analysis outcome measures: Topics by Science.gov

Sample records for analysis outcome measures

Cost-effectiveness with multiple outcomes.

PubMed

Bjørner, Jakob; Keiding, Hans

2004-12-01

In a large number of situations, activities in health care have to be measured in terms of outcome and cost. However, the cases where outcome is fully captured by a single measure are rather few, so that one uses some index for outcome, computed by weighing together several outcome measures using subjective and somewhat arbitrary weights. In the paper we propose an approach to cost-effectiveness analysis where such artificial aggregation is avoided. This is achieved by assigning to each activity the weights which are the most favourable in a comparison with the other options available, so that activities which have a poor score in this method are guaranteed to be inferior. The method corresponds to applying Data envelopment analysis, known from the theory of productivity, to the context of health economic evaluations. The method is applied to an analysis of the cost-effectiveness of alternative health plans using data from the Medical Outcome Study (JAMA 1996; 276: 1039-1047), where outcome is measured as improvement in mental and physical health. 2004 John Wiley & Sons, Ltd.
Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

PubMed

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Implicit Measures: A Normative Analysis and Review

ERIC Educational Resources Information Center

De Houwer, Jan; Teige-Mocigemba, Sarah; Spruyt, Adriaan; Moors, Agnes

2009-01-01

Implicit measures can be defined as outcomes of measurement procedures that are caused in an automatic manner by psychological attributes. To establish that a measurement outcome is an implicit measure, one should examine (a) whether the outcome is causally produced by the psychological attribute it was designed to measure, (b) the nature of the…
Multidimensional change in psychotherapy.

PubMed

Jones, E E

1980-04-01

Assessed psychotherapy outcome for 177 patients who were seen for an average of 31 therapy hours with the Rating Scales for Outcome of Therapy and a Therapist Questionnaire. Results of a components analysis did not support Storrow's rational groupings of the Rating Scales into five dimensions and suggested that two general areas of psychological adjustment underlie the 11 scales. A second components analysis that included both outcome measures supports only in part the contention that when results from diverse outcome measures are factor analyzed, the factors necessarily are associated with method of measurement rather than substantive dimensions of change.
Implicit measures: A normative analysis and review.

PubMed

De Houwer, Jan; Teige-Mocigemba, Sarah; Spruyt, Adriaan; Moors, Agnes

2009-05-01

Implicit measures can be defined as outcomes of measurement procedures that are caused in an automatic manner by psychological attributes. To establish that a measurement outcome is an implicit measure, one should examine (a) whether the outcome is causally produced by the psychological attribute it was designed to measure, (b) the nature of the processes by which the attribute causes the outcome, and (c) whether these processes operate automatically. This normative analysis provides a heuristic framework for organizing past and future research on implicit measures. The authors illustrate the heuristic function of their framework by using it to review past research on the 2 implicit measures that are currently most popular: effects in implicit association tests and affective priming tasks. (PsycINFO Database Record (c) 2009 APA, all rights reserved).
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
Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

PubMed

Landau, Sabine; Emsley, Richard; Dunn, Graham

2018-06-01

Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise. Investigators increasingly carry out explanatory analyses to decompose total treatment effects into components that are mediated by an intermediate continuous outcome and a non-mediated part. Traditional mediation analysis might be performed based on (A) post-treatment values of the intermediate and clinical outcomes alone, (B) respective change scores or (C) conditioning on baseline measures of both intermediate and clinical outcomes. Using causal diagrams and Monte Carlo simulation, we investigated the performance of the three competing mediation approaches. We considered a data generating model that included three possible confounding processes involving baseline variables: The first two processes modelled baseline measures of the clinical variable or the intermediate variable as common causes of post-treatment measures of these two variables. The third process allowed the two baseline variables themselves to be correlated due to past common causes. We compared the analysis models implied by the competing mediation approaches with this data generating model to hypothesise likely biases in estimators, and tested these in a simulation study. We applied the methods to a randomised trial of pragmatic rehabilitation in patients with chronic fatigue syndrome, which examined the role of limiting activities as a mediator. Estimates of causal mediation effects derived by approach (A) will be biased if one of the three processes involving baseline measures of intermediate or clinical outcomes is operating. Necessary assumptions for the change score approach (B) to provide unbiased estimates under either process include the independence of baseline measures and change scores of the intermediate variable. Finally, estimates provided by the analysis of covariance approach (C) were found to be unbiased under all the three processes considered here. When applied to the example, there was evidence of mediation under all methods but the estimate of the indirect effect depended on the approach used with the proportion mediated varying from 57% to 86%. Trialists planning mediation analyses should measure baseline values of putative mediators as well as of continuous clinical outcomes. An analysis of covariance approach is recommended to avoid potential biases due to confounding processes involving baseline measures of intermediate or clinical outcomes, and not simply for increased precision.
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.
DEFINING THE RELEVANT OUTCOME MEASURES IN MEDICAL DEVICE ASSESSMENTS: AN ANALYSIS OF THE DEFINITION PROCESS IN HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Jacobs, Esther; Antoine, Sunya-Lee; Prediger, Barbara; Neugebauer, Edmund; Eikermann, Michaela

2017-01-01

Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials. In 2012-14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers. Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes. This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.
Differences between seven measures of self-reported numbers of clients of female sex workers in southern India: implications for individual- and population-level analysis.

PubMed

Deering, Kathleen N; Vickerman, P; Pickles, M; Moses, S; Blanchard, J F; Ramesh, B M; Isac, S; Boily, M-C

2013-02-01

Quantifying sexual activity of sub-populations with high-risk sexual behaviour is important in understanding HIV epidemiology. This study examined inconsistency of seven outcomes measuring self-reported clients per month (CPM) of female sex workers (FSWs) in southern India and implications for individual/population-level analysis. Multivariate negative binomial regression was used to compare key social/environmental factors associated with each outcome. A transmission dynamics model was used to assess the impact of differences between outcomes on population-level FSW/client HIV prevalence. Outcomes based on 'clients per last working day' produced lower estimates than those based on 'clients per typical day'. Although the outcomes were strongly correlated, their averages differed by approximately two-fold (range 39.0-79.1 CPM). The CPM measure chosen did not greatly influence standard epidemiological 'risk factor' analysis. Differences across outcomes influenced HIV prevalence predictions. Due to this uncertainty, we recommend basing population-based estimates on the range of outcomes, particularly when assessing the impact of interventions.
Deconstructing Therapy Outcome Measurement with Rasch Analysis of a Measure of General Clinical Distress: The Symptom Checklist-90-Revised

ERIC Educational Resources Information Center

Elliott, Robert; Fox, Christine M.; Beltyukova, Svetlana A.; Stone, Gregory E.; Gunderson, Jennifer; Zhang, Xi

2006-01-01

Rasch analysis was used to illustrate the usefulness of item-level analyses for evaluating a common therapy outcome measure of general clinical distress, the Symptom Checklist-90-Revised (SCL-90-R; Derogatis, 1994). Using complementary therapy research samples, the instrument's 5-point rating scale was found to exceed clients' ability to make…
Causal inference with measurement error in outcomes: Bias analysis and estimation methods.

PubMed

Shu, Di; Yi, Grace Y

2017-01-01

Inverse probability weighting estimation has been popularly used to consistently estimate the average treatment effect. Its validity, however, is challenged by the presence of error-prone variables. In this paper, we explore the inverse probability weighting estimation with mismeasured outcome variables. We study the impact of measurement error for both continuous and discrete outcome variables and reveal interesting consequences of the naive analysis which ignores measurement error. When a continuous outcome variable is mismeasured under an additive measurement error model, the naive analysis may still yield a consistent estimator; when the outcome is binary, we derive the asymptotic bias in a closed-form. Furthermore, we develop consistent estimation procedures for practical scenarios where either validation data or replicates are available. With validation data, we propose an efficient method for estimation of average treatment effect; the efficiency gain is substantial relative to usual methods of using validation data. To provide protection against model misspecification, we further propose a doubly robust estimator which is consistent even when either the treatment model or the outcome model is misspecified. Simulation studies are reported to assess the performance of the proposed methods. An application to a smoking cessation dataset is presented.
Early functional MRI activation predicts motor outcome after ischemic stroke: a longitudinal, multimodal study.

PubMed

Du, Juan; Yang, Fang; Zhang, Zhiqiang; Hu, Jingze; Xu, Qiang; Hu, Jianping; Zeng, Fanyong; Lu, Guangming; Liu, Xinfeng

2018-05-15

An accurate prediction of long term outcome after stroke is urgently required to provide early individualized neurorehabilitation. This study aimed to examine the added value of early neuroimaging measures and identify the best approaches for predicting motor outcome after stroke. This prospective study involved 34 first-ever ischemic stroke patients (time since stroke: 1-14 days) with upper limb impairment. All patients underwent baseline multimodal assessments that included clinical (age, motor impairment), neurophysiological (motor-evoked potentials, MEP) and neuroimaging (diffusion tensor imaging and motor task-based fMRI) measures, and also underwent reassessment 3 months after stroke. Bivariate analysis and multivariate linear regression models were used to predict the motor scores (Fugl-Meyer assessment, FMA) at 3 months post-stroke. With bivariate analysis, better motor outcome significantly correlated with (1) less initial motor impairment and disability, (2) less corticospinal tract injury, (3) the initial presence of MEPs, (4) stronger baseline motor fMRI activations. In multivariate analysis, incorporating neuroimaging data improved the predictive accuracy relative to only clinical and neurophysiological assessments. Baseline fMRI activation in SMA was an independent predictor of motor outcome after stroke. A multimodal model incorporating fMRI and clinical measures best predicted the motor outcome following stroke. fMRI measures obtained early after stroke provided independent prediction of long-term motor outcome.
Outcomes mapping study for childhood vaccination communication: too few concepts were measured in too many ways.

PubMed

Kaufman, Jessica; Ryan, Rebecca; Bosch-Capblanch, Xavier; Cartier, Yuri; Cliff, Julie; Glenton, Claire; Lewin, Simon; Rada, Gabriel; Ames, Heather; Muloliwa, Artur Manuel; Oku, Afiong; Oyo-Ita, Angela; Hill, Sophie

2016-04-01

The objectives of this article are to (1) comprehensively catalog outcomes measured in trials of childhood vaccination communication interventions and (2) analyze patterns and trends in outcome selection. To achieve these objectives, we developed a Trial Outcomes Map for vaccination communication. We searched the Cochrane Central Register of Controlled Trials for trials of childhood vaccination communication interventions, extracting verbatim all outcome information from included trials. Through thematic grouping, we categorized outcomes based on conceptual similarities, forming a Trial Outcomes Map. We identified 112 relevant trials containing 209 outcomes. Thematic analysis revealed three overarching Outcome Categories: consumer-, vaccination-, and health system-related outcomes. These categories contain 21 Outcome Types (eg, "knowledge," "cost"), measured using 66 different Outcome Variables. Vaccination outcomes were measured most frequently and health system-related outcomes least frequently. Consumer outcomes are increasingly measured in more recent trials. The number of measures used for the same outcomes complicates data synthesis and interpretation. Despite recent trends toward including consumer outcomes, intermediate outcome measurement is lacking, hampering understanding of how and why vaccination communication interventions do or do not work. This Map may improve outcome consistency in future trials and will contribute to a forthcoming core outcome set. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Modeling and Predicting Hearing Aid Outcome

PubMed Central

Humes, Larry E.

2003-01-01

Following a brief tutorial on the application of factor analysis to hearing aid outcome measures, three studies of hearing aid outcome measures in elderly adults are presented and analyzed. Two of the studies were completed at Indiana University (IU-1 and IU-2), and one was a collaborative multisite study by the Veterans Administration and the National Institute of Deafness and other Communication Disorders (NIDCD/VA). IU-1 measured hearing aid outcome in 173 elderly wearers of single-channel, linear, in-the-ear hearing aids with output-limiting compression, whereas IU-2 obtained the same extensive set of outcome measures from 53 elderly wearers of two-channel, wide-dynamic-range compression, in-the-canal hearing aids. In the NIDCD/VA study, 333 to 338 participants wore three single-channel circuits in succession, with each circuit housed within an in-the-ear shell. The three circuits included in that study and in this analysis were: (1) linear with peak clipping, (2) linear with output-limiting compression, and (3) single-channel, wide-dynamic-range compression. Evaluation of the many outcome measures completed in each study using principal components factor analysis revealed that from three (both IU studies) to five (NIDCD/VA study) principal components captured the individual differences in hearing aid outcome. This was independent of hearing aid type (in-the-ear or in-the-canal) and circuitry. Subsequent multiple regression analyses of individual differences in performance along each dimension of hearing aid outcome revealed that these individual differences could be accounted for reasonably well by various prefit variables for some dimensions of outcome, but not others. In general, measures of speech recognition performance were well accounted for by prefit measures, with the best predictors being hearing loss, cognitive performance, and age. Measures of hearing aid usage were less well accounted for by prefit measures, with the most accurate predictor of current hearing aid use being prior hearing aid use. The outcome dimension accounted for most poorly was that associated with hearing aid satisfaction, with subjective measures of aided sound quality being the best predictor of performance along this dimension of hearing aid outcome. Additional multicenter, large-scale studies are needed to develop more complete models of hearing aid outcome and to identify the variables that influence various aspects of hearing aid outcome. It is only through this additional research that it will be possible to optimize outcome for hearing aid wearers. PMID:15004647
Considerations for analysis of time-to-event outcomes measured with error: Bias and correction with SIMEX.

PubMed

Oh, Eric J; Shepherd, Bryan E; Lumley, Thomas; Shaw, Pamela A

2018-04-15

For time-to-event outcomes, a rich literature exists on the bias introduced by covariate measurement error in regression models, such as the Cox model, and methods of analysis to address this bias. By comparison, less attention has been given to understanding the impact or addressing errors in the failure time outcome. For many diseases, the timing of an event of interest (such as progression-free survival or time to AIDS progression) can be difficult to assess or reliant on self-report and therefore prone to measurement error. For linear models, it is well known that random errors in the outcome variable do not bias regression estimates. With nonlinear models, however, even random error or misclassification can introduce bias into estimated parameters. We compare the performance of 2 common regression models, the Cox and Weibull models, in the setting of measurement error in the failure time outcome. We introduce an extension of the SIMEX method to correct for bias in hazard ratio estimates from the Cox model and discuss other analysis options to address measurement error in the response. A formula to estimate the bias induced into the hazard ratio by classical measurement error in the event time for a log-linear survival model is presented. Detailed numerical studies are presented to examine the performance of the proposed SIMEX method under varying levels and parametric forms of the error in the outcome. We further illustrate the method with observational data on HIV outcomes from the Vanderbilt Comprehensive Care Clinic. Copyright © 2017 John Wiley & Sons, Ltd.
The development of leadership outcome-indicators evaluating the contribution of clinical specialists and advanced practitioners to health care: a secondary analysis.

PubMed

Elliott, Naomi; Begley, Cecily; Kleinpell, Ruth; Higgins, Agnes

2014-05-01

To report a secondary analysis of data collected from the case study phase of a national study of advanced practitioners and to develop leadership outcome-indicators appropriate for advanced practitioners. In many countries, advanced practitioners in nursing and midwifery have responsibility as leaders for health care development, but without having leadership outcome measures available they are unable to demonstrate the results of their activities. In Ireland, a sequential mixed method research study was used to develop a validated tool for the evaluation of clinical specialists and advanced practitioners. Despite strong evidence of leadership activities, few leadership-specific outcomes were generated from the primary analysis. Secondary analysis of a multiple case study data set. Data set comprised 23 case studies of advanced practitioner/clinical specialists from 13 sites across each region in Ireland from all divisions of the Nursing Board Register. Data were collected 2008-2010. Data sources included non-participant observation (n = 92 hours) of advanced practitioners in practice, interviews with clinicians (n = 21), patients (n = 20) and directors of nursing/midwifery (n = 13) and documents. Analysis focused on leadership outcome-indicator development in line with the National Health Service's Good Indicators Guide. The four categories of leadership outcomes for advanced practitioner developed were as follows: (i) capacity and capability building of multidisciplinary team; (ii) measure of esteem; (iii) new initiatives for clinical practice and healthcare delivery; and (iv) clinical practice based on evidence. The proposed set of leadership outcome-indicators derived from a secondary analysis captures the complexity of leadership in practice. They add to existing clinical outcomes measuring advanced practice. © 2013 John Wiley & Sons Ltd.
The Analysis of Ratings Using Generalizability Theory for Student Outcome Assessment. AIR 1988 Annual Forum Paper.

ERIC Educational Resources Information Center

Erwin, T. Dary

Rating scales are a typical method for evaluating a student's performance in outcomes assessment. The analysis of the quality of information from rating scales poses special measurement problems when researchers work with faculty in their development. Generalizability measurement theory offers a set of techniques for estimating errors or…
Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes.

PubMed

Achana, Felix A; Cooper, Nicola J; Bujkiewicz, Sylwia; Hubbard, Stephanie J; Kendrick, Denise; Jones, David R; Sutton, Alex J

2014-07-21

Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on outcomes not directly considered by the studies included in the analysis. Accounting for the dependency between outcomes in a multivariate meta-analysis may or may not improve the precision of effect estimates from a network meta-analysis compared to analysing each outcome separately.
Validating Multidimensional Outcome Assessment Using the TBI Common Data Elements: An Analysis of the TRACK-TBI Pilot Sample.

PubMed

Nelson, Lindsay D; Ranson, Jana; Ferguson, Adam R; Giacino, Joseph; Okonkwo, David O; Valadka, Alex; Manley, Geoffrey; McCrea, Michael

2017-06-08

The Glasgow Outcome Scale-Extended (GOSE) is often the primary outcome measure in clinical trials for traumatic brain injury (TBI). Although the GOSE's capture of global function outcome has several strengths, concerns have been raised about its limited ability to identify mild disability and failure to capture the full scope of problems patients exhibit after TBI. This analysis examined the convergence of disability ratings across a multidimensional set of outcome domains in the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot study. The study collected measures recommended by the TBI Common Data Elements (CDE) Workgroup. Patients presenting to 3 emergency departments with a TBI of any severity enrolled in TRACK-TBI prospectively after injury; outcome measures were collected at 3 and six months postinjury. Analyses examined frequency of impairment and overlap between impairment status across the CDE outcome domains of Global Level of Functioning (GOSE), Neuropsychological (cognitive) Impairment, Psychological Status, TBI Symptoms, and Quality of Life. GOSE score correlated in the expected direction with other outcomes (M Spearman's rho = .21 and .49 with neurocognitive and self-report outcomes, respectively). The subsample in the Upper Good Recovery (GOSE 8) category appeared quite healthy across most other outcomes, although 19.0% had impaired executive functioning (Trail Making Test Part B). A significant minority of participants in the Lower Good Recovery subgroup (GOSE 7) met criteria for impairment across numerous other outcome measures. The findings highlight the multidimensional nature of TBI recovery and the limitations of applying only a single outcome measure.

Meta-Analysis of Treatment Outcomes Measured by the Y-OQ and Y-OQ-SR Comparing Wilderness and Non-Wilderness Treatment Programs

ERIC Educational Resources Information Center

Gillis, Harold L.; Speelman, Elizabeth; Linville, Noelle; Bailey, Emily; Kalle, Ashley; Oglesbee, Nathan; Sandlin, James; Thompson, Lauren; Jensen, Jennifer

2016-01-01

Background: Monitoring youth treatments requires outcome instruments sensitive to change. The Y-OQ and the Y-OQ-SR measure behavioral change during psychological treatment. Objective: The focus of this study was to compare treatment progress of youth in studies using the Youth Outcome Questionnaire (YOQ) or the Youth Outcome Questionnaire Self…
Acute effects of tea constituents L-theanine, caffeine, and epigallocatechin gallate on cognitive function and mood: a systematic review and meta-analysis.

PubMed

Camfield, David A; Stough, Con; Farrimond, Jonathon; Scholey, Andrew B

2014-08-01

A systematic review and meta-analysis was conducted on 11 randomized placebo-controlled human studies of acute effects of tea constituents L-theanine and epigallocatechin gallate, administered alone or in combination with caffeine, on cognitive function and mood. The outcome measures of mood were alertness, calmness, and contentedness, derived from the Bond-Lader scales, and state anxiety, from the State-Trait Anxiety Inventory. Cognitive measures assessed were attentional switch, intersensory attention, and rapid visual information processing. Standardized mean differences between placebo and treatment groups are presented for each study and outcome measure. Meta-analysis using a random-effects model was conducted when data were available for three or more studies. Evidence of moderate effect sizes in favor of combined caffeine and L-theanine in the first 2 hours postdose were found for outcome measures Bond-Lader alertness, attentional switching accuracy, and, to a lesser extent, some unisensory and multisensory attentional outcomes. Moderator analysis of caffeine and L-theanine doses revealed trends toward greater change in effect size for caffeine dose than for L-theanine dose, particularly during the first hour postdose. © 2014 International Life Sciences Institute.
Interaction of participant characteristics and type of AAC with individuals with ASD: a meta-analysis.

PubMed

Ganz, Jennifer B; Mason, Rose A; Goodwyn, Fara D; Boles, Margot B; Heath, Amy K; Davis, John L

2014-11-01

Individuals with autism spectrum disorders (ASD) and complex communication needs often rely on augmentative and alternative communication (AAC) as a means of functional communication. This meta-analysis investigated how individual characteristics moderate effectiveness of three types of aided AAC: the Picture Exchange Communication System (PECS), speech-generating devices (SGDs), and other picture-based AAC. Effectiveness was measured via the Improvement Rate Difference. Results indicated that AAC has small to moderate effects on speech outcomes, and that SGDs appear to be most effective when considering any outcome measure with individuals with ASD without comorbid intellectual/developmental disorders (IDD). PECS appears to be most effective when considering any outcome measure with individuals with ASD and IDD. SGDs and PECS were the most effective type of AAC for preschoolers, when aggregating across outcome measures. No difference was found between systems for elementary-aged and older individuals.
CHoice of Outcome In Cbt for psychosEs (CHOICE): The Development of a New Service User–Led Outcome Measure of CBT for Psychosis

PubMed Central

Greenwood, Kathryn E.; Sweeney, Angela; Williams, Sally; Garety, Philippa; Kuipers, Elizabeth; Scott, Jan; Peters, Emmanuelle

2010-01-01

Outcome measures for cognitive behavior therapy for psychosis (CBTp) have been derived from pharmacological studies, focusing on symptom change rather than outcomes such as distress or fulfilment. This study presents the development and psychometric properties of a new outcome measure (CHoice of Outcome In Cbt for psychosEs [CHOICE]), which reflects more strongly the aims of CBTp and the priorities of service users. Service users who had received CBTp participated in focus groups to discuss their outcome priorities, using a topic guide generated by a panel of experts in CBTp. A qualitative thematic analysis was undertaken to reach consensus on themes and generate items. Response scales were constructed for 3 dimensions: severity, satisfaction, and importance. The resulting questionnaire was piloted with service users who had not received CBTp, stratified by service type, ethnicity, and first language to ensure that it was user friendly and applicable prior to CBTp. The psychometric properties of the measure were then examined in a sample of 152 service users. Twenty-four items, and 2 of the dimensions (severity and satisfaction), were retained in the final measure. A factor analysis revealed a single psychological recovery factor interspersed throughout with both CBTp and recovery items. Test-retest reliability, construct validity, and sensitivity to change following CBTp were confirmed. The CHOICE measure is unique in being the first psychometrically adequate service user–led outcome measure of CBTp. It provides the opportunity to examine the evidence base for CBTp with an assessment approach that prioritizes service user definitions of recovery and CBT aims. PMID:19880823
Measuring the Quality of VET Using the Student Outcomes Survey. Occasional Paper

ERIC Educational Resources Information Center

Lee, Wang-Sheng; Polidano, Cain

2010-01-01

The aim of this report is to examine the potential use of information from the Student Outcomes Survey, including the use of student course satisfaction information and post-study outcomes, as a means of determining markers of training quality. In an analysis of the student course satisfaction measures, the authors found there are very small…
A Portfolio Analysis Tool for Measuring NASAs Aeronautics Research Progress toward Planned Strategic Outcomes

NASA Technical Reports Server (NTRS)

Tahmasebi, Farhad; Pearce, Robert

2016-01-01

Description of a tool for portfolio analysis of NASA's Aeronautics research progress toward planned community strategic Outcomes is presented. The strategic planning process for determining the community Outcomes is also briefly described. Stakeholder buy-in, partnership performance, progress of supporting Technical Challenges, and enablement forecast are used as the criteria for evaluating progress toward Outcomes. A few illustrative examples are also presented.
Behavioral and cognitive outcomes for clinical trials in children with neurofibromatosis type 1.

PubMed

van der Vaart, Thijs; Rietman, André B; Plasschaert, Ellen; Legius, Eric; Elgersma, Ype; Moll, Henriëtte A

2016-01-12

To evaluate the appropriateness of cognitive and behavioral outcome measures in clinical trials in neurofibromatosis type 1 (NF1) by analyzing the degree of deficits compared to reference groups, test-retest reliability, and how scores correlate between outcome measures. Data were analyzed from the Simvastatin for cognitive deficits and behavioral problems in patients with neurofibromatosis type 1 (NF1-SIMCODA) trial, a randomized placebo-controlled trial of simvastatin for cognitive deficits and behavioral problems in children with NF1. Outcome measures were compared with age-specific reference groups to identify domains of dysfunction. Pearson r was computed for before and after measurements within the placebo group to assess test-retest reliability. Principal component analysis was used to identify the internal structure in the outcome data. Strongest mean score deviations from the reference groups were observed for full-scale intelligence (-1.1 SD), Rey Complex Figure Test delayed recall (-2.0 SD), attention problems (-1.2 SD), and social problems (-1.1 SD). Long-term test-retest reliability were excellent for Wechsler scales (r > 0.88), but poor to moderate for other neuropsychological tests (r range 0.52-0.81) and Child Behavioral Checklist subscales (r range 0.40-0.79). The correlation structure revealed 2 strong components in the outcome measures behavior and cognition, with no correlation between these components. Scores on psychosocial quality of life correlate strongly with behavioral problems and less with cognitive deficits. Children with NF1 show distinct deficits in multiple domains. Many outcome measures showed weak test-retest correlations over the 1-year trial period. Cognitive and behavioral outcomes are complementary. This analysis demonstrates the need to include reliable outcome measures on a variety of cognitive and behavioral domains in clinical trials for NF1. © 2015 American Academy of Neurology.
A multicenter study analyzing the relationship of a standardized radiographic scoring system of adolescent idiopathic scoliosis and the Scoliosis Research Society outcomes instrument.

PubMed

Wilson, Philip L; Newton, Peter O; Wenger, Dennis R; Haher, Thomas; Merola, Andrew; Lenke, Larry; Lowe, Thomas; Clements, David; Betz, Randy

2002-09-15

A multicenter study examining the association between radiographic and outcomes measures in adolescent idiopathic scoliosis. To evaluate the association between an objective radiographic scoring system and patient quality of life measures as determined by the Scoliosis Research Society outcomes instrument. Although surgical correction of scoliosis has been reported to be positively correlated with patient outcomes, studies to date have been unable to demonstrate an association between radiographic measures of deformity and outcomes measures in patients with adolescent idiopathic scoliosis. A standardized radiographic deformity scoring system and the Scoliosis Research Society outcome tool were used prospectively in seven scoliosis centers to collect data on patients with adolescent idiopathic scoliosis. A total of 354 data points for 265 patients consisting of those with nonoperative or preoperative curves >or=10 degrees, as well as those with surgically treated curves, were analyzed. Correlation analysis was performed to identify significant relationships between any of the radiographic measures, the Harms Study Group radiographic deformity scores (total, sagittal, coronal), and the seven Scoliosis Research Society outcome domains (Total Pain, General Self-Image, General Function, Activity, Postoperative Self-Image, Postoperative Function, and Satisfaction) as well as Scoliosis Research Society outcomes instrument total scores. Radiographic measures that were identified as significantly correlated with Scoliosis Research Society outcome scores were then entered into a stepwise regression analysis. The coronal measures of thoracic curve and lumbar curve magnitude were found to be significantly correlated with the Total Pain, General Self-Image, and total Scoliosis Research Society scores (P < 0.0001). The thoracic and upper thoracic curve magnitudes were also correlated with General Function (P < 0.002). The "coronal" subscore as well as the "total" score of the Harms Study Group radiographic scoring system were also significantly correlated with these Scoliosis Research Society domain and total scores. No radiographic measures taken after surgery were significantly correlated with the postoperative domains of the Scoliosis Research Society outcomes instrument. Stepwise regression analysis of these radiographic measures as predictors of Scoliosis Research Society scores resulted in adjusted R2 values of 0.03-0.07 (P < 0.0001). Although these results show that a significant association exists between the radiographic Cobb angle measure of the scoliosis and the Scoliosis Research Society outcomes scores, the low R2 values indicate that variables other than the radiographic appearance of the deformity (e.g., psychosocial, functional) must also be affecting these scores. The Cobb angle measure of the major deformity has a small, but statistically significant, correlation with the reported Total Pain, General Self-Image, and General Function as measured by the Scoliosis Research Society outcomes instrument. None of the radiographic measures in this population correlated with postoperative domain scores of the Scoliosis Research Society outcomes tool.
Reproducibility and Temporal Structure in Weekly Resting-State fMRI over a Period of 3.5 Years

PubMed Central

Choe, Ann S.; Jones, Craig K.; Joel, Suresh E.; Muschelli, John; Belegu, Visar; Caffo, Brian S.; Lindquist, Martin A.; van Zijl, Peter C. M.; Pekar, James J.

2015-01-01

Resting-state functional MRI (rs-fMRI) permits study of the brain’s functional networks without requiring participants to perform tasks. Robust changes in such resting state networks (RSNs) have been observed in neurologic disorders, and rs-fMRI outcome measures are candidate biomarkers for monitoring clinical trials, including trials of extended therapeutic interventions for rehabilitation of patients with chronic conditions. In this study, we aim to present a unique longitudinal dataset reporting on a healthy adult subject scanned weekly over 3.5 years and identify rs-fMRI outcome measures appropriate for clinical trials. Accordingly, we assessed the reproducibility, and characterized the temporal structure of, rs-fMRI outcome measures derived using independent component analysis (ICA). Data was compared to a 21-person dataset acquired on the same scanner in order to confirm that the values of the single-subject RSN measures were within the expected range as assessed from the multi-participant dataset. Fourteen RSNs were identified, and the inter-session reproducibility of outcome measures—network spatial map, temporal signal fluctuation magnitude, and between-network connectivity (BNC)–was high, with executive RSNs showing the highest reproducibility. Analysis of the weekly outcome measures also showed that many rs-fMRI outcome measures had a significant linear trend, annual periodicity, and persistence. Such temporal structure was most prominent in spatial map similarity, and least prominent in BNC. High reproducibility supports the candidacy of rs-fMRI outcome measures as biomarkers, but the presence of significant temporal structure needs to be taken into account when such outcome measures are considered as biomarkers for rehabilitation-style therapeutic interventions in chronic conditions. PMID:26517540
Economic evaluations and usefulness of standardized nursing terminologies.

PubMed

Stone, Patricia W; Lee, Nam-Ju; Giannini, Melinna; Bakken, Suzanne

2004-01-01

To review different types of economic analyses commonly found in healthcare literature, discuss methodologic considerations in framing economic analyses, identify useful resources for economic evaluations, and describe the current and potential roles of standardized nursing terminologies in providing cost and outcome data for economic analysis. The Advanced Billing Concepts Code Resource-based Relative Value Scale and Nursing Outcomes Classification. Using case studies, the applicability of standardized nursing terminologies in cost-effectiveness analysis is demonstrated. While there is potential to inform specific questions, comparisons across analyses are limited because of the many outcome measures. Including a standardized quality-of-life measure in nursing terminologies would allow for the calculation of accepted outcome measures and dollars per quality adjusted life years gained. The nurse's ability to assess and contribute to all aspects of rigorous economic evidence is an essential competency for responsible practice.
Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes

PubMed Central

2014-01-01

Background Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. Methods The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Results Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on outcomes not directly considered by the studies included in the analysis. Conclusions Accounting for the dependency between outcomes in a multivariate meta-analysis may or may not improve the precision of effect estimates from a network meta-analysis compared to analysing each outcome separately. PMID:25047164
Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

PubMed

Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

2017-10-01

Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to a large extent, to selective outcome reporting. Readers should be aware of this to avoid implementation of false or misleading results in clinical practice. No funding received and there are no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com
Implementation of learning outcome attainment measurement system in aviation engineering higher education

NASA Astrophysics Data System (ADS)

Salleh, I. Mohd; Mat Rani, M.

2017-12-01

This paper aims to discuss the effectiveness of the Learning Outcome Attainment Measurement System in assisting Outcome Based Education (OBE) for Aviation Engineering Higher Education in Malaysia. Direct assessments are discussed to show the implementation processes that become a key role in the successful outcome measurement system. A case study presented in this paper involves investigation on the implementation of the system in Aircraft Structure course for Bachelor in Aircraft Engineering Technology program in UniKL-MIAT. The data has been collected for five semesters, starting from July 2014 until July 2016. The study instruments used include the report generated in Learning Outcomes Measurements System (LOAMS) that contains information on the course learning outcomes (CLO) individual and course average performance reports. The report derived from LOAMS is analyzed and the data analysis has revealed that there is a positive significant correlation between the individual performance and the average performance reports. The results for analysis of variance has further revealed that there is a significant difference in OBE grade score among the report. Independent samples F-test results, on the other hand, indicate that the variances of the two populations are unequal.
A meta-analysis of brief alcohol interventions for adolescents and young adults: Variability in effects across alcohol measures

PubMed Central

Tanner-Smith, Emily E.; Risser, Mark D.

2016-01-01

Background Brief alcohol interventions are one approach for reducing drinking among youth, but may vary in effectiveness depending on the type of alcohol assessments used to measure effects. Objectives To conduct a meta-analysis that examined the effectiveness of brief alcohol interventions for adolescents and young adults, with particular emphasis on exploring variability in effects across outcome measurement characteristics. Method Eligible studies were those using an experimental or quasi-experimental design to examine the effects of a brief alcohol intervention on a post-intervention alcohol use measure for youth ages 11–30. A comprehensive literature review identified 190 unique samples that were included in the meta-analysis. Taking a Bayesian approach, we used random-effects multilevel models to estimate the average effect and model variability across outcome measurement types. Results Brief alcohol interventions led to significant reductions in self-reported alcohol use among adolescents ( g¯ = 0.25, 95% CrI [0.13, 0.37]) and young adults ( g¯ = 0.15, 95% CrI [0.12, 0.18]). These results were consistent across outcomes with varying reference periods, but varied across outcome construct type and assessment instruments. Among adolescents, effects were larger when measured using the Timeline Followback; among young adults, effects were smaller when measured using the Alcohol Use Disorders Identification Test. Conclusion The strength of the beneficial effects of brief alcohol interventions on youth’s alcohol use may vary depending upon the outcome measure utilized. Nevertheless, significant effects were observed across measures. Although effects were modest in size, they were clinically significant and show promise for interrupting problematic alcohol use trajectories among youth. PMID:26905387
The enduring effects of psychodynamic treatments vis-a-vis alternative treatments: A multilevel longitudinal meta-analysis

NASA Astrophysics Data System (ADS)

Kivlighan, D. Martin, III

Although evidence suggests that the benefits of psychodynamic treatments are sustained over time, presently it is unclear whether these sustained benefits are superior to non-psychodynamic treatments. Additionally, the extant literature comparing the sustained benefits of psychodynamic treatments compared to alternative treatments is limited with methodological shortcomings. The purpose of the current study was to conduct a rigorous test of the growth of the benefits of psychodynamic treatments relative to alternative treatments across distinct domains of change (i.e., all outcome measures, targeted outcome measures, non-targeted outcome measures, and personality outcome measures). To do so, the study employed strict inclusion criteria to identify randomized clinical trials that directly compared at least one bona fide psychodynamic treatment and one bona fide non-psychodynamic treatment. Hierarchical linear modeling (Raudenbush, Bryk, Cheong & Congdon, du Toit, 2011) was used to longitudinally model the impact of psychodynamic treatments compared to non-psychodynamic treatments at post-treatment and to compare the growth (i.e., slope) of effects beyond treatment completion. Findings from the present meta-analysis indicated that psychodynamic treatments and non-psychodynamic treatments were equally efficacious at post-treatment and at follow-up for combined outcomes ( k = 20), targeted outcomes (k =19), non-targeted outcomes (k =17), and personality outcomes (k =6). Clinical implications, directions for future research, and limitations are discussed.
Minnesota's Tech Prep Outcome Evaluation Model.

ERIC Educational Resources Information Center

Brown, James M.; Pucel, David; Twohig, Cathy; Semler, Steve; Kuchinke, K. Peter

1998-01-01

Describes the Minnesota Tech Prep Consortia Evaluation System, which collects outcomes data on enrollment, retention, related job placement, higher education, dropouts, and diplomas/degrees awarded. Explains outcome measures, database development, data collection and analysis methods, and remaining challenges. (SK)
An evaluation of interrupted and uninterrupted measurement of vocal stereotypy on perceived treatment outcomes.

PubMed

Carroll, Regina A; Kodak, Tiffany

2014-01-01

The type of procedure used to measure a target behavior may directly influence the perceived treatment outcomes. In the present study, we examined the influence of different data-analysis procedures on the outcomes of two commonly used treatments on the vocal stereotypy of 2 children with an autism spectrum disorder. In Study 1, we compared an interrupted and uninterrupted data-analysis procedure to measure vocal stereotypy during the implementation of response interruption and redirection (RIRD). The results showed that the interrupted data-analysis procedure overestimated the effectiveness of RIRD. In Study 2, we examined the influence of different data-analysis procedures on the interpretation of the relative effects of 2 different treatments for vocal stereotypy. Specifically, we compared interrupted and uninterrupted data-analysis procedures during the implementation of RIRD and noncontingent reinforcement (NCR) as a treatment for vocal stereotypy. The results showed that, as in Study 1, the interrupted data-analysis procedure overestimated the effectiveness of RIRD; however, this effect was not apparent with NCR. These findings suggest that different types of data analysis can influence the perceived success of a treatment. © Society for the Experimental Analysis of Behavior.
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.
Tri-Center Analysis: Determining Measures of Trichotomous Central Tendency for the Parametric Analysis of Tri-Squared Test Results

ERIC Educational Resources Information Center

Osler, James Edward

2014-01-01

This monograph provides an epistemological rational for the design of a novel post hoc statistical measure called "Tri-Center Analysis". This new statistic is designed to analyze the post hoc outcomes of the Tri-Squared Test. In Tri-Center Analysis trichotomous parametric inferential parametric statistical measures are calculated from…
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.

STATISTICAL METHODOLOGY FOR THE SIMULTANEOUS ANALYSIS OF MULTIPLE TYPES OF OUTCOMES IN NONLINEAR THRESHOLD MODELS.

EPA Science Inventory

Multiple outcomes are often measured on each experimental unit in toxicology experiments. These multiple observations typically imply the existence of correlation between endpoints, and a statistical analysis that incorporates it may result in improved inference. When both disc...
Applying economic principles to outcomes analysis.

PubMed

Shauver, Melissa J; Chung, Kevin C

2013-04-01

This article presents an introduction to economic outcomes for the plastic surgeon investigator. Types of economic outcomes are introduced and the matter of perspective is discussed. Examples from the plastic surgery literature are presented. The current and future importance of economic outcome measures is emphasized. Copyright © 2013 Elsevier Inc. All rights reserved.
Integrating Hospital Administrative Data to Improve Health Care Efficiency and Outcomes: “The Socrates Story”

PubMed Central

Lawrence, Justin; Delaney, Conor P.

2013-01-01

Evaluation of health care outcomes has become increasingly important as we strive to improve quality and efficiency while controlling cost. Many groups feel that analysis of large datasets will be useful in optimizing resource utilization; however, the ideal blend of clinical and administrative data points has not been developed. Hospitals and health care systems have several tools to measure cost and resource utilization, but the data are often housed in disparate systems that are not integrated and do not permit multisystem analysis. Systems Outcomes and Clinical Resources AdministraTive Efficiency Software (SOCRATES) is a novel data merging, warehousing, analysis, and reporting technology, which brings together disparate hospital administrative systems generating automated or customizable risk-adjusted reports. Used in combination with standardized enhanced care pathways, SOCRATES offers a mechanism to improve the quality and efficiency of care, with the ability to measure real-time changes in outcomes. PMID:24436649
Integrating hospital administrative data to improve health care efficiency and outcomes: "the socrates story".

PubMed

Lawrence, Justin; Delaney, Conor P

2013-03-01

Evaluation of health care outcomes has become increasingly important as we strive to improve quality and efficiency while controlling cost. Many groups feel that analysis of large datasets will be useful in optimizing resource utilization; however, the ideal blend of clinical and administrative data points has not been developed. Hospitals and health care systems have several tools to measure cost and resource utilization, but the data are often housed in disparate systems that are not integrated and do not permit multisystem analysis. Systems Outcomes and Clinical Resources AdministraTive Efficiency Software (SOCRATES) is a novel data merging, warehousing, analysis, and reporting technology, which brings together disparate hospital administrative systems generating automated or customizable risk-adjusted reports. Used in combination with standardized enhanced care pathways, SOCRATES offers a mechanism to improve the quality and efficiency of care, with the ability to measure real-time changes in outcomes.
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.
A meta-analysis of multicultural competencies and psychotherapy process and outcome.

PubMed

Tao, Karen W; Owen, Jesse; Pace, Brian T; Imel, Zac E

2015-07-01

For decades, psychologists have emphasized the provision of multiculturally competent psychotherapy to reduce racial and ethnic disparities in mental health treatment. However, the relationship between multicultural competencies (MC) and other measures of clinical process and treatment outcome has shown heterogeneity in effect sizes. This meta-analysis tested the association of client ratings of therapist MC with measures of therapeutic processes and outcome, including: (a) working alliance, (b) client satisfaction, (c) general counseling competence, (d) session impact, and (e) symptom improvement. Among 18 studies (20 independent samples) included in the analysis, the correlation between therapist MC and outcome (r = .29) was much smaller than the association with process measures (r = .75), but there were no significant differences in correlations across different types of MC or clinical process measures. Providing some evidence of publication bias, effect sizes from published studies (r = .67) were larger than those from unpublished dissertations (r = .28). Moderator analyses indicated that client age, gender, the representation of racial-ethnic minority (R-EM) clients, and clinical setting were not associated with effect size variability. Based on these findings, we discuss implications and recommendations for future research that might lead to a better understanding of the effects of therapist MC on treatment process and outcome. Primary needs in future research include the development and evaluation of observer ratings of therapist MC and the implementation of longitudinal research designs. (c) 2015 APA, all rights reserved).
Measure of functional independence dominates discharge outcome prediction after inpatient rehabilitation for stroke.

PubMed

Brown, Allen W; Therneau, Terry M; Schultz, Billie A; Niewczyk, Paulette M; Granger, Carl V

2015-04-01

Identifying clinical data acquired at inpatient rehabilitation admission for stroke that accurately predict key outcomes at discharge could inform the development of customized plans of care to achieve favorable outcomes. The purpose of this analysis was to use a large comprehensive national data set to consider a wide range of clinical elements known at admission to identify those that predict key outcomes at rehabilitation discharge. Sample data were obtained from the Uniform Data System for Medical Rehabilitation data set with the diagnosis of stroke for the years 2005 through 2007. This data set includes demographic, administrative, and medical variables collected at admission and discharge and uses the FIM (functional independence measure) instrument to assess functional independence. Primary outcomes of interest were functional independence measure gain, length of stay, and discharge to home. The sample included 148,367 people (75% white; mean age, 70.6±13.1 years; 97% with ischemic stroke) admitted to inpatient rehabilitation a mean of 8.2±12 days after symptom onset. The total functional independence measure score, the functional independence measure motor subscore, and the case-mix group were equally the strongest predictors for any of the primary outcomes. The most clinically relevant 3-variable model used the functional independence measure motor subscore, age, and walking distance at admission (r(2)=0.107). No important additional effect for any other variable was detected when added to this model. This analysis shows that a measure of functional independence in motor performance and age at rehabilitation hospital admission for stroke are predominant predictors of outcome at discharge in a uniquely large US national data set. © 2015 American Heart Association, Inc.
Item Banks for Measuring Emotional Distress from the Patient-Reported Outcomes Measurement Information System (PROMIS[R]): Depression, Anxiety, and Anger

ERIC Educational Resources Information Center

Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David

2011-01-01

The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS[R]). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and…
Testing Multiple Outcomes in Repeated Measures Designs

ERIC Educational Resources Information Center

Lix, Lisa M.; Sajobi, Tolulope

2010-01-01

This study investigates procedures for controlling the familywise error rate (FWR) when testing hypotheses about multiple, correlated outcome variables in repeated measures (RM) designs. A content analysis of RM research articles published in 4 psychology journals revealed that 3 quarters of studies tested hypotheses about 2 or more outcome…
Functional swallowing outcomes following treatment for oropharyngeal carcinoma: a systematic review of the evidence comparing trans-oral surgery versus non-surgical management.

PubMed

Dawe, N; Patterson, J; O'Hara, J

2016-08-01

Trans-oral surgical and non-surgical management options for oropharyngeal squamous cell carcinoma (OPSCC) appear to offer similar survival outcomes. Functional outcomes, in particular swallowing, have become of increasing interest in the debate regarding treatment options. Contemporary reviews on function following treatment frequently include surrogate markers and limit the value of comparative analysis. A systematic review was performed to establish whether direct comparisons of swallowing outcomes could be made between trans-oral surgical approaches (trans-oral laser microsurgery (TLM)/trans-oral robotic surgery (TORS)) and (chemo)radiotherapy ((C)RT). Systematic review. MEDLINE, Embase and Cochrane databases were interrogated using the following MeSH terms: antineoplastic protocols, chemotherapy, radiotherapy, deglutition disorders, swallowing, lasers, and trans-oral surgery. Two authors performed independent systematic reviews and consensus was sought if opinions differed. The WHO ICF classification was applied to generate analysis based around body functions and structure, activity limitations and participation restriction. Thirty-seven citations were included in the analysis. Twenty-six papers reported the outcomes for OPSCC treatment following primary (C)RT in 1377 patients, and 15 papers following contemporary trans-oral approaches in 768 patients. Meta-analysis was not feasible due to varying methodology and heterogeneity of outcome measures. Instrumental swallowing assessments were presented in 13/26 (C)RT versus 2/15 TLM/TORS papers. However, reporting methods of these studies were not standardised. This variety of outcome measures and the wide-ranging intentions of authors applying the measures in individual studies limit any practical direct comparisons of the effects of treatment on swallowing outcomes between interventions. From the current evidence, no direct comparisons could be made of swallowing outcomes between the surgical and non-surgical modalities. Swallowing is a multidimensional construct, and the range of assessments utilised by authors reflects the variety of available reporting methods. The MD Anderson Dysphagia Inventory is a subjective measure that allows limited comparison between the currently available heterogeneous data, and is explored in detail. The findings highlight that further research may identify the most appropriate tools for measuring swallowing in patients with OPSCC. Consensus should allow their standardised integration into future studies and randomised control trials. © 2015 John Wiley & Sons Ltd.
Analysis of baseline, average, and longitudinally measured blood pressure data using linear mixed models.

PubMed

Hossain, Ahmed; Beyene, Joseph

2014-01-01

This article compares baseline, average, and longitudinal data analysis methods for identifying genetic variants in genome-wide association study using the Genetic Analysis Workshop 18 data. We apply methods that include (a) linear mixed models with baseline measures, (b) random intercept linear mixed models with mean measures outcome, and (c) random intercept linear mixed models with longitudinal measurements. In the linear mixed models, covariates are included as fixed effects, whereas relatedness among individuals is incorporated as the variance-covariance structure of the random effect for the individuals. The overall strategy of applying linear mixed models decorrelate the data is based on Aulchenko et al.'s GRAMMAR. By analyzing systolic and diastolic blood pressure, which are used separately as outcomes, we compare the 3 methods in identifying a known genetic variant that is associated with blood pressure from chromosome 3 and simulated phenotype data. We also analyze the real phenotype data to illustrate the methods. We conclude that the linear mixed model with longitudinal measurements of diastolic blood pressure is the most accurate at identifying the known single-nucleotide polymorphism among the methods, but linear mixed models with baseline measures perform best with systolic blood pressure as the outcome.
Correlation of Site of Embryo Transfer with IVF Outcome: Analysis of 743 Cycles from a Single Center

PubMed Central

Singh, Neeta; Lata, Kusum; Malhotra, Neena; Vanamail, P.

2017-01-01

Objective: To investigate the influence of site of embryo transfer (ET) on reproductive outcome. Materials and Methods: A retrospective analysis of 743 ultrasound-guided ET in fresh in vitro fertilization (IVF) cycles from a single center over a period of 4 years was conducted. The distance between the fundal endometrial surface and the air bubble was measured, and accordingly, patients were divided into four groups (≤10 mm; >10 and ≤15 mm; >15 and 20 mm; >20 and <25 mm). Setting: Tertiary Assisted Reproductive Technology (ART) center. Patient(s): All patients enrolled in the IVF program undergoing ET. Intervention(s): Controlled ovarian hyperstimulation (OS), IVF, and ET. Main Outcome Measure(s): Cleavage rate and clinical pregnancy rate. Result(s): Clinical pregnancy rate was significantly more in groups 2 and 3 compared to the other groups. Logistic regression analysis showed that one unit increase in embryos transfer will enhance the pregnancy outcome about 3.7 (adjusted odds ratio) times with 95% confidence limits 2.6 to 5.4. Similarly, pregnancy outcome will be 3.1 (95% confidence limits: 1.5–6.4) times higher for distance group >15 and <20 mm compared to less than 10-mm distance group. Ectopic pregnancy rates were similar in all the four groups. Conclusion: The present study demonstrates that site of ET has significant difference on reproductive outcome. PMID:28904498
Smoking outcome expectancies in military veteran smokers with posttraumatic stress disorder.

PubMed

Carmody, Timothy P; McFall, Miles; Saxon, Andrew J; Malte, Carol A; Chow, Bruce; Joseph, Anne M; Beckham, Jean C; Cook, Jessica W

2012-08-01

Smoking outcome expectancies were investigated in treatment-seeking military Veteran smokers with posttraumatic stress disorder (PTSD). The investigation of smoking outcome expectancies may enhance our understanding of the relationship between PTSD and cigarette smoking. Participants were 943 military Veterans with a diagnosis of PTSD who were current smokers enrolled in a randomized multisite effectiveness trial to test whether the integration of smoking cessation treatment into mental health care (integrated care) improves prolonged abstinence rates compared with referral to specialized smoking cessation clinics (usual care). Using confirmatory factor analysis (CFA), we evaluated the conceptual model of smoking outcome expectancies measured on the Smoking Consequences Questionnaire-Adult (SCQ-A) version. The Kraemer method of mediation analysis was used to investigate the role of smoking outcome expectancies in mediating relationships between PTSD symptoms and smoking behavior, tobacco dependence, and abstinence self-efficacy. The CFA supported the 10-factor structure of the SCQ-A in smokers with PTSD. Relationships between measures of PTSD symptoms and tobacco dependence were mediated by the smoking outcome expectancy regarding negative affect reduction. This same smoking outcome expectancy mediated relationships between PTSD symptoms and smoking abstinence self-efficacy. The findings support the use of the SCQ-A as a valid measure of smoking outcome expectancies in military Veteran smokers with PTSD. Moreover, they suggest that smoking outcome expectancies may play an important role in explaining the relationship between PTSD and cigarette smoking.
Wound healing outcomes: Using big data and a modified intent-to-treat method as a metric for reporting healing rates.

PubMed

Ennis, William J; Hoffman, Rachel A; Gurtner, Geoffrey C; Kirsner, Robert S; Gordon, Hanna M

2017-08-01

Chronic wounds are increasing in prevalence and are a costly problem for the US healthcare system and throughout the world. Typically outcomes studies in the field of wound care have been limited to small clinical trials, comparative effectiveness cohorts and attempts to extrapolate results from claims databases. As a result, outcomes in real world clinical settings may differ from these published studies. This study presents a modified intent-to-treat framework for measuring wound outcomes and measures the consistency of population based outcomes across two distinct settings. In this retrospective observational analysis, we describe the largest to date, cohort of patient wound outcomes derived from 626 hospital based clinics and one academic tertiary care clinic. We present the results of a modified intent-to-treat analysis of wound outcomes as well as demographic and descriptive data. After applying the exclusion criteria, the final analytic sample includes the outcomes from 667,291 wounds in the national sample and 1,788 wounds in the academic sample. We found a consistent modified intent to treat healing rate of 74.6% from the 626 clinics and 77.6% in the academic center. We recommend that a standard modified intent to treat healing rate be used to report wound outcomes to allow for consistency and comparability in measurement across providers, payers and healthcare systems. © 2017 by the Wound Healing Society.
Meta-analysis of randomized controlled trials comparing outcomes for stapled hemorrhoidopexy versus LigaSure hemorrhoidectomy for symptomatic hemorrhoids in adults.

PubMed

Lee, Ko-Chao; Chen, Hong-Hwa; Chung, Kuan-Chih; Hu, Wan-Hsiang; Chang, Chia-Lo; Lin, Shung-Eing; Tsai, Kai-Lung; Lu, Chien-Chang

2013-01-01

This purpose of the meta-analysis was to compare treatment outcomes for adult patients with symptomatic hemorrhoids treated by stapled hemorrhoidopexy or LigaSure hemorrhoidectomy. A search of public medical databases was made to identify randomized controlled trials (RCTs) comparing stapled hemorrhoidopexy (SH) with LigaSure hemorrhoidectomy (LH) for the treatment of adult patients with symptomatic grade 3 and grade 4 hemorrhoids. Postoperative pain as measured using a visual analog scale was the primary outcome, and rate of recurrent prolapse and postoperative bleeding were secondary outcome measures. Four RCTs were identified that met the inclusion criteria. Data for the pooled outcomes were analyzed using odds ratio (OR) analysis. None of the studies in the analysis indicated a significant difference between SH and LH for the outcomes VAS pain score, recurrence rate, or postoperative bleeding. Pooled analysis revealed a significant OR in favor of the SH method for recurrent prolapse (OR = 5.529, P = 0.016) for up to 2 years after surgery. No significant differences between the two methods were identified for VAS pain scores (OR = -1.060, P = 0.149) or postoperative bleeding OR = 1.188, P = 0.871). Pooled analysis of RCT results comparing SH to LH for symptomatic hemorrhoids revealed a significantly greater incidence of recurrent prolapse for SH. The two techniques were associated with similar levels of postoperative pain and postoperative bleeding. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Measuring voice outcomes: state of the science review.

PubMed

Carding, Pau N; Wilson, J A; MacKenzie, K; Deary, I J

2009-08-01

Researchers evaluating voice disorder interventions currently have a plethora of voice outcome measurement tools from which to choose. Faced with such a wide choice, it would be beneficial to establish a clear rationale to guide selection. This article reviews the published literature on the three main areas of voice outcome assessment: (1) perceptual rating of voice quality, (2) acoustic measurement of the speech signal and (3) patient self-reporting of voice problems. We analysed the published reliability, validity, sensitivity to change and utility of the common outcome measurement tools in each area. From the data, we suggest that routine voice outcome measurement should include (1) an expert rating of voice quality (using the Grade-Roughness-Breathiness-Asthenia-Strain rating scale) and (2) a short self-reporting tool (either the Vocal Performance Questionnaire or the Vocal Handicap Index 10). These measures have high validity, the best reported reliability to date, good sensitivity to change data and excellent utility ratings. However, their application and administration require attention to detail. Acoustic measurement has arguable validity and poor reliability data at the present time. Other areas of voice outcome measurement (e.g. stroboscopy and aerodynamic phonatory measurements) require similarly detailed research and analysis.
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
Random measurement error: Why worry? An example of cardiovascular risk factors.

PubMed

Brakenhoff, Timo B; van Smeden, Maarten; Visseren, Frank L J; Groenwold, Rolf H H

2018-01-01

With the increased use of data not originally recorded for research, such as routine care data (or 'big data'), measurement error is bound to become an increasingly relevant problem in medical research. A common view among medical researchers on the influence of random measurement error (i.e. classical measurement error) is that its presence leads to some degree of systematic underestimation of studied exposure-outcome relations (i.e. attenuation of the effect estimate). For the common situation where the analysis involves at least one exposure and one confounder, we demonstrate that the direction of effect of random measurement error on the estimated exposure-outcome relations can be difficult to anticipate. Using three example studies on cardiovascular risk factors, we illustrate that random measurement error in the exposure and/or confounder can lead to underestimation as well as overestimation of exposure-outcome relations. We therefore advise medical researchers to refrain from making claims about the direction of effect of measurement error in their manuscripts, unless the appropriate inferential tools are used to study or alleviate the impact of measurement error from the analysis.
Outcome measurement of hand function following mirror therapy for stroke rehabilitation: A systematic review.

PubMed

Cantero-Téllez, Raquel; Naughton, Nancy; Algar, Lori; Valdes, Kristin

2018-02-28

Systematic review. Mirror therapy is a treatment used to address hand function following a stroke. Measurement of outcomes using appropriate assessment tools is crucial; however, many assessment options exist. The purpose of this study is to systematically review outcome measures that are used to assess hand function following mirror therapy after stroke and, in addition, to identify the psychometric and descriptive properties of the included measures and through the linking process determine if the outcome measures are representative of the International Classification of Functioning, Disability and Health (ICF). Following a comprehensive literature search, outcome measures used in the included studies were linked to the ICF and analyzed based on descriptive information and psychometric properties. Eleven studies met inclusion criteria and included 24 different assessment tools to measure hand or upper limb function. Most outcome measures used in the selected studies (63%) were rated by the evaluating therapist. Thirteen outcome measures (54%) linked to the ICF body function category and 10 measures (42%) linked to activities and participation. One outcome measure was linked to not defined, and all other ICF categories were not represented. A majority of outcome measures have been assessed for validity, reliability, and responsiveness, but responsiveness was the least investigated psychometric property. Current studies on mirror therapy after stroke are not consistent in the assessment tools used to determine hand function. Understanding of study outcomes requires analysis of the assessment tools. The outcome measures used in the included studies are not representative of personal and environmental factors, but tools linking to body functions and activities and participations provide important information on functional outcome. Integrating a combination of measures that are psychometrically sound and reflective of the ICF should be considered for assessment of hand function after mirror therapy after stroke. Copyright © 2018 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.
Examining the role of unmeasured confounding in mediation analysis with genetic and genomic applications.

PubMed

Lutz, Sharon M; Thwing, Annie; Schmiege, Sarah; Kroehl, Miranda; Baker, Christopher D; Starling, Anne P; Hokanson, John E; Ghosh, Debashis

2017-07-19

In mediation analysis if unmeasured confounding is present, the estimates for the direct and mediated effects may be over or under estimated. Most methods for the sensitivity analysis of unmeasured confounding in mediation have focused on the mediator-outcome relationship. The Umediation R package enables the user to simulate unmeasured confounding of the exposure-mediator, exposure-outcome, and mediator-outcome relationships in order to see how the results of the mediation analysis would change in the presence of unmeasured confounding. We apply the Umediation package to the Genetic Epidemiology of Chronic Obstructive Pulmonary Disease (COPDGene) study to examine the role of unmeasured confounding due to population stratification on the effect of a single nucleotide polymorphism (SNP) in the CHRNA5/3/B4 locus on pulmonary function decline as mediated by cigarette smoking. Umediation is a flexible R package that examines the role of unmeasured confounding in mediation analysis allowing for normally distributed or Bernoulli distributed exposures, outcomes, mediators, measured confounders, and unmeasured confounders. Umediation also accommodates multiple measured confounders, multiple unmeasured confounders, and allows for a mediator-exposure interaction on the outcome. Umediation is available as an R package at https://github.com/SharonLutz/Umediation A tutorial on how to install and use the Umediation package is available in the Additional file 1.

Low Back Pain Subgroups using Fear-Avoidance Model Measures: Results of a Cluster Analysis

PubMed Central

Beneciuk, Jason M.; Robinson, Michael E.; George, Steven Z.

2012-01-01

Objectives The purpose of this secondary analysis was to test the hypothesis that an empirically derived psychological subgrouping scheme based on multiple Fear-Avoidance Model (FAM) constructs would provide additional capabilities for clinical outcomes in comparison to a single FAM construct. Methods Patients (n = 108) with acute or sub-acute low back pain (LBP) enrolled in a clinical trial comparing behavioral physical therapy interventions to classification based physical therapy completed baseline questionnaires for pain catastrophizing (PCS), fear-avoidance beliefs (FABQ-PA, FABQ-W), and patient-specific fear (FDAQ). Clinical outcomes were pain intensity and disability measured at baseline, 4-weeks, and 6-months. A hierarchical agglomerative cluster analysis was used to create distinct cluster profiles among FAM measures and discriminant analysis was used to interpret clusters. Changes in clinical outcomes were investigated with repeated measures ANOVA and differences in results based on cluster membership were compared to FABQ-PA subgrouping used in the original trial. Results Three distinct FAM subgroups (Low Risk, High Specific Fear, and High Fear & Catastrophizing) emerged from cluster analysis. Subgroups differed on baseline pain and disability (p’s<.01) with the High Fear & Catastrophizing subgroup associated with greater pain than the Low Risk subgroup (p<.01) and the greatest disability (p’s<.05). Subgroup × time interactions were detected for both pain and disability (p’s<.05) with the High Fear & Catastrophizing subgroup reporting greater changes in pain and disability than other subgroups (p’s<.05). In contrast, FABQ-PA subgroups used in the original trial were not associated with interactions for clinical outcomes. Discussion These data suggest that subgrouping based on multiple FAM measures may provide additional information on clinical outcomes in comparison to determining subgroup status by FABQ-PA alone. Subgrouping methods for patients with LBP should include multiple psychological factors to further explore if patients can be matched with appropriate interventions. PMID:22510537
Measures of Social Deprivation That Predict Health Care Access and Need within a Rational Area of Primary Care Service Delivery

PubMed Central

Butler, Danielle C; Petterson, Stephen; Phillips, Robert L; Bazemore, Andrew W

2013-01-01

Objective To develop a measure of social deprivation that is associated with health care access and health outcomes at a novel geographic level, primary care service area. Data Sources/Study Setting Secondary analysis of data from the Dartmouth Atlas, AMA Masterfile, National Provider Identifier data, Small Area Health Insurance Estimates, American Community Survey, Area Resource File, and Behavioural Risk Factor Surveillance System. Data were aggregated to primary care service areas (PCSAs). Study Design Social deprivation variables were selected from literature review and international examples. Factor analysis was used. Correlation and multivariate analyses were conducted between index, health outcomes, and measures of health care access. The derived index was compared with poverty as a predictor of health outcomes. Data Collection/Extraction Methods Variables not available at the PCSA level were estimated at block level, then aggregated to PCSA level. Principal Findings Our social deprivation index is positively associated with poor access and poor health outcomes. This pattern holds in multivariate analyses controlling for other measures of access. A multidimensional measure of deprivation is more strongly associated with health outcomes than a measure of poverty alone. Conclusions This geographic index has utility for identifying areas in need of assistance and is timely for revision of 35-year-old provider shortage and geographic underservice designation criteria used to allocate federal resources. PMID:22816561
Femoral neck shortening in adult patients under the age of 55 years is associated with worse functional outcomes: Analysis of the prospective multi-center study of hip fracture outcomes in China (SHOC).

PubMed

Slobogean, Gerard P; Stockton, David J; Zeng, Bing-Fang; Wang, Dong; Ma, Baotong; Pollak, Andrew N

2017-08-01

Young femoral neck fracture patients require surgical fixation to preserve the native hip joint and accommodate increased functional demands. Recent reports have identified a high incidence of fracture shortening and this may have negative functional consequences. We sought to determine if fracture shortening is associated with poor functional outcome in young femoral neck fracture patients. One hundred and forty-two patients with femoral neck fractures age 18-55 were recruited in this prospective cohort study across three Level 1 trauma hospitals in Mainland China. Patient-reported and objective functional outcomes were measured with the Harris Hip Score (HHS), Timed Up and Go (TUG), and SF-36 Physical Component Summary (SF-36 PCS) at 12 months. Radiographic fracture shortening was measured along the long axis of the femoral neck and corrected for magnification. Severe shortening was defined as ≥10mm. The primary analysis measured associations between severe radiographic shortening and HHS at one-year post-fixation. One hundred and two patients had complete radiographic and functional outcomes available for analysis at one year. The mean age of participants was 43.7±10.8years and 53% were male. Fifty-five percent of fractures were displaced and 37% were vertically orientated (Pauwels Type 3). The mean functional outcome scores were: HHS 90.0±10.8, TUG 12.0±5.1s, and PCS 48.5±8.6. Severe shortening occurred in 13% of patients and was associated with worse functional outcome scores: HHS mean difference 9.9 (p=0.025), TUG mean difference 3.2s (p=0.082), and PCS mean difference 5.4 (p=0.055). Severe shortening is associated with clinically important decreases in functional outcome as measured by HHS following fixation of young femoral neck fractures, occurring in 13% of patients in this population. The principle of fracture site compression utilized by modern constructs may promote healing; however, excessive shortening is associated with worse patient-reported outcomes and objective functional measures. Copyright © 2017 Elsevier Ltd. All rights reserved.
The Importance of Comprehensive Cam Correction: Radiographic Parameters Are Predictive of Patient-Reported Outcome Measures at 2 Years After Hip Arthroscopy.

PubMed

Lansdown, Drew A; Kunze, Kyle; Ukwuani, Gift; Waterman, Brian R; Nho, Shane J

2018-06-01

The specific influence of preoperative and postoperative radiographic measurements on patient-reported outcome measures after hip arthroscopy for femoroacetabular impingement (FAI) remains unclear. To investigate the relationship between radiographic measurements and 2-year outcomes after hip arthroscopy for the treatment of FAI. Case series; Level of evidence, 4. A clinical registry of patients undergoing primary hip arthroscopy for FAI between January 1, 2012, and December 31, 2014, was queried. Outcome measures included the Hip Outcome Score (HOS) Activities of Daily Living (ADL), HOS Sport-Specific Subscale (SSS), modified Harris Hip Score (mHHS), and visual analog scale (VAS) for pain and satisfaction. Preoperative and postoperative radiographic measurements were recorded. Univariate analysis was conducted to identify relationships between all radiographic and demographic variables and outcome scores. A multivariate regression analysis, controlling for demographic factors, was used to identify independent associations between radiographic measurements on plain radiographs and patient-reported outcomes. The authors identified 707 patients who underwent primary hip arthroscopic management for FAI who were included for analysis. Two-year outcome surveys were completed for 78% to 84% of patients. The mean age of the patients was 33.2 ± 12.3 years, and 64.4% of the patients (n = 456) were female. The mean anteroposterior (AP) alpha angle decreased by 34.3° ( P < .0001), false profile alpha angle by 25.2° ( P < .0001), Dunn lateral alpha angle by 28.9° ( P < .0001), lateral center edge angle by 2.6° ( P < .0001), and anterior center edge angle by 3.4° ( P < .0001). The HOS-ADL score increased from 65.7 ± 18.7 preoperatively to 85.9 ± 16.7 postoperatively ( P < .0001), HOS-SSS increased from 43.4 ± 23.1 to 72.6 ± 27.2 ( P < .0001), and mHHS increased from 57.7 ± 14.0 to 79.1 ± 17.2 ( P < .0001). With multivariate analysis, independent predictors of the postoperative HOS-ADL score included the preoperative false profile alpha angle (beta = -0.16, P = .028). Independent predictors of HOS-SSS score were preoperative AP alpha angle (beta = -0.33, P = .032) and preoperative false profile alpha angle (beta = -0.28, P = .041). For the postoperative mHHS score, independent predictors included preoperative AP alpha angle (beta = -0.18, P = .046), preoperative false profile alpha angle (beta = -0.20, P = .014), and postoperative false profile alpha angle (beta = -0.48, P = .035). The preoperative AP alpha angle (beta = 0.28, P = .024) was a significant predictor for the postoperative VAS pain score. The preoperative false profile alpha angle (beta = -0.34, P = .040) was a significant predictor for the postoperative VAS satisfaction score. The authors observed that radiographic measurements, specifically the preoperative false profile alpha angle, AP alpha angle, and postoperative false profile alpha angle, are independent predictors of 2-year clinical outcomes. The femoral-side measurements were the strongest independent predictors of outcomes, especially measurements of the anterior and lateral-based CAM lesion.
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 ...
TROPHI: development of a tool to measure complex, multi-factorial patient handling interventions.

PubMed

Fray, Mike; Hignett, Sue

2013-01-01

Patient handling interventions are complex and multi-factorial. It has been difficult to make comparisons across different strategies due to the lack of a comprehensive outcome measurement method. The Tool for Risk Outstanding in Patient Handling Interventions (TROPHI) was developed to address this gap by measuring outcomes and comparing performance across interventions. Focus groups were held with expert patient handling practitioners (n = 36) in four European countries (Finland, Italy, Portugal and the UK) to identify preferred outcomes to be measured for interventions. A systematic literature review identified 598 outcome measures; these were critically appraised and the most appropriate measurement tool was selected for each outcome. TROPHI was evaluated in the four EU countries (eight sites) and by an expert panel (n = 16) from the European Panel of Patient Handling Ergonomics for usability and practical application. This final stage added external validity to the research by exploring transferability potential and presenting the data and analysis to allow respondent (participant) validation. Patient handling interventions are complex and multi-factorial and it has been difficult to make comparisons due to the lack of a comprehensive outcome measurement method. The Tool for Risk Outstanding in Patient Handling Interventions (TROPHI) was developed to address this gap by measuring outcomes to compare performance across interventions.
Safety outcomes in the United States: trends and challenges in measurement.

PubMed

Greenberg, Michael D; Haviland, Amelia M; Yu, Hao; Farley, Donna O

2009-04-01

To prepare Agency for Healthcare Research and Quality (AHRQ) for monitoring the impact of its own patient safety initiative, by exploring available outcomes data, assessing usability of measures, and estimating national trends in patient outcomes. Annual summary data on incidence of Joint Commission Sentinel Events, MEDMARX medication error events, and MDS measures of falls and pressure ulcers in nursing home residents. HCUP National Inpatient Sample (NIS) administrative claims data. Description and assessment of published summary data on selected safety measures. Analysis of selected Patient Safety Indicators (PSIs) and Utah–Missouri adverse event measures using HCUP NIS claims data (1994–2003). Interpretation of safety outcome trends requires close attention to the characteristics of underlying data sources and measures. Encounter-based measures have been affected by changes in definitions and ICD-9 coding, as well as by changes in the structure of administrative datasets like HCUP NIS. Historical trends are mixed for the safety outcome measures reviewed, with some measures showing improvement, others deterioration, and still others remaining fairly stable. Constructing national trends of safety outcomes is difficult because of limitations in available data sources and measures. Tracking growth in the adoption of safe practices could offer an important strategy for complementing existing safety measurement capabilities.
Analysis of Traditional versus Three-Dimensional Augmented Curriculum on Anatomical Learning Outcome Measures

ERIC Educational Resources Information Center

Peterson, Diana Coomes; Mlynarczyk, Gregory S.A.

2016-01-01

This study examined whether student learning outcome measures are influenced by the addition of three-dimensional and digital teaching tools to a traditional dissection and lecture learning format curricula. The study was performed in a semester long graduate level course that incorporated both gross anatomy and neuroanatomy curricula. Methods…
Measuring the Outcomes of State Policies for Gifted Education: An Equity Analysis of Texas School Districts.

ERIC Educational Resources Information Center

Baker, Bruce D.

2001-01-01

This article introduces a set of policy tools for measuring outcomes of gifted education policies and applies these tools to data on the distribution of Texas gifted education spending. Results indicate continued vast inequities across school districts and unacceptable correlations among student population characteristics, community wealth, and…
General Outcome Measures for Verbal Operants

ERIC Educational Resources Information Center

Kubina, Richard M., Jr.; Wolfe, Pamela; Kostewicz, Douglas E.

2009-01-01

A general outcome measure (GOM) can be used to show progress towards a long-term goal. GOMs should sample domains of behavior across ages, be sensitive to change over time, be inexpensive and easy to use, and facilitate decision making. Skinner's (1957) analysis of verbal behavior may benefit from the development of GOM. To develop GOM, we…
Modeling the outcomes of nursing home care.

PubMed

Rohrer, J E; Hogan, A J

1987-01-01

In this exploratory analysis using data on 290 patients, we use regression analysis to model patient outcomes in two Veterans Administration nursing homes. We find resource use, as measured with minutes of nursing time, to be associated with outcomes when case mix is controlled. Our results suggest that, under case-based reimbursement systems, nursing homes could increase their revenues by withholding unskilled and psychosocial care and discouraging physicians' visits. Implications for nursing home policy are discussed.
Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

PubMed

Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

2015-04-15

Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.
Comparative Study of Outcome Measures and Analysis Methods for Traumatic Brain Injury Trials

PubMed Central

Alali, Aziz S.; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B.

2015-01-01

Abstract Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a “super” dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data. PMID:25317951
Glyburide-Novel Prophylaxis and Effective Treatment for Traumatic Brain Injury

DTIC Science & Technology

2011-08-01

between apnea and various neurological abnormalities measured at 24 hours and at later times. Indeed, our analysis showed a high degree of correlation...7 and 14 after blast-TBI. Conventional Analysis . After blast-TBI, we observed significant deficits in un- coerced (spontaneous Rearing) and in...intensity-response” relationship between blast intensity and outcome. Detailed analysis of the outcomes at 24 hours in individual animals showed
Examining the Error of Mis-Specifying Nonlinear Confounding Effect With Application on Accelerometer-Measured Physical Activity.

PubMed

Lee, Paul H

2017-06-01

Some confounders are nonlinearly associated with dependent variables, but they are often adjusted using a linear term. The purpose of this study was to examine the error of mis-specifying the nonlinear confounding effect. We carried out a simulation study to investigate the effect of adjusting for a nonlinear confounder in the estimation of a causal relationship between the exposure and outcome in 3 ways: using a linear term, binning into 5 equal-size categories, or using a restricted cubic spline of the confounder. Continuous, binary, and survival outcomes were simulated. We examined the confounder across varying measurement error. In addition, we performed a real data analysis examining the 3 strategies to handle the nonlinear effects of accelerometer-measured physical activity in the National Health and Nutrition Examination Survey 2003-2006 data. The mis-specification of a nonlinear confounder had little impact on causal effect estimation for continuous outcomes. For binary and survival outcomes, this mis-specification introduced bias, which could be eliminated using spline adjustment only when there is small measurement error of the confounder. Real data analysis showed that the associations between high blood pressure, high cholesterol, and diabetes and mortality adjusted for physical activity with restricted cubic spline were about 3% to 11% larger than their counterparts adjusted with a linear term. For continuous outcomes, confounders with nonlinear effects can be adjusting with a linear term. Spline adjustment should be used for binary and survival outcomes on confounders with small measurement error.
Mediation analysis when a continuous mediator is measured with error and the outcome follows a generalized linear model

PubMed Central

Valeri, Linda; Lin, Xihong; VanderWeele, Tyler J.

2014-01-01

Mediation analysis is a popular approach to examine the extent to which the effect of an exposure on an outcome is through an intermediate variable (mediator) and the extent to which the effect is direct. When the mediator is mis-measured the validity of mediation analysis can be severely undermined. In this paper we first study the bias of classical, non-differential measurement error on a continuous mediator in the estimation of direct and indirect causal effects in generalized linear models when the outcome is either continuous or discrete and exposure-mediator interaction may be present. Our theoretical results as well as a numerical study demonstrate that in the presence of non-linearities the bias of naive estimators for direct and indirect effects that ignore measurement error can take unintuitive directions. We then develop methods to correct for measurement error. Three correction approaches using method of moments, regression calibration and SIMEX are compared. We apply the proposed method to the Massachusetts General Hospital lung cancer study to evaluate the effect of genetic variants mediated through smoking on lung cancer risk. PMID:25220625
Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS.

PubMed

Saldanha, Ian J; Li, Tianjing; Yang, Cui; Ugarte-Gil, Cesar; Rutherford, George W; Dickersin, Kay

2016-02-01

Methods to develop core outcome sets, the minimum outcomes that should be measured in research in a topic area, vary. We applied social network analysis methods to understand outcome co-occurrence patterns in human immunodeficiency virus (HIV)/AIDS systematic reviews and identify outcomes central to the network of outcomes in HIV/AIDS. We examined all Cochrane reviews of HIV/AIDS as of June 2013. We defined a tie as two outcomes (nodes) co-occurring in ≥2 reviews. To identify central outcomes, we used normalized node betweenness centrality (nNBC) (the extent to which connections between other outcomes in a network rely on that outcome as an intermediary). We conducted a subgroup analysis by HIV/AIDS intervention type (i.e., clinical management, biomedical prevention, behavioral prevention, and health services). The 140 included reviews examined 1,140 outcomes, 294 of which were unique. The most central outcome overall was all-cause mortality (nNBC = 23.9). The most central and most frequent outcomes differed overall and within subgroups. For example, "adverse events (specified)" was among the most central but not among the most frequent outcomes, overall. Social network analysis methods are a novel application to identify central outcomes, which provides additional information potentially useful for developing core outcome sets. Copyright © 2016 Elsevier Inc. All rights reserved.
Measurement issues in the evaluation of chronic disease self-management programs.

PubMed

Nolte, Sandra; Elsworth, Gerald R; Newman, Stanton; Osborne, Richard H

2013-09-01

To provide an in-depth analysis of outcome measures used in the evaluation of chronic disease self-management programs consistent with the Stanford curricula. Based on a systematic review on self-management programs, effect sizes derived from reported outcome measures are categorized according to the quality of life appraisal model developed by Schwartz and Rapkin which classifies outcomes from performance-based measures (e.g., clinical outcomes) to evaluation-based measures (e.g., emotional well-being). The majority of outcomes assessed in self-management trials are based on evaluation-based methods. Overall, effects on knowledge--the only performance-based measure observed in selected trials--are generally medium to large. In contrast, substantially more inconsistent results are found for both perception- and evaluation-based measures that mostly range between nil and small positive effects. Effectiveness of self-management interventions and resulting recommendations for health policy makers are most frequently derived from highly variable evaluation-based measures, that is, types of outcomes that potentially carry a substantial amount of measurement error and/or bias such as response shift. Therefore, decisions regarding the value and efficacy of chronic disease self-management programs need to be interpreted with care. More research, especially qualitative studies, is needed to unravel cognitive processes and the role of response shift bias in the measurement of change.
Key performance outcomes of patient safety curricula: root cause analysis, failure mode and effects analysis, and structured communications skills.

PubMed

Fassett, William E

2011-10-10

As colleges and schools of pharmacy develop core courses related to patient safety, course-level outcomes will need to include both knowledge and performance measures. Three key performance outcomes for patient safety coursework, measured at the course level, are the ability to perform root cause analyses and healthcare failure mode effects analyses, and the ability to generate effective safety communications using structured formats such as the Situation-Background-Assessment-Recommendation (SBAR) situational briefing model. Each of these skills is widely used in patient safety work and competence in their use is essential for a pharmacist's ability to contribute as a member of a patient safety team.
Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.

PubMed

Soni-Jaiswal, Archana; Lakhani, Raj; Hopkins, Claire

2017-07-11

A core outcome set (COS) is an agreed standardised collection of outcomes that should be measured and reported by all trials for a specific clinical area, in this case chronic rhinosinusitis. These are not restrictive and researchers may continue to explore other outcomes alongside these that they feel are relevant to their intervention. The aim of this systematic review was to identify the need for a COS for chronic rhinosinusitis. A sensitive search strategy was used to identify all published Cochrane systematic reviews and randomised control trials of intervention for adult patients with chronic rhinosinusitis. Two independent authors reviewed these to obtain a list of outcomes and outcome measures reported by each clinical trial. Sixty-nine randomised control trials and eight Cochrane systematic reviews were included in this study. They reported 68 individual outcomes and outcome measures, with an average of four to ten outcomes per clinical trial. These outcomes were mapped to 23 subcategories belonging to eight core categories. The key finding of this review was the heterogeneity of outcomes reported and measured by clinical trials of patients with chronic rhinosinusitis, precluding meaningful meta-analysis of data. This review supports the need for development of a COS, to be used in future trials on adult patients with chronic rhinosinusitis.

Cluster analysis and prediction of treatment outcomes for chronic rhinosinusitis.

PubMed

Soler, Zachary M; Hyer, J Madison; Rudmik, Luke; Ramakrishnan, Viswanathan; Smith, Timothy L; Schlosser, Rodney J

2016-04-01

Current clinical classifications of chronic rhinosinusitis (CRS) have weak prognostic utility regarding treatment outcomes. Simplified discriminant analysis based on unsupervised clustering has identified novel phenotypic subgroups of CRS, but prognostic utility is unknown. We sought to determine whether discriminant analysis allows prognostication in patients choosing surgery versus continued medical management. A multi-institutional prospective study of patients with CRS in whom initial medical therapy failed who then self-selected continued medical management or surgical treatment was used to separate patients into 5 clusters based on a previously described discriminant analysis using total Sino-Nasal Outcome Test-22 (SNOT-22) score, age, and missed productivity. Patients completed the SNOT-22 at baseline and for 18 months of follow-up. Baseline demographic and objective measures included olfactory testing, computed tomography, and endoscopy scoring. SNOT-22 outcomes for surgical versus continued medical treatment were compared across clusters. Data were available on 690 patients. Baseline differences in demographics, comorbidities, objective disease measures, and patient-reported outcomes were similar to previous clustering reports. Three of 5 clusters identified by means of discriminant analysis had improved SNOT-22 outcomes with surgical intervention when compared with continued medical management (surgery was a mean of 21.2 points better across these 3 clusters at 6 months, P < .05). These differences were sustained at 18 months of follow-up. Two of 5 clusters had similar outcomes when comparing surgery with continued medical management. A simplified discriminant analysis based on 3 common clinical variables is able to cluster patients and provide prognostic information regarding surgical treatment versus continued medical management in patients with CRS. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Astronaut Preflight Cardiovascular Variables Associated with Vascular Compliance are Highly Correlated with Post-Flight Eye Outcome Measures in the Visual Impairment Intracranial Pressure (VIIP) Syndrome Following Long Duration Spaceflight

NASA Technical Reports Server (NTRS)

Otto, Christian; Ploutz-Snyder, R.

2015-01-01

The detection of the first VIIP case occurred in 2005, and adequate eye outcome measures were available for 31 (67.4%) of the 46 long duration US crewmembers who had flown on the ISS since its first crewed mission in 2000. Therefore, this analysis is limited to a subgroup (22 males and 9 females). A "cardiovascular profile" for each astronaut was compiled by examining twelve individual parameters; eleven of these were preflight variables: systolic blood pressure, pulse pressure, body mass index, percentage body fat, LDL, HDL, triglycerides, use of anti-lipid medication, fasting serum glucose, and maximal oxygen uptake in ml/kg. Each of these variables was averaged across three preflight annual physical exams. Astronaut age prior to the long duration mission, and inflight salt intake was also included in the analysis. The group of cardiovascular variables for each crew member was compared with seven VIIP eye outcome variables collected during the immediate post-flight period: anterior-posterior axial length of the globe measured by ultrasound and optical biometry; optic nerve sheath diameter, optic nerve diameter, and optic nerve to sheath ratio- each measured by ultrasound and magnetic resonance imaging (MRI), intraocular pressure (IOP), change in manifest refraction, mean retinal nerve fiber layer (RNFL) on optical coherence tomography (OCT), and RNFL of the inferior and superior retinal quadrants. Since most of the VIIP eye outcome measures were added sequentially beginning in 2005, as knowledge of the syndrome improved, data were unavailable for 22.0% of the outcome measurements. To address the missing data, we employed multivariate multiple imputation techniques with predictive mean matching methods to accumulate 200 separate imputed datasets for analysis. We were able to impute data for the 22.0% of missing VIIP eye outcomes. We then applied Rubin's rules for collapsing the statistical results across our 200 multiply imputed data sets to assess the canonical correlation between the eye outcomes and the twelve astronaut cardiovascular variables available for all 31 subjects. Results: A highly significant canonical correlation was observed among the canonical solutions (p<.00001), with an average best canonical correlation of.97. The results suggest a strong association between astronauts' measures of cardiovascular health and the seven eye outcomes of the VIIP syndrome used in this analysis. Furthermore, the "joint test" revealed a significant difference in cardiovascular profile between male and female astronauts (Prob > F = 0.00001). Overall, female astronauts demonstrated a significantly healthier cardiovascular status. Individually, the female astronauts had significantly healthier profiles on seven of twelve cardiovascular variables than the men (p values ranging from <0.0001 to <0.05). Male astronauts did not demonstrate significantly healthier values on any of the twelve cardiovascular variables measured
Optimising technology to measure functional vision, mobility and service outcomes for people with low vision or blindness: protocol for a prospective cohort study in Australia and Malaysia

PubMed Central

Deverell, Lil; Meyer, Denny; Lau, Bee Theng; Al Mahmud, Abdullah; Sukunesan, Suku; Bhowmik, Jahar; Chai, Almon; McCarthy, Chris; Zheng, Pan; Pipingas, Andrew; Islam, Fakir M Amirul

2017-01-01

Introduction Orientation and mobility (O&M) specialists assess the functional vision and O&M skills of people with mobility problems, usually relating to low vision or blindness. There are numerous O&M assessment checklists but no measures that reduce qualitative assessment data to a single comparable score suitable for assessing any O&M client, of any age or ability, in any location. Functional measures are needed internationally to align O&M assessment practices, guide referrals, profile O&M clients, plan appropriate services and evaluate outcomes from O&M programmes (eg, long cane training), assistive technology (eg, hazard sensors) and medical interventions (eg, retinal implants). This study aims to validate two new measures of functional performance vision-related outcomes in orientation and mobility (VROOM) and orientation and mobility outcomes (OMO) in the context of ordinary O&M assessments in Australia, with cultural comparisons in Malaysia, also developing phone apps and online training to streamline professional assessment practices. Methods and analysis This multiphase observational study will employ embedded mixed methods with a qualitative/quantitative priority: corating functional vision and O&M during social inquiry. Australian O&M agencies (n=15) provide the sampling frame. O&M specialists will use quota sampling to generate cross-sectional assessment data (n=400) before investigating selected cohorts in outcome studies. Cultural relevance of the VROOM and OMO tools will be investigated in Malaysia, where the tools will inform the design of assistive devices and evaluate prototypes. Exploratory and confirmatory factor analysis, Rasch modelling, cluster analysis and analysis of variance will be undertaken along with descriptive analysis of measurement data. Qualitative findings will be used to interpret VROOM and OMO scores, filter statistically significant results, warrant their generalisability and identify additional relevant constructs that could also be measured. Ethics and dissemination Ethical approval has been granted by the Human Research Ethics Committee at Swinburne University (SHR Project 2016/316). Dissemination of results will be via agency reports, journal articles and conference presentations. PMID:29273657
Which factors differentiate athletes with hip/groin pain from those without? A systematic review with meta-analysis

PubMed Central

Mosler, Andrea B; Agricola, Rintje; Weir, Adam; Hölmich, Per; Crossley, Kay M

2015-01-01

Background Hip and groin injuries are common in many sports. Understanding the factors differentiating athletes with hip/groin pain from those without these injuries could facilitate management and prevention. Objective Conduct a systematic review and meta-analysis of the literature on factors differentiating athletes with and without hip/groin pain. Methods The review was registered as PROSPERO CRD42014007416 and a comprehensive, systematic search was conducted in June 2014. Inclusion criteria were: cross-sectional, cohort or case–control study designs of n>10 that examined outcome measures differentiating athletes with and without hip/groin pain. Two authors independently screened search results, assessed study quality, and performed data extraction. Methodological heterogeneity was determined and data pooled for meta-analysis when appropriate. A best evidence synthesis was performed on the remaining outcome measures. Results Of 2251 titles identified, 17 articles were included of which 10 were high quality. Sixty two different outcome measures were examined, 8 underwent meta-analysis. Pooled data showed strong evidence that athletes with hip/groin pain demonstrated: pain and lower strength on the adductor squeeze test, reduced range of motion in hip internal rotation and bent knee fall out; however, hip external rotation range was equivalent to controls. Strong evidence was found that lower patient-reported outcome (PRO) scores, altered trunk muscle function, and moderate evidence of bone oedema and secondary cleft sign were associated with hip/groin pain. Conclusions PROs, pain and reduced strength on the adductor squeeze test, reduced range of motion in internal rotation and bent knee fall out are the outcome measures that best differentiate athletes with hip/groin pain from those without this pain. PMID:26031646
Utility of the Mayo-Portland adaptability inventory-4 for self-reported outcomes in a military sample with traumatic brain injury.

PubMed

Kean, Jacob; Malec, James F; Cooper, Douglas B; Bowles, Amy O

2013-12-01

To investigate the psychometric properties of the Mayo-Portland Adaptability Inventory-4 (MPAI-4) obtained by self-report in a large sample of active duty military personnel with traumatic brain injury (TBI). Consecutive cohort who completed the MPAI-4 as a part of a larger battery of clinical outcome measures at the time of intake to an outpatient brain injury clinic. Medical center. Consecutively referred sample of active duty military personnel (N=404) who suffered predominantly mild (n=355), but also moderate (n=37) and severe (n=12), TBI. Not applicable. MPAI-4 RESULTS: Initial factor analysis suggested 2 salient dimensions. In subsequent analysis, the ratio of the first and second eigenvalues (6.84:1) and parallel analysis indicated sufficient unidimensionality in 26 retained items. Iterative Rasch analysis resulted in the rescaling of the measure and the removal of 5 additional items for poor fit. The items of the final 21-item Mayo-Portland Adaptability Inventory-military were locally independent, demonstrated monotonically increasing responses, adequately fit the item response model, and permitted the identification of nearly 5 statistically distinct levels of disability in the study population. Slight mistargeting of the population resulted in the global outcome, as measured by the Mayo-Portland Adaptability Inventory-military, tending to be less reflective of very mild levels of disability. These data collected in a relatively large sample of active duty service members with TBI provide insight into the ability of patients to self-report functional impairment and the distinct effects of military deployment on outcome, providing important guidance for the meaningful measurement of outcome in this population. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Magnetic resonance imaging-based measures predictive of short-term surgical outcome in patients with Chiari malformation Type I: a pilot study.

PubMed

Alperin, Noam; Loftus, James Ryan; Bagci, Ahmet M; Lee, Sang H; Oliu, Carlos J; Shah, Ashish H; Green, Barth A

2017-01-01

OBJECTIVE This study identifies quantitative imaging-based measures in patients with Chiari malformation Type I (CM-I) that are associated with positive outcomes after suboccipital decompression with duraplasty. METHODS Fifteen patients in whom CM-I was newly diagnosed underwent MRI preoperatively and 3 months postoperatively. More than 20 previously described morphological and physiological parameters were derived to assess quantitatively the impact of surgery. Postsurgical clinical outcomes were assessed in 2 ways, based on resolution of the patient's chief complaint and using a modified Chicago Chiari Outcome Scale (CCOS). Statistical analyses were performed to identify measures that were different between the unfavorable- and favorable-outcome cohorts. Multivariate analysis was used to identify the strongest predictors of outcome. RESULTS The strongest physiological parameter predictive of outcome was the preoperative maximal cord displacement in the upper cervical region during the cardiac cycle, which was significantly larger in the favorable-outcome subcohorts for both outcome types (p < 0.05). Several hydrodynamic measures revealed significantly larger preoperative-to-postoperative changes in the favorable-outcome subcohort. Predictor sets for the chief-complaint classification included the cord displacement, percent venous drainage through the jugular veins, and normalized cerebral blood flow with 93.3% accuracy. Maximal cord displacement combined with intracranial volume change predicted outcome based on the modified CCOS classification with similar accuracy. CONCLUSIONS Tested physiological measures were stronger predictors of outcome than the morphological measures in patients with CM-I. Maximal cord displacement and intracranial volume change during the cardiac cycle together with a measure that reflects the cerebral venous drainage pathway emerged as likely predictors of decompression outcome in patients with CM-I.
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.
THE ANALYSIS OF MIXED 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, and multiple analyses may increase the overall type I error. One approach to analyzing these outcomes in an integrated way is through the use of a composite score. We int...
Diffusion Tensor Imaging in Relation to Cognitive and Functional Outcome of Traumatic Brain Injury in Children

PubMed Central

Levin, Harvey S.; Wilde, Elisabeth A.; Chu, Zili; Yallampalli, Ragini; Hanten, Gerri R.; Li, Xiaoqi; Chia, Jon; Vasquez, Carmen; Hunter, Jill V.

2008-01-01

Objective To investigate the relation of white matter integrity using diffusion tensor imaging (DTI) to cognitive and functional outcome of moderate to severe traumatic brain injury (TBI) in children. Design Prospective observational study of children who had sustained moderate to severe TBI and a comparison group of children who had sustained orthopedic injury (OI). Participants Thirty-two children who had sustained moderate to severe TBI and 36 children with OI were studied. Methods Fiber tracking analysis of DTI acquired at 3-month postinjury and assessment of global outcome and cognitive function within 2 weeks of brain imaging. Global outcome was assessed using the Glasgow Outcome Scale and the Flanker task was used to measure cognitive processing speed and resistance to interference. Results Fractional anisotropy and apparent diffusion coefficient values differentiated the groups and both cognitive and functional outcome measures were related to the DTI findings. Dissociations were present wherein the relation of Fractional anisotropy to cognitive performance differed between the TBI and OI groups. A DTI composite measure of white matter integrity was related to global outcome in the children with TBI. Conclusions DTI is sensitive to white matter injury at 3 months following moderate to severe TBI in children, including brain regions that appear normal on conventional magnetic resonance imaging. DTI measures reflecting diffusion of water parallel and perpendicular to white matter tracts as calculated by fiber tracking analysis are related to global outcome, cognitive processing speed, and speed of resolving interference in children with moderate to severe TBI. Longitudinal data are needed to determine whether these relations between DTI and neurobehavioral outcome of TBI in children persist at longer follow-up intervals. PMID:18650764
Performance Measurement using KPKU- BUMN in X School Education Foundation

NASA Astrophysics Data System (ADS)

Arijanto, Sugih; Harsono, Ambar; Taroepratjeka, Harsono

2016-01-01

The purpose of this research is to determine X School's Strengths and Opportunity of Improvement through performance measurement using KPKU-BUMN (Kriteria Penilaian Kinerja Unggul - Kementerian Badan Usaha Milik Negara). KPKU-BUMN is developed based on Malcolm Baldrige Criteria for Performance Excellent (MBCfPE). X school is an education foundation at Bandung that has provides education from kindergarten, elementary school, to junior and senior high school. The measurement is implemented by two aspects, Process and Result. The Process is measured by A-D-L-I approaches (Approach- Deployment-Learning- Integration), on the other hand The Result is measured by Le-T-C-I approach (Level-Trend- Comparison-Integration). There are six processes that will be measured: (1) Leadership, (2) Strategic Planning, (3) Customer Focus, (4) Measurement, Analysis and Knowledge Management, (5) Work Force Focus, and (6) Operation Focus. Meanwhile, the result are (a) product & process outcomes, (b) customer-focused outcomes, (c) workforce-focused outcomes, (d) leadership & governance outcomes, and (e) financial & market outcomes. The overall score for X School is 284/1000, which means X School is at “early result” level at “poor” global image.
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.
Subjective Socioeconomic Status and Adolescent Health: A Meta-Analysis

PubMed Central

Quon, Elizabeth C.; McGrath, Jennifer J.

2017-01-01

Objective To comprehensively and quantitatively examine the association between subjective socioeconomic status (SES) and health outcomes during adolescence. Methods Forty-four studies met criteria for inclusion in the meta-analysis. Information on study quality, demographics, subjective SES, health outcomes, and covariates were extracted from each study. Fisher’s Z was selected as the common effect size metric across studies. Random-effect meta-analytic models were employed and fail-safe numbers were generated to address publication bias. Results Overall, subjective SES was associated with health during adolescence (Fisher’s Z = .10). The magnitude of the effect varied by type of health outcome, with larger effects observed for mental health outcomes, self-rated health, and general health symptoms; and nonsignificant effects observed for biomarkers of health and substance-use-related health behaviors. Of the measures of subjective SES employed in the reviewed studies, perception of financial constraints, was most strongly associated with adolescent health outcomes. Analysis of covariates indicated that inclusion of objective SES covariates did not affect the association between subjective SES and health. Conclusions This meta-analysis has implications for the measurement of subjective SES in adolescents, for the conceptualization of subjective and objective SES, and for the pathways between SES and health in adolescents. PMID:24245837
Osteoarthritis year in review: rehabilitation and outcomes.

PubMed

Davis, A M

2012-03-01

This review highlights seminal publications of rehabilitation interventions and outcomes in osteoarthritis (OA) of the hip or knee. Medline, CINAHL, and Embase databases from September 2010 through August 2011 were searched using the key words 'osteoarthritis', rehabilitation, physical therapy, exercise, and outcome(s), limited to human and English. Rehabilitation intervention studies were included if they were randomized trials (RCT), systematic reviews or meta-analyses. Studies of surgical interventions were excluded unless they included evaluation of a rehabilitation intervention. Outcome studies were included if they contributed methodologically to advancing outcome measurement. Reviews of measurement properties of outcomes were excluded. Eight publications were selected and reviewed that relate to interventions evaluating manual therapy in hip or knee OA, tele-rehabilitation and performance and participation measures as outcomes. One systematic review of hip and knee OA, one meta-analysis of knee OA provide limited support for the benefit of manual therapy with exercise for improving pain and function to a lesser extent in the short-term (3 months). Study quality overall was low. One high quality RCT in knee replacement of usual outpatient physiotherapy vs internet-based tele-rehabilitation based on a non-inferiority analysis demonstrated comparable outcomes on Western Ontario McMaster Universities' Osteoarthritis questionnaire (WOMAC) pain and function and performance measures. Three studies demonstrated that observed performance measures such as timed walk tests and stair-climbing and timed-up-and-go measure concepts differ from self-report of difficulty with physical function. Additionally, two studies showed differential times of recovery following total knee replacement (TKR). Two studies evaluated participation. One demonstrated the conceptual distinction of activity limitations and participation and a second re-analyzed trial data from knee OA studies. In one study, there were larger effects in combined activity/participation than for activity alone for arthroscopic lavage compared to intraarticular steroid and, in a second study, the effect was larger for activity with an advanced pharmacy intervention whereas the physiotherapy intervention demonstrated a larger effect for activity/participation. Interventions of manual therapy for hip and knee OA provided limited evidence of effectiveness. These studies are of limited quality due to lack of blinding and disclosure of co-intervention. Tele-rehabilitation may be a viable option to improve access to rehabilitation post joint replacement for those in rural and remote areas. Data continue to support the need to include performance measures as well as patient-reported outcomes in evaluating outcomes in OA. Additionally, measures of participation should be considered as core outcomes. Copyright Â© 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
The added value of ordinal analysis in clinical trials: an example in traumatic brain injury.

PubMed

Roozenbeek, Bob; Lingsma, Hester F; Perel, Pablo; Edwards, Phil; Roberts, Ian; Murray, Gordon D; Maas, Andrew Ir; Steyerberg, Ewout W

2011-01-01

In clinical trials, ordinal outcome measures are often dichotomized into two categories. In traumatic brain injury (TBI) the 5-point Glasgow outcome scale (GOS) is collapsed into unfavourable versus favourable outcome. Simulation studies have shown that exploiting the ordinal nature of the GOS increases chances of detecting treatment effects. The objective of this study is to quantify the benefits of ordinal analysis in the real-life situation of a large TBI trial. We used data from the CRASH trial that investigated the efficacy of corticosteroids in TBI patients (n = 9,554). We applied two techniques for ordinal analysis: proportional odds analysis and the sliding dichotomy approach, where the GOS is dichotomized at different cut-offs according to baseline prognostic risk. These approaches were compared to dichotomous analysis. The information density in each analysis was indicated by a Wald statistic. All analyses were adjusted for baseline characteristics. Dichotomous analysis of the six-month GOS showed a non-significant treatment effect (OR = 1.09, 95% CI 0.98 to 1.21, P = 0.096). Ordinal analysis with proportional odds regression or sliding dichotomy showed highly statistically significant treatment effects (OR 1.15, 95% CI 1.06 to 1.25, P = 0.0007 and 1.19, 95% CI 1.08 to 1.30, P = 0.0002), with 2.05-fold and 2.56-fold higher information density compared to the dichotomous approach respectively. Analysis of the CRASH trial data confirmed that ordinal analysis of outcome substantially increases statistical power. We expect these results to hold for other fields of critical care medicine that use ordinal outcome measures and recommend that future trials adopt ordinal analyses. This will permit detection of smaller treatment effects.
A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review.

PubMed

Faure Walker, Nicholas A; Norris, Joseph M; Shah, Taimur T; Yap, Tet; Cathcart, Paul; Moore, Caroline M; Ahmed, Hashim U; Emberton, Mark; Minhas, Suks

2018-02-01

To systematically review erectile function (EF) outcomes following primary whole gland (WG) and focal ablative therapies for localized prostate cancer to ascertain whether the treatment modality or intended treatment volume affects the time taken to recover baseline EF. A systematic review was performed according to the preferred reporting items for systematic review and meta-analysis statement. Inclusion criteria were men with localized prostate cancer treated with primary, ablative therapy. Primary outcome was the return to baseline EF measured with objective, validated symptoms scores. Secondary outcome was use of phosphodiesterase inhibitors or erectile aids. Meta-analysis was not performed owing to heterogenous outcome measures. Of 222 articles identified in February 2017, 55 studies which reported EF after ablative therapy were identified but only 17 used validated outcome measures and met inclusion criteria. WG cryotherapy was used in 2 studies, WG high-intensity focused ultrasound (HIFU) in 5, focal cryotherapy in 2, focal HIFU in 3, focal phototherapy or laser therapy in 4, vascular-targeted photodynamic therapy in 3, and irreversible electroporation in 2. WG cryotherapy was associated with a significant decline in EF at 6 months with minimal improvement at 36 months. Baseline IIEF-15 of patients undergoing focal HIFU fell 30 points at 1 month but returned to baseline by 6 months. The remaining focal therapies demonstrated minimal or no effect on EF, but the men in these studies had small foci of disease. The review is limited by lack of randomized studies and heterogenous outcome measures. Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogenous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures for comparison. However, FT in general resulted in less effect on EF than WG ablation. Copyright © 2018 Elsevier Inc. All rights reserved.
Investigating the effect of independent, blinded digital image assessment on the STOP GAP trial.

PubMed

Patsko, Emily; Godolphin, Peter J; Thomas, Kim S; Hepburn, Trish; Mitchell, Eleanor J; Craig, Fiona E; Bath, Philip M; Montgomery, Alan A

2017-02-02

Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low-risk studies. In dermatology, one popular method of blinding is to have independent outcome assessors who are unaware of treatment allocation assessing the endpoint using digital photographs. However, this can be complex, expensive and time-consuming. The objective of this study was to compare the effect of blinded and unblinded outcome assessment on the results of the STOP GAP trial. The STOP GAP trial compared prednisolone to ciclosporin in treating pyoderma gangrenosum. Participants' lesions were measured at baseline and at 6 weeks to calculate the primary outcome, speed of healing. Independent blinded assessors obtained measurements from digital photographs using specialist software. In addition, unblinded treating clinicians estimated lesion area by measuring length and width. The primary outcome was determined using blinded measurements where available, otherwise unblinded measurements were used (method referred to as trial measurements). In this study, agreement between the trial and unblinded measurements was determined using the intraclass correlation coefficient (ICC). The STOP GAP trial's primary analysis was repeated using unblinded measurements only. We introduced differential and nondifferential error in unblinded measurements and investigated the effect on the STOP GAP trial's primary analysis. Eighty-six (80%) of the 108 patients were assessed using digital images. Agreement between trial and unblinded measurements was excellent (ICC = 0.92 at baseline; 0.83 at 6 weeks). There was no evidence that the results of the trial primary analysis differed according to how the primary outcome was assessed (p value for homogeneity = 1.00). Blinded digital image assessment in the STOP GAP trial did not meaningfully alter trial conclusions compared with unblinded assessment. However, as the process brought added accuracy and credibility to the trial it was considered worthwhile. These findings question the usefulness of digital image assessment in a trial with an objective outcome and where bias is not expected to be excessive. Further research should investigate if there are alternative, less complex ways of incorporating blinding in clinical trials. Current Controlled Trials, www.isrctn.com ISRCTN35898459. Registered on 26 May 2009.
Measuring ability to assess claims about treatment effects: a latent trait analysis of items from the ‘Claim Evaluation Tools’ database using Rasch modelling

PubMed Central

Austvoll-Dahlgren, Astrid; Guttersrud, Øystein; Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D

2017-01-01

Background The Claim Evaluation Tools database contains multiple-choice items for measuring people’s ability to apply the key concepts they need to know to be able to assess treatment claims. We assessed items from the database using Rasch analysis to develop an outcome measure to be used in two randomised trials in Uganda. Rasch analysis is a form of psychometric testing relying on Item Response Theory. It is a dynamic way of developing outcome measures that are valid and reliable. Objectives To assess the validity, reliability and responsiveness of 88 items addressing 22 key concepts using Rasch analysis. Participants We administrated four sets of multiple-choice items in English to 1114 people in Uganda and Norway, of which 685 were children and 429 were adults (including 171 health professionals). We scored all items dichotomously. We explored summary and individual fit statistics using the RUMM2030 analysis package. We used SPSS to perform distractor analysis. Results Most items conformed well to the Rasch model, but some items needed revision. Overall, the four item sets had satisfactory reliability. We did not identify significant response dependence between any pairs of items and, overall, the magnitude of multidimensionality in the data was acceptable. The items had a high level of difficulty. Conclusion Most of the items conformed well to the Rasch model’s expectations. Following revision of some items, we concluded that most of the items were suitable for use in an outcome measure for evaluating the ability of children or adults to assess treatment claims. PMID:28550019
Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy.

PubMed

Kalsi-Ryan, Sukhvinder; Singh, Anoushka; Massicotte, Eric M; Arnold, Paul M; Brodke, Darrel S; Norvell, Daniel C; Hermsmeyer, Jeffrey T; Fehlings, Michael G

2013-10-15

Narrative review. To identify suitable outcome measures that can be used to quantify neurological and functional impairment in the management of cervical spondylotic myelopathy (CSM). CSM is the leading cause of acquired spinal cord disability, causing varying degrees of neurological impairment which impact on independence and quality of life. Because this impairment can have a heterogeneous presentation, a single outcome measure cannot define the broad range of deficits seen in this population. Therefore, it is necessary to define outcome measures that characterize the deficits with greater validity and sensitivity. This review was conducted in 3 stages. Stage I: To evaluate the current use of outcome measures in CSM, PubMed was searched using the name of the outcome measure and the common abbreviation combined with "CSM" or "myelopathy." Stage II: Having identified a lack of appropriate outcome measures, we constructed criteria by which measures appropriate for assessing the various aspects of CSM could be identified. Stage III: A second literature search was then conducted looking at specified outcomes that met these criteria. All literature was reviewed to determine specificity and psychometric properties of outcomes for CSM. Nurick grade, modified Japanese Orthopaedic Association Scale, visual analogue scale (VAS) for pain, Short Form (36) Health Survey (SF-36), and Neck Disability Index were the most commonly cited measures. The Short-Form 36 Health Survey and Myelopathy Disability Index have been validated in the CSM population with multiple studies, whereas the modified Japanese Orthopaedic Association Scale score, Nurick grade, and European Myelopathy Scale each had only one study assessing psychometric characteristics. No validity, reliability, or responsiveness studies were found for the VAS or Neck Disability Index in the CSM population. We recommend that the modified Japanese Orthopaedic Association Scale, Nurick grade, Myelopathy Disability Index, Neck Disability Index, and 30-Meter Walk Test are most appropriate for the assessment of CSM. However, 6 additional outcome measures (QuickDASH, Berg Balance Scale, Graded Redefined Assessment of Strength Sensibility and Prehension, Grip Dynamometer, and GAITRite Analysis) were identified, which provide complementary assessments for CSM. SUMMARY STATEMENTS: There does not exist a single or composite of outcome instruments that measures myelopathy impairment, function/disability, and participation that have also demonstrated reliability, validity, and responsiveness in a CSM population. More work in the development and psychometric evaluation of new or existing measures is necessary to identify the ideal composite of measures to be used in the clinical and research settings. The mJOA, Nurick grade, NDI, MDI, and 30MWT should be adopted in any clinical practice that treats CSM both for screening and clinical follow-up. We propose that clinicians and researchers consider using the ancillary measures identified, such as the QuickDASH, Berg Balance Scale, GRASSP version 1.0, Grip Strength, and GAITRite Analysis. It is highly recommended that baseline and follow-up measurements should be performed in patients with CSM.
Do Concomitant Cranium and Axis Injuries Predict Worse Outcome? A Trauma Database Quantitative Analysis

PubMed Central

Chittiboina, Prashant; Banerjee, Anirban Deep; Nanda, Anil

2011-01-01

We performed a trauma database analysis to identify the effect of concomitant cranial injuries on outcome in patients with fractures of the axis. We identified patients with axis fractures over a 14-year period. A binary outcome measure was used. Univariate and multiple logistic regression analysis were performed. There were 259 cases with axis fractures. Closed head injury was noted in 57% and skull base trauma in 14%. Death occurred in 17 cases (6%). Seventy-two percent had good outcome. Presence of abnormal computed tomography head findings, skull base fractures, and visceral injury was significantly associated with poor outcome. Skull base injury in association with fractures of the axis is a significant independent predictor of worse outcomes, irrespective of the severity of the head injury. We propose that presence of concomitant cranial and upper vertebral injuries require careful evaluation in view of the associated poor prognosis. PMID:22470268
Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

PubMed

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

Outcomes Across the Value Chain for a Comprehensive Employee Health and Wellness Intervention: A Cohort Study by Degrees of Health Engagement.

PubMed

Long, D Adam; Reed, Roger W; Duncan, Ian

2016-07-01

Evaluate a large employer's wellness intervention by studying outcomes across the value chain, and testing Health Engagement's (HE) dose-response relationship to outcomes. Evaluation included 37 measures across eight outcomes domains (OD) using repeated measures, analysis of variance and logistic regression. Participants with higher HE had better pre-post percent changes than control: 1.7% higher for Motivation (OD1), 3.4% for Behavior (OD2), 1.0% for Emotion (OD3), 5.8% for Biometrics (OD4), 6.3% for Compliance (OD5), and 5.2% for Claims (OD6). They also had 0.5% less Productivity loss (OD7), and odds of Turnover (OD8) one-quarter to one-half that of control. A dose-response relationship with degrees of HE was also shown. Three outcomes domains (OD6 to OD8) can be monetized for cost-benefit analysis. Authors recommend, however, staying focused on driving HE and using metrics from all OD to assess value.
Mismatch negativity is a stronger indicator of functional outcomes than neurocognition or theory of mind in patients with schizophrenia.

PubMed

Lee, Seung-Hwan; Sung, Kyongae; Lee, Kyong-Sang; Moon, Eunok; Kim, Chang-Gyu

2014-01-03

Mismatch negativity (MMN) is known to be associated with neurocognition, social cognition, and functional outcomes. The present study explored the relationships of MMN with neurocognition, theory of mind, and functional outcomes in patients with schizophrenia, first-degree relatives of patients with schizophrenia, and healthy controls. Twenty-five patients with schizophrenia, 21 first-degree relatives of patients with schizophrenia, and 29 healthy controls were recruited. We examined symptom severity, neurocognition, theory of mind, functional outcomes, and MMN. MMN amplitudes decreased in order of patients with schizophrenia, then first-degree relatives, then healthy controls. MMN amplitude was significantly correlated with measures of neurocognition, theory of mind, and functional outcome measurements in patients with schizophrenia. However, the most powerful correlations were those between MMN in the frontal region and measures of functional outcomes. The power and frequency of the correlations were weaker in first-degree relatives and healthy controls than in patients with schizophrenia. Hierarchical regression analysis revealed that functional outcomes (relative to measures of neurocognition and theory of mind) constituted the most powerful predictor of MMN. Our results suggest that MMN reflects functional outcomes more efficiently than do measures of neurocognition and theory of mind in patients with schizophrenia. © 2013.
Prenatal nutrition services: a cost analysis.

PubMed

Splett, P L; Caldwell, H M; Holey, E S; Alton, I R

1987-02-01

The scarcity of information about program costs in relation to quality care prompted a cost analysis of prenatal nutrition services in two urban settings. This study examined prenatal nutrition services in terms of total costs, per client costs, per visit costs, and cost per successful outcome. Standard cost-accounting principles were used. Outcome measures, based on written quality assurance criteria, were audited using standard procedures. In the studied programs, nutrition services were delivered for a per client cost of $72 in a health department setting and $121 in a hospital-based prenatal care program. Further analysis illustrates that total and per client costs can be misleading and that costs related to successful outcomes are much higher. The three levels of cost analysis reported provide baseline data for quantifying the costs of providing prenatal nutrition services to healthy pregnant women. Cost information from these cost analysis procedures can be used to guide adjustments in service delivery to assure successful outcomes of nutrition care. Accurate cost and outcome data are necessary prerequisites to cost-effectiveness and cost-benefit studies.
Measuring the Early Adulthood Outcomes of Young Adults with Disabilities: Developing Constructs Using NLTS2 Data

ERIC Educational Resources Information Center

Shogren, Karrie A.; Shaw, Leslie A.; Little, Todd D.

2016-01-01

Secondary data analysis was used to develop and examine disability-related differences in outcome constructs from the National Longitudinal Transition Study-2. Findings suggest that outcome constructs could be created that represented key elements of quality of life domains including social relationships, financial independence, financial…
Measuring the Early Adulthood Outcomes of Young Adults with Disabilities: Developing Constructs Using NLTS2 Data

ERIC Educational Resources Information Center

Shogren, Karrie A.; Shaw, Leslie A.; Little, Todd D.

2016-01-01

Secondary data analysis was used to develop and examine disability-related differences in outcome constructs from the National Longitudinal Transition Study-2 (NLTS2). Findings suggest that outcome constructs could be created that represented key elements of quality of life domains including social relationships, financial independence, financial…
The effects of work organization on the health of immigrant manual workers: A longitudinal analysis.

PubMed

Arcury, Thomas A; Chen, Haiying; Mora, Dana C; Walker, Francis O; Cartwright, Michael S; Quandt, Sara A

2016-01-01

This analysis uses a longitudinal design to examine the associations of work organization and health outcomes among Latino manual workers. Participants included 247 Latino workers who completed baseline and 1-year follow-up interviews and clinical examinations. Health outcome measures were epicondylitis, rotator cuff syndrome, back pain, and depressive symptoms. Independent measures were measures of job demand, job control, and job support. Workers commonly experienced rotator cuff syndrome (6.5%), back pain (8.9%), and depressive symptoms (11.2%); fewer experienced epicondylitis (2.4%). Psychological demand was associated with rotator cuff syndrome; awkward position and decision latitude were associated with back pain. Decreased skill variety but increased decision latitude was associated with elevated depressive symptoms. Work context factors are important for health outcomes among vulnerable workers. Further research is needed to expand upon this work, particularly cultural perspectives on job support.
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.
Confirmatory Factor Analysis of a Family Quality of Life Scale for Families of Kindergarten Children without Disabilities

ERIC Educational Resources Information Center

Zuna, Nina I.; Selig, James P.; Summers, Jean Ann; Turnbull, Ann P.

2009-01-01

Recently, within the field of special education, attention has been accorded to the conceptualization and measurement of family outcomes. The Family Quality of Life (FQOL) Scale is an instrument that can be used to measure family outcomes for families who have children with disabilities, and it has been demonstrated to have psychometric validity.…
Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study

PubMed Central

2012-01-01

Background Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment. Methods This post-hoc analysis used data from a large, 3-year prospective, non-interventional observational study of individuals treated for schizophrenia in the United States conducted between July 1997 and September 2003. At study enrollment, individuals were classified as non-remitted or remitted using the Schizophrenia Working Group Definition of symptom remission (8 core symptoms rated as mild or less). Mental health service use was measured using medical records. Costs were based on the sites’ medical information systems. Functional outcomes were measured with multiple patient-reported measures and the clinician-rated Quality of Life Scale (QLS). Symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Outcomes for non-remitted and remitted patients were compared over time using mixed effects models for repeated measures or generalized estimating equations after adjusting for multiple baseline characteristics. Results At enrollment, most of the 2,284 study participants (76.1%) did not meet remission criteria. Non-remitted patients had significantly higher PANSS total scores at baseline, a lower likelihood of being Caucasian, a higher likelihood of hospitalization in the previous year, and a greater likelihood of a substance use diagnosis (all p < 0.05). Total mental health costs were significantly higher for non-remitted patients over the 3-year study (p = 0.008). Non-remitted patients were significantly more likely to be victims of crime, exhibit violent behavior, require emergency services, and lack paid employment during the 3-year study (all p < 0.05). Non-remitted patients also had significantly lower scores on the QLS, SF-12 Mental Component Summary Score, and Global Assessment of Functioning during the 3-year study. Conclusions In this post-hoc analysis of a 3-year prospective observational study, the failure to achieve symptomatic remission at enrollment was associated with higher subsequent healthcare costs and worse functional outcomes. Further examination of outcomes for schizophrenia patients who fail to achieve remission at initial assessment by their subsequent clinical status is warranted. PMID:23216976
Better Informing Decision Making with Multiple Outcomes Cost-Effectiveness Analysis under Uncertainty in Cost-Disutility Space

PubMed Central

McCaffrey, Nikki; Agar, Meera; Harlum, Janeane; Karnon, Jonathon; Currow, David; Eckermann, Simon

2015-01-01

Introduction Comparing multiple, diverse outcomes with cost-effectiveness analysis (CEA) is important, yet challenging in areas like palliative care where domains are unamenable to integration with survival. Generic multi-attribute utility values exclude important domains and non-health outcomes, while partial analyses—where outcomes are considered separately, with their joint relationship under uncertainty ignored—lead to incorrect inference regarding preferred strategies. Objective The objective of this paper is to consider whether such decision making can be better informed with alternative presentation and summary measures, extending methods previously shown to have advantages in multiple strategy comparison. Methods Multiple outcomes CEA of a home-based palliative care model (PEACH) relative to usual care is undertaken in cost disutility (CDU) space and compared with analysis on the cost-effectiveness plane. Summary measures developed for comparing strategies across potential threshold values for multiple outcomes include: expected net loss (ENL) planes quantifying differences in expected net benefit; the ENL contour identifying preferred strategies minimising ENL and their expected value of perfect information; and cost-effectiveness acceptability planes showing probability of strategies minimising ENL. Results Conventional analysis suggests PEACH is cost-effective when the threshold value per additional day at home ( 1) exceeds $1,068 or dominated by usual care when only the proportion of home deaths is considered. In contrast, neither alternative dominate in CDU space where cost and outcomes are jointly considered, with the optimal strategy depending on threshold values. For example, PEACH minimises ENL when 1=$2,000 and 2=$2,000 (threshold value for dying at home), with a 51.6% chance of PEACH being cost-effective. Conclusion Comparison in CDU space and associated summary measures have distinct advantages to multiple domain comparisons, aiding transparent and robust joint comparison of costs and multiple effects under uncertainty across potential threshold values for effect, better informing net benefit assessment and related reimbursement and research decisions. PMID:25751629
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.
Development of a wheelchair mobility skills test for children and adolescents: combining evidence with clinical expertise.

PubMed

Sol, Marleen Elisabeth; Verschuren, Olaf; de Groot, Laura; de Groot, Janke Frederike

2017-02-13

Wheelchair mobility skills (WMS) training is regarded by children using a manual wheelchair and their parents as an important factor to improve participation and daily physical activity. Currently, there is no outcome measure available for the evaluation of WMS in children. Several wheelchair mobility outcome measures have been developed for adults, but none of these have been validated in children. Therefore the objective of this study is to develop a WMS outcome measure for children using the current knowledge from literature in combination with the clinical expertise of health care professionals, children and their parents. Mixed methods approach. Phase 1: Item identification of WMS items through a systematic review using the 'COnsensus-based Standards for the selection of health Measurement Instruments' (COSMIN) recommendations. Phase 2: Item selection and validation of relevant WMS items for children, using a focus group and interviews with children using a manual wheelchair, their parents and health care professionals. Phase 3: Feasibility of the newly developed Utrecht Pediatric Wheelchair Mobility Skills Test (UP-WMST) through pilot testing. Phase 1: Data analysis and synthesis of nine WMS related outcome measures showed there is no widely used outcome measure with levels of evidence across all measurement properties. However, four outcome measures showed some levels of evidence on reliability and validity for adults. Twenty-two WMS items with the best clinimetric properties were selected for further analysis in phase 2. Phase 2: Fifteen items were deemed as relevant for children, one item needed adaptation and six items were considered not relevant for assessing WMS in children. Phase 3: Two health care professionals administered the UP-WMST in eight children. The instructions of the UP-WMST were clear, but the scoring method of the height difference items needed adaptation. The outdoor items for rolling over soft surface and the side slope item were excluded in the final version of the UP-WMST due to logistic reasons. The newly developed 15 item UP-WMST is a validated outcome measure which is easy to administer in children using a manual wheelchair. More research regarding reliability, construct validity and responsiveness is warranted before the UP-WMST can be used in practice.
Rasch Measurement Analysis of the Mayo-Portland Adaptability Inventory (MPAI-4) in a Community-Based Rehabilitation Sample

PubMed Central

Malec, James F.; Altman, Irwin M.; Swick, Shannon

2011-01-01

Abstract The precise measurement of patient outcomes depends upon clearly articulated constructs and refined clinical assessment instruments that work equally well for all subgroups within a population. This is a challenging task in those with acquired brain injury (ABI) because of the marked heterogeneity of the disorder and subsequent outcomes. Alhough essential, the iterative process of instrument refinement is often neglected. This present study was undertaken to examine validity, reliability, dimensionality and item estimate invariance of the Mayo-Portland Adaptability Inventory – 4 (MPAI-4), an outcome measure for persons with ABI. The sampled population included 603 persons with traumatic ABI participating in a home- and community-based rehabilitation program. Results indicated that the MPAI-4 is a valid, reliable measure of outcome following traumatic ABI, which measures a broad but unitary core construct of outcome after ABI. Further, the MPAI-4 is composed of items that are unbiased toward selected subgroups except where differences could be expected [e.g., more chronic traumatic brain injury (TBI) patients are better able to negotiate demands of transportation than more acute TBI patients]. We address the trade-offs between strict unidimensionality and clinical applicability in measuring outcome, and illustrate the advantages and disadvantages of applying single-parameter measurement models to broad constructs. PMID:21332409
Rasch measurement analysis of the Mayo-Portland Adaptability Inventory (MPAI-4) in a community-based rehabilitation sample.

PubMed

Kean, Jacob; Malec, James F; Altman, Irwin M; Swick, Shannon

2011-05-01

The precise measurement of patient outcomes depends upon clearly articulated constructs and refined clinical assessment instruments that work equally well for all subgroups within a population. This is a challenging task in those with acquired brain injury (ABI) because of the marked heterogeneity of the disorder and subsequent outcomes. Although essential, the iterative process of instrument refinement is often neglected. This present study was undertaken to examine validity, reliability, dimensionality and item estimate invariance of the Mayo-Portland Adaptability Inventory - 4 (MPAI-4), an outcome measure for persons with ABI. The sampled population included 603 persons with traumatic ABI participating in a home- and community-based rehabilitation program. Results indicated that the MPAI-4 is a valid, reliable measure of outcome following traumatic ABI, which measures a broad but unitary core construct of outcome after ABI. Further, the MPAI-4 is composed of items that are unbiased toward selected subgroups except where differences could be expected [e.g., more chronic traumatic brain injury (TBI) patients are better able to negotiate demands of transportation than more acute TBI patients]. We address the trade-offs between strict unidimensionality and clinical applicability in measuring outcome, and illustrate the advantages and disadvantages of applying single-parameter measurement models to broad constructs.
Future time perspective: A systematic review and meta-analysis.

PubMed

Kooij, Dorien T A M; Kanfer, Ruth; Betts, Matt; Rudolph, Cort W

2018-04-23

The ability to foresee, anticipate, and plan for future desired outcomes is crucial for well-being, motivation, and behavior. However, theories in organizational psychology do not incorporate time-related constructs such as Future Time Perspective (FTP), and research on FTP remains disjointed and scattered, with different domains focusing on different aspects of the construct, using different measures, and assessing different antecedents and consequences. In this review and meta-analysis, we aim to clarify the FTP construct, advance its theoretical development, and demonstrate its importance by (a) integrating theory and empirical findings across different domains of research to identify major outcomes and antecedents of FTP, and (b) empirically examining whether and how these variables are moderated by FTP measures and dimensions. Results of a meta-analysis of k = 212 studies reveal significant relationships between FTP and major classes of consequences (i.e., those related to achievement, well-being, health behavior, risk behavior, and retirement planning), and between antecedents and FTP, as well as moderating effects of different FTP measures and dimensions. Highlighting the importance of FTP for organizational psychology theories, our findings demonstrate that FTP predicts these outcomes over and above the big five personality traits and mediates the associations between these personality traits and outcomes. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
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
Optimising technology to measure functional vision, mobility and service outcomes for people with low vision or blindness: protocol for a prospective cohort study in Australia and Malaysia.

PubMed

Deverell, Lil; Meyer, Denny; Lau, Bee Theng; Al Mahmud, Abdullah; Sukunesan, Suku; Bhowmik, Jahar; Chai, Almon; McCarthy, Chris; Zheng, Pan; Pipingas, Andrew; Islam, Fakir M Amirul

2017-12-21

Orientation and mobility (O&M) specialists assess the functional vision and O&M skills of people with mobility problems, usually relating to low vision or blindness. There are numerous O&M assessment checklists but no measures that reduce qualitative assessment data to a single comparable score suitable for assessing any O&M client, of any age or ability, in any location. Functional measures are needed internationally to align O&M assessment practices, guide referrals, profile O&M clients, plan appropriate services and evaluate outcomes from O&M programmes (eg, long cane training), assistive technology (eg, hazard sensors) and medical interventions (eg, retinal implants). This study aims to validate two new measures of functional performance vision-related outcomes in orientation and mobility (VROOM) and orientation and mobility outcomes (OMO) in the context of ordinary O&M assessments in Australia, with cultural comparisons in Malaysia, also developing phone apps and online training to streamline professional assessment practices. This multiphase observational study will employ embedded mixed methods with a qualitative/quantitative priority: corating functional vision and O&M during social inquiry. Australian O&M agencies (n=15) provide the sampling frame. O&M specialists will use quota sampling to generate cross-sectional assessment data (n=400) before investigating selected cohorts in outcome studies. Cultural relevance of the VROOM and OMO tools will be investigated in Malaysia, where the tools will inform the design of assistive devices and evaluate prototypes. Exploratory and confirmatory factor analysis, Rasch modelling, cluster analysis and analysis of variance will be undertaken along with descriptive analysis of measurement data. Qualitative findings will be used to interpret VROOM and OMO scores, filter statistically significant results, warrant their generalisability and identify additional relevant constructs that could also be measured. Ethical approval has been granted by the Human Research Ethics Committee at Swinburne University (SHR Project 2016/316). Dissemination of results will be via agency reports, journal articles 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.
Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

PubMed

Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

2014-04-01

In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.
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…
Standardized Testing for Outcome Assessment: Analysis of the Educational Testing Systems MBA Tests

ERIC Educational Resources Information Center

Wright, Robert E.

2010-01-01

The use of standardized tests for outcome assessment has grown dramatically in recent years. Two driving factors have been the No Child Left Behind legislation, and the increase in outcome assessment measures by accrediting agencies such as AACSB, the international accrediting body for business schools. Despite the growth in usage, little effort…

Assessing vocational outcome expectancy in individuals with serious mental illness: a factor-analytic approach.

PubMed

Iwanaga, Kanako; Umucu, Emre; Wu, Jia-Rung; Yaghmaian, Rana; Lee, Hui-Ling; Fitzgerald, Sandra; Chan, Fong

2017-07-04

Self-determination theory (SDT) and self-efficacy theory (SET) can be used to conceptualize self-determined motivation to engage in mental health and vocational rehabilitation (VR) services and to predict recovery. To incorporate SDT and SET as a framework for vocational recovery, developing and validating SDT/SET measures in vocational rehabilitation is warranted. Outcome expectancy is an important SDT/SET variable affecting rehabilitation engagement and recovery. The purpose of this study was to validate the Vocational Outcome Expectancy Scale (VOES) for use within the SDT/SET vocational recovery framework. One hundred and twenty-four individuals with serious mental illness (SMI) participated in this study. Measurement structure of the VOES was evaluated using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Both EFA and CFA results supported a two-factor structure: (a) positive outcome expectancy, and (b) negative outcome expectancy. The internal consistency reliability coefficients for both factors were acceptable. In addition, positive outcome expectancy correlated stronger than negative outcome expectancy with other SDT/SET constructs in the expected directions. The VOES is a brief, reliable and valid instrument for assessing vocational outcome expectancy in individuals with SMI that can be integrated into SDT/SET as a vocational rehabilitation engagement and recovery model in psychiatric rehabilitation.
Measurement error, time lag, unmeasured confounding: Considerations for longitudinal estimation of the effect of a mediator in randomised clinical trials.

PubMed

Goldsmith, K A; Chalder, T; White, P D; Sharpe, M; Pickles, A

2018-06-01

Clinical trials are expensive and time-consuming and so should also be used to study how treatments work, allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments. These treatment processes can be studied using mediation analysis. Randomised treatment makes some of the assumptions of mediation models plausible, but the mediator-outcome relationship could remain subject to bias. In addition, mediation is assumed to be a temporally ordered longitudinal process, but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption. This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) to address these issues. In particular, autoregressive and simplex models were used to study measurement error in the mediator, different time lags in the mediator-outcome relationship, unmeasured confounding of the mediator and outcome, and the assumption of a constant mediator-outcome relationship over time. Results showed that allowing for measurement error and unmeasured confounding were important. Contemporaneous rather than lagged mediator-outcome effects were more consistent with the data, possibly due to the wide spacing of measurements. Assuming a constant mediator-outcome relationship over time increased precision.
Measurement error, time lag, unmeasured confounding: Considerations for longitudinal estimation of the effect of a mediator in randomised clinical trials

PubMed Central

Goldsmith, KA; Chalder, T; White, PD; Sharpe, M; Pickles, A

2016-01-01

Clinical trials are expensive and time-consuming and so should also be used to study how treatments work, allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments. These treatment processes can be studied using mediation analysis. Randomised treatment makes some of the assumptions of mediation models plausible, but the mediator–outcome relationship could remain subject to bias. In addition, mediation is assumed to be a temporally ordered longitudinal process, but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption. This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) to address these issues. In particular, autoregressive and simplex models were used to study measurement error in the mediator, different time lags in the mediator–outcome relationship, unmeasured confounding of the mediator and outcome, and the assumption of a constant mediator–outcome relationship over time. Results showed that allowing for measurement error and unmeasured confounding were important. Contemporaneous rather than lagged mediator–outcome effects were more consistent with the data, possibly due to the wide spacing of measurements. Assuming a constant mediator–outcome relationship over time increased precision. PMID:27647810
Measuring performance improvement: total organizational commitment or clinical specialization.

PubMed

Caron, Aleece; Jones, Paul; Neuhauser, Duncan; Aron, David C

2004-01-01

Resources for hospitals are limited when they are faced with multiple publicly reported performance measures as tools to assess quality. The leadership in these organizations may choose to focus on 1 or 2 of these outcomes. An alternative approach is that the leadership may commit resources or create conditions that result in improved quality over a broad range of measures. We used aggregated data on mortality, length of stay, and obstetrical outcomes from Greater Cleveland Health Quality Choice data to test these theories. We used Pearson correlation analysis to determine of outcomes were correlated with one another. We used repeated-measures ANOVA to determine if an association existed between outcome and time and outcome and hospital. All of the outcomes across all hospitals demonstrate a trend of overall improvement. Both the Pearson and ANOVA result support the hypothesis for the organization-wide approach to quality improvement. Hospital that make improvements in one clinical area trend to make improvements in others. Hospitals that produce improvements in limited clinical or administrative areas may not have completely adopted CQI into their culture or may not have yet realized the benefits of their organizational commitments, but use some of the concepts to improve quality outcomes.
Measuring ability to assess claims about treatment effects: a latent trait analysis of items from the 'Claim Evaluation Tools' database using Rasch modelling.

PubMed

Austvoll-Dahlgren, Astrid; Guttersrud, Øystein; Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D

2017-05-25

The Claim Evaluation Tools database contains multiple-choice items for measuring people's ability to apply the key concepts they need to know to be able to assess treatment claims. We assessed items from the database using Rasch analysis to develop an outcome measure to be used in two randomised trials in Uganda. Rasch analysis is a form of psychometric testing relying on Item Response Theory. It is a dynamic way of developing outcome measures that are valid and reliable. To assess the validity, reliability and responsiveness of 88 items addressing 22 key concepts using Rasch analysis. We administrated four sets of multiple-choice items in English to 1114 people in Uganda and Norway, of which 685 were children and 429 were adults (including 171 health professionals). We scored all items dichotomously. We explored summary and individual fit statistics using the RUMM2030 analysis package. We used SPSS to perform distractor analysis. Most items conformed well to the Rasch model, but some items needed revision. Overall, the four item sets had satisfactory reliability. We did not identify significant response dependence between any pairs of items and, overall, the magnitude of multidimensionality in the data was acceptable. The items had a high level of difficulty. Most of the items conformed well to the Rasch model's expectations. Following revision of some items, we concluded that most of the items were suitable for use in an outcome measure for evaluating the ability of children or adults to assess treatment claims. © 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.
Analysis of temporal dynamics in imagery during acute limb ischemia and reperfusion

NASA Astrophysics Data System (ADS)

Irvine, John M.; Regan, John; Spain, Tammy A.; Caruso, Joseph D.; Rodriquez, Maricela; Luthra, Rajiv; Forsberg, Jonathon; Crane, Nicole J.; Elster, Eric

2014-03-01

Ischemia and reperfusion injuries present major challenges for both military and civilian medicine. Improved methods for assessing the effects and predicting outcome could guide treatment decisions. Specific issues related to ischemia and reperfusion injury can include complications arising from tourniquet use, such as microvascular leakage in the limb, loss of muscle strength and systemic failures leading to hypotension and cardiac failure. Better methods for assessing the viability of limbs/tissues during ischemia and reducing complications arising from reperfusion are critical to improving clinical outcomes for at-risk patients. The purpose of this research is to develop and assess possible prediction models of outcome for acute limb ischemia using a pre-clinical model. Our model relies only on non-invasive imaging data acquired from an animal study. Outcome is measured by pathology and functional scores. We explore color, texture, and temporal features derived from both color and thermal motion imagery acquired during ischemia and reperfusion. The imagery features form the explanatory variables in a model for predicting outcome. Comparing model performance to outcome prediction based on direct observation of blood chemistry, blood gas, urinalysis, and physiological measurements provides a reference standard. Initial results show excellent performance for the imagery-base model, compared to predictions based direct measurements. This paper will present the models and supporting analysis, followed by recommendations for future investigations.
The strategic use of outcome information.

PubMed

Thompson, D I; Sirio, C; Holt, P

2000-10-01

Most health care executives see outcome measurement as a technical or tactical matter rather than as a strategic tool. Accordingly, provider investment in outcome measurement and management is relatively small. Nevertheless, outcome information can be key to achieving an organization's strategic objectives. Advances in risk adjustment and improvements in technology for data collection and analysis have made outcome measurement a practical tool for individual hospital use. Strategically integrated outcome measurement efforts can give providers a competitive advantage over organizations that only use outcomes tactically. One of the best examples of an acute care provider that has used outcome information for strategic advantage is Intermountain Health Care (IHC; Salt Lake City). In 1997 IHC made clinical quality and outcomes the primary focus of its five-year strategic plan. To support the new strategy IHC's board of trustees approved the development of an outcome information system that generated data along clinical processes of care and the creation of a new management structure to use these data to hold professionals accountable and to set and achieve clinical improvement goals. From 1996 to 1999, IHC's share of the commercial health care market in Utah increased from roughly 50% to about 62% of the market, with the result that it has stopped actively marketing its services. Health care executives will not willingly invest in outcomes until they believe that they have business value. Therefore, making the business case for outcomes can help improve the quality of health care and the lives of individuals.
Critical thinking as an educational outcome: an evaluation of current tools of measurement.

PubMed

Adams, M H; Whitlow, J F; Stover, L M; Johnson, K W

1996-01-01

Critical thinking, an outcome criterion of the National League for Nursing and the Council of Baccalaureate and Higher Degree Programs, is an abstract skill difficult to measure. The authors provide a comprehensive review of four instruments designed to measure critical thinking and summarize research in which the tools were used. Analysis of this information will empower nursing faculty members to select a critical-thinking instrument that is individualized to the needs of their respective nursing programs.
The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review

PubMed Central

Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

2017-01-01

Introduction Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. Methods and analysis The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. Ethics and dissemination The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first authorâ€™s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. PMID:28679677
Overcoming redundancies in bedside nursing assessments by validating a parsimonious meta-tool: findings from a methodological exercise study.

PubMed

Palese, Alvisa; Marini, Eva; Guarnier, Annamaria; Barelli, Paolo; Zambiasi, Paola; Allegrini, Elisabetta; Bazoli, Letizia; Casson, Paola; Marin, Meri; Padovan, Marisa; Picogna, Michele; Taddia, Patrizia; Chiari, Paolo; Salmaso, Daniele; Marognolli, Oliva; Canzan, Federica; Ambrosi, Elisa; Saiani, Luisa; Grassetti, Luca

2016-10-01

There is growing interest in validating tools aimed at supporting the clinical decision-making process and research. However, an increased bureaucratization of clinical practice and redundancies in the measures collected have been reported by clinicians. Redundancies in clinical assessments affect negatively both patients and nurses. To validate a meta-tool measuring the risks/problems currently estimated by multiple tools used in daily practice. A secondary analysis of a database was performed, using a cross-validation and a longitudinal study designs. In total, 1464 patients admitted to 12 medical units in 2012 were assessed at admission with the Brass, Barthel, Conley and Braden tools. Pertinent outcomes such as the occurrence of post-discharge need for resources and functional decline at discharge, as well as falls and pressure sores, were measured. Explorative factor analysis of each tool, inter-tool correlations and a conceptual evaluation of the redundant/similar items across tools were performed. Therefore, the validation of the meta-tool was performed through explorative factor analysis, confirmatory factor analysis and the structural equation model to establish the ability of the meta-tool to predict the outcomes estimated by the original tools. High correlations between the tools have emerged (from r 0.428 to 0.867) with a common variance from 18.3% to 75.1%. Through a conceptual evaluation and explorative factor analysis, the items were reduced from 42 to 20, and the three factors that emerged were confirmed by confirmatory factor analysis. According to the structural equation model results, two out of three emerged factors predicted the outcomes. From the initial 42 items, the meta-tool is composed of 20 items capable of predicting the outcomes as with the original tools. © 2016 John Wiley & Sons, Ltd.
Associations between nine family dinner frequency measures and child weight, dietary and psychosocial outcomes

PubMed Central

Fulkerson, Jayne A.; Friend, Sarah E.; Neumark-Sztainer, Dianne

2015-01-01

Background Family meal frequency has been consistently and significantly associated with positive youth dietary and psychosocial outcomes but less consistently associated with weight outcomes. Family meal frequency measurement has varied widely and it is unclear how this variation may impact relationships with youth weight, dietary, and psychosocial outcomes. Objective This study assesses how five parent/caregiver-reported and four child-reported family dinner frequency measures correlate with each other and are associated with health-related outcomes. Design/Participants This secondary, cross-sectional analysis uses baseline, parent/caregiver (n=160) and 8–12 year old child (n=160) data from the Healthy Home Offerings via the Mealtime Environment (HOME) Plus trial (collected 2011–2012). Data were obtained from objective measurements, dietary recall interviews, and psychosocial surveys. Outcome measures Outcomes included child body mass index z-scores (BMIz), fruit, vegetable and sugar-sweetened beverage intake, dietary quality (Healthy Eating Index-2010 [HEI-2010]), family connectedness, and meal conversations. Statistical analyses performed Pearson correlations and general linear models were used to assess associations between family dinner frequency measures and outcomes. Results All family dinner frequency measures had comparable means and were correlated within and across parent/caregiver- and child-reporters (r=0.17–0.94, p<0.01). In unadjusted analyses, 78% of family dinner frequency measures were significantly associated with BMIz scores and 100% were significantly associated with fruit/vegetable intake and HEI-2010. In adjusted models, most significant associations with dietary and psychosocial outcomes remained but associations with child BMIz remained significant only for parent/caregiver- (β±SE= −0.07±0.03; p<0.05) and child-reported (β±SE= −0.06+0.02; p<0.01) family dinner frequency measures asking about ‘sitting and eating’ dinner. Conclusions In spite of phrasing variations in family dinner frequency measures (e.g., which family members were present and how meals were occurring), few differences were found in associations with dietary and psychosocial outcomes but differences were apparent for child BMIz, which suggests phrasing of family dinner frequency measures may influence associations found with weight outcomes. PMID:26875023
Analysis of subarachnoid hemorrhage using the Nationwide Inpatient Sample: the NIS-SAH Severity Score and Outcome Measure.

PubMed

Washington, Chad W; Derdeyn, Colin P; Dacey, Ralph G; Dhar, Rajat; Zipfel, Gregory J

2014-08-01

Studies using the Nationwide Inpatient Sample (NIS), a large ICD-9-based (International Classification of Diseases, Ninth Revision) administrative database, to analyze aneurysmal subarachnoid hemorrhage (SAH) have been limited by an inability to control for SAH severity and the use of unverified outcome measures. To address these limitations, the authors developed and validated a surrogate marker for SAH severity, the NIS-SAH Severity Score (NIS-SSS; akin to Hunt and Hess [HH] grade), and a dichotomous measure of SAH outcome, the NIS-SAH Outcome Measure (NIS-SOM; akin to modified Rankin Scale [mRS] score). Three separate and distinct patient cohorts were used to define and then validate the NIS-SSS and NIS-SOM. A cohort (n = 148,958, the "model population") derived from the 1998-2009 NIS was used for developing the NIS-SSS and NIS-SOM models. Diagnoses most likely reflective of SAH severity were entered into a regression model predicting poor outcome; model coefficients of significant factors were used to generate the NIS-SSS. Nationwide Inpatient Sample codes most likely to reflect a poor outcome (for example, discharge disposition, tracheostomy) were used to create the NIS-SOM. Data from 716 patients with SAH (the "validation population") treated at the authors' institution were used to validate the NIS-SSS and NIS-SOM against HH grade and mRS score, respectively. Lastly, 147,395 patients (the "assessment population") from the 1998-2009 NIS, independent of the model population, were used to assess performance of the NIS-SSS in predicting outcome. The ability of the NIS-SSS to predict outcome was compared with other common measures of disease severity (All Patient Refined Diagnosis Related Group [APR-DRG], All Payer Severity-adjusted DRG [APS-DRG], and DRG). RESULTS The NIS-SSS significantly correlated with HH grade, and there was no statistical difference between the abilities of the NIS-SSS and HH grade to predict mRS-based outcomes. As compared with the APR-DRG, APSDRG, and DRG, the NIS-SSS was more accurate in predicting SAH outcome (area under the curve [AUC] = 0.69, 0.71, 0.71, and 0.79, respectively). A strong correlation between NIS-SOM and mRS was found, with an agreement and kappa statistic of 85% and 0.63, respectively, when poor outcome was defined by an mRS score > 2 and 95% and 0.84 when poor outcome was defined by an mRS score > 3. Data in this study indicate that in the analysis of NIS data sets, the NIS-SSS is a valid measure of SAH severity that outperforms previous measures of disease severity and that the NIS-SOM is a valid measure of SAH outcome. It is critically important that outcomes research in SAH using administrative data sets incorporate the NIS-SSS and NIS-SOM to adjust for neurology-specific disease severity.
Routine educational outcome measures in health studies: Key Stage 1 in the ORACLE Children Study follow-up of randomised trial cohorts.

PubMed

Jones, David R; Pike, Katie; Kenyon, Sara; Pike, Laura; Henderson, Brian; Brocklehurst, Peter; Marlow, Neil; Salt, Alison; Taylor, David J

2011-01-01

Statutory educational attainment measures are rarely used as health study outcomes, but Key Stage 1 (KS1) data formed secondary outcomes in the long-term follow-up to age 7 years of the ORACLE II trial of antibiotic use in preterm babies. This paper describes the approach, compares different approaches to analysis of the KS1 data and compares use of summary KS1 (level) data with use of individual question scores. 3394 children born to women in the ORACLE Children Study and resident in England at age 7. Analysis of educational achievement measured by national end of KS1 data (KS1) using Poisson regression modelling and anchoring of the KS1 data using external standards. KS1 summary level data were obtained for 3239 (95%) eligible children; raw individual question scores were obtained for 1899 (54%). Use of individual question scores where available did not change the conclusion of no evidence of treatment effects based on summary KS1 outcome data. When accessible for medical research purposes, routinely collected educational outcome data may have advantages of low cost and standardised definition. Here, summary scores lead to similar conclusions to raw (individual question) scores and so are attractive and cost-effective alternatives.
Racial disparities in African Americans with diabetes: process and outcome mismatch.

PubMed

Bulger, John B; Shubrook, Jay H; Snow, Richard

2012-08-01

Over the past 2 decades, numerous studies have demonstrated the existence of racial disparities in patient care in the United States. Specifically, African Americans with diabetes are less likely to have recommended process of care measures performed and outcome benchmarks for quality of care. To evaluate the delivery of diabetes care (processes and outcomes) associated with racial categories using a national web-based registry-the American Osteopathic Association Clinical Assessment Program (AOA-CAP). A retrospective analysis of data retrieved from the AOA-CAP database on outcomes and process measures for diabetes. A total of 10,699 Caucasian and African American patients who received diabetes care had data entered into the AOA-CAP registry between July 1, 2005, and October 30, 2010. African Americans represented 3123 patients (29%), Caucasians 7576 (71%). Demographic, process of care, and outcomes comparisons between ethnicities were carried out using ?2 and t tests. Composite measures of process and outcomes of diabetes care were created to investigate the effect of race on care. The process of care composite measure was significantly different among African American patients (P = .02) who were more likely to receive all indicated care than Caucasian patients (33.9% vs 31.6%). Evaluation of the composite outcome measure, which quantifies the percentage of patients achieving control of all 3 intermediate outcomes, was (P <.001) lower in African Americans than in Caucasians (8.1% vs 12.3%). African American patients with diabetes were as likely or more likely to have recommended process of care measures performed. In spite of this, intermediate diabetes outcomes were still poorer in the same African American population.
Size and consistency of problem-solving consultation outcomes: an empirical analysis.

PubMed

Hurwitz, Jason T; Kratochwill, Thomas R; Serlin, Ronald C

2015-04-01

In this study, we analyzed extant data to evaluate the variability and magnitude of students' behavior change outcomes (academic, social, and behavioral) produced by consultants through problem-solving consultation with teachers. Research questions were twofold: (a) Do consultants produce consistent and sizeable positive student outcomes across their cases as measured through direct and frequent assessment? and (b) What proportion of variability in student outcomes is attributable to consultants? Analyses of extant data collected from problem-solving consultation outcome studies that used single-case, time-series AB designs with multiple participants were analyzed. Four such studies ultimately met the inclusion criteria for the extant data, comprising 124 consultants who worked with 302 school teachers regarding 453 individual students. Consultants constituted the independent variable, while the primary dependent variable was a descriptive effect size based on student behavior change as measured by (a) curriculum-based measures, (b) permanent products, or (c) direct observations. Primary analyses involved visual and statistical evaluation of effect size magnitude and variability observed within and between consultants and studies. Given the nested nature of the data, multilevel analyses were used to assess consultant effects on student outcomes. Results suggest that consultants consistently produced positive effect sizes on average across their cases, but outcomes varied between consultants. Findings also indicated that consultants, teachers, and the corresponding studies accounted for a significant proportion of variability in student outcomes. This investigation advances the use of multilevel and integrative data analyses to evaluate consultation outcomes and extends research on problem-solving consultation, consultant effects, and meta-analysis of case study AB designs. Practical implications for evaluating consultation service delivery in school settings are also discussed. Copyright © 2015 Society for the Study of School Psychology. Published by Elsevier Ltd. 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
Clinical, operational and economic outcomes of point-of-care blood gas analysis in COPD patients.

PubMed

Oliver, Paloma; Buno, Antonio; Alvarez-Sala, Rodolfo; Fernandez-Calle, Pilar; Alcaide, Maria Jose; Casitas, Raquel; Garcia-Quero, Cristina; Madero, Rosario; Gomez-Rioja, Ruben; Iturzaeta, Jose Manuel

2015-04-01

Arterial blood gas analysis is relevant in chronic obstructive pulmonary disease (COPD) management. The aim of this study was to evaluate whether the use of a blood gas analyzer in pulmonology departments improves the clinical, operational and economic outcomes when compared with clinical laboratory measurements. It is an observational prospective study. 112 patients were selected. After specimen collection, the measurement was performed both in pulmonology office as point-of-care and in laboratory. We evaluated clinical outcomes (modification of the indication of long-term oxygen therapy (LTOT) according to results, changes in blood gas analysis results, relationship of the partial pressure of oxygen (PaO2) obtained in the medical visit and velocity of change of the PaO2, influence of total haemoglobin concentration and the change in PaO2), operational outcomes (turnaround time (TAT) from specimen collection to receiving the blood gas analysis report) and economic outcomes (overall cost per process of patient care). There were discrepancies in the indication of LTOT in 13.4% of patients. All parameters showed changes. PaO2 levels showed changes in 2 ways, though they frequently increase over time. The correlation was not good in the other two clinical outcomes. The median TATs in pulmonology office were 1 min versus 79 in laboratory, with 52 min for specimen preparation and transport and 17 min for TAT intralaboratory. The overall cost for the 112 patients in pulmonology office and laboratory was 16,769.89€ and 22,260.97€ respectively. The use of a blood gas analyzer in a pulmonology office improves clinical, operational and economic outcomes when compared with clinical laboratory. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Using Case-Mix Adjustment Methods To Measure the Effectiveness of Substance Abuse Treatment: Three Examples Using Client Employment Outcomes.

ERIC Educational Resources Information Center

Koenig, Lane; Fields, Errol L.; Dall, Timothy M.; Ameen, Ansari Z.; Harwood, Henrick J.

This report demonstrates three applications of case-mix methods using regression analysis. The results are used to assess the relative effectiveness of substance abuse treatment providers. The report also examines the ability of providers to improve client employment outcomes, an outcome domain relatively unexamined in the assessment of provider…
"Hits" (Not "Discussion Posts") Predict Student Success in Online Courses: A Double Cross-Validation Study

ERIC Educational Resources Information Center

Ramos, Cheryl; Yudko, Errol

2008-01-01

The efficacy of individual components of an online course on positive course outcome was examined via stepwise multiple regression analysis. Outcome was measured as the student's total score on all exams given during the course. The predictors were page hits, discussion posts, and discussion reads. The vast majority of the variance of outcome was…
Can we "predict" long-term outcome for ambulatory transcutaneous electrical nerve stimulation in patients with chronic pain?

PubMed

Köke, Albère J; Smeets, Rob J E M; Perez, Roberto S; Kessels, Alphons; Winkens, Bjorn; van Kleef, Maarten; Patijn, Jacob

2015-03-01

Evidence for effectiveness of transcutaneous electrical nerve stimulation (TENS) is still inconclusive. As heterogeneity of chronic pain patients might be an important factor for this lack of efficacy, identifying factors for a successful long-term outcome is of great importance. A prospective study was performed to identify variables with potential predictive value for 2 outcome measures on long term (6 months); (1) continuation of TENS, and (2) a minimally clinical important pain reduction of ≥ 33%. At baseline, a set of risk factors including pain-related variables, psychological factors, and disability was measured. In a multiple logistic regression analysis, higher patient's expectations, neuropathic pain, no severe pain (< 80 mm visual analogue scale [VAS]) were independently related to long-term continuation of TENS. For the outcome "minimally clinical important pain reduction," the multiple logistic regression analysis indicated that no multisited pain (> 2 pain locations) and intermittent pain were positively and independently associated with a minimally clinical important pain reduction of ≥ 33%. The results showed that factors associated with a successful outcome in the long term are dependent on definition of successful outcome. © 2014 World Institute of Pain.

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.
The effect of social integration on outcomes after major lower extremity amputation.

PubMed

Hawkins, Alexander T; Pallangyo, Anthony J; Herman, Ayesiga M; Schaumeier, Maria J; Smith, Ann D; Hevelone, Nathanael D; Crandell, David M; Nguyen, Louis L

2016-01-01

Major lower extremity (MLE) amputation is a common procedure that results in a profound change in a patient's life. We sought to determine the association between social support and outcomes after amputation. We hypothesized that patients with greater social support will have better post amputation outcomes. From November 2011 to May 2013, we conducted a cross-sectional, observational, multicenter study. Social integration was measured by the social integration subset of the Short Form Craig Handicap Assessment and Reporting Technique. Systemic social support was assessed by comparing a United States and Tanzanian population. Walking function was measured using the 6-minute walk test and quality of life (QoL) was measured using the EuroQol-5D. We recruited 102 MLE amputees. Sixty-three patients were enrolled in the United States with a mean age of 58.0. Forty-two (67%) were male. Patients with low social integration were more likely to be unable to ambulate (no walk 39% vs slow walk 23% vs fast walk 10%; P = .01) and those with high social integration were more likely to be fast walkers (no walk 10% vs slow walk 59% vs fast walk 74%; P = .01). This relationship persisted in a multivariable analysis. Increasing social integration scores were also positively associated with increasing QoL scores in a multivariable analysis (β, .002; standard error, 0.0008; P = .02). In comparing the United States population with the Tanzanian cohort (39 subjects), there were no differences between functional or QoL outcomes in the systemic social support analysis. In the United States population, increased social integration is associated with both improved function and QoL outcomes among MLE amputees. Systemic social support, as measured by comparing the United States population with a Tanzanian population, was not associated with improved function or QoL outcomes. In the United States, steps should be taken to identify and aid amputees with poor social integration. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
The Effect of Social Integration on Outcomes after Major Lower Extremity Amputation

PubMed Central

Hawkins, Alexander T.; Pallangyo, Anthony J.; Herman, Ayesiga M.; Schaumeier, Maria J.; Smith, Ann D.; Hevelone, Nathanael D.; Crandell, David M.; Nguyen, Louis

2016-01-01

Objective Major lower extremity amputation is a common procedure that results in a profound change in a patient's life. We sought to determine the association between social support and outcomes after amputation. We hypothesized that patients with greater social support will have better post amputation outcomes. Methods From November 2011 to May 2013, we conducted a cross-sectional, observational, multicenter study. Social integration was measured by the social integration subset of the Short Form (Craig Handicap Assessment and Reporting Technique (CHART). Systemic social support was assessed by comparing a US and Tanzanian population. Walking function was measured using the 6MWT and quality of life (QoL) was measured using the EQ-5D. Results 102 major lower extremity amputees were recruited. 63 patients were enrolled in the US with a mean age of 58.0. Forty-two (67%) were male. Patients with low social integration were more likely to be unable to ambulate (no walk 39% vs. slow walk 23% vs. fast walk 10%; P=.01) and those with high social integration were more likely to be fast walkers (no walk 10% vs. slow walk 59% vs. fast walk 74%; P=.01). This relationship persisted in a multivariable analysis. Increasing social integration scores were also positively associated with increasing quality of life scores in a multivariable analysis (β .002; SE .0008; P = .02). In comparing the US population with the Tanzanian cohort (39 subjects), there were no significant differences between functional or quality of life outcomes in the systemic social support analysis. Conclusions In the US population, increased social integration is associated with both improved function and quality of life outcomes among major lower extremity amputees. Systemic social support, as measured by comparing the US population with a Tanzanian population, was not associated with improved function or quality of life outcomes. In the US, steps should be taken to identify and aid amputees with poor social integration. PMID:26474508
Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis.

PubMed

Malek, Sarah; Sample, Susannah J; Schwartz, Zeev; Nemke, Brett; Jacobson, Peer B; Cozzi, Elizabeth M; Schaefer, Susan L; Bleedorn, Jason A; Holzman, Gerianne; Muir, Peter

2012-10-04

Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 - transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen - non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (SR ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs.
Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis

PubMed Central

2012-01-01

Background Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Results Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (SR ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. Conclusion Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs. PMID:23035739
Cost-effectiveness analysis of the most common orthopaedic surgery procedures: knee arthroscopy and knee anterior cruciate ligament reconstruction.

PubMed

Lubowitz, James H; Appleby, David

2011-10-01

The purpose of this study was to determine the cost-effectiveness of knee arthroscopy and anterior cruciate ligament (ACL) reconstruction. Retrospective analysis of prospectively collected data from a single-surgeon, institutional review board-approved outcomes registry included 2 cohorts: surgically treated knee arthroscopy and ACL reconstruction patients. Our outcome measure is cost-effectiveness (cost of a quality-adjusted life-year [QALY]). The QALY is calculated by multiplying difference in health-related quality of life, before and after treatment, by life expectancy. Health-related quality of life is measured by use of the Quality of Well-Being scale, which has been validated for cost-effectiveness analysis. Costs are facility charges per the facility cost-to-charges ratio plus surgeon fee. Sensitivity analyses are performed to determine the effect of variations in costs or outcomes. There were 93 knee arthroscopy and 35 ACL reconstruction patients included at a mean follow-up of 2.1 years. Cost per QALY was $5,783 for arthroscopy and $10,326 for ACL reconstruction (2009 US dollars). Sensitivity analysis shows that our results are robust (relatively insensitive) to variations in costs or outcomes. Knee arthroscopy and knee ACL reconstruction are very cost-effective. Copyright © 2011 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
The effect of losartan on progressive aortic dilatation in patients with Marfan's syndrome: a meta-analysis of prospective randomized clinical trials.

PubMed

Gao, Linggen; Chen, Lei; Fan, Li; Gao, Dewei; Liang, Zhiru; Wang, Rong; Lu, Wenning

2016-08-15

To assess the effect of losartan therapy on progressive aortic dilatation and on clinical outcome in patients with Marfan's syndrome (MFS). The meta-analysis was instituted, which included studies identified by a systematic review of MEDLINE of peer-reviewed publications. Echocardiogram or MRI measurements of the aortic root dimension and outcome measures of death, cardiovascular surgery and aortic dissection or rupture were compared between patients who were treated and untreated with losartan therapy. Six randomized trials with 1398 subjects met all the inclusion criteria and were included in the meta-analysis. Compared with non-losartan treatment, losartan therapy significantly decreased the rate of aortic dilatation (SMD=-0.13 with 95% CI -0.25 to 0.00, p=0.04). The clinical outcome beneficial was not observed in the losartan treatment group when compared with no losartan treatment group (odds ratio=1.04 with 95% CI of 0.57-1.87). Given the current results of the meta-analysis and together with the lack of associated side effects, it would be reasonable to use losartan in MFS patients with aortic root dilatation. However, no clinical outcome benefits were observed in the losartan treatment group when compared with no losartan treatment group. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Examining the Effects of Intensive Supervision and Aftercare Programs for At-Risk Youth: A Systematic Review and Meta-Analysis.

PubMed

Bouchard, Jessica; Wong, Jennifer S

2018-05-01

Community correctional sentences are administered to more juvenile offenders in North America than any other judicial sentence. Particularly prominent in juvenile corrections is intensive supervision probation and aftercare/reentry, yet the effects of these supervision-oriented interventions on recidivism are mixed. The purpose of this meta-analysis is to determine the effects of intensive supervision probation and aftercare/reentry on juvenile recidivism. An extensive search of the literature and application of strict inclusion criteria resulted in the selection of 27 studies that contributed 55 individual effect sizes. Studies were pooled based on intervention type (intensive supervision probation or aftercare/reentry) and outcome measure (alleged or convicted offenses). The pooled analyses yielded contradictory results with respect to outcome measure; in both cases, supervision had a beneficial effect on alleged offenses and negatively affected convicted offenses. These patterns across intervention type and outcome measure, as well as recommendations for future research, are discussed.
A real-time monitoring system for the facial nerve.

PubMed

Prell, Julian; Rachinger, Jens; Scheller, Christian; Alfieri, Alex; Strauss, Christian; Rampp, Stefan

2010-06-01

Damage to the facial nerve during surgery in the cerebellopontine angle is indicated by A-trains, a specific electromyogram pattern. These A-trains can be quantified by the parameter "traintime," which is reliably correlated with postoperative functional outcome. The system presented was designed to monitor traintime in real-time. A dedicated hardware and software platform for automated continuous analysis of the intraoperative facial nerve electromyogram was specifically designed. The automatic detection of A-trains is performed by a software algorithm for real-time analysis of nonstationary biosignals. The system was evaluated in a series of 30 patients operated on for vestibular schwannoma. A-trains can be detected and measured automatically by the described method for real-time analysis. Traintime is monitored continuously via a graphic display and is shown as an absolute numeric value during the operation. It is an expression of overall, cumulated length of A-trains in a given channel; a high correlation between traintime as measured by real-time analysis and functional outcome immediately after the operation (Spearman correlation coefficient [rho] = 0.664, P < .001) and in long-term outcome (rho = 0.631, P < .001) was observed. Automated real-time analysis of the intraoperative facial nerve electromyogram is the first technique capable of reliable continuous real-time monitoring. It can critically contribute to the estimation of functional outcome during the course of the operative procedure.
Measuring the Efficiency of Public Universities: Using Data Envelopment Analysis (DEA) to Examine Public Universities in Saudi Arabia

ERIC Educational Resources Information Center

Alabdulmenem, Fahad Mohammed

2017-01-01

Saudi Arabia is one of the countries that allot substantial amount of government resources for education. Thus, it is important to measure how these resources are used to generate favorable academic outcomes for its nationals. In this study, data envelopment analysis (DEA) is used to measure the relative efficiency of 25 public universities in…
Economic analysis of cancer treatment costs: another tool for oncology managers.

PubMed

Chirikos, T N; Ruckdeschel, J C; Krischer, J P

2001-01-01

Oncology managers increasingly need more information about how much and why treatment costs vary across cancer patients. In response to this need, our Center is building an analytic capacity for investigating economic aspects of cancer treatment. Economic analysis is characterized by a simultaneous consideration of treatment costs and outcomes; it focuses on how treatment cost/outcome ratios vary across patient populations with similar diseases. In this paper, we present an overview of our work, with special emphasis on the measurement of outcomes and the inputs or costs of treatment, the variability of cost/outcome ratios, and the analysis of the factors that predict or explain this observed variation. We illustrate how the analysis is conducted, set out selected results relating to lung and breast cancer patients, and assess some of the advantages and disadvantages of the approach. Among other things, we conclude that economic analysis of cancer treatment costs is feasible and that it can provide useful data for managerial decision making.
Item-Level Psychometrics of the Glasgow Outcome Scale: Extended Structured Interviews.

PubMed

Hong, Ickpyo; Li, Chih-Ying; Velozo, Craig A

2016-04-01

The Glasgow Outcome Scale-Extended (GOSE) structured interview captures critical components of activities and participation, including home, shopping, work, leisure, and family/friend relationships. Eighty-nine community dwelling adults with mild-moderate traumatic brain injury (TBI) were recruited (average = 2.7 year post injury). Nine items of the 19 items were used for the psychometrics analysis purpose. Factor analysis and item-level psychometrics were investigated using the Rasch partial-credit model. Although the principal components analysis of residuals suggests that a single measurement factor dominates the measure, the instrument did not meet the factor analysis criteria. Five items met the rating scale criteria. Eight items fit the Rasch model. The instrument demonstrated low person reliability (0.63), low person strata (2.07), and a slight ceiling effect. The GOSE demonstrated limitations in precisely measuring activities/participation for individuals after TBI. Future studies should examine the impact of the low precision of the GOSE on effect size. © The Author(s) 2016.
The impact of outcomes measurement on the hospital-physician relationship.

PubMed

Longo, D R

1994-01-01

Hospitals and physicians have a mutually dependent relationship. Although both are responsible for patient care, conflicts arise as physicians attempt to maintain professional autonomy and hospitals attempt to maintain organizational stability. In recent years the outcomes measurement movement has influenced this relationship in a variety of ways. This review chapter traces the major sociological, historical, theoretical, and political influences that have contributed to these conflicts. Additionally, based on an analysis of these trends, speculation is offered on the future of the hospital-physician relationship as society increasingly holds both groups responsible for outcomes of care.
Quantifying the process and outcomes of person-centered planning.

PubMed

Holburn, S; Jacobson, J W; Vietze, P M; Schwartz, A A; Sersen, E

2000-09-01

Although person-centered planning is a popular approach in the field of developmental disabilities, there has been little systematic assessment of its process and outcomes. To measure person-centered planning, we developed three instruments designed to assess its various aspects. We then constructed variables comprising both a Process and an Outcome Index using a combined rational-empirical method. Test-retest reliability and measures of internal consistency appeared adequate. Variable correlations and factor analysis were generally consistent with our conceptualization and resulting item and variable classifications. Practical implications for intervention integrity, program evaluation, and organizational performance are discussed.
Complex networks untangle competitive advantage in Australian football

NASA Astrophysics Data System (ADS)

Braham, Calum; Small, Michael

2018-05-01

We construct player-based complex network models of Australian football teams for the 2014 Australian Football League season; modelling the passes between players as weighted, directed edges. We show that analysis of these measures can give an insight into the underlying structure and strategy of Australian football teams, quantitatively distinguishing different playing styles. The relationships observed between network properties and match outcomes suggest that successful teams exhibit well-connected passing networks with the passes distributed between all 22 players as evenly as possible. Linear regression models of team scores and match margins show significant improvements in R2 and Bayesian information criterion when network measures are added to models that use conventional measures, demonstrating that network analysis measures contain useful, extra information. Several measures, particularly the mean betweenness centrality, are shown to be useful in predicting the outcomes of future matches, suggesting they measure some aspect of the intrinsic strength of teams. In addition, several local centrality measures are shown to be useful in analysing individual players' differing contributions to the team's structure.
Complex networks untangle competitive advantage in Australian football.

PubMed

Braham, Calum; Small, Michael

2018-05-01

We construct player-based complex network models of Australian football teams for the 2014 Australian Football League season; modelling the passes between players as weighted, directed edges. We show that analysis of these measures can give an insight into the underlying structure and strategy of Australian football teams, quantitatively distinguishing different playing styles. The relationships observed between network properties and match outcomes suggest that successful teams exhibit well-connected passing networks with the passes distributed between all 22 players as evenly as possible. Linear regression models of team scores and match margins show significant improvements in R 2 and Bayesian information criterion when network measures are added to models that use conventional measures, demonstrating that network analysis measures contain useful, extra information. Several measures, particularly the mean betweenness centrality, are shown to be useful in predicting the outcomes of future matches, suggesting they measure some aspect of the intrinsic strength of teams. In addition, several local centrality measures are shown to be useful in analysing individual players' differing contributions to the team's structure.
Defining the value framework for prostate brachytherapy using patient-centered outcome metrics and time-driven activity-based costing.

PubMed

Thaker, Nikhil G; Pugh, Thomas J; Mahmood, Usama; Choi, Seungtaek; Spinks, Tracy E; Martin, Neil E; Sio, Terence T; Kudchadker, Rajat J; Kaplan, Robert S; Kuban, Deborah A; Swanson, David A; Orio, Peter F; Zelefsky, Michael J; Cox, Brett W; Potters, Louis; Buchholz, Thomas A; Feeley, Thomas W; Frank, Steven J

2016-01-01

Value, defined as outcomes over costs, has been proposed as a measure to evaluate prostate cancer (PCa) treatments. We analyzed standardized outcomes and time-driven activity-based costing (TDABC) for prostate brachytherapy (PBT) to define a value framework. Patients with low-risk PCa treated with low-dose-rate PBT between 1998 and 2009 were included. Outcomes were recorded according to the International Consortium for Health Outcomes Measurement standard set, which includes acute toxicity, patient-reported outcomes, and recurrence and survival outcomes. Patient-level costs to 1 year after PBT were collected using TDABC. Process mapping and radar chart analyses were conducted to visualize this value framework. A total of 238 men were eligible for analysis. Median age was 64 (range, 46-81). Median followup was 5 years (0.5-12.1). There were no acute Grade 3-5 complications. Expanded Prostate Cancer Index Composite 50 scores were favorable, with no clinically significant changes from baseline to last followup at 48 months for urinary incontinence/bother, bowel bother, sexual function, and vitality. Ten-year outcomes were favorable, including biochemical failure-free survival of 84.1%, metastasis-free survival 99.6%, PCa-specific survival 100%, and overall survival 88.6%. TDABC analysis demonstrated low resource utilization for PBT, with 41% and 10% of costs occurring in the operating room and with the MRI scan, respectively. The radar chart allowed direct visualization of outcomes and costs. We successfully created a visual framework to define the value of PBT using the International Consortium for Health Outcomes Measurement standard set and TDABC costs. PBT is associated with excellent outcomes and low costs. Widespread adoption of this methodology will enable value comparisons across providers, institutions, and treatment modalities. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
Ranking Surgical Residency Programs: Reputation Survey or Outcomes Measures?

PubMed

Wilson, Adam B; Torbeck, Laura J; Dunnington, Gary L

2015-01-01

The release of general surgery residency program rankings by Doximity and U.S. News & World Report accentuates the need to define and establish measurable standards of program quality. This study evaluated the extent to which program rankings based solely on peer nominations correlated with familiar program outcomes measures. Publicly available data were collected for all 254 general surgery residency programs. To generate a rudimentary outcomes-based program ranking, surgery programs were rank-ordered according to an average percentile rank that was calculated using board pass rates and the prevalence of alumni publications. A Kendall τ-b rank correlation computed the linear association between program rankings based on reputation alone and those derived from outcomes measures to validate whether reputation was a reasonable surrogate for globally judging program quality. For the 218 programs with complete data eligible for analysis, the mean board pass rate was 72% with a standard deviation of 14%. A total of 60 programs were placed in the 75th percentile or above for the number of publications authored by program alumni. The correlational analysis reported a significant correlation of 0.428, indicating only a moderate association between programs ranked by outcomes measures and those ranked according to reputation. Seventeen programs that were ranked in the top 30 according to reputation were also ranked in the top 30 based on outcomes measures. This study suggests that reputation alone does not fully capture a representative snapshot of a program's quality. Rather, the use of multiple quantifiable indicators and attributes unique to programs ought to be given more consideration when assigning ranks to denote program quality. It is advised that the interpretation and subsequent use of program rankings be met with caution until further studies can rigorously demonstrate best practices for awarding program standings. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.
A repeated measures model for analysis of continuous outcomes in sequential parallel comparison design studies.

PubMed

Doros, Gheorghe; Pencina, Michael; Rybin, Denis; Meisner, Allison; Fava, Maurizio

2013-07-20

Previous authors have proposed the sequential parallel comparison design (SPCD) to address the issue of high placebo response rate in clinical trials. The original use of SPCD focused on binary outcomes, but recent use has since been extended to continuous outcomes that arise more naturally in many fields, including psychiatry. Analytic methods proposed to date for analysis of SPCD trial continuous data included methods based on seemingly unrelated regression and ordinary least squares. Here, we propose a repeated measures linear model that uses all outcome data collected in the trial and accounts for data that are missing at random. An appropriate contrast formulated after the model has been fit can be used to test the primary hypothesis of no difference in treatment effects between study arms. Our extensive simulations show that when compared with the other methods, our approach preserves the type I error even for small sample sizes and offers adequate power and the smallest mean squared error under a wide variety of assumptions. We recommend consideration of our approach for analysis of data coming from SPCD trials. Copyright © 2013 John Wiley & Sons, Ltd.
Compass 2012 data analysis and reporting.

DOT National Transportation Integrated Search

2014-05-01

Past efforts include data analysis and reporting performance and outcomes for signs, pavement, shoulders, roadsides, drainage, traffic, and bridges. In : the 2005 Compass report, measures for bridge inspection and maintenance were added, and historic...

Compass 2011 data analysis and reporting.

DOT National Transportation Integrated Search

2013-05-01

Past efforts include data analysis and reporting performance and outcomes for signs, pavement, shoulders, roadsides, drainage, traffic, and bridges. In : the 2005 Compass report, measures for bridge inspection and maintenance were added, and historic...
Can Research Design Explain Variation in Head Start Research Results? A Meta-Analysis of Cognitive and Achievement Outcomes

ERIC Educational Resources Information Center

Shager, Hilary M.; Schindler, Holly S.; Magnuson, Katherine A.; Duncan, Greg J.; Yoshikawa, Hirokazu; Hart, Cassandra M. D.

2013-01-01

This study explores the extent to which differences in research design explain variation in Head Start program impacts. We employ meta-analytic techniques to predict effect sizes for cognitive and achievement outcomes as a function of the type and rigor of research design, quality and type of outcome measure, activity level of control group, and…
The Patient-Centered Medical Home (PCMH) Framing Typology for Understanding the Structure, Function, and Outcomes of PCMHs.

PubMed

Kieber-Emmons, Autumn M; Miller, William L

2017-01-01

Patient-centered medical homes (PCHMs) aspire to transform today's challenged primary care services. However, it is unclear which PCMH characteristics produce specific outcomes of interest for care delivery. This study tested a novel typology of PCMH practice transformation, the PCMH framing typology, and evaluated measurable outcomes by each type. Using the Patient-Centered Primary Care Collaborative 2012 to 2013 Annual Review, this secondary analysis of the published PCMH literature extracted data from publications of 59 PCMHs. Each of the 59 sites was categorized as 1 of 4 PCMH types: add-on, renovated, hybrid, or integrated. Six outcome measures (cost reductions, decreased emergency department/hospital utilization, improved quality, improved access, increased preventive services, and improved patient satisfaction) were independently coded for each site. Practices were combined based on type, and mean outcomes scores for each measure were displayed on radar graphs for comparison. While each type showed a characteristic pattern of success, only the integrated type improved in all 6 outcomes. No type achieved high success in all measures. There seem to be 4 types of PCMH, each of which shows a distinctive outcomes profile. Within the PCMH framing typology, direction is emerging for how best to transform primary care to achieve the greatest success. © Copyright 2017 by the American Board of Family Medicine.
A Qualitative Study of US Clinical Ethics Services: Objectives and Outcomes.

PubMed

McClimans, Leah; Pressgrove, Geah; Rhea, James

2016-01-01

The quality of clinical ethics services in health care organizations is increasingly seen as an important aspect of the overall quality of care. But measuring this quality is difficult because there is a lack of clarity and consensus regarding the objectives of clinical ethics and the best outcome domains to measure. The aim of this qualitative study is to explore the views of experts about the objectives and outcomes of clinical ethics services in the US. We interviewed 19 experts in clinical ethics, focusing on the appropriate objectives and outcomes of a clinical ethics service (CES). Participants were selected using a purposive snowball sampling strategy. The development of the interview protocol was informed by the clinical ethics literature as well as by research and theories that inform clinical ethics practice. Interviews were conducted by phone, recorded, and transcribed for individual analysis. Analysis proceeded through the development of a codebook of categories using QDA Miner software. Our experts identified 12 objectives and nine outcomes. Some of these identifications were familiar (e.g., mediation and satisfaction) and some were novel (e.g., be of service and transformation). We found that experts are divided in their emphasis on the kinds of objectives that are most important. In terms of outcomes, our experts were concerned with the appropriateness of different proxy and direct measures. This study provides the perspectives of a select group of experts on the objectives and outcomes appropriate for a CES in the United States. The themes identified will be used in future research to inform a Delphi study to refine and obtain expert consensus.
Primary Care Outcomes Questionnaire: psychometric testing of a new instrument.

PubMed

Murphy, Mairead; Hollinghurst, Sandra; Cowlishaw, Sean; Salisbury, Chris

2018-06-01

Patients attend primary care for many reasons and to achieve a range of possible outcomes. There is currently no Patient Reported Outcome Measure (PROM) designed to capture these diverse outcomes, and trials of interventions in primary care may thus fail to detect beneficial effects. This study describes the psychometric testing of the Primary Care Outcomes Questionnaire (PCOQ), which was designed to capture a broad range of outcomes relevant to primary care. Questionnaires were administered in primary care in South West England. Patients completed the PCOQ in GP waiting rooms before a consultation, and a second questionnaire, including the PCOQ and seven comparator PROMs, after 1 week. Psychometric testing included exploratory factor analysis on the PCOQ, internal consistency, correlation coefficients between domain scores and comparator measures, and repeated measures effect sizes indicating change across 1 week. In total, 602 patients completed the PCOQ at baseline, and 264 (44%) returned the follow-up questionnaire. Exploratory factor analysis suggested four dimensions underlying the PCOQ items: health and wellbeing, health knowledge and self-care, confidence in health provision, and confidence in health plan. Each dimension was internally consistent and correlated as expected with comparator PROMs, providing evidence of construct validity. Patients reporting an improvement in their main problem exhibited small to moderate improvements in relevant domain scores on the PCOQ. The PCOQ was acceptable, feasible, showed strong psychometric properties, and was responsive to change. It is a promising new tool for assessment of outcomes of primary care interventions from a patient perspective. © British Journal of General Practice 2018.
Current-reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review

PubMed Central

Hall, Deborah A; Szczepek, Agnieszka J; Kennedy, Veronica; Haider, Haúla

2015-01-01

Introduction In Europe alone, over 70 million people experience tinnitus. Despite its considerable socioeconomic relevance, progress in developing successful treatments has been limited. Clinical effectiveness is judged according to change in primary outcome measures, but because tinnitus is a subjective condition, the definition of outcomes is challenging and it remains unclear which distinct aspects of tinnitus (ie, ‘domains’) are most relevant for assessment. The development of a minimum outcome reporting standard would go a long way towards addressing these problems. In 2006, a consensus meeting recommended using 1 of 4 questionnaires for tinnitus severity as an outcome in clinical trials, in part because of availability in different language translations. Our initiative takes an approach motivated by clinimetrics, first by determining what to measure before seeking to determine how to measure it. Agreeing on the domains that contribute to tinnitus severity (ie, ‘what’) is the first step towards achieving a minimum outcome reporting standard for tinnitus that has been reached via a methodologically rigorous and transparent process. Methods and analysis Deciding what should be the core set of outcomes requires a great deal of discussion and so lends itself well to international effort. This protocol lays out the first-step methodology in defining a Core Domain Set for clinical trials of tinnitus by establishing existing knowledge and practice with respect to which outcome domains have been measured and which instruments used in recent registered and published clinical trials. Ethics and dissemination No ethical issues are foreseen. Findings will be reported at national and international ear, nose and throat (ENT) and audiology conferences and in a peer-reviewed journal, using PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. Trial registration number The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. PMID:26560061
Examining the feasibility of an economic analysis of dyadic developmental psychotherapy for children with maltreatment associated psychiatric problems in the United Kingdom.

PubMed

Boyer, Nicole R S; Boyd, Kathleen A; Turner-Halliday, Fiona; Watson, Nicholas; Minnis, Helen

2014-12-10

Children with maltreatment associated psychiatric problems are at increased risk of developing behavioural or mental health disorders. Dyadic Developmental Psychotherapy (DDP) was proposed as treatment for children with maltreatment histories in the USA, however, being new to the UK little is known of its effectiveness or cost-effectiveness. As part of an exploratory study, this paper explores the feasibility of undertaking economic analysis of DDP in the UK. Feasibility for economic analysis was determined by ensuring such analysis could meet key criteria for economic evaluation. Phone interviews were conducted with professionals (therapists trained and accredited or in the process of becoming accredited DDP practitioners). Three models were developed to represent alternative methods of DDP service delivery. Once appropriate comparators were determined, economic scenarios were constructed. Cost analyses were undertaken from a societal perspective. Finally, appropriate outcome measurement was explored through clinical opinion, literature and further discussions with clinical experts. Three DDP models were constructed: DDP Full-Basic, DDP Home-Based and DDP Long-Term. Two potential comparator interventions were identified and defined as Consultation with Carers and Individual Psychotherapy. Costs of intervention completion per case were estimated to be: £6,700 (DDP Full-Basic), £7,100 (Consultations with Carers), £7,200 (DDP Home-Based), £11,400 (Individual Psychotherapy) and £14,500 (DDP Long-Term). None of the models of service delivery were found to currently measure effectiveness consistently. The Strengths and Difficulties Questionnaire (SDQ) was deemed an appropriate primary outcome measure, however, it does not cover all disorders DDP intends to treat and the SDQ is not a direct measure of health gain. Inclusion of quality of life measurement is required for comprehensive economic analysis. Economic analysis of DDP in the UK is feasible if vital next steps are taken to measure intervention outcomes consistently, ideally with a quality of life measurement. An economic analysis using the models constructed could determine the potential cost-effectiveness of DDP in the UK and identify the most efficient mode of service delivery.
Music-Induced Analgesia in Chronic Pain Conditions: A Systematic Review and Meta-Analysis.

PubMed

Garza-Villarreal, Eduardo A; Pando, Victor; Vuust, Peter; Parsons, Christine

2017-11-01

Music is increasingly used as an adjuvant for the management of chronic pain (CP), as it is non-invasive, inexpensive, and patients usually report positive experiences with it. However, little is known about its clinical efficacy in chronic pain patients. We aimed to determine the effect of music as an adjuvant for chronic pain, as well as to identify characteristics of music interventions associated with positive clinical outcomes. In this systematic review and meta-analysis, we investigated randomized controlled trials (RCTs) of adult patients that reported any type of music intervention for chronic pain, chosen by the researcher or patient, lasting for any duration. Searches were performed using PsycINFO, Scopus, and PubMed for RCTs published until the end of May 2016. The primary outcome was reduction in self-reported pain using a standardized pain measurement instrument, reported post-intervention. The secondary outcomes were: quality of life measures, depression, anxiety, and related measures. The study was pre-registered with PROSPERO (CRD42016039837), and the meta-analysis was performed using RevMan 5.3 (The Nordic Cochrane Centre for The Cochrane Collaboration, Copenhagen, Denmark). We identified 768 titles and abstracts, and we included 14 RTCs that fulfilled our criteria. The sample size of the studies varied between 25 and 200 patients. We found that music reduced self-reported chronic pain and depressive symptoms. We also found that music had a greater effect when the patient chose the music, compared to when the researcher chose it. The sample size of RCTs was small and sometimes with different outcome measures. There was high heterogeneity associated with pooled estimates. Our analysis suggests that music may be beneficial as an adjuvant for chronic pain patients, as it reduces self-reported pain and its common comorbidities. Importantly, the analgesic effect of music appears higher with self-chosen over researcher-chosen music. Pain, music, analgesia, music-induced analgesia, chronic pain, meta-analysis, systematic review, therapy.
Brain natriuretic peptide predicts functional outcome in ischemic stroke

PubMed Central

Rost, Natalia S; Biffi, Alessandro; Cloonan, Lisa; Chorba, John; Kelly, Peter; Greer, David; Ellinor, Patrick; Furie, Karen L

2011-01-01

Background Elevated serum levels of brain natriuretic peptide (BNP) have been associated with cardioembolic (CE) stroke and increased post-stroke mortality. We sought to determine whether BNP levels were associated with functional outcome after ischemic stroke. Methods We measured BNP in consecutive patients aged ≥18 years admitted to our Stroke Unit between 2002–2005. BNP quintiles were used for analysis. Stroke subtypes were assigned using TOAST criteria. Outcomes were measured as 6-month modified Rankin Scale score (“good outcome” = 0–2 vs. “poor”) as well as mortality. Multivariate logistic regression was used to assess association between the quintiles of BNP and outcomes. Predictive performance of BNP as compared to clinical model alone was assessed by comparing ROC curves. Results Of 569 ischemic stroke patients, 46% were female; mean age was 67.9 ± 15 years. In age- and gender-adjusted analysis, elevated BNP was associated with lower ejection fraction (p<0.0001) and left atrial dilatation (p<0.001). In multivariate analysis, elevated BNP decreased the odds of good functional outcome (OR 0.64, 95%CI 0.41–0.98) and increased the odds of death (OR 1.75, 95%CI 1.36–2.24) in these patients. Addition of BNP to multivariate models increased their predictive performance for functional outcome (p=0.013) and mortality (p<0.03) after CE stroke. Conclusions Serum BNP levels are strongly associated with CE stroke and functional outcome at 6 months after ischemic stroke. Inclusion of BNP improved prediction of mortality in patients with CE stroke. PMID:22116811
Outcome measures in older persons with acquired joint contractures: a systematic review and content analysis using the ICF (International Classification of Functioning, Disability and Health) as a reference.

PubMed

Bartoszek, Gabriele; Fischer, Uli; Müller, Martin; Strobl, Ralf; Grill, Eva; Nadolny, Stephan; Meyer, Gabriele

2016-02-09

Joint contractures are a common health problem in older persons with significant impact on activities of daily living. We aimed to retrieve outcome measures applied in studies on older persons with joint contractures and to identify and categorise the concepts contained in these outcome measures using the ICF (International Classification of Functioning, Disability and Health) as a reference. Electronic searches of Medline, EMBASE, CINAHL, Pedro and the Cochrane Library were conducted (1/2002-8/2012). We included studies in the geriatric rehabilitation and nursing home settings with participants aged ≥ 65 years and with acquired joint contractures. Two independent reviewers extracted the outcome measures and transferred them to concepts using predefined conceptual frameworks. Concepts were subsequently linked to the ICF categories. From the 1057 abstracts retrieved, 60 studies met the inclusion criteria. We identified 52 single outcome measures and 24 standardised assessment instruments. A total of 1353 concepts were revealed from the outcome measures; 96.2% could be linked to 50 ICF categories in the 2nd level; 3.8% were not categorised. Fourteen of the 50 categories (28%) belonged to the component Body Functions, 4 (8%) to the component Body Structures, 26 (52%) to the component Activities and Participation, and 6 (12%) to the component Environmental Factors. The ICF is a valuable reference for identifying and quantifying the concepts of outcome measures on joint contractures in older people. The revealed ICF categories remain to be validated in populations with joint contractures in terms of clinical relevance and personal impact.
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.
Symptoms of depression and anxiety predict treatment response and long-term physical health outcomes in rheumatoid arthritis: secondary analysis of a randomized controlled trial

PubMed Central

Norton, Sam; Scott, David L.; Steer, Sophia; Hotopf, Matthew

2016-01-01

Objective. The aim of this analysis is to examine the longitudinal impact of symptoms of depression/anxiety on treatment response, long-term disease activity and physical disability in RA. Methods. Secondary analysis of clinical trial data was performed. Data were collected at baseline and at 6-monthly intervals for 2 years. The EuroQoL (EQ-5DTM) indicated depression/anxiety symptom severity. Our primary outcomes of interest were (i) DAS-28 and (ii) physical disability measured via the HAQ. Secondary outcomes were: tender and swollen joint counts, patient global assessment, ESR and odds of reaching clinical remission. Multilevel models were used to assess the impact of baseline and persistent depression/anxiety on outcomes over 2 years. Results. Data from 379 patients were included. After adjusting for covariates, baseline depression/anxiety symptoms were associated with increased DAS-28 outcomes and increased tender joint counts. Persistent depression/anxiety symptoms were associated with increased DAS-28 scores, HAQ scores, tender joint counts and patient global assessment of disease activity, and reduced odds of reaching clinical remission. Patients with symptoms of depression/anxiety at baseline also showed a 50% reduction in prednisolone treatment effect, in comparison with patients with no symptoms of depression/anxiety at baseline. Conclusion. Baseline and persistent symptoms of depression/anxiety are associated with poorer health outcomes over time, as well as reduced treatment response. Mental health should be routinely measured both in clinical practice and in research, and managed alongside rheumatological disease to optimize health outcomes. Further research is required to examine whether treatment of mental disorders can improve rheumatological outcomes. PMID:26350486
Symptoms of depression and anxiety predict treatment response and long-term physical health outcomes in rheumatoid arthritis: secondary analysis of a randomized controlled trial.

PubMed

Matcham, Faith; Norton, Sam; Scott, David L; Steer, Sophia; Hotopf, Matthew

2016-02-01

The aim of this analysis is to examine the longitudinal impact of symptoms of depression/anxiety on treatment response, long-term disease activity and physical disability in RA. Secondary analysis of clinical trial data was performed. Data were collected at baseline and at 6-monthly intervals for 2 years. The EuroQoL (EQ-5D(TM)) indicated depression/anxiety symptom severity. Our primary outcomes of interest were (i) DAS-28 and (ii) physical disability measured via the HAQ. Secondary outcomes were: tender and swollen joint counts, patient global assessment, ESR and odds of reaching clinical remission. Multilevel models were used to assess the impact of baseline and persistent depression/anxiety on outcomes over 2 years. Data from 379 patients were included. After adjusting for covariates, baseline depression/anxiety symptoms were associated with increased DAS-28 outcomes and increased tender joint counts. Persistent depression/anxiety symptoms were associated with increased DAS-28 scores, HAQ scores, tender joint counts and patient global assessment of disease activity, and reduced odds of reaching clinical remission. Patients with symptoms of depression/anxiety at baseline also showed a 50% reduction in prednisolone treatment effect, in comparison with patients with no symptoms of depression/anxiety at baseline. Baseline and persistent symptoms of depression/anxiety are associated with poorer health outcomes over time, as well as reduced treatment response. Mental health should be routinely measured both in clinical practice and in research, and managed alongside rheumatological disease to optimize health outcomes. Further research is required to examine whether treatment of mental disorders can improve rheumatological outcomes. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology.
Endovascular repair or open repair for ruptured abdominal aortic aneurysm: a Cochrane systematic review

PubMed Central

Badger, S A; Harkin, D W; Blair, P H; Ellis, P K; Kee, F; Forster, R

2016-01-01

Objectives Emergency endovascular aneurysm repair (eEVAR) may improve outcomes for patients with ruptured abdominal aortic aneurysm (RAAA). The study aim was to compare the outcomes for eEVAR with conventional open surgical repair for the treatment of RAAA. Setting A systematic review of relevant publications was performed. Randomised controlled trials (RCTs) comparing eEVAR with open surgical repair for RAAA were included. Participants 3 RCTs were included, with a total of 761 patients with RAAA. Interventions Meta-analysis was performed with fixed-effects models with ORs and 95% CIs for dichotomous data and mean differences with 95% CIs for continuous data. Primary and secondary outcome measures Primary outcome was short-term mortality. Secondary outcome measures included aneurysm-specific and general complication rates, quality of life and economic analysis. Results Overall risk of bias was low. There was no difference between the 2 interventions on 30-day (or in-hospital) mortality, OR 0.91 (95% CI 0.67 to 1.22; p=0.52). 30-day complications included myocardial infarction, stroke, composite cardiac complications, renal complications, severe bowel ischaemia, spinal cord ischaemia, reoperation, amputation and respiratory failure. Reporting was incomplete, and no robust conclusion was drawn. For complication outcomes that did include at least 2 studies in the meta-analysis, there was no clear evidence to support a difference between eEVAR and open repair. Longer term outcomes and cost per patient were evaluated in only a single study, thus precluding definite conclusions. Conclusions Outcomes between eEVAR and open repair, specifically 30-day mortality, are similar. However, further high-quality trials are required, as the paucity of data currently limits the conclusions. PMID:26873043
Octanoic acid in alcohol-responsive essential tremor

PubMed Central

McCrossin, Gayle; Lungu, Codrin; Considine, Elaine; Toro, Camilo; Nahab, Fatta B.; Auh, Sungyoung; Buchwald, Peter; Grimes, George J.; Starling, Judith; Potti, Gopal; Scheider, Linda; Kalowitz, Daniel; Bowen, Daniel; Carnie, Andrea; Hallett, Mark

2013-01-01

Objective: To assess safety and efficacy of an oral, single, low dose of octanoic acid (OA) in subjects with alcohol-responsive essential tremor (ET). Methods: We conducted a double-blind, placebo-controlled, crossover, phase I/II clinical trial evaluating the effect of 4 mg/kg OA in 19 subjects with ET. The primary outcome was accelerometric postural tremor power of the dominant hand 80 minutes after administration. Secondary outcomes included digital spiral analysis, pharmacokinetic sampling, as well as safety measures. Results: OA was safe and well tolerated. Nonserious adverse events were mild (Common Terminology Criteria for Adverse Events grade 1) and equally present after OA and placebo. At the primary outcome, OA effects were not different from placebo. Secondary outcome analyses of digital spiral analysis, comparison across the entire time course in weighted and nonweighted accelerometry, as well as nondominant hand tremor power did not show a benefit of OA over placebo. The analysis of individual time points showed that OA improved tremor at 300 minutes (dominant hand, F1,16 = 5.49, p = 0.032 vs placebo), with a maximum benefit at 180 minutes after OA (both hands, F1,16 = 6.1, p = 0.025). Conclusions: Although the effects of OA and placebo at the primary outcome were not different, secondary outcome measures suggest superiority of OA in reducing tremor at later time points, warranting further trials at higher dose levels. Classification of evidence: This study provides Class I evidence that a single 4-mg/kg dose of OA is not effective in reducing postural tremor in patients with ET at a primary outcome of 80 minutes, but is effective for a secondary outcome after 180 minutes. PMID:23408867
A longitudinal analysis of nursing home outcomes.

PubMed

Porell, F; Caro, F G; Silva, A; Monane, M

1998-10-01

To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures.
Developing focused wellness programs: using concept analysis to increase business value.

PubMed

Byczek, Lance; Kalina, Christine M; Levin, Pamela F

2003-09-01

Concept analysis is a useful tool in providing clarity to an abstract idea as well as an objective basis for developing wellness program products, goals, and outcomes. To plan for and develop successful wellness programs, it is critical for occupational health nurses to clearly understand a program concept as applied to a particular community or population. Occupational health nurses can use the outcome measures resulting from the concept analysis process to help demonstrate the business value of their wellness programs. This concept analysis demonstrates a predominance of the performance related attributes of fitness in the scientific literature.
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.
Application of WHO recommendations in outcome assessment of clinical series published in hand surgery journals with five years interval.

PubMed

Alarab, H; Dubert, T

2015-02-01

Outcome measurement is becoming increasingly important in hand surgery. The International classification of functioning, disability and health (ICF), is a WHO multi-dimensional approach to health condition including three domains: body "functions and structures", activities and participation. The aim of this study was to measure how often these three ICF domains were included in outcome measurements of the clinical series published in the American, European and French hand surgery journals. Our study included clinical series published in 2007 and 2012 in the American Journal Of Hand Surgery, European Journal Of Hand Surgery and Chirurgie de la Main. Analysis of each of these publications was done in two steps. First, we checked the presence or absence of the three domains of ICF in outcome measurement without considering the way it was measured. Then, we reported the use of evaluation instruments and/or quantitative measurement for each domain. We included 54 series in 2007 and 119 in 2012. The number of series reporting on the three domains and using at least one quantitative measurement for each domain represents 6% of articles in 2007 and 10% in 2012. This study shows that the quality of outcome measurement has improved over these 5 years, but remains poor according to the ICF recommendation. Copyright © 2015 Elsevier Masson SAS. All rights reserved.
Beyond the Shadow of a Trait: Understanding Discounting through Item-Level Analysis of Personality Scales

ERIC Educational Resources Information Center

Charlton, Shawn R.; Gossett, Bradley D.; Charlton, Veda A.

2011-01-01

Temporal discounting, the loss in perceived value associated with delayed outcomes, correlates with a number of personality measures, suggesting that an item-level analysis of trait measures might provide a more detailed understanding of discounting. The current report details two studies that investigate the utility of such an item-level…

Measurement of Trained Speech Patterns in Stuttering: Interjudge and Intrajudge Agreement of Experts by Means of Modified Time-Interval Analysis

ERIC Educational Resources Information Center

Alpermann, Anke; Huber, Walter; Natke, Ulrich; Willmes, Klaus

2010-01-01

Improved fluency after stuttering therapy is usually measured by the percentage of stuttered syllables. However, outcome studies rarely evaluate the use of trained speech patterns that speakers use to manage stuttering. This study investigated whether the modified time interval analysis can distinguish between trained speech patterns, fluent…
Bias and Precision of Measures of Association for a Fixed-Effect Multivariate Analysis of Variance Model

ERIC Educational Resources Information Center

Kim, Soyoung; Olejnik, Stephen

2005-01-01

The sampling distributions of five popular measures of association with and without two bias adjusting methods were examined for the single factor fixed-effects multivariate analysis of variance model. The number of groups, sample sizes, number of outcomes, and the strength of association were manipulated. The results indicate that all five…
Conceptualization and Exploration of Composite Career Anchors: An Analysis of Information Systems Personnel.

ERIC Educational Resources Information Center

Ramakrishna, Hindupur V.; Potosky, Denise

2003-01-01

Information systems professionals (n=163) completed measures of career anchors and outcomes (career/job satisfaction, job performance, perceived advancement prospects); 46% had multiple dominant anchors and these individuals did not have significantly different career outcomes than those with single dominant anchors. (Contains 26 references.) (SK)
Mendelian randomization analysis of a time-varying exposure for binary disease outcomes using functional data analysis methods.

PubMed

Cao, Ying; Rajan, Suja S; Wei, Peng

2016-12-01

A Mendelian randomization (MR) analysis is performed to analyze the causal effect of an exposure variable on a disease outcome in observational studies, by using genetic variants that affect the disease outcome only through the exposure variable. This method has recently gained popularity among epidemiologists given the success of genetic association studies. Many exposure variables of interest in epidemiological studies are time varying, for example, body mass index (BMI). Although longitudinal data have been collected in many cohort studies, current MR studies only use one measurement of a time-varying exposure variable, which cannot adequately capture the long-term time-varying information. We propose using the functional principal component analysis method to recover the underlying individual trajectory of the time-varying exposure from the sparsely and irregularly observed longitudinal data, and then conduct MR analysis using the recovered curves. We further propose two MR analysis methods. The first assumes a cumulative effect of the time-varying exposure variable on the disease risk, while the second assumes a time-varying genetic effect and employs functional regression models. We focus on statistical testing for a causal effect. Our simulation studies mimicking the real data show that the proposed functional data analysis based methods incorporating longitudinal data have substantial power gains compared to standard MR analysis using only one measurement. We used the Framingham Heart Study data to demonstrate the promising performance of the new methods as well as inconsistent results produced by the standard MR analysis that relies on a single measurement of the exposure at some arbitrary time point. © 2016 WILEY PERIODICALS, INC.
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.
Examination of Variables That May Affect the Relationship Between Cognition and Functional Status in Individuals with Mild Cognitive Impairment: A Meta-Analysis

PubMed Central

Mcalister, Courtney; Schmitter-Edgecombe, Maureen; Lamb, Richard

2016-01-01

The objective of this meta-analysis was to improve understanding of the heterogeneity in the relationship between cognition and functional status in individuals with mild cognitive impairment (MCI). Demographic, clinical, and methodological moderators were examined. Cognition explained an average of 23% of the variance in functional outcomes. Executive function measures explained the largest amount of variance (37%), whereas global cognitive status and processing speed measures explained the least (20%). Short- and long-delayed memory measures accounted for more variance (35% and 31%) than immediate memory measures (18%), and the relationship between cognition and functional outcomes was stronger when assessed with informant-report (28%) compared with self-report (21%). Demographics, sample characteristics, and type of everyday functioning measures (i.e., questionnaire, performance-based) explained relatively little variance compared with cognition. Executive functioning, particularly measured by Trails B, was a strong predictor of everyday functioning in individuals with MCI. A large proportion of variance remained unexplained by cognition. PMID:26743326
Assessing the quality of the volume-outcome relationship in uro-oncology.

PubMed

Mayer, Erik K; Purkayastha, Sanjay; Athanasiou, Thanos; Darzi, Ara; Vale, Justin A

2009-02-01

To assess systematically the quality of evidence for the volume-outcome relationship in uro-oncology, and thus facilitate the formulating of health policy within this speciality, as 'Implementation of Improving Outcome Guidance' has led to centralization of uro-oncology based on published studies that have supported a 'higher volume-better outcome' relationship, but improved awareness of methodological drawbacks in health service research has questioned the strength of this proposed volume-outcome relationship. We systematically searched previous relevant reports and extracted all articles from 1980 onwards assessing the volume-outcome relationship for cystectomy, prostatectomy and nephrectomy at the institution and/or surgeon level. Studies were assessed for their methodological quality using a previously validated rating system. Where possible, meta-analytical methods were used to calculate overall differences in outcome measures between low and high volume healthcare providers. In all, 22 studies were included in the final analysis; 19 of these were published in the last 5 years. Only four studies appropriately explored the effect of both the institution and surgeon volume on outcome measures. Mortality and length of stay were the most frequently measured outcomes. The median total quality scores within each of the operation types were 8.5, 9 and 8 for cystectomy, prostatectomy and nephrectomy, respectively (possible maximum score 18). Random-effects modelling showed a higher risk of mortality in low-volume institutions than in higher-volume institutions for both cystectomy and nephrectomy (odds ratio 1.88, 95% confidence interval 1.54-2.29, and 1.28, 1.10-1.49, respectively). The methodological quality of volume-outcome research as applied to cystectomy, prostatectomy and nephrectomy is only modest at best. Accepting several limitations, pooled analysis confirms a higher-volume, lower-mortality relationship for cystectomy and nephrectomy. Future research should focus on the development of a quality framework with a validated scoring system for the bench-marking of data to improve validity and facilitate rational policy-making within the speciality of uro-oncology.
Health-related quality-of-life outcome measures in paediatric palliative care: A systematic review of psychometric properties and feasibility of use

PubMed Central

Coombes, Lucy H; Wiseman, Theresa; Lucas, Grace; Sangha, Amrit; Murtagh, Fliss EM

2016-01-01

Background: The number of children worldwide requiring palliative care services is increasing due to advances in medical care and technology. The use of outcome measures is important to improve the quality and effectiveness of care. Aim: To systematically identify health-related quality-of-life outcome measures that could be used in paediatric palliative care and examine their feasibility of use and psychometric properties. Design: A systematic literature review and analysis of psychometric properties. Data sources: PsychInfo, Medline and EMBASE were searched from 1 January 1990 to 10 December 2014. Hand searches of the reference list of included studies and relevant reviews were also performed. Results: From 3460 articles, 125 papers were selected for full-text assessment. A total of 41 articles met the eligibility criteria and examined the psychometric properties of 22 health-related quality-of-life measures. Evidence was limited as at least half of the information on psychometric properties per instrument was missing. Measurement error was not analysed in any of the included articles and responsiveness was only analysed in one study. The methodological quality of included studies varied greatly. Conclusion: There is currently no ‘ideal’ outcome assessment measure for use in paediatric palliative care. The domains of generic health-related quality-of-life measures are not relevant to all children receiving palliative care and some domains within disease-specific measures are only relevant for that specific population. Potential solutions include adapting an existing measure or developing more individualized patient-centred outcome and experience measures. Either way, it is important to continue work on outcome measurement in this field. PMID:27247087
Toward spanning the quality chasm: an examination of team functioning measures.

PubMed

Strasser, Dale C; Burridge, Andrea Backscheider; Falconer, Judith A; Uomoto, Jay M; Herrin, Jeph

2014-11-01

To examine the effect of 5 measures of team functioning on patient outcomes. Observational, exploratory, measurement. Team functioning surveys and patient outcomes collected 1 year apart in a clinical trial were analyzed. The findings are discussed in context of the domains of team functioning, team effectiveness, and quality improvement. 27 Veterans Affairs medical centers. Staff (t1: N=356; t2: N=273) on inpatient teams and patients (t1: N=4266; t2: N=3213) treated by the teams. Not applicable. Five measures of team functioning (Physician Engagement, Shared Leadership, Supervisor Team Support, Teamness, and Team Effectiveness scales) and 3 measures of patient outcomes (functional improvement, discharge destination, and length of stay) were assessed at 2 time points with hierarchical generalized linear models to evaluate the association between team functioning measures and changes in patient outcomes. Associations (P<.05) between team functioning measures and patient outcomes were found for 3 of the 15 analyses over the study period. Higher Physician Engagement scale score was associated with lower length of stay (P=.017), and increased scores on Teamness and Team Effectiveness scales correlated with higher rates of community discharge (P=.044 and .049, respectively). This exploratory analysis revealed trends that team functioning corresponds with patient outcomes in clinically relevant patterns. An increase in community discharge and a decrease in length of stay were associated with higher scores of team functioning. Here, we find evidence that modifiable attributes of team functioning have a measurable effect on patient outcomes. Such findings are promising and support the need for further research on team effectiveness. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Conservation covenants on private land: issues with measuring and achieving biodiversity outcomes in Australia.

PubMed

Fitzsimons, James A; Carr, C Ben

2014-09-01

Conservation covenants and easements have become essential tools to secure biodiversity outcomes on private land, and to assist in meeting international protection targets. In Australia, the number and spatial area of conservation covenants has grown significantly in the past decade. Yet there has been little research or detailed policy analysis of conservation covenanting in Australia. We sought to determine how conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties, and factors inhibiting or contributing to measuring these outcomes. In addition, we also investigated the drivers and constraints associated with actually delivering the biodiversity outcomes, drawing on detailed input from covenanting programs. Although all conservation covenanting programs had the broad aim of maintaining or improving biodiversity in their covenants in the long term, the specific stated objectives of conservation covenanting programs varied. Programs undertook monitoring and evaluation in different ways and at different spatial and temporal scales. Thus, it was difficult to determine the extent Australian conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties on a national scale. Lack of time available to covenantors to undertake management was one of the biggest impediments to achieving biodiversity conservation outcomes. A lack of financial resources and human capital to monitor, knowing what to monitor, inconsistent monitoring methodologies, a lack of benchmark data, and length of time to achieve outcomes were all considered potential barriers to monitoring the biodiversity conservation outcomes of conservation covenants.
Conservation Covenants on Private Land: Issues with Measuring and Achieving Biodiversity Outcomes in Australia

NASA Astrophysics Data System (ADS)

Fitzsimons, James A.; Carr, C. Ben

2014-09-01

Conservation covenants and easements have become essential tools to secure biodiversity outcomes on private land, and to assist in meeting international protection targets. In Australia, the number and spatial area of conservation covenants has grown significantly in the past decade. Yet there has been little research or detailed policy analysis of conservation covenanting in Australia. We sought to determine how conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties, and factors inhibiting or contributing to measuring these outcomes. In addition, we also investigated the drivers and constraints associated with actually delivering the biodiversity outcomes, drawing on detailed input from covenanting programs. Although all conservation covenanting programs had the broad aim of maintaining or improving biodiversity in their covenants in the long term, the specific stated objectives of conservation covenanting programs varied. Programs undertook monitoring and evaluation in different ways and at different spatial and temporal scales. Thus, it was difficult to determine the extent Australian conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties on a national scale. Lack of time available to covenantors to undertake management was one of the biggest impediments to achieving biodiversity conservation outcomes. A lack of financial resources and human capital to monitor, knowing what to monitor, inconsistent monitoring methodologies, a lack of benchmark data, and length of time to achieve outcomes were all considered potential barriers to monitoring the biodiversity conservation outcomes of conservation covenants.
Wisconsin Versus Minnesota: A Border Battle for the Healthiest State.

PubMed

Pollock, Elizabeth; Norrbom, Corina; Ehlinger, Edward; Remington, Patrick

2016-08-01

Measuring and ranking the health of counties helps raise awareness of health disparities based on where people live. Recently, there has been increasing interest in comparing the health of counties across state lines, to potentially measure the impact of local and state-level policies. The counties in Minnesota (n = 87) and Wisconsin (n = 72) were combined into a single 2-state region, and all 159 counties were ranked according to the County Health Rankings methods, with summary ranks for health outcomes and health factors. Multivariable regression analysis was then used to examine the potential impact of state-based programs and policies on health outcomes. Minnesota was healthier overall than Wisconsin, with lower rates of premature death and better quality of life. Minnesota also performed better than Wisconsin for all 9 health behavior measures, 4 of 7 clinical care measures, 7 of 8 social and economic factors, and 3 of 5 physical environment measures. Furthermore, counties in Wisconsin were more likely to have lower (worse) ranks than counties in Minnesota for both health outcomes and health factors, as well as for the subcategories that make up these summary ranks. Regression analysis showed that Minnesota’s better health status was explained primarily by healthier behaviors and more desirable social and economic factors. Minnesota’s better health outcomes are largely explained by better social, economic, and behavioral factors. These findings suggest a need for examination of policies and strategies that may be influencing the observed differences across these 2 states.
Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II.

PubMed

Cox, Emily; Martin, Bradley C; Van Staa, Tjeerd; Garbe, Edeltraut; Siebert, Uwe; Johnson, Michael L

2009-01-01

The goal of comparative effectiveness analysis is to examine the relationship between two variables, treatment, or exposure and effectiveness or outcome. Unlike data obtained through randomized controlled trials, researchers face greater challenges with causal inference with observational studies. Recognizing these challenges, a task force was formed to develop a guidance document on methodological approaches to addresses these biases. The task force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This report, the second of three reported in this issue of the Journal, discusses the inherent biases when using secondary data sources for comparative effectiveness analysis and provides methodological recommendations to help mitigate these biases. The task force report provides recommendations and tools for researchers to mitigate threats to validity from bias and confounding in measurement of exposure and outcome. Recommendations on design of study included: the need for data analysis plan with causal diagrams; detailed attention to classification bias in definition of exposure and clinical outcome; careful and appropriate use of restriction; extreme care to identify and control for confounding factors, including time-dependent confounding. Design of nonrandomized studies of comparative effectiveness face several daunting issues, including measurement of exposure and outcome challenged by misclassification and confounding. Use of causal diagrams and restriction are two techniques that can improve the theoretical basis for analyzing treatment effects in study populations of more homogeneity, with reduced loss of generalizability.
Health outcomes are about choices and values: an economic perspective on the health outcomes movement.

PubMed

Shiell, A

1997-01-01

The aim of the health outcomes movement is to reorientate health services so that the spotlight shines less on what is done and more on what is achieved. The health outcomes movement, thus far, has been most successful in addressing what appear to be technical questions relating to the measurement and analysis of health outcomes and in placing their routine use on the agenda of clinical practice and health services planning. If there is one lesson to be drawn from an economic perspective, however, it is that health outcomes are about values and not just technicalities. The need to make choices forces one to consider whether what is achieved is also what is most valued. The success of health service delivery, be it at a clinical, planning or systems level, must therefore be measured against agreed objectives. It follows that time must be taken to establish what patients and the community want from their health services and what each is prepared to give up to achieve its ends. Value judgements are unavoidable. The challenge lies not in measuring the outcomes of health interventions but in deciding what the objectives of the health system ought to be.
The association between interpersonal problems and treatment outcome in patients with eating disorders.

PubMed

Ung, Elise Meyn; Erichsen, Cecilie Birkmose; Poulsen, Stig; Lau, Marianne Engelbrecht; Simonsen, Sebastian; Davidsen, Annika Helgadóttir

2017-01-01

Interpersonal problems are thought to play an essential role in the development and maintenance of eating disorders. The aim of the current study was to investigate whether a specific interpersonal profile could be identified in a group of patients diagnosed with Bulimia Nervosa, Binge Eating Disorder, or Eating Disorders Not Otherwise Specified, and to explore if specific types of interpersonal problems were systematically related to treatment outcome in this group of patients. The participants were 159 patients who received systemic/narrative outpatient group psychotherapy. Interpersonal problems were measured at baseline, and eating disorder symptoms were measured pre- and post treatment. Data were analysed with the Structural Summary Method, a particular method for the analysis of the Inventory of Interpersonal Problems, and hierarchical regression analysis was conducted. The patients demonstrated a generally Non-assertive and Friendly-submissive interpersonal style. No significant association between the overall level of interpersonal problems and treatment outcome was identified. However, the results showed a correlation between being cold and hostile and poor treatment outcome, while being domineering showed a trend approaching significance in predicting better treatment outcome. The results indicate that patients with eating disorders show a specific interpersonal profile, and suggest that particular types of interpersonal problems are associated with treatment outcome.
Negative decision outcomes are more common among people with lower decision-making competence: an item-level analysis of the Decision Outcome Inventory (DOI).

PubMed

Parker, Andrew M; Bruine de Bruin, Wändi; Fischhoff, Baruch

2015-01-01

Most behavioral decision research takes place in carefully controlled laboratory settings, and examination of relationships between performance and specific real-world decision outcomes is rare. One prior study shows that people who perform better on hypothetical decision tasks, assessed using the Adult Decision-Making Competence (A-DMC) measure, also tend to experience better real-world decision outcomes, as reported on the Decision Outcomes Inventory (DOI). The DOI score reflects avoidance of outcomes that could result from poor decisions, ranging from serious (e.g., bankruptcy) to minor (e.g., blisters from sunburn). The present analyses go beyond the initial work, which focused on the overall DOI score, by analyzing the relationships between specific decision outcomes and A-DMC performance. Most outcomes are significantly more likely among people with lower A-DMC scores, even after taking into account two variables expected to produce worse real-world decision outcomes: younger age and lower socio-economic status. We discuss the usefulness of DOI as a measure of successful real-world decision-making.
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.
Imaging Heterogeneity in Lung Cancer: Techniques, Applications, and Challenges.

PubMed

Bashir, Usman; Siddique, Muhammad Musib; Mclean, Emma; Goh, Vicky; Cook, Gary J

2016-09-01

Texture analysis involves the mathematic processing of medical images to derive sets of numeric quantities that measure heterogeneity. Studies on lung cancer have shown that texture analysis may have a role in characterizing tumors and predicting patient outcome. This article outlines the mathematic basis of and the most recent literature on texture analysis in lung cancer imaging. We also describe the challenges facing the clinical implementation of texture analysis. Texture analysis of lung cancer images has been applied successfully to FDG PET and CT scans. Different texture parameters have been shown to be predictive of the nature of disease and of patient outcome. In general, it appears that more heterogeneous tumors on imaging tend to be more aggressive and to be associated with poorer outcomes and that tumor heterogeneity on imaging decreases with treatment. Despite these promising results, there is a large variation in the reported data and strengths of association.
Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty.

PubMed

Moskal, Joseph T; Capps, Susan G

2016-09-01

Previous meta-analyses established that tranexamic acid confers benefits when used during total hip arthroplasty (THA). However, 2 of these meta-analyses included a variety of routes of administration of tranexamic acid in THA (topical, intravenous, oral, and intra-articular), another meta-analysis included a variety of antifibrinolytic drugs (not restricted to a single drug), and the final meta-analysis included nonrandomized controlled trials. This meta-analysis focused on a single medication, tranexamic acid, administered in a specific way, intravenously in patients undergoing primary THA, using data reported only in randomized controlled studies. Outcomes were restricted to blood loss, allogeneic transfusion rates, and complications. Other outcomes, such as return to function or clinical scores, could not be evaluated because of lack of consistent reporting. To better understand the effects of intravenous tranexamic acid in THA on clinical outcomes, such as recovery, return to function, and patient-reported outcome measures, it would be helpful to have more controlled trials examining these measures in a standardized manner. Intravenous tranexamic acid was beneficial for blood loss intraoperatively, blood loss through drains, and total blood loss during hospitalization, in addition to reducing allogeneic transfusion rates. No difference between intravenous tranexamic acid and placebo was found for most complications, except deep venous thrombosis, which showed favorable results with placebo. [Orthopedics.2016; 39(5):e883-e892.]. Copyright 2016, SLACK Incorporated.
Do the EULAR Sjögren's syndrome outcome measures correlate with health status in primary Sjögren's syndrome?

PubMed

Lendrem, Dennis; Mitchell, Sheryl; McMeekin, Peter; Gompels, Luke; Hackett, Katie; Bowman, Simon; Price, Elizabeth; Pease, Colin T; Emery, Paul; Andrews, Jacqueline; Lanyon, Peter; Hunter, John; Gupta, Monica; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Griffiths, Bridget; Ng, Wan-Fai

2015-04-01

This study sets out to investigate the relationship between health status [EuroQol five-dimensions questionnaire (EQ-5D)] in primary SS and three of the European League Against Rheumatism (EULAR) SS outcome measures-the disease activity index (ESSDAI), the patient reported index (ESSPRI) and the sicca score. In particular, the goal was to establish whether there is a relationship between the EULAR outcome measures and quality of life. Health status was evaluated using a standardized measure developed by the EuroQol Group-the EQ5D. This permits calculation of two measures of health status: time trade-off (TTO) values and the EQ-5D visual analogue scale (VAS) scores. We used Spearman's rank correlation analysis to investigate the strength of association between health status and three EULAR measures of physician- and patient-reported disease activity in 639 patients from the UK primary SS registry (UKPSSR) cohort. This study demonstrates that the EULAR SS disease-specific outcome measures are significantly correlated with health outcome values (P < 0.001). Higher scores on the ESSDAI, EULAR sicca score and ESSPRI are associated with poorer health states-i.e. lower TTO values and lower VAS scores. While all three are significantly correlated with TTO values and EQ-5D VAS scores, the effect is strongest for the ESSPRI. This study provides further evidence supporting the use of ESSDAI, EULAR sicca score and ESSPRI measures in the clinic. We also discuss the need for disease-specific measures of health status and their comparison with standardized health outcome measures. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The Influence of AHI1 Variants on the Diagnosis and Treatment Outcome in Schizophrenia

PubMed Central

Porcelli, Stefano; Pae, Chi-Un; Han, Changsu; Lee, Soo-Jung; Patkar, Ashwin A.; Masand, Prakash S.; Balzarro, Beatrice; Alberti, Siegfried; De Ronchi, Diana; Serretti, Alessandro

2015-01-01

The present study aimed to explore whether four single nucleotide polymorphisms (SNPs) within the AHI1 gene could be associated with schizophrenia (SCZ) and whether they could predict the clinical outcomes in SCZ patients treated with antipsychotics. Four hundred twenty-six (426) in-patients with SCZ and 345 controls were genotyped for four AHI1 SNPs (rs11154801, rs7750586, rs9647635 and rs9321501). Baseline and clinical measures for SCZ patients were assessed through the Positive and Negative Syndrome Scale (PANSS). Allelic and genotypic frequencies in SCZ subjects were compared with those of controls using the χ2 statistics. The repeated-measure ANOVA was used for the assessment of treatment outcomes measured by PANSS changes. The case-control analysis did not show any difference in the genotypic distribution of the SNPs, while in the allelic analysis, a weak association was found between the rs9647635 A allele and SCZ. Furthermore, in the haplotype analysis, three haplotypes resulted in being associated with SCZ. On the other hand, two SNPs (rs7750586 and rs9647635) were associated with clinical improvement of negative symptoms in the allelic analysis, although in the genotypic analysis, only trends of association were found for the same SNPs. Our findings suggest a possible influence of AHI1 variants on SCZ susceptibility and antipsychotic response, particularly concerning negative symptomatology. Subsequent well-designed studies would be mandatory to confirm our results due to the methodological shortcomings of the present study. PMID:25622261
Measurement of trained speech patterns in stuttering: interjudge and intrajudge agreement of experts by means of modified time-interval analysis.

PubMed

Alpermann, Anke; Huber, Walter; Natke, Ulrich; Willmes, Klaus

2010-09-01

Improved fluency after stuttering therapy is usually measured by the percentage of stuttered syllables. However, outcome studies rarely evaluate the use of trained speech patterns that speakers use to manage stuttering. This study investigated whether the modified time interval analysis can distinguish between trained speech patterns, fluent speech, and stuttered speech. Seventeen German experts on stuttering judged a speech sample on two occasions. Speakers of the sample were stuttering adults, who were not undergoing therapy, as well as participants in a fluency shaping and a stuttering modification therapy. Results showed satisfactory inter-judge and intra-judge agreement above 80%. Intervals with trained speech patterns were identified as consistently as stuttered and fluent intervals. We discuss limitations of the study, as well as implications of our findings for the development of training for identification of trained speech patterns and future outcome studies. The reader will be able to (a) explain different methods to measure the use of trained speech patterns, (b) evaluate whether German experts are able to discriminate intervals with trained speech patterns reliably from fluent and stuttered intervals and (c) describe how the measurement of trained speech patterns can contribute to outcome studies.
Establishing Long-Term Efficacy in Chronic Disease: Use of Recursive Partitioning and Propensity Score Adjustment to Estimate Outcome in MS

PubMed Central

Goodin, Douglas S.; Jones, Jason; Li, David; Traboulsee, Anthony; Reder, Anthony T.; Beckmann, Karola; Konieczny, Andreas; Knappertz, Volker

2011-01-01

Context Establishing the long-term benefit of therapy in chronic diseases has been challenging. Long-term studies require non-randomized designs and, thus, are often confounded by biases. For example, although disease-modifying therapy in MS has a convincing benefit on several short-term outcome-measures in randomized trials, its impact on long-term function remains uncertain. Objective Data from the 16-year Long-Term Follow-up study of interferon-beta-1b is used to assess the relationship between drug-exposure and long-term disability in MS patients. Design/Setting To mitigate the bias of outcome-dependent exposure variation in non-randomized long-term studies, drug-exposure was measured as the medication-possession-ratio, adjusted up or down according to multiple different weighting-schemes based on MS severity and MS duration at treatment initiation. A recursive-partitioning algorithm assessed whether exposure (using any weighing scheme) affected long-term outcome. The optimal cut-point that was used to define “high” or “low” exposure-groups was chosen by the algorithm. Subsequent to verification of an exposure-impact that included all predictor variables, the two groups were compared using a weighted propensity-stratified analysis in order to mitigate any treatment-selection bias that may have been present. Finally, multiple sensitivity-analyses were undertaken using different definitions of long-term outcome and different assumptions about the data. Main Outcome Measure Long-Term Disability. Results In these analyses, the same weighting-scheme was consistently selected by the recursive-partitioning algorithm. This scheme reduced (down-weighted) the effectiveness of drug exposure as either disease duration or disability at treatment-onset increased. Applying this scheme and using propensity-stratification to further mitigate bias, high-exposure had a consistently better clinical outcome compared to low-exposure (Cox proportional hazard ratio = 0.30–0.42; p<0.0001). Conclusions Early initiation and sustained use of interferon-beta-1b has a beneficial impact on long-term outcome in MS. Our analysis strategy provides a methodological framework for bias-mitigation in the analysis of non-randomized clinical data. Trial Registration Clinicaltrials.gov NCT00206635 PMID:22140424
Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial.

PubMed

Hofmeijer, Jeannette; Kappelle, L Jaap; Algra, Ale; Amelink, G Johan; van Gijn, Jan; van der Worp, H Bart

2009-04-01

Patients with space-occupying hemispheric infarctions have a poor prognosis, with case fatality rates of up to 80%. In a pooled analysis of randomised trials, surgical decompression within 48 h of stroke onset reduced case fatality and improved functional outcome; however, the effect of surgery after longer intervals is unknown. The aim of HAMLET was to assess the effect of decompressive surgery within 4 days of the onset of symptoms in patients with space-occupying hemispheric infarction. Patients with space-occupying hemispheric infarction were randomly assigned within 4 days of stroke onset to surgical decompression or best medical treatment. The primary outcome measure was the modified Rankin scale (mRS) score at 1 year, which was dichotomised between good (0-3) and poor (4-6) outcome. Other outcome measures were the dichotomy of mRS score between 4 and 5, case fatality, quality of life, and symptoms of depression. Analysis was by intention to treat. This trial is registered, ISRCTN94237756. Between November, 2002, and October, 2007, 64 patients were included; 32 were randomly assigned to surgical decompression and 32 to best medical treatment. Surgical decompression had no effect on the primary outcome measure (absolute risk reduction [ARR] 0%, 95% CI -21 to 21) but did reduce case fatality (ARR 38%, 15 to 60). In a meta-analysis of patients in DECIMAL (DEcompressive Craniectomy In MALignant middle cerebral artery infarction), DESTINY (DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY), and HAMLET who were randomised within 48 h of stroke onset, surgical decompression reduced poor outcome (ARR 16%, -0.1 to 33) and case fatality (ARR 50%, 34 to 66). Surgical decompression reduces case fatality and poor outcome in patients with space-occupying infarctions who are treated within 48 h of stroke onset. There is no evidence that this operation improves functional outcome when it is delayed for up to 96 h after stroke onset. The decision to perform the operation should depend on the emphasis patients and relatives attribute to survival and dependency.
Structural equation modeling of motor impairment, gross motor function, and the functional outcome in children with cerebral palsy.

PubMed

Park, Eun-Young; Kim, Won-Ho

2013-05-01

Physical therapy intervention for children with cerebral palsy (CP) is focused on reducing neurological impairments, improving strength, and preventing the development of secondary impairments in order to improve functional outcomes. However, relationship between motor impairments and functional outcome has not been proved definitely. This study confirmed the construct of motor impairment and performed structural equation modeling (SEM) between motor impairment, gross motor function, and functional outcomes of regarding activities of daily living in children with CP. 98 children (59 boys, 39 girls) with CP participated in this cross-sectional study. Mean age was 11 y 5 mo (SD 1 y 9 mo). The Manual Muscle Test (MMT), the Modified Ashworth Scale (MAS), range of motion (ROM) measurement, and the selective motor control (SMC) scale were used to assess motor impairments. Gross motor function and functional outcomes were measured using the Gross Motor Function Measure (GMFM) and the Functional Skills domain of the Pediatric Evaluation of Disability Inventory (PEDI) respectively. Measurement of motor impairment was consisted of strength, spasticity, ROM, and SMC. The construct of motor impairment was confirmed though an examination of a measurement model. The proposed SEM model showed good fit indices. Motor impairment effected gross motor function (β=-.0869). Gross motor function and motor impairment affected functional outcomes directly (β=0.890) and indirectly (β=-0.773) respectively. We confirmed that the construct of motor impairment consist of strength, spasticity, ROM, and SMC and it was identified through measurement model analysis. Functional outcomes are best predicted by gross motor function and motor impairments have indirect effects on functional outcomes. Copyright © 2013 Elsevier Ltd. All rights reserved.
A Gender Analysis of the Study of the Pharmacotherapy of Psychotic Depression (STOP-PD): gender and age as predictors of response and treatment-associated changes in body mass index and metabolic measures

PubMed Central

Deligiannidis, Kristina M.; Rothschild, Anthony J.; Barton, Bruce A.; Kroll-Desrosiers, Aimee R.; Meyers, Barnett S.; Flint, Alastair J.; Whyte, Ellen M.; Mulsant, Benoit H.

2014-01-01

Background: Gender differences exist in psychiatric disorders; however gender has not been well studied in psychotic depression. This analysis of the largest clinical trial in psychotic depression examined the effects of age and gender on clinical characteristics and predictors of treatment outcome and treatment-associated changes in body mass index (BMI) and metabolic measures. Methods: Analyses were performed on data from 259 subjects aged 18-93 in the double-blind randomized controlled trial of olanzapine plus sertraline (OLZ/SERT) vs. olanzapine plus placebo (OLZ/PBO) for psychotic depression (STOP-PD). Sociodemographic factors, clinical characteristics, treatment outcome and treatment-associated changes in BMI and metabolic measures were analyzed by gender and age. Results: Female gender was associated with divorced (χ2=5.3, d.f.=1, p=0.03) or widowed (χ2=8.1, d.f.=1, p=<0.01) marital status. Co-morbid anxiety disorders were more common in females than males (χ2=4.9, d.f.=1, p=0.03). Hallucinations(χ2=7.8, d.f.=1, p=0.005) and delusions with disorganization (t-test= −2.10, d.f. =257, p=0.04) were significantly associated with female gender as were higher cholesterol measures( χ2=7.15, d.f.=1, p=0.008).There were no significant interactions between treatment and gender in terms of change in BMI. Gender was not associated with treatment response. Discussion: This is the first analysis of gender and age as predictors of treatment outcome and treatment-associated changes in BMI and metabolic adverse effects in psychotic depression. Gender differences exist in patients with psychotic depression, most notably the presence of hallucinations. Female gender was associated with metabolic measures. Future studies with larger sample sizes may detect small gender differences in treatment outcome and treatment-associated changes in BMI and metabolic measures in psychotic depression. PMID:24229753
Hips don't lie: Waist-to-hip ratio in trauma patients.

PubMed

Joseph, Bellal; Zangbar, Bardiya; Haider, Ansab Abbas; Kulvatunyou, Naroung; Khalil, Mazhar; Tang, Andrew; O'Keeffe, Terence; Friese, Randall S; Orouji Jokar, Tahereh; Vercruysse, Gary; Latifi, Rifat; Rhee, Peter

2015-12-01

Obesity measured by body mass index (BMI) is known to be associated with worse outcomes in trauma patients. Recent studies have assessed the impact of distribution of body fat measured by waist-hip ratio (WHR) on outcomes in nontrauma patients. The aim of this study was to assess the impact of distribution of body fat (WHR) on outcomes in trauma patients. A 6-month (June to November 2013) prospective cohort analysis of all admitted trauma patients was performed at our Level 1 trauma center. WHR was measured in each patient on the first day of hospital admission. Patients were stratified into two groups: patients with WHR of 1 or greater and patients with WHR of less than 1. Outcome measures were complications and in-hospital mortality. Complications were defined as infectious, pulmonary, and renal complications. Regression and correlation analyses were performed. A total of 240 patients were enrolled, of which 28.8% patients (n = 69) had WHR of 1 or greater. WHR had a weak correlation with BMI (R = 0.231, R = 0.481). Eighteen percent (n = 43) of the patients developed complications, and the mortality rate was 10% (n = 24). Patients with a WHR of 1 or greater were more likely to develop in-hospital complications (32% vs. 13%, p = 0.001) and had a higher mortality rate (24% vs. 4%, p = 0.001) compared with the patients with a WHR of less than 1. In multivariate analysis, a WHR of 1 or greater was an independent predictor for the development of complications (odds ratio, 3.1; 95% confidence interval 1.08-9.2; p = 0.03) and mortality (odds ratio, 13.1; 95% confidence interval, 1.1-70; p = 0.04). Distribution of body fat as measured by WHR independently predicts mortality and complications in trauma patients. WHR is better than BMI in predicting adverse outcomes in trauma patients. Assessing the fat distribution pattern in trauma patients may help improve patient outcomes through focused targeted intervention. Prognostic study, level II.
Persistent Sleep Disturbances Independently Predict Poorer Functional and Social Outcomes 1 Year After Mild Traumatic Brain Injury.

PubMed

Chan, Lai Gwen; Feinstein, Anthony

2015-01-01

To investigate the effect of sleep disturbances on functional and social outcomes after mild traumatic brain injury. Outpatient traumatic brain injury clinic in a tertiary trauma center. A total of 374 mild traumatic brain injury patients were assessed within 3 months of injury and followed up every 3 months for 1 year. Analysis of a historical cohort in a naturalistic clinical setting. At each visit, symptoms of concussion and psychological distress and indices of functional and social outcomes were measured with the Rivermead Postconcussion Questionnaire, 28-item General Health Questionnaire, and Rivermead Head Injury Follow-up Questionnaire, respectively. Changes in outcome scores over time were explored using repeated measures analysis of variance and compared between subjects with persistent (SD) and recovered (SR) sleep disturbances. Predictors of functional/social outcome were determined using linear regression. The percentages of subjects reporting sleep disturbances at each time point were 71.9%, 57.2%, 55.1%, and 53.7%, respectively. For functional and social outcomes, significant effects of time (F3,315 = 9.54; P < .001), group (SD vs SR) F1,317 = 5.32; P = .022, and time X group interaction F3,315 = 4.14; P = .007 were found. Persistent sleep disturbance (P = 0.011) and higher symptom burden at 6 months postinjury (P < .0001) were independent predictors of poorer outcome. Sleep disturbance, independent of psychological distress, is an important prognostic factor of functional and social outcomes after mild traumatic brain injury.
Post-thrombotic syndrome in children: a systematic review of frequency of occurrence, validity of outcome measures, and prognostic factors

PubMed Central

Goldenberg, Neil A.; Donadini, Marco P.; Kahn, Susan R.; Crowther, Mark; Kenet, Gili; Nowak-Göttl, Ulrike; Manco-Johnson, Marilyn J.

2010-01-01

Background Post-thrombotic syndrome is a manifestation of chronic venous insufficiency following deep venous thrombosis. This systematic review was conducted to critically evaluate pediatric evidence on frequency of occurrence, validity of outcome measures, and prognostic indicators of post-thrombotic syndrome. Design and Methods A comprehensive literature search of original reports revealed 19 eligible studies, totaling 977 patients with upper/lower extremity deep venous thrombosis. Calculated weighted mean frequency of post-thrombotic syndrome was 26% (95% confidence interval: 23–28%) overall, and differed significantly by prospective/non-prospective analysis and use/non-use of a standardized outcome measure. Results Standardized post-thrombotic syndrome outcome measures included an adaptation of the Villalta scale, the Clinical-Etiologic-Anatomic-Pathologic classification, and the Manco-Johnson instrument. Data on validity were reported only for the Manco-Johnson instrument. No publications on post-thrombotic syndrome-related quality of life outcomes were identified. Candidate prognostic factors for post-thrombotic syndrome in prospective studies included use/non-use of thrombolysis and plasma levels of factor VIII activity and D-dimer. Conclusions Given that affected children must endure chronic sequelae for many decades, it is imperative that future collaborative pediatric prospective cohort studies and trials assess as key objectives and outcomes the incidence, severity, prognostic indicators, and health impact of post-thrombotic syndrome, using validated measures. PMID:20595095
Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation.

PubMed

Williams, Valerie J; Piva, Sara R; Irrgang, James J; Crossley, Chad; Fitzgerald, G Kelley

2012-08-01

Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than another when applied to subjects with knee OA. We believe that all 3 instruments are appropriate outcome measures to examine change in functional status of patients with knee OA.
Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment.

PubMed

Onslow, Mark; Jones, Mark; O'Brian, Sue; Packman, Ann; Menzies, Ross; Lowe, Robyn; Arnott, Simone; Bridgman, Kate; de Sonneville, Caroline; Franken, Marie-Christine

2018-04-17

This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland-Altman plots, analysis of covariance, and Spearman rho correlations. Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.
Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016

PubMed Central

Fahl Mar, Kaysee; Schilling, Joshua; Brown, Walter A.

2018-01-01

Background Recent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of increasing placebo response and stable efficacy outcome measures is unique to the conditions previously studied or if it occurs in trials for conditions with physiologically-measured symptoms, such as hypertension. Method For this reason, we evaluated the efficacy data reported in the US Food and Drug Administration Medical and Statistical reviews for 23 antihypertensive programs (32,022 patients, 63 trials, 142 treatment arms). Placebo and medication response, effect sizes, and drug-placebo differences were calculated for each treatment arm and examined over time using meta-regression. We also explored the relationship of sample size, trial duration, baseline blood pressure, and number of treatment arms to placebo/drug response and efficacy outcome measures. Results Like trials of other conditions, placebo response has risen significantly over time (R2 = 0.093, p = 0.018) and effect size (R2 = 0.013, p = 0.187) drug-placebo difference (R2 = 0.013, p = 0.182) and success rate (134/142, 94.4%) have remained unaffected, likely due to a significant compensatory increase in antihypertensive response (R2 = 0.086, p<0.001). Treatment arms are likely overpowered with sample sizes increasing over time (R2 = 0.387, p<0.0001) and stable, large effect sizes (0.78 ±0.37). The exploratory analysis of sample size, trial duration, baseline blood pressure, and number of treatment arms yielded mixed results unlikely to explain the pattern of placebo response and efficacy outcomes over time. The magnitude of placebo response had no relationship to effect size (p = 0.877), antihypertensive-placebo differences (p = 0.752), or p-values (p = 0.963) but was correlated with antihypertensive response (R2 = 0.347, p<0.0001). Conclusions As hypothesized, this study shows that placebo response is increasing in clinical trials for hypertension without any evidence of this increase impacting trial outcomes. Attempting to control placebo response in clinical trials for hypertension may not be necessary for successful efficacy outcomes. In exploratory analysis, we noted that despite finding significant relationships, none of the trial or patient characteristics we examined offered a clear explanation of the rise in placebo and stability in outcome measures over time. Collectively, these data suggest that the phenomenon of increasing placebo response and stable efficacy outcomes may be a general trend, occurring across trials for various psychiatric and medical conditions with physiological and non-physiological endpoints. PMID:29489874
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…
Workplace Outcomes in Work-Disability Prevention Research: A Review with Recommendations for Future Research.

PubMed

Young, Amanda E; Viikari-Juntura, Eira; Boot, Cécile R L; Chan, Chetwyn; de Porras, David Gimeno Ruiz; Linton, Steven J

2016-12-01

Introduction Outcome assessment is a central issue in work disability prevention research. The goal of this paper was to (1) ascertain the most salient workplace outcomes; (2) evaluate the congruence between business and science perspectives; (3) illustrate new perspectives on assessing longitudinal outcomes; and (4) provide recommendations for advancing outcome evaluation in this area of research. Methods The authors participated in a year-long collaboration that culminated in a sponsored 3-day conference, "Improving Research of Employer Practices to Prevent Disability", held October 14-16, 2015, in Hopkinton, MA, USA. The collaboration included a topical review of the literature, group conference calls to identify key areas and challenges, drafting of initial documents, review of industry publications, and a conference presentation that included feedback from peer researchers and a question/answer session with a special panel of knowledge experts with direct employer experience. Results Numerous workplace work-disability prevention outcome measures were identified. Analysis indicated that their applicability varied depending on the type of work disability the worker was experiencing. For those who were working, but with health-related work limitations (Type 1), predominant outcomes were measures of productivity, presenteeism, and work-related limitations. For those who were off work due to a health condition (Type 2), predominant outcomes were measures of time off work, supervisor/employee interactions, and return-to-work (RTW) preparation. For those who had returned to work (Type 3), predominant outcomes were measures of presenteeism, time until RTW, percentage of work resumption, employment characteristics, stigma, work engagement, co-worker interactions, and sustained or durable RTW. For those who had withdrawn from the labor force (Type 4), predominant outcomes were cost and vocational status. Discussion Currently available measures provide a good basis to use more consistent outcomes in disability prevention in the future. The research area would also benefit from more involvement of employers as stakeholders, and multilevel conceptualizations of disability outcomes.
The Use of Propensity Scores in Mediation Analysis

ERIC Educational Resources Information Center

Jo, Booil; Stuart, Elizabeth A.; MacKinnon, David P.; Vinokur, Amiram D.

2011-01-01

Mediation analysis uses measures of hypothesized mediating variables to test theory for how a treatment achieves effects on outcomes and to improve subsequent treatments by identifying the most efficient treatment components. Most current mediation analysis methods rely on untested distributional and functional form assumptions for valid…
Upper airway changes in syndromic craniosynostosis patients following midface or monobloc advancement: correlation between volume changes and respiratory outcome.

PubMed

Nout, Erik; Bannink, Natalja; Koudstaal, Maarten J; Veenland, Jifke F; Joosten, Koen F M; Poublon, Rene M L; van der Wal, Karel G H; Mathijssen, Irene M J; Wolvius, Eppo B

2012-04-01

In syndromic craniosynostosis patients, respiratory insufficiency may be a pressing indication to surgically increase the patency of the upper airway by midface or monobloc advancement. In this study the volume changes of the upper airway and the respiratory outcome following midface (Le Fort I or III) or monobloc advancement in ten syndromic craniosynostosis patients are evaluated. Pre- and postoperatively, the airway volume was measured using a semi-automatic region growing method. Respiratory data were correlated to the volume measurements. In nine patients the outcome of upper airway volume measurements correlated well to the respiratory outcome. Three of these patients showed a minimal airway volume gain or even volume loss, and no respiratory improvement was found. In one monobloc patient improvement of the respiratory outcome without an evident volume gain of the upper airway was found. The majority of patients with Le Fort III advancement showed respiratory improvement, which for the greater part correlated to the results of the volume analysis. In monobloc patients the respiratory outcomes and volume measurements were less obvious. Preoperative endoscopy of the upper airway is advocated to identify the level of obstruction in patients with residual obstructive sleep apnoea. Copyright © 2011 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Linear Combinations of Multiple Outcome Measures to Improve the Power of Efficacy Analysis ---Application to Clinical Trials on Early Stage Alzheimer Disease

PubMed Central

Xiong, Chengjie; Luo, Jingqin; Morris, John C; Bateman, Randall

2018-01-01

Modern clinical trials on Alzheimer disease (AD) focus on the early symptomatic stage or even the preclinical stage. Subtle disease progression at the early stages, however, poses a major challenge in designing such clinical trials. We propose a multivariate mixed model on repeated measures to model the disease progression over time on multiple efficacy outcomes, and derive the optimum weights to combine multiple outcome measures by minimizing the sample sizes to adequately power the clinical trials. A cross-validation simulation study is conducted to assess the accuracy for the estimated weights as well as the improvement in reducing the sample sizes for such trials. The proposed methodology is applied to the multiple cognitive tests from the ongoing observational study of the Dominantly Inherited Alzheimer Network (DIAN) to power future clinical trials in the DIAN with a cognitive endpoint. Our results show that the optimum weights to combine multiple outcome measures can be accurately estimated, and that compared to the individual outcomes, the combined efficacy outcome with these weights significantly reduces the sample size required to adequately power clinical trials. When applied to the clinical trial in the DIAN, the estimated linear combination of six cognitive tests can adequately power the clinical trial. PMID:29546251
Job coach factors associated with community-based employment service programme outcome measures for people with disabilities--a Taiwan case study.

PubMed

Yun-Tung, Wang

2010-01-01

The aim of this study is to explore whether/which job coach factors were significantly associated with the community-based employment service (CBES) programme outcome measures in Taiwan. This study used the 2003-2005 CBES programme for People with Disabilities Database in Taipei City in Taiwan (n = 3924) to do a secondary data analysis using hierarchical multiple linear regression. This study found that 'occurrences of the services provided by the job coaches' variable was definitely the dominant predictor and explained additional 19.6% and 27.8% of the variances of annual salary and annual working month outcome measures, respectively. In addition, among six composition variables of 'occurrences of the services provided by the job coaches', 'occurrences of follow-up guidance', 'occurrences of intensive guidance', and 'occurrences of consultation before interviews with employer/director of human resources' were more powerful than the other three in predicting outcomes. Job coach factors in this study were significantly correlated with CBES programme outcome measures for people with disabilities in Taiwan after controlling for the socio-demographic variables. It indicates that the more inputs in the people with disabilities made by job coaches equates to better outcomes in this Taiwan case study.
Goal specificity: a proxy measure for improvements in environmental outcomes in collaborative governance.

PubMed

Biddle, Jennifer C; Koontz, Tomas M

2014-12-01

Collaborative governance critics continually call for evidence to support its prevalent use. As is often the case in environmental policy, environmental outcomes occur at a rate incompatible with political agendas. In addition, a multitude of possibly confounding variables makes it difficult to correlate collaborative governance processes with environmental outcomes. The findings of this study offer empirical evidence that collaborative processes have a measurable, beneficial effect on environmental outcomes. Through the use of a unique paired-waterbody design, our dataset reduced the potential for confounding variables to impact our environmental outcome measurements. The results of a path analysis indicate that the output of setting specific pollutant reduction goals is significantly related to watershed partnerships' level of attainment of their environmental improvement goals. The action of setting specific goals (e.g. percentage of load reductions in pollutant levels) is fostered by sustained participation from partnership members throughout the lifecycle of the collaborative. In addition, this study demonstrates the utility of logic modeling for environmental planning and management, and suggests that the process of setting specific pollutant reduction goals is a useful proxy measure for reporting progress towards improvements in environmental outcomes when long-term environmental data are not available. Copyright © 2014 Elsevier Ltd. All rights reserved.
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.

The Irvine, Beatties, and Bresnahan (IBB) Forelimb Recovery Scale: An Assessment of Reliability and Validity

PubMed Central

Irvine, Karen-Amanda; Ferguson, Adam R.; Mitchell, Kathleen D.; Beattie, Stephanie B.; Lin, Amity; Stuck, Ellen D.; Huie, J. Russell; Nielson, Jessica L.; Talbott, Jason F.; Inoue, Tomoo; Beattie, Michael S.; Bresnahan, Jacqueline C.

2014-01-01

The IBB scale is a recently developed forelimb scale for the assessment of fine control of the forelimb and digits after cervical spinal cord injury [SCI; (1)]. The present paper describes the assessment of inter-rater reliability and face, concurrent and construct validity of this scale following SCI. It demonstrates that the IBB is a reliable and valid scale that is sensitive to severity of SCI and to recovery over time. In addition, the IBB correlates with other outcome measures and is highly predictive of biological measures of tissue pathology. Multivariate analysis using principal component analysis (PCA) demonstrates that the IBB is highly predictive of the syndromic outcome after SCI (2), and is among the best predictors of bio-behavioral function, based on strong construct validity. Altogether, the data suggest that the IBB, especially in concert with other measures, is a reliable and valid tool for assessing neurological deficits in fine motor control of the distal forelimb, and represents a powerful addition to multivariate outcome batteries aimed at documenting recovery of function after cervical SCI in rats. PMID:25071704
Strength, Multijoint Coordination, and Sensorimotor Processing Are Independent Contributors to Overall Balance Ability

PubMed Central

Lawrence, Emily L.; Cesar, Guilherme M.; Bromfield, Martha R.; Peterson, Richard; Valero-Cuevas, Francisco J.; Sigward, Susan M.

2015-01-01

For young adults, balance is essential for participation in physical activities but is often disrupted following lower extremity injury. Clinical outcome measures such as single limb balance (SLB), Y-balance (YBT), and the single limb hop and balance (SLHB) tests are commonly used to quantify balance ability following injury. Given the varying demands across tasks, it is likely that such outcome measures provide useful, although task-specific, information. But the extent to which they are independent and contribute to understanding the multiple contributors to balance is not clear. Therefore, the purpose of this study was to investigate the associations among these measures as they relate to the different contributors to balance. Thirty-seven recreationally active young adults completed measures including Vertical Jump, YBT, SLB, SLHB, and the new Lower Extremity Dexterity test. Principal components analysis revealed that these outcome measures could be thought of as quantifying the strength, multijoint coordination, and sensorimotor processing contributors to balance. Our results challenge the practice of using a single outcome measure to quantify the naturally multidimensional mechanisms for everyday functions such as balance. This multidimensional approach to, and interpretation of, multiple contributors to balance may lead to more effective, specialized training and rehabilitation regimens. PMID:26665007
Choosing Assessment Instruments for Bulimia Practice and Outcome Research

ERIC Educational Resources Information Center

Sandberg, Katie; Erford, Bradley T.

2013-01-01

Six commonly used instruments for assessment of eating disorders were analyzed. Effect size results from Erford et al.'s (2013) meta-analysis for the treatment of bulimia nervosa were used to compare each scale's ability to measure treatment outcomes for bulimia nervosa. Effect size comparisons indicated higher overall effect sizes using the…
Component Analysis of Adherence in a Family Intervention

ERIC Educational Resources Information Center

Hill, Laura G.; Owens, Robert W.

2013-01-01

Purpose: Most studies of adherence use a single global measure to examine the relation of adherence to outcomes. These studies inform us about effects of overall implementation but not about importance of specific program elements. Previous research on the Strengthening Families Program 10-14 has shown that outcomes were unrelated to global…
Six-Word Memoirs: A Content Analysis of First-Year Course Learning Outcomes

ERIC Educational Resources Information Center

Rubin, Lisa

2016-01-01

First-year courses prepare students for the transition to, and success in, college. Institutions are interested in assessing student learning outcomes to achieve institutional goals and maintain accreditation. Though it may be difficult to measure student learning and success, colleges aim to assess student learning in the classroom by setting…
Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-analysis.

PubMed

Mannan, A; Smith, T O

2016-03-01

Implant malposition in total knee arthroplasty (TKA) often results in unsatisfactory outcomes. Rotational malalignment leads to impaired patellar tracking, stability and joint biomechanics. Patient-specific instrumentation aims to improve three-dimensional implant positioning while reducing overall costs of instrumentation. A PRISMA compliant search of all relevant literature between 2000 and 2014 was performed. The primary outcome of interest was deviation from a neutral femoral and tibial axial alignment of patient-specific instrumentation (PSI) vs conventional instrumentation. Femoral rotation was measured with reference to the transepicondylar axis. Tibial rotation was reported with reference to the anterior tibial tuberosity and a "best fit" with the anterior tibial cortex. Six randomised studies met the inclusion criteria reporting on a total of 444 knees. Computed tomography (CT) based PSI systems were used exclusively in three studies, and two further studies in association with magnetic resonance imaging (MRI). MRI was used exclusively in one study. Mean femoral rotation in the conventional group was: -1.7 to 1.6° (vs -1.7 to 1° in the PSI group). Meta-analysis demonstrated a significant treatment effect favouring PSI with increased accuracy in "three-degree outliers" with femoral rotation: Z=2.07, P=0.04. A single study reported tibial rotational outcomes with no significant difference demonstrated in conventional instrumentation vs PSI. This Level 1 meta-analysis demonstrates favourable femoral rotational alignment outcomes in PSI knee arthroplasty. Only limited data is available for tibial rotational outcomes. Further studies with standardised "gold-standard" measurement criteria are required to clarify tibial rotational outcomes in PSI TKA. 1. Copyright © 2015 Elsevier B.V. All rights reserved.
Palliative care in the home: a scoping review of study quality, primary outcomes, and thematic component analysis.

PubMed

Hofmeister, Mark; Memedovich, Ally; Dowsett, Laura E; Sevick, Laura; McCarron, Tamara; Spackman, Eldon; Stafinski, Tania; Menon, Devidas; Noseworthy, Tom; Clement, Fiona

2018-03-07

The aim of palliative care is to improve the quality of life of patients and families through the prevention and relief of suffering. Frequently, patients may choose to receive palliative care in the home. The objective of this paper is to summarize the quality and primary outcomes measured within the palliative care in the home literature. This will synthesize the current state of the literature and inform future work. A scoping review was completed using PRISMA guidelines. PubMed, Embase, CINAHL, Web of Science, Cochrane Library, EconLit, PsycINFO, Centre for Reviews and Dissemination, Database of Abstracts of Reviews of Effects, and National Health Service Economic Evaluation Database were searched from inception to August 2016. Inclusion criteria included: 1) care was provided in the "home of the patient" as defined by the study, 2) outcomes were reported, and 3) reported original data. Thematic component analysis was completed to categorize interventions. Fifty-three studies formed the final data set. The literature varied extensively. Five themes were identified: accessibility of healthcare, caregiver support, individualized patient centered care, multidisciplinary care provision, and quality improvement. Primary outcomes were resource use, symptom burden, quality of life, satisfaction, caregiver distress, place of death, cost analysis, or described experiences. The majority of studies were of moderate or unclear quality. There is robust literature of varying quality, assessing different components of palliative care in the home interventions, and measuring different outcomes. To be meaningful to patients, these interventions need to be consistently evaluated with outcomes that matter to patients. Future research could focus on reaching a consensus for outcomes to evaluate palliative care in the home interventions.
Developing measures of community-relevant outcomes for violence prevention programs: a community-based participatory research approach to measurement.

PubMed

Hausman, Alice J; Baker, Courtney N; Komaroff, Eugene; Thomas, Nicole; Guerra, Terry; Hohl, Bernadette C; Leff, Stephen S

2013-12-01

Community-Based Participatory Research is a research paradigm that encourages community participation in designing and implementing evaluation research, though the actual outcome measures usually reflect the "external" academic researchers' view of program effect and the policy-makers' needs for decision-making. This paper describes a replicable process by which existing standardized psychometric scales commonly used in youth-related intervention programs were modified to measure indicators of program success defined by community partners. This study utilizes a secondary analysis of data gathered in the context of a community-based youth violence prevention program. Data were retooled into new measures developed using items from the Alabama Parenting Questionnaire, the Hare Area Specific Self-Esteem Scale, and the Youth Asset Survey. These measures evaluated two community-defined outcome indicators, "More Parental Involvement" and "Showing Kids Love." Results showed that existing scale items can be re-organized to create measures of community-defined outcomes that are psychometrically reliable and valid. Results also show that the community definitions of parent or parenting caregivers exemplified by the two indicators are similar to how these constructs have been defined in previous research, but they are not synonymous. There are nuanced differences that are important and worthy of better understanding, in part through better measurement.
The effect of measuring serum doxycycline concentrations on clinical outcomes during treatment of chronic Q fever.

PubMed

van Roeden, S E; Bleeker-Rovers, C P; Kampschreur, L M; de Regt, M J A; Vermeulen Windsant, A; Hoepelman, A I M; Wever, P C; Oosterheert, J J

2018-04-01

First choice treatment for chronic Q fever is doxycycline plus hydroxychloroquine. Serum doxycycline concentration (SDC) >5 μg/mL has been associated with a favourable serological response, but the effect on clinical outcomes is unknown. To assess the effect of measuring SDC during treatment of chronic Q fever on clinical outcomes. We performed a retrospective cohort study, to assess the effect of measuring SDC on clinical outcomes in patients treated with doxycycline and hydroxychloroquine for chronic Q fever. Primary outcome was the first disease-related event (new complication or chronic Q fever-related mortality); secondary outcomes were all-cause mortality and PCR-positivity. Multivariable analysis was performed with a Cox proportional hazards model, with shared-frailty terms for different hospitals included. We included 201 patients (mean age 68 years, 83% male): in 167 patients (83%) SDC was measured, 34 patients (17%) were treated without SDC measurement. First SDC was >5 μg/mL in 106 patients (63%), all with 200 mg doxycycline daily. In patients with SDC measured, dosage was adjusted in 41% (n = 68), concerning an increase in 64 patients. Mean SDC was 4.1 μg/mL before dosage increase, and 5.9 μg/mL afterwards. SDC measurement was associated with a lower risk for disease-related events (HR 0.51, 95% CI 0.26-0.97, P = 0.04), but not with all-cause mortality or PCR-positivity. SDC measurement decreases the risk for disease-related events, potentially through more optimal dosing or improved compliance. We recommend measurement of SDC and striving for SDC >5 μg/mL and <10 μg/mL during treatment of chronic Q fever.
Factor Analysis of the Modified Sexual Adjustment Questionnaire-Male

PubMed Central

Wilmoth, Margaret C.; Hanlon, Alexandra L.; Ng, Lit Soo; Bruner, Debra W.

2015-01-01

Background and Purpose The Sexual Adjustment Questionnaire (SAQ) is used in National Cancer Institute–sponsored clinical trials as an outcome measure for sexual functioning. The tool was revised to meet the needs for a clinically useful, theory-based outcome measure for use in both research and clinical settings. This report describes the modifications and validity testing of the modified Sexual Adjustment Questionnaire-Male (mSAQ-Male). Methods This secondary analysis of data from a large Radiation Therapy Oncology Group trial employed principal axis factor analytic techniques in estimating validity of the revised tool. The sample size was 686; most subjects were White, older than the age 60 years, and with a high school education and a Karnofsky performance scale (KPS) score of greater than 90. Results A 16-item, 3-factor solution resulted from the factor analysis. The mSAQ-Male was also found to be sensitive to changes in physical sexual functioning as measured by the KPS. Conclusion The mSAQ-Male is a valid self-report measure of sexuality that can be used clinically to detect changes in male sexual functioning. PMID:25255676
Medication Regimen Complexity Measured by MRCI: A Systematic Review to Identify Health Outcomes.

PubMed

Alves-Conceição, Vanessa; Rocha, Kérilin Stancine Santos; Silva, Fernanda Vilanova Nascimento; Silva, Rafaella Oliveira Santos; Silva, Daniel Tenório da; Lyra-Jr, Divaldo Pereira de

2018-05-01

To perform a systematic review to identify health outcomes related to medication regimen complexity as measured by the Medication Regimen Complexity Index (MRCI) instrument. Cochrane Library, LILACS, PubMed, Scopus, EMBASE, Open Thesis, and Web of Science were searched from January 1, 2004, until April 02, 2018, using the following search terms: outcome assessment, drug therapy, and Medication Regimen Complexity Index and their synonyms in different combinations. Studies that used the MRCI instrument to measure medication regimen complexity and related it to clinical, humanistic, and/or economic outcomes were evaluated. Two reviewers independently carried out the analysis of the titles, abstracts, and complete texts according to the eligibility criteria, performed data extraction, and evaluated study quality. A total of 23 studies met the inclusion criteria; 18 health outcomes related to medication regimen complexity were found. The health outcomes most influenced by medication regimen complexity were hospital readmission, medication adherence, hospitalization, adverse drug events, and emergency sector visit. Only one study related medication regimen complexity with humanistic outcomes, and no study related medication regimen complexity to economic outcomes. Most of the studies were of good methodological quality. Relevance to Patient Care and Clinical Practice: Health care professionals should pay attention to medication regimen complexity of the patients because this may influence health outcomes. This study identified some health outcomes that may be influenced by medication regimen complexity: hospitalization, hospital readmission, and medication adherence were more prevalent, showing a significant association between MRCI increase and these health outcomes.
The effectiveness of health communication strategies in health education in Kushima, Japan.

PubMed

Ebina, Ryoko; Kawasaki, Fumiko; Taniguchi, Izumi; Togari, Taisuke; Yamazaki, Yoshihiko; Sparks, Michael

2010-03-01

Japan's 2008 health policy focuses more than ever on health education for behaviour change and outcome measures for physical health status. This is at odds with contemporary health promotion and health education, which frame health as a resource for everyday life and indicate that the evaluation of interventions should measure broader aspects of health rather than just physical aspects. The application of a combination of different health communication models and theories allows for a customized approach, depending on the types of change that are being sought, and can lead to increased relevance as well as a better fit when it comes to evaluating the achievement of broad health promotion goals. This article explores the application of the Outcome Model for Health Promotion to a two-year health education intervention in Kushima, Japan. This model measures program effectiveness from four aspects: physical health outcomes; intermediate health outcomes; health promotion outcomes; and health promotion actions. A quantitative and qualitative longitudinal, mixed model study design and methods were used for the analysis. Data was taken from health exams, structured interviews, and participant observations collected from 67 participants at four times over two years. This intervention relied primarily on health education and communication to achieve mental and social health outcomes more significantly and faster than physical health outcomes. The importance of moving outcome measurement beyond direct health achievements is discussed in light of the relationships between physical, mental, and social health and its determinants, and our results.
Body mass index and outcome in renal transplant recipients: a systematic review and meta-analysis.

PubMed

Lafranca, Jeffrey A; IJermans, Jan N M; Betjes, Michiel G H; Dor, Frank J M F

2015-05-12

Whether overweight or obese end stage renal disease (ESRD) patients are suitable for renal transplantation (RT) is often debated. The objective of this review and meta-analysis was to systematically investigate the outcome of low versus high BMI recipients after RT. Comprehensive searches were conducted in MEDLINE OvidSP, Web of Science, Google Scholar, Embase, and CENTRAL (the Cochrane Library 2014, issue 8). We reviewed four major guidelines that are available regarding (potential) RT recipients. The methodology was in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and written based on the PRISMA statement. The quality assessment of studies was performed by using the GRADE tool. A meta-analysis was performed using Review Manager 5.3. Random-effects models were used. After identifying 5,526 studies addressing this topic, 56 studies were included. We extracted data for 37 outcome measures (including data of more than 209,000 RT recipients), of which 26 could be meta-analysed. The following outcome measures demonstrated significant differences in favour of low BMI (<30) recipients: mortality (RR = 1.52), delayed graft function (RR = 1.52), acute rejection (RR = 1.17), 1-, 2-, and 3-year graft survival (RR = 0.97, 0.95, and 0.97), 1-, 2-, and 3-year patient survival (RR = 0.99, 0.99, and 0.99), wound infection and dehiscence (RR = 3.13 and 4.85), NODAT (RR = 2.24), length of hospital stay (2.31 days), operation duration (0.77 hours), hypertension (RR = 1.35), and incisional hernia (RR = 2.72). However, patient survival expressed in hazard ratios was in significant favour of high BMI recipients. Differences in other outcome parameters were not significant. Several of the pooled outcome measurements show significant benefits for 'low' BMI (<30) recipients. Therefore, we postulate that ESRD patients with a BMI >30 preferably should lose weight prior to RT. If this cannot be achieved with common measures, in morbidly obese RT candidates, bariatric surgery could be considered.
Association Between Arterial Hyperoxia and Outcome in Subsets of Critical Illness: A Systematic Review, Meta-Analysis, and Meta-Regression of Cohort Studies.

PubMed

Helmerhorst, Hendrik J F; Roos-Blom, Marie-José; van Westerloo, David J; de Jonge, Evert

2015-07-01

Oxygen is vital during critical illness, but hyperoxia may harm patients. Our aim was to systematically evaluate the methodology and findings of cohort studies investigating the effects of hyperoxia in critically ill adults. A meta-analysis and meta-regression analysis of cohort studies published between 2008 and 2015 was conducted. Electronic databases of MEDLINE, EMBASE, and Web of Science were systematically searched for the keywords hyperoxia and mortality or outcome. Publications assessing the effect of arterial hyperoxia on outcome in critically ill adults (≥ 18 yr) admitted to critical care units were eligible. We excluded studies in patients with chronic obstructive pulmonary disease, extracorporeal life support or hyperbaric oxygen therapy, and animal studies. Due to a lack of data, no studies dedicated to patients with acute lung injury, sepsis, shock, or multiple trauma could be included. Studies were included independent of admission diagnosis and definition of hyperoxia. The primary outcome measure was in-hospital mortality, and results were stratified for relevant subgroups (cardiac arrest, traumatic brain injury, stroke, post-cardiac surgery, and any mechanical ventilation). The effects of arterial oxygenation on functional outcome, long-term mortality, and discharge variables were studied as secondary outcomes. Twenty-four studies were included of which five studies were only for a subset of the analyses. Nineteen studies were pooled for meta-analyses and showed that arterial hyperoxia during admission increases hospital mortality: adjusted odds ratio, 1.21 (95% CI, 1.08-1.37) (p = 0.001). Functional outcome measures were diverse and generally showed a more favorable outcome for normoxia. In various subsets of critically ill patients, arterial hyperoxia was associated with poor hospital outcome. Considering the substantial heterogeneity of included studies and the lack of a clinical definition, more evidence is needed to provide optimal oxygen targets to critical care physicians.
Purchasing population health: aligning financial incentives to improve health outcomes.

PubMed

Kindig, D A

1999-01-01

To review the concept of population health, including its definition, measurement, and determinants, and to suggest an approach for aligning financial incentives toward this goal. DATA SOURCE, STUDY DESIGN, DATA EXTRACTION: Literature review, policy analysis The article presents the argument that a major reason for our slow progress toward health outcome improvement is that there is no operational definition of population health and that financial incentives are not aligned to this goal. Current attempts at process measures as indicators of quality or outcome are not adequate for the task. It is suggested that some measure of health-adjusted life expectancy be adopted for this purpose, and that integrated delivery systems and other agents responsible for nonmedical determinants be rewarded for improvement in this measure. This will require the development of an investment portfolio across the determinants of health based on relative marginal return to health, with horizontal integration strategies across sectoral boundaries. A 20-year three-phase development strategy is proposed, including components of research and acceptance, integrated health system implementation, and cross-sectoral integration. The U.S. health care system is a $1 trillion industry without a definition of its product. Until population outcome measures are developed and rewarded for, we will not solve the twenty-first century challenge of maximizing health outcome improvement for the resources available.
Purchasing population health: aligning financial incentives to improve health outcomes.

PubMed

Kindig, D A

1998-06-01

To review the concept of population health, including its definition, measurement, and determinants, and to suggest an approach for aligning financial incentives toward this goal. DATA SOURCE, STUDY DESIGN, DATA EXTRACTION. Literature review, policy analysis The article presents the argument that a major reason for our slow progress toward health outcome improvement is that there is no operational definition of population health and that financial incentives are not aligned to this goal. Current attempts at process measures as indicators of quality or outcome are not adequate for the task. It is suggested that some measure of health-adjusted life expectancy be adopted for this purpose, and that integrated delivery systems and other agents responsible for nonmedical determinants be rewarded for improvement in this measure. This will require the development of an investment portfolio across the determinants of health based on relative marginal return to health, with horizontal integration strategies across sectoral boundaries. A 20-year three-phase development strategy is proposed, including components of research and acceptance, integrated health system implementation, and cross-sectoral integration. The U.S. healthcare system is a $1 trillion industry without a definition of its product. Until population outcome measures are developed and rewarded for, we will not solve the twenty-first century challenge of maximizing health outcome improvement for the resources available.
The connection between strong social support and joint replacement outcomes.

PubMed

Theiss, Mark M; Ellison, Michael W; Tea, Christine G; Warner, Julia F; Silver, Renee M; Murphy, Valerie J

2011-05-18

A myriad of emotional, informational, and tangible needs can easily overwhelm patients as they seek to navigate a complicated surgical procedure. This article demonstrates that a dedicated family member or friend supporting their loved one before, during, and after joint replacement surgery measurably impacts quality and outcomes. The multidisciplinary, multihospital study team developed the following Opportunity Statement: "To define, measure, and implement a progressive family/friend support system across the continuum of care promoting optimal patient recovery after total joint arthroplasty." The team used the modified Groningen Orthopedic Social Support Scale to measure levels of social support and associated these levels with other patient outcomes.Analysis of 1722 observations across 4 hospitals found that patients with strong social support have shorter hospital stays, are more likely to be discharged home, to meet ambulation and transfer-out-of-bed targets, and to score hospital quality of care higher, and are more confident and ready to go home on discharge. Three presence intervals were also found to be significant predictors of key outcome measures: family/friend presence during the preoperative classes, in the preoperative holding area, and during the last physical therapy session. These intervals may serve as reasonable social support proxies for organizations desiring to measure social support to ultimately affect quality and outcomes. Copyright 2011, SLACK Incorporated.
A longitudinal analysis of nursing home outcomes.

PubMed Central

Porell, F; Caro, F G; Silva, A; Monane, M

1998-01-01

OBJECTIVE: To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. DATA SOURCES: Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. STUDY DESIGN: Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. PRINCIPAL FINDINGS: The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. CONCLUSIONS: The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures. PMID:9776939
Orthodontic trial outcomes: Plentiful, inconsistent, and in need of uniformity? A scoping review.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Fleming, Padhraig S

2018-06-01

The selection of appropriate outcomes that matter to both patients and operators is increasingly appreciated, with core outcome sets in clinical trials gaining in popularity. The first step in core outcome set development is the generation of a list of possible important outcomes based on a scoping literature review. Moreover, outcome heterogeneity is known to detract from the findings of systematic reviews and meta-analyses. The aim of this study was to identify the range of outcome domains and specific outcome measures in contemporary orthodontic research. Multiple electronic databases were searched from December 31, 2012, to December 31, 2016, to identify clinical trials of orthodontic interventions, with no language restrictions. Abstracts, eligible full texts, and reference lists were screened, and all reported primary and nonprimary outcomes and methods of measurement were recorded. The search identified 1267 abstracts, of which 189 full-text articles were retrieved, and 164 studies were included in the analysis. A total of 54 outcomes were identified and categorized into 14 outcome domains. The most frequently measured outcomes were patient-reported pain, periodontal health, tooth angulation/inclination changes, and treatment duration, followed by rate of tooth movement and skeletal changes. Outcomes that followed the overall course of treatment were assessed in only 14 studies. Patient perspectives are increasingly being accounted for in orthodontic trials; however, there is little consistency in outcome selection among them. The identified list of outcomes will be used to inform a ranking exercise with service users and providers to establish an agreed core outcome set for future orthodontic clinical trials. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.
The effect of Medicaid reimbursement on quality of care in nursing homes.

PubMed

Cohen, J W; Spector, W D

1996-02-01

This study uses a nationally representative sample of nursing homes and nursing home residents to examine the effect of Medicaid reimbursement on quality of care. The analysis shows that both reimbursement approach and level affect nursing home quality, as measured by case-mix adjusted staff to resident ratios. The analysis also shows that staffing ratios have a significant impact on resident outcomes, and these impacts vary by professional category of staff. Reimbursement does not have a significant impact on outcomes, however.

Postoperative weight bearing and patient reported outcomes at one year following tibial plateau fractures.

PubMed

Thewlis, Dominic; Fraysse, Francois; Callary, Stuart A; Verghese, Viju Daniel; Jones, Claire F; Findlay, David M; Atkins, Gerald J; Rickman, Mark; Solomon, Lucian B

2017-07-01

Tibial plateau fractures are complex and the current evidence for postoperative rehabilitation is weak, especially related to the recommended postoperative weight bearing. The primary aim of this study was to investigate if loading in the first 12 weeks of recovery is associated with patient reported outcome measures at 26 and 52 weeks postoperative. We hypothesized that there would be no association between loading and patient reported outcome measures. Seventeen patients, with a minimum of 52-week follow-up following fragment-specific open reduction and internal fixation for tibial plateau fracture, were selected for this retrospective analysis. Postoperatively, patients were advised to load their limb to a maximum of 20kg during the first 6 weeks. Loading data were collected during walking using force platforms. A ratio of limb loading (affected to unaffected) was calculated at 2, 6 and 12 weeks postoperative. Knee Injury and Osteoarthritis Scores were collected at 6, 12, 26 and 52 weeks postoperative. The association between loading ratios and patient reported outcomes were investigated. Compliance with weight bearing recommendations and changes in the patient reported outcome measures are described. Fracture reduction and migration were assessed on plain radiographs. No fractures demonstrated any measurable postoperative migration at 52 weeks. Significant improvements were seen in all patient reported outcome measures over the first 52 weeks, despite poor adherence to postoperative weight bearing restrictions. There were no associations between weight bearing ratio and patient reported outcomes at 52 weeks postoperative. Significant associations were identified between the loading ratio at 2 weeks and knee-related quality of life at six months (R 2 =0.392), and between the loading ratio at 6 weeks combined with injury severity and knee-related quality of life at 26 weeks (R 2 =0.441). In summary, weight bearing as tolerated does not negatively affect the results of tibial plateau fracture and may therefore be safe for postoperative management. These findings should be taken in context of the sample size, which was not sufficient for sub-group analysis to investigate the role of impaction grafting. Copyright © 2017 Elsevier Ltd. All rights reserved.
[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.
A Tool for Measuring NASA's Aeronautics Research Progress Toward Planned Strategic Community Outcomes

NASA Technical Reports Server (NTRS)

Tahmasebi, Farhad; Pearce, Robert

2016-01-01

Description of a tool for portfolio analysis of NASA's Aeronautics research progress toward planned community strategic Outcomes is presented. For efficiency and speed, the tool takes advantage of a function developed in Excels Visual Basic for Applications. The strategic planning process for determining the community Outcomes is also briefly discussed. Stakeholder buy-in, partnership performance, progress of supporting Technical Challenges, and enablement forecast are used as the criteria for evaluating progress toward Outcomes. A few illustrative examples of using the tool are also presented.
Measurement properties of painDETECT: Rasch analysis of responses from community-dwelling adults with neuropathic pain.

PubMed

Packham, Tara L; Cappelleri, Joseph C; Sadosky, Alesia; MacDermid, Joy C; Brunner, Florian

2017-03-04

painDETECT (PD-Q) is a self-reported assessment of pain qualities developed as a screening tool for pain of neuropathic origin. Rasch analysis is a strategy for examining the measurement characteristics of a scale using a form of item response theory. We conducted a Rasch analysis to consider if the scoring and measurement properties of PD-Q would support its use as an outcome measure. Rasch analysis was conducted on PD-Q scores drawn from a cross-sectional study of the burden and costs of NeP. The analysis followed an iterative process based on recommendations in the literature, including examination of sequential scoring categories, unidimensionality, reliability and differential item function. Data from 624 persons with a diagnosis of painful diabetic polyneuropathy, small fibre neuropathy, and neuropathic pain associated with chronic low back pain, spinal cord injury, HIV-related pain, or chronic post-surgical pain was used for this analysis. PD-Q demonstrated fit to the Rasch model after adjustments of scoring categories for four items, and omission of the time course and radiating questions. The resulting seven-item scale of pain qualities demonstrated good reliability with a person-separation index of 0.79. No scoring bias (differential item functioning) was found for this version. Rasch modelling suggests the seven pain-qualities items from PD-Q may be used as an outcome measure. Further research is required to confirm validity and responsiveness in a clinical setting.
The Brighton musculoskeletal Patient-Reported Outcome Measure (BmPROM): An assessment of validity, reliability, and responsiveness.

PubMed

Bryant, Elizabeth; Murtagh, Shemane; Finucane, Laura; McCrum, Carol; Mercer, Christopher; Smith, Toby; Canby, Guy; Rowe, David A; Moore, Ann P

2018-05-11

In response for the need of a freely available, stand-alone, validated outcome measure for use within musculoskeletal (MSK) physiotherapy practice, sensitive enough to measure clinical effectiveness, we developed an MSK patient reported outcome measure. This study examined the validity and reliability of the newly developed Brighton musculoskeletal Patient-Reported Outcome Measure (BmPROM) within physiotherapy outpatient settings. Two hundred twenty-four patients attending physiotherapy outpatient departments in South East England with an MSK condition participated in this study. The BmPROM was assessed for user friendliness (rated feedback, N = 224), reliability (internal consistency and test-retest reliability, n = 42), validity (internal and external construct validity, N = 224), and responsiveness (internal, n = 25). Exploratory factor analysis indicated that a two-factor model provides a good fit to the data. Factors were representative of "Functionality" and "Wellbeing". Correlations observed between the BmPROM and SF-36 domains provided evidence of convergent validity. Reliability results indicated that both subscales were internally consistent with alphas above the acceptable limits for both "Functionality" (α = .85, 95% CI [.81, .88]) and 'Wellbeing' (α = .80, 95% CI [.75, .84]). Test-retest analyses (n = 42) demonstrated a high degree of reliability between "Functionality" (ICC = .84; 95% CI [.72, .91]) and "Wellbeing" scores (ICC = .84; 95% CI [.72, .91]). Further examination of test-retest reliability through the Bland-Altman analysis demonstrated that the difference between "Functionality" and "Wellbeing" test scores did not vary as a function of absolute test score. Large treatment effect sizes were found for both subscales (Functionality d = 1.10; Wellbeing 1.03). The BmPROM is a reliable and valid outcome measure for use in evaluating physiotherapy treatment of MSK conditions. Copyright © 2018 John Wiley & Sons, Ltd.
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.
Systematic review of middle ear implants: do they improve hearing as much as conventional hearing AIDS?

PubMed

Tysome, James R; Moorthy, Ram; Lee, Ambrose; Jiang, Dan; O'Connor, Alec Fitzgerald

2010-12-01

A systematic review to determine whether middle ear implants (MEIs) improve hearing as much as hearing aids. Databases included MEDLINE, EMBASE, DARE, and Cochrane searched with no language restrictions from 1950 or the start date of each database. Initial search found 644 articles, of which 17 met the inclusion criteria of MEI in adults with a sensorineural hearing loss, where hearing outcomes and patient-reported outcome measures (PROMs) compared MEI with conventional hearing aids (CHAs). Study quality assessment included whether ethical approval was gained, the study was prospective, eligibility criteria specified, a power calculation made and appropriate controls, outcome measures, and analysis performed. Middle ear implant outcome analysis included residual hearing, complications, and comparison to CHA in terms of functional gain, speech perception in quiet and in noise, and validated PROM questionnaires. Because of heterogeneity of outcome measures, comparisons were made by structured review. The quality of studies was moderate to poor with short follow-up. The evidence supports the use of MEI because, overall, they do not decrease residual hearing, result in a functional gain in hearing comparable to CHA, and may improve perception of speech in noise and sound quality. We recommend the publication of long-term results comparing MEI with CHA, reporting a minimum of functional gain, speech perception in quiet and in noise, complications, and a validated PROM to guide the engineering of the new generation of MEI in the future.
An introduction to clinical microeconomic analysis: purposes and analytic methods.

PubMed

Weintraub, W S; Mauldin, P D; Becker, E R

1994-06-01

The recent concern with health care economics has fostered the development of a new discipline that is generally called clinical microeconomics. This is a discipline in which microeconomic methods are used to study the economics of specific medical therapies. It is possible to perform stand alone cost analyses, but more profound insight into the medical decision making process may be accomplished by combining cost studies with measures of outcome. This is most often accomplished with cost-effectiveness or cost-utility studies. In cost-effectiveness studies there is one measure of outcome, often death. In cost-utility studies there are multiple measures of outcome, which must be grouped together to give an overall picture of outcome or utility. There are theoretical limitations to the determination of utility that must be accepted to perform this type of analysis. A summary statement of outcome is quality adjusted life years (QALYs), which is utility time socially discounted survival. Discounting is used because people value a year of future life less than a year of present life. Costs are made up of in-hospital direct, professional, follow-up direct, and follow-up indirect costs. Direct costs are for medical services. Indirect costs reflect opportunity costs such as lost time at work. Cost estimates are often based on marginal costs, or the cost for one additional procedure of the same type. Finally an overall statistic may be generated as cost per unit increase in effectiveness, such as dollars per QALY.(ABSTRACT TRUNCATED AT 250 WORDS)
Defining the Value Framework for Prostate Brachytherapy using Patient-Centered Outcome Metrics and Time-Driven Activity-Based Costing

PubMed Central

Thaker, Nikhil G.; Pugh, Thomas J.; Mahmood, Usama; Choi, Seungtaek; Spinks, Tracy E.; Martin, Neil E.; Sio, Terence T.; Kudchadker, Rajat J.; Kaplan, Robert S.; Kuban, Deborah A.; Swanson, David A.; Orio, Peter F.; Zelefsky, Michael J.; Cox, Brett W.; Potters, Louis; Buchholz, Thomas A.; Feeley, Thomas W.; Frank, Steven J.

2017-01-01

PURPOSE Value, defined as outcomes over costs, has been proposed as a measure to evaluate prostate cancer (PCa) treatments. We analyzed standardized outcomes and time-driven activity-based costing (TDABC) for prostate brachytherapy (PBT) to define a value framework. METHODS AND MATERIALS Patients with low-risk PCa treated with low-dose rate PBT between 1998 and 2009 were included. Outcomes were recorded according to the International Consortium for Health Outcomes Measurement (ICHOM) standard set, which includes acute toxicity, patient-reported outcomes, and recurrence and survival outcomes. Patient-level costs to one year after PBT were collected using TDABC. Process mapping and radar chart analyses were conducted to visualize this value framework. RESULTS A total of 238 men were eligible for analysis. Median age was 64 (range, 46–81). Median follow-up was 5 years (0.5–12.1). There were no acute grade 3–5 complications. EPIC-50 scores were favorable, with no clinically significant changes from baseline to last follow-up at 48 months for urinary incontinence/bother, bowel bother, sexual function, and vitality. Ten-year outcomes were favorable, including biochemical failure-free survival of 84.1%, metastasis-free survival 99.6%, PCa-specific survival 100%, and overall survival 88.6%. TDABC analysis demonstrated low resource utilization for PBT, with 41% and 10% of costs occurring in the operating room and with the MRI scan, respectively. The radar chart allowed direct visualization of outcomes and costs. CONCLUSIONS We successfully created a visual framework to define the value of PBT using the ICHOM standard set and TDABC costs. PBT is associated with excellent outcomes and low costs. Widespread adoption of this methodology will enable value comparisons across providers, institutions, and treatment modalities. PMID:26916105
Evaluation of the Environmental Scoring System in Multiple Child Asthma Intervention Programs in Boston, Massachusetts.

PubMed

Dong, Zhao; Nath, Anjali; Guo, Jing; Bhaumik, Urmi; Chin, May Y; Dong, Sherry; Marshall, Erica; Murphy, Johnna S; Sandel, Megan T; Sommer, Susan J; Ursprung, W W Sanouri; Woods, Elizabeth R; Reid, Margaret; Adamkiewicz, Gary

2018-01-01

To test the applicability of the Environmental Scoring System, a quick and simple approach for quantitatively measuring environmental triggers collected during home visits, and to evaluate its contribution to improving asthma outcomes among various child asthma programs. We pooled and analyzed data from multiple child asthma programs in the Greater Boston Area, Massachusetts, collected in 2011 to 2016, to examine the association of environmental scores (ES) with measures of asthma outcomes and compare the results across programs. Our analysis showed that demographics were important contributors to variability in asthma outcomes and total ES, and largely explained the differences among programs at baseline. Among all programs in general, we found that asthma outcomes were significantly improved and total ES significantly reduced over visits, with the total Asthma Control Test score negatively associated with total ES. Our study demonstrated that the Environmental Scoring System is a useful tool for measuring home asthma triggers and can be applied regardless of program and survey designs, and that demographics of the target population may influence the improvement in asthma outcomes.
The relationship between hypophosphataemia and outcomes during low-intensity and high-intensity continuous renal replacement therapy.

PubMed

Bellomo, Rinaldo; Cass, Alan; Cole, Louise; Finfer, Simon; Gallagher, Martin; Kim, Inbyung; Lee, Joanne; Lo, Serigne; McArthur, Colin; McGuinness, Shay; McGuiness, Shay; Norton, Robyn; Myburgh, John; Scheinkestel, Carlos

2014-03-01

To identify risk factors for development of hypophosphataemia in patients treated with two different intensities of continuous renal replacement therapy (CRRT) and to assess the independent association of hypophosphataemia with major clinical outcomes. We performed secondary analysis of data collected from 1441 patients during a large, multicentre randomised controlled trial of CRRT intensity. We allocated patients to two different intensities of CRRT (25mL/kg/hour vs 40 mL/kg/hour of effluent generation) and obtained daily measurement of serum phosphate levels. We obtained 14 115 phosphate measurements and identified 462 patients (32.1%) with hypophosphataemia, with peak incidence on Day 2 and Day 3. With lower intensity CRRT, there were 58 episodes of hypophosphataemia/1000 patient days, compared with 112 episodes/1000 patient days with higher intensity CRRT (P < 0.001). On multivariable logistic regression analysis, higher intensity CRRT, female sex, higher Acute Physiology and Chronic Health Evaluation score and hypokalaemia were independently associated with an increased odds ratio (OR) for hypophosphataemia. On multivariable models, hypophosphataemia was associated with better clinical outcomes, but when analysis was confined to patients alive at 96 hours, hypophosphataemia was not independently associated with clinical outcomes. Hypophosphataemia is common during CRRT and its incidence increases with greater CRRT intensity. Hypophosphataemia is not a robust independent predictor of mortality. Its greater incidence in the higher intensity CRRT arm of the Randomised Evaluation of Normal vs Augmented Level trial does not explain the lack of improved outcomes with such treatment.
Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980

PubMed Central

Irvin, Veronica L.; Kaplan, Robert M.

2015-01-01

Purpose We reviewed large-budget, National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) with behavioral interventions to assess (1) publication rates, (2) trial registration, (3) use of objective measures, (4) significant behavior and physiological change, and (5) effect sizes. Methods We identified large-budget grants (>$500,000/year) funded by NIH (National Heart Lung and Blood Institute (NHLBI) or National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK)) for cardiovascular disease (dates January 1, 1980 to December 31, 2012). Among 106 grants that potentially met inclusion criteria, 20 studies were not published and 48 publications were excluded, leaving 38 publications for analysis. ClinicalTrials.gov abstracts were used to determine whether outcome measures had been pre-specified. Results Three fourths of trials were registered in ClinicalTrials.gov and all published pre-specified outcomes. Twenty-six trials reported a behavioral outcome with 81 % reporting significant improvements for the target behavior. Thirty-two trials reported a physiological outcome. All were objectively measured, and 81 % reported significant benefit. Seventeen trials reported morbidity outcomes, and seven reported a significant benefit. Nine trials assessed mortality, and all were null for this outcome. Conclusions Behavioral trials complied with trial registration standards. Most reported a physiological benefit, but few documented morbidity or mortality benefits. PMID:26507906
Acute Physiologic Stress and Subsequent Anxiety Among Family Members of ICU Patients.

PubMed

Beesley, Sarah J; Hopkins, Ramona O; Holt-Lunstad, Julianne; Wilson, Emily L; Butler, Jorie; Kuttler, Kathryn G; Orme, James; Brown, Samuel M; Hirshberg, Eliotte L

2018-02-01

The ICU is a complex and stressful environment and is associated with significant psychologic morbidity for patients and their families. We sought to determine whether salivary cortisol, a physiologic measure of acute stress, was associated with subsequent psychologic distress among family members of ICU patients. This is a prospective, observational study of family members of adult ICU patients. Adult medical and surgical ICU in a tertiary care center. Family members of ICU patients. Participants provided five salivary cortisol samples over 24 hours at the time of the patient ICU admission. The primary measure of cortisol was the area under the curve from ground; the secondary measure was the cortisol awakening response. Outcomes were obtained during a 3-month follow-up telephone call. The primary outcome was anxiety, measured by the Hospital Anxiety and Depression Scale-Anxiety. Secondary outcomes included depression and posttraumatic stress disorder. Among 100 participants, 92 completed follow-up. Twenty-nine participants (32%) reported symptoms of anxiety at 3 months, 15 participants (16%) reported depression symptoms, and 14 participants (15%) reported posttraumatic stress symptoms. In our primary analysis, cortisol level as measured by area under the curve from ground was not significantly associated with anxiety (odds ratio, 0.94; p = 0.70). In our secondary analysis, however, cortisol awakening response was significantly associated with anxiety (odds ratio, 1.08; p = 0.02). Roughly one third of family members experience anxiety after an ICU admission for their loved one, and many family members also experience depression and posttraumatic stress. Cortisol awakening response is associated with anxiety in family members of ICU patients 3 months following the ICU admission. Physiologic measurements of stress among ICU family members may help identify individuals at particular risk of adverse psychologic outcomes.
Which outcomes are most important to people with aphasia and their families? an international nominal group technique study framed within the ICF.

PubMed

Wallace, Sarah J; Worrall, Linda; Rose, Tanya; Le Dorze, Guylaine; Cruice, Madeline; Isaksen, Jytte; Kong, Anthony Pak Hin; Simmons-Mackie, Nina; Scarinci, Nerina; Gauvreau, Christine Alary

2017-07-01

To identify important treatment outcomes from the perspective of people with aphasia and their families using the ICF as a frame of reference. The nominal group technique was used with people with aphasia and their family members in seven countries to identify and rank important treatment outcomes from aphasia rehabilitation. People with aphasia identified outcomes for themselves; and family members identified outcomes for themselves and for the person with aphasia. Outcomes were analysed using qualitative content analysis and ICF linking. A total of 39 people with aphasia and 29 family members participated in one of 16 nominal groups. Inductive qualitative content analysis revealed the following six themes: (1) Improved communication; (2) Increased life participation; (3) Changed attitudes through increased awareness and education about aphasia; (4) Recovered normality; (5) Improved physical and emotional well-being; and (6) Improved health (and support) services. Prioritized outcomes for both participant groups linked to all ICF components; primary activity/participation (39%) and body functions (36%) for people with aphasia, and activity/participation (49%) and environmental factors (28%) for family members. Outcomes prioritized by family members relating to the person with aphasia, primarily linked to body functions (60%). People with aphasia and their families identified treatment outcomes which span all components of the ICF. This has implications for research outcome measurement and clinical service provision which currently focuses on the measurement of body function outcomes. The wide range of desired outcomes generated by both people with aphasia and their family members, highlights the importance of collaborative goal setting within a family-centred approach to rehabilitation. These results will be combined with other stakeholder perspectives to establish a core outcome set for aphasia treatment research. Implications for Rehabilitation Important outcomes for people with aphasia and their families span all components of the ICF. The relevancy and translation of research findings may be increased by measuring and reporting research outcomes which are important to people living with aphasia. The results of this study indicate that important treatment outcomes for people living with aphasia most frequently link to the activity/participation and body function components of the ICF. The outcomes identified in this study suggest a broad role for clinicians working in aphasia rehabilitation. The categories of identified outcomes may be used clinically as a starting point in goal-setting discussions with clients and their families.
Aortic stiffness predicts functional outcome in patients after ischemic stroke.

PubMed

Gasecki, Dariusz; Rojek, Agnieszka; Kwarciany, Mariusz; Kubach, Marlena; Boutouyrie, Pierre; Nyka, Walenty; Laurent, Stephane; Narkiewicz, Krzysztof

2012-02-01

Increased aortic stiffness (measured by carotid-femoral pulse wave velocity) and central augmentation index have been shown to independently predict cardiovascular events, including stroke. We studied whether pulse wave velocity and central augmentation index predict functional outcome after ischemic stroke. In a prospective study, we enrolled 99 patients with acute ischemic stroke (age 63.7 ± 12.4 years, admission National Institutes of Health Stroke Scale score 6.6 ± 6.6, mean ± SD). Carotid-femoral pulse wave velocity and central augmentation index (SphygmoCor) were measured 1 week after stroke onset. Functional outcome was evaluated 90 days after stroke using the modified Rankin Scale with modified Rankin Scale score of 0 to 1 considered an excellent outcome. In univariate analysis, low carotid-femoral pulse wave velocity (P=0.000001) and low central augmentation index (P=0.028) were significantly associated with excellent stroke outcome. Age, severity of stroke, presence of previous stroke, diabetes, heart rate, and peripheral pressures also predicted stroke functional outcome. In multivariate analysis, the predictive value of carotid-femoral pulse wave velocity (<9.4 m/s) remained significant (OR, 0.21; 95% CI, 0.06-0.79; P=0.02) after adjustment for age, National Institutes of Health Stroke Scale score on admission, and presence of previous stroke. By contrast, central augmentation index had no significant predictive value after adjustment. This study indicates that aortic stiffness is an independent predictor of functional outcome in patients with acute ischemic stroke.
Motivational and Skills, Social, and Self-Management Predictors of College Outcomes: Constructing the Student Readiness Inventory

ERIC Educational Resources Information Center

Le, Huy; Casillas, Alex; Robbins, Steven B.; Langley, Ronelle

2005-01-01

The authors used a rational-empirical approach to construct the Student Readiness Inventory, measuring psychosocial and academic-related skill factors found to predict two important college outcomes, academic performance and retention, in a recent meta-analysis. The initial item pool was administered to 5,970 first-year college students and high…
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,…
Longitudinal Multicenter Analysis of Outcomes After Cessation of Control Measures for Vancomycin-Resistant Enterococci.

PubMed

Lemieux, Camille; Gardam, Michael; Evans, Gerald; John, Michael; Suh, Kathryn N; vanWalraven, Carl; Vicencio, Elisa; Coulby, Cameron; Roth, Virginia; Hota, Susy

2017-01-01

OBJECTIVE To assess clinically relevant outcomes after complete cessation of control measures for vancomycin-resistant enterococci (VRE). DESIGN Quasi-experimental ecological study over 3.5 years. METHODS All VRE screening and isolation practices at 4 large academic hospitals in Ontario, Canada, were stopped on July 1, 2012. In total, 618 anonymized abstracted charts of patients with VRE-positive clinical isolates identified between July 1, 2010, and December 31, 2013, were reviewed to determine whether the case was a true VRE infection, a VRE colonization or contaminant, or a true VRE bacteremia. All deaths within 30 days of the last VRE infection were also reviewed to determine whether the death was fully or partially attributable to VRE. All-cause mortality was evaluated over the study period. Generalized estimating equation methods were used to cluster outcome rates within hospitals, and negative binomial models were created for each outcome. RESULTS The incidence rate ratio (IRR) for VRE infections was 0.59 and the associated P value was .34. For VRE bacteremias, the IRR was 0.54 and P=.38; for all-cause mortality the IRR was 0.70 and P=.66; and for VRE attributable death, the IRR was 0.35 and P=.49. VRE control measures were not significantly associated with any of the outcomes. Rates of all outcomes appeared to increase during the 18-month period after cessation of VRE control measures, but none reached statistical significance. CONCLUSION Clinically significant VRE outcomes remain rare. Cessation of all control measures for VRE had no significant attributable adverse clinical impact. Infect Control Hosp Epidemiol 2016;1-7.
The development of Music in Dementia Assessment Scales (MiDAS)

PubMed Central

McDermott, Orii; Orrell, Martin; Ridder, Hanne Mette

2015-01-01

There is a need to develop an outcome measure specific to music therapy in dementia that reflects a holistic picture of the therapy process and outcome. This study aimed to develop a clinically relevant and scientifically robust music therapy outcome measure incorporating the values and views of people with dementia. Focus groups and interviews were conducted to obtain qualitative data on what music meant to people with dementia and the observed effects of music. Expert and peer consultations were conducted at each stage of the measure development to maximise its content validity. The new measure was field-tested by clinicians in a care home. Feedback from the clinicians and music therapy experts were incorporated during the review and refinement process of the measure. A review of the existing literature, the experiential results and the consensus process enabled the development of the new outcome measure “Music in Dementia Assessment Scales (MiDAS)”. Analysis of the qualitative data identified five key areas of the impact of music on people with dementia and they were transformed as the five Visual Analogue Scale (VAS) items: levels of Interest, Response, Initiation, Involvement and Enjoyment. MiDAS comprises the five VAS items and a supplementary checklist of notable positive and negative reactions from the individual. This study demonstrates that it is possible to design and develop an easy to apply and rigorous quantitative outcome measure which has a high level of clinical relevance for people with dementia, care home staff and music therapists. PMID:26246670

The development of Music in Dementia Assessment Scales (MiDAS).

PubMed

McDermott, Orii; Orrell, Martin; Ridder, Hanne Mette

2015-07-03

There is a need to develop an outcome measure specific to music therapy in dementia that reflects a holistic picture of the therapy process and outcome. This study aimed to develop a clinically relevant and scientifically robust music therapy outcome measure incorporating the values and views of people with dementia. Focus groups and interviews were conducted to obtain qualitative data on what music meant to people with dementia and the observed effects of music. Expert and peer consultations were conducted at each stage of the measure development to maximise its content validity. The new measure was field-tested by clinicians in a care home. Feedback from the clinicians and music therapy experts were incorporated during the review and refinement process of the measure. A review of the existing literature, the experiential results and the consensus process enabled the development of the new outcome measure "Music in Dementia Assessment Scales (MiDAS)". Analysis of the qualitative data identified five key areas of the impact of music on people with dementia and they were transformed as the five Visual Analogue Scale (VAS) items: levels of Interest, Response, Initiation, Involvement and Enjoyment. MiDAS comprises the five VAS items and a supplementary checklist of notable positive and negative reactions from the individual. This study demonstrates that it is possible to design and develop an easy to apply and rigorous quantitative outcome measure which has a high level of clinical relevance for people with dementia, care home staff and music therapists.
Individual patient meta-analysis of exercise training effects on systemic brain natriuretic peptide expression in heart failure.

PubMed

Smart, N A; Meyer, T; Butterfield, J A; Faddy, S C; Passino, C; Malfatto, G; Jonsdottir, S; Sarullo, F; Wisloff, U; Vigorito, C; Giallauria, F

2012-06-01

Brain natriuretic peptide (BNP) predicts exercise performance and exercise training may modulate BNP and its N-terminal portion (NT-pro-BNP), we therefore conducted an individual patient analysis of exercise training effects on BNP and NT-pro-BNP. To use an individual patient meta-analysis to relate changes in BNP, NT-pro-BNP, and peak VO(2); to link these changes to volume parameters of exercise training programmes (intensity etc.); and to identify patient characteristics likely to lead to greater improvements in BNP, NT-pro-BNP, and peak VO(2). Individual patient meta-analysis. A systematic search was conducted of Medline (Ovid), Embase.com, Cochrane Central Register of Controlled Trials, and CINAHL (until July 2008) to identify randomized controlled trials of aerobic and/or resistance exercise training in systolic heart failure patients measuring BNP and/or NT-pro-BNP. Primary outcome measures were change in BNP, NT-pro-BNP, and peak VO2. Subanalyses were conducted to identify (1) patient groups that benefit most and (2) exercise programme parameters enhancing favourable changes in primary outcome measures. Ten randomized controlled studies measuring BNP or NT-pro-BNP met eligibility criteria, authors provided individual patient data for 565 patients (313 exercise and 252 controls). Exercise training had favourable effects on BNP (-28.3%, p < 0.0001), NT-pro-BNP (-37.4%, p = < 0.0001), and peak VO(2) (17.8%, p < 0.0001). The analysis showed a significant change in primary outcome measures; moreover, change in BNP (r = -0.31, p < 0.0001) and NT-pro-BNP (r = -0.22, p < 0.0001) were correlated with peak VO(2) change. Exercise training has favourable effects on BNP, NT-pro-BNP, and peak VO(2) in heart failure patients and BNP/NT-pro-BNP changes were correlated with peak VO(2) changes.
Examination of Variables That May Affect the Relationship Between Cognition and Functional Status in Individuals with Mild Cognitive Impairment: A Meta-Analysis.

PubMed

Mcalister, Courtney; Schmitter-Edgecombe, Maureen; Lamb, Richard

2016-03-01

The objective of this meta-analysis was to improve understanding of the heterogeneity in the relationship between cognition and functional status in individuals with mild cognitive impairment (MCI). Demographic, clinical, and methodological moderators were examined. Cognition explained an average of 23% of the variance in functional outcomes. Executive function measures explained the largest amount of variance (37%), whereas global cognitive status and processing speed measures explained the least (20%). Short- and long-delayed memory measures accounted for more variance (35% and 31%) than immediate memory measures (18%), and the relationship between cognition and functional outcomes was stronger when assessed with informant-report (28%) compared with self-report (21%). Demographics, sample characteristics, and type of everyday functioning measures (i.e., questionnaire, performance-based) explained relatively little variance compared with cognition. Executive functioning, particularly measured by Trails B, was a strong predictor of everyday functioning in individuals with MCI. A large proportion of variance remained unexplained by cognition. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Single-case synthesis tools II: Comparing quantitative outcome measures.

PubMed

Zimmerman, Kathleen N; Pustejovsky, James E; Ledford, Jennifer R; Barton, Erin E; Severini, Katherine E; Lloyd, Blair P

2018-03-07

Varying methods for evaluating the outcomes of single case research designs (SCD) are currently used in reviews and meta-analyses of interventions. Quantitative effect size measures are often presented alongside visual analysis conclusions. Six measures across two classes-overlap measures (percentage non-overlapping data, improvement rate difference, and Tau) and parametric within-case effect sizes (standardized mean difference and log response ratio [increasing and decreasing])-were compared to determine if choice of synthesis method within and across classes impacts conclusions regarding effectiveness. The effectiveness of sensory-based interventions (SBI), a commonly used class of treatments for young children, was evaluated. Separately from evaluations of rigor and quality, authors evaluated behavior change between baseline and SBI conditions. SBI were unlikely to result in positive behavior change across all measures except IRD. However, subgroup analyses resulted in variable conclusions, indicating that the choice of measures for SCD meta-analyses can impact conclusions. Suggestions for using the log response ratio in SCD meta-analyses and considerations for understanding variability in SCD meta-analysis conclusions are discussed. Copyright © 2018 Elsevier Ltd. All rights reserved.
Role of subdural electrocorticography in prediction of long-term seizure outcome in epilepsy surgery

PubMed Central

Juhász, Csaba; Shah, Aashit; Sood, Sandeep; Chugani, Harry T.

2009-01-01

Since prediction of long-term seizure outcome using preoperative diagnostic modalities remains suboptimal in epilepsy surgery, we evaluated whether interictal spike frequency measures obtained from extraoperative subdural electrocorticography (ECoG) recording could predict long-term seizure outcome. This study included 61 young patients (age 0.4–23.0 years), who underwent extraoperative ECoG recording prior to cortical resection for alleviation of uncontrolled focal seizures. Patient age, frequency of preoperative seizures, neuroimaging findings, ictal and interictal ECoG measures were preoperatively obtained. The seizure outcome was prospectively measured [follow-up period: 2.5–6.4 years (mean 4.6 years)]. Univariate and multivariate logistic regression analyses determined how well preoperative demographic and diagnostic measures predicted long-term seizure outcome. Following the initial cortical resection, Engel Class I, II, III and IV outcomes were noted in 35, 6, 12 and 7 patients, respectively. One child died due to disseminated intravascular coagulation associated with pseudomonas sepsis 2 days after surgery. Univariate regression analyses revealed that incomplete removal of seizure onset zone, higher interictal spike-frequency in the preserved cortex and incomplete removal of cortical abnormalities on neuroimaging were associated with a greater risk of failing to obtain Class I outcome. Multivariate logistic regression analysis revealed that incomplete removal of seizure onset zone was the only independent predictor of failure to obtain Class I outcome. The goodness of regression model fit and the predictive ability of regression model were greatest in the full regression model incorporating both ictal and interictal measures [R2 0.44; Area under the receiver operating characteristic (ROC) curve: 0.81], slightly smaller in the reduced model incorporating ictal but not interictal measures (R2 0.40; Area under the ROC curve: 0.79) and slightly smaller again in the reduced model incorporating interictal but not ictal measures (R2 0.27; Area under the ROC curve: 0.77). Seizure onset zone and interictal spike frequency measures on subdural ECoG recording may both be useful in predicting the long-term seizure outcome of epilepsy surgery. Yet, the additive clinical impact of interictal spike frequency measures to predict long-term surgical outcome may be modest in the presence of ictal ECoG and neuroimaging data. PMID:19286694
The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review.

PubMed

Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

2017-07-05

Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first authorâ€™s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © 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.
London Measure of Unplanned Pregnancy: guidance for its use as an outcome measure

PubMed Central

Hall, Jennifer A; Barrett, Geraldine; Copas, Andrew; Stephenson, Judith

2017-01-01

Background The London Measure of Unplanned Pregnancy (LMUP) is a psychometrically validated measure of the degree of intention of a current or recent pregnancy. The LMUP is increasingly being used worldwide, and can be used to evaluate family planning or preconception care programs. However, beyond recommending the use of the full LMUP scale, there is no published guidance on how to use the LMUP as an outcome measure. Ordinal logistic regression has been recommended informally, but studies published to date have all used binary logistic regression and dichotomized the scale at different cut points. There is thus a need for evidence-based guidance to provide a standardized methodology for multivariate analysis and to enable comparison of results. This paper makes recommendations for the regression method for analysis of the LMUP as an outcome measure. Materials and methods Data collected from 4,244 pregnant women in Malawi were used to compare five regression methods: linear, logistic with two cut points, and ordinal logistic with either the full or grouped LMUP score. The recommendations were then tested on the original UK LMUP data. Results There were small but no important differences in the findings across the regression models. Logistic regression resulted in the largest loss of information, and assumptions were violated for the linear and ordinal logistic regression. Consequently, robust standard errors were used for linear regression and a partial proportional odds ordinal logistic regression model attempted. The latter could only be fitted for grouped LMUP score. Conclusion We recommend the linear regression model with robust standard errors to make full use of the LMUP score when analyzed as an outcome measure. Ordinal logistic regression could be considered, but a partial proportional odds model with grouped LMUP score may be required. Logistic regression is the least-favored option, due to the loss of information. For logistic regression, the cut point for un/planned pregnancy should be between nine and ten. These recommendations will standardize the analysis of LMUP data and enhance comparability of results across studies. PMID:28435343
Measuring Outcomes in a Community Resilience Program: A New Metric for Evaluating Results at the Household Level.

PubMed

Eisenman, David P; Adams, Rachel M; Rivard, Helene

2016-09-28

Community resilience programs require metrics for evaluation but none exist for measuring outcomes at the household and neighborhood level. We develop and describe a new index, the LACCDR index of community resilience, to examine how resilience varied across communities at baseline, prior to implementation of the Los Angeles County Community Disaster Resilience Project (LACCDR). We surveyed 4700 adult residents in the sixteen LACCDR communities in English, Spanish and Korean. Each of the survey domains were selected a priori as outcome indicators aligned to the theoretical levers of community resilience. Survey questions were drawn and adapted from published studies and national surveys. Factor analysis demonstrated five separate factors composed from 18 items and explaining 46.7% of the variance. The factors were characterized as community engagement, emergency supplies, communication with neighbors, civic engagement, and collective efficacy. Baseline results for the 16 communities are provided. We conclude that the LACCDR community resilience index can be used to measure resilience program outcomes at the neighborhood and household levels.
Low Hemoglobin Concentrations Are Associated With Sarcopenia, Physical Performance, and Disability in Older Australian Men in Cross-sectional and Longitudinal Analysis: The Concord Health and Ageing in Men Project.

PubMed

Hirani, Vasant; Naganathan, Vasi; Blyth, Fiona; Le Couteur, David G; Seibel, Markus J; Waite, Louise M; Handelsman, David J; Hsu, Ben; Cumming, Robert G

2016-12-01

The objective of this study is to examine associations between Hb levels and sarcopenia, low muscle strength, functional measures, and activities of daily living (ADL) and instrumental ADL (IADL) disabilities in older Australian men. Men aged 70 years and older (2005-2007) from the Concord Health and Ageing in Men Project were assessed at baseline (n = 1,705), 2 years (n = 1,367), and 5 years (n = 958). The main outcome measurements were walking speed, muscle strength, ADL and IADL disabilities, and sarcopenia using the Foundation for the National Institutes of Health criteria (low appendicular lean mass adjusted for body mass index < 0.789 and poor grip strength < 26kg). Analysis was performed using Hb levels as a continuous measure, unadjusted and adjusted by age, income, body mass index, measures of health, estimated glomerular function, inflammatory markers, and medication use. Receiver operating characteristic curve analysis was performed to determine a threshold of Hb for each outcome. In cross-sectional and longitudinal analysis, for every 1g/dL increase in Hb, there was a significant reduction in risk of sarcopenia, slow walking speed, poor grip strength, inability to perform chair stands, and ADL and IADL disabilities in unadjusted, age-adjusted, and multivariate-adjusted analysis. The highest value of the Youden Index for Hb was 14.2g/dL for sarcopenia and grip strength, 14.5g/dL for walking speed, and 14.4g/dL for all other outcomes. Declines in Hb levels over time are associated with poor functional outcomes. The risks and benefits of interventions to increase Hb among older men warrant further investigation to differentiate whether this is an active contributor to age-related debility or a passive biomarker of it. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Effects of poststroke pyrexia on stroke outcome : a meta-analysis of studies in patients.

PubMed

Hajat, C; Hajat, S; Sharma, P

2000-02-01

The effect of pyrexia on cerebral ischemia has been extensively studied in animals. In humans, however, such studies are small and the results conflicting. We undertook a meta-analysis using all such published studies on the effect of hyperthermia on stroke outcome. Three databases were searched for all published studies that examined the relationship of raised temperature after stroke onset and eventual outcome. Combined probability values and odds ratios were obtained. A heterogeneity test was performed to ensure that the data were suitable for such an analysis. Morbidity and mortality were used as outcome measures. Nine studies were identified totaling 3790 patients, providing our study with 99% power to detect a 9% increase in morbidity and 84% power to detect a 1% increase in mortality for the pyrexial group. The combined odds ratio for mortality was 1.19 (95% CI, 0.99 to 1.43). A heterogeneity test was highly nonsignificant (P>0.05) for mortality, suggesting that the data were sufficiently similar to be meta-analyzed. Combined probability values were highly significant for both morbidity (P<0.0001) and mortality (P<0. 00000001). The results from this meta-analysis suggest that pyrexia after stroke onset is associated with a marked increase in morbidity and mortality. Measures should be taken to combat fever in the clinical setting to prevent stroke progression. The possible benefit of therapeutic hypothermia in the management of acute stroke should be further investigated.
Measuring the Impact of Longitudinal Faculty Development: A Study of Academic Achievement.

PubMed

Newman, Lori R; Pelletier, Stephen R; Lown, Beth A

2016-12-01

Although faculty development programs in medical education have increased over the past two decades, there is a lack of rigorous program evaluation. The aim of this study was to determine quantifiable outcomes of Harvard Medical School's (HMS's) Fellowship in Medical Education and evaluate attainment of its goals. In 2005 and 2009 the authors collected curricula vitae (CVs) and conducted within-subject analysis of 42 fellowship graduates and also conducted comparison analysis between 12 academic year 2005 fellows and 12 faculty who did not participate in the program. The authors identified 10 metrics of academic advancement. CV analysis for the 42 graduates started 2 years prior to fellowship enrollment and continued for 2-year intervals until June 2009 (10 years of data collection). CV analysis for the comparison group was from 2003 to 2009. The authors also analyzed association between gender and academic outcomes. Fellowship graduates demonstrated significant changes in 4 of 10 academic metrics by the end of the fellowship year: academic promotion, educational leadership, education committees, and education funding. Two metrics-educational leadership and committees-showed increased outcomes two years post fellowship, with a positive trend for promotions. Fellowship graduates significantly outpaced the comparison group in 6 of 10 metrics. Women did significantly more committee work, secured more education funding, and were promoted more often than men. Findings indicate that the HMS Fellowship in Medical Education meets programmatic goals and produces positive, measurable academic outcomes. Standardized evaluation metrics of longitudinal faculty development programs would aid cross-institutional comparisons.
Validation of the CMT Pediatric Scale as an outcome measure of disability

PubMed Central

Burns, Joshua; Ouvrier, Robert; Estilow, Tim; Shy, Rosemary; Laurá, Matilde; Pallant, Julie F.; Lek, Monkol; Muntoni, Francesco; Reilly, Mary M.; Pareyson, Davide; Acsadi, Gyula; Shy, Michael E.; Finkel, Richard S.

2012-01-01

Objective Charcot-Marie-Tooth disease (CMT) is a common heritable peripheral neuropathy. There is no treatment for any form of CMT although clinical trials are increasingly occurring. Patients usually develop symptoms during the first two decades of life but there are no established outcome measures of disease severity or response to treatment. We identified a set of items that represent a range of impairment levels and conducted a series of validation studies to build a patient-centered multi-item rating scale of disability for children with CMT. Methods As part of the Inherited Neuropathies Consortium, patients aged 3–20 years with a variety of CMT types were recruited from the USA, UK, Italy and Australia. Initial development stages involved: definition of the construct, item pool generation, peer review and pilot testing. Based on data from 172 patients, a series of validation studies were conducted, including: item and factor analysis, reliability testing, Rasch modeling and sensitivity analysis. Results Seven areas for measurement were identified (strength, dexterity, sensation, gait, balance, power, endurance), and a psychometrically robust 11-item scale constructed (Charcot-Marie-Tooth disease Pediatric Scale: CMTPedS). Rasch analysis supported the viability of the CMTPedS as a unidimensional measure of disability in children with CMT. It showed good overall model fit, no evidence of misfitting items, no person misfit and it was well targeted for children with CMT. Interpretation The CMTPedS is a well-tolerated outcome measure that can be completed in 25-minutes. It is a reliable, valid and sensitive global measure of disability for children with CMT from the age of 3 years. PMID:22522479
Duration of untreated psychosis and clinical outcomes of first episode psychosis: An observational and an instrumental variables analysis.

PubMed

Sullivan, Sarah A; Carroll, Robert; Peters, Tim J; Amos, Tim; Jones, Peter B; Marshall, Max; Birchwood, Max; Fowler, David; Johnson, Sonia; Fisher, Helen L; Major, Barnaby; Rahaman, Nikola; Joyce, John; Chamberlain-Kent, Nick; Lawrence, Jo; Moran, Paul; Tilling, Kate

2018-04-26

Duration of untreated psychosis (DUP) is considered as a key prognostic variable in psychosis. Yet, it is unclear whether a longer DUP causes worse outcomes or whether reported associations have alternative explanations. Data from 2 cohorts of patients with first episode psychosis were used (n = 2134). Measures of DUP were assessed at baseline and outcomes at 12 months. Regression models were used to investigate the associations between DUP and outcomes. We also investigated whether any associations were replicated using instrumental variables (IV) analysis to reduce the effect of residual confounding and measurement bias. There were associations between DUP per 1-year increase and positive psychotic symptoms (7.0% in symptom score increase 95% confidence interval (CI) 4.0%, 10.0%, P < .001), worse recovery (risk difference [RD] 0.78, 95%, CI 0.68, 0.83, P < .001) and worse global functioning (0.62 decrease in functioning score 95% CI -1.19, -0.04, P = .035). There was no evidence of an association with negative psychotic symptoms (1.0%, 95%, CI -2.0%, 5.0%, P = .455). The IV analysis showed weaker evidence of associations in the same direction between DUP per 1-year increase and positive psychotic symptoms, recovery and global functioning. However, there was evidence of an inverse association with negative psychotic symptoms (decrease of 15.0% in symptom score 95% CI -26.0%, -3.0%, P = .016). We have confirmed previous findings of a positive association between positive psychotic symptoms, global functioning and recovery and DUP using regression analysis. IV analysis shows some support for these findings. Future investigation using IV analysis should be repeated in large data sets. © 2018 John Wiley & Sons Australia, Ltd.
Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care.

PubMed

Sheppard, Lauren; Dewey, Helen; Bernhardt, Julie; Collier, Janice M; Ellery, Fiona; Churilov, Leonid; Tay-Teo, Kiu; Wu, Olivia; Moodie, Marj

2016-06-01

A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke. © 2016 World Stroke Organization.
Development and validation of the Simulation Learning Effectiveness Inventory.

PubMed

Chen, Shiah-Lian; Huang, Tsai-Wei; Liao, I-Chen; Liu, Chienchi

2015-10-01

To develop and psychometrically test the Simulation Learning Effectiveness Inventory. High-fidelity simulation helps students develop clinical skills and competencies. Yet, reliable instruments measuring learning outcomes are scant. A descriptive cross-sectional survey was used to validate psychometric properties of the instrument measuring students' perception of stimulation learning effectiveness. A purposive sample of 505 nursing students who had taken simulation courses was recruited from a department of nursing of a university in central Taiwan from January 2010-June 2010. The study was conducted in two phases. In Phase I, question items were developed based on the literature review and the preliminary psychometric properties of the inventory were evaluated using exploratory factor analysis. Phase II was conducted to evaluate the reliability and validity of the finalized inventory using confirmatory factor analysis. The results of exploratory and confirmatory factor analyses revealed the instrument was composed of seven factors, named course arrangement, equipment resource, debriefing, clinical ability, problem-solving, confidence and collaboration. A further second-order analysis showed comparable fits between a three second-order factor (preparation, process and outcome) and the seven first-order factor models. Internal consistency was supported by adequate Cronbach's alphas and composite reliability. Convergent and discriminant validities were also supported by confirmatory factor analysis. The study provides evidence that the Simulation Learning Effectiveness Inventory is reliable and valid for measuring student perception of learning effectiveness. The instrument is helpful in building the evidence-based knowledge of the effect of simulation teaching on students' learning outcomes. © 2015 John Wiley & Sons Ltd.
Fibromyalgia syndrome module at OMERACT 9: domain construct.

PubMed

Mease, Philip; Arnold, Lesley M; Choy, Ernest H; Clauw, Daniel J; Crofford, Leslie J; Glass, Jennifer M; Martin, Susan A; Morea, Jessica; Simon, Lee; Strand, C Vibeke; Williams, David A

2009-10-01

The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.
Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

PubMed

Khanpour Ardestani, Samaneh; Karkhaneh, Mohammad; Yu, Hai Chuan; Hydrie, Muhammad Zafar Iqbal; Vohra, Sunita

2017-12-19

Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials. © 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.
Comparison of Physician-Predicted to Measured Low Vision Outcomes

PubMed Central

Chan, Tiffany L.; Goldstein, Judith E.; Massof, Robert W.

2013-01-01

Purpose To compare low vision rehabilitation (LVR) physicians’ predictions of the probability of success of LVR to patients’ self-reported outcomes after provision of usual outpatient LVR services; and to determine if patients’ traits influence physician ratings. Methods 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. Following patient evaluation, 38 LVR physicians 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. Results 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 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. Conclusions Physicians’ predictions of LVR outcomes appear to be influenced by knowledge of patients’ cognitive functioning and the combination of visual acuity and functional ability - information physicians acquire from the patient’s history and examination. However, physicians’ predictions do not agree with observed changes in functional ability from the patient’s perspective; they are no better than chance. PMID:23873036
Sensitivity subgroup analysis based on single-center vs. multi-center trial status when interpreting meta-analyses pooled estimates: the logical way forward.

PubMed

Alexander, Paul E; Bonner, Ashley J; Agarwal, Arnav; Li, Shelly-Anne; Hariharan, Abishek; Izhar, Zain; Bhatnagar, Neera; Alba, Carolina; Akl, Elie A; Fei, Yutong; Guyatt, Gordon H; Beyene, Joseph

2016-06-01

Prior studies regarding whether single-center trial estimates are larger than multi-center are equivocal. We examined the extent to which single-center trials yield systematically larger effects than multi-center trials. We searched the 119 core clinical journals and the Cochrane Database of Systematic Reviews for meta-analyses (MAs) of randomized controlled trials (RCTs) published during 2012. In this meta-epidemiologic study, for binary variables, we computed the pooled ratio of ORs (RORs), and for continuous outcomes mean difference in standardized mean differences (SMDs), we conducted weighted random-effects meta-regression and random-effects MA modeling. Our primary analyses were restricted to MAs that included at least five RCTs and in which at least 25% of the studies used each of single trial center (SC) and more trial center (MC) designs. We identified 81 MAs for the odds ratio (OR) and 43 for the SMD outcome measures. Based on our analytic plan, our primary analysis (core) is based on 25 MAs/241 RCTs (binary outcome) and 18 MAs/173 RCTs (continuous outcome). Based on the core analysis, we found no difference in magnitude of effect between SC and MC for binary outcomes [RORs: 1.02; 95% confidence interval (CI): 0.83, 1.24; I(2) 20.2%]. Effect sizes were systematically larger for SC than MC for the continuous outcome measure (mean difference in SMDs: -0.13; 95% CI: -0.21, -0.05; I(2) 0%). Our results do not support prior findings of larger effects in SC than MC trials addressing binary outcomes but show a very similar small increase in effect in SC than MC trials addressing continuous outcomes. Authors of systematic reviews would be wise to include all trials irrespective of SC vs. MC design and address SC vs. MC status as a possible explanation of heterogeneity (and consider sensitivity analyses). Copyright © 2015 Elsevier Inc. All rights reserved.
Does parental mediation of media influence child outcomes? A meta-analysis on media time, aggression, substance use, and sexual behavior.

PubMed

Collier, Kevin M; Coyne, Sarah M; Rasmussen, Eric E; Hawkins, Alan J; Padilla-Walker, Laura M; Erickson, Sage E; Memmott-Elison, Madison K

2016-05-01

The current study examined how parental mediation of media (restrictive mediation, active mediation, and coviewing) influenced child outcomes. Three meta-analyses, 1 for each type of mediation, were conducted on a total of 57 studies. Each analysis assessed the effectiveness of parental mediation on 4 pertinent child outcomes: media use, aggression, substance use, and sexual behavior. The overall results indicated small, but significant relationships between child outcomes and restrictive mediation (r+ = -.06), and coviewing (r+ = .09). Overall active mediation was nonsignificant, though active mediation was individually related to lower levels of aggression (r+ = -.08), sexual behavior (r+ = -.06), and substance use (r+ = -.11). This analysis revealed that parents may have the ability to mitigate some of the adverse effects of the media by using certain mediation strategies. Overall, a cooperative effort from the communication and parenting fields is necessary for a comprehensive analysis of parental mediation as well as a disentanglement of the various parental mediation measures. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The use of actigraphy in the monitoring of sleep and activity in ADHD: A meta-analysis.

PubMed

De Crescenzo, Franco; Licchelli, Serena; Ciabattini, Marco; Menghini, Deny; Armando, Marco; Alfieri, Paolo; Mazzone, Luigi; Pontrelli, Giuseppe; Livadiotti, Susanna; Foti, Francesca; Quested, Digby; Vicari, Stefano

2016-04-01

Attention deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood. There is an increasing need to find objective measures and markers of the disorder in order to assess the efficacy of the therapies and to improve follow-up strategies. Actigraphy is an objective method for recording motor activity and sleep parameters that has been used in many studies in ADHD. Our meta-analysis aimed to assess the current evidence on the role of actigraphy in both the detection of changes in motor activity and in sleep patterns in ADHD. A systematic review was carried out to find studies comparing children with unmedicated ADHD versus controls, using actigraphic measures as an outcome. The primary outcome measures were "sleep duration" and daytime "activity mean". As secondary outcome measures we analyzed "sleep onset latency", "sleep efficiency" and "wake after sleep onset". Twenty-four studies comprising 2179 children were included in this review. We show evidence that ADHD compared to typically developing children present a higher mean activity during structured sessions, a similar sleep duration, and a moderately altered sleep pattern. This study highlights the role of actigraphy as an objective tool for the ambulatory monitoring of sleep and activity in ADHD. Copyright © 2015 Elsevier Ltd. All rights reserved.
Outcome expectations and use of smokeless tobacco (snus): a cross-sectional study among young Norwegian snus users.

PubMed

Wiium, Nora; Aarø, Leif E

2011-02-01

In this study, measures of outcome expectancies related to use of snus (wet snuff) were used to predict reported frequency of snus use. Data stem from a nation-wide survey in Norway among 16- to 20-year-olds. Only users of snus were included in the statistical analyses (n = 589). The main outcome measure, frequency of snus use, was measured as a categorical variable - occasional, weekly and daily use. Four dimensions of outcome expectancies (mood regulation, smoking control, weight control and negative health outcomes) were measured and confirmed in a confirmatory factor analysis. Informants tended to believe that snus use is harmful to health, but still they supported the idea of snus as a way to control own cigarette smoking. In a SEM model, two of the four dimensions of outcome expectancies turned out to be particularly significant predictors of frequency of snus use - mood regulation and smoking control. No significant interactions with gender were found. Males scored higher than females on "mood regulation", and "smoking control", while females scored higher than males on "negative health outcomes". If more smokers were convinced that snus use is a less harmful alternative, more of them might start using snus, not only because there is some association between health outcome expectancies and snus use, but also because snus use by many is perceived as a remedy to stop smoking and as a way to gain some of the mood regulation benefits which are usually associated with smoking. © 2010 The Authors. Scandinavian Journal of Psychology © 2010 The Scandinavian Psychological Associations.
Multiphase Method for Analysing Online Discussions

ERIC Educational Resources Information Center

Häkkinen, P.

2013-01-01

Several studies have analysed and assessed online performance and discourse using quantitative and qualitative methods. Quantitative measures have typically included the analysis of participation rates and learning outcomes in terms of grades. Qualitative measures of postings, discussions and context features aim to give insights into the nature…
Oedema is associated with clinical outcome following emergency abdominal surgery.

PubMed

Vaughan-Shaw, P G; Saunders, J; Smith, T; King, A T; Stroud, M A

2013-09-01

Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24 kg/m(2) vs 27 kg/m(2), p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ(2) =13.1, df=1, p=0.001). Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery.
Oedema is associated with clinical outcome following emergency abdominal surgery

PubMed Central

Vaughan-Shaw, PG; Saunders, J; Smith, T; King, AT

2013-01-01

Introduction Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. Methods A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Results Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24kg/m2 vs 27kg/m2, p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ2=13.1, df=1, p=0.001). Conclusions Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery. PMID:24025285
The use of propensity score methods with survival or time-to-event outcomes: reporting measures of effect similar to those used in randomized experiments.

PubMed

Austin, Peter C

2014-03-30

Propensity score methods are increasingly being used to estimate causal treatment effects in observational studies. In medical and epidemiological studies, outcomes are frequently time-to-event in nature. Propensity-score methods are often applied incorrectly when estimating the effect of treatment on time-to-event outcomes. This article describes how two different propensity score methods (matching and inverse probability of treatment weighting) can be used to estimate the measures of effect that are frequently reported in randomized controlled trials: (i) marginal survival curves, which describe survival in the population if all subjects were treated or if all subjects were untreated; and (ii) marginal hazard ratios. The use of these propensity score methods allows one to replicate the measures of effect that are commonly reported in randomized controlled trials with time-to-event outcomes: both absolute and relative reductions in the probability of an event occurring can be determined. We also provide guidance on variable selection for the propensity score model, highlight methods for assessing the balance of baseline covariates between treated and untreated subjects, and describe the implementation of a sensitivity analysis to assess the effect of unmeasured confounding variables on the estimated treatment effect when outcomes are time-to-event in nature. The methods in the paper are illustrated by estimating the effect of discharge statin prescribing on the risk of death in a sample of patients hospitalized with acute myocardial infarction. In this tutorial article, we describe and illustrate all the steps necessary to conduct a comprehensive analysis of the effect of treatment on time-to-event outcomes. © 2013 The authors. Statistics in Medicine published by John Wiley & Sons, Ltd.
Dimensional personality traits and alcohol treatment outcome: a systematic review and meta-analysis.

PubMed

Foulds, James; Newton-Howes, Giles; Guy, Nicola H; Boden, Joseph M; Mulder, Roger T

2017-08-01

To identify dimensional personality traits associated with treatment outcome for patients with an alcohol use disorder (AUD). Systematic review and meta-analysis of clinical trials and longitudinal studies of ≥ 8 weeks in patients receiving treatment for AUD, in which the association between personality dimensions and treatment outcome was reported. Primary outcomes were relapse and alcohol consumption measures. Treatment retention was a secondary outcome. Eighteen studies, including 4783 subjects, were identified. Twelve studies used Cloninger's Temperament and Personality Questionnaire (TPQ) or Temperament and Character Inventory (TCI). Remaining studies used a broad range of other personality measures. Compared with non-relapsers, patients who relapsed had higher novelty-seeking [standardized mean difference in novelty-seeking score 0.28; 95% confidence interval (CI) = 0.12, 0.44], lower persistence (-0.30, 95% = CI -0.48, -0.12), lower reward dependence (-0.16, 95% CI = -0.31, -0.01) and lower cooperativeness (-0.23, 95% CI = -0.41, -0.04). Few studies reported on alcohol consumption outcomes, therefore findings for those outcomes were inconclusive. Lower novelty-seeking predicted better retention in treatment in two of three studies. Most studies reported findings only for those retained in treatment, and did not attempt to account for missing data; therefore, findings for the primary outcomes cannot be generalized to patients who dropped out of treatment. Studies using personality instruments other than the TCI or TPQ reported no consistent findings on the association between personality variables and treatment outcome. Among patients receiving treatment for an alcohol use disorder, those who relapse during follow-up have higher novelty-seeking, lower persistence, lower reward dependence and lower cooperativeness than those who do not relapse. © 2017 Society for the Study of Addiction.
RACE AS LIVED EXPERIENCE

PubMed Central

Garcia, John A.; Sanchez, Gabriel R.; Sanchez-Youngman, Shannon; Vargas, Edward D.; Ybarra, Vickie D.

2015-01-01

A growing body of social science research has sought to conceptualize race as a multidimensional concept in which context, societal relations, and institutional dynamics are key components. Utilizing a specially designed survey, we develop and use multiple measures of race (skin color, ascribed race, and discrimination experiences) to capture race as “lived experience” and assess their impact on Latinos’ self-rated health status. We model these measures of race as a lived experience to test the explanatory power of race, both independently and as an integrated scale with categorical regression, scaling, and dimensional analyses. Our analyses show that our multiple measures of race have significant and negative effects on Latinos’ self-reported health. Skin color is a dominant factor that impacts self-reported health both directly and indirectly. We then advocate for the utilization of multiple measures of race, adding to those used in our analysis, and their application to other health and social outcomes. Our analysis provides important contributions across a wide range of health, illness, social, and political outcomes for communities of color. PMID:26681972
A model-based correction for outcome reporting bias in meta-analysis.

PubMed

Copas, John; Dwan, Kerry; Kirkham, Jamie; Williamson, Paula

2014-04-01

It is often suspected (or known) that outcomes published in medical trials are selectively reported. A systematic review for a particular outcome of interest can only include studies where that outcome was reported and so may omit, for example, a study that has considered several outcome measures but only reports those giving significant results. Using the methodology of the Outcome Reporting Bias (ORB) in Trials study of (Kirkham and others, 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal 340, c365), we suggest a likelihood-based model for estimating the effect of ORB on confidence intervals and p-values in meta-analysis. Correcting for bias has the effect of moving estimated treatment effects toward the null and hence more cautious assessments of significance. The bias can be very substantial, sometimes sufficient to completely overturn previous claims of significance. We re-analyze two contrasting examples, and derive a simple fixed effects approximation that can be used to give an initial estimate of the effect of ORB in practice.
The Long-Term Conditions Questionnaire: conceptual framework and item development.

PubMed

Peters, Michele; Potter, Caroline M; Kelly, Laura; Hunter, Cheryl; Gibbons, Elizabeth; Jenkinson, Crispin; Coulter, Angela; Forder, Julien; Towers, Ann-Marie; A'Court, Christine; Fitzpatrick, Ray

2016-01-01

To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions. Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions. Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire. The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey.
Relationship between admissions committee review and student performance in medical school and internship.

PubMed

Gilliland, William R; Dong, Ting; Artino, Anthony R; Waechter, Donna M; Cruess, David F; DeZee, Kent J; McManigle, John E; Durning, Steven J

2012-09-01

To investigate the association between tertiary reviewer (admissions committee member) comments and medical students' performance during medical school and into internship. We collected data from seven year-groups (1993-1999) and coded tertiary reviewer comments into 14 themes. We then conducted an exploratory factor analysis to reduce the dimensions of the themes (excluding the Overall impression theme). Subsequently, we performed Pearson correlation analyses and multiple linear regression analysis to examine the relationship between the factors and seven outcome measures: medical school preclinical grade point average (GPA), medical school clinical GPA, cumulative medical school GPA, U.S. Medical Licensing Examination Step 1 and 2 scores, and scores on a program director's evaluation measuring intern professionalism and expertise. We extracted seven factors from the 13 themes and found small-to-moderate, significant correlations between the factors, the Overall impression theme, and the outcome measures. In particular, positive comments on Test and Maturity were associated with higher U.S. Medical Licensing Examination Step 1 and 2 scores. Negative comments on Interview and Recommendations were associated with lower ratings of professionalism during internship. Comments on Overall impression were significantly associated with all the outcome measures. Tertiary reviewer comments were weakly associated with performance in medical school and internship. Compared with positive comments, negative comments had stronger associations with medical school and internship performance measures.
Health economics research into supporting carers of people with dementia: A systematic review of outcome measures

PubMed Central

2012-01-01

Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups. Generic measures may not be sensitive enough to fully capture the QoL effects for certain populations, such as carers, so there is a need to consider additional outcome measures, which are preference based where possible to enable cost-effectiveness analysis to be undertaken. This paper reviews outcome measures commonly used in health services research and health economics research involving carers of people with dementia. An electronic database search was conducted in PubMed, Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment database. Studies were eligible for inclusion if they included an outcome measure for carers of people with dementia. 2262 articles were identified. 455 articles describing 361 studies remained after exclusion criteria were applied. 228 outcome measures were extracted from the studies. Measures were categorised into 44 burden measures, 43 mastery measures, 61 mood measures, 32 QoL measures, 27 social support and relationships measures and 21 staff competency and morale measures. The choice of instrument has implications on funding decisions; therefore, researchers need to choose appropriate instruments for the population being measured and the type of intervention undertaken. If an instrument is not sensitive enough to detect changes in certain populations, the effect of an intervention may be underestimated, and hence interventions which may appear to be beneficial to participants are not deemed cost-effective and are not funded. If this is the case, it is essential that additional outcome measures which detect changes in broader QoL are included, whilst still retaining preference based utility measures such as EQ-5D to allow QALY calculation for comparability with other interventions. PMID:23181515
Health economics research into supporting carers of people with dementia: a systematic review of outcome measures.

PubMed

Jones, Carys; Edwards, Rhiannon Tudor; Hounsome, Barry

2012-11-26

Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups. Generic measures may not be sensitive enough to fully capture the QoL effects for certain populations, such as carers, so there is a need to consider additional outcome measures, which are preference based where possible to enable cost-effectiveness analysis to be undertaken. This paper reviews outcome measures commonly used in health services research and health economics research involving carers of people with dementia. An electronic database search was conducted in PubMed, Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment database. Studies were eligible for inclusion if they included an outcome measure for carers of people with dementia. 2262 articles were identified. 455 articles describing 361 studies remained after exclusion criteria were applied. 228 outcome measures were extracted from the studies. Measures were categorised into 44 burden measures, 43 mastery measures, 61 mood measures, 32 QoL measures, 27 social support and relationships measures and 21 staff competency and morale measures. The choice of instrument has implications on funding decisions; therefore, researchers need to choose appropriate instruments for the population being measured and the type of intervention undertaken. If an instrument is not sensitive enough to detect changes in certain populations, the effect of an intervention may be underestimated, and hence interventions which may appear to be beneficial to participants are not deemed cost-effective and are not funded. If this is the case, it is essential that additional outcome measures which detect changes in broader QoL are included, whilst still retaining preference based utility measures such as EQ-5D to allow QALY calculation for comparability with other interventions.
The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol.

PubMed

Rasmussen, Helle Mätzke; Pedersen, Niels Wisbech; Overgaard, Søren; Hansen, Lars Kjaersgaard; Dunkhase-Heinl, Ulrike; Petkov, Yanko; Engell, Vilhelm; Baker, Richard; Holsgaard-Larsen, Anders

2015-12-07

Children with cerebral palsy (CP) often have an altered gait. Orthopaedic surgery, spasticity management, physical therapy and orthotics are used to improve the gait. Interventions are individually tailored and are planned on the basis of clinical examinations and standardised measurements to assess walking ('care as usual'). However, these measurements do not describe features in the gait that reflect underlying neuro-musculoskeletal impairments. This can be done with 3-dimensional instrumented gait analysis (IGA). The aim of this study is to test the hypothesis that improvements in gait following individually tailored interventions when IGA is used are superior to those following 'care as usual'. A prospective, single blind, randomised, parallel group study will be conducted. Children aged 5 to 8 years with spastic CP, classified at Gross Motor Function Classification System levels I or II, will be included. The interventions under investigation are: 1) individually tailored interdisciplinary interventions based on the use of IGA, and 2) 'care as usual'. The primary outcome is gait measured by the Gait Deviation Index. Secondary outcome measures are: walking performance (1-min walk test) and patient-reported outcomes of functional mobility (Pediatric Evaluation of Disability Inventory), health-related quality of life (The Pediatric Quality of Life Inventory Cerebral Palsy Module) and overall health, pain and participation (The Pediatric Outcome Data Collection Instrument). The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks; however, exclusively for the patient-reported outcomes. To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention based on the use of IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA. ClinicalTrials.gov NCT02160457 . Registered June 2, 2014.
Correlation of PROMIS Physical Function and Pain CAT Instruments With Oswestry Disability Index and Neck Disability Index in Spine Patients.

PubMed

Papuga, Mark O; Mesfin, Addisu; Molinari, Robert; Rubery, Paul T

2016-07-15

A prospective and retrospective cross-sectional cohort analysis. The aim of this study was to show that Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive testing (CAT) assessments for physical function and pain interference can be efficiently collected in a standard office visit and to evaluate these scores with scores from previously validated Oswestry Disability Index (ODI) and Neck Disability Index (NDI) providing evidence of convergent validity for use in patients with spine pathology. Spinal surgery outcomes are highly variable, and substantial debate continues regarding the role and value of spine surgery. The routine collection of patient-based outcomes instruments in spine surgery patients may inform this debate. Traditionally, the inefficiency associated with collecting standard validated instruments has been a barrier to routine use in outpatient clinics. We utilized several CAT instruments available through PROMIS and correlated these with the results obtained using "gold standard" legacy outcomes measurement instruments. All measurements were collected at a routine clinical visit. The ODI and the NDI assessments were used as "gold standard" comparisons for patient-reported outcomes. PROMIS CAT instruments required 4.5 ± 1.8 questions and took 35 ± 16 seconds to complete, compared with ODI/NDI requiring 10 questions and taking 188 ± 85 seconds when administered electronically. Linear regression analysis of retrospective scores involving a primary back complaint revealed moderate to strong correlations between ODI and PROMIS physical function with r values ranging from 0.5846 to 0.8907 depending on the specific assessment and patient subsets examined. Routine collection of physical function outcome measures in clinical practice offers the ability to inform and improve patient care. We have shown that several PROMIS CAT instruments can be efficiently administered during routine clinical visits. The moderate to strong correlations found validate the utility of computer adaptive testing when compared with the gold standard "static" legacy assessments. 4.
Fibromyalgia Syndrome Module at OMERACT 9

PubMed Central

Mease, Philip; Arnold, Lesley M; Choy, Ernest H; Clauw, Daniel J.; Crofford, Leslie; Glass, Jennifer M; Martin, Susan A; Morea, Jessica; Simon, Lee; Strand, Vibeke; Williams, David A

2012-01-01

Objectives (1) Establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measures’ performance characteristics, (3) discuss development of a responder index for the assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, (6) establish a research agenda for work regarding outcomes research. Methods (1) Results of univariate and multivariate analysis of 10 different FM clinical trials of four different drugs, mapping key domains identified in previously presented patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, breakout discussions to vote on possible essential domains and reliable measures. (2) Updates presented regarding outcome measures’ status. (3) Presented update on objective markers to measure FM disease state. 4) The issue of cognitive dysfunction (dyscognition) in FM was reviewed. Results (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials, dyscognition and depression in some trial, and domains of research interest include stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers. (2) FM domains’ outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing number of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. Conclusions A multidimensional symptom core set is proposed for the evaluation of FM in clinical trials. There is ongoing research on improved measures of single domains and composite measures. PMID:19820221
Does the NRS Capture Changes in Communication during Inpatient Stroke Rehabilitation?

PubMed

Barr, Leigh G; Kubilius, Barbra; Ansley, Barb; Whiteman, Rhonda; Sahlas, Demetrios J

2017-10-01

In Ontario, the National Rehabilitation Reporting System (NRS) is mandated for use as a measurement of change for stroke patients after admission to and discharge from rehabilitation. The NRS includes the functional independence measure (FIM) and supplementary measurement items developed by the Canadian Institute for Health Information (CIHI). Uncertainty exists regarding the efficacy of the NRS as the sole measure of outcome for communication in stroke rehabilitation patients. The use of additional speech-language pathology outcome measurement tools for this population has therefore been suggested. This study sought to establish whether the FIM and CIHI communication items capture quantifiable gains during stroke rehabilitation and therefore whether additional measures are needed to assess outcomes. A retrospective analysis was completed of 1252 complete data records of stroke patients discharged from inpatient rehabilitation at Hamilton Health Sciences between 2006 and 2011. Statistically significant improvements were observed in all total matched FIM scores (M = 72.68 to M = 96.39, P < .001) and for each expression (M = 4.61 to M = 5.35, P < .001) and comprehension (M = 4.69 to M = 5.33, P < .001) subscale. The most severely affected group demonstrated the greatest gains. These findings were independent of stroke severity. Additional outcome measurement tools for communication are therefore not required to assess outcomes in rehabilitation of stroke patients, although additional research is necessary to evaluate the clinical significance of the improvements that are observed using existing measurements of change. Copyright © 2017 National Stroke Association. All rights reserved.
Working plan for the use of patient-reported outcome measures in adults with brain tumours: a Response Assessment in Neuro-Oncology (RANO) initiative.

PubMed

Dirven, Linda; Armstrong, Terri S; Blakeley, Jaishri O; Brown, Paul D; Grant, Robin; Jalali, Rakesh; Leeper, Heather; Mendoza, Tito; Nayak, Lakshmi; Reijneveld, Jaap C; Le Rhun, Emilie; Walbert, Tobias; Weller, Michael; Wen, Patrick Y; Taphoorn, Martin J B

2018-03-01

The Response Assessment in Neuro-Oncology-Patient-Reported Outcome (RANO-PRO) working group is an international multidisciplinary collaboration that provides guidance on the use of patient-reported outcome (PRO) measures in clinical trials and practice for adult patients with brain tumours. Findings from both PROs and traditional outcome measures, such as survival, and clinical or radiological response, are essential to inform the research community, policy makers, physicians, and patients in the treatment decision-making process. Previous initiatives in oncology have focused on guidelines concerning the collection, analysis, interpretation, and reporting of PRO data. However, we recommend the application of appropriate PRO instruments, with respect to its content and measurement properties (ie, research question, content validity, and other measurement properties), in brain tumour research. PROs should be well defined and reliable to generate high-quality evidence, and our recommendations on the use of specific PRO measures could help to improve the quality of PRO evidence derived from neuro-oncological studies, and might add a new dimension in how the value of therapeutics is assessed in patients with brain tumours. In this Policy Review, we present the RANO-PRO working plan for the use of PROs in adults with brain tumours. Copyright © 2018 Elsevier Ltd. All rights reserved.
Secondary outcome analysis for data from an outcome-dependent sampling design.

PubMed

Pan, Yinghao; Cai, Jianwen; Longnecker, Matthew P; Zhou, Haibo

2018-04-22

Outcome-dependent sampling (ODS) scheme is a cost-effective way to conduct a study. For a study with continuous primary outcome, an ODS scheme can be implemented where the expensive exposure is only measured on a simple random sample and supplemental samples selected from 2 tails of the primary outcome variable. With the tremendous cost invested in collecting the primary exposure information, investigators often would like to use the available data to study the relationship between a secondary outcome and the obtained exposure variable. This is referred as secondary analysis. Secondary analysis in ODS designs can be tricky, as the ODS sample is not a random sample from the general population. In this article, we use the inverse probability weighted and augmented inverse probability weighted estimating equations to analyze the secondary outcome for data obtained from the ODS design. We do not make any parametric assumptions on the primary and secondary outcome and only specify the form of the regression mean models, thus allow an arbitrary error distribution. Our approach is robust to second- and higher-order moment misspecification. It also leads to more precise estimates of the parameters by effectively using all the available participants. Through simulation studies, we show that the proposed estimator is consistent and asymptotically normal. Data from the Collaborative Perinatal Project are analyzed to illustrate our method. Copyright © 2018 John Wiley & Sons, Ltd.
Analyzing Multiple Outcomes in Clinical Research Using Multivariate Multilevel Models

PubMed Central

Baldwin, Scott A.; Imel, Zac E.; Braithwaite, Scott R.; Atkins, David C.

2014-01-01

Objective Multilevel models have become a standard data analysis approach in intervention research. Although the vast majority of intervention studies involve multiple outcome measures, few studies use multivariate analysis methods. The authors discuss multivariate extensions to the multilevel model that can be used by psychotherapy researchers. Method and Results Using simulated longitudinal treatment data, the authors show how multivariate models extend common univariate growth models and how the multivariate model can be used to examine multivariate hypotheses involving fixed effects (e.g., does the size of the treatment effect differ across outcomes?) and random effects (e.g., is change in one outcome related to change in the other?). An online supplemental appendix provides annotated computer code and simulated example data for implementing a multivariate model. Conclusions Multivariate multilevel models are flexible, powerful models that can enhance clinical research. PMID:24491071

Cohort profile: the chronic kidney disease prognosis consortium.

PubMed

Matsushita, Kunihiro; Ballew, Shoshana H; Astor, Brad C; Jong, Paul E de; Gansevoort, Ron T; Hemmelgarn, Brenda R; Levey, Andrew S; Levin, Adeera; Wen, Chi-Pang; Woodward, Mark; Coresh, Josef

2013-12-01

The Chronic Kidney Disease Prognosis Consortium (CKD-PC) was established in 2009 to provide comprehensive evidence about the prognostic impact of two key kidney measures that are used to define and stage CKD, estimated glomerular filtration rate (eGFR) and albuminuria, on mortality and kidney outcomes. CKD-PC currently consists of 46 cohorts with data on these kidney measures and outcomes from >2 million participants spanning across 40 countries/regions all over the world. CKD-PC published four meta-analysis articles in 2010-11, providing key evidence for an international consensus on the definition and staging of CKD and an update for CKD clinical practice guidelines. The consortium continues to work on more detailed analysis (subgroups, different eGFR equations, other exposures and outcomes, and risk prediction). CKD-PC preferably collects individual participant data but also applies a novel distributed analysis model, in which each cohort runs statistical analysis locally and shares only analysed outputs for meta-analyses. This distributed model allows inclusion of cohorts which cannot share individual participant level data. According to agreement with cohorts, CKD-PC will not share data with third parties, but is open to including further eligible cohorts. Each cohort can opt in/out for each topic. CKD-PC has established a productive and effective collaboration, allowing flexible participation and complex meta-analyses for studying CKD.
Refining the Association of Fever with Functional Outcome in Aneurysmal Subarachnoid Hemorrhage.

PubMed

Kramer, Christopher L; Pegoli, Marianna; Mandrekar, Jay; Lanzino, Giuseppe; Rabinstein, Alejandro A

2017-02-01

We analyzed the impact of cause, severity, and duration of fever on functional outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Fever characteristics were analyzed in 584 consecutive patients with aSAH. Fever was defined as core body temperature ≥38.3 °C on ≥2 consecutive days. Subfebrile measurements were those between 37 and 38.2 °C. Febrile and subfebrile loads were the number of hours with fever or subfebrile measurements, respectively. Univariate and multivariate logistic regression models were developed to define predictors of outcome using various categorizations of fever cause, severity, and duration. Febrile measurements were observed in 281/584 (48.1 %) patients, recurring over a mean duration of 2.1 ± 3.0 days. Early fever within 24 and 72 h was encountered in 69 (11.9 %) and 110 (18.9 %) of patients, respectively. An infectious source was discovered in 126 (44.8 %) febrile patients. On univariate analysis, days of fever, febrile load, and fever onset within 24 and 72 h were associated with poor outcome (all p < 0.001); but subfebrile load was not (p = 0.56). On multivariate model constructed with all variables associated with outcome on univariate analyses, days of fever remained independently associated with poor outcome (OR 1.14 of poor outcome per day of fever, 95 % CI 1.06-1.22; p = 0.0006) displacing all other fever measures from the final model. Early onset of fever, number of hours with fever, and especially days of fever are associated with poor functional outcome. Conversely, subfebrile load does not influence clinical outcome. These data suggest prolonged fever should be avoided, but subfebrile temperatures may not justify intervention.
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.
Complete Placenta Previa: Ultrasound Biometry and Surgical Outcomes

PubMed Central

Wortman, Alison C.; Schaefer, Stephanie L.; McIntire, Donald D.; Sheffield, Jeanne S.; Twickler, Diane M.

2018-01-01

Objective To evaluate the relationship between surgical outcomes and ultrasound measurement of placental extension beyond the cervical os in women with placenta previa. Study Design This is a retrospective cohort study of singleton pregnancies with placenta previa undergoing third-trimester ultrasound and delivering at our institution from 2002 through 2011. For study purposes, an investigator measured placental extension, defined as the placental distance from the internal os across the placenta continuing out to the lowest placental edge. If morbidly adherent placentation was suspected, women were excluded. Receiver operating characteristic (ROC) curves were developed for pertinent surgical outcomes, and multivariate analysis was performed to determine the placental extension with the best predictive discriminatory zone. Results In total, 157 women had placenta previa, ultrasound, and delivery data: 86 (55%) had a placental extension of <40 mm, and 71 (45%) had a placental extension of ≥40 mm. Women with placental extension of ≥40 mm had increased surgical time, blood loss > 2,000 mL, blood transfusion, and rate of peripartum hysterectomy. After multivariate analysis, only peripartum hysterectomy and surgical time > 90 minutes remained significant, p ≤ 0.05 and p ≤ 0.01, respectively. Conclusion In women with placenta previa, the placental extension ultrasound measurement of ≥40 mm is a predictor of adverse surgical outcomes. PMID:29686936
Complete Placenta Previa: Ultrasound Biometry and Surgical Outcomes.

PubMed

Wortman, Alison C; Schaefer, Stephanie L; McIntire, Donald D; Sheffield, Jeanne S; Twickler, Diane M

2018-04-01

Objective To evaluate the relationship between surgical outcomes and ultrasound measurement of placental extension beyond the cervical os in women with placenta previa. Study Design This is a retrospective cohort study of singleton pregnancies with placenta previa undergoing third-trimester ultrasound and delivering at our institution from 2002 through 2011. For study purposes, an investigator measured placental extension, defined as the placental distance from the internal os across the placenta continuing out to the lowest placental edge. If morbidly adherent placentation was suspected, women were excluded. Receiver operating characteristic (ROC) curves were developed for pertinent surgical outcomes, and multivariate analysis was performed to determine the placental extension with the best predictive discriminatory zone. Results In total, 157 women had placenta previa, ultrasound, and delivery data: 86 (55%) had a placental extension of <40 mm, and 71 (45%) had a placental extension of ≥40 mm. Women with placental extension of ≥40 mm had increased surgical time, blood loss > 2,000 mL, blood transfusion, and rate of peripartum hysterectomy. After multivariate analysis, only peripartum hysterectomy and surgical time > 90 minutes remained significant, p ≤ 0.05 and p ≤ 0.01, respectively. Conclusion In women with placenta previa, the placental extension ultrasound measurement of ≥40 mm is a predictor of adverse surgical outcomes.
A Systematic Review of Neighborhood and Institutional Relationships Related to Education

ERIC Educational Resources Information Center

Johnson, Odis, Jr.

2012-01-01

This review explores the conceptualization and measurement of neighborhood and institutional relationships related to children's educational outcomes in neighborhood effects research. The review's analysis first summarizes early statements about neighborhood and school relationships within the field. The analysis next situates neighborhood and…
The effectiveness of virtual reality interventions in improving balance in adults with impaired balance compared to standard or no treatment: A systematic review.

PubMed

Booth, Vicky; Masud, Tahir; Bath-Hextall, Fiona

Balance impairment can result in falls and reduced activities of daily living and function. Virtual reality and interactive gaming systems provide a novel and potentially environmentally flexible treatment option to improve postural stability and reduce falls in balance impaired populations. There are no existing systematic reviews in this topic area. To search, critically appraise and synthesise the best available evidence on whether virtual reality interventions, including interactive gaming systems, are effective at improving balance in adults with impaired balance. Adults with impaired, altered or reduced balance identified either through reduced balance outcome measure score or increased risk or incidence of falls.Types of interventions:Any virtual reality or interactive gaming systems used within a rehabilitative setting.The primary outcome was an objective measure of balance (i.e. balance outcome measure such as Berg Balance Score) or number and/or incidence of falls. Secondary outcome measures of interest included any adverse effects experienced, an outcome measure indicating functional balance (i.e. walking speed), quality of life (through use of an objective measure i.e. EuroQOL), and number of days in hospital due to falls.Types of studies:Randomised controlled trials (RCT). A three-stage strategy searched the following electronic databases: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, PsycBITE, OTseeker, Ei Compendex, Inspec, Current Controlled Trials, and the National Institute of Health Clinical Trials Database. The methodological quality of each included study was independently assessed using the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) to systematically comment on influence of bias. Data was individually extracted from the included studies using the standardised JBI data extraction tool from JBI-MAStARI. Data was analysed using Review Manager 5 software. Results were expressed as mean difference (MD) with 95% confidence intervals for continuous outcomes. Meta-analysis was not possible due to the variation of the interventions given and small number of included trials; hence, a description of the results was given. Four studies were included in the systematic review. All the included studies used different types of virtual reality or interactive gaming interventions. Two of the included studies used the same balance outcome measure. There was a notable inconsistency of balance outcome measurement between all the included studies. No data was given regarding falls in any of the studies. A secondary outcome, the 10m walk test, was recorded in two of the studies. The four included studies had small sample sizes and poor methodological quality. Despite the presentation of statistically significant results, the clinical significance is questionable. The review can not recommend the inclusion of virtual reality or interactive gaming systems into the rehabilitation of balance impairment based on the results of the four included studies. Further investigation in this topic area is required.
A randomized trial of face-to-face counselling versus telephone counselling versus bibliotherapy for occupational stress.

PubMed

Kilfedder, Catherine; Power, Kevin; Karatzias, Thanos; McCafferty, Aileen; Niven, Karen; Chouliara, Zoë; Galloway, Lisa; Sharp, Stephen

2010-09-01

The aim of the present study was to compare the effectiveness and acceptability of three interventions for occupational stress. A total of 90 National Health Service employees were randomized to face-to-face counselling or telephone counselling or bibliotherapy. Outcomes were assessed at post-intervention and 4-month follow-up. Clinical Outcomes in Routine Evaluation (CORE), General Health Questionnaire (GHQ-12), and Perceived Stress Scale (PSS-10) were used to evaluate intervention outcomes. An intention-to-treat analyses was performed. Repeated measures analysis revealed significant time effects on all measures with the exception of CORE Risk. No significant group effects were detected on all outcome measures. No time by group significant interaction effects were detected on any of the outcome measures with the exception of CORE Functioning and GHQ total. With regard to acceptability of interventions, participants expressed a preference for face-to-face counselling over the other two modalities. Overall, it was concluded that the three intervention groups are equally effective. Given that bibliotherapy is the least costly of the three, results from the present study might be considered in relation to a stepped care approach to occupational stress management with bibliotherapy as the first line of intervention, followed by telephone and face-to-face counselling as required.
Prediction of IOI-HA scores using speech reception thresholds and speech discrimination scores in quiet.

PubMed

Brännström, K Jonas; Lantz, Johannes; Nielsen, Lars Holme; Olsen, Steen Østergaard

2014-02-01

Outcome measures can be used to improve the quality of the rehabilitation by identifying and understanding which variables influence the outcome. This information can be used to improve outcomes for clients. In clinical practice, pure-tone audiometry, speech reception thresholds (SRTs), and speech discrimination scores (SDSs) in quiet or in noise are common assessments made prior to hearing aid (HA) fittings. It is not known whether SRT and SDS in quiet relate to HA outcome measured with the International Outcome Inventory for Hearing Aids (IOI-HA). The aim of the present study was to investigate the relationship between pure-tone average (PTA), SRT, and SDS in quiet and IOI-HA in both first-time and experienced HA users. SRT and SDS were measured in a sample of HA users who also responded to the IOI-HA. Fifty-eight Danish-speaking adult HA users. The psychometric properties were evaluated and compared to previous studies using the IOI-HA. The associations and differences between the outcome scores and a number of descriptive variables (age, gender, fitted monaurally/binaurally with HA, first-time/experienced HA users, years of HA use, time since last HA fitting, best ear PTA, best ear SRT, or best ear SDS) were examined. A multiple forward stepwise regression analysis was conducted using scores on the separate IOI-HA items, the global score, and scores on the introspection and interaction subscales as dependent variables to examine whether the descriptive variables could predict these outcome measures. Scores on single IOI-HA items, the global score, and scores on the introspection (items 1, 2, 4, and 7) and interaction (items 3, 5, and 6) subscales closely resemble those previously reported. Multiple regression analysis showed that the best ear SDS predicts about 18-19% of the outcome on items 3 and 5 separately, and about 16% on the interaction subscale (sum of items 3, 5, and 6) CONCLUSIONS: The best ears SDS explains some of the variance displayed in the IOI-HA global score and the interaction subscale. The relation between SDS and IOI-HA suggests that a poor unaided SDS might in itself be a limiting factor for the HA rehabilitation efficacy and hence the IOI-HA outcome. The clinician could use this information to align the user's HA expectations to what is within possible reach. American Academy of Audiology.
Cochlear implantation in adults: a systematic review and meta-analysis.

PubMed

Gaylor, James M; Raman, Gowri; Chung, Mei; Lee, Jounghee; Rao, Madhumathi; Lau, Joseph; Poe, Dennis S

2013-03-01

Sensorineural hearing loss is the third leading cause of years lived with disability worldwide. Cochlear implants may provide a viable alternative to hearing aids for this type of hearing loss. The Coverage and Analysis Group at the Centers for Medicare & Medicaid Services was interested in an evaluation of recently published literature on this topic. In addition, this meta-analysis is to our knowledge the first to evaluate quality-of-life (QOL) outcomes in adults with cochlear implants. To evaluate the communication-related outcomes and health-related QOL outcomes after unilateral or bilateral cochlear implantation in adults with sensorineural hearing loss. MEDLINE, Cochrane Central Register of Controlled Trials, Scopus, and previous reports from January 1, 2004, through May 31, 2012. Published studies of adult patients undergoing unilateral or bilateral procedures with multichannel cochlear implants and assessments using open-set sentence tests, multisyllable word tests, or QOL measures. Five researchers extracted information on population characteristics, outcomes of interest, and study design and assessed the studies for risk of bias. Discrepancies were resolved by consensus. A total of 42 studies met the inclusion criteria. Most unilateral implant studies showed a statistically significant improvement in mean speech scores as measured by open-set sentence or multisyllable word tests; meta-analysis revealed a significant improvement in QOL after unilateral implantation. Results from studies assessing bilateral implantation showed improvement in communication-related outcomes compared with unilateral implantation and additional improvements in sound localization compared with unilateral device use or implantation only. Based on a few studies, the QOL outcomes varied across tests after bilateral implantation. Unilateral cochlear implants provide improved hearing and significantly improve QOL, and improvements in sound localization are noted for bilateral implantation. Future studies of longer duration, higher-quality reporting, and large databases or registries of patients with long-term follow-up data are needed to yield stronger evidence.
Does the Neighborhood Context Alter the Link between Youth's After-School Time Activities and Developmental Outcomes? A Multilevel Analysis

ERIC Educational Resources Information Center

Fauth, Rebecca C.; Roth, Jodie L.; Brooks-Gunn, Jeanne

2007-01-01

This article examines links between different measures of after-school time activity participation (5 specific activities and breadth) on youth's developmental outcomes (anxiety/depression, delinquency, and substance use) over 6 years and whether these links are moderated by neighborhood-level variables. The sample (N = 1,315) of 9- and…
Estimation of health effects of prenatal methylmercury exposure using structural equation models.

PubMed

Budtz-Jørgensen, Esben; Keiding, Niels; Grandjean, Philippe; Weihe, Pal

2002-10-14

Observational studies in epidemiology always involve concerns regarding validity, especially measurement error, confounding, missing data, and other problems that may affect the study outcomes. Widely used standard statistical techniques, such as multiple regression analysis, may to some extent adjust for these shortcomings. However, structural equations may incorporate most of these considerations, thereby providing overall adjusted estimations of associations. This approach was used in a large epidemiological data set from a prospective study of developmental methyl-mercury toxicity. Structural equation models were developed for assessment of the association between biomarkers of prenatal mercury exposure and neuropsychological test scores in 7 year old children. Eleven neurobehavioral outcomes were grouped into motor function and verbally mediated function. Adjustment for local dependence and item bias was necessary for a satisfactory fit of the model, but had little impact on the estimated mercury effects. The mercury effect on the two latent neurobehavioral functions was similar to the strongest effects seen for individual test scores of motor function and verbal skills. Adjustment for contaminant exposure to poly chlorinated biphenyls (PCBs) changed the estimates only marginally, but the mercury effect could be reduced to non-significance by assuming a large measurement error for the PCB biomarker. The structural equation analysis allows correction for measurement error in exposure variables, incorporation of multiple outcomes and incomplete cases. This approach therefore deserves to be applied more frequently in the analysis of complex epidemiological data sets.
Patient-based outcomes in patients with primary tinnitus undergoing tinnitus retraining therapy.

PubMed

Berry, Julie A; Gold, Susan L; Frederick, Ellen Alvarez; Gray, William C; Staecker, Hinrich

2002-10-01

To determine whether the Tinnitus Handicap Inventory (THI), a validated patient-based outcomes measure, may improve our ability to quantify impact and assess therapy for patients with tinnitus. Nonrandomized, prospective analysis of 32 patients undergoing tinnitus retraining therapy (TRT). Assessment tools included comprehensive audiology, a subjective self-assessment survey of tinnitus characteristics, and the THI. Tinnitus Handicap Inventory scores were assessed at baseline and 6 months following TRT. Baseline analysis revealed significant correlation between the subjective presence of hyperacusis and higher total, emotional, and catastrophic THI scores. Tinnitus Handicap Inventory scores correlated with subjective perception of overall tinnitus effect (P<.001). Mean pure-tone threshold average was 17.4 dB, and mean speech discrimination was 97.0%. There were no consistent correlations between baseline audiologic parameters and THI scores. Following 6 months of TRT, the total, emotional, functional, and catastrophic THI scores significantly improved (P<.001). Loudness discomfort levels also significantly improved (P< or =.02). There is significant improvement in self-perceived disability following TRT as measured by the THI. The results confirm the utility of the THI as a patient-based outcomes measure for quantifying treatment status in patients with primary tinnitus.
Modeling Verdict Outcomes Using Social Network Measures: The Watergate and Caviar Network Cases.

PubMed

Masías, Víctor Hugo; Valle, Mauricio; Morselli, Carlo; Crespo, Fernando; Vargas, Augusto; Laengle, Sigifredo

2016-01-01

Modelling criminal trial verdict outcomes using social network measures is an emerging research area in quantitative criminology. Few studies have yet analyzed which of these measures are the most important for verdict modelling or which data classification techniques perform best for this application. To compare the performance of different techniques in classifying members of a criminal network, this article applies three different machine learning classifiers-Logistic Regression, Naïve Bayes and Random Forest-with a range of social network measures and the necessary databases to model the verdicts in two real-world cases: the U.S. Watergate Conspiracy of the 1970's and the now-defunct Canada-based international drug trafficking ring known as the Caviar Network. In both cases it was found that the Random Forest classifier did better than either Logistic Regression or Naïve Bayes, and its superior performance was statistically significant. This being so, Random Forest was used not only for classification but also to assess the importance of the measures. For the Watergate case, the most important one proved to be betweenness centrality while for the Caviar Network, it was the effective size of the network. These results are significant because they show that an approach combining machine learning with social network analysis not only can generate accurate classification models but also helps quantify the importance social network variables in modelling verdict outcomes. We conclude our analysis with a discussion and some suggestions for future work in verdict modelling using social network measures.
Developments in Measuring Functional Activities: Where Do We Go with the PEDI-CAT?

ERIC Educational Resources Information Center

Ketelaar, Marjolijn; Wassenberg-Severijnen, Jeltje

2010-01-01

During the past 30 years many pediatric assessment and outcome measures have been developed. Based on Rasch analysis, the Pediatric Evaluation of Disability Inventory (PEDI) was designed to measure functional status by asking parents about both the skills of their children and the performance of daily tasks in three functionally important domains…
Assessing Motivation of Secondary School Students: An Analysis of Promotion and Prevention Orientations as Measured by the Regulatory Focus Questionnaire

ERIC Educational Resources Information Center

Hodis, Flaviu A.; Hodis, Georgeta M.

2017-01-01

Measuring human motivation requires understanding the outcomes individuals value and the strategies they prefer to employ to attain them. Knowledge of promotion and prevention, two pivotal motivation orientations, provide key information regarding these aspects. The Regulatory Focus Questionnaire, which measures these two independent constructs,…
Identification of chronic rhinosinusitis phenotypes using cluster analysis.

PubMed

Soler, Zachary M; Hyer, J Madison; Ramakrishnan, Viswanathan; Smith, Timothy L; Mace, Jess; Rudmik, Luke; Schlosser, Rodney J

2015-05-01

Current clinical classifications of chronic rhinosinusitis (CRS) have been largely defined based upon preconceived notions of factors thought to be important, such as polyp or eosinophil status. Unfortunately, these classification systems have little correlation with symptom severity or treatment outcomes. Unsupervised clustering can be used to identify phenotypic subgroups of CRS patients, describe clinical differences in these clusters and define simple algorithms for classification. A multi-institutional, prospective study of 382 patients with CRS who had failed initial medical therapy completed the Sino-Nasal Outcome Test (SNOT-22), Rhinosinusitis Disability Index (RSDI), Medical Outcomes Study Short Form-12 (SF-12), Pittsburgh Sleep Quality Index (PSQI), and Patient Health Questionnaire (PHQ-2). Objective measures of CRS severity included Brief Smell Identification Test (B-SIT), CT, and endoscopy scoring. All variables were reduced and unsupervised hierarchical clustering was performed. After clusters were defined, variations in medication usage were analyzed. Discriminant analysis was performed to develop a simplified, clinically useful algorithm for clustering. Clustering was largely determined by age, severity of patient reported outcome measures, depression, and fibromyalgia. CT and endoscopy varied somewhat among clusters. Traditional clinical measures, including polyp/atopic status, prior surgery, B-SIT and asthma, did not vary among clusters. A simplified algorithm based upon productivity loss, SNOT-22 score, and age predicted clustering with 89% accuracy. Medication usage among clusters did vary significantly. A simplified algorithm based upon hierarchical clustering is able to classify CRS patients and predict medication usage. Further studies are warranted to determine if such clustering predicts treatment outcomes. © 2015 ARS-AAOA, LLC.
Neurological Outcome Scale for Traumatic Brain Injury: III. Criterion-Related Validity and Sensitivity to Change in the NABIS Hypothermia-II Clinical Trial

PubMed Central

Wilde, Elisabeth A.; Moretti, Paolo; MacLeod, Marianne C.; Pedroza, Claudia; Drever, Pamala; Fourwinds, Sierra; Frisby, Melisa L.; Beers, Sue R.; Scott, James N.; Hunter, Jill V.; Traipe, Elfrides; Valadka, Alex B.; Okonkwo, David O.; Zygun, David A.; Puccio, Ava M.; Clifton, Guy L.

2013-01-01

Abstract The Neurological Outcome Scale for Traumatic Brain Injury (NOS-TBI) is a measure assessing neurological functioning in patients with TBI. We hypothesized that the NOS-TBI would exhibit adequate concurrent and predictive validity and demonstrate more sensitivity to change, compared with other well-established outcome measures. We analyzed data from the National Acute Brain Injury Study: Hypothermia-II clinical trial. Participants were 16–45 years of age with severe TBI assessed at 1, 3, 6, and 12 months postinjury. For analysis of criterion-related validity (concurrent and predictive), Spearman's rank-order correlations were calculated between the NOS-TBI and the Glasgow Outcome Scale (GOS), GOS-Extended (GOS-E), Disability Rating Scale (DRS), and Neurobehavioral Rating Scale-Revised (NRS-R). Concurrent validity was demonstrated through significant correlations between the NOS-TBI and GOS, GOS-E, DRS, and NRS-R measured contemporaneously at 3, 6, and 12 months postinjury (all p<0.0013). For prediction analyses, the multiplicity-adjusted p value using the false discovery rate was <0.015. The 1-month NOS-TBI score was a significant predictor of outcome in the GOS, GOS-E, and DRS at 3 and 6 months postinjury (all p<0.015). The 3-month NOS-TBI significantly predicted GOS, GOS-E, DRS, and NRS-R outcomes at 6 and 12 months postinjury (all p<0.0015). Sensitivity to change was analyzed using Wilcoxon's signed rank-sum test of subsamples demonstrating no change in the GOS or GOS-E between 3 and 6 months. The NOS-TBI demonstrated higher sensitivity to change, compared with the GOS (p<0.038) and GOS-E (p<0.016). In summary, the NOS-TBI demonstrated adequate concurrent and predictive validity as well as sensitivity to change, compared with gold-standard outcome measures. The NOS-TBI may enhance prediction of outcome in clinical practice and measurement of outcome in TBI research. PMID:23617608
Accreditation standards for undergraduate forensic science programs

NASA Astrophysics Data System (ADS)

Miller, Marilyn Tebbs

Undergraduate forensic science programs are experiencing unprecedented growth in numbers of programs offered and, as a result, student enrollments are increasing. Currently, however, these programs are not subject to professional specialized accreditation. This study sought to identify desirable student outcome measures for undergraduate forensic science programs that should be incorporated into such an accreditation process. To determine desirable student outcomes, three types of data were collected and analyzed. All the existing undergraduate forensic science programs in the United States were examined with regard to the input measures of degree requirements and curriculum content, and for the output measures of mission statements and student competencies. Accreditation procedures and guidelines for three other science-based disciplines, computer science, dietetics, and nursing, were examined to provide guidance on accreditation processes for forensic science education programs. Expert opinion on outcomes for program graduates was solicited from the major stakeholders of undergraduate forensic science programs-forensic science educators, crime laboratory directors, and recent graduates. Opinions were gathered by using a structured Internet-based survey; the total response rate was 48%. Examination of the existing undergraduate forensic science programs revealed that these programs do not use outcome measures. Of the accreditation processes for other science-based programs, nursing education provided the best model for forensic science education, due primarily to the balance between the generality and the specificity of the outcome measures. From the analysis of the questionnaire data, preliminary student outcomes, both general and discipline-specific, suitable for use in the accreditation of undergraduate forensic science programs were determined. The preliminary results were reviewed by a panel of experts and, based on their recommendations, the outcomes identified were revised and refined. The results of this study were used to identify student outcomes and to suggest accreditation standards and an accreditation process for undergraduate forensic science programs based on those outcomes.
Are K-12 learners motivated in physical education? A meta-analysis.

PubMed

Chen, Senlin; Chen, Ang; Zhu, Xihe

2012-03-01

Previous studies devoted to K-12 learner motivation in physical education share a general assumption that students may lack motivation. This meta-analytic study examined published original studies (n = 79) to determine students' motivation level and the association between motivation and outcomes. Original means of motivation measures were converted and aggregated to determine motivation levels. Correlation effect sizes were calculated to determine the association between motivation and outcome measures. The analyses revealed that K-12 students are motivated regardless of the theoretical constructs used in the studies (M > 50). The correlation effect sizes (r = .20-.30, p < .05) indicate a weak association between motivation and outcome. The findings suggest a need to involve meaningful learning and pedagogy variables in motivation research.

Impact of a labor and delivery safety bundle on a modified adverse outcomes index.

PubMed

Tolcher, Mary Catherine; Torbenson, Vanessa E; Weaver, Amy L; McGree, Michaela E; El-Nashar, Sherif A; Nesbitt, Katharine M; Gostout, Bobbie S; Famuyide, Abimbola O

2016-03-01

The Obstetrics Adverse Outcomes Index was designed to measure the quality of perinatal care and includes 10 adverse events that may occur at or around the time of delivery. We hypothesized that adverse outcomes in the labor and delivery suite, including hypoxic ischemic encephalopathy, could be decreased with a combination of interventions, even among high-risk pregnancies. The objective of the study was to evaluate the impact of a labor and delivery care bundle on adverse obstetrics outcomes as measured by a modified Obstetrics Adverse Outcomes Index, Weighted Adverse Outcomes Index, and Severity Index. This is a retrospective cohort study including all women who delivered at our academic, tertiary care institution over a 3 year period of time, before and after the implementation of an intervention to decrease adverse outcomes. Outcome measures consisted of previously reported indices that were modified including the addition of hypoxic ischemic encephalopathy. The adverse outcomes index is a percentage of deliveries with 1 or more adverse events, the weighted adverse outcomes index is the sum of the points assigned to cases with adverse outcomes divided by the number of deliveries, and the severity index is the sum of the adverse outcome scores divided by the number of deliveries with an identified adverse outcome. A segmented regression analysis was utilized to evaluate the differences in the level and trend of each index before and after our intervention using calendar month as the unit of analysis. During the study period, 5826 deliveries met inclusion criteria. Comparing the pre- and postintervention periods, high-risk pregnancy was more common in the postintervention period (73.5% vs 79.4%, P < .001). Overall, there was a decrease in both the Modified Weighted Adverse Outcomes Index (P = .0497) and the Modified Severity Index (P = 0.01) comparing the pre- and postintervention periods; there was no difference in the Modified Adverse Outcomes Index (P = .43). For low-risk pregnancies, there was no significant difference in the levels for any of the measured indices over the study period (P = .61, P = .41, and P = .34 for the Modified Adverse Outcomes Index, Modified Weighted Adverse Outcomes Index, and Modified Severity Index, respectively). Among the high-risk pregnancies, the monthly Modified Weighted Adverse Outcomes Index decreased by 4.2 ± 1.8 (P = .03). The monthly Modified Severity Index decreased by 53.9 ± 17.7 points from the pre- to the postintervention periods (P = .01) and was < 50% of the predicted Modified Severity Index had the intervention not been implemented. The cesarean delivery rate was increasing prior to the intervention, but the rate was stable after the intervention, and the absolute rate did not differ between the pre- and the postintervention periods (28.4% vs 30.0%, P = .20). Overall and for high-risk pregnancies, the implementation of the labor and delivery care bundle had a positive impact on the Modified Weighted Adverse Outcomes Index and Modified Severity Index but not the Modified Adverse Outcomes Index. Copyright © 2016 Elsevier Inc. All rights reserved.
Early Postoperative Measures Predict 1- and 2-Year Outcomes After Unilateral Total Knee Arthroplasty: Importance of Contralateral Limb Strength

PubMed Central

Snyder-Mackler, Lynn

2010-01-01

Background Total knee arthroplasty (TKA) has been shown to be an effective surgical intervention for people with end-stage knee osteoarthritis. However, recovery of function is variable, and not all people have successful outcomes. Objective The aim of this study was to discern which early postoperative functional measures could predict functional ability at 1 year and 2 years after surgery. Design and Methods One hundred fifty-five people who underwent unilateral TKA participated in the prospective longitudinal study. Functional evaluations were performed at the initial outpatient physical therapy appointment and at 1 and 2 years after surgery. Evaluations consisted of measurements of height, weight, quadriceps muscle strength (force-generating capacity), and knee range of motion; the Timed “Up & Go” Test (TUG); the stair-climbing task (SCT); and the Knee Outcome Survey (KOS) questionnaire. The ability to predict 1- and 2-year outcomes on the basis of early postoperative measures was analyzed with a hierarchical regression. Differences in functional scores were evaluated with a repeated-measures analysis of variance. Results The TUG, SCT, and KOS scores at 1 and 2 years showed significant improvements over the scores at the initial evaluation (P<.001). A weaker quadriceps muscle in the limb that did not undergo surgery (“nonoperated limb”) was related to poorer 1- and 2-year outcomes even after the influence of the other early postoperative measures was accounted for in the regression. Older participants with higher body masses also had poorer outcomes at 1 and 2 years. Postoperative measures were better predictors of TUG and SCT times than of KOS scores. Conclusions Rehabilitation regimens after TKA should include exercises to improve the strength of the nonoperated limb as well as to treat the deficits imposed by the surgery. Emphasis on treating age-related impairments and reducing body mass also might improve long-term outcomes. PMID:19959653
Individual-Level Influences on Perceptions of Neighborhood Disorder: A Multilevel Analysis

ERIC Educational Resources Information Center

Latkin, Carl A.; German, Danielle; Hua, Wei; Curry, Aaron D.

2009-01-01

Health outcomes are associated with aggregate neighborhood measures and individual neighborhood perceptions. In this study, the authors sought to delineate individual, social network, and spatial factors that may influence perceptions of neighborhood disorder. Multilevel regression analysis showed that neighborhood perceptions were more negative…
Relationship between brain function (aEEG) and brain structure (MRI) and their predictive value for neurodevelopmental outcome of preterm infants.

PubMed

Hüning, Britta; Storbeck, Tobias; Bruns, Nora; Dransfeld, Frauke; Hobrecht, Julia; Karpienski, Julia; Sirin, Selma; Schweiger, Bernd; Weiss, Christel; Felderhoff-Müser, Ursula; Müller, Hanna

2018-05-22

To improve the prediction of neurodevelopmental outcome in very preterm infants, this study used the combination of amplitude-integrated electroencephalography (aEEG) within the first 72 h of life and cranial magnetic resonance imaging (MRI) at term equivalent age. A single-center cohort of 38 infants born before 32 weeks of gestation was subjected to both investigations. Structural measurements were performed on MRI. Multiple regression analysis was used to identify independent factors including functional and structural brain measurements associated with outcome at a corrected age of 24 months. aEEG parameters significantly correlated with MRI measurements. Reduced deep gray matter volume was associated with low Burdjalov Score on day 3 (p < 0.0001) and day 1-3 (p = 0.0012). The biparietal width and the transcerebellar diameter were related to Burdjalov Score on day 1 (p = 0.0111; p = 0.0002). The final multiple regression analysis revealed independent predictors of neurodevelopmental outcome: intraventricular hemorrhage (p = 0.0060) and interhemispheric distance (p = 0.0052) for mental developmental index; Burdjalov Score day 1 (p = 0.0201) and interhemispheric distance (p = 0.0142) for psychomotor developmental index. Functional aEEG parameters were associated with altered brain maturation on MRI. The combination of aEEG and MRI contributes to the prediction of outcome at 24 months. What is Known: • Prematurity remains a risk factor for impaired neurodevelopment. • aEEG is used to measure brain activity in preterm infants and cranial MRI is performed to identify structural gray and white matter abnormalities with impact on neurodevelopmental outcome. What is New: • aEEG parameters observed within the first 72 h of life were associated with altered deep gray matter volumes, biparietal width, and transcerebellar diameter at term equivalent age. • The combination of aEEG and MRI contributes to the prediction of neurodevelopmental outcome at 2 years of corrected age in very preterm infants.
Estrogen supplementation to progesterone as luteal phase support in patients undergoing in vitro fertilization: systematic review and meta-analysis.

PubMed

Zhang, Xiao-Mei; Lv, Fang; Wang, Pin; Huang, Xia-Man; Liu, Kai-Feng; Pan, Yu; Dong, Nai-Jun; Ji, Yu-Rong; She, Hong; Hu, Rong

2015-02-01

Meta-analyses have found conflicting results with respect to the use of progesterone or progesterone plus estrogen as luteal phase support for in vitro fertilization (IVF) protocols involving gonadotropins and/or gonadotropin-releasing hormone analogs. The aim of the present study was to perform an updated meta-analysis on the efficacy of progesterone versus progesterone plus estrogen as luteal phase support. We searched the MEDLINE, Cochrane Library, and Google Scholar databases (up to March 18, 2014). The search terms were (estrogen OR estradiol OR oestradiol) AND (progesterone) AND (IVF OR in vitro fertilization) AND (randomized OR prospective). We did not limit the form of estrogen and included subjects who contributed more than 1 cycle to a study. The primary outcome was clinical pregnancy rate. Secondary outcomes were ongoing pregnancy rate, fertilization rate, implantation rate, and miscarriage rate. A total of 11 articles were included in the present analysis, with variable numbers of studies assessing each outcome measure. Results of statistical analyses indicated that progesterone plus estrogen treatment was more likely to result in clinical pregnancy than progesterone alone (pooled odds ratio 1.617, 95% confidence interval 1.059-2.471; P = 0.026). No significant difference between the 2 treatment regimens was found for the other outcome measures. Progesterone plus estrogen for luteal phase support is associated with a higher clinical pregnancy rate than progesterone alone in women undergoing IVF, but other outcomes such as ongoing pregnancy rate, fertilization rate, implantation rate, and miscarriage rate are the same for both treatments.
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…
The Impact of Background Music on Adult Listeners: A Meta-Analysis

ERIC Educational Resources Information Center

Kampfe, Juliane; Sedlmeier, Peter; Renkewitz, Frank

2011-01-01

Background music has been found to have beneficial, detrimental, or no effect on a variety of behavioral and psychological outcome measures. This article reports a meta-analysis that attempts to summarize the impact of background music. A global analysis shows a null effect, but a detailed examination of the studies that allow the calculation of…
Effects of Vocal Function Exercises: A Systematic Review.

PubMed

Angadi, Vrushali; Croake, Daniel; Stemple, Joseph

2017-11-03

The purpose of the present review was to systematically analyze the evidence for the effectiveness of vocal function exercises (VFEs) in improving voice production. A systematic literature search was performed by two independent reviewers using PubMed and EBSCOHost to access relevant databases and to locate outcome studies that used VFEs as an intervention. Articles that met inclusion criteria were appraised based on the American Speech-Language and Hearing Association's levels of evidence. Effect sizes for outcomes were calculated using Hedge's g. Voice outcomes were categorized according to the five domains of voice assessment: visual perceptual analysis, acoustic analysis, aerodynamic analysis, auditory-perceptual analysis, and patient self-report measures. Twenty-one articles were included for the final appraisal. All studies demonstrated positive effects of VFEs as demonstrated by effect sizes across selected voice parameters. Effect sizes across parameters ranged from -0.59 to 1.55. None of the included studies reported adverse voice outcomes as a result of VFEs. Outcome studies demonstrate that VFEs are efficacious in enhancing vocal function in individuals with normal and disordered voices, presbylaryngeus, and professional voice users. The available research suggests moderate to strong evidence to support the use of VFEs for a variety of voice disorders. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.
Heart Rate Variability as a Feeding Intervention Outcome Measure in the Preterm Infant.

PubMed

Pados, Britt F; Thoyre, Suzanne M; Knafl, George J; Nix, William Brant

2017-10-01

Feeding interventions for preterm infants aim to reduce the physiologic stress of feeding to promote growth. Heart rate variability (HRV) is a potential noninvasive measure of physiologic stress that may be useful for evaluating efficacy of feeding interventions. To evaluate whether HRV is a sensitive measure of physiologic stress compared with standard physiologic outcomes in the context of a feeding intervention study. This was a secondary analysis of a within-subjects, cross-over design study comparing usual care feeding with a gentle, coregulated (CoReg) feeding approach in 14 infants born less than 35 weeks' postmenstrual age. HRV indices were calculated from electrocardiogram data and compared with standard physiologic outcomes, including oxygen saturation (Spo2), respiratory rate (RR), apnea, heart rate (HR), and bradycardia. Data were analyzed using linear mixed modeling. Infants fed using the CoReg approach had fewer apneic events and higher RR, suggesting they were able to breathe more during feeding. No statistically significant differences were found in SpO2, HR, bradycardia, or high frequency power (the most commonly reported measure of HRV). Infants fed using the usual care approach had significantly higher SD12, a measure of HRV indicating randomness in the HR, which is a potential indicator of elevated stress. SD12 was more sensitive to stress than SpO2, HR, and bradycardia. The utility of HRV as a measure of feeding outcomes in clinical practice needs further exploration. Further exploration of HRV as an intervention outcome measure is needed, particularly evaluating nonlinear indices, such as SD12.
Usefulness of fetal urine production measurement for prediction of perinatal outcomes in uteroplacental insufficiency.

PubMed

Lee, Seung Mi; Jun, Jong Kwan; Kim, Su Ah; Lee, Eun Ja; Kim, Byoung Jae; Park, Chan-Wook; Park, Joong Shin

2014-12-01

To evaluate whether fetal urine production measurement is useful for predicting adverse outcomes in patients with uteroplacental insufficiency. We enrolled patients with uteroplacental insufficiency at 24 to 40 weeks' gestation and normal pregnancies matched for gestational age and divided them into 3 groups according to perinatal outcomes: group 1 (n = 141), a control group of normal pregnancies; group 2 (n = 29), uteroplacental insufficiency without adverse outcomes; and group 3 (n = 18), uteroplacental insufficiency with adverse outcomes. An adverse outcome was defined as 1 or more of the following: (1) cesarean delivery because of fetal distress; (2) admission to the neonatal intensive care unit; (3) cord arterial pH less than 7.15 at birth; and (4) low 5-minute Apgar score (<7). The fetal urine production rate was obtained by serial bladder volume measurement using virtual organ computer-aided analysis. For bladder volume determination, we scanned the bladder in the 3-dimensional mode and defined the bladder surface contour in the reference plane, repeating the rotation of the reference plane with an angle of 30° and determining the surface contour on each plane. Statistical methods, including the Mann-Whitney U test, Fisher exact test, χ(2) test, and Kruskal-Wallis analysis of variance, were used. Group 3 had a lower mean fetal urine production rate than groups 1 and 2, whereas the urine production rate was not different between groups 1 and 2 (group 1, 49.0 mL/h; group 2, 59.4 mL/h; group 3, 20.7 mL/h; P < .001 between groups 1 and 3 and between groups 2 and 3). This difference between groups 2 and 3 remained significant after adjusting for the amniotic fluid index, umbilical artery Doppler pulsatility index, and presence of fetal growth restriction. Uteroplacental insufficiency cases with adverse perinatal outcomes had a lower fetal urine production rate than those without adverse outcomes. This difference might be used to predict adverse perinatal outcomes in uteroplacental insufficiency. © 2013 by the American Institute of Ultrasound in Medicine.
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.
The work and social adjustment scale: reliability, sensitivity and value.

PubMed

Zahra, Daniel; Qureshi, Adam; Henley, William; Taylor, Rod; Quinn, Cath; Pooler, Jill; Hardy, Gillian; Newbold, Alexandra; Byng, Richard

2014-06-01

To investigate the psychometric properties of the Work and Social Adjustment Scale (WSAS) as an outcome measure for the Improving Access to Psychological Therapy programme, assessing its value as an addition to the Patient Health (PHQ-9) and Generalised Anxiety Disorder questionnaires (GAD-7). Little research has investigated these properties to date. Reliability and responsiveness to change were assessed using data from 4,835 patients. Principal components analysis was used to determine whether the WSAS measures a factor distinct from the PHQ-9 and GAD-7. The WSAS measures a distinct social functioning factor, has high internal reliability, and is sensitive to treatment effects. The WSAS, PHQ-9 and GAD-7 perform comparably on measures of reliability and sensitivity. The WSAS also measures a distinct social functioning component suggesting it has potential as an additional outcome measure.
PROMIS Peer Relationships Short Form: How Well Does Self-Report Correlate With Data From Peers?

PubMed

Devine, Katie A; Willard, Victoria W; Hocking, Matthew C; Stapleton, Jerod L; Rotter, David; Bukowski, William M; Noll, Robert B

2018-05-24

To examine the psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS®) peer relationships short form (PR-SF), including association with peer-reported friendships, likeability, and social reputation. 203 children (Mage = 10.12 years, SD = 2.37, range = 6-14) in Grades 1-8 completed the 8-item PR-SF and friendship nominations, like ratings, and social reputation measures about their peers during 2 classroom visits approximately 4 months apart, as part of a larger study. A confirmatory factor analysis, followed by an exploratory factor analysis, was conducted to examine the factor structure of the PR-SF. Spearman correlations between the PR-SF and peer-reported outcomes evaluated construct validity. For the PR-SF, a 2-factor solution demonstrated better fit than a 1-factor solution. The 2 factors appear to assess friendship quality (3 items) and peer acceptance (5 items). Reliability was marginal for the friendship quality factor (.66) but adequate for the acceptance factor (.85); stability was .34 for the PR-SF over 4 months. The PR-SF (8 items) and acceptance factor (5 items) both had modest but significant correlations with measures of friendship (rs = .25-.27), likeability (rs = .21-.22), and social reputation (rs = .29-.44). The PR-SF appears to be measuring two distinct aspects of social functioning. The 5-item peer acceptance scale is modestly associated with peer-reported friendship, likeability, and social reputation. Although not a replacement for peer-reported outcomes, the PR-SF is a promising patient-reported outcome for peer relationships in youth.
Mirror therapy for improving lower limb motor function and mobility after stroke: A systematic review and meta-analysis.

PubMed

Broderick, P; Horgan, F; Blake, C; Ehrensberger, M; Simpson, D; Monaghan, K

2018-06-01

Mirror therapy has been proposed as an effective intervention for lower limb rehabilitation post stroke. This systematic review with meta-analysis examined if lower limb mirror therapy improved the primary outcome measures of muscle tone and motor function and the secondary outcome measures balance characteristics, functional ambulation, walking velocity, passive range of motion (PROM) for ankle dorsiflexion and gait characteristics in patients with stroke compared to other interventions. Standardised mean differences (SMD) and mean differences (MD) were used to assess the effect of mirror therapy on lower limb functioning. Nine studies were included in the review. Among the primary outcome measures there was evidence of a significant effect of mirror therapy on motor function compared with sham and non-sham interventions (SMD 0.54; 95% CI 0.24-0.93). Furthermore, among the secondary outcome measures there was evidence of a significant effect of mirror therapy for balance capacity (SMD -0.55; 95% CI -1.01 to -0.10), walking velocity (SMD 0.71; 95% CI 0.35-1.07), PROM for ankle dorsiflexion (SMD 1.20; 95% CI 0.71-1.69) and step length (SMD 0.56; 95% CI -0.00 to 1.12). The results indicate that using mirror therapy for the treatment of certain lower limb deficits in patients with stroke may have a positive effect. Although results are somewhat positive, overly favourable interpretation is cautioned due to methodological issues concerning included studies. Copyright © 2018 Elsevier B.V. All rights reserved.
Evolution of Multidisciplinary Translational Teams (MTTs): Insights for Accelerating Translational Innovations

PubMed Central

Calhoun, William J.; Bhavnani, Suresh; Rose, Robert M.; Ameredes, Bill; Brasier, Allan R.

2015-01-01

Abstract There is growing consensus about the factors critical for development and productivity of multidisciplinary teams, but few studies have evaluated their longitudinal changes. We present a longitudinal study of 10 multidisciplinary translational teams (MTTs), based on team process and outcome measures, evaluated before and after 3 years of CTSA collaboration. Using a mixed methods approach, an expert panel of five judges (familiar with the progress of the teams) independently rated team performance based on four process and four outcome measures, and achieved a rating consensus. Although all teams made progress in translational domains, other process and outcome measures were highly variable. The trajectory profiles identified four categories of team performance. Objective bibliometric analysis of CTSA‐supported MTTs with positive growth in process scores showed that these teams tended to have enhanced scientific outcomes and published in new scientific domains, indicating the conduct of innovative science. Case exemplars revealed that MTTs that experienced growth in both process and outcome evaluative criteria also experienced greater innovation, defined as publications in different areas of science. Of the eight evaluative criteria, leadership‐related behaviors were the most resistant to the interventions introduced. Well‐managed MTTs demonstrate objective productivity and facilitate innovation. PMID:25801998
Evolution of Multidisciplinary Translational Teams (MTTs): Insights for Accelerating Translational Innovations.

PubMed

Wooten, Kevin C; Calhoun, William J; Bhavnani, Suresh; Rose, Robert M; Ameredes, Bill; Brasier, Allan R

2015-10-01

There is growing consensus about the factors critical for development and productivity of multidisciplinary teams, but few studies have evaluated their longitudinal changes. We present a longitudinal study of 10 multidisciplinary translational teams (MTTs), based on team process and outcome measures, evaluated before and after 3 years of CTSA collaboration. Using a mixed methods approach, an expert panel of five judges (familiar with the progress of the teams) independently rated team performance based on four process and four outcome measures, and achieved a rating consensus. Although all teams made progress in translational domains, other process and outcome measures were highly variable. The trajectory profiles identified four categories of team performance. Objective bibliometric analysis of CTSA-supported MTTs with positive growth in process scores showed that these teams tended to have enhanced scientific outcomes and published in new scientific domains, indicating the conduct of innovative science. Case exemplars revealed that MTTs that experienced growth in both process and outcome evaluative criteria also experienced greater innovation, defined as publications in different areas of science. Of the eight evaluative criteria, leadership-related behaviors were the most resistant to the interventions introduced. Well-managed MTTs demonstrate objective productivity and facilitate innovation. © 2015 Wiley Periodicals, Inc.
Prevention of Postoperative Bile Leak in Partial Cystectomy for Hydatid Liver Disease: Tricks of the Trade.

PubMed

Peker, Kivanc Derya; Gumusoglu, Alpen Yahya; Seyit, Hakan; Kabuli, Hamit Ahmet; Salik, Aysun Erbahceci; Gonenc, Murat; Kapan, Selin; Alis, Halil

2015-12-01

The presence of postoperative bile leak is the major outcome measure for the assessment of operative success in partial cystectomy for hydatid liver disease. However, the optimal operative strategy to reduce the postoperative bile leak rate is yet to be defined. Medical records of patients who underwent partial cystectomy for hydatid liver disease between January 2013 and January 2015 were reviewed in this retrospective analysis. All patients were managed with a specific operative protocol. The primary outcome measure was the rate of persistent postoperative bile leak. The secondary outcome measures were the morbidity and mortality rate, and the length of hospital stay. Twenty-eight patients were included in the study. Only one patient (3.6 %) developed persistent postoperative bile leak. The overall morbidity and mortality rate was 17.8 and 0 %, respectively. The median length of hospital stay was 5 days. Aggressive preventative surgical measures have led to low persistent bile leak rates with low morbidity and mortality.
Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial.

PubMed

Schneider, Michael; Ammendolia, Carlo; Murphy, Donald; Glick, Ronald; Piva, Sara; Hile, Elizabeth; Tudorascu, Dana; Morton, Sally C

2014-01-01

Lumbar spinal stenosis is the most common reason for spinal surgery in older adults. Previous studies have shown that surgery is effective for severe cases of stenosis, but many patients with mild to moderate symptoms are not surgical candidates. These patients and their providers are seeking effective non-surgical treatment methods to manage their symptoms; yet there is a paucity of comparative effectiveness research in this area. This knowledge gap has hindered the development of clinical practice guidelines for non-surgical treatment approaches for lumbar spinal stenosis. This study is a prospective randomized controlled clinical trial that will be conducted from November 2013 through October 2016. The sample will consist of 180 older adults (>60 years) who have both an anatomic diagnosis of stenosis confirmed by diagnostic imaging, and signs/symptoms consistent with a clinical diagnosis of lumbar spinal stenosis confirmed by clinical examination. Eligible subjects will be randomized into one of three pragmatic treatment groups: 1) usual medical care; 2) individualized manual therapy and rehabilitative exercise; or 3) community-based group exercise. All subjects will be treated for a 6-week course of care. The primary subjective outcome is the Swiss Spinal Stenosis Questionnaire, a self-reported measure of pain/function. The primary objective outcome is the Self-Paced Walking Test, a measure of walking capacity. The secondary objective outcome will be a measurement of physical activity during activities of daily living, using the SenseWear Armband, a portable device to be worn on the upper arm for one week. The primary analysis will use linear mixed models to compare the main effects of each treatment group on the changes in each outcome measure. Secondary analyses will include a responder analysis by group and an exploratory analysis of potential baseline predictors of treatment outcome. Our study should provide evidence that helps to inform patients and providers about the clinical benefits of three non-surgical approaches to the management of lumbar spinal stenosis symptoms. ClinicalTrials.gov identifier: NCT01943435.
Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Lumbar spinal stenosis is the most common reason for spinal surgery in older adults. Previous studies have shown that surgery is effective for severe cases of stenosis, but many patients with mild to moderate symptoms are not surgical candidates. These patients and their providers are seeking effective non-surgical treatment methods to manage their symptoms; yet there is a paucity of comparative effectiveness research in this area. This knowledge gap has hindered the development of clinical practice guidelines for non-surgical treatment approaches for lumbar spinal stenosis. Methods/design This study is a prospective randomized controlled clinical trial that will be conducted from November 2013 through October 2016. The sample will consist of 180 older adults (>60 years) who have both an anatomic diagnosis of stenosis confirmed by diagnostic imaging, and signs/symptoms consistent with a clinical diagnosis of lumbar spinal stenosis confirmed by clinical examination. Eligible subjects will be randomized into one of three pragmatic treatment groups: 1) usual medical care; 2) individualized manual therapy and rehabilitative exercise; or 3) community-based group exercise. All subjects will be treated for a 6-week course of care. The primary subjective outcome is the Swiss Spinal Stenosis Questionnaire, a self-reported measure of pain/function. The primary objective outcome is the Self-Paced Walking Test, a measure of walking capacity. The secondary objective outcome will be a measurement of physical activity during activities of daily living, using the SenseWear Armband, a portable device to be worn on the upper arm for one week. The primary analysis will use linear mixed models to compare the main effects of each treatment group on the changes in each outcome measure. Secondary analyses will include a responder analysis by group and an exploratory analysis of potential baseline predictors of treatment outcome. Discussion Our study should provide evidence that helps to inform patients and providers about the clinical benefits of three non-surgical approaches to the management of lumbar spinal stenosis symptoms. Trial registration ClinicalTrials.gov identifier: NCT01943435 PMID:24872875
Impact of clinical registries on quality of patient care and health outcomes: protocol for a systematic review.

PubMed

Hoque, Dewan Md Emdadul; Kumari, Varuni; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M

2016-04-26

Many developed countries have regional and national clinical registries aimed at improving health outcomes of patients diagnosed with particular diseases or cared for in particular healthcare settings. Clinical quality registries (CQRs) are clinical registries established with the purpose of monitoring quality of care and providing feedback to improve health outcomes. The aim of this systematic review is to understand the impact of CQRs on (1) mortality/survival; (2) measures of outcome that reflect a process or outcome of healthcare; (3) healthcare utilisation and (4) costs. The PRISMA-P methodology, checklist and standard strategy using predefined inclusion and exclusion criteria and structured data abstraction tools will be followed. A search of the electronic databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL will be undertaken, in addition to Google Scholar and grey literature, to identify studies in English covering the period January 1980 to December 2014. Case-control, cohort, randomised controlled trials and controlled clinical trials which describe the registry as an intervention will be eligible for inclusion. Narrative synthesis of study findings will be conducted, guided by a conceptual framework developed to analyse the outcome measure of the registry using defined criteria. If sufficient studies are identified with a similar outcome of interest and measure using the same comparator and time of interval, results will be pooled for random-effects meta-analysis. Test for heterogeneity and sensitivity analysis will be conducted. To identify reporting bias, forest plots and funnel plots will be created and, if required, Egger's test will be conducted. Ethical approval is not required as primary data will not be collected. Review results will be published as a part of thesis, peer-reviewed journal and conferences. CRD42015017319. 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/

Graphic Strategies for Analyzing and Interpreting Curricular Mapping Data

PubMed Central

Leonard, Sean T.

2010-01-01

Objective To describe curricular mapping strategies used in analyzing and interpreting curricular mapping data and present findings on how these strategies were used to facilitate curricular development. Design Nova Southeastern University's doctor of pharmacy curriculum was mapped to the college's educational outcomes. The mapping process included development of educational outcomes followed by analysis of course material and semi-structured interviews with course faculty members. Data collected per course outcome included learning opportunities and assessment measures used. Assessment Nearly 1,000 variables and 10,000 discrete rows of curricular data were collected. Graphic representations of curricular data were created using bar charts and stacked area graphs relating the learning opportunities to the educational outcomes. Graphs were used in the curricular evaluation and development processes to facilitate the identification of curricular holes, sequencing misalignments, learning opportunities, and assessment measures. Conclusion Mapping strategies that use graphic representations of curricular data serve as effective diagnostic and curricular development tools. PMID:20798804
Graphic strategies for analyzing and interpreting curricular mapping data.

PubMed

Armayor, Graciela M; Leonard, Sean T

2010-06-15

To describe curricular mapping strategies used in analyzing and interpreting curricular mapping data and present findings on how these strategies were used to facilitate curricular development. Nova Southeastern University's doctor of pharmacy curriculum was mapped to the college's educational outcomes. The mapping process included development of educational outcomes followed by analysis of course material and semi-structured interviews with course faculty members. Data collected per course outcome included learning opportunities and assessment measures used. Nearly 1,000 variables and 10,000 discrete rows of curricular data were collected. Graphic representations of curricular data were created using bar charts and stacked area graphs relating the learning opportunities to the educational outcomes. Graphs were used in the curricular evaluation and development processes to facilitate the identification of curricular holes, sequencing misalignments, learning opportunities, and assessment measures. Mapping strategies that use graphic representations of curricular data serve as effective diagnostic and curricular development tools.
Panel discussion review: Session two - Interpretation of Observed Associations between Multiple Ambient Air Pollutants and Health Effects in Epidemiologic Analysis

EPA Science Inventory

Air pollution epidemiologic research has often utilized ambient air concentrations measured from centrally located monitors as a surrogate measure of exposure to these pollutants. Associations between these ambient concentrations and health outcomes such as lung function, hospita...
The Measurement and Analysis of College Student Satisfaction.

ERIC Educational Resources Information Center

Betz, Ellen L.; and Others

As part of an intensive study of college student satisfaction a questionnaire has been designed to measure six dimensions of student satisfaction: policies and procedures, working conditions, compensation (relationship of input to outcomes), quality of education, social life, and recognition. A field test of this instrument, the College Student…
Measuring Intervention Effectiveness: The Benefits of an Item Response Theory Approach

ERIC Educational Resources Information Center

McEldoon, Katherine; Cho, Sun-Joo; Rittle-Johnson, Bethany

2012-01-01

Assessing the effectiveness of educational interventions relies on quantifying differences between interventions groups over time in a between-within design. Binary outcome variables (e.g., correct responses versus incorrect responses) are often assessed. Widespread approaches use percent correct on assessments, and repeated measures analysis of…
A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

PubMed Central

Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

2017-01-01

Introduction A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). Methods and analysis The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethics and dissemination Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. Trial registration number ISCRTN88609453; Pre-results. PMID:28928192
Incidence of delayed seizures, delayed cerebral ischemia and poor outcome with the use of levetiracetam versus phenytoin after aneurysmal subarachnoid hemorrhage.

PubMed

Karamchandani, Rahul Ramesh; Fletcher, Jeffrey James; Pandey, Aditya Swarup; Rajajee, Venkatakrishna

2014-09-01

Current guidelines recommend against the use of phenytoin following aneurysmal subarachnoid hemorrhage (aSAH) but consider other anticonvulsants, such as levetiracetam, acceptable. Our objective was to evaluate the risk of poor functional outcomes, delayed cerebral ischemia (DCI) and delayed seizures in aSAH patients treated with levetiracetam versus phenytoin. Medical records of patients with aSAH admitted between 2005-2012 receiving anticonvulsant prophylaxis with phenytoin or levetiracetam for >72 hours were reviewed. The primary outcome measure was poor functional outcome, defined as modified Rankin Scale (mRS) score >3 at first recorded follow-up. Secondary outcomes measures included DCI and the incidence of delayed seizures. The association between the use of levetiracetam and phenytoin and the outcomes of interest was studied using logistic regression. Medical records of 564 aSAH patients were reviewed and 259 included in the analysis after application of inclusion/exclusion criteria. Phenytoin was used exclusively in 43 (17%), levetiracetam exclusively in 132 (51%) while 84 (32%) patients were switched from phenytoin to levetiracetam. Six (2%) patients had delayed seizures, 94 (36%) developed DCI and 63 (24%) had mRS score >3 at follow-up. On multivariate analysis, only modified Fisher grade and seizure before anticonvulsant administration were associated with DCI while age, Hunt-Hess grade and presence of intraparenchymal hematoma were associated with mRS score >3. Choice of anticonvulsant was not associated with any of the outcomes of interest. There was no difference in the rate of delayed seizures, DCI or poor functional outcome in patients receiving phenytoin versus levetiracetam after aSAH. The high rate of crossover from phenytoin suggests that levetiracetam may be better tolerated. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
Model testing for reliability and validity of the Outcome Expectations for Exercise Scale.

PubMed

Resnick, B; Zimmerman, S; Orwig, D; Furstenberg, A L; Magaziner, J

2001-01-01

Development of a reliable and valid measure of outcome expectations for exercise appropriate for older adults will help establish the relationship between outcome expectations and exercise. Once established, this measure can be used to facilitate the development of interventions to strengthen outcome expectations and improve adherence to regular exercise in older adults. Building on initial psychometrics of the Outcome Expectation for Exercise (OEE) Scale, the purpose of the current study was to use structural equation modeling to provide additional support for the reliability and validity of this measure. The OEE scale is a 9-item measure specifically focusing on the perceived consequences of exercise for older adults. The OEE scale was given to 191 residents in a continuing care retirement community. The mean age of the participants was 85 +/- 6.1 and the majority were female (76%), White (99%), and unmarried (76%). Using structural equation modeling, reliability was based on R2 values, and validity was based on a confirmatory factor analysis and path coefficients. There was continued evidence for reliability of the OEE based on R2 values ranging from .42 to .77, and validity with path coefficients ranging from .69 to .87, and evidence of model fit (X2 of 69, df = 27, p < .05, NFI = .98, RMSEA = .07). The evidence of reliability and validity of this measure has important implications for clinical work and research. The OEE scale can be used to identify older adults who have low outcome expectations for exercise, and interventions can then be implemented to strengthen these expectations and thereby improve exercise behavior.
Association of Leukoaraiosis With Convalescent Rehabilitation Outcome in Patients With Ischemic Stroke.

PubMed

Senda, Joe; Ito, Keiichi; Kotake, Tomomitsu; Kanamori, Masahiko; Kishimoto, Hideo; Kadono, Izumi; Suzuki, Yoshiro; Katsuno, Masahisa; Nishida, Yoshihiro; Ishiguro, Naoki; Sobue, Gen

2016-01-01

We investigated the factors influencing inpatient convalescent rehabilitation outcomes in patients with ischemic stroke, particularly severity of leukoaraiosis on magnetic resonance imaging. Participants included 520 patients with ischemic stroke (317 men and 203 women; mean age, 72.8±8.4 years) who were transferred from acute care hospitals for inpatient convalescent rehabilitation. Ischemic stroke subtypes included lacunar infarction (n=41), atherothrombosis (n=223), artery-to-artery embolism (n=67), cardiogenic embolism (n=97), undetermined embolism (n=76), and uncategorized ischemic stroke (n=16). Leukoaraiosis was graded according to periventricular hyperintensity (PVH) and deep white matter hyperintensity on magnetic resonance imaging. Functional Independence Measure scores were assessed on admission and at discharge. Multiple regression analysis revealed that rehabilitation outcomes, measured as total Functional Independence Measure scores, were significantly associated with leukoaraiosis estimated by PVH grade. This association was observed after adjustment for factors such as severity, age, and poststroke history. In all patients, PVH grades were associated with Functional Independence Measure motor scores (P<0.001), whereas in patients with artery-to-artery embolism or cardiogenic embolism and deep white matter hyperintensity grades were associated with Functional Independence Measure cognitive scores (P<0.05). Our study revealed that the degree of leukoaraiosis was associated with inpatient convalescent rehabilitation outcome in patients with ischemic stroke. Furthermore, the PVH grade was associated with motor function outcome, whereas the deep white matter hyperintensity grade correlated with cognitive function outcome, likely because the progression patterns and anatomic backgrounds of PVH and deep white matter hyperintensity differ according to ischemic stroke subtype. © 2015 American Heart Association, Inc.
My Therapist is a Student? The Impact of Therapist Experience and Client Severity on Cognitive Behavioural Therapy Outcomes for People with Anxiety Disorders.

PubMed

Mason, Liam; Grey, Nick; Veale, David

2016-03-01

Allocation of trainee therapist cases is often performed based on intuition and clinical circumstances, with lack of empirical evidence on the role of severity of presenting problem. This has the potential to be anxiety-provoking for supervisors, trainees and service users themselves. To determine how therapist experience interacts with symptom severity in predicting client outcomes. An intention-to-treat analysis of annual outcome data for primary and secondary care clients seen by a specialist anxiety disorders service. 196 clients were stratified into mild, moderate and baseline severe symptoms of anxiety (GAD-7) and depression (PHQ-9). We measured percentage change on these measures, as well as number of sessions and therapy dropout. We also examined rates of reliable and clinically significant change on disorder-specific measures. We hypothesized that qualified therapists would achieve better outcomes than trainees, particularly for severe presentations. Overall, outcomes were comparable between trainee and qualified therapists on all measures, and trainees additionally utilized fewer therapy sessions. There was however an interaction between anxiety severity (GAD-7) and therapist group, such that severely anxious clients achieved greater symptom improvement with qualified as compared to trainee therapists. Further, for trainee but not qualified therapists, baseline anxiety was negatively associated with rate of reliable and clinically significant change on disorder-specific measures. These findings indicate generally favourable outcomes for trainee therapists delivering manualized treatments for anxiety disorders. They additionally suggest that trainee therapists may benefit from additional support when working with clients that present with severe anxiety.
A 5-Year Review of Clinical Outcome Measures Published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery.

PubMed

Hasenstein, Todd; Greene, Timothy; Meyr, Andrew J

2017-05-01

This investigation presents a review of all of the clinical outcome measures used by authors and published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery from January 1, 2011, to December 31, 2015. Of 1,336 articles published during this time frame, 655 (49.0%) were classified as original research and included in this analysis. Of these 655 articles, 151 (23.1%) included at least one clinical outcome measure. Thirty-seven unique clinical outcome scales were used by authors and published during this period. The most frequently reported scales in the 151 included articles were the American Orthopaedic Foot and Ankle Society scales (54.3%; n = 82), visual analog scale (35.8%; n = 54), Medical Outcomes Study Short Form Health Survey (any version) (10.6%; n = 16), Foot Function Index (5.3%; n = 8), Maryland Foot Score (4.0%; n = 6), and Olerud and Molander scoring system (4.0%; n = 6). Twenty-four articles (15.9%) used some form of original/subjective measure of patient satisfaction/expectation. The results of this investigation detail the considerable variety of clinical outcome measurement tools used by authors in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery and might support the need for a shift toward the consistent use of a smaller number of valid, reliable, and clinically useful scales in the podiatric medical literature.
Similar Superior Patient-Reported Outcome Measures for Anterior and Posterolateral Approaches After Total Hip Arthroplasty: Postoperative Patient-Reported Outcome Measure Improvement After 3 months in 12,774 Primary Total Hip Arthroplasties Using the Anterior, Anterolateral, Straight Lateral, or Posterolateral Approach.

PubMed

Peters, Rinne M; van Beers, Loes W A H; van Steenbergen, Liza N; Wolkenfelt, Julius; Ettema, Harmen B; Ten Have, Bas L E F; Rijk, Paul C; Stevens, Martin; Bulstra, Sjoerd K; Poolman, Rudolf W; Zijlstra, Wierd P

2018-06-01

Patient-reported outcome measures (PROMs) are used to evaluate the outcome of total hip arthroplasty (THA). We determined the effect of surgical approach on PROMs after primary THA. All primary THAs, with registered preoperative and 3 months postoperative PROMs were selected from the Dutch Arthroplasty Register. Based on surgical approach, 4 groups were discerned: (direct) anterior, anterolateral, direct lateral, and posterolateral approaches. The following PROMs were recorded: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS); Oxford Hip Score; EQ-5D index score; EQ-5D thermometer; and Numeric Rating Scale measuring pain, both active and in rest. The difference between preoperative and postoperative scores was calculated (delta-PROM) and used as primary outcome measure. Multivariable linear regression analysis was performed for comparisons. Cohen's d was calculated as measure of effect size. All examined 4 approaches resulted in a significant increase of PROMs after primary THA in the Netherlands (n = 12,274). The anterior and posterolateral approaches were associated with significantly more improvement in HOOS-PS scores compared with the anterolateral and direct lateral approaches. Furthermore, the posterolateral and anterior approaches showed greater improvement on Numeric Rating Scale pain scores compared with the anterolateral approach. No relevant differences in delta-PROM were seen between the anterior and posterolateral surgical approaches. Anterior and posterolateral surgical approaches showed more improvement in self-reported physical functioning (HOOS-PS) compared with anterolateral and direct lateral approaches in patients receiving a primary THA. However, clinical differences were only small. Copyright © 2018 Elsevier Inc. All rights reserved.
Impact of female adult eating disorder inpatients' attitudes to compulsive exercise on outcome at discharge and follow-up.

PubMed

Danielsen, Marit; Rø, Øyvind; Romild, Ulla; Bjørnelv, Sigrid

2016-01-01

The link between compulsive exercise and eating disorders is well known, but research with clinical samples has been limited. The purpose of the study was to investigate changes in attitudes towards compulsive exercise and its impact on outcome at follow-up in female adult hospitalised patients with eating disorders. The sample consisted of 78 patients: Diagnostic distribution: anorexia nervosa 59 % (n = 46), approximately 22 % (n = 16) in bulimia nervosa, and Eating Disorder not Otherwise Specified respectively. The average follow-up period was 26 months (SD =15 months). Compulsive exercise was measured by the Exercise and Eating Disorder (EED) questionnaire. Other measures were the Eating Disorder Inventory (EDI-2), Body Attitude Test (BAT), Symptom Checklist (SCL-90), Inventory of Interpersonal Problems (IIP 64), Beck Depression Inventory (BDI), and body mass index (BMI). Outcome measures were EDI-2 and BMI (patients with admission BMI ≤ 18.5). Paired sample t-tests and mixed model regression analysis were conducted to investigate changes in compulsive exercise and predictors of outcome respectively. All measures revealed significant improvements (p < .01 - p < .001) from admission to follow-up. EED scores significantly predicted changes in EDI-2 scores and BMI (p < .01 and p < .001 respectively). Other significant predictors were BAT, SCL-90, IIP-64, BMI (p < .01-.001) (EDI-2 as outcome measure), and BAT and BDI (p < .001) (BMI as outcome measure). The results demonstrated significant improvements in attitudes towards compulsive exercise during treatment and follow-up. The change in compulsive exercise scores predicted the longer-term course of eating disorder symptoms and BMI.
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
Estimating scaled treatment effects with multiple outcomes.

PubMed

Kennedy, Edward H; Kangovi, Shreya; Mitra, Nandita

2017-01-01

In classical study designs, the aim is often to learn about the effects of a treatment or intervention on a single outcome; in many modern studies, however, data on multiple outcomes are collected and it is of interest to explore effects on multiple outcomes simultaneously. Such designs can be particularly useful in patient-centered research, where different outcomes might be more or less important to different patients. In this paper, we propose scaled effect measures (via potential outcomes) that translate effects on multiple outcomes to a common scale, using mean-variance and median-interquartile range based standardizations. We present efficient, nonparametric, doubly robust methods for estimating these scaled effects (and weighted average summary measures), and for testing the null hypothesis that treatment affects all outcomes equally. We also discuss methods for exploring how treatment effects depend on covariates (i.e., effect modification). In addition to describing efficiency theory for our estimands and the asymptotic behavior of our estimators, we illustrate the methods in a simulation study and a data analysis. Importantly, and in contrast to much of the literature concerning effects on multiple outcomes, our methods are nonparametric and can be used not only in randomized trials to yield increased efficiency, but also in observational studies with high-dimensional covariates to reduce confounding bias.
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
Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial.

PubMed

Ismail-Beigi, Faramarz; Craven, Timothy; Banerji, Mary Ann; Basile, Jan; Calles, Jorge; Cohen, Robert M; Cuddihy, Robert; Cushman, William C; Genuth, Saul; Grimm, Richard H; Hamilton, Bruce P; Hoogwerf, Byron; Karl, Diane; Katz, Lois; Krikorian, Armand; O'Connor, Patrick; Pop-Busui, Rodica; Schubart, Ulrich; Simmons, Debra; Taylor, Harris; Thomas, Abraham; Weiss, Daniel; Hramiak, Irene

2010-08-07

Hyperglycaemia is associated with increased risk of cardiovascular complications in people with type 2 diabetes. We investigated whether reduction of blood glucose concentration decreases the rate of microvascular complications in people with type 2 diabetes. ACCORD was a parallel-group, randomised trial done in 77 clinical sites in North America. People with diabetes, high HbA(1c) concentrations (>7.5%), and cardiovascular disease (or >or=2 cardiovascular risk factors) were randomly assigned by central randomisation to intensive (target haemoglobin A(1c) [HbA(1c)] of <6.0%) or standard (7.0-7.9%) glycaemic therapy. In this analysis, the prespecified composite outcomes were: dialysis or renal transplantation, high serum creatinine (>291.7 micromol/L), or retinal photocoagulation or vitrectomy (first composite outcome); or peripheral neuropathy plus the first composite outcome (second composite outcome). 13 prespecified secondary measures of kidney, eye, and peripheral nerve function were also assessed. Investigators and participants were aware of treatment group assignment. Analysis was done for all patients who were assessed for microvascular outcomes, on the basis of treatment assignment, irrespective of treatments received or compliance to therapies. ACCORD is registered with ClinicalTrials.gov, number NCT00000620. 10 251 patients were randomly assigned, 5128 to the intensive glycaemia control group and 5123 to standard group. Intensive therapy was stopped before study end because of higher mortality in that group, and patients were transitioned to standard therapy. At transition, the first composite outcome was recorded in 443 of 5107 patients in the intensive group versus 444 of 5108 in the standard group (HR 1.00, 95% CI 0.88-1.14; p=1.00), and the second composite outcome was noted in 1591 of 5107 versus 1659 of 5108 (0.96, 0.89-1.02; p=0.19). Results were similar at study end (first composite outcome 556 of 5119 vs 586 of 5115 [HR 0.95, 95% CI 0.85-1.07, p=0.42]; and second 1956 of 5119 vs 2046 of 5115, respectively [0.95, 0.89-1.01, p=0.12]). Intensive therapy did not reduce the risk of advanced measures of microvascular outcomes, but delayed the onset of albuminuria and some measures of eye complications and neuropathy. Seven secondary measures at study end favoured intensive therapy (p<0.05). Microvascular benefits of intensive therapy should be weighed against the increase in total and cardiovascular disease-related mortality, increased weight gain, and high risk for severe hypoglycaemia. US National Institutes of Health; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Aging; National Eye Institute; Centers for Disease Control and Prevention; and General Clinical Research Centers. Copyright 2010 Elsevier Ltd. All rights reserved.
The relationship between thoracic hyperkyphosis and the Scoliosis Research Society outcomes instrument.

PubMed

Petcharaporn, Maty; Pawelek, Jeff; Bastrom, Tracey; Lonner, Baron; Newton, Peter O

2007-09-15

A retrospective chart review and radiographic analysis. To evaluate the association between thoracic hyperkyphosis and patient quality of life measures as determined by the Scoliosis Research Society (SRS) outcomes instrument. Although validated outcomes questionnaires (e.g., Pediatric Outcomes Data Collection Instrument and SRS) have been used to evaluate patients with scoliosis, there has been little written about the effects of sagittal plane alignment on these functional outcome measurements. Data from the SRS outcomes instrument were collected from patients with thoracic hyperkyphosis as well as those with normal spinal alignment. A total of 50 patients with thoracic kyphosis >or=45 degrees were compared with 50 normal patients with thoracic kyphosis <45 degrees . Correlation analysis was performed to identify significant relationships between the magnitude of the major kyphotic curve and the 4 SRS outcome questionnaire domains (Total Pain, General Self-Image, General Function, and Activity). Lower SRS scores indicate an increase in symptoms. The average age of the subjects was 14 +/- 4 years (range, 8-18 years). The thoracic kyphosis varied between 11 degrees and 95 degrees for all subjects. Significant negative correlations were found between kyphosis magnitude and the total pain, general self-image, general function, overall level of activity, and total SRS scores (P < 0.0001). Of the 4 domains, self-image had the highest correlation with kyphosis magnitude while activity had the lowest. These findings indicate that higher kyphosis magnitudes were associated with increased pain, lower self-image, and decreased function and activity. Patients with thoracic hyperkyphosis were significantly more symptomatic than normal subjects in all domains. The r values for this analysis of kyphosis (0.40-0.66), in fact were substantially greater than those previously reported for scoliosis magnitude versus SRS Questionnaire scores (0.16-0.26), suggesting this instrument may be even better suited for the evaluation of hyperkyphosis patients.
A meta-analysis of active video games on health outcomes among children and adolescents.

PubMed

Gao, Z; Chen, S; Pasco, D; Pope, Z

2015-09-01

This meta-analysis synthesizes current literature concerning the effects of active video games (AVGs) on children/adolescents' health-related outcomes. A total of 512 published studies on AVGs were located, and 35 articles were included based on the following criteria: (i) data-based research articles published in English between 1985 and 2015; (ii) studied some types of AVGs and related outcomes among children/adolescents and (iii) had at least one comparison within each study. Data were extracted to conduct comparisons for outcome measures in three separate categories: AVGs and sedentary behaviours, AVGs and laboratory-based exercise, and AVGs and field-based physical activity. Effect size for each entry was calculated with the Comprehensive Meta-Analysis software in 2015. Mean effect size (Hedge's g) and standard deviation were calculated for each comparison. Compared with sedentary behaviours, AVGs had a large effect on health outcomes. The effect sizes for physiological outcomes were marginal when comparing AVGs with laboratory-based exercises. The comparison between AVGs and field-based physical activity had null to moderate effect sizes. AVGs could yield equivalent health benefits to children/adolescents as laboratory-based exercise or field-based physical activity. Therefore, AVGs can be a good alternative for sedentary behaviour and addition to traditional physical activity and sports in children/adolescents. © 2015 World Obesity.
Social Cognitive Training for Schizophrenia: A Meta-Analytic Investigation of Controlled Research

PubMed Central

Kurtz, Matthew M.; Richardson, Christi L.

2012-01-01

A wealth of evidence has revealed that deficits in social cognitive skills (including facial affect recognition (FAR), social cue perception, Theory of Mind (ToM), and attributional style) are evident in schizophrenia and are linked to a variety of domains of functional outcome. In light of these associations, a growing number of studies have attempted to ameliorate these deficits as a means of improving outcome in the disorder through the use of structured behavioral training. This study used quantitative methods of meta-analysis to assess the efficacy of behavioral training programs designed to improve social cognitive function. A total of 19 studies consisting of 692 clients were aggregated from relevant databases. Outcome measures were organized according to whether they were social cognitive tests proximal to the intervention or whether they represented measures of treatment generalization (symptoms, observer-rated community, and institutional function). With respect to social cognitive measures, weighted effect-size analysis revealed that there were moderate-large effects of social cognitive training procedures on FAR (identification, d = 0.71 and discrimination, d = 1.01) and small-moderate effects of training on ToM (d = 0.46), while effects on social cue perception and attributional style were not significant. For measures of generalization, weighted effect-size analysis revealed that there were moderate-large effect on total symptoms (d = 0.68) and observer-rated community and institutional function (d = 0.78). Effects of social cognitive training programs on positive and negative symptoms of schizophrenia were nonsignificant. Moderating variables and implications for future research and treatment development are discussed. PMID:21525166

Cell assisted lipotransfer in breast augmentation and reconstruction: A systematic review of safety, efficacy, use of patient reported outcomes and study quality.

PubMed

Arshad, Zeeshaan; Karmen, Lindsey; Choudhary, Rajan; Smith, James A; Branford, Olivier A; Brindley, David A; Pettitt, David; Davies, Benjamin M

2016-12-01

Cell assisted lipotransfer serves as a novel technique for both breast reconstruction and breast augmentation. This systematic review assesses the efficacy, safety and use of patient reported outcome measures in studies involving cell assisted lipotransfer. We also carry out an objective assessment of study quality focussing on recruitment, follow-up and provide an up-to-date clinical trial landscaping analysis. Key electronic databases were searched according to PRISMA guidelines and pre-defined inclusion and exclusion criteria. Two independent reviewers examined the retrieved publications and performed data extraction. 3980 publications were identified. Following screening, 11 studies were included for full review, representing a total of 336 patients with a follow-up time ranging from six to 42 months. A degree of variation was noted in graft retention and reported satisfaction levels, although there were only three comparative studies with conflicting results. Complications occurred at a rate of 37%. Additionally, there was a paucity of objective outcomes assessments (e.g. 3D assessment modalities or validated patient reported outcome measures) in the selected studies. Cell assisted lipotransfer is a surgical technique that is currently employed sparingly within the plastic & reconstructive surgery community. Presently, further technical and outcome standardization is required, in addition to rigorous randomized controlled trials and supporting long-term follow-up data to better determine procedural safety and efficacy. Routine use of more objective outcome measures, particularly 3D assessments and validated patient reported outcome measures, will also help facilitate wider clinical adoption and establish procedural utility.
Negative control exposure studies in the presence of measurement error: implications for attempted effect estimate calibration

PubMed Central

Sanderson, Eleanor; Macdonald-Wallis, Corrie; Davey Smith, George

2018-01-01

Abstract Background Negative control exposure studies are increasingly being used in epidemiological studies to strengthen causal inference regarding an exposure-outcome association when unobserved confounding is thought to be present. Negative control exposure studies contrast the magnitude of association of the negative control, which has no causal effect on the outcome but is associated with the unmeasured confounders in the same way as the exposure, with the magnitude of the association of the exposure with the outcome. A markedly larger effect of the exposure on the outcome than the negative control on the outcome strengthens inference that the exposure has a causal effect on the outcome. Methods We investigate the effect of measurement error in the exposure and negative control variables on the results obtained from a negative control exposure study. We do this in models with continuous and binary exposure and negative control variables using analysis of the bias of the estimated coefficients and Monte Carlo simulations. Results Our results show that measurement error in either the exposure or negative control variables can bias the estimated results from the negative control exposure study. Conclusions Measurement error is common in the variables used in epidemiological studies; these results show that negative control exposure studies cannot be used to precisely determine the size of the effect of the exposure variable, or adequately adjust for unobserved confounding; however, they can be used as part of a body of evidence to aid inference as to whether a causal effect of the exposure on the outcome is present. PMID:29088358
Negative control exposure studies in the presence of measurement error: implications for attempted effect estimate calibration.

PubMed

Sanderson, Eleanor; Macdonald-Wallis, Corrie; Davey Smith, George

2018-04-01

Negative control exposure studies are increasingly being used in epidemiological studies to strengthen causal inference regarding an exposure-outcome association when unobserved confounding is thought to be present. Negative control exposure studies contrast the magnitude of association of the negative control, which has no causal effect on the outcome but is associated with the unmeasured confounders in the same way as the exposure, with the magnitude of the association of the exposure with the outcome. A markedly larger effect of the exposure on the outcome than the negative control on the outcome strengthens inference that the exposure has a causal effect on the outcome. We investigate the effect of measurement error in the exposure and negative control variables on the results obtained from a negative control exposure study. We do this in models with continuous and binary exposure and negative control variables using analysis of the bias of the estimated coefficients and Monte Carlo simulations. Our results show that measurement error in either the exposure or negative control variables can bias the estimated results from the negative control exposure study. Measurement error is common in the variables used in epidemiological studies; these results show that negative control exposure studies cannot be used to precisely determine the size of the effect of the exposure variable, or adequately adjust for unobserved confounding; however, they can be used as part of a body of evidence to aid inference as to whether a causal effect of the exposure on the outcome is present.
The development and demise of a cataract surgery database.

PubMed

Lum, Flora; Schachat, Andrew P; Jampel, Henry D

2002-03-01

The American Academy of Ophthalmology (AAO; San Francisco) launched a national eye care outcomes initiative in 1996, in response to strong interest by third-party payers and managed care in performance measurement and outcomes. The AAO's outcomes initiative NEON (National Eyecare Outcomes Network) began with the design and launch of a prospective observational registry of patients undergoing cataract surgery. Participants submitted a common set of data regarding patients' demographics, preoperative ophthalmologic history, physical exam, test results, functional status and symptoms, intraoperative procedures and events, and postoperative outcomes for all patients undergoing first or second eye cataract surgery. Between January 1, 1996, and March 30, 2001, a total of 249 ophthalmologists submitted data on 17,876 patients undergoing first or second eye surgery. All preoperative, intraoperative, and postoperative clinical data forms were submitted for 9,937 patients (55.7%). After surgery, 93% of patients achieved a best corrected visual acuity of 20/40, 89% improved their visual functioning, and 92% experienced fewer cataract-related symptoms. At the end of March 2001, NEON was discontinued because of a lack of participation and demand by members or third parties for this information. The momentum for accountability and performance measures never quite materialized into advantages for contracting for physicians or requirements by payers. In the future, more scientific evidence regarding the validity and meaning of outcome measures and differences in measurements, investment in health information technology infrastructure, use of technology to collect information at the point of care, and incentives favoring data collection and analysis will be needed to pave the way for renewed interest in outcomes.
Outcome expectations for exercise scale: utility and psychometrics.

PubMed

Resnick, B; Zimmerman, S I; Orwig, D; Furstenberg, A L; Magaziner, J

2000-11-01

The purpose of this study was to develop a measure of outcome expectations for exercise specifically for the older adult (The Outcome Expectations for Exercise [OEE] Scale), and to test the reliability and validity of this measure in a sample of older individuals. This scale was developed based on Bandura's theory of self-efficacy and the work of prior researchers in the development of measures of outcome expectations. The OEE scale, which was completed during a face-to-face interview, was tested in a sample of 175 residents in a continuing care retirement community. There was support for the internal consistency of the OEE scale (alpha coefficient of .89), and some support for reliability based on a structural equation modeling approach that used R2 estimates, although less than half of these were greater than 0.5. There was evidence of validity of the measure based on: (a) a confirmatory factor analysis in which the model fit the data (normed fit index [NFI] = .99, root mean square error of approximation [RMSEA] - .07, chi2/df = 2.8); (b) support for the hypothesis that those who exercised regularly had higher OEE scores than those who did not (F = 31.3, p < .05, eta squared = .15); and (c) a statistically significant relationship between outcome expectations and self-efficacy expectations (r = .66). This study provides some initial support for the reliability and validity of the OEE scale. Outcome expectations for exercise were related to exercise behavior in the older adult, and the OEE scale can help identify older adults with low outcome expectations for exercise. Interventions can then be implemented to help these individuals strengthen their outcome expectations, which may subsequently improve exercise behavior.
Validation of a Health Literacy Measure for Adolescents and Young Adults Diagnosed with Cancer.

PubMed

McDonald, Fiona E J; Patterson, Pandora; Costa, Daniel S J; Shepherd, Heather L

2016-03-01

Health literacy can influence long-term health outcomes. This study aimed to validate an adapted version of the Functional, Communicative and Critical Health Literacy measure for adolescent and young adult (AYA) cancer patients and survivors (N = 105; age 12-24 years). Exploratory factor analysis was used to validate the measure, and indicated that a slightly modified item structure better fit the results. Furthermore, item response theory analysis highlighted location and discrimination parameter differences among items. Acceptability of the measure was high. This is the first validation of a health literacy measure among AYAs with an illness such as cancer.
Using Rasch Analysis to Inform Rating Scale Development

ERIC Educational Resources Information Center

Van Zile-Tamsen, Carol

2017-01-01

The use of surveys, questionnaires, and rating scales to measure important outcomes in higher education is pervasive, but reliability and validity information is often based on problematic Classical Test Theory approaches. Rasch Analysis, based on Item Response Theory, provides a better alternative for examining the psychometric quality of rating…
Dyadic Interracial Interactions: A Meta-Analysis

ERIC Educational Resources Information Center

Toosi, Negin R.; Babbitt, Laura G.; Ambady, Nalini; Sommers, Samuel R.

2012-01-01

This meta-analysis examined over 40 years of research on interracial interactions by exploring 4 types of outcomes: explicit attitudes toward interaction partners, participants' self-reports of their own emotional state, nonverbal or observed behavior, and objective measures of performance. Data were collected from 108 samples (N = 12,463)…
Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback.

PubMed

Riley, William; Begun, James W; Meredith, Les; Miller, Kristi K; Connolly, Kathy; Price, Rebecca; Muri, Janet H; McCullough, Mac; Davis, Stanley

2016-12-01

To improve safety practices and reduce adverse events in perinatal units of acute care hospitals. Primary data collected from perinatal units of 14 hospitals participating in the intervention between 2008 and 2012. Baseline secondary data collected from the same hospitals between 2006 and 2007. A prospective study involving 342,754 deliveries was conducted using a quality improvement collaborative that supported three primary interventions. Primary measures include adoption of three standardized care processes and four measures of outcomes. Chart audits were conducted to measure the implementation of standardized care processes. Outcome measures were collected and validated by the National Perinatal Information Center. The hospital perinatal units increased use of all three care processes, raising consolidated overall use from 38 to 81 percent between 2008 and 2012. The harms measured by the Adverse Outcome Index decreased 14 percent, and a run chart analysis revealed two special causes associated with the interventions. This study demonstrates the ability of hospital perinatal staff to implement efforts to reduce perinatal harm using a quality improvement collaborative. Findings help inform the relationship between the use of standardized care processes, teamwork training, and improved perinatal outcomes, and suggest that a multiplicity of integrated strategies, rather than a single intervention, may be essential to achieve high reliability. © Health Research and Educational Trust.
Inadequate performance measures affecting practices, organizations and outcomes of Ontario's family health teams.

PubMed

Ashcroft, Rachelle

2014-01-01

Emphasis on quantity as the main performance measure may be posing challenges for Family Health Team (FHT) practices and organizational structures. This study asked: What healthcare practices and organizational structures are encouraged by the FHT model? An exploratory qualitative design guided by discourse analysis was used. This paper presents findings from in-depth semi-structured interviews conducted with seven policy informants and 29 FHT leaders. Participants report that performance measures value quantity and are not inclusive of the broad scope of attributes that comprise primary healthcare. Performance measures do not appear to be accurately capturing the demand for healthcare services, or the actual amount of services being provided by FHTs. RESULTS suggest that unintended consequences of performance measures may be posing challenges to access and health outcomes. It is recommended that performance measures be developed and used to measure, support and encourage FHTs to achieve the goals of PHC. Copyright © 2014 Longwoods Publishing.
Competition in health insurance markets: limitations of current measures for policy analysis.

PubMed

Scanlon, Dennis P; Chernew, Michael; Swaminathan, Shailender; Lee, Woolton

2006-12-01

Health care reform proposals often rely on increased competition in health insurance markets to drive improved performance in health care costs, access, and quality. We examine a range of data issues related to the measures of health insurance competition used in empirical studies published from 1994-2004. The literature relies exclusively on market structure and penetration variables to measure competition. While these measures are correlated, the degree of correlation is modest, suggesting that choice of measure could influence empirical results. Moreover, certain measurement issues such as the lack of data on PPO enrollment, the treatment of small firms, and omitted market characteristics also could affect the conclusions in empirical studies. Importantly, other types of measures related to competition (e.g., the availability of information on price and outcomes, degree of entry barriers, etc.) are important from both a theoretical and policy perspective, but their impact on market outcomes has not been widely studied.
Occurrences and sources of Differential Item Functioning (DIF) in patient-reported outcome measures: Description of DIF methods, and review of measures of depression, quality of life and general health

PubMed Central

Teresi, Jeanne A.; Ramirez, Mildred; Lai, Jin-Shei; Silver, Stephanie

2009-01-01

Examination of the equivalence of measures involves several levels, including conceptual equivalence of meaning, as well as quantitative tests of differential item functioning (DIF). The purpose of this review is to examine DIF in patient-reported outcomes. Reviewed were measures of self-reported depression, quality of life (QoL) and general health. Most measures of depression contained large amounts of DIF, and the impact of DIF at the scale level was typically sizeable. The studies of QoL and health measures identified a moderate amount of DIF; however, many of these studies examined only one type of DIF (uniform). Relative to DIF analyses of depression measures, less analysis of the impact of DIF on QoL and health measures was performed, and the authors of these analyses generally did not recommend remedial action, with one notable exception. While these studies represent good beginning efforts to examine measurement equivalence in patient-reported outcome measures, more cross-validation work is required using other (often larger) samples of different ethnic and language groups, as well as other methods that permit more extensive analyses of the type of DIF, together with magnitude and impact. PMID:20165561
[Shoulder disability questionnaires: a systematic review].

PubMed

Fayad, F; Mace, Y; Lefevre-Colau, M M

2005-07-01

To identify all available shoulder disability questionnaires designed to measure physical functioning and to examine those with satisfactory clinimetric quality. We used the Medline database and the "Guide des outils de mesure de l'évaluation en médecine physique et de réadaptation" textbook to search for questionnaires. Analysis took into account the development methodology, clinimetric quality of the instruments and frequency of their utilization. We classified the instruments according to the International Classification of Functioning, Disability and Health. Thirty-eight instruments have been developed to measure disease-, shoulder- or upper extremity-specific outcome. Four scales assess upper-extremity disability and 3 others shoulder disability. We found 6 scales evaluating disability and shoulder pain, 7 scales measuring the quality of life in patients with various conditions of the shoulder, 14 scales combining objective and subjective measures, 2 pain scales and 2 unclassified scales. Older instruments developed before the advent of modern measurement development methodology usually combine objective and subjective measures. Recent instruments were designed with appropriate methodology. Most are self-administered questionnaires. Numerous shoulder outcome measure instruments are available. There is no "gold standard" for assessing shoulder function outcome in the general population.
Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

PubMed Central

Varadhan, Krishna K; Neal, Keith R

2012-01-01

Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789
Mediation Analysis: A Practitioner's Guide.

PubMed

VanderWeele, Tyler J

2016-01-01

This article provides an overview of recent developments in mediation analysis, that is, analyses used to assess the relative magnitude of different pathways and mechanisms by which an exposure may affect an outcome. Traditional approaches to mediation in the biomedical and social sciences are described. Attention is given to the confounding assumptions required for a causal interpretation of direct and indirect effect estimates. Methods from the causal inference literature to conduct mediation in the presence of exposure-mediator interactions, binary outcomes, binary mediators, and case-control study designs are presented. Sensitivity analysis techniques for unmeasured confounding and measurement error are introduced. Discussion is given to extensions to time-to-event outcomes and multiple mediators. Further flexible modeling strategies arising from the precise counterfactual definitions of direct and indirect effects are also described. The focus throughout is on methodology that is easily implementable in practice across a broad range of potential applications.
IRT Analysis of General Outcome Measures in Grades 1-8. Technical Report # 0916

ERIC Educational Resources Information Center

Alonzo, Julie; Anderson, Daniel; Tindal, Gerald

2009-01-01

We present scaling outcomes for mathematics assessments used in the fall to screen students at risk of failing to learn the knowledge and skills described in the National Council of Teachers of Mathematics (NCTM) Focal Point Standards. At each grade level, the assessment consisted of a 48-item test with three 16-item sub-test sets aligned to the…
The Changing Association between Prenatal Participation in WIC and Birth Outcomes in New York City

ERIC Educational Resources Information Center

Joyce, Ted; Gibson, Diane; Colman, Silvie

2005-01-01

We analyze the relationship between prenatal WIC participation and birth outcomes in New York City from 1988 - 2001. The analysis is unique for several reasons. First, we have over 800,000 births to women on Medicaid, the largest sample ever used to analyze prenatal participation in WIC. Second, we focus on measures of fetal growth distinct from…
A Cross-Sectional Review of Reporting Variation in Postoperative Bowel Dysfunction After Rectal Cancer Surgery.

PubMed

Chapman, Stephen J; Bolton, William S; Corrigan, Neil; Young, Neville; Jayne, David G

2017-02-01

Postoperative bowel dysfunction affects quality of life after sphincter-preserving rectal cancer surgery, but the extent of the problem is not clearly defined because of inconsistent outcome measures used to characterize the condition. The purpose of this study was to assess variation in the reporting of postoperative bowel dysfunction and to make recommendations for standardization in future studies. If possible, a quantitative synthesis of bowel dysfunction symptoms was planned. MEDLINE and EMBASE databases, as well as the Cochrane Library, were queried systematically between 2004 and 2015. The studies selected reported at least 1 component of bowel dysfunction after resection of rectal cancer. The main outcome measures were reporting, measurement, and definition of postoperative bowel dysfunction. Of 5428 studies identified, 234 met inclusion criteria. Widely reported components of bowel dysfunction were incontinence to stool (227/234 (97.0%)), frequency (168/234 (71.8%)), and incontinence to flatus (158/234 (67.5%)). Urgency and stool clustering were reported less commonly, with rates of 106 (45.3%) of 234 and 61 (26.1%) of 234. Bowel dysfunction measured as a primary outcome was associated with better reporting (OR = 3.49 (95% CI, 1.99-6.23); p < 0.001). Less than half of the outcomes were assessed using a dedicated research tool (337/720 (46.8%)), and the remaining descriptive measures were infrequently defined (56/383 (14.6%)). Heterogeneity in the reporting, measurement, and definition of postoperative bowel dysfunction precluded pooling of results and limited interpretation. Considerable variation exists in the reporting, measurement, and definition of postoperative bowel dysfunction. These inconsistencies preclude reliable estimates of incidence and meta-analysis. A broadly accepted outcome measure may address this deficit in future studies.
Potential Bedside Utility of the Clock-Drawing Test in Evaluating Rapid Therapeutic Response in the Natural Course of Schizophrenia: A Preliminary Study.

PubMed

Ransing, Ramdas Sarjerao; Khairkar, Praveen Homdeorao; Mishra, Kshirod; Sakekar, Gajanan

2017-01-01

The Clock-Drawing Test (CDT) is a brief, relatively time-efficient, easy to administer at bedside, and well-proven cognitive screening test that assesses a broad range of cognitive abilities in stroke, delirium, and dementia. However, challenges of comprehensive therapeutic outcome evaluations in schizophrenia can also be potentially overcome using CDT. The authors aimed to measure the therapeutic outcome using CDT in 101 schizophrenia patients, irrespective of their diagnostic subtypes. A repeated measures analysis of variance found that improvements on CDT and the Positive and Negative Syndrome Scale were closely correlated, reflecting critical information about therapeutic response measures in schizophrenia.
Value in cardiovascular care.

PubMed

Bradley, Steven M; Strauss, Craig E; Ho, P Michael

2017-08-01

Healthcare value, defined as health outcomes achieved relative to the costs of care, has been proposed as a unifying approach to measure improvements in the quality and affordability of healthcare. Although value is of increasing interest to payers, many providers remain unfamiliar with how value differs from other approaches to the comparison of cost and outcomes (ie, cost-effectiveness analysis). While cost-effectiveness studies can be used by policy makers and payers to inform decisions about coverage and reimbursement for new therapies, the assessment of healthcare can guide improvements in the delivery of healthcare to achieve better outcomes at lower cost. Comparison on value allows for the identification of healthcare delivery organisations or care delivery settings where patient outcomes have been optimised at a lower cost. Gaps remain in the measurement of healthcare value, particularly as it relates to patient-reported health status (symptoms, functional status and health-related quality of life). The use of technology platforms that capture health status measures with minimal disruption to clinical workflow (ie, web portals, automated telephonic systems and tablets to facilitate capture outside of in-person clinical interaction) is facilitating use of health status measures to improve clinical care and optimise patient outcomes. Furthermore, the use of a value framework has catalysed quality improvement efforts and research to seek better patient outcomes at lower cost. © 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.

Psychometric evaluation of an inpatient consumer survey measuring satisfaction with psychiatric care.

PubMed

Ortiz, Glorimar; Schacht, Lucille

2012-01-01

Measurement of consumers' satisfaction in psychiatric settings is important because it has been correlated with improved clinical outcomes and administrative measures of high-quality care. These consumer satisfaction measurements are actively used as performance measures required by the accreditation process and for quality improvement activities. Our objectives were (i) to re-evaluate, through exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), the structure of an instrument intended to measure consumers' satisfaction with care in psychiatric settings and (ii) to examine and publish the psychometric characteristics, validity and reliability, of the Inpatient Consumer Survey (ICS). To psychometrically test the structure of the ICS, 34 878 survey results, submitted by 90 psychiatric hospitals in 2008, were extracted from the Behavioral Healthcare Performance Measurement System (BHPMS). Basic descriptive item-response and correlation analyses were performed for total surveys. Two datasets were randomly created for analysis. A random sample of 8229 survey results was used for EFA. Another random sample of 8261 consumer survey results was used for CFA. This same sample was used to perform validity and reliability analyses. The item-response analysis showed that the mean range for a disagree/agree five-point scale was 3.10-3.94. Correlation analysis showed a strong relationship between items. Six domains (dignity, rights, environment, empowerment, participation, and outcome) with internal reliabilities between good to moderate (0.87-0.73) were shown to be related to overall care satisfaction. Overall reliability for the instrument was excellent (0.94). Results from CFA provided support for the domains structure of the ICS proposed through EFA. The overall findings from this study provide evidence that the ICS is a reliable measure of consumer satisfaction in psychiatric inpatient settings. The analysis has shown the ICS to provide valid and reliable results and to focus on the specific concerns of consumers of psychiatric inpatient care. Scores by item indicate that opportunity for improvement exists across healthcare organizations.
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.
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.
Evaluation of Internal Construct Validity and Unidimensionality of the Brachial Assessment Tool, A Patient-Reported Outcome Measure for Brachial Plexus Injury.

PubMed

Hill, Bridget; Pallant, Julie; Williams, Gavin; Olver, John; Ferris, Scott; Bialocerkowski, Andrea

2016-12-01

To evaluate the internal construct validity and dimensionality of a new patient-reported outcome measure for people with traumatic brachial plexus injury (BPI) based on the International Classification of Functioning, Disability and Health definition of activity. Cross-sectional study. Outpatient clinics. Adults (age range, 18-82y) with a traumatic BPI (N=106). There were 106 people with BPI who completed a 51-item 5-response questionnaire. Responses were analyzed in 4 phases (missing responses, item correlations, exploratory factor analysis, and Rasch analysis) to evaluate the properties of fit to the Rasch model, threshold response, local dependency, dimensionality, differential item functioning, and targeting. Not applicable, as this study addresses the development of an outcome measure. Six items were deleted for missing responses, and 10 were deleted for high interitem correlations >.81. The remaining 35 items, while demonstrating fit to the Rasch model, showed evidence of local dependency and multidimensionality. Items were divided into 3 subscales: dressing and grooming (8 items), arm and hand (17 items), and no hand (6 items). All 3 subscales demonstrated fit to the model with no local dependency, minimal disordered thresholds, no unidimensionality or differential item functioning for age, time postinjury, or self-selected dominance. Subscales were combined into 3 subtests and demonstrated fit to the model, no misfit, and unidimensionality, allowing calculation of a summary score. This preliminary analysis supports the internal construct validity of the Brachial Assessment Tool, a unidimensional targeted 4-response patient-reported outcome measure designed to solely assess activity after traumatic BPI regardless of level of injury, age at recruitment, premorbid limb dominance, and time postinjury. Further examination is required to determine test-retest reliability and responsiveness. Copyright Â© 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Clinical relevance of gait research applied to clinical trials in spinal cord injury.

PubMed

Ditunno, John; Scivoletto, Giorgio

2009-01-15

The restoration of walking function following SCI is extremely important to consumers and has stimulated a response of new treatments by scientists, the pharmaceutical industry and clinical entrepreneurs. Several of the proposed interventions: (1) the use of functional electrical stimulation (FES) and (2) locomotor training have been examined in clinical trials and recent reviews of the scientific literature. Each of these interventions is based on research of human locomotion. Therefore, the systematic study of walking function and gait in normal individuals and those with injury to the spinal cord has contributed to the identification of the impairments of walking, the development of new treatments and how they will be measured to determine effectiveness. In this context gait research applied to interventions to improve walking function is of high clinical relevance. This research helps identify walking impairments to be corrected and measures of walking function to be utilized as endpoints for clinical trials. The most common impairments following SCI diagnosed by observational gait analysis include inadequate hip extension during stance, persistent plantar flexion and hip/knee flexion during swing and foot placement at heel strike. FES has been employed as one strategy for correcting these impairments based on analysis that range from simple measures of speed, cadence and stride length to more sophisticated systems of three- dimensional video motion analysis and multichannel EMG tracings of integrated walking. A recent review of the entire FES literature identified 36 studies that merit comment and the full range of outcome measures for walking function were used from simple velocity to the video analysis of motion. In addition to measures of walking function developed for FES interventions, the first randomized multicenter clinical trial on locomotor training in subacute SCI was recently published with an extensive review of these measures. In this study outcome measures of motor strength (impairment), balance, Walking Index for SCI (WISCI), speed, 5min walk (walking capacities) and locomotor functional independence measure (L-FIM), a disability measure all showed improvement in walking function based on the strategy of the response of activity based plasticity to step training. Although the scientific basis for this intervention will be covered in other articles in this series, the evolution of clinical outcome measures of walking function continues to be important for the determination of effectiveness in clinical trials.
Total disc arthroplasty versus anterior cervical interbody fusion: use of the Spine Tango registry to supplement the evidence from randomized control trials.

PubMed

Staub, Lukas P; Ryser, Christoph; Röder, Christoph; Mannion, Anne F; Jarvik, Jeffrey G; Aebi, Max; Aghayev, Emin

2016-02-01

Several randomized controlled trials (RCTs) have compared patient outcomes of anterior (cervical) interbody fusion (AIF) with those of total disc arthroplasty (TDA). Because RCTs have known limitations with regard to their external validity, the comparative effectiveness of the two therapies in daily practice remains unknown. This study aimed to compare patient-reported outcomes after TDA versus AIF based on data from an international spine registry. A retrospective analysis of registry data was carried out. Inclusion criteria were degenerative disc or disc herniation of the cervical spine treated by single-level TDA or AIF, no previous surgery, and a Core Outcome Measures Index (COMI) completed at baseline and at least 3 months' follow-up. Overall, 987 patients were identified. Neck and arm pain relief and COMI score improvement were the outcome measures. Three separate analyses were performed to compare TDA and AIF surgical outcomes: (1) mimicking an RCT setting, with admission criteria typical of those in published RCTs, a 1:1 matched analysis was carried out in 739 patients; (2) an analysis was performed on 248 patients outside the classic RCT spectrum, that is, with one or more typical RCT exclusion criteria; (3) a subgroup analysis of all patients with additional follow-up longer than 2 years (n=149). Matching resulted in 190 pairs with an average follow-up of 17 months that had no residual significant differences for any patient characteristics. Small but statistically significant differences in outcome were observed in favor of TDA, which are potentially clinically relevant. Subgroup analyses of atypical patients and of patients with longer-term follow-up showed no significant differences in outcome between the treatments. The results of this observational study were in accordance with those of the published RCTs, suggesting substantial pain reduction both after AIF and TDA, with slightly greater benefit after arthroplasty. The analysis of atypical patients suggested that, in patients outside the spectrum of clinical trials, both surgical interventions appeared to work to a similar extent to that shown for the cohort in the matched study. Also, in the longer-term perspective, both therapies resulted in similar benefits to the patients. Copyright © 2015 Elsevier Inc. All rights reserved.
The EXCITE Trial: Predicting a Clinically Meaningful Motor Activity Log Outcome

PubMed Central

Park, Si-Woon; Wolf, Steven L.; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S.

2013-01-01

Background and Objective This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. Methods A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Results Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Conclusions Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT. PMID:18780883
The EXCITE Trial: Predicting a clinically meaningful motor activity log outcome.

PubMed

Park, Si-Woon; Wolf, Steven L; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S

2008-01-01

This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT.
Reducing turnover is not enough: The need for proficient organizational cultures to support positive youth outcomes in child welfare.

PubMed

Williams, Nathaniel J; Glisson, Charles

2013-11-01

High caseworker turnover has been identified as a factor in the poor outcomes of child welfare services. However, almost no empirical research has examined the relationship between caseworker turnover and youth outcomes in child welfare systems and there is an important knowledge gap regarding whether, and how, caseworker turnover relates to outcomes for youth. We hypothesized that the effects of caseworker turnover are moderated by organizational culture such that reduced caseworker turnover is only associated with improved youth outcomes in organizations with proficient cultures. The study applied hierarchical linear models (HLM) analysis to the second National Survey of Child and Adolescent Well-being (NSCAW II) with a U.S. nationwide sample of 2,346 youth aged 1.5- to 18-years-old and 1,544 caseworkers in 73 child welfare agencies. Proficient organizational culture was measured by caseworkers' responses to the Organizational Social Context (OSC) measure; staff turnover was reported by the agencies' directors; and youth outcomes were measured as total problems in psychosocial functioning with the Child Behavior Checklist (CBCL) completed by the youths' caregivers at intake and at 18 month follow-up. The association between caseworker turnover and youth outcomes was moderated by organizational culture. Youth outcomes were improved with lower staff turnover in proficient organizational cultures and the best outcomes occurred in organizations with low turnover and high proficiency. To be successful, efforts to improve child welfare services by lowering staff turnover must also create proficient cultures that expect caseworkers to be competent and responsive to the needs of the youth and families they serve.
Do postoperative radiographically verified technical success, improved cosmesis, and trunk shift corroborate with patient-reported outcomes in Lenke 1C adolescent idiopathic scoliosis?

PubMed

Sharma, Shallu; Bünger, Cody Eric; Andersen, Thomas; Sun, Haolin; Wu, Chunsen; Hansen, Ebbe Stender

2015-07-01

To examine correlation between postoperative radiographic and cosmetic improvements in Lenke 1C adolescent idiopathic scoliosis (AIS) with patients' self-rated outcomes of health and disability at follow-up as determined by the Scoliosis Research Society questionnaire (SRS-30), Oswestry Disability Index score (ODI) and measure of overall health quality Euroqol-5d (EQ-5D). 24 Lenke 1C scoliosis patients, mean age 16.5 (12.8-38.1) years, treated with posterior pedicle screw-only construct, were included. The coronal profile indices (radiographic and cosmetic) regarding magnitude of spinal deformity and truncal balance were measured preoperatively, postoperatively and at final follow-up. A comprehensive index of overall back symmetry was also measured by means of the Posterior Trunk Symmetry Index (POTSI). Pearson's correlation analysis determined the association between the radiographic-cosmetic indices and patient-rated outcomes. Mean follow-up for the cohort was 4.4 (±1.86) years. The thoracic apical vertebra-first thoracic vertebra horizontal distance (AV-TI) correction had significant correlation with function, self-image, and mental health SRS-30 scores (0.55, 0.54, 0.66). Similarly, thoracic apical vertebra horizontal translation from central sacral vertical line (AV-CSVL) correction at follow-up had significant correlation with self-image and management domains (0.57, 0.50). Follow-up POTSI correlated well with SRS-30 and EQ-5D scores (r = -0.64, -0.54). Postoperative leftward trunk shift/spinal imbalance did not influence overall cosmesis and outcomes; significant spinal realignment was evident in follow-up resulting in physiological balance and acceptable cosmesis and outcomes. Significant, but less than "perfect" correlations were observed between the radiographic, cosmetic measures and patient-rated outcomes. Thoracic AV-CSVL, AV-T1 correction and POTSI associated significantly with SRS-30 scores. Whereas, thoracic Cobb angle, Cobb correction, and coronal balance did not correlate with any patient-rated outcome measure. It is, therefore, inferred that the patients-rated subjective outcomes are only poorly reflected by the objectively measured radiographic and cosmetic measures of deformity correction.
Measuring Outcomes in a Community Resilience Program: A New Metric for Evaluating Results at the Household Level

PubMed Central

Eisenman, David P.; Adams, Rachel M.; Rivard, Helene

2016-01-01

Community resilience programs require metrics for evaluation but none exist for measuring outcomes at the household and neighborhood level. Objectives: We develop and describe a new index, the LACCDR index of community resilience, to examine how resilience varied across communities at baseline, prior to implementation of the Los Angeles County Community Disaster Resilience Project (LACCDR). Methods: We surveyed 4700 adult residents in the sixteen LACCDR communities in English, Spanish and Korean. Each of the survey domains were selected a priori as outcome indicators aligned to the theoretical levers of community resilience. Survey questions were drawn and adapted from published studies and national surveys. Results: Factor analysis demonstrated five separate factors composed from 18 items and explaining 46.7% of the variance. The factors were characterized as community engagement, emergency supplies, communication with neighbors, civic engagement, and collective efficacy. Baseline results for the 16 communities are provided. Conclusions: We conclude that the LACCDR community resilience index can be used to measure resilience program outcomes at the neighborhood and household levels. PMID:27807510
A Comparative Analysis of the Validity of US State- and County-Level Social Capital Measures and Their Associations with Population Health

ERIC Educational Resources Information Center

Lee, Chul-Joo; Kim, Daniel

2013-01-01

The goals of this study were to validate a number of available collective social capital measures at the US state and county levels, and to examine the relative extent to which these social capital measures are associated with population health outcomes. Measures of social capital at the US state level included aggregate indices based on the…
The Long-Term Conditions Questionnaire: conceptual framework and item development

PubMed Central

Peters, Michele; Potter, Caroline M; Kelly, Laura; Hunter, Cheryl; Gibbons, Elizabeth; Jenkinson, Crispin; Coulter, Angela; Forder, Julien; Towers, Ann-Marie; A’Court, Christine; Fitzpatrick, Ray

2016-01-01

Purpose To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions. Materials and methods Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions. Results Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire. Conclusion The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey. PMID:27621678
Bayesian inference for joint modelling of longitudinal continuous, binary and ordinal events.

PubMed

Li, Qiuju; Pan, Jianxin; Belcher, John

2016-12-01

In medical studies, repeated measurements of continuous, binary and ordinal outcomes are routinely collected from the same patient. Instead of modelling each outcome separately, in this study we propose to jointly model the trivariate longitudinal responses, so as to take account of the inherent association between the different outcomes and thus improve statistical inferences. This work is motivated by a large cohort study in the North West of England, involving trivariate responses from each patient: Body Mass Index, Depression (Yes/No) ascertained with cut-off score not less than 8 at the Hospital Anxiety and Depression Scale, and Pain Interference generated from the Medical Outcomes Study 36-item short-form health survey with values returned on an ordinal scale 1-5. There are some well-established methods for combined continuous and binary, or even continuous and ordinal responses, but little work was done on the joint analysis of continuous, binary and ordinal responses. We propose conditional joint random-effects models, which take into account the inherent association between the continuous, binary and ordinal outcomes. Bayesian analysis methods are used to make statistical inferences. Simulation studies show that, by jointly modelling the trivariate outcomes, standard deviations of the estimates of parameters in the models are smaller and much more stable, leading to more efficient parameter estimates and reliable statistical inferences. In the real data analysis, the proposed joint analysis yields a much smaller deviance information criterion value than the separate analysis, and shows other good statistical properties too. © The Author(s) 2014.
Improving hand functional use in subjects with multiple sclerosis using a musical keyboard: a randomized controlled trial.

PubMed

Gatti, Roberto; Tettamanti, Andrea; Lambiase, Simone; Rossi, Paolo; Comola, Mauro

2015-06-01

Playing an instrument implies neuroplasticity in different cerebral regions. This phenomenon has been described in subjects with stroke, suggesting that it could play a role in hand rehabilitation. The aim of this study is to analyse the effectiveness of playing a musical keyboard in improving hand function in subjects with multiple sclerosis. Nineteen hospitalized subjects were randomized in two groups: nine played a turned-on musical keyboard by sequences of fingers movements (audio feedback present) and 10 performed the same exercises on a turned-off musical keyboard (audio feedback absent). Training duration was half an hour per day for 15 days. Primary outcome was the perceived hand functional use measured by ABILHAND Questionnaire. Secondary outcomes were hand dexterity, measured by Nine-Hole Peg Test, and hand strength, measured by Jamar and Pinch dynamometers. Two-way analysis of variance was used for data analysis. The interaction time × group was significant (p = 0.003) for ABILHAND Questionnaire in favour of experimental group (mean between-group difference 0.99 logit [IC95%: 0.44; 1.54]). The two groups showed a significant time effect for all outcomes except for Jamar measure. Playing a musical keyboard seems a valid method to train the functional use of hands in subjects with multiple sclerosis. Copyright © 2014 John Wiley & Sons, Ltd.
Patient population management: taking the leap from variance analysis to outcomes measurement.

PubMed

Allen, K M

1998-01-01

Case managers today at BCHS have a somewhat different role than at the onset of the Collaborative Practice Model. They are seen throughout the organization as: Leaders/participants on cross-functional teams. Systems change agents. Integrating/merging with quality services and utilization management. Outcomes managers. One of the major cross-functional teams is in the process of designing a Care Coordinator role. These individuals will, as one of their functions, assume responsibility for daily patient care management activities. A variance tracking program has come into the Utilization Management (UM) department as part of a software package purchased to automate UM work activities. This variance program could potentially be used by the new care coordinators as the role develops. The case managers are beginning to use a Decision Support software, (Transition Systems Inc.) in the collection of data that is based on a cost accounting system and linked to clinical events. Other clinical outcomes data bases are now being used by the case manager to help with the collection and measurement of outcomes information. Hoshin planning will continue to be a framework for defining and setting the targets for clinical and financial improvements throughout the organization. Case managers will continue to be involved in many of these system-wide initiatives. In the words of Galileo, 1579, "You need to count what's countable, measure what's measurable, and what's not measurable, make measurable."
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
Auckland Stroke Outcomes Study. Part 1: Gender, stroke types, ethnicity, and functional outcomes 5 years poststroke.

PubMed

Feigin, V L; Barker-Collo, S; Parag, V; Senior, H; Lawes, C M M; Ratnasabapathy, Y; Glen, E

2010-11-02

Studying long-term stroke outcomes including body functioning (neurologic and neuropsychological impairments) and activity limitations and participation is essential for long-term evidence-based rehabilitation and service planning, resource allocation, and improving health outcomes in stroke. However, reliable data to address these issues is lacking. This study (February 2007-December 2008) sourced its participants from the population-based incidence study conducted in Auckland in 2002-2003. Participants completed structured self-administered questionnaires, and a face-to-face interview including a battery of neuropsychological tests. Logistic regression analysis was used to analyze associations between and within functional outcomes and their potential predictors. Of 418 5-year stroke survivors, two-thirds had good functional outcome in terms of neurologic impairment and disability (defined as modified Rankin Score <3), 22.5% had cognitive impairment indicative of dementia, 20% had experienced a recurrent stroke, almost 15% were institutionalized, and 29.6% had symptoms suggesting depression. Highly significant correlations were found between and within various measurements of body functioning (especially neuropsychological impairments), activity, and participation. Age, dependency, and depression were independently associated with most outcomes analyzed. The strong associations between neuropsychological impairment and other functional outcomes and across various measurements of body functioning, activity, and participation justify utilizing a multidisciplinary approach to studying and managing long-term stroke outcomes. Observed gender and ethnic differences in some important stroke outcomes warrant further investigations.
Perinatal and maternal outcomes in planned home and obstetric unit births in women at ‘higher risk’ of complications: secondary analysis of the Birthplace national prospective cohort study

PubMed Central

Li, Y; Townend, J; Rowe, R; Brocklehurst, P; Knight, M; Linsell, L; Macfarlane, A; McCourt, C; Newburn, M; Marlow, N; Pasupathy, D; Redshaw, M; Sandall, J; Silverton, L; Hollowell, J

2015-01-01

Objective To explore and compare perinatal and maternal outcomes in women at ‘higher risk’ of complications planning home versus obstetric unit (OU) birth. Design Prospective cohort study. Setting OUs and planned home births in England. Population 8180 ‘higher risk’ women in the Birthplace cohort. Methods We used Poisson regression to calculate relative risks adjusted for maternal characteristics. Sensitivity analyses explored possible effects of differences in risk between groups and alternative outcome measures. Main outcome measures Composite perinatal outcome measure encompassing ‘intrapartum related mortality and morbidity’ (intrapartum stillbirth, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus or clavicle) and neonatal admission within 48 hours for more than 48 hours. Two composite maternal outcome measures capturing intrapartum interventions/adverse maternal outcomes and straightforward birth. Results The risk of ‘intrapartum related mortality and morbidity’ or neonatal admission for more than 48 hours was lower in planned home births than planned OU births [adjusted relative risks (RR) 0.50, 95% CI 0.31–0.81]. Adjustment for clinical risk factors did not materially affect this finding. The direction of effect was reversed for the more restricted outcome measure ‘intrapartum related mortality and morbidity’ (RR adjusted for parity 1.92, 95% CI 0.97–3.80). Maternal interventions were lower in planned home births. Conclusions The babies of ‘higher risk’ women who plan birth in an OU appear more likely to be admitted to neonatal care than those whose mothers plan birth at home, but it is unclear if this reflects a real difference in morbidity. Rates of intrapartum related morbidity and mortality did not differ statistically significantly between settings at the 5% level but a larger study would be required to rule out a clinically important difference between the groups. PMID:25603762
The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines

PubMed Central

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-01-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4–10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child’s health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. PMID:24134922

Long-term outcome of pronation-external rotation ankle fractures treated with syndesmotic screws only.

PubMed

Lambers, Kaj T A; van den Bekerom, Michel P J; Doornberg, Job N; Stufkens, Sjoerd A S; van Dijk, C Niek; Kloen, Peter

2013-09-04

There is sparse information in the literature on the outcome of Maisonneuve-type pronation-external rotation ankle fractures treated with syndesmotic screws. The primary aim of this study was to determine the long-term results of such treatment of these fractures as indicated by standardized patient-based and physician-based outcome measures. The secondary aim was to identify predictors of the outcome with use of bivariate and multivariate statistical analysis. Fifty patients with pronation-external rotation (predominantly Maisonneuve) fractures were treated with open reduction and internal fixation of the syndesmosis utilizing only one or two screws. The results were evaluated at a mean of twenty-one years after the fracture utilizing three standardized outcomes instruments: (1) the Foot and Ankle Ability Measure (FAAM), (2) the American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale, and (3) the Center for Epidemiologic Studies-Depression (CES-D) Scale. Osteoarthritis was graded according to the van Dijk and revised Takakura radiographic scoring systems. Bivariate and multivariate analyses were performed to identify predictors of long-term outcome. Forty-four (92%) of forty-eighty patients had good or excellent AOFAS scores, and forty-four (90%) of forty-nine had good or excellent FAAM scores. Arthrodesis for severe osteoarthritis was performed in two patients. Radiographic evidence of osteoarthritis was observed in twenty-four (49%) of forty-nine patients. Multivariate analysis identified pain as the most important independent predictor of long-term ankle function as indicated by the AOFAS and FAAM scores, explaining 91% and 53% of the variation in scores, respectively. Analysis of pain as the dependent variable in bivariate analyses revealed that depression, ankle range of motion, and a subsequent surgery were significantly correlated with higher pain scores. No firm conclusions could be drawn after multivariate analysis of predictors of pain. Long-term functional outcomes at a mean of twenty-one years after pronation-external rotation ankle fractures treated with one or two syndesmotic screws were good to excellent in the great majority of patients despite substantial radiographic evidence of osteoarthritis in one-half of the patients. The most important predictor of long-term functional outcome was patient-reported pain rather than physician-reported function or posttraumatic osteoarthritis. There was no significant association between radiographic signs of posttraumatic osteoarthritis and perceived pain in the present series.
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.
A model for national outcome audit in vascular surgery.

PubMed

Prytherch, D R; Ridler, B M; Beard, J D; Earnshaw, J J

2001-06-01

The aim was to model vascular surgical outcome in a national study using POSSUM scoring. One hundred and twenty-one British and Irish surgeons completed data questionnaires on patients undergoing arterial surgery under their care (mean 12 patients, range 1-49) in May/June 1998. A total of 1480 completed data records were available for logistic regression analysis using P-POSSUM methodology. Information collected included all POSSUM data items plus other factors thought to have a significant bearing on patient outcome: "extra items". The main outcome measures were death and major postoperative complications. The data were checked and inconsistent records were excluded. The remaining 1313 were divided into two sets for analysis. The first "training" set was used to obtain logistic regression models that were applied prospectively to the second "test" dataset. using POSSUM data items alone, it was possible to predict both mortality and morbidity after vascular reconstruction using P-POSSUM analysis. The addition of the "extra items" found significant in regression analysis did not significantly improve the accuracy of prediction. It was possible to predict both mortality and morbidity derived from the preoperative physiology components of the POSSUM data items alone. this study has shown that P-POSSUM methodology can be used to predict outcome after arterial surgery across a range of surgeons in different hospitals and could form the basis of a national outcome audit. It was also possible to obtain accurate models for both mortality and major morbidity from the POSSUM physiology scores alone. Copyright 2001 Harcourt Publishers Limited.
Can staff and patient perspectives on hospital safety predict harm-free care? An analysis of staff and patient survey data and routinely collected outcomes

PubMed Central

Lawton, Rebecca; O'Hara, Jane Kathryn; Sheard, Laura; Reynolds, Caroline; Cocks, Kim; Armitage, Gerry; Wright, John

2015-01-01

Background Patients have the potential to provide feedback on the safety of their care. Recently, tools have been developed that ask patients to provide feedback on those factors that are known to contribute to safety, therefore providing information that can be used proactively to manage safety in hospitals. The aim of this study was to investigate whether the safety information provided by patients is different from that provided by staff and whether it is related to safety outcomes. Method Data were collected from 33 hospital wards across 3 acute hospital Trusts in the UK. Staff on these wards were asked to complete the four outcome measures of the Hospital Survey of Patient Safety Culture, while patients were asked to complete the Patient Measure of Safety and the friends and family test. We also collated publicly reported safety outcome data for ‘harm-free care’ on each ward. This patient safety thermometer measure is used in the UK NHS to record the percentage of patients on a single day of each month on every ward who have received harm-free care (ie, no pressure ulcers, falls, urinary tract infections and hospital acquired new venous thromboembolisms). These data were used to address questions about the relationship between measures and the extent to which patient and staff perceptions of safety predict safety outcomes. Results The friends and family test, a single item measure of patient experience was associated with patients’ perceptions of safety, but was not associated with safety outcomes. Staff responses to the patient safety culture survey were not significantly correlated with patient responses to the patient measure of safety, but both independently predicted safety outcomes. The regression models showed that staff perceptions (adjusted r2=0.39) and patient perceptions (adjusted r2=0.30) of safety independently predicted safety outcomes. When entered together both measures accounted for 49% of the variance in safety outcomes (adjusted r2=0.49), suggesting that there is overlap but some unique variance is also explained by these two measures. Based on responses to the Patient Measure of Safety it was also possible to identify differences between the acute Hospital Trusts. Discussion The findings suggest that although the views of patients and staff predict some overlapping variance in patient safety outcomes, both also offer a unique perspective on patient safety, contributing independently to the prediction of safety outcomes. These findings suggest that feedback from patients about the safety of the care that they receive can be used, in addition to data from staff to drive safety improvements in healthcare. Trial registration number ISRCTN07689702. PMID:25862755
Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis

PubMed Central

Lee, Hopin; Wiggers, John; Kamper, Steven J; Williams, Amanda; O'Brien, Kate M; Hodder, Rebecca K; Yoong, Sze Lin; Campbell, Elizabeth; Haskins, Robin; Robson, Emma K; McAuley, James H; Williams, Christopher M

2017-01-01

Introduction Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. Methods and analysis Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. Ethics and dissemination The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015–0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. Trial registration number ACTRN12615000490572 and ACTRN12615000478516; Pre-results. PMID:28674135
Modeling Verdict Outcomes Using Social Network Measures: The Watergate and Caviar Network Cases

PubMed Central

2016-01-01

Modelling criminal trial verdict outcomes using social network measures is an emerging research area in quantitative criminology. Few studies have yet analyzed which of these measures are the most important for verdict modelling or which data classification techniques perform best for this application. To compare the performance of different techniques in classifying members of a criminal network, this article applies three different machine learning classifiers–Logistic Regression, Naïve Bayes and Random Forest–with a range of social network measures and the necessary databases to model the verdicts in two real–world cases: the U.S. Watergate Conspiracy of the 1970’s and the now–defunct Canada–based international drug trafficking ring known as the Caviar Network. In both cases it was found that the Random Forest classifier did better than either Logistic Regression or Naïve Bayes, and its superior performance was statistically significant. This being so, Random Forest was used not only for classification but also to assess the importance of the measures. For the Watergate case, the most important one proved to be betweenness centrality while for the Caviar Network, it was the effective size of the network. These results are significant because they show that an approach combining machine learning with social network analysis not only can generate accurate classification models but also helps quantify the importance social network variables in modelling verdict outcomes. We conclude our analysis with a discussion and some suggestions for future work in verdict modelling using social network measures. PMID:26824351
Evaluation of Liver Biomarkers as Prognostic Factors for Outcomes to Yttrium-90 Radioembolization of Primary and Secondary Liver Malignancies.

PubMed

Henrie, Adam M; Wittstrom, Kristina; Delu, Adam; Deming, Paulina

2015-09-01

The objective of this study was to examine indicators of liver function and inflammation for prognostic value in predicting outcomes to yttrium-90 radioembolization (RE). In a retrospective analysis, markers of liver function and inflammation, biomarkers required to stage liver function and inflammation, and data regarding survival, tumor response, and progression after RE were recorded. Univariate regression models were used to investigate the prognostic value of liver biomarkers in predicting outcome to RE as measured by survival, tumor progression, and radiographic and biochemical tumor response. Markers from all malignancy types were analyzed together. A subgroup analysis was performed on markers from patients with metastatic colorectal cancer. A total of 31 patients received RE from 2004 to 2014. Median survival after RE for all malignancies combined was 13.6 months (95% CI: 6.7-17.6 months). Results from an exploratory analysis of patient data suggest that liver biomarkers, including albumin concentrations, international normalized ratio, bilirubin concentrations, and the model for end-stage liver disease score, possess prognostic value in predicting outcomes to RE.
Comparing the Performance of Improved Classify-Analyze Approaches For Distal Outcomes in Latent Profile Analysis

PubMed Central

Dziak, John J.; Bray, Bethany C.; Zhang, Jieting; Zhang, Minqiang; Lanza, Stephanie T.

2016-01-01

Several approaches are available for estimating the relationship of latent class membership to distal outcomes in latent profile analysis (LPA). A three-step approach is commonly used, but has problems with estimation bias and confidence interval coverage. Proposed improvements include the correction method of Bolck, Croon, and Hagenaars (BCH; 2004), Vermunt’s (2010) maximum likelihood (ML) approach, and the inclusive three-step approach of Bray, Lanza, & Tan (2015). These methods have been studied in the related case of latent class analysis (LCA) with categorical indicators, but not as well studied for LPA with continuous indicators. We investigated the performance of these approaches in LPA with normally distributed indicators, under different conditions of distal outcome distribution, class measurement quality, relative latent class size, and strength of association between latent class and the distal outcome. The modified BCH implemented in Latent GOLD had excellent performance. The maximum likelihood and inclusive approaches were not robust to violations of distributional assumptions. These findings broadly agree with and extend the results presented by Bakk and Vermunt (2016) in the context of LCA with categorical indicators. PMID:28630602
Refining a measure of brain injury sequelae to predict postacute rehabilitation outcome: rating scale analysis of the Mayo-Portland Adaptability Inventory.

PubMed

Malec, J F; Moessner, A M; Kragness, M; Lezak, M D

2000-02-01

Evaluate the psychometric properties of the Mayo-Portland Adaptability Inventory (MPAI). Rating scale (Rasch) analysis of MPAI and principal component analysis of residuals; the predictive validity of the MPAI measures and raw scores was assessed in a sample from a day rehabilitation program. Outpatient brain injury rehabilitation. 305 persons with brain injury. A 22-item scale reflecting severity of sequelae of brain injury that contained a mix of indicators of impairment, activity, and participation was identified. Scores and measures for MPAI scales were strongly correlated and their predictive validities were comparable. Impairment, activity, and participation define a single dimension of brain injury sequelae. The MPAI shows promise as a measure of this construct.
Tutorial in Biostatistics: Instrumental Variable Methods for Causal Inference*

PubMed Central

Baiocchi, Michael; Cheng, Jing; Small, Dylan S.

2014-01-01

A goal of many health studies is to determine the causal effect of a treatment or intervention on health outcomes. Often, it is not ethically or practically possible to conduct a perfectly randomized experiment and instead an observational study must be used. A major challenge to the validity of observational studies is the possibility of unmeasured confounding (i.e., unmeasured ways in which the treatment and control groups differ before treatment administration which also affect the outcome). Instrumental variables analysis is a method for controlling for unmeasured confounding. This type of analysis requires the measurement of a valid instrumental variable, which is a variable that (i) is independent of the unmeasured confounding; (ii) affects the treatment; and (iii) affects the outcome only indirectly through its effect on the treatment. This tutorial discusses the types of causal effects that can be estimated by instrumental variables analysis; the assumptions needed for instrumental variables analysis to provide valid estimates of causal effects and sensitivity analysis for those assumptions; methods of estimation of causal effects using instrumental variables; and sources of instrumental variables in health studies. PMID:24599889
A points-based algorithm for prognosticating clinical outcome of Chiari malformation Type I with syringomyelia: results from a predictive model analysis of 82 surgically managed adult patients.

PubMed

Thakar, Sumit; Sivaraju, Laxminadh; Jacob, Kuruthukulangara S; Arun, Aditya Atal; Aryan, Saritha; Mohan, Dilip; Sai Kiran, Narayanam Anantha; Hegde, Alangar S

2018-01-01

OBJECTIVE Although various predictors of postoperative outcome have been previously identified in patients with Chiari malformation Type I (CMI) with syringomyelia, there is no known algorithm for predicting a multifactorial outcome measure in this widely studied disorder. Using one of the largest preoperative variable arrays used so far in CMI research, the authors attempted to generate a formula for predicting postoperative outcome. METHODS Data from the clinical records of 82 symptomatic adult patients with CMI and altered hindbrain CSF flow who were managed with foramen magnum decompression, C-1 laminectomy, and duraplasty over an 8-year period were collected and analyzed. Various preoperative clinical and radiological variables in the 57 patients who formed the study cohort were assessed in a bivariate analysis to determine their ability to predict clinical outcome (as measured on the Chicago Chiari Outcome Scale [CCOS]) and the resolution of syrinx at the last follow-up. The variables that were significant in the bivariate analysis were further analyzed in a multiple linear regression analysis. Different regression models were tested, and the model with the best prediction of CCOS was identified and internally validated in a subcohort of 25 patients. RESULTS There was no correlation between CCOS score and syrinx resolution (p = 0.24) at a mean ± SD follow-up of 40.29 ± 10.36 months. Multiple linear regression analysis revealed that the presence of gait instability, obex position, and the M-line-fourth ventricle vertex (FVV) distance correlated with CCOS score, while the presence of motor deficits was associated with poor syrinx resolution (p ≤ 0.05). The algorithm generated from the regression model demonstrated good diagnostic accuracy (area under curve 0.81), with a score of more than 128 points demonstrating 100% specificity for clinical improvement (CCOS score of 11 or greater). The model had excellent reliability (κ = 0.85) and was validated with fair accuracy in the validation cohort (area under the curve 0.75). CONCLUSIONS The presence of gait imbalance and motor deficits independently predict worse clinical and radiological outcomes, respectively, after decompressive surgery for CMI with altered hindbrain CSF flow. Caudal displacement of the obex and a shorter M-line-FVV distance correlated with good CCOS scores, indicating that patients with a greater degree of hindbrain pathology respond better to surgery. The proposed points-based algorithm has good predictive value for postoperative multifactorial outcome in these patients.
Assessment of a new web-based sexual concurrency measurement tool for men who have sex with men.

PubMed

Rosenberg, Eli S; Rothenberg, Richard B; Kleinbaum, David G; Stephenson, Rob B; Sullivan, Patrick S

2014-11-10

Men who have sex with men (MSM) are the most affected risk group in the United States' human immunodeficiency virus (HIV) epidemic. Sexual concurrency, the overlapping of partnerships in time, accelerates HIV transmission in populations and has been documented at high levels among MSM. However, concurrency is challenging to measure empirically and variations in assessment techniques used (primarily the date overlap and direct question approaches) and the outcomes derived from them have led to heterogeneity and questionable validity of estimates among MSM and other populations. The aim was to evaluate a novel Web-based and interactive partnership-timing module designed for measuring concurrency among MSM, and to compare outcomes measured by the partnership-timing module to those of typical approaches in an online study of MSM. In an online study of MSM aged ≥18 years, we assessed concurrency by using the direct question method and by gathering the dates of first and last sex, with enhanced programming logic, for each reported partner in the previous 6 months. From these methods, we computed multiple concurrency cumulative prevalence outcomes: direct question, day resolution / date overlap, and month resolution / date overlap including both 1-month ties and excluding ties. We additionally computed variants of the UNAIDS point prevalence outcome. The partnership-timing module was also administered. It uses an interactive month resolution calendar to improve recall and follow-up questions to resolve temporal ambiguities, combines elements of the direct question and date overlap approaches. The agreement between the partnership-timing module and other concurrency outcomes was assessed with percent agreement, kappa statistic (κ), and matched odds ratios at the individual, dyad, and triad levels of analysis. Among 2737 MSM who completed the partnership section of the partnership-timing module, 41.07% (1124/2737) of individuals had concurrent partners in the previous 6 months. The partnership-timing module had the highest degree of agreement with the direct question. Agreement was lower with date overlap outcomes (agreement range 79%-81%, κ range .55-.59) and lowest with the UNAIDS outcome at 5 months before interview (65% agreement, κ=.14, 95% CI .12-.16). All agreements declined after excluding individuals with 1 sex partner (always classified as not engaging in concurrency), although the highest agreement was still observed with the direct question technique (81% agreement, κ=.59, 95% CI .55-.63). Similar patterns in agreement were observed with dyad- and triad-level outcomes. The partnership-timing module showed strong concurrency detection ability and agreement with previous measures. These levels of agreement were greater than others have reported among previous measures. The partnership-timing module may be well suited to quantifying concurrency among MSM at multiple levels of analysis.
Are More Stringent NCLB State Accountability Systems Associated with Better Student Outcomes? An Analysis of NAEP Results across States

ERIC Educational Resources Information Center

Wei, Xin

2012-01-01

This study developed a comprehensive measure of the stringency level of NCLB states' accountability systems, including the strength of their annual measurable objectives, confidence intervals, performance indexing, retesting, minimum subgroup size, and the difficulty levels of proficiency standards. This study related accountability stringency in…
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…
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.
Measurement properties of the Health of the Nation Outcome Scales (HoNOS) family of measures: protocol for a systematic review

PubMed Central

Harris, Meredith G; Sparti, Claudia; Scheurer, Roman; Coombs, Tim; Pirkis, Jane; Ruud, Torleif; Kisely, Steve; Hanssen-Bauer, Ketil; Siqveland, Johan; Burgess, Philip M

2018-01-01

Introduction The Health of the Nation Outcome Scales (HoNOS) for adults, and equivalent measures for children and adolescents and older people, are widely used in clinical practice and research contexts to measure mental health and functional outcomes. Additional HoNOS measures have been developed for special populations and applications. Stakeholders require synthesised information about the measurement properties of these measures to assess whether they are fit for use with intended service settings and populations and to establish performance benchmarks. This planned systematic review will critically appraise evidence on the measurement properties of the HoNOS family of measures. Methods and analysis Journal articles meeting inclusion criteria will be identified via a search of seven electronic databases: MEDLINE via EBSCOhost, PsycINFO via APA PsycNET, Embase via Elsevier, Cumulative Index to Nursing and Allied Health Literature via EBSCOhost, Web of Science via Thomson Reuters, Google Scholar and the Cochrane Library. Variants of ‘Health of the Nation Outcome Scales’ or ‘HoNOS’ will be searched as text words. No restrictions will be placed on setting or language of publication. Reference lists of relevant studies and reviews will be scanned for additional eligible studies. Appraisal of reliability, validity, responsiveness and interpretability will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Feasibility/utility will be appraised using definitions and criteria derived from previous reviews. For reliability studies, we will also apply the Guidelines for Reporting Reliability and Agreement Studies to assess quality of reporting. Results will be synthesised narratively, separately for each measure, and by subgroup (eg, treatment setting, rater profession/experience or training) where possible. Meta-analyses will be undertaken where data are adequate. Ethics and dissemination Ethics approval is not required as no primary data will be collected. Outcomes will be disseminated to stakeholders via reports, journal articles and presentations at meetings and conferences. PROSPERO registration number CRD42017057871. PMID:29678991
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.
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.
“Decrease in television viewing predicts lower BMI at one year follow up in adolescents but not adults”

PubMed Central

French, Simone A.; Mitchell, Nathan R.; Hannan, Peter J.

2012-01-01

Objective To examine associations between television viewing, sugar-sweetened beverage consumption, eating out, physical activity and body weight change over 1 year. Design Secondary data analysis from randomized intervention trial. Setting Households in the community. Participants Adults (n=153) and adolescents (n=72) from the same households. Intervention(s) Households were randomized to a home-based obesity prevention intervention or to a no-intervention control group for a one-year period. Main Outcome Measure(s) Self-reported television viewing hours, diet and physical activity. Body mass index computed from measured weight and height (primary outcome measure). Analysis Mixed-model regression. Results Among adolescents, a significant prospective association was observed between decreases in television viewing hours and lower BMI z-score at one year follow-up (decreased TV hours: BMI z-score mean = 0.65; no change or increase TV hrs: BMI zscore = 0.92; p < .02). No significant prospective associations were observed among adults. Conclusions and Implications Reducing television viewing may be an effective strategy to prevent excess weight gain among adolescents. PMID:22591582
Selection into medical school: from tools to domains.

PubMed

Wilkinson, Tom M; Wilkinson, Tim J

2016-10-03

Most research into the validity of admissions tools focuses on the isolated correlations of individual tools with later outcomes. Instead, looking at how domains of attributes, rather than tools, predict later success is likely to be more generalizable. We aim to produce a blueprint for an admissions scheme that is broadly relevant across institutions. We broke down all measures used for admissions at one medical school into the smallest possible component scores. We grouped these into domains on the basis of a multicollinearity analysis, and conducted a regression analysis to determine the independent validity of each domain to predict outcomes of interest. We identified four broad domains: logical reasoning and problem solving, understanding people, communication skills, and biomedical science. Each was independently and significantly associated with performance in final medical school examinations. We identified two potential errors in the design of admissions schema that can undermine their validity: focusing on tools rather than outcomes, and including a wide range of measures without objectively evaluating the independent contribution of each. Both could be avoided by following a process of programmatic assessment for selection.

Measuring patients' perceptions of the outcomes of treatment for early prostate cancer.

PubMed

Clark, Jack A; Bokhour, Barbara G; Inui, Thomas S; Silliman, Rebecca A; Talcott, James A

2003-08-01

Compared with careful attention to the physical (eg, urinary, bowel, sexual) dysfunction that may follow treatment, little attention has been given to the behavioral, emotional, and interpersonal changes that the diagnosis of early prostate cancer and subsequent physical dysfunction may bring. To construct patient-centered measures of the outcomes of treatment for early prostate cancer. Qualitative study followed by survey of early prostate cancer patients and group of comparable patients with no history of prostate cancer. Analysis of focus groups identified relevant domains of quality of life, which were represented by Likert scale items included in survey questionnaires. Psychometric analyses of survey data defined scales evaluated with respect to internal consistency and validity. Qualitative analysis identified three domains: urinary control, sexuality, and uncertainty about the cancer and its treatment. Psychometric analysis defined 11 scales. Seven were generically relevant to most older men: urinary control (eg, embarrassment with leakage), sexual intimacy (eg, anxiety about completing intercourse), sexual confidence (eg, comfort with sexuality), marital affection (eg, emotional distance from spouse/partner), masculine self esteem (eg, feeling oneself a whole man), health worry (eg, apprehensiveness about health changes), and PSA concern (eg, closely attending to one's PSA). Four scales were specific to the treatment experience: perceived cancer control, quality of treatment decision making, regret of treatment choice, and cancer-related outlook. The scales provide definition and metrics for patient-centered research in this area. They complement measures of physical dysfunction and bring into resolution outcomes of treatment that have gone unnoticed in previous studies.
Application of a simplified definition of diastolic function in severe sepsis and septic shock.

PubMed

Lanspa, Michael J; Gutsche, Andrea R; Wilson, Emily L; Olsen, Troy D; Hirshberg, Eliotte L; Knox, Daniel B; Brown, Samuel M; Grissom, Colin K

2016-08-04

Left ventricular diastolic dysfunction is common in patients with severe sepsis or septic shock, but the best approach to categorization is unknown. We assessed the association of common measures of diastolic function with clinical outcomes and tested the utility of a simplified definition of diastolic dysfunction against the American Society of Echocardiography (ASE) 2009 definition. In this prospective observational study, patients with severe sepsis or septic shock underwent transthoracic echocardiography within 24 h of onset of sepsis (median 4.3 h). We measured echocardiographic parameters of diastolic function and used random forest analysis to assess their association with clinical outcomes (28-day mortality and ICU-free days to day 28) and thereby suggest a simplified definition. We then compared patients categorized by the ASE 2009 definition and our simplified definition. We studied 167 patients. The ASE 2009 definition categorized only 35 % of patients. Random forest analysis demonstrated that the left atrial volume index and deceleration time, central to the ASE 2009 definition, were not associated with clinical outcomes. Our simplified definition used only e' and E/e', omitting the other measurements. The simplified definition categorized 87 % of patients. Patients categorized by either ASE 2009 or our novel definition had similar clinical outcomes. In both definitions, worsened diastolic function was associated with increased prevalence of ischemic heart disease, diabetes, and hypertension. A novel, simplified definition of diastolic dysfunction categorized more patients with sepsis than ASE 2009 definition. Patients categorized according to the simplified definition did not differ from patients categorized according to the ASE 2009 definition in respect to clinical outcome or comorbidities.
Whole Blood Gene Expression Profiling Predicts Severe Morbidity and Mortality in Cystic Fibrosis: A 5-Year Follow-Up Study.

PubMed

Saavedra, Milene T; Quon, Bradley S; Faino, Anna; Caceres, Silvia M; Poch, Katie R; Sanders, Linda A; Malcolm, Kenneth C; Nichols, David P; Sagel, Scott D; Taylor-Cousar, Jennifer L; Leach, Sonia M; Strand, Matthew; Nick, Jerry A

2018-05-01

Cystic fibrosis pulmonary exacerbations accelerate pulmonary decline and increase mortality. Previously, we identified a 10-gene leukocyte panel measured directly from whole blood, which indicates response to exacerbation treatment. We hypothesized that molecular characteristics of exacerbations could also predict future disease severity. We tested whether a 10-gene panel measured from whole blood could identify patient cohorts at increased risk for severe morbidity and mortality, beyond standard clinical measures. Transcript abundance for the 10-gene panel was measured from whole blood at the beginning of exacerbation treatment (n = 57). A hierarchical cluster analysis of subjects based on their gene expression was performed, yielding four molecular clusters. An analysis of cluster membership and outcomes incorporating an independent cohort (n = 21) was completed to evaluate robustness of cluster partitioning of genes to predict severe morbidity and mortality. The four molecular clusters were analyzed for differences in forced expiratory volume in 1 second, C-reactive protein, return to baseline forced expiratory volume in 1 second after treatment, time to next exacerbation, and time to morbidity or mortality events (defined as lung transplant referral, lung transplant, intensive care unit admission for respiratory insufficiency, or death). Clustering based on gene expression discriminated between patient groups with significant differences in forced expiratory volume in 1 second, admission frequency, and overall morbidity and mortality. At 5 years, all subjects in cluster 1 (very low risk) were alive and well, whereas 90% of subjects in cluster 4 (high risk) had suffered a major event (P = 0.0001). In multivariable analysis, the ability of gene expression to predict clinical outcomes remained significant, despite adjustment for forced expiratory volume in 1 second, sex, and admission frequency. The robustness of gene clustering to categorize patients appropriately in terms of clinical characteristics, and short- and long-term clinical outcomes, remained consistent, even when adding in a secondary population with significantly different clinical outcomes. Whole blood gene expression profiling allows molecular classification of acute pulmonary exacerbations, beyond standard clinical measures, providing a predictive tool for identifying subjects at increased risk for mortality and disease progression.
Quantitative outcome measures for systemic sclerosis-related Microangiopathy - Reliability of image acquisition in Nailfold Capillaroscopy.

PubMed

Dinsdale, Graham; Moore, Tonia; O'Leary, Neil; Berks, Michael; Roberts, Christopher; Manning, Joanne; Allen, John; Anderson, Marina; Cutolo, Maurizio; Hesselstrand, Roger; Howell, Kevin; Pizzorni, Carmen; Smith, Vanessa; Sulli, Alberto; Wildt, Marie; Taylor, Christopher; Murray, Andrea; Herrick, Ariane L

2017-09-01

Nailfold capillaroscopic parameters hold increasing promise as outcome measures for clinical trials in systemic sclerosis (SSc). Their inclusion as outcomes would often naturally require capillaroscopy images to be captured at several time points during any one study. Our objective was to assess repeatability of image acquisition (which has been little studied), as well as of measurement. 41 patients (26 with SSc, 15 with primary Raynaud's phenomenon) and 10 healthy controls returned for repeat high-magnification (300×) videocapillaroscopy mosaic imaging of 10 digits one week after initial imaging (as part of a larger study of reliability). Images were assessed in a random order by an expert blinded observer and 4 outcome measures extracted: (1) overall image grade and then (where possible) distal vessel locations were marked, allowing (2) vessel density (across the whole nailfold) to be calculated (3) apex width measurement and (4) giant vessel count. Intra-rater, intra-visit and intra-rater inter-visit (baseline vs. 1week) reliability were examined in 475 and 392 images respectively. A linear, mixed-effects model was used to estimate variance components, from which intra-class correlation coefficients (ICCs) were determined. Intra-visit and inter-visit reliability estimates (ICCs) were (respectively): overall image grade, 0.97 and 0.90; vessel density, 0.92 and 0.65; mean vessel width, 0.91 and 0.79; presence of giant capillary, 0.68 and 0.56. These estimates were conditional on each parameter being measurable. Within-operator image analysis and acquisition are reproducible. Quantitative nailfold capillaroscopy, at least with a single observer, provides reliable outcome measures for clinical studies including randomised controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.
Correlations between FEV1 and patient-reported outcomes: A pooled analysis of 23 clinical trials in patients with chronic obstructive pulmonary disease.

PubMed

Donohue, James F; Jones, Paul W; Bartels, Christian; Marvel, Jessica; D'Andrea, Peter; Banerji, Donald; Morris, David G; Patalano, Francesco; Fogel, Robert

2018-04-01

In clinical trials of inhaled bronchodilators, chronic obstructive pulmonary disease (COPD) guidelines recommend that patient-reported outcomes (PROs) are assessed alongside lung function. How these endpoints are related is unclear. Pooled longitudinal data from 23 randomised controlled COPD studies were analyzed (N = 23,213). Treatments included long-acting β 2 agonists, long-acting muscarinic antagonists (LABAs or LAMAs) and the LABA/LAMA combination QVA149. Outcome measures were Transition Dyspnoea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) scores, COPD exacerbation frequency and rescue medication use. Relationships between changes in trough forced expiratory volume in one second (ΔFEV 1 ) and outcomes following treatment were assessed using correlations of data summaries and model-based analysis: generalized linear mixed-effect regression modelling to determine if ΔFEV 1 could predict patient outcomes with different treatments. Mean age was 64 years, 73% were male, and most had moderate (45%) or severe (52%) disease. Statistically significant correlations were observed between ΔFEV 1 and each outcome measure (exacerbations Rs = 0.05; rescue medication, SGRQ, TDI, r = 0.11-0.16; all p < .001). Patients with greater improvements in trough FEV 1 had on average better SGRQ and TDI scores, fewer exacerbations, and used less rescue medication. For SGRQ and TDI scores, minimal clinically important differences were observed over the range of pooled ΔFEV 1 values. Model-based predictions confirmed the treatment effect was partly explained by changes in FEV 1 from baseline with improvements in PROs observed across all treatments when trough FEV 1 improved. Across all endpoints active treatments were better than placebo (p < .0001), and LABA/LAMA treatment resulted in numerically better treatment outcomes than either monocomponent. These data suggest that FEV 1 improvements post-bronchodilation correlate with PRO improvements. Further improvements in patient outcomes may be expected by maximizing lung function improvements. Registration details for the 23 randomised controlled studies used in this pooled analysis are supplied in Additional File 4. Copyright © 2017 Elsevier Ltd. All rights reserved.
Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

PubMed Central

Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John

2017-01-01

Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding. Design Cross sectional study of randomized controlled trials (RCTs). Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013. Participants Random sample of RCTs focused on drug efficacy. Main outcome measure Association between financial ties of principal investigators and study outcome. Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9). Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base. PMID:28096109
Confirmatory Factor Analysis of a Family Quality of Life Scale for Taiwanese Families of Children with Intellectual Disability/Developmental Delay

ERIC Educational Resources Information Center

Chiu, Chun-Yu; Seo, Hyojeong; Turnbull, Ann P.; Summer, Jean Ann

2017-01-01

The Beach Center Family Quality of Life Scale is an internationally validated instrument for measuring family outcomes. To revise the scale for better alignment with the Family Quality of Life theory, the authors excluded non-outcome items in this revision. In this study, we examined reliability and validity of the revised scale (i.e., the FQoL…
Issues Relating to Selective Reporting When Including Non-Randomized Studies in Systematic Reviews on the Effects of Healthcare Interventions

ERIC Educational Resources Information Center

Norris, Susan L.; Moher, David; Reeves, Barnaby C.; Shea, Beverley; Loke, Yoon; Garner, Sarah; Anderson, Laurie; Tugwell, Peter; Wells, George

2013-01-01

Background: Selective outcome and analysis reporting (SOR and SAR) occur when only a subset of outcomes measured and analyzed in a study is fully reported, and are an important source of potential bias. Key methodological issues: We describe what is known about the prevalence and effects of SOR and SAR in both randomized controlled trials (RCTs)…
Perioperative fever and outcome in surgical patients with aneurysmal subarachnoid hemorrhage.

PubMed

Todd, Michael M; Hindman, Bradley J; Clarke, William R; Torner, James C; Weeks, Julie B; Bayman, Emine O; Shi, Qian; Spofford, Christina M

2009-05-01

We examined the incidence of perioperative fever and its relationship to outcome among patients enrolled in the Intraoperative Hypothermia for Aneurysm Surgery Trial. One thousand patients with initial World Federation of Neurological Surgeons grades of I to III undergoing clipping of intracranial aneurysms after subarachnoid hemorrhage were randomized to intraoperative normothermia (36 degrees C-37 degrees C) or hypothermia (32.5 degrees C-33.5 degrees C). Fever (> or =38.5 degrees C) and other complications (including infections) occurring between admission and discharge (or death) were recorded. Functional and neuropsychologic outcomes were assessed 3 months postoperatively. The primary outcome variable for the trial was dichotomized Glasgow Outcome Scale (good outcome versus all others). Fever was reported in 41% of patients. In 97% of these, fever occurred in the postoperative period. The median time from surgery to first fever was 3 days. All measures of outcome were worse in patients who developed fever, even in those without infections or who were World Federation of Neurological Surgeons grade I. Logistic regression analyses were performed to adjust for differences in preoperative factors (e.g., age, Fisher grade, initial neurological status). This demonstrated that fever continued to be significantly associated with most outcome measures, even when infection was added to the model. An alternative stepwise model selection process including all fever-related measures from the preoperative and intraoperative period (e.g., hydrocephalus, duration of surgery, intraoperative blood loss) resulted in the loss of significance for dichotomized Glasgow Outcome Scale, but significant associations between fever and several other outcome measures remained. After adding postoperative delayed ischemic neurological deficits to the model, only worsened National Institutes of Health Stroke Scale score, Barthel Activities of Daily Living index, and discharge destination (home versus other) remained independently associated with fever. These findings suggest that fever is associated with worsened outcome in surgical subarachnoid hemorrhage patients, although, because the association between fever and the primary outcome measure for the trial is dependent on the covariates used in the analysis (particularly operative events and delayed ischemic neurological deficits), we cannot rule out the possibility that fever is a marker for other events. Only a formal trial of fever treatment or prevention can address this issue.
Effect of routine diagnostic imaging for patients with musculoskeletal disorders: A meta-analysis.

PubMed

Karel, Yasmaine H J M; Verkerk, Karin; Endenburg, Silvio; Metselaar, Sven; Verhagen, Arianne P

2015-10-01

The increasing use of diagnostic imaging has led to high expenditures, unnecessary invasive procedures and/or false-positive diagnoses, without certainty that the patients actually benefit from these imaging procedures. This review explores whether diagnostic imaging leads to better patient-reported outcomes in individuals with musculoskeletal disorders. Databases were searched from inception to September 2013, together with scrutiny of selected bibliographies. Trials were eligible when: 1) a diagnostic imaging procedure was compared with any control group not getting or not receiving the results of imaging; 2) the population included individuals suffering from musculoskeletal disorders, and 3) if patient-reported outcomes were available. Primary outcome measures were pain and function. Secondary outcome measures were satisfaction and quality of life. Subgroup analysis was done for different musculoskeletal complaints and high technological medical imaging (MRI/CT). Eleven trials were eligible. The effects of diagnostic imaging were only evaluated in patients with low back pain (n=7) and knee complaints (n=4). Overall, there was a moderate level of evidence for no benefit of diagnostic imaging on all outcomes compared with controls. A significant but clinically irrelevant effect was found in favor of no (routine) imaging in low back pain patients in terms of pain severity at short [SMD 0.17 (0.04-0.31)] and long-term follow-up [SMD 0.13 (0.02-0.24)], and for overall improvement [RR 1.15 (1.03-1.28)]. Subgroup analysis did not significantly change these results. These results strengthen the available evidence that routine referral to diagnostic imaging by general practitioners for patients with knee and low back pain yields little to no benefit. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
Readability Level of Spanish-Language Patient-Reported Outcome Measures in Audiology and Otolaryngology

PubMed Central

Coco, Laura; Colina, Sonia; Atcherson, Samuel R.

2017-01-01

Purpose The purpose of this study was to examine the readability level of the Spanish versions of several audiology- and otolaryngology-related patient-reported outcome measures (PROMs) and include a readability analysis of 2 translation approaches when available—the published version and a “functionalist” version—using a team-based collaborative approach including community members. Method Readability levels were calculated using the Fry Graph adapted for Spanish, as well as the Fernandez-Huerta and the Spaulding formulae for several commonly used audiology- and otolaryngology-related PROMs. Results Readability calculations agreed with previous studies analyzing audiology-related PROMs in English and demonstrated many Spanish-language PROMs were beyond the 5th grade reading level suggested for health-related materials written for the average population. In addition, the functionalist versions of the PROMs yielded lower grade-level (improved) readability levels than the published versions. Conclusion Our results suggest many of the Spanish-language PROMs evaluated here are beyond the recommended readability levels and may be influenced by the approach to translation. Moreover, improved readability may be possible using a functionalist approach to translation. Future analysis of the suitability of outcome measures and the quality of their translations should move beyond readability and include an evaluation of the individual's comprehension of the written text. PMID:28892821
A systematic review of types and efficacy of online interventions for cancer patients.

PubMed

McAlpine, Heidi; Joubert, Lynette; Martin-Sanchez, Fernando; Merolli, Mark; Drummond, Katharine J

2015-03-01

This review examines the evidence-based literature surrounding the use of online resources for adult cancer patients. The focus is online resources that connect patients with their healthcare clinician and with supportive and educational resources, their efficacy and the outcome measures used to assess them. The following databases were systematically searched for relevant literature: MEDLINE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, Inspec and Computers and Applied Science. Included were studies conducted in an outpatient setting, and reporting a measurable, clinically relevant outcome. Fourteen studies satisfied the inclusion criteria. The efficacy of online interventions was varied, with some demonstrating positive effects on quality of life and related measures, and two demonstrating poorer outcomes for intervention participants. The majority of interventions reported mixed results. Included interventions were too heterogeneous for meta-analysis. The overall benefit of online interventions for cancer patients is unclear. Although there is a plethora of interventions reported without analysis, current interventions demonstrate mixed efficacy of limited duration when rigorously evaluated. The efficacy of on-line interventions for cancer patients is unclear. All on-line interventions should be developed using the available evidence-base and rigorously evaluated to expand our understanding of this area. Crown Copyright © 2014. Published by Elsevier Ireland Ltd. All rights reserved.
Preoperative Nutritional Status as an Adjunct Predictor of Major Postoperative Complications Following Anterior Cervical Discectomy and Fusion.

PubMed

Fu, Michael C; Buerba, Rafael A; Grauer, Jonathan N

2016-05-01

Retrospective analysis of the National Surgical Quality Improvement Program (NSQIP), a prospectively collected multicenter surgical outcomes database. To determine the effect of preoperative nutritional status, as measured by serum albumin concentration, on outcomes following anterior cervical discectomy and fusion (ACDF). Nutritional status has been shown to be an important predictor of postoperative recovery and outcomes. Serum albumin concentration is an established marker of overall nutrition and systemic disease, however, its correlation to outcomes following ACDF is unknown. ACDF cases from 2005 to 2010 were identified in the NSQIP and categorized by preoperative serum albumin: normal (≥3.5 g/dL), hypoalbuminemic (<3.5 g/dL), or not measured. Independent demographic and comorbidity variables were assessed, including American Society of Anesthesiologists (ASA) classification. Risk factors for major postoperative complications were identified, including preoperative hypoalbuminemia, and incorporated into a multivariable logistic regression model to determine the strength of preoperative hypoalbuminemia as an adjusted predictor of major postoperative complications. There were 3671 ACDF cases, of which 1382 (37.6%) had preoperative albumin measurements. Patients with albumin measurements were older and more likely to have higher ASA class, hypertension, and diabetes. Hypoalbuminemic patients had higher rates of having any major postoperative complication(s), specifically pulmonary complications, cardiac complications, and reoperation, relative to those with normal albumin (all P<0.01). These patients also had longer lengths of stay (5.0 vs. 1.9 d). With multivariable regression, preoperative hypoalbuminemia was a strong independent predictor of major postoperative complications, with an adjusted odds ratio of 3.37 (P=0.003). In this analysis of a prospective surgical outcomes database, preoperative serum hypoalbuminemia was an important adjunct predictor of major complications following ACDF. In high-risk patients with multiple medical comorbidities, we recommend that clinicians consider nutritional screening and optimization as part of preoperative risk assessment.
Classification of comorbidity in trauma: the reliability of pre-injury ASA physical status classification.

PubMed

Ringdal, Kjetil G; Skaga, Nils Oddvar; Steen, Petter Andreas; Hestnes, Morten; Laake, Petter; Jones, J Mary; Lossius, Hans Morten

2013-01-01

Pre-injury comorbidities can influence the outcomes of severely injured patients. Pre-injury comorbidity status, graded according to the American Society of Anesthesiologists Physical Status (ASA-PS) classification system, is an independent predictor of survival in trauma patients and is recommended as a comorbidity score in the Utstein Trauma Template for Uniform Reporting of Data. Little is known about the reliability of pre-injury ASA-PS scores. The objective of this study was to examine whether the pre-injury ASA-PS system was a reliable scale for grading comorbidity in trauma patients. Nineteen Norwegian trauma registry coders were invited to participate in a reliability study in which 50 real but anonymised patient medical records were distributed. Reliability was analysed using quadratic weighted kappa (κ(w)) analysis with 95% CI as the primary outcome measure and unweighted kappa (κ) analysis, which included unknown values, as a secondary outcome measure. Fifteen of the invitees responded to the invitation, and ten participated. We found moderate (κ(w)=0.77 [95% CI: 0.64-0.87]) to substantial (κ(w)=0.95 [95% CI: 0.89-0.99]) rater-against-reference standard reliability using κ(w) and fair (κ=0.46 [95% CI: 0.29-0.64]) to substantial (κ=0.83 [95% CI: 0.68-0.94]) reliability using κ. The inter-rater reliability ranged from moderate (κ(w)=0.66 [95% CI: 0.45-0.81]) to substantial (κ(w)=0.96 [95% CI: 0.88-1.00]) for κ(w) and from slight (κ=0.36 [95% CI: 0.21-0.54]) to moderate (κ=0.75 [95% CI: 0.62-0.89]) for κ. The rater-against-reference standard reliability varied from moderate to substantial for the primary outcome measure and from fair to substantial for the secondary outcome measure. The study findings indicate that the pre-injury ASA-PS scale is a reliable score for classifying comorbidity in trauma patients. Copyright © 2012 Elsevier Ltd. All rights reserved.
Actigraphy scoring for sleep outcome measures in chronic obstructive pulmonary disease.

PubMed

Kapella, Mary C; Vispute, Sachin; Zhu, Bingqian; Herdegen, James J

2017-09-01

Actigraphy is commonly used to measure sleep outcomes so that sleep can be measured conveniently at home over multiple nights. Actigraphy has been validated in people with sleep disturbances; however, the validity of scoring settings in people with chronic medical illnesses such as chronic obstructive pulmonary disease remains unclear. The purpose of this secondary analysis was to compare actigraphy-customized scoring settings with polysomnography (PSG) for the measurement of sleep outcomes in people with chronic obstructive pulmonary disease who have insomnia. Participants underwent overnight sleep assessment simultaneously by PSG and actigraphy at the University of Illinois of Chicago Sleep Science Center. Fifty participants (35 men and 15 women) with mild-to-severe chronic obstructive pulmonary disease and co-existing insomnia were included in the analysis. Sleep onset latency, total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE) were calculated independently from data derived from PSG and actigraphy. Actigraphy sleep outcome scores obtained at the default setting and several customized actigraphy settings were compared to the scored PSG results. Although no single setting was optimal for all sleep outcomes, the combination of 10 consecutive immobile minutes for sleep onset or end and an activity threshold of 10 worked well. Actigraphy overestimated TST and SE and underestimated WASO, but there was no difference in variance between PSG and actigraphy in TST and SE when the 10 × 10 combination was used. As the average TST and SE increased, the agreement between PSG and actigraphy appeared to increase, and as the average WASO decreased, the agreement between PSG and actigraphy appeared to increase. Results support the conclusion that the default actigraphy settings may not be optimal for people with chronic obstructive pulmonary disease and co-existing insomnia. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.
Use of the Hill Interaction Matrix in Individual Counseling Research.

ERIC Educational Resources Information Center

Boyd, Robert E.

Research in counseling effectiveness is moving from the use of gross outcome measures to analysis of the counseling process. One successful approach has been the adoption of a social-psychological model of interview analysis which attempts to specify within-interview conditions which facilitate client behavior change. The criteria and procedure…
Longitudinal Trend Analysis of Performance Indicators for South Carolina's Technical Colleges

ERIC Educational Resources Information Center

Hossain, Mohammad Nurul

2010-01-01

This study included an analysis of the trend of performance indicators for the technical college sector of higher education in South Carolina. In response to demands for accountability and transparency in higher education, the state of South Carolina developed sector specific performance indicators to measure various educational outcomes for each…
Assessing Learning Outcomes: An Analysis of the Goals-2 Instrument

ERIC Educational Resources Information Center

Sabbag, Anelise Guimaraes; Zieffler, Andrew

2015-01-01

The test instrument GOALS-2 was designed primarily to evaluate the effectiveness of the CATALST curriculum. The purpose of this study was to perform a psychometric analysis of this instrument. Undergraduate students from six universities in the United States (n = 289) were administered the instrument. Three measurement models were fit and…
“Skill of Generalized Additive Model to Detect PM2.5 Health Signal in the Presence of Confounding Variables”

EPA Science Inventory

Summary. Measures of health outcomes are collinear with meteorology and air quality, making analysis of connections between human health and air quality difficult. The purpose of this analysis was to determine time scales and periods shared by the variables of interest (and...
Towards capturing meaningful outcomes for people with dementia in psychosocial intervention research: A pan-European consultation.

PubMed

Øksnebjerg, Laila; Diaz-Ponce, Ana; Gove, Dianne; Moniz-Cook, Esme; Mountain, Gail; Chattat, Rabih; Woods, Bob

2018-06-19

People with dementia are often marginalized and excluded from influence, also in relation to dementia research. There is, however, a growing requirement for inclusion through Patient and Public Involvement (PPI), but there is still limited knowledge on how researchers can fully benefit from the involvement of people with dementia in the development and testing of psychosocial interventions. This paper describes the results of a pan-European consultation with people with dementia, synthesizing their views on outcomes of psychosocial interventions. To involve people with dementia in establishing what are meaningful outcomes when participating in psychosocial interventions. Consultations took place at four divergent sites across Europe, involving twenty-five people with dementia from nine European countries. The methods used for the consultation were developed through an iterative process involving people with dementia. Data from the consultation were analysed from a thematic analysis approach. The results suggested that people with dementia wish to participate in interventions that enhance their well-being, confidence, health, social participation and human rights. This highlights a need for improvements in psychosocial research to capture these outcomes. Involving people with dementia in discussions of psychosocial interventions has enhanced our understanding about meaningful outcome measures in research and methods of data collection. This study suggests that new outcome measures in psychosocial research are needed where concepts of positive psychology and social health can guide innovation and outcome measurement. © 2018 The Authors. Health Expectations published by John Wiley & Sons Ltd.

Behavioral and locomotor measurements using an open field activity monitoring system for skeletal muscle diseases.

PubMed

Tatem, Kathleen S; Quinn, James L; Phadke, Aditi; Yu, Qing; Gordish-Dressman, Heather; Nagaraju, Kanneboyina

2014-09-29

The open field activity monitoring system comprehensively assesses locomotor and behavioral activity levels of mice. It is a useful tool for assessing locomotive impairment in animal models of neuromuscular disease and efficacy of therapeutic drugs that may improve locomotion and/or muscle function. The open field activity measurement provides a different measure than muscle strength, which is commonly assessed by grip strength measurements. It can also show how drugs may affect other body systems as well when used with additional outcome measures. In addition, measures such as total distance traveled mirror the 6 min walk test, a clinical trial outcome measure. However, open field activity monitoring is also associated with significant challenges: Open field activity measurements vary according to animal strain, age, sex, and circadian rhythm. In addition, room temperature, humidity, lighting, noise, and even odor can affect assessment outcomes. Overall, this manuscript provides a well-tested and standardized open field activity SOP for preclinical trials in animal models of neuromuscular diseases. We provide a discussion of important considerations, typical results, data analysis, and detail the strengths and weaknesses of open field testing. In addition, we provide recommendations for optimal study design when using open field activity in a preclinical trial.
The Impact of ICT on Educational Performance and its Efficiency in Selected EU and OECD Countries: A Non-Parametric Analysis

ERIC Educational Resources Information Center

Aristovnik, Aleksander

2012-01-01

The purpose of the paper is to review some previous researches examining ICT efficiency and the impact of ICT on educational output/outcome as well as different conceptual and methodological issues related to performance measurement. Moreover, a definition, measurements and the empirical application of a model measuring the efficiency of ICT use…
A tutorial on Bayesian bivariate meta-analysis of mixed binary-continuous outcomes with missing treatment effects.

PubMed

Gajic-Veljanoski, Olga; Cheung, Angela M; Bayoumi, Ahmed M; Tomlinson, George

2016-05-30

Bivariate random-effects meta-analysis (BVMA) is a method of data synthesis that accounts for treatment effects measured on two outcomes. BVMA gives more precise estimates of the population mean and predicted values than two univariate random-effects meta-analyses (UVMAs). BVMA also addresses bias from incomplete reporting of outcomes. A few tutorials have covered technical details of BVMA of categorical or continuous outcomes. Limited guidance is available on how to analyze datasets that include trials with mixed continuous-binary outcomes where treatment effects on one outcome or the other are not reported. Given the advantages of Bayesian BVMA for handling missing outcomes, we present a tutorial for Bayesian BVMA of incompletely reported treatment effects on mixed bivariate outcomes. This step-by-step approach can serve as a model for our intended audience, the methodologist familiar with Bayesian meta-analysis, looking for practical advice on fitting bivariate models. To facilitate application of the proposed methods, we include our WinBUGS code. As an example, we use aggregate-level data from published trials to demonstrate the estimation of the effects of vitamin K and bisphosphonates on two correlated bone outcomes, fracture, and bone mineral density. We present datasets where reporting of the pairs of treatment effects on both outcomes was 'partially' complete (i.e., pairs completely reported in some trials), and we outline steps for modeling the incompletely reported data. To assess what is gained from the additional work required by BVMA, we compare the resulting estimates to those from separate UVMAs. We discuss methodological findings and make four recommendations. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
A Patient-Assessed Morbidity to Evaluate Outcome in Surgically Treated Vestibular Schwannomas.

PubMed

Al-Shudifat, Abdul Rahman; Kahlon, Babar; Höglund, Peter; Lindberg, Sven; Magnusson, Måns; Siesjo, Peter

2016-10-01

Outcome after treatment of vestibular schwannomas can be evaluated by health providers as mortality, recurrence, performance, and morbidity. Because mortality and recurrence are rare events, evaluation has to focus on performance and morbidity. The latter has mostly been reported by health providers. In the present study, we validate 2 new scales for patient-assessed performance and morbidity in comparison with different outcome tools, such as quality of life (QOL) (European Quality of Life-5 dimensions [EQ-5D]), facial nerve score, and work capacity. There were 167 total patients in a retrospective (n = 90) and prospective (n = 50) cohort of surgically treated vestibular schwannomas. A new patient-assessed morbidity score (paMS), a patient-assessed Karnofsky score (paKPS), the patient-assessed QOL (EQ-5D) score, work capacity, and the House-Brackmann facial nerve score were used as outcome measures. Analysis of paMS components and their relation to other outcomes was done as uni- and multivariate analysis. All outcome instruments, except EQ-5D and paKPS, showed a significant decrease postoperatively. Only the facial nerve score (House-Brackmann facial nerve score) differed significantly between the retrospective and prospective cohorts. Out of the 16 components of the paMS, hearing dysfunction, tear dysfunction, balance dysfunction, and eye irritation were most often reported. Both paMS and EQ-5D correlated significantly with work capacity. Standard QOL and performance instruments may not be sufficiently sensitive or specific to measure outcome at the cohort level after surgical treatment of vestibular schwannomas. A morbidity score may yield more detailed information on symptoms that can be relevant for rehabilitation and occupational training after surgery. Copyright © 2016 Elsevier Inc. All rights reserved.
Replacement of aprotinin by ε-aminocaproic acid in infants undergoing cardiac surgery: consequences for blood loss and outcome.

PubMed

Martin, K; Gertler, R; MacGuill, M; Mayr, N P; Hapfelmeier, A; Hörer, J; Vogt, M; Tassani, P; Wiesner, G

2013-04-01

Once aprotinin was no longer available for clinical use, ε-aminocaproic acid (EACA) and tranexamic acid became the only two options for antifibrinolytic therapy. We compared aprotinin and EACA with respect to their blood-sparing efficacy and other major clinical outcome criteria in infants undergoing cardiac surgery. We retrospectively analysed data from a large consecutive cohort of infants (n=227) aged 31-365 days undergoing primary cardiac surgery requiring cardiopulmonary bypass encompassing the transition from aprotinin to EACA (aprotinin n=88, EACA n=139); all other aspects including the medical team and departmental protocols remained unchanged. The primary outcome was postoperative blood loss measured as chest tube output (CTO). Secondary outcome parameters were transfusion requirements, reoperation due to bleeding, renal, vascular, and neurological complications, and in-hospital mortality. CTO was significantly higher in the EACA patients {aprotinin 18 (13-27) ml kg(-1) 24 h(-1), EACA 23 (15-37) ml kg(-1) 24 h(-1) [mean (inter-quartile range)], P=0.001}, but transfusion requirements and donor exposures were not significantly different. A sensitivity analysis strengthened our finding that the increased blood loss in the EACA group was attributable to lower efficacy of EACA. There were no significant differences in the other clinical outcome measures. CTO was lower in aprotinin-treated patients. Nonetheless, EACA remains a suitable substitute without measurable differences in other clinical outcome criteria.
A 5-Year Review of Clinical Outcome Measures Published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery®.

PubMed

Hasenstein, Todd; Greene, Timothy; Meyr, Andrew J

This investigation presents a review of all of the clinical outcome measures used by authors and published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery ® from January 1, 2011, to December 31, 2015. Of 1,336 articles published during this time frame, 655 (49.0%) were classified as original research and included in this analysis. Of these 655 articles, 151 (23.1%) included at least one clinical outcome measure. Thirty-seven unique clinical outcome scales were used by authors and published during this period. The most frequently reported scales in the 151 included articles were the American Orthopaedic Foot and Ankle Society scales (54.3%; n = 82), visual analog scale (35.8%; n = 54), Medical Outcomes Study Short Form Health Survey (any version) (10.6%; n = 16), Foot Function Index (5.3%; n = 8), Maryland Foot Score (4.0%; n = 6), and Olerud and Molander scoring system (4.0%; n = 6). Twenty-four (15.9%) articles used some form of original/subjective measure of patient satisfaction/expectation. The results of this investigation detail the considerable variety of clinical outcome measurement tools used by authors in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery ® and might support the need for a shift toward the consistent use of a smaller number of valid, reliable, and clinically useful scales in the podiatric medical literature. Copyright © 2017 American Podiatric Medical Association and the American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.
A Systematic Review and Meta-Analysis of a Measure of Staff/Child Interaction Quality (the Classroom Assessment Scoring System) in Early Childhood Education and Care Settings and Child Outcomes.

PubMed

Perlman, Michal; Falenchuk, Olesya; Fletcher, Brooke; McMullen, Evelyn; Beyene, Joseph; Shah, Prakesh S

2016-01-01

The quality of staff/child interactions as measured by the Classroom Assessment Scoring System (CLASS) in Early Childhood Education and Care (ECEC) programs is thought to be important for children's outcomes. The CLASS is made of three domains that assess Emotional Support, Classroom Organization and Instructional Support. It is a relatively new measure that is being used increasingly for research, quality monitoring/accountability and other applied purposes. Our objective was to evaluate the association between the CLASS and child outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Studies that measured association between the CLASS and child outcomes for preschool-aged children who attended ECEC programs were included after screening by two independent reviewers. Searches and data extraction were conducted by two independent reviewers. Thirty-five studies were systematically reviewed of which 19 provided data for meta-analyses. Most studies had moderate to high risk of bias. Of the 14 meta-analyses we conducted, associations between Classroom Organization and Pencil Tapping and between Instructional Support and SSRS Social Skills were significant with pooled correlations of .06 and .09 respectively. All associations were in the expected direction. In the systematic review, significant correlations were reported mainly from one large dataset. Substantial heterogeneity in use of the CLASS, its dimensions, child outcomes and statistical measures was identified. Greater consistency in study methodology is urgently needed. Given the multitude of factors that impact child development it is encouraging that our analyses revealed some, although small, associations between the CLASS and children's outcomes.
A Systematic Review and Meta-Analysis of a Measure of Staff/Child Interaction Quality (the Classroom Assessment Scoring System) in Early Childhood Education and Care Settings and Child Outcomes

PubMed Central

Perlman, Michal; Falenchuk, Olesya; Fletcher, Brooke; McMullen, Evelyn; Beyene, Joseph; Shah, Prakesh S.

2016-01-01

The quality of staff/child interactions as measured by the Classroom Assessment Scoring System (CLASS) in Early Childhood Education and Care (ECEC) programs is thought to be important for children’s outcomes. The CLASS is made of three domains that assess Emotional Support, Classroom Organization and Instructional Support. It is a relatively new measure that is being used increasingly for research, quality monitoring/accountability and other applied purposes. Our objective was to evaluate the association between the CLASS and child outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Studies that measured association between the CLASS and child outcomes for preschool-aged children who attended ECEC programs were included after screening by two independent reviewers. Searches and data extraction were conducted by two independent reviewers. Thirty-five studies were systematically reviewed of which 19 provided data for meta-analyses. Most studies had moderate to high risk of bias. Of the 14 meta-analyses we conducted, associations between Classroom Organization and Pencil Tapping and between Instructional Support and SSRS Social Skills were significant with pooled correlations of .06 and .09 respectively. All associations were in the expected direction. In the systematic review, significant correlations were reported mainly from one large dataset. Substantial heterogeneity in use of the CLASS, its dimensions, child outcomes and statistical measures was identified. Greater consistency in study methodology is urgently needed. Given the multitude of factors that impact child development it is encouraging that our analyses revealed some, although small, associations between the CLASS and children’s outcomes. PMID:28036333
“Nothing About Me Without Me”: An Interpretative Review of Patient Accessible Electronic Health Records

PubMed Central

Callahan, Ryan; Sevdalis, Nick; Mayer, Erik K; Darzi, Ara

2015-01-01

Background Patient accessible electronic health records (PAEHRs) enable patients to access and manage personal clinical information that is made available to them by their health care providers (HCPs). It is thought that the shared management nature of medical record access improves patient outcomes and improves patient satisfaction. However, recent reviews have found that this is not the case. Furthermore, little research has focused on PAEHRs from the HCP viewpoint. HCPs include physicians, nurses, and service providers. Objective We provide a systematic review of reviews of the impact of giving patients record access from both a patient and HCP point of view. The review covers a broad range of outcome measures, including patient safety, patient satisfaction, privacy and security, self-efficacy, and health outcome. Methods A systematic search was conducted using Web of Science to identify review articles on the impact of PAEHRs. Our search was limited to English-language reviews published between January 2002 and November 2014. A total of 73 citations were retrieved from a series of Boolean search terms including “review*” with “patient access to records”. These reviews went through a novel scoring system analysis whereby we calculated how many positive outcomes were reported per every outcome measure investigated. This provided a way to quantify the impact of PAEHRs. Results Ten reviews covering chronic patients (eg, diabetes and hypertension) and primary care patients, as well as HCPs were found but eight were included for the analysis of outcome measures. We found mixed outcomes across both patient and HCP groups, with approximately half of the reviews showing positive changes with record access. Patients believe that record access increases their perception of control; however, outcome measures thought to create psychological concerns (such as patient anxiety as a result of seeing their medical record) are still unanswered. Nurses are more likely than physicians to gain time efficiencies by using a PAEHR system with the main concern from physicians being the security of the PAEHRs. Conclusions This review implements a novel scoring system, which shows there is a lack of rigorous empirical testing that separates the effect of record access from other existing disease management programs. Current research is too targeted within certain clinical groups’ needs, and although there are positive signs for the adoption of PAEHRs, there is currently insufficient evidence about the effect of PAEHRs on health outcomes for patients or HCPs. PMID:26123476
Effect of Heliox on Respiratory Outcomes during Rigid Bronchoscopy in Term Lambs.

PubMed

Sowder, Justin C; Dahl, Mar Janna; Zuspan, Kaitlin R; Albertine, Kurt H; Null, Donald M; Barneck, Mitchell D; Grimmer, J Fredrik

2018-03-01

Objective To (1) compare physiologic changes during rigid bronchoscopy during spontaneous and mechanical ventilation and (2) evaluate the efficacy of a helium-oxygen (heliox) gas mixture as compared with room air during rigid bronchoscopy. Study Design Crossover animal study evaluating physiologic parameters during rigid bronchoscopy. Outcomes were compared with predicted computational fluid analysis. Setting Simulated ventilation via computational fluid dynamics analysis and term lambs undergoing rigid bronchoscopy. Methods Respiratory and physiologic outcomes were analyzed in a lamb model simulating bronchoscopy during foreign body aspiration to compare heliox with room air. The main outcome measures were blood oxygen saturation, heart rate, blood pressure, partial pressure of oxygen, and partial pressure of carbon dioxide. Computational fluid dynamics analysis was performed with SOLIDWORKS within a rigid pediatric bronchoscope during simulated ventilation comparing heliox with room air. Results For room air, lambs desaturated within 3 minutes during mechanical ventilation versus normal oxygen saturation during spontaneous ventilation ( P = .01). No improvement in respiratory outcomes was seen between heliox and room air during mechanical ventilation. Computational fluid dynamics analysis demonstrates increased turbulence within size 3.5 bronchoscopes when comparing heliox and room air. Meaningful comparisons could not be made due to the intolerance of the lambs to heliox in vivo. Conclusion During mechanical ventilation on room air, lambs desaturate more quickly during rigid bronchoscopy on settings that should be adequate. Heliox does not improve ventilation during rigid bronchoscopy.
Adjunctive Corticosteroids for Pneumocystis jirovecii Pneumonia in Non-HIV-infected Patients: A Systematic Review and Meta-analysis of Observational Studies.

PubMed

Fujikura, Yuji; Manabe, Toshie; Kawana, Akihiko; Kohno, Shigeru

2017-02-01

The clinical benefits of adjunctive corticosteroids for Pneumocystis jirovecii (P. jirovecii) pneumonia in patients not infected with the human immunodeficiency virus (HIV) has not been evaluated by meta-analysis. We conducted a systematic review of published studies describing the effects of adjunctive corticosteroids on outcome in non-HIV P. jirovecii pneumonia patients. Two investigators independently searched the PubMed and Cochrane databases for eligible articles written in English. A meta-analysis was performed using a random-effects model for measuring mortality as the primary outcome, and the need for intubation or mechanical ventilation as the secondary outcome. Seven observational studies were eligible. In these studies, adjunctive corticosteroids did not affect mortality in non-HIV patients (odds ratio [OR] 1.26; 95% CI 0.60-2.67) and there was no beneficial effect in patients with severe hypoxemia (PaO 2 <70mmHg) (OR 0.90; 95% CI 0.44-1.83). No significant effect on the secondary outcome was observed (OR 1.34; 95% CI 0.44-4.11). Although the studies were observational, meta-analysis showed that adjunctive corticosteroids did not improve the outcome of P. jirovecii pneumonia in non-HIV patients. The results warrant a randomized controlled trial. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.
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.
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
Heart rate variability measured early in patients with evolving acute coronary syndrome and 1-year outcomes of rehospitalization and mortality.

PubMed

Harris, Patricia R E; Stein, Phyllis K; Fung, Gordon L; Drew, Barbara J

2014-01-01

This study sought to examine the prognostic value of heart rate variability (HRV) measurement initiated immediately after emergency department presentation for patients with acute coronary syndrome (ACS). Altered HRV has been associated with adverse outcomes in heart disease, but the value of HRV measured during the earliest phases of ACS related to risk of 1-year rehospitalization and death has not been established. Twenty-four-hour Holter recordings of 279 patients with ACS were initiated within 45 minutes of emergency department arrival; recordings with ≥18 hours of sinus rhythm were selected for HRV analysis (number [N] =193). Time domain, frequency domain, and nonlinear HRV were examined. Survival analysis was performed. During the 1-year follow-up, 94 patients were event-free, 82 were readmitted, and 17 died. HRV was altered in relation to outcomes. Predictors of rehospitalization included increased normalized high frequency power, decreased normalized low frequency power, and decreased low/high frequency ratio. Normalized high frequency >42 ms(2) predicted rehospitalization while controlling for clinical variables (hazard ratio [HR] =2.3; 95% confidence interval [CI] =1.4-3.8, P=0.001). Variables significantly associated with death included natural logs of total power and ultra low frequency power. A model with ultra low frequency power <8 ms(2) (HR =3.8; 95% CI =1.5-10.1; P=0.007) and troponin >0.3 ng/mL (HR =4.0; 95% CI =1.3-12.1; P=0.016) revealed that each contributed independently in predicting mortality. Nonlinear HRV variables were significant predictors of both outcomes. HRV measured close to the ACS onset may assist in risk stratification. HRV cut-points may provide additional, incremental prognostic information to established assessment guidelines, and may be worthy of additional study.
Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

PubMed

Merriwether, Ericka N; Rakel, Barbara A; Zimmerman, Miriam B; Dailey, Dana L; Vance, Carol G T; Darghosian, Leon; Golchha, Meenakshi; Geasland, Katherine M; Chimenti, Ruth; Crofford, Leslie J; Sluka, Kathleen A

2017-08-01

The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. Dual site, university-based outpatient clinics. Women aged 20 to 67 years diagnosed with fibromyalgia. Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. PROMIS static SF instruments had fair to high internal consistency (Cronbach α = 0.58 to 0.94, P < 0.05). PROMIS 'physical function' domain score was highly correlated with FIQR 'function' score (r = -0.73). The PROMIS 'total' score was highly correlated with the FIQR total score (r = -0.72). Correlations with FIQR total score of each of the three PROMIS domain scores were r = -0.65 for 'physical function,' r = -0.63 for 'global,' and r = -0.57 for 'symptom' domain. PROMIS 'physical function,' 'global,' and 'symptom' scores explained 58% of the FIQR total score variance. Select PROMIS static SF instruments demonstrate convergent validity with the FIQR, a legacy measure of fibromyalgia disease severity. These results highlight the potential utility of select PROMIS static SFs for assessment and tracking of patient-reported outcomes in fibromyalgia. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
Reliability and validity analysis of the open-source Chinese Foot and Ankle Outcome Score (FAOS).

PubMed

Ling, Samuel K K; Chan, Vincent; Ho, Karen; Ling, Fona; Lui, T H

2017-12-21

Develop the first reliable and validated open-source outcome scoring system in the Chinese language for foot and ankle problems. Translation of the English FAOS into Chinese following regular protocols. First, two forward-translations were created separately, these were then combined into a preliminary version by an expert committee, and was subsequently back-translated into English. The process was repeated until the original and back translations were congruent. This version was then field tested on actual patients who provided feedback for modification. The final Chinese FAOS version was then tested for reliability and validity. Reliability analysis was performed on 20 subjects while validity analysis was performed on 50 subjects. Tools used to validate the Chinese FAOS were the SF36 and Pain Numeric Rating Scale (NRS). Internal consistency between the FAOS subgroups was measured using Cronbach's alpha. Spearman's correlation was calculated between each subgroup in the FAOS, SF36 and NRS. The Chinese FAOS passed both reliability and validity testing; meaning it is reliable, internally consistent and correlates positively with the SF36 and the NRS. The Chinese FAOS is a free, open-source scoring system that can be used to provide a relatively standardised outcome measure for foot and ankle studies. Copyright © 2017 Elsevier Ltd. All rights reserved.
Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients

PubMed Central

Winterstein, Andrew P.; McGuine, Timothy A.; Carr, Kathleen E.; Hetzel, Scott J.

2013-01-01

Background: Knee injury among young, active female patients remains a public health issue. Clinicians are called upon to pay greater attention to patient-oriented outcomes to evaluate the impact of these injuries. Little agreement exists on which outcome measures are best, and clinicians cite several barriers to their use. Single Assessment Numerical Evaluation (SANE) may provide meaningful outcome information while lessening the time burden associated with other patient-oriented measures. Hypothesis: The SANE and International Knee Documentation Committee (IKDC) scores would be strongly correlated in a cohort of young active female patients with knee injuries from preinjury through 1-year follow-up and that a minimal clinically important difference (MCID) could be calculated for the SANE score. Study Design: Observational prospective cohort. Methods: Two hundred sixty-three subjects completed SANE and IKDC at preinjury by recall, time of injury, and 3, 6, and 12 months postinjury. Pearson correlation coefficients were used to assess the association between SANE and IKDC. Repeated-measures analysis of variance was used to determine differences in SANE and IKDC over time. MCID was calculated for SANE using IKDC MCID as an anchor. Results: Moderate to strong correlations were seen between SANE and IKDC (0.65-0.83). SANE, on average, was 2.7 (95% confidence interval, 1.5-3.9; P < 0.00) units greater than IKDC over all time points. MCID for the SANE was calculated as 7 for a 6-month follow-up and 19 for a 12-month follow-up. Conclusion: SANE scores were moderately to strongly correlated to IKDC scores across all time points. Reported MCID values for the SANE should be utilized to measure meaningful changes over time for young, active female patients with knee injuries. Clinical Relevance: Providing clinicians with patient-oriented outcome measures that can be obtained with little clinician and patient burden may allow for greater acceptance and use of outcome measures in clinical settings. PMID:24427427
Assessing the impact of race, social factors and air pollution on birth outcomes: a population-based study.

PubMed

Gray, Simone C; Edwards, Sharon E; Schultz, Bradley D; Miranda, Marie Lynn

2014-01-29

Both air pollution exposure and socioeconomic status (SES) are important indicators of children's health. Using highly resolved modeled predictive surfaces, we examine the joint effects of air pollution exposure and measures of SES in a population level analysis of pregnancy outcomes in North Carolina (NC). Daily measurements of particulate matter <2.5 μm in aerodynamic diameter (PM2.5) and ozone (O3) were calculated through a spatial hierarchical Bayesian model which produces census-tract level point predictions. Using multilevel models and NC birth data from 2002-2006, we examine the association between pregnancy averaged PM2.5 and O3, individual and area-based SES indicators, and birth outcomes. Maternal race and education, and neighborhood household income were associated with adverse birth outcomes. Predicted concentrations of PM2.5 and O3 were also associated with an additional effect on reductions in birth weight and increased risks of being born low birth weight and small for gestational age. This paper builds on and complements previous work on the relationship between pregnancy outcomes and air pollution exposure by using 1) highly resolved air pollution exposure data; 2) a five-year population level sample of pregnancies; and 3) including personal and areal level measures of social determinants of pregnancy outcomes. Results show a stable and negative association between air pollution exposure and adverse birth outcomes. Additionally, the more socially disadvantaged populations are at a greater risk; controlling for both SES and environmental stressors provides a better understanding of the contributing factors to poor children's health outcomes.
Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire.

PubMed

Rothaug, Judith; Zaslansky, Ruth; Schwenkglenks, Matthias; Komann, Marcus; Allvin, Renée; Backström, Ragnar; Brill, Silviu; Buchholz, Ingo; Engel, Christoph; Fletcher, Dominique; Fodor, Lucian; Funk, Peter; Gerbershagen, Hans J; Gordon, Debra B; Konrad, Christoph; Kopf, Andreas; Leykin, Yigal; Pogatzki-Zahn, Esther; Puig, Margarita; Rawal, Narinder; Taylor, Rod S; Ullrich, Kristin; Volk, Thomas; Yahiaoui-Doktor, Maryam; Meissner, Winfried

2013-11-01

PAIN OUT is a European Commission-funded project aiming at improving postoperative pain management. It combines a registry that can be useful for quality improvement and research using treatment and patient-reported outcome measures. The core of the project is a patient questionnaire-the International Pain Outcomes questionnaire-that comprises key patient-level outcomes of postoperative pain management, including pain intensity, physical and emotional functional interference, side effects, and perceptions of care. Its psychometric quality after translation and adaptation to European patients is the subject of this validation study. The questionnaire was administered to 9,727 patients in 10 languages in 8 European countries and Israel. Construct validity was assessed using factor analysis. Discriminant validity assessment used Mann-Whitney U tests to detect mean group differences between 2 surgical disciplines. Internal consistency reliability was calculated as Cronbach's alpha. Factor analysis resulted in a 3-factor structure explaining 53.6% of variance. Cronbach's alpha at overall scale level was high (.86), and for the 3 subscales was low, moderate, or high (range, .53-.89). Significant mean group differences between general and orthopedic surgery patients confirmed discriminant validity. The psychometric quality of the International Pain Outcomes questionnaire can be regarded as satisfactory. The International Pain Outcomes questionnaire provides an instrument for postoperative pain assessment and improvement of quality of care, which demonstrated good psychometric quality when translated into a variety of languages in a large European and Israeli patient population. This measure provides the basis for the first comprehensive postoperative pain registry in Europe and other countries. Copyright © 2013. Published by Elsevier Inc.

Occupation-Based Intervention for Addictive Disorders: A Systematic Review.

PubMed

Wasmuth, Sally; Pritchard, Kevin; Kaneshiro, Kellie

2016-03-01

Addictive disorders disrupt individuals' occupational lives, suggesting that occupational therapists can play a crucial role in addiction rehabilitation. Occupation-based interventions are those in which an occupation is performed, and occupations are defined as those activities a person engages in to structure time and create meaning in one's life. This review asked: In persons with addictive disorders, are occupation-based interventions more effective than treatment as usual in improving short and long-term recovery outcomes? A systematic literature search was performed by a medical librarian in Ovid MEDLINE, PsychINFO, Social Work Abstracts, OTSeeker, HealthSTAR, CINAHL, and ACPJournalClub. Authors screened 1095 articles for inclusion criteria (prospective outcome studies examining the effectiveness of an occupation-based intervention with a sample primarily consisting of a diagnosis of a substance-related or addictive disorder and with at least five participants), and two authors appraised the resulting 66 articles using a standard appraisal tool, yielding 26 articles for qualitative synthesis and 8 with shared outcome measures for quantitative analysis. Occupation-based interventions in the areas of work, leisure, and social participation were found to have been used to treat addictive disorders. Occupation-based interventions in the area of social participation all elicited better outcomes than their respective control/comparison groups. Not all occupation-based interventions in the area of leisure elicited better outcomes than their comparison group, but in the eight articles with shared outcome measures, quantitative analysis demonstrated leisure interventions produced larger effect sizes than social participation interventions. Copyright © 2015 Elsevier Inc. All rights reserved.
Negative affect and sleep disturbance may be associated with response to epidural steroid injections for spine-related pain.

PubMed

Karp, Jordan F; Yu, Lan; Friedly, Janna; Amtmann, Dagmar; Pilkonis, Paul A

2014-02-01

To describe whether negative affect and sleep impairment are associated with the clinical effect of epidural steroid injections (ESIs) for low back pain. Observational study; patients were evaluated before ESI and 1 and 3 months after ESI. Spine center and related treatment sites. Participants (N=158) seeking treatment for low back pain with or without radiculopathy. ESI for low back pain with or without radiculopathy. We assessed the dependent (global pain severity for back and leg pain, pain behavior, pain interference) and independent variables (depression, sleep disturbance, and covariates of back pain response) with the Patient-Reported Outcome Measurement Information System (PROMIS) and legacy measures. Outcome was assessed cross-sectionally using multiple regression and longitudinally with path analysis. After 1 month, sleep disturbance was the only predictor for the global ratings of improvement in back pain (R(2)=16.8%) and leg pain (R(2)=11.4%). The proportions of variance explained by sleep disturbance and negative affect for all dependent variables were greater at 3 months than 1 month. Mediation analysis was significant for negative affect for the 3-month outcomes on PROMIS pain behavior (β=.87, P<.01) and pain interference (β=.37, P<.01). There was no evidence of mediation by sleep disturbance for any outcome. Negative affect and sleep disturbance are associated with worse outcomes after ESI. Further research is needed to determine if treatment of negative affect and sleep disturbance prior to or concurrently with ESI will improve outcomes. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Nervous System Sensitization as a Predictor of Outcome in the Treatment of Peripheral Musculoskeletal Conditions: A Systematic Review.

PubMed

O'Leary, Helen; Smart, Keith M; Moloney, Niamh A; Doody, Catherine M

2017-02-01

Research suggests that peripheral and central nervous system sensitization can contribute to the overall pain experience in peripheral musculoskeletal (MSK) conditions. It is unclear, however, whether sensitization of the nervous system results in poorer outcomes following the treatment. This systematic review investigated whether nervous system sensitization in peripheral MSK conditions predicts poorer clinical outcomes in response to a surgical or conservative intervention. Four electronic databases were searched to identify the relevant studies. Eligible studies had a prospective design, with a follow-up assessing the outcome in terms of pain or disability. Studies that used baseline indices of nervous system sensitization were included, such as quantitative sensory testing (QST) or questionnaires that measured centrally mediated symptoms. Thirteen studies met the inclusion criteria, of which six were at a high risk of bias. The peripheral MSK conditions investigated were knee and hip osteoarthritis, shoulder pain, and elbow tendinopathy. QST parameters indicative of sensitization (lower electrical pain thresholds, cold hyperalgesia, enhanced temporal summation, lower punctate sharpness thresholds) were associated with negative outcome (more pain or disability) in 5 small exploratory studies. Larger studies that accounted for multiple confounders in design and analysis did not support a predictive relationship between QST parameters and outcome. Two studies used self-report measures to capture comorbid centrally mediated symptoms, and found higher questionnaire scores were independently predictive of more persistent pain following a total joint arthroplasty. This systematic review found insufficient evidence to support an independent predictive relationship between QST measures of nervous system sensitization and treatment outcome. Self-report measures demonstrated better predictive ability. Further high-quality prognostic research is warranted. © 2016 World Institute of Pain.
Automated assessment of early hypoxic brain edema in non-enhanced CT predicts outcome in patients after cardiac arrest.

PubMed

Hanning, Uta; Sporns, Peter Bernhard; Lebiedz, Pia; Niederstadt, Thomas; Zoubi, Tarek; Schmidt, Rene; Knecht, Stefan; Heindel, Walter; Kemmling, André

2016-07-01

Early prediction of potential neurological recovery in patients after cardiac arrest is challenging. Recent studies suggest that the densitrometic gray-white matter ratio (GWR) determined from cranial computed tomography (CT) scans may be a reliable predictor of poor outcome. We evaluated an automated, rater independent method to determine GWR in CT as an early objective imaging predictor of clinical outcome. We analyzed imaging data of 84 patients after cardiac arrest that underwent noncontrast CT within 24h after arrest. To determine GWR in CT we applied two methods using a recently published automated probabilistic gray-white matter segmentation algorithm (GWR_aut) and conventional manual measurements within gray-white regions of interest (GWR_man). Neurological outcome was graded by the cerebral performance category (CPC). As part of standard routine CPC was assessed by the treating physician in the intensive care unit at admission and at discharge to normal ward. The performance of GWR measures (automated and manual) to predict the binary clinical endpoints of poor (CPC3-5) and good outcome (CPC1-2) was assessed by ROC analysis with increasing discrimination thresholds. Results of GWR_aut were compared to GWR_man of two raters. Of 84 patients, 55 (65%) showed a poor outcome. ROC curve analysis revealed reliable outcome prediction of GWR_aut (AUC 0.860) and GWR_man (AUC 0.707 and 0.699, respectively). Predictive power of GWR_aut was higher than GWR_man by each rater (p=0.019 and p=0.021, respectively) at an optimal cut-off of 1.084 to predict poor outcome (optimal criterion with 92.7% sensitivity, 72.4% specificity). Interrater reliability of GWR_man by intra-class correlation coefficient (ICC) was moderate (0.551). Automated quantification of GWR in CT may be used as an objective observer-independent imaging marker for outcome in patients after cardiac arrest. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Cost-effectiveness of a complex workplace dietary intervention: an economic evaluation of the Food Choice at Work study

PubMed Central

Fitzgerald, Sarah; Murphy, Aileen; Kirby, Ann; Geaney, Fiona; Perry, Ivan J

2018-01-01

Objective To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. Design Single-study economic evaluation of a cluster-controlled trial (Food Choice at Work (FCW) study) with 1-year follow-up. Setting Four multinational manufacturing workplaces in Cork, Ireland. Participants 517 randomly selected employees (18–65 years) from four workplaces. Interventions Cost data were obtained from the FCW study. Nutrition education included individual nutrition consultations, nutrition information (traffic light menu labelling, posters, leaflets and emails) and presentations. System-level dietary modification included menu modification (restriction of fat, sugar and salt), increase in fibre, fruit discounts, strategic positioning of healthier alternatives and portion size control. The combined intervention included nutrition education and system-level dietary modification. No intervention was implemented in the control. Outcomes The primary outcome was an improvement in health-related quality of life, measured using the EuroQoL 5 Dimensions 5 Levels questionnaire. The secondary outcome measure was reduction in absenteeism, which is measured in monetary amounts. Probabilistic sensitivity analysis (Monte Carlo simulation) assessed parameter uncertainty. Results The system-level intervention dominated the education and combined interventions. When compared with the control, the incremental cost-effectiveness ratio (€101.37/quality-adjusted life-year) is less than the nationally accepted ceiling ratio, so the system-level intervention can be considered cost-effective. The cost-effectiveness acceptability curve indicates there is some decision uncertainty surrounding this, arising from uncertainty surrounding the differences in effectiveness. These results are reiterated when the secondary outcome measure is considered in a cost–benefit analysis, whereby the system-level intervention yields the highest net benefit (€56.56 per employee). Conclusions System-level dietary modification alone offers the most value per improving employee health-related quality of life and generating net benefit for employers by reducing absenteeism. While system-level dietary modification strategies are potentially sustainable obesity prevention interventions, future research should include long-term outcomes to determine if improvements in outcomes persist. Trial registration number ISRCTN35108237; Post-results. PMID:29502090
Linguistic analysis of discourse in aphasia: A review of the literature.

PubMed

Bryant, Lucy; Ferguson, Alison; Spencer, Elizabeth

This review examined previous research applications of linguistic discourse analysis to assess the language of adults with aphasia. A comprehensive literature search of seven databases identified 165 studies that applied linguistic measures to samples of discourse collected from people with aphasia. Analysis of methodological applications revealed an increase in published research using linguistic discourse analysis over the past 40 years, particularly to measure the generalisation of therapy outcomes to language in use. Narrative language samples were most frequently subject to analysis though all language genres were observed across included studies. A total of 536 different linguistic measures were applied to examine language behaviours. Growth in the research use of linguistic discourse analysis and suggestions that this growth may be reflected in clinical practice requires further investigation. Future research directions are discussed to investigate clinical use of discourse analysis and examine the differences that exist between research and clinical practice.
Interim analysis of STR effectiveness

DOT National Transportation Integrated Search

1978-01-01

The present report describes the status of the NHTSA Short Term Rehabilitation Study (STR) as of December, 1977, and summarizes the progress of data collection efforts by the eleven participating ASAP projects. Outcome measures considered as indicati...
Tumour heterogeneity in glioblastoma assessed by MRI texture analysis: a potential marker of survival

PubMed Central

Pérez-Beteta, Julián; Luque, Belén; Arregui, Elena; Calvo, Manuel; Borrás, José M; López, Carlos; Martino, Juan; Velasquez, Carlos; Asenjo, Beatriz; Benavides, Manuel; Herruzo, Ismael; Martínez-González, Alicia; Pérez-Romasanta, Luis; Arana, Estanislao; Pérez-García, Víctor M

2016-01-01

Objective: The main objective of this retrospective work was the study of three-dimensional (3D) heterogeneity measures of post-contrast pre-operative MR images acquired with T1 weighted sequences of patients with glioblastoma (GBM) as predictors of clinical outcome. Methods: 79 patients from 3 hospitals were included in the study. 16 3D textural heterogeneity measures were computed including run-length matrix (RLM) features (regional heterogeneity) and co-occurrence matrix (CM) features (local heterogeneity). The significance of the results was studied using Kaplan–Meier curves and Cox proportional hazards analysis. Correlation between the variables of the study was assessed using the Spearman's correlation coefficient. Results: Kaplan–Meyer survival analysis showed that 4 of the 11 RLM features and 4 of the 5 CM features considered were robust predictors of survival. The median survival differences in the most significant cases were of over 6 months. Conclusion: Heterogeneity measures computed on the post-contrast pre-operative T1 weighted MR images of patients with GBM are predictors of survival. Advances in knowledge: Texture analysis to assess tumour heterogeneity has been widely studied. However, most works develop a two-dimensional analysis, focusing only on one MRI slice to state tumour heterogeneity. The study of fully 3D heterogeneity textural features as predictors of clinical outcome is more robust and is not dependent on the selected slice of the tumour. PMID:27319577
Tumour heterogeneity in glioblastoma assessed by MRI texture analysis: a potential marker of survival.

PubMed

Molina, David; Pérez-Beteta, Julián; Luque, Belén; Arregui, Elena; Calvo, Manuel; Borrás, José M; López, Carlos; Martino, Juan; Velasquez, Carlos; Asenjo, Beatriz; Benavides, Manuel; Herruzo, Ismael; Martínez-González, Alicia; Pérez-Romasanta, Luis; Arana, Estanislao; Pérez-García, Víctor M

2016-07-04

The main objective of this retrospective work was the study of three-dimensional (3D) heterogeneity measures of post-contrast pre-operative MR images acquired with T 1 weighted sequences of patients with glioblastoma (GBM) as predictors of clinical outcome. 79 patients from 3 hospitals were included in the study. 16 3D textural heterogeneity measures were computed including run-length matrix (RLM) features (regional heterogeneity) and co-occurrence matrix (CM) features (local heterogeneity). The significance of the results was studied using Kaplan-Meier curves and Cox proportional hazards analysis. Correlation between the variables of the study was assessed using the Spearman's correlation coefficient. Kaplan-Meyer survival analysis showed that 4 of the 11 RLM features and 4 of the 5 CM features considered were robust predictors of survival. The median survival differences in the most significant cases were of over 6 months. Heterogeneity measures computed on the post-contrast pre-operative T 1 weighted MR images of patients with GBM are predictors of survival. Texture analysis to assess tumour heterogeneity has been widely studied. However, most works develop a two-dimensional analysis, focusing only on one MRI slice to state tumour heterogeneity. The study of fully 3D heterogeneity textural features as predictors of clinical outcome is more robust and is not dependent on the selected slice of the tumour.
The effects of co-morbidity in defining major depression subtypes associated with long-term course and severity.

PubMed

Wardenaar, K J; van Loo, H M; Cai, T; Fava, M; Gruber, M J; Li, J; de Jonge, P; Nierenberg, A A; Petukhova, M V; Rose, S; Sampson, N A; Schoevers, R A; Wilcox, M A; Alonso, J; Bromet, E J; Bunting, B; Florescu, S E; Fukao, A; Gureje, O; Hu, C; Huang, Y Q; Karam, A N; Levinson, D; Medina Mora, M E; Posada-Villa, J; Scott, K M; Taib, N I; Viana, M C; Xavier, M; Zarkov, Z; Kessler, R C

2014-11-01

Although variation in the long-term course of major depressive disorder (MDD) is not strongly predicted by existing symptom subtype distinctions, recent research suggests that prediction can be improved by using machine learning methods. However, it is not known whether these distinctions can be refined by added information about co-morbid conditions. The current report presents results on this question. Data came from 8261 respondents with lifetime DSM-IV MDD in the World Health Organization (WHO) World Mental Health (WMH) Surveys. Outcomes included four retrospectively reported measures of persistence/severity of course (years in episode; years in chronic episodes; hospitalization for MDD; disability due to MDD). Machine learning methods (regression tree analysis; lasso, ridge and elastic net penalized regression) followed by k-means cluster analysis were used to augment previously detected subtypes with information about prior co-morbidity to predict these outcomes. Predicted values were strongly correlated across outcomes. Cluster analysis of predicted values found three clusters with consistently high, intermediate or low values. The high-risk cluster (32.4% of cases) accounted for 56.6-72.9% of high persistence, high chronicity, hospitalization and disability. This high-risk cluster had both higher sensitivity and likelihood ratio positive (LR+; relative proportions of cases in the high-risk cluster versus other clusters having the adverse outcomes) than in a parallel analysis that excluded measures of co-morbidity as predictors. Although the results using the retrospective data reported here suggest that useful MDD subtyping distinctions can be made with machine learning and clustering across multiple indicators of illness persistence/severity, replication with prospective data is needed to confirm this preliminary conclusion.
Relevance of individual participant data meta-analysis for studies in obstetrics: delivery versus expectant monitoring for hypertensive disorders of pregnancy.

PubMed

Broekhuijsen, Kim; Bernardes, Thomas; van Baaren, Gert-Jan; Tajik, Parvin; Novikova, Natalia; Thangaratinam, Shakila; Boers, Kim; Koopmans, Corine M; Wallace, Kedra; Shennan, Andrew H; Langenveld, Josje; Groen, Henk; van den Berg, Paul P; Mol, Ben Willem J; Franssen, Maureen T M

2015-08-01

Like many other research subjects in obstetrics, research on immediate delivery versus expectant monitoring for women with hypertensive disorders of pregnancy faces certain challenges when it comes to interpretation and generalisation of the results; relatively rare outcomes are studied, in a clinically heterogeneous population, while the clinical practice in some countries has dictated that studies in term pregnancy were completed before earlier gestational ages could be studied. This has resulted in multiple smaller studies, some studying surrogate outcome measures, with different in- and exclusion criteria, and without enough power for reliable subgroup analyses. All this complicates the generation of definitive answers and implementation of the results into clinical practice. Performing multiple studies and subsequently pooling their results in a meta-analysis can be a way to overcome the difficulties of studying relatively rare outcomes and subgroups with enough power, as well as a solution to reach a final answer on questions involving an uncertain and possibly harmful intervention. However, in the case of the current studies on delivery versus expectant monitoring in women with hypertensive disorders of pregnancy, differences regarding eligibility criteria, outcome measures and subgroup definitions make it difficult to pool their results in an aggregate meta-analysis. Individual patient data meta-analysis (IPDMA) has the potential to overcome these challenges, because it allows for flexibility regarding the choice of endpoints and standardisation of inclusion and exclusion criteria across studies. In addition, it has more statistical power for informative subgroup analyses. We therefore propose an IPDMA on immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy, and advocate the use of IPDMA for research questions in obstetrics that face similar challenges. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Factors associated with reduced functional outcome and quality of life in patients having limb-sparing surgery for soft tissue sarcomas - a national multicenter study of 128 patients.

PubMed

Saebye, Casper; Fugloe, Hanna M; Nymark, Tine; Safwat, Akmal; Petersen, Michael M; Baad-Hansen, Thomas; Krarup-Hansen, Anders; Keller, Johnny

2017-02-01

Limb-sparing surgery for sarcomas has become possible in most cases. However, the impact of the procedure on the functional outcome has only been investigated in a few studies. The aim of this study has been to identify tumor- and patient-related factors associated with reduced functional outcome and quality of life after limb-sparing surgery in soft tissue sarcoma patients. In total, 128 patients (mean age = 58, female/male = 54/74) who were treated with limb-sparing surgery without bone resection for soft tissue sarcomas in Denmark during the period 1 January 2009 to 31 December 2011 were included. Patients were asked to participate at least one year after surgery, and patients who had experienced local recurrence or metastatic disease were excluded. The Toronto Extremity Salvage Score (TESS) measured functional disability, while the Musculoskeletal Tumor Society Score (MSTS) measured functional impairment. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 measured quality of life. Tumor- and patient-related factors (age, gender, tumor depth, tumor size, malignancy, comorbidity, location, and radiotherapy) were extracted from the Danish National Sarcoma Database. Wilcoxon rank-sum test and Kruskal-Wallis were used for univariable analysis. Adjusted odds ratios were estimated by using multiple logistic regression models. In the multiple regression analysis, it was found that female gender (p = 0.03), lower extremity tumors (p < 0.01) and radiotherapy (p = 0.02) resulted in an increased risk of a lower TESS score. Initial reduced postoperative function was found to be associated with a lower functional outcome. Patients with reduced functional outcome have increased risk for reduced quality of life (p < 0.01). The results of this study show that patient- and tumor-related factors have an important role in the functional outcome.
Study protocol for the PHANTOM study: prehospital assessment of noninvasive tissue oximetry monitoring.

PubMed

Weatherall, Andrew; Garner, Alan; Lovell, Nigel; Redmond, Stephen; Lee, Anna; Skowno, Justin; Egan, Jonathan

2014-10-03

Traumatic brain injury is a major cause of mortality and morbidity worldwide. It can be worsened by secondary injury particularly with hypoxia or hypotension. Current prehospital guidelines emphasise regular measurement of peripheral oxygen saturation and blood pressure but there is no monitor in use to provide direct information relating to blood flow or oxygen delivery to the brain tissue. This prospective cohort study will assess the utility of near-infrared spectroscopy monitoring in prehospital medicine in demonstrating injury, pathophysiology and associations with long-term functional outcomes. A prospective cohort study will be conducted in prehospital services where physician/paramedic teams respond rapidly to patients suffering significant traumatic injuries. A study observer accompanying the clinical team will apply non-invasive near-infrared spectroscopy tissue oximetry using a Nonin EQUANOX 7610 Regional Oximetry monitor (TM Nonin Medical, Inc.). This will be applied to patients with traumatic injuries less than 30 minutes old requiring transport. Measurements will be taken at two sites on the forehead and one on the forearm. Clinical teams will be blinded to all monitoring values. Near-infrared spectroscopy tissue oximetry parameters of oxyhaemoglobin%, deoxyhaemoglobin%, total tissue haemoglobin index and regional oxygen saturation will be recorded. Separate statistical analysis relating to time spent with cerebral regional oxygen saturation values < 45% and time series analysis will be performed to demonstrate associations with acute phase outcomes including injuries seen on cerebral imaging, and long-term functional outcomes measured by Glasgow Outcome Score and Extended Glasgow Outcome Score will then be undertaken. This prospective cohort study will demonstrate associations evident from the earliest stages of prehospital treatment between near-infrared spectroscopy tissue oximetry values and both acute and long-term outcomes of patients suffering traumatic injuries. This may provide the basis for future interventional studies utilising near-infrared spectroscopy tissue oximetry to guide prehospital trauma care. This trial is registered with the Australian and New Zealand Clinical Trials Registry. The registration number is ACTRN12611001124921 .
Cost-Value Analysis and the SAVE: A Work in Progress, But an Option for Localised Decision Making?

PubMed

Karnon, Jonathan; Partington, Andrew

2015-12-01

Cost-value analysis aims to address the limitations of the quality-adjusted life-year (QALY) by incorporating the strength of public concerns for fairness in the allocation of scarce health care resources. To date, the measurement of value has focused on equity weights to reflect societal preferences for the allocation of QALY gains. Another approach is to use a non-QALY-based measure of value, such as an outcome 'equivalent to saving the life of a young person' (a SAVE). This paper assesses the feasibility and validity of using the SAVE as a measure of value for the economic evaluation of health care technologies. A web-based person trade-off (PTO) survey was designed and implemented to estimate equivalent SAVEs for outcome events associated with the progression and treatment of early-stage breast cancer. The estimated equivalent SAVEs were applied to the outputs of an existing decision analytic model for early breast cancer. The web-based PTO survey was undertaken by 1094 respondents. Validation tests showed that 68 % of eligible responses revealed consistent ordering of responses and 32 % displayed ordinal transitivity, while 37 % of respondents showing consistency and ordinal transitivity approached cardinal transitivity. Using consistent and ordinally transitive responses, the mean incremental cost per SAVE gained was £ 3.72 million. Further research is required to improve the validity of the SAVE, which may include a simpler web-based survey format or a face-to-face format to facilitate more informed responses. A validated method for estimating equivalent SAVEs is unlikely to replace the QALY as the globally preferred measure of outcome, but the SAVE may provide a useful alternative for localized decision makers with relatively small, constrained budgets-for example, in programme budgeting and marginal analysis.
Resilience following spinal cord injury: A prospective controlled study investigating the influence of the provision of group cognitive behavior therapy during inpatient rehabilitation.

PubMed

Guest, Rebecca; Craig, Ashley; Nicholson Perry, Kathryn; Tran, Yvonne; Ephraums, Catherine; Hales, Alison; Dezarnaulds, Annalisa; Crino, Rocco; Middleton, James

2015-11-01

To examine change in resilience in people with spinal cord injury (SCI) when group cognitive behavior therapy (GCBT) was added to routine psychosocial rehabilitation (RPR). A prospective repeated-measures cohort design was used to determine the efficacy of the addition of GCBT (n = 50). The control group consisted of individuals receiving RPR, which included access to individual CBT (ICBT) when required (n = 38). Groups were assessed on 3 occasions: soon after admission, within 2 weeks of discharge, and 6-months postdischarge. Measures included sociodemographic, injury, and psychosocial factors. The outcome variable was resilience, considered an important outcome measure for recovery. To adjust for baseline differences in self-efficacy, depressive mood and anxiety between the 2 groups, these factors were entered into a repeated measures multivariate analysis of covariance (MANCOVA) as covariates. Latent class analysis was used to determine the best-fitting model of resilience trajectories for both groups. The MANCOVA indicated that the addition of GCBT to psychosocial rehabilitation did not result in improved resilience compared with the ICBT group. Trajectory data indicated over 60% were demonstrating acceptable resilience irrespective of group. Changes in resilience mean scores suggest the addition of GCBT adds little to resilience outcomes. Latent class modeling indicated both groups experienced similar trajectories of improvement and deterioration. Results highlight the importance of conducting multivariate modeling analysis that isolates subgroups of related cases over time to understand complex trajectories. Further research is needed to clarify individual differences in CBT intervention preference as well as other factors which impact on resilience. (c) 2015 APA, all rights reserved).
The influence of individual, group, and relative self-esteem on outcome for patients undergoing group cognitive-behavioural therapy treatment.

PubMed

Parker, Thomas J; Page, Andrew C; Hooke, Geoff R

2013-11-01

Despite a strong association between individual self-esteem and treatment outcome in group cognitive-behavioural therapy (GCBT), no study has investigated how patient outcomes might be influenced by an individual's self-esteem relative to other group members. The study comprised a retrospective examination of patients' data and used a multiple regression analysis to identify predictors of treatment outcome. Patients' pre-treatment self-esteem scores were assessed on a continuum and assigned to be low, medium, or high. Therapy groups were assigned to be either low, balanced or high self-esteem groups based on averaged self-esteem scores of participants. In this study, 3,878 patients who had completed a 10-day intensive cognitive behavioural group therapy programme at a private psychiatric facility were included in the study. The Rosenberg Self-Esteem measure was chosen to assess self-esteem. The three subscales of the Depression Anxiety Stress Scales were used as the outcome measures. Patient outcomes were influenced by pre-treatment self-esteem scores, such that higher initial self-esteem was associated with better treatment outcomes. Low group self-esteem was predictive of significantly better outcomes for depression, relative to higher self-esteem groups. Additionally, the combined influence of high individual self-esteem and low group self-esteem was associated with significantly enhanced depression improvement. High self-esteem patients perform better on outcome measures following completion of GCBT. Low self-esteem groups show greater improvement in depression symptoms. Similar results for depression are achieved when patients with high self-esteem complete treatment in low self-esteem groups. © 2013 The British Psychological Society.
Reducing turnover is not enough: The need for proficient organizational cultures to support positive youth outcomes in child welfare

PubMed Central

Glisson, Charles

2013-01-01

Objective High caseworker turnover has been identified as a factor in the poor outcomes of child welfare services. However, almost no empirical research has examined the relationship between caseworker turnover and youth outcomes in child welfare systems and there is an important knowledge gap regarding whether, and how, caseworker turnover relates to outcomes for youth. We hypothesized that the effects of caseworker turnover are moderated by organizational culture such that reduced caseworker turnover is only associated with improved youth outcomes in organizations with proficient cultures. Methods The study applied hierarchical linear models (HLM) analysis to the second National Survey of Child and Adolescent Well-being (NSCAW II) with a U.S. nationwide sample of 2,346 youth aged 1.5- to 18-years-old and 1,544 caseworkers in 73 child welfare agencies. Proficient organizational culture was measured by caseworkers’ responses to the Organizational Social Context (OSC) measure; staff turnover was reported by the agencies’ directors; and youth outcomes were measured as total problems in psychosocial functioning with the Child Behavior Checklist (CBCL) completed by the youths’ caregivers at intake and at 18 month follow-up. Results The association between caseworker turnover and youth outcomes was moderated by organizational culture. Youth outcomes were improved with lower staff turnover in proficient organizational cultures and the best outcomes occurred in organizations with low turnover and high proficiency. Conclusions To be successful, efforts to improve child welfare services by lowering staff turnover must also create proficient cultures that expect caseworkers to be competent and responsive to the needs of the youth and families they serve. PMID:24273363
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.
A Comparative Analysis of the Validity of US State- and County-Level Social Capital Measures and Their Associations with Population Health

PubMed Central

Lee, Chul-joo; Kim, Daniel

2014-01-01

The goals of this study were to validate a number of available collective social capital measures at the U.S. state and county levels, and to examine the relative extent to which these social capital measures are associated with population health outcomes. Measures of social capital at the U.S. state level included aggregate indices based on the Annenberg National Health Communication Survey (ANHCS) and the Behavioral Risk Factor Surveillance System (BRFSS), Petris Social Capital Index (PSCI), Putnam’s index, and Kim et al.’s scales. County-level measures consisted of Rupasingha et al.’s social capital index (RGFI) and a BRFSS-derived measure. These measures, except for the PSCI, showed evidence of acceptable validity. Moreover, we observed differences across the social capital measures in their associations with population health outcomes. The implications of the findings for future research in this area are discussed. PMID:25574069
Understanding quality of life and patient expectations among adolescents with neonatal brachial plexus palsy: a qualitative and quantitative pilot study.

PubMed

Squitieri, Lee; Larson, Bradley P; Chang, Kate W C; Yang, Lynda J S; Chung, Kevin C

2013-12-01

To explore the quality of life (QOL) and patient expectations among adolescents with neonatal brachial plexus palsy (NBPP)and their parents using qualitative and quantitative approaches. A total of 18 adolescents (10-17 y) with residual NBPP impairment and their parents under went separate 1-hour tape-recorded semistructured interviews. We also collected quantitative physical examination measures and patient-rated outcome scores, specifically the Pediatric Outcomes Data Collection Instrument and the Child Health Questionnaire, to quantify the severity of each adolescent’s functional deficit and increase our understanding of QOL and patient expectations. Through qualitative analysis, we identified several patient- and system-dependent factors contributing to QOL, such as social impact and peer acceptance, emotional adjustment,aesthetic concerns and body image, functional limitations, physical and occupational therapy, finances, pain, and family dynamics. Despite residual impairment, most adolescents and their parents reported a good overall QOL according to quantitative outcome measures. Our study results showed that functional and aesthetic factors were responsible for most observed differences in QOL among NBPP adolescents. We also found that the Pediatric Outcomes Data Collection Instrument might be more sensitive than the Child Health Questionnaire in assessing patient expectations and QOL among this patient population. Understanding patient expectations and QOL in NBPP adolescents is essential for medical decision making and advancing care. Physical examination measurements alone may not be sufficient for measuring outcome, and knowledge regarding environmental factors and family dynamics is important for clinicians to consider when counseling families of children with NBPP and improving overall outcome. Prognostic IV.

The brief serenity scale: a psychometric analysis of a measure of spirituality and well-being.

PubMed

Kreitzer, Mary Jo; Gross, Cynthia R; Waleekhachonloet, On-anong; Reilly-Spong, Maryanne; Byrd, Marcia

2009-03-01

This article describes a factor analysis of a 22-item version of the Serenity Scale, a tool that measures spirituality and well-being. A sample of 87 participants, enrolled in a National Institutes of Health-funded clinical trial examining the impact of mindfulness-based stress reduction on symptom management post-solid organ transplantation, completed the abbreviated instrument. Exploratory factor analysis yielded three subscales: acceptance, inner haven, and trust. The Serenity Scale was positively associated with positive affect and mindful awareness and inversely related to negative affect, anxiety, depression, health distress and transplant-related stress. Serenity, a dimension of spirituality that is secular and distinct from religious orientation or religiosity, shows promise as a tool that could be used to measure outcomes of nursing interventions that improve health and well-being. Spirituality is recognized as being an essential component of holistic nursing practice. As nurses expand their use of spiritual interventions, it is important to document outcomes related to nursing care. The Serenity Scale appears to capture a dimension of spirituality, a state of acceptance, inner haven and trust that is distinct from other spirituality instruments.
IMPACT: Investigating the impact of Models of Practice for Allied health Care in subacuTe settings. A protocol for a quasi-experimental mixed methods study of cost effectiveness and outcomes for patients exposed to different models of allied health care.

PubMed

Coker, Freya; Williams, Cylie M; Taylor, Nicholas F; Caspers, Kirsten; McAlinden, Fiona; Wilton, Anita; Shields, Nora; Haines, Terry P

2018-05-10

This protocol considers three allied health staffing models across public health subacute hospitals. This quasi-experimental mixed-methods study, including qualitative process evaluation, aims to evaluate the impact of additional allied health services in subacute care, in rehabilitation and geriatric evaluation management settings, on patient, health service and societal outcomes. This health services research will analyse outcomes of patients exposed to different allied health models of care at three health services. Each health service will have a control ward (routine care) and an intervention ward (additional allied health). This project has two parts. Part 1: a whole of site data extraction for included wards. Outcome measures will include: length of stay, rate of readmissions, discharge destinations, community referrals, patient feedback and staff perspectives. Part 2: Functional Independence Measure scores will be collected every 2-3 days for the duration of 60 patient admissions.Data from part 1 will be analysed by linear regression analysis for continuous outcomes using patient-level data and logistic regression analysis for binary outcomes. Qualitative data will be analysed using a deductive thematic approach. For part 2, a linear mixed model analysis will be conducted using therapy service delivery and days since admission to subacute care as fixed factors in the model and individual participant as a random factor. Graphical analysis will be used to examine the growth curve of the model and transformations. The days since admission factor will be used to examine non-linear growth trajectories to determine if they lead to better model fit. Findings will be disseminated through local reports and to the Department of Health and Human Services Victoria. Results will be presented at conferences and submitted to peer-reviewed journals. The Monash Health Human Research Ethics committee approved this multisite research (HREC/17/MonH/144 and HREC/17/MonH/547). © 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.
Opportunities for crash and injury reduction: A multiharm approach for crash data analysis.

PubMed

Mallory, Ann; Kender, Allison; Moorhouse, Kevin

2017-05-29

A multiharm approach for analyzing crash and injury data was developed for the ultimate purpose of getting a richer picture of motor vehicle crash outcomes for identifying research opportunities in crash safety. Methods were illustrated using a retrospective analysis of 69,597 occupant cases from NASS CDS from 2005 to 2015. Occupant cases were analyzed by frequency and severity of outcome: fatality, injury by Abbreviated Injury Scale (AIS), number of cases, attributable fatality, disability, and injury costs. Comparative analysis variables included precrash scenario, impact type, and injured body region. Crash and injury prevention opportunities vary depending on the search parameters. For example, occupants in rear-end crash scenarios were more frequent than in any other precrash configuration, yet there were significantly more fatalities and serious injury cases in control loss, road departure, and opposite direction crashes. Fatality is most frequently associated with head and thorax injury, and disability is primarily associated with extremity injury. Costs attributed to specific body regions are more evenly distributed, dominated by injuries to the head, thorax, and extremities but with contributions from all body regions. Though AIS 3+ can be used as a single measure of harm, an analysis based on multiple measures of harm gives a much more detailed picture of the risk presented by a particular injury or set of crash conditions. The developed methods represent a new approach to crash data mining that is expected to be useful for the identification of research priorities and opportunities for reduction of crashes and injuries. As the pace of crash safety improvement accelerates with innovations in both active and passive safety, these techniques for combining outcome measures for insights beyond fatality and serious injury will be increasingly valuable.
Identification of complex metabolic states in critically injured patients using bioinformatic cluster analysis.

PubMed

Cohen, Mitchell J; Grossman, Adam D; Morabito, Diane; Knudson, M Margaret; Butte, Atul J; Manley, Geoffrey T

2010-01-01

Advances in technology have made extensive monitoring of patient physiology the standard of care in intensive care units (ICUs). While many systems exist to compile these data, there has been no systematic multivariate analysis and categorization across patient physiological data. The sheer volume and complexity of these data make pattern recognition or identification of patient state difficult. Hierarchical cluster analysis allows visualization of high dimensional data and enables pattern recognition and identification of physiologic patient states. We hypothesized that processing of multivariate data using hierarchical clustering techniques would allow identification of otherwise hidden patient physiologic patterns that would be predictive of outcome. Multivariate physiologic and ventilator data were collected continuously using a multimodal bioinformatics system in the surgical ICU at San Francisco General Hospital. These data were incorporated with non-continuous data and stored on a server in the ICU. A hierarchical clustering algorithm grouped each minute of data into 1 of 10 clusters. Clusters were correlated with outcome measures including incidence of infection, multiple organ failure (MOF), and mortality. We identified 10 clusters, which we defined as distinct patient states. While patients transitioned between states, they spent significant amounts of time in each. Clusters were enriched for our outcome measures: 2 of the 10 states were enriched for infection, 6 of 10 were enriched for MOF, and 3 of 10 were enriched for death. Further analysis of correlations between pairs of variables within each cluster reveals significant differences in physiology between clusters. Here we show for the first time the feasibility of clustering physiological measurements to identify clinically relevant patient states after trauma. These results demonstrate that hierarchical clustering techniques can be useful for visualizing complex multivariate data and may provide new insights for the care of critically injured patients.
Developing a Web-Based Nursing Practice and Research Information Management System: A Pilot Study.

PubMed

Choi, Jeeyae; Lapp, Cathi; Hagle, Mary E

2015-09-01

Many hospital information systems have been developed and implemented to collect clinical data from the bedside and have used the information to improve patient care. Because of a growing awareness that the use of clinical information improves quality of care and patient outcomes, measuring tools (electronic and paper based) have been developed, but most of them require multiple steps of data collection and analysis. This necessitated the development of a Web-based Nursing Practice and Research Information Management System that processes clinical nursing data to measure nurses' delivery of care and its impact on patient outcomes and provides useful information to clinicians, administrators, researchers, and policy makers at the point of care. This pilot study developed a computer algorithm based on a falls prevention protocol and programmed the prototype Web-based Nursing Practice and Research Information Management System. It successfully measured performance of nursing care delivered and its impact on patient outcomes successfully using clinical nursing data from the study site. Although Nursing Practice and Research Information Management System was tested with small data sets, results of study revealed that it has the potential to measure nurses' delivery of care and its impact on patient outcomes, while pinpointing components of nursing process in need of improvement.
Core outcome measures for exercise studies in people with multiple sclerosis: recommendations from a multidisciplinary consensus meeting.

PubMed

Paul, Lorna; Coote, Susan; Crosbie, Jean; Dixon, Diane; Hale, Leigh; Holloway, Ed; McCrone, Paul; Miller, Linda; Saxton, John; Sincock, Caroline; White, Lesley

2014-10-01

Evidence shows that exercise is beneficial for people with multiple sclerosis (MS); however, statistical pooling of data is difficult because of the diversity of outcome measures used. The objective of this review is to report the recommendations of an International Consensus Meeting for a core set of outcome measures for use in exercise studies in MS. From the 100 categories of the International Classification of Function Core Sets for MS, 57 categories were considered as likely/potentially likely to be affected by exercise and were clustered into seven core groups. Outcome measures to address each group were evaluated regarding, for example, psychometric properties. The following are recommended: Modified Fatigue Impact Scale (MFIS) or Fatigue Severity Scale (FSS) for energy and drive, 6-Minute Walk Test (6MWT) for exercise tolerance, Timed Up and Go (TUG) for muscle function and moving around, Multiple Sclerosis Impact Scale (MSIS-29) or Multiple Sclerosis Quality of Life-54 Instrument (MSQoL54) for quality of life and body mass index (BMI) or waist-hip ratio (WHR) for the health risks associated with excess body fat. A cost effectiveness analysis and qualitative evaluation should be included where possible. Using these core measures ensures that future meta-analyses of exercise studies in MS are more robust and thus more effectively inform practice. © The Author(s) 2014.
Asthma Outcomes: Healthcare Utilization and Costs

PubMed Central

Akinbami, Lara J.; Sullivan, Sean D.; Campbell, Jonathan D.; Grundmeier, Robert W.; Hartert, Tina V.; Lee, Todd A.; Smith, Robert A.

2014-01-01

Background Measures of healthcare utilization and indirect impact of asthma morbidity are used to assess clinical interventions and estimate cost. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to propose standardized measurement, collection, analysis, and reporting of healthcare utilization and cost outcomes in future asthma studies. Methods We used comprehensive literature reviews and expert opinion to compile a list of asthma healthcare utilization outcomes that we classified as core (required in future studies), supplemental (used according to study aims and standardized) and emerging (requiring validation and standardization). We also have identified methodology to assign cost to these outcomes. This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results We identified 3 ways to promote comparability across clinical trials for measures of healthcare utilization, resource use, and cost: (1) specify the study perspective (patient, clinician, payer, society), (2) standardize the measurement period (ideally, 12 months), and (3) use standard units to measure healthcare utilization and other asthma-related events. Conclusions Large clinical trials and observational studies should collect and report detailed information on healthcare utilization, intervention resources, and indirect impact of asthma, so that costs can be calculated and cost-effectiveness analyses can be conducted across several studies. Additional research is needed to develop standard, validated survey instruments for collection of provider-reported and participant-reported data regarding asthma-related health care. PMID:22386509
Dose range finding study for the efficacy of meloxicam administered prior to sodium urate-induced synovitis in cats.

PubMed

Carroll, Gwendolyn L; Narbe, Ruediger; Kerwin, Sharon C; Taylor, Lathrop; Peterson, Kurt; Hartsfield, Sandee M

2011-07-01

To determine the lowest efficacious dose of oral meloxicam for relieving pain in cats with a sodium urate (SU)-induced acute inflammatory synovitis. Randomized, blinded, controlled, and four-way crossover study. Eight surgically neutered cats (four males, four females) paired according to sex. Each pair of cats was treated with 0 (placebo), 0.025, 0.05, or 0.075 mg kg(-1) oral meloxicam once daily for 4 days prior to injection, into alternating stifles, of 1 mL of 20 mg mL(-1) SU crystals, beginning with the right stifle. Each cat received each of the four treatments, separated by at least 21 days. Analgesic efficacy was evaluated based on objective (e.g., pressure mat data total force, contact pressure, and contact area) and subjective (e.g., scores for Analgesia Scale [AS], Lameness Scale [LS], and Visual Analog Scale [VAS]) outcome measures for pain assessment. All outcome measures were recorded before and during 30 hours after SU injection. The pre-defined primary outcome measure was the area under the response-time curve (AUC(0-30) hours) of the total force of the injected limb. Data were analyzed by analysis of variance. A sequential test procedure was applied and the test sequence stopped in case of a nonsignificant result. Meloxicam at doses of 0.05 and 0.075 mg kg(-1) day(-1) PO was significantly different from placebo for the pre-defined primary outcome measure (i.e., AUC(0-30) hours of total force). All tested meloxicam doses were lower than placebo for the subjective outcome measures (i.e., AUC(0-30) hours of AS, LS, and VAS). The lowest efficacious dose of meloxicam for relieving pain in cats with an SU-induced synovitis was 0.05 mg kg(-1) day(-1) PO according to the pre-defined primary outcome measure. However, lower doses may also be effective as seen in the subjective outcome measures. © 2011 The Authors. Veterinary Anaesthesia and Analgesia. © 2011 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesiologists.
Modern psychometrics applied in rheumatology--a systematic review.

PubMed

Siemons, Liseth; Ten Klooster, Peter M; Taal, Erik; Glas, Cees Aw; Van de Laar, Mart Afj

2012-10-31

Although item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology. Literature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed. Most studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale. IRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient and the clinician. Also, the measurement precision of outcome measures along the scale was only evaluated occasionally. Performed IRT analyses should be adequately explained, justified, and reported. A global consensus about uniform guidelines should be reached concerning the minimum number of assumptions which should be met and best ways of testing these assumptions, in order to stimulate the quality appraisal of performed IRT analyses.
Quality Improvement Initiatives in Colorectal Surgery: Value of Physician Feedback.

PubMed

Waters, Joshua A; Francone, Todd; Marcello, Peter W; Roberts, Patricia L; Schoetz, David J; Read, Thomas E; Stafford, Caitlin; Ricciardi, Rocco

2017-02-01

The impact of process improvement through surgeon feedback on outcomes is unclear. We sought to evaluate the effect of biannual surgeon-specific feedback on outcomes and adherence to departmental and Surgical Care Improvement Project process measures on colorectal surgery outcomes. This was a retrospective analysis of prospectively collected 100% capture surgical quality improvement data. This study was conducted at the department of colorectal surgery at a tertiary care teaching hospital from January 2008 through December 2013. Each surgeon was provided with biannual feedback on process adherence and surgeon-specific outcomes of urinary tract infection, deep vein thrombosis, surgical site infection, anastomotic leak, 30-day readmission, reoperation, and mortality. We recorded adherence to Surgical Care Improvement Project process measures and departmentally implemented measures (ie, anastomotic leak testing) as well as surgeon-specific outcomes. We abstracted 7975 operations. There was no difference in demographics, laparoscopy, or blood loss. Adherence to catheter removal increased from 73% to 100% (p < 0.0001), whereas urinary tract infection decreased 52% (p < 0.01). Adherence to thromboprophylaxis administration remained unchanged as did the deep vein thrombosis rate (p = not significant). Adherence to preoperative antibiotic administration increased from 72% to 100% (p < 0.0001), whereas surgical site infection did not change (7.6%-6.6%; p = 0.3). There were 2589 operative encounters with anastomoses. For right-sided anastomoses, the proportion of handsewn anastomoses declined from 19% to 1.5% (p < 0.001). For left-sided anastomoses, without diversion, anastomotic leak testing adherence increased from 88% to 95% (p < 0.01). Overall leak rate decreased from 5.2% to 2.9% (p < 0.05). Concurrent process changes make isolation of the impact from individual process improvement changes challenging. Nearly complete adherence to process measures for deep vein thrombosis and surgical site infection did not lead to measureable outcomes improvement. Process measure adherence was associated with decreased rate of anastomotic leak and urinary tract infection. Biannual surgeon-specific feedback of outcomes was associated with improved process measure adherence and improvement in surgical quality.
Construction and validation of the chronic acquired polyneuropathy patient-reported index, “CAP-PRI:” a disease-specific, health-related quality of life instrument

PubMed Central

Gwathmey, Kelly G.; Conaway, Mark R.; Seyedsadjadi, Reza; Joshi, Amruta; Barnett, Carolina; Bril, Vera; Ng, Eduardo; David, William; Gable, Karissa; Guptill, Jeffrey T.; Hobson-Webb, Lisa D.; Dineen, Jennifer; Hehir, Michael; Brannagan, Thomas H.; Byun, Esther; Adler, Margaret; Burns, Ted M.

2016-01-01

Introduction Generic health-related quality of life (HRQOL) patient-reported outcome measures have been used in patients with chronic immune-mediated polyneuropathies. We have created a disease-specific HRQOL instrument. Methods and Results The 15-item chronic acquired polyneuropathy patient-reported index (CAP-PRI) was developed and validated in multiple steps. Items were initially generated through patient and specialist input. The performance of the preliminary 20 items was analyzed from a prospective, 5-center study involving chronic immune-mediated polyneuropathy patients. Data analysis suggested modification to a 15-item scale with 3 response categories, rather than 5. The final CAP-PRI was then validated in another prospective, 5-center study. The CAP-PRI appeared to be a unidimensional outcome measure that fits the Rasch Partial Credit Model in our multicenter cohort. It correlated appropriately with the outcome measures commonly used in this patient population. Discussion The CAP-PRI is a simple, easy, disease-specific HRQOL measure that appears to be useful for clinical care and possibly also for clinical trials. PMID:26600438
Problems in the Latina paradox: measuring social support for pregnant immigrant women from Mexico.

PubMed

Fleuriet, K Jill

2009-04-01

Women who have immigrated to the United States from Mexico have better than expected birth outcomes. Part of this apparent health 'paradox' has been explained by high levels of social support which are thought to offset known risk factors for low birth weight. Yet common measures of social support during pregnancy suffer from presumptions of cultural homogeneity and a-priori definitions of meaningful social support. Analysis of qualitative data from ethnographic research with 28 low-income immigrant women from Mexico living in south Texas demonstrates that preferences for certain kinds of social support vary considerably, based on how each woman makes meaning of being pregnant. This diversity is one more piece of evidence that minority cultures cannot be essentialised in health disparities research. By not measuring the diversity of desire for different kinds of support, existing correlations between social support and birth outcomes may obscure other important psychosocial mediators, such as pregnancy-related social status, that could impact birth outcomes. Moreover, a measure of pregnancy-related status may offer a more thorough explanation of the 'protective effect' that could be explored independent of immigrant status.
Evaluating Individual Students' Perceptions of Instructional Quality: An Investigation of their Factor Structure, Measurement Invariance, and Relations to Educational Outcomes.

PubMed

Scherer, Ronny; Nilsen, Trude; Jansen, Malte

2016-01-01

Students' perceptions of instructional quality are among the most important criteria for evaluating teaching effectiveness. The present study evaluates different latent variable modeling approaches (confirmatory factor analysis, exploratory structural equation modeling, and bifactor modeling), which are used to describe these individual perceptions with respect to their factor structure, measurement invariance, and the relations to selected educational outcomes (achievement, self-concept, and motivation in mathematics). On the basis of the Programme for International Student Assessment (PISA) 2012 large-scale data sets of Australia, Canada, and the USA (N = 26,746 students), we find support for the distinction between three factors of individual students' perceptions and full measurement invariance across countries for all modeling approaches. In this regard, bifactor exploratory structural equation modeling outperformed alternative approaches with respect to model fit. Our findings reveal significant relations to the educational outcomes. This study synthesizes different modeling approaches of individual students' perceptions of instructional quality and provides insights into the nature of these perceptions from an individual differences perspective. Implications for the measurement and modeling of individually perceived instructional quality are discussed.
The use of cognitive ability measures as explanatory variables in regression analysis.

PubMed

Junker, Brian; Schofield, Lynne Steuerle; Taylor, Lowell J

2012-12-01

Cognitive ability measures are often taken as explanatory variables in regression analysis, e.g., as a factor affecting a market outcome such as an individual's wage, or a decision such as an individual's education acquisition. Cognitive ability is a latent construct; its true value is unobserved. Nonetheless, researchers often assume that a test score , constructed via standard psychometric practice from individuals' responses to test items, can be safely used in regression analysis. We examine problems that can arise, and suggest that an alternative approach, a "mixed effects structural equations" (MESE) model, may be more appropriate in many circumstances.
Private practice outcomes: validated outcomes data collection in private practice.

PubMed

Goldstein, Jack

2010-10-01

Improved patient care is related to validated outcome measures requiring the collection of three distinct data types: (1) demographics; (2) patient outcome measures; and (3) physician treatment. Previous impediments to widespread data collection have been: cost, office disruption, personnel requirements, physician motivation, data integration, and security. There are currently few means to collect data to be used for collaborative analysis. We therefore developed an inexpensive, patient-centric mechanism to reduce redundant data entry, limiting cost and personnel requirements. Using an intuitive touch-screen kiosk interface program, all data elements have been captured in a private practice setting since 2000. Developed for small to medium sized offices, this is scalable to larger organizations. Questionnaire navigation is patient driven, with demographics shared with EMR and billing systems. Integration of billing and EMR with outcomes minimizes cost and personnel time. Data are deidentified locally and may be centrally shared. Since data are entered by the patients, minimal personnel costs are incurred. Physician disincentives are minimized with cost reduction, time savings and ease of use. To date, we have collected high level data on most total joint patients, with excellent patient compliance. By addressing impediments to broad application, we may enable widespread local data collection in all practice settings. Data may be shared centrally, allowing comparative effectiveness research to become a reality. Future success will require broad physician participation, uniformity of data collected, and designation of a central site for receipt of data and its collaborative comparative analysis.
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).
Using Organization Risk Analyzer (ORA) to Explore the Relationship of Nursing Unit Communication to Patient Safety and Quality Outcomes

PubMed Central

Effken, Judith A.; Carley, Kathleen M.; Gephart, Sheila; Verran, Joyce A.; Bianchi, Denise; Reminga, Jeff; Brewer, Barbara

2011-01-01

Purpose We used Organization Risk Analyzer (ORA), a dynamic network analysis tool, to identify patient care unit communication patterns associated with patient safety and quality outcomes. Although ORA had previously had limited use in healthcare, we felt it could effectively model communication on patient care units. Methods Using a survey methodology, we collected communication network data from nursing staff on seven patient care units on two different days. Patient outcome data were collected via a separate survey. Results of the staff survey were used to represent the communication networks for each unit in ORA. We then used ORA's analysis capability to generate communication metrics for each unit. ORA's visualization capability was used to better understand the metrics. Results We identified communication patterns that correlated with two safety (falls and medication errors) and five quality (e.g., symptom management, complex self care, and patient satisfaction) outcome measures. Communication patterns differed substantially by shift. Conclusion The results demonstrate the utility of ORA for healthcare research and the relationship of nursing unit communication patterns to patient safety and quality outcomes. PMID:21536492
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
Small renal masses: The molecular markers associated with outcome of patients with kidney tumors 7 cm or less

NASA Astrophysics Data System (ADS)

Spirina, L. V.; Usynin, Y. A.; Kondakova, I. V.; Yurmazov, Z. A.; Slonimskaya, E. M.; Pikalova, L. V.

2016-08-01

The investigation of molecular mechanisms of tumor cell behavior in small renal masses is required to achieve the better cancer survival. The aim of the study is to find molecular markers associated with outcome of patients with kidney tumors 7 cm or less. A homogenous group of 20 patients T1N0M0-1 (mean age 57.6 ± 2.2 years) with kidney cancer was selected for the present analysis. The content of transcription and growth factors was determined by ELISA. The levels of AKT-mTOR signaling pathway components were measured by Western blotting analysis. The molecular markers associated with unfavorable outcome of patients with kidney tumors 7 cm or less were high levels of NF-kB p50, NF-kB p65, HIF-1, HIF-2, VEGF and CAIX. AKT activation with PTEN loss also correlated with the unfavorable outcome of kidney cancer patients with tumor size 7 cm or less. It is observed that the biological features of kidney cancer could predict the outcome of patients.
A new method to predict anatomical outcome after idiopathic macular hole surgery.

PubMed

Liu, Peipei; Sun, Yaoyao; Dong, Chongya; Song, Dan; Jiang, Yanrong; Liang, Jianhong; Yin, Hong; Li, Xiaoxin; Zhao, Mingwei

2016-04-01

To investigate whether a new macular hole closure index (MHCI) could predict anatomic outcome of macular hole surgery. A vitrectomy with internal limiting membrane peeling, air-fluid exchange, and gas tamponade were performed on all patients. The postoperative anatomic status of the macular hole was defined by spectral-domain OCT. MHCI was calculated as (M+N)/BASE based on the preoperative OCT status. M and N were the curve lengths of the detached photoreceptor arms, and BASE was the length of the retinal pigment epithelial layer (RPE layer) detaching from the photoreceptors. Postoperative anatomical outcomes were divided into three grades: A (bridge-like closure), B (good closure), and C (poor closure or no closure). Correlation analysis was performed between anatomical outcomes and MHCI. Receiver operating characteristic (ROC) curves were derived for MHCI, indicating good model discrimination. ROC curves were also assessed by the area under the curve, and cut-offs were calculated. Other predictive parameters reported previously, which included the MH minimum, the MH height, the macular hole index (MHI), the diameter hole index (DHI), and the tractional hole index (THI) had been compared as well. MHCI correlated significantly with postoperative anatomical outcomes (r = 0.543, p = 0.000), but other predictive parameters did not. The areas under the curves indicated that MHCI could be used as an effective predictor of anatomical outcome. Cut-off values of 0.7 and 1.0 were obtained for MHCI from ROC curve analysis. MHCI demonstrated a better predictive effect than other parameters, both in the correlation analysis and ROC analysis. MHCI could be an easily measured and accurate predictive index for postoperative anatomical outcomes.

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