical results showed improvement, compared to pre-operative values. The patellar tilt and lateral patellar shift were not changed; however, descent of the patella was observed. Therefore, mild patellofemoral problems should not be a contraindication of the open-wedge high tibial osteotomy. Case series, Level IV.

Senior Computational Scientist | Center for Cancer Research

Cancer.gov

The Basic Science Program (BSP) pursues independent, multidisciplinary research in basic and applied molecular biology, immunology, retrovirology, cancer biology, and human genetics. Research efforts and support are an integral part of the Center for Cancer Research (CCR) at the Frederick National Laboratory for Cancer Research (FNLCR). The Cancer & Inflammation Program (CIP), Basic Science Program, HLA Immunogenetics Section, under the leadership of Dr. Mary Carrington, studies the influence of human leukocyte antigens (HLA) and specific KIR/HLA genotypes on risk of and outcomes to infection, cancer, autoimmune disease, and maternal-fetal disease. Recent studies have focused on the impact of HLA gene expression in disease, the molecular mechanism regulating expression levels, and the functional basis for the effect of differential expression on disease outcome. The lab’s further focus is on the genetic basis for resistance/susceptibility to disease conferred by immunogenetic variation. KEY ROLES/RESPONSIBILITIES The Senior Computational Scientist will provide research support to the CIP-BSP-HLA Immunogenetics Section performing bio-statistical design, analysis and reporting of research projects conducted in the lab. This individual will be involved in the implementation of statistical models and data preparation. Successful candidate should have 5 or more years of competent, innovative biostatistics/bioinformatics research experience, beyond doctoral training Considerable experience with statistical software, such as SAS, R and S-Plus Sound knowledge, and demonstrated experience of theoretical and applied statistics Write program code to analyze data using statistical analysis software Contribute to the interpretation and publication of research results

Composite scores in comparative effectiveness research: counterbalancing parsimony and dimensionality in patient-reported outcomes.

PubMed

Schwartz, Carolyn E; Patrick, Donald L

2014-07-01

When planning a comparative effectiveness study comparing disease-modifying treatments, competing demands influence choice of outcomes. Current practice emphasizes parsimony, although understanding multidimensional treatment impact can help to personalize medical decision-making. We discuss both sides of this 'tug of war'. We discuss the assumptions, advantages and drawbacks of composite scores and multidimensional outcomes. We describe possible solutions to the multiple comparison problem, including conceptual hierarchy distinctions, statistical approaches, 'real-world' benchmarks of effectiveness and subgroup analysis. We conclude that comparative effectiveness research should consider multiple outcome dimensions and compare different approaches that fit the individual context of study objectives.

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

PubMed Central

Scott, Jared T.; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Background Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. Methods We searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. Results 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Conclusion Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes. PMID:28727834

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals.

PubMed

Howard, Benjamin; Scott, Jared T; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. We searched PubMed for randomized controlled trials from Jan 1, 2010 -Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.

Arthroscopic Debridement for Primary Degenerative Osteoarthritis of the Elbow Leads to Significant Improvement in Range of Motion and Clinical Outcomes: A Systematic Review.

PubMed

Sochacki, Kyle R; Jack, Robert A; Hirase, Takashi; McCulloch, Patrick C; Lintner, David M; Liberman, Shari R; Harris, Joshua D

2017-12-01

The purpose of this investigation was to determine whether arthroscopic debridement of primary elbow osteoarthritis results in statistically significant and clinically relevant improvement in (1) elbow range of motion and (2) clinical outcomes with (3) low complication and reoperation rates. A systematic review was registered with PROSPERO and performed using PRISMA guidelines. Databases were searched for studies that investigated the outcomes of arthroscopic debridement for the treatment of primary osteoarthritis of the elbow in adult human patients. Study methodological quality was analyzed. Studies that included post-traumatic arthritis were excluded. Elbow motion and all elbow-specific patient-reported outcome scores were eligible for analysis. Comparisons between preoperative and postoperative values from each study were made using 2-sample Z-tests (http://in-silico.net/tools/statistics/ztest) using a P value < .05. Nine articles (209 subjects, 213 elbows, 187 males, 22 females, mean age 45.7 ± 7.1 years, mean follow-up 41.7 ± 16.3. months; 75% right, 25% left; 79% dominant elbow, 21% nondominant) were analyzed. Elbow extension (23.4°-10.7°, Δ 12.7°), flexion (115.9°-128.7°, Δ 12.8°), and global arc of motion (94.5°-117.6°, Δ 23.1°) had statistically significant and clinically relevant improvement following arthroscopic debridement (P < .0001 for all). There was also a statistically significant (P < .0001) and clinically relevant improvement in the Mayo Elbow Performance Score (60.7-84.6, Δ 23.9) postoperatively. Six patients (2.8%) had postoperative complications. Nine (4.2%) underwent reoperation. Elbow arthroscopic debridement for primary degenerative osteoarthritis results in statistically significant and clinically relevant improvement in elbow range of motion and clinical outcomes with low complication and reoperation rates. Systematic review of level IV studies. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Clopidogrel-Proton Pump Inhibitor Drug-Drug Interaction and Risk of Adverse Clinical Outcomes Among PCI-Treated ACS Patients: A Meta-analysis.

PubMed

Serbin, Michael A; Guzauskas, Gregory F; Veenstra, David L

2016-08-01

Uncertainty regarding clopidogrel effectiveness attenuation because of a drug-drug interaction with proton pump inhibitors (PPI) has led to conflicting guidelines on concomitant therapy. In particular, the effect of this interaction in patients who undergo a percutaneous coronary intervention (PCI), a population known to have increased risk of adverse cardiovascular events, has not been systematically evaluated. To synthesize the evidence of the effect of clopidogrel-PPI drug interaction on adverse cardiovascular outcomes in a PCI patient population. We conducted a systematic literature review for studies reporting clinical outcomes in patients who underwent a PCI and were initiated on clopidogrel with or without a PPI. Studies were included in the analysis if they reported at least 1 of the clinical outcomes of interest (major adverse cardiovascular event [MACE], cardiovascular death, all-cause death, myocardial infarction, stroke, stent thrombosis, and bleed events). We excluded studies that were not exclusive to PCI patients or had no PCI subgroup analysis and/or did not report at least a 6-month follow-up. Statistical and clinical heterogeneity were evaluated and HRs and 95% CIs for adverse clinical events were pooled using the DerSimonian and Laird random-effects meta-analysis method. We identified 12 studies comprising 50,277 PCI patients that met our inclusion and exclusion criteria. Our analysis included retrospective analyses of randomized controlled trials (2), health registries (3), claims databases (2), and institutional records (5); no prospective studies of PCI patients were identified. On average, patients were in their mid-60s, male, and had an array of comorbidities, including hyperlipidemia, diabetes, hypertension, and smoking history. Concomitant therapy following PCI resulted in statistically significant increases in composite MACE (HR = 1.28; 95% CI = 1.24-1.32), myocardial infarction (HR = 1.51; 95% CI = 1.40-1.62), and stroke (HR = 1.46; 95% CI = 1.15-1.86). However, concomitant therapy had no statistically significant effect on stent thrombosis, mortality measured by all-cause or cardiovascular death, or major bleeding before or after the grouping of studies that reported a major or minor bleed outcome. Only 1 study reported on gastrointestinal bleed, and pooled analysis could not be conducted. Statistical testing suggested heterogeneity among studies, but subgroup analysis did not reveal a clear source. Based on the results from this meta-analysis of retrospective analyses of randomized controlled trials and observational studies, concomitant clopidogrel-PPI therapy following PCI appears to be significantly associated with adverse cardiovascular events. Further research on the effect of individual PPIs is needed. Serbin, Guzauskas, and Veenstra were supported by the NIH Common Fund and NIA (1U01AG047109-01, Veenstra, PI) via the Personalized Medicine Economics Research (PriMER) project. The authors do not report any conflicting interests. All authors contributed to the study concept and design. Serbin took the lead in data collection; data interpretation was performed primarily by Serbin, with assistance from the other authors. The manuscript was written primarily by Serbin, along with Guzauskas, and revised by Guzauskas and Veenstra, with assistance from Serbin.

Classical Statistics and Statistical Learning in Imaging Neuroscience

PubMed Central

Bzdok, Danilo

2017-01-01

Brain-imaging research has predominantly generated insight by means of classical statistics, including regression-type analyses and null-hypothesis testing using t-test and ANOVA. Throughout recent years, statistical learning methods enjoy increasing popularity especially for applications in rich and complex data, including cross-validated out-of-sample prediction using pattern classification and sparsity-inducing regression. This concept paper discusses the implications of inferential justifications and algorithmic methodologies in common data analysis scenarios in neuroimaging. It is retraced how classical statistics and statistical learning originated from different historical contexts, build on different theoretical foundations, make different assumptions, and evaluate different outcome metrics to permit differently nuanced conclusions. The present considerations should help reduce current confusion between model-driven classical hypothesis testing and data-driven learning algorithms for investigating the brain with imaging techniques. PMID:29056896

Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.

PubMed

Weidenhammer, W; Linde, K; Melchart, D

2004-08-01

In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies. Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities? The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed. 426 patients with the main diagnosis "Migraine" and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 +/- 11.7 years (range 14-73 yrs). 4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment. Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later. Copyright 2004 S. Karger GmbH, Freiburg

Toward standardized reporting for a cohort study on functioning: The Swiss Spinal Cord Injury Cohort Study.

PubMed

Prodinger, Birgit; Ballert, Carolina S; Brach, Mirjam; Brinkhof, Martin W G; Cieza, Alarcos; Hug, Kerstin; Jordan, Xavier; Post, Marcel W M; Scheel-Sailer, Anke; Schubert, Martin; Tennant, Alan; Stucki, Gerold

2016-02-01

Functioning is an important outcome to measure in cohort studies. Clear and operational outcomes are needed to judge the quality of a cohort study. This paper outlines guiding principles for reporting functioning in cohort studies and addresses some outstanding issues. Principles of how to standardize reporting of data from a cohort study on functioning, by deriving scores that are most useful for further statistical analysis and reporting, are outlined. The Swiss Spinal Cord Injury Cohort Study Community Survey serves as a case in point to provide a practical application of these principles. Development of reporting scores must be conceptually coherent and metrically sound. The International Classification of Functioning, Disability and Health (ICF) can serve as the frame of reference for this, with its categories serving as reference units for reporting. To derive a score for further statistical analysis and reporting, items measuring a single latent trait must be invariant across groups. The Rasch measurement model is well suited to test these assumptions. Our approach is a valuable guide for researchers and clinicians, as it fosters comparability of data, strengthens the comprehensiveness of scope, and provides invariant, interval-scaled data for further statistical analyses of functioning.

A collaborative sequential meta-analysis of individual patient data from randomized trials of endovascular therapy and tPA vs. tPA alone for acute ischemic stroke: ThRombEctomy And tPA (TREAT) analysis: statistical analysis plan for a sequential meta-analysis performed within the VISTA-Endovascular collaboration.

PubMed

MacIsaac, Rachael L; Khatri, Pooja; Bendszus, Martin; Bracard, Serge; Broderick, Joseph; Campbell, Bruce; Ciccone, Alfonso; Dávalos, Antoni; Davis, Stephen M; Demchuk, Andrew; Diener, Hans-Christoph; Dippel, Diederik; Donnan, Geoffrey A; Fiehler, Jens; Fiorella, David; Goyal, Mayank; Hacke, Werner; Hill, Michael D; Jahan, Reza; Jauch, Edward; Jovin, Tudor; Kidwell, Chelsea S; Liebeskind, David; Majoie, Charles B; Martins, Sheila Cristina Ouriques; Mitchell, Peter; Mocco, J; Muir, Keith W; Nogueira, Raul; Saver, Jeffrey L; Schonewille, Wouter J; Siddiqui, Adnan H; Thomalla, Götz; Tomsick, Thomas A; Turk, Aquilla S; White, Philip; Zaidat, Osama; Lees, Kennedy R

2015-10-01

Endovascular treatment has been shown to restore blood flow effectively. Second-generation medical devices such as stent retrievers are now showing overwhelming efficacy in clinical trials, particularly in conjunction with intravenous recombinant tissue plasminogen activator. This statistical analysis plan utilizing a novel, sequential approach describes a prospective, individual patient data analysis of endovascular therapy in conjunction with intravenous recombinant tissue plasminogen activator agreed upon by the Thrombectomy and Tissue Plasminogen Activator Collaborative Group. This protocol will specify the primary outcome for efficacy, as 'favorable' outcome defined by the ordinal distribution of the modified Rankin Scale measured at three-months poststroke, but with modified Rankin Scales 5 and 6 collapsed into a single category. The primary analysis will aim to answer the questions: 'what is the treatment effect of endovascular therapy with intravenous recombinant tissue plasminogen activator compared to intravenous tissue plasminogen activator alone on full scale modified Rankin Scale at 3 months?' and 'to what extent do key patient characteristics influence the treatment effect of endovascular therapy?'. Key secondary outcomes include effect of endovascular therapy on death within 90 days; analyses of modified Rankin Scale using dichotomized methods; and effects of endovascular therapy on symptomatic intracranial hemorrhage. Several secondary analyses will be considered as well as expanding patient cohorts to intravenous recombinant tissue plasminogen activator-ineligible patients, should data allow. This collaborative meta-analysis of individual participant data from randomized trials of endovascular therapy vs. control in conjunction with intravenous thrombolysis will demonstrate the efficacy and generalizability of endovascular therapy with intravenous thrombolysis as a concomitant medication. © 2015 World Stroke Organization.

Analysis and meta-analysis of single-case designs: an introduction.

PubMed

Shadish, William R

2014-04-01

The last 10 years have seen great progress in the analysis and meta-analysis of single-case designs (SCDs). This special issue includes five articles that provide an overview of current work on that topic, including standardized mean difference statistics, multilevel models, Bayesian statistics, and generalized additive models. Each article analyzes a common example across articles and presents syntax or macros for how to do them. These articles are followed by commentaries from single-case design researchers and journal editors. This introduction briefly describes each article and then discusses several issues that must be addressed before we can know what analyses will eventually be best to use in SCD research. These issues include modeling trend, modeling error covariances, computing standardized effect size estimates, assessing statistical power, incorporating more accurate models of outcome distributions, exploring whether Bayesian statistics can improve estimation given the small samples common in SCDs, and the need for annotated syntax and graphical user interfaces that make complex statistics accessible to SCD researchers. The article then discusses reasons why SCD researchers are likely to incorporate statistical analyses into their research more often in the future, including changing expectations and contingencies regarding SCD research from outside SCD communities, changes and diversity within SCD communities, corrections of erroneous beliefs about the relationship between SCD research and statistics, and demonstrations of how statistics can help SCD researchers better meet their goals. Copyright © 2013 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

The volume-mortality relation for radical cystectomy in England: retrospective analysis of hospital episode statistics

PubMed Central

Bottle, Alex; Darzi, Ara W; Athanasiou, Thanos; Vale, Justin A

2010-01-01

Objectives To investigate the relation between volume and mortality after adjustment for case mix for radical cystectomy in the English healthcare setting using improved statistical methodology, taking into account the institutional and surgeon volume effects and institutional structural and process of care factors. Design Retrospective analysis of hospital episode statistics using multilevel modelling. Setting English hospitals carrying out radical cystectomy in the seven financial years 2000/1 to 2006/7. Participants Patients with a primary diagnosis of cancer undergoing an inpatient elective cystectomy. Main outcome measure Mortality within 30 days of cystectomy. Results Compared with low volume institutions, medium volume ones had a significantly higher odds of in-hospital and total mortality: odds ratio 1.72 (95% confidence interval 1.00 to 2.98, P=0.05) and 1.82 (1.08 to 3.06, P=0.02). This was only seen in the final model, which included adjustment for structural and processes of care factors. The surgeon volume-mortality relation showed weak evidence of reduced odds of in-hospital mortality (by 35%) for the high volume surgeons, although this did not reach statistical significance at the 5% level. Conclusions The relation between case volume and mortality after radical cystectomy for bladder cancer became evident only after adjustment for structural and process of care factors, including staffing levels of nurses and junior doctors, in addition to case mix. At least for this relatively uncommon procedure, adjusting for these confounders when examining the volume-outcome relation is critical before considering centralisation of care to a few specialist institutions. Outcomes other than mortality, such as functional morbidity and disease recurrence may ultimately influence towards centralising care. PMID:20305302

The effect of missing KIR ligands, activating KIR genotype and haplotype on the outcome of T-cell-replete hematopoietic stem cell transplantation from HLA-identical siblings in Thai patients.

PubMed

Khanuntong, S; Kuptawintu, P; Upaisilpsathaporn, K; Poolchareon, A; Bunworasate, U; Hirankarn, N

2016-06-01

This study was a retrospective analysis of Thai patients undergoing T-replete hematopoietic stem cell transplant from human leukocyte antigen (HLA)-identical sibling donors. We investigated 66 patients, including 40 patients with acute myeloid leukemia (AML), 12 patients with acute lymphoblastic leukemia and 14 patients with chronic myeloid leukemia. Killer cell immunoglobulin-like receptor (KIR) genes and HLA ligands were typed by polymerase chain reaction-sequence specific oligonucleotide probes. We analyzed the effect of the number of missing KIR ligands (Bw4, C1 and C2) on clinical outcomes. A beneficial effect of missing KIR ligand was not observed in both univariate and multivariate analysis. When we analyzed the effect of specific missing KIR ligand on clinical outcomes, there was a trend that patients with missing A11 ligand had lower relapse rate (P = 0.076). Therefore, we also conducted the analysis by including the group with missing KIR ligands of Bw4, C1, C2 and A11. Patients with two or more than two missing KIR ligands had a trend for better clinical outcome including reduced relapse (P = 055) and statistically significant in terms of reduced acute graft-vs-host disease (aGVHD) rate (P = 0.013). In multivariate analysis, patients with two or more than two missing KIR ligands had a statistically significant better clinical outcome in terms of reduced aGVHD rate (HR = 0.155, 95%CI = 0.040-0.605, P = 0.007). The association between clinical outcome with KIR haplotypes, centromeric B haplotype and activating KIR was not observed here. Although the sample size in this study is rather limited, these data can later be subjected to meta-analysis to help reach the conclusion of the usefulness of this additional promising KIR genotyping in various hematopoietic stem cell transplantation types. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparing Distributions of Environmental Outcomes for Regulatory Environmental Justice Analysis

PubMed Central

Maguire, Kelly; Sheriff, Glenn

2011-01-01

Economists have long been interested in measuring distributional impacts of policy interventions. As environmental justice (EJ) emerged as an ethical issue in the 1970s, the academic literature has provided statistical analyses of the incidence and causes of various environmental outcomes as they relate to race, income, and other demographic variables. In the context of regulatory impacts, however, there is a lack of consensus regarding what information is relevant for EJ analysis, and how best to present it. This paper helps frame the discussion by suggesting a set of questions fundamental to regulatory EJ analysis, reviewing past approaches to quantifying distributional equity, and discussing the potential for adapting existing tools to the regulatory context. PMID:21655146

The median hazard ratio: a useful measure of variance and general contextual effects in multilevel survival analysis.

PubMed

Austin, Peter C; Wagner, Philippe; Merlo, Juan

2017-03-15

Multilevel data occurs frequently in many research areas like health services research and epidemiology. A suitable way to analyze such data is through the use of multilevel regression models (MLRM). MLRM incorporate cluster-specific random effects which allow one to partition the total individual variance into between-cluster variation and between-individual variation. Statistically, MLRM account for the dependency of the data within clusters and provide correct estimates of uncertainty around regression coefficients. Substantively, the magnitude of the effect of clustering provides a measure of the General Contextual Effect (GCE). When outcomes are binary, the GCE can also be quantified by measures of heterogeneity like the Median Odds Ratio (MOR) calculated from a multilevel logistic regression model. Time-to-event outcomes within a multilevel structure occur commonly in epidemiological and medical research. However, the Median Hazard Ratio (MHR) that corresponds to the MOR in multilevel (i.e., 'frailty') Cox proportional hazards regression is rarely used. Analogously to the MOR, the MHR is the median relative change in the hazard of the occurrence of the outcome when comparing identical subjects from two randomly selected different clusters that are ordered by risk. We illustrate the application and interpretation of the MHR in a case study analyzing the hazard of mortality in patients hospitalized for acute myocardial infarction at hospitals in Ontario, Canada. We provide R code for computing the MHR. The MHR is a useful and intuitive measure for expressing cluster heterogeneity in the outcome and, thereby, estimating general contextual effects in multilevel survival analysis. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

Therapeutic whole-body hypothermia reduces mortality in severe traumatic brain injury if the cooling index is sufficiently high: meta-analyses of the effect of single cooling parameters and their integrated measure.

PubMed

Olah, Emoke; Poto, Laszlo; Hegyi, Peter; Szabo, Imre; Hartmann, Petra; Solymar, Margit; Petervari, Erika; Balasko, Marta; Habon, Tamas; Rumbus, Zoltan; Tenk, Judit; Rostas, Ildiko; Weinberg, Jordan; Romanovsky, Andrej A; Garami, Andras

2018-04-21

Therapeutic hypothermia was investigated repeatedly as a tool to improve the outcome of severe traumatic brain injury (TBI), but previous clinical trials and meta-analyses found contradictory results. We aimed to determine the effectiveness of therapeutic whole-body hypothermia on the mortality of adult patients with severe TBI by using a novel approach of meta-analysis. We searched the PubMed, EMBASE, and Cochrane Library databases from inception to February 2017. The identified human studies were evaluated regarding statistical, clinical, and methodological designs to ensure inter-study homogeneity. We extracted data on TBI severity, body temperature, mortality, and cooling parameters; then we calculated the cooling index, an integrated measure of therapeutic hypothermia. Forest plot of all identified studies showed no difference in the outcome of TBI between cooled and not cooled patients, but inter-study heterogeneity was high. On the contrary, by meta-analysis of RCTs which were homogenous with regards to statistical, clinical designs and precisely reported the cooling protocol, we showed decreased odds ratio for mortality in therapeutic hypothermia compared to no cooling. As independent factors, milder and longer cooling, and rewarming at < 0.25°C/h were associated with better outcome. Therapeutic hypothermia was beneficial only if the cooling index (measure of combination of cooling parameters) was sufficiently high. We conclude that high methodological and statistical inter-study heterogeneity could underlie the contradictory results obtained in previous studies. By analyzing methodologically homogenous studies, we show that cooling improves the outcome of severe TBI and this beneficial effect depends on certain cooling parameters and on their integrated measure, the cooling index.

Regression Rates Following the Treatment of Aggressive Posterior Retinopathy of Prematurity with Bevacizumab Versus Laser: 8-Year Retrospective Analysis

PubMed Central

Nicoară, Simona D.; Ştefănuţ, Anne C.; Nascutzy, Constanta; Zaharie, Gabriela C.; Toader, Laura E.; Drugan, Tudor C.

2016-01-01

Background Retinopathy is a serious complication related to prematurity and a leading cause of childhood blindness. The aggressive posterior form of retinopathy of prematurity (APROP) has a worse anatomical and functional outcome following laser therapy, as compared with the classic form of the disease. The main outcome measures are the APROP regression rate, structural outcomes, and complications associated with intravitreal bevacizumab (IVB) versus laser photocoagulation in APROP. Material/Methods This is a retrospective case series that includes infants with APROP who received either IVB or laser photocoagulation and had a follow-up of at least 60 weeks (for the laser photocoagulation group) and 80 weeks (for the IVB group). In the first group, laser photocoagulation of the retina was carried out and in the second group, 1 bevacizumab injection was administered intravitreally. The following parameters were analyzed in each group: sex, gestational age, birth weight, postnatal age and postmenstrual age at treatment, APROP regression, sequelae, and complications. Statistical analysis was performed using Microsoft Excel and IBM SPSS (version 23.0). Results The laser photocoagulation group consisted of 6 premature infants (12 eyes) and the IVB group consisted of 17 premature infants (34 eyes). Within the laser photocoagulation group, the evolution was favorable in 9 eyes (75%) and unfavorable in 3 eyes (25%). Within the IVB group, APROP regressed in 29 eyes (85.29%) and failed to regress in 5 eyes (14.71%). These differences are statistically significant, as proved by the McNemar test (P<0.001). Conclusions The IVB group had a statistically significant better outcome compared with the laser photocoagulation group, in APROP in our series. PMID:27062023

Does restoration of focal lumbar lordosis for single level degenerative spondylolisthesis result in better patient-reported clinical outcomes? A systematic literature review.

PubMed

Rhee, Chanseok; Visintini, Sarah; Dunning, Cynthia E; Oxner, William M; Glennie, R Andrew

2017-10-01

It is controversial whether the surgical restoration of sagittal balance and spinopelvic angulation in a single level lumbar degenerative spondylolisthesis results in clinical improvements. The purpose of this study to systematically review the available literature to determine whether the surgical correction of malalignment in lumbar degenerative spondylolisthesis correlates with improvements in patient-reported clinical outcomes. Literature searches were performed via Ovid Medline, Embase, CENTRAL and Web of Science using search terms "lumbar," "degenerative/spondylolisthesis" and "surgery/surgical/surgeries/fusion". This resulted in 844 articles and after reviewing the abstracts and full-texts, 13 articles were included for summary and final analysis. There were two Level II articles, four Level III articles and five Level IV articles. Most commonly used patient-reported outcome measures (PROMs) were Oswestery disability index (ODI) and visual analogue scale (VAS). Four articles were included for the final statistical analysis. There was no statistically significant difference between the patient groups who achieved successful surgical correction of malalignment and those who did not for either ODI (mean difference -0.94, CI -8.89-7.00) or VAS (mean difference 1.57, CI -3.16-6.30). Two studies assessed the efficacy of manual reduction of lumbar degenerative spondylolisthesis and their clinical outcomes after the operation, and there was no statistically significant improvement. Overall, the restoration of focal lumbar lordosis and restoration of sagittal balance for single-level lumbar degenerative spondylolisthesis does not seem to yield clinical improvements but well-powered studies on this specific topic is lacking in the current literature. Future well-powered studies are needed for a more definitive conclusion. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prostate Cancer Disparities in an Incarcerated Community

DTIC Science & Technology

2013-09-01

Based Medicine & Health Outcomes Research 12901 Bruce B Downs Blvd. MDC 02 Tampa, Florida 33612-4799 (Study Design and Interpretation) Task 1...Clinical Research 12901 Bruce B. Downs Blvd. MDC 2 Tampa, Florida 33612-4799 (Statistical Analysis) University of South Florida Center for Evidence

Analysis and meta-analysis of single-case designs with a standardized mean difference statistic: a primer and applications.

PubMed

Shadish, William R; Hedges, Larry V; Pustejovsky, James E

2014-04-01

This article presents a d-statistic for single-case designs that is in the same metric as the d-statistic used in between-subjects designs such as randomized experiments and offers some reasons why such a statistic would be useful in SCD research. The d has a formal statistical development, is accompanied by appropriate power analyses, and can be estimated using user-friendly SPSS macros. We discuss both advantages and disadvantages of d compared to other approaches such as previous d-statistics, overlap statistics, and multilevel modeling. It requires at least three cases for computation and assumes normally distributed outcomes and stationarity, assumptions that are discussed in some detail. We also show how to test these assumptions. The core of the article then demonstrates in depth how to compute d for one study, including estimation of the autocorrelation and the ratio of between case variance to total variance (between case plus within case variance), how to compute power using a macro, and how to use the d to conduct a meta-analysis of studies using single-case designs in the free program R, including syntax in an appendix. This syntax includes how to read data, compute fixed and random effect average effect sizes, prepare a forest plot and a cumulative meta-analysis, estimate various influence statistics to identify studies contributing to heterogeneity and effect size, and do various kinds of publication bias analyses. This d may prove useful for both the analysis and meta-analysis of data from SCDs. Copyright © 2013 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Does high-flow nasal cannula oxygen improve outcome in acute hypoxemic respiratory failure? A systematic review and meta-analysis.

PubMed

Lin, Si-Ming; Liu, Kai-Xiong; Lin, Zhi-Hong; Lin, Pei-Hong

2017-10-01

To evaluate the efficacy of high-flow nasal cannula (HFNC) in the rate of intubation and mortality for patients with acute hypoxemic respiratory failure. We searched Pubmed, EMBASE, and the Cochrane Library for relevant studies. Two reviewers extracted data and reviewed the quality of the studies independently. The primary outcome was the rate of intubation; secondary outcome was mortality in the hospital. Study-level data were pooled using a random-effects model when I2 was >50% or a fixed-effects model when I2 was <50%. Eight randomized controlled studies with a total of 1,818patients were considered. Pooled analysis showed that no statistically significant difference was found between groups regarding the rate of intubation (odds ratio [OR] = 0.79; 95% confidence interval [CI]: 0.60-1.04; P = 0.09; I2 = 36%) and no statistically significant difference was found between groups regarding hospital mortality (OR = 0.89; 95% CI: 0.62-127; P = 0.51; I2 = 47%). The use of HFNC showed a trend toward reduction in the intubation rate, which did not meet statistical significance, in patients with acute respiratory failure compared with conventional oxygen therapy (COT) and noninvasive ventilation (NIV). Moreover no difference in mortality. So, Large, well-designed, randomized, multi-center trials are needed to confirm the effects of HFNC in acute hypoxemic respiratory failure patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Predicting Risk Sensitivity in Humans and Lower Animals: Risk as Variance or Coefficient of Variation

ERIC Educational Resources Information Center

Weber, Elke U.; Shafir, Sharoni; Blais, Ann-Renee

2004-01-01

This article examines the statistical determinants of risk preference. In a meta-analysis of animal risk preference (foraging birds and insects), the coefficient of variation (CV), a measure of risk per unit of return, predicts choices far better than outcome variance, the risk measure of normative models. In a meta-analysis of human risk…

Mediation Analysis with Survival Outcomes: Accelerated Failure Time vs. Proportional Hazards Models.

PubMed

Gelfand, Lois A; MacKinnon, David P; DeRubeis, Robert J; Baraldi, Amanda N

2016-01-01

Survival time is an important type of outcome variable in treatment research. Currently, limited guidance is available regarding performing mediation analyses with survival outcomes, which generally do not have normally distributed errors, and contain unobserved (censored) events. We present considerations for choosing an approach, using a comparison of semi-parametric proportional hazards (PH) and fully parametric accelerated failure time (AFT) approaches for illustration. We compare PH and AFT models and procedures in their integration into mediation models and review their ability to produce coefficients that estimate causal effects. Using simulation studies modeling Weibull-distributed survival times, we compare statistical properties of mediation analyses incorporating PH and AFT approaches (employing SAS procedures PHREG and LIFEREG, respectively) under varied data conditions, some including censoring. A simulated data set illustrates the findings. AFT models integrate more easily than PH models into mediation models. Furthermore, mediation analyses incorporating LIFEREG produce coefficients that can estimate causal effects, and demonstrate superior statistical properties. Censoring introduces bias in the coefficient estimate representing the treatment effect on outcome-underestimation in LIFEREG, and overestimation in PHREG. With LIFEREG, this bias can be addressed using an alternative estimate obtained from combining other coefficients, whereas this is not possible with PHREG. When Weibull assumptions are not violated, there are compelling advantages to using LIFEREG over PHREG for mediation analyses involving survival-time outcomes. Irrespective of the procedures used, the interpretation of coefficients, effects of censoring on coefficient estimates, and statistical properties should be taken into account when reporting results.

[Results of two treatment regimens for pyelonephritis during pregnancy and correlation with pregnancy outcome].

PubMed

Calegari, Saron Souza; Konopka, Cristine Kolling; Balestrin, Bruna; Hoffmann, Maurício Scopel; de Souza, Floriano Soeiro; Resener, Elaine Verena

2012-08-01

To determine the epidemiological profile of women admitted for urinary tract infection as well as to verify the most prevalent agents and response to antibiotic therapy. A retrospective study of 106 pregnant women admitted to a university hospital for urinary tract infection treatment during the period between January 2007 to December 2010. The evaluation was based on analysis of the medical records of these pregnant women, with the observation of hospitalization and pregnancy data, as well as its outcome. Statistical analysis was performed using Statistical Package for the Social Science, version 15.0. The bilateral Fisher exact test and Student's t test were used for data analysis, as well as descriptive statistical methods. Positive urine cultures were observed in 60.5% of pregnant women admitted due to urinary tract infection. The most frequent infectious agent was Escherichia coli and no difference in resistance, recurrence or complications was observed between the most frequent etiologic agents. Pregnant women with previous UTI had a higher recurrence risk (OR=10.8; p<0.05). The antibiotics most commonly used during hospitalization were ampicillin and cefazolin. Change of therapeutic agent due to bacterial resistance occurred in 11.9% of patients who took cefazolin and in 20% of patients who took ampicillin (OR=5.5; p<0.05). The rate of gestational complications was the same for both treatments. There was no difference in mean number of days of hospitalization between the treatments. In the studied population ampicillin showed a higher rate of bacterial resistance than cefazolin, requiring a larger number of treatment regimen exchanges, without resulting in differences in clinical outcome or time of hospitalization.

Statistical analysis of subjective preferences for video enhancement

NASA Astrophysics Data System (ADS)

Woods, Russell L.; Satgunam, PremNandhini; Bronstad, P. Matthew; Peli, Eli

2010-02-01

Measuring preferences for moving video quality is harder than for static images due to the fleeting and variable nature of moving video. Subjective preferences for image quality can be tested by observers indicating their preference for one image over another. Such pairwise comparisons can be analyzed using Thurstone scaling (Farrell, 1999). Thurstone (1927) scaling is widely used in applied psychology, marketing, food tasting and advertising research. Thurstone analysis constructs an arbitrary perceptual scale for the items that are compared (e.g. enhancement levels). However, Thurstone scaling does not determine the statistical significance of the differences between items on that perceptual scale. Recent papers have provided inferential statistical methods that produce an outcome similar to Thurstone scaling (Lipovetsky and Conklin, 2004). Here, we demonstrate that binary logistic regression can analyze preferences for enhanced video.

Allowing for uncertainty due to missing continuous outcome data in pairwise and network meta-analysis.

PubMed

Mavridis, Dimitris; White, Ian R; Higgins, Julian P T; Cipriani, Andrea; Salanti, Georgia

2015-02-28

Missing outcome data are commonly encountered in randomized controlled trials and hence may need to be addressed in a meta-analysis of multiple trials. A common and simple approach to deal with missing data is to restrict analysis to individuals for whom the outcome was obtained (complete case analysis). However, estimated treatment effects from complete case analyses are potentially biased if informative missing data are ignored. We develop methods for estimating meta-analytic summary treatment effects for continuous outcomes in the presence of missing data for some of the individuals within the trials. We build on a method previously developed for binary outcomes, which quantifies the degree of departure from a missing at random assumption via the informative missingness odds ratio. Our new model quantifies the degree of departure from missing at random using either an informative missingness difference of means or an informative missingness ratio of means, both of which relate the mean value of the missing outcome data to that of the observed data. We propose estimating the treatment effects, adjusted for informative missingness, and their standard errors by a Taylor series approximation and by a Monte Carlo method. We apply the methodology to examples of both pairwise and network meta-analysis with multi-arm trials. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Using Computational Modeling to Assess the Impact of Clinical Decision Support on Cancer Screening within Community Health Centers

PubMed Central

Carney, Timothy Jay; Morgan, Geoffrey P.; Jones, Josette; McDaniel, Anna M.; Weaver, Michael; Weiner, Bryan; Haggstrom, David A.

2014-01-01

Our conceptual model demonstrates our goal to investigate the impact of clinical decision support (CDS) utilization on cancer screening improvement strategies in the community health care (CHC) setting. We employed a dual modeling technique using both statistical and computational modeling to evaluate impact. Our statistical model used the Spearman’s Rho test to evaluate the strength of relationship between our proximal outcome measures (CDS utilization) against our distal outcome measure (provider self-reported cancer screening improvement). Our computational model relied on network evolution theory and made use of a tool called Construct-TM to model the use of CDS measured by the rate of organizational learning. We employed the use of previously collected survey data from community health centers Cancer Health Disparities Collaborative (HDCC). Our intent is to demonstrate the added valued gained by using a computational modeling tool in conjunction with a statistical analysis when evaluating the impact a health information technology, in the form of CDS, on health care quality process outcomes such as facility-level screening improvement. Significant simulated disparities in organizational learning over time were observed between community health centers beginning the simulation with high and low clinical decision support capability. PMID:24953241

Outcomes assessment following treatment of spasmodic dysphonia with botulinum toxin.

PubMed

Courey, M S; Garrett, C G; Billante, C R; Stone, R E; Portell, M D; Smith, T L; Netterville, J L

2000-09-01

Spasmodic dysphonia (SD), a disabling focal dystonia involving the laryngeal musculature, is most commonly treated by the intramuscular injection of botulinum toxin (BTX). Although the treatment is well tolerated and generally produces clinical voice improvement, it has never been statistically shown to alter the patient's perception of voice quality or general health. Declining resources for medical care mandate that treatment outcomes be documented. A prospective analysis of the effects of BTX on the patient's perception of voice and general health was undertaken. The Voice Handicap Index (VHI) and Short Form 36 (SF-36) surveys were administered to patients before treatment and 1 month after. Pretreatment and posttreatment scores were analyzed with a Student's t-test. On the VHI, improvements in the patients' perception of their functional, physical, and emotional voice handicap reached statistical significance (p < or = .0005). On the SF-36, patients had statistically significant improvements in mental health (p < or = .03) and social functioning (p < or = .04). Treatment of SD with BTX significantly lessened the patients' perception of dysphonia. In addition, it improved their social functioning and their perception of their mental health. These outcome measures justify the continued treatment of SD with BTX.

Adult asthma disease management: an analysis of studies, approaches, outcomes, and methods.

PubMed

Maciejewski, Matthew L; Chen, Shih-Yin; Au, David H

2009-07-01

Disease management has been implemented for patients with asthma in various ways. We describe the approaches to and components of adult asthma disease-management interventions, examine the outcomes evaluated, and assess the quality of published studies. We searched the MEDLINE, EMBASE, CINAHL, PsychInfo, and Cochrane databases for studies published in 1986 through 2008, on adult asthma management. With the studies that met our inclusion criteria, we examined the clinical, process, medication, economic, and patient-reported outcomes reported, and the study designs, provider collaboration during the studies, and statistical methods. Twenty-nine articles describing 27 studies satisfied our inclusion criteria. There was great variation in the content, extent of collaboration between physician and non-physician providers responsible for intervention delivery, and outcomes examined across the 27 studies. Because of limitations in the design of 22 of the 27 studies, the differences in outcomes assessed, and the lack of rigorous statistical adjustment, we could not draw definitive conclusions about the effectiveness or cost-effectiveness of the asthma disease-management programs or which approach was most effective. Few well-designed studies with rigorous evaluations have been conducted to evaluate disease-management interventions for adults with asthma. Current evidence is insufficient to recommend any particular intervention.

Can Propensity Score Analysis Approximate Randomized Experiments Using Pretest and Demographic Information in Pre-K Intervention Research?

PubMed

Dong, Nianbo; Lipsey, Mark W

2017-01-01

It is unclear whether propensity score analysis (PSA) based on pretest and demographic covariates will meet the ignorability assumption for replicating the results of randomized experiments. This study applies within-study comparisons to assess whether pre-Kindergarten (pre-K) treatment effects on achievement outcomes estimated using PSA based on a pretest and demographic covariates can approximate those found in a randomized experiment. Data-Four studies with samples of pre-K children each provided data on two math achievement outcome measures with baseline pretests and child demographic variables that included race, gender, age, language spoken at home, and mother's highest education. Research Design and Data Analysis-A randomized study of a pre-K math curriculum provided benchmark estimates of effects on achievement measures. Comparison samples from other pre-K studies were then substituted for the original randomized control and the effects were reestimated using PSA. The correspondence was evaluated using multiple criteria. The effect estimates using PSA were in the same direction as the benchmark estimates, had similar but not identical statistical significance, and did not differ from the benchmarks at statistically significant levels. However, the magnitude of the effect sizes differed and displayed both absolute and relative bias larger than required to show statistical equivalence with formal tests, but those results were not definitive because of the limited statistical power. We conclude that treatment effect estimates based on a single pretest and demographic covariates in PSA correspond to those from a randomized experiment on the most general criteria for equivalence.

Does the Extended Glasgow Outcome Scale Add Value to the Conventional Glasgow Outcome Scale?

PubMed Central

Weir, James; Steyerberg, Ewout W.; Butcher, Isabella; Lu, Juan; Lingsma, Hester F.; McHugh, Gillian S.; Roozenbeek, Bob; Maas, Andrew I.R.

2012-01-01

Abstract The Glasgow Outcome Scale (GOS) is firmly established as the primary outcome measure for use in Phase III trials of interventions in traumatic brain injury (TBI). However, the GOS has been criticized for its lack of sensitivity to detect small but clinically relevant changes in outcome. The Glasgow Outcome Scale-Extended (GOSE) potentially addresses this criticism, and in this study we estimate the efficiency gain associated with using the GOSE in place of the GOS in ordinal analysis of 6-month outcome. The study uses both simulation and the reanalysis of existing data from two completed TBI studies, one an observational cohort study and the other a randomized controlled trial. As expected, the results show that using an ordinal technique to analyze the GOS gives a substantial gain in efficiency relative to the conventional analysis, which collapses the GOS onto a binary scale (favorable versus unfavorable outcome). We also found that using the GOSE gave a modest but consistent increase in efficiency relative to the GOS in both studies, corresponding to a reduction in the required sample size of the order of 3–5%. We recommend that the GOSE be used in place of the GOS as the primary outcome measure in trials of TBI, with an appropriate ordinal approach being taken to the statistical analysis. PMID:22026476

Economic effectiveness of disease management programs: a meta-analysis.

PubMed

Krause, David S

2005-04-01

The economic effectiveness of disease management programs, which are designed to improve the clinical and economic outcomes for chronically ill individuals, has been evaluated extensively. A literature search was performed with MEDLINE and other published sources for the period covering January 1995 to September 2003. The search was limited to empirical articles that measured the direct economic outcomes for asthma, diabetes, and heart disease management programs. Of the 360 articles and presentations evaluated, only 67 met the selection criteria for meta-analysis, which included 32,041 subjects. Although some studies contained multiple measurements of direct economic outcomes, only one average effect size per study was included in the meta-analysis. Based on the studies included in the research, a meta-analysis provided a statistically significant answer to the question of whether disease management programs are economically effective. The magnitude of the observed average effect size for equally weighted studies was 0.311 (95% CI = 0.272-0.350). Statistically significant differences of effect sizes by study design, disease type and intensity of disease management program interventions were not found after a moderating variable, disease severity, was taken into consideration. The results suggest that disease management programs are more effective economically with severely ill enrollees and that chronic disease program interventions are most effective when coordinated with the overall level of disease severity. The findings can be generalized, which may assist health care policy makers and practitioners in addressing the issue of providing economically effective care for the growing number of individuals with chronic illness.

Combination of pharmacotherapy and psychotherapy in the treatment of chronic depression: A systematic review and meta-analysis

PubMed Central

2012-01-01

Background Chronic depression represents a substantial portion of depressive disorders and is associated with severe consequences. This review examined whether the combination of pharmacological treatments and psychotherapy is associated with higher effectiveness than pharmacotherapy alone via meta-analysis; and identified possible treatment effect modifiers via meta-regression-analysis. Methods A systematic search was conducted in the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ISI Web of Science, BIOSIS, PsycINFO, and CINAHL. Primary efficacy outcome was a response to treatment; primary acceptance outcome was dropping out of the study. Only randomized controlled trials were considered. Results We identified 8 studies with a total of 9 relevant comparisons. Our analysis revealed small, but statistically not significant effects of combined therapies on outcomes directly related to depression (BR = 1.20) with substantial heterogeneity between studies (I² = 67%). Three treatment effect modifiers were identified: target disorders, the type of psychotherapy and the type of pharmacotherapy. Small but statistically significant effects of combined therapies on quality of life (SMD = 0.18) were revealed. No differences in acceptance rates and the long-term effects between combined treatments and pure pharmacological interventions were observed. Conclusions This systematic review could not provide clear evidence for the combination of pharmacotherapy and psychotherapy. However, due to the small amount of primary studies further research is needed for a conclusive decision. PMID:22694751

Novel Mechanism for Reducing Acute and Chronic Neurodegeneration After Traumatic Brain Injury

DTIC Science & Technology

2017-07-01

glutamate from the brain. Scope: We will test this novel and powerful neuroprotective treatment in a rat model of repetitive mild (concussive) TBIs...variability. 2. Completed statistical analysis of behavioral experiments examining effects of rGOT and rGOT + OxAc on outcome on rotarod and Morris water ...neuroprotective treatment in a rat model of a single moderate TBI and in a rat model of repetitive mild (concussive) TBIs. Outcome measures include blood and

The Unequal Impact of Food Insecurity on Cognitive and Behavioral Outcomes among 5-Year-Old Urban Children.

PubMed

Hobbs, Savannah; King, Christian

2018-05-09

To examine the associations of food insecurity with children's cognitive and behavioral outcomes using quantile regression. Secondary analysis of the Fragile Families and Child Wellbeing Study dataset. A total of 2,046 children aged 5 years. Child behavioral outcomes were measured using externalizing (aggressive) and internalizing (emotional) behavior problems. Child cognitive outcomes were measured using the Peabody Vocabulary test and the Woodcock-Johnson letter-word identification test. Food insecurity was measured using the US Department of Agriculture's Food Security Module. Unconditional quantile regressions were employed. Statistical significance was set at P ≤ .05. Negative associations between food insecurity and child behavior problems (externalizing and internalizing) were largest for children with the most behavior problems. For Peabody Vocabulary scores, the negative association with food insecurity was statistically significant only for children in the top half of the distribution (≥50th percentile). The analysis found mixed evidence of an association between food insecurity and the Woodcock-Johnson letter-word identification test. These associations were similar for boys and girls. Because children's cognitive skills and behavioral problems have long-lasting implications and effects later in life, reducing the risk of food insecurity might particularly benefit children with greater externalizing and internalizing behavior problems. Copyright © 2018 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Clinical and radiographic assessment of various predictors for healing outcome 1 year after periapical surgery.

PubMed

von Arx, Thomas; Jensen, Simon Storgård; Hänni, Stefan

2007-02-01

This clinical study prospectively evaluated the influence of various predictors on healing outcome 1 year after periapical surgery. The study cohort included 194 teeth in an equal number of patients. Three teeth were lost for the follow-up (1.5% drop-out rate). Clinical and radiographic measures were used to determine the healing outcome. For statistical analysis, results were dichotomized (healed versus nonhealed). The overall success rate was 83.8% (healed cases). The only individual predictors to prove significant for the outcome were pain at initial examination (p=0.030) and other clinical signs or symptoms at initial examination (p=0.042), meaning that such teeth had lower healing rates 1 year after periapical surgery compared with teeth without such signs or symptoms. Logistic regression revealed that pain at initial examination (odds ratio=2.59, confidence interval=1.2-5.6, p=0.04) was the only predictor reaching significance. Several predictors almost reached statistical significance: lesion size (p=0.06), retrofilling material (p=0.06), and postoperative healing course (p=0.06).

Risk Driven Outcome-Based Command and Control (C2) Assessment

DTIC Science & Technology

2000-01-01

shaping the risk ranking scores into more interpretable and statistically sound risk measures. Regression analysis was applied to determine what...Architecture Framework Implementation, AFCEA Coursebook 503J, February 8-11, 2000, San Diego, California. [Morgan and Henrion, 1990] M. Granger Morgan and

Statistical Discourse Analysis: A Method for Modelling Online Discussion Processes

ERIC Educational Resources Information Center

Chiu, Ming Ming; Fujita, Nobuko

2014-01-01

Online forums (synchronous and asynchronous) offer exciting data opportunities to analyze how people influence one another through their interactions. However, researchers must address several analytic difficulties involving the data (missing values, nested structure [messages within topics], non-sequential messages), outcome variables (discrete…

Late response to patient-reported outcome questionnaires after surgery was associated with worse outcome.

PubMed

Hutchings, Andrew; Grosse Frie, Kirstin; Neuburger, Jenny; van der Meulen, Jan; Black, Nick

2013-02-01

Nonresponse to patient-reported outcome (PRO) questionnaires after surgery might bias the results. Our aim was to gauge the potential impact of nonresponse bias by comparing the outcomes of early and late responders. This study compares 59,565 early and 20,735 late responders who underwent a hip or knee replacement, hernia repair, or varicose vein (VV) surgery. The association between timeliness of response and three outcomes (the mean postoperative disease-specific PRO and generic PRO scores and the proportion reporting a fair or poor result) was examined by regression analysis. Late responders were slightly more likely to be young, nonwhite, deprived, and have a more severe preoperative condition with poorer quality of life. Late response was associated with a slightly poorer outcome in all four procedures although not statistically significant (P < 0.05) for VV surgery. Adjusting for preoperative characteristics reduced the strength of the associations, but they remained statistically significant. As nonresponse to PRO questionnaires introduces slight bias, differences in response rates between hospitals should be taken into account when making comparisons so as to avoid overestimating the performance of those with lower response rates and failing to detect poor performing hospitals. Copyright © 2013 Elsevier Inc. All rights reserved.

MWASTools: an R/bioconductor package for metabolome-wide association studies.

PubMed

Rodriguez-Martinez, Andrea; Posma, Joram M; Ayala, Rafael; Neves, Ana L; Anwar, Maryam; Petretto, Enrico; Emanueli, Costanza; Gauguier, Dominique; Nicholson, Jeremy K; Dumas, Marc-Emmanuel

2018-03-01

MWASTools is an R package designed to provide an integrated pipeline to analyse metabonomic data in large-scale epidemiological studies. Key functionalities of our package include: quality control analysis; metabolome-wide association analysis using various models (partial correlations, generalized linear models); visualization of statistical outcomes; metabolite assignment using statistical total correlation spectroscopy (STOCSY); and biological interpretation of metabolome-wide association studies results. The MWASTools R package is implemented in R (version  > =3.4) and is available from Bioconductor: https://bioconductor.org/packages/MWASTools/. m.dumas@imperial.ac.uk. Supplementary data are available at Bioinformatics online. © The Author(s) 2017. Published by Oxford University Press.

Binomial outcomes in dataset with some clusters of size two: can the dependence of twins be accounted for? A simulation study comparing the reliability of statistical methods based on a dataset of preterm infants.

PubMed

Sauzet, Odile; Peacock, Janet L

2017-07-20

The analysis of perinatal outcomes often involves datasets with some multiple births. These are datasets mostly formed of independent observations and a limited number of clusters of size two (twins) and maybe of size three or more. This non-independence needs to be accounted for in the statistical analysis. Using simulated data based on a dataset of preterm infants we have previously investigated the performance of several approaches to the analysis of continuous outcomes in the presence of some clusters of size two. Mixed models have been developed for binomial outcomes but very little is known about their reliability when only a limited number of small clusters are present. Using simulated data based on a dataset of preterm infants we investigated the performance of several approaches to the analysis of binomial outcomes in the presence of some clusters of size two. Logistic models, several methods of estimation for the logistic random intercept models and generalised estimating equations were compared. The presence of even a small percentage of twins means that a logistic regression model will underestimate all parameters but a logistic random intercept model fails to estimate the correlation between siblings if the percentage of twins is too small and will provide similar estimates to logistic regression. The method which seems to provide the best balance between estimation of the standard error and the parameter for any percentage of twins is the generalised estimating equations. This study has shown that the number of covariates or the level two variance do not necessarily affect the performance of the various methods used to analyse datasets containing twins but when the percentage of small clusters is too small, mixed models cannot capture the dependence between siblings.

Application of a faith-based integration tool to assess mental and physical health interventions

PubMed Central

Saunders, Donna M.; Leak, Jean; Carver, Monique E.; Smith, Selina A.

2017-01-01

Background To build on current research involving faith-based interventions (FBIs) for addressing mental and physical health, this study a) reviewed the extent to which relevant publications integrate faith concepts with health and b) initiated analysis of the degree of FBI integration with intervention outcomes. Methods Derived from a systematic search of articles published between 2007 and 2017, 36 studies were assessed with a Faith-Based Integration Assessment Tool (FIAT) to quantify faith-health integration. Basic statistical procedures were employed to determine the association of faith-based integration with intervention outcomes. Results The assessed studies possessed (on average) moderate, inconsistent integration because of poor use of faith measures, and moderate, inconsistent use of faith practices. Analysis procedures for determining the effect of FBI integration on intervention outcomes were inadequate for formulating practical conclusions. Conclusions Regardless of integration, interventions were associated with beneficial outcomes. To determine the link between FBI integration and intervention outcomes, additional analyses are needed. PMID:29354795

Evaluation of breast reduction surgery effect on body posture and gait pattern using three-dimensional gait analysis.

PubMed

Sahin, Ismail; Iskender, Salim; Ozturk, Serdar; Balaban, Birol; Isik, Selcuk

2013-06-01

Breast hypertrophy is a significant health burden with symptoms of back and shoulder pain, intertrigo, and shoulder grooving from the bra straps. Women often rely on surgery to relieve these symptoms, and they are mostly satisfied with the results. The satisfaction from surgery usually is evaluated by subjective measures. Objective evidence testing of the surgical outcomes is lacking. In this study, 10 women with breast hypertrophy underwent reduction mammaplasty. Their surgical outcomes were evaluated using three-dimensional gait analysis before surgery and 2 months afterward. A statistical difference was sought between the kinematic data of the spine, hip, knee, and ankle joints. The average maximum anterior pelvic tilt angles decreased 41 %, and the average maximum spine anterior flexion angles decreased 30 %. The difference between the pre- and postoperative values was statistically significant. The analysis of the kinematic data showed no significant difference in the hip, knee, or ankle joint angles postoperatively. The outcomes of breast reduction surgery have been evaluated mostly by subjective means until recently. As an objective evidence for surgical gain in the current study, reduction mammaplasty resulted in the patients' improved body posture when walking. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Secondary mediation and regression analyses of the PTClinResNet database: determining causal relationships among the International Classification of Functioning, Disability and Health levels for four physical therapy intervention trials.

PubMed

Mulroy, Sara J; Winstein, Carolee J; Kulig, Kornelia; Beneck, George J; Fowler, Eileen G; DeMuth, Sharon K; Sullivan, Katherine J; Brown, David A; Lane, Christianne J

2011-12-01

Each of the 4 randomized clinical trials (RCTs) hosted by the Physical Therapy Clinical Research Network (PTClinResNet) targeted a different disability group (low back disorder in the Muscle-Specific Strength Training Effectiveness After Lumbar Microdiskectomy [MUSSEL] trial, chronic spinal cord injury in the Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury [STOMPS] trial, adult stroke in the Strength Training Effectiveness Post-Stroke [STEPS] trial, and pediatric cerebral palsy in the Pediatric Endurance and Limb Strengthening [PEDALS] trial for children with spastic diplegic cerebral palsy) and tested the effectiveness of a muscle-specific or functional activity-based intervention on primary outcomes that captured pain (STOMPS, MUSSEL) or locomotor function (STEPS, PEDALS). The focus of these secondary analyses was to determine causal relationships among outcomes across levels of the International Classification of Functioning, Disability and Health (ICF) framework for the 4 RCTs. With the database from PTClinResNet, we used 2 separate secondary statistical approaches-mediation analysis for the MUSSEL and STOMPS trials and regression analysis for the STEPS and PEDALS trials-to test relationships among muscle performance, primary outcomes (pain related and locomotor related), activity and participation measures, and overall quality of life. Predictive models were stronger for the 2 studies with pain-related primary outcomes. Change in muscle performance mediated or predicted reductions in pain for the MUSSEL and STOMPS trials and, to some extent, walking speed for the STEPS trial. Changes in primary outcome variables were significantly related to changes in activity and participation variables for all 4 trials. Improvement in activity and participation outcomes mediated or predicted increases in overall quality of life for the 3 trials with adult populations. Variables included in the statistical models were limited to those measured in the 4 RCTs. It is possible that other variables also mediated or predicted the changes in outcomes. The relatively small sample size in the PEDALS trial limited statistical power for those analyses. Evaluating the mediators or predictors of change between each ICF level and for 2 fundamentally different outcome variables (pain versus walking) provided insights into the complexities inherent across 4 prevalent disability groups.

Empirical evidence about inconsistency among studies in a pair-wise meta-analysis.

PubMed

Rhodes, Kirsty M; Turner, Rebecca M; Higgins, Julian P T

2016-12-01

This paper investigates how inconsistency (as measured by the I 2 statistic) among studies in a meta-analysis may differ, according to the type of outcome data and effect measure. We used hierarchical models to analyse data from 3873 binary, 5132 continuous and 880 mixed outcome meta-analyses within the Cochrane Database of Systematic Reviews. Predictive distributions for inconsistency expected in future meta-analyses were obtained, which can inform priors for between-study variance. Inconsistency estimates were highest on average for binary outcome meta-analyses of risk differences and continuous outcome meta-analyses. For a planned binary outcome meta-analysis in a general research setting, the predictive distribution for inconsistency among log odds ratios had median 22% and 95% CI: 12% to 39%. For a continuous outcome meta-analysis, the predictive distribution for inconsistency among standardized mean differences had median 40% and 95% CI: 15% to 73%. Levels of inconsistency were similar for binary data measured by log odds ratios and log relative risks. Fitted distributions for inconsistency expected in continuous outcome meta-analyses using mean differences were almost identical to those using standardized mean differences. The empirical evidence on inconsistency gives guidance on which outcome measures are most likely to be consistent in particular circumstances and facilitates Bayesian meta-analysis with an informative prior for heterogeneity. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd.

A comparison of two experimental design approaches in applying conjoint analysis in patient-centered outcomes research: a randomized trial.

PubMed

Kinter, Elizabeth T; Prior, Thomas J; Carswell, Christopher I; Bridges, John F P

2012-01-01

While the application of conjoint analysis and discrete-choice experiments in health are now widely accepted, a healthy debate exists around competing approaches to experimental design. There remains, however, a paucity of experimental evidence comparing competing design approaches and their impact on the application of these methods in patient-centered outcomes research. Our objectives were to directly compare the choice-model parameters and predictions of an orthogonal and a D-efficient experimental design using a randomized trial (i.e., an experiment on experiments) within an application of conjoint analysis studying patient-centered outcomes among outpatients diagnosed with schizophrenia in Germany. Outpatients diagnosed with schizophrenia were surveyed and randomized to receive choice tasks developed using either an orthogonal or a D-efficient experimental design. The choice tasks elicited judgments from the respondents as to which of two patient profiles (varying across seven outcomes and process attributes) was preferable from their own perspective. The results from the two survey designs were analyzed using the multinomial logit model, and the resulting parameter estimates and their robust standard errors were compared across the two arms of the study (i.e., the orthogonal and D-efficient designs). The predictive performances of the two resulting models were also compared by computing their percentage of survey responses classified correctly, and the potential for variation in scale between the two designs of the experiments was tested statistically and explored graphically. The results of the two models were statistically identical. No difference was found using an overall chi-squared test of equality for the seven parameters (p = 0.69) or via uncorrected pairwise comparisons of the parameter estimates (p-values ranged from 0.30 to 0.98). The D-efficient design resulted in directionally smaller standard errors for six of the seven parameters, of which only two were statistically significant, and no differences were found in the observed D-efficiencies of their standard errors (p = 0.62). The D-efficient design resulted in poorer predictive performance, but this was not significant (p = 0.73); there was some evidence that the parameters of the D-efficient design were biased marginally towards the null. While no statistical difference in scale was detected between the two designs (p = 0.74), the D-efficient design had a higher relative scale (1.06). This could be observed when the parameters were explored graphically, as the D-efficient parameters were lower. Our results indicate that orthogonal and D-efficient experimental designs have produced results that are statistically equivalent. This said, we have identified several qualitative findings that speak to the potential differences in these results that may have been statistically identified in a larger sample. While more comparative studies focused on the statistical efficiency of competing design strategies are needed, a more pressing research problem is to document the impact the experimental design has on respondent efficiency.

MRI textures as outcome predictor for Gamma Knife radiosurgery on vestibular schwannoma

NASA Astrophysics Data System (ADS)

Langenhuizen, P. P. J. H.; Legters, M. J. W.; Zinger, S.; Verheul, H. B.; Leenstra, S.; de With, P. H. N.

2018-02-01

Vestibular schwannomas (VS) are benign brain tumors that can be treated with high-precision focused radiation with the Gamma Knife in order to stop tumor growth. Outcome prediction of Gamma Knife radiosurgery (GKRS) treatment can help in determining whether GKRS will be effective on an individual patient basis. However, at present, prognostic factors of tumor control after GKRS for VS are largely unknown, and only clinical factors, such as size of the tumor at treatment and pre-treatment growth rate of the tumor, have been considered thus far. This research aims at outcome prediction of GKRS by means of quantitative texture feature analysis on conventional MRI scans. We compute first-order statistics and features based on gray-level co- occurrence (GLCM) and run-length matrices (RLM), and employ support vector machines and decision trees for classification. In a clinical dataset, consisting of 20 tumors showing treatment failure and 20 tumors exhibiting treatment success, we have discovered that the second-order statistical metrics distilled from GLCM and RLM are suitable for describing texture, but are slightly outperformed by simple first-order statistics, like mean, standard deviation and median. The obtained prediction accuracy is about 85%, but a final choice of the best feature can only be made after performing more extensive analyses on larger datasets. In any case, this work provides suitable texture measures for successful prediction of GKRS treatment outcome for VS.

A d-statistic for single-case designs that is equivalent to the usual between-groups d-statistic.

PubMed

Shadish, William R; Hedges, Larry V; Pustejovsky, James E; Boyajian, Jonathan G; Sullivan, Kristynn J; Andrade, Alma; Barrientos, Jeannette L

2014-01-01

We describe a standardised mean difference statistic (d) for single-case designs that is equivalent to the usual d in between-groups experiments. We show how it can be used to summarise treatment effects over cases within a study, to do power analyses in planning new studies and grant proposals, and to meta-analyse effects across studies of the same question. We discuss limitations of this d-statistic, and possible remedies to them. Even so, this d-statistic is better founded statistically than other effect size measures for single-case design, and unlike many general linear model approaches such as multilevel modelling or generalised additive models, it produces a standardised effect size that can be integrated over studies with different outcome measures. SPSS macros for both effect size computation and power analysis are available.

Assessment of statistical methods used in library-based approaches to microbial source tracking.

PubMed

Ritter, Kerry J; Carruthers, Ethan; Carson, C Andrew; Ellender, R D; Harwood, Valerie J; Kingsley, Kyle; Nakatsu, Cindy; Sadowsky, Michael; Shear, Brian; West, Brian; Whitlock, John E; Wiggins, Bruce A; Wilbur, Jayson D

2003-12-01

Several commonly used statistical methods for fingerprint identification in microbial source tracking (MST) were examined to assess the effectiveness of pattern-matching algorithms to correctly identify sources. Although numerous statistical methods have been employed for source identification, no widespread consensus exists as to which is most appropriate. A large-scale comparison of several MST methods, using identical fecal sources, presented a unique opportunity to assess the utility of several popular statistical methods. These included discriminant analysis, nearest neighbour analysis, maximum similarity and average similarity, along with several measures of distance or similarity. Threshold criteria for excluding uncertain or poorly matched isolates from final analysis were also examined for their ability to reduce false positives and increase prediction success. Six independent libraries used in the study were constructed from indicator bacteria isolated from fecal materials of humans, seagulls, cows and dogs. Three of these libraries were constructed using the rep-PCR technique and three relied on antibiotic resistance analysis (ARA). Five of the libraries were constructed using Escherichia coli and one using Enterococcus spp. (ARA). Overall, the outcome of this study suggests a high degree of variability across statistical methods. Despite large differences in correct classification rates among the statistical methods, no single statistical approach emerged as superior. Thresholds failed to consistently increase rates of correct classification and improvement was often associated with substantial effective sample size reduction. Recommendations are provided to aid in selecting appropriate analyses for these types of data.

The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial.

PubMed

Shakur, Haleema; Roberts, Ian; Edwards, Philip; Elbourne, Diana; Alfirevic, Zarko; Ronsmans, Carine

2016-05-17

Severe haemorrhage is a leading cause of maternal death worldwide. Most haemorrhage deaths occur soon after childbirth. Severe post-partum bleeding is sometimes managed by the surgical removal of the uterus (hysterectomy). Death and hysterectomy are important health consequences of post-partum haemorrhage, and clinical trials of interventions aimed at preventing these outcomes are needed. The World Maternal Antifibrinolytic trial aims to determine the effect of tranexamic acid on death, hysterectomy and other health outcomes in women with post-partum haemorrhage. It is an international, multicentre, randomised trial. Approximately 20,000 women with post-partum haemorrhage will be randomly allocated to receive an intravenous injection of either tranexamic acid or matching placebo in addition to usual care. The primary outcome measure is a composite of death in hospital or hysterectomy within 42 days of delivery. The cause of death will be described. Secondary outcomes include death, death due to bleeding, hysterectomy, thromboembolic events, blood transfusion, surgical and radiological interventions, complications, adverse events and quality of life. The health status and occurrence of thromboembolic events in breastfed babies will also be reported. We will conduct subgroup analyses for the primary outcome by time to treatment, type of delivery and cause of haemorrhage. We will conduct an analysis of treatment effect adjusted for baseline risk. The World Maternal Antifibrinolytic trial should provide reliable evidence for the efficacy of tranexamic acid in the prevention of death, hysterectomy and other outcomes that are important to patients. We present a protocol update and the statistical analysis plan for the trial. Current Controlled Trials ISRCTN76912190 (Registration date 08 December 2008), Clinicaltrials.gov NCT00872469 (Registration date 30 March 2009) and Pan African Clinical Trials Registry: PACTR201007000192283 (Registration date 02 September 2010).

Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).

PubMed

Young, Grace J; Lewis, Amanda L; Lane, J Athene; Winton, Helen L; Drake, Marcus J; Blair, Peter S

2017-10-03

Current management for men with lower urinary tract symptoms (LUTS) is a pathway that results in prostate surgery in a significant proportion. While helpful in relieving benign prostatic obstruction (BPO), surgery may be ineffective for men suffering from difficulties not relating to BPO. The UPSTREAM trial started recruitment in October 2014 with the aim of establishing whether a care pathway including urodynamics (a diagnostic tool for BPO and thus an indication of whether surgery is needed) is no worse for men, in terms of symptomatic outcome, than one without (routine care). This analysis plan outlines the main outcomes of the study and specific design choices, such as non-inferiority margins. The trial is currently recruiting in 26 hospitals across the UK, randomising men to either urodynamics or routine care, with recruitment set to end on the 31 December 2016. All outcomes will be measured 18 months after randomisation to allow sufficient time for surgical procedures and recovery. The primary outcome is based on a non-inferiority design with a margin of 1 point on the International Prostate Symptom Score (IPSS) scale. The key secondary outcome for this trial is surgery rate per arm, which is estimated to be at least 18% lower in the urodynamics arm. Surgery rates, adverse events, flow rate, urinary symptoms and sexual symptoms are secondary outcomes to be assessed for superiority. This is an update to the UPSTREAM protocol, which has already been published in this journal. This a priori statistical analysis plan aims to reduce reporting bias by allowing access to the trial's objectives and plans in advance of recruitment end. The results of the trial are expected to be published soon after the trial end date of 30 September 2018. ISRCTN registry, ISRCTN56164274 . Registered on 8 April 2014.

Response Adjusted for Days of Antibiotic Risk (RADAR): evaluation of a novel method to compare strategies to optimize antibiotic use.

PubMed

Schweitzer, V A; van Smeden, M; Postma, D F; Oosterheert, J J; Bonten, M J M; van Werkhoven, C H

2017-12-01

The Response Adjusted for Days of Antibiotic Risk (RADAR) statistic was proposed to improve the efficiency of trials comparing antibiotic stewardship strategies to optimize antibiotic use. We studied the behaviour of RADAR in a non-inferiority trial in which a β-lactam monotherapy strategy (n = 656) was non-inferior to fluoroquinolone monotherapy (n = 888) for patients with moderately severe community-acquired pneumonia. Patients were ranked according to clinical outcome, using five or eight categories, and antibiotic use. RADAR was calculated as the probability that the β-lactam group had a more favourable ranking than the fluoroquinolone group. To investigate the sensitivity of RADAR to detrimental clinical outcome we simulated increasing rates of 90-day mortality in the β-lactam group and performed the RADAR and non-inferiority analysis. The RADAR of the β-lactam group compared with the fluoroquinolone group was 60.3% (95% CI 57.9%-62.7%) using five and 58.4% (95% CI 56.0%-60.9%) using eight clinical outcome categories, all in favour of β-lactam. Sample sizes for RADAR were 38% (250/653) and 89% (580/653) of the non-inferiority sample size calculation, using five or eight clinical outcome categories, respectively. With simulated mortality rates, loss of non-inferiority of the β-lactam group occurred at a relative risk of 1.125 in the conventional analysis, whereas using RADAR the β-lactam group lost superiority at a relative risk of mortality of 1.25 and 1.5, with eight and five clinical outcome categories, respectively. RADAR favoured β-lactam over fluoroquinolone therapy for community-acquired pneumonia. Although RADAR required fewer patients than conventional non-inferiority analysis, the statistic was less sensitive to detrimental outcomes. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Can statistical linkage of missing variables reduce bias in treatment effect estimates in comparative effectiveness research studies?

PubMed

Crown, William; Chang, Jessica; Olson, Melvin; Kahler, Kristijan; Swindle, Jason; Buzinec, Paul; Shah, Nilay; Borah, Bijan

2015-09-01

Missing data, particularly missing variables, can create serious analytic challenges in observational comparative effectiveness research studies. Statistical linkage of datasets is a potential method for incorporating missing variables. Prior studies have focused upon the bias introduced by imperfect linkage. This analysis uses a case study of hepatitis C patients to estimate the net effect of statistical linkage on bias, also accounting for the potential reduction in missing variable bias. The results show that statistical linkage can reduce bias while also enabling parameter estimates to be obtained for the formerly missing variables. The usefulness of statistical linkage will vary depending upon the strength of the correlations of the missing variables with the treatment variable, as well as the outcome variable of interest.

A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy.

PubMed

Fabiani, Massimo; Bella, Antonino; Rota, Maria C; Clagnan, Elena; Gallo, Tolinda; D'Amato, Maurizio; Pezzotti, Patrizio; Ferrara, Lorenza; Demicheli, Vittorio; Martinelli, Domenico; Prato, Rosa; Rizzo, Caterina

2015-05-05

Although concerns about safety of influenza vaccination during pregnancy have been raised in the past, vaccination of pregnant women was recommended in many countries during the 2009 A/H1N1 pandemic influenza. A retrospective cohort study was conducted to evaluate the risk of adverse maternal, fetal and neonatal outcomes among pregnant women vaccinated with a MF59-adjuvanted A/H1N1 pandemic influenza vaccine. The study was carried out in four Italian regions (Piemonte, Friuli-Venezia-Giulia, Lazio, and Puglia) among 102,077 pregnant women potentially exposed during the second or third trimester of gestation to the vaccination campaign implemented in 2009/2010. Based on data retrieved from the regional administrative databases, the statistical analysis was performed using the Cox proportional-hazards model, adjusting for the propensity score to account for the potential confounding effect due to the socio-demographic characteristics and the clinical and reproductive history of women. A total of 100,332 pregnant women were eligible for the analysis. Of these, 2003 (2.0%) received the A/H1N1 pandemic influenza vaccination during the second or third trimester of gestation. We did not observe any statistically significant association between the A/H1N1 pandemic influenza vaccination and different maternal outcomes (hospital admissions for influenza, pneumonia, hypertension, eclampsia, diabetes, thyroid disease, and anaemia), fetal outcomes (fetal death after the 22nd gestational week) and neonatal outcomes (pre-term birth, low birth weight, low 5-min Apgar score, and congenital malformations). Pre-existing health-risk conditions (hospital admissions and drug prescriptions for specific diseases before the onset of pregnancy) were observed more frequently among vaccinated women, thus suggesting that concomitant chronic conditions increased vaccination uptake. The results of this study add some evidence on the safety of A/H1N1 pandemic influenza vaccination during pregnancy but, because of the reduced statistical power, meta-analyses and large multi-centres studies are needed in order to obtain more conclusive results, especially for rare outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Publication Bias Currently Makes an Accurate Estimate of the Benefits of Enrichment Programs Difficult: A Postmortem of Two Meta-Analyses Using Statistical Power Analysis

ERIC Educational Resources Information Center

Warne, Russell T.

2016-01-01

Recently Kim (2016) published a meta-analysis on the effects of enrichment programs for gifted students. She found that these programs produced substantial effects for academic achievement (g = 0.96) and socioemotional outcomes (g = 0.55). However, given current theory and empirical research these estimates of the benefits of enrichment programs…

Continuing the Conversation about Face-to-Face, Online, and Blended Learning a Meta-Analysis of Empirical Literature 2006-2017

ERIC Educational Resources Information Center

Wandera, Silas

2017-01-01

This paper serves two purposes. First, it statistically compares learning outcomes of face-to-face, online and blended learning instruction. Then it looks at the instructional practices that are associated with effective blended and online learning. A meta-analysis of 30 studies, with 3,687 participants, resulted in 36 effect sizes. The contrasts…

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

PubMed Central

Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

2015-01-01

Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed. PMID:26581079

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

PubMed

Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed.

75 FR 81999 - Notice of Submission for OMB Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-29

... comments which: (1) Evaluate whether the proposed collection of information is necessary for the proper...) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information... study will use descriptive statistics and regression analysis to study how student outcomes and school...

Linguistic Alternatives to Quantitative Research Strategies. Part One: How Linguistic Mechanisms Advance Research Outcomes

ERIC Educational Resources Information Center

Yeager, Joseph; Sommer, Linda

2007-01-01

Combining psycholinguistic technologies and systems analysis created advances in motivational profiling and numerous new behavioral engineering applications. These advances leapfrog many mainstream statistical research methods, producing superior research results via cause-effect language mechanisms. Entire industries explore motives ranging from…

Regulatory considerations in the design of comparative observational studies using propensity scores.

PubMed

Yue, Lilly Q

2012-01-01

In the evaluation of medical products, including drugs, biological products, and medical devices, comparative observational studies could play an important role when properly conducted randomized, well-controlled clinical trials are infeasible due to ethical or practical reasons. However, various biases could be introduced at every stage and into every aspect of the observational study, and consequently the interpretation of the resulting statistical inference would be of concern. While there do exist statistical techniques for addressing some of the challenging issues, often based on propensity score methodology, these statistical tools probably have not been as widely employed in prospectively designing observational studies as they should be. There are also times when they are implemented in an unscientific manner, such as performing propensity score model selection for a dataset involving outcome data in the same dataset, so that the integrity of observational study design and the interpretability of outcome analysis results could be compromised. In this paper, regulatory considerations on prospective study design using propensity scores are shared and illustrated with hypothetical examples.

Conditions, interventions, and outcomes in nursing research: a comparative analysis of North American and European/International journals. (1981-1990).

PubMed

Abraham, I L; Chalifoux, Z L; Evers, G C; De Geest, S

1995-04-01

This study compared the conceptual foci and methodological characteristics of research projects which tested the effects of nursing interventions, published in four general nursing research journals with predominantly North American, and two with predominantly European/International authorship and readership. Dimensions and variables of comparison included: nature of subjects, design issues, statistical methodology, statistical power, and types of interventions and outcomes. Although some differences emerged, the most striking and consistent finding was that there were no statistically significant differences (and thus similarities) in the content foci and methodological parameters of the intervention studies published in both groups of journals. We conclude that European/International and North American nursing intervention studies, as reported in major general nursing research journals, are highly similar in the parameters studied, yet in need of overall improvement. Certainly, there is no empirical support for the common (explicit or implicit) ethnocentric American bias that leadership in nursing intervention research resides with and in the United States of America.

Family home visiting outcomes for mothers with and without intellectual disabilities.

PubMed

Monsen, K; Sanders, A; Yu, F; Radosevich, D; Geppert, J

2011-05-01

The purpose of this study was to evaluate outcomes of public health nurse home visiting for mothers with intellectual disabilities (ID) and a comparison group. The study was a secondary analysis of existing de-identified family home visiting data. It used a two-group comparative, 1:3 match design. Sixty-eight clients were in the study (n = 17 for mothers with ID and n = 51 for mothers without ID). Client characteristics and problem prevalence were compared using standard descriptive and inferential statistics. Mixed model methods were used for the analysis of outcomes, accounting for baseline scores, time of services and matched cases. Mothers with and without ID showed statistically significant improvement following family home visiting services. For both groups, discharge scores were consistently higher than the corresponding admission scores, with a mean increase of 0.37 (range = 0.05-0.90). Mothers without ID attained higher outcomes than mothers with ID. Seven of 21 outcomes significantly improved for mothers with ID, and 10 of 21 for the comparison group. The percentage of mothers with ID attaining the benchmark of 4 ranged from 13.3% to 90.4% and for the comparison group ranged from 30% to 95.7%. Public health nurses addressed 15 environmental, psychosocial, physiological and behavioural problems for both groups. Family home visiting appears to be effective in assisting parents with ID to have improved outcomes in many domains. These results provide an opportunity for service providers, home visiting nurses and public health agencies to understand the unique needs of mothers with ID. © 2011 The Authors. Journal of Intellectual Disability Research © 2011 Blackwell Publishing Ltd.

Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

PubMed

Probst, Pascal; Knebel, Phillip; Grummich, Kathrin; Tenckhoff, Solveig; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

2016-07-01

Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P < 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P < 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P < 0.001). Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

Risk factors and outcomes of imipenem-resistant Acinetobacter bloodstream infection in North-eastern Malaysia

PubMed Central

Deris, Zakuan Zainy; Shafei, Mohd Nazri; Harun, Azian

2011-01-01

Objective To determine the risk factors and outcomes of imipenem-resistant Acinetobacter baumannii (IRAB) bloodstream infection (BSI) cases, since there is very little publication on Acinetobacter baumannii infections from Malaysia. Methods A cross sectional study of 41 cases (73.2%) of imipenem-sensitive Acinetobacter baumanii (ISAB) and 15 cases (26.8%) of IRAB was conducted in a teaching hospital which was located at North-Eastern state of Malaysia. Results There was no independent risk factor for IRAB BSI identified but IRAB BSI was significantly associated with longer bacteraemic days [OR 1.23 (95% CI 1.01, 1.50)]. Although prior use of carbepenems and cephalosporin were higher among IRAB than ISAB group, statistically they were not significant. There was no significant difference in term of outcomes between the two groups. Conclusions Although statistically not significant, this analysis compliments previous publication highlighting the importance of appropriate empiric antibiotic usage in hospital especially carbepenems and need further evaluation with bigger subjects. PMID:23569782

Outcomes of Zika virus infection during pregnancy: contributions to the debate on the efficiency of cohort studies.

PubMed

Duarte, Elisabeth Carmen; Garcia, Leila Posenato; de Araújo, Wildo Navegantes; Velez, Maria P

2017-12-02

Zika infection during pregnancy (ZIKVP) is known to be associated with adverse outcomes. Studies on this matter involve both rare outcomes and rare exposures and methodological choices are not straightforward. Cohort studies will surely offer more robust evidences, but their efficiency must be enhanced. We aim to contribute to the debate on sample selection strategies in cohort studies to assess outcomes associated with ZKVP. A study can be statistically more efficient than another if its estimates are more accurate (precise and valid), even if the studies involve the same number of subjects. Sample size and specific design strategies can enhance or impair the statistical efficiency of a study, depending on how the subjects are distributed in subgroups pertinent to the analysis. In most ZIKVP cohort studies to date there is an a priori identification of the source population (pregnant women, regardless of their exposure status) which is then sampled or included in its entirety (census). Subsequently, the group of pregnant women is classified according to exposure (presence or absence of ZIKVP), respecting the exposed:unexposed ratio in the source population. We propose that the sample selection be done from the a priori identification of groups of pregnant women exposed and unexposed to ZIKVP. This method will allow for an oversampling (even 100%) of the pregnant women with ZKVP and a optimized sampling from the general population of pregnant women unexposed to ZIKVP, saving resources in the unexposed group and improving the expected number of incident cases (outcomes) overall. We hope that this proposal will broaden the methodological debate on the improvement of statistical power and protocol harmonization of cohort studies that aim to evaluate the association between Zika infection during pregnancy and outcomes for the offspring, as well as those with similar objectives.

Care management for Type 2 diabetes in the United States: a systematic review and meta-analysis.

PubMed

Egginton, Jason S; Ridgeway, Jennifer L; Shah, Nilay D; Balasubramaniam, Saranya; Emmanuel, Joann R; Prokop, Larry J; Montori, Victor M; Murad, Mohammad Hassan

2012-03-22

This systematic review and meta-analysis aims at assessing the composition and performance of care management models evaluated in the last decade and their impact on patient important outcomes. A comprehensive literature search of electronic bibliographic databases was performed to identify care management trials in type 2 diabetes. Random effects meta-analysis was used when feasible to pool outcome measures. Fifty-two studies were eligible. Most commonly reported were surrogate outcomes (such as HbA1c and LDL), followed by process measures (clinic visit or testing frequency). Less frequently reported were quality of life, patient satisfaction, self-care, and healthcare utilization. Most care management modalities were carved out from primary care. Meta-analysis demonstrated a statistically significant but trivial reduction of HbA1c (weighted difference in means -0.21%, 95% confidence interval -0.40 to -0.03, p < .03) and LDL-cholesterol (weighted difference in means -3.38 mg/dL, 95% confidence interval -6.27 to -0.49, p < .02). Most care management programs for patients with type 2 diabetes are 'carved-out', accomplish limited effects on metabolic outcomes, and have unknown effects on patient important outcomes. Comparative effectiveness research of different models of care management is needed to inform the design of medical homes for patients with chronic conditions.

Impact of Hurricane Exposure on Reproductive Health Outcomes, Florida, 2004.

PubMed

Grabich, Shannon C; Robinson, Whitney R; Konrad, Charles E; Horney, Jennifer A

2017-08-01

Prenatal hurricane exposure may be an increasingly important contributor to poor reproductive health outcomes. In the current literature, mixed associations have been suggested between hurricane exposure and reproductive health outcomes. This may be due, in part, to residual confounding. We assessed the association between hurricane exposure and reproductive health outcomes by using a difference-in-difference analysis technique to control for confounding in a cohort of Florida pregnancies. We implemented a difference-in-difference analysis to evaluate hurricane weather and reproductive health outcomes including low birth weight, fetal death, and birth rate. The study population for analysis included all Florida pregnancies conceived before or during the 2003 and 2004 hurricane season. Reproductive health data were extracted from vital statistics records from the Florida Department of Health. In 2004, 4 hurricanes (Charley, Frances, Ivan, and Jeanne) made landfall in rapid succession; whereas in 2003, no hurricanes made landfall in Florida. Overall models using the difference-in-difference analysis showed no association between exposure to hurricane weather and reproductive health. The inconsistency of the literature on hurricane exposure and reproductive health may be in part due to biases inherent in pre-post or regression-based county-level comparisons. We found no associations between hurricane exposure and reproductive health. (Disaster Med Public Health Preparedness. 2017;11:407-411).

Multimodal interventions including nutrition in the prevention and management of disease-related malnutrition in adults: a systematic review of randomised control trials.

PubMed

Thorne, Frances; Baldwin, Christine

2014-06-01

There has been a move to improve nutritional status in malnourished patients through the use of multimodal interventions (MI). There are currently no systematic reviews that have examined their effectiveness. This analysis aimed to examine the effects on nutritional, clinical, functional and patient-centred outcomes. A systematic review and meta-analysis using Cochrane methodology. 15 studies were included in the analysis, 13 comparing MI with usual care and 2 comparing MI with a nutrition intervention alone. Quality of studies varied and studies reported few relevant outcomes. Only 3 outcomes were compatible with meta-analysis; weight, mortality and length of stay (LOS). No statistically significant differences between groups were found. Narrative review was inconclusive. There was no evidence of benefit in the intervention groups in relation to body composition, functional status or quality of life (QoL). Intervention groups appeared to show a trend towards increased energy and protein intake however data was provided by only 2 studies (301 participants). No conclusive evidence of benefit for MI on any of the reviewed outcomes was found. Well designed, high quality trials addressing the impact of MI on relevant nutritional, functional and clinical outcomes are required. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Interrupted time-series analysis: studying trends in neurosurgery.

PubMed

Wong, Ricky H; Smieliauskas, Fabrice; Pan, I-Wen; Lam, Sandi K

2015-12-01

OBJECT Neurosurgery studies traditionally have evaluated the effects of interventions on health care outcomes by studying overall changes in measured outcomes over time. Yet, this type of linear analysis is limited due to lack of consideration of the trend's effects both pre- and postintervention and the potential for confounding influences. The aim of this study was to illustrate interrupted time-series analysis (ITSA) as applied to an example in the neurosurgical literature and highlight ITSA's potential for future applications. METHODS The methods used in previous neurosurgical studies were analyzed and then compared with the methodology of ITSA. RESULTS The ITSA method was identified in the neurosurgical literature as an important technique for isolating the effect of an intervention (such as a policy change or a quality and safety initiative) on a health outcome independent of other factors driving trends in the outcome. The authors determined that ITSA allows for analysis of the intervention's immediate impact on outcome level and on subsequent trends and enables a more careful measure of the causal effects of interventions on health care outcomes. CONCLUSIONS ITSA represents a significant improvement over traditional observational study designs in quantifying the impact of an intervention. ITSA is a useful statistical procedure to understand, consider, and implement as the field of neurosurgery evolves in sophistication in big-data analytics, economics, and health services research.

Patient engagement: an investigation at a primary care clinic

PubMed Central

Gill, Preetinder Singh

2013-01-01

Background Engaged employees are an asset to any organization. They are instrumental in ensuring good commercial outcomes through continuous innovation and incremental improvement. A health care facility is similar to a regular work setting in many ways. A health care provider and a patient have roles akin to a team leader and a team member/stakeholder, respectively. Hence it can be argued that the concept of employee engagement can be applied to patients in health care settings in order to improve health outcomes. Methods Patient engagement data were collected using a survey instrument from a primary care clinic in the northern Indian state of Punjab. Canonical correlation equations were formulated to identify combinations which were strongly related to each other. In addition, the cause-effect relationship between patient engagement and patient-perceived health outcomes was described using structural equation modeling. Results Canonical correlation analysis showed that the first set of canonical variables had a fairly strong relationship, ie, a magnitude > 0.80 at the 95% confidence interval, for five dimensions of patient engagement. Structural equation modeling analysis yielded a β ≥ 0.10 and a Student’s t statistic ≥ 2.96 for these five dimensions. The threshold Student’s t statistic was 1.99. Hence it was found the β values were significant at the 95% confidence interval for all census regions. Conclusion A scaled reliable survey instrument was developed to measured patient engagement. Better patient engagement is associated with better patient-perceived health outcomes. This study provides preliminary evidence that patient engagement has a causal relationship with patient-perceived health outcomes. PMID:23515133

Prognostic factors for risk stratification of adult cancer patients with chemotherapy-induced febrile neutropenia: a systematic review and meta-analysis.

PubMed

Lee, Yee Mei; Lang, Dora; Lockwood, Craig

Increasing numbers of studies identify new prognostic factors for categorising chemotherapy-induced febrile neutropenia adult cancer patients into high- or low-risk groups for adverse outcomes. These groupings are used to tailor therapy according to level of risk. However many emerging factors with prognostic significance remain controversial, being based on single studies only. A systematic review was conducted to determine the strength of association of all identified factors associated with the outcomes of chemotherapy-induced febrile neutropenia patients. The participants included were adults of 15 years old and above, with a cancer diagnosis and who underwent cancer treatment.The review focused on clinical factors and their association with the outcomes of cancer patients with chemotherapy-induced febrile neutropenia at presentation of fever.All quantitative studies published in English which investigated clinical factors for risk stratification of adult cancer patients with chemotherapy-induced febrile neutropenia were considered.The primary outcome of interest was to identify the clinical factors for risk stratification of adult cancer patients with chemotherapy-induced febrile neutropenia. Electronic databases searched from their respective inception date up to December 2011 include MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, Science-Direct, Scopus and Mednar. The quality of the included studies was subjected to assessment by two independent reviewers. The standardised critical appraisal tool from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) was used to assess the following criteria: representativeness of study population; clearly defined prognostic factors and outcomes; whether potential confounders were addressed and appropriate statistical analysis was undertaken for the study design. Data extraction was performed using a modified version of the standardised extraction tool from the JBI-MAStARI. Prognostic factors and the accompanying odds ratio reported for the significance of these factors that were identified by multivariate regression, were extracted from each included study. Studies results were pooled in statistical meta-analysis using Review Manager 5.1. Where statistical pooling was not possible, the findings were presented in narrative form. Seven studies (four prospective cohort and three retrospective cohort) investigating 22 factors in total were included. Fixed effects meta-analysis showed: hypotension [OR=1.66, 95%CI, 1.14-2.41, p=0.008] and thrombocytopenia [OR=3.92, 95%CI, 2.19-7.01, p<0.00001)] were associated with high-risk of adverse outcomes for febrile neutropenia. Other factors that were statistically significant from single studies included: age of patients, clinical presentation at fever onset, presence or absence of co-morbidities, infections, duration and severity of neutropenia state. Five prognostic factors failed to demonstrate an association between the variables and the outcomes measured and they include: presence of pneumonia, total febrile days, median days to fever, recovery from neutropenia and presence of moderate clinical symptoms in association with Gram-negative bacteraemia. Despite the overall limitations identified in the included studies, this review has provided a synthesis of the best available evidence for the prognostic factors used in risk stratification of febrile neutropenia patients. However, the dynamic aspects of prognostic model development, validation and utilisation have not been addressed adequately thus far. Given the findings of this review, it is timely to address these issues and improve the utilisation of prognostic models in the management of febrile neutropenia patients. The identified factors are similar to the factors in current prognostic models. However, additional factors that were reported to be statistically significant in this review (thrombocytopenia, presence of central venous catheter, and duration and severity of neutropenia) have not previously been included in prognostic models. This review has found these factors may improve the performance of current models by adding or replacing some of the factors. The role of risk stratification of chemotherapy-induced febrile neutropenia patients continues to evolve as the practice of risk-based therapy has been demonstrated to be beneficial to patients, clinicians and health care organisations. Further research to identify new factors /markers is needed to develop a new model which is reliable and accurate for these patients, regardless of cancer types. A robust and well-validated prognostic model is the key to enhance patient safety in the risk-based management of cancer patients with chemotherapy-induced febrile neutropenia.

Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study.

PubMed

Egbewale, Bolaji E; Lewis, Martyn; Sim, Julius

2014-04-09

Analysis of variance (ANOVA), change-score analysis (CSA) and analysis of covariance (ANCOVA) respond differently to baseline imbalance in randomized controlled trials. However, no empirical studies appear to have quantified the differential bias and precision of estimates derived from these methods of analysis, and their relative statistical power, in relation to combinations of levels of key trial characteristics. This simulation study therefore examined the relative bias, precision and statistical power of these three analyses using simulated trial data. 126 hypothetical trial scenarios were evaluated (126,000 datasets), each with continuous data simulated by using a combination of levels of: treatment effect; pretest-posttest correlation; direction and magnitude of baseline imbalance. The bias, precision and power of each method of analysis were calculated for each scenario. Compared to the unbiased estimates produced by ANCOVA, both ANOVA and CSA are subject to bias, in relation to pretest-posttest correlation and the direction of baseline imbalance. Additionally, ANOVA and CSA are less precise than ANCOVA, especially when pretest-posttest correlation ≥ 0.3. When groups are balanced at baseline, ANCOVA is at least as powerful as the other analyses. Apparently greater power of ANOVA and CSA at certain imbalances is achieved in respect of a biased treatment effect. Across a range of correlations between pre- and post-treatment scores and at varying levels and direction of baseline imbalance, ANCOVA remains the optimum statistical method for the analysis of continuous outcomes in RCTs, in terms of bias, precision and statistical power.

Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study

PubMed Central

2014-01-01

Background Analysis of variance (ANOVA), change-score analysis (CSA) and analysis of covariance (ANCOVA) respond differently to baseline imbalance in randomized controlled trials. However, no empirical studies appear to have quantified the differential bias and precision of estimates derived from these methods of analysis, and their relative statistical power, in relation to combinations of levels of key trial characteristics. This simulation study therefore examined the relative bias, precision and statistical power of these three analyses using simulated trial data. Methods 126 hypothetical trial scenarios were evaluated (126 000 datasets), each with continuous data simulated by using a combination of levels of: treatment effect; pretest-posttest correlation; direction and magnitude of baseline imbalance. The bias, precision and power of each method of analysis were calculated for each scenario. Results Compared to the unbiased estimates produced by ANCOVA, both ANOVA and CSA are subject to bias, in relation to pretest-posttest correlation and the direction of baseline imbalance. Additionally, ANOVA and CSA are less precise than ANCOVA, especially when pretest-posttest correlation ≥ 0.3. When groups are balanced at baseline, ANCOVA is at least as powerful as the other analyses. Apparently greater power of ANOVA and CSA at certain imbalances is achieved in respect of a biased treatment effect. Conclusions Across a range of correlations between pre- and post-treatment scores and at varying levels and direction of baseline imbalance, ANCOVA remains the optimum statistical method for the analysis of continuous outcomes in RCTs, in terms of bias, precision and statistical power. PMID:24712304

Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.

PubMed

Gay, Hawkins C; Baldridge, Abigail S; Huffman, Mark D

2017-12-01

Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. Analysis of the data was conducted between December 2016 and April 2017. Effectiveness outcomes included freedom from atrial arrhythmias after ablation and proportion of participants without any arrhythmia recurrence over the 12 months of follow-up after a 3-month blanking period. Safety outcomes included major adverse device- or procedure-related events. The SMART AF trial participants' mean age was 58.7 (10.8) years, and 72% were men. The time from initial proposal submission to final analysis was 11 months. Freedom from atrial arrhythmias at 12 months postprocedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the 2 analyses, but contact force range or regression models could not be reproduced. The feasibility of a reproduction analysis of the SMART-AF trial was demonstrated through an academic data-sharing platform. Data sharing can be facilitated through incentivizing collaboration, sharing statistical code, and creating more decentralized data sharing platforms with fewer restrictions to data access.

Missing data treatments matter: an analysis of multiple imputation for anterior cervical discectomy and fusion procedures.

PubMed

Ondeck, Nathaniel T; Fu, Michael C; Skrip, Laura A; McLynn, Ryan P; Cui, Jonathan J; Basques, Bryce A; Albert, Todd J; Grauer, Jonathan N

2018-04-09

The presence of missing data is a limitation of large datasets, including the National Surgical Quality Improvement Program (NSQIP). In addressing this issue, most studies use complete case analysis, which excludes cases with missing data, thus potentially introducing selection bias. Multiple imputation, a statistically rigorous approach that approximates missing data and preserves sample size, may be an improvement over complete case analysis. The present study aims to evaluate the impact of using multiple imputation in comparison with complete case analysis for assessing the associations between preoperative laboratory values and adverse outcomes following anterior cervical discectomy and fusion (ACDF) procedures. This is a retrospective review of prospectively collected data. Patients undergoing one-level ACDF were identified in NSQIP 2012-2015. Perioperative adverse outcome variables assessed included the occurrence of any adverse event, severe adverse events, and hospital readmission. Missing preoperative albumin and hematocrit values were handled using complete case analysis and multiple imputation. These preoperative laboratory levels were then tested for associations with 30-day postoperative outcomes using logistic regression. A total of 11,999 patients were included. Of this cohort, 63.5% of patients had missing preoperative albumin and 9.9% had missing preoperative hematocrit. When using complete case analysis, only 4,311 patients were studied. The removed patients were significantly younger, healthier, of a common body mass index, and male. Logistic regression analysis failed to identify either preoperative hypoalbuminemia or preoperative anemia as significantly associated with adverse outcomes. When employing multiple imputation, all 11,999 patients were included. Preoperative hypoalbuminemia was significantly associated with the occurrence of any adverse event and severe adverse events. Preoperative anemia was significantly associated with the occurrence of any adverse event, severe adverse events, and hospital readmission. Multiple imputation is a rigorous statistical procedure that is being increasingly used to address missing values in large datasets. Using this technique for ACDF avoided the loss of cases that may have affected the representativeness and power of the study and led to different results than complete case analysis. Multiple imputation should be considered for future spine studies. Copyright © 2018 Elsevier Inc. All rights reserved.

Multivariate analysis of longitudinal rates of change.

PubMed

Bryan, Matthew; Heagerty, Patrick J

2016-12-10

Longitudinal data allow direct comparison of the change in patient outcomes associated with treatment or exposure. Frequently, several longitudinal measures are collected that either reflect a common underlying health status, or characterize processes that are influenced in a similar way by covariates such as exposure or demographic characteristics. Statistical methods that can combine multivariate response variables into common measures of covariate effects have been proposed in the literature. Current methods for characterizing the relationship between covariates and the rate of change in multivariate outcomes are limited to select models. For example, 'accelerated time' methods have been developed which assume that covariates rescale time in longitudinal models for disease progression. In this manuscript, we detail an alternative multivariate model formulation that directly structures longitudinal rates of change and that permits a common covariate effect across multiple outcomes. We detail maximum likelihood estimation for a multivariate longitudinal mixed model. We show via asymptotic calculations the potential gain in power that may be achieved with a common analysis of multiple outcomes. We apply the proposed methods to the analysis of a trivariate outcome for infant growth and compare rates of change for HIV infected and uninfected infants. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes

PubMed Central

2010-01-01

Background The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Methods/Design Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Discussion Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location. We believe that variability of simulated exposure values at geocoded addresses will improve knowledge on variability of exposures, improving therefore validity of individual exposures to input in posterior statistical analysis. PMID:20950449

A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes.

PubMed

Ribeiro, Manuel C; Pereira, Maria J; Soares, Amílcar; Branquinho, Cristina; Augusto, Sofia; Llop, Esteve; Fonseca, Susana; Nave, Joaquim G; Tavares, António B; Dias, Carlos M; Silva, Ana; Selemane, Ismael; de Toro, Joaquin; Santos, Mário J; Santos, Fernanda

2010-10-15

The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location. We believe that variability of simulated exposure values at geocoded addresses will improve knowledge on variability of exposures, improving therefore validity of individual exposures to input in posterior statistical analysis.

Meta-analysis of studies comparing oncologic outcomes of radical prostatectomy and brachytherapy for localized prostate cancer

PubMed Central

Cozzi, Gabriele; Musi, Gennaro; Bianchi, Roberto; Bottero, Danilo; Brescia, Antonio; Cioffi, Antonio; Cordima, Giovanni; Delor, Maurizio; Di Trapani, Ettore; Ferro, Matteo; Matei, Deliu Victor; Russo, Andrea; Mistretta, Francesco Alessandro; De Cobelli, Ottavio

2017-01-01

Background: The aim of this study was to compare oncologic outcomes of radical prostatectomy (RP) with brachytherapy (BT). Methods: A literature review was conducted according to the ‘Preferred reporting items for systematic reviews and meta-analyses’ (PRISMA) statement. We included studies reporting comparative oncologic outcomes of RP versus BT for localized prostate cancer (PCa). From each comparative study, we extracted the study design, the number and features of the included patients, and the oncologic outcomes expressed as all-cause mortality (ACM), PCa-specific mortality (PCSM) or, when the former were unavailable, as biochemical recurrence (BCR). All of the data retrieved from the selected studies were recorded in an electronic database. Cumulative analysis was conducted using the Review Manager version 5.3 software, designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). Statistical heterogeneity was tested using the Chi-square test. Results: Our cumulative analysis did not show any significant difference in terms of BCR, ACM or PCSM rates between the RP and BT cohorts. Only three studies reported risk-stratified outcomes of intermediate- and high-risk patients, which are the most prone to treatment failure. Conclusions: our analysis suggested that RP and BT may have similar oncologic outcomes. However, the analysis included a limited number of studies, and most of them were retrospective, making it impossible to derive any definitive conclusion, especially for intermediate- and high-risk patients. In this scenario, appropriate urologic counseling remains of utmost importance. PMID:29662542

Meta-analysis of studies comparing oncologic outcomes of radical prostatectomy and brachytherapy for localized prostate cancer.

PubMed

Cozzi, Gabriele; Musi, Gennaro; Bianchi, Roberto; Bottero, Danilo; Brescia, Antonio; Cioffi, Antonio; Cordima, Giovanni; Delor, Maurizio; Di Trapani, Ettore; Ferro, Matteo; Matei, Deliu Victor; Russo, Andrea; Mistretta, Francesco Alessandro; De Cobelli, Ottavio

2017-11-01

The aim of this study was to compare oncologic outcomes of radical prostatectomy (RP) with brachytherapy (BT). A literature review was conducted according to the 'Preferred reporting items for systematic reviews and meta-analyses' (PRISMA) statement. We included studies reporting comparative oncologic outcomes of RP versus BT for localized prostate cancer (PCa). From each comparative study, we extracted the study design, the number and features of the included patients, and the oncologic outcomes expressed as all-cause mortality (ACM), PCa-specific mortality (PCSM) or, when the former were unavailable, as biochemical recurrence (BCR). All of the data retrieved from the selected studies were recorded in an electronic database. Cumulative analysis was conducted using the Review Manager version 5.3 software, designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). Statistical heterogeneity was tested using the Chi-square test. Our cumulative analysis did not show any significant difference in terms of BCR, ACM or PCSM rates between the RP and BT cohorts. Only three studies reported risk-stratified outcomes of intermediate- and high-risk patients, which are the most prone to treatment failure. our analysis suggested that RP and BT may have similar oncologic outcomes. However, the analysis included a limited number of studies, and most of them were retrospective, making it impossible to derive any definitive conclusion, especially for intermediate- and high-risk patients. In this scenario, appropriate urologic counseling remains of utmost importance.

Successful Vocational Rehabilitation of Clients with Retinitis Pigmentosa.

ERIC Educational Resources Information Center

Taheri-Araghi, M.; Hendren, G.

1994-01-01

Statistical analysis of 10 personal (client) variables and four program variables related to 76 people who became blind from retinitis pigmentosa revealed that 6 variables predicted clients' rehabilitation outcomes: age, gender, race, work status, amount of case-service money spent on the client's behalf, and number of changes in career objectives…

Co-administration of furosemide with albumin for overcoming diuretic resistance in patients with hypoalbuminemia: a meta-analysis.

PubMed

Kitsios, Georgios D; Mascari, Paolo; Ettunsi, Riad; Gray, Anthony W

2014-04-01

To systematically review clinical studies of co-administration of albumin and loop diuretics in hypoalbuminemic patients as a strategy to overcome diuretic resistance. Systematic search of electronic databases up to October 2012. We included randomized clinical trials of adults with hypoalbuminemia, comparing co-administration of loop diuretics and albumin versus loop diuretics alone. Quantitative data were synthesized with meta-analytic techniques for clinical, surrogate (urinary volume and urinary sodium excretion) and intermediate (pharmacokinetic and hemodynamic parameters) outcomes. Ten studies were included, of which 8 trials with crossover design were synthesized with meta-analysis. A statistically significant increase in the amount of urine volume (increment of 231 mL [95% confidence interval 135.5-326.5]) and sodium excreted (15.9 mEq [4.9-26.8]) at 8 hours were found in favor of co-administration of albumin and furosemide. These differences were no longer statistically significant at 24 hours. Meta-analyses for intermediate outcomes (ie, furosemide excretion, distribution volume etc.) did not reveal statistically significant differences. Synthesis of a heterogeneous body of evidence shows transient effects of modest clinical significance for co-administration of albumin with furosemide in hypoalbuminemic patients. Pragmatic, large-scale randomized studies are needed to delineate the role of this strategy. Copyright © 2014 Elsevier Inc. All rights reserved.

Standardized Reporting of the Eczema Area and Severity Index (EASI) and the Patient-Oriented Eczema Measure (POEM): A Recommendation by the Harmonising Outcome Measures for Eczema (HOME) Initiative.

PubMed

Grinich, E; Schmitt, J; Küster, D; Spuls, P I; Williams, H C; Chalmers, J R; Thomas, K S; Apfelbacher, C; Prinsen, C A C; Furue, M; Stuart, B; Carter, B; Simpson, E

2018-05-10

Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development, 1 harmonization of outcome reporting, 2 statistical analysis, 3 quality assessment 4 and reporting of findings. 1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision-making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed-upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

High statistical heterogeneity is more frequent in meta-analysis of continuous than binary outcomes.

PubMed

Alba, Ana C; Alexander, Paul E; Chang, Joanne; MacIsaac, John; DeFry, Samantha; Guyatt, Gordon H

2016-02-01

We compared the distribution of heterogeneity in meta-analyses of binary and continuous outcomes. We searched citations in MEDLINE and Cochrane databases for meta-analyses of randomized trials published in 2012 that reported a measure of heterogeneity of either binary or continuous outcomes. Two reviewers independently performed eligibility screening and data abstraction. We evaluated the distribution of I(2) in meta-analyses of binary and continuous outcomes and explored hypotheses explaining the difference in distributions. After full-text screening, we selected 671 meta-analyses evaluating 557 binary and 352 continuous outcomes. Heterogeneity as assessed by I(2) proved higher in continuous than in binary outcomes: the proportion of continuous and binary outcomes reporting an I(2) of 0% was 34% vs. 52%, respectively, and reporting an I(2) of 60-100% was 39% vs. 14%. In continuous but not binary outcomes, I(2) increased with larger number of studies included in a meta-analysis. Increased precision and sample size do not explain the larger I(2) found in meta-analyses of continuous outcomes with a larger number of studies. Meta-analyses evaluating continuous outcomes showed substantially higher I(2) than meta-analyses of binary outcomes. Results suggest differing standards for interpreting I(2) in continuous vs. binary outcomes may be appropriate. Copyright © 2016 Elsevier Inc. All rights reserved.

Measuring determinants of career satisfaction of anesthesiologists: validation of a survey instrument.

PubMed

Afonso, Anoushka M; Diaz, James H; Scher, Corey S; Beyl, Robbie A; Nair, Singh R; Kaye, Alan David

2013-06-01

To measure the parameter of job satisfaction among anesthesiologists. Survey instrument. Academic anesthesiology departments in the United States. 320 anesthesiologists who attended the annual meeting of the ASA in 2009 (95% response rate). The anonymous 50-item survey collected information on 26 independent demographic variables and 24 dependent ranked variables of career satisfaction among practicing anesthesiologists. Mean survey scores were calculated for each demographic variable and tested for statistically significant differences by analysis of variance. Questions within each domain that were internally consistent with each other within domains were identified by Cronbach's alpha ≥ 0.7. P-values ≤ 0.05 were considered statistically significant. Cronbach's alpha analysis showed strong internal consistency for 10 dependent outcome questions in the practice factor-related domain (α = 0.72), 6 dependent outcome questions in the peer factor-related domain (α = 0.71), and 8 dependent outcome questions in the personal factor-related domain (α = 0.81). Although age was not a variable, full-time status, early satisfaction within the first 5 years of practice, working with respected peers, and personal choice factors were all significantly associated with anesthesiologist job satisfaction. Improvements in factors related to job satisfaction among anesthesiologists may lead to higher early and current career satisfaction. Copyright © 2013 Elsevier Inc. All rights reserved.

The effect of partially exposed connective tissue graft on root-coverage outcomes: a systematic review and meta-analysis.

PubMed

Dodge, Austin; Garcia, Jeffrey; Luepke, Paul; Lai, Yu-Lin; Kassab, Moawia; Lin, Guo-Hao

2018-04-01

The aim of this systematic review was to compare the root-coverage outcomes of using a partially exposed connective tissue graft (CTG) technique with a fully covered CTG technique for root coverage. An electronic search up to February 28 th , 2017, was performed to identify human clinical studies with data comparing outcomes of root coverage using CTG, with and without a partially exposed graft. Five clinical studies were selected for inclusion in this review. For each study, the gain of keratinized gingiva, reduction of recession depth, number of surgical sites achieving complete root coverage, percentage of root coverage, gain of tissue thickness, and changes of probing depth and clinical attachment level were recorded. Meta-analysis for the comparison of complete root coverage between the two techniques presented no statistically significant differences. A statistically significant gain of keratinized tissue in favor of the sites with an exposed CTG and a tendency of greater reduction in recession depth were seen at the sites with a fully covered CTG. Based on the results, the use of a partially exposed CTG in root-coverage procedures could achieve greater gain in keratinized gingiva, while a fully covered CTG might be indicated for procedures aiming to reduce recession depth. © 2018 Eur J Oral Sci.

Comparison of methods for the analysis of relatively simple mediation models.

PubMed

Rijnhart, Judith J M; Twisk, Jos W R; Chinapaw, Mai J M; de Boer, Michiel R; Heymans, Martijn W

2017-09-01

Statistical mediation analysis is an often used method in trials, to unravel the pathways underlying the effect of an intervention on a particular outcome variable. Throughout the years, several methods have been proposed, such as ordinary least square (OLS) regression, structural equation modeling (SEM), and the potential outcomes framework. Most applied researchers do not know that these methods are mathematically equivalent when applied to mediation models with a continuous mediator and outcome variable. Therefore, the aim of this paper was to demonstrate the similarities between OLS regression, SEM, and the potential outcomes framework in three mediation models: 1) a crude model, 2) a confounder-adjusted model, and 3) a model with an interaction term for exposure-mediator interaction. Secondary data analysis of a randomized controlled trial that included 546 schoolchildren. In our data example, the mediator and outcome variable were both continuous. We compared the estimates of the total, direct and indirect effects, proportion mediated, and 95% confidence intervals (CIs) for the indirect effect across OLS regression, SEM, and the potential outcomes framework. OLS regression, SEM, and the potential outcomes framework yielded the same effect estimates in the crude mediation model, the confounder-adjusted mediation model, and the mediation model with an interaction term for exposure-mediator interaction. Since OLS regression, SEM, and the potential outcomes framework yield the same results in three mediation models with a continuous mediator and outcome variable, researchers can continue using the method that is most convenient to them.

Graphical tools for network meta-analysis in STATA.

PubMed

Chaimani, Anna; Higgins, Julian P T; Mavridis, Dimitris; Spyridonos, Panagiota; Salanti, Georgia

2013-01-01

Network meta-analysis synthesizes direct and indirect evidence in a network of trials that compare multiple interventions and has the potential to rank the competing treatments according to the studied outcome. Despite its usefulness network meta-analysis is often criticized for its complexity and for being accessible only to researchers with strong statistical and computational skills. The evaluation of the underlying model assumptions, the statistical technicalities and presentation of the results in a concise and understandable way are all challenging aspects in the network meta-analysis methodology. In this paper we aim to make the methodology accessible to non-statisticians by presenting and explaining a series of graphical tools via worked examples. To this end, we provide a set of STATA routines that can be easily employed to present the evidence base, evaluate the assumptions, fit the network meta-analysis model and interpret its results.

Graphical Tools for Network Meta-Analysis in STATA

PubMed Central

Chaimani, Anna; Higgins, Julian P. T.; Mavridis, Dimitris; Spyridonos, Panagiota; Salanti, Georgia

2013-01-01

Network meta-analysis synthesizes direct and indirect evidence in a network of trials that compare multiple interventions and has the potential to rank the competing treatments according to the studied outcome. Despite its usefulness network meta-analysis is often criticized for its complexity and for being accessible only to researchers with strong statistical and computational skills. The evaluation of the underlying model assumptions, the statistical technicalities and presentation of the results in a concise and understandable way are all challenging aspects in the network meta-analysis methodology. In this paper we aim to make the methodology accessible to non-statisticians by presenting and explaining a series of graphical tools via worked examples. To this end, we provide a set of STATA routines that can be easily employed to present the evidence base, evaluate the assumptions, fit the network meta-analysis model and interpret its results. PMID:24098547

EUCLID: an outcome analysis tool for high-dimensional clinical studies

NASA Astrophysics Data System (ADS)

Gayou, Olivier; Parda, David S.; Miften, Moyed

2007-03-01

Treatment management decisions in three-dimensional conformal radiation therapy (3DCRT) and intensity-modulated radiation therapy (IMRT) are usually made based on the dose distributions in the target and surrounding normal tissue. These decisions may include, for example, the choice of one treatment over another and the level of tumour dose escalation. Furthermore, biological predictors such as tumour control probability (TCP) and normal tissue complication probability (NTCP), whose parameters available in the literature are only population-based estimates, are often used to assess and compare plans. However, a number of other clinical, biological and physiological factors also affect the outcome of radiotherapy treatment and are often not considered in the treatment planning and evaluation process. A statistical outcome analysis tool, EUCLID, for direct use by radiation oncologists and medical physicists was developed. The tool builds a mathematical model to predict an outcome probability based on a large number of clinical, biological, physiological and dosimetric factors. EUCLID can first analyse a large set of patients, such as from a clinical trial, to derive regression correlation coefficients between these factors and a given outcome. It can then apply such a model to an individual patient at the time of treatment to derive the probability of that outcome, allowing the physician to individualize the treatment based on medical evidence that encompasses a wide range of factors. The software's flexibility allows the clinicians to explore several avenues to select the best predictors of a given outcome. Its link to record-and-verify systems and data spreadsheets allows for a rapid and practical data collection and manipulation. A wide range of statistical information about the study population, including demographics and correlations between different factors, is available. A large number of one- and two-dimensional plots, histograms and survival curves allow for an easy visual analysis of the population. Several visual and analytical methods are available to quantify the predictive power of the multivariate regression model. The EUCLID tool can be readily integrated with treatment planning and record-and-verify systems.

EUCLID: an outcome analysis tool for high-dimensional clinical studies.

PubMed

Gayou, Olivier; Parda, David S; Miften, Moyed

2007-03-21

Treatment management decisions in three-dimensional conformal radiation therapy (3DCRT) and intensity-modulated radiation therapy (IMRT) are usually made based on the dose distributions in the target and surrounding normal tissue. These decisions may include, for example, the choice of one treatment over another and the level of tumour dose escalation. Furthermore, biological predictors such as tumour control probability (TCP) and normal tissue complication probability (NTCP), whose parameters available in the literature are only population-based estimates, are often used to assess and compare plans. However, a number of other clinical, biological and physiological factors also affect the outcome of radiotherapy treatment and are often not considered in the treatment planning and evaluation process. A statistical outcome analysis tool, EUCLID, for direct use by radiation oncologists and medical physicists was developed. The tool builds a mathematical model to predict an outcome probability based on a large number of clinical, biological, physiological and dosimetric factors. EUCLID can first analyse a large set of patients, such as from a clinical trial, to derive regression correlation coefficients between these factors and a given outcome. It can then apply such a model to an individual patient at the time of treatment to derive the probability of that outcome, allowing the physician to individualize the treatment based on medical evidence that encompasses a wide range of factors. The software's flexibility allows the clinicians to explore several avenues to select the best predictors of a given outcome. Its link to record-and-verify systems and data spreadsheets allows for a rapid and practical data collection and manipulation. A wide range of statistical information about the study population, including demographics and correlations between different factors, is available. A large number of one- and two-dimensional plots, histograms and survival curves allow for an easy visual analysis of the population. Several visual and analytical methods are available to quantify the predictive power of the multivariate regression model. The EUCLID tool can be readily integrated with treatment planning and record-and-verify systems.

Applying quantitative bias analysis to estimate the plausible effects of selection bias in a cluster randomised controlled trial: secondary analysis of the Primary care Osteoarthritis Screening Trial (POST).

PubMed

Barnett, L A; Lewis, M; Mallen, C D; Peat, G

2017-12-04

Selection bias is a concern when designing cluster randomised controlled trials (c-RCT). Despite addressing potential issues at the design stage, bias cannot always be eradicated from a trial design. The application of bias analysis presents an important step forward in evaluating whether trial findings are credible. The aim of this paper is to give an example of the technique to quantify potential selection bias in c-RCTs. This analysis uses data from the Primary care Osteoarthritis Screening Trial (POST). The primary aim of this trial was to test whether screening for anxiety and depression, and providing appropriate care for patients consulting their GP with osteoarthritis would improve clinical outcomes. Quantitative bias analysis is a seldom-used technique that can quantify types of bias present in studies. Due to lack of information on the selection probability, probabilistic bias analysis with a range of triangular distributions was also used, applied at all three follow-up time points; 3, 6, and 12 months post consultation. A simple bias analysis was also applied to the study. Worse pain outcomes were observed among intervention participants than control participants (crude odds ratio at 3, 6, and 12 months: 1.30 (95% CI 1.01, 1.67), 1.39 (1.07, 1.80), and 1.17 (95% CI 0.90, 1.53), respectively). Probabilistic bias analysis suggested that the observed effect became statistically non-significant if the selection probability ratio was between 1.2 and 1.4. Selection probability ratios of > 1.8 were needed to mask a statistically significant benefit of the intervention. The use of probabilistic bias analysis in this c-RCT suggested that worse outcomes observed in the intervention arm could plausibly be attributed to selection bias. A very large degree of selection of bias was needed to mask a beneficial effect of intervention making this interpretation less plausible.

Agile Airmen: Developing the Capacity to Quickly Create Innovative Ideas

DTIC Science & Technology

2011-03-23

economic growth.26 In contrast, a 2008 statistical analysis finds a high correlation to economic growth. Eric Hanushek and Ludger Woessmann studied... Hanushek and Woessmann analysis identified STEM leaders as vital to America‟s long-term prosperity, but having quality teachers who can teach STEM...accessed November 10, 2010). 27 Eric A. Hanushek & Ludger Woessmann, "Do Better Schools Lead to More Growth? Cognitive Skills, Economic Outcomes

Living Animals in the Classroom: A Meta-Analysis on Learning Outcome and a Treatment-Control Study Focusing on Knowledge and Motivation

ERIC Educational Resources Information Center

Hummel, Eberhard; Randler, Christoph

2012-01-01

Prior research states that the use of living animals in the classroom leads to a higher knowledge but those previous studies have methodological and statistical problems. We applied a meta-analysis and developed a treatment-control study in a middle school classroom. The treatments (film vs. living animal) differed only by the presence of the…

A global goodness-of-fit statistic for Cox regression models.

PubMed

Parzen, M; Lipsitz, S R

1999-06-01

In this paper, a global goodness-of-fit test statistic for a Cox regression model, which has an approximate chi-squared distribution when the model has been correctly specified, is proposed. Our goodness-of-fit statistic is global and has power to detect if interactions or higher order powers of covariates in the model are needed. The proposed statistic is similar to the Hosmer and Lemeshow (1980, Communications in Statistics A10, 1043-1069) goodness-of-fit statistic for binary data as well as Schoenfeld's (1980, Biometrika 67, 145-153) statistic for the Cox model. The methods are illustrated using data from a Mayo Clinic trial in primary billiary cirrhosis of the liver (Fleming and Harrington, 1991, Counting Processes and Survival Analysis), in which the outcome is the time until liver transplantation or death. The are 17 possible covariates. Two Cox proportional hazards models are fit to the data, and the proposed goodness-of-fit statistic is applied to the fitted models.

The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial.

PubMed

Williams, Aled L; Phillips, Ceri J; Watkins, Alan; Rushton, Alison B

2014-10-25

Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes, few studies have been conducted. Within musculoskeletal physiotherapy, the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed, but the impact of this mentoring on patient outcomes remains unknown. The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy. A stepped wedge cluster randomised controlled trial (CRCT) has been designed to recruit a minimum of 12 senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service (NHS) organization. Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods. Patients will be blinded to whether their physiotherapist has received the intervention. The primary outcome measure will be the Patient-Specific Functional Scale; secondary outcome measures will include the EQ-5D, patient activation, patient satisfaction and physiotherapist performance. Sample size considerations used published methods describing stepped wedge designs, conventional values of 0.80 for statistical power and 0.05 for statistical significance, and pragmatic groupings of 12 participating physiotherapists in three clusters. Based on an intergroup difference of 1.0 on the PSFS with a standard deviation of 2.0, 10 patients are required to complete outcome measures per physiotherapist, at time period 1 (prior to intervention roll-out) and at each of time periods 2, 3 and 4, giving a sample size of 480 patients. To account for the potential loss to follow-up of 33%, 720 sets of patient outcomes will be collected.All physiotherapist participants will receive 150 hours of mentored clinical practice as the intervention and usual in-service training as control. Consecutive, consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline, discharge and 12 months post-baseline. The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters. Assigned 31 July 2012: ISRCTN79599220.

Comparison of endothelial changes and power settings between torsional and longitudinal phacoemulsification.

PubMed

Reuschel, Anna; Bogatsch, Holger; Barth, Thomas; Wiedemann, Renate

2010-11-01

To compare the intraoperative and postoperative outcomes of conventional longitudinal phacoemulsification and torsional phacoemulsification. Department of Ophthalmology, University of Leipzig, Germany. Randomized single-center clinical trial. Eyes with senile cataract were randomized to have phacoemulsification using the Infiniti Vision System and the torsional mode (OZil) or conventional longitudinal mode. Primary outcomes were corrected distance visual acuity (CDVA) and central endothelial cell density (ECD), calculated according to the Conference on Harmonisation-E9 Guidelines in which missing values were substituted by the median in each group (primary analysis) and the loss was then calculated using actual data (secondary analysis). Secondary outcomes were ultrasound (US) time, cumulative dissipated energy (CDE), and percentage total equivalent power in position 3. Postoperative follow-up was at 3 months. The mean preoperative CDVA was 0.41 logMAR in the torsional group and 0.38 logMAR in the longitudinal group, improving to 0.07 logMAR postoperatively in both groups. The mean ECD loss was 7.2% ± 4.6% in the torsional group (72 patients) and 7.1% ± 4.4% in the longitudinal group (76 patients), with no statistically significant differences in the primary analysis (P = .342) or secondary analysis (P = .906). The mean US time, CDE, and percentage total equivalent power in position 3 were statistically significantly lower in the torsional group (98 patients) than in the longitudinal group (94 patients) (P<.001). The torsional mode was as safe as the longitudinal mode in phacoemulsification for age-related cataract. Copyright © 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

The role of remote ischemic preconditioning in organ protection after cardiac surgery: a meta-analysis.

PubMed

Haji Mohd Yasin, Nur A B; Herbison, Peter; Saxena, Pankaj; Praporski, Slavica; Konstantinov, Igor E

2014-01-01

Remote ischemic preconditioning (RIPC) appears to protect distant organs from ischemia-reperfusion injury. We undertook meta-analysis of clinical studies to evaluate the effects of RIPC on organ protection and clinical outcomes in patients undergoing cardiac surgery. A review of evidence for cardiac, renal, and pulmonary protection after RIPC was performed. We also did meta-regressions on RIPC variables, such as duration of ischemia, cuff pressure, and timing of application of preconditioning. Secondary outcomes included length of hospital and intensive care unit stay, duration of mechanical ventilation, and mortality at 30 days. Randomized control trials (n = 25) were included in the study for quantitative analysis of cardiac (n = 16), renal (n = 6), and pulmonary (n = 3) protection. RIPC provided statistically significant cardiac protection (standardized mean difference [SMD], -0.77; 95% confidence interval [CI], -1.15, -0.39; Z = 3.98; P < 0.0001) and on subgroup analysis, the protective effect remained consistent for all types of cardiac surgical procedures. However, there was no evidence of renal protection (SMD, 0.74; 95% CI, 0.53, 1.02; Z = 1.81; P = 0.07) or pulmonary protection (SMD, -0.03; 95% CI, -0.56, 0.50; Z = 0.12; P = 0.91). There was no statistical difference in the short-term clinical outcomes between the RIPC and control groups. RIPC provides cardiac protection, but there is no evidence of renal or pulmonary protection in patients undergoing cardiac surgery using cardiopulmonary bypass. Larger multicenter trials are required to define the role of RIPC in surgical practice. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

The significance of intrauterine growth restriction is different from prematurity for the outcome of infants with gastroschisis.

PubMed

Puligandla, Pramod S; Janvier, Annie; Flageole, Hélène; Bouchard, Sarah; Mok, Elise; Laberge, Jean-Martin

2004-08-01

Recent reviews of gastroschisis identify prematurity and low birth weight as predictors of morbidity and mortality. The authors compared the outcomes of intrauterine growth-restricted infants (IUGR) with gastroschisis to those without growth restriction because IUGR is different from prematurity. A retrospective analysis was performed for infants born with gastroschisis between 1990 and 2000 at 2 pediatric hospitals. Patients were segregated into 3 groups based on birth weight corrected for gestational age: group 1 (IUGR, 25th percentile). Patient demographics, method of closure, number of surgeries, presence of atresia, and time to full enteral feedings (FPO days) were assessed. Mortality rate, length of stay (LOS), and readmission rates were also compared. Analysis of variance (ANOVA)/Student's t test and Fisher's. Exact tests were used for statistical analysis (P <.05 significant). Regression analysis was also performed. One hundred thirteen patients were included (group 1 = 17; group 2 = 43; group 3 = 53). Overall, infants with IUGR had similar outcomes to non-IUGR infants, including FPO and total parenteral nutrition (TPN) days, LOS, readmission, and mortality rates. The method of closure did not affect outcome. Infants with atresia had significantly increased times to full feeding (95 v 34 days; P =.034), more surgeries (2.7 v 1.4; P =.002), and longer LOS (106 v 48 days; P =.011). Infants born at less than 37 weeks' gestation had significantly increased fasting (NPO) days (28 v 18 days; P =.005) and longer LOS (65 v 37 days; P =.006) when compared with infants born at greater than 37 weeks. Logistic regression analysis identified the presence of atresia as an independent risk factor for gastrointestinal dysfunction and the need for prolonged TPN. Prematurity also adversely affected these same parameters, although it did not reach statistical significance. Although infants with gastroschisis are generally small for gestational age, the outcomes of growth-restricted infants are similar to those of other infants. The type of closure does not affect outcome, regardless of birth weight. The presence of atresia or prematurity does lead to longer times for full feeding and LOS. Therefore, routine premature delivery of infants with gastroschisis should not be advocated, even in the context of IUGR.

A Bifactor Approach to Model Multifaceted Constructs in Statistical Mediation Analysis.

PubMed

Gonzalez, Oscar; MacKinnon, David P

Statistical mediation analysis allows researchers to identify the most important mediating constructs in the causal process studied. Identifying specific mediators is especially relevant when the hypothesized mediating construct consists of multiple related facets. The general definition of the construct and its facets might relate differently to an outcome. However, current methods do not allow researchers to study the relationships between general and specific aspects of a construct to an outcome simultaneously. This study proposes a bifactor measurement model for the mediating construct as a way to parse variance and represent the general aspect and specific facets of a construct simultaneously. Monte Carlo simulation results are presented to help determine the properties of mediated effect estimation when the mediator has a bifactor structure and a specific facet of a construct is the true mediator. This study also investigates the conditions when researchers can detect the mediated effect when the multidimensionality of the mediator is ignored and treated as unidimensional. Simulation results indicated that the mediation model with a bifactor mediator measurement model had unbiased and adequate power to detect the mediated effect with a sample size greater than 500 and medium a - and b -paths. Also, results indicate that parameter bias and detection of the mediated effect in both the data-generating model and the misspecified model varies as a function of the amount of facet variance represented in the mediation model. This study contributes to the largely unexplored area of measurement issues in statistical mediation analysis.

Assessment of quality outcomes for robotic pancreaticoduodenectomy: identification of the learning curve.

PubMed

Boone, Brian A; Zenati, Mazen; Hogg, Melissa E; Steve, Jennifer; Moser, Arthur James; Bartlett, David L; Zeh, Herbert J; Zureikat, Amer H

2015-05-01

Quality assessment is an important instrument to ensure optimal surgical outcomes, particularly during the adoption of new surgical technology. The use of the robotic platform for complex pancreatic resections, such as the pancreaticoduodenectomy, requires close monitoring of outcomes during its implementation phase to ensure patient safety is maintained and the learning curve identified. To report the results of a quality analysis and learning curve during the implementation of robotic pancreaticoduodenectomy (RPD). A retrospective review of a prospectively maintained database of 200 consecutive patients who underwent RPD in a large academic center from October 3, 2008, through March 1, 2014, was evaluated for important metrics of quality. Patients were analyzed in groups of 20 to minimize demographic differences and optimize the ability to detect statistically meaningful changes in performance. Robotic pancreaticoduodenectomy. Optimization of perioperative outcome parameters. No statistical differences in mortality rates or major morbidity were noted during the study. Statistical improvements in estimated blood loss and conversions to open surgery occurred after 20 cases (600 mL vs 250 mL [P = .002] and 35.0% vs 3.3% [P < .001], respectively), incidence of pancreatic fistula after 40 cases (27.5% vs 14.4%; P = .04), and operative time after 80 cases (581 minutes vs 417 minutes [P < .001]). Complication rates, lengths of stay, and readmission rates showed continuous improvement that did not reach statistical significance. Outcomes for the last 120 cases (representing optimized metrics beyond the learning curve) included a mean operative time of 417 minutes, median estimated blood loss of 250 mL, a conversion rate of 3.3%, 90-day mortality of 3.3%, a clinically significant (grade B/C) pancreatic fistula rate of 6.9%, and a median length of stay of 9 days. Continuous assessment of quality metrics allows for safe implementation of RPD. We identified several inflexion points corresponding to optimization of performance metrics for RPD that can be used as benchmarks for surgeons who are adopting this technology.

Assessment of the quality of primary care for the elderly according to the Chronic Care Model 1

PubMed Central

Silva, Líliam Barbosa; Soares, Sônia Maria; Silva, Patrícia Aparecida Barbosa; Santos, Joseph Fabiano Guimarães; Miranda, Lívia Carvalho Viana; Santos, Raquel Melgaço

2018-01-01

ABSTRACT Objective: to evaluate the quality of care provided to older people with diabetes mellitus and/or hypertension in the Primary Health Care (PHC) according to the Chronic Care Model (CCM) and identify associations with care outcomes. Method: cross-sectional study involving 105 older people with diabetes mellitus and/or hypertension. The Patient Assessment of Chronic Illness Care (PACIC) questionnaire was used to evaluate the quality of care. The total score was compared with care outcomes that included biochemical parameters, body mass index, pressure levels and quality of life. Data analysis was based on descriptive statistics and multiple logistic regression. Results: there was a predominance of females and a median age of 72 years. The median PACIC score was 1.55 (IQ 1.30-2.20). Among the PACIC dimensions, the “delivery system design/decision support” was the one that presented the best result. There was no statistical difference between the medians of the overall PACIC score and individual care outcomes. However, when the quality of life and health satisfaction were simultaneously evaluated, a statistical difference between the medians was observed. Conclusion: the low PACIC scores found indicate that chronic care according to the CCM in the PHC seems still to fall short of its assumptions. PMID:29538582

Assessment of the quality of primary care for the elderly according to the Chronic Care Model.

PubMed

Silva, Líliam Barbosa; Soares, Sônia Maria; Silva, Patrícia Aparecida Barbosa; Santos, Joseph Fabiano Guimarães; Miranda, Lívia Carvalho Viana; Santos, Raquel Melgaço

2018-03-08

to evaluate the quality of care provided to older people with diabetes mellitus and/or hypertension in the Primary Health Care (PHC) according to the Chronic Care Model (CCM) and identify associations with care outcomes. cross-sectional study involving 105 older people with diabetes mellitus and/or hypertension. The Patient Assessment of Chronic Illness Care (PACIC) questionnaire was used to evaluate the quality of care. The total score was compared with care outcomes that included biochemical parameters, body mass index, pressure levels and quality of life. Data analysis was based on descriptive statistics and multiple logistic regression. there was a predominance of females and a median age of 72 years. The median PACIC score was 1.55 (IQ 1.30-2.20). Among the PACIC dimensions, the "delivery system design/decision support" was the one that presented the best result. There was no statistical difference between the medians of the overall PACIC score and individual care outcomes. However, when the quality of life and health satisfaction were simultaneously evaluated, a statistical difference between the medians was observed. the low PACIC scores found indicate that chronic care according to the CCM in the PHC seems still to fall short of its assumptions.

Comparison of the predictive validity of diagnosis-based risk adjusters for clinical outcomes.

PubMed

Petersen, Laura A; Pietz, Kenneth; Woodard, LeChauncy D; Byrne, Margaret

2005-01-01

Many possible methods of risk adjustment exist, but there is a dearth of comparative data on their performance. We compared the predictive validity of 2 widely used methods (Diagnostic Cost Groups [DCGs] and Adjusted Clinical Groups [ACGs]) for 2 clinical outcomes using a large national sample of patients. We studied all patients who used Veterans Health Administration (VA) medical services in fiscal year (FY) 2001 (n = 3,069,168) and assigned both a DCG and an ACG to each. We used logistic regression analyses to compare predictive ability for death or long-term care (LTC) hospitalization for age/gender models, DCG models, and ACG models. We also assessed the effect of adding age to the DCG and ACG models. Patients in the highest DCG categories, indicating higher severity of illness, were more likely to die or to require LTC hospitalization. Surprisingly, the age/gender model predicted death slightly more accurately than the ACG model (c-statistic of 0.710 versus 0.700, respectively). The addition of age to the ACG model improved the c-statistic to 0.768. The highest c-statistic for prediction of death was obtained with a DCG/age model (0.830). The lowest c-statistics were obtained for age/gender models for LTC hospitalization (c-statistic 0.593). The c-statistic for use of ACGs to predict LTC hospitalization was 0.783, and improved to 0.792 with the addition of age. The c-statistics for use of DCGs and DCG/age to predict LTC hospitalization were 0.885 and 0.890, respectively, indicating the best prediction. We found that risk adjusters based upon diagnoses predicted an increased likelihood of death or LTC hospitalization, exhibiting good predictive validity. In this comparative analysis using VA data, DCG models were generally superior to ACG models in predicting clinical outcomes, although ACG model performance was enhanced by the addition of age.

Predictors of outcome after elective endovascular abdominal aortic aneurysm repair and external validation of a risk prediction model.

PubMed

Wisniowski, Brendan; Barnes, Mary; Jenkins, Jason; Boyne, Nicholas; Kruger, Allan; Walker, Philip J

2011-09-01

Endovascular abdominal aortic aneurysm (AAA) repair (EVAR) has been associated with lower operative mortality and morbidity than open surgery but comparable long-term mortality and higher delayed complication and reintervention rates. Attention has therefore been directed to identifying preoperative and operative variables that influence outcomes after EVAR. Risk-prediction models, such as the EVAR Risk Assessment (ERA) model, have also been developed to help surgeons plan EVAR procedures. The aims of this study were (1) to describe outcomes of elective EVAR at the Royal Brisbane and Women's Hospital (RBWH), (2) to identify preoperative and operative variables predictive of outcomes after EVAR, and (3) to externally validate the ERA model. All elective EVAR procedures at the RBWH before July 1, 2009, were reviewed. Descriptive analyses were performed to determine the outcomes. Univariate and multivariate analyses were performed to identify preoperative and operative variables predictive of outcomes after EVAR. Binomial logistic regression analyses were used to externally validate the ERA model. Before July 1, 2009, 197 patients (172 men), who were a mean age of 72.8 years, underwent elective EVAR at the RBWH. Operative mortality was 1.0%. Survival was 81.1% at 3 years and 63.2% at 5 years. Multivariate analysis showed predictors of survival were age (P = .0126), American Society of Anesthesiologists (ASA) score (P = .0180), and chronic obstructive pulmonary disease (P = .0348) at 3 years and age (P = .0103), ASA score (P = .0006), renal failure (P = .0048), and serum creatinine (P = .0022) at 5 years. Aortic branch vessel score was predictive of initial (30-day) type II endoleak (P = .0015). AAA tortuosity was predictive of midterm type I endoleak (P = .0251). Female sex was associated with lower rates of initial clinical success (P = .0406). The ERA model fitted RBWH data well for early death (C statistic = .906), 3-year survival (C statistic = .735), 5-year survival (C statistic = .800), and initial type I endoleak (C statistic = .850). The outcomes of elective EVAR at the RBWH are broadly consistent with those of a nationwide Australian audit and recent randomized trials. Age and ASA score are independent predictors of midterm survival after elective EVAR. The ERA model predicts mortality-related outcomes and initial type I endoleak well for RBWH elective EVAR patients. Copyright © 2011 Society for Vascular Surgery. All rights reserved.

Outcome of transforaminal lumbar interbody fusion in spondylolisthesis-A clinico-radiological correlation.

PubMed

Balasubramanian, Vijay Anand; Douraiswami, Balaji; Subramani, Suresh

2018-06-01

Lumbar spondylolisthesis is a common cause of morbidity in middle aged individuals. Spinal fusion with instrumentation has become the gold standard for lumbar segmental instability. Studies which correlate the improvement in radiology postoperatively with functional outcome show contrasting reports. This study is aimed at finding the correlation between clinical and radiological outcomes after surgery with transforaminal lumbar interbody fusion. A retrospective study in 35 patients who underwent transforaminal lumbar interbody fusion in a period of 1 year was done. Preoperative pain (VAS Score), functional ability (ODI), radiological parameters (slip angle, slip grade, disc height, foraminal height, lumbar lordosis) were compared with postoperative recordings at the last followup. Functional improvement (Macnab's criteria) and fusion (Lee's fusion criteria) were assessed. Statistical analysis was done with student's paired t -test and Pearson's correlation coefficient. VAS score, ODI improved from 8 to 2 and 70 to 15 respectively. Slip angle improved from 23°to 5° on an average. 80% patients showed fusion and 85% showed good clinical outcome at 1 year followup. Analyzing with Pearson correlation coefficient showed no significant relation between pain scores and radiological parameters. But there was statistically significant relation between radiological fusion and the final clinical outcome. TLIF produces spinal fusion in most individuals. Strong spinal fusion is essential for good clinical outcome in spondylolisthesis patients who undergo TLIF. Reduction in slip is not necessary for all patients with listhesis.

Motivational interviewing and intimate partner violence: a randomized trial.

PubMed

Saftlas, Audrey F; Harland, Karisa K; Wallis, Anne B; Cavanaugh, Joseph; Dickey, Penny; Peek-Asa, Corinne

2014-02-01

To determine if motivational interviewing (MI) improves self-efficacy (primary outcome), depressive symptoms (secondary outcome), and stage-of-readiness-to-change (secondary outcome) among women in abusive relationships. Randomized controlled trial among women who experienced intimate partner violence in a current relationship over the past 12 months. Subjects were recruited from two family planning clinics (December 2007 to May 2010). The intervention included an initial face-to-face session and three telephone sessions administered 1-, 2-, and 4-months postenrollment, each using MI to identify personal goals. Controls were referred to community-based resources. Outcomes were measured by self-administered questionnaires before randomization and 6 months later. Modified intent-to-treat analyses of completed participants were conducted using multivariate analysis of variance for continuous outcomes and polytomous logistic regression for categorical outcomes. Three hundred six eligible women were enrolled (recruitment rate = 64%); 204 completed the 6-month follow-up (completion rate = 67%). Depressive symptoms decreased to a greater extent in MI than referral women (P = .07). Self-efficacy and stage-of-readiness-to-change increased more in MI than referral women, but these differences were not statistically significant. With a lower than projected sample size, our findings did not achieve statistical significance at the 5% level but suggest a beneficial effect of the MI intervention on reducing depressive symptoms. Copyright © 2014 Elsevier Inc. All rights reserved.

Associations between maternal antioxidant intakes in pregnancy and infant allergic outcomes.

PubMed

West, Christina E; Dunstan, Janet; McCarthy, Suzi; Metcalfe, Jessica; D'Vaz, Nina; Meldrum, Suzanne; Oddy, Wendy H; Tulic, Meri K; Prescott, Susan L

2012-11-14

Antioxidant intakes in pregnancy may influence fetal immune programming and the risk of allergic disease. We investigated associations between maternal intakes of β-carotene, vitamin C, vitamin E, copper and zinc, and infant allergic outcomes. Antioxidant intakes of pregnant women (n = 420) assessed prospectively by a food frequency questionnaire, were examined in relation to allergic outcomes at 1 year of age (n = 300). The main relationships with allergic outcomes were seen with dietary vitamin C and copper. Specifically, higher maternal dietary vitamin C intake was associated with a reduced risk of any diagnosed infant allergic disease and wheeze. After adjustment for potential confounders the relationship with wheeze remained statistically significant. There was also an inverse linear relationship between vitamin C and food allergy. Higher dietary copper intake was associated with reduced risk of eczema, wheeze and any allergic disease. The relationship with wheeze and any allergic disease remained statistically significant in multivariate analysis, and there was also an inverse linear relationship between copper and food allergy. However, these relationships were only seen for nutrients present in food. There were no relationships between β-carotene, vitamin E or zinc and any allergic outcomes. In summary, this study suggests that maternal diet of fresh foods rich in vitamin C is associated with reduced risk of infant wheeze, and that copper intake is associated with reduced risk of several allergic outcomes.

Employee and family assistance video counseling program: a post launch retrospective comparison with in-person counseling outcomes.

PubMed

Veder, Barbara; Pope, Stan; Mani, Michèle; Beaudoin, Kelly; Ritchie, Janice

2014-01-01

Access to technologically mediated information and services under the umbrella of mental and physical health has become increasingly available to clients via Internet modalities, according to a recent study. In May 2010, video counseling was added to the counseling services offered through the Employee and Family Assistance Program at Shepell·fgi as a pilot project with a full operational launch in September 2011. The objective of this study was to conduct a retrospective post launch examination of the video counseling service through an analysis of the reported clinical outcomes of video and in-person counseling modalities. A chronological sample of 68 video counseling (VC) cases and 68 in-person (IP) cases were collected from a pool of client clinical files closed in 2012. To minimize the variables impacting the study and maintain as much clinical continuity as possible, the IP and the VC clients must have attended clinical sessions with any one of six counselors who provided both the VC and the IP services. The study compared the two counseling modalities along the following data points (see glossary of terms): (1) client demographic profiles (eg, age, gender, whether the sessions involved individuals or conjoint sessions with couples or families, etc), (2) presenting issue, (3) average session hours, (4) client rating of session helpfulness, (5) rates of goal completion, (6) client withdrawal rates, (7) no show and late cancellation rates, and (8) pre/post client self-assessment. Specific to VC, we examined client geographic location. Data analysis demonstrates that the VC and the IP showed a similar representation of presenting issues with nearly identical outcomes for client ratings of session helpfulness, rates of goal completion, pre/post client self-assessment, average session duration, and client geographic location. There were no statistically significant differences in the rates of withdrawal from counseling, no shows, and late cancellations between the VC and the IP counseling. The statistical analysis of the data was done on SPSS statistical software using 2-sample and pairwise comparison t tests at a 95% level of significance. Based on the study, VC and IP show similar outcomes in terms of client rating of session and goal attainment.

Factors influencing utilization of hospital services by adult sickle cell disease patients: a systematic review.

PubMed

Benenson, Irina; Jadotte, Yuri; Echevarria, Mercedes

2017-03-01

Painful vaso-occlusive crisis is a hallmark of sickle cell disease (SCD) that commonly results in utilization of hospital services. Recurrent use of hospital services by SCD patients is associated with high healthcare costs and adverse clinical outcomes. Understanding the factors influencing the pattern of utilization is a first step in improving medical care of this patient population while reducing healthcare expenditures. The primary objective of this systematic review was to determine what modifiable and non-modifiable factors influence utilization of hospital services by adult SCD patients. Adult SCD patients of both sexes who utilized hospital services for acute or emergency care. Non-modifiable and modifiable factors influencing utilization of hospital services. Prospective and retrospective cohort studies, case-control and analytical cross-sectional studies. The primary outcome of interest was high utilization of hospital services by adult SCD patients based on non-modifiable and modifiable factors measured as an odds ratio (analytical outcome). The secondary outcome was the prevalence of non-modifiable and modifiable factors among SCD patients who utilized hospital services measured as an event rate (descriptive outcome). A comprehensive multi-step search was undertaken to find both published and unpublished studies. Only studies published in the English language were included. The search was not limited by year of publication. Retrieved papers were assessed for methodological quality using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument. Data were extracted using a researcher-developed tool. Included studies were combined in a statistical meta-analysis. The meta-analysis was based on a random effect model. For studies that did not allow statistical pooling, the findings have been presented in a narrative form. Fourteen studies were included in this review. The analysis demonstrated that male patients accounted for 40.8% (95% confidence interval [CI] 0.370-0.447) of all utilizing patients. Sickle cell disease patients who were publically insured accounted for 76.5% (95% CI 0.632-0.861) of all patients who had hospital encounters. Patients aged 25-35 years had the highest rate of utilization, and the rate of utilization declined in patients older than 50 years. High utilizing patients had more diagnoses of acute chest syndrome and sepsis than patients who were moderate or low utilizers. The majority of SCD patients who utilized hospital services were women, young people and publically insured individuals. Patients with particularly high level of utilization had more frequent diagnoses of acute chest syndrome and sepsis.

Assessment of Reliable Change Using 95% Credible Intervals for the Differences in Proportions: A Statistical Analysis for Case-Study Methodology.

PubMed

Unicomb, Rachael; Colyvas, Kim; Harrison, Elisabeth; Hewat, Sally

2015-06-01

Case-study methodology studying change is often used in the field of speech-language pathology, but it can be criticized for not being statistically robust. Yet with the heterogeneous nature of many communication disorders, case studies allow clinicians and researchers to closely observe and report on change. Such information is valuable and can further inform large-scale experimental designs. In this research note, a statistical analysis for case-study data is outlined that employs a modification to the Reliable Change Index (Jacobson & Truax, 1991). The relationship between reliable change and clinical significance is discussed. Example data are used to guide the reader through the use and application of this analysis. A method of analysis is detailed that is suitable for assessing change in measures with binary categorical outcomes. The analysis is illustrated using data from one individual, measured before and after treatment for stuttering. The application of this approach to assess change in categorical, binary data has potential application in speech-language pathology. It enables clinicians and researchers to analyze results from case studies for their statistical and clinical significance. This new method addresses a gap in the research design literature, that is, the lack of analysis methods for noncontinuous data (such as counts, rates, proportions of events) that may be used in case-study designs.

Statistical grand rounds: understanding the mechanism: mediation analysis in randomized and nonrandomized studies.

PubMed

Mascha, Edward J; Dalton, Jarrod E; Kurz, Andrea; Saager, Leif

2013-10-01

In comparative clinical studies, a common goal is to assess whether an exposure, or intervention, affects the outcome of interest. However, just as important is to understand the mechanism(s) for how the intervention affects outcome. For example, if preoperative anemia was shown to increase the risk of postoperative complications by 15%, it would be important to quantify how much of that effect was due to patients receiving intraoperative transfusions. Mediation analysis attempts to quantify how much, if any, of the effect of an intervention on outcome goes though prespecified mediator, or "mechanism" variable(s), that is, variables sitting on the causal pathway between exposure and outcome. Effects of an exposure on outcome can thus be divided into direct and indirect, or mediated, effects. Mediation is claimed when 2 conditions are true: the exposure affects the mediator and the mediator (adjusting for the exposure) affects the outcome. Understanding how an intervention affects outcome can validate or invalidate one's original hypothesis and also facilitate further research to modify the responsible factors, and thus improve patient outcome. We discuss the proper design and analysis of studies investigating mediation, including the importance of distinguishing mediator variables from confounding variables, the challenge of identifying potential mediators when the exposure is chronic versus acute, and the requirements for claiming mediation. Simple designs are considered, as well as those containing multiple mediators, multiple outcomes, and mixed data types. Methods are illustrated with data collected by the National Surgical Quality Improvement Project (NSQIP) and utilized in a companion paper which assessed the effects of preoperative anemic status on postoperative outcomes.

Positive smoking outcome expectancies mediate the association between negative affect and smoking urge among women during a quit attempt.

PubMed

Cano, Miguel Ángel; Lam, Cho Y; Chen, Minxing; Adams, Claire E; Correa-Fernández, Virmarie; Stewart, Diana W; McClure, Jennifer B; Cinciripini, Paul M; Wetter, David W

2014-08-01

Ecological momentary assessment was used to examine associations between negative affect, positive smoking outcome expectancies, and smoking urge during the first 7 days of a smoking quit attempt. Participants were 302 female smokers who enrolled in an individually tailored smoking cessation treatment study. Multilevel mediation analysis was used to examine the temporal relationship among the following: (a) the effects of negative affect and positive smoking outcome expectancies at 1 assessment point (e.g., time j) on smoking urge at the subsequent time point (e.g., time j + 1) in Model 1; and, (b) the effects of negative affect and smoking urge at time j on positive smoking outcome expectancies at time j + 1 in Model 2. The results from Model 1 showed a statistically significant effect of negative affect at time j on smoking urge at time j + 1, and this effect was mediated by positive smoking outcome expectancies at time j, both within- and between-participants. In Model 2, the within-participant indirect effect of negative affect at time j on positive smoking outcome expectancies at time j + 1 through smoking urge at time j was nonsignificant. However, a statistically significant indirect between-participants effect was found in Model 2. The findings support the hypothesis that urge and positive smoking outcome expectancies increase as a function of negative affect, and suggest a stronger effect of expectancies on urge as opposed to the effect of urge on expectancies.

Positive Smoking Outcome Expectancies Mediate the Association between Negative Affect and Smoking Urge among Women During a Quit Attempt

PubMed Central

Cano, Miguel Ángel; Lam, Cho Y.; Chen, Minxing; Adams, Claire E.; Correa-Fernández, Virmarie; Stewart, Diana W.; McClure, Jennifer B.; Cinciripini, Paul M.; Wetter, David W.

2014-01-01

Ecological momentary assessment was used to examine associations between negative affect, positive smoking outcome expectancies, and smoking urge during the first 7 days of a smoking quit attempt. Participants were 302 female smokers who enrolled in an individually tailored smoking cessation treatment study. Multilevel mediation analysis was used to examine the temporal relationship among: 1) the effects of negative affect and positive smoking outcome expectancies at one assessment point (e.g., time j) on smoking urge at the subsequent time point (e.g., time j + 1) in Model 1; and, 2) the effects of negative affect and smoking urge at time j on positive smoking outcome expectancies at time j + 1 in Model 2. The results from Model 1 showed a statistically significant effect of negative affect at time j on smoking urge at time j + 1, and this effect was mediated by positive smoking outcome expectancies at time j, both within- and between-participant. In Model 2, the within-participant indirect effect of negative affect at time j on positive smoking outcome expectancies at time j + 1 through smoking urge at time j was nonsignificant. However, a statistically significant indirect between-participant effect was found in Model 2. The findings support the hypothesis that urge and positive smoking outcome expectancies increase as a function of negative affect, and suggest a stronger effect of expectancies on urge as opposed to the effect of urge on expectancies. PMID:24796849

Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

PubMed

Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

2018-05-18

This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to improved weight loss outcomes in online social networking groups. © 2018 John Wiley & Sons Ltd.

A general method for handling missing binary outcome data in randomized controlled trials

PubMed Central

Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen

2014-01-01

Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Participants A total of 489 and 1758 participants from two smoking cessation trials. Measurements The abstinence outcomes were obtained using telephone interviews. Findings The estimated intervention effects from both trials depend on the sensitivity parameters used. The findings differ considerably in magnitude and statistical significance under quite extreme assumptions about the missing data, but are reasonably consistent under more moderate assumptions. Conclusions A new method for undertaking sensitivity analyses when handling missing data in trials with binary outcomes allows a wide range of assumptions about the missing data to be assessed. In two smoking cessation trials the results were insensitive to all but extreme assumptions. PMID:25171441

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

The concept of a composite perioperative quality index in kidney transplantation.

PubMed

Taber, David J; McGillicuddy, John W; Bratton, Charles F; Lin, Angello; Chavin, Kenneth D; Baliga, Prabhakar K

2014-04-01

Public reporting of patient and graft outcomes in a national registry and close Centers for Medicare and Medicaid Services oversight has resulted in transplantation being a highly regulated surgical discipline. Despite this, transplantation surgery lacks comprehensive tracking and reporting of perioperative quality measures. Therefore, the aim of this study was to determine the association between a kidney transplantation centers' perioperative quality benchmarking and graft and patient outcomes. This was an analysis of 2011 aggregate data compiled from 2 national datasets that track outcomes from member hospitals and transplantation centers. The transplantation centers included in this study were composed of accredited US kidney transplantation centers that report data through the national registry and are associate members of the University HealthSystem Consortium. A total of 16,811 kidney transplantations were performed at 236 centers in the United States in 2011, of which 10,241 (61%) from 93 centers were included in the analysis. Of the 6 perioperative quality indicators, 3 benchmarked metrics were significantly associated with a kidney transplantation center's underperformance: mean ICU length of stay (C-statistic 0.731; p = 0.002), 30-day readmissions (C-statistic 0.697; p = 0.012) and in-hospital complications (C-statistic 0.785; p = 0.001). The composite quality index strongly correlated with inadequate center performance (C-statistic 0.854; p < 0.001, R(2) = 0.349). The centers in the lowest quartile of the quality index performed 2,400 kidney transplantations in 2011, which led to 2,640 more hospital days, 4,560 more ICU days, 120 more postoperative complications, and 144 more patients with 30-day readmissions, when compared with centers in the 3 higher-quality quartiles. An objective index of a transplantation center's quality of perioperative care is significantly associated with patient and graft survival. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

[Accidents at work and occupational diseases trend in agriculture insurance management. The contribution of INAIL data's for the knowledge of a worrying phenomenon].

PubMed

Calandriello, Luigi; Goggiamani, Angela; Ienzi, Emanuela; Naldini, Silvia; Orsini, Dario

2013-01-01

The author's describe accidents at work and occupational diseases outcome's measure in Agricolture insurance management acquired through statistical approach based on data processing provided by INAIL Bank data. Accident's incidence in Agricolture is compared to main insurance managements, using frequency index of accidents appearance selected on line of work and type of consequence. Concerning occupational diseases the authors describes the complaints and compensation with the comparison referring the analysis to statistical general data. The data define a worrying phenomenon.

ABCA Transporter Gene Expression and Poor Outcome in Epithelial Ovarian Cancer

PubMed Central

Hedditch, Ellen L.; Gao, Bo; Russell, Amanda J.; Lu, Yi; Emmanuel, Catherine; Beesley, Jonathan; Johnatty, Sharon E.; Chen, Xiaoqing; Harnett, Paul; George, Joshy; Williams, Rebekka T.; Flemming, Claudia; Lambrechts, Diether; Despierre, Evelyn; Lambrechts, Sandrina; Vergote, Ignace; Karlan, Beth; Lester, Jenny; Orsulic, Sandra; Walsh, Christine; Fasching, Peter; Beckmann, Matthias W.; Ekici, Arif B.; Hein, Alexander; Matsuo, Keitaro; Hosono, Satoyo; Nakanishi, Toru; Yatabe, Yasushi; Pejovic, Tanja; Bean, Yukie; Heitz, Florian; Harter, Philipp; du Bois, Andreas; Schwaab, Ira; Hogdall, Estrid; Kjaer, Susan K.; Jensen, Allan; Hogdall, Claus; Lundvall, Lene; Engelholm, Svend Aage; Brown, Bob; Flanagan, James; Metcalf, Michelle D; Siddiqui, Nadeem; Sellers, Thomas; Fridley, Brooke; Cunningham, Julie; Schildkraut, Joellen; Iversen, Ed; Weber, Rachel P.; Berchuck, Andrew; Goode, Ellen; Bowtell, David D.; Chenevix-Trench, Georgia; deFazio, Anna; Norris, Murray D.; MacGregor, Stuart; Haber, Michelle; Henderson, Michelle J.

2014-01-01

Background ATP-binding cassette (ABC) transporters play various roles in cancer biology and drug resistance, but their association with outcomes in serous epithelial ovarian cancer (EOC) is unknown. Methods The relationship between clinical outcomes and ABC transporter gene expression in two independent cohorts of high-grade serous EOC tumors was assessed with real-time quantitative polymerase chain reaction, analysis of expression microarray data, and immunohistochemistry. Associations between clinical outcomes and ABCA transporter gene single nucleotide polymorphisms were tested in a genome-wide association study. Impact of short interfering RNA–mediated gene suppression was determined by colony forming and migration assays. Association with survival was assessed with Kaplan–Meier analysis and log-rank tests. All statistical tests were two-sided. Results Associations with outcome were observed with ABC transporters of the “A” subfamily, but not with multidrug transporters. High-level expression of ABCA1, ABCA6, ABCA8, and ABCA9 in primary tumors was statistically significantly associated with reduced survival in serous ovarian cancer patients. Low levels of ABCA5 and the C-allele of rs536009 were associated with shorter overall survival (hazard ratio for death = 1.50; 95% confidence interval [CI] =1.26 to 1.79; P = 6.5e−6). The combined expression pattern of ABCA1, ABCA5, and either ABCA8 or ABCA9 was associated with particularly poor outcome (mean overall survival in group with adverse ABCA1, ABCA5 and ABCA9 gene expression = 33.2 months, 95% CI = 26.4 to 40.1; vs 55.3 months in the group with favorable ABCA gene expression, 95% CI = 49.8 to 60.8; P = .001), independently of tumor stage or surgical debulking status. Suppression of cholesterol transporter ABCA1 inhibited ovarian cancer cell growth and migration in vitro, and statin treatment reduced ovarian cancer cell migration. Conclusions Expression of ABCA transporters was associated with poor outcome in serous ovarian cancer, implicating lipid trafficking as a potentially important process in EOC. PMID:24957074

The effects and interactions of student, teacher, and setting variables on reading outcomes for kindergartners receiving supplemental reading intervention.

PubMed

Hagan-Burke, Shanna; Coyne, Michael D; Kwok, Oi-Man; Simmons, Deborah C; Kim, Minjung; Simmons, Leslie E; Skidmore, Susan T; Hernandez, Caitlin L; McSparran Ruby, Maureen

2013-01-01

This exploratory study examined the influences of student, teacher, and setting characteristics on kindergarteners' early reading outcomes and investigated whether those relations were moderated by type of intervention. Participants included 206 kindergarteners identified as at risk for reading difficulties and randomly assigned to one of two supplemental interventions: (a) an experimental explicit, systematic, code-based program or (b) their schools' typical kindergarten reading intervention. Results from separate multilevel structural equation models indicated that among student variables, entry-level alphabet knowledge was positively associated with phonemic and decoding outcomes in both conditions. Entry-level rapid automatized naming also positively influenced decoding outcomes in both conditions. However, its effect on phonemic outcomes was statistically significant only among children in the typical practice comparison condition. Regarding teacher variables, the quality of instruction was associated with significantly higher decoding outcomes in the typical reading intervention condition but had no statistically significant influence on phonemic outcomes in either condition. Among setting variables, instruction in smaller group sizes was associated with better phonemic outcomes in the comparison condition but had no statistically significant influence on outcomes of children in the intervention group. Mode of delivery (i.e., pullout vs. in class) had no statistically significant influence on either outcome variable.

Efficacy of exposure versus cognitive therapy in anxiety disorders: systematic review and meta-analysis

PubMed Central

2011-01-01

Background There is growing evidence of the effectiveness of Cognitive Behavioural Therapy (CBT) for a wide range of psychological disorders. There is a continued controversy about whether challenging maladaptive thoughts rather than use of behavioural interventions alone is associated with the greatest efficacy. However little is known about the relative efficacy of various components of CBT. This review aims to compare the relative efficacy of Cognitive Therapy (CT) versus Exposure (E) for a range of anxiety disorders using the most clinically relevant outcome measures and estimating the summary relative efficacy by combining the studies in a meta-analysis. Methods Psych INFO, MEDLINE and EMBASE were searched from the first available year to May 2010. All randomised controlled studies comparing the efficacy of exposure with cognitive therapy were included. Odds ratios (OR) or standardised means' differences (Hedges' g) for the most clinically relevant primary outcomes were calculated. Outcomes of the studies were grouped according to specific disorders and were combined in meta-analyses exploring short-term and long-term outcomes. Results 20 Randomised Controlled Trials with (n = 1,308) directly comparing the efficacy of CT and E in anxiety disorders were included in the meta-analysis. No statistically significant difference in the relative efficacy of CT and E was revealed in Post Traumatic Stress Disorder (PTSD), in Obsessive Compulsive Disorder (OCD) and in Panic Disorder (PD). There was a statistically significant difference favouring CT versus E in Social Phobia both in the short-term (Z = 3.72, p = 0.0002) and the long-term (Z = 3.28, p = 0.001) outcomes. Conclusions On the basis of extant literature, there appears to be no evidence of differential efficacy between cognitive therapy and exposure in PD, PTSD and OCD and strong evidence of superior efficacy of cognitive therapy in social phobia PMID:22185596

Alternative and traditional assessments: Their comparative impact on students' attitudes and science learning outcomes. An exploratory study

NASA Astrophysics Data System (ADS)

Century, Daisy Nelson

This probing study focused on alternative and traditional assessments, their comparative impacts on students' attitudes and science learning outcomes. Four basic questions were asked: What type of science learning stemming from the instruction can best be assessed by the use of traditional paper-and pencil test? What type of science learning stemming from the instruction can best be assessed by the use of alternative assessment? What are the differences in the types of learning outcomes that can be assessed by the use of paper-pencil test and alternative assessment test? Is there a difference in students' attitude towards learning science when assessment of outcomes is by alternative assessment means compared to traditional means compared to traditional means? A mixed methodology involving quantitative and qualitative techniques was utilized. However, the study was essentially a case study. Quantitative data analysis included content achievement and attitude results, to which non-parametric statistics were applied. Analysis of qualitative data was done as a case study utilizing pre-set protocols resulting in a narrative summary style of report. These outcomes were combined in order to produce conclusions. This study revealed that the traditional method yielded more concrete cognitive content learning than did the alternative assessment. The alternative assessment yielded more psychomotor, cooperative learning and critical thinking skills. In both the alternative and the traditional methods the student's attitudes toward science were positive. There was no significant differences favoring either group. The quantitative findings of no statistically significant differences suggest that at a minimum there is no loss in the use of alternative assessment methods, in this instance, performance testing. Adding the results from the qualitative analysis to this suggests (1) that class groups were more satisfied when alternative methods were employed, and (2) that the two assessment methodologies are complementary to each other, and thus should probably be used together to produce maximum benefit.

The Relationship between Teaching Presence and Student Course Outcomes in an Online International Population

ERIC Educational Resources Information Center

Wendt, Jillian; Courduff, Jennifer

2018-01-01

A causal comparative research design was utilized in this study to examine the relationship between international students' perceptions of teacher presence in the online learning environment and students' achievement as measured by end of course grades. Spearman's analysis indicated no statistically significant correlation between the composite…

Computer-Based Instruction and Health Professions Education: A Meta-Analysis of Outcomes.

ERIC Educational Resources Information Center

Cohen, Peter A.; Dacanay, Lakshmi S.

1992-01-01

The meta-analytic techniques of G. V. Glass were used to statistically integrate findings from 47 comparative studies on computer-based instruction (CBI) in health professions education. A clear majority of the studies favored CBI over conventional methods of instruction. Results show higher-order applications of computers to be especially…

Relationship of Class-Size to Classroom Processes, Teacher Satisfaction and Pupil Affect: A Meta-Analysis.

ERIC Educational Resources Information Center

Smith, Mary Lee; Glass, Gene V.

Using data from previously completed research, the authors of this report attempted to examine the relationship between class size and measures of outcomes such as student attitudes and behavior, classroom processes and learning environment, and teacher satisfaction. The authors report that statistical integration of the existing research…

Challenge in Enhancing the Teaching and Learning of Variable Measurements in Quantitative Research

ERIC Educational Resources Information Center

Kee, Chang Peng; Osman, Kamisah; Ahmad, Fauziah

2013-01-01

Statistical analysis is one component that cannot be avoided in a quantitative research. Initial observations noted that students in higher education institution faced difficulty analysing quantitative data which were attributed to the confusions of various variable measurements. This paper aims to compare the outcomes of two approaches applied in…

Editorial: Introduction to the Special Section on Causal Inference in Cross Sectional and Longitudinal Mediational Models

PubMed Central

West, Stephen G.

2016-01-01

Psychologists have long had interest in the processes through which antecedent variables produce their effects on the outcomes of ultimate interest (e.g., Wood-worth's Stimulus-Organism-Response model). Models involving such meditational processes have characterized many of the important psychological theories of the 20th century and continue to the present day. However, it was not until Judd and Kenny (1981) and Baron and Kenny (1986) combined ideas from experimental design and structural equation modeling that statistical methods for directly testing such models, now known as mediation analysis, began to be developed. Methodologists have improved these statistical methods, developing new, more efficient estimators for mediated effects. They have also extended mediation analysis to multilevel data structures, models involving multiple mediators, models in which interactions occur, and an array of noncontinuous outcome measures (see MacKinnon, 2008). This work nicely maps on to key questions of applied researchers and has led to an outpouring of research testing meditational models (As of August, 2011, Baron and Kenny's article has had over 24,000 citations according to Google Scholar). PMID:26736046

Epidural space identification: a meta-analysis of complications after air versus liquid as the medium for loss of resistance.

PubMed

Schier, Robert; Guerra, Diana; Aguilar, Jorge; Pratt, Gregory F; Hernandez, Mike; Boddu, Krishna; Riedel, Bernhard

2009-12-01

The best method for identifying the epidural space for neuraxial blocks is controversial. We conducted this meta-analysis to test the hypothesis that loss of resistance with liquid reduces complications with epidural placement. The MEDLINE, EMBASE, and Cochrane databases were searched for prospective, randomized studies comparing air versus liquid as the medium for loss of resistance during epidural space identification in adults. Data were abstracted from 5 studies (4 obstetric and 1 nonobstetric) (n = 4422 patients) that met inclusion criteria and analyzed for the following 6 outcomes: difficult catheter insertion, paresthesia, intravascular catheter insertion, accidental dural puncture, postdural puncture headache, and partial block. The overall risk differences for adverse outcome between the different mediums were not statistically different for the obstetric population. A small, but statistically significant, risk difference for postdural puncture headache was observed when fluid was used during epidural placement for chronic pain management. Larger studies that overcome limitations of heterogeneity across studies and a relatively infrequent occurrence of complications are required to determine the optimal medium for loss of resistance during epidural block.

Use of the Oxford Handicap Scale at hospital discharge to predict Glasgow Outcome Scale at 6 months in patients with traumatic brain injury.

PubMed

Perel, Pablo; Edwards, Phil; Shakur, Haleema; Roberts, Ian

2008-11-06

Traumatic brain injury (TBI) is an important cause of acquired disability. In evaluating the effectiveness of clinical interventions for TBI it is important to measure disability accurately. The Glasgow Outcome Scale (GOS) is the most widely used outcome measure in randomised controlled trials (RCTs) in TBI patients. However GOS measurement is generally collected at 6 months after discharge when loss to follow up could have occurred. The objectives of this study were to evaluate the association and predictive validity between a simple disability scale at hospital discharge, the Oxford Handicap Scale (OHS), and the GOS at 6 months among TBI patients. The study was a secondary analysis of a randomised clinical trial among TBI patients (MRC CRASH Trial). A Spearman correlation was estimated to evaluate the association between the OHS and GOS. The validity of different dichotomies of the OHS for predicting GOS at 6 months was assessed by calculating sensitivity, specificity and the C statistic. Uni and multivariate logistic regression models were fitted including OHS as explanatory variable. For each model we analysed its discrimination and calibration. We found that the OHS is highly correlated with GOS at 6 months (spearman correlation 0.75) with evidence of a linear relationship between the two scales. The OHS dichotomy that separates patients with severe dependency or death showed the greatest discrimination (C statistic: 84.3). Among survivors at hospital discharge the OHS showed a very good discrimination (C statistic 0.78) and excellent calibration when used to predict GOS outcome at 6 months. We have shown that the OHS, a simple disability scale available at hospital discharge can predict disability accurately, according to the GOS, at 6 months. OHS could be used to improve the design and analysis of clinical trials in TBI patients and may also provide a valuable clinical tool for physicians to improve communication with patients and relatives when assessing a patient's prognosis at hospital discharge.

A brief introduction to probability.

PubMed

Di Paola, Gioacchino; Bertani, Alessandro; De Monte, Lavinia; Tuzzolino, Fabio

2018-02-01

The theory of probability has been debated for centuries: back in 1600, French mathematics used the rules of probability to place and win bets. Subsequently, the knowledge of probability has significantly evolved and is now an essential tool for statistics. In this paper, the basic theoretical principles of probability will be reviewed, with the aim of facilitating the comprehension of statistical inference. After a brief general introduction on probability, we will review the concept of the "probability distribution" that is a function providing the probabilities of occurrence of different possible outcomes of a categorical or continuous variable. Specific attention will be focused on normal distribution that is the most relevant distribution applied to statistical analysis.

On the analysis of very small samples of Gaussian repeated measurements: an alternative approach.

PubMed

Westgate, Philip M; Burchett, Woodrow W

2017-03-15

The analysis of very small samples of Gaussian repeated measurements can be challenging. First, due to a very small number of independent subjects contributing outcomes over time, statistical power can be quite small. Second, nuisance covariance parameters must be appropriately accounted for in the analysis in order to maintain the nominal test size. However, available statistical strategies that ensure valid statistical inference may lack power, whereas more powerful methods may have the potential for inflated test sizes. Therefore, we explore an alternative approach to the analysis of very small samples of Gaussian repeated measurements, with the goal of maintaining valid inference while also improving statistical power relative to other valid methods. This approach uses generalized estimating equations with a bias-corrected empirical covariance matrix that accounts for all small-sample aspects of nuisance correlation parameter estimation in order to maintain valid inference. Furthermore, the approach utilizes correlation selection strategies with the goal of choosing the working structure that will result in the greatest power. In our study, we show that when accurate modeling of the nuisance correlation structure impacts the efficiency of regression parameter estimation, this method can improve power relative to existing methods that yield valid inference. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Quantitative investigation of inappropriate regression model construction and the importance of medical statistics experts in observational medical research: a cross-sectional study.

PubMed

Nojima, Masanori; Tokunaga, Mutsumi; Nagamura, Fumitaka

2018-05-05

To investigate under what circumstances inappropriate use of 'multivariate analysis' is likely to occur and to identify the population that needs more support with medical statistics. The frequency of inappropriate regression model construction in multivariate analysis and related factors were investigated in observational medical research publications. The inappropriate algorithm of using only variables that were significant in univariate analysis was estimated to occur at 6.4% (95% CI 4.8% to 8.5%). This was observed in 1.1% of the publications with a medical statistics expert (hereinafter 'expert') as the first author, 3.5% if an expert was included as coauthor and in 12.2% if experts were not involved. In the publications where the number of cases was 50 or less and the study did not include experts, inappropriate algorithm usage was observed with a high proportion of 20.2%. The OR of the involvement of experts for this outcome was 0.28 (95% CI 0.15 to 0.53). A further, nation-level, analysis showed that the involvement of experts and the implementation of unfavourable multivariate analysis are associated at the nation-level analysis (R=-0.652). Based on the results of this study, the benefit of participation of medical statistics experts is obvious. Experts should be involved for proper confounding adjustment and interpretation of statistical models. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Influence of surgeon specialization upon the results of colon cancer surgery. Usefulness of propensity scores].

PubMed

Martínez-Ramos, D; Escrig-Sos, J; Miralles-Tena, J M; Rivadulla-Serrano, M I; Daroca-José, J M; Salvador Sanchís, J L

2008-07-01

surgeon influence on colorectal cancer surgery outcomes has been repeatedly studied in the scientific literature, but conclusions have been contradictory. Here we study whether surgeon specialization is a determinant factor for outcome in these patients. The importance of propensity scores (PS) in surgical research is also studied. a retrospective study was performed and medical records were reviewed for 236 patients who were intervened for colon cancer in Castellon General Hospital (Spain). Cases were divided into two groups (specialist and non-specialist surgeons), and both 5-year surveillance and disease free survival were compared. Comparisons were first made with no adjustments, and then subsequently using PS analysis. the initial (non-adjusted) analysis was clearly favourable for the specialist surgeon group (5-year surveillance, 64.3 vs. 79.3%, p = 0.028). After adjusting for PS no statistical significance was obtained. surgeon specialization had no significant impact on patient outcome after colon cancer surgery. Propensity score analysis is an important tool in the analysis of surgical non-randomized studies, particularly when events under scrutiny are rare.

The maternal and neonatal outcomes for an urban Indigenous population compared with their non-Indigenous counterparts and a trend analysis over four triennia.

PubMed

Kildea, Sue; Stapleton, Helen; Murphy, Rebecca; Kosiak, Machellee; Gibbons, Kristen

2013-08-30

Indigenous Australians experience significantly disproportionate poorer health outcomes compared to their non-Indigenous counterparts. Despite the recognised importance of maternal infant health (MIH), there is surprisingly little empirical research to guide service redesign that successfully addresses the disparities. This paper reports on a service evaluation that also compared key MIH indicators for Indigenous and non-Indigenous mothers and babies over a 12-year period 1998-2009. Trend analysis with logistic regression, using the independent variables of ethnicity and triennia, explored changes over time (1998-2009) between two cohorts: 1,523 births to Indigenous mothers and 43,693 births to non-Indigenous mothers. We included bivariate and multivariate analysis on key indicators (e.g. teenage births, preterm birth, low birth weight, smoking) and report odds ratios (ORs), 95% CIs and logistic regression adjusting for important confounders. We excluded transfers in from other areas which are identified within the database. Bivariate analysis revealed Indigenous women were statistically more likely to have spontaneous onset of labour and a non-instrumental vaginal birth. They were less likely to take epidurals for pain relief in labour, have assisted births, caesarean sections or perineal trauma. Despite better labour outcomes, Indigenous babies were more likely to be born preterm (< 37 weeks) and be low birth weight (< 2500 g); these differences remained significant in multivariate analysis. The trend analysis revealed relatively stable rates for teenage pregnancy, small for gestational age, low birth weight babies, and perinatal mortality for both cohorts, with the gap between cohorts consistent over time. A statistical widening of the gap in preterm birth and smoking rates was found with preterm birth demonstrating a relative increase of 51% over this period. The comprehensive database from a large urban hospital allowed a thorough examination of outcomes and contributing factors. The gap between both cohorts remains static in several areas but in some cases worsened. Alternative models for delivering care to Indigenous women and their babies have shown improved outcomes, including preterm birth, though not all have been sustained over time and none are available Australia-wide. New models of care, which recognise the heterogeneity of Indigenous communities, incorporate a multiagency approach, and are set within a research framework, are urgently needed.

A Statistical Method for Synthesizing Mediation Analyses Using the Product of Coefficient Approach Across Multiple Trials

PubMed Central

Huang, Shi; MacKinnon, David P.; Perrino, Tatiana; Gallo, Carlos; Cruden, Gracelyn; Brown, C Hendricks

2016-01-01

Mediation analysis often requires larger sample sizes than main effect analysis to achieve the same statistical power. Combining results across similar trials may be the only practical option for increasing statistical power for mediation analysis in some situations. In this paper, we propose a method to estimate: 1) marginal means for mediation path a, the relation of the independent variable to the mediator; 2) marginal means for path b, the relation of the mediator to the outcome, across multiple trials; and 3) the between-trial level variance-covariance matrix based on a bivariate normal distribution. We present the statistical theory and an R computer program to combine regression coefficients from multiple trials to estimate a combined mediated effect and confidence interval under a random effects model. Values of coefficients a and b, along with their standard errors from each trial are the input for the method. This marginal likelihood based approach with Monte Carlo confidence intervals provides more accurate inference than the standard meta-analytic approach. We discuss computational issues, apply the method to two real-data examples and make recommendations for the use of the method in different settings. PMID:28239330

Multiple statistical tests: Lessons from a d20.

PubMed

Madan, Christopher R

2016-01-01

Statistical analyses are often conducted with α= .05. When multiple statistical tests are conducted, this procedure needs to be adjusted to compensate for the otherwise inflated Type I error. In some instances in tabletop gaming, sometimes it is desired to roll a 20-sided die (or 'd20') twice and take the greater outcome. Here I draw from probability theory and the case of a d20, where the probability of obtaining any specific outcome is (1)/ 20, to determine the probability of obtaining a specific outcome (Type-I error) at least once across repeated, independent statistical tests.

Assessment of Outcomes of Treatment of Fractures of Distal Femur with a Locking Plate Taking into Account Factors Influencing the Result.

PubMed

Pakuła, Grzegorz; Kwiatkowski, Krzysztof; Kuczmera, Piotr; Fudalej, Piotr

2015-10-01

The aim of this paper is to evaluate the results of treatment of distal femoral fractures (DFF) fixed with locking plates and analysis of factors that influence the final outcome. The patients were treated at the Department of Traumatology and Orthopedics, Military Medical Institute in Warsaw, and the Department of Orthopedics and Traumatology, 4th Military Research Hospital in Wroclaw. We analysed 39 patients with 42 fractures of the distal femur. Treatment results were analysed using the KOOS and KSS scales. Factors influencing the outcome were also investigated. Statistical analysis was performed using STATISTICA v. 10. Mean KOOS scores indicate a predominance of poor outcomes, while mean KSS scores indicate good outcomes. Treatment outcomes were significantly influenced by pain and limited mobility. 1. Subjective evaluation of treatment of fractures of the distal femur using the KOOS scale per form edworse than a clinical evaluation using the KSS. 2. Post-operative management should emphasise pain relief and restoration of the performance of the treated lower limb to ensure good mobility without crutches. 3. Despite the use of modern operational methods of fracture fixation, treatment of distal femur fractures is still a challenge.

Epidemiologic tools to study the influence of environmental factors on fecundity and pregnancy-related outcomes.

PubMed

Slama, Rémy; Ballester, Ferran; Casas, Maribel; Cordier, Sylvaine; Eggesbø, Merete; Iniguez, Carmen; Nieuwenhuijsen, Mark; Philippat, Claire; Rey, Sylvie; Vandentorren, Stéphanie; Vrijheid, Martine

2014-01-01

Adverse pregnancy outcomes entail a large health burden for the mother and offspring; a part of it might be avoided by better understanding the role of environmental factors in their etiology. Our aims were to review the assessment tools to characterize fecundity troubles and pregnancy-related outcomes in human populations and their sensitivity to environmental factors. For each outcome, we reviewed the possible study designs, main sources of bias, and their suggested cures. In terms of study design, for most pregnancy outcomes, cohorts with recruitment early during or even before pregnancy allow efficient characterization of pregnancy-related events, time-varying confounders, and in utero exposures that may impact birth outcomes and child health. Studies on congenital anomalies require specific designs, assessment of anomalies in medical pregnancy terminations, and, for congenital anomalies diagnosed postnatally, follow-up during several months after birth. Statistical analyses should take into account environmental exposures during the relevant time windows; survival models are an appropriate approach for fecundity, fetal loss, and gestational duration/preterm delivery. Analysis of gestational duration could distinguish pregnancies according to delivery induction (and possibly pregnancy-related conditions). In conclusion, careful design and analysis are required to better characterize environmental effects on human reproduction.

Predicting dire outcomes of patients with community acquired pneumonia.

PubMed

Cooper, Gregory F; Abraham, Vijoy; Aliferis, Constantin F; Aronis, John M; Buchanan, Bruce G; Caruana, Richard; Fine, Michael J; Janosky, Janine E; Livingston, Gary; Mitchell, Tom; Monti, Stefano; Spirtes, Peter

2005-10-01

Community-acquired pneumonia (CAP) is an important clinical condition with regard to patient mortality, patient morbidity, and healthcare resource utilization. The assessment of the likely clinical course of a CAP patient can significantly influence decision making about whether to treat the patient as an inpatient or as an outpatient. That decision can in turn influence resource utilization, as well as patient well being. Predicting dire outcomes, such as mortality or severe clinical complications, is a particularly important component in assessing the clinical course of patients. We used a training set of 1601 CAP patient cases to construct 11 statistical and machine-learning models that predict dire outcomes. We evaluated the resulting models on 686 additional CAP-patient cases. The primary goal was not to compare these learning algorithms as a study end point; rather, it was to develop the best model possible to predict dire outcomes. A special version of an artificial neural network (NN) model predicted dire outcomes the best. Using the 686 test cases, we estimated the expected healthcare quality and cost impact of applying the NN model in practice. The particular, quantitative results of this analysis are based on a number of assumptions that we make explicit; they will require further study and validation. Nonetheless, the general implication of the analysis seems robust, namely, that even small improvements in predictive performance for prevalent and costly diseases, such as CAP, are likely to result in significant improvements in the quality and efficiency of healthcare delivery. Therefore, seeking models with the highest possible level of predictive performance is important. Consequently, seeking ever better machine-learning and statistical modeling methods is of great practical significance.

Laparoscopic versus robotic-assisted Roux-en-Y gastric bypass: a retrospective, single-center study of early perioperative outcomes at a community hospital.

PubMed

Ahmad, Arif; Carleton, Jared D; Ahmad, Zoha F; Agarwala, Ashish

2016-09-01

The purpose of this study was to compare the operative and early perioperative outcomes of laparoscopic versus robotic-assisted Roux-en-Y gastric bypass procedures performed in a community hospital setting. The study was a chart review and analysis of the early perioperative outcomes of a total of 345 Roux-en-Y gastric bypass procedures performed by a single surgeon in a community hospital setting from January 2011 to October 2014. Of these, 173 procedures were performed laparoscopically and 172 were performed with robotic assistance utilizing the daVinci(®) surgical platform. Factors such as baseline patient characteristics, operative time, estimated blood loss (EBL), conversions to open procedure, complication rates, adverse events, length of stay (LOS), and return to the operating room for the two groups were retrospectively analyzed from a prospectively maintained database. Student's t test with unequal variances was used for statistical analysis, and a p value <0.05 was used for significance. There were no statistically significant differences in complication rates, EBL, or LOS between the two groups. There was a significant difference between the total operative times (135.30 ± 37.60 min for the laparoscopic procedure versus 154.84 ± 38.44 min for the robotic procedure, p < 0.05). There were no adverse intraoperative events, conversions to open procedures, leaks, strictures, returns to the operating room within 30 days, or mortalities in either group. Our study, which is the first of its kind to analyze the operative and early perioperative outcomes between laparoscopic and robotic-assisted Roux-en-Y gastric bypass procedures in the US community hospital setting, indicates that both are comparable in terms of safety, efficacy, and operative and early perioperative outcomes.

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

PubMed Central

Abdel-Fattah, Mohamed; MacLennan, Graeme; Kilonzo, Mary; Assassa, R Phil; McCormick, Kirsty; Davidson, Tracey; McDonald, Alison; N’Dow, James; Wardle, Judith; Norrie, John

2017-01-01

Introduction Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. Methods and analysis A pragmatic, multicentre, non-inferiority randomised controlled trial. Primary outcome measure The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. Secondary outcome measures The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. Statistical analysis The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. Ethics and dissemination The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. Trial registration number ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020. PMID:28801396

[Quality assessment in anesthesia].

PubMed

Kupperwasser, B

1996-01-01

Quality assessment (assurance/improvement) is the set of methods used to measure and improve the delivered care and the department's performance against pre-established criteria or standards. The four stages of the self-maintained quality assessment cycle are: problem identification, problem analysis, problem correction and evaluation of corrective actions. Quality assessment is a measurable entity for which it is necessary to define and calibrate measurement parameters (indicators) from available data gathered from the hospital anaesthesia environment. Problem identification comes from the accumulation of indicators. There are four types of quality indicators: structure, process, outcome and sentinel indicators. The latter signal a quality defect, are independent of outcomes, are easier to analyse by statistical methods and closely related to processes and main targets of quality improvement. The three types of methods to analyse the problems (indicators) are: peer review, quantitative methods and risks management techniques. Peer review is performed by qualified anaesthesiologists. To improve its validity, the review process should be explicited and conclusions based on standards of practice and literature references. The quantitative methods are statistical analyses applied to the collected data and presented in a graphic format (histogram, Pareto diagram, control charts). The risks management techniques include: a) critical incident analysis establishing an objective relationship between a 'critical' event and the associated human behaviours; b) system accident analysis, based on the fact that accidents continue to occur despite safety systems and sophisticated technologies, checks of all the process components leading to the impredictable outcome and not just the human factors; c) cause-effect diagrams facilitate the problem analysis in reducing its causes to four fundamental components (persons, regulations, equipment, process). Definition and implementation of corrective measures, based on the findings of the two previous stages, are the third step of the evaluation cycle. The Hawthorne effect is an outcome improvement, before the implementation of any corrective actions. Verification of the implemented actions is the final and mandatory step closing the evaluation cycle.

Ultrastructural analysis of different-made staplers' staples.

PubMed

Gentilli, S; Portigliotti, L; Aronici, M; Ferrante, D; Surico, D; Milanesio, M; Gianotti, V; Gatti, G; Addante, A; Garavoglia, M

2012-10-01

Recently, Chinese-made mechanical staplers with lower price respect to American-made ones have been introduced in clinical practice. In literature, small case series compare the clinical outcomes of different staplers concluding that the new stapler devices perform as well as the American ones. The aim of this study is to compare with an ultrastructural analysis the staples of different staplers in order to verify the existence of differences that might explain significant price disparity and condition clinical outcomes. Each stapler was subjected to morphological analysis, energy dispersive X-Ray spectroscopy, metal release assessment followed by inductively coupled plasma mass spectroscopy. P-values were considered statistically significant when <0.05. Autosuture staples have square section whereas the other American one and Chinese made staples have round sections. Roughness index and chips presence before and after ageing tests were comparable for all samples except for Ethicon Endo-Surgery stapler. Energy dispersive X-Ray spectroscopy showed that all staplers are made of pure Titanium but Ethicon Endo-Surgery staples are made with an alloy. Metal release analysis release statistically significant differences between samples in simulated body fluid 20 days solution (P=0.002) and in Aquaregia at 14 days solution. Discussion. Stapling devices have became routinely used in gastrointestinal surgery mainly because of operative time reduction. Recently, new Chinese-made mechanical staplers, with significantly lower prices, have been introduced in clinical practice. In literature, there are some studies that compare clinical outcomes of American-made and Chinese-made staplers on small groups of patients but doesn't exist any work which consider structural differences between traditional and new devices. In our study, for the first time, we propose a comparison between two American-made staplers and three Chinese-made staplers which evaluate morphology, metal composition and chemical staples release. Our study suggest that there are some ultrastructural differences between commercially available staplers with no correlation to price disparity. More studies are needed to confirm our results and to verify if our findings could condition clinical outcomes.

Expression of FOXP3, CD68, and CD20 at Diagnosis in the Microenvironment of Classical Hodgkin Lymphoma Is Predictive of Outcome

PubMed Central

Greaves, Paul; Clear, Andrew; Coutinho, Rita; Wilson, Andrew; Matthews, Janet; Owen, Andrew; Shanyinde, Milensu; Lister, T. Andrew; Calaminici, Maria; Gribben, John G.

2013-01-01

Purpose The immune microenvironment is key to the pathophysiology of classical Hodgkin lymphoma (CHL). Twenty percent of patients experience failure of their initial treatment, and others receive excessively toxic treatment. Prognostic scores and biomarkers have yet to influence outcomes significantly. Previous biomarker studies have been limited by the extent of tissue analyzed, statistical inconsistencies, and failure to validate findings. We aimed to overcome these limitations by validating recently identified microenvironment biomarkers (CD68, FOXP3, and CD20) in a new patient cohort with a greater extent of tissue and by using rigorous statistical methodology. Patients and Methods Diagnostic tissue from 122 patients with CHL was microarrayed and stained, and positive cells were counted across 10 to 20 high-powered fields per patient by using an automated system. Two statistical analyses were performed: a categorical analysis with test/validation set-defined cut points and Kaplan-Meier estimated outcome measures of 5-year overall survival (OS), disease-specific survival (DSS), and freedom from first-line treatment failure (FFTF) and an independent multivariate analysis of absolute uncategorized counts. Results Increased CD20 expression confers superior OS. Increased FOXP3 expression confers superior OS, and increased CD68 confers inferior FFTF and OS. FOXP3 varies independently of CD68 expression and retains significance when analyzed as a continuous variable in multivariate analysis. A simple score combining FOXP3 and CD68 discriminates three groups: FFTF 93%, 62%, and 47% (P < .001), DSS 93%, 82%, and 63% (P = .03), and OS 93%, 82%, and 59% (P = .002). Conclusion We have independently validated CD68, FOXP3, and CD20 as prognostic biomarkers in CHL, and we demonstrate, to the best of our knowledge for the first time, that combining FOXP3 and CD68 may further improve prognostic stratification. PMID:23045593

A Binomial Test of Group Differences with Correlated Outcome Measures

ERIC Educational Resources Information Center

Onwuegbuzie, Anthony J.; Levin, Joel R.; Ferron, John M.

2011-01-01

Building on previous arguments for why educational researchers should not provide effect-size estimates in the face of statistically nonsignificant outcomes (Robinson & Levin, 1997), Onwuegbuzie and Levin (2005) proposed a 3-step statistical approach for assessing group differences when multiple outcome measures are individually analyzed…

A study of best practices in promoting sustainable urbanization in China.

PubMed

Tan, Yongtao; Xu, Hui; Jiao, Liudan; Ochoa, J Jorge; Shen, Liyin

2017-05-15

In the past twenty years, various sustainable urban development policies and methods had been implemented within China, such that sustainable urbanization is now more widely accepted. Some of these policies and methods have been found to be successful in improving the sustainability of cities in China. Those practices can be defined as the best practices of sustainable urbanization, which can provide useful references for future urban developments. However, few existing studies examine how to learn from these best practices. Combining the methods of content analysis and social network analysis, this paper conducts a comprehensive study on 150 best practices of sustainable urbanization in China. The methods and outcomes of the 150 best practices are identified. The research findings demonstrate the statistics of categories, methods and outcomes of the 150 best practices and the main adopted methods. The achieved outcomes in different regions of China are also presented. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effectiveness of patient navigation programs for adult cancer patients undergoing treatment: a systematic review.

PubMed

Tho, Poh Chi; Ang, Emily

2016-02-01

Advancements in technology and medical treatment have made cancer care treatment more complex. With the current trend of sub-specialization in health care, cancer patients commonly receive care from multiple specialists and have wider treatment options. In view of this, there is a need to coordinate care and integrate information to enhance care and quality of outcomes for patients. Since the successful implementation of programs for increasing the survival rate of breast cancer patients at Harlem Hospital Center, New York, USA, patient navigation programs have been widely introduced in healthcare settings. Some literature has identified nurses as a primary candidate in assuming the role of a navigator. However, there is a need to further explore the effectiveness of patient navigation programs for their effectiveness in improving quality of life, and patient satisfaction and outcomes during the commencement of cancer treatment. The objective of this review was to synthesize the best available evidence on the effectiveness of patient navigation programs in adult cancer patients undergoing treatments such as radiotherapy and/or chemotherapy. This review considered studies that included adults aged 18 years and over, diagnosed with any type of cancer and undergoing treatment in an acute care hospital setting, including inpatient and outpatient/ambulatory care.This review considered studies that evaluated nurse-led patient navigation programs versus no patient navigation program or non-structured care coordination.A patient navigation program includes patient education, psychosocial support, and care coordination.This review considered randomized controlled trials and quasi-experimental studies.The review focused on the effects of patient navigator program clinical/patient outcomes. The review included studies on patient wellbeing and clinical outcomes, but excluded studies that had examined the impact of these programs on efficiency-related outcomes, such as length of hospital stay and resource use. A three-step search strategy was utilized to find both published and unpublished studies in the databases: CINAHL, MEDLINE, Academic Search Complete, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Science Direct, Google Scholar (SCIRUS), MEDNAR (first 200 hits) and ProQuest Dissertations and Theses published between 1990 to 2013. Only studies published in English were included in this review. Two reviewers independently evaluated the methodological quality of studies that met the inclusion criteria for the review, using a standardized critical appraisal instrument from the Joanna Briggs Institute. Data was extracted from the included papers using the standardized data extraction tool from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument. Quantitative data was pooled in a statistical meta-analysis using Review Manager 5.3. Effect sizes expressed as weighted mean differences (for continuous data) and their 95% confidence intervals were calculated for analysis. Heterogeneity was assessed statistically using the standard Chi-square test. Where statistical pooling was not possible, the findings are presented in narrative form. After the process of study selection, four studies (two randomized controlled trials and two quasi-experimental studies) with a total of 667 participants were included in the review. The results demonstrated no statistically significant difference in the quality of life of patients with cancer who had undergone patient navigation programs (pooled weighted difference = 0.41 [95% CI = -2.89 to 3.71], P=0.81). However, the two included studies that assessed patient satisfaction as an outcome measure both showed statistically significant improvements (p-values = 0.03 and 0.001, respectively). In the study that assessed patient distress level, there was no statistically significant difference found between the: nurse-led navigation and non-navigation groups (P = 0.675). Nurse-led patient navigation programs were not effective in addressing outcomes such as quality of life and distress levels, the systematic review did not find any significant difference between the two groups. However, there was a statistically significance difference in increasing patient satisfaction.There is limited evidence that patient navigation programs improve the outcomes of quality of life and reduce distress (for adult patients with cancer undergoing treatment). However, there is good evidence that patient navigation programs improve patients' satisfaction. Therefore it is recommended that patient navigation programs are used for adult cancer patients in the acute care setting to improve patients' satisfaction.There may be a need to explore a more rigorous evaluation of nurse-led navigation programs to determine their effectiveness. Researchers should consider multi-site studies and larger sample sizes for better generalization.

Potential errors and misuse of statistics in studies on leakage in endodontics.

PubMed

Lucena, C; Lopez, J M; Pulgar, R; Abalos, C; Valderrama, M J

2013-04-01

To assess the quality of the statistical methodology used in studies of leakage in Endodontics, and to compare the results found using appropriate versus inappropriate inferential statistical methods. The search strategy used the descriptors 'root filling' 'microleakage', 'dye penetration', 'dye leakage', 'polymicrobial leakage' and 'fluid filtration' for the time interval 2001-2010 in journals within the categories 'Dentistry, Oral Surgery and Medicine' and 'Materials Science, Biomaterials' of the Journal Citation Report. All retrieved articles were reviewed to find potential pitfalls in statistical methodology that may be encountered during study design, data management or data analysis. The database included 209 papers. In all the studies reviewed, the statistical methods used were appropriate for the category attributed to the outcome variable, but in 41% of the cases, the chi-square test or parametric methods were inappropriately selected subsequently. In 2% of the papers, no statistical test was used. In 99% of cases, a statistically 'significant' or 'not significant' effect was reported as a main finding, whilst only 1% also presented an estimation of the magnitude of the effect. When the appropriate statistical methods were applied in the studies with originally inappropriate data analysis, the conclusions changed in 19% of the cases. Statistical deficiencies in leakage studies may affect their results and interpretation and might be one of the reasons for the poor agreement amongst the reported findings. Therefore, more effort should be made to standardize statistical methodology. © 2012 International Endodontic Journal.

Cognitive Transfer Outcomes for a Simulation-Based Introductory Statistics Curriculum

ERIC Educational Resources Information Center

Backman, Matthew D.; Delmas, Robert C.; Garfield, Joan

2017-01-01

Cognitive transfer is the ability to apply learned skills and knowledge to new applications and contexts. This investigation evaluates cognitive transfer outcomes for a tertiary-level introductory statistics course using the CATALST curriculum, which exclusively used simulation-based methods to develop foundations of statistical inference. A…

Modeling time-to-event (survival) data using classification tree analysis.

PubMed

Linden, Ariel; Yarnold, Paul R

2017-12-01

Time to the occurrence of an event is often studied in health research. Survival analysis differs from other designs in that follow-up times for individuals who do not experience the event by the end of the study (called censored) are accounted for in the analysis. Cox regression is the standard method for analysing censored data, but the assumptions required of these models are easily violated. In this paper, we introduce classification tree analysis (CTA) as a flexible alternative for modelling censored data. Classification tree analysis is a "decision-tree"-like classification model that provides parsimonious, transparent (ie, easy to visually display and interpret) decision rules that maximize predictive accuracy, derives exact P values via permutation tests, and evaluates model cross-generalizability. Using empirical data, we identify all statistically valid, reproducible, longitudinally consistent, and cross-generalizable CTA survival models and then compare their predictive accuracy to estimates derived via Cox regression and an unadjusted naïve model. Model performance is assessed using integrated Brier scores and a comparison between estimated survival curves. The Cox regression model best predicts average incidence of the outcome over time, whereas CTA survival models best predict either relatively high, or low, incidence of the outcome over time. Classification tree analysis survival models offer many advantages over Cox regression, such as explicit maximization of predictive accuracy, parsimony, statistical robustness, and transparency. Therefore, researchers interested in accurate prognoses and clear decision rules should consider developing models using the CTA-survival framework. © 2017 John Wiley & Sons, Ltd.

Quantifying, displaying and accounting for heterogeneity in the meta-analysis of RCTs using standard and generalised Q statistics

PubMed Central

2011-01-01

Background Clinical researchers have often preferred to use a fixed effects model for the primary interpretation of a meta-analysis. Heterogeneity is usually assessed via the well known Q and I2 statistics, along with the random effects estimate they imply. In recent years, alternative methods for quantifying heterogeneity have been proposed, that are based on a 'generalised' Q statistic. Methods We review 18 IPD meta-analyses of RCTs into treatments for cancer, in order to quantify the amount of heterogeneity present and also to discuss practical methods for explaining heterogeneity. Results Differing results were obtained when the standard Q and I2 statistics were used to test for the presence of heterogeneity. The two meta-analyses with the largest amount of heterogeneity were investigated further, and on inspection the straightforward application of a random effects model was not deemed appropriate. Compared to the standard Q statistic, the generalised Q statistic provided a more accurate platform for estimating the amount of heterogeneity in the 18 meta-analyses. Conclusions Explaining heterogeneity via the pre-specification of trial subgroups, graphical diagnostic tools and sensitivity analyses produced a more desirable outcome than an automatic application of the random effects model. Generalised Q statistic methods for quantifying and adjusting for heterogeneity should be incorporated as standard into statistical software. Software is provided to help achieve this aim. PMID:21473747

[An evaluation of clinical characteristics and prognosis of brain-stem infarction in diabetics].

PubMed

Lu, Zheng-qi; Li, Hai-yan; Hu, Xue-qiang; Zhang, Bing-jun

2011-01-01

To analyze the relationship between diabetics and the onset, clinical outcomes and prognosis of brainstem infarction, and to evaluate the impact of diabetes on brainstem infarction. Compare 172 cases of acute brainstem infarction in patients with or without diabetes. Analyze the associated risk factors of patients with brain-stem infarction in diabetics by multi-variate logistic regression analysis. Compare the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin scale (mRS) Score, pathogenetic condition and the outcome of the two groups in different times. The systolic blood pressure (SBP), TG, LDL-C, apolipoprotein B (Apo B), glutamyl transpeptidase (γ-GT), fibrinogen (Fb), fasting blood glucose (FPG) and glycosylated hemoglobin(HbA1c)in diabetic group were higher than those in non-diabetic group, which was statistically significant (P < 0.05). From multi-variate logistic regression analysis, γ-GT, Apo B and FPG were the risk predictors of diabetes with brainstem infarction(OR = 1.017, 4.667 and 3.173, respectively), while HDL-C was protective (OR = 0.288). HbA1c was a risk predictor of severity for acute brainstem infarction (OR = 1.299), while Apo A was beneficial (OR = 0.212). Compared with brain-stem infarction in non-diabetic group, NIHSS score and intensive care therapy of diabetic groups on the admission had no statistically significance, while the NIHSS score on discharge and the outcome at 6 months' of follow-up were statistically significant. Diabetes is closely associated with brainstem infarction. Brainstem infarction with diabetes cause more rapid progression, poorer prognosis, higher rates of mortality as well as disability and higher recurrence rate of cerebral infarction.

Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial.

PubMed

Vavrek, Darcy A; Sharma, Rajiv; Haas, Mitchell

2014-06-01

The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy (SMT) in patients with chronic low back pain (LBP). We randomized 400 patients with chronic LBP to receive a dose of 0, 6, 12, or 18 sessions of SMT. Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days. Multiple regression was performed on outcomes and log-transformed cost data. Lost productivity accounts for most societal costs of chronic LBP. Cost of treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age (P = .03), greater disability (P = .01), lower quality-adjusted life year scores (P = .01), and higher costs in the period preceding enrollment (P < .01). Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days (P = .03) and 19.8 disability-free days (P = .04). No statistically significant group differences in quality-adjusted life years were noted. A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity. Copyright © 2014 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Improving esthetic results in benign parotid surgery: statistical evaluation of facelift approach, sternocleidomastoid flap, and superficial musculoaponeurotic system flap application.

PubMed

Bianchi, Bernardo; Ferri, Andrea; Ferrari, Silvano; Copelli, Chiara; Sesenna, Enrico

2011-04-01

The purpose of this article was to analyze the efficacy of facelift incision, sternocleidomastoid muscle flap, and superficial musculoaponeurotic system flap for improving the esthetic results in patients undergoing partial parotidectomy for benign parotid tumor resection. The usefulness of partial parotidectomy is discussed, and a statistical evaluation of the esthetic results was performed. From January 1, 1996, to January 1, 2007, 274 patients treated for benign parotid tumors were studied. Of these, 172 underwent partial parotidectomy. The 172 patients were divided into 4 groups: partial parotidectomy with classic or modified Blair incision without reconstruction (group 1), partial parotidectomy with facelift incision and without reconstruction (group 2), partial parotidectomy with facelift incision associated with sternocleidomastoid muscle flap (group 3), and partial parotidectomy with facelift incision associated with superficial musculoaponeurotic system flap (group 4). Patients were considered, after a follow-up of at least 18 months, for functional and esthetic evaluation. The functional outcome was assessed considering the facial nerve function, Frey syndrome, and recurrence. The esthetic evaluation was performed by inviting the patients and a blind panel of 1 surgeon and 2 secretaries of the department to give a score of 1 to 10 to assess the final cosmetic outcome. The statistical analysis was finally performed using the Mann-Whitney U test for nonparametric data to compare the different group results. P less than .05 was considered significant. No recurrence developed in any of the 4 groups or in any of the 274 patients during the follow-up period. The statistical analysis, comparing group 1 and the other groups, revealed a highly significant statistical difference (P < .0001) for all groups. Also, when group 2 was compared with groups 3 and 4, the difference was highly significantly different statistically (P = .0018 for group 3 and P = .0005 for group 4). Finally, when groups 3 and 4 were compared, the difference was not statistically significant (P = .3467). Partial parotidectomy is the real key point for improving esthetic results in benign parotid surgery. The evaluation of functional complications and the recurrence rate in this series of patients has confirmed that this technique can be safely used for parotid benign tumor resection. The use of a facelift incision alone led to a high statistically significant improvement in the esthetic outcome. When the facelift incision was used with reconstructive techniques, such as the sternocleidomastoid muscle flap or the superficial musculoaponeurotic system flap, the esthetic results improved further. Finally, no statistically significant difference resulted comparing the use of the superficial musculoaponeurotic system and the sternocleidomastoid muscle flap. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Multivariate Analysis of Longitudinal Rates of Change

PubMed Central

Bryan, Matthew; Heagerty, Patrick J.

2016-01-01

Longitudinal data allow direct comparison of the change in patient outcomes associated with treatment or exposure. Frequently, several longitudinal measures are collected that either reflect a common underlying health status, or characterize processes that are influenced in a similar way by covariates such as exposure or demographic characteristics. Statistical methods that can combine multivariate response variables into common measures of covariate effects have been proposed by Roy and Lin [1]; Proust-Lima, Letenneur and Jacqmin-Gadda [2]; and Gray and Brookmeyer [3] among others. Current methods for characterizing the relationship between covariates and the rate of change in multivariate outcomes are limited to select models. For example, Gray and Brookmeyer [3] introduce an “accelerated time” method which assumes that covariates rescale time in longitudinal models for disease progression. In this manuscript we detail an alternative multivariate model formulation that directly structures longitudinal rates of change, and that permits a common covariate effect across multiple outcomes. We detail maximum likelihood estimation for a multivariate longitudinal mixed model. We show via asymptotic calculations the potential gain in power that may be achieved with a common analysis of multiple outcomes. We apply the proposed methods to the analysis of a trivariate outcome for infant growth and compare rates of change for HIV infected and uninfected infants. PMID:27417129

An exploratory analysis of treatment completion and client and organizational factors using hierarchical linear modeling.

PubMed

Woodward, Albert; Das, Abhik; Raskin, Ira E; Morgan-Lopez, Antonio A

2006-11-01

Data from the Alcohol and Drug Services Study (ADSS) are used to analyze the structure and operation of the substance abuse treatment industry in the United States. Published literature contains little systematic empirical analysis of the interaction between organizational characteristics and treatment outcomes. This paper addresses that deficit. It develops and tests a hierarchical linear model (HLM) to address questions about the empirical relationship between treatment inputs (industry costs, types and use of counseling and medical personnel, diagnosis mix, patient demographics, and the nature and level of services used in substance abuse treatment), and patient outcomes (retention and treatment completion rates). The paper adds to the literature by demonstrating a direct and statistically significant link between treatment completion and the organizational and staffing structure of the treatment setting. Related reimbursement issues, questions for future analysis, and limitations of the ADSS for this analysis are discussed.

Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302)

PubMed Central

Rathkopf, Dana E.; Smith, Matthew R.; de Bono, Johann S.; Logothetis, Christopher J.; Shore, Neal D.; de Souza, Paul; Fizazi, Karim; Mulders, Peter F.A.; Mainwaring, Paul; Hainsworth, John D.; Beer, Tomasz M.; North, Scott; Fradet, Yves; Van Poppel, Hendrik; Carles, Joan; Flaig, Thomas W.; Efstathiou, Eleni; Yu, Evan Y.; Higano, Celestia S.; Taplin, Mary-Ellen; Griffin, Thomas W.; Todd, Mary; Yu, Margaret; Park, Youn C.; Kheoh, Thian; Small, Eric J.; Scher, Howard I.; Molina, Arturo; Ryan, Charles J.; Saad, Fred

2015-01-01

Background Abiraterone acetate (an androgen biosynthesis inhibitor) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer (mCRPC). Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy. Objective Report the prespecified third interim analysis (IA) of efficacy and safety outcomes in study COU-AA-302. Design, setting, and participants Study COU-AA-302, a double-blind placebo-controlled study, enrolled patients with mCRPC from April 2009 to June 2010. A total of 1088 patients were stratified by Eastern Cooperative Oncology Group performance status (0 vs 1). Intervention Patients were randomised 1:1 to abiraterone 1000 mg plus prednisone 5 mg twice daily by mouth versus prednisone. Outcome measurements and statistical analysis Co–primary end points were radiographic progression-free survival (rPFS) and overall survival (OS). Median times to event outcomes were estimated using the Kaplan-Meier method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived using the Cox model, and treatment comparison used the log-rank test. The O’Brien-Fleming Lan-DeMets α-spending function was used for OS. Adverse events were summarised descriptively. Results and limitations With a median follow-up duration of 27.1 mo, improvement in rPFS was statistically significant with abiraterone treatment versus prednisone (median: 16.5 vs 8.2 mo; HR: 0.52 [95% CI, 0.45–0.61]; p < 0.0001). Abiraterone improved OS (median: 35.3 vs 30.1 mo; HR: 0.79 [95% CI, 0.66–0.95]; p = 0.0151) but did not reach the prespecified statistical efficacy boundary (α-level: 0.0035). A post hoc multivariate analysis for OS using known prognostic factors supported the primary results (HR: 0.74 [95% CI, 0.61–0.89]; p = 0.0017), and all clinically relevant secondary end points and patient-reported outcomes improved. While the post hoc nature of the long-term safety analysis is a limitation, the safety profile with longer treatment exposure was consistent with prior reports. Conclusions The updated IA of study COU-AA-302 in patients with mCRPC without prior chemotherapy confirms that abiraterone delays disease progression, pain, and functional deterioration and has clinical benefit with a favourable safety profile, including in patients treated for ≥24 mo. Trial registration Study COU-AA-302, ClinicalTrials.gov number, NCT00887198. PMID:24647231

Is the concomitant use of clopidogrel and Proton Pump Inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty?: a systematic review and meta-analysis of recently published studies (2012 - 2016).

PubMed

Bundhun, Pravesh Kumar; Teeluck, Abhishek Rishikesh; Bhurtu, Akash; Huang, Wei-Qiang

2017-01-05

Controversies were previously observed with the concomitant use of clopidogrel and Proton Pump Inhibitors (PPIs), especially omeprazole, following coronary angioplasty. Even though several studies showed no interaction between clopidogrel and PPIs, questions have been raised about the decrease in antiplatelet effects of clopidogrel with PPIs. A previously published meta-analysis showed concomitant use of clopidogrel and PPIs to be associated with higher adverse cardiovascular outcomes. However, data which were used were extracted from studies published before the year 2012. Whether these controversies still exist in this new era is not clear. Therefore, we aim to show if the concomitant use of clopidogrel and PPIs is still associated with higher adverse outcomes following Percutaneous Coronary Intervention (PCI) using data obtained from recently published studies (2012 to 2016). Electronic databases were searched for recent publications (2012-2016) comparing (clopidogrel plus PPIs) versus clopidogrel alone following PCI. Adverse cardiovascular outcomes were considered as the clinical endpoints. Odds Ratios (OR) with 95% Confidence Intervals (CI) were used as the statistical parameters and the pooled analyses were performed with RevMan 5.3 software. Eleven studies with a total number of 84,729 patients (29,235 patients from the PPIs group versus 55,494 patients from the non-PPIs group) were included. Results of this analysis showed that short term mortality and Target Vessel Revascularization (TVR) significantly favored the non-PPIs group with OR: 1.55; 95% CI: 1.43-1.68, P < 0.00001 and OR: 1.26; 95% CI: 1.06-1.49, P = 0.009 respectively. Long-term Major Adverse Cardiac Events (MACEs), Myocardial Infarction (MI), Stent Thrombosis (ST) and TVR significantly favored patients who did not use PPIs with OR: 1.37; 95% CI: 1.23-1.53, P < 0.00001, OR: 1.41; 95% CI: 1.26-1.57, P < 0.00001 and OR: 1.38; 95% CI: 1.13-1.70, P = 0.002 and OR: 1.28; 95% CI: 1.01-1.61, P = 0.04 respectively. However, the result for long term mortality was not statistically significant. The combined use of clopidogrel with PPIs is still associated with significantly higher adverse cardiovascular events such as MACEs, ST and MI following PCI supporting results of the previously published meta-analysis. However, long-term mortality is not statistically significant warranting further analysis with randomized patients.

Five years (2004-2009) of a restrictive law-regulating ART in Italy significantly reduced delivery rate: analysis of 10,706 cycles.

PubMed

Levi Setti, P E; Albani, E; Matteo, M; Morenghi, E; Zannoni, E; Baggiani, A M; Arfuso, V; Patrizio, P

2013-02-01

Was the delivery rate of ART cycles negatively affected by the enactment of the Law 40/2004 by the Italian Parliament which imposed a long list of restrictions for ART procedures? This large and extensive comparative analysis of ART outcomes prior to and after the introduction of the Law 40 revealed a significant reduction in pregnancy and delivery rates per cycle, independent of age or other clinical variables, once the law went into effect. Several studies have been published on the effect of Law 40/2004 on ART outcomes, some authors demonstrating a negative impact of the Law in relation to specific etiologies of infertility, other authors showing opposite conclusions. Retrospective clinical study of 3808 patients treated prior to the enactment of the Law, September 1996-March 2004 (Group I) and 6898 treated during the Law, March 2004-May 2009 (Group II). A total of 10 706 ART cycles were analysed, 3808 performed before and 6898 after the application of the Law. An intention-to-treat statistical analysis was performed to detect pregnancy and delivery rates (pregnancies ≥ 24 weeks) per started cycle. A P value of <0.05 was considered statistically significant. We analysed different outcomes: differences in fertilization, pregnancy and delivery rate, multiple pregnancies and miscarriage rates between the two time periods. The delivery rate for started cycle was 20% before and 16.0% after the introduction of the Law representing a 25% reduction (P < 0.001). The multivariate analysis, corrected by female age of >38 years, duration of infertility, basal FSH level and number of retrieved oocytes, showed a 16% lower delivery rate (odds ratio: 0.84; confidence interval: 0.75-0.94). This statistical approach removed the risk that the observed effects were due to chance and confirmed unequivocally that the Law was an independent factor responsible for the reduced likelihood of a successful outcome. This is a retrospective study. A prospective randomized study, with patients treated in the same time period and randomized to restrictions or not, would have minimized potential limitations due to differences in years of treatments. Our findings based on the analysis of such a large number of cycles proved clearly and unequivocally that imposing restrictions on the practice of ART penalized patients. These data represent a relevant clinical contribution for countries still debating the enactment of restrictive limitations of ART.

Multiple thrombophilic single nucleotide polymorphisms lack a significant effect on outcomes in fresh IVF cycles: an analysis of 1717 patients.

PubMed

Patounakis, George; Bergh, Eric; Forman, Eric J; Tao, Xin; Lonczak, Agnieszka; Franasiak, Jason M; Treff, Nathan; Scott, Richard T

2016-01-01

The aim of the study is to determine if thrombophilic single nucleotide polymorphisms (SNPs) affect outcomes in fresh in vitro fertilization (IVF) cycles in a large general infertility population. A prospective cohort analysis was performed at a university-affiliated private IVF center of female patients undergoing fresh non-donor IVF cycles. The effect of the following thrombophilic SNPs on IVF outcomes were explored: factor V (Leiden and H1299R), prothrombin (G20210A), factor XIII (V34L), β-fibrinogen (-455G → A), plasminogen activator inhibitor-1 (4G/5G), human platelet antigen-1 (a/b9L33P), and methylenetetrahydrofolate reductase (C677T and A1298C). The main outcome measures included positive pregnancy test, clinical pregnancy, embryo implantation, live birth, and pregnancy loss. Patients (1717) were enrolled in the study, and a total of 4169 embryos were transferred. There were no statistically significant differences in positive pregnancy test, clinical pregnancy, embryo implantation, live birth, or pregnancy loss in the analysis of 1717 patients attempting their first cycle of IVF. Receiver operator characteristics and logistic regression analyses showed that outcomes cannot be predicted by the cumulative number of thrombophilic mutations present in the patient. Individual and cumulative thrombophilic SNPs do not affect IVF outcomes. Therefore, initial screening for these SNPs is not indicated.

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

PubMed

Robinson, Emily J; Goldstein, Laura H; McCrone, Paul; Perdue, Iain; Chalder, Trudie; Mellers, John D C; Richardson, Mark P; Murray, Joanna; Reuber, Markus; Medford, Nick; Stone, Jon; Carson, Alan; Landau, Sabine

2017-06-06

Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee. The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS. The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials. ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).

The effect of the Family Case Management Program on 1996 birth outcomes in Illinois.

PubMed

Keeton, Kristie; Saunders, Stephen E; Koltun, David

2004-03-01

The purpose of this study was to determine if birth outcomes for Medicaid recipients were improved with participation in the Illinois Family Case Management Program. Health program data files were linked with the 1996 Illinois Vital Records linked birth-death certificate file. Logistic regression was used to characterize the variation in birth outcomes as a function of Family Case Management participation while statistically controlling for measurable factors found to be confounders. Results of the logistic regression analysis show that women who participated in the Family Care Management Program were significantly less likely to give birth to very low birth weight infants (odds ratio [OR] = 0.86, 95% confidence interval [CI] = 0.75, 0.99) and low birth weight infants (OR = 0.83, CI = 0.79, 0.89). For infant mortality, however, the adjusted OR (OR = 0.98, CI = 0.82, 1.17), although under 1, was not statistically significant. These results suggest that the Family Case Management Program may be effective in reducing very low birth weight and low birth weight rates among infants born to low-income women.

Cost-effectiveness analysis of internet-mediated cognitive behavioural therapy for depression in the primary care setting: results based on a controlled trial

PubMed Central

Metsini, Alexandra; Madsen, Jens-Henrik; Hange, Dominique; Petersson, Eva-Lisa L; Eriksson, Maria CM; Kivi, Marie; Andersson, Per-Åke Å; Svensson, Mikael

2018-01-01

Objective To perform a cost-effectiveness analysis of a randomised controlled trial of internet-mediated cognitive behavioural therapy (ICBT) compared with treatment as usual (TaU) for patients with mild to moderate depression in the Swedish primary care setting. In particular, the objective was to assess from a healthcare and societal perspective the incremental cost-effectiveness ratio (ICER) of ICBT versus TaU at 12 months follow-up. Design A cost-effectiveness analysis alongside a pragmatic effectiveness trial. Setting Sixteen primary care centres (PCCs) in south-west Sweden. Participants Ninety patients diagnosed with mild to moderate depression at the PCCs. Main outcome measure ICERs calculated as (CostICBT−CostTaU)/(Health outcomeICBT−Health outcomeTaU)=ΔCost/ΔHealth outcomes, the health outcomes being changes in the Beck Depression Inventory-II (BDI-II) score and quality-adjusted life-years (QALYs). Results The total cost per patient for ICBT was 4044 Swedish kronor (SEK) (€426) (healthcare perspective) and SEK47 679 (€5028) (societal perspective). The total cost per patient for TaU was SEK4434 (€468) and SEK50 343 (€5308). In both groups, the largest cost was associated with productivity loss. The differences in cost per patient were not statistically significant. The mean reduction in BDI-II score was 13.4 and 13.8 units in the ICBT and TaU groups, respectively. The mean QALYs per patient was 0.74 and 0.79 in the ICBT and TaU groups, respectively. The differences in BDI-II score reduction and mean QALYs were not statistically significant. The uncertainty of the study estimates when assessed by bootstrapping indicated that no firm conclusion could be drawn as to whether ICBT treatment compared with TaU was the most cost-effective use of resources. Conclusions ICBT was regarded to be as cost-effective as TaU as costs, health outcomes and cost-effectiveness were similar for ICBT and TaU, both from a healthcare and societal perspective. Trial registration number ID NR 30511. PMID:29903785

Exploring the use of routinely-available, retrospective data to study the association between malaria control scale-up and micro-economic outcomes in Zambia.

PubMed

Comfort, Alison; Leegwater, Anthony; Nakhimovsky, Sharon; Kansembe, Henry; Hamainza, Busiku; Bwalya, Benson; Alilio, Martin; Johns, Ben; Olsho, Lauren

2017-01-04

Country-level evidence on the impact of malaria control on micro-economic outcomes is vital for mobilizing domestic and donor resources for malaria control. Using routinely available survey data could facilitate this investigation in a cost-efficient way. The authors used Malaria Indicator Surveys (MIS) and Living Conditions Monitoring Survey (LCMS) data from 2006 to 2010 for all 72 districts in Zambia to relate malaria control scale-up with household food spending (proxy for household well-being), educational attainment and agricultural production. The authors used two quasi-experimental designs: (1) a generalized propensity score for a continuous treatment variable (defined as coverage from owning insecticide-treated bed nets and/or receipt of indoor residual spraying); and, (2) a district fixed effects model to assess changes in the outcome relative to changes in treatment pre-post scale-up. The unit of analysis was at district level. The authors also conducted simulations post-analysis to assess statistical power. Micro-economic outcomes increased (33% increase in food spending) concurrently with malaria control coverage (62% increase) from 2006 to 2010. Despite using data from all 72 districts, both analytic methods yielded wide confidence intervals that do not conclusively link outcomes and malaria control coverage increases. The authors cannot rule out positive, null or negative effects. The upper bound estimates of the results show that if malaria control coverage increases from 60 to 70%, food spending could increase up to 14%, maize production could increase up to 57%, and years of schooling could increase up to 0.5 years. Simulations indicated that the generalized propensity score model did not have good statistical power. While it is technically possible to use routinely available survey data to relate malaria control scale-up and micro-economic outcomes, it is not clear from this analysis that meaningful results can be obtained when survey data are highly aggregated. Researchers in similar settings should assess the feasibility of disaggregating existing survey data. Additionally, large surveys, such as LCMS and MIS, could incorporate data on both malaria coverage and household expenditures, respectively.

Clinical characteristics in 53 patients with cat scratch optic neuropathy.

PubMed

Chi, Sulene L; Stinnett, Sandra; Eggenberger, Eric; Foroozan, Rod; Golnik, Karl; Lee, Michael S; Bhatti, M Tariq

2012-01-01

To describe the clinical manifestations and to identify risk factors associated with visual outcome in a large cohort of patients with cat scratch optic neuropathy (CSON). Multicenter, retrospective chart review. Fifty-three patients (62 eyes) with serologically positive CSON from 5 academic neuro-ophthalmology services evaluated over an 11-year period. Institutional review board/ethics committee approval was obtained. Data from medical record charts were collected to detail the clinical manifestations and to analyze visual outcome metrics. Generalized estimating equations and logistic regression analysis were used in the statistical analysis. Six patients (9 eyes) were excluded from visual outcome statistical analysis because of a lack of follow-up. Demographic information, symptoms at presentation, clinical characteristics, length of follow-up, treatment used, and visual acuity (at presentation and final follow-up). Mean patient age was 27.8 years (range, 8-65 years). Mean follow-up time was 170.8 days (range, 1-1482 days). Simultaneous bilateral involvement occurred in 9 (17%) of 53 patients. Visual acuity on presentation ranged from 20/20 to counting fingers (mean, 20/160). Sixty-eight percent of eyes retained a visual acuity of 20/40 or better at final follow-up (defined as favorable visual outcome). Sixty-seven percent of patients endorsed a history of cat or kitten scratch. Neuroretinitis (macular star) developed in 28 eyes (45%). Only 5 patients had significant visual complications (branch retinal artery occlusion, macular hole, and corneal decompensation). Neither patient age nor any other factor except good initial visual acuity and absence of systemic symptoms was associated with a favorable visual outcome. There was no association between visual acuity at final follow-up and systemic antibiotic or steroid use. Patients with CSON have a good overall visual prognosis. Good visual acuity at presentation was associated with a favorable visual outcome. The absence of a macular star does not exclude the possibility of CSON. The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Applying quantitative adiposity feature analysis models to predict benefit of bevacizumab-based chemotherapy in ovarian cancer patients

NASA Astrophysics Data System (ADS)

Wang, Yunzhi; Qiu, Yuchen; Thai, Theresa; More, Kathleen; Ding, Kai; Liu, Hong; Zheng, Bin

2016-03-01

How to rationally identify epithelial ovarian cancer (EOC) patients who will benefit from bevacizumab or other antiangiogenic therapies is a critical issue in EOC treatments. The motivation of this study is to quantitatively measure adiposity features from CT images and investigate the feasibility of predicting potential benefit of EOC patients with or without receiving bevacizumab-based chemotherapy treatment using multivariate statistical models built based on quantitative adiposity image features. A dataset involving CT images from 59 advanced EOC patients were included. Among them, 32 patients received maintenance bevacizumab after primary chemotherapy and the remaining 27 patients did not. We developed a computer-aided detection (CAD) scheme to automatically segment subcutaneous fat areas (VFA) and visceral fat areas (SFA) and then extracted 7 adiposity-related quantitative features. Three multivariate data analysis models (linear regression, logistic regression and Cox proportional hazards regression) were performed respectively to investigate the potential association between the model-generated prediction results and the patients' progression-free survival (PFS) and overall survival (OS). The results show that using all 3 statistical models, a statistically significant association was detected between the model-generated results and both of the two clinical outcomes in the group of patients receiving maintenance bevacizumab (p<0.01), while there were no significant association for both PFS and OS in the group of patients without receiving maintenance bevacizumab. Therefore, this study demonstrated the feasibility of using quantitative adiposity-related CT image features based statistical prediction models to generate a new clinical marker and predict the clinical outcome of EOC patients receiving maintenance bevacizumab-based chemotherapy.

Drawing Nomograms with R: applications to categorical outcome and survival data.

PubMed

Zhang, Zhongheng; Kattan, Michael W

2017-05-01

Outcome prediction is a major task in clinical medicine. The standard approach to this work is to collect a variety of predictors and build a model of appropriate type. The model is a mathematical equation that connects the outcome of interest with the predictors. A new patient with given clinical characteristics can be predicted for outcome with this model. However, the equation describing the relationship between predictors and outcome is often complex and the computation requires software for practical use. There is another method called nomogram which is a graphical calculating device allowing an approximate graphical computation of a mathematical function. In this article, we describe how to draw nomograms for various outcomes with nomogram() function. Binary outcome is fit by logistic regression model and the outcome of interest is the probability of the event of interest. Ordinal outcome variable is also discussed. Survival analysis can be fit with parametric model to fully describe the distributions of survival time. Statistics such as the median survival time, survival probability up to a specific time point are taken as the outcome of interest.

Dexamethasone treatment and prognostic factors in community-acquired bacterial meningitis: a Danish retrospective population-based cohort study.

PubMed

Bodilsen, Jacob; Dalager-Pedersen, Michael; Schønheyder, Henrik Carl; Nielsen, Henrik

2014-06-01

The morbidity and mortality in community-acquired bacterial meningitis (CABM) remain substantial and treatment outcomes and predictors of a poor prognosis must be assessed regularly. We aimed to describe the outcome of patients with CABM treated with dexamethasone and to assess the performance of the Dutch Meningitis Risk Score (DMRS). We retrospectively evaluated all adults with CABM in North Denmark Region, 1998-2012. Outcomes included in-hospital mortality and Glasgow Outcome Scale (GOS) score. A GOS score of 5 was categorized as a favourable outcome and scores of 1-4 as unfavourable. We used logistic analysis to compute relative risks (RRs) with 95% confidence intervals (CIs) for an unfavourable outcome adjusted for age, sex, and comorbidity. We identified a total of 172 cases of CABM. In-hospital mortality was unaffected by the implementation of dexamethasone in 2003 (19% vs 20%). Dexamethasone treatment was associated with a prompt diagnosis of meningitis and a statistically insignificant decrease in the risk of an unfavourable outcome (33% vs 53%; adjusted RR 0.64, 95% CI 0.41-1.01) and in-hospital mortality (15% vs 24%; adjusted RR 0.72, 95% CI 0.35-1.48). Of the risk factors included in the DMRS, we found age and tachycardia to be significantly associated with an unfavourable outcome in the multivariate analyses. Patients treated with dexamethasone were more likely to have a favourable outcome, although statistical significance was not reached. Several parameters included in the Dutch risk score were also negative predictors in our cohort, although the entire risk score could not be validated due to a lack of data.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zauls, A. Jason, E-mail: zauls@musc.edu; Watkins, John M.; Wahlquist, Amy E.

Purpose: The American Society for Radiation Oncology published a Consensus Statement for accelerated partial breast irradiation identifying three groups: Suitable, Cautionary, and Unsuitable. The objective of this study was to compare oncologic outcomes in women treated with MammoSite brachytherapy (MB) vs. whole breast irradiation (WBI) after stratification into Statement groups. Methods: Eligible women had invasive carcinoma or ductal carcinoma in situ (DCIS) {<=}3 cm, and {<=}3 lymph nodes positive. Women were stratified by radiation modality and Statement groups. Survival analysis methods including Kaplan-Meier estimation, Cox regression, and competing risks analysis were used to assess overall survival (OS), disease-free survival (DFS),more » time to local failure (TTLF), and tumor bed failure (TBF). Results: A total of 459 (183 MB and 276 WBI) patients were treated from 2002 to 2009. After a median follow-up of 45 months, we found no statistical differences by stratification group or radiation modality with regard to OS and DFS. At 4 years TTLF or TBF were not statistically different between the cohorts. Univariate analysis in the MB cohort revealed that nodal positivity (pN1 vs. pN0) was related to TTLF (hazard ratio 6.39, p = 0.02). There was a suggestion that DCIS histology had an increased risk of failure when compared with invasive ductal carcinoma (hazard ratio 3.57, p = 0.06). Conclusions: MB and WBI patients stratified by Statement groups seem to combine women who will have similar outcomes regardless of radiation modality. Although outcomes were similar, we remain guarded in overinterpretation of these preliminary results until further analysis and long-term follow-up data become available. Caution should be used in treating women with DCIS or pN1 disease with MB.« less

A better way to evaluate remote monitoring programs in chronic disease care: receiver operating characteristic analysis.

PubMed

Brown Connolly, Nancy E

2014-12-01

This foundational study applies the process of receiver operating characteristic (ROC) analysis to evaluate utility and predictive value of a disease management (DM) model that uses RM devices for chronic obstructive pulmonary disease (COPD). The literature identifies a need for a more rigorous method to validate and quantify evidence-based value for remote monitoring (RM) systems being used to monitor persons with a chronic disease. ROC analysis is an engineering approach widely applied in medical testing, but that has not been evaluated for its utility in RM. Classifiers (saturated peripheral oxygen [SPO2], blood pressure [BP], and pulse), optimum threshold, and predictive accuracy are evaluated based on patient outcomes. Parametric and nonparametric methods were used. Event-based patient outcomes included inpatient hospitalization, accident and emergency, and home health visits. Statistical analysis tools included Microsoft (Redmond, WA) Excel(®) and MedCalc(®) (MedCalc Software, Ostend, Belgium) version 12 © 1993-2013 to generate ROC curves and statistics. Persons with COPD were monitored a minimum of 183 days, with at least one inpatient hospitalization within 12 months prior to monitoring. Retrospective, de-identified patient data from a United Kingdom National Health System COPD program were used. Datasets included biometric readings, alerts, and resource utilization. SPO2 was identified as a predictive classifier, with an optimal average threshold setting of 85-86%. BP and pulse were failed classifiers, and areas of design were identified that may improve utility and predictive capacity. Cost avoidance methodology was developed. RESULTS can be applied to health services planning decisions. Methods can be applied to system design and evaluation based on patient outcomes. This study validated the use of ROC in RM program evaluation.

Surgical adverse outcome reporting as part of routine clinical care.

PubMed

Kievit, J; Krukerink, M; Marang-van de Mheen, P J

2010-12-01

In The Netherlands, health professionals have created a doctor-driven standardised system to report and analyse adverse outcomes (AO). The aim is to improve healthcare by learning from past experiences. The key elements of this system are (1) an unequivocal definition of an adverse outcome, (2) appropriate contextual information and (3) a three-dimensional hierarchical classification system. First, to assess whether routine doctor-driven AO reporting is feasible. Second, to investigate how doctors can learn from AO reporting and analysis to improve the quality of care. Feasibility was assessed by how well doctors reported AO in the surgical department of a Dutch university hospital over a period of 9 years. AO incidence was analysed per patient subgroup and over time, in a time-trend analysis of three equal 3-year periods. AO were analysed case by case and statistically, to learn lessons from past events. In 19,907 surgical admissions, 9189 AOs were reported: one or more AO in 18.2% of admissions. On average, 55 lessons were learnt each year (in 4.3% of AO). More AO were reported in P3 than P1 (OR 1.39 (1.23-1.57)). Although minor AO increased, fatal AO decreased over time (OR 0.59 (0.45-0.77)). Doctor-driven AO reporting is shown to be feasible. Lessons can be learnt from case-by-case analyses of individual AO, as well as by statistical analysis of AO groups and subgroups (illustrated by time-trend analysis), thus contributing to the improvement of the quality of care. Moreover, by standardising AO reporting, data can be compared across departments or hospitals, to generate (confidential) mirror information for professionals cooperating in a peer-review setting.

Surgical adverse outcome reporting as part of routine clinical care

PubMed Central

Krukerink, M; Marang-van de Mheen, P J

2010-01-01

Background In The Netherlands, health professionals have created a doctor-driven standardised system to report and analyse adverse outcomes (AO). The aim is to improve healthcare by learning from past experiences. The key elements of this system are (1) an unequivocal definition of an adverse outcome, (2) appropriate contextual information and (3) a three-dimensional hierarchical classification system. Objectives First, to assess whether routine doctor-driven AO reporting is feasible. Second, to investigate how doctors can learn from AO reporting and analysis to improve the quality of care. Methods Feasibility was assessed by how well doctors reported AO in the surgical department of a Dutch university hospital over a period of 9 years. AO incidence was analysed per patient subgroup and over time, in a time-trend analysis of three equal 3-year periods. AO were analysed case by case and statistically, to learn lessons from past events. Results In 19 907 surgical admissions, 9189 AOs were reported: one or more AO in 18.2% of admissions. On average, 55 lessons were learnt each year (in 4.3% of AO). More AO were reported in P3 than P1 (OR 1.39 (1.23–1.57)). Although minor AO increased, fatal AO decreased over time (OR 0.59 (0.45–0.77)). Conclusions Doctor-driven AO reporting is shown to be feasible. Lessons can be learnt from case-by-case analyses of individual AO, as well as by statistical analysis of AO groups and subgroups (illustrated by time-trend analysis), thus contributing to the improvement of the quality of care. Moreover, by standardising AO reporting, data can be compared across departments or hospitals, to generate (confidential) mirror information for professionals cooperating in a peer-review setting. PMID:20430928

Influential input classification in probabilistic multimedia models

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maddalena, Randy L.; McKone, Thomas E.; Hsieh, Dennis P.H.

1999-05-01

Monte Carlo analysis is a statistical simulation method that is often used to assess and quantify the outcome variance in complex environmental fate and effects models. Total outcome variance of these models is a function of (1) the uncertainty and/or variability associated with each model input and (2) the sensitivity of the model outcome to changes in the inputs. To propagate variance through a model using Monte Carlo techniques, each variable must be assigned a probability distribution. The validity of these distributions directly influences the accuracy and reliability of the model outcome. To efficiently allocate resources for constructing distributions onemore » should first identify the most influential set of variables in the model. Although existing sensitivity and uncertainty analysis methods can provide a relative ranking of the importance of model inputs, they fail to identify the minimum set of stochastic inputs necessary to sufficiently characterize the outcome variance. In this paper, we describe and demonstrate a novel sensitivity/uncertainty analysis method for assessing the importance of each variable in a multimedia environmental fate model. Our analyses show that for a given scenario, a relatively small number of input variables influence the central tendency of the model and an even smaller set determines the shape of the outcome distribution. For each input, the level of influence depends on the scenario under consideration. This information is useful for developing site specific models and improving our understanding of the processes that have the greatest influence on the variance in outcomes from multimedia models.« less

Regional variation in the severity of pesticide exposure outcomes: applications of geographic information systems and spatial scan statistics.

PubMed

Sudakin, Daniel L; Power, Laura E

2009-03-01

Geographic information systems and spatial scan statistics have been utilized to assess regional clustering of symptomatic pesticide exposures reported to a state Poison Control Center (PCC) during a single year. In the present study, we analyzed five subsequent years of PCC data to test whether there are significant geographic differences in pesticide exposure incidents resulting in serious (moderate, major, and fatal) medical outcomes. A PCC provided the data on unintentional pesticide exposures for the time period 2001-2005. The geographic location of the caller, the location where the exposure occurred, the exposure route, and the medical outcome were abstracted. There were 273 incidents resulting in moderate effects (n = 261), major effects (n = 10), or fatalities (n = 2). Spatial scan statistics identified a geographic area consisting of two adjacent counties (one urban, one rural), where statistically significant clustering of serious outcomes was observed. The relative risk of moderate, major, and fatal outcomes was 2.0 in this spatial cluster (p = 0.0005). PCC data, geographic information systems, and spatial scan statistics can identify clustering of serious outcomes from human exposure to pesticides. These analyses may be useful for public health officials to target preventive interventions. Further investigation is warranted to understand better the potential explanations for geographical clustering, and to assess whether preventive interventions have an impact on reducing pesticide exposure incidents resulting in serious medical outcomes.

Common mental disorder and its association with academic performance among Debre Berhan University students, Ethiopia.

PubMed

Haile, Yohannes Gebreegziabhere; Alemu, Sisay Mulugeta; Habtewold, Tesfa Dejenie

2017-01-01

Common mental disorder (CMD) is prevalent in industrialized and non-industrialized countries. The prevalence of CMD among university students was 28.8-44.7% and attributed to several risk factors, such as schooling. The aim of this study was to assess the prevalence and risk factors of CMD. In addition, the association between CMD and academic performance was tested. Institution based cross-sectional study was conducted with 422 students at Debre Berhan university from March to April 2015. CMD was the primary outcome variable whereas academic performance was the secondary outcome variable. Kessler psychological distress (K10) scale was used to assess CMD. Bivariate and multiple logistic regression analysis were performed for modeling the primary outcome variable; independent samples T test and linear regression analysis were carried out for modeling the secondary outcome variable. The strength of association was interpreted using odds ratio and regression coefficient (β) and decision on statistical significance was made at a p value of 0.05. Data were entered using EPI-data version 3.1 software and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20.01 software. The prevalence of CMD was 63.1%. Field of study (p = 0.008, OR = 0.2, 95% CI 0.04-0.61), worshiping (p = 0.04, OR = 1.8, 95% CI 1.02-3.35), insomnia (p < 0.001, OR = 3.8, 95% CI 2.21-6.57), alcohol drinking (p = 0.006, OR = 2.7, 95% CI 1.33-5.66), and headache (p = 0.02, OR = 2.1, 95% CI 1.10-3.86) were identified risk factors for CMD. The mean cumulative grade point average of students with CMD was lower by 0.02 compared to those without CMD, but not statistically significant (p = 0.70, β = -0.02, 95% CI -0.15 to 0.10). CMD explained only 0.8% (r 2  = 0.008) of the difference in academic performance between students. At least three out of five students fulfilled CMD diagnostic criteria. The statistically significant risk factors were field of study, worshiping, insomnia, alcohol drinking, and headache. Moreover, there was no statistically significant association between CMD and academic performance. Undertaking integrated evidence-based intervention focusing on students with poor sleep quality, poor physical health, and who drink alcohol is essential if the present finding confirmed by a longitudinal study.

Reflective Outcomes of Convergent and Divergent Group Tasking in the Online Learning Environment

ERIC Educational Resources Information Center

Hawkes, Mark

2007-01-01

Using collaborative critical reflection as an index, this study examines the asynchronous and face-to-face discourse of 28 suburban Chicago elementary teachers developing problem based learning (PBL) curriculum. Statistical analysis of the corpus produced by the 2 mediums shows that the asynchronous online network emerges as the medium of choice…

Gender and Racial/Ethnic Differences in Salary and Other Characteristics of Postsecondary Faculty: Fall 1998. Statistical Analysis Report.

ERIC Educational Resources Information Center

Bradburn, Ellen M.; Sikora, Anna C.

Using data from the 1999 National Study of Postsecondary Faculty (NSOPF:99), this study examined how gender and race/ethnicity relate to a number of faculty outcomes and characteristics, including: salary, rank, tenure status, education, experience, institution type, teaching field, workload, and research productivity. The study focused on…

Compared efficacy of preservation solutions on the outcome of liver transplantation: Meta-analysis.

PubMed

Szilágyi, Ágnes Lilla; Mátrai, Péter; Hegyi, Péter; Tuboly, Eszter; Pécz, Daniella; Garami, András; Solymár, Margit; Pétervári, Erika; Balaskó, Márta; Veres, Gábor; Czopf, László; Wobbe, Bastian; Szabó, Dorottya; Wagner, Juliane; Hartmann, Petra

2018-04-28

To compare the effects of the four most commonly used preservation solutions on the outcome of liver transplantations. A systematic literature search was performed using MEDLINE, Scopus, EMBASE and the Cochrane Library databases up to January 31 st , 2017. The inclusion criteria were comparative, randomized controlled trials (RCTs) for deceased donor liver (DDL) allografts with adult and pediatric donors using the gold standard University of Wisconsin (UW) solution or histidine-tryptophan-ketoglutarate (HTK), Celsior (CS) and Institut Georges Lopez (IGL-1) solutions. Fifteen RCTs (1830 livers) were included; the primary outcomes were primary non-function (PNF) and one-year post-transplant graft survival (OGS-1). All trials were homogenous with respect to donor and recipient characteristics. There was no statistical difference in the incidence of PNF with the use of UW, HTK, CS and IGL-1 (RR = 0.02, 95%CI: 0.01-0.03, P = 0.356). Comparing OGS-1 also failed to reveal any difference between UW, HTK, CS and IGL-1 (RR = 0.80, 95%CI: 0.80-0.80, P = 0.369). Two trials demonstrated higher PNF levels for UW in comparison with the HTK group, and individual studies described higher rates of biliary complications where HTK and CS were used compared to the UW and IGL-1 solutions. However, the meta-analysis of the data did not prove a statistically significant difference: the UW, CS, HTK and IGL-1 solutions were associated with nearly equivalent outcomes. Alternative solutions for UW yield the same degree of safety and effectiveness for the preservation of DDLs, but further well-designed clinical trials are warranted.

Maternal satisfaction as an outcome criterion in research on labor analgesia: data analysis from the recent literature.

PubMed

Dualé, Christian; Nicolas-Courbon, Aurélie; Gerbaud, Laurent; Lemery, Didier; Bonnin, Martine; Pereira, Bruno

2015-03-01

To investigate whether maternal satisfaction (MS) is taken into consideration as an outcome criterion in clinical research on analgesia for labor. A systematic review of articles reporting analgesia for labor from a panel of 17 influential journals was undertaken. A total of 116 articles were analyzed, including 282 within-study groups. The scope of MS, the type of outcome measure used, and the time of measurement were noted. Each available observation was assigned an ordinal value of MS (ordMS), according to data distribution. The factors influencing ordMS were identified by multivariable analysis. The methods used to assess MS were very variable, even within the different measurement tools reported. The weighted distribution of ordMS was 17.8%, 21.8%, 31.2%, and 29.3% for levels "poor," "fair," "good," and "excellent," respectively. In comparative studies, statistical differences for analgesia were related to statistical differences for MS (P<0.0001), but only the negative predictive value was high (0.87). Power to detect a difference in MS between treatment groups was low in general, but it influenced reporting of a significant difference for MS (P<0.0001). The obstetrical factors influencing ordMS were: the body mass index, the initial cervical dilatation, and the within-study percentage of nulliparous women. The techniques alternative to epidural analgesia negatively influenced ordMS. A standard and validated tool to assess MS in clinical research on analgesia for labor is still to be developed. Power should be improved by acting on sample sizes or sensitivity of the outcome.

A systematic review and meta-analysis of educational interventions for children and adolescents with acquired brain injury.

PubMed

Linden, Mark A; Glang, Ann E; McKinlay, Audrey

2018-01-01

Children with brain injuries face significant challenges in their recovery. One of the greatest is transitioning from hospital/home to school where they face issues such as reintegration, lack of understanding and catching up with missed work. Many children struggle with their altered circumstances and require additional supports to meet the academic demands of systems which are ill equipped to teach them. To summarise the best available evidence for the use of educational interventions to improve academic attainment in childhood survivors of acquired brain injury (ABI). Six electronic databases (Cinahl, Embase, Medline, PsycINFO, Pubmed, & Web of Science) were systematically searched for randomised controlled trials published between 1980 and 2017. Two authors independently reviewed these studies and extracted data on type of intervention, characteristics of participants, outcome measures, findings and recommendations. The Cochrane Collaboration's Risk of Bias tool was used to assess systematic error in the included studies. Four studies met the inclusion criteria (n = 296 children and adolescents). Three studies (n = 287) were included in meta-analysis for the primary outcome which showed no statistically significant difference between the intervention and control conditions on academic attainment (SMD 1.31, 95% CI -0.06 to 2.68, p = 0.06). No statistically significant differences were found which favoured the intervention for the secondary outcomes of attention, internalising or externalising behavior. All effect sizes were considered as small. This review suggests that no currently effective educational interventions exist for children with ABI. Greater efforts are required to produce effective and rigorously tested interventions to improve outcomes for these children.

Four-corner fusion: comparison of patient satisfaction and functional outcome of conventional K-wire technique vs. a new locking plate.

PubMed

Hernekamp, J F; Reinecke, A; Neubrech, F; Bickert, B; Kneser, U; Kremer, T

2016-04-01

Four-corner fusion is a standard procedure for advanced carpal collapse. Several operative techniques and numerous implants for osseous fixation have been described. Recently, a specially designed locking plate (Aptus©, Medartis, Basel, Switzerland) was introduced. The purpose of this study was to compare functional results after osseous fixation using K-wires (standard of care, SOC) with four-corner fusion and locking plate fixation. 21 patients who underwent four-corner fusion in our institution between 2008 and 2013 were included in a retrospective analysis. In 11 patients, osseous fixation was performed using locking plates whereas ten patients underwent bone fixation with conventional K-wires. Outcome parameters were functional outcome, osseous consolidation, patient satisfaction (DASH- and Krimmer Score), pain and perioperative morbidity and the time until patients returned to daily work. Patients were divided in two groups and paired t-tests were performed for statistical analysis. No implant related complications were observed. Osseous consolidation was achieved in all cases. Differences between groups were not significant regarding active range of motion (AROM), pain and function. Overall patient satisfaction was acceptable in all cases; differences in the DASH questionnaire and the Krimmer questionnaire were not significant. One patient of the plate group required conversion to total wrist arthrodesis without implant-related complications. Both techniques for four-corner fusion have similar healing rates. Using the more expensive locking implant avoids a second operation for K-wire removal, but no statistical differences were detected in functional outcome as well as in patient satisfaction when compared to SOC.

Overcoming bias in estimating the volume-outcome relationship.

PubMed

Tsai, Alexander C; Votruba, Mark; Bridges, John F P; Cebul, Randall D

2006-02-01

To examine the effect of hospital volume on 30-day mortality for patients with congestive heart failure (CHF) using administrative and clinical data in conventional regression and instrumental variables (IV) estimation models. The primary data consisted of longitudinal information on comorbid conditions, vital signs, clinical status, and laboratory test results for 21,555 Medicare-insured patients aged 65 years and older hospitalized for CHF in northeast Ohio in 1991-1997. The patient was the primary unit of analysis. We fit a linear probability model to the data to assess the effects of hospital volume on patient mortality within 30 days of admission. Both administrative and clinical data elements were included for risk adjustment. Linear distances between patients and hospitals were used to construct the instrument, which was then used to assess the endogeneity of hospital volume. When only administrative data elements were included in the risk adjustment model, the estimated volume-outcome effect was statistically significant (p=.029) but small in magnitude. The estimate was markedly attenuated in magnitude and statistical significance when clinical data were added to the model as risk adjusters (p=.39). IV estimation shifted the estimate in a direction consistent with selective referral, but we were unable to reject the consistency of the linear probability estimates. Use of only administrative data for volume-outcomes research may generate spurious findings. The IV analysis further suggests that conventional estimates of the volume-outcome relationship may be contaminated by selective referral effects. Taken together, our results suggest that efforts to concentrate hospital-based CHF care in high-volume hospitals may not reduce mortality among elderly patients.

Primary Definitive Procedure versus Conventional Three-staged Procedure for the Management of Low-type Anorectal Malformation in Females: A Randomized Controlled Trial.

PubMed

Gupta, Alisha; Agarwala, Sandeep; Sreenivas, Vishnubhatla; Srinivas, Madhur; Bhatnagar, Veereshwar

2017-01-01

Females with Krickenbeck low-type anorectal malformations - vestibular fistula (VF) and perineal fistula (PF) - are managed either by a primary definitive or conventional three-staged approach. Ultimate outcome in these children may be affected by wound dehiscence leading to healing by fibrosis. Most of the literature favors one approach over other based on retrospective analysis of their outcomes. Whether a statistically significant difference in wound dehiscence rates between these approaches exists needed to be seen. A randomized controlled trial for girls <14 years with VF or PF was done. Random tables were used to randomize 33 children to Group I (primary procedure) and 31 to Group II (three-staged procedure). Statistical analysis was done for significance of difference ( P < 0.05) in the primary outcome (wound dehiscence) and secondary outcomes (immediate and early postoperative complications). Of the 64 children randomized, 54 (84%) had VF. Both groups were comparable in demography, clinical profile and age at surgery. The incidence of wound dehiscence (39.4% vs. 18.2%; P = 0.04), immediate postoperative complications (51.5% vs. 12.9%; P = 0.001), and early postoperative complications (42.4% vs. 12.9%; P = 0.01) was significantly higher in Group I as compared to Group II. Six of 13 children (46.2%) with dehiscence in Group I required a diverting colostomy to be made. Females with VF or PF undergoing primary definitive procedure have a significantly higher incidence of wound dehiscence ( P = 0.04), immediate ( P = 0.001) and early postoperative complications ( P = 0.01).

Developing and Testing a Model to Predict Outcomes of Organizational Change

PubMed Central

Gustafson, David H; Sainfort, François; Eichler, Mary; Adams, Laura; Bisognano, Maureen; Steudel, Harold

2003-01-01

Objective To test the effectiveness of a Bayesian model employing subjective probability estimates for predicting success and failure of health care improvement projects. Data Sources Experts' subjective assessment data for model development and independent retrospective data on 221 healthcare improvement projects in the United States, Canada, and the Netherlands collected between 1996 and 2000 for validation. Methods A panel of theoretical and practical experts and literature in organizational change were used to identify factors predicting the outcome of improvement efforts. A Bayesian model was developed to estimate probability of successful change using subjective estimates of likelihood ratios and prior odds elicited from the panel of experts. A subsequent retrospective empirical analysis of change efforts in 198 health care organizations was performed to validate the model. Logistic regression and ROC analysis were used to evaluate the model's performance using three alternative definitions of success. Data Collection For the model development, experts' subjective assessments were elicited using an integrative group process. For the validation study, a staff person intimately involved in each improvement project responded to a written survey asking questions about model factors and project outcomes. Results Logistic regression chi-square statistics and areas under the ROC curve demonstrated a high level of model performance in predicting success. Chi-square statistics were significant at the 0.001 level and areas under the ROC curve were greater than 0.84. Conclusions A subjective Bayesian model was effective in predicting the outcome of actual improvement projects. Additional prospective evaluations as well as testing the impact of this model as an intervention are warranted. PMID:12785571

Comparative analysis of arthroscopic debridement in osseous versus soft tissue anterior ankle impingement.

PubMed

Devgan, Ashish; Rohilla, Rajesh; Tanwar, Milind; Jain, Aditya; Siwach, Karan; Devgan, Radika

2016-01-01

Arthroscopic debridement has been a gold standard procedure for anterior ankle impingement, both in cases of osseous and soft tissue impingement. There is sparse literature on comparative outcome with respect to functional results between the two types of impingement post-arthroscopic debridement. Our study included 14 patients diagnosed as cases of anterior ankle impingement on the basis of clinical and radiological examination. They were segregated into two groups (on the basis of cause of impingement (osseous versus soft tissue)). Both groups were treated by arthroscopic debridement. Primary outcome was patient satisfaction, which was assessed by Likert scale and clinical outcomes were measured using AOFAS ankle-hind foot scale, VAS score, range of motion and time to return to pre-injury activity level in both groups. Mean follow-up was of 15 months where eleven patients reported an excellent recovery, two patients had good recovery while one patient reported poor outcome. Mean AOFAS ankle hind foot scale improved from 50.5 preoperatively to 85.71 postoperatively (statistically significant; p value - 0.0001). Mean Likert scale value post-operative was 4.21. VAS score showed significant improvement in patients of both the groups. Range of motion was slightly better in soft tissue impingement type with a relatively shorter time to return to sports or preinjury activity level as compared to osseous impingement group. The patients in both the groups had comparable outcomes with no statistically significant difference with regard to patient satisfaction and clinical outcome.

Accuracy comparison of guided surgery for dental implants according to the tissue of support: a systematic review and meta-analysis.

PubMed

Raico Gallardo, Yolanda Natali; da Silva-Olivio, Isabela Rodrigues Teixeira; Mukai, Eduardo; Morimoto, Susana; Sesma, Newton; Cordaro, Luca

2017-05-01

To systematically assess the current dental literature comparing the accuracy of computer-aided implant surgery when using different supporting tissues (tooth, mucosa, or bone). Two reviewers searched PubMed (1972 to January 2015) and the Cochrane Central Register of Controlled Trials (Central) (2002 to January 2015). For the assessment of accuracy, studies were included with the following outcome measures: (i) angle deviation, (ii) deviation at the entry point, and (iii) deviation at the apex. Eight clinical studies from the 1602 articles initially identified met the inclusion criteria for the qualitative analysis. Four studies (n = 599 implants) were evaluated using meta-analysis. The bone-supported guides showed a statistically significant greater deviation in angle (P < 0.001), entry point (P = 0.01), and the apex (P = 0.001) when compared to the tooth-supported guides. Conversely, when only retrospective studies were analyzed, not significant differences are revealed in the deviation of the entry point and apex. The mucosa-supported guides indicated a statistically significant greater reduction in angle deviation (P = 0.02), deviation at the entry point (P = 0.002), and deviation at the apex (P = 0.04) when compared to the bone-supported guides. Between the mucosa- and tooth-supported guides, there were no statistically significant differences for any of the outcome measures. It can be concluded that the tissue of the guide support influences the accuracy of computer-aided implant surgery. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Baseline for the Multivariate Comparison of Resting-State Networks

PubMed Central

Allen, Elena A.; Erhardt, Erik B.; Damaraju, Eswar; Gruner, William; Segall, Judith M.; Silva, Rogers F.; Havlicek, Martin; Rachakonda, Srinivas; Fries, Jill; Kalyanam, Ravi; Michael, Andrew M.; Caprihan, Arvind; Turner, Jessica A.; Eichele, Tom; Adelsheim, Steven; Bryan, Angela D.; Bustillo, Juan; Clark, Vincent P.; Feldstein Ewing, Sarah W.; Filbey, Francesca; Ford, Corey C.; Hutchison, Kent; Jung, Rex E.; Kiehl, Kent A.; Kodituwakku, Piyadasa; Komesu, Yuko M.; Mayer, Andrew R.; Pearlson, Godfrey D.; Phillips, John P.; Sadek, Joseph R.; Stevens, Michael; Teuscher, Ursina; Thoma, Robert J.; Calhoun, Vince D.

2011-01-01

As the size of functional and structural MRI datasets expands, it becomes increasingly important to establish a baseline from which diagnostic relevance may be determined, a processing strategy that efficiently prepares data for analysis, and a statistical approach that identifies important effects in a manner that is both robust and reproducible. In this paper, we introduce a multivariate analytic approach that optimizes sensitivity and reduces unnecessary testing. We demonstrate the utility of this mega-analytic approach by identifying the effects of age and gender on the resting-state networks (RSNs) of 603 healthy adolescents and adults (mean age: 23.4 years, range: 12–71 years). Data were collected on the same scanner, preprocessed using an automated analysis pipeline based in SPM, and studied using group independent component analysis. RSNs were identified and evaluated in terms of three primary outcome measures: time course spectral power, spatial map intensity, and functional network connectivity. Results revealed robust effects of age on all three outcome measures, largely indicating decreases in network coherence and connectivity with increasing age. Gender effects were of smaller magnitude but suggested stronger intra-network connectivity in females and more inter-network connectivity in males, particularly with regard to sensorimotor networks. These findings, along with the analysis approach and statistical framework described here, provide a useful baseline for future investigations of brain networks in health and disease. PMID:21442040

Comparative study of oncologic outcomes for laparoscopic vs. open surgery in transverse colon cancer

PubMed Central

Kim, Woo Ram; Baek, Se Jin; Kim, Chang Woo; Jang, Hyun A; Cho, Min Soo; Bae, Sung Uk; Hur, Hyuk; Min, Byung Soh; Lee, Kang Young; Kim, Nam Kyu; Sohn, Seung Kuk

2014-01-01

Purpose Laparoscopic resection for transverse colon cancer is a technically challenging procedure that has been excluded from various large randomized controlled trials of which the long-term outcomes still need to be verified. The purpose of this study was to evaluate long-term oncologic outcomes for transverse colon cancer patients undergoing laparoscopic colectomy (LAC) or open colectomy (OC). Methods This retrospective review included patients with transverse colon cancer who received a colectomy between January 2006 and December 2010. Short-term and five-year oncologic outcomes were compared between these groups. Results A total of 131 patients were analyzed in the final study (LAC, 84 patients; OC, 47 patients). There were no significant differences in age, gender, body mass index, tumor location, operative procedure, or blood loss between groups, but the mean operative time in LAC was significantly longer (LAC, 246.8 minutes vs. OC, 213.8 minutes; P = 0.03). Hospital stay was much shorter for LAC than OC (9.1 days vs. 14.5 days, P < 0.01). Postoperative complication rates were not statistically different between the two groups. In terms of long-term oncologic data, the 5-year disease-free survival and overall survival were not statistically different between both groups, and subgroup analysis according to cancer stage also revealed no differences. Conclusion LAC for transverse colon cancer is feasible and safe with comparable short- and long-term outcomes. PMID:24761404

Comparative study of oncologic outcomes for laparoscopic vs. open surgery in transverse colon cancer.

PubMed

Kim, Woo Ram; Baek, Se Jin; Kim, Chang Woo; Jang, Hyun A; Cho, Min Soo; Bae, Sung Uk; Hur, Hyuk; Min, Byung Soh; Baik, Seung Hyuk; Lee, Kang Young; Kim, Nam Kyu; Sohn, Seung Kuk

2014-01-01

Laparoscopic resection for transverse colon cancer is a technically challenging procedure that has been excluded from various large randomized controlled trials of which the long-term outcomes still need to be verified. The purpose of this study was to evaluate long-term oncologic outcomes for transverse colon cancer patients undergoing laparoscopic colectomy (LAC) or open colectomy (OC). This retrospective review included patients with transverse colon cancer who received a colectomy between January 2006 and December 2010. Short-term and five-year oncologic outcomes were compared between these groups. A total of 131 patients were analyzed in the final study (LAC, 84 patients; OC, 47 patients). There were no significant differences in age, gender, body mass index, tumor location, operative procedure, or blood loss between groups, but the mean operative time in LAC was significantly longer (LAC, 246.8 minutes vs. OC, 213.8 minutes; P = 0.03). Hospital stay was much shorter for LAC than OC (9.1 days vs. 14.5 days, P < 0.01). Postoperative complication rates were not statistically different between the two groups. In terms of long-term oncologic data, the 5-year disease-free survival and overall survival were not statistically different between both groups, and subgroup analysis according to cancer stage also revealed no differences. LAC for transverse colon cancer is feasible and safe with comparable short- and long-term outcomes.

Use of eCompliance, an innovative biometric system for monitoring of tuberculosis treatment in rural Uganda.

PubMed

Snidal, Sarah Jane; Barnard, Genevieve; Atuhairwe, Emmanuel; Ben Amor, Yanis

2015-06-01

Directly observed therapy short-course (DOTS) requires direct observation of tuberculosis (TB) patients and manual recording of doses taken. Programmatically, manual tracking is both time-consuming and prone to human error. Our project in western Uganda assessed the impact on TB treatment outcomes of a comprehensive patient support program including eCompliance, a biometric medical record device, with the aim of increasing TB patient retention. Through an observational study of 142 patients, DOTS outcomes of patients in the intervention group were compared with two control groups. Descriptive statistical comparisons, case-cohort analysis, and difference in change over time were used to assess the impact. Intervention patients had a higher cure rate than all other patients (55.6% versus 28.3% [P < 0.01]) and the odds of having a "cured" outcome were 3.17 higher (P < 0.05). The intervention group had a statistically significantly lower odds of having a negative outcome (0% versus.17% [P < 0.01]) than patients from the control groups. Additionally, the intervention group had a lost to follow-up rate lower than all other groups (0% versus 7%) that was trending on significant. In resource-limited settings, implementing comprehensive DOTS including eCompliance may reduce the occurrence of negative DOTS outcomes for patients. © The American Society of Tropical Medicine and Hygiene.

Transanal hemorrhoidal dearterialization with mucopexy versus open hemorrhoidectomy in the treatment of hemorrhoids: a meta-analysis of randomized control trials.

PubMed

Xu, L; Chen, H; Lin, G; Ge, Q; Qi, H; He, X

2016-12-01

The aim of this study was to analyse the outcomes of transanal hemorrhoidal dearterialization with mucopexy (THDm) versus open hemorrhoidectomy (OH) in the management of hemorrhoids. Randomized controlled trials in English were found by searching PubMed, Web of science, EMBASE, and the Cochrane Library database. Trials that compared THDm with OH were identified. Data were extracted independently for each study, and a meta-analysis was performed using fixed and random effects models. Four trials, including 316 patients, met the inclusion criteria. No statistically significant differences were noted in either total complications or postoperative bleeding, incontinence, recurrent prolapse, and urinary retention rate. Operative time was significantly longer for THDm with Doppler guidance than for THDm without Doppler guidance. Patients returned to normal activities faster after THDm than after OH. No statistically significant differences between THDm and OH were noted with regard to recurrence and reoperation rates. Our meta-analysis shows that THDm and OH are equally effective and can be attempted for the management of hemorrhoids. However, for THDm with Doppler guidance, more instruments and a longer operative time are required. Future large-scale, high-quality, multicenter trials with long-term outcomes are needed to prove these results and determine whether Doppler guidance in THD is truly necessary or not.

Replica analysis of overfitting in regression models for time-to-event data

NASA Astrophysics Data System (ADS)

Coolen, A. C. C.; Barrett, J. E.; Paga, P.; Perez-Vicente, C. J.

2017-09-01

Overfitting, which happens when the number of parameters in a model is too large compared to the number of data points available for determining these parameters, is a serious and growing problem in survival analysis. While modern medicine presents us with data of unprecedented dimensionality, these data cannot yet be used effectively for clinical outcome prediction. Standard error measures in maximum likelihood regression, such as p-values and z-scores, are blind to overfitting, and even for Cox’s proportional hazards model (the main tool of medical statisticians), one finds in literature only rules of thumb on the number of samples required to avoid overfitting. In this paper we present a mathematical theory of overfitting in regression models for time-to-event data, which aims to increase our quantitative understanding of the problem and provide practical tools with which to correct regression outcomes for the impact of overfitting. It is based on the replica method, a statistical mechanical technique for the analysis of heterogeneous many-variable systems that has been used successfully for several decades in physics, biology, and computer science, but not yet in medical statistics. We develop the theory initially for arbitrary regression models for time-to-event data, and verify its predictions in detail for the popular Cox model.

Patellar denervation with electrocautery in total knee arthroplasty without patellar resurfacing: a meta-analysis.

PubMed

Cheng, Tao; Zhu, Chen; Guo, Yongyuan; Shi, Sifeng; Chen, Desheng; Zhang, Xianlong

2014-11-01

The impact of patellar denervation with electrocautery in total knee arthroplasty (TKA) on post-operative outcomes has been under debate. This study aims to conduct a meta-analysis and systematic review to compare the benefits and risks of circumpatellar electrocautery with those of non-electrocautery in primary TKAs. Comparative and randomized clinical studies were identified by conducting an electronic search of articles dated up to September 2012 in PubMed, EMBASE, Scopus, and the Cochrane databases. Six studies that focus on a total of 849 knees were analysed. A random-effects model was conducted using the inverse-variance method for continuous variables and the Mantel-Haenszel method for dichotomous variables. There was no significant difference in the incidence of anterior knee pain between the electrocautery and non-electrocautery groups. In term of patellar score and Knee Society Score, circumpatellar electrocautery improved clinical outcomes compared with non-electrocautery in TKAs. The statistical differences were in favour of the electrocautery group but have minimal clinical significance. In addition, the overall complications indicate no statistical significance between the two groups. This study shows no strong evidence either for or against electrocautery compared with non-electrocautery in TKAs. Therapeutic study (systematic review and meta-analysis), Level III.

A retrospective analysis of mathieu and tip urethroplasty techniques for distal hypospadias repair; A 20 year experience.

PubMed

Oztorun, Kenan; Bagbanci, Sahin; Dadali, Mumtaz; Emir, Levent; Karabulut, Ayhan

2017-09-01

We aimed to identify the changes in the application rate of two surgical techniques in distal hypospadias repair in years and compare the most popular two surgical repair techniques for distal hypospadias in terms of surgical outcomes, the factors that affect the outcomes, which were performed over a 20 year period. In this study, the records of 492 consecutive patients that had undergone an operation for distal hypospadias in the urology clinic of Ankara between May 1990 and December 2010 using either Mathieu or TIPU surgical techniques were reviewed retrospectively. The patients who had glanular, coronal, and subcoronal meatus, were accepted as distal hypospadias cases. Among the 492 examined medical records, it was revealed that 331 and 161 surgical interventions were performed by using the Mathieu urethroplasty technique (Group-1) and TIP urethroplasty technique (Group-2), respectively. Group-1 was divided into two subgroups; namely Group-1a (patients with primary hypospadias) and Group-1b (patients with previous hypospadias operation). Likewise, Group-2 was divided into two subgroups; namely group-2a and group-2b. The patients' ages, number of previously urethroplasty operations, localization of the external urethral meatus prior to the operation, chordee state, length of the newly formed urethra, whether urinary diversion was done or not, post-operative complications and data regarding the follow-up period were evaluated, and the effects of these variables on the surgical outcome were investigated via statistical analyses. The primary objective of this study is to identify the changes in the application rate of two surgical techniques in distal hypospadias repair over the a 20 year period, and the secondary objectives are to compare the most popular two surgical repair techniques for distal hypospadias in terms of surgical outcomes, and the factors affecting the outcomes. Independent samples t test and Pearson's Chisquare test was used for statistical analysis. p<0.05 was considered as statistically significant. There were no statistically significant differences between the subgroups in terms of age, length of the neo-urethra, number of previously performed urethroplasty operations, surgical success rates, or complications (p>0.05). The concurrent utilization of the cystostomy and urethral stent was significantly more frequent in group-1 (p<0.05; Pearson's Chi-square test). It was determined that over time, TIP urethroplasty has become a more preferred technique for the repair of distal hypospadias. Both surgical techniques have similar success rates in distal hypospadias cases. TIP urethroplasty has become the method of choice over time.

Interventions for reducing self-stigma in people with mental illnesses: a systematic review of randomized controlled trials.

PubMed

Büchter, Roland Brian; Messer, Melanie

2017-01-01

Background: Self-stigma occurs when people with mental illnesses internalize negative stereotypes and prejudices about their condition. It can reduce help-seeking behaviour and treatment adherence. The effectiveness of interventions aimed at reducing self-stigma in people with mental illness is systematically reviewed. Results are discussed in the context of a logic model of the broader social context of mental illness stigma. Methods: Medline, Embase, PsycINFO, ERIC, and CENTRAL were searched for randomized controlled trials in November 2013. Studies were assessed with the Cochrane risk of bias tool. Results: Five trials were eligible for inclusion, four of which provided data for statistical analyses. Four studies had a high risk of bias. The quality of evidence was very low for each set of interventions and outcomes. The interventions studied included various group based anti-stigma interventions and an anti-stigma booklet. The intensity and fidelity of most interventions was high. Two studies were considered to be sufficiently homogeneous to be pooled for the outcome self-stigma. The meta-analysis did not find a statistically significant effect (SMD [95% CI] at 3 months: -0.26 [-0.64, 0.12], I 2 =0%, n=108). None of the individual studies found sustainable effects on other outcomes, including recovery, help-seeking behaviour and self-stigma. Conclusions: The effectiveness of interventions against self-stigma is uncertain. Previous studies lacked statistical power, used questionable outcome measures and had a high risk of bias. Future studies should be based on robust methods and consider practical implications regarding intervention development (relevance, implementability, and placement in routine services).

Mediation Analysis with Survival Outcomes: Accelerated Failure Time vs. Proportional Hazards Models

PubMed Central

Gelfand, Lois A.; MacKinnon, David P.; DeRubeis, Robert J.; Baraldi, Amanda N.

2016-01-01

Objective: Survival time is an important type of outcome variable in treatment research. Currently, limited guidance is available regarding performing mediation analyses with survival outcomes, which generally do not have normally distributed errors, and contain unobserved (censored) events. We present considerations for choosing an approach, using a comparison of semi-parametric proportional hazards (PH) and fully parametric accelerated failure time (AFT) approaches for illustration. Method: We compare PH and AFT models and procedures in their integration into mediation models and review their ability to produce coefficients that estimate causal effects. Using simulation studies modeling Weibull-distributed survival times, we compare statistical properties of mediation analyses incorporating PH and AFT approaches (employing SAS procedures PHREG and LIFEREG, respectively) under varied data conditions, some including censoring. A simulated data set illustrates the findings. Results: AFT models integrate more easily than PH models into mediation models. Furthermore, mediation analyses incorporating LIFEREG produce coefficients that can estimate causal effects, and demonstrate superior statistical properties. Censoring introduces bias in the coefficient estimate representing the treatment effect on outcome—underestimation in LIFEREG, and overestimation in PHREG. With LIFEREG, this bias can be addressed using an alternative estimate obtained from combining other coefficients, whereas this is not possible with PHREG. Conclusions: When Weibull assumptions are not violated, there are compelling advantages to using LIFEREG over PHREG for mediation analyses involving survival-time outcomes. Irrespective of the procedures used, the interpretation of coefficients, effects of censoring on coefficient estimates, and statistical properties should be taken into account when reporting results. PMID:27065906

The distribution of outcomes research papers across clinical journals.

PubMed

Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

2011-06-01

This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

RETRACTED ARTICLE: Clinical effectiveness of continuous passive motion (CPM) following femoroacetabular impingement surgery in adolescents.

PubMed

Hosalkar, Harish; Bomar, James D

2012-08-01

This study hypothesizes that the use of continuous passive motion (CPM) following open femoroacetabular impingement (FAI) surgery in the adolescent population improves clinical outcomes in terms of the modified Harris hip score (mHHS). Twenty-nine symptomatic adolescent FAI patients were postoperatively divided into one of three groups; no CPM, two days of inpatient CPM, and two weeks of CPM. mHHS was used preoperatively and postoperatively at six weeks, three months, six months, and nine months in all cases. Kruskal-Wallis (KW) analysis was performed to determine statistical differences in mHHS. mHHS was then re-evaluated using the Mann-Whitney test. There were no statistically significant differences in hip scores between the three groups preoperatively (p = 0.158). There were statistically significant differences (p < 0.001) in mHHS between the three groups at all postoperative time periods. The group that received two weeks of CPM had the best outcome scores. The results of this study suggest that postoperative CPM use following open hip preservation surgery for symptomatic FAI in adolescents improves clinical outcomes. These benefits seem to be related to the duration of CPM. Retrospective comparative study, Level III. Patients treated one way compared with patients treated another way at the same institution.

The taxonomy statistic uncovers novel clinical patterns in a population of ischemic stroke patients.

PubMed

Tukiendorf, Andrzej; Kaźmierski, Radosław; Michalak, Sławomir

2013-01-01

In this paper, we describe a simple taxonomic approach for clinical data mining elaborated by Marczewski and Steinhaus (M-S), whose performance equals the advanced statistical methodology known as the expectation-maximization (E-M) algorithm. We tested these two methods on a cohort of ischemic stroke patients. The comparison of both methods revealed strong agreement. Direct agreement between M-S and E-M classifications reached 83%, while Cohen's coefficient of agreement was κ = 0.766(P < 0.0001). The statistical analysis conducted and the outcomes obtained in this paper revealed novel clinical patterns in ischemic stroke patients. The aim of the study was to evaluate the clinical usefulness of Marczewski-Steinhaus' taxonomic approach as a tool for the detection of novel patterns of data in ischemic stroke patients and the prediction of disease outcome. In terms of the identification of fairly frequent types of stroke patients using their age, National Institutes of Health Stroke Scale (NIHSS), and diabetes mellitus (DM) status, when dealing with rough characteristics of patients, four particular types of patients are recognized, which cannot be identified by means of routine clinical methods. Following the obtained taxonomical outcomes, the strong correlation between the health status at moment of admission to emergency department (ED) and the subsequent recovery of patients is established. Moreover, popularization and simplification of the ideas of advanced mathematicians may provide an unconventional explorative platform for clinical problems.

Evaluating the Impact of Database Heterogeneity on Observational Study Results

PubMed Central

Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

2013-01-01

Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

Multinomial logistic regression analysis for differentiating 3 treatment outcome trajectory groups for headache-associated disability.

PubMed

Lewis, Kristin Nicole; Heckman, Bernadette Davantes; Himawan, Lina

2011-08-01

Growth mixture modeling (GMM) identified latent groups based on treatment outcome trajectories of headache disability measures in patients in headache subspecialty treatment clinics. Using a longitudinal design, 219 patients in headache subspecialty clinics in 4 large cities throughout Ohio provided data on their headache disability at pretreatment and 3 follow-up assessments. GMM identified 3 treatment outcome trajectory groups: (1) patients who initiated treatment with elevated disability levels and who reported statistically significant reductions in headache disability (high-disability improvers; 11%); (2) patients who initiated treatment with elevated disability but who reported no reductions in disability (high-disability nonimprovers; 34%); and (3) patients who initiated treatment with moderate disability and who reported statistically significant reductions in headache disability (moderate-disability improvers; 55%). Based on the final multinomial logistic regression model, a dichotomized treatment appointment attendance variable was a statistically significant predictor for differentiating high-disability improvers from high-disability nonimprovers. Three-fourths of patients who initiated treatment with elevated disability levels did not report reductions in disability after 5 months of treatment with new preventive pharmacotherapies. Preventive headache agents may be most efficacious for patients with moderate levels of disability and for patients with high disability levels who attend all treatment appointments. Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Effectiveness of School-Based Teen Pregnancy Prevention Programs in the USA: a Systematic Review and Meta-Analysis.

PubMed

Marseille, Elliot; Mirzazadeh, Ali; Biggs, M Antonia; P Miller, Amanda; Horvath, Hacsi; Lightfoot, Marguerita; Malekinejad, Mohsen; Kahn, James G

2018-05-01

School-based programs have been a mainstay of youth pregnancy prevention efforts in the USA. We conducted a systematic review and meta-analysis to assess their effectiveness. Eligible studies evaluated the effect on pregnancy rates of programs delivered in elementary, middle, or high schools in the USA and Canada, published between January 1985 and September 2016. The primary outcome was pregnancy; secondary outcomes were delay in sexual initiation, condom use, and oral contraception use. Randomized controlled trials (RCTs) and non-RCTs with comparator groups were eligible. We developed a comprehensive search strategy, applied to major bibliographic databases, article bibliographies, gray literature, and contact with authors. We calculated risk ratios (RR) with 95% confidence intervals (CI) for each outcome and pooled data in random effects meta-analysis. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess evidence quality. Ten RCTs and 11 non-RCTs conducted from 1984 to 2016 yielded 30 unique pooled comparisons for pregnancy, of which 24 were not statistically significant. Six showed statistically significant changes in pregnancy rates: two with increased risk (RR 1.30, 95% CI 1.02-1.65; and RR 1.39, 95% CI 1.10-1.75) and four with decreased risk ranging from RR 0.56, 95% CI 0.41-0.77, to RR 0.75, 95% CI 0.58-0.96. All studies were at high risk of bias, and the quality of evidence was low or very low. Identified evidence indicated no consistent difference in rates of pregnancies between intervention recipients and controls.

Prevalence of oropharyngeal dysphagia in Parkinson's disease: a meta-analysis.

PubMed

Kalf, J G; de Swart, B J M; Bloem, B R; Munneke, M

2012-05-01

Dysphagia is a potentially harmful feature, also in Parkinson's disease (PD). As published prevalence rates vary widely, we aimed to estimate the prevalence of oropharyngeal dysphagia in PD in a meta-analysis. We conducted a systematic literature search in February 2011 and two independent reviewers selected the papers. We computed the estimates of the pooled prevalence weighted by sample size. Twelve studies were suitable for calculating prevalence rates. Ten studies provided an estimate based on subjective outcomes, which proved statistically heterogeneous (p < 0.001), with a pooled prevalence estimate with random effect analysis of 35% (95% CI 28-41). Four studies provided an estimate based on objective measurements, which were statistically homogeneous (p = 0.23), with a pooled prevalence estimate of 82% (95% CI 77-87). In controls the pooled subjective prevalence was 9% (95% CI 2-17), while the pooled objective prevalence was 23% (95% CI 13-32). The pooled relative risk was 3.2 for both subjective outcomes (95% CI 2.32-4.41) and objective outcomes (95% CI 2.08-4.98). Clinical heterogeneity between studies was chiefly explained by differences in disease severity. Subjective dysphagia occurs in one third of community-dwelling PD patients. Objectively measured dysphagia rates were much higher, with 4 out of 5 patients being affected. This suggests that dysphagia is common in PD, but patients do not always report swallowing difficulties unless asked. This underreporting calls for a proactive clinical approach to dysphagia, particularly in light of the serious clinical consequences. Copyright © 2011 Elsevier Ltd. All rights reserved.

A prospective randomised study to compare the utility and outcomes of subdural and subperiosteal drains for the treatment of chronic subdural haematoma.

PubMed

Kaliaperumal, Chandrasekaran; Khalil, Ayman; Fenton, Eoin; Okafo, Uchenna; Kaar, George; O'Sullivan, Michael; Marks, Charles

2012-11-01

The usage of a drain following evacuation of a chronic subdural haematoma (CSDH) is known to reduce recurrence. In this study we aim to compare the clinical outcomes and recurrence rate of utilising two different types of drains (subperiosteal and subdural drain) following drainage of a CSDH. Prospective randomised single-centre study analysing 50 patients who underwent CSDH treatment. Two types of drains, subperiosteal (SPD) and subdural (SDD), were utilised on consecutive alternate patients following burr-hole craniostomy, with a total of 25 patients in each group. The drains were left in for 48-h duration and then removed. The modified Rankin Scale (mRS) was used for outcome measurement at 3 and 6 months. Data analysis was performed by unpaired t test with Welch's correction. It was observed that none of the patients in either group had haematoma recurrence during a 6-month follow-up, and a significant difference in outcome was noted at 6 months (p = 0.0118) more than at 3 months (p = 0.0493) according to the statistical analysis. Postoperative seizure and inadvertent placement of the subdural drain into the brain parenchyma were the two complications noted in this study. Anticoagulant use prior to the surgery did not affect the outcome in either group. We conclude there was no recurrence of CSDH utilising the SDD and SPD following burr-hole craniostomy. The mRS measurement at the 6-month follow-up was found to be statistically significant, with better outcomes with utilisation of the SPD. The SPD may thus prove to be more beneficial than the SDD in the treatment of CSDH. A multi-centre study with a larger group of patients is recommended to reinforce the results from our study.

"Are cognitive interventions effective in Alzheimer's disease? A controlled meta- analysis of the effects of bias": Correction to Oltra-Cucarella et al. (2016).

PubMed

2016-07-01

Reports an error in "Are Cognitive Interventions Effective in Alzheimer's Disease? A Controlled Meta-Analysis of the Effects of Bias" by Javier Oltra-Cucarella, Rubén Pérez-Elvira, Raul Espert and Anita Sohn McCormick (Neuropsychology, Advanced Online Publication, Apr 7, 2016, np). In the article the first sentence of the third paragraph of the Source of bias subsection in the Statistical Analysis subsection of the Correlational Meta-Analysis section should read "For the control condition bias, three comparison groups were differentiated: (a) a structured cognitive intervention, (b) a placebo control condition, and (c) a pharma control condition without cognitive intervention or no treatment at all." (The following abstract of the original article appeared in record 2016-16656-001.) There is limited evidence about the efficacy of cognitive interventions for Alzheimer's disease (AD). However, aside from the methodological quality of the studies analyzed, the methodology used in previous meta-analyses is itself a risk of bias as different types of effect sizes (ESs) were calculated and combined. This study aimed at examining the results of nonpharmacological interventions for AD with an adequate control of statistical methods and to demonstrate a different approach to meta-analysis. ESs were calculated with the independent groups pre/post design. Average ESs for separate outcomes were calculated and moderator analyses were performed so as to offer an overview of the effects of bias. Eighty-seven outcomes from 19 studies (n = 812) were meta-analyzed. ESs were small on average for cognitive and functional outcomes after intervention. Moderator analyses showed no effect of control of bias, although ESs were different from zero only in some circumstances (e.g., memory outcomes in randomized studies). Cognitive interventions showed no more efficacy than placebo interventions, and functional ESs were consistently low across conditions. cognitive interventions delivered may not be effective in AD probably due to the fact that the assumptions behind the cognitive interventions might be inadequate. Future directions include a change in the type of intervention as well as the use of outcomes other than standardized tests. Additional studies with larger sample sizes and different designs are needed to increase the power of both primary studies and meta-analyses. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Effect of Creatine Monohydrate on Clinical Progression in Patients With Parkinson Disease

PubMed Central

2015-01-01

IMPORTANCE There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies. OBJECTIVE To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease. DESIGN, SETTING, AND PATIENTS The Long-term Study 1, a multicenter, double-blind, parallel-group, placebo-controlled, 1:1 randomized efficacy trial. Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) Parkinson disease. Participants were enrolled from March 2007 to May 2010 and followed up until September 2013. INTERVENTIONS Participants were randomized to placebo or creatine (10 g/d) monohydrate for a minimum of 5 years (maximum follow-up, 8 years). MAIN OUTCOMES AND MEASURES The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up, compared between the 2 treatment groups using a global statistical test. Clinical status was defined by 5 outcome measures: Modified Rankin Scale, Symbol Digit Modalities Test, PDQ-39 Summary Index, Schwab and England Activities of Daily Living scale, and ambulatory capacity. All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test. Higher summed ranks (range, 5–4775) indicate worse outcomes. RESULTS The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis (n = 955). The median follow-up time was 4 years. Of the 955 participants, the mean of the summed ranks for placebo was 2360 (95% CI, 2249–2470) and for creatine was 2414 (95% CI, 2304–2524). The global statistical test yielded t1865.8 = −0.75 (2-sided P = .45). There were no detectable differences (P < .01 to partially adjust for multiple comparisons) in adverse and serious adverse events by body system. CONCLUSIONS AND RELEVANCE Among patients with early and treated Parkinson disease, treatment with creatine monohydrate for at least 5 years, compared with placebo did not improve clinical outcomes. These findings do not support the use of creatine monohydrate in patients with Parkinson disease. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00449865 PMID:25668262

Prognostic factors for return-to-work following surgery for carpal tunnel syndrome: a systematic review.

PubMed

Peters, Susan; Johnston, Venerina; Hines, Sonia; Ross, Mark; Coppieters, Michel

2016-09-01

Carpal tunnel syndrome (CTS) is a common problem, that can be effectively managed by surgery. Screening for prognostic factors is important to identify workers who are at a greater risk of a poor work outcome in order to implement tailored interventions to facilitate their return-to-work. To synthesize the best available evidence on the association of preoperative prognostic factors with work-related outcomes in people who have undergone carpal tunnel surgery. Participants included those who were employed at the time of surgery, underwent carpal tunnel surgery and planned to return-to-work. The primary outcome was return-to-work. Quantitative studies investigating at least one prognostic factor for a work-related outcome in studies of workers who had carpal tunnel surgery were considered. Eleven electronic databases were searched from their respective inception date up to July 2015. A total of 3893 publications were reviewed. The quality of the included studies was assessed by two reviewers using a modified version of an appraisal tool (Joanna Briggs Institute Meta-analysis of Statistical Assessment and Review Instrument [JBI-MAStARI]). The following criteria were evaluated: study population representativeness, clearly defined prognostic factors and outcomes, potential confounding variables and appropriate statistical analysis. Data extraction was performed using a modified version of the standardized extraction tool from JBI-MAStARI. Statistical pooling was not possible. Findings are presented in tables and narrative format. Eleven studies (13 publications) investigating 93 prognostic factors for delayed return-to-work or prolonged work disability outcomes and 27 prognostic factors for work role functioning in 4187 participants were identified.Prognostic factors associated with workers' increased likelihood of an earlier return-to-work in a moderate-to-high-quality study included worker expected or desired fewer days off work, occupation, lower pain anxiety and if CTS had not altered their work role.Prognostic factors for a poorer work-related outcome included older age, lower household income, greater upper extremity functional limitation, greater than two musculoskeletal pain sites, lower recovery expectations, worse mental health status, job accommodation availability, high job strain, high job demands with high job control, poor co-worker relationships, poor baseline work role functioning, less-supportive workplace policies, preoperative work absence due to CTS or work disability of any cause, workers' compensation status, attorney involvement, and post-diagnosis surgical wait time. For workers who have had carpal tunnel surgery, there are a number of factors which may be modified in order to improve return-to-work times.

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review.

PubMed

Maglione, Margaret A; Raaen, Laura; Chen, Christine; Azhar, Gulrez; Shahidinia, Nima; Shen, Mimi; Maksabedian, Ervant; Shanman, Roberta M; Newberry, Sydne; Hempel, Susanne

2018-06-01

This systematic review synthesizes evidence on the effects of Medication-Assisted Treatment (MAT) for opioid use disorder (OUD) on functional outcomes, including cognitive (e.g., memory), physical (e.g., fatigue), occupational (e.g., return to work), social/behavioral (e.g., criminal activity), and neurological (e.g., balance) function. Five databases were searched from inception to July 2017 to identify English-language controlled trials, case control studies, and cohort comparisons of one or more groups; cross-sectional studies were excluded. Two independent reviewers screened identified literature, abstracted study-level information, and assessed the quality of included studies. Meta-analyses used the Hartung-Knapp method for random-effects models. The quality of evidence was assessed using the GRADE approach. A comprehensive search followed by 1411 full text publication screenings yielded 30 randomized controlled trials (RCTs) and 10 observational studies meeting inclusion criteria. The studies reported highly diverse functional outcome measures. Only one RCT was rated as high quality, but several methodologically sound observational studies were identified. The statistical power to detect differences in functional outcomes was unclear in most studies. When compared with matched "healthy" controls with no history of substance use disorder (SUD), in two studies MAT patients had significantly poorer working memory and cognitive speed. One study found MAT patients scored worse in aggressive responding than did "healthy" controls. A large observational study found that MAT users had twice the odds of involvement in an injurious traffic accident as non-users. When compared with persons with OUD not on MAT, one cohort study found lower fatigue rates among buprenorphine-treated OUD patients. No differences were reported for occupational outcomes and results for criminal activity and other social/behavioral areas were mixed. There were few differences among MAT drug types. A pooled analysis of three RCTs found a significantly lower prevalence of fatigue with buprenorphine compared to methadone, while a meta-analysis of the same RCTs found no statistical difference in insomnia prevalence. Three RCTs that focused on cognitive function compared the effects of buprenorphine to methadone; no statistically significant differences in memory, cognitive speed and flexibility, attention, or vision were reported. The quality of evidence for most functional outcomes was rated low or very low. In sum, weaknesses in the body of evidence prevent strong conclusions about the effects of MAT for opioid use disorder on functional outcomes. Rigorous studies of functional effects would strengthen the body of literature. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Patients' expectations of deep brain stimulation, and subjective perceived outcome related to clinical measures in Parkinson's disease: a mixed-method approach.

PubMed

Maier, Franziska; Lewis, Catharine J; Horstkoetter, Nina; Eggers, Carsten; Kalbe, Elke; Maarouf, Mohammad; Kuhn, Jens; Zurowski, Mateusz; Moro, Elena; Woopen, Christiane; Timmermann, Lars

2013-11-01

To study patients' expectations of subthalamic deep brain stimulation (STN-DBS) and their subjective perceived outcome, by using qualitative and quantitative methods in Parkinson's disease (PD). PD patients were prospectively examined before and 3 months after surgery. Semistructured interviews regarding preoperative expectations and postsurgical subjective perceived outcome were conducted. These were analysed using content analysis. For statistical analyses, patients were classified according to their subjective perceived outcome, resulting in three different subjective outcome groups (negative, mixed, positive outcome). The groups were used for multiple comparisons between and within each group regarding motor impairment, quality of life (QoL), neuropsychiatric status and cognitive functioning, using standard instruments. A logistic regression analysis was conducted to find predictors of subjective negative outcome. Receiver operating characteristic curves were used to analyse cut-off scores for predictive tests. Of the 30 PD patients participating, 8 had a subjective negative outcome, 8 a mixed and 14 a positive outcome. All groups significantly improved in motor functioning. Patients with subjective negative outcome were characterised by preoperative unrealistic expectations, no postsurgical improvement in QoL, and significantly higher presurgical and postsurgical apathy and depression scores. Higher preoperative apathy and depression scores were significant predictors of negative subjective outcome. Cut-off scores for apathy and depression were identified. The mixed-method approach proved useful in examining a patient's subjective perception of STN-DBS outcome. Our results show that significant motor improvement does not necessarily lead to a positive subjective outcome. Moreover, PD patients should be screened carefully before surgery regarding apathy and depression. (DRKS-ID: DRKS00003221).

Multivariate analysis in thoracic research.

PubMed

Mengual-Macenlle, Noemí; Marcos, Pedro J; Golpe, Rafael; González-Rivas, Diego

2015-03-01

Multivariate analysis is based in observation and analysis of more than one statistical outcome variable at a time. In design and analysis, the technique is used to perform trade studies across multiple dimensions while taking into account the effects of all variables on the responses of interest. The development of multivariate methods emerged to analyze large databases and increasingly complex data. Since the best way to represent the knowledge of reality is the modeling, we should use multivariate statistical methods. Multivariate methods are designed to simultaneously analyze data sets, i.e., the analysis of different variables for each person or object studied. Keep in mind at all times that all variables must be treated accurately reflect the reality of the problem addressed. There are different types of multivariate analysis and each one should be employed according to the type of variables to analyze: dependent, interdependence and structural methods. In conclusion, multivariate methods are ideal for the analysis of large data sets and to find the cause and effect relationships between variables; there is a wide range of analysis types that we can use.

Arthroscopy for treating temporomandibular joint disorders.

PubMed

Currie, Roger

2011-01-01

The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline Embase, Lilacs, Allied and Complementary Medicine Database (AMED) and CINAHL databases were searched. In addition the reference lists of the included articles were checked and 14 journals hand searched. Randomised controlled clinical trials (RCT) of arthroscopy for treating TMDs were included. There were no restrictions regarding the language or date of publication. Two review authors independently extracted data, and three review authors independently assessed the risk of bias of included trials. The authors of the selected articles were contacted for additional information. Pooling of trials was only attempted if at least two trials of comparable protocols, with the same conditions and similar outcome measurements were available. Statistical analysis was performed in accordance with the Cochrane Collaboration guidelines. Seven RCTs (n = 349) met the inclusion criteria. All the studies were either at high or unclear risk of bias. Pain was evaluated after six months in two studies. No statistically significant differences were found between the arthroscopy versus nonsurgical groups (standardised mean difference (SMD) = 0.004; 95% confidence interval (CI) - 0.46 to 0.55, P = 0.81). Two studies analysed pain 12 months after surgery (arthroscopy and arthrocentesis) in 81 patients. No statistically significant differences were found (mean difference (MD) = 0.10; 95% CI -1.46 to 1.66, P = 0.90). Three studies analysed the same outcome in patients who had been submitted to arthroscopic surgery or to open surgery and a statistically significant difference was found after 12 months (SMD = 0.45; 95% CI 0.01 to 0.89, P = 0.05) in favour of open surgery.The two studies compared the maximum interincisal opening in six different clinical outcomes (interincisal opening over 35 mm; maximum protrusion over 5 mm; click; crepitation; tenderness on palpation in the TMJ and the jaw muscles 12 months after arthroscopy and open surgery). The outcome measures did not present statistically significant differences (odds ratio (OR) = 1.00; 95% CI 0.45 to 2.21, P = 1.00). Two studies compared the maximum interincisal opening after 12 months of postsurgical follow-up. A statistically significant difference in favour of the arthroscopy group was observed (MD = 5.28; 95% CI 3.46 to 7.10, P < 0.0001).The two studies compared the mandibular function after 12 months of follow-up with 40 patients evaluated. The outcome measure was mandibular functionality (MFIQ). This difference was not statistically significant (MD = 1.58; 95% CI -0.78 to 3.94, P = 0.19). Both arthroscopy and nonsurgical treatments reduced pain after six months. When compared with arthroscopy, open surgery was more effective at reducing pain after 12 months. Nevertheless, there were no differences in mandibular functionality or in other outcomes in clinical evaluations. Arthroscopy led to greater improvement in maximum interincisal opening after 12 months than arthrocentesis; however, there was no difference in pain.

Refractive Outcomes of 20 Eyes Undergoing ICL Implantation for Correction of Hyperopic Astigmatism.

PubMed

Coskunseven, Efekan; Kavadarli, Isilay; Sahin, Onurcan; Kayhan, Belma; Pallikaris, Ioannis

2017-09-01

To analyze 1-week, 1-month, and 12-month postoperative refractive outcomes of eyes that under-went ICL implantation to correct hyperopic astigmatism. The study enrolled 20 eyes of patients with an average age of 32 years (range: 21 to 40 years). The outcomes of spherical and cylindrical refraction, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), vault, and angle parameters were evaluated 1 week, 1 month, and 12 months postoperatively. The preoperative mean UDVA was 0.15 ± 0.11 (decimal) (20/133 Snellen) and increased to 0.74 ± 0.25 (20/27 Snellen) postoperatively, with a change of 0.59 (decimal) (20/33.9 Snellen) (P < .0001), which was statistically significant. The preoperative mean CDVA was 0.74 ± 0.25 (decimal) (20/27 Snellen) and increased to 0.78 ± 0.21 (20/25 Snellen), with a change of 0.03 (decimal) (20/666 Snellen) (P < .052), which was not statistically significant. The mean preoperative sphere was 6.86 ± 1.77 diopters (D) and the mean preoperative cylinder was -1.44 ± 0.88 D. The mean 12-month postoperative sphere decreased to 0.46 ± 0.89 D (P < .001) and cylinder decreased to -0.61 ± 0.46 D (P < .001), with a change of 6.40 D, both of which were statistically significant. The mean 1-month postoperative vault was 0.65 ± 0.13 mm and decreased to 0.613 ± 0.10 mm at 1 year postoperatively, with a change of 0.44 mm (P < .003). The preoperative/12-month and 1-month/12-month trabecular-iris angle (TIA), trabecular-iris space area 500 mm from the scleral spur (TISA500), and angle opening distance 500 mm from the scleral spur (AOD500) values were analyzed nasally, temporally, and inferiorly. All differences were statistically significant between preoperative/12-month analysis. The only differences between 1- and 12-month analysis were on TISA500 inferior (P < .002) and AOD500 nasal (0.031) values. ICL hyperopic toric implantation is a safe method and provides stable refractive outcomes in patients with high hyperopia (up to 10.00 D) and astigmatism (up to 6.00 D). [J Refract Surg. 2017;33(9):604-609.]. Copyright 2017, SLACK Incorporated.

Advanced Statistics for Exotic Animal Practitioners.

PubMed

Hodsoll, John; Hellier, Jennifer M; Ryan, Elizabeth G

2017-09-01

Correlation and regression assess the association between 2 or more variables. This article reviews the core knowledge needed to understand these analyses, moving from visual analysis in scatter plots through correlation, simple and multiple linear regression, and logistic regression. Correlation estimates the strength and direction of a relationship between 2 variables. Regression can be considered more general and quantifies the numerical relationships between an outcome and 1 or multiple variables in terms of a best-fit line, allowing predictions to be made. Each technique is discussed with examples and the statistical assumptions underlying their correct application. Copyright © 2017 Elsevier Inc. All rights reserved.

Correlation and simple linear regression.

PubMed

Zou, Kelly H; Tuncali, Kemal; Silverman, Stuart G

2003-06-01

In this tutorial article, the concepts of correlation and regression are reviewed and demonstrated. The authors review and compare two correlation coefficients, the Pearson correlation coefficient and the Spearman rho, for measuring linear and nonlinear relationships between two continuous variables. In the case of measuring the linear relationship between a predictor and an outcome variable, simple linear regression analysis is conducted. These statistical concepts are illustrated by using a data set from published literature to assess a computed tomography-guided interventional technique. These statistical methods are important for exploring the relationships between variables and can be applied to many radiologic studies.

A pre-admission program for underrepresented minority and disadvantaged students: application, acceptance, graduation rates and timeliness of graduating from medical school.

PubMed

Strayhorn, G

2000-04-01

To determine whether students' performances in a pre-admission program predicted whether participants would (1) apply to medical school, (2) get accepted, and (3) graduate. Using prospectively collected data from participants in the University of North Carolina at Chapel Hill's Medical Education Development Program (MEDP) and data from the Association of American Colleges Student and Applicant Information Management System, the author identified 371 underrepresented minority (URM) students who were full-time participants and completed the program between 1984 and 1989, prior to their acceptance into medical school. Logistic regression analysis was used to determine whether MEDP performance significantly predicted (after statistically controlling for traditional predictors of these outcomes) the proportions of URM participants who applied to medical school and were accepted, the timeliness of graduating, and the proportion graduating. Odds ratios with 95% confidence intervals were calculated to determine the associations between the independent and outcome variables. In separate logistic regression models, MEDP performance predicted the study's outcomes after statistically controlling for traditional predictors with 95% confidence intervals. Pre-admission programs with similar outcomes can improve the diversity of the physician workforce and the access to health care for underrepresented minority and economically disadvantaged populations.

[Analysis of pregnancy outcomes of polycystic ovary syndrome patients after frozen embryo transfer].

PubMed

Lyu, X D; Qiao, J

2018-01-25

Objective: To investigate pregnancy outcomes of the patients with polycystic ovary syndrome (PCOS) after frozen embryo transfer (FET) . Methods: Data of 2 367 PCOS patients received in vitro fertilization-embryo transfer [including fresh embryo transfer (fET) and FET] from January 2009 to December 2015 in Peking University Third Hospital were evaluated retrospectively. The basal characteristics, pregnancy complications and outcomes were analyzed, then identified the relative factors followed. Results: Totally 2 367 patients received in vitro fertilization-embryo transfer: 1 106 were treated with fET, and the rest 1 261 cases were treated with FET. The incidence of gestational diabetes mellitus (GDM) was lower in FET group [4.04%(51/1 261) versus 6.15%(68/1 106)], the difference was statistically significant ( P< 0.05). Singletons born after FET had higher birth weight than fET [(3 406±548) versus (3 360±533) g], the difference was statistically significant ( P< 0.05). There was no difference of other pregnancy complications between the two groups (all P> 0.05). fET was an independent risk factor for GDM (adjusted OR= 1.570, 95% CI: 1.075-2.294). Conclusion: Compared with fET, FET could decrease the risk of GDM and receive better neonatal outcomes in patients with PCOS.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

PubMed

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

Do outcomes after kidney transplantation differ for black patients in England versus New York State? A comparative, population-cohort analysis.

PubMed

Tahir, Sanna; Gillott, Holly; Jackson-Spence, Francesca; Nath, Jay; Mytton, Jemma; Evison, Felicity; Sharif, Adnan

2017-05-09

Inferior outcomes for black kidney transplant recipients in the USA may not be generalisable elsewhere. In this population cohort analysis, we compared outcomes for black kidney transplant patients in England versus New York State. Retrospective, comparative, population cohort study utilising administrative data registries. English data were derived from Hospital Episode Statistics, while New York State data were derived from Statewide Planning and Research Cooperative System. All adults receiving their first kidney-alone allograft between 2003 and 2013 were eligible for inclusion. The primary outcome measure was mortality post kidney transplantation (including inhospital death, 30-day mortality and 1-year mortality). Secondary outcome measures included postoperative admission length of stay, risk of rehospitalisation, development of cardiac events, stroke, cancer or fracture and finally transplant rejection/failure. Cox proportional hazards regression was used to investigate relationship between ethnicity, country and outcome. Black patients comprised 6.5% of the English cohort (n=1215/18 493) and 23.0% of the New York State cohort (n=2660/11 602). Compared with New York State, black kidney transplant recipients in England were more likely younger, male, living-donor kidney recipients and had dissimilar medical comorbidities. Inpatient mortality was not statistically different, but death within 30 days, 1 year or kidney transplant rejection/failure was lower among black patients in England versus black patients in New York State. In adjusted regression analysis, with black ethnicity the reference group, white patients had reduced risk for 30-day mortality (OR 0.62 (95% CI 0.44 to 0.86)) and 1-year mortality (OR 0.79 (95% CI 0.63 to 0.99)) in New York State but no difference was observed in England. Compared with England, black kidney transplant patients in New York State had increased HR for kidney transplant rejection rejection/failure by median follow-up (HR 2.15, 95% CI 1.91 to 2.43). Outcomes after kidney transplantation for black patients may not be translatable between countries. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Influence of circular stapler diameter on postoperative stenosis after laparoscopic gastrojejunal anastomosis in morbid obesity.

PubMed

Markar, Sheraz R; Penna, Marta; Venkat-Ramen, Vishal; Karthikesalingam, Alan; Hashemi, Majid

2012-01-01

The aim of the present study was to provide a pooled analysis of individual small trials comparing 21-mm and 25-mm circular stapled laparoscopic gastrojejunal (GJ) anastomosis in morbid obesity surgery. A systematic literature search of MEDLINE, Embase, and Cochrane library databases was performed to identify all relevant studies comparing 21-mm and 25-mm circular stapled laparoscopic GJ anastomosis in morbid obesity surgery. The primary outcomes were GJ stenosis and the interval to GJ stenosis. The secondary outcomes were the estimated weight loss, GJ diameter, and the number of endoscopic dilations. Pooled odds ratios were calculated for categorical outcomes and weighted mean differences for continuous outcomes. Five trials were included, comprising 1217 patients (393 with 21-mm and 824 with 25-mm circular GJ anastomoses). The primary outcome analysis revealed a significantly increased incidence of intraluminal stenosis associated with the 21-mm circular stapler (pooled odds ratio 3.54; P < .0001). The secondary outcome analysis revealed a significantly reduced GJ anastomotic diameter on endoscopy with the 21-mm circular stapler group (weighted mean difference -1.67; P = .002). Statistical analysis revealed no significant difference between the groups for the interval to stenosis, number of endoscopic dilations, and estimated weight loss. The results of the present pooled analysis have demonstrated a significantly increased incidence of symptomatic stenosis associated with the 21-mm circular stapler compared with the 25-mm stapler. This serves as evidence to validate the preferential selection of the 25-mm circular stapler for laparoscopic GJ bypass. Copyright © 2012 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Plasma big endothelin-1 levels at admission and future cardiovascular outcomes: A cohort study in patients with stable coronary artery disease.

PubMed

Zhou, Bing-Yang; Guo, Yuan-Lin; Wu, Na-Qiong; Zhu, Cheng-Gang; Gao, Ying; Qing, Ping; Li, Xiao-Lin; Wang, Yao; Dong, Qian; Liu, Geng; Xu, Rui Xia; Cui, Chuan-Jue; Sun, Jing; Li, Jian-Jun

2017-03-01

Big endothelin-1 (ET-1) has been proposed as a novel prognostic indicator of acute coronary syndrome, while its predicting role of cardiovascular outcomes in patients with stable coronary artery disease (CAD) is unclear. A total of 3154 consecutive patients with stable CAD were enrolled and followed up for 24months. The outcomes included all-cause death, non-fatal myocardial infarction, stroke and unplanned revascularization (percutaneous coronary intervention and coronary artery bypass grafting). Baseline big ET-1 was measured using sandwich enzyme immunoassay method. Cox proportional hazard regression analysis and Kaplan-Meier analysis were used to evaluate the prognostic value of big ET-1 on cardiovascular outcomes. One hundred and eighty-nine (5.99%) events occurred during follow-up. Patients were divided into two groups: events group (n=189) and non-events group (n=2965). The results indicated that the events group had higher levels of big ET-1 compared to non-events group. Multivariable Cox proportional hazard regression analysis showed that big ET-1 was positively and statistically correlated with clinical outcomes (Hazard Ratio: 1.656, 95% confidence interval: 1.099-2.496, p=0.016). Additionally, the Kaplan-Meier analysis revealed that patients with higher big ET-1 presented lower event-free survival (p=0.016). The present study firstly suggests that big ET-1 is an independent risk marker of cardiovascular outcomes in patients with stable CAD. And more studies are needed to confirm our findings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Child-Staff Ratios in Early Childhood Education and Care Settings and Child Outcomes: A Systematic Review and Meta-Analysis.

PubMed

Perlman, Michal; Fletcher, Brooke; Falenchuk, Olesya; Brunsek, Ashley; McMullen, Evelyn; Shah, Prakesh S

2017-01-01

Child-staff ratios are a key quality indicator in early childhood education and care (ECEC) programs. Better ratios are believed to improve child outcomes by increasing opportunities for individual interactions and educational instruction from staff. The purpose of this systematic review, and where possible, meta-analysis, was to evaluate the association between child-staff ratios in preschool ECEC programs and children's outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Cross-sectional or longitudinal studies that evaluated the relationship between child-staff ratios in ECEC classrooms serving preschool aged children and child outcomes were independently identified by two reviewers. Data were independently extracted from included studies by two raters and differences between raters were resolved by consensus. Searches revealed 29 eligible studies (31 samples). Child-staff ratios ranged from 5 to 14.5 preschool-aged children per adult with a mean of 8.65. All 29 studies were included in the systematic review. However, the only meta-analysis that could be conducted was based on three studies that explored associations between ratios and children's receptive language. Results of this meta-analysis were not significant. Results of the qualitative systematic review revealed few significant relationships between child-staff ratios and child outcomes construed broadly. Thus, the available literature reveal few, if any, relationships between child-staff ratios in preschool ECEC programs and children's developmental outcomes. Substantial heterogeneity in the assessment of ratios, outcomes measured, and statistics used to capture associations limited quantitative synthesis. Other methodological limitations of the research integrated in this synthesis are discussed.

Child-Staff Ratios in Early Childhood Education and Care Settings and Child Outcomes: A Systematic Review and Meta-Analysis

PubMed Central

Perlman, Michal; Fletcher, Brooke; Falenchuk, Olesya; Brunsek, Ashley; McMullen, Evelyn; Shah, Prakesh S.

2017-01-01

Child-staff ratios are a key quality indicator in early childhood education and care (ECEC) programs. Better ratios are believed to improve child outcomes by increasing opportunities for individual interactions and educational instruction from staff. The purpose of this systematic review, and where possible, meta-analysis, was to evaluate the association between child-staff ratios in preschool ECEC programs and children’s outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Cross-sectional or longitudinal studies that evaluated the relationship between child-staff ratios in ECEC classrooms serving preschool aged children and child outcomes were independently identified by two reviewers. Data were independently extracted from included studies by two raters and differences between raters were resolved by consensus. Searches revealed 29 eligible studies (31 samples). Child-staff ratios ranged from 5 to 14.5 preschool-aged children per adult with a mean of 8.65. All 29 studies were included in the systematic review. However, the only meta-analysis that could be conducted was based on three studies that explored associations between ratios and children’s receptive language. Results of this meta-analysis were not significant. Results of the qualitative systematic review revealed few significant relationships between child-staff ratios and child outcomes construed broadly. Thus, the available literature reveal few, if any, relationships between child-staff ratios in preschool ECEC programs and children’s developmental outcomes. Substantial heterogeneity in the assessment of ratios, outcomes measured, and statistics used to capture associations limited quantitative synthesis. Other methodological limitations of the research integrated in this synthesis are discussed. PMID:28103288

Application of the statistical process control method for prospective patient safety monitoring during the learning phase: robotic kidney transplantation with regional hypothermia (IDEAL phase 2a-b).

PubMed

Sood, Akshay; Ghani, Khurshid R; Ahlawat, Rajesh; Modi, Pranjal; Abaza, Ronney; Jeong, Wooju; Sammon, Jesse D; Diaz, Mireya; Kher, Vijay; Menon, Mani; Bhandari, Mahendra

2014-08-01

Traditional evaluation of the learning curve (LC) of an operation has been retrospective. Furthermore, LC analysis does not permit patient safety monitoring. To prospectively monitor patient safety during the learning phase of robotic kidney transplantation (RKT) and determine when it could be considered learned using the techniques of statistical process control (SPC). From January through May 2013, 41 patients with end-stage renal disease underwent RKT with regional hypothermia at one of two tertiary referral centers adopting RKT. Transplant recipients were classified into three groups based on the robotic training and kidney transplant experience of the surgeons: group 1, robot trained with limited kidney transplant experience (n=7); group 2, robot trained and kidney transplant experienced (n=20); and group 3, kidney transplant experienced with limited robot training (n=14). We employed prospective monitoring using SPC techniques, including cumulative summation (CUSUM) and Shewhart control charts, to perform LC analysis and patient safety monitoring, respectively. Outcomes assessed included post-transplant graft function and measures of surgical process (anastomotic and ischemic times). CUSUM and Shewhart control charts are time trend analytic techniques that allow comparative assessment of outcomes following a new intervention (RKT) relative to those achieved with established techniques (open kidney transplant; target value) in a prospective fashion. CUSUM analysis revealed an initial learning phase for group 3, whereas groups 1 and 2 had no to minimal learning time. The learning phase for group 3 varied depending on the parameter assessed. Shewhart control charts demonstrated no compromise in functional outcomes for groups 1 and 2. Graft function was compromised in one patient in group 3 (p<0.05) secondary to reasons unrelated to RKT. In multivariable analysis, robot training was significantly associated with improved task-completion times (p<0.01). Graft function was not adversely affected by either the lack of robotic training (p=0.22) or kidney transplant experience (p=0.72). The LC and patient safety of a new surgical technique can be assessed prospectively using CUSUM and Shewhart control chart analytic techniques. These methods allow determination of the duration of mentorship and identification of adverse events in a timely manner. A new operation can be considered learned when outcomes achieved with the new intervention are at par with outcomes following established techniques. Statistical process control techniques allowed for robust, objective, and prospective monitoring of robotic kidney transplantation and can similarly be applied to other new interventions during the introduction and adoption phase. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Bayesian inference on risk differences: an application to multivariate meta-analysis of adverse events in clinical trials.

PubMed

Chen, Yong; Luo, Sheng; Chu, Haitao; Wei, Peng

2013-05-01

Multivariate meta-analysis is useful in combining evidence from independent studies which involve several comparisons among groups based on a single outcome. For binary outcomes, the commonly used statistical models for multivariate meta-analysis are multivariate generalized linear mixed effects models which assume risks, after some transformation, follow a multivariate normal distribution with possible correlations. In this article, we consider an alternative model for multivariate meta-analysis where the risks are modeled by the multivariate beta distribution proposed by Sarmanov (1966). This model have several attractive features compared to the conventional multivariate generalized linear mixed effects models, including simplicity of likelihood function, no need to specify a link function, and has a closed-form expression of distribution functions for study-specific risk differences. We investigate the finite sample performance of this model by simulation studies and illustrate its use with an application to multivariate meta-analysis of adverse events of tricyclic antidepressants treatment in clinical trials.

A general method for handling missing binary outcome data in randomized controlled trials.

PubMed

Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen

2014-12-01

The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. We propose a sensitivity analysis where standard analyses, which could include 'missing = smoking' and 'last observation carried forward', are embedded in a wider class of models. We apply our general method to data from two smoking cessation trials. A total of 489 and 1758 participants from two smoking cessation trials. The abstinence outcomes were obtained using telephone interviews. The estimated intervention effects from both trials depend on the sensitivity parameters used. The findings differ considerably in magnitude and statistical significance under quite extreme assumptions about the missing data, but are reasonably consistent under more moderate assumptions. A new method for undertaking sensitivity analyses when handling missing data in trials with binary outcomes allows a wide range of assumptions about the missing data to be assessed. In two smoking cessation trials the results were insensitive to all but extreme assumptions. © 2014 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

High EphA2 protein expression in renal cell carcinoma is associated with a poor disease outcome.

PubMed

Xu, Jinsheng; Zhang, Junxia; Cui, Liwen; Zhang, Huiran; Zhang, Shenglei; Bai, Yaling

2014-08-01

The receptor tyrosine kinase, ephrin type-A receptor 2 (EphA2), is normally expressed at sites of cell-to-cell contact in adult epithelial tissues, however, recent studies have shown that it is also overexpressed in various types of epithelial carcinomas, with the greatest level of EphA2 expression observed in metastatic lesions. In the present study, the association between the expression of EphA2 and the outcome of RCC patients was assessed. The high expression level of EphA2 was identified by log-rank test for a statistically significant prediction of the RCC outcome. In an overall multivariate analysis, the high expression level of EphA2 was identified as an independent predictor of RCC outcome. The length of survival of the patients with high EphA2 expression was shorter than that of the patients with a low level of expression (relative risk, 2.304; 95% CI, 1.102-4.818; P=0.027). The analysis of the expression levels of EphA2 in tumor tissues may aid in the identification of the patient subgroup that are at a high risk of a poor disease outcome.

Reliability and validity of the Outcome Expectations for Exercise Scale-2.

PubMed

Resnick, Barbara

2005-10-01

Development of a reliable and valid measure of outcome expectations for exercise for older adults will help establish the relationship between outcome expectations and exercise and facilitate the development of interventions to increase physical activity in older adults. The purpose of this study was to test the reliability and validity of the Outcome Expectations for Exercise-2 Scale (OEE-2), a 13-item measure with two subscales: positive OEE (POEE) and negative OEE (NOEE). The OEE-2 scale was given to 161 residents in a continuing-care retirement community. There was some evidence of validity based on confirmatory factor analysis, Rasch-analysis INFIT and OUTFIT statistics, and convergent validity and test criterion relationships. There was some evidence for reliability of the OEE-2 based on alpha coefficients, person- and item-separation reliability indexes, and R(2)values. Based on analyses, suggested revisions are provided for future use of the OEE-2. Although ongoing reliability and validity testing are needed, the OEE-2 scale can be used to identify older adults with low outcome expectations for exercise, and interventions can then be implemented to strengthen these expectations and improve exercise behavior.

The rank-heat plot is a novel way to present the results from a network meta-analysis including multiple outcomes.

PubMed

Veroniki, Areti Angeliki; Straus, Sharon E; Fyraridis, Alexandros; Tricco, Andrea C

2016-08-01

To present a novel and simple graphical approach to improve the presentation of the treatment ranking in a network meta-analysis (NMA) including multiple outcomes. NMA simultaneously compares many relevant interventions for a clinical condition from a network of trials, and allows ranking of the effectiveness and/or safety of each intervention. There are numerous ways to present the NMA results, which can challenge their interpretation by research users. The rank-heat plot is a novel graph that can be used to quickly recognize which interventions are most likely the best or worst interventions with respect to their effectiveness and/or safety for a single or multiple outcome(s) and may increase interpretability. Using empirical NMAs, we show that the need for a concise and informative presentation of results is imperative, particularly as the number of competing treatments and outcomes in an NMA increases. The rank-heat plot is an efficient way to present the results of ranking statistics, particularly when a large amount of data is available, and it is targeted to users from various backgrounds. Copyright © 2016 Elsevier Inc. All rights reserved.

A Statistical Model for Misreported Binary Outcomes in Clustered RCTs of Education Interventions

ERIC Educational Resources Information Center

Schochet, Peter Z.

2013-01-01

In education randomized control trials (RCTs), the misreporting of student outcome data could lead to biased estimates of average treatment effects (ATEs) and their standard errors. This article discusses a statistical model that adjusts for misreported binary outcomes for two-level, school-based RCTs, where it is assumed that misreporting could…

A simple technique investigating baseline heterogeneity helped to eliminate potential bias in meta-analyses.

PubMed

Hicks, Amy; Fairhurst, Caroline; Torgerson, David J

2018-03-01

To perform a worked example of an approach that can be used to identify and remove potentially biased trials from meta-analyses via the analysis of baseline variables. True randomisation produces treatment groups that differ only by chance; therefore, a meta-analysis of a baseline measurement should produce no overall difference and zero heterogeneity. A meta-analysis from the British Medical Journal, known to contain significant heterogeneity and imbalance in baseline age, was chosen. Meta-analyses of baseline variables were performed and trials systematically removed, starting with those with the largest t-statistic, until the I 2 measure of heterogeneity became 0%, then the outcome meta-analysis repeated with only the remaining trials as a sensitivity check. We argue that heterogeneity in a meta-analysis of baseline variables should not exist, and therefore removing trials which contribute to heterogeneity from a meta-analysis will produce a more valid result. In our example none of the overall outcomes changed when studies contributing to heterogeneity were removed. We recommend routine use of this technique, using age and a second baseline variable predictive of outcome for the particular study chosen, to help eliminate potential bias in meta-analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

Education of staff in preschool aged classrooms in child care centers and child outcomes: A meta-analysis and systematic review.

PubMed

Falenchuk, Olesya; Perlman, Michal; McMullen, Evelyn; Fletcher, Brooke; Shah, Prakesh S

2017-01-01

Staff education is considered key to quality of early childhood education and care (ECEC) programs. However, findings about associations between staff education and children's outcomes have been inconsistent. We conducted a systematic review and meta-analysis of associations between ECEC staff education and child outcomes. Searches of Medline, PsycINFO, and ERIC, websites of large datasets and reference sections of all retrieved articles were conducted. Eligible studies provided a statistical link between staff education and child outcomes for preschool-aged children in ECEC programs. Titles, abstracts and paper reviews as well as all data extraction were conducted by two independent raters. Of the 823 studies reviewed for eligibility, 39 met our inclusion criteria. Research in this area is observational in nature and subject to the inherent biases of that research design. Results from our systematic review were hampered by heterogeneity in how staff education was defined, variability in whose education was measured and the child outcomes that were assessed. However, overall the qualitative summary indicates that associations between staff education and childhood outcomes are non-existent to very borderline positive. In our meta-analysis of more homogeneous studies we identified certain positive, albeit very weak, associations between staff education and children's language outcomes (specifically, vocabulary and letter word identification) and no significant association with a mathematics outcome (WJ Applied Problems). Thus, our findings suggest that within the range of education levels found in the existing literature, education is not a key driver of child outcomes. However, since we only explored levels of education that were reported in the literature, our findings cannot be used to argue for lowering education standards in ECEC settings.

Education of staff in preschool aged classrooms in child care centers and child outcomes: A meta-analysis and systematic review

PubMed Central

Falenchuk, Olesya; Perlman, Michal; McMullen, Evelyn; Fletcher, Brooke; Shah, Prakesh S.

2017-01-01

Staff education is considered key to quality of early childhood education and care (ECEC) programs. However, findings about associations between staff education and children’s outcomes have been inconsistent. We conducted a systematic review and meta-analysis of associations between ECEC staff education and child outcomes. Searches of Medline, PsycINFO, and ERIC, websites of large datasets and reference sections of all retrieved articles were conducted. Eligible studies provided a statistical link between staff education and child outcomes for preschool-aged children in ECEC programs. Titles, abstracts and paper reviews as well as all data extraction were conducted by two independent raters. Of the 823 studies reviewed for eligibility, 39 met our inclusion criteria. Research in this area is observational in nature and subject to the inherent biases of that research design. Results from our systematic review were hampered by heterogeneity in how staff education was defined, variability in whose education was measured and the child outcomes that were assessed. However, overall the qualitative summary indicates that associations between staff education and childhood outcomes are non-existent to very borderline positive. In our meta-analysis of more homogeneous studies we identified certain positive, albeit very weak, associations between staff education and children’s language outcomes (specifically, vocabulary and letter word identification) and no significant association with a mathematics outcome (WJ Applied Problems). Thus, our findings suggest that within the range of education levels found in the existing literature, education is not a key driver of child outcomes. However, since we only explored levels of education that were reported in the literature, our findings cannot be used to argue for lowering education standards in ECEC settings. PMID:28854281

Posttreatment Variables Improve Outcome Prediction after Intra-Arterial Therapy for Acute Ischemic Stroke

PubMed Central

Prabhakaran, Shyam; Jovin, Tudor G.; Tayal, Ashis H.; Hussain, Muhammad S.; Nguyen, Thanh N.; Sheth, Kevin N.; Terry, John B.; Nogueira, Raul G.; Horev, Anat; Gandhi, Dheeraj; Wisco, Dolora; Glenn, Brenda A.; Ludwig, Bryan; Clemmons, Paul F.; Cronin, Carolyn A.; Tian, Melissa; Liebeskind, David; Zaidat, Osama O.; Castonguay, Alicia C.; Martin, Coleman; Mueller-Kronast, Nils; English, Joey D.; Linfante, Italo; Malisch, Timothy W.; Gupta, Rishi

2014-01-01

Background There are multiple clinical and radiographic factors that influence outcomes after endovascular reperfusion therapy (ERT) in acute ischemic stroke (AIS). We sought to derive and validate an outcome prediction score for AIS patients undergoing ERT based on readily available pretreatment and posttreatment factors. Methods The derivation cohort included 511 patients with anterior circulation AIS treated with ERT at 10 centers between September 2009 and July 2011. The prospective validation cohort included 223 patients with anterior circulation AIS treated in the North American Solitaire Acute Stroke registry. Multivariable logistic regression identified predictors of good outcome (modified Rankin score ≤2 at 3 months) in the derivation cohort; model β coefficients were used to assign points and calculate a risk score. Discrimination was tested using C statistics with 95% confidence intervals (CIs) in the derivation and validation cohorts. Calibration was assessed using the Hosmer-Lemeshow test and plots of observed to expected outcomes. We assessed the net reclassification improvement for the derived score compared to the Totaled Health Risks in Vascular Events (THRIVE) score. Subgroup analysis in patients with pretreatment Alberta Stroke Program Early CT Score (ASPECTS) and posttreatment final infarct volume measurements was also performed to identify whether these radiographic predictors improved the model compared to simpler models. Results Good outcome was noted in 186 (36.4%) and 100 patients (44.8%) in the derivation and validation cohorts, respectively. Combining readily available pretreatment and posttreatment variables, we created a score (acronym: SNARL) based on the following parameters: symptomatic hemorrhage [2 points: none, hemorrhagic infarction (HI)1–2 or parenchymal hematoma (PH) type 1; 0 points: PH2], baseline National Institutes of Health Stroke Scale score (3 points: 0–10; 1 point: 11–20; 0 points: >20), age (2 points: <60 years; 1 point: 60–79 years; 0 points: >79 years), reperfusion (3 points: Thrombolysis In Cerebral Ischemia score 2b or 3) and location of clot (1 point: M2; 0 points: M1 or internal carotid artery). The SNARL score demonstrated good discrimination in the derivation (C statistic 0.79, 95% CI 0.75–0.83) and validation cohorts (C statistic 0.74, 95% CI 0.68–0.81) and was superior to the THRIVE score (derivation cohort: C statistic 0.65, 95% CI 0.60–0.70; validation cohort: C-statistic 0.59, 95% CI 0.52–0.67; p < 0.01 in both cohorts) but was inferior to a score that included age, ASPECTS, reperfusion status and final infarct volume (C statistic 0.86, 95% CI 0.82–0.91; p = 0.04). Compared with the THRIVE score, the SNARL score resulted in a net reclassification improvement of 34.8%. Conclusions Among AIS patients treated with ERT, pretreatment scores such as the THRIVE score provide only fair prognostic information. Inclusion of posttreatment variables such as reperfusion and symptomatic hemorrhage greatly influences outcome and results in improved outcome prediction. PMID:24942008

Nucleated red blood cells in growth-restricted fetuses: associations with short-term neonatal outcome.

PubMed

Minior, V K; Bernstein, P S; Divon, M Y

2000-01-01

To determine the utility of the neonatal nucleated red blood cell (NRBC) count as an independent predictor of short-term perinatal outcome in growth-restricted fetuses. Hospital charts of neonates with a discharge diagnosis indicating a birth weight <10th percentile were reviewed for perinatal outcome. We studied all eligible neonates who had a complete blood count on the first day of life. After multiple gestations, anomalous fetuses and diabetic pregnancies were excluded; 73 neonates comprised the study group. Statistical analysis included ANOVA, simple and stepwise regression. Elevated NRBC counts were significantly associated with cesarean section for non-reassuring fetal status, neonatal intensive care unit admission and duration of neonatal intensive care unit stay, respiratory distress and intubation, thrombocytopenia, hyperbilirubinemia, intraventricular hemorrhage and neonatal death. Stepwise regression analysis including gestational age at birth, birth weight and NRBC count demonstrated that in growth-restricted fetuses, NRBC count was the strongest predictor of neonatal intraventricular hemorrhage, neonatal respiratory distress and neonatal death. An elevated NRBC count independently predicts adverse perinatal outcome in growth-restricted fetuses. Copyright 2000 S. Karger AG, Basel.

Interventions for encouraging sexual behaviours intended to prevent cervical cancer

PubMed Central

Shepherd, Jonathan P; Frampton, Geoff K; Harris, Petra

2014-01-01

Background Human papillomavirus (HPV) is the key risk factor for cervical cancer. Continuing high rates of HPV and other sexually transmitted infections (STIs) in young people demonstrate the need for effective behavioural interventions. Objectives To assess the effectiveness of behavioural interventions for young women to encourage safer sexual behaviours to prevent transmission of STIs (including HPV) and cervical cancer. Search methods Systematic literature searches were performed on the following databases: Cochrane Central Register of Controlled Trials (CENTRAL Issue 4, 2009) Cochrane Gynaecological Cancer Review Group (CGCRG) Specialised Register, MEDLINE, EMBASE, CINAHL, PsychINFO, Social Science Citation Index and Trials Register of Promoting Health Interventions (TRoPHI) up to the end of 2009. All references were screened for inclusion against selection criteria. Selection criteria Randomised controlled trials (RCTs) of behavioural interventions for young women up to the age of 25 years that included, amongst other things, information provision about the transmission and prevention of STIs. Trials had to measure behavioural outcomes (e.g. condom use) and/or biological outcomes (e.g. incidence of STIs, cervical cancer). Data collection and analysis A narrative synthesis was conducted. Meta-analysis was not considered appropriate due to heterogeneity between the interventions and trial populations. Main results A total of 5271 references were screened and of these 23 RCTs met the inclusion criteria. Most were conducted in the USA and in health-care clinics (e.g. family planning). The majority of interventions provided information about STIs and taught safer sex skills (e.g. communication), occasionally supplemented with provision of resources (e.g. free sexual health services). They were heterogeneous in duration, contact time, provider, behavioural aims and outcomes. A variety of STIs were addressed including HIV and chlamydia. None of the trials explicitly mentioned HPV or cervical cancer prevention. Statistically significant effects for behavioural outcomes (e.g. increasing condom use) were common, though not universal and varied according to the type of outcome. There were no statistically significant effects of abstaining from or reducing sexual activity. There were few statistically significant effects on biological (STI) outcomes. Considerable uncertainty exists in the risk of bias due to incomplete or ambiguous reporting. Authors’ conclusions Behavioural interventions for young women which aim to promote sexual behaviours protective of STI transmission can be effective, primarily at encouraging condom use. Future evaluations should include a greater focus on HPV and its link to cervical cancer, with long-term follow-up to assess impact on behaviour change, rates of HPV infection and progression to cervical cancer. Studies should use an RCT design where possible with integral process evaluation and cost-effectiveness analysis where appropriate. Given the predominance of USA studies in this systematic review evaluations conducted in other countries would be particularly useful. PMID:21491379

Effect of maternal multiple micronutrient vs iron-folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh: the JiVitA-3 randomized trial.

PubMed

West, Keith P; Shamim, Abu Ahmed; Mehra, Sucheta; Labrique, Alain B; Ali, Hasmot; Shaikh, Saijuddin; Klemm, Rolf D W; Wu, Lee S-F; Mitra, Maithilee; Haque, Rezwanul; Hanif, Abu A M; Massie, Allan B; Merrill, Rebecca Day; Schulze, Kerry J; Christian, Parul

Maternal micronutrient deficiencies may adversely affect fetal and infant health, yet there is insufficient evidence of effects on these outcomes to guide antenatal micronutrient supplementation in South Asia. To assess effects of antenatal multiple micronutrient vs iron-folic acid supplementation on 6-month infant mortality and adverse birth outcomes. Cluster randomized, double-masked trial in Bangladesh, with pregnancy surveillance starting December 4, 2007, and recruitment on January 11, 2008. Six-month infant follow-up ended August 30, 2012. Surveillance included 127,282 women; 44,567 became pregnant and were included in the analysis and delivered 28,516 live-born infants. Median gestation at enrollment was 9 weeks (interquartile range, 7-12). Women were provided supplements containing 15 micronutrients or iron-folic acid alone, taken daily from early pregnancy to 12 weeks postpartum. The primary outcome was all-cause infant mortality through 6 months (180 days). Prespecified secondary outcomes in this analysis included stillbirth, preterm birth (<37 weeks), and low birth weight (<2500 g). To maintain overall significance of α = .05, a Bonferroni-corrected α = .01 was calculated to evaluate statistical significance of primary and 4 secondary risk outcomes (.05/5). Among the 22,405 pregnancies in the multiple micronutrient group and the 22,162 pregnancies in the iron-folic acid group, there were 14,374 and 14,142 live-born infants, respectively, included in the analysis. At 6 months, multiple micronutrients did not significantly reduce infant mortality; there were 764 deaths (54.0 per 1000 live births) in the iron-folic acid group and 741 deaths (51.6 per 1000 live births) in the multiple micronutrient group (relative risk [RR], 0.95; 95% CI, 0.86-1.06). Multiple micronutrient supplementation resulted in a non-statistically significant reduction in stillbirths (43.1 vs 48.2 per 1000 births; RR, 0.89; 95% CI, 0.81-0.99; P = .02) and significant reductions in preterm births (18.6 vs 21.8 per 100 live births; RR, 0.85; 95% CI, 0.80-0.91; P < .001) and low birth weight (40.2 vs 45.7 per 100 live births; RR, 0.88; 95% CI, 0.85-0.91; P < .001). In Bangladesh, antenatal multiple micronutrient compared with iron-folic acid supplementation did not reduce all-cause infant mortality to age 6 months but resulted in a non-statistically significant reduction in stillbirths and significant reductions in preterm births and low birth weight. clinicaltrials.gov Identifier: NCT00860470.

Within-Subject Mediation Analysis in AB/BA Crossover Designs.

PubMed

Josephy, Haeike; Vansteelandt, Stijn; Vanderhasselt, Marie-Anne; Loeys, Tom

2015-05-01

Crossover trials are widely used to assess the effect of a reversible exposure on an outcome of interest. To gain further insight into the underlying mechanisms of this effect, researchers may be interested in exploring whether or not it runs through a specific intermediate variable: the mediator. Mediation analysis in crossover designs has received scant attention so far and is mostly confined to the traditional Baron and Kenny approach. We aim to tackle mediation analysis within the counterfactual framework and elucidate the assumptions under which the direct and indirect effects can be identified in AB/BA crossover studies. Notably, we show that both effects are identifiable in certain statistical models, even in the presence of unmeasured time-independent (or upper-level) confounding of the mediator-outcome relation. Employing the mediation formula, we derive expressions for the direct and indirect effects in within-subject designs for continuous outcomes that lend themselves to linear modelling, under a large variety of settings. We discuss an estimation approach based on regressing differences in outcomes on differences in mediators and show how to allow for period effects as well as different types of moderation. The performance of this approach is compared to other existing methods through simulations and is illustrated with data from a neurobehavioural study. Lastly, we demonstrate how a sensitivity analysis can be performed that is able to assess the robustness of both the direct and indirect effect against violation of the "no unmeasured lower-level mediator-outcome confounding" assumption.

Symptomatic outcome following laparoscopic Heller's cardiomyotomy with Dor fundoplication versus laparoscopic Heller's cardiomyotomy with angle of His accentuation: results of a randomized controlled trial.

PubMed

Balakrishna, Pavithra; Parshad, Rajinder; Rohila, Jitender; Saraya, Anoop; Makharia, Govind; Sharma, Raju

2015-08-01

The type of anti-reflux procedure to be used as an adjunct to laparoscopic Heller's cardiomyotomy (LHCM) in Achalasia cardia is controversial. We compared Angle of His accentuation and Dor fundoplication in a randomized controlled trial. From May 2010 to October 2013, 62 patients undergoing LHCM were randomized to receive either Dor fundoplication (Dor group) or Angle of His accentuation (AOH group) as an anti-reflux procedure. Symptomatic outcome was evaluated using modified Mellow and Pinkas scale for dysphagia and modified DeMeester's score for regurgitation and heartburn. Achalasia-specific quality-of-life (QOL) questionnaire was used to assess quality of life. The primary outcome was symptomatic relief and the secondary outcome was postoperative heartburn. Statistical analysis was done using SPSS software. All the procedures were completed laparoscopically with no mortality. Morbidity was similar in the two groups (6.4 %). Median operative time was higher in Dor group (170 vs 130 min). At a median follow-up of 21 months relief of dysphagia, regurgitation, and heartburn was seen in 87, 90.3, and 90.3 % patients in Dor group versus 93.5, 96.7, and 77.4 % in AOH group patients with significant improvement in symptom scores. Improvement was similar in both groups with no statistically significant difference in the symptom scores (p = 0.48 for dysphagia, p = 0.37 for regurgitation, and p = 0.19 for heartburn). The QOL improved in both groups [62.3 to 12.3 (p = 0.02) in Dor group and 63.9-13 (p = 0.02) in AOH group] with no statistically significant difference between the two groups (p = 0.96). There was no statistically significant difference in the postoperative heartburn between the two groups (p = 0.19). Laparoscopic Heller's cardiomyotomy with either Angle of His accentuation or Dor fundoplication leads to similar improvement in symptoms and quality of life.

Disease-specific quality of life after septoplasty and bilateral inferior turbinate outfracture in patients with nasal obstruction.

PubMed

Resende, Lucas; Carmo, Carolina do; Mocellin, Leão; Pasinato, Rogério; Mocellin, Marcos

2017-07-29

Septal deviations might cause nasal obstruction and negative impact on the quality of life of individuals. The efficacy of septoplasty for treatment of septal deviation and the predictors of satisfactory surgical outcomes remain controversial. Technical variability, heterogeneity of research samples and absence of a solid tool for clinical evaluation are the main hindrances to the establishment of reliable statistical data regarding the procedure. To evaluate the clinical improvements in the disease-specific quality-of-life between patients submitted to septoplasty with bilateral outfracture of the inferior turbinate under sedation and local anesthesia in a tertiary hospital and to assess possible clinical-epidemiological variables associated with functional outcome. Fifty-two patients consecutively submitted to septoplasty with bilateral outfracture of the inferior turbinate for treatment of nasal obstruction filled in forms regarding clinical and epidemiological information during enrollment and had their symptom objectively quantified using the Nose Obstruction Symptom Evaluation (NOSE) scale preoperatively and one and three months after the procedure. Statistical analysis aimed to determine overall and stratified surgical outcomes and to investigate correlations between the clinical-epidemiological variables with the scores obtained. Statistically significant improvement in the preoperative NOSE questionnaire compared to the scores obtained three months after surgery was demonstrated (p<0.001, T-Wilcoxon), with strong correlation between the preoperative score and the postoperative improvement during this period (r=-0.614, p<0.001, Spearman). After one month, patients reached in average 87.15% of the result obtained at the study termination. Smokers and patients with rhinitis and/or pulmonary comorbidity showed increased average preoperative NOSE scores, although without statistical significance (p>0.05). Gender, age, history of rhinitis and presence of pulmonary comorbidity did not influence significantly surgical outcomes (p>0.05). Smokers presented greater reduction in NOSE scores during the study (p=0.043, U-Mann-Whitney). Septoplasty with bilateral outfracture of the inferior turbinate has proven to significantly improve disease-specific quality-of-life and this favorable outcome seems to occur precociously. Copyright © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Development and validation of a national data registry for midwife-led births: the Midwives Alliance of North America Statistics Project 2.0 dataset.

PubMed

Cheyney, Melissa; Bovbjerg, Marit; Everson, Courtney; Gordon, Wendy; Hannibal, Darcy; Vedam, Saraswathi

2014-01-01

In 2004, the Midwives Alliance of North America's (MANA's) Division of Research developed a Web-based data collection system to gather information on the practices and outcomes associated with midwife-led births in the United States. This system, called the MANA Statistics Project (MANA Stats), grew out of a widely acknowledged need for more reliable data on outcomes by intended place of birth. This article describes the history and development of the MANA Stats birth registry and provides an analysis of the 2.0 dataset's content, strengths, and limitations. Data collection and review procedures for the MANA Stats 2.0 dataset are described, along with methods for the assessment of data accuracy. We calculated descriptive statistics for client demographics and contributing midwife credentials, and assessed the quality of data by calculating point estimates, 95% confidence intervals, and kappa statistics for key outcomes on pre- and postreview samples of records. The MANA Stats 2.0 dataset (2004-2009) contains 24,848 courses of care, 20,893 of which are for women who planned a home or birth center birth at the onset of labor. The majority of these records were planned home births (81%). Births were attended primarily by certified professional midwives (73%), and clients were largely white (92%), married (87%), and college-educated (49%). Data quality analyses of 9932 records revealed no differences between pre- and postreviewed samples for 7 key benchmarking variables (kappa, 0.98-1.00). The MANA Stats 2.0 data were accurately entered by participants; any errors in this dataset are likely random and not systematic. The primary limitation of the 2.0 dataset is that the sample was captured through voluntary participation; thus, it may not accurately reflect population-based outcomes. The dataset's primary strength is that it will allow for the examination of research questions on normal physiologic birth and midwife-led birth outcomes by intended place of birth. © 2014 by the American College of Nurse-Midwives.

Retrospective Evaluation of the Impact of a Geriatric Trauma Institute on Fragility Hip Fracture Patient Outcomes.

PubMed

Katrancha, Elizabeth D; Zipf, Jami; Abrahams, Nancy; Schroeder, Richard

Fragility hip fractures occur in the older than 65-year population at an alarming rate. It is estimated that 260,000 hip fractures occur annually. Patient outcomes following hip fractures are devastating. One of every 5 patients dies within 1 year of injury, and 1 of 3 remains in a nursing home for years after the injury. Published literature recommends an interdisciplinary approach to caring for hip-fractured patients and expediting surgery to improve outcomes. The purpose of this study was to retrospectively evaluate the impact of the Geriatric Trauma Institute (GTI) on fragility hip fracture patient outcomes. Specific outcomes included length of stay (LOS), length of time from emergency department (ED) arrival to operating room (OR), complication rate, and discharge destination. This study is a single-center pre- and post-retrospective chart review. Data were collected using database queries within the hospital system. Pre-GTI (n = 326) patients older than 65 years with International Classification of Disease, Ninth Revision (ICD-9) codes 820.0-820.9 (hip fractures) admitted to either a primary care physician or orthopaedic surgeon service between April 1, 2011, and April 1, 2013, were compared with post-GTI (n = 245) patients older than 65 years with ICD-9 codes 820.0-820.9 (hip fractures) admitted to trauma services (GTI) between May 1, 2013, and May 1, 2015. Descriptive statistics including demographic data (age, sex) and comparison of outcomes (LOS, ED to OR time, complications, and disposition) across the groups using standard analysis of variance (ANOVA) and correlation techniques. No statistical difference was found between groups for age, sex, or time from ED to OR pre- versus post-time period using one-way ANOVA, F(1,569) = 1.08, p = .30. The complication rate was calculated pre- and post-GTI and compared using the 2-proportion z-test. The difference between the pre-GTI group (16.6%; 54 of 326 patients) and the post-GTI group (9.4%; 23 of 245 patients) was statistically significant, p = .013. Mean LOS was statistically significantly higher in the pre-GTI group (M = 5) than in the post-GTI group (M = 5.2), U = 33,55, z = -3.32, p = .001. No statistical significance was found between pre- and postdischarge destination, χ(4) = .4.82, p = .307; likelihood ratio test, χ(4) = .5.19, p = .269. This retrospective pre- and post-GTI chart review demonstrates the effectiveness of a multidisciplinary team approach in decreasing complications and LOS for fragility hip-fractured patients. A team approach to the care of these patients improves outcomes and quality of life.

Empirical Analysis of Green Supply Chain Management Practices in Indian Automobile Industry

NASA Astrophysics Data System (ADS)

Luthra, S.; Garg, D.; Haleem, A.

2014-04-01

Environmental sustainability and green environmental issues have an increasing popularity among researchers and supply chain practitioners. An attempt has been made to identify and empirically analyze green supply chain management (GSCM) practices in Indian automobile industry. Six main GSCM practices (having 37 sub practices) and four expected performance outcomes (having 16 performances) have been identified by implementing GSCM practices from literature review. Questionnaire based survey has been made to validate these practices and performance outcomes. 123 complete questionnaires were collected from Indian automobile organizations and used for empirical analysis of GSCM practices in Indian automobile industry. Descriptive statistics have been used to know current implementation status of GSCM practices in Indian automobile industry and multiple regression analysis has been carried out to know the impact on expected organizational performance outcomes by current GSCM practices adopted by Indian automobile industry. The results of study suggested that environmental, economic, social and operational performances improve with the implementation of GSCM practices. This paper may play an important role to understand various GSCM implementation issues and help practicing managers to improve their performances in the supply chain.

Comments on: blood product transfusion in emergency department patients: a case control study of practice patterns and impact on outcome.

PubMed

Karami, Manoochehr; Khazaei, Salman

2017-12-06

Clinical decision makings according studies result require the valid and correct data collection, andanalysis. However, there are some common methodological and statistical issues which may ignore by authors. In individual matched case- control design bias arising from the unconditional analysis instead of conditional analysis. Using an unconditional logistic for matched data causes the imposition of a large number of nuisance parameters which may result in seriously biased estimates.

A mixed method pilot study: the researchers' experiences.

PubMed

Secomb, Jacinta M; Smith, Colleen

2011-08-01

This paper reports on the outcomes of a small well designed pilot study. Pilot studies often disseminate limited or statistically meaningless results without adding to the body knowledge on the comparative research benefits. The design a pre-test post-test group parallel randomised control trial and inductive content analysis of focus group transcripts was tested specifically to increase outcomes in a proposed larger study. Strategies are now in place to overcome operational barriers and recruitment difficulties. Links between the qualitative and quantitative arms of the proposed larger study have been made; it is anticipated that this will add depth to the final report. More extensive reporting on the outcomes of pilot studies would assist researchers and increase the body of knowledge in this area.

Methods for network meta-analysis of continuous outcomes using individual patient data: a case study in acupuncture for chronic pain.

PubMed

Saramago, Pedro; Woods, Beth; Weatherly, Helen; Manca, Andrea; Sculpher, Mark; Khan, Kamran; Vickers, Andrew J; MacPherson, Hugh

2016-10-06

Network meta-analysis methods, which are an extension of the standard pair-wise synthesis framework, allow for the simultaneous comparison of multiple interventions and consideration of the entire body of evidence in a single statistical model. There are well-established advantages to using individual patient data to perform network meta-analysis and methods for network meta-analysis of individual patient data have already been developed for dichotomous and time-to-event data. This paper describes appropriate methods for the network meta-analysis of individual patient data on continuous outcomes. This paper introduces and describes network meta-analysis of individual patient data models for continuous outcomes using the analysis of covariance framework. Comparisons are made between this approach and change score and final score only approaches, which are frequently used and have been proposed in the methodological literature. A motivating example on the effectiveness of acupuncture for chronic pain is used to demonstrate the methods. Individual patient data on 28 randomised controlled trials were synthesised. Consistency of endpoints across the evidence base was obtained through standardisation and mapping exercises. Individual patient data availability avoided the use of non-baseline-adjusted models, allowing instead for analysis of covariance models to be applied and thus improving the precision of treatment effect estimates while adjusting for baseline imbalance. The network meta-analysis of individual patient data using the analysis of covariance approach is advocated to be the most appropriate modelling approach for network meta-analysis of continuous outcomes, particularly in the presence of baseline imbalance. Further methods developments are required to address the challenge of analysing aggregate level data in the presence of baseline imbalance.

Epidemiologic Tools to Study the Influence of Environmental Factors on Fecundity and Pregnancy-related Outcomes

PubMed Central

Slama, Rémy; Ballester, Ferran; Casas, Maribel; Cordier, Sylvaine; Eggesbø, Merete; Iniguez, Carmen; Nieuwenhuijsen, Mark; Philippat, Claire; Rey, Sylvie; Vandentorren, Stéphanie; Vrijheid, Martine

2014-01-01

Adverse pregnancy outcomes entail a large health burden for the mother and offspring; a part of it might be avoided by better understanding the role of environmental factors in their etiology. Our aims were to review the assessment tools to characterize fecundity troubles and pregnancy-related outcomes in human populations and their sensitivity to environmental factors. For each outcome, we reviewed the possible study designs, main sources of bias, and their suggested cures. In terms of study design, for most pregnancy outcomes, cohorts with recruitment early during or even before pregnancy allow efficient characterization of pregnancy-related events, time-varying confounders, and in utero exposures that may impact birth outcomes and child health. Studies on congenital anomalies require specific designs, assessment of anomalies in medical pregnancy terminations, and, for congenital anomalies diagnosed postnatally, follow-up during several months after birth. Statistical analyses should take into account environmental exposures during the relevant time windows; survival models are an appropriate approach for fecundity, fetal loss, and gestational duration/preterm delivery. Analysis of gestational duration could distinguish pregnancies according to delivery induction (and possibly pregnancy-related conditions). In conclusion, careful design and analysis are required to better characterize environmental effects on human reproduction. PMID:24363355

Effects of dance movement therapy on selected cardiovascular parameters and estimated maximum oxygen consumption in hypertensive patients.

PubMed

Aweto, H A; Owoeye, O B A; Akinbo, S R A; Onabajo, A A

2012-01-01

Objective:Arterial hypertension is a medical condition associated with increased risks of of death, cardiovascular mortality and cardiovascular morbidity including stroke, coronary heart disease, atrial fibrillation and renal insufficiency. Regular physical exercise is considered to be an important part of the non-pharmacologictreatment of hypertension. The purpose of this study was to investigate the effects of dance movement therapy (DMT) on selected cardiovascular parameters and estimated maximum oxygen consumption in hypertensive patients. Fifty (50) subjects with hypertension participated in the study. They were randomly assigned to 2 equal groups; A (DMT group) and B (Control group). Group A carried out dance movement therapy 2 times a week for 4 weeks while group B underwent some educational sessions 2 times a week for the same duration. All the subjects were on anti-hypertensive drugs. 38 subjects completed the study with the DMTgroup having a total of 23 subjects (10 males and 13 females) and the control group 15 subjects (6 males and 9 females). Descriptive statistics of mean, standard deviation and inferential statistics of paired and independentt-testwere used for data analysis. Following four weeks of dance movement therapy, paired t-test analysis showed that there was a statistically significant difference in the Resting systolic blood pressure (RSBP) (p < 0.001*), Resting diastolic blood pressure (RDBP) (p < 0.001*), Resting heart rate (RHR) (p = 0.024*), Maximum heart rate (MHR) (p=0.002*) and Estimated oxygen consumption (VO2max) (p = 0.023*) in subjects in group A (p < 0.05) while there was no significant difference observed in outcome variables of subjects in group B (p > 0.05). Independent t-test analysis between the differences in the pre and post intervention scores of groups A and B also showed statistically significant differences in all the outcome variables (p <0.05). DMT was effective in improving cardiovascular parameters and estimated maximum oxygen consumption in hypertensive patients.

Remedial Coursetaking at U.S. Public 2- and 4-Year Institutions: Scope, Experiences, and Outcomes. Statistical Analysis Report. NCES 2016-405

ERIC Educational Resources Information Center

Chen, Xianglei

2016-01-01

Every year, millions of new college students arrive on campus lacking the necessary academic skills to perform at the college level. Postsecondary institutions address this problem with extensive remedial programs designed to strengthen students' basic skills. While much research on the effectiveness of remedial education has been conducted,…

Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: a case-control study.

PubMed

Lauritano, Dorina; Petruzzi, Massimo; Di Stasio, Dario; Lucchese, Alberta

2014-03-01

The aim of this study was to evaluate the efficacy of palifermin, an N-terminal truncated version of endogenous keratinocyte growth factor, in the control of oral mucositis during antiblastic therapy. Twenty patients undergoing allogeneic stem-cell transplantation for acute lymphoblastic leukaemia were treated with palifermin, and compared to a control group with the same number of subjects and similar inclusion criteria. Statistical analysis were performed to compare the outcomes in the treatment vs. control groups. In the treatment group, we found a statistically significant reduction in the duration of parenteral nutrition (P=0.002), duration of mucositis (P=0.003) and the average grade of mucositis (P=0.03). The statistical analysis showed that the drug was able to decrease the severity of mucositis. These data, although preliminary, suggest that palifermin could be a valid therapeutic adjuvant to improve the quality of life of patients suffering from leukaemia.

A study of two statistical methods as applied to shuttle solid rocket booster expenditures

NASA Technical Reports Server (NTRS)

Perlmutter, M.; Huang, Y.; Graves, M.

1974-01-01

The state probability technique and the Monte Carlo technique are applied to finding shuttle solid rocket booster expenditure statistics. For a given attrition rate per launch, the probable number of boosters needed for a given mission of 440 launches is calculated. Several cases are considered, including the elimination of the booster after a maximum of 20 consecutive launches. Also considered is the case where the booster is composed of replaceable components with independent attrition rates. A simple cost analysis is carried out to indicate the number of boosters to build initially, depending on booster costs. Two statistical methods were applied in the analysis: (1) state probability method which consists of defining an appropriate state space for the outcome of the random trials, and (2) model simulation method or the Monte Carlo technique. It was found that the model simulation method was easier to formulate while the state probability method required less computing time and was more accurate.

Expanding the enablement framework and testing an evaluative instrument for diabetes patient education.

PubMed

Leeseberg Stamler, L; Cole, M M; Patrick, L J

2001-08-01

Strategies to delay or prevent complications from diabetes include diabetes patient education. Diabetes educators seek to provide education that meets the needs of clients and influences positive health outcomes. (1) To expand prior research exploring an enablement framework for patient education by examining perceptions of patient education by persons with diabetes and (2) to test the mastery of stress instrument (MSI) as a potential evaluative instrument for patient education. Triangulated data collection with a convenience sample of adults taking diabetes education classes. Half the sample completed audio-taped semi-structured interviews pre, during and posteducation and all completed the MSI posteducation. Qualitative data were analysed using latent content analysis, descriptive statistics were completed. Qualitative analysis revealed content categories similar to previous work with prenatal participants, supporting the enablement framework. Statistical analyses noted congruence with psychometric findings from development of MSI; secondary qualitative analyses revealed congruency between MSI scores and patient perceptions. Mastery is an outcome congruent with the enablement framework for patient education across content areas. Mastery of stress instrument may be a instrument for identification of patients who are coping well with diabetes self-management, as well as those who are not and who require further nursing interventions.

Non-operative management (NOM) of blunt hepatic trauma: 80 cases.

PubMed

Özoğul, Bünyami; Kısaoğlu, Abdullah; Aydınlı, Bülent; Öztürk, Gürkan; Bayramoğlu, Atıf; Sarıtemur, Murat; Aköz, Ayhan; Bulut, Özgür Hakan; Atamanalp, Sabri Selçuk

2014-03-01

Liver is the most frequently injured organ upon abdominal trauma. We present a group of patients with blunt hepatic trauma who were managed without any invasive diagnostic tools and/or surgical intervention. A total of 80 patients with blunt liver injury who were hospitalized to the general surgery clinic or other clinics due to the concomitant injuries were followed non-operatively. The normally distributed numeric variables were evaluated by Student's t-test or one way analysis of variance, while non-normally distributed variables were analyzed by Mann-Whitney U-test or Kruskal-Wallis variance analysis. Chi-square test was also employed for the comparison of categorical variables. Statistical significance was assumed for p<0.05. There was no significant relationship between patients' Hgb level and liver injury grade, outcome, and mechanism of injury. Also, there was no statistical relationship between liver injury grade, outcome, and mechanism of injury and ALT levels as well as AST level. There was no mortality in any of the patients. During the last quarter of century, changes in the diagnosis and treatment of liver injury were associated with increased survival. NOM of liver injury in patients with stable hemodynamics and hepatic trauma seems to be the gold standard.

Proper interpretation of chronic toxicity studies and their statistics: A critique of "Which level of evidence does the US National Toxicology Program provide? Statistical considerations using the Technical Report 578 on Ginkgo biloba as an example".

PubMed

Kissling, Grace E; Haseman, Joseph K; Zeiger, Errol

2015-09-02

A recent article by Gaus (2014) demonstrates a serious misunderstanding of the NTP's statistical analysis and interpretation of rodent carcinogenicity data as reported in Technical Report 578 (Ginkgo biloba) (NTP, 2013), as well as a failure to acknowledge the abundant literature on false positive rates in rodent carcinogenicity studies. The NTP reported Ginkgo biloba extract to be carcinogenic in mice and rats. Gaus claims that, in this study, 4800 statistical comparisons were possible, and that 209 of them were statistically significant (p<0.05) compared with 240 (4800×0.05) expected by chance alone; thus, the carcinogenicity of Ginkgo biloba extract cannot be definitively established. However, his assumptions and calculations are flawed since he incorrectly assumes that the NTP uses no correction for multiple comparisons, and that significance tests for discrete data operate at exactly the nominal level. He also misrepresents the NTP's decision making process, overstates the number of statistical comparisons made, and ignores the fact that the mouse liver tumor effects were so striking (e.g., p<0.0000000000001) that it is virtually impossible that they could be false positive outcomes. Gaus' conclusion that such obvious responses merely "generate a hypothesis" rather than demonstrate a real carcinogenic effect has no scientific credibility. Moreover, his claims regarding the high frequency of false positive outcomes in carcinogenicity studies are misleading because of his methodological misconceptions and errors. Published by Elsevier Ireland Ltd.

Proper interpretation of chronic toxicity studies and their statistics: A critique of “Which level of evidence does the US National Toxicology Program provide? Statistical considerations using the Technical Report 578 on Ginkgo biloba as an example”

PubMed Central

Kissling, Grace E.; Haseman, Joseph K.; Zeiger, Errol

2014-01-01

A recent article by Gaus (2014) demonstrates a serious misunderstanding of the NTP’s statistical analysis and interpretation of rodent carcinogenicity data as reported in Technical Report 578 (Ginkgo biloba) (NTP 2013), as well as a failure to acknowledge the abundant literature on false positive rates in rodent carcinogenicity studies. The NTP reported Ginkgo biloba extract to be carcinogenic in mice and rats. Gaus claims that, in this study, 4800 statistical comparisons were possible, and that 209 of them were statistically significant (p<0.05) compared with 240 (4800 × 0.05) expected by chance alone; thus, the carcinogenicity of Ginkgo biloba extract cannot be definitively established. However, his assumptions and calculations are flawed since he incorrectly assumes that the NTP uses no correction for multiple comparisons, and that significance tests for discrete data operate at exactly the nominal level. He also misrepresents the NTP’s decision making process, overstates the number of statistical comparisons made, and ignores that fact that that the mouse liver tumor effects were so striking (e.g., p<0.0000000000001) that it is virtually impossible that they could be false positive outcomes. Gaus’ conclusion that such obvious responses merely “generate a hypothesis” rather than demonstrate a real carcinogenic effect has no scientific credibility. Moreover, his claims regarding the high frequency of false positive outcomes in carcinogenicity studies are misleading because of his methodological misconceptions and errors. PMID:25261588

Spontaneous movements of preterm infants is associated with outcome of gross motor development.

PubMed

Miyagishima, Saori; Asaka, Tadayoshi; Kamatsuka, Kaori; Kozuka, Naoki; Kobayashi, Masaki; Igarashi, Lisa; Hori, Tsukasa; Tsutsumi, Hiroyuki

2018-04-30

We conducted a longitudinal cohort study to analyze the relationship between outcome of gross motor development in preterm infants and factors that might affect their development. Preterm infants with a birth weight of <1500 g were recruited. We measured spontaneous antigravity limbs movements by 3D motion capture system at 3 months corrected age. Gross motor developmental outcomes at 6 and 12 months corrected age were evaluated using the Alberta Infant Motor Scale (AIMS). Statistical analysis was carried out by canonical correlation analysis. Eighteen preterm infants were included. In the 6 months corrected age analysis, spontaneous movement had a major effect on Prone and Sitting at 6 months corrected age of AIMS. In the 12 months corrected age analysis, spontaneous movement had a major effect on Sitting and Standing at 12 months corrected age of AIMS. In preterm infants, better antigravity spontaneous movements at 3 months corrected age were significantly correlated with better gross motor development at 6 or 12 months corrected age. Copyright © 2018 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

On the costs and benefits of emotional labor: a meta-analysis of three decades of research.

PubMed

Hülsheger, Ute R; Schewe, Anna F

2011-07-01

This article provides a quantitative review of the link of emotional labor (emotion-rule dissonance, surface acting, and deep acting) with well-being and performance outcomes. The meta-analysis is based on 494 individual correlations drawn from a final sample of 95 independent studies. Results revealed substantial relationships of emotion-rule dissonance and surface acting with indicators of impaired well-being (ρs between .39 and .48) and job attitudes (ρs between -.24 and -.40) and a small negative relationship with performance outcomes (ρs between -.20 and -.05). Overall, deep acting displayed weak relationships with indicators of impaired well-being and job attitudes but positive relationships with emotional performance and customer satisfaction (ρs .18 and .37). A meta-analytic regression analysis provides information on the unique contribution of emotion-rule dissonance, surface acting, and deep acting in statistically predicting well-being and performance outcomes. Furthermore, a mediation analysis confirms theoretical models of emotional labor which suggest that surface acting partially mediates the relationship of emotion-rule dissonance with well-being. Implications for future research as well as pragmatic ramifications for organizational practices are discussed in conclusion.

The Use of Online Modules and the Effect on Student Outcomes in a High School Chemistry Class

NASA Astrophysics Data System (ADS)

Lamb, Richard L.; Annetta, Len

2013-10-01

The purpose of the study was to review the efficacy of online chemistry simulations in a high school chemistry class and provide discussion of the factors that may affect student learning. The sample consisted of 351 high school students exposed to online simulations. Researchers administered a pretest, intermediate test and posttest to measure chemistry content knowledge acquired during the use of online chemistry laboratory simulations. The authors also analyzed student journal entries as an attitudinal measure of chemistry during the simulation experience. The four analyses conducted were Repeated Time Measures Analysis of Variance, a three-way Analysis of Variance, Logistic Regression and Multiple Analysis of Variance. Each of these analyses provides for a slightly different aspect of factors regarding student attitudes and outcomes. Results indicate that there is a statistically significant main effect across grouping type (experimental versus control, p = 0.042, α = 0.05). Analysis of student journal entries suggests that attitudinal factors may affect student outcomes concerning the use of online supplemental instruction. Implications for this study show that the use of online simulations promotes increased understanding of chemistry content through open-ended and interactive questioning.

A novel complete-case analysis to determine statistical significance between treatments in an intention-to-treat population of randomized clinical trials involving missing data.

PubMed

Liu, Wei; Ding, Jinhui

2018-04-01

The application of the principle of the intention-to-treat (ITT) to the analysis of clinical trials is challenged in the presence of missing outcome data. The consequences of stopping an assigned treatment in a withdrawn subject are unknown. It is difficult to make a single assumption about missing mechanisms for all clinical trials because there are complicated reactions in the human body to drugs due to the presence of complex biological networks, leading to data missing randomly or non-randomly. Currently there is no statistical method that can tell whether a difference between two treatments in the ITT population of a randomized clinical trial with missing data is significant at a pre-specified level. Making no assumptions about the missing mechanisms, we propose a generalized complete-case (GCC) analysis based on the data of completers. An evaluation of the impact of missing data on the ITT analysis reveals that a statistically significant GCC result implies a significant treatment effect in the ITT population at a pre-specified significance level unless, relative to the comparator, the test drug is poisonous to the non-completers as documented in their medical records. Applications of the GCC analysis are illustrated using literature data, and its properties and limits are discussed.

Nateglinide versus repaglinide for type 2 diabetes mellitus in China.

PubMed

Li, Chanjuan; Xia, Jielai; Zhang, Gaokui; Wang, Suzhen; Wang, Ling

2009-12-01

The purpose of this study is to evaluate efficacy and safety of nateglinide tablet administration in comparison with those of repaglinide tablet as control on treating type 2 diabetes mellitus in China. Pooled-analysis with analysis of covariance (ANCOVA) method was applied to assess the efficacy and safety based on original data collected from four independent randomized clinical trials with similar research protocols. However meta-analysis was applied based on the outcomes of the four studies. The results by meta-analysis were comparable to those obtained by pooled-analysis. The means of HbA(1c), and fasting blood glucose in both the nateglinide and repaglinide groups were reduced significantly after 12 weeks duration but no statistical differences in reduction between the two groups. The adverse reaction rates were 9.89 and 6.51% in the nateglinide and repaglinide groups respectively, with the rate difference showing no statistical significance, and the Odds Ratio of adverse reaction rate (95% confidence interval) was 1.59 (0.99, 2.55). Both nateglinide and repaglinide administration have similarly significant effects on reducing HbA(1c) and FBG. However, the adverse reaction rate in the nateglinide group is higher than that in the latter using repaglinide but no statistical significance difference as revealed in the four clinical trials detailed below.

Study populations and casemix: influence on analysis of postoperative outcomes.

PubMed

Isbister, W H

2000-04-01

The importance of patient casemix as a determinant of surgical outcome is now being recognized. The present study was undertaken in order to compare the presentation and outcomes in colorectal patients managed surgically by the same surgeon, in the same way, in different settings. Colorectal outcome data from the University Department of Surgery in Wellington and the King Faisal Specialist Hospital in Riyadh were analysed in order to determine casemix differences between the two hospitals. Data relating to the type of surgery, the surgeon, the patient's disease, the operation performed and the postoperative complications were compared. Specific colorectal clinical indicators were compared for two commonly performed operations for rectal cancer: anterior resection and abdomino-perineal resection of the rectum. Wellington patients were slightly older and there were more females. Emergency surgery was more frequent in Wellington. Left hemicolectomy, sigmoid colectomy, abscess drainage and pilonidal surgery were more common in Wellington whereas abdomino-perineal resection and anterior resection of the rectum, stoma closure, fistula surgery, seton insertion, restorative proctocolectomy and ileostomy were undertaken more frequently in Riyadh. More complex anal fistulas were managed in Riyadh. Condylomata accuminata, pilonidal abscess, anorectal abscess, rectal prolapse and diverticular disease were rarely seen in Riyadh. There were more postoperative pulmonary and cardiac complications in Wellington. Patients having anterior resection of the rectum were younger in Riyadh and there were proportionally more females. There were some obvious numerical outcome differences in postoperative atelectasis, wound infection, anastomotic leak and deep vein thrombosis rates but none of these reached statistical significance except atelectasis. In Riyadh the usual male-to-female ratio of patients undergoing abdomino-perineal resection was reversed but, again, none of the numerical outcome differences observed reached statistical significance except postoperative atelectasis and intraabdominal abscess. Although not statistically significant, the results of the present study suggest that when the same surgeon operates using the same technique in different communities, the outcomes may be different. Care should thus be taken when comparing different populations with different casemixes before definitive conclusions are made in comparative studies.

Hypnosis as an adjunct to cognitive-behavioral psychotherapy for obesity: a meta-analytic reappraisal.

PubMed

Allison, D B; Faith, M S

1996-06-01

I. Kirsch, G. Montgomery, and G. Sapirstein (1995) meta-analyzed 6 weight-loss studies comparing the efficacy of cognitive-behavior therapy (CBT) alone to CBT plus hypnotherapy and concluded that "the addition of hypnosis substantially enhanced treatment outcome" (p.214). Kirsch reported a mean effect size (expressed as d) of 1.96. After correcting several transcription and computational inaccuracies in the original meta-analysis, these 6 studies yield a smaller mean effect size (.26). Moreover, if 1 questionable study is removed from the analysis, the effect sizes become more homogeneous and the mean (.21) is no longer statistically significant. It is concluded that the addition of hypnosis to CBT for weight loss results in, at most, a small enhancement of treatment outcome.

Identifying sexual orientation health disparities in adolescents: analysis of pooled data from the Youth Risk Behavior Survey, 2005 and 2007.

PubMed

Mustanski, Brian; Van Wagenen, Aimee; Birkett, Michelle; Eyster, Sandra; Corliss, Heather L

2014-02-01

We studied sexual orientation disparities in health outcomes among US adolescents by pooling multiple Youth Risk Behavior Survey (YRBS) data sets from 2005 and 2007 for 14 jurisdictions. Here we describe the methodology for pooling and analyzing these data sets. Sexual orientation-related items assessed sexual orientation identity, gender of sexual contacts, sexual attractions, and harassment regarding sexual orientation. Wording of items varied across jurisdictions, so we created parallel variables and composite sexual minority variables. We used a variety of statistical approaches to address issues with the analysis of pooled data and to meet the aims of individual articles, which focused on a range of health outcomes and behaviors related to cancer, substance use, sexual health, mental health, violence, and injury.

Identifying Sexual Orientation Health Disparities in Adolescents: Analysis of Pooled Data From the Youth Risk Behavior Survey, 2005 and 2007

PubMed Central

Van Wagenen, Aimee; Birkett, Michelle; Eyster, Sandra; Corliss, Heather L.

2014-01-01

We studied sexual orientation disparities in health outcomes among US adolescents by pooling multiple Youth Risk Behavior Survey (YRBS) data sets from 2005 and 2007 for 14 jurisdictions. Here we describe the methodology for pooling and analyzing these data sets. Sexual orientation–related items assessed sexual orientation identity, gender of sexual contacts, sexual attractions, and harassment regarding sexual orientation. Wording of items varied across jurisdictions, so we created parallel variables and composite sexual minority variables. We used a variety of statistical approaches to address issues with the analysis of pooled data and to meet the aims of individual articles, which focused on a range of health outcomes and behaviors related to cancer, substance use, sexual health, mental health, violence, and injury. PMID:24328640

Characteristics of meta-analyses and their component studies in the Cochrane Database of Systematic Reviews: a cross-sectional, descriptive analysis

PubMed Central

2011-01-01

Background Cochrane systematic reviews collate and summarise studies of the effects of healthcare interventions. The characteristics of these reviews and the meta-analyses and individual studies they contain provide insights into the nature of healthcare research and important context for the development of relevant statistical and other methods. Methods We classified every meta-analysis with at least two studies in every review in the January 2008 issue of the Cochrane Database of Systematic Reviews (CDSR) according to the medical specialty, the types of interventions being compared and the type of outcome. We provide descriptive statistics for numbers of meta-analyses, numbers of component studies and sample sizes of component studies, broken down by these categories. Results We included 2321 reviews containing 22,453 meta-analyses, which themselves consist of data from 112,600 individual studies (which may appear in more than one meta-analysis). Meta-analyses in the areas of gynaecology, pregnancy and childbirth (21%), mental health (13%) and respiratory diseases (13%) are well represented in the CDSR. Most meta-analyses address drugs, either with a control or placebo group (37%) or in a comparison with another drug (25%). The median number of meta-analyses per review is six (inter-quartile range 3 to 12). The median number of studies included in the meta-analyses with at least two studies is three (inter-quartile range 2 to 6). Sample sizes of individual studies range from 2 to 1,242,071, with a median of 91 participants. Discussion It is clear that the numbers of studies eligible for meta-analyses are typically very small for all medical areas, outcomes and interventions covered by Cochrane reviews. This highlights the particular importance of suitable methods for the meta-analysis of small data sets. There was little variation in number of studies per meta-analysis across medical areas, across outcome data types or across types of interventions being compared. PMID:22114982

Therapeutic effect of erythropoietin in patients with traumatic brain injury: a meta-analysis of randomized controlled trials.

PubMed

Liu, Wen-Chao; Wen, Liang; Xie, Tao; Wang, Hao; Gong, Jiang-Biao; Yang, Xiao-Feng

2017-07-01

OBJECTIVE Erythropoietin (EPO) exerts a neuroprotective effect in animal models of traumatic brain injury (TBI). However, its effectiveness in human patients with TBI is unclear. In this study, the authors conducted the first meta-analysis to assess the effectiveness and safety of EPO in patients with TBI. METHODS In December 2015, a systematic search was performed of PubMed, Web of Science, MEDLINE, Embase, the Cochrane Library databases, and Google Scholar. Only English-language publications of randomized controlled trials (RCTs) using EPO in patients with TBI were selected for analysis. The assessed outcomes included mortality, favorable neurological outcome, hospital stay, and associated adverse effects. Continuous variables were presented as mean difference (MD) with a 95% confidence interval (CI). Dichotomous variables were presented as risk ratio (RR) or risk difference (RD) with a 95% CI. Statistical heterogeneity was examined using both I 2 and chi-square tests. RESULTS Of the 346 studies identified in the search, 5 RCTs involving 915 patients met the inclusion criteria. The overall results demonstrated that EPO significantly reduced mortality (RR 0.69, 95% CI 0.49-0.96, p = 0.03) and shortened the hospitalization time (MD -7.59, 95% CI -9.71 to -5.46, p < 0.0001) for patients with TBI. Pooled results of favorable outcome (RR 1.00, 95% CI 0.88-1.15, p = 0.97) and deep vein thrombosis (DVT; RD 0.00, 95% CI -0.05 to 0.05, p = 1.00) did not show a significant difference. CONCLUSIONS The authors suggested that EPO is beneficial for patients with TBI in terms of reducing mortality and shortening hospitalization time without increasing the risk of DVT. However, its effect on improving favorable neurological outcomes did not reach statistical significance. Therefore, more well-designed RCTs are necessary to ascertain the optimum dosage and time window of EPO treatment for patients with TBI.

Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews.

PubMed

Devji, Tahira; Johnston, Bradley C; Patrick, Donald L; Bhandari, Mohit; Thabane, Lehana; Guyatt, Gordon H

2017-09-27

Meta-analyses of clinical trials often provide sufficient information for decision-makers to evaluate whether chance can explain apparent differences between interventions. Interpretation of the magnitude and importance of treatment effects beyond statistical significance can, however, be challenging, particularly for patient-reported outcomes (PROs) measured using questionnaires with which clinicians have limited familiarity. The objectives of our study are to systematically evaluate Cochrane systematic review authors' approaches to calculation, reporting and interpretation of pooled estimates of patient-reported outcome measures (PROMs) in meta-analyses. We will conduct a methodological survey of a random sample of Cochrane systematic reviews published from 1 January 2015 to 1 April 2017 that report at least one statistically significant pooled result for at least one PRO in the abstract. Author pairs will independently review all titles, abstracts and full texts identified by the literature search, and they will extract data using a standardised data extraction form. We will extract the following: year of publication, number of included trials, number of included participants, clinical area, type of intervention(s) and control(s), type of meta-analysis and use of the Grading of Recommendations, Assessment, Development and Evaluation approach to rate the quality of evidence, as well as information regarding the characteristics of PROMs, calculation and presentation of PROM effect estimates and interpretation of PROM effect estimates. We will document and summarise the methods used for the analysis, reporting and interpretation of each summary effect measure. We will summarise categorical variables with frequencies and percentages and continuous outcomes as means and/or medians and associated measures of dispersion. Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effect of paracetamol (acetaminophen) on body temperature in acute stroke: A meta-analysis.

PubMed

Fang, Junjie; Chen, Chensong; Cheng, Hongsen; Wang, Ren; Ma, Linhao

2017-10-01

The objective of this study was to assess the efficacy of paracetamol (acetaminophen) on body temperature in acute stroke. Medline, Cochrane Central Register of Controlled Trials, EMBASE, Chinese BioMedical Literature Database, China National Knowledge Infrastructure, and the World Health Organization (WHO) International Clinical Trials Registry Platform were searched electronically. Relevant journals and references of studies included were hand-searched for randomized controlled trials (RCT) and controlled clinical trials (CCT) regarding the efficacy of paracetamol (acetaminophen) on body temperature in acute stroke. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 5.3 software by the Cochrane Collaboration. Five studies were included. To compare the efficacy of paracetamol (acetaminophen) in acute stroke, the pooled RR (Risk Ratio) and its 95% CI of body temperature reduction at 24h from the start of treatment were -0.3 (95% CI: -0.52 to -0.08), with statistical significance (P=0.007). Consistently, the pooled RR (Risk Ratio) and its 95% CI of body temperature at 24h from the start of treatment were -0.22 (-0.29, -0.15), with statistical significance (P<0.00001). When analyzing the body temperature reduction after 5days from the start of treatment, the pooled RR (Risk Ratio) and its 95% CI were 0.04 (95% CI: -0.20 to 0.29), with no statistical significance (P=0.73). For functional outcome (mRS≤2) analysis, the pooled RR and its 95% CI were 1.08 (0.88, 1.32), with no statistical significance (P=0.45). In addition, the difference of serious adverse events between acetaminophen and placebo was 0.86 (95% CI: 0.62 to 1.2), with no statistical significance (P=0.27). Acetaminophen was revealed to have some favorable influence in body temperature reduction in acute stroke, but showed no important effect on improving functional outcome and reducing adverse events of patients. What is already known on this subject? Paracetamol (acetaminophen) is one of the most commonly used antipyretic drugs and has some capability to reduce body temperature through acting on central nervous system. Acetaminophen showed some capability to decrease body temperature for acute stroke. Acetaminophen could not improve functional outcome and reduce adverse events of patients with acute stroke. Copyright © 2017 Elsevier Inc. All rights reserved.

ABCA transporter gene expression and poor outcome in epithelial ovarian cancer.

PubMed

Hedditch, Ellen L; Gao, Bo; Russell, Amanda J; Lu, Yi; Emmanuel, Catherine; Beesley, Jonathan; Johnatty, Sharon E; Chen, Xiaoqing; Harnett, Paul; George, Joshy; Williams, Rebekka T; Flemming, Claudia; Lambrechts, Diether; Despierre, Evelyn; Lambrechts, Sandrina; Vergote, Ignace; Karlan, Beth; Lester, Jenny; Orsulic, Sandra; Walsh, Christine; Fasching, Peter; Beckmann, Matthias W; Ekici, Arif B; Hein, Alexander; Matsuo, Keitaro; Hosono, Satoyo; Nakanishi, Toru; Yatabe, Yasushi; Pejovic, Tanja; Bean, Yukie; Heitz, Florian; Harter, Philipp; du Bois, Andreas; Schwaab, Ira; Hogdall, Estrid; Kjaer, Susan K; Jensen, Allan; Hogdall, Claus; Lundvall, Lene; Engelholm, Svend Aage; Brown, Bob; Flanagan, James; Metcalf, Michelle D; Siddiqui, Nadeem; Sellers, Thomas; Fridley, Brooke; Cunningham, Julie; Schildkraut, Joellen; Iversen, Ed; Weber, Rachel P; Berchuck, Andrew; Goode, Ellen; Bowtell, David D; Chenevix-Trench, Georgia; deFazio, Anna; Norris, Murray D; MacGregor, Stuart; Haber, Michelle; Henderson, Michelle J

2014-07-01

ATP-binding cassette (ABC) transporters play various roles in cancer biology and drug resistance, but their association with outcomes in serous epithelial ovarian cancer (EOC) is unknown. The relationship between clinical outcomes and ABC transporter gene expression in two independent cohorts of high-grade serous EOC tumors was assessed with real-time quantitative polymerase chain reaction, analysis of expression microarray data, and immunohistochemistry. Associations between clinical outcomes and ABCA transporter gene single nucleotide polymorphisms were tested in a genome-wide association study. Impact of short interfering RNA-mediated gene suppression was determined by colony forming and migration assays. Association with survival was assessed with Kaplan-Meier analysis and log-rank tests. All statistical tests were two-sided. Associations with outcome were observed with ABC transporters of the "A" subfamily, but not with multidrug transporters. High-level expression of ABCA1, ABCA6, ABCA8, and ABCA9 in primary tumors was statistically significantly associated with reduced survival in serous ovarian cancer patients. Low levels of ABCA5 and the C-allele of rs536009 were associated with shorter overall survival (hazard ratio for death = 1.50; 95% confidence interval [CI] =1.26 to 1.79; P = 6.5e-6). The combined expression pattern of ABCA1, ABCA5, and either ABCA8 or ABCA9 was associated with particularly poor outcome (mean overall survival in group with adverse ABCA1, ABCA5 and ABCA9 gene expression = 33.2 months, 95% CI = 26.4 to 40.1; vs 55.3 months in the group with favorable ABCA gene expression, 95% CI = 49.8 to 60.8; P = .001), independently of tumor stage or surgical debulking status. Suppression of cholesterol transporter ABCA1 inhibited ovarian cancer cell growth and migration in vitro, and statin treatment reduced ovarian cancer cell migration. Expression of ABCA transporters was associated with poor outcome in serous ovarian cancer, implicating lipid trafficking as a potentially important process in EOC. © The Author 2014. Published by Oxford University Press. All rights reserved.

Outcomes of polio eradication activities in Uttar Pradesh, India: the Social Mobilization Network (SM Net) and Core Group Polio Project (CGPP)

PubMed Central

2011-01-01

Background The primary strategy to interrupt transmission of wild poliovirus in India is to improve supplemental immunization activities and routine immunization coverage in priority districts with a focus on 107 high-risk blocks of western Uttar Pradesh and central Bihar. Villages or urban areas with a history of wild poliovirus transmission, or hard-to-reach or resistant populations are categorized as high-risk areas within blocks. The Social Mobilization Network (SM Net) was formed in Uttar Pradesh in 2003 to support polio eradication efforts through improved planning, implementation and monitoring of social mobilization activities in those high-risk areas. In this paper, we examine the vaccination outcomes in districts of SM Net where the CORE Group works. Methods We carried out a secondary data analysis of routine monitoring information collected by the SM Net and the Government of India. These data include information about vaccination outcomes in SM Net areas and non-SM Net areas within the districts where the CORE Group operates. Statistical analysis was used to compare, between SM Net and non-SM Net areas, vaccination outcomes considered sensitive to social mobilization efforts of the SM Net. We employed Generalized Estimating Equations (GEE) statistical method to account for Intra-cluster Correlation (ICC), and used 'Quasi-likelihood under the independence model criterion (QIC)' as the model selection method. Results Vaccination outcomes in SM Net areas were as high as or higher than in non-SM Net areas. There was considerable variation in vaccination outcomes between districts. Conclusions While not conclusive, the results suggest that the social mobilization efforts of the SM Net and the CORE Group are helping to increase vaccination levels in high-risk areas of Uttar Pradesh. Vaccination outcomes in CORE Group areas were equal or higher than in non-CORE, non-SM Net areas. This occurred even though SM Net areas are those with more community resistance to polio vaccination and/or are have harder-to-reach populations than non-SM Net areas. Other likely explanations for the relatively good vaccination performance in SM Net areas are not apparent. PMID:21569256

Expression of Vascular Endothelial Growth Factor in Odontogenic Cysts: Is There Any Impression on Clinical Outcome?

PubMed

Sadri, Donia; Farhadi, Sareh; Shahabi, Zahra; Sarshar, Samaneh

2016-01-01

The recent scientific reports have shown that angiogenesis can affect biological behavior of pathologic lesions. Regarding unique clinical outcome of Odontogenic keratocyst (OKC), the present study was aimed to compare angiogenesis in Odontogenic keratocyst and Dentigerous cyst (DC). In this experimental study, tissue sections of 46 samples of OKC and DC were stained through immunohistochemical method using Vascular Endothelial Growth Factor (VEGF) antibody. VEGF expression was evaluated in epithelial cells, fibroblasts and endothelial cells. The average percentage of stained cells in any samples was categorized to 3 groups as follows: SCORE 0: 10% of cells or less are positive. SCORE 1: 10 to 50% of cells are positive. SCORE 2: more than 50% of cells are positive. Mann-U-Whitney, T-test and chi-square was used for statistical analysis. The average of VEGF expression in 24 samples of DC was 20.2% and in 22 samples of OKC was 52.6%, respectively. The average of VEGF expression in these two cysts had statistical significant differences. (PV= 0.045). There was significant statistical differences between two cysts in the terms of VEGF SCORE (PV= 0.000). OKC samples had significantly higher SCORE for the purpose of VEGF incidence than DC. Also, there were no differences between VEGF expression in epithelial cells of two cysts (PV= 0.268) there were significant statistical differences between two cysts in terms of endothelial cell staining. The endothelial cell staining was significantly higher in OKC than DC (PV= 0.037%). Regarding higher expression of Vascular Endothelial Growth factor in OKC than DC, it seems that angiogenesis may have great impression on clinical outcome of OKC.

Mean values of Arnett's soft tissue analysis in Maratha ethnic (Indian) population - A cephalometric study.

PubMed

Singh, Shikha; Deshmukh, Sonali; Merani, Varsha; Rejintal, Neeta

2016-01-01

The aim of this article is to evaluate the mean cephalometric values for Arnett's soft tissue analysis in the Maratha ethnic (Indian) population. Lateral cephalograms of 60 patients (30 males and 30 females) aged 18-26 years were obtained with the patients in the Natural Head Position (NHP), with teeth in maximum intercuspation and lips in the rest position. Moreover, hand tracings were also done. The statistical analysis was performed with the help of a statistical software, the Statistical Package for the Social Sciences version 16, and Microsoft word and Excel (Microsoft office 2007) were used to generate the analytical data. Statistical significance was tested atP level (1% and 5% level of significance). Statistical analysis using student's unpaired t-test were performed. Various cephalometric values for the Maratha ethnic (Indian) population differed from Caucasian cephalometric values such as nasolabial inclination, incisor proclination, and exposure, which may affect the outcome of the orthodontic and orthognathic treatment. Marathas have more proclined maxillary incisors, less prominent chin, less facial length, acute nasolabial angle, and all soft tissue thickness are greater in Marathas except lower lip thickness (in Maratha males and females) and upper lip angle (in Maratha males) than those of the Caucasian population. It is a fact that all different ethnic races have different facial characters. The variability of the soft tissue integument in people with different ethnic origin makes it necessary to study the soft tissue standards of a particular community and consider those norms when planning an orthodontic and orthognathic treatment for particular racial and ethnic patients.

A hands-on practical tutorial on performing meta-analysis with Stata.

PubMed

Chaimani, Anna; Mavridis, Dimitris; Salanti, Georgia

2014-11-01

Statistical synthesis of research findings via meta-analysis is widely used to assess the relative effectiveness of competing interventions. A series of three papers aimed at familiarising mental health scientists with the key statistical concepts and problems in meta-analysis was recently published in this journal. One paper focused on the selection and interpretation of the appropriate model to synthesise results (fixed effect or random effects model) whereas the other two papers focused on two major threats that compromise the validity of meta-analysis results, namely publication bias and missing outcome data. In this paper we provide guidance on how to undertake meta-analysis using Stata, one of the most commonly used software packages for meta-analysis. We address the three topics covered in the previous issues of the journal, focusing on their implementation in Stata using a working example from mental health research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

[Cultural adaptation and content validation of the «Pain level» outcome of the Nursing Outcomes Classification].

PubMed

Bellido-Vallejo, José Carlos; Rodríguez-Torres, María Del Carmen; López-Medina, Isabel María; Pancorbo-Hidalgo, Pedro Luis

2013-01-01

To translate and culturally adapt the Pain Level outcome to the Spanish context to validate the contents of the Spanish version of the «Pain level» outcome. The original English version of the «Pain level» outcome was translated into Spanish (twice); then back-translated into English, and all the discrepancies were resolved after consulting with NOC authors. A panel consisting of 21 experts in pain care assessed this culturally adapted Spanish version, in order to score the content validity. In the first step, the experts scored the adequacy of each indicator to the concept «Pain level». In the second round, three new indicators were scored. The Statistical analysis included content validity index (CVI), probability of agreement by chance, and modified kappa statistic. A Spanish version was developed including label, definition, two groups of indicators, and two measurement scales. This version is fully adapted to the Spanish context and language. A set of 21 indicators (19 translated and two new) was selected, and 4 were deleted (three translated and one new). The CVI-average score was 0.83 and the CVI-universal agreement was 0.05. The Spanish-version of the outcome «Pain level» is semantically and culturally to adapted to a Spanish context and preserves equivalency with the original. Content validation has identified indicators useful for practice. The clinimetric properties (validity and reliability) of the adapted version could be tested in a clinical study with people suffering from acute pain. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Predictive Factors for Response of Intracranial Dural Arteriovenous Fistulas to Transarterial Onyx Embolization: Angiographic Subgroup Analysis of Treatment Outcomes.

PubMed

Kim, Byungjun; Jeon, Pyoung; Kim, Keonha; Kim, Sungtae; Kim, Hyungjin; Byun, Hong Sik; Jo, Kyung-Il

2016-04-01

Endovascular treatment using Onyx has been increasingly used to treat intracranial dural arteriovenous fistulas (DAVFs). This study evaluated predictive factors for favorable treatment outcome in patients with intracranial noncavernous DAVFs treated by transarterial Onyx embolization. Between August 2008 and August 2014, 55 patients who underwent transarterial Onyx embolization for noncavernous DAVFs were retrospectively reviewed. Patients' demographic, clinical, and procedural data were analyzed to find statistically significant predictive factors for favorable treatment outcomes after Onyx embolization. Fistulas were classified angiographically according to the relationship between fistulas and dural venous sinuses and the presence of leptomeningeal venous reflux. Sixty-eight Onyx embolizations were performed in 55 patients. Immediate angiographic cure was achieved in 28 patients, and 14 of 27 patients with residual shunts showed progressive occlusion at follow-up imaging studies. Therefore, the overall favorable treatment outcome was 76.4% (42/55). The remaining 13 patients (23.6%) showed persistent residual shunts, and 3 (5.5%) of them showed aggravation of residual lesion on follow-up studies. Of 25 patients with non-sinus fistulas, 23 patients (92%) showed favorable treatment outcomes, and 19 of 30 patients (63.3%) with sinus fistulas showed favorable outcomes. Among the evaluated variables, non-sinus DAVFs was a statistically significant predictive factor for favorable response to transarterial Onyx embolization (P < 0.05). Transarterial Onyx embolization is a highly effective treatment method for non-sinus DAVFs. Careful consideration of angiographic features and multimodal embolization strategies are required for treatment of sinus DAVFs. Copyright © 2016 Elsevier Inc. All rights reserved.

The Chinese version of the Outcome Expectations for Exercise scale: validation study.

PubMed

Lee, Ling-Ling; Chiu, Yu-Yun; Ho, Chin-Chih; Wu, Shu-Chen; Watson, Roger

2011-06-01

Estimates of the reliability and validity of the English nine-item Outcome Expectations for Exercise (OEE) scale have been tested and found to be valid for use in various settings, particularly among older people, with good internal consistency and validity. Data on the use of the OEE scale among older Chinese people living in the community and how cultural differences might affect the administration of the OEE scale are limited. To test the validity and reliability of the Chinese version of the Outcome Expectations for Exercise scale among older people. A cross-sectional validation study was designed to test the Chinese version of the OEE scale (OEE-C). Reliability was examined by testing both the internal consistency for the overall scale and the squared multiple correlation coefficient for the single item measure. The validity of the scale was tested on the basis of both a traditional psychometric test and a confirmatory factor analysis using structural equation modelling. The Mokken Scaling Procedure (MSP) was used to investigate if there were any hierarchical, cumulative sets of items in the measure. The OEE-C scale was tested in a group of older people in Taiwan (n=108, mean age=77.1). There was acceptable internal consistency (alpha=.85) and model fit in the scale. Evidence of the validity of the measure was demonstrated by the tests for criterion-related validity and construct validity. There was a statistically significant correlation between exercise outcome expectations and exercise self-efficacy (r=.34, p<.01). An analysis of the Mokken Scaling Procedure found that nine items of the scale were all retained in the analysis and the resulting scale was reliable and statistically significant (p=.0008). The results obtained in the present study provided acceptable levels of reliability and validity evidence for the Chinese Outcome Expectations for Exercise scale when used with older people in Taiwan. Future testing of the OEE-C scale needs to be carried out to see whether these results are generalisable to older Chinese people living in urban areas. Copyright © 2010 Elsevier Ltd. All rights reserved.

Management of non-traumatic avascular necrosis of the femoral head-a comparative analysis of the outcome of multiple small diameter drilling and core decompression with fibular grafting.

PubMed

Mohanty, S P; Singh, K A; Kundangar, R; Shankar, V

2017-04-01

The purpose of this study was to compare the clinical and radiological outcomes of multiple small diameter drilling and core decompression with fibular strut grafting in the management of non-traumatic avascular necrosis (AVN) of the femoral head. Outcomes of patients with AVN treated by multiple small diameter drilling (group 1) were compared retrospectively with patients treated by core decompression and fibular grafting (group 2). Harris hip score (HHS) was used to assess the clinical status pre- and postoperatively. Modified Ficat and Arlet classification was used to assess the radiological stage pre- and postoperatively. Forty-six patients (68 hips) were included in this study. Group 1 consisted of 33 hips, and group 2 consisted of 35 hips. In stages I and IIB, there was no statistically significant difference in the final HHS between the two groups. However, in stages IIA and III, hips in group 2 had a better final HHS (P < 0.05). In terms of radiographic progression, there was no statistical difference between hips in stages I, IIA and stage IIB. However, in stage III, hips belonging to group 2 had better results (P < 0.05). Kaplan-Meier survivorship analysis showed better outcome in group 2 in stage III (P < 0.05). Hips with AVN in the precollapse stage can be salvaged by core decompression with or without fibular grafting. Multiple small diameter drilling is relatively simple and carries less morbidity and hence preferred in stages I and II. However, in stage III disease, core decompression with fibular strut grafting gives better results.

Compared efficacy of preservation solutions on the outcome of liver transplantation: Meta-analysis

PubMed Central

Szilágyi, Ágnes Lilla; Mátrai, Péter; Hegyi, Péter; Tuboly, Eszter; Pécz, Daniella; Garami, András; Solymár, Margit; Pétervári, Erika; Balaskó, Márta; Veres, Gábor; Czopf, László; Wobbe, Bastian; Szabó, Dorottya; Wagner, Juliane; Hartmann, Petra

2018-01-01

AIM To compare the effects of the four most commonly used preservation solutions on the outcome of liver transplantations. METHODS A systematic literature search was performed using MEDLINE, Scopus, EMBASE and the Cochrane Library databases up to January 31st, 2017. The inclusion criteria were comparative, randomized controlled trials (RCTs) for deceased donor liver (DDL) allografts with adult and pediatric donors using the gold standard University of Wisconsin (UW) solution or histidine-tryptophan-ketoglutarate (HTK), Celsior (CS) and Institut Georges Lopez (IGL-1) solutions. Fifteen RCTs (1830 livers) were included; the primary outcomes were primary non-function (PNF) and one-year post-transplant graft survival (OGS-1). RESULTS All trials were homogenous with respect to donor and recipient characteristics. There was no statistical difference in the incidence of PNF with the use of UW, HTK, CS and IGL-1 (RR = 0.02, 95%CI: 0.01-0.03, P = 0.356). Comparing OGS-1 also failed to reveal any difference between UW, HTK, CS and IGL-1 (RR = 0.80, 95%CI: 0.80-0.80, P = 0.369). Two trials demonstrated higher PNF levels for UW in comparison with the HTK group, and individual studies described higher rates of biliary complications where HTK and CS were used compared to the UW and IGL-1 solutions. However, the meta-analysis of the data did not prove a statistically significant difference: the UW, CS, HTK and IGL-1 solutions were associated with nearly equivalent outcomes. CONCLUSION Alternative solutions for UW yield the same degree of safety and effectiveness for the preservation of DDLs, but further well-designed clinical trials are warranted. PMID:29713134

The median hazard ratio: a useful measure of variance and general contextual effects in multilevel survival analysis

PubMed Central

Wagner, Philippe; Merlo, Juan

2016-01-01

Multilevel data occurs frequently in many research areas like health services research and epidemiology. A suitable way to analyze such data is through the use of multilevel regression models (MLRM). MLRM incorporate cluster‐specific random effects which allow one to partition the total individual variance into between‐cluster variation and between‐individual variation. Statistically, MLRM account for the dependency of the data within clusters and provide correct estimates of uncertainty around regression coefficients. Substantively, the magnitude of the effect of clustering provides a measure of the General Contextual Effect (GCE). When outcomes are binary, the GCE can also be quantified by measures of heterogeneity like the Median Odds Ratio (MOR) calculated from a multilevel logistic regression model. Time‐to‐event outcomes within a multilevel structure occur commonly in epidemiological and medical research. However, the Median Hazard Ratio (MHR) that corresponds to the MOR in multilevel (i.e., ‘frailty’) Cox proportional hazards regression is rarely used. Analogously to the MOR, the MHR is the median relative change in the hazard of the occurrence of the outcome when comparing identical subjects from two randomly selected different clusters that are ordered by risk. We illustrate the application and interpretation of the MHR in a case study analyzing the hazard of mortality in patients hospitalized for acute myocardial infarction at hospitals in Ontario, Canada. We provide R code for computing the MHR. The MHR is a useful and intuitive measure for expressing cluster heterogeneity in the outcome and, thereby, estimating general contextual effects in multilevel survival analysis. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:27885709

Mid-term functional outcome after the internal fixation of distal radius fractures

PubMed Central

2012-01-01

Background Distal radius fracture is a common injury with a variety of operative and non-operative management options. There remains debate as to the optimal treatment for a given patient and fracture. Despite the popularity of volar locking plate fixation, there are few large cohort or long term follow up studies to justify this modality. Our aim was to report the functional outcome of a large number of patients at a significant follow up time after fixation of their distal radius with a volar locking plate. Methods 180 patients with 183 fractures and a mean age of 62.4 years were followed up retrospectively at a mean of 30 months (Standard deviation = 10.4). Functional assessment was performed using the Disabilities of the Arm, Shoulder and Hand (DASH) and modified MAYO wrist scores. Statistical analysis was performed to identify possible variables affecting outcome and radiographs were assessed to determine time to fracture union. Results The median DASH score was 2.3 and median MAYO score was 90 for the whole group. Overall, 133 patients (74%) had a good or excellent DASH and MAYO score. Statistical analysis showed that no specific variable including gender, age, fracture type, post-operative immobilisation or surgeon grade significantly affected outcome. Complications occurred in 27 patients (15%) and in 11 patients were major (6%). Conclusion This single centre large population series demonstrates good to excellent results in the majority of patients after volar locking plate fixation of the distal radius, with complication rates comparable to other non-operative and operative treatment modalities. On this basis we recommend this mode of fixation for distal radius fractures requiting operative intervention. PMID:22280557

Mid-term functional outcome after the internal fixation of distal radius fractures.

PubMed

Phadnis, Joideep; Trompeter, Alex; Gallagher, Kieran; Bradshaw, Lucy; Elliott, David S; Newman, Kevin J

2012-01-26

Distal radius fracture is a common injury with a variety of operative and non-operative management options. There remains debate as to the optimal treatment for a given patient and fracture. Despite the popularity of volar locking plate fixation, there are few large cohort or long term follow up studies to justify this modality. Our aim was to report the functional outcome of a large number of patients at a significant follow up time after fixation of their distal radius with a volar locking plate. 180 patients with 183 fractures and a mean age of 62.4 years were followed up retrospectively at a mean of 30 months (Standard deviation=10.4). Functional assessment was performed using the Disabilities of the Arm, Shoulder and Hand (DASH) and modified MAYO wrist scores. Statistical analysis was performed to identify possible variables affecting outcome and radiographs were assessed to determine time to fracture union. The median DASH score was 2.3 and median MAYO score was 90 for the whole group. Overall, 133 patients (74%) had a good or excellent DASH and MAYO score. Statistical analysis showed that no specific variable including gender, age, fracture type, post-operative immobilisation or surgeon grade significantly affected outcome. Complications occurred in 27 patients (15%) and in 11 patients were major (6%). This single centre large population series demonstrates good to excellent results in the majority of patients after volar locking plate fixation of the distal radius, with complication rates comparable to other non-operative and operative treatment modalities. On this basis we recommend this mode of fixation for distal radius fractures requiting operative intervention.

Indications and Visual Outcome of Penetrating Keratoplasty in Tertiary Eye Care Institute in Uttarakhand

PubMed Central

Gupta, Neeti; Dhasmana, Renu; Nagpal, Ramesh Chander; Bahadur, Harsh; Maitreya, Amit

2016-01-01

Introduction Corneal blindness forms significant proportion of visual blindness in developing countries and penetrating keratoplasty (PK) can restore vision for this. The prognosis of PK is dependent on the corneal diseases responsible for corneal blindness. Aim To evaluate the indications and visual outcome of PK in tertiary eye care institute in Uttarakhand. Materials and Methods Data was reviewed from the medical records of 145 PK done in Department of Ophthalmology, Himalayan Institute of Medical Sciences from January 2012 to October 2014. Analysis of data was done for evaluation of the indications and visual outcome by Paired student’s t-test for hypothesis testing of grouped values of preoperative and last follow-up best corrected visual acuity in cases of optical and therapeutic grafts. A p-value < 0.05 was considered statistically significant. Results In this study data of 145 eyes of 138 patients was reviewed. The most common indication for keratoplasty was corneal scarring including adherent leucoma 48 (33.10%). Therapeutic keratoplasty was done for 33 cases with maximum 30(20.68%) cases of infectious keratitis. One case of tectonic graft was included in therapeutic keratoplasty group for analysis. There was statistically significant difference (p=.0001) in best corrected visual acuity improvement from 1.39 logMAR+ 0.022(SD) preoperatively to 0.367 logMAR+0.44(SD) postoperatively and 1.4 logMAR+.000(SD) preoperatively to 0.16 logMAR+0.57(SD) postoperatively for optical and therapeutic grafts respectively. Conclusion Infective keratitis either active or healed was the major indication for keratoplasty. Poor prognosis indications were most common in this part of the country. The visual outcome following corneal transplantation was encouraging particularly in cases of optical keratoplasty. PMID:27504319

Evaluation of a Canadian back pain mass media campaign.

PubMed

Gross, Douglas P; Russell, Anthony S; Ferrari, Robert; Battié, Michele C; Schopflocher, Donald; Hu, Richard; Waddell, Gordon; Buchbinder, Rachelle

2010-04-15

Quasi-experimental before-and-after design with control group. We evaluated a back pain mass media campaign's impact on population back pain beliefs, work disability, and health utilization outcomes. Building on previous campaigns in Australia and Scotland, a back pain mass media campaign (Don't Take it Lying Down) was implemented in Alberta, Canada. A variety of media formats were used with radio ads predominating because of budget constraints. Changes in back pain beliefs were studied using telephone surveys of random samples from intervention and control provinces before campaign onset and afterward. The Back Beliefs Questionnaire (BBQ) was used along with specific questions about the importance of staying active. For evaluating behaviors, we extracted data from governmental and workers' compensation databases between January 1999 and July 2008. Outcomes included indicators of number of visits to health care providers, use of diagnostic imaging, and compensation claim incidence and duration. Analysis included time series analysis and ANOVA testing of the interaction between province and time. Belief surveys were conducted with a total of 8566 subjects over the 4-year period. Changes on BBQ scores were not statistically significant, however, the proportion of subjects agreeing with the statement, "If you have back pain you should try to stay active" increased in Alberta from 56% to 63% (P = 0.008) with no change in the control group (consistently approximately 60%). No meaningful or statistically significant effects were seen on the behavioral outcomes. A Canadian media campaign appears to have had a small impact on public beliefs specifically related to campaign messaging to stay active, but no impact was observed on health utilization or work disability outcomes. Results are likely because of the modest level of awareness achieved by the campaign and future campaigns will likely require more extensive media coverage.

Further dissemination of medical education projects after presentation at a pediatric national meeting (1998-2008).

PubMed

Smith, Sherilyn; Kind, Terry; Beck, Gary; Schiller, Jocelyn; McLauchlan, Heather; Harris, Mitchell; Gigante, Joseph

2014-01-01

Further dissemination of medical education work presented at national meetings is limited. The purpose of this study was to explore dissemination outcomes of scholarly work in pediatric medical education. Council on Medical Student Education in Pediatrics (COMSEP) members who presented at COMSEP national meetings from 1998 to 2008 received a questionnaire about scholarly dissemination outcomes. Descriptive statistics and chi-square analysis explored variables related to dissemination. Qualitative analysis of free text comments explored barriers to dissemination. Outcomes were determined for 81% of presentations (138/171). The dissemination rate was 67% (92/138 presentations), with 47 publications (34%). Dissemination rates did not vary by presentation type (poster vs. oral) or project type. There was no relationship between presentation type, project type, and dissemination method. Barriers included perceived inadequate time, mentorship, and methodological skills for scholarly work. Most projects were further disseminated. Additional resources including mentoring and protected time for scholarly work are needed by educators to optimize dissemination.

Dosage Parameters in Pediatric Outcome Studies Reported in 9 Peer-Reviewed Occupational Therapy Journals from 2008 to 2014: A Content Analysis

PubMed Central

Gee, Bryan M.; Lloyd, Kimberly; Devine, Nancy; Tyrrell, Erin; Evans, Trisha; Hill, Rebekah; Dineen, Stacee; Magalogo, Kristin

2016-01-01

Occupational therapists determine the dosage when establishing the plan of care for their pediatric clients. A content analysis was conducted using 123 pediatric occupational therapy outcomes studies from 9 scholarly international occupational therapy journals. The parameters of dosage were calculated using descriptive statistics in order to obtain a representation of dosage available within the current collage of pediatric occupational therapy outcomes studies. The results revealed that most studies reported portions of dosage parameters within the published studies. The average findings for the subcomponents related to dosage were session length (minutes) M = 58.7, duration of plan of care (weeks) M = 12.1, session frequency (per week) M = 3.4, and total hours of therapy (hours) M = 18.1. This first attempt at describing and calculating dosage related to pediatric occupational therapy practice indicates that evidence is lacking within the published literature to adequately guide OT dosage decisions. Further research related to dosage in pediatric occupational therapy practice is needed. PMID:26949547

Comparison of clinician-predicted to measured low vision outcomes.

PubMed

Chan, Tiffany L; Goldstein, Judith E; Massof, Robert W

2013-08-01

To compare low-vision rehabilitation (LVR) clinicians' predictions of the probability of success of LVR with patients' self-reported outcomes after provision of usual outpatient LVR services and to determine if patients' traits influence clinician ratings. The Activity Inventory (AI), a self-report visual function questionnaire, was administered pre-and post-LVR to 316 low-vision patients served by 28 LVR centers that participated in a collaborative observational study. The physical component of the Short Form-36, Geriatric Depression Scale, and Telephone Interview for Cognitive Status were also administered pre-LVR to measure physical capability, depression, and cognitive status. After patient evaluation, 38 LVR clinicians estimated the probability of outcome success (POS) using their own criteria. The POS ratings and change in functional ability were used to assess the effects of patients' baseline traits on predicted outcomes. A regression analysis with a hierarchical random-effects model showed no relationship between LVR physician POS estimates and AI-based outcomes. In another analysis, kappa statistics were calculated to determine the probability of agreement between POS and AI-based outcomes for different outcome criteria. Across all comparisons, none of the kappa values were significantly different from 0, which indicates that the rate of agreement is equivalent to chance. In an exploratory analysis, hierarchical mixed-effects regression models show that POS ratings are associated with information about the patient's cognitive functioning and the combination of visual acuity and functional ability, as opposed to visual acuity or functional ability alone. Clinicians' predictions of LVR outcomes seem to be influenced by knowledge of patients' cognitive functioning and the combination of visual acuity and functional ability-information clinicians acquire from the patient's history and examination. However, clinicians' predictions do not agree with observed changes in functional ability from the patient's perspective; they are no better than chance.

Comparing extracorporeal cardiopulmonary resuscitation with conventional cardiopulmonary resuscitation: A meta-analysis.

PubMed

Kim, Su Jin; Kim, Hyun Jung; Lee, Hee Young; Ahn, Hyeong Sik; Lee, Sung Woo

2016-06-01

The objective was to determine whether extracorporeal cardiopulmonary resuscitation (ECPR), when compared with conventional cardiopulmonary resuscitation (CCPR), improves outcomes in adult patients, and to determine appropriate conditions that can predict good survival outcome in ECPR patients through a meta-analysis. We searched the relevant literature of comparative studies between ECPR and CCPR in adults, from the MEDLINE, EMBASE, and Cochrane databases. The baseline information and outcome data (survival, good neurologic outcome at discharge, at 3-6 months, and at 1 year after arrest) were extracted. Beneficial effect of ECPR on outcome was analyzed according to time interval, location of arrest (out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA)), and pre-defined population inclusion criteria (witnessed arrest, initial shockable rhythm, cardiac etiology of arrest and CPR duration) by using Review Manager 5.3. Cochran's Q test and I(2) were calculated. 10 of 1583 publications were included. Although survival to discharge did not show clear superiority in OHCA, ECPR showed statistically improved survival and good neurologic outcome as compared to CCPR, especially at 3-6 months after arrest. In the subgroup of patients with pre-defined inclusion criteria, the pooled meta-analysis found similar results in studies with pre-defined criteria. Survival and good neurologic outcome tended to be superior in the ECPR group at 3-6 months after arrest. The effect of ECPR on survival to discharge in OHCA was not clearly shown. As ECPR showed better outcomes than CCPR in studies with pre-defined criteria, strict indications criteria should be considered when implementation of ECPR. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Interventions for reducing self-stigma in people with mental illnesses: a systematic review of randomized controlled trials

PubMed Central

Büchter, Roland Brian; Messer, Melanie

2017-01-01

Background: Self-stigma occurs when people with mental illnesses internalize negative stereotypes and prejudices about their condition. It can reduce help-seeking behaviour and treatment adherence. The effectiveness of interventions aimed at reducing self-stigma in people with mental illness is systematically reviewed. Results are discussed in the context of a logic model of the broader social context of mental illness stigma. Methods: Medline, Embase, PsycINFO, ERIC, and CENTRAL were searched for randomized controlled trials in November 2013. Studies were assessed with the Cochrane risk of bias tool. Results: Five trials were eligible for inclusion, four of which provided data for statistical analyses. Four studies had a high risk of bias. The quality of evidence was very low for each set of interventions and outcomes. The interventions studied included various group based anti-stigma interventions and an anti-stigma booklet. The intensity and fidelity of most interventions was high. Two studies were considered to be sufficiently homogeneous to be pooled for the outcome self-stigma. The meta-analysis did not find a statistically significant effect (SMD [95% CI] at 3 months: –0.26 [–0.64, 0.12], I2=0%, n=108). None of the individual studies found sustainable effects on other outcomes, including recovery, help-seeking behaviour and self-stigma. Conclusions: The effectiveness of interventions against self-stigma is uncertain. Previous studies lacked statistical power, used questionable outcome measures and had a high risk of bias. Future studies should be based on robust methods and consider practical implications regarding intervention development (relevance, implementability, and placement in routine services). PMID:28496396

Preoperative Patellofemoral Chondromalacia is Not a Contraindication for Fixed-Bearing Medial Unicompartmental Knee Arthroplasty.

PubMed

Adams, Alexander J; Kazarian, Gregory S; Lonner, Jess H

2017-06-01

Patellofemoral chondromalacia (PFCM) has historically been considered a contraindication for unicompartmental knee arthroplasty (UKA), but there is limited data assessing PFCM's impact on the results of fixed-bearing UKA. Our objective was to assess the impact of medial patellar and/or medial trochlear PFCM on overall and patellofemoral-specific 2-year outcomes after fixed-bearing medial UKA. Intraoperative notes defined the presence and location of PFCM during fixed bearing medial UKA. Outcome measures included the New Knee Society Score (NKSS), Kneeling Ability Score (KAS) and Forgotten Joint Score (FJS-12). Thirty-one knees with PFCM (PFCM group), and 52 knees without PFCM (N-PFCM group) were included for analysis. Mann-Whitney U tests assessed the statistical significance of observed differences, and a Bonferroni correction was applied, adjusting threshold for significance to P = .005. At minimum follow-up of 2 years, no statistical differences were detected between the N-PFCM and PFCM groups in the postoperative NKSS (159 vs 157, P = .731), preoperative to postoperative NKSS change (P = .447), FJS-12 (70.5 vs 67.6, P = .471), or KAS (71% vs 65%, P = .217). Patients with isolated patellar chondromalacia (n = 13) demonstrated trends toward worse outcomes according to NKSS (147, P = .198), FJS-12 (58, P = .094), and KAS (46%, P = .018), but were statistically insignificant. No failures occurred in either group. Functional outcomes of fixed-bearing medial UKA are not adversely impacted by the presence of PFCM involving the medial patellar facet and/or medial or central trochlea. Further follow-up is needed to determine longer-term implications of fixed-bearing medial UKA in patients with PFCM. Copyright © 2017 Elsevier Inc. All rights reserved.

Measuring and improving the quality of postoperative epidural analgesia for major abdominal surgery using statistical process control charts.

PubMed

Duncan, Fiona; Haigh, Carol

2013-10-01

To explore and improve the quality of continuous epidural analgesia for pain relief using Statistical Process Control tools. Measuring the quality of pain management interventions is complex. Intermittent audits do not accurately capture the results of quality improvement initiatives. The failure rate for one intervention, epidural analgesia, is approximately 30% in everyday practice, so it is an important area for improvement. Continuous measurement and analysis are required to understand the multiple factors involved in providing effective pain relief. Process control and quality improvement Routine prospectively acquired data collection started in 2006. Patients were asked about their pain and side effects of treatment. Statistical Process Control methods were applied for continuous data analysis. A multidisciplinary group worked together to identify reasons for variation in the data and instigated ideas for improvement. The key measure for improvement was a reduction in the percentage of patients with an epidural in severe pain. The baseline control charts illustrated the recorded variation in the rate of several processes and outcomes for 293 surgical patients. The mean visual analogue pain score (VNRS) was four. There was no special cause variation when data were stratified by surgeons, clinical area or patients who had experienced pain before surgery. Fifty-seven per cent of patients were hypotensive on the first day after surgery. We were able to demonstrate a significant improvement in the failure rate of epidurals as the project continued with quality improvement interventions. Statistical Process Control is a useful tool for measuring and improving the quality of pain management. The applications of Statistical Process Control methods offer the potential to learn more about the process of change and outcomes in an Acute Pain Service both locally and nationally. We have been able to develop measures for improvement and benchmarking in routine care that has led to the establishment of a national pain registry. © 2013 Blackwell Publishing Ltd.

Surgical management of gynecomastia: an outcome analysis.

PubMed

Kasielska, Anna; Antoszewski, Bogusław

2013-11-01

The aim of the study was to evaluate the surgical management of gynecomastia focusing on techniques, complications, and aesthetic results. The authors also proposed an evaluation scale of the cosmetic results after the treatment. We conducted a retrospective analysis of 113 patients undergoing the surgery for gynecomastia in our department. Preoperative clinical evaluation included the grade of gynecomastia, its etiology, and side, whereas postoperative analysis concerned histologic findings, complications, and cosmetic results. Operative techniques included subcutaneous mastectomy through circumareolar approach in 94 patients, subcutaneous mastectomy with skin excision in 9 patients, inverted-T reduction mastopexy with nipple-areola complex (NAC) transposition in 6 subjects, and breast amputation through inframammary fold approach with free transplantation of NAC in 4 cases. Complications occurred in a total of 25 patients and did not differ statistically within Simon stages. The operative technique appeared to be the crucial determinant of good aesthetic outcome. The postoperative result of shape and symmetry of the NAC was not as satisfactory as postoperative breast size and symmetry. We showed that subcutaneous mastectomy using a circumareolar incision without additional liposuction provides a good or very good aesthetic outcome in patients with Simon grades I to IIa gynecomastia and that it is challenging to achieve a very good or even a good aesthetic outcome in patients with Simon grades IIb to III gynecomastia.

Interventions with children and parents to improve physical activity and body mass index: a meta-analysis.

PubMed

Dellert, Jane Cerruti; Johnson, Portia

2014-01-01

Examine the effect of interventions with parents and children on children's physical activity and body mass index (BMI). Computerized searches for intervention studies published between 1990 and 2011 used multiple ProQuest databases, including unpublished dissertations and theses to minimize publication bias. English-language, intervention-testing studies of children, parents, or families with outcomes of physical activity or BMI were retrieved from peer-reviewed journals, dissertations, and theses. Eliminated studies had no control or comparison group; had no continuous outcome variable; had no physical activity/exercise and/or BMI as outcomes; or had incomplete statistics necessary for meta-analysis (means, standard deviations, or confidence intervals). Twenty-one studies met inclusion criteria. Quality criteria were control group, objective outcome variable measure, clarity of variable definitions, and number and reason for subject withdrawal. Meta-analysis on the raw difference of means estimated mean weighted effect size (MWES) assessed dispersion of effects and computed a summary effect. MWES for interventions with parents and children on physical activity (Z = 2.92; confidence interval [CI] = .09 to .48; p = .002) and on BMI for interventions with children alone (Z = -2.10; CI = -.16 to -.01; p = .02) was significant. A significant effect on physical activity but not on BMI was found when interventions included both parents and their children.

Tranexamic acid versus aminocaproic acid for blood management after total knee and total hip arthroplasty: A systematic review and meta-analysis.

PubMed

Liu, Qiuliang; Geng, Peishuo; Shi, Longyan; Wang, Qi; Wang, Pengliang

2018-06-01

To compare the efficacy and safety of tranexamic acid and aminocaproic acid for reducing blood loss and transfusion requirements after total knee and total hip arthroplasty. We conduct electronic searches of Medline (1966-2017.11), PubMed (1966-2017.11), Embase (1980-2017.11), ScienceDirect (1985-2017.11) and the Cochrane Library (1900-2017.11). The primary outcomes, including total blood loss, hemoglobin decline and transfusion requirements. Secondary outcomes include length of hospital stay and postoperative complications such as the incidence of deep vein thrombosis and pulmonary embolism. Each outcome is combined and calculated using the statistical software STATA 12.0. Fixed/random effect model is adopted based on the heterogeneity tested by I 2 statistic. A total of 1714 patients are analyzed across three randomized controlled trials (RCTs) and one non-RCT. The present meta-analysis reveals that TXA is associated with a significantly reduction of total blood loss and postoperative hemoglobin drop compared with EACA. No significant differences are identified in terms of transfusion rates, length of hospital stay, and the incidence of postoperative complications. Although total blood loss and postoperative hemoglobin drop are significant greater in EACA groups, there is no significant difference between TXA and EACA groups in terms of transfusion rates. Based on the current evidence available, higher quality RCTs are still required for further research. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Meta-analysis of Prolene Hernia System mesh versus Lichtenstein mesh in open inguinal hernia repair.

PubMed

Sanjay, Pandanaboyana; Watt, David G; Ogston, Simon A; Alijani, Afshin; Windsor, John A

2012-10-01

This study was designed to systematically analyse all published randomized clinical trials comparing the Prolene Hernia System (PHS) mesh and Lichtenstein mesh for open inguinal hernia repair. A literature search was performed using the Cochrane Colorectal Cancer Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE, Embase and Science Citation Index Expanded. Randomized trials comparing the Lichtenstein Mesh repair (LMR) with the Prolene Hernia System were included. Statistical analysis was performed using Review Manager Version 5.1 software. The primary outcome measures were hernia recurrence and chronic pain after operation. Secondary outcome measures included surgical time, peri-operative complications, time to return to work, early and long-term postoperative complications. Six randomized clinical trials were identified as suitable, containing 1313 patients. There was no statistical difference between the two types of repair in operation time, time to return to work, incidence of chronic groin pain, hernia recurrence or long-term complications. The PHS group had a higher rate of peri-operative complications, compared to Lichtenstein mesh repair (risk ratio (RR) 0.71, 95% confidence interval 0.55-0.93, P=0.01). The use of PHS mesh was associated with an increased risk of peri-operative complications compared to LMR. Both mesh repair techniques have comparable short- and long-term outcomes. Copyright © 2012 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Speech outcome in unilateral complete cleft lip and palate patients: a descriptive study.

PubMed

Rullo, R; Di Maggio, D; Addabbo, F; Rullo, F; Festa, V M; Perillo, L

2014-09-01

In this study, resonance and articulation disorders were examined in a group of patients surgically treated for cleft lip and palate, considering family social background, and children's ability of self monitoring their speech output while speaking. Fifty children (32 males and 18 females) mean age 6.5 ± 1.6 years, affected by non-syndromic complete unilateral cleft of the lip and palate underwent the same surgical protocol. The speech level was evaluated using the Accordi's speech assessment protocol that focuses on intelligibility, nasality, nasal air escape, pharyngeal friction, and glottal stop. Pearson product-moment correlation analysis was used to detect significant associations between analysed parameters. A total of 16% (8 children) of the sample had severe to moderate degree of nasality and nasal air escape, presence of pharyngeal friction and glottal stop, which obviously compromise speech intelligibility. Ten children (10%) showed a barely acceptable phonological outcome: nasality and nasal air escape were mild to moderate, but the intelligibility remained poor. Thirty-two children (64%) had normal speech. Statistical analysis revealed a significant correlation between the severity of nasal resonance and nasal air escape (p ≤ 0.05). No statistical significant correlation was found between the final intelligibility and the patient social background, neither between the final intelligibility nor the age of the patients. The differences in speech outcome could be explained with a specific, subjective, and inborn ability, different for each child, in self-monitoring their speech output.

Assessing correlations between the spatial distribution of the dose to the rectal wall and late rectal toxicity after prostate radiotherapy: an analysis of data from the MRC RT01 trial (ISRCTN 47772397)

NASA Astrophysics Data System (ADS)

Buettner, Florian; Gulliford, Sarah L.; Webb, Steve; Sydes, Matthew R.; Dearnaley, David P.; Partridge, Mike

2009-11-01

Many studies have been performed to assess correlations between measures derived from dose-volume histograms and late rectal toxicities for radiotherapy of prostate cancer. The purpose of this study was to quantify correlations between measures describing the shape and location of the dose distribution and different outcomes. The dose to the rectal wall was projected on a two-dimensional map. In order to characterize the dose distribution, its centre of mass, longitudinal and lateral extent, and eccentricity were calculated at different dose levels. Furthermore, the dose-surface histogram (DSH) was determined. Correlations between these measures and seven clinically relevant rectal-toxicity endpoints were quantified by maximally selected standardized Wilcoxon rank statistics. The analysis was performed using data from the RT01 prostate radiotherapy trial. For some endpoints, the shape of the dose distribution is more strongly correlated with the outcome than simple DSHs. Rectal bleeding was most strongly correlated with the lateral extent of the dose distribution. For loose stools, the strongest correlations were found for longitudinal extent; proctitis was most strongly correlated with DSH. For the other endpoints no statistically significant correlations could be found. The strengths of the correlations between the shape of the dose distribution and outcome differed considerably between the different endpoints. Due to these significant correlations, it is desirable to use shape-based tools in order to assess the quality of a dose distribution.

Prediction of neurodevelopmental outcome after hypoxic-ischemic encephalopathy treated with hypothermia by diffusion tensor imaging analyzed using tract-based spatial statistics.

PubMed

Tusor, Nora; Wusthoff, Courtney; Smee, Natalie; Merchant, Nazakat; Arichi, Tomoki; Allsop, Joanna M; Cowan, Frances M; Azzopardi, Denis; Edwards, A David; Counsell, Serena J

2012-07-01

Objective biomarkers are needed to assess neuroprotective therapies after perinatal hypoxic-ischemic encephalopathy (HIE). We tested the hypothesis that, in infants who underwent therapeutic hypothermia after perinatal HIE, neurodevelopmental performance was predicted by fractional anisotropy (FA) values in the white matter (WM) on early diffusion tensor imaging (DTI) as assessed by means of tract-based spatial statistics (TBSS). We studied 43 term infants with HIE. Developmental assessments were carried out at a median (range) age of 24 (12-28) mo. As compared with infants with favorable outcomes, those with unfavorable outcomes had significantly lower FA values (P < 0.05) in the centrum semiovale, corpus callosum (CC), anterior and posterior limbs of the internal capsule, external capsules, fornix, cingulum, cerebral peduncles, optic radiations, and inferior longitudinal fasciculus. In a second analysis in 32 assessable infants, the Griffiths Mental Development Scales (Revised) (GMDS-R) showed a significant linear correlation (P < 0.05) between FA values and developmental quotient (DQ) and all its component subscale scores. DTI analyzed by TBSS provides a qualified biomarker that can be used to assess the efficacy of additional neuroprotective therapies after HIE.

Disadvantage of survival outcomes in widowed patients with colorectal neuroendocrine neoplasm: an analysis of surveillance, epidemiology and end results database.

PubMed

Li, Jing; Wang, Ying; Han, Fang; Wang, Zhu; Xu, Lichun; Tong, Jiandong

2016-12-13

Marital status correlates with health. Our goal was to examine the impact of marital status on the survival outcomes of patients with colorectal neuroendocrine neoplasms (NENs). The Surveillance, Epidemiology and End Results program was used to identify 1,289 eligible patients diagnosed between 2004 and 2010 with colorectal NENs. Statistical analyses were performed using Chi-square, Kaplan-Meier, and Cox regression proportional hazards methods. Patients in the widowed group had the highest proportion of larger tumor (>2cm), and higher ratio of poor grade (Grade III and IV) and more tumors at advanced stage (P<0.05). The 5-year cause specific survival (CSS) was 76% in the married group, 51% in the widowed group, 73% in the single group, and 72% in the divorced/separated group, which manifest statistically significant difference in the univariate log-rank test and Cox regression model (P<0.05). Furthermore, marital status was an independent prognostic factor only in Distant stage (P<0.001). In conclusion, patients in widowed group were at greater risk of cancer specific mortality from colorectal NENs and social support may lead to improved outcomes for patients with NENs.

Cost-effectiveness research in cancer therapy: a systematic review of literature trends, methods and the influence of funding.

PubMed

Al-Badriyeh, Daoud; Alameri, Marwah; Al-Okka, Randa

2017-01-27

To perform a first-time analysis of the cost-effectiveness (CE) literature on chemotherapies, of all types, in cancer, in terms of trends and change over time, including the influence of industry funding. Systematic review. A wide range of cancer-related research settings within healthcare, including health systems, hospitals and medical centres. All literature comparative CE research of drug-based cancer therapies in the period 1986 to 2015. Primary outcomes are the literature trends in relation to journal subject category, authorship, research design, data sources, funds and consultation involvement. An additional outcome measure is the association between industry funding and study outcomes. Descriptive statistics and the χ 2 , Fisher exact or Somer's D tests were used to perform non-parametric statistics, with a p value of <0.05 as the statistical significance measure. Total 574 publications were analysed. The drug-related CE literature expands over time, with increased publishing in the healthcare sciences and services journal subject category (p<0.001). The retrospective data collection in studies increased over time (p<0.001). The usage of prospective data, however, has been decreasing (p<0.001) in relation to randomised clinical trials (RCTs), but is unchanging for non-RCT studies. The industry-sponsored CE studies have especially been increasing (p<0.001), in contrast to those sponsored by other sources. While paid consultation involvement grew throughout the years, the declaration of funding for this is relatively limited. Importantly, there is evidence that industry funding is associated with favourable result to the sponsor (p<0.001). This analysis demonstrates clear trends in how the CE cancer research is presented to the practicing community, including in relation to journals, study designs, authorship and consultation, together with increased financial sponsorship by pharmaceutical industries, which may be more influencing study outcomes than other funding sources. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris.

PubMed

Lu, Liming; Xuan, Meiling; Yan, Yuhong; Li, Geng; Zhou, Li; Wen, Zehuai; Lu, Chuanjian

2016-10-03

Psoriasis vulgaris (PV) has been causing increasing concern due to its highly prevalent, harmful and therapy-resistant characteristics. The YXBCM01 (Chinese herbal medicine) for PV trial evaluates the effects of YXBCM01 on relapse rate in patients suffering from PV. As an update to the published design and method for the trial, this paper presents the statistical plan for the main publication to avoid the risk of outcome reporting bias, selective reporting, and data-driven results. This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 600 PV patients (300 in each group) will be randomized to one of two arms: participants in the experimental group will receive the YXBCM01 granule 5.5 g twice daily for 12 weeks. Placebo granules are given to patients in the control group at a dose of 5.5 g twice daily for 12 weeks. The sequential topical therapy is administrated simultaneously to all eligible patients by using calcipotriol betamethasone ointment once daily (a treatment area of up to 30 % body surface area (BSA), fingertip unit is recommended) in the first 4 weeks (maximum of 100 g weekly), followed by calcipotriol betamethasone ointment once daily for the remaining 8 weeks (maximum of 100 g weekly). The primary outcome measure is relapse rate in the treatment period and follow-up period. The secondary outcome measures include time to relapse, time to onset, rebound rate, cumulative consumption of topical medicine, visual analog scale (VAS), BSA, the Dermatology Life Quality Index (DLQI) and the Medical Outcomes Study (MOS) 36-item short form health survey (SF-36). Application of this statistical analysis plan to the YXBCM01 for PV trial will facilitate unbiased evaluation of these important clinical data. This study will provide evidence regarding the value of YXBCM01 as an intervention for PV patients. Chinese Clinical Trial Registry: ChiCTR-TRC-13003233 , registered on 26 May 2013.

Daniel Goodman’s empirical approach to Bayesian statistics

USGS Publications Warehouse

Gerrodette, Tim; Ward, Eric; Taylor, Rebecca L.; Schwarz, Lisa K.; Eguchi, Tomoharu; Wade, Paul; Himes Boor, Gina

2016-01-01

Bayesian statistics, in contrast to classical statistics, uses probability to represent uncertainty about the state of knowledge. Bayesian statistics has often been associated with the idea that knowledge is subjective and that a probability distribution represents a personal degree of belief. Dr. Daniel Goodman considered this viewpoint problematic for issues of public policy. He sought to ground his Bayesian approach in data, and advocated the construction of a prior as an empirical histogram of “similar” cases. In this way, the posterior distribution that results from a Bayesian analysis combined comparable previous data with case-specific current data, using Bayes’ formula. Goodman championed such a data-based approach, but he acknowledged that it was difficult in practice. If based on a true representation of our knowledge and uncertainty, Goodman argued that risk assessment and decision-making could be an exact science, despite the uncertainties. In his view, Bayesian statistics is a critical component of this science because a Bayesian analysis produces the probabilities of future outcomes. Indeed, Goodman maintained that the Bayesian machinery, following the rules of conditional probability, offered the best legitimate inference from available data. We give an example of an informative prior in a recent study of Steller sea lion spatial use patterns in Alaska.

Gene-Based Association Analysis for Censored Traits Via Fixed Effect Functional Regressions.

PubMed

Fan, Ruzong; Wang, Yifan; Yan, Qi; Ding, Ying; Weeks, Daniel E; Lu, Zhaohui; Ren, Haobo; Cook, Richard J; Xiong, Momiao; Swaroop, Anand; Chew, Emily Y; Chen, Wei

2016-02-01

Genetic studies of survival outcomes have been proposed and conducted recently, but statistical methods for identifying genetic variants that affect disease progression are rarely developed. Motivated by our ongoing real studies, here we develop Cox proportional hazard models using functional regression (FR) to perform gene-based association analysis of survival traits while adjusting for covariates. The proposed Cox models are fixed effect models where the genetic effects of multiple genetic variants are assumed to be fixed. We introduce likelihood ratio test (LRT) statistics to test for associations between the survival traits and multiple genetic variants in a genetic region. Extensive simulation studies demonstrate that the proposed Cox RF LRT statistics have well-controlled type I error rates. To evaluate power, we compare the Cox FR LRT with the previously developed burden test (BT) in a Cox model and sequence kernel association test (SKAT), which is based on mixed effect Cox models. The Cox FR LRT statistics have higher power than or similar power as Cox SKAT LRT except when 50%/50% causal variants had negative/positive effects and all causal variants are rare. In addition, the Cox FR LRT statistics have higher power than Cox BT LRT. The models and related test statistics can be useful in the whole genome and whole exome association studies. An age-related macular degeneration dataset was analyzed as an example. © 2016 WILEY PERIODICALS, INC.

Gene-based Association Analysis for Censored Traits Via Fixed Effect Functional Regressions

PubMed Central

Fan, Ruzong; Wang, Yifan; Yan, Qi; Ding, Ying; Weeks, Daniel E.; Lu, Zhaohui; Ren, Haobo; Cook, Richard J; Xiong, Momiao; Swaroop, Anand; Chew, Emily Y.; Chen, Wei

2015-01-01

Summary Genetic studies of survival outcomes have been proposed and conducted recently, but statistical methods for identifying genetic variants that affect disease progression are rarely developed. Motivated by our ongoing real studies, we develop here Cox proportional hazard models using functional regression (FR) to perform gene-based association analysis of survival traits while adjusting for covariates. The proposed Cox models are fixed effect models where the genetic effects of multiple genetic variants are assumed to be fixed. We introduce likelihood ratio test (LRT) statistics to test for associations between the survival traits and multiple genetic variants in a genetic region. Extensive simulation studies demonstrate that the proposed Cox RF LRT statistics have well-controlled type I error rates. To evaluate power, we compare the Cox FR LRT with the previously developed burden test (BT) in a Cox model and sequence kernel association test (SKAT) which is based on mixed effect Cox models. The Cox FR LRT statistics have higher power than or similar power as Cox SKAT LRT except when 50%/50% causal variants had negative/positive effects and all causal variants are rare. In addition, the Cox FR LRT statistics have higher power than Cox BT LRT. The models and related test statistics can be useful in the whole genome and whole exome association studies. An age-related macular degeneration dataset was analyzed as an example. PMID:26782979

Evaluation of anterior knee pain in a PS total knee arthroplasty: the role of patella-friendly femoral component and patellar size.

PubMed

Atzori, F; Sabatini, L; Deledda, D; Schirò, M; Lo Baido, R; Baido, R L; Massè, A

2015-04-01

Total knee arthroplasty gives excellent objective results. Nevertheless, the subjective findings do not match the normal knee perception: Often, it depends on patellar pain onset. In this study, we analyzed clinical and radiological items that can affect resurfaced patellar tracking, and role of a patella-friendly femoral component and patellar size on patellar pain onset. Thirty consecutive patients were implanted using the same-cemented posterior-stabilized TKA associated with patella resurfacing. Fifteen patients were implanted using a classical femoral component, while another 15 patients were implanted using a patella-friendly femoral component. The statistical analysis was set to detect a significant difference (p < 0.05) in clinical and radiological outcomes related to several surgical parameters. Clinical and functional outcomes were recorded using the Knee Society Scoring System (KSS) and patellar pain with the Burnett questionnaire. Mean follow-up was 25 months. KSS results were excellent in both groups. Group 2 (patella-friendly femoral model) reached a higher percentage of 100 points in the clinical and functional KSS, but there was no statistical difference. Also, no statistical differences for Burnett Questionnaire results were recorded. We had one case of patellar clunk syndrome in the standard femoral component group and one poor result in the second group. Postoperative radiographic measurements evidenced no statistical differences in both groups. In group 1 (classical femoral component), better significant result (p < 0.05) war recorded at clinical evaluation according to the Knee Society Scoring System (KSS) in case of wider patellar component resurfaced. The present study reveals no statistically significant difference in the incidence of anterior knee pain between classical and "patella-friendly" femoral components. With the particular type of implant design utilized in this study, when the classical femoral component is used, bigger patellar implant sizes (38 and 41 mm) showed superior clinical outcome.

ICSI Outcome in Infertile Couples with Different Causes of Infertility: A Cross-Sectional Study.

PubMed

Ashrafi, Mahnaz; Jahanian Sadatmahalleh, Shahideh; Akhoond, Mohammad Reza; Ghaffari, Firouzeh; Zolfaghari, Zahra

2013-07-01

Different success rate of Intracytoplasmic Sperm injection (ICSI) has been observed in various causes of infertility. In this study, we evaluated the relation between ICSI outcome and different causes of infertility. We also aimed to examine parameters that might predict the pregnancy success rate following ICSI. This cross sectional study included1492 infertile women referred to Infertility Center of Royan Institute between 2010 and 2011. We assigned two groups including pregnant (n=504) and non-pregnant (n=988), while all participants underwent ICSI cycles. All statistics were performed by SPSS program. Statistical Analysis was carried out using Chi-square and t test. Logistic regression was done to build a prediction model in ICSI cycles. The overall clinical pregnancy rate in our study was 33.9% (n=1492). There was a statistically significant difference in mean serum concentration on day 3 after application of luteinizing hormone (LH) between the pregnant and the non-pregnant groups (p<0.05). However, There were no significant differences between two groups in the serum concentrations on day 3 after application of the following hormones: folliclestimulating hormone (FSH), thyroid-stimulating hormone (TSH), and metoclopramidestimulated prolactin (PRL) . We found no association between different causes of infertility and clinical outcomes . The number of metaphase II (MII) oocytes, embryo transfer, number of good embryo (grade A, B, AB), total dose of gonadotropin, endometrial thickness, maternal age, number of previous cycle were statistically significant between two groups (p<0.05). Our results indicate that ICSI in an effective option in couples with different causes of infertility. These variables were integrated into a statistical model to allow the prediction for the chance of pregnancy following ICSI cycles. It is required that each infertility center gather enough information about the causes of infertility in order to provide more information and better assistance to patients. Therefore, we suggest that physicians prepare adequate training and required information regarding these procedures for infertile couples in order to improve their knowledge.

Learning curves for single incision and conventional laparoscopic right hemicolectomy: a multidimensional analysis.

PubMed

Park, Yoonah; Yong, Yuen Geng; Yun, Seong Hyeon; Jung, Kyung Uk; Huh, Jung Wook; Cho, Yong Beom; Kim, Hee Cheol; Lee, Woo Yong; Chun, Ho-Kyung

2015-05-01

This study aimed to compare the learning curves and early postoperative outcomes for conventional laparoscopic (CL) and single incision laparoscopic (SIL) right hemicolectomy (RHC). This retrospective study included the initial 35 cases in each group. Learning curves were evaluated by the moving average of operative time, mean operative time of every five consecutive cases, and cumulative sum (CUSUM) analysis. The learning phase was considered overcome when the moving average of operative times reached a plateau, and when the mean operative time of every five consecutive cases reached a low point and subsequently did not vary by more than 30 minutes. Six patients with missing data in the CL RHC group were excluded from the analyses. According to the mean operative time of every five consecutive cases, learning phase of SIL and CL RHC was completed between 26 and 30 cases, and 16 and 20 cases, respectively. Moving average analysis revealed that approximately 31 (SIL) and 25 (CL) cases were needed to complete the learning phase, respectively. CUSUM analysis demonstrated that 10 (SIL) and two (CL) cases were required to reach a steady state of complication-free performance, respectively. Postoperative complications rate was higher in SIL than in CL group, but the difference was not statistically significant (17.1% vs. 3.4%). The learning phase of SIL RHC is longer than that of CL RHC. Early oncological outcomes of both techniques were comparable. However, SIL RHC had a statistically insignificant higher complication rate than CL RHC during the learning phase.

Improving information retrieval in functional analysis.

PubMed

Rodriguez, Juan C; González, Germán A; Fresno, Cristóbal; Llera, Andrea S; Fernández, Elmer A

2016-12-01

Transcriptome analysis is essential to understand the mechanisms regulating key biological processes and functions. The first step usually consists of identifying candidate genes; to find out which pathways are affected by those genes, however, functional analysis (FA) is mandatory. The most frequently used strategies for this purpose are Gene Set and Singular Enrichment Analysis (GSEA and SEA) over Gene Ontology. Several statistical methods have been developed and compared in terms of computational efficiency and/or statistical appropriateness. However, whether their results are similar or complementary, the sensitivity to parameter settings, or possible bias in the analyzed terms has not been addressed so far. Here, two GSEA and four SEA methods and their parameter combinations were evaluated in six datasets by comparing two breast cancer subtypes with well-known differences in genetic background and patient outcomes. We show that GSEA and SEA lead to different results depending on the chosen statistic, model and/or parameters. Both approaches provide complementary results from a biological perspective. Hence, an Integrative Functional Analysis (IFA) tool is proposed to improve information retrieval in FA. It provides a common gene expression analytic framework that grants a comprehensive and coherent analysis. Only a minimal user parameter setting is required, since the best SEA/GSEA alternatives are integrated. IFA utility was demonstrated by evaluating four prostate cancer and the TCGA breast cancer microarray datasets, which showed its biological generalization capabilities. Copyright © 2016 Elsevier Ltd. All rights reserved.

Preoperative Toxoplasma gondii serostatus does not affect long-term survival of cardiac transplant recipients. Analysis of the Spanish Heart Transplantation Registry.

PubMed

Barge-Caballero, Eduardo; Almenar-Bonet, Luis; Crespo-Leiro, María G; Brossa-Loidi, Vicens; Rangel-Sousa, Diego; Gómez-Bueno, Manuel; Farrero-Torres, Marta; Díaz-Molina, Beatriz; Delgado-Jiménez, Juan; Martínez-Sellés, Manuel; López-Granados, Amador; De-la-Fuente-Galán, Luis; González-Costello, José; Garrido-Bravo, Iris P; Blasco-Peiró, Teresa; Rábago-Juan-Aracil, Gregorio; González-Vílchez, Francisco

2018-01-01

It's unclear whether pre-transplant T. gondii seropositivity is associated with impaired survival in heart transplant recipients. To test the above-mentioned hypothesis in the Spanish Heart Transplantation Registry. Post-transplant outcomes of 4048 patients aged >16years who underwent first, single-organ heart transplantation in 17 Spanish institutions from 1984 to 2014 were studied. Long-term post-transplant survival and survival free of cardiac death or retransplantation of 2434 (60%) T. gondii seropositive recipients and 1614 (40%) T. gondii seronegative recipients were compared. T. gondii seropositive recipients were older, had higher body mass index, and presented higher prevalence of hypertension, hypercholesterolemia, COPD and Cytomegalovirus seropositivity than T. gondii seronegative recipients. In univariable analysis, pre-transplant T. gondii seropositivity was associated with increased post-transplant all-cause mortality (non-adjusted HR 1.15; 95% CI 1.04-1.26). However, this effect was no longer statistically significant after multivariable adjustment by recipient's age and sex (adjusted HR 1.01, 95% CI 0.92-1.11). Extended multivariable adjustment by other potential confounders showed similar results (adjusted HR 0.99, 95% CI 0.89-1.11). T. gondii seropositivity had no significant effect on the composite outcome cardiac death or retransplantation (non-adjusted HR 1.08, 95% CI 0.95-1.24, p=0.235). The distribution of the causes of death was comparable in T. gondii seropositive and T. gondii seronegative recipients. No statistically significant impact of donor's T. gondii serostatus or donor-recipient T. gondii serostatus matching on post-transplant survival was observed. Our analysis did not show a significant independent effect of preoperative T. gondii serostatus on long-term outcomes after heart transplantation. Copyright © 2017 Elsevier B.V. All rights reserved.

Surgical resident supervision in the operating room and outcomes of care in Veterans Affairs hospitals.

PubMed

Itani, Kamal M F; DePalma, Ralph G; Schifftner, Tracy; Sanders, Karen M; Chang, Barbara K; Henderson, William G; Khuri, Shukri F

2005-11-01

There has been concern that a reduced level of surgical resident supervision in the operating room (OR) is correlated with worse patient outcomes. Until September 2004, Veterans' Affairs (VA) hospitals entered in the surgical record level 3 supervision on every surgical case when the attending physician was available but not physically present in the OR or the OR suite. In this study, we assessed the impact of level 3 on risk-adjusted morbidity and mortality in the VA system. Surgical cases entered into the National Surgical Quality Improvement Program database between 1998 and 2004, from 99 VA teaching facilities, were included in a logistic regression analysis for each year. Level 3 versus all other levels of supervision were forced into the model, and patient characteristics then were selected stepwise to arrive at a final model. Confidence limits for the odds ratios were calculated by profile likelihood. A total of 610,660 cases were available for analysis. Thirty-day mortality and morbidity rates were reported in 14,441 (2.36%) and 63,079 (10.33%) cases, respectively. Level 3 supervision decreased from 8.72% in 1998 to 2.69% in 2004. In the logistic regression analysis, the odds ratios for mortality for level 3 ranged from .72 to 1.03. Only in the year 2000 were the odds ratio for mortality statistically significant at the .05 level (odds ratio, .72; 95% confidence interval, .594-.858). For morbidity, the odds ratios for level 3 supervision ranged from .66 to 1.01, and all odds ratios except for the year 2004 were statistically significant. Between 1998 and 2004, the level of resident supervision in the OR did not affect clinical outcomes adversely for surgical patients in the VA teaching hospitals.

Suture, synthetic, or biologic in contaminated ventral hernia repair.

PubMed

Bondre, Ioana L; Holihan, Julie L; Askenasy, Erik P; Greenberg, Jacob A; Keith, Jerrod N; Martindale, Robert G; Roth, J Scott; Liang, Mike K

2016-02-01

Data are lacking to support the choice between suture, synthetic mesh, or biologic matrix in contaminated ventral hernia repair (VHR). We hypothesize that in contaminated VHR, suture repair is associated with the lowest rate of surgical site infection (SSI). A multicenter database of all open VHR performed at from 2010-2011 was reviewed. All patients with follow-up of 1 mo and longer were included. The primary outcome was SSI as defined by the Centers for Disease Control and Prevention. The secondary outcome was hernia recurrence (assessed clinically or radiographically). Multivariate analysis (stepwise regression for SSI and Cox proportional hazard model for recurrence) was performed. A total of 761 VHR were reviewed for a median (range) follow-up of 15 (1-50) mo: there were 291(38%) suture, 303 (40%) low-density and/or mid-density synthetic mesh, and 167(22%) biologic matrix repair. On univariate analysis, there were differences in the three groups including ethnicity, ASA, body mass index, institution, diabetes, primary versus incisional hernia, wound class, hernia size, prior VHR, fascial release, skin flaps, and acute repair. The unadjusted outcomes for SSI (15.1%; 17.8%; 21.0%; P = 0.280) and recurrence (17.8%; 13.5%; 21.5%; P = 0.074) were not statistically different between groups. On multivariate analysis, biologic matrix was associated with a nonsignificant reduction in both SSI and recurrences, whereas synthetic mesh associated with fewer recurrences compared to suture (hazard ratio = 0.60; P = 0.015) and nonsignificant increase in SSI. Interval estimates favored biologic matrix repair in contaminated VHR; however, these results were not statistically significant. In the absence of higher level evidence, surgeons should carefully balance risk, cost, and benefits in managing contaminated ventral hernia repair. Copyright © 2016 Elsevier Inc. All rights reserved.

Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis.

PubMed

Lewis, G N; Rice, D A; McNair, P J; Kluger, M

2015-04-01

Several studies have identified clinical, psychosocial, patient characteristic, and perioperative variables that are associated with persistent postsurgical pain; however, the relative effect of these variables has yet to be quantified. The aim of the study was to provide a systematic review and meta-analysis of predictor variables associated with persistent pain after total knee arthroplasty (TKA). Included studies were required to measure predictor variables prior to or at the time of surgery, include a pain outcome measure at least 3 months post-TKA, and include a statistical analysis of the effect of the predictor variable(s) on the outcome measure. Counts were undertaken of the number of times each predictor was analysed and the number of times it was found to have a significant relationship with persistent pain. Separate meta-analyses were performed to determine the effect size of each predictor on persistent pain. Outcomes from studies implementing uni- and multivariable statistical models were analysed separately. Thirty-two studies involving almost 30 000 patients were included in the review. Preoperative pain was the predictor that most commonly demonstrated a significant relationship with persistent pain across uni- and multivariable analyses. In the meta-analyses of data from univariate models, the largest effect sizes were found for: other pain sites, catastrophizing, and depression. For data from multivariate models, significant effects were evident for: catastrophizing, preoperative pain, mental health, and comorbidities. Catastrophizing, mental health, preoperative knee pain, and pain at other sites are the strongest independent predictors of persistent pain after TKA. © The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial.

PubMed

Kieburtz, Karl; Tilley, Barbara C; Elm, Jordan J; Babcock, Debra; Hauser, Robert; Ross, G Webster; Augustine, Alicia H; Augustine, Erika U; Aminoff, Michael J; Bodis-Wollner, Ivan G; Boyd, James; Cambi, Franca; Chou, Kelvin; Christine, Chadwick W; Cines, Michelle; Dahodwala, Nabila; Derwent, Lorelei; Dewey, Richard B; Hawthorne, Katherine; Houghton, David J; Kamp, Cornelia; Leehey, Maureen; Lew, Mark F; Liang, Grace S Lin; Luo, Sheng T; Mari, Zoltan; Morgan, John C; Parashos, Sotirios; Pérez, Adriana; Petrovitch, Helen; Rajan, Suja; Reichwein, Sue; Roth, Jessie Tatsuno; Schneider, Jay S; Shannon, Kathleen M; Simon, David K; Simuni, Tanya; Singer, Carlos; Sudarsky, Lewis; Tanner, Caroline M; Umeh, Chizoba C; Williams, Karen; Wills, Anne-Marie

2015-02-10

There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies. To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease. The Long-term Study 1, a multicenter, double-blind, parallel-group, placebo-controlled, 1:1 randomized efficacy trial. Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) Parkinson disease. Participants were enrolled from March 2007 to May 2010 and followed up until September 2013. Participants were randomized to placebo or creatine (10 g/d) monohydrate for a minimum of 5 years (maximum follow-up, 8 years). The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up, compared between the 2 treatment groups using a global statistical test. Clinical status was defined by 5 outcome measures: Modified Rankin Scale, Symbol Digit Modalities Test, PDQ-39 Summary Index, Schwab and England Activities of Daily Living scale, and ambulatory capacity. All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test. Higher summed ranks (range, 5-4775) indicate worse outcomes. The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis (n = 955). The median follow-up time was 4 years. Of the 955 participants, the mean of the summed ranks for placebo was 2360 (95% CI, 2249-2470) and for creatine was 2414 (95% CI, 2304-2524). The global statistical test yielded t1865.8 = -0.75 (2-sided P = .45). There were no detectable differences (P < .01 to partially adjust for multiple comparisons) in adverse and serious adverse events by body system. Among patients with early and treated Parkinson disease, treatment with creatine monohydrate for at least 5 years, compared with placebo did not improve clinical outcomes. These findings do not support the use of creatine monohydrate in patients with Parkinson disease. clinicaltrials.gov Identifier: NCT00449865.

Choice Experiments to Quantify Preferences for Health and Healthcare: State of the Practice.

PubMed

Mühlbacher, Axel; Johnson, F Reed

2016-06-01

Stated-preference methods increasingly are used to quantify preferences in health economics, health technology assessment, benefit-risk analysis and health services research. The objective of stated-preference studies is to acquire information about trade-off preferences among treatment outcomes, prioritization of clinical decision criteria, likely uptake or adherence to healthcare products and acceptability of healthcare services or policies. A widely accepted approach to eliciting preferences is discrete-choice experiments. Patient, physician, insurant or general-public respondents choose among constructed, experimentally controlled alternatives described by decision-relevant features or attributes. Attributes can represent complete health states, sets of treatment outcomes or characteristics of a healthcare system. The observed pattern of choice reveals how different respondents or groups of respondents implicitly weigh, value and assess different characteristics of treatments, products or services. An important advantage of choice experiments is their foundation in microeconomic utility theory. This conceptual framework provides tests of internal validity, guidance for statistical analysis of latent preference structures, and testable behavioural hypotheses. Choice experiments require expertise in survey-research methods, random-utility theory, experimental design and advanced statistical analysis. This paper should be understood as an introduction to setting up a basic experiment rather than an exhaustive critique of the latest findings and procedures. Where appropriate, we have identified topics of active research where a broad consensus has not yet been established.

Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.

PubMed

Ovesen, Christian; Jakobsen, Janus Christian; Gluud, Christian; Steiner, Thorsten; Law, Zhe; Flaherty, Katie; Dineen, Rob A; Bath, Philip M; Sprigg, Nikola; Christensen, Hanne

2018-06-13

We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status. Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

Development and optimization of SPECT gated blood pool cluster analysis for the prediction of CRT outcome.

PubMed

Lalonde, Michel; Wells, R Glenn; Birnie, David; Ruddy, Terrence D; Wassenaar, Richard

2014-07-01

Phase analysis of single photon emission computed tomography (SPECT) radionuclide angiography (RNA) has been investigated for its potential to predict the outcome of cardiac resynchronization therapy (CRT). However, phase analysis may be limited in its potential at predicting CRT outcome as valuable information may be lost by assuming that time-activity curves (TAC) follow a simple sinusoidal shape. A new method, cluster analysis, is proposed which directly evaluates the TACs and may lead to a better understanding of dyssynchrony patterns and CRT outcome. Cluster analysis algorithms were developed and optimized to maximize their ability to predict CRT response. About 49 patients (N = 27 ischemic etiology) received a SPECT RNA scan as well as positron emission tomography (PET) perfusion and viability scans prior to undergoing CRT. A semiautomated algorithm sampled the left ventricle wall to produce 568 TACs from SPECT RNA data. The TACs were then subjected to two different cluster analysis techniques, K-means, and normal average, where several input metrics were also varied to determine the optimal settings for the prediction of CRT outcome. Each TAC was assigned to a cluster group based on the comparison criteria and global and segmental cluster size and scores were used as measures of dyssynchrony and used to predict response to CRT. A repeated random twofold cross-validation technique was used to train and validate the cluster algorithm. Receiver operating characteristic (ROC) analysis was used to calculate the area under the curve (AUC) and compare results to those obtained for SPECT RNA phase analysis and PET scar size analysis methods. Using the normal average cluster analysis approach, the septal wall produced statistically significant results for predicting CRT results in the ischemic population (ROC AUC = 0.73;p < 0.05 vs. equal chance ROC AUC = 0.50) with an optimal operating point of 71% sensitivity and 60% specificity. Cluster analysis results were similar to SPECT RNA phase analysis (ROC AUC = 0.78, p = 0.73 vs cluster AUC; sensitivity/specificity = 59%/89%) and PET scar size analysis (ROC AUC = 0.73, p = 1.0 vs cluster AUC; sensitivity/specificity = 76%/67%). A SPECT RNA cluster analysis algorithm was developed for the prediction of CRT outcome. Cluster analysis results produced results equivalent to those obtained from Fourier and scar analysis.

Development and optimization of SPECT gated blood pool cluster analysis for the prediction of CRT outcome

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lalonde, Michel, E-mail: mlalonde15@rogers.com; Wassenaar, Richard; Wells, R. Glenn

2014-07-15

Purpose: Phase analysis of single photon emission computed tomography (SPECT) radionuclide angiography (RNA) has been investigated for its potential to predict the outcome of cardiac resynchronization therapy (CRT). However, phase analysis may be limited in its potential at predicting CRT outcome as valuable information may be lost by assuming that time-activity curves (TAC) follow a simple sinusoidal shape. A new method, cluster analysis, is proposed which directly evaluates the TACs and may lead to a better understanding of dyssynchrony patterns and CRT outcome. Cluster analysis algorithms were developed and optimized to maximize their ability to predict CRT response. Methods: Aboutmore » 49 patients (N = 27 ischemic etiology) received a SPECT RNA scan as well as positron emission tomography (PET) perfusion and viability scans prior to undergoing CRT. A semiautomated algorithm sampled the left ventricle wall to produce 568 TACs from SPECT RNA data. The TACs were then subjected to two different cluster analysis techniques, K-means, and normal average, where several input metrics were also varied to determine the optimal settings for the prediction of CRT outcome. Each TAC was assigned to a cluster group based on the comparison criteria and global and segmental cluster size and scores were used as measures of dyssynchrony and used to predict response to CRT. A repeated random twofold cross-validation technique was used to train and validate the cluster algorithm. Receiver operating characteristic (ROC) analysis was used to calculate the area under the curve (AUC) and compare results to those obtained for SPECT RNA phase analysis and PET scar size analysis methods. Results: Using the normal average cluster analysis approach, the septal wall produced statistically significant results for predicting CRT results in the ischemic population (ROC AUC = 0.73;p < 0.05 vs. equal chance ROC AUC = 0.50) with an optimal operating point of 71% sensitivity and 60% specificity. Cluster analysis results were similar to SPECT RNA phase analysis (ROC AUC = 0.78, p = 0.73 vs cluster AUC; sensitivity/specificity = 59%/89%) and PET scar size analysis (ROC AUC = 0.73, p = 1.0 vs cluster AUC; sensitivity/specificity = 76%/67%). Conclusions: A SPECT RNA cluster analysis algorithm was developed for the prediction of CRT outcome. Cluster analysis results produced results equivalent to those obtained from Fourier and scar analysis.« less

Systematic review of practice guideline dissemination and implementation strategies for healthcare teams and team-based practice.

PubMed

Medves, Jennifer; Godfrey, Christina; Turner, Carly; Paterson, Margo; Harrison, Margaret; MacKenzie, Lindsay; Durando, Paola

2010-06-01

To synthesis the literature relevant to guideline dissemination and implementation strategies for healthcare teams and team-based practice. Systematic approach utilising Joanna Briggs Institute methods. Two reviewers screened all articles and where there was disagreement, a third reviewer determined inclusion. Initial search revealed 12,083 of which 88 met the inclusion criteria. Ten dissemination and implementation strategies identified with distribution of educational materials the most common. Studies were assessed for patient or practitioner outcomes and changes in practice, knowledge and economic outcomes. A descriptive analysis revealed multiple approaches using teams of healthcare providers were reported to have statistically significant results in knowledge, practice and/or outcomes for 72.7% of the studies. Team-based care using practice guidelines locally adapted can affect positively patient and provider outcomes. © 2010 The Authors. Journal Compilation © Blackwell Publishing Asia Pty Ltd.

Guidelines for the Investigation of Mediating Variables in Business Research.

PubMed

MacKinnon, David P; Coxe, Stefany; Baraldi, Amanda N

2012-03-01

Business theories often specify the mediating mechanisms by which a predictor variable affects an outcome variable. In the last 30 years, investigations of mediating processes have become more widespread with corresponding developments in statistical methods to conduct these tests. The purpose of this article is to provide guidelines for mediation studies by focusing on decisions made prior to the research study that affect the clarity of conclusions from a mediation study, the statistical models for mediation analysis, and methods to improve interpretation of mediation results after the research study. Throughout this article, the importance of a program of experimental and observational research for investigating mediating mechanisms is emphasized.

Pregnancy outcomes in women with inflammatory bowel disease following exposure to thiopurines and antitumor necrosis factor drugs: a systematic review with meta-analysis.

PubMed

Mozaffari, S; Abdolghaffari, A H; Nikfar, S; Abdollahi, M

2015-05-01

Several studies have indicated the harmful effect of flare-up periods in pregnant women with inflammatory bowel disease (IBD) on their newborns. Therefore, an effective and safe medical treatment during pregnancy is of great concern in IBD patients. The aim of this study was to perform a meta-analysis on the outcomes of thiopurines use and a systematic review of antitumor necrosis factor (anti-TNF) drugs used during pregnancy in women with IBD. The results of cohorts evaluating the safety of anti-TNF drugs during pregnancy up to July 2013 were collected and analyzed. In the meta-analysis, a total of 312 pregnant women with IBD who used thiopurines were compared with 1149 controls (women with IBD who were not treated with any medication and women who were exposed to drugs other than thiopurines) to evaluate the drug effect on different pregnancy outcomes, including prematurity, low birth weight, congenital abnormalities, spontaneous abortion, and neonatal adverse outcomes. Results of statistical analysis demonstrated that congenital abnormalities were increased significantly in thiopurine-exposed group in comparison with control group who did not receive any medicine for IBD treatment. The summary odds ratio was 2.95 with 95% confidence interval = 1.03-8.43 (p = 0.04). We observed no significant differences in occurrence of other adverse pregnancy outcomes between compared groups. The results of cohorts evaluated the safety of anti-TNF drugs during pregnancy demonstrated no increase in occurrence of adverse pregnancy outcomes in comparison with controls except for the significant decrease in gestational age of newborns of drug-exposed mothers in one trial. In conclusion, a benefit-risk ratio should be considered in prescribing or continuing medicinal therapy during pregnancy of IBD patients. © The Author(s) 2014.

Functional outcomes of laminectomy and laminotomy for the surgical management lumbar spine stenosis.

PubMed

Williams, Mark G; Wafai, Ahmad M; Podmore, Malcolm D

2017-12-01

This clinical descriptive study aims to establish if differences exist in functional outcomes, to include both leg and lower back pain (LBP) as well as disability, in patients undergoing laminectomy or laminotomy surgery for lumbar spinal stenosis (LSS). We conducted a single centre, prospective study of 119 patients undergoing laminectomy or laminotomy surgery for LSS, from 2006 and 2012. Clinical outcomes for back and leg pain were analyses using Oswestry Disability Index (ODI) questionnaires and visual analogue scale (VAS) scores collected preoperatively, at 6 weeks and 1 year. Further analysis subdivided patients into two groups based on initial LBP VAS scores. Fifty-five percent of patients were females (n=65) and 45% males (n=54), with a mean age of 68.7 years and L4/5 being the level most frequently decompressed. Considering all surgeries, a statistically significant reduction in VAS back pain between pre-op and 6 weeks was seen (4.99 to 3.00, P<0.001). There was a significant (P<0.0001) average reductions in LBP by 1.66 units and leg pain by 3.33 units after 1 year, with minimal difference between laminectomy and laminotomy. In the VAS back ≥5 group, laminectomy patient's pain increased by 0.63 units between 6 weeks and 1 year whilst laminotomy patients experienced a reduction in back pain of 0.51 units (P=0.063). ODI scores significantly improved for laminectomy and laminotomy by an average of 19.1%, 95% CI: 13.4-24.9% and 10.8%, 95% CI: 5.8-15.7%, with no statistically significant difference between groups. No statistically significant differences were demonstrated between laminectomy and laminotomy outcomes, for LBP, leg pain or disability in our institute. On the basis of functional outcomes laminectomy remains a feasible approach in the treatment of lumbar spine stenosis. The data presented in this manuscript provides frequency data for subsequent comparative studies.

Prognostic significance of electrical alternans versus signal averaged electrocardiography in predicting the outcome of electrophysiological testing and arrhythmia-free survival

NASA Technical Reports Server (NTRS)

Armoundas, A. A.; Rosenbaum, D. S.; Ruskin, J. N.; Garan, H.; Cohen, R. J.

1998-01-01

OBJECTIVE: To investigate the accuracy of signal averaged electrocardiography (SAECG) and measurement of microvolt level T wave alternans as predictors of susceptibility to ventricular arrhythmias. DESIGN: Analysis of new data from a previously published prospective investigation. SETTING: Electrophysiology laboratory of a major referral hospital. PATIENTS AND INTERVENTIONS: 43 patients, not on class I or class III antiarrhythmic drug treatment, undergoing invasive electrophysiological testing had SAECG and T wave alternans measurements. The SAECG was considered positive in the presence of one (SAECG-I) or two (SAECG-II) of three standard criteria. T wave alternans was considered positive if the alternans ratio exceeded 3.0. MAIN OUTCOME MEASURES: Inducibility of sustained ventricular tachycardia or fibrillation during electrophysiological testing, and 20 month arrhythmia-free survival. RESULTS: The accuracy of T wave alternans in predicting the outcome of electrophysiological testing was 84% (p < 0.0001). Neither SAECG-I (accuracy 60%; p < 0.29) nor SAECG-II (accuracy 71%; p < 0.10) was a statistically significant predictor of electrophysiological testing. SAECG, T wave alternans, electrophysiological testing, and follow up data were available in 36 patients while not on class I or III antiarrhythmic agents. The accuracy of T wave alternans in predicting the outcome of arrhythmia-free survival was 86% (p < 0.030). Neither SAECG-I (accuracy 65%; p < 0.21) nor SAECG-II (accuracy 71%; p < 0.48) was a statistically significant predictor of arrhythmia-free survival. CONCLUSIONS: T wave alternans was a highly significant predictor of the outcome of electrophysiological testing and arrhythmia-free survival, while SAECG was not a statistically significant predictor. Although these results need to be confirmed in prospective clinical studies, they suggest that T wave alternans may serve as a non-invasive probe for screening high risk populations for malignant ventricular arrhythmias.

Predicting Team Performance through Human Behavioral Sensing and Quantitative Workflow Instrumentation

DTIC Science & Technology

2016-07-27

make risk-informed decisions during serious games . Statistical models of intra- game performance were developed to determine whether behaviors in...specific facets of the gameplay workflow were predictive of analytical performance and games outcomes. A study of over seventy instrumented teams revealed...more accurate game decisions. 2 Keywords: Humatics · Serious Games · Human-System Interaction · Instrumentation · Teamwork · Communication Analysis

Risk factors for hydrocephalus and neurological deficit in children born with an encephalocele.

PubMed

Da Silva, Stephanie L; Jeelani, Yasser; Dang, Ha; Krieger, Mark D; McComb, J Gordon

2015-04-01

There is a known association of hydrocephalus with encephaloceles. Risk factors for hydrocephalus and neurological deficit were ascertained in a series of patients born with an encephalocele. A retrospective analysis was undertaken of patients treated for encephaloceles at Children's Hospital Los Angeles between 1994 and 2012. The following factors were evaluated for their prognostic value: age at presentation, sex, location of encephalocele, size, contents, microcephaly, presence of hydrocephalus, CSF leak, associated cranial anomalies, and neurological outcome. Seventy children were identified, including 38 girls and 32 boys. The median age at presentation was 2 months. The mean follow-up duration was 3.7 years. Encephalocele location was classified as anterior (n = 14) or posterior (n = 56) to the coronal suture. The average maximum encephalocele diameter was 4 cm (range 0.5-23 cm). Forty-seven encephaloceles contained neural tissue. Eight infants presented at birth with CSF leaking from the encephalocele, with 1 being infected. Six patients presented with hydrocephalus, while 11 developed progressive hydrocephalus postoperatively. On univariate analysis, the presence of neural tissue, cranial anomalies, encephalocele size of at least 2 cm, seizure disorder, and microcephaly were each positively associated with hydrocephalus. On multivariate logistic regression modeling, the single prognostic factor for hydrocephalus of borderline statistical significance was the presence of neural tissue (odds ratio [OR] = 5.8, 95% confidence interval [CI] = 0.8-74.0). Fourteen patients had severe developmental delay, 28 had mild/moderate delay, and 28 were neurologically normal. On univariate analysis, the presence of cranial anomalies, larger size of encephalocele, hydrocephalus, and microcephaly were positively associated with neurological deficit. In the multivariable model, the only statistically significant prognostic factor for neurological deficit was presence of hydrocephalus (OR 17.2, 95% CI 1.7-infinity). In multivariate models, the presence of neural tissue was borderline significantly associated with hydrocephalus and the presence of hydrocephalus was significantly associated with neurological deficit. The location of the encephalocele did not have a statistically significant association with incidence of hydrocephalus or neurological deficit. In contrast to modestly good/fair neurological outcome in children with an encephalocele without hydrocephalus, the presence of hydrocephalus resulted in a far worse neurological outcome.

Characteristics and treatment outcomes of patients with multi-drug resistant tuberculosis at a tertiary care hospital in Peshawar, Pakistan

PubMed Central

Khan, Mazhar A.; Mehreen, Sumaira; Basit, Anila; Khan, Raza A.; Jan, Faheem; Ullah, Irfan; Ihtesham, Muhammad; Khan, Afsar; Ullah, Ubaid; Javaid, Arshad

2015-01-01

Objectives: To determine characteristics and treatment outcomes of multidrugs resistant tuberculosis (MDR-TB) patients and risk factors for poor outcomes in MDR-TB patients in a tertiary care hospital in Peshawar, Pakistan. Methods: This retrospective study was conducted at the Programmatic Management of Drug Resistant TB Unit, Lady Reading Hospital Peshawar, Pakistan and included all MDR-TB patients registered between January 2012 and December 2012. A special proforma was used for data collection. Analysis was performed using SPSS version 16, after exporting data from the proforma. Differences in proportions were assessed using Pearson’s Chi square test whereas for predictors of poor outcomes, multivariate logistic regression analysis with Wald Statistical criteria using backward elimination method was performed. Results: The treatment success rate was 74.3%. In univariate analysis, poor outcomes were associated in patients with age ≥44 years (odds ratio [OR]=0.250; 95% confidence interval [CI]: 0.114-0.519, p=0.001), rural residence (OR=0.417; 95% CI: 0.18-0.937, p=0.03), lung cavitation (OR=0.22; 95% CI, 0.007-0.067, p=0.001), resistance to second line drugs (SLD) (OR=3.441; 95% CI: 1.579-7.497, p=0.001), and resistance to ofloxacin (OR=2.944; 95% CI: 1.361-6.365, p=0.005); whereas multivariate logistic regression analysis, poor outcomes were associated in patients with age ≥44 years (OR=0.249, 95% CI: 0.075-0.828, p=0.023), rural residence (OR=0.143, 95% CI: 0.052-0.774, p=0.032), and cavitatory lungs (OR=0.022, 95% CI: 0.007-0.072, p=0.000). Conclusion: The MDR-TB patient needs special attention for better treatment outcomes. The presence of older age, rural area residence, resistance to ofloxacin, SLD resistance, and cavitary disease are independent prognostic factors for poor outcome in patients with MDR-TB. PMID:26620989

Impact of the 80-hour work week on mortality and morbidity in trauma patients: an analysis of the National Trauma Data Bank.

PubMed

Morrison, C Anne; Wyatt, Matthew M; Carrick, Matthew M

2009-06-01

The implementation of the 80-h work week restrictions implemented by the Accreditation Council for Graduate Medical Education (ACGME) in July 2003 were intended, in part, to improve patient outcomes by reducing fatigue-related resident errors. Although concerns were raised regarding the possibility for increased error due to decreased continuity of patient care, recent studies have shown no significant change in mortality or complication rates since the onset of these new restrictions. This study is the first to examine the effects of the 80-h work week on mortality in trauma patients on a national level. Data were obtained from the National Trauma Data Bank (NTDB) version 6.2 from 1994 to 2005. Data were then divided into two groups: "pre-80-h work week" (2001-2002) and "post-80-h work week" (2004-2005). Because the ACGME's guidelines were implemented mid-year in 2003, and because the NTDB classifies admission date only by year, all patients admitted during 2003 were excluded from the analysis. Information regarding patient demographics and hospital type (teaching versus nonteaching) was collected. Our primary outcome measure was mortality. Secondary outcomes included length of mechanical ventilation, length of ICU stay, and length of hospitalization. The overall mortality rate decreased from 4.64% in the pre-80-h work week to 4.46% in the post-80-h work week (P < 0.0001). Of particular interest were the differences in outcomes observed in academic versus nonacademic institutions. In university hospitals, the mortality decreased from 5.16% to 5.03% (P = 0.03), whereas in nonteaching hospitals, mortality increased from 3.37% to 3.85% (P < 0.001). There were also small but statistically significant improvements seen in secondary outcomes during the post-80-h work week. Despite the great deal of controversy surrounding the 80-h work week, few papers exist that specifically examine patient mortality within the field of trauma surgery. This large retrospective analysis demonstrates slightly decreased mortality and morbidity among trauma patients in university hospitals nationwide after implementation of the 80-h work week, even when controlling for possible confounders. Although these differences are not likely to be clinically important, the data are statistically very significant. Therefore, we conclude that the 80-h work week has not resulted in any significant deterioration in patient outcomes in this particular population.

Hamstring autograft versus soft-tissue allograft in anterior cruciate ligament reconstruction: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Cvetanovich, Gregory L; Mascarenhas, Randy; Saccomanno, Maristella F; Verma, Nikhil N; Cole, Brian J; Bush-Joseph, Charles A; Bach, Bernard R

2014-12-01

To compare outcomes of anterior cruciate ligament (ACL) reconstruction with hamstring autograft versus soft-tissue allograft by systematic review and meta-analysis. A systematic review of randomized controlled studies comparing hamstring autograft with soft-tissue allograft in ACL reconstruction was performed. Studies were identified by strict inclusion and exclusion criteria. Descriptive statistics were reported. Where possible, the data were pooled and a meta-analysis was performed using RevMan software (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark). Dichotomous data were reported as risk ratios, whereas continuous data were reported as standardized mean differences and 95% confidence intervals. Heterogeneity was assessed by use of I(2) for each meta-analysis. Study methodologic quality was analyzed with the Modified Coleman Methodology Score and Jadad scale. Five studies with 504 combined patients (251 autograft and 253 allograft; 374 male and 130 female patients) with a mean age of 29.9 ± 2.2 years were included. The allografts used were fresh-frozen hamstring, irradiated hamstring, mixture of fresh-frozen and cryopreserved hamstring, fresh-frozen tibialis anterior, and fresh-frozen Achilles tendon grafts without bone blocks. The mean follow-up period was 47.4 ± 26.9 months, with a mean follow-up rate of 83.3% ± 8.6%. Two studies found a longer operative time with autograft than with allograft (77.1 ± 2.0 minutes v 59.9 ± 0.9 minutes, P = .008). Meta-analysis showed no statistically significant differences between autografts and allografts for any outcome measures (P > .05 for all tests). One study found significantly greater laxity for irradiated allograft than for autograft. The methodologic quality of the 5 studies was poor, with a mean Modified Coleman Methodology Score of 54.4 ± 6.9 and mean Jadad score of 1.6 ± 1.5. On the basis of this systematic review and meta-analysis of 5 randomized controlled trials, there is no statistically significant difference in outcome between patients undergoing ACL reconstruction with hamstring autograft and those undergoing ACL reconstruction with soft-tissue allograft. These results may not extrapolate to younger patient populations. The methodology of the available randomized controlled trials comparing hamstring autograft and soft-tissue allograft is poor. Level II, systematic review of Level I and II studies. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Two-year neurodevelopmental outcomes of extremely preterm infants treated with early hydrocortisone: treatment effect according to gestational age at birth.

PubMed

Baud, Olivier; Trousson, Clémence; Biran, Valérie; Leroy, Emilie; Mohamed, Damir; Alberti, Corinne

2018-01-10

To determine whether early hydrocortisone treatment in extremely preterm infants affects neurodevelopmental outcomes at 2 years of age according to gestational age at birth. This is an exploratory analysis of neurodevelopmental outcomes by gestational age strata from the PREMILOC trial, in which patients were randomly assigned to receive either placebo or low-dose hydrocortisone and randomisation was stratified by gestational age groups (24-25 and 26-27 weeks of gestation). Neurodevelopmental impairment (NDI) was assessed using a standardised neurological examination and the revised Brunet-Lézine scale at 22 months of corrected age. A total of 379 of 406 survivors were evaluated, 96/98 in the gestational age group of 24-25 weeks and 283/308 in the gestational age group of 26-27 weeks. Among surviving infants born at 24-25 weeks, significant improvement in global neurological assessment was observed in the hydrocortisone group compared with the placebo group (P=0.02) with a risk of moderate-to-severe NDI of 2% and 18%, respectively (risk difference 16 (95% CI -28% to -5%)). In contrast, no statistically significant difference between treatment groups was observed in infants born at 26-27 weeks (P=0.95) with a similar risk of moderate-to-severe NDI of 9% in both groups. The incidence of cerebral palsy or other major neurological impairments were found similar between treatment groups in each gestational group. In an exploratory analysis of neurodevelopmental outcomes from the PREMILOC trial, early low-dose hydrocortisone was associated with a statistically significant improvement in neurodevelopmental outcomes in infants born at 24 and 25 weeks of gestation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Risk Factors and Birth Outcomes of Anaemia in Early Pregnancy in a Nulliparous Cohort

PubMed Central

Masukume, Gwinyai; Khashan, Ali S.; Kenny, Louise C.; Baker, Philip N.; Nelson, Gill

2015-01-01

Background Anaemia in pregnancy is a major public health and economic problem worldwide, that contributes to both maternal and fetal morbidity and mortality. Objective The aim of the study was to calculate the prevalence of anaemia in early pregnancy in a cohort of ‘low risk’ women participating in a large international multicentre prospective study (n = 5 609), to identify the modifiable risk factors for anaemia in pregnancy in this cohort, and to compare the birth outcomes between pregnancies with and without anaemia in early gestation. Methods The study is an analysis of data that were collected prospectively during the Screening for Pregnancy Endpoints study. Anaemia was defined according to the World Health Organization’s definition of anaemia in pregnancy (haemoglobin < 11g/dL). Binary logistic regression with adjustment for potential confounders (country, maternal age, having a marital partner, ethnic origin, years of schooling, and having paid work) was the main method of analysis. Results The hallmark findings were the low prevalence of anaemia (2.2%), that having no marital partner was an independent risk factor for having anaemia (OR 1.34, 95% CI 1.01-1.78), and that there was no statistically significant effect of anaemia on adverse pregnancy outcomes (small for gestational age, pre-tem birth, mode of delivery, low birth weight, APGAR score < 7 at one and five minutes). Adverse pregnancy outcomes were however more common in those with anaemia than in those without. Conclusion In this low risk healthy pregnant population we found a low anaemia rate. The absence of a marital partner was a non-modifiable factor, albeit one which may reflect a variety of confounding factors, that should be considered for addition to anaemia’s conceptual framework of determinants. Although not statistically significant, clinically, a trend towards a higher risk of adverse pregnancy outcomes was observed in women that were anaemic in early pregnancy. PMID:25875012