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.

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.

The performance of different propensity score methods for estimating absolute effects of treatments on survival outcomes: A simulation study.

PubMed

Austin, Peter C; Schuster, Tibor

2016-10-01

Observational studies are increasingly being used to estimate the effect of treatments, interventions and exposures on outcomes that can occur over time. Historically, the hazard ratio, which is a relative measure of effect, has been reported. However, medical decision making is best informed when both relative and absolute measures of effect are reported. When outcomes are time-to-event in nature, the effect of treatment can also be quantified as the change in mean or median survival time due to treatment and the absolute reduction in the probability of the occurrence of an event within a specified duration of follow-up. We describe how three different propensity score methods, propensity score matching, stratification on the propensity score and inverse probability of treatment weighting using the propensity score, can be used to estimate absolute measures of treatment effect on survival outcomes. These methods are all based on estimating marginal survival functions under treatment and lack of treatment. We then conducted an extensive series of Monte Carlo simulations to compare the relative performance of these methods for estimating the absolute effects of treatment on survival outcomes. We found that stratification on the propensity score resulted in the greatest bias. Caliper matching on the propensity score and a method based on earlier work by Cole and Hernán tended to have the best performance for estimating absolute effects of treatment on survival outcomes. When the prevalence of treatment was less extreme, then inverse probability of treatment weighting-based methods tended to perform better than matching-based methods. © The Author(s) 2014.

Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures.

PubMed

Morel, Thomas; Cano, Stefan J

2017-11-02

Our ability to evaluate outcomes which genuinely reflect patients' unmet needs, hopes and concerns is of pivotal importance. However, much current clinical research and practice falls short of this objective by selecting outcome measures which do not capture patient value to the fullest. In this Opinion, we discuss Patient-Centered Outcomes Measures (PCOMs), which have the potential to systematically incorporate patient perspectives to measure those outcomes that matter most to patients. We argue for greater multi-stakeholder collaboration to develop PCOMs, with rare disease patients and families at the center. Beyond advancing the science of patient input, PCOMs are powerful tools to translate care or observed treatment benefit into an 'interpretable' measure of patient benefit, and thereby help demonstrate clinical effectiveness. We propose mixed methods psychometric research as the best route to deliver fit-for-purpose PCOMs in rare diseases, as this methodology brings together qualitative and quantitative research methods in tandem with the explicit aim to efficiently utilise data from small samples. And, whether one opts to develop a brand-new PCOM or to select or adapt an existing outcome measure for use in a rare disease, the anchors remain the same: patients, their daily experience of the rare disease, their preferences, core concepts and values. Ultimately, existing value frameworks, registries, and outcomes-based contracts largely fall short of consistently measuring the full range of outcomes that matter to patients. We argue that greater use of PCOMs in rare diseases would enable a fast track to Patient-Centered Care.

Selection and visualisation of outcome measures for complex post-acute acquired brain injury rehabilitation interventions

PubMed Central

Ford, Catherine Elaine Longworth; Malley, Donna; Bateman, Andrew; Clare, Isabel C.H.; Wagner, Adam P.; Gracey, Fergus

2016-01-01

Background Outcome measurement challenges rehabilitation services to select tools that promote stakeholder engagement in measuring complex interventions. Objectives To examine the suitability of outcome measures for complex post-acute acquired brain injury (ABI) rehabilitation interventions, report outcomes of a holistic, neuropsychological ABI rehabilitation program and propose a simple way of visualizing complex outcomes. Methods Patient/carer reported outcome measures (PROMS), experience measures (PREMS) and staff-rated measures were collected for consecutive admissions over 1 year to an 18-week holistic, neuropsychological rehabilitation programme at baseline, 18 weeks and 3- and 6-month follow-up. Results Engagement with outcome measurement was poorest for carers and at follow-up for all stakeholders. Dependence, abilities, adjustment, unmet needs, symptomatology including executive dysfunction, and self-reassurance showed improvements at 18 weeks. Adjustment, social participation, perceived health, symptomatology including dysexecutive difficulties, and anxiety were worse at baseline for those who did not complete rehabilitation, than those who did. A radar plot facilitated outcome visualization. Conclusions Engagement with outcome measurement was best when time and support were provided. Supplementing patient- with staff-rated and attendance measures may explain missing data and help quantify healthcare needs. The MPAI4, EBIQ and DEX-R appeared suitable measures to evaluate outcomes and distinguish those completing and not completing neuropsychological rehabilitation. PMID:27341362

Clinical outcome measurement: Models, theory, psychometrics and practice.

PubMed

McClimans, Leah; Browne, John; Cano, Stefan

In the last decade much has been made of the role that models play in the epistemology of measurement. Specifically, philosophers have been interested in the role of models in producing measurement outcomes. This discussion has proceeded largely within the context of the physical sciences, with notable exceptions considering measurement in economics. However, models also play a central role in the methods used to develop instruments that purport to quantify psychological phenomena. These methods fall under the umbrella term 'psychometrics'. In this paper, we focus on Clinical Outcome Assessments (COAs) and discuss two measurement theories and their associated models: Classical Test Theory (CTT) and Rasch Measurement Theory. We argue that models have an important role to play in coordinating theoretical terms with empirical content, but to do so they must serve: 1) as a representation of the measurement interaction; and 2) in conjunction with a theory of the attribute in which we are interested. We conclude that Rasch Measurement Theory is a more promising approach than CTT in these regards despite the latter's popularity with health outcomes researchers. Copyright © 2017. Published by Elsevier Ltd.

Outcome Measurement in Economic Evaluations of Public Health Interventions: a Role for the Capability Approach?

PubMed Central

Lorgelly, Paula K.; Lawson, Kenny D.; Fenwick, Elisabeth A.L.; Briggs, Andrew H.

2010-01-01

Public health interventions have received increased attention from policy makers, and there has been a corresponding increase in the number of economic evaluations within the domain of public health. However, methods to evaluate public health interventions are less well established than those for medical interventions. Focusing on health as an outcome measure is likely to underestimate the impact of many public health interventions. This paper provides a review of outcome measures in public health; and describes the benefits of using the capability approach as a means to developing an all encompassing outcome measure. PMID:20623024

Sufficient Dimension Reduction for Longitudinally Measured Predictors

PubMed Central

Pfeiffer, Ruth M.; Forzani, Liliana; Bura, Efstathia

2013-01-01

We propose a method to combine several predictors (markers) that are measured repeatedly over time into a composite marker score without assuming a model and only requiring a mild condition on the predictor distribution. Assuming that the first and second moments of the predictors can be decomposed into a time and a marker component via a Kronecker product structure, that accommodates the longitudinal nature of the predictors, we develop first moment sufficient dimension reduction techniques to replace the original markers with linear transformations that contain sufficient information for the regression of the predictors on the outcome. These linear combinations can then be combined into a score that has better predictive performance than the score built under a general model that ignores the longitudinal structure of the data. Our methods can be applied to either continuous or categorical outcome measures. In simulations we focus on binary outcomes and show that our method outperforms existing alternatives using the AUC, the area under the receiver-operator characteristics (ROC) curve, as a summary measure of the discriminatory ability of a single continuous diagnostic marker for binary disease outcomes. PMID:22161635

Toddlers' Verb Lexicon Diversity and Grammatical Outcomes

ERIC Educational Resources Information Center

Hadley, Pamela A.; Rispoli, Matthew; Hsu, Ning

2016-01-01

Purpose: The goals of this study were to quantify longitudinal expectations for verb lexicon growth and to determine whether verb lexicon measures were better predictors of later grammatical outcomes than noun lexicon measures. Method: Longitudinal parent-report measures from the MacArthur-Bates Communicative Development Inventory (Fenson et al.,…

How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.

PubMed

Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R; Boers, Maarten; Tugwell, Peter; Clarke, Mike; Williamson, Paula R; Terwee, Caroline B

2016-09-13

In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a "Core Outcome Set" (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.

An Evaluation of Auditory Verbal Therapy Using the Rate of Early Language Development as an Outcome Measure

ERIC Educational Resources Information Center

Hogan, Sarah; Stokes, Jacqueline; White, Catherine; Tyszkiewicz, Elizabeth; Woolgar, Alexandra

2008-01-01

Providing unbiased data concerning the outcomes of particular intervention methods is imperative if professionals and parents are to assimilate information which could contribute to an "informed choice". An evaluation of Auditory Verbal Therapy (AVT) was conducted using a formal assessment of spoken language as an outcome measure. Spoken…

Focused Evidence Review: Psychometric Properties of Patient-Reported Outcome Measures for Chronic Musculoskeletal Pain.

PubMed

Goldsmith, Elizabeth S; Taylor, Brent C; Greer, Nancy; Murdoch, Maureen; MacDonald, Roderick; McKenzie, Lauren; Rosebush, Christina E; Wilt, Timothy J

2018-05-01

Developing successful interventions for chronic musculoskeletal pain requires valid, responsive, and reliable outcome measures. The Minneapolis VA Evidence-based Synthesis Program completed a focused evidence review on key psychometric properties of 17 self-report measures of pain severity and pain-related functional impairment suitable for clinical research on chronic musculoskeletal pain. Pain experts of the VA Pain Measurement Outcomes Workgroup identified 17 pain measures to undergo systematic review. In addition to a MEDLINE search on these 17 measures (1/2000-1/2017), we hand-searched (without publication date limits) the reference lists of all included studies, prior systematic reviews, and-when available-Web sites dedicated to each measure (PROSPERO registration CRD42017056610). Our primary outcome was the measure's minimal important difference (MID). Secondary outcomes included responsiveness, validity, and test-retest reliability. Outcomes were synthesized through evidence mapping and qualitative comparison. Of 1635 abstracts identified, 331 articles underwent full-text review, and 43 met inclusion criteria. Five measures (Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), SF-36 Bodily Pain Scale (SF-36 BPS), Numeric Rating Scale (NRS), and Visual Analog Scale (VAS)) had data reported on MID, responsiveness, validity, and test-retest reliability. Seven measures had data reported on three of the four psychometric outcomes. Eight measures had reported MIDs, though estimation methods differed substantially and often were not clinically anchored. In this focused evidence review, the most evidence on key psychometric properties in chronic musculoskeletal pain populations was found for the ODI, RMDQ, SF-36 BPS, NRS, and VAS. Key limitations in the field include substantial variation in methods of estimating psychometric properties, defining chronic musculoskeletal pain, and reporting patient demographics. Registered in the PROSPERO database: CRD42017056610.

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials

PubMed Central

Donovan, Dennis M.; Bigelow, George E.; Brigham, Gregory S.; Carroll, Kathleen M.; Cohen, Allan J.; Gardin, John G.; Hamilton, John A.; Huestis, Marilyn A.; Hughes, John R.; Lindblad, Robert; Marlatt, G. Alan; Preston, Kenzie L.; Selzer, Jeffrey A.; Somoza, Eugene C.; Wakim, Paul G.; Wells, Elizabeth A.

2012-01-01

Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them. PMID:21781202

Validation of a Measure of College Students' Intoxicated Behaviors: Associations with Alcohol Outcome Expectancies, Drinking Motives, and Personality

ERIC Educational Resources Information Center

Westmaas, Johann; Moeller, Scott; Woicik, Patricia Butler

2007-01-01

Objective: The authors aimed to develop a measure of college students' intoxicated behaviors and to validate the measure using scales assessing alcohol outcome expectancies, motives for drinking, and personality traits. Participants and Method Summary: The authors administered these measures and an inventory describing 50 intoxicated behaviors to…

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

PubMed

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

2016-12-01

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

A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement

PubMed Central

de Roos, Paul; Bloem, Bastiaan R.; Kelley, Thomas A.; Antonini, Angelo; Dodel, Richard; Hagell, Peter; Marras, Connie; Martinez-Martin, Pablo; Mehta, Shyamal H.; Odin, Per; Chaudhuri, Kallol Ray; Weintraub, Daniel; Wilson, Bil; Uitti, Ryan J.

2017-01-01

Background Parkinson’s disease (PD) is a progressive neurodegenerative condition that is expected to double in prevalence due to demographic shifts. Value-based healthcare is a proposed strategy to improve outcomes and decrease costs. To move towards an actual value-based health care system, condition-specific outcomes that are meaningful to patients are essential. Objective Propose a global consensus standard set of outcome measures for PD. Methods Established methods for outcome measure development were applied, as outlined and used previously by the International Consortium for Health Outcomes Measurement (ICHOM). An international group, representing both patients and experts from the fields of neurology, psychiatry, nursing, and existing outcome measurement efforts, was convened. The group participated in six teleconferences over a six-month period, reviewed existing data and practices, and ultimately proposed a standard set of measures by which patients should be tracked, and how often data should be collected. Results The standard set applies to all cases of idiopathic PD, and includes assessments of motor and non-motor symptoms, ability to work, PD-related health status, and hospital admissions. Baseline demographic and clinical variables are included to enable case mix adjustment. Conclusions The Standard Set is now ready for use and pilot testing in the clinical setting. Ultimately, we believe that using the set of outcomes proposed here will allow clinicians and scientists across the world to document, report, and compare PD-related outcomes in a standardized fashion. Such international benchmarks will improve our understanding of the disease course and allow for identification of ‘best practices’, ultimately leading to better informed treatment decisions. PMID:28671140

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.

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.

Outcome measures for clinical rehabilitation trials: impairment, function, quality of life, or value?

PubMed

Wade, Derick T

2003-10-01

Choosing outcome measures in rehabilitation research depends on the standard research skills of clear thinking, attention to detail, and minimizing the amount of data collected. In rehabilitation, outcome is more difficult to measure because (1) usually several outcomes are relevant, (2) relevant outcomes are affected by multiple factors in addition to treatment, and (3) even good measures rarely reflect the specific interest of any individual patient or member of the rehabilitation team, leading to some dissent. Measurement of general quality of life is not possible because there is little agreement as to the nature of the construct; moreover, measurement of relevant aspects of quality of life would probably give similar results. Cost in terms of resources can be estimated, but there is no validated or even widely accepted method of relating this to benefit in a fair, open, and rational way. Outcome is best measured at the level of behavior (activities), with other measures being used to aid interpretation.

Measuring what matters to patients: Using goal content to inform measure choice and development.

PubMed

Jacob, Jenna; Edbrooke-Childs, Julian; Law, Duncan; Wolpert, Miranda

2017-04-01

Personalised care requires personalised outcomes and ways of feeding back clinically useful information to clinicians and practitioners, but it is not clear how to best personalise outcome measurement and feedback using existing standardised outcome measures. The constant comparison method of grounded theory was used to compare goal themes derived from goals set at the outset of therapy for 180 children aged between 4 and 17 years, visiting eight child and adolescent mental health services, to existing standardised outcome measures used as part of common national datasets. In all, 20 out of 27 goal themes corresponded to items on at least one commonly used outcome measure. Consideration of goal themes helped to identify potential relevant outcome measures. However, there were several goal themes that were not captured by items on standardised outcome measures. These seemed to be related to existential factors such as understanding, thinking about oneself and future planning. This presents a powerful framework for how clinicians can use goals to help select a standardised outcome measure (where this is helpful) in addition to the use of a goal-based outcome measure and personalise choices. There may be areas not captured by standardised outcome measures that may be important for children and young people and which may only be currently captured in goal measurement. There is an indication that we may not be measuring what is important to children and young people. We may need to develop or look for new measures that capture these areas.

Elicited and Spontaneous Communicative Functions and Stability of Conversational Measures with Children Who Have Pragmatic Language Impairments

ERIC Educational Resources Information Center

Adams, Catherine; Lloyd, Julian

2005-01-01

Background: The preliminary phase of a project aimed at establishing appropriate outcome measures for intervention with children who have pragmatic language impairments (PLI) is reported. Assessment methods for children with PLI are considered in the context of developing outcome measures for intervention studies. Communicative function…

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…

Focusing on Student Academic Outcomes. A Working Paper.

ERIC Educational Resources Information Center

Alexander, Joanne M.; Stark, Joan S.

Current methods and instruments for assessing college student academic outcomes are identified and described, and possible outcome measures of NCRIPTAL's (National Center for Research to Improve Postsecondary Teaching and Learning) are suggested. Section I defines college outcomes from several perspectives, including pressures for outcome…

How is the sustainability of chronic disease health programmes empirically measured in hospital and related healthcare services?—a scoping review

PubMed Central

Francis, Linda; Dunt, David; Cadilhac, Dominique A

2016-01-01

Objectives Programmes to address chronic disease are a focus of governments worldwide. Despite growth in ‘implementation science’, there is a paucity of knowledge regarding the best means to measure sustainability. The aim of this review was to summarise current practice for measuring sustainability outcomes of chronic disease health programmes, providing guidance for programme planners and future directions for the academic field. Settings A scoping review of the literature spanning 1985–2015 was conducted using MEDLINE, CINAHL, PsychINFO and The Cochrane Library limited to English language and adults. Main search terms included chronic disease, acute care, sustainability, institutionalisation and health planning. A descriptive synthesis was required. Settings included primary care, hospitals, mental health centres and community health. Participants Programmes included preventing or managing chronic conditions including diabetes, heart disease, depression, respiratory disease, cancer, obesity, dental hygiene and multiple chronic diseases. Primary and secondary outcome measures Outcome measures included clarifying a sustainability definition, types of methodologies used, timelines for assessment, criteria levels to determine outcomes and how methodology varies between intervention types. Results Among 153 abstracts retrieved, 87 were retained for full article review and 42 included in the qualitative synthesis. Five definitions for sustainability outcome were identified with ‘maintenance of programme activities’ most frequent. Achieving sustainability was dependent on inter-relationships between various organisational and social contexts supporting a broad scale approach to evaluation. An increasing trend in use of mixed methods designs over multiple time points to determine sustainability outcomes was found. Conclusions Despite the importance and investment in chronic disease programmes, few studies are undertaken to measure sustainability. Methods to evaluate sustainability are diverse with some emerging patterns in measurement found. Use of mixed methods approaches over multiple time points may serve to better guide measurement of sustainability. Consensus on aspects of standardised measurement would promote the future possibility of meta-analytic syntheses. PMID:27246000

Effectiveness of IT-based diabetes management interventions: a review of the literature.

PubMed

Costa, Beth M; Fitzgerald, Kristine J; Jones, Kay M; Dunning Am, Trisha

2009-11-17

Information technology (IT) is increasingly being used in general practice to manage health care including type 2 diabetes. However, there is conflicting evidence about whether IT improves diabetes outcomes. This review of the literature about IT-based diabetes management interventions explores whether methodological issues such as sample characteristics, outcome measures, and mechanisms causing change in the outcome measures could explain some of the inconsistent findings evident in IT-based diabetes management studies. Databases were searched using terms related to IT and diabetes management. Articles eligible for review evaluated an IT-based diabetes management intervention in general practice and were published between 1999 and 2009 inclusive in English. Studies that did not include outcome measures were excluded. Four hundred and twenty-five articles were identified, sixteen met the inclusion criteria: eleven GP focussed and five patient focused interventions were evaluated. Nine were RCTs, five non-randomised control trials, and two single-sample before and after designs. Important sample characteristics such as diabetes type, familiarity with IT, and baseline diabetes knowledge were not addressed in any of the studies reviewed. All studies used HbA1c as a primary outcome measure, and nine reported a significant improvement in mean HbA1c over the study period; only two studies reported the HbA1c assay method. Five studies measured diabetes medications and two measured psychological outcomes. Patient lifestyle variables were not included in any of the studies reviewed. IT was the intervention method considered to effect changes in the outcome measures. Only two studies mentioned alternative possible causal mechanisms. Several limitations could affect the outcomes of IT-based diabetes management interventions to an unknown degree. These limitations make it difficult to attribute changes solely to such interventions.

42 CFR 67.101 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Section 1142 of the Social Security Act to support research on the outcomes, effectiveness, and... services and procedures; projects to improve methods and data bases for outcomes and effectiveness research..., performance measures, and review criteria; conferences; and research on dissemination methods. (b) The...

Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

PubMed

Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

2014-05-01

The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of the end product. This scoping review reinforced the need for clear methods and standards for core set development. Based on these findings, OMERACT will make its own conceptual framework and working process more explicit. Proposals for how to achieve this were discussed at the OMERACT 11 conference.

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)

Prosthetists' perceptions and use of outcome measures in clinical practice: Long-term effects of focused continuing education.

PubMed

Hafner, Brian J; Spaulding, Susan E; Salem, Rana; Morgan, Sara J; Gaunaurd, Ignacio; Gailey, Robert

2017-06-01

Continuing education is intended to facilitate clinicians' skills and knowledge in areas of practice, such as administration and interpretation of outcome measures. To evaluate the long-term effect of continuing education on prosthetists' confidence in administering outcome measures and their perceptions of outcomes measurement in clinical practice. Pretest-posttest survey methods. A total of 66 prosthetists were surveyed before, immediately after, and 2 years after outcomes measurement education and training. Prosthetists were grouped as routine or non-routine outcome measures users, based on experience reported prior to training. On average, prosthetists were just as confident administering measures 1-2 years after continuing education as they were immediately after continuing education. In all, 20% of prosthetists, initially classified as non-routine users, were subsequently classified as routine users at follow-up. Routine and non-routine users' opinions differed on whether outcome measures contributed to efficient patient evaluations (79.3% and 32.4%, respectively). Both routine and non-routine users reported challenges integrating outcome measures into normal clinical routines (20.7% and 45.9%, respectively). Continuing education had a long-term impact on prosthetists' confidence in administering outcome measures and may influence their clinical practices. However, remaining barriers to using standardized measures need to be addressed to keep practitioners current with evolving practice expectations. Clinical relevance Continuing education (CE) had a significant long-term impact on prosthetists' confidence in administering outcome measures and influenced their clinical practices. In all, approximately 20% of prosthetists, who previously were non-routine outcome measure users, became routine users after CE. There remains a need to develop strategies to integrate outcome measurement into routine clinical practice.

Methodological Issues in Examining Measurement Equivalence in Patient Reported Outcomes Measures: Methods Overview to the Two-Part Series, “Measurement Equivalence of the Patient Reported Outcomes Measurement Information System® (PROMIS®) Short Forms”

PubMed Central

Teresi, Jeanne A.; Jones, Richard N.

2017-01-01

The purpose of this article is to introduce the methods used and challenges confronted by the authors of this two-part series of articles describing the results of analyses of measurement equivalence of the short form scales from the Patient Reported Outcomes Measurement Information System® (PROMIS®). Qualitative and quantitative approaches used to examine differential item functioning (DIF) are reviewed briefly. Qualitative methods focused on generation of DIF hypotheses. The basic quantitative approaches used all rely on a latent variable model, and examine parameters either derived directly from item response theory (IRT) or from structural equation models (SEM). A key methods focus of these articles is to describe state-of-the art approaches to examination of measurement equivalence in eight domains: physical health, pain, fatigue, sleep, depression, anxiety, cognition, and social function. These articles represent the first time that DIF has been examined systematically in the PROMIS short form measures, particularly among ethnically diverse groups. This is also the first set of analyses to examine the performance of PROMIS short forms in patients with cancer. Latent variable model state-of-the-art methods for examining measurement equivalence are introduced briefly in this paper to orient readers to the approaches adopted in this set of papers. Several methodological challenges underlying (DIF-free) anchor item selection and model assumption violations are presented as a backdrop for the articles in this two-part series on measurement equivalence of PROMIS measures. PMID:28983448

Methodological Issues in Examining Measurement Equivalence in Patient Reported Outcomes Measures: Methods Overview to the Two-Part Series, "Measurement Equivalence of the Patient Reported Outcomes Measurement Information System® (PROMIS®) Short Forms".

PubMed

Teresi, Jeanne A; Jones, Richard N

2016-01-01

The purpose of this article is to introduce the methods used and challenges confronted by the authors of this two-part series of articles describing the results of analyses of measurement equivalence of the short form scales from the Patient Reported Outcomes Measurement Information System ® (PROMIS ® ). Qualitative and quantitative approaches used to examine differential item functioning (DIF) are reviewed briefly. Qualitative methods focused on generation of DIF hypotheses. The basic quantitative approaches used all rely on a latent variable model, and examine parameters either derived directly from item response theory (IRT) or from structural equation models (SEM). A key methods focus of these articles is to describe state-of-the art approaches to examination of measurement equivalence in eight domains: physical health, pain, fatigue, sleep, depression, anxiety, cognition, and social function. These articles represent the first time that DIF has been examined systematically in the PROMIS short form measures, particularly among ethnically diverse groups. This is also the first set of analyses to examine the performance of PROMIS short forms in patients with cancer. Latent variable model state-of-the-art methods for examining measurement equivalence are introduced briefly in this paper to orient readers to the approaches adopted in this set of papers. Several methodological challenges underlying (DIF-free) anchor item selection and model assumption violations are presented as a backdrop for the articles in this two-part series on measurement equivalence of PROMIS measures.

A novel method for reproducibly measuring the effects of interventions to improve emotional climate, indices of team skills and communication, and threat to patient outcome in a high-volume thoracic surgery center.

PubMed

Nurok, Michael; Lipsitz, Stuart; Satwicz, Paul; Kelly, Andrea; Frankel, Allan

2010-05-01

To create and test a reproducible method for measuring emotional climate, surgical team skills, and threats to patient outcome by conducting an observational study to assess the impact of a surgical team skills and communication improvement intervention on these measurements. Observational study. Operating rooms in a high-volume thoracic surgery center from September 5, 2007, through June 30, 2008. Thoracic surgery operating room teams. Two 90-minute team skills training sessions focused on findings from a standardized safety culture survey administered to all participants and highlighting positive and problematic aspects of team skills, communication, and leadership. The sessions created an interactive forum to educate team members on the importance of communication and to role-play optimal interactive and communication strategies. Calculated indices of emotional climate, team skills, and threat to patient outcome. The calculated communication and team skills score improved from the preintervention to postintervention periods, but the improvement extinguished during the 3 months after the intervention (P < .001). The calculated threat-to-outcome score improved following the team training intervention and remained statistically improved 3 months later (P < .001). Using a new method for measuring emotional climate, teamwork, and threats to patient outcome, we were able to determine that a teamwork training intervention can improve a calculated score of team skills and communication and decrease a calculated score of threats to patient outcome. However, the effect is only durable for threats to patient outcome.

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program.

PubMed

Gaunaurd, Ignacio; Spaulding, Susan E; Amtmann, Dagmar; Salem, Rana; Gailey, Robert; Morgan, Sara J; Hafner, Brian J

2015-08-01

Outcome measures can be used in prosthetic practices to evaluate interventions, inform decision making, monitor progress, document outcomes, and justify services. Strategies to enhance prosthetists' ability to use outcome measures are needed to facilitate their adoption in routine practice. To assess prosthetists' use of outcome measures and evaluate the effects of training on their confidence in administering performance-based measures. Cross-sectional and single-group pretest-posttest survey. Seventy-nine certified prosthetists (mean of 16.0 years of clinical experience) were surveyed about their experiences with 20 standardized outcome measures. Prosthetists were formally trained by the investigators to administer the Timed Up and Go and Amputee Mobility Predictor. Prosthetists' confidence in administering the Timed Up and Go and Amputee Mobility Predictor was measured before and after training. The majority of prosthetists (62%) were classified as non-routine outcome measure users. Confidence administering the Timed Up and Go and Amputee Mobility Predictor prior to training was low-to-moderate across the study sample. Training significantly (p < 0.0001) improved prosthetists' confidence in administering both instruments. Prosthetists in this study reported limited use of and confidence with standardized outcome measures. Interactive training resulted in a statistically significant increase of prosthetists' confidence in administering the Timed Up and Go and Amputee Mobility Predictor and may facilitate use of outcome measures in clinical practice. Frequency of outcome measure use in the care of persons with limb loss has not been studied. Study results suggest that prosthetists may not regularly use standardized outcome measures and report limited confidence in administering them. Training enhances confidence and may encourage use of outcome measures in clinical practice. © The International Society for Prosthetics and Orthotics 2014.

Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

ERIC Educational Resources Information Center

Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

2017-01-01

Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health…

The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology.

PubMed

Schmitt, Jochen; Apfelbacher, Christian; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric L; Furue, Masutaka; Chalmers, Joanne; Williams, Hywel C

2015-01-01

Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care.

How to Measure Outcomes of Peripheral Nerve Surgery

PubMed Central

Wang, Yirong; Sunitha, Malay; Chung, Kevin C.

2013-01-01

Synopsis Evaluation of outcomes after peripheral nerve surgeries include a number of assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, neurophysiological and patient- reported outcomes. This review makes a list of measurements addressing these aspects as well as advantage and disadvantage of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers focus on measurements best relevant to specific conditions and research questions. PMID:23895715

How to measure outcomes of peripheral nerve surgery.

PubMed

Wang, Yirong; Sunitha, Malay; Chung, Kevin C

2013-08-01

Evaluation of outcomes after peripheral nerve surgeries include several assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, and neurophysiologic and patient-reported outcomes. This review lists measurements addressing these aspects as well as the advantages and disadvantages of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers to focus on measurements best relevant to specific conditions and research questions. Copyright © 2013 Elsevier Inc. All rights reserved.

Methodological Issues in Monitoring Health Services and Outcomes for Stroke Survivors: A Case Study

PubMed Central

Stuart, Mary; Papini, Donato; Benvenuti, Francesco; Nerattini, Marco; Roccato, Enrico; Macellari, Velio; Stanhope, Steven; Macko, Richard; Weinrich, Michael

2010-01-01

Background Obtaining comprehensive health outcomes and health services utilization data on stroke patients has been difficult. This research grew out of a memorandum of understanding between the NIH and the ISS (its Italian equivalent) to foster collaborative research on rehabilitation. Objective The purpose of this study was to pilot a methodology using administrative data to monitor and improve health outcomes for stroke survivors in Tuscany. Methods This study used qualitative and quantitative methods to study health resources available to and utilized by stroke survivors during the first 12 months post-stroke in two Italian health authorities (AUSL10 and 11). Mortality rates were used as an outcome measure. Results Number of inpatient days, number of prescriptions, and prescription costs were significantly higher for patients in AUSL 10 compared to AUSL 11. There was no significant difference between mortality rates. Conclusion Using administrative data to monitor process and outcomes for chronic stroke has the potential to save money and improve outcomes. However, measures of functional impairment and more sensitive outcome measures than mortality are important. Additional recommendations for enhanced data collection and reporting are discussed. PMID:21057665

Alternative outcome definitions and their effect on the performance of methods for observational outcome studies.

PubMed

Reich, Christian G; Ryan, Patrick B; Schuemie, Martijn J

2013-10-01

A systematic risk identification system has the potential to test marketed drugs for important Health Outcomes of Interest or HOI. For each HOI, multiple definitions are used in the literature, and some of them are validated for certain databases. However, little is known about the effect of different definitions on the ability of methods to estimate their association with medical products. Alternative definitions of HOI were studied for their effect on the performance of analytical methods in observational outcome studies. A set of alternative definitions for three HOI were defined based on literature review and clinical diagnosis guidelines: acute kidney injury, acute liver injury and acute myocardial infarction. The definitions varied by the choice of diagnostic codes and the inclusion of procedure codes and lab values. They were then used to empirically study an array of analytical methods with various analytical choices in four observational healthcare databases. The methods were executed against predefined drug-HOI pairs to generate an effect estimate and standard error for each pair. These test cases included positive controls (active ingredients with evidence to suspect a positive association with the outcome) and negative controls (active ingredients with no evidence to expect an effect on the outcome). Three different performance metrics where used: (i) Area Under the Receiver Operator Characteristics (ROC) curve (AUC) as a measure of a method's ability to distinguish between positive and negative test cases, (ii) Measure of bias by estimation of distribution of observed effect estimates for the negative test pairs where the true effect can be assumed to be one (no relative risk), and (iii) Minimal Detectable Relative Risk (MDRR) as a measure of whether there is sufficient power to generate effect estimates. In the three outcomes studied, different definitions of outcomes show comparable ability to differentiate true from false control cases (AUC) and a similar bias estimation. However, broader definitions generating larger outcome cohorts allowed more drugs to be studied with sufficient statistical power. Broader definitions are preferred since they allow studying drugs with lower prevalence than the more precise or narrow definitions while showing comparable performance characteristics in differentiation of signal vs. no signal as well as effect size estimation.

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol.

PubMed

Blom, Kimberly C; Farina, Sasha; Gomez, Yessica-Haydee; Campbell, Norm R C; Hemmelgarn, Brenda R; Cloutier, Lyne; McKay, Donald W; Dawes, Martin; Tobe, Sheldon W; Bolli, Peter; Gelfer, Mark; McLean, Donna; Bartlett, Gillian; Joseph, Lawrence; Featherstone, Robin; Schiffrin, Ernesto L; Daskalopoulou, Stella S

2015-04-01

Despite progress in automated blood pressure measurement (BPM) technology, there is limited research linking hard outcomes to automated office BPM (OBPM) treatment targets and thresholds. Equivalences for automated BPM devices have been estimated from approximations of standardized manual measurements of 140/90 mmHg. Until outcome-driven targets and thresholds become available for automated measurement methods, deriving evidence-based equivalences between automated methods and standardized manual OBPM is the next best solution. The MeasureBP study group was initiated by the Canadian Hypertension Education Program to close this critical knowledge gap. MeasureBP aims to define evidence-based equivalent values between standardized manual OBPM and automated BPM methods by synthesizing available evidence using a systematic review and individual subject-level data meta-analyses. This manuscript provides a review of the literature and MeasureBP study protocol. These results will lay the evidenced-based foundation to resolve uncertainties within blood pressure guidelines which, in turn, will improve the management of hypertension.

New agreement measures based on survival processes

PubMed Central

Guo, Ying; Li, Ruosha; Peng, Limin; Manatunga, Amita K.

2013-01-01

Summary The need to assess agreement arises in many scenarios in biomedical sciences when measurements were taken by different methods on the same subjects. When the endpoints are survival outcomes, the study of agreement becomes more challenging given the special characteristics of time-to-event data. In this paper, we propose a new framework for assessing agreement based on survival processes that can be viewed as a natural representation of time-to-event outcomes. Our new agreement measure is formulated as the chance-corrected concordance between survival processes. It provides a new perspective for studying the relationship between correlated survival outcomes and offers an appealing interpretation as the agreement between survival times on the absolute distance scale. We provide a multivariate extension of the proposed agreement measure for multiple methods. Furthermore, the new framework enables a natural extension to evaluate time-dependent agreement structure. We develop nonparametric estimation of the proposed new agreement measures. Our estimators are shown to be strongly consistent and asymptotically normal. We evaluate the performance of the proposed estimators through simulation studies and then illustrate the methods using a prostate cancer data example. PMID:23844617

Progress on core outcome sets for critical care research.

PubMed

Blackwood, Bronagh; Marshall, John; Rose, Louise

2015-10-01

Appropriate selection and definition of outcome measures are essential for clinical trials to be maximally informative. Core outcome sets (an agreed, standardized collection of outcomes measured and reported in all trials for a specific clinical area) were developed due to established inconsistencies in trial outcome selection. This review discusses the rationale for, and methods of, core outcome set development, as well as current initiatives in critical care. Recent systematic reviews of reported outcomes and measurement instruments relevant to the critically ill highlight inconsistencies in outcome selection, definition, and measurement, thus establishing the need for core outcome sets. Current critical care initiatives include development of core outcome sets for trials aimed at reducing mechanical ventilation duration; rehabilitation following critical illness; long-term outcomes in acute respiratory failure; and epidemic and pandemic studies of severe acute respiratory infection. Development and utilization of core outcome sets for studies relevant to the critically ill is in its infancy compared to other specialties. Notwithstanding, core outcome set development frameworks and guidelines are available, several sets are in various stages of development, and there is strong support from international investigator-led collaborations including the International Forum for Acute Care Trialists.

Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM).

PubMed

McNamara, Robert L; Spatz, Erica S; Kelley, Thomas A; Stowell, Caleb J; Beltrame, John; Heidenreich, Paul; Tresserras, Ricard; Jernberg, Tomas; Chua, Terrance; Morgan, Louise; Panigrahi, Bishnu; Rosas Ruiz, Alba; Rumsfeld, John S; Sadwin, Lawrence; Schoeberl, Mark; Shahian, David; Weston, Clive; Yeh, Robert; Lewin, Jack

2015-05-19

Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments. The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient-reported health status (Seattle Angina Questionnaire [SAQ-7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ-2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons. ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Theoretical framework and methodological development of common subjective health outcome measures in osteoarthritis: a critical review

PubMed Central

Pollard, Beth; Johnston, Marie; Dixon, Diane

2007-01-01

Subjective measures involving clinician ratings or patient self-assessments have become recognised as an important tool for the assessment of health outcome. The value of a health outcome measure is usually assessed by a psychometric evaluation of its reliability, validity and responsiveness. However, psychometric testing involves an accumulation of evidence and has recognised limitations. It has been suggested that an evaluation of how well a measure has been developed would be a useful additional criteria in assessing the value of a measure. This paper explored the theoretical background and methodological development of subjective health status measures commonly used in osteoarthritis research. Fourteen subjective health outcome measures commonly used in osteoarthritis research were examined. Each measure was explored on the basis of their i) theoretical framework (was there a definition of what was being assessed and was it part of a theoretical model?) and ii) methodological development (what was the scaling strategy, how were the items generated and reduced, what was the response format and what was the scoring method?). Only the AIMS, SF-36 and WHOQOL defined what they were assessing (i.e. the construct of interest) and no measure assessed was part of a theoretical model. None of the clinician report measures appeared to have implemented a scaling procedure or described the rationale for the items selected or scoring system. Of the patient self-report measures, the AIMS, MPQ, OXFORD, SF-36, WHOQOL and WOMAC appeared to follow a standard psychometric scaling method. The DRP and EuroQol used alternative scaling methods. The review highlighted the general lack of theoretical framework for both clinician report and patient self-report measures. This review also drew attention to the wide variation in the methodological development of commonly used measures in OA. While, in general the patient self-report measures had good methodological development, the clinician report measures appeared less well developed. It would be of value if new measures defined the construct of interest and, that the construct, be part of theoretical model. By ensuring measures are both theoretically and empirically valid then improvements in subjective health outcome measures should be possible. PMID:17343739

Decoding Learning Gains: Measuring Outcomes and the Pivotal Role of the Major and Student Backgrounds. SERU Project and Consortium Research Paper. Research & Occasional Paper Series: CSHE.5.09

ERIC Educational Resources Information Center

Thomas, Gregg; Douglass, John Aubrey

2009-01-01

Throughout the world, interest in gauging learning outcomes at all levels of education has grown considerably over the past decade. In higher education, measuring "learning outcomes" is viewed by many stakeholders as a relatively new method to judge the "value added" of colleges and universities. The potential to accurately…

A Review of Preventative Methods against Human Leishmaniasis Infection

PubMed Central

Stockdale, Lisa; Newton, Robert

2013-01-01

Background Leishmaniasis is an intracellular parasitic infection transmitted to humans via the sandfly. Approximately 350 million people are at risk of contracting the disease and an estimated 1.6 million new cases occur annually. Of the two main forms, visceral and cutaneous, the visceral form is fatal in 85–90% of untreated cases. Aims This literature review aims to identify and evaluate the current evidence base for the use of various preventative methods against human leishmaniasis. Methods A literature search was performed of the relevant database repositories for primary research conforming to a priori inclusion and exclusion criteria. Results A total of 84 controlled studies investigating 12 outcome measures were identified, implementing four broad categories of preventative interventions: animal reservoir control, vector population control, human reservoir control and a category for multiple concurrently implemented interventions. The primary studies investigated a heterogeneous mix of outcome measures using a range of different methods. Conclusions This review highlights an absence of research measuring human-specific outcomes (35% of the total) across all intervention categories. The apparent inability of study findings to be generalizable across different geographic locations, points towards gaps in knowledge regarding the biology of transmission of Leishmania in different settings. More research is needed which investigates human infection as the primary outcome measure as opposed to intermediate surrogate markers, with a focus on developing a human vaccine. PMID:23818997

Measurement of health outcomes.

PubMed

Thavorncharoensap, Montarat

2014-05-01

Health outcomes are one of the most important components of health technology assessments (HTAs). All HTA outcomes should be measured from a relevant sample using a properly designed study and method. A number of recommendations on health outcome measurements are made in this second edition of Thailand's HTA guidelines. In particular the use of final outcomes, rather than surrogate outcomes, in HTAs is stressed. Where surrogate outcomes are used, strong justification and evidence must be provided. Effectiveness is preferred over efficacy. The relative treatment effect (the difference between health outcome that would be experienced by patients receiving the technology and that experienced by the same group were they to receive an alternative technology) should be derived from a systematic review of head-to-head RCTs. Mixed treatment comparison (MTC) should be used only to provide supplementary data that cannot be obtained from a head-to-head comparison. Where no direct comparison evidence exists, indirect comparison and observational study data can be used.

Outcomes Measurement in Voice Disorders: Application of an Acoustic Index of Dysphonia Severity

ERIC Educational Resources Information Center

Awan, Shaheen N.; Roy, Nelson

2009-01-01

Purpose: The purpose of this experiment was to assess the ability of an acoustic model composed of both time-based and spectral-based measures to track change following voice disorder treatment and to serve as a possible treatment outcomes measure. Method: A weighted, four-factor acoustic algorithm consisting of shimmer, pitch sigma, the ratio of…

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

A Local Agreement Pattern Measure Based on Hazard Functions for Survival Outcomes

PubMed Central

Dai, Tian; Guo, Ying; Peng, Limin; Manatunga, Amita K.

2017-01-01

Summary Assessing agreement is often of interest in biomedical and clinical research when measurements are obtained on the same subjects by different raters or methods. Most classical agreement methods have been focused on global summary statistics, which cannot be used to describe various local agreement patterns. The objective of this work is to study the local agreement pattern between two continuous measurements subject to censoring. In this paper, we propose a new agreement measure based on bivariate hazard functions to characterize the local agreement pattern between two correlated survival outcomes. The proposed measure naturally accommodates censored observations, fully captures the dependence structure between bivariate survival times and provides detailed information on how the strength of agreement evolves over time. We develop a nonparametric estimation method for the proposed local agreement pattern measure and study theoretical properties including strong consistency and asymptotical normality. We then evaluate the performance of the estimator through simulation studies and illustrate the method using a prostate cancer data example. PMID:28724196

A local agreement pattern measure based on hazard functions for survival outcomes.

PubMed

Dai, Tian; Guo, Ying; Peng, Limin; Manatunga, Amita K

2018-03-01

Assessing agreement is often of interest in biomedical and clinical research when measurements are obtained on the same subjects by different raters or methods. Most classical agreement methods have been focused on global summary statistics, which cannot be used to describe various local agreement patterns. The objective of this work is to study the local agreement pattern between two continuous measurements subject to censoring. In this article, we propose a new agreement measure based on bivariate hazard functions to characterize the local agreement pattern between two correlated survival outcomes. The proposed measure naturally accommodates censored observations, fully captures the dependence structure between bivariate survival times and provides detailed information on how the strength of agreement evolves over time. We develop a nonparametric estimation method for the proposed local agreement pattern measure and study theoretical properties including strong consistency and asymptotical normality. We then evaluate the performance of the estimator through simulation studies and illustrate the method using a prostate cancer data example. © 2017, The International Biometric Society.

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.

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

PubMed

Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

2015-06-01

This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

Implications of construction method and spatial scale on measures of the built environment.

PubMed

Strominger, Julie; Anthopolos, Rebecca; Miranda, Marie Lynn

2016-04-28

Research surrounding the built environment (BE) and health has resulted in inconsistent findings. Experts have identified the need to examine methodological choices, such as development and testing of BE indices at varying spatial scales. We sought to examine the impact of construction method and spatial scale on seven measures of the BE using data collected at two time points. The Children's Environmental Health Initiative conducted parcel-level assessments of 57 BE variables in Durham, NC (parcel N = 30,319). Based on a priori defined variable groupings, we constructed seven mutually exclusive BE domains (housing damage, property disorder, territoriality, vacancy, public nuisances, crime, and tenancy). Domain-based indices were developed according to four different index construction methods that differentially account for number of parcels and parcel area. Indices were constructed at the census block level and two alternative spatial scales that better depict the larger neighborhood context experienced by local residents: the primary adjacency community and secondary adjacency community. Spearman's rank correlation was used to assess if indices and relationships among indices were preserved across methods. Territoriality, public nuisances, and tenancy were weakly to moderately preserved across methods at the block level while all other indices were well preserved. Except for the relationships between public nuisances and crime or tenancy, and crime and housing damage or territoriality, relationships among indices were poorly preserved across methods. The number of indices affected by construction method increased as spatial scale increased, while the impact of construction method on relationships among indices varied according to spatial scale. We found that the impact of construction method on BE measures was index and spatial scale specific. Operationalizing and developing BE measures using alternative methods at varying spatial scales before connecting to health outcomes allows researchers to better understand how methodological decisions may affect associations between health outcomes and BE measures. To ensure that associations between the BE and health outcomes are not artifacts of methodological decisions, researchers would be well-advised to conduct sensitivity analysis using different construction methods. This approach may lead to more robust results regarding the BE and health outcomes.

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 ...

Outcome measurement in Australian rehabilitation environments.

PubMed

Douglas, Heather; Swanson, Cheryl; Gee, Travis; Bellamy, Nicholas

2005-09-01

To determine the frequency and pattern of methods of outcome assessment used in Australian physical rehabilitation environments. Postal survey. A questionnaire on service type, staffing, numbers of adults treated and outcome measures used for 7 conditions related to injury and road trauma as well as stroke and neuromuscular disorders was sent to 973 services providing adult physical rehabilitation treatment. Questionnaires were completed by 440 service providers for a response rate of 45%, similar to that reported in a recent European survey reported in this journal. A small number of measures were reported as in use by most respondents, while a large number of measures were used by a few respondents. Measures of physical changes were used more frequently than those of generic well-being or quality of life. Ease of use and reporting to other professionals were cited as the most important reasons in selection of outcome measures. This Australian-wide survey detected considerable heterogeneity in outcome measurement procedures used in rehabilitation environments. While the goal of measurement may vary between providers and differ between conditions, the results highlight opportunities for harmonization, bench-marking and measurement of health-related quality of life.

Practice patterns when treating patients with low back pain: a survey of physical therapists.

PubMed

Davies, Claire; Nitz, Arthur J; Mattacola, Carl G; Kitzman, Patrick; Howell, Dana; Viele, Kert; Baxter, David; Brockopp, Dorothy

2014-08-01

Low back pain (LBP), is a common musculoskeletal problem, affecting 75-85% of adults in their lifetime. Direct costs of LBP in the USA were estimated over 85 billion dollars in 2005 resulting in a significant economic burden for the healthcare system. LBP classification systems and outcome measures are available to guide physical therapy assessments and intervention. However, little is known about which, if any, physical therapists use in clinical practice. The purpose of this study was to identify the use of and barriers to LBP classification systems and outcome measures among physical therapists in one state. A mixed methods study using a cross-sectional cohort design with descriptive qualitative methods was performed. A survey collected both quantitative and qualitative data relevant to classification systems and outcome measures used by physical therapists working with patients with LBP. Physical therapists responded using classification systems designed to direct treatment predominantly. The McKenzie method was the most frequent approach to classify LBP. Barriers to use of classification systems and outcome measures were lack of knowledge, too limiting and time. Classification systems are being used for decision-making in physical therapy practice for patients with LBP. Lack of knowledge and training seems to be the main barrier to the use of classification systems in practice. The Oswestry Disability Index and Numerical Pain Scale were the most commonly used outcome measures. The main barrier to their use was lack of time. Continuing education and reading the literature were identified as important tools to teach evidence-based practice to physical therapists in practice.

The Learning Outcomes Race: The Value of Self-Reported Gains in Large Research Universities

ERIC Educational Resources Information Center

Douglass, John Aubrey; Thomson, Gregg; Zhao, Chun-Mei

2012-01-01

Throughout the world, measuring "learning outcomes" is viewed by many stakeholders as a relatively new method to judge the "value added" of colleges and universities. The potential to accurately measure learning gains is also a diagnostic tool for institutional self-improvement. This essay discussed the marketisation of…

“Wish You Were Here”: Examining Characteristics, Outcomes, and Statistical Solutions for Missing Cases in Web-Based Psychotherapeutic Trials

PubMed Central

Dear, Blake F; Heller, Gillian Z; Crane, Monique F; Titov, Nickolai

2018-01-01

Background Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. Objective Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. Methods First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. Results Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from −32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). Conclusions Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect. PMID:29674311

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal.

PubMed

Conlon, Anna S C; Taylor, Jeremy M G; Elliott, Michael R

2014-04-01

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21-29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431-440). The method is applied to data from a macular degeneration study and an ovarian cancer study.

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal

PubMed Central

Conlon, Anna S. C.; Taylor, Jeremy M. G.; Elliott, Michael R.

2014-01-01

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21–29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431–440). The method is applied to data from a macular degeneration study and an ovarian cancer study. PMID:24285772

Development of a core set of outcome measures for OAB treatment.

PubMed

Foust-Wright, Caroline; Wissig, Stephanie; Stowell, Caleb; Olson, Elizabeth; Anderson, Anita; Anger, Jennifer; Cardozo, Linda; Cotterill, Nikki; Gormley, Elizabeth Ann; Toozs-Hobson, Philip; Heesakkers, John; Herbison, Peter; Moore, Kate; McKinney, Jessica; Morse, Abraham; Pulliam, Samantha; Szonyi, George; Wagg, Adrian; Milsom, Ian

2017-12-01

Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Healthcare quality measurement in orthopaedic surgery: current state of the art.

PubMed

Auerbach, Andrew

2009-10-01

Improving quality of care in arthroplasty is of increasing importance to payors, hospitals, surgeons, and patients. Efforts to compel improvement have traditionally focused measurement and reporting of data describing structural factors, care processes (or 'quality measures'), and clinical outcomes. Reporting structural measures (eg, surgical case volume) has been used with varying degrees of success. Care process measures, exemplified by initiatives such as the Surgical Care Improvement Project measures, are chosen based on the strength of randomized trial evidence linking the process to improved outcomes. However, evidence linking improved performance on Surgical Care Improvement Project measures with improved outcomes is limited. Outcome measures in surgery are of increasing importance as an approach to compel care improvement with prominent examples represented by the National Surgical Quality Improvement Project. Although outcomes-focused approaches are often costly, when linked to active benchmarking and collaborative activities, they may improve care broadly. Moreover, implementation of computerized data systems collecting information formerly collected on paper only will facilitate benchmarking. In the end, care will only be improved if these data are used to define methods for innovating care systems that deliver better outcomes at lower or equivalent costs.

Outcome assessment for spasticity management in the patient with traumatic brain injury: the state of the art.

PubMed

Elovic, Elie P; Simone, Lisa K; Zafonte, Ross

2004-01-01

The objective of this article was to (1) review the engineering and medical literature to structure the available information concerning the assessment of spasticity in the neurological population; (2) to discuss the strengths and weaknesses of the different methods currently in use in spasticity assessment; and (3) make recommendations for future efforts in spasticity outcome assessment. Spasticity textbooks, Web sites, and OVID, IEEE, and Medline searches from 1966 through 2003 of spasticity, quantitative measure, or outcome assessment in the rehabilitation population were used as data sources. Over 500 articles were reviewed. Articles that discussed outcome measures used to assess interventions and evaluation of spasticity were included. Authors reviewed the articles looking at inclusion criteria, data collection, methodology, assessment methods, and conclusions for validity and relevance to this article. Issues such as clinical relevance, real-world function and lack of objectivity, and time consumed during performance are important issues for spasticity assessment. Some measures such as the Ashworth Scale remain in common use secondary to ease of use despite their obvious functional limitations. More functional outcome goals are plagued by being more time consuming and a general inability to demonstrate changes after an intervention. This may be secondary to the other factors that combine with spasticity to cause dysfunction at that level. Quantitative metrics can provide more objective measurements but their clinical relevance is sometimes problematic. The assessment of spasticity outcome is still somewhat problematic. Further work is necessary to develop measures that have real-world functional significance to both the individuals being treated and the clinicians. A lack of objectivity is still a problem. In the future it is important for clinicians and the engineers to work together in the development of better outcome measures.

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.

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.

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

Linking quality indicators to clinical trials: an automated approach

PubMed Central

Coiera, Enrico; Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B.

2017-01-01

Abstract Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials, is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of 522 quality of care indicators for 22 common conditions drawn from the CareTrack study were automatically mapped to outcome measures reported in 13 971 trials from ClinicalTrials.gov. Intervention Text mining methods extracted phrases mentioning indicators and outcome phrases, and these were compared using the Levenshtein edit distance ratio to measure similarity. Main Outcome Measure Number of care indicators that mapped to outcome measures in clinical trials. Results While only 13% of the 522 CareTrack indicators were thought to have Level I or II evidence behind them, 353 (68%) could be directly linked to randomized controlled trials. Within these 522, 50 of 70 (71%) Level I and II evidence-based indicators, and 268 of 370 (72%) Level V (consensus-based) indicators could be linked to evidence. Of the indicators known to have evidence behind them, only 5.7% (4 of 70) were mentioned in the trial reports but were missed by our method. Conclusions We automatically linked indicators to clinical trial registrations with high precision. Whilst the majority of quality indicators studied could be directly linked to research evidence, a small portion could not and these require closer scrutiny. It is feasible to support the process of indicator development using automated methods to identify research evidence. PMID:28651340

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

Effectiveness of Telebehavioral Health Program Nurse Case Managers (NCM): Data Collection Tools and the Process for NCM-Sensitive Outcome Measures.

PubMed

Carlson, Judy; Cohen, Roslyn; Bice-Stephens, Wynona

2014-01-01

As a part of our nation's pursuit of improvements in patient care outcomes, continuity of care, and cost containment, the case manager has become a vital member on interdisciplinary teams and in health care agencies. Telebehavioral health programs, as a relatively new method of delivering behavioral health care, have recently begun to incorporate case management into their multidisciplinary teams. To determine the efficacy and efficiency of healthcare programs, program managers are charged with the determination of the outcomes of the care rendered to patient populations. However, programs that use telehealth methods to deliver care have unique structures in place that impact ability to collect outcome data. A military medical center that serves the Pacific region developed surveys and processes to distribute, administer, and collect information about a telehealth environment to obtain outcome data for the nurse case manager. This report describes the survey development and the processes created to capture nurse case manager outcomes. Additionally, the surveys and processes developed in this project for measuring outcomes may be useful in other settings and disciplines.

[Development of methods and instruments for external quality assurance in inpatient parent-child rehabilitation and prevention].

PubMed

Neuderth, S; Lukasczik, M; Musekamp, G; Gerlich, C; Saupe-Heide, M; Löbmann, R; Vogel, H

2013-02-01

There so far is no standardized program for external quality assurance in inpatient parent-child prevention and rehabilitation in Germany. Therefore, instruments and methods of external quality assurance were developed and evaluated on behalf of the federal-level health insurance institutions. On the level of structure quality, a modular questionnaire for assessing structural features of rehabilitation/prevention centers, basic and allocation criteria as well as a checklist for visitations were developed. Structural data were collected in a nationwide survey of parent-child prevention and rehabilitation centers. Process and outcome quality data were collected in n=38 centers. Process quality was assessed using multiple methods (process-related structural features, case-related routine documentation, and incident-related patient questionnaires). Outcome quality was measured via patient questionnaires (n=1 799 patients). We used a multi-level modelling approach by adjusting relevant confounders on institutional and patient levels. The methods, instruments and analyzing procedures developed for measuring quality on the level of structure, processes and outcomes were adjusted in cooperation with all relevant stakeholders. Results are exemplarily presented for all quality assurance tools. For most of the risk-adjusted outcome parameters, we found no significant differences between institutions. For the first time, a comprehensive, standardized and generally applicable set of methods and instruments for routine use in comparative quality measurement of inpatient parent-child prevention and rehabilitation is available. However, it should be considered that the very heterogeneous field of family-oriented measures can not be covered entirely by an external quality assurance program. Therefore, methods and instruments have to be adapted continuously to the specifics of this area of health care and to new developments. © Georg Thieme Verlag KG Stuttgart · New York.

Advances in Patient-Reported Outcomes: The NIH PROMIS® Measures

PubMed Central

Broderick, Joan E.; DeWitt, Esi Morgan; Rothrock, Nan; Crane, Paul K.; Forrest, Christopher B.

2013-01-01

Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems. PMID:25848562

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.

Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014

PubMed Central

Hatemi, Gulen; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Gul, Ahmet; Levi, Virna; Aydin, Sibel Z.; Mumcu, Gonca; Sertel-Berk, Ozlem; Stevens, Randall M.; Yazici, Hasan; Merkel, Peter A.

2016-01-01

Objective There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014). Methods During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. Results Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients’ perspectives, concerns, and ideas into outcome measure development was emphasized. Conclusion The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS. PMID:26373563

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung's disease treatment.

PubMed

Allin, Benjamin; Bradnock, Timothy; Kenny, Simon; Walker, Gregor; Knight, Marian

2016-12-07

Use of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung's disease (HD) research and is limiting the development of a robust evidence base to support clinical practice. Candidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel; panel 2 is a non-neonatal panel; and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1 to 9 based on how important they think the measures are in determining the overall success of their/their child's/their patient's HD. In round 2, experts will be presented with the same list of outcome measures and graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure, taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels, which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. Results of the Delphi process will be discussed, and outcomes will be re-scored. Outcome measures where >70% of participants at the meeting scored it 7-9 and <15% scored it 1-3 will form the core outcome set. Development of a core outcome set will help to reduce heterogeneity of outcome measure reporting in HD. This will increase the quality of research taking place and ultimately improve care provided to infants with HD.

A Systematic Review of Palliative Care Intervention Outcomes and Outcome Measures in Low-Resource Countries.

PubMed

Potts, Maryellen; Cartmell, Kathleen B; Nemeth, Lynne; Bhattacharjee, Gautam; Qanungo, Suparna

2018-05-01

To meet the growing need for palliative care in low-resource countries, palliative care programs should be evidence based and contextually appropriate. This study was conducted to synthesize the current evidence to guide future programmatic and research efforts. This systematic review evaluated palliative care outcome measures, outcomes, and interventions in low-resource countries. After title searches, abstracts and full-text articles were screened for inclusion. Data were extracted to report on intervention models, outcome measures used, and intervention outcomes. Eighteen papers were reviewed, reporting on interventions conducted across nine low-resource countries. These interventions evaluated home-based palliative care models; a community-managed model; palliative care integrated with hospitals, hospices, or HIV clinics; and models focused on patients' self-management. Three studies were randomized controlled trials. Other studies used nonrandomized trials, cohort studies, mixed methods, pre-post test evaluation, cost-accounting evaluation, and cross-sectional surveys. Thirteen studies measured physical outcomes, 10 using multidimensional instruments. Nine studies measured psychological outcomes, eight using multidimensional instruments. Nine studies measured social outcomes, seven using multidimensional instruments. Nine studies measured outcomes across multiple domains. Across outcomes evaluated, results were reported in the direction of benefit associated with palliative care interventions. Many palliative care intervention models exist to serve patients in low-resource countries. Yet, limited high-quality evidence from low-resource countries is available to document intervention outcomes. Rigorous experimental studies and greater measurement of multidimensional aspects of palliative care are needed to advance the science of palliative care in low-resource settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

[Improving care for cleft lip and palate patients: uniform and patient-orientated outcome measures].

PubMed

Haj, M; de Gier, H H W; van Veen-van der Hoek, M; Versnel, S L; van Adrichem, L N; Wolvius, E B; Hazelzet, J A; Koudstaal, M J

2018-02-01

The quality of care for patients with cleft lip and palate is extremely variable across the world. Treatment protocols differ and methods of data registration are not uniform. Improving this care by means of comparative research is challenging. The best treatment programmes can be identified by uniformly registering patient-orientated outcomes and comparing the outcomes with those of other treatment centres. That knowledge can be used to improve one's own care. An international team consisting of specialists and cleft lip and palate patients has developed a set of outcome measures that are considered by patients to be most important. This team is coordinated by the International Consortium of Health Outcomes Measurement (ICHOM). The cleft lip and palate outcome set can be used by all centres worldwide in following up on cleft lip and palate patients. In the Erasmus Medical Centre in Rotterdam, the 'Zorgmonitor Schisis' (Care Monitor Cleft Lip and Palate) has been built, an application in which these outcome measures are collected at fixed times. Implementing this set of outcome measures in other cleft lip and palate treatment centres and using the outcomes as (inter)national benchmarks will result in transparency and the improvement of the treatment of cleft lip and palate worldwide.

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.

Best methods for evaluating educational impact: a comparison of the efficacy of commonly used measures of library instruction

PubMed Central

Schilling, Katherine; Applegate, Rachel

2012-01-01

Objectives and Background: Libraries are increasingly called upon to demonstrate student learning outcomes and the tangible benefits of library educational programs. This study reviewed and compared the efficacy of traditionally used measures for assessing library instruction, examining the benefits and drawbacks of assessment measures and exploring the extent to which knowledge, attitudes, and behaviors actually paralleled demonstrated skill levels. Methods: An overview of recent literature on the evaluation of information literacy education addressed these questions: (1) What evaluation measures are commonly used for evaluating library instruction? (2) What are the pros and cons of popular evaluation measures? (3) What are the relationships between measures of skills versus measures of attitudes and behavior? Research outcomes were used to identify relationships between measures of attitudes, behaviors, and skills, which are typically gathered via attitudinal surveys, written skills tests, or graded exercises. Results and Conclusions: Results provide useful information about the efficacy of instructional evaluation methods, including showing significant disparities between attitudes, skills, and information usage behaviors. This information can be used by librarians to implement the most appropriate evaluation methods for measuring important variables that accurately demonstrate students' attitudes, behaviors, or skills. PMID:23133325

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…

Liaison psychiatry for older adults in the general hospital: service activity, development and outcomes.

PubMed

Mujic, Fedza; Cairns, Ruth; Mak, Vivienne; Squire, Clare; Wells, Andrew; Al-Harrasi, Ahmed; Prince, Martin

2018-02-01

Aims and method This study used data collected to describe the activity, case-load characteristics and outcome measures for all patients seen during a 6-year period. The service reviewed 2153 patients over 6 years with referral rates and case-load characteristics comparable to those described in a previous study period. The team saw 82% of patients on the day they were referred. Data and outcome measures collected showed significant complexity in the cases seen and statistically significant improvement in Health of the Nation Outcome Scales (HoNOS) scores following service input. Clinical implications The outcome measures used were limited, but the study supports the need for specialist liaison psychiatry for older adults (LPOA) services in the general hospital. The Framework of Outcome Measures - Liaison Psychiatry has now been introduced, but it remains unclear how valid this is in LPOA. It is of note that cost-effectiveness secondary to service input and training activities are not adequately monitored. Declaration of interest None.

Methods for interpreting change over time in patient-reported outcome measures.

PubMed

Wyrwich, K W; Norquist, J M; Lenderking, W R; Acaster, S

2013-04-01

Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.

Outcomes of Interorganizational Networks in Canada for Chronic Disease Prevention: Insights From a Concept Mapping Study, 2015.

PubMed

Willis, Cameron; Kernoghan, Alison; Riley, Barbara; Popp, Janice; Best, Allan; Milward, H Brinton

2015-11-19

We conducted a mixed methods study from June 2014 to March 2015 to assess the perspectives of stakeholders in networks that adopt a population approach for chronic disease prevention (CDP). The purpose of the study was to identify important and feasible outcome measures for monitoring network performance. Participants from CDP networks in Canada completed an online concept mapping exercise, which was followed by interviews with network stakeholders to further understand the findings. Nine concepts were considered important outcomes of CDP networks: enhanced learning, improved use of resources, enhanced or increased relationships, improved collaborative action, network cohesion, improved system outcomes, improved population health outcomes, improved practice and policy planning, and improved intersectoral engagement. Three themes emerged from participant interviews related to measurement of the identified concepts: the methodological difficulties in measuring network outcomes, the dynamic nature of network evolution and function and implications for outcome assessment, and the challenge of measuring multisectoral engagement in CDP networks. Results from this study provide initial insights into concepts that can be used to describe the outcomes of networks for CDP and may offer foundations for strengthening network outcome-monitoring strategies and methodologies.

Assessing Educational Outcomes in Middle Childhood: Validation of the Teacher Academic Attainment Scale

ERIC Educational Resources Information Center

Johnson, Samantha; Marlow, Neil; Wolke, Dieter

2012-01-01

Aim: Assessing educational outcomes in high-risk populations is crucial for defining long-term outcomes. As standardized tests are costly and time-consuming, we assessed the use of the Teacher Academic Attainment Scale (TAAS) as an outcome measure. Method: Three hundred and forty three children in mainstream schools aged 10 to 11 years (144 males,…

Wellness and Academic Outcomes among Disadvantaged Students in South Africa: An Exploratory Study

ERIC Educational Resources Information Center

Morris-Paxton, Angela A.; Van Lingen, Johanna M.; Elkonin, Diane

2017-01-01

Objective: The aim of this study was to measure possible impacts of a salutogenic lifestyle education programme on wellness and academic outcomes in a group of socioeconomically disadvantaged students in the first year of higher education. Setting: University in the Eastern Cape Province, South Africa. Methods: A mixed-methods approach was…

Current Methods of Evaluating Speech-Language Outcomes for Preschoolers with Communication Disorders: A Scoping Review Using the ICF-CY

ERIC Educational Resources Information Center

Cunningham, Barbara Jane; Washington, Karla N.; Binns, Amanda; Rolfe, Katelyn; Robertson, Bernadette; Rosenbaum, Peter

2017-01-01

Purpose: The purpose of this scoping review was to identify current measures used to evaluate speech-language outcomes for preschoolers with communication disorders within the framework of the International Classification of Functioning, Disability and Health-Children and Youth Version (ICF-CY; World Health Organization, 2007). Method: The review…

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

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review.

PubMed

Taylor, Johanna; Böhnke, Jan R; Wright, Judy; Kellar, Ian; Alderson, Sarah L; Hughes, Tom; Holt, Richard I G; Siddiqi, Najma

2017-02-14

People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed. This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist. The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups. COMET registration: http://www.comet-initiative.org/studies/details/911 . Registered on 1 July 2016.

Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.

PubMed

Pukall, Caroline F; Bergeron, Sophie; Brown, Candace; Bachmann, Gloria; Wesselmann, Ursula

2017-08-01

Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia. Given that provoked vestibulodynia (PVD)-characterized by provoked pain localized to the vaginal opening-is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested. Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

Health Outcomes of a Series of Bonny Method of Guided Imagery and Music Sessions: A Systematic Review.

PubMed

McKinney, Cathy H; Honig, Timothy J

2017-03-01

The Bonny Method of Guided Imagery and Music (GIM) is a music-centered approach to exploring consciousness for personal growth and transformation. Applications have been reported in a variety of clinical and nonclinical contexts. The purpose of this study was to review evidence that a series of Bonny Method of GIM sessions may promote positive health outcomes in adults. This systematic review examined randomized and nonrandomized controlled trials and repeated measures designs that reported psychological or physiological outcomes following a series of at least six individual Bonny Method of GIM sessions. Researchers assessed each study for risk of bias and computed effect sizes for outcome variables. Of 270 non-duplicate titles retrieved, nine met criteria for inclusion, and eight had moderate or low risk of bias. These included 275 participants 18-78 years of age representing a variety of populations. Multiple studies measured anxiety, depression, mood disturbance, interpersonal problems, quality of life, sense of coherence, and/or psychiatric symptoms and found medium to large effect sizes. Four included physiological measures (systolic and diastolic blood pressure, beta-endorphin, cortisol, and pain) and reported medium to large effect sizes, none of which were replicated across studies in this review. Evidence is promising that a series of Bonny Method of GIM sessions may be effective for improving both psychological and physiological health and may be therapeutically indicated for adults seeking treatment with medical, mental health, and nonclinical needs. Further research is needed to replicate findings within outcomes and populations. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

The use of routine outcome measures in two child and adolescent mental health services: a completed audit cycle

PubMed Central

2013-01-01

Background Routine outcome measurement (ROM) is important for assessing the clinical effectiveness of health services and for monitoring patient outcomes. Within Child and Adolescent Mental Health Services (CAMHS) in the UK the adoption of ROM in CAMHS has been supported by both national and local initiatives (such as government strategies, local commissioning policy, and research). Methods With the aim of assessing how these policies and initiatives may have influenced the uptake of ROM within two different CAMHS we report the findings of two case-note audits: a baseline audit conducted in January 2011 and a re-audit conducted two years later in December 2012-February 2013. Results The findings show an increase in both the single and repeated use of outcome measures from the time of the original audit, with repeated use (baseline and follow-up) of the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) scale increasing from 10% to 50% of cases. Re-audited case-notes contained more combined use of different outcome measures, with greater consensus on which measures to use. Outcome measures that were applicable across a wide range of clinical conditions were more likely to be used than symptom-specific measures, and measures that were completed by the clinician were found more often than measures completed by the service user. Conclusions The findings show a substantial improvement in the use of outcome measures within CAMHS. These increases in use were found across different service organisations which were subject to different types of local service priorities and drivers. PMID:24139139

Item Response Theory and Health Outcomes Measurement in the 21st Century

PubMed Central

Hays, Ron D.; Morales, Leo S.; Reise, Steve P.

2006-01-01

Item response theory (IRT) has a number of potential advantages over classical test theory in assessing self-reported health outcomes. IRT models yield invariant item and latent trait estimates (within a linear transformation), standard errors conditional on trait level, and trait estimates anchored to item content. IRT also facilitates evaluation of differential item functioning, inclusion of items with different response formats in the same scale, and assessment of person fit and is ideally suited for implementing computer adaptive testing. Finally, IRT methods can be helpful in developing better health outcome measures and in assessing change over time. These issues are reviewed, along with a discussion of some of the methodological and practical challenges in applying IRT methods. PMID:10982088

The Popularity of Outcome Measures for Hip and Knee Arthroplasties.

PubMed

Lovelock, Thomas M; Broughton, Nigel S; Williams, Cylie M

2018-01-01

The optimal methods of determining outcomes following hip and knee arthroplasty remain controversial. The objectives of this study were to determine the most frequently used outcome measures in randomized controlled trials (RCT) and study protocols registered with clinical trials registries (CTR) on hip and knee arthroplasty. A systematic search strategy was undertaken to identify the outcome measures used in RCT and CTR following joint arthroplasty. Databases searched included Embase, Ovid MEDLINE (including In-Process), Cochrane Central Register of Controlled Trials, CINAHL Plus, clinicaltrials.gov, ISRCTN registry, and ANZCTR. Differences in the use of outcome measures between RCT and CTR were assessed using logistic regression. There were 291 RCT and 113 CTR on hip arthroplasty and 452 RCT and 184 CTR on knee arthroplasty that met the inclusion criteria. The most popular outcome measures were the Harris Hip Score and the Knee Society Score. Multiple outcome measures were used in greater than 50% of the included studies. The Oxford Hip Score, Oxford Knee Score, EuroQol-5D, and Knee Injury and Osteoarthritis Outcome Score (all P < .001) were used in significantly more CTR than RCT. There is a clear preference for the use of the Harris Hip Score and Knee Society Score, contrary to existing international guidelines and reviews on the topic. Both measures require clinician input, which potentially influences their validity and increases their overall administration cost. Some patient-reported outcome measures, such as the Oxford Hip and Knee Scores, EuroQol-5D, and KOOS, appear to be increasing in popularity. Copyright © 2017 Elsevier Inc. All rights reserved.

The use of shoulder scoring systems and outcome measures in the UK

PubMed Central

Lamb, J; Rambani, R; Venkateswaran, B

2014-01-01

Introduction In future, outcomes following shoulder surgery may be subject to public survey. Many outcome measures exist but we do not know whether there is a consensus between shoulder surgeons in the UK. The aim of this study was to survey the preferred outcome measures used by National Health Service (NHS) shoulder surgeons operating in the UK. Methods A total of 350 shoulder surgeons working in NHS hospitals were asked to complete a short written questionnaire regarding their use of scoring systems and outcome measures. Questionnaires were sent and responses were received by post. Results Overall, 217 responses were received (62%). Of the respondents, 171 (79%) use an outcome measure in their shoulder practice while 46 (21%) do not. There were 118 surgeons (69%) who use more than one outcome measure. The Oxford shoulder score was most commonly used by 150 surgeons (69%), followed by the Constant score with 106 (49%), the Oxford shoulder instability score with 82 (38%), and the Disabilities of the Arm, Shoulder and Hand score with 54 (25%). The less commonly used outcome measures were the SF-36® and SF-12® health questionnaires with 19 (9%), the University of California at Los Angeles activity score with 8 (4%), the American Shoulder and Elbow Surgeons shoulder assessment form with 8 (4%) and the EQ-5D™ with 10 (3%). Conclusions Validated outcome measures should be adopted by all practising surgeons in all specialties. This will allow better assessment of treatments in addition to assessment of surgical performance in a transparent way. PMID:25350180

A thick placenta: a predictor of adverse pregnancy outcomes.

PubMed

Miwa, Ichiro; Sase, Masakatsu; Torii, Mayumi; Sanai, Hiromi; Nakamura, Yasuhiko; Ueda, Kazuyuki

2014-01-01

The aim of this study is to evaluate the efficacy of an ultrasonographic measurement of placental thickness and the correlation of a thick placenta with adverse perinatal outcome. Placental thickness was measured in single gravidas, 16 to 40 weeks of gestation, between 2005 and 2009. Placentas were considered to be thick if their measured thickness were above the 95th percentile for gestational age. The incidence of thick placentas was 4.3% (138/3,183). Perinatal morbidity and neonatal conditions were worse in cases with thick placenta rather than without thick placenta. Ultrasonographic measurement of placental thickness is a simple method to estimate placental size. Thick placenta may be a useful predictor of adverse pregnancy outcomes.

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…

Using General Outcome Measures to Predict Student Performance on State-Mandated Assessments: An Applied Approach for Establishing Predictive Cutscores

ERIC Educational Resources Information Center

Leblanc, Michael; Dufore, Emily; McDougal, James

2012-01-01

Cutscores for reading and math (general outcome measures) to predict passage on New York state-mandated assessments were created by using a freely available Excel workbook. The authors used linear regression to create the cutscores and diagnostic indicators were provided. A rationale and procedure for using this method is outlined. This method…

Validation of a Quantitative Single-Subject Based Evaluation for Rehabilitation-Induced Improvement Assessment.

PubMed

Gandolla, Marta; Molteni, Franco; Ward, Nick S; Guanziroli, Eleonora; Ferrigno, Giancarlo; Pedrocchi, Alessandra

2015-11-01

The foreseen outcome of a rehabilitation treatment is a stable improvement on the functional outcomes, which can be longitudinally assessed through multiple measures to help clinicians in functional evaluation. In this study, we propose an automatic comprehensive method of combining multiple measures in order to assess a functional improvement. As test-bed, a functional electrical stimulation based treatment for foot drop correction performed with chronic post-stroke participants is presented. Patients were assessed on five relevant outcome measures before, after intervention, and at a follow-up time-point. A novel algorithm based on variables minimum detectable change is proposed and implemented in a custom-made software, combining the outcome measures to obtain a unique parameter: capacity score. The difference between capacity scores at different timing is three holded to obtain improvement evaluation. Ten clinicians evaluated patients on the Improvement Clinical Global Impression scale. Eleven patients underwent the treatment, and five resulted to achieve a stable functional improvement, as assessed by the proposed algorithm. A statistically significant agreement between intra-clinicians and algorithm-clinicians evaluations was demonstrated. The proposed method evaluates functional improvement on a single-subject yes/no base by merging different measures (e.g., kinematic, muscular) and it is validated against clinical evaluation.

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

Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review

PubMed Central

2014-01-01

Background Integrating rehabilitation services through wearable systems has the potential to accurately assess the type, intensity, duration, and quality of movement necessary for procuring key outcome measures. Objectives This review aims to explore wearable accelerometry-based technology (ABT) capable of assessing mobility-related functional activities intended for rehabilitation purposes in community settings for neurological populations. In this review, we focus on the accuracy of ABT-based methods, types of outcome measures, and the implementation of ABT in non-clinical settings for rehabilitation purposes. Data sources Cochrane, PubMed, Web of Knowledge, EMBASE, and IEEE Xplore. The search strategy covered three main areas, namely wearable technology, rehabilitation, and setting. Study selection Potentially relevant studies were categorized as systems either evaluating methods or outcome parameters. Methods Methodological qualities of studies were assessed by two customized checklists, depending on their categorization and rated independently by three blinded reviewers. Results Twelve studies involving ABT met the eligibility criteria, of which three studies were identified as having implemented ABT for rehabilitation purposes in non-clinical settings. From the twelve studies, seven studies achieved high methodological quality scores. These studies were not only capable of assessing the type, quantity, and quality measures of functional activities, but could also distinguish healthy from non-healthy subjects and/or address disease severity levels. Conclusion While many studies support ABT’s potential for telerehabilitation, few actually utilized it to assess mobility-related functional activities outside laboratory settings. To generate more appropriate outcome measures, there is a clear need to translate research findings and novel methods into practice. PMID:24625308

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.

A pilot mixed methods study of patient satisfaction with chiropractic care for back pain.

PubMed

Rowell, Robert M; Polipnick, Judith

2008-10-01

Patient satisfaction is important to payers, clinicians, and patients. The concept of satisfaction is multifactorial and measurement is challenging. Our objective was to explore the use of a mixed-methods design to examine patient satisfaction with chiropractic care for low back pain. Patients were treated 3 times per week for 3 weeks. Outcomes were collected at week 3 and week 4. Qualitative interviews were conducted by the treating clinician and a nontreating staff member. Outcome measures were the Roland Morris Back Pain Disability Questionnaire, the visual analog scale for pain, and the Patient Satisfaction Scale. Interviews were recorded and transcribed and analyzed for themes and constructs of satisfaction. We compared qualitative interview data with quantitative outcomes, and qualitative data from 2 different interviewers. All patients reported high levels of satisfaction. Clinical outcomes were unremarkable with little change noted on visual analog scale and Roland Morris Back Pain Disability Questionnaire scores. We categorized patient comments into the same constructs of satisfaction as those identified for the Patient Satisfaction Scale: Information, Effectiveness, and Caring. An additional construct (Quality of Care) and additional subcategories were identified. Satisfaction with care is not explained by outcome alone. The qualitative data collected from 2 different interviewers had few differences. The results of this study suggest that it is feasible to use a mixed-methods design to examine patient satisfaction. We were able to refine data collection and analysis procedures for the outcome measures and qualitative interview data. We identified limitations and offer recommendations for the next step: the implementation of a larger study.

Development of a core outcome set for use in determining the overall success of gastroschisis treatment.

PubMed

Allin, Benjamin; Ross, Andrew; Marven, Sean; J Hall, Nigel; Knight, Marian

2016-07-27

Gastroschisis research is limited in quality by the presence of significant heterogeneity in outcome measure reporting (PloS One 10(1):e0116908, 2015). Using core outcome sets in research is one proposed method for addressing this problem (Trials 13:103, 2012; Clin Rheumatol 33(9):1313-1322, 2014; Health Serv Res Policy 17(1):1-2, 2012). Ultimately, standardising outcome measure reporting will improve research quality and translate into improvements in patient care. Candidate outcome measures have been identified through systematic reviews. These outcome measures will form the starting point for an online, three-phase Delphi process that will be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel, panel 2 is a non-neonatal panel and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1-9 based on how important they think the measures are in determining the overall success of their/their child's/their patient's gastroschisis treatment. In round 2, experts will be presented with the same list of outcome measures and with graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. The results of the Delphi process will be discussed, and outcomes re-scored. Outcome measures where > 70 % of the participants at the meeting scored them as 7-9 and < 15 % scored them as 1-3 will form the core outcome set. Development of a core outcome set will help to reduce the heterogeneity of the outcome measure reporting in gastroschisis. This will increase the quality of research taking place and ultimately improve care provided to infants with gastroschisis.

Routine measurement of outcomes in Australia's public sector mental health services

PubMed Central

Pirkis, Jane; Burgess, Philip; Coombs, Tim; Clarke, Adam; Jones-Ellis, David; Dickson, Rosemary

2005-01-01

Objective This paper describes the Australian experience to date with a national 'roll out' of routine outcome measurement in public sector mental health services. Methods Consultations were held with 123 stakeholders representing a range of roles. Results Australia has made an impressive start to nationally implementing routine outcome measurement in mental health services, although it still has a long way to go. All States/Territories have established data collection systems, although some are more streamlined than others. Significant numbers of clinicians and managers have been trained in the use of routine outcome measures, and thought is now being given to ongoing training strategies. Outcome measurement is now occurring 'on the ground'; all States/Territories will be reporting data for 2003–04, and a number have been doing so for several years. Having said this, there is considerable variability regarding data coverage, completeness and compliance. Some States/Territories have gone to considerable lengths to 'embed' outcome measurement in day-to-day practice. To date, reporting of outcome data has largely been limited to reports profiling individual consumers and/or aggregate reports that focus on compliance and data quality issues, although a few States/Territories have begun to turn their attention to producing aggregate reports of consumers by clinician, team or service. Conclusion Routine outcome measurement is possible if it is supported by a co-ordinated, strategic approach and strong leadership, and there is commitment from clinicians and managers. The Australian experience can provide lessons for other countries. PMID:15840170

Yes, but Can They Earn a Living? Methods for Creating an Effective System of Measuring Labor Market Outcomes in Higher Education. Research & Occasional Paper Series: CSHE.5.13

ERIC Educational Resources Information Center

Moore, Richard W.; Chapman, Kenneth; Huber, Bettina; Shors, Mark

2013-01-01

A new federal initiative calls for a College Scorecard which will include a yet to be determined measure of graduate earnings. In this paper we examine the political context that drives this initiative and examine the nascent efforts of four states to develop statewide systems to measure the labor market outcomes of higher education. We propose…

"Not just little adults": qualitative methods to support the development of pediatric patient-reported outcomes.

PubMed

Arbuckle, Rob; Abetz-Webb, Linda

2013-01-01

The US FDA and the European Medicines Agency (EMA) have issued incentives and laws mandating clinical research in pediatrics. While guidances for the development and validation of patient-reported outcomes (PROs) or health-related quality of life (HRQL) measures have been issued by these agencies, little attention has focused on pediatric PRO development methods. With reference to the literature, this article provides an overview of specific considerations that should be made with regard to the development of pediatric PRO measures, with a focus on performing qualitative research to ensure content validity. Throughout the questionnaire development process it is critical to use developmentally appropriate language and techniques to ensure outcomes have content validity, and will be reliable and valid within narrow age bands (0-2, 3-5, 6-8, 9-11, 12-14, 15-17 years). For qualitative research, sample sizes within those age bands must be adequate to demonstrate saturation while taking into account children's rapid growth and development. Interview methods, interview guides, and length of interview must all take developmental stage into account. Drawings, play-doh, or props can be used to engage the child. Care needs to be taken during cognitive debriefing, where repeated questioning can lead a child to change their answers, due to thinking their answer is incorrect. For the PROs themselves, the greatest challenge is in measuring outcomes in children aged 5-8 years. In this age range, while self-report is generally more valid, parent reports of observable behaviors are generally more reliable. As such, 'team completion' or a parent-administered child report is often the best option for children aged 5-8 years. For infants and very young children (aged 0-4 years), patient rating of observable behaviors is necessary, and, for adolescents and children aged 9 years and older, self-reported outcomes are generally valid and reliable. In conclusion, the development of PRO measures for use in children requires careful tailoring of qualitative methods, and performing research within narrow age bands. The best reporter should be carefully considered dependent on the child's age, developmental ability, and the concept being measured, and team completion should be considered alongside self-completion and observer measures.

Achieving Goal-Concordant Care: A Conceptual Model and Approach to Measuring Serious Illness Communication and Its Impact

PubMed Central

Curtis, J. Randall; Tulsky, James A.

2018-01-01

Abstract Background: High-quality care for seriously ill patients aligns treatment with their goals and values. Failure to achieve “goal-concordant” care is a medical error that can harm patients and families. Because communication between clinicians and patients enables goal concordance and also affects the illness experience in its own right, healthcare systems should endeavor to measure communication and its outcomes as a quality assessment. Yet, little consensus exists on what should be measured and by which methods. Objectives: To propose measurement priorities for serious illness communication and its anticipated outcomes, including goal-concordant care. Methods: We completed a narrative review of the literature to identify links between serious illness communication, goal-concordant care, and other outcomes. We used this review to identify gaps and opportunities for quality measurement in serious illness communication. Results: Our conceptual model describes the relationship between communication, goal-concordant care, and other relevant outcomes. Implementation-ready measures to assess the quality of serious illness communication and care include (1) the timing and setting of serious illness communication, (2) patient experience of communication and care, and (3) caregiver bereavement surveys that include assessment of perceived goal concordance of care. Future measurement priorities include direct assessment of communication quality, prospective patient or family assessment of care concordance with goals, and assessment of the bereaved caregiver experience. Conclusion: Improving serious illness care necessitates ensuring that high-quality communication has occurred and measuring its impact. Measuring patient experience and receipt of goal-concordant care should be our highest priority. We have the tools to measure both. PMID:29091522

Multidimensional outcome considerations in assessing the efficacy of medical educational programs.

PubMed

Blumberg, Phyllis

2003-01-01

To be accredited, schools must evaluate the effectiveness of their programs. Educators are looking for specific indicators beyond the traditional measures. Data from multiple methods, including indicators of student performance and of the institutional environment, can be used to determine if educational program goals are met. This article outlines specific ways to consider three types of efficacy outcomes that are consistent with accreditation guidelines: educational, clinical career, and environmental outcomes. Specific measurable outcomes for each of these categories are derived from higher education literature: for example, learning approaches and information acquisition for education; professional behaviors and interpersonal dimensions for clinical career, and scholarship of teaching and teaching itself as a shared and valued activity for environmental outcomes. These outcomes address student assessment and program evaluation. Data from problem-based learning programs illustrate these outcomes. Educators can determine if educational program innovations have met their goals by collecting efficacy outcome data.

Associations between Motivational Orientations and Chronically Accessible Outcomes in Leisure-Time Physical Activity: Are Appearance-Related Outcomes Controlling in Nature?

ERIC Educational Resources Information Center

McLachlan, Sarah; Hagger, Martin S.

2010-01-01

This study aimed to explore relations between chronically accessible outcomes in physical activity and scaled measures of motivational orientations from a self-determination perspective. Methods from construct and attitude accessibility research and the Levesque and Pelletier (2003) study were used to identify participants' chronically accessible…

Identifying Mechanisms of Change in a Conversation Therapy for Aphasia Using Behaviour Change Theory and Qualitative Methods

ERIC Educational Resources Information Center

Johnson, Fiona M.; Best, Wendy; Beckley, Firle Christina; Maxim, Jane; Beeke, Suzanne

2017-01-01

Background: Conversation therapy for aphasia is a complex intervention comprising multiple components and targeting multiple outcomes. UK Medical Research Council (MRC) guidelines published in 2008 recommend that in addition to measuring the outcomes of complex interventions, evaluation should seek to clarify how such outcomes are produced,…

Joint modelling compared with two stage methods for analysing longitudinal data and prospective outcomes: A simulation study of childhood growth and BP.

PubMed

Sayers, A; Heron, J; Smith, Adac; Macdonald-Wallis, C; Gilthorpe, M S; Steele, F; Tilling, K

2017-02-01

There is a growing debate with regards to the appropriate methods of analysis of growth trajectories and their association with prospective dependent outcomes. Using the example of childhood growth and adult BP, we conducted an extensive simulation study to explore four two-stage and two joint modelling methods, and compared their bias and coverage in estimation of the (unconditional) association between birth length and later BP, and the association between growth rate and later BP (conditional on birth length). We show that the two-stage method of using multilevel models to estimate growth parameters and relating these to outcome gives unbiased estimates of the conditional associations between growth and outcome. Using simulations, we demonstrate that the simple methods resulted in bias in the presence of measurement error, as did the two-stage multilevel method when looking at the total (unconditional) association of birth length with outcome. The two joint modelling methods gave unbiased results, but using the re-inflated residuals led to undercoverage of the confidence intervals. We conclude that either joint modelling or the simpler two-stage multilevel approach can be used to estimate conditional associations between growth and later outcomes, but that only joint modelling is unbiased with nominal coverage for unconditional associations.

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.

Dichotomisation using a distributional approach when the outcome is skewed.

PubMed

Sauzet, Odile; Ofuya, Mercy; Peacock, Janet L

2015-04-24

Dichotomisation of continuous outcomes has been rightly criticised by statisticians because of the loss of information incurred. However to communicate a comparison of risks, dichotomised outcomes may be necessary. Peacock et al. developed a distributional approach to the dichotomisation of normally distributed outcomes allowing the presentation of a comparison of proportions with a measure of precision which reflects the comparison of means. Many common health outcomes are skewed so that the distributional method for the dichotomisation of continuous outcomes may not apply. We present a methodology to obtain dichotomised outcomes for skewed variables illustrated with data from several observational studies. We also report the results of a simulation study which tests the robustness of the method to deviation from normality and assess the validity of the newly developed method. The review showed that the pattern of dichotomisation was varying between outcomes. Birthweight, Blood pressure and BMI can either be transformed to normal so that normal distributional estimates for a comparison of proportions can be obtained or better, the skew-normal method can be used. For gestational age, no satisfactory transformation is available and only the skew-normal method is reliable. The normal distributional method is reliable also when there are small deviations from normality. The distributional method with its applicability for common skewed data allows researchers to provide both continuous and dichotomised estimates without losing information or precision. This will have the effect of providing a practical understanding of the difference in means in terms of proportions.

Epidemiologic research using probabilistic outcome definitions.

PubMed

Cai, Bing; Hennessy, Sean; Lo Re, Vincent; Small, Dylan S

2015-01-01

Epidemiologic studies using electronic healthcare data often define the presence or absence of binary clinical outcomes by using algorithms with imperfect specificity, sensitivity, and positive predictive value. This results in misclassification and bias in study results. We describe and evaluate a new method called probabilistic outcome definition (POD) that uses logistic regression to estimate the probability of a clinical outcome using multiple potential algorithms and then uses multiple imputation to make valid inferences about the risk ratio or other epidemiologic parameters of interest. We conducted a simulation to evaluate the performance of the POD method with two variables that can predict the true outcome and compared the POD method with the conventional method. The simulation results showed that when the true risk ratio is equal to 1.0 (null), the conventional method based on a binary outcome provides unbiased estimates. However, when the risk ratio is not equal to 1.0, the traditional method, either using one predictive variable or both predictive variables to define the outcome, is biased when the positive predictive value is <100%, and the bias is very severe when the sensitivity or positive predictive value is poor (less than 0.75 in our simulation). In contrast, the POD method provides unbiased estimates of the risk ratio both when this measure of effect is equal to 1.0 and not equal to 1.0. Even when the sensitivity and positive predictive value are low, the POD method continues to provide unbiased estimates of the risk ratio. The POD method provides an improved way to define outcomes in database research. This method has a major advantage over the conventional method in that it provided unbiased estimates of risk ratios and it is easy to use. Copyright © 2014 John Wiley & Sons, Ltd.

Tools in the assessment of sarcopenia

PubMed Central

Cooper, C; Fielding, R; Visser, M; van Loon, LJ; Rolland, Y; Orwoll, E; Reid, K; Boonen, S; Dere, W; Epstein, S; Mitlak, B; Tsouderos, Y; Sayer, AA; Rizzoli, R; Reginster, JY; Kanis, JA

2013-01-01

Summary This review provides a framework for development of an operational definition of sarcopenia and of the potential endpoints that might be adopted in clinical trials among older adults. Introduction While the clinical relevance of sarcopenia is widely recognized, there is currently no universally accepted definition of the disorder. The development of interventions to alter the natural history of sarcopenia also requires consensus on the most appropriate endpoints for determining outcomes of clinical importance which might be utilised in intervention studies. Methods and results We review current approaches to the definition of sarcopenia, and the methods used for the assessment of various aspects of physical function in older people. The potential endpoints of muscle mass, muscle strength, muscle power and muscle fatigue, as well as the relationships between them, are explored with reference to the availability and practicality of the available methods for measuring these endpoints in clinical trials. Conclusions Based on current evidence, none of the four potential outcomes in question is sufficiently comprehensive to recommend as a uniform single outcome in randomised clinical trials. We propose that sarcopenia may be optimally defined (for the purposes of clinical trial inclusion criteria, as well as epidemiological studies) using a combination of measures of muscle mass and physical performance. The choice of outcome measures for clinical trials in sarcopenia is more difficult; co-primary outcomes, tailored to the specific intervention in question, may be the best way forward in this difficult but clinically important area. PMID:23842964

Development of an outcome measurement system for service planning for children and youth with special needs

PubMed Central

Kertoy, M K; Russell, D J; Rosenbaum, P; Jaffer, S; Law, M; McCauley, D; Gorter, J W

2013-01-01

Aim This study described the process used in developing an outcome measurement framework for system planning to improve services for children and youth with special needs and their families in a Canadian province. The study reports the results of several parent-completed measures, which would be useful in service planning as well as the acceptability and utility of these measures for use by families and service centres. Methods/results Development of a theoretical framework, consultation with key stakeholders, testing the utility of selected outcome measures and initial dissemination of results were critical elements in the successful development of an outcome system. Consultation with stakeholders confirmed use of the International Classification of Functioning, Disability and Health and the child-within-family-within community model as theoretical frameworks while building valuable partnerships and identifying potential barriers to implementation. Pilot testing showed three outcome measures were feasible for families to complete and the measures provided information about services for children that was valuable to families as well as service providers. Gaps in service delivery were identified and the need for better communication between service providers and communities to facilitate integrated services was highlighted. Conclusion The findings from this study can be used to implement an outcome measurement system for children with special needs and may serve as a resource for international researchers who are working to develop valid tools as well as outcome systems that are useful for system planning. PMID:22845889

Understanding the outcomes measures used in Huntington disease pharmacologicaltrials: A systematic review

PubMed Central

Carlozzi, Noelle E; Miciura, Angela; Migliore, Nicholas; Dayalu, Praveen

2014-01-01

Background The identification of the gene mutation causing Huntington disease has raised hopes for new treatments to ease symptoms and slow functional decline. As such, there has been a push towards designing efficient pharmacological trials (i.e., drug trials), especially with regard to selecting outcomes measures that are both brief and sensitive to changes across the course of the disease, from subtle prodromal changes, to more severe end-stage changes. Objectives Recently, to aid in efficient development of new HD research studies, the National Institute of Neurological Disorders and Stroke (NINDS) published recommendations for measurement selection in HD. While these recommendations are helpful, many of the recommended measures have little published data in HD. As such, we conducted a systematic review of the literature to identify the most common outcomes measures used in HD clinical trials. Methods Major medical databases, including PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials, were used to identify peer-reviewed journal articles in English from 2001 through April 2013; 151 pharmacological trials were identified. Results The majority of HD clinical trials employed clinician-reported outcomes measures (93%); patient reported outcome measures (11%) and observer reported outcome measures (3%) were used with much less frequency. Conclusions We provide a review of the most commonly used measures across these trials, compare these measures to the clinical recommendations made by the NINDS working groups, and provide recommendations for selecting measures for future clinical trials that meet the Food and Drug Administration standards. PMID:25300328

Improving Cross-Sector Comparisons: Going Beyond the Health-Related QALY.

PubMed

Brazier, John; Tsuchiya, Aki

2015-12-01

The quality-adjusted life-year (QALY) has become a widely used measure of health outcomes for use in informing decision making in health technology assessment. However, there is growing recognition of outcomes beyond health within the health sector and in related sectors such as social care and public health. This paper presents the advantages and disadvantages of ten possible approaches covering extending the health-related QALY and using well-being and monetary-based methods, in order to address the problem of using multiple outcome measures to inform resource allocation within and between sectors.

"Wish You Were Here": Examining Characteristics, Outcomes, and Statistical Solutions for Missing Cases in Web-Based Psychotherapeutic Trials.

PubMed

Karin, Eyal; Dear, Blake F; Heller, Gillian Z; Crane, Monique F; Titov, Nickolai

2018-04-19

Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from -32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect. ©Eyal Karin, Blake F Dear, Gillian Z Heller, Monique F Crane, Nickolai Titov. Originally published in JMIR Mental Health (http://mental.jmir.org), 19.04.2018.

Predicting work-related disability and medical cost outcomes: a comparison of injury severity scoring methods.

PubMed

Sears, Jeanne M; Blanar, Laura; Bowman, Stephen M

2014-01-01

Acute work-related trauma is a leading cause of death and disability among U.S. workers. Occupational health services researchers have described the pressing need to identify valid injury severity measures for purposes such as case-mix adjustment and the construction of appropriate comparison groups in programme evaluation, intervention, quality improvement, and outcome studies. The objective of this study was to compare the performance of several injury severity scores and scoring methods in the context of predicting work-related disability and medical cost outcomes. Washington State Trauma Registry (WTR) records for injuries treated from 1998 to 2008 were linked with workers' compensation claims. Several Abbreviated Injury Scale (AIS)-based injury severity measures (ISS, New ISS, maximum AIS) were estimated directly from ICD-9-CM codes using two software packages: (1) ICDMAP-90, and (2) Stata's user-written ICDPIC programme (ICDPIC). ICDMAP-90 and ICDPIC scores were compared with existing WTR scores using the Akaike Information Criterion, amount of variance explained, and estimated effects on outcomes. Competing risks survival analysis was used to evaluate work disability outcomes. Adjusted total medical costs were modelled using linear regression. The linked sample contained 6052 work-related injury events. There was substantial agreement between WTR scores and those estimated by ICDMAP-90 (kappa=0.73), and between WTR scores and those estimated by ICDPIC (kappa=0.68). Work disability and medical costs increased monotonically with injury severity, and injury severity was a significant predictor of work disability and medical cost outcomes in all models. WTR and ICDMAP-90 scores performed better with regard to predicting outcomes than did ICDPIC scores, but effect estimates were similar. Of the three severity measures, maxAIS was usually weakest, except when predicting total permanent disability. Injury severity was significantly associated with work disability and medical cost outcomes for work-related injuries. Injury severity can be estimated using either ICDMAP-90 or ICDPIC when ICD-9-CM codes are available. We observed little practical difference between severity measures or scoring methods. This study demonstrated that using existing software to estimate injury severity may be useful to enhance occupational injury surveillance and research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Use of Objective Metrics in Dynamic Facial Reanimation: A Systematic Review.

PubMed

Revenaugh, Peter C; Smith, Ryan M; Plitt, Max A; Ishii, Lisa; Boahene, Kofi; Byrne, Patrick J

2018-06-21

Facial nerve deficits cause significant functional and social consequences for those affected. Existing techniques for dynamic restoration of facial nerve function are imperfect and result in a wide variety of outcomes. Currently, there is no standard objective instrument for facial movement as it relates to restorative techniques. To determine what objective instruments of midface movement are used in outcome measurements for patients treated with dynamic methods for facial paralysis. Database searches from January 1970 to June 2017 were performed in PubMed, Embase, Cochrane Library, Web of Science, and Scopus. Only English-language articles on studies performed in humans were considered. The search terms used were ("Surgical Flaps"[Mesh] OR "Nerve Transfer"[Mesh] OR "nerve graft" OR "nerve grafts") AND (face [mh] OR facial paralysis [mh]) AND (innervation [sh]) OR ("Face"[Mesh] OR facial paralysis [mh]) AND (reanimation [tiab]). Two independent reviewers evaluated the titles and abstracts of all articles and included those that reported objective outcomes of a surgical technique in at least 2 patients. The presence or absence of an objective instrument for evaluating outcomes of midface reanimation. Additional outcome measures were reproducibility of the test, reporting of symmetry, measurement of multiple variables, and test validity. Of 241 articles describing dynamic facial reanimation techniques, 49 (20.3%) reported objective outcome measures for 1898 patients. Of those articles reporting objective measures, there were 29 different instruments, only 3 of which reported all outcome measures. Although instruments are available to objectively measure facial movement after reanimation techniques, most studies do not report objective outcomes. Of objective facial reanimation instruments, few are reproducible and able to measure symmetry and multiple data points. To accurately compare objective outcomes in facial reanimation, a reproducible, objective, and universally applied instrument is needed.

The development of an outcome measure for liaison mental health services.

PubMed

Guthrie, Else; Harrison, Mathew; Brown, Richard; Sandhu, Rajdeep; Trigwell, Peter; Abraham, Seri; Nawaz, Shazada; Kelsall, Peter; Thomasson, Rachel

2018-06-01

Aims and methodTo develop and pilot a clinician-rated outcome scale to evaluate symptomatic outcomes in liaison psychiatry services. Three hundred and sixty patient contacts with 207 separate individuals were rated using six subscales (mood, psychosis, cognition, substance misuse, mind-body problems and behavioural disturbance) plus two additional items (side-effects of medication and capacity to consent for medical treatment). Each item was rated on a five-point scale from 0 to 5 (nil, mild, moderate, severe and very severe). The liaison outcome measure was acceptable and easy to use. All subscales showed acceptable interrater reliability, with the exception of the mind-body subscale. Overall, the measure appears to show stability and sensitivity to change.Clinical implicationsThe measure provides a useful and robust way to determine symptomatic change in a liaison mental health setting, although the mind-body subscale requires modification.Declaration of interestNone.

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.

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.

How is the sustainability of chronic disease health programmes empirically measured in hospital and related healthcare services?-a scoping review.

PubMed

Francis, Linda; Dunt, David; Cadilhac, Dominique A

2016-05-31

Programmes to address chronic disease are a focus of governments worldwide. Despite growth in 'implementation science', there is a paucity of knowledge regarding the best means to measure sustainability. The aim of this review was to summarise current practice for measuring sustainability outcomes of chronic disease health programmes, providing guidance for programme planners and future directions for the academic field. A scoping review of the literature spanning 1985-2015 was conducted using MEDLINE, CINAHL, PsychINFO and The Cochrane Library limited to English language and adults. Main search terms included chronic disease, acute care, sustainability, institutionalisation and health planning. A descriptive synthesis was required. Settings included primary care, hospitals, mental health centres and community health. Programmes included preventing or managing chronic conditions including diabetes, heart disease, depression, respiratory disease, cancer, obesity, dental hygiene and multiple chronic diseases. Outcome measures included clarifying a sustainability definition, types of methodologies used, timelines for assessment, criteria levels to determine outcomes and how methodology varies between intervention types. Among 153 abstracts retrieved, 87 were retained for full article review and 42 included in the qualitative synthesis. Five definitions for sustainability outcome were identified with 'maintenance of programme activities' most frequent. Achieving sustainability was dependent on inter-relationships between various organisational and social contexts supporting a broad scale approach to evaluation. An increasing trend in use of mixed methods designs over multiple time points to determine sustainability outcomes was found. Despite the importance and investment in chronic disease programmes, few studies are undertaken to measure sustainability. Methods to evaluate sustainability are diverse with some emerging patterns in measurement found. Use of mixed methods approaches over multiple time points may serve to better guide measurement of sustainability. Consensus on aspects of standardised measurement would promote the future possibility of meta-analytic syntheses. 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/

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.

Best methods for evaluating educational impact: a comparison of the efficacy of commonly used measures of library instruction.

PubMed

Schilling, Katherine; Applegate, Rachel

2012-10-01

Libraries are increasingly called upon to demonstrate student learning outcomes and the tangible benefits of library educational programs. This study reviewed and compared the efficacy of traditionally used measures for assessing library instruction, examining the benefits and drawbacks of assessment measures and exploring the extent to which knowledge, attitudes, and behaviors actually paralleled demonstrated skill levels. An overview of recent literature on the evaluation of information literacy education addressed these questions: (1) What evaluation measures are commonly used for evaluating library instruction? (2) What are the pros and cons of popular evaluation measures? (3) What are the relationships between measures of skills versus measures of attitudes and behavior? Research outcomes were used to identify relationships between measures of attitudes, behaviors, and skills, which are typically gathered via attitudinal surveys, written skills tests, or graded exercises. Results provide useful information about the efficacy of instructional evaluation methods, including showing significant disparities between attitudes, skills, and information usage behaviors. This information can be used by librarians to implement the most appropriate evaluation methods for measuring important variables that accurately demonstrate students' attitudes, behaviors, or skills.

A randomized controlled trial of the different impression methods for the complete denture fabrication: Patient reported outcomes.

PubMed

Jo, Ayami; Kanazawa, Manabu; Sato, Yusuke; Iwaki, Maiko; Akiba, Norihisa; Minakuchi, Shunsuke

2015-08-01

To compare the effect of conventional complete dentures (CD) fabricated using two different impression methods on patient-reported outcomes in a randomized controlled trial (RCT). A cross-over RCT was performed with edentulous patients, required maxillomandibular CDs. Mandibular CDs were fabricated using two different methods. The conventional method used a custom tray border moulded with impression compound and a silicone. The simplified used a stock tray and an alginate. Participants were randomly divided into two groups. The C-S group had the conventional method used first, followed by the simplified. The S-C group was in the reverse order. Adjustment was performed four times. A wash out period was set for 1 month. The primary outcome was general patient satisfaction, measured using visual analogue scales, and the secondary outcome was oral health-related quality of life, measured using the Japanese version of the Oral Health Impact Profile for edentulous (OHIP-EDENT-J) questionnaire scores. Twenty-four participants completed the trial. With regard to general patient satisfaction, the conventional method was significantly more acceptable than the simplified. No significant differences were observed between the two methods in the OHIP-EDENT-J scores. This study showed CDs fabricated with a conventional method were significantly more highly rated for general patient satisfaction than a simplified. CDs, fabricated with the conventional method that included a preliminary impression made using alginate in a stock tray and subsequently a final impression made using silicone in a border moulded custom tray resulted in higher general patient satisfaction. UMIN000009875. Copyright © 2015 Elsevier Ltd. All rights reserved.

Upper Limb Outcome Measures Used in Stroke Rehabilitation Studies: A Systematic Literature Review

PubMed Central

Santisteban, Leire; Térémetz, Maxime; Bleton, Jean-Pierre; Baron, Jean-Claude; Maier, Marc A.; Lindberg, Påvel G.

2016-01-01

Background Establishing which upper limb outcome measures are most commonly used in stroke studies may help in improving consensus among scientists and clinicians. Objective In this study we aimed to identify the most commonly used upper limb outcome measures in intervention studies after stroke and to describe domains covered according to ICF, how measures are combined, and how their use varies geographically and over time. Methods Pubmed, CinHAL, and PeDRO databases were searched for upper limb intervention studies in stroke according to PRISMA guidelines and477 studies were included. Results In studies 48different outcome measures were found. Only 15 of these outcome measures were used in more than 5% of the studies. The Fugl-Meyer Test (FMT)was the most commonly used measure (in 36% of studies). Commonly used measures covered ICF domains of body function and activity to varying extents. Most studies (72%) combined multiple outcome measures: the FMT was often combined with the Motor Activity Log (MAL), the Wolf Motor Function Test and the Action Research Arm Test, but infrequently combined with the Motor Assessment Scale or the Nine Hole Peg Test. Key components of manual dexterity such as selective finger movements were rarely measured. Frequency of use increased over a twelve-year period for the FMT and for assessments of kinematics, whereas other measures, such as the MAL and the Jebsen Taylor Hand Test showed decreased use over time. Use varied largely between countries showing low international consensus. Conclusions The results showed a large diversity of outcome measures used across studies. However, a growing number of studies used the FMT, a neurological test with good psychometric properties. For thorough assessment the FMT needs to be combined with functional measures. These findings illustrate the need for strategies to build international consensus on appropriate outcome measures for upper limb function after stroke. PMID:27152853

Swallowing outcomes following Intensity Modulated Radiation Therapy (IMRT) for head & neck cancer - a systematic review.

PubMed

Roe, Justin W G; Carding, Paul N; Dwivedi, Raghav C; Kazi, Rehan A; Rhys-Evans, Peter H; Harrington, Kevin J; Nutting, Christopher M

2010-10-01

A systematic review to establish what evidence is available for swallowing outcomes following IMRT for head and neck cancer. Online electronic databases were searched to identify papers published in English from January 1998 to December 2009. Papers were independently appraised by two reviewers for methodological quality, method of swallowing evaluation and categorized according to the World Health Organisation's International Classification of Health Functions. The impact of radiation dose to dysphagia aspiration risk structures (DARS) was also evaluated. Sixteen papers met the inclusion criteria. The literature suggests that limiting the radiation dose to certain structures may result in favourable swallowing outcomes. Methodological limitations included variable assessment methods and outcome measures and heterogeneity of patients. There are only limited prospective data, especially where pre-treatment measures have been taken and compared to serial post-treatment assessment. Few studies have investigated the impact of IMRT on swallow function and the impact on everyday life. Initial studies have reported potential benefits but are limited in terms of study design and outcome data. Further well designed, prospective, longitudinal swallowing studies including multidimensional evaluation methods are required to enable a more comprehensive understanding of dysphagia complications and inform pre-treatment counselling and rehabilitation planning. Copyright © 2010 Elsevier Ltd. All rights reserved.

Post-injury personality in the prediction of outcome following severe acquired brain injury.

PubMed

Cattran, Charlotte Jane; Oddy, Michael; Wood, Rodger Llewellyn; Moir, Jane Frances

2011-01-01

The aim of the study was to examine the utility of five measures of non-cognitive neurobehavioural (NCNB) changes that often occur following acquired brain injury, in predicting outcome (measured in terms of participation and social adaptation) at 1-year follow-up. The study employed a longitudinal, correlational design. Multiple regression was employed to investigate the value of five new NCNB measures of social perception, emotional regulation, motivation, impulsivity and disinhibition in the prediction of outcome as measured by the Mayo-Portland Adaptability Inventory (MPAI). Two NCNB measures (motivation and emotional regulation) were found to significantly predict outcome at 1-year follow-up, accounting for 53% of the variance in MPAI total scores. These measures provide a method of quantifying the extent of NCNB changes following brain injury. The predictive value of the measures indicates that they may represent a useful tool which could aid clinicians in identifying early-on those whose symptoms are likely to persist and who may require ongoing intervention. This could facilitate the planning of rehabilitation programmes.

Outcome of Vaginoplasty in Male-to-Female Transgenders: A Systematic Review of Surgical Techniques.

PubMed

Horbach, Sophie E R; Bouman, Mark-Bram; Smit, Jan Maerten; Özer, Müjde; Buncamper, Marlon E; Mullender, Margriet G

2015-06-01

Gender reassignment surgery is the keystone of the treatment of transgender patients. For male-to-female transgenders, this involves the creation of a neovagina. Many surgical methods for vaginoplasty have been opted. The penile skin inversion technique is the method of choice for most gender surgeons. However, the optimal surgical technique for vaginoplasty in transgender women has not yet been identified, as outcomes of the different techniques have never been compared. With this systematic review, we aim to give a detailed overview of the published outcomes of all currently available techniques for vaginoplasty in male-to-female transgenders. A PubMed and EMBASE search for relevant publications (1995-present), which provided data on the outcome of techniques for vaginoplasty in male-to-female transgender patients. Main outcome measures are complications, neovaginal depth and width, sexual function, patient satisfaction, and improvement in quality of life (QoL). Twenty-six studies satisfied the inclusion criteria. The majority of these studies were retrospective case series of low to intermediate quality. Outcome of the penile skin inversion technique was reported in 1,461 patients, bowel vaginoplasty in 102 patients. Neovaginal stenosis was the most frequent complication in both techniques. Sexual function and patient satisfaction were overall acceptable, but many different outcome measures were used. QoL was only reported in one study. Comparison between techniques was difficult due to the lack of standardization. The penile skin inversion technique is the most researched surgical procedure. Outcome of bowel vaginoplasty has been reported less frequently but does not seem to be inferior. The available literature is heterogeneous in patient groups, surgical procedure, outcome measurement tools, and follow-up. Standardized protocols and prospective study designs are mandatory for correct interpretation and comparability of data. © 2015 International Society for Sexual Medicine.

Client Predictors of Short-term Psychotherapy Outcomes among Asian and White American Outpatients

PubMed Central

Kim, Jin E.; Zane, Nolan W.; Blozis, Shelley A.

2015-01-01

Purpose To examine predictors of psychotherapy outcomes, focusing on client characteristics that are especially salient for culturally diverse clients. Method Sixty clients (31 women; 27 White Americans, 33 Asian Americans) participated in this treatment study. Client characteristics were measured at pre-treatment, and outcomes were measured post-fourth session via therapist ratings of functioning and symptomatology. Regression analyses were utilized to test for predictors of outcomes, and bootstrap analyses were utilized to test for mediators. Results Higher levels of somatic symptoms predicted lower psychosocial functioning at post-treatment. Avoidant coping style predicted more negative symptoms and more psychological discomfort. Non-English language preference predicted worse outcomes; this effect was mediated by an avoidant coping style. Conclusions Language preference, avoidant coping style, and somatic symptoms predicted treatment outcome in a culturally diverse sample. Findings suggest that race/ethnicity-related variables may function through mediating proximal variables to affect outcomes. PMID:22836681

Classification accuracy of claims-based methods for identifying providers failing to meet performance targets.

PubMed

Hubbard, Rebecca A; Benjamin-Johnson, Rhondee; Onega, Tracy; Smith-Bindman, Rebecca; Zhu, Weiwei; Fenton, Joshua J

2015-01-15

Quality assessment is critical for healthcare reform, but data sources are lacking for measurement of many important healthcare outcomes. With over 49 million people covered by Medicare as of 2010, Medicare claims data offer a potentially valuable source that could be used in targeted health care quality improvement efforts. However, little is known about the operating characteristics of provider profiling methods using claims-based outcome measures that may estimate provider performance with error. Motivated by the example of screening mammography performance, we compared approaches to identifying providers failing to meet guideline targets using Medicare claims data. We used data from the Breast Cancer Surveillance Consortium and linked Medicare claims to compare claims-based and clinical estimates of cancer detection rate. We then demonstrated the performance of claim-based estimates across a broad range of operating characteristics using simulation studies. We found that identification of poor performing providers was extremely sensitive to algorithm specificity, with no approach identifying more than 65% of poor performing providers when claims-based measures had specificity of 0.995 or less. We conclude that claims have the potential to contribute important information on healthcare outcomes to quality improvement efforts. However, to achieve this potential, development of highly accurate claims-based outcome measures should remain a priority. Copyright © 2014 John Wiley & Sons, Ltd.

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Marshman, Zoe; Benson, Philip; Colonio Salazar, Fiorella B; Fleming, Padhraig S

2017-08-04

Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. The project has been registered on the Core Outcome Measures in Effectiveness Trials ( COMET ) website, January 2016.

The nature and outcomes of work: a replication and extension of interdisciplinary work-design research.

PubMed

Edwards, J R; Scully, J A; Brtek, M D

2000-12-01

Research into the changing nature of work requires comprehensive models of work design. One such model is the interdisciplinary framework (M. A. Campion, 1988), which integrates 4 work-design approaches (motivational, mechanistic, biological, perceptual-motor) and links each approach to specific outcomes. Unfortunately, studies of this framework have used methods that disregard measurement error, overlook dimensions within each work-design approach, and treat each approach and outcome separately. This study reanalyzes data from M. A. Campion (1988), using structural equation models that incorporate measurement error, specify multiple dimensions for each work-design approach, and examine the work-design approaches and outcomes jointly. Results show that previous studies underestimate relationships between work-design approaches and outcomes and that dimensions within each approach exhibit relationships with outcomes that differ in magnitude and direction.

Toward Quantifying the Aesthetic Outcomes of Breast Cancer Treatment: Comparison of Clinical Photography and Colorimetry

PubMed Central

Kim, Min Soon; Rodney, William N.; Cooper, Tara; Kite, Chris; Reece, Gregory P.; Markey, Mia K.

2011-01-01

Rationale, aims and objectives Scarring is a significant cause of dissatisfaction for women who undergo breast surgery. Scar tissue may be clinically distinguished from normal skin by aberrant color, rough surface texture, increased thickness (hypertrophy), and firmness. Colorimeters or spectrophotometers can be used to quantitatively assess scar color, but they require direct patient interaction and can cost thousands of dollars By comparison, digital photography is already in widespread use to document clinical outcomes and requires less patient interaction. Thus, assessment of scar coloration by digital photography is an attractive alternative. The goal of this study was to compare color measurements obtained by digital photography and colorimetry. Method Agreement between photographic and colorimetric measurements of color were evaluated. Experimental conditions were controlled by performing measurements on artificial scars created by a makeup artist. The colorimetric measurements of the artificial scars were compared to those reported in the literature for real scars in order to confirm the validity of this approach. We assessed the agreement between the colorimetric and photographic measurements of color using a hypothesis test for equivalence, the intra-class correlation coefficient (ICC), and the Bland-Altman method. Results Overall, good agreement was obtained for three parameters (L*a*b*) measured by colorimetry and photography from the results of three statistical analyses. Conclusion Color measurements obtained by digital photography were equivalent to those obtained using colorimetry. Thus, digital photography is a reliable, cost-effective measurement method of skin color and should be further investigated for quantitative analysis of surgical outcomes. PMID:19239578

Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set.

PubMed

Khalil, Asma; Perry, Helen; Duffy, James; Reed, Keith; Baschat, Ahmet; Deprest, Jan; Hecher, Kurt; Lewi, Liesbeth; Lopriore, Enrico; Oepkes, Dick

2017-07-14

Twin-Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS. An international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus 'core' outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context. The development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is likely to advance the quality of research studies and their effective use in order to guide clinical practice and improve patient care, maternal, short-term perinatal outcomes and long-term neurodevelopmental outcomes. Core Outcome Measures in Effectiveness Trials (COMET), 921 Registered on July 2016. International Prospective Register of Systematic Reviews (PROSPERO), CRD42016043999 . Registered on 2 August 2016.

Comparison of Nurse Staffing Measurements in Staffing-Outcomes Research.

PubMed

Park, Shin Hye; Blegen, Mary A; Spetz, Joanne; Chapman, Susan A; De Groot, Holly A

2015-01-01

Investigators have used a variety of operational definitions of nursing hours of care in measuring nurse staffing for health services research. However, little is known about which approach is best for nurse staffing measurement. To examine whether various nursing hours measures yield different model estimations when predicting patient outcomes and to determine the best method to measure nurse staffing based on the model estimations. We analyzed data from the University HealthSystem Consortium for 2005. The sample comprised 208 hospital-quarter observations from 54 hospitals, representing information on 971 adult-care units and about 1 million inpatient discharges. We compared regression models using different combinations of staffing measures based on productive/nonproductive and direct-care/indirect-care hours. Akaike Information Criterion and Bayesian Information Criterion were used in the assessment of staffing measure performance. The models that included the staffing measure calculated from productive hours by direct-care providers were best, in general. However, the Akaike Information Criterion and Bayesian Information Criterion differences between models were small, indicating that distinguishing nonproductive and indirect-care hours from productive direct-care hours does not substantially affect the approximation of the relationship between nurse staffing and patient outcomes. This study is the first to explicitly evaluate various measures of nurse staffing. Productive hours by direct-care providers are the strongest measure related to patient outcomes and thus should be preferred in research on nurse staffing and patient outcomes.

The Association between Outpatient Buprenorphine Detoxification Duration and Clinical Treatment Outcomes: A Review

PubMed Central

Sigmon, Stacey C.; Strain, Eric C.; Heil, Sarah H.; Higgins, Stephen T.

2011-01-01

Background The association between buprenorphine taper duration and treatment outcomes is not well understood. This review evaluated whether duration of outpatient buprenorphine taper is significantly associated with treatment outcomes. Methods Studies that were published in peer-reviewed journals, administered buprenorphine as an outpatient taper to opioid-dependent participants, and provided data on at least one of three primary treatment outcome measures (opioid abstinence, retention, peak withdrawal severity) were reviewed. Primary treatment outcomes were evaluated as a function of taper duration using hierarchical linear regressions using pre-taper maintenance as a cofactor. Results Twenty-eight studies were reviewed. Taper duration significantly predicted percent of opioid-negative samples provided during treatment, however pre-taper maintenance period predicted percent participants abstinent on the final day of treatment. High rates of relapse were reported. No significant association between taper duration and retention in treatment or peak withdrawal severity was observed. Conclusion The data reviewed here suggest taper duration is associated with opioid abstinence achieved during detoxification but not with other markers of treatment outcome. The reviewed studies varied widely on several parameters (e.g., frequency of urinalysis testing, provision of ancillary medications) that may influence treatment outcome and thus could have interfered with the ability to identify relationships between taper duration and outcomes. Future studies evaluating opioid detoxification should utilize rigorous experimental methods and report a wider range of outcome measures in order to help advance our understanding of the association between taper duration and treatment outcomes. PMID:21741781

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.

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.

Developing tools to measure quality in congenital catheterization and interventions: the congenital cardiac catheterization project on outcomes (C3PO).

PubMed

Chaudhry-Waterman, Nadia; Coombs, Sandra; Porras, Diego; Holzer, Ralf; Bergersen, Lisa

2014-01-01

The broad range of relatively rare procedures performed in pediatric cardiac catheterization laboratories has made the standardization of care and risk assessment in the field statistically quite problematic. However, with the growing number of patients who undergo cardiac catheterization, it has become imperative that the cardiology community overcomes these challenges to study patient outcomes. The Congenital Cardiac Catheterization Project on Outcomes was able to develop benchmarks, tools for measurement, and risk adjustment methods while exploring procedural efficacy. Based on the success of these efforts, the collaborative is pursuing a follow-up project, the Congenital Cardiac Catheterization Project on Outcomes-Quality Improvement, aimed at improving the outcomes for all patients undergoing catheterization for congenital heart disease by reducing radiation exposure.

An Introduction to Item Response Theory for Patient-Reported Outcome Measurement

PubMed Central

Nguyen, Tam H.; Han, Hae-Ra; Kim, Miyong T.

2015-01-01

The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured. PMID:24403095

An introduction to item response theory for patient-reported outcome measurement.

PubMed

Nguyen, Tam H; Han, Hae-Ra; Kim, Miyong T; Chan, Kitty S

2014-01-01

The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured.

Comparison of commonly used orthopaedic outcome measures using palm-top computers and paper surveys.

PubMed

Saleh, Khaled J; Radosevich, David M; Kassim, Rida A; Moussa, Mohamed; Dykes, Darrell; Bottolfson, Helena; Gioe, Terence J; Robinson, Harry

2002-11-01

Measuring patient-perceived outcomes following orthopaedic procedures have become an important component of clinical research and patient care. General and disease-specific outcomes measures have been developed and applied in orthopaedics to assess the patients' perceived health status. Unfortunately, paper-based, self-administered instruments remain inefficient for collecting data because of: (a) missing data (b) respondent error, and (c) the costs to administer and enter data. To study the comparability of palm-top computer devices and paper-pencil self-administered questionnaires in the collection of health-related quality of life (HRQL) information from patients. The comparability of administering HRQL questionnaires using palm-top computer and traditional paper-based forms was tested in a sample of 96 patients with complaints of hip and/or knee pain. Each patient completed mailed versions of the Medical Outcomes Study (MOS), 36-item Health Survey (SF-36), and Western Ontario and McMasters University Arthritis Index (WOMAC) three weeks prior to presenting to clinic. At the clinic they were asked to complete the same outcomes measures using the palm-top computer or a paper-and-pencil version. In the analysis, scale distributions, floor and ceiling effects, internal consistency and retest reliability of scales were compared across the two data collection methods. Because the baseline characteristics of the groups were not strictly comparable according to age, the data were analyzed for the entire sample and stratified according to age. Few statistically significant differences were found for the means, variances and intra-class correlation coefficients between the methods of administration. While the scale distribution between the two methods was comparable, the internal consistency of the scales was dissimilar. Administration of HRQL questionnaires using portable palm-top computer devices has the potential advantage of decreased cost and convenience. These data lend some support for the comparability of palm-top computers and paper surveys for outcomes measures widely used in the field of orthopaedic surgery. The present study identified the lack of reliability across modes of administration that requires further study in a randomized comparability trial. These mode effects are important for orthopaedic surgeons to appreciate before implementing innovative data-capture technologies in their practices.

Relationships between Student, Staff, and Administrative Measures of School Climate and Student Health and Academic Outcomes

PubMed Central

Gase, Lauren Nichol; Gomez, Louis M.; Kuo, Tony; Glenn, Beth A.; Inkelas, Moira; Ponce, Ninez A.

2018-01-01

BACKGROUND School climate is an integral part of a comprehensive approach to improving the wellbeing of students; however, little is known about the relationships between its different domains and measures. This study examined the relationships between student, staff, and administrative measures of school climate in order to understand the extent to which they were related to each other and student outcomes. METHODS The sample included 33,572 secondary school students from 121 schools in Los Angeles County during the 2014–2015 academic year. A multilevel regression model was constructed to examine the association between the domains and measures of school climate and five outcomes of student wellbeing: depressive symptoms or suicidal ideation, tobacco use, alcohol use, marijuana use, and grades. RESULTS Student, staff, and administrative measures of school climate were weakly correlated. Strong associations were found between student outcomes and student reports of engagement and safety, while school staff reports and administrative measures of school climate showed limited associations with student outcomes. CONCLUSIONS As schools seek to measure and implement interventions aimed at improving school climate, consideration should be given to grounding these efforts in a multi-dimensional conceptualization of climate that values student perspectives and includes elements of both engagement and safety. PMID:28382671

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.

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.

A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instruments.

PubMed

Moza, A; Benstoem, C; Autschbach, R; Stoppe, C; Goetzenich, A

2015-12-02

Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field. This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed. The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints.

Measurement and evaluation practices of factors that contribute to effective health promotion collaboration functioning: A scoping review.

PubMed

Stolp, Sean; Bottorff, Joan L; Seaton, Cherisse L; Jones-Bricker, Margaret; Oliffe, John L; Johnson, Steven T; Errey, Sally; Medhurst, Kerensa; Lamont, Sonia

2017-04-01

The purpose of this scoping review was to identify promising factors that underpin effective health promotion collaborations, measurement approaches, and evaluation practices. Measurement approaches and evaluation practices employed in 14 English-language articles published between January 2001 and October 2015 were considered. Data extraction included research design, health focus of the collaboration, factors being evaluated, how factors were conceptualized and measured, and outcome measures. Studies were methodologically diverse employing either quantitative methods (n=9), mixed methods (n=4), or qualitative methods (n=1). In total, these 14 studies examined 113 factors, 88 of which were only measured once. Leadership was the most commonly studied factor but was conceptualized differently across studies. Six factors were significantly associated with outcome measures across studies; leadership (n=3), gender (n=2), trust (n=2), length of the collaboration (n=2), budget (n=2) and changes in organizational model (n=2). Since factors were often conceptualized differently, drawing conclusions about their impact on collaborative functioning remains difficult. The use of reliable and validated tools would strengthen evaluation of health promotion collaborations and would support and enhance the effectiveness of collaboration. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Goal achievement as a patient‐generated outcome measure for stress urinary incontinence

PubMed Central

Milne, Jill L.; Robert, Magali; Tang, Selphee; Drummond, Neil; Ross, Sue

2009-01-01

Abstract Objectives  To explore women’s goals and goal attainment for the conservative and surgical treatment of stress urinary incontinence (SUI), and to examine the feasibility of Goal Attainment Scaling (GAS) as an outcome measure in this population. Background  Despite the range of treatments for SUI, little is known about the outcomes patients consider important. Current instruments measure the impact of SUI on the ability to live a ‘normal’ life without addressing what normal looks like for the patient. Patient‐generated measures that address what a patient aims to achieve may fill this gap. Design  A mixed‐methods exploratory design combined semi‐structured interviews with validated questionnaires and individualized rating of goal achievement. Setting and participants  Participants with SUI (n = 18) were interviewed in their homes prior to initiation of treatment and 3–6 months afterwards. Main variables  Participants reported individualized goals pre‐treatment and rated goal attainment after surgical and conservative therapy. Quality of life impact and change were measured using short forms of the Incontinence Impact Questionnaire and Urinary Distress Inventory. Results  Women expressed a median of four highly individualized treatment‐related goals but goal achievement following conservative treatment was poor. GAS was not feasible as an outcome measure; women readily identified personal goals but could not independently identify graded levels of attainment for each goal. Conclusions  Although further work is needed to examine the most feasible, valid, and reliable method of measuring goal achievement in research, asking patients with UI to identify pre‐treatment goals may provide useful information to guide treatment‐related decision making. PMID:19754692

Assessing Medication Effects in the MTA Study Using Neuropsychological Outcomes

ERIC Educational Resources Information Center

Epstein, Jeffery N.; Conners, C. Keith; Hervey, Aaron S.; Tonev, Simon T.; Arnold, L. Eugene; Abikoff, Howard B.; Elliott, Glen; Greenhill, Laurence L.; Hechtman, Lily; Hoagwood, Kimberly; Hinshaw, Stephen P.; Hoza, Betsy; Jensen, Peter S.; March, John S.; Newcorn, Jeffrey H.; Pelham, William E.; Severe, Joanne B.; Swanson, James M.; Wells, Karen; Vitiello, Benedetto; Wigal, Timothy

2006-01-01

Background: While studies have increasingly investigated deficits in reaction time (RT) and RT variability in children with attention deficit/hyperactivity disorder (ADHD), few studies have examined the effects of stimulant medication on these important neuropsychological outcome measures. Methods: 316 children who participated in the Multimodal…

Improving health care, Part 1: The clinical value compass.

PubMed

Nelson, E C; Mohr, J J; Batalden, P B; Plume, S K

1996-04-01

CLINICAL VALUE COMPASS APPROACH: The clinical Value Compass, named to reflect its similarity in layout to a directional compass, has at its four cardinal points (1) functional status, risk status, and well-being; (2) costs; (3) satisfaction with health care and perceived benefit; and (4) clinical outcomes. To manage and improve the value of health care services, providers will need to measure the value of care for similar patient populations, analyze the internal delivery processes, run tests of changed delivery processes, and determine if these changes lead to better outcomes and lower costs. GETTING STARTED--OUTCOMES AND AIM: In the case example, the team's aim is "to find ways to continually improve the quality and value of care for AMI (acute myocardial infection) patients." VALUE MEASURES--SELECT A SET OF OUTCOME AND COST MEASURES: Four to 12 outcome and cost measures are sufficient to get started. In the case example, the team chose 1 or more measures for each quadrant of the value compass. An operational definition is a clearly specified method explaining how to measure a variable. Measures in the case example were based on information from the medical record, administrative and financial records, and patient reports and ratings at eight weeks postdischarge. Measurement systems that quantify the quality of processes and results of care are often add-ons to routine care delivery. However, the process of measurement should be intertwined with the process of care delivery so that front-line providers are involved in both managing the patient and measuring the process and related outcomes and costs.

Predicting reading outcomes with progress monitoring slopes among middle grade students

PubMed Central

Tolar, Tammy D.; Barth, Amy E.; Fletcher, Jack M.; Francis, David J.; Vaughn, Sharon

2013-01-01

Effective implementation of response-to-intervention (RTI) frameworks depends on efficient tools for monitoring progress. Evaluations of growth (i.e., slope) may be less efficient than evaluations of status at a single time point, especially if slopes do not add to predictions of outcomes over status. We examined progress monitoring slope validity for predicting reading outcomes among middle school students by evaluating latent growth models for different progress monitoring measure-outcome combinations. We used multi-group modeling to evaluate the effects of reading ability, reading intervention, and progress monitoring administration condition on slope validity. Slope validity was greatest when progress monitoring was aligned with the outcome (i.e., word reading fluency slope was used to predict fluency outcomes in contrast to comprehension outcomes), but effects varied across administration conditions (viz., repeated reading of familiar vs. novel passages). Unless the progress monitoring measure is highly aligned with outcome, slope may be an inefficient method for evaluating progress in an RTI context. PMID:24659899

[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.

Design and validation of instruments to measure knowledge.

PubMed

Elliott, T E; Regal, R R; Elliott, B A; Renier, C M

2001-01-01

Measuring health care providers' learning after they have participated in educational interventions that use experimental designs requires valid, reliable, and practical instruments. A literature review was conducted. In addition, experience gained from designing and validating instruments for measuring the effect of an educational intervention informed this process. The eight main steps for designing, validating, and testing the reliability of instruments for measuring learning outcomes are presented. The key considerations and rationale for this process are discussed. Methods for critiquing and adapting existent instruments and creating new ones are offered. This study may help other investigators in developing valid, reliable, and practical instruments for measuring the outcomes of educational activities.

Defining a standard set of patient-centered outcomes for men with localized prostate cancer.

PubMed

Martin, Neil E; Massey, Laura; Stowell, Caleb; Bangma, Chris; Briganti, Alberto; Bill-Axelson, Anna; Blute, Michael; Catto, James; Chen, Ronald C; D'Amico, Anthony V; Feick, Günter; Fitzpatrick, John M; Frank, Steven J; Froehner, Michael; Frydenberg, Mark; Glaser, Adam; Graefen, Markus; Hamstra, Daniel; Kibel, Adam; Mendenhall, Nancy; Moretti, Kim; Ramon, Jacob; Roos, Ian; Sandler, Howard; Sullivan, Francis J; Swanson, David; Tewari, Ashutosh; Vickers, Andrew; Wiegel, Thomas; Huland, Hartwig

2015-03-01

Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review.

PubMed

Steins, Dax; Dawes, Helen; Esser, Patrick; Collett, Johnny

2014-03-13

Integrating rehabilitation services through wearable systems has the potential to accurately assess the type, intensity, duration, and quality of movement necessary for procuring key outcome measures. This review aims to explore wearable accelerometry-based technology (ABT) capable of assessing mobility-related functional activities intended for rehabilitation purposes in community settings for neurological populations. In this review, we focus on the accuracy of ABT-based methods, types of outcome measures, and the implementation of ABT in non-clinical settings for rehabilitation purposes. Cochrane, PubMed, Web of Knowledge, EMBASE, and IEEE Xplore. The search strategy covered three main areas, namely wearable technology, rehabilitation, and setting. Potentially relevant studies were categorized as systems either evaluating methods or outcome parameters. Methodological qualities of studies were assessed by two customized checklists, depending on their categorization and rated independently by three blinded reviewers. Twelve studies involving ABT met the eligibility criteria, of which three studies were identified as having implemented ABT for rehabilitation purposes in non-clinical settings. From the twelve studies, seven studies achieved high methodological quality scores. These studies were not only capable of assessing the type, quantity, and quality measures of functional activities, but could also distinguish healthy from non-healthy subjects and/or address disease severity levels. While many studies support ABT's potential for telerehabilitation, few actually utilized it to assess mobility-related functional activities outside laboratory settings. To generate more appropriate outcome measures, there is a clear need to translate research findings and novel methods into practice.

A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty.

PubMed

Gagnier, Joel J; Mullins, Megan; Huang, Hsiaomin; Marinac-Dabic, Danica; Ghambaryan, Anna; Eloff, Benjamin; Mirza, Faisal; Bayona, Manuel

2017-05-01

While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines. Published by Elsevier Inc.

Predictive performance of four frailty measures in an older Australian population

PubMed Central

Widagdo, Imaina S.; Pratt, Nicole; Russell, Mary; Roughead, Elizabeth E.

2015-01-01

Background: there are several different frailty measures available for identifying the frail elderly. However, their predictive performance in an Australian population has not been examined. Objective: to examine the predictive performance of four internationally validated frailty measures in an older Australian population. Methods: a retrospective study in the Australian Longitudinal Study of Ageing (ALSA) with 2,087 participants. Frailty was measured at baseline using frailty phenotype (FP), simplified frailty phenotype (SFP), frailty index (FI) and prognostic frailty score (PFS). Odds ratios (OR) were calculated to measure the association between frailty and outcomes at Wave 3 including mortality, hospitalisation, nursing home admission, fall and a combination of all outcomes. Predictive performance was measured by assessing sensitivity, specificity, positive and negative predictive values (PPV and NPV) and likelihood ratio (LR). Area under the curve (AUC) of dichotomised and the multilevel or continuous model of the measures was examined. Results: prevalence of frailty varied from 2% up to 49% between the measures. Frailty was significantly associated with an increased risk of any outcome, OR (95% confidence interval) for FP: 1.9 (1.4–2.8), SFP: 3.6 (1.5–8.8), FI: 3.4 (2.7–4.3) and PFS: 2.3 (1.8–2.8). PFS had high sensitivity across all outcomes (sensitivity: 55.2–77.1%). The PPV for any outcome was highest for SFP and FI (70.8 and 69.7%, respectively). Only FI had acceptable accuracy in predicting outcomes, AUC: 0.59–0.70. Conclusions: being identified as frail by any of the four measures was associated with an increased risk of outcomes; however, their predictive accuracy varied. PMID:26504118

Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures

PubMed Central

Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J.; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G.; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A.; Tugwell, Peter S.; Guillemin, Francis

2016-01-01

Objective The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. Methods The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Results Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Conclusion Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures. PMID:26077410

Physical Therapy and Exercise Interventions in Huntington’s Disease: A Mixed Methods Systematic Review

PubMed Central

Fritz, Nora E.; Rao, Ashwini K.; Kegelmeyer, Deb; Kloos, Anne; Busse, Monica; Hartel, Lynda; Carrier, Judith; Quinn, Lori

2017-01-01

Background: A number of studies evaluating physical therapy and exercise interventions in Huntington’s disease have been conducted over the past 15 years. However, an assessment of the quality and strength of the evidence in support of these interventions is lacking. Objective: The purpose of this systematic review was to investigate the effectiveness of physical therapy and exercise interventions in people with Huntington’s disease, and to examine the perceptions of patients, families and caregivers of these interventions. Methods: This mixed-methods systematic review utilized the Joanna Briggs Institute (JBI) approach and extraction tools to evaluate the literature from January 2003 until May 2016. The review considered interventions that included exercise and physical therapy interventions, and included both quantitative and qualitative outcome measures. Results: Twenty (20) studies met the inclusion criteria, including eighteen (18) that had quantitative outcome measures and two (2) that utilized qualitative methods. JBI Levels of evidence for the 18 quantitative studies were as follows: Eight studies were at evidence Level 1, seven were at Level 2, two were at Level 3, and one was at Level 4. Conclusions: Our review suggests that there is preliminary support for the benefits of exercise and physical activity in Huntington’s disease in terms of motor function, gait speed, and balance, as well as a range of physical and social benefits identified through patient-reported outcomes. Variability in mode of intervention as well as outcome measures limits the interpretability of these studies, and high-quality studies that incorporate adaptive trial designs for this rare disease are needed. PMID:28968244

International Airline Quality Measurement

DOT National Transportation Integrated Search

1998-01-01

Historically, airline quality has been measured through the use of surveys that ask the consumers to make a comparison between expectations and outcomes. This method was informative but very cumbersome in a rapidly changing environment. This paper ou...

Evaluating the Impact of the U.S. National Toxicology Program: A Case Study on Hexavalent Chromium

PubMed Central

Xie, Yun; Holmgren, Stephanie; Andrews, Danica M. K.; Wolfe, Mary S.

2016-01-01

Background: Evaluating the impact of federally funded research with a broad, methodical, and objective approach is important to ensure that public funds advance the mission of federal agencies. Objectives: We aimed to develop a methodical approach that would yield a broad assessment of National Toxicology Program’s (NTP’s) effectiveness across multiple sectors and demonstrate the utility of the approach through a case study. Methods: A conceptual model was developed with defined activities, outputs (products), and outcomes (proximal, intermediate, distal) and applied retrospectively to NTP’s research on hexavalent chromium (CrVI). Proximal outcomes were measured by counting views of and requests for NTP’s products by external stakeholders. Intermediate outcomes were measured by bibliometric analysis. Distal outcomes were assessed through Web and LexisNexis searches for documents related to legislation or regulation changes. Results: The approach identified awareness of NTP’s work on CrVI by external stakeholders (proximal outcome) and citations of NTP’s research in scientific publications, reports, congressional testimonies, and legal and policy documents (intermediate outcome). NTP’s research was key to the nation’s first-ever drinking water standard for CrVI adopted by California in 2014 (distal outcome). By applying this approach to a case study, the utility and limitations of the approach were identified, including challenges to evaluating the outcomes of a research program. Conclusions: This study identified a broad and objective approach for assessing NTP’s effectiveness, including methodological needs for more thorough and efficient impact assessments in the future. Citation: Xie Y, Holmgren S, Andrews DMK, Wolfe MS. 2017. Evaluating the impact of the U.S. National Toxicology Program: a case study on hexavalent chromium. Environ Health Perspect 125:181–188; http://dx.doi.org/10.1289/EHP21 PMID:27483499

Implementation outcome assessment instruments used in physical healthcare settings and their measurement properties: a systematic review protocol

PubMed Central

Vitoratou, Silia; Sevdalis, Nick; Hull, Louise

2017-01-01

Introduction Over the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures. Methods and analysis The following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored. Ethics and dissemination Ethical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for reviewers of papers and grants to determine the psychometric quality of the measures used in implementation research. Trial registration number International Prospective Register of Systematic Reviews (PROSPERO): CRD42017065348. PMID:28993392

Determination of patellofemoral pain sub-groups and development of a method for predicting treatment outcome using running gait kinematics.

PubMed

Watari, Ricky; Kobsar, Dylan; Phinyomark, Angkoon; Osis, Sean; Ferber, Reed

2016-10-01

Not all patients with patellofemoral pain exhibit successful outcomes following exercise therapy. Thus, the ability to identify patellofemoral pain subgroups related to treatment response is important for the development of optimal therapeutic strategies to improve rehabilitation outcomes. The purpose of this study was to use baseline running gait kinematic and clinical outcome variables to classify patellofemoral pain patients on treatment response retrospectively. Forty-one individuals with patellofemoral pain that underwent a 6-week exercise intervention program were sub-grouped as treatment Responders (n=28) and Non-responders (n=13) based on self-reported measures of pain and function. Baseline three-dimensional running kinematics, and self-reported measures underwent a linear discriminant analysis of the principal components of the variables to retrospectively classify participants based on treatment response. The significance of the discriminant function was verified with a Wilk's lambda test (α=0.05). The model selected 2 gait principal components and had a 78.1% classification accuracy. Overall, Non-responders exhibited greater ankle dorsiflexion, knee abduction and hip flexion during the swing phase and greater ankle inversion during the stance phase, compared to Responders. This is the first study to investigate an objective method to use baseline kinematic and self-report outcome variables to classify on patellofemoral pain treatment outcome. This study represents a significant first step towards a method to help clinicians make evidence-informed decisions regarding optimal treatment strategies for patients with patellofemoral pain. Copyright © 2016 Elsevier Ltd. All rights reserved.

Methods and Measures Used for Follow-up at 15 Years of the English and Romanian Adoptee (ERA) Study

ERIC Educational Resources Information Center

Monographs of the Society for Research in Child Development, 2010

2010-01-01

This chapter covers the methods and measures used in the ERA study, with a special focus on age 15 outcomes. First, the authors outline the sample participation rate for the 15-year follow-up--the percentages in all cases referring to the numbers at the time of initial sample contact. They then describe the measures used in this monograph,…

Resource-use measurement based on patient recall: issues and challenges for economic evaluation.

PubMed

Thorn, Joanna C; Coast, Joanna; Cohen, David; Hollingworth, William; Knapp, Martin; Noble, Sian M; Ridyard, Colin; Wordsworth, Sarah; Hughes, Dyfrig

2013-06-01

Accurate resource-use measurement is challenging within an economic evaluation, but is a fundamental requirement for estimating efficiency. Considerable research effort has been concentrated on the appropriate measurement of outcomes and the policy implications of economic evaluation, while methods for resource-use measurement have been relatively neglected. Recently, the Database of Instruments for Resource Use Measurement (DIRUM) was set up at http://www.dirum.org to provide a repository where researchers can share resource-use measures and methods. A workshop to discuss the issues was held at the University of Birmingham in October 2011. Based on material presented at the workshop, this article highlights the state of the art of UK instruments for resource-use data collection based on patient recall. We consider methodological issues in the design and analysis of resource-use instruments, and the challenges associated with designing new questionnaires. We suggest a method of developing a good practice guideline, and identify some areas for future research. Consensus amongst health economists has yet to be reached on many aspects of resource-use measurement. We argue that researchers should now afford costing methodologies the same attention as outcome measurement, and we hope that this Current Opinion article will stimulate a debate on methods of resource-use data collection and establish a research agenda to improve the precision and accuracy of resource-use estimates.

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

Program Evaluation of Group-based Cognitive Behavioral Therapy for Insomnia: a Focus on Treatment Adherence and Outcomes in Older Adults with Co-morbidities.

PubMed

Ludwin, Brian M; Bamonti, Patricia; Mulligan, Elizabeth A

2017-11-21

To describe a program evaluation of the interrelationship of adherence and treatment outcomes in a sample of veteran older adults with co-morbidities who participated in group-based cognitive behavioral therapy for insomnia. Retrospective data extraction was performed for 14 older adults. Adherence measures and sleep outcomes were measured with sleep diaries and Insomnia Severity Index. Demographic and clinical information was extracted through chart review. Adherence with prescribed time in bed, daily sleep diaries, and maintaining consistent time out of bed and time in bed was generally high. There were moderate, though not significant, improvements in consistency of time in bed and time out of bed over time. Adherence was not significantly associated with sleep outcomes despite improvements in most sleep outcomes. The non-significant relationship between sleep outcomes and adherence may reflect the moderating influence of co-morbidities or may suggest a threshold effect beyond which stricter adherence has a limited impact on outcomes. Development of multi-method adherence measures across all treatment components will be important to understand the influence of adherence on treatment outcomes as monitoring adherence to time in bed and time out of bed had limited utility for understanding treatment outcomes in our sample.

Publicly Reported Wound Healing Rates: The Fantasy and the Reality

PubMed Central

Fife, Caroline E.; Eckert, Kristen A.; Carter, Marissa J.

2018-01-01

Significance: We compare real-world data from the U.S. Wound Registry (USWR) with randomized controlled trials and publicly reported wound outcomes and develop criteria for honest reporting of wound outcomes, a requirement of the new Quality Payment Program (QPP). Recent Advances: Because no method has existed by which wounds could be stratified according to their likelihood of healing among real-world patients, practitioners have reported fantastically high healing rates. The USWR has developed several risk-stratified wound healing quality measures for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) as part of its Qualified Clinical Data Registry (QCDR). This allows practitioners to report DFU and VLU healing rates in comparison to the likelihood of whether the wound would have healed. Critical Issues: Under the new QPP, practitioners must report at least one practice-relevant outcome measure, and it must be risk adjusted so that clinicians caring for the sickest patients do not appear to have worse outcomes than their peers. The Wound Healing Index is a validated risk-stratification method that can predict whether a DFU or VLU will heal, leveling the playing field for outcome reporting and removing the need to artificially inflate healing rates. Wound care practitioners can report the USWR DFU and VLU risk-stratified outcome measure to satisfy the quality reporting requirements of the QPP. Future Directions: Per the requirements of the QPP, the USWR will begin publicly reporting of risk-stratified healing rates once quality measure data have met the reporting standards of the Centers for Medicare and Medicaid Services. Some basic rules for data censoring are proposed for public reporting of healing rates, and others are needed, which should be decided by consensus among the wound care community. PMID:29644145

CONTENT VALIDITY OF SYMPTOM-BASED MEASURES FOR DIABETIC, CHEMOTHERAPY, AND HIV PERIPHERAL NEUROPATHY

PubMed Central

GEWANDTER, JENNIFER S.; BURKE, LAURIE; CAVALETTI, GUIDO; DWORKIN, ROBERT H.; GIBBONS, CHRISTOPHER; GOVER, TONY D.; HERRMANN, DAVID N.; MCARTHUR, JUSTIN C.; MCDERMOTT, MICHAEL P.; RAPPAPORT, BOB A.; REEVE, BRYCE B.; RUSSELL, JAMES W.; SMITH, A. GORDON; SMITH, SHANNON M.; TURK, DENNIS C.; VINIK, AARON I.; FREEMAN, ROY

2017-01-01

Introduction No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. Methods This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. Results Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. Conclusions Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. PMID:27447116

Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol.

PubMed

Gagnier, Joel J; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Buchbinder, Rachelle

2017-07-20

The selection of appropriate outcomes or domains is crucial when designing clinical trials, to appreciate the effects of different interventions, pool results, and make valid comparisons between trials. If the findings are to influence policy and practice, then the chosen outcomes need to be relevant and important to key stakeholders, including patients and the public, healthcare professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. Recent reviews of the measurement properties of patient-reported outcome measures for shoulder disorders revealed a large selection of diverse measures, many with questionable validity, reliability, and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials of shoulder disorders. The purpose of the present project is to develop and disseminate a COS for clinical trials in shoulder disorders. The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence. The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials. There would be an expectation that the core set of outcomes would always be collected and reported, but it would not preclude use of additional outcomes in a particular trial.

The effects of kinesiotape on athletic-based performance outcomes in healthy, active individuals: a literature synthesis

PubMed Central

Drouin, Jillian L.; McAlpine, Caitlin T.; Primak, Kari A.; Kissel, Jaclyn

2013-01-01

Context: The effect of the application of kinesiotape to skin overlying musculature on measurable athletic-based performance outcomes in healthy individuals has not been well established. Objective: To systematically search and assess the quality of the literature on the effect of kinesiotape on athletic-based performance outcomes in healthy, active individuals. Methods: An electronic search strategy was conducted in MANTIS, Cochrane Library and EBSCO databases. Retrieved articles that met the eligibility criteria were rated for methodological quality by using an adaption of the critical appraisal criteria in Clinical Epidemiology by Sackett et al. Results: Ten articles met the inclusion criteria. Seven articles had positive results in at least one athletic-based performance measure compared to controls. Conclusion: Evidence is lacking to support the use of kinesiotape as a successful measure for improving athletic-based performance outcomes in healthy individuals. However, there is no evidence to show that kinesiotape has a negative effect on any of the performace measures. PMID:24302784

The Outcome and Assessment Information Set (OASIS): A Review of Validity and Reliability

PubMed Central

O’CONNOR, MELISSA; DAVITT, JOAN K.

2015-01-01

The Outcome and Assessment Information Set (OASIS) is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality. Since its inception in 1999, there has been debate over the reliability and validity of the OASIS as a research tool and outcome measure. A systematic literature review of English-language articles identified 12 studies published in the last 10 years examining the validity and reliability of the OASIS. Empirical findings indicate the validity and reliability of the OASIS range from low to moderate but vary depending on the item studied. Limitations in the existing research include: nonrepresentative samples; inconsistencies in methods used, items tested, measurement, and statistical procedures; and the changes to the OASIS itself over time. The inconsistencies suggest that these results are tentative at best; additional research is needed to confirm the value of the OASIS for measuring patient outcomes, research, and quality improvement. PMID:23216513

Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

PubMed

Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

2018-03-01

This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in the studies that report the results of test-retest reliability. Copyright © 2017 Elsevier Ltd. All rights reserved.

International comparison of observation-specific spatial buffers: maximizing the ability to estimate physical activity.

PubMed

Frank, Lawrence D; Fox, Eric H; Ulmer, Jared M; Chapman, James E; Kershaw, Suzanne E; Sallis, James F; Conway, Terry L; Cerin, Ester; Cain, Kelli L; Adams, Marc A; Smith, Graham R; Hinckson, Erica; Mavoa, Suzanne; Christiansen, Lars B; Hino, Adriano Akira F; Lopes, Adalberto A S; Schipperijn, Jasper

2017-01-23

Advancements in geographic information systems over the past two decades have increased the specificity by which an individual's neighborhood environment may be spatially defined for physical activity and health research. This study investigated how different types of street network buffering methods compared in measuring a set of commonly used built environment measures (BEMs) and tested their performance on associations with physical activity outcomes. An internationally-developed set of objective BEMs using three different spatial buffering techniques were used to evaluate the relative differences in resulting explanatory power on self-reported physical activity outcomes. BEMs were developed in five countries using 'sausage,' 'detailed-trimmed,' and 'detailed,' network buffers at a distance of 1 km around participant household addresses (n = 5883). BEM values were significantly different (p < 0.05) for 96% of sausage versus detailed-trimmed buffer comparisons and 89% of sausage versus detailed network buffer comparisons. Results showed that BEM coefficients in physical activity models did not differ significantly across buffering methods, and in most cases BEM associations with physical activity outcomes had the same level of statistical significance across buffer types. However, BEM coefficients differed in significance for 9% of the sausage versus detailed models, which may warrant further investigation. Results of this study inform the selection of spatial buffering methods to estimate physical activity outcomes using an internationally consistent set of BEMs. Using three different network-based buffering methods, the findings indicate significant variation among BEM values, however associations with physical activity outcomes were similar across each buffering technique. The study advances knowledge by presenting consistently assessed relationships between three different network buffer types and utilitarian travel, sedentary behavior, and leisure-oriented physical activity outcomes.

Initial constructs for patient-centered outcome measures to evaluate brain-computer interfaces.

PubMed

Andresen, Elena M; Fried-Oken, Melanie; Peters, Betts; Patrick, Donald L

2016-10-01

The authors describe preliminary work toward the creation of patient-centered outcome (PCO) measures to evaluate brain-computer interface (BCI) as an assistive technology (AT) for individuals with severe speech and physical impairments (SSPI). In Phase 1, 591 items from 15 existing measures were mapped to the International Classification of Functioning, Disability and Health (ICF). In Phase 2, qualitative interviews were conducted with eight people with SSPI and seven caregivers. Resulting text data were coded in an iterative analysis. Most items (79%) were mapped to the ICF environmental domain; over half (53%) were mapped to more than one domain. The ICF framework was well suited for mapping items related to body functions and structures, but less so for items in other areas, including personal factors. Two constructs emerged from qualitative data: quality of life (QOL) and AT. Component domains and themes were identified for each. Preliminary constructs, domains and themes were generated for future PCO measures relevant to BCI. Existing instruments are sufficient for initial items but do not adequately match the values of people with SSPI and their caregivers. Field methods for interviewing people with SSPI were successful, and support the inclusion of these individuals in PCO research. Implications for Rehabilitation Adapted interview methods allow people with severe speech and physical impairments to participate in patient-centered outcomes research. Patient-centered outcome measures are needed to evaluate the clinical implementation of brain-computer interface as an assistive technology.

Use of Continuous Glucose Monitoring as an Outcome Measure in Clinical Trials

PubMed Central

Calhoun, Peter; Kollman, Craig

2012-01-01

Abstract Objective Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Research Design and Methods Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian® [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5–57 years; mean, 18±12 years). Results Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P=0.92), and the correlation of the two was high (r=0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P=0.05] and 262 mg/dL vs. 257 mg/dL [P=0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). Conclusions A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials. PMID:23013201

A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia.

PubMed

Duffy, James M N; van 't Hooft, Janneke; Gale, Chris; Brown, Mark; Grobman, William; Fitzpatrick, Ray; Karumanchi, S Ananth; Lucas, Nuala; Magee, Laura; Mol, Ben; Stark, Michael; Thangaratinam, Shakila; Wilson, Mathew; von Dadelszen, Peter; Williamson, Paula; Khan, Khalid S; Ziebland, Sue; McManus, Richard J

2016-10-01

Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus 'core' outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. PROSPECTIVE REGISTRATION: [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529. Copyright © 2016 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.

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.

Improving Value for Patients with Eczema.

PubMed

Block, Julie

2018-04-01

Chronic diseases now represent a cost majority in the United States health care system. Contributing factors to rising costs include expensive novel and emerging therapies, under-treatment of disease, under-management of comorbidities, and patient dissatisfaction with care results. Critical to identifying replicable improvement methods is a reliable model to measure value. If we understand value within healthcare consumerism to be equal to a patient's health outcome improvement over costs associated with care (Value=Outcomes/Costs), we can use this equation to measure the improvement of value. Research and literature show that patient activation-the skills and confidence that equip patients to become actively engaged in their health care-impact health outcomes, costs, and patient experience. Reaching patient activation through engagement methods including shared decision-making (SDM) lead to improved value of care received. The National Eczema Association (NEA) Shared Decision-Making Resource Center can be a transformative strategy to measure and evaluate value of health care interventions for eczema patients to advance a value-driven health care system in the United States. Through this Resource Center, NEA will measure patient value through their own perceptions using validated PRO instruments and other patient-generated health data. Assessment of this data will reveal findings that can assist researchers in evaluating the impact this care framework on patient-perceived value across other chronic diseases. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Predicting Story Goodness Performance from Cognitive Measures Following Traumatic Brain Injury

ERIC Educational Resources Information Center

Le, Karen; Coelho, Carl; Mozeiko, Jennifer; Krueger, Frank; Grafman, Jordan

2012-01-01

Purpose: This study examined the prediction of performance on measures of the Story Goodness Index (SGI; Le, Coelho, Mozeiko, & Grafman, 2011) from executive function (EF) and memory measures following traumatic brain injury (TBI). It was hypothesized that EF and memory measures would significantly predict SGI outcomes. Method: One hundred…

Pulmonary Vascular Input Impedance is a Combined Measure of Pulmonary Vascular Resistance and Stiffness and Predicts Clinical Outcomes Better than PVR Alone in Pediatric Patients with Pulmonary Hypertension

PubMed Central

Hunter, Kendall S.; Lee, Po-Feng; Lanning, Craig J.; Ivy, D. Dunbar; Kirby, K. Scott; Claussen, Lori R.; Chan, K. Chen; Shandas, Robin

2011-01-01

Background Pulmonary vascular resistance (PVR) is the current standard for evaluating reactivity in children with pulmonary arterial hypertension (PAH). However, PVR measures only the mean component of right ventricular afterload and neglects pulsatile effects. We recently developed and validated an method to measure pulmonary vascular input impedance, which revealed excellent correlation between the zero-harmonic impedance value and PVR, and suggested a correlation between higher harmonic impedance values and pulmonary vascular stiffness (PVS). Here we show that input impedance can be measured routinely and easily in the catheterization laboratory, that impedance provides PVR and PVS from a single measurement, and that impedance is a better predictor of disease outcomes compared to PVR. Methods Pressure and velocity waveforms within the main PA were measured during right-heart catheterization of patients with normal PA hemodynamics (n=14) and those with PAH undergoing reactivity evaluation (49 subjects; 95 conditions). A correction factor needed to transform velocity into flow was obtained by calibrating against cardiac output. Input impedance was obtained off-line by dividing Fourier-transformed pressure and flow waveforms. Results Exceptional correlation was found between the indexed zero harmonic of impedance and indexed PVR (y=1.095·x+1.381, R2=0.9620). Additionally, the modulus sum of the first two harmonics of impedance was found to best correlate with indexed pulse pressure over stroke volume (PP/SV) (y=13.39·x-0.8058, R2=0.7962). Amongst a subset of PAH patients (n=25), cumulative logistic regression between outcomes to total indexed impedance was better (RL2=0.4012) than between outcomes and indexed PVR (RL2=0.3131). Conclusions Input impedance can be consistently and easily obtained from PW Doppler and a single catheter pressure measurement, provides comprehensive characterization of the main components of RV afterload, and better predicts patient outcomes compared to PVR alone. PMID:18082509

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.

Physical Therapy and Exercise Interventions in Huntington's Disease: A Mixed Methods Systematic Review.

PubMed

Fritz, Nora E; Rao, Ashwini K; Kegelmeyer, Deb; Kloos, Anne; Busse, Monica; Hartel, Lynda; Carrier, Judith; Quinn, Lori

2017-01-01

A number of studies evaluating physical therapy and exercise interventions in Huntington's disease have been conducted over the past 15 years. However, an assessment of the quality and strength of the evidence in support of these interventions is lacking. The purpose of this systematic review was to investigate the effectiveness of physical therapy and exercise interventions in people with Huntington's disease, and to examine the perceptions of patients, families and caregivers of these interventions. This mixed-methods systematic review utilized the Joanna Briggs Institute (JBI) approach and extraction tools to evaluate the literature from January 2003 until May 2016. The review considered interventions that included exercise and physical therapy interventions, and included both quantitative and qualitative outcome measures. Twenty (20) studies met the inclusion criteria, including eighteen (18) that had quantitative outcome measures and two (2) that utilized qualitative methods. JBI Levels of evidence for the 18 quantitative studies were as follows: Eight studies were at evidence Level 1, seven were at Level 2, two were at Level 3, and one was at Level 4. Our review suggests that there is preliminary support for the benefits of exercise and physical activity in Huntington's disease in terms of motor function, gait speed, and balance, as well as a range of physical and social benefits identified through patient-reported outcomes. Variability in mode of intervention as well as outcome measures limits the interpretability of these studies, and high-quality studies that incorporate adaptive trial designs for this rare disease are needed.

Pretreatment Prediction of the Outcomes of Intranasal Steroid Sprays in Cases with Inferior Turbinate Hypertrophy

PubMed Central

Karataş, Abdullah

2017-01-01

Objective Intranasal steroid sprays (INSS) are frequently prescribed for treating inferior turbinate hypertrophy (ITH). Complications due to the long-term application of INSS such as crusting, epistaxis, nasal mucosa dryness, and septal perforation may occur. Predicting patients who would benefit from INSS early might lower treatment costs and complication rates. We examined the predictive value of nasal decongestant response rates for the outcomes of INSS in ITH. Methods Fifty patients with bilateral ITH were included in two groups: patients benefiting from INSS and those not benefiting. Nasal airflow was assessed by peak nasal inspiratory flow (PNIF) measurement in all cases. Measurements were taken three times: before and after the application of nasal decongestant sprays and after the application of INSS. Results In both groups, the nasal air flow rates significantly increased after the application of nasal decongestant sprays; however, the nasal decongestant response rates were higher in the group with patients benefiting from INSS. There was a strong correlation between the nasal air flow rates measured after the application of nasal decongestant sprays and after the application of INSS. The cut-off value for the relationship between increased nasal air flow rates after the application of nasal decongestant sprays and outcomes of INSS was 23%. Conclusion Measurement of nasal airflow increase rate after the application of nasal decongestant sprays is a simple and easy method for the early prediction of the outcomes of INSS in ITH. A higher than 23% increase in nasal air flow rates after the application of nasal decongestant sprays indicates much better outcomes of INSS for patients. PMID:29392066

Development of a Research Methods and Statistics Concept Inventory

ERIC Educational Resources Information Center

Veilleux, Jennifer C.; Chapman, Kate M.

2017-01-01

Research methods and statistics are core courses in the undergraduate psychology major. To assess learning outcomes, it would be useful to have a measure that assesses research methods and statistical literacy beyond course grades. In two studies, we developed and provided initial validation results for a research methods and statistical knowledge…

Core outcome sets for research and clinical practice.

PubMed

Chiarotto, Alessandro; Ostelo, Raymond W; Turk, Dennis C; Buchbinder, Rachelle; Boers, Maarten

This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients. Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Smoking and Adverse Maternal and Child Health Outcomes in Brazil

PubMed Central

2013-01-01

Introduction: Numerous studies from high-income countries document the causal relationship between cigarette smoking during pregnancy and adverse maternal and child health (MCH) outcomes. Less research has been conducted in low and middle income countries, but a burgeoning literature can be found for Brazil. Methods: We review Brazilian studies of the prevalence of maternal smoking, the relative risk of smoking-attributable adverse MCH outcomes, and present new estimates for these outcomes, using the attributable fraction method. Results: We found that Brazilian studies of the relative risks of smoking-attributable adverse MCH outcomes were broadly consistent with previous reviews. Based on a comparison of maternal smoking over time, smoking during pregnancy has declined by about 50% over the last 20 years in Brazil. For 2008, we estimate that 5,352 cases of spontaneous abortion, 10,929 cases of preterm birth, 20,717 cases of low birth weight, and 29 cases of sudden infant death syndrome are attributable to maternal smoking. Between 1989 and 2008, the percent of smoking-attributable adverse MCH outcomes in Brazil was at least halved. Conclusions: The results show that over a 20-year period, during which Brazil implemented numerous effective tobacco control measures, the country experienced a dramatic decrease in both maternal smoking prevalence and smoking-attributable adverse MCH outcomes. Countries that implement effective tobacco control measures can expect to reduce both maternal smoking and adverse MCH outcomes, thereby improving the public health. PMID:23873977

Ordinal preference elicitation methods in health economics and health services research: using discrete choice experiments and ranking methods.

PubMed

Ali, Shehzad; Ronaldson, Sarah

2012-09-01

The predominant method of economic evaluation is cost-utility analysis, which uses cardinal preference elicitation methods, including the standard gamble and time trade-off. However, such approach is not suitable for understanding trade-offs between process attributes, non-health outcomes and health outcomes to evaluate current practices, develop new programmes and predict demand for services and products. Ordinal preference elicitation methods including discrete choice experiments and ranking methods are therefore commonly used in health economics and health service research. Cardinal methods have been criticized on the grounds of cognitive complexity, difficulty of administration, contamination by risk and preference attitudes, and potential violation of underlying assumptions. Ordinal methods have gained popularity because of reduced cognitive burden, lower degree of abstract reasoning, reduced measurement error, ease of administration and ability to use both health and non-health outcomes. The underlying assumptions of ordinal methods may be violated when respondents use cognitive shortcuts, or cannot comprehend the ordinal task or interpret attributes and levels, or use 'irrational' choice behaviour or refuse to trade-off certain attributes. CURRENT USE AND GROWING AREAS: Ordinal methods are commonly used to evaluate preference for attributes of health services, products, practices, interventions, policies and, more recently, to estimate utility weights. AREAS FOR ON-GOING RESEARCH: There is growing research on developing optimal designs, evaluating the rationalization process, using qualitative tools for developing ordinal methods, evaluating consistency with utility theory, appropriate statistical methods for analysis, generalizability of results and comparing ordinal methods against each other and with cardinal measures.

Predicting Well-being Longitudinally for Mothers Rearing Offspring with Intellectual and Developmental Disabilities

PubMed Central

Grein, Katherine A.; Glidden, Laraine Masters

2014-01-01

Background Well-being outcomes for parents of children with intellectual and developmental disabilities (IDD) may vary from positive to negative at different times and for different measures of well-being. Predicting and explaining this variability has been a major focus of family research for reasons that have both theoretical and applied implications. Methods The current study used data from a 23-year longitudinal investigation of adoptive and birth parents of children with IDD to determine which early child, mother, and family characteristics would predict the variance in maternal outcomes 20 years after their original measurement. Using hierarchical regression analyses, we tested the predictive power of variables measured when children were 7 years old on outcomes of maternal well-being when children were 26 years old. Outcome variables included maternal self-report measures of depression and well–being. Results Final models of well-being accounted for 20% to 34% of variance. For most outcomes, Family Accord and/or the personality variable of Neuroticism (emotional stability/instability) were significant predictors, but some variables demonstrated a different pattern. Conclusions These findings confirm that 1) Characteristics of the child, mother, and family during childhood can predict outcomes of maternal well-being 20 years later; and 2) Different predictor-outcome relationships can vary substantially, highlighting the importance of using multiple measures to gain a more comprehensive understanding of maternal well-being. These results have implications for refining prognoses for parents and for tailoring service delivery to individual child, parent, and family characteristics. PMID:25185956

Reiki Therapy for Symptom Management in Children Receiving Palliative Care: A Pilot Study.

PubMed

Thrane, Susan E; Maurer, Scott H; Ren, Dianxu; Danford, Cynthia A; Cohen, Susan M

2017-05-01

Pain may be reported in one-half to three-fourths of children with cancer and other terminal conditions and anxiety in about one-third of them. Pharmacologic methods do not always give satisfactory symptom relief. Complementary therapies such as Reiki may help children manage symptoms. This pre-post mixed-methods single group pilot study examined feasibility, acceptability, and the outcomes of pain, anxiety, and relaxation using Reiki therapy with children receiving palliative care. A convenience sample of children ages 7 to 16 and their parents were recruited from a palliative care service. Two 24-minute Reiki sessions were completed at the children's home. Paired t tests or Wilcoxon signed-rank tests were calculated to compare change from pre to post for outcome variables. Significance was set at P < .10. Cohen d effect sizes were calculated. The final sample included 8 verbal and 8 nonverbal children, 16 mothers, and 1 nurse. All mean scores for outcome variables decreased from pre- to posttreatment for both sessions. Significant decreases for pain for treatment 1 in nonverbal children ( P = .063) and for respiratory rate for treatment 2 in verbal children ( P = .009). Cohen d effect sizes were medium to large for most outcome measures. Decreased mean scores for outcome measures indicate that Reiki therapy did decrease pain, anxiety, heart, and respiratory rates, but small sample size deterred statistical significance. This preliminary work suggests that complementary methods of treatment such as Reiki may be beneficial to support traditional methods to manage pain and anxiety in children receiving palliative care.

Measuring benefits of transit oriented development.

DOT National Transportation Integrated Search

2014-10-01

Transit-oriented development (TOD) in New Jersey is evaluated using a variety of methods and different outcome measures. : Data was gathered from respondents residing around eight train stations in New Jersey and up to two miles away from those : sta...

Measuring sap flow in plants

USDA-ARS?s Scientific Manuscript database

Sap flow measurements provide a powerful tool for quantifying plant water use and monitoring qualitative physiological responses of plants to environmental conditions. As such, sap flow methods are widely employed to invesitgate the agronomic, ecological and hydrological outcomes of plant growth. T...

Measuring the Effects of Self-Awareness: Construction of the Self-Awareness Outcomes Questionnaire

PubMed Central

Sutton, Anna

2016-01-01

Dispositional self-awareness is conceptualized in several different ways, including insight, reflection, rumination and mindfulness, with the latter in particular attracting extensive attention in recent research. While self-awareness is generally associated with positive psychological well-being, these different conceptualizations are also each associated with a range of unique outcomes. This two part, mixed methods study aimed to advance understanding of dispositional self-awareness by developing a questionnaire to measure its outcomes. In Study 1, expert focus groups categorized and extended an initial pool of potential items from previous research. In Study 2, these items were reduced to a 38 item self-report questionnaire with four factors representing three beneficial outcomes (reflective self-development, acceptance and proactivity) and one negative outcome (costs). Regression of these outcomes against self-awareness measures revealed that self-reflection and insight predicted beneficial outcomes, rumination predicted reduced benefits and increased costs, and mindfulness predicted both increased proactivity and costs. These studies help to refine the self-awareness concept by identifying the unique outcomes associated with the concepts of self-reflection, insight, reflection, rumination and mindfulness. It can be used in future studies to evaluate and develop awareness-raising techniques to maximize self-awareness benefits while minimizing related costs. PMID:27872672

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

Routine outcome measurement in mental health service consumers: who should provide support for the self-assessments?

PubMed

Gelkopf, Marc; Pagorek-Eshel, Shira; Trauer, Tom; Roe, David

2015-06-01

This study examined whether mental health community service users completed outcome self-reports differently when assessments were supervised by internal vs. external staff. The examination of potential differences between the two has useful implications for mental health systems that take upon themselves the challenge of Routine Outcome Measurement (ROM), as it might impact allocation of public resources and managed care program planning. 73 consumers completed the Manchester Short Assessment of Quality of Life (MANSA), a shortened version of the Recovery Assessment Scale (RAS), and a functioning questionnaire. Questionnaires were administered, once using support provided by internal staff and once using support provided by external professional staff, with a one-month time interval and in random order. A MANOVA Repeated Measures showed no differences in outcomes of quality of life and recovery between internal and external support. Functioning scores were higher for the internal support when the internal assessments were performed first. Overall, except for the differences in functioning assessment, outcome scores were not determined by the supporting agency. This might indicate that when measuring quality of life and recovery, different supporting methods can be used to gather outcome measures and internal staff might be a good default agency to do this. Differences found in functioning assessment are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Improving the Rank Precision of Population Health Measures for Small Areas with Longitudinal and Joint Outcome Models

PubMed Central

Athens, Jessica K.; Remington, Patrick L.; Gangnon, Ronald E.

2015-01-01

Objectives The University of Wisconsin Population Health Institute has published the County Health Rankings since 2010. These rankings use population-based data to highlight health outcomes and the multiple determinants of these outcomes and to encourage in-depth health assessment for all United States counties. A significant methodological limitation, however, is the uncertainty of rank estimates, particularly for small counties. To address this challenge, we explore the use of longitudinal and pooled outcome data in hierarchical Bayesian models to generate county ranks with greater precision. Methods In our models we used pooled outcome data for three measure groups: (1) Poor physical and poor mental health days; (2) percent of births with low birth weight and fair or poor health prevalence; and (3) age-specific mortality rates for nine age groups. We used the fixed and random effects components of these models to generate posterior samples of rates for each measure. We also used time-series data in longitudinal random effects models for age-specific mortality. Based on the posterior samples from these models, we estimate ranks and rank quartiles for each measure, as well as the probability of a county ranking in its assigned quartile. Rank quartile probabilities for univariate, joint outcome, and/or longitudinal models were compared to assess improvements in rank precision. Results The joint outcome model for poor physical and poor mental health days resulted in improved rank precision, as did the longitudinal model for age-specific mortality rates. Rank precision for low birth weight births and fair/poor health prevalence based on the univariate and joint outcome models were equivalent. Conclusion Incorporating longitudinal or pooled outcome data may improve rank certainty, depending on characteristics of the measures selected. For measures with different determinants, joint modeling neither improved nor degraded rank precision. This approach suggests a simple way to use existing information to improve the precision of small-area measures of population health. PMID:26098858

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.

Psychosocial Adjustment and Life Satisfaction until 5 Years after Severe Brain Damage

ERIC Educational Resources Information Center

Sorbo, Ann K.; Blomqvist, Maritha; Emanuelsson, Ingrid M.; Rydenhag, Bertil

2009-01-01

The objectives of this study were to describe psychosocial adjustment and outcome over time for severely brain-injured patients and to find suitable outcome measures for clinical practice during the rehabilitation process and for individual rehabilitation planning after discharge from hospital. The methods include a descriptive, prospective,…

Outcome Measures of Triple Board Graduates, 1991-2003

ERIC Educational Resources Information Center

Warren, Marla J.; Dunn, David W.; Rushton, Jerry

2006-01-01

Objective: To describe program outcomes for the Combined Training Program in Child and Adolescent Psychiatry, Pediatrics, and Psychiatry (Triple Board Program). Method: All Triple Board Program graduates to date (1991-2003) were asked to participate in a 37-item written survey from February to April 2004. Results: The response rate was 80.7%. Most…

2004 Strategic Master Plan for Higher Education. Update on Implementation

ERIC Educational Resources Information Center

Washington Higher Education Coordinating Board, 2005

2005-01-01

The 2004 Strategic Master Plan for Higher Education identified clear and measurable goals that focused on outcomes rather than inputs alone. To reinforce this outcomes-based approach, the plan proposed that the state develop a new funding method to reward public colleges and universities for student success. Specifically, it proposed that the…

Whose Standards? (B) Reaching the Assessment Puzzle

ERIC Educational Resources Information Center

Polimeni, John M.; Iorgulescu, Raluca I.

2009-01-01

Love it or hate it, assessment has become the new reality on college and university campuses. Although measuring student achievement of course outcomes is not an easy task, assessment does not need to be a complex or painful experience. This paper describes the methods used to assess student achievement of the stated course outcomes in…

A Powerful, Potential Outcomes Method for Estimating Any Estimand across Multiple Groups

ERIC Educational Resources Information Center

Pattanayak, Cassandra W.; Rubin, Donald B.; Zell, Elizabeth R.

2013-01-01

In educational research, outcome measures are often estimated across separate studies or across schools, districts, or other subgroups to assess the overall causal effect of an active treatment versus a control treatment. Students may be partitioned into such strata or blocks by experimental design, or separated into studies within a…

Association of Various Components of Media Literacy and Adolescent Smoking

ERIC Educational Resources Information Center

Primack, Brian A.; Hobbs, Renee

2009-01-01

Objective: To determine which specific aspects of media literacy were most strongly associated with smoking outcomes. Methods: Students at a public high school responded to cross-sectional survey items measuring smoking outcomes, components of media literacy, and other variables. Results: Of the 1211 participants, 19% were current smokers (N =…

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.

Measurement of Harm Outcomes in Older Adults after Hospital Discharge: Reliability and Validity

PubMed Central

Douglas, Alison; Letts, Lori; Eva, Kevin; Richardson, Julie

2012-01-01

Objectives. Defining and validating a measure of safety contributes to further validation of clinical measures. The objective was to define and examine the psychometric properties of the outcome “incidents of harm.” Methods. The Incident of Harm Caregiver Questionnaire was administered to caregivers of older adults discharged from hospital by telephone. Caregivers completed daily logs for one month and medical charts were examined. Results. Test-retest reliability (n = 38) was high for the occurrence of an incident of harm (yes/no; kappa = 1.0) and the type of incident (agreement = 100%). Validation against daily logs found no disagreement regarding occurrence or types of incidents. Validation with medical charts found no disagreement regarding incident occurrence and disagreement in half regarding incident type. Discussion. The data support the Incident of Harm Caregiver Questionnaire as a reliable and valid estimation of incidents for this sample and are important to researchers as a method to measure safety when validating clinical measures. PMID:22649728

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.

The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate

PubMed Central

Harman, Nicola L.; Bruce, Iain A.; Kirkham, Jamie J.; Tierney, Stephanie; Callery, Peter; O'Brien, Kevin; Williamson, Paula R.

2015-01-01

Background Approximately 75% of children with cleft palate (CP) have Otitis Media with Effusion (OME) histories. Evidence for the effective management of OME in these children is lacking. The inconsistency in outcome measurement in previous studies has led to a call for the development of a Core Outcome Set (COS). Despite the increase in the number of published COS, involvement of patients in the COS development process, and methods to integrate the views of patients and health professionals, to date have been limited. Methods and Findings A list of outcomes measured in previous research was identified through reviewing the literature. Opinion on the importance of each of these outcomes was then sought from key stakeholders: Ear, Nose and Throat (ENT) surgeons, audiologists, cleft surgeons, speech and language therapists, specialist cleft nurses, psychologists, parents and children. The opinion of health professionals was sought in a three round Delphi survey where participants were asked to score each outcome using a bespoke online system. Parents and children were also asked to score outcomes in a survey and provided an in-depth insight into having OME through semi-structured interviews. The results of the Delphi survey, interviews and parent/patient survey were brought together in a final consensus meeting with representation from all stakeholders. A final set of eleven outcomes reached the definition of “consensus in” to form the recommended COS: hearing; chronic otitis media (COM); OME; receptive language skills; speech development; psycho social development; acute otitis media (AOM); cholesteatoma; side effects of treatment; listening skills; otalgia. Conclusions We have produced a recommendation about the outcomes that should be measured, as a minimum, in studies of the management of OME in children with CP. The development process included input from key stakeholders and used novel methodology to integrate the opinion of healthcare professionals, parents and children. PMID:26115172

Geographic access to mammography and its relationship to breast cancer screening and stage at diagnosis: a systematic review

PubMed Central

Khan-Gates, Jenna A.; Ersek, Jennifer L.; Eberth, Jan M.; Adams, Swann A.; Pruitt, Sandi

2016-01-01

Introduction A review was conducted to summarize the current evidence and gaps in the literature on geographic access to mammography and its relationship to breast cancer-related outcomes. Methods Ovid Medline and PubMed were searched for articles published between January 1, 2000 and April 1, 2013 using Medical Subject Headings and key terms representing geographic accessibility and breast cancer-related outcomes. Due to a paucity of breast cancer treatment and mortality outcomes meeting the criteria (N=6), outcomes were restricted to breast cancer screening and stage at diagnosis. Studies included one or more of the following types of geographic accessibility measures: capacity, density, distance and travel time. Study findings were grouped by outcome and type of geographic measure. Results Twenty-one articles met inclusion criteria. Fourteen articles included stage at diagnosis as an outcome, five included mammography utilization, and two included both. Geographic measures of mammography accessibility varied widely across studies. Findings also varied, but most articles found either increased geographic access to mammography associated with increased utilization and decreased late-stage at diagnosis or no statistically significant association. Conclusion The gaps and methodologic heterogeneity in the literature to date limit definitive conclusions about an underlying association between geographic mammography access and breast cancer-related outcomes. Future studies should focus on the development and application of more precise and consistent measures of geographic access to mammography. PMID:26219677

What quantum measurements measure

NASA Astrophysics Data System (ADS)

Griffiths, Robert B.

2017-09-01

A solution to the second measurement problem, determining what prior microscopic properties can be inferred from measurement outcomes ("pointer positions"), is worked out for projective and generalized (POVM) measurements, using consistent histories. The result supports the idea that equipment properly designed and calibrated reveals the properties it was designed to measure. Applications include Einstein's hemisphere and Wheeler's delayed choice paradoxes, and a method for analyzing weak measurements without recourse to weak values. Quantum measurements are noncontextual in the original sense employed by Bell and Mermin: if [A ,B ]=[A ,C ]=0 ,[B ,C ]≠0 , the outcome of an A measurement does not depend on whether it is measured with B or with C . An application to Bohm's model of the Einstein-Podolsky-Rosen situation suggests that a faulty understanding of quantum measurements is at the root of this paradox.

Capturing Change: Creating a Template to Examine the Educational Experiences and Outcomes of the AONE Foundation Nurse Manager Fellowship.

PubMed

Mackoff, Barbara L; Meadows, Mary T; Nash, Alice

2017-03-01

The aim of the study is to create a mixed-methods evaluation template to examine the educational experiences and outcomes of participants in the Nurse Manager Fellowship (NMF) sponsored by the American Organization of Nurse Executives (AONE) Foundation. The focus was to capture change as reported by the nurse manager (NM) fellows and the senior leaders who sponsored them and to gain access to the participants' lived experiences as leadership learners. The AONE Foundation's NMF conducts a yearlong professional development program with a cohort of 30 fellows who meet 4 times a year in face-to-face sessions and complete a capstone project. Four data collection methods were used. Participants completed 2 quantitative leadership program outcome surveys, as well as 1 qualitative measure to focus on self-perceived change outcomes. Their sponsors completed a qualitative perception of change measure. The participants' reflections, self-reports, and the sponsor observations capture impactful changes in the NM fellows' increases in knowledge and application in the spheres of self, organization, and community. The enhancement of the participants' self-identification as leaders was also demonstrated. The variety of data collection methods suggests both distinct choices in creating future evaluation templates for the fellowship and approaches that might be adapted by other organizations.

The Cervical Dystonia Impact Profile (CDIP-58): Can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

PubMed Central

Cano, Stefan J; Warner, Thomas T; Thompson, Alan J; Bhatia, Kailash P; Fitzpatrick, Ray; Hobart, Jeremy C

2008-01-01

Background The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. Methods We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. Results A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data ≤ 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha ≥ 0.92, test-retest intraclass correlations ≥ 0.83); and 5) validity was supported. Conclusion This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis. PMID:18684327

The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

PubMed Central

2011-01-01

Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to assess the effectiveness of a 12 week exercise intervention (the HOPE programme) designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT), measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL), EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life measure and the geriatric depression scale (GDS), measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS), record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881 PMID:21651805

Case matching and the reduction of selection bias in quasi-experiments: The relative importance of pretest measures of outcome, of unreliable measurement, and of mode of data analysis.

PubMed

Cook, Thomas D; Steiner, Peter M

2010-03-01

In this article, we note the many ontological, epistemological, and methodological similarities between how Campbell and Rubin conceptualize causation. We then explore 3 differences in their written emphases about individual case matching in observational studies. We contend that (a) Campbell places greater emphasis than Rubin on the special role of pretest measures of outcome among matching variables; (b) Campbell is more explicitly concerned with unreliability in the covariates; and (c) for analyzing the outcome, only Rubin emphasizes the advantages of using propensity score over regression methods. To explore how well these 3 factors reduce bias, we reanalyze and review within-study comparisons that contrast experimental and statistically adjusted nonexperimental causal estimates from studies with the same target population and treatment content. In this context, the choice of covariates counts most for reducing selection bias, and the pretest usually plays a special role relative to all the other covariates considered singly. Unreliability in the covariates also influences bias reduction but by less. Furthermore, propensity score and regression methods produce comparable degrees of bias reduction, though these within-study comparisons may not have met the theoretically specified conditions most likely to produce differences due to analytic method.

Lest we forget: Comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health

PubMed Central

Reuben, Aaron; Moffitt, Terrie E.; Caspi, Avshalom; Belsky, Daniel W.; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2017-01-01

Background Adverse childhood experiences (ACEs; e.g., abuse, neglect, parental loss, etc.) have been associated with increased risk for later-life disease and dysfunction using adults’ retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. Methods We estimated agreement between ACEs prospectively-recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively-recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N=1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g., biomarkers and neuropsychological tests) and subjective (e.g., self-reported) means. Results Dunedin and CDC ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r=.47, p<.001; weighted Kappa = .31, 95% CI: .27–.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively-recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Conclusions Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may respectively bias retrospective ACE measures toward underestimating the impact of adversity on objectively-measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. PMID:27647050

Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: Systematic review and consensus recommendations

PubMed Central

Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O’Brien, John T.; Mountain, Gail; Woods, Bob; Perneczky, Robert; McCleery, Jenny; Pickett, James; Challis, David; Charlesworth, Georgina; Featherstone, Katie; Jones, Roy; Schneider, Justine; Shepperd, Sasha; Thompson-Coon, Jo; Ballard, Clive; Burns, Alistair; Garrard, Peter; Kehoe, Patrick; Passmore, Peter; Robinson, Louise

2017-01-01

Background There are no disease-modifying treatments for dementia. There is also no consensus on disease modifying outcomes. We aimed to produce the first evidence-based consensus on core outcome measures for trials of disease modification in mild-to-moderate dementia. Methods and findings We defined disease-modification interventions as those aiming to change the underlying pathology. We systematically searched electronic databases and previous systematic reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate dementia. We included 149/22,918 of the references found; with 81 outcome measures from 125 trials. Trials involved participants with Alzheimer’s disease (AD) alone (n = 111), or AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric symptoms, quality of life, global). We calculated the number of trials and of participants using each outcome. We detailed psychometric properties of each outcome. We sought the views of people living with dementia and family carers in three cities through Alzheimer’s society focus groups. Attendees at a consensus conference (experts in dementia research, disease-modification and harmonisation measures) decided on the core set of outcomes using these results. Recommended core outcomes were cognition as the fundamental deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition should be measured by Mini Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made recommendations for measuring important, but non-core domains which may not change despite disease modification. Limitations Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties. Interpretation This is the first review to identify the 81 outcome measures the research community uses for disease-modifying trials in mild-to-moderate dementia. Our recommendations will facilitate designing, comparing and meta-analysing disease modification trials in mild-to-moderate dementia, increasing their value. Trial registration PROSPERO no. CRD42015027346. PMID:28662127

Assessing and improving health in the workplace: an integration of subjective and objective measures with the STress Assessment and Research Toolkit (St.A.R.T.) method

PubMed Central

2012-01-01

Background The aim of this work was to introduce a new combined method of subjective and objective measures to assess psychosocial risk factors at work and improve workers’ health and well-being. In the literature most of the research on work-related stress focuses on self-report measures and this work represents the first methodology capable of integrating different sources of data. Method An integrated method entitled St.A.R.T. (STress Assessment and Research Toolkit) was used in order to assess psychosocial risk factors and two health outcomes. In particular, a self-report questionnaire combined with an observational structured checklist was administered to 113 workers from an Italian retail company. Results The data showed a correlation between subjective data and the rating data of the observational checklist for the psychosocial risk factors related to work contexts such as customer relationship management and customer queue. Conversely, the factors related to work content (workload and boredom) measured with different methods (subjective vs. objective) showed a discrepancy. Furthermore, subjective measures of psychosocial risk factors were more predictive of workers’ psychological health and exhaustion than rating data. The different objective measures played different roles, however, in terms of their influence on the two health outcomes considered. Conclusions It is important to integrate self-related assessment of stressors with objective measures for a better understanding of workers’ conditions in the workplace. The method presented could be considered a useful methodology for combining the two measures and differentiating the impact of different psychological risk factors related to work content and context on workers’ health. PMID:22995286

Towards quantifying the aesthetic outcomes of breast cancer treatment: comparison of clinical photography and colorimetry.

PubMed

Kim, Min Soon; Rodney, William N; Cooper, Tara; Kite, Chris; Reece, Gregory P; Markey, Mia K

2009-02-01

Scarring is a significant cause of dissatisfaction for women who undergo breast surgery. Scar tissue may be clinically distinguished from normal skin by aberrant colour, rough surface texture, increased thickness (hypertrophy) and firmness. Colorimeters or spectrophotometers can be used to quantitatively assess scar colour, but they require direct patient interaction and can cost thousands of dollars. By comparison, digital photography is already in widespread use to document clinical outcomes and requires less patient interaction. Thus, assessment of scar coloration by digital photography is an attractive alternative. The goal of this study was to compare colour measurements obtained by digital photography and colorimetry. Agreements between photographic and colorimetric measurements of colour were evaluated. Experimental conditions were controlled by performing measurements on artificial scars created by a make-up artist. The colorimetric measurements of the artificial scars were compared with those reported in the literature for real scars in order to confirm the validity of this approach. We assessed the agreement between the colorimetric and photographic measurements of colour using a hypothesis test for equivalence, the intraclass correlation coefficient and the Bland-Altman method. Overall, good agreement was obtained for three parameters (L*a*b*) measured by colorimetry and photography from the results of three statistical analyses. Colour measurements obtained by digital photography were equivalent to those obtained using colorimetry. Thus, digital photography is a reliable, cost-effective measurement method of skin colour and should be further investigated for quantitative analysis of surgical outcomes.

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.

Corruption costs lives: evidence from a cross-country study.

PubMed

Li, Qiang; An, Lian; Xu, Jing; Baliamoune-Lutz, Mina

2018-01-01

This paper investigates the effect of corruption on health outcomes by using cross-country panel data covering about 150 countries for the period of 1995 to 2012. We employ ordinary least squares (OLS), fixed-effects and two-stage least squares (2SLS) estimation methods, and find that corruption significantly increases mortality rates, and reduces life expectancy and immunization rates. The results are consistent across different regions, gender, and measures of corruption. The findings suggest that reducing corruption can be an effective method to improve health outcomes.

Teacher, parent, and peer reports of early aggression as screening measures for long-term maladaptive outcomes: Who provides the most useful information?

PubMed Central

Clemans, Katherine H.; Musci, Rashelle J.; Leoutsakos, Jeannie-Marie S.; Ialongo, Nicholas S.

2014-01-01

Objective This study compared the ability of teacher, parent, and peer reports of aggressive behavior in early childhood to accurately classify cases of maladaptive outcomes in late adolescence and early adulthood. Method Weighted kappa analyses determined optimal cut points and relative classification accuracy among teacher, parent, and peer reports of aggression assessed for 691 students (54% male; 84% African American, 13% White) in the fall of first grade. Outcomes included antisocial personality, substance use, incarceration history, risky sexual behavior, and failure to graduate from high school on time. Results Peer reports were the most accurate classifier of all outcomes in the full sample. For most outcomes, the addition of teacher or parent reports did not improve overall classification accuracy once peer reports were accounted for. Additional gender-specific and adjusted kappa analyses supported the superior classification utility of the peer report measure. Conclusion The results suggest that peer reports provided the most useful classification information of the three aggression measures. Implications for targeted intervention efforts which use screening measures to identify at-risk children are discussed. PMID:24512126

Protocol for developing, disseminating and implementing a core outcome set for endometriosis.

PubMed

Hirsch, Martin; Duffy, James M N; Barker, Claire; Hummelshoj, Lone; Johnson, Neil P; Mol, Ben; Khan, Khalid S; Farquhar, Cindy

2016-12-21

Endometriosis is a common gynaecological disease characterised by pain and subfertility. Randomised controlled trials evaluating treatments for endometriosis have reported many different outcomes and outcome measures. This variation restricts effective data synthesis limiting the usefulness of research to inform clinical practice. To address these methodological concerns, we aim to develop, disseminate and implement a core outcome set for endometriosis engaging with key stakeholders, including healthcare professionals, researchers and women with endometriosis. An international steering group has been established, including healthcare professionals, researchers and patient representatives. Potential outcomes identified from a systematic review of the literature will be entered into a modified Delphi method. Key stakeholders will be invited to participate including healthcare professionals, researchers and women with endometriosis. Participants will be invited to score individual outcomes on a nine-point Likert scale anchored between 1 (not important) and 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group converge towards consensus, 'core', outcomes. High-quality outcome measures will be associated with core outcomes. The implementation of a core outcome set for endometriosis within future clinical trials, systematic reviews and clinical guidelines will enhance the availability of comparable data to facilitate evidence-based patient care. This study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number: 691. 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/.

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.

Developing core outcome sets for clinical trials: issues to consider

PubMed Central

2012-01-01

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

Longitudinal data subject to irregular observation: A review of methods with a focus on visit processes, assumptions, and study design.

PubMed

Pullenayegum, Eleanor M; Lim, Lily Sh

2016-12-01

When data are collected longitudinally, measurement times often vary among patients. This is of particular concern in clinic-based studies, for example retrospective chart reviews. Here, typically no two patients will share the same set of measurement times and moreover, it is likely that the timing of the measurements is associated with disease course; for example, patients may visit more often when unwell. While there are statistical methods that can help overcome the resulting bias, these make assumptions about the nature of the dependence between visit times and outcome processes, and the assumptions differ across methods. The purpose of this paper is to review the methods available with a particular focus on how the assumptions made line up with visit processes encountered in practice. Through this we show that no one method can handle all plausible visit scenarios and suggest that careful analysis of the visit process should inform the choice of analytic method for the outcomes. Moreover, there are some commonly encountered visit scenarios that are not handled well by any method, and we make recommendations with regard to study design that would minimize the chances of these problematic visit scenarios arising. © The Author(s) 2014.

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.

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Chiren, Sarah G; Godinez-Puig, Victoria; Chen, Brian R; Kurta, Anastasia O; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Cartee, Todd V; Maher, Ian A; Alam, Murad; Sobanko, Joseph F

2017-07-12

Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

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.

Multihop teleportation of two-qubit state via the composite GHZ-Bell channel

NASA Astrophysics Data System (ADS)

Zou, Zhen-Zhen; Yu, Xu-Tao; Gong, Yan-Xiao; Zhang, Zai-Chen

2017-01-01

A multihop teleportation protocol in quantum communication network is introduced to teleport an arbitrary two-qubit state, between two nodes without directly sharing entanglement pairs. Quantum channels are built among neighbor nodes based on a five-qubit entangled system composed of GHZ and Bell pairs. The von Neumann measurements in all intermediate nodes and the source node are implemented, and then the measurement outcomes are sent to the destination node independently. After collecting all the measurement outcomes at the destination node, an efficient method is proposed to calculate the unitary operations for transforming the receiver's states to the state teleported. Therefore, only adopting the proper unitary operations at the destination node, the desired quantum state can be recovered perfectly. The transmission flexibility and efficiency of quantum network with composite GHZ-Bell channel are improved by transmitting measurement outcomes of all nodes in parallelism and reducing hop-by-hop teleportation delay.

Analysis of Longitudinal Studies With Repeated Outcome Measures: Adjusting for Time-Dependent Confounding Using Conventional Methods.

PubMed

Keogh, Ruth H; Daniel, Rhian M; VanderWeele, Tyler J; Vansteelandt, Stijn

2018-05-01

Estimation of causal effects of time-varying exposures using longitudinal data is a common problem in epidemiology. When there are time-varying confounders, which may include past outcomes, affected by prior exposure, standard regression methods can lead to bias. Methods such as inverse probability weighted estimation of marginal structural models have been developed to address this problem. However, in this paper we show how standard regression methods can be used, even in the presence of time-dependent confounding, to estimate the total effect of an exposure on a subsequent outcome by controlling appropriately for prior exposures, outcomes, and time-varying covariates. We refer to the resulting estimation approach as sequential conditional mean models (SCMMs), which can be fitted using generalized estimating equations. We outline this approach and describe how including propensity score adjustment is advantageous. We compare the causal effects being estimated using SCMMs and marginal structural models, and we compare the two approaches using simulations. SCMMs enable more precise inferences, with greater robustness against model misspecification via propensity score adjustment, and easily accommodate continuous exposures and interactions. A new test for direct effects of past exposures on a subsequent outcome is described.

Measuring Outcome in the Treatment of Cocaine Dependence

PubMed Central

Crits-Christoph, Paul; Gallop, Robert; Gibbons, Mary Beth Connolly; Sadicario, Jaclyn S.; Woody, George

2015-01-01

Background Little in known about the extent to which outcome measures used in studies of the treatment of cocaine dependence are associated with longer-term use and with broader measures of clinical improvement. The current study examined reductions in use, and abstinence-oriented measures, in relation to functioning and longer-term clinical benefits in the treatment of cocaine dependence. Methods Overall drug use, cocaine use, and functioning in a number of addiction-related domains for 487 patients diagnosed with DSM-IV cocaine dependence and treated with one of four psychosocial interventions in the NIDA Cocaine Collaborative Treatment Study were assessed monthly during 6 months of treatment and at 9, 12, 15, and 18 month follow-up. Results Measures of during-treatment reduction in use were moderately correlated with drug and cocaine use measures 12 months, but showed non-significant or small correlations with measures of functioning at 12 months. Highest correlations were evident for abstinence measures (maximum consecutive days abstinence and completely abstinent) during treatment in relation to sustained (3 month) abstinence at 12 months. Latent class analysis of patterns of change over time revealed that most patients initially (months 1 to 4 of treatment) either became abstinent immediately or continued to use every month. Over the couse of follow-up, patients either maintained abstinence or used regularly – intermittent use was less common. Conclusions There were generally small associations between various measures of cocaine use and longer-term clinical benefits, other than abstinence was associated with continued abstinence. No one method of measuring outcome of treatment of cocaine dependence appears superior to others. PMID:26366427

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)

Development of a Measure to Assess the Impact of Epilepsy on People with an Intellectual Disability: The Glasgow Epilepsy Outcome Scale-Client Version (GEOS-C)

ERIC Educational Resources Information Center

Watkins, J.; Espie, C. A.; Curtice, L.; Mantala, K.; Corp, A.; Foley, J.

2006-01-01

Background: Epilepsy is common in people with intellectual disability, yet clinicians and researchers seldom obtain information directly from the client. The development and preliminary validation of a novel measure for use with people with mild to moderate intellectual disabilities is described. Methods: Focus group methods (6 groups; 24…

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

Public reporting of cost and quality information in orthopaedics.

PubMed

Marjoua, Youssra; Butler, Craig A; Bozic, Kevin J

2012-04-01

Public reporting of patient health outcomes offers the potential to incentivize quality improvement by fostering increased accountability among providers. Voluntary reporting of risk-adjusted outcomes in cardiac surgery, for example, is viewed as a "watershed event" in healthcare accountability. However, public reporting of outcomes, cost, and quality information in orthopaedic surgery remains limited by comparison, attributable in part to the lack of standard assessment methods and metrics, provider fear of inadequate adjustment of health outcomes for patient characteristics (risk adjustment), and historically weak market demand for this type of information. We review the origins of public reporting of outcomes in surgical care, identify existing initiatives specific to orthopaedics, outline the challenges and opportunities, and propose recommendations for public reporting of orthopaedic outcomes. We performed a comprehensive review of the literature through a bibliographic search of MEDLINE and Google Scholar databases from January 1990 to December 2010 to identify articles related to public reporting of surgical outcomes. Orthopaedic-specific quality reporting efforts include the early FDA adverse event reporting MedWatch program and the involvement of surgeons in the Physician Quality Reporting Initiative. Issues that require more work include balancing different stakeholder perspectives on quality reporting measures and methods, defining accountability and attribution for outcomes, and appropriately risk-adjusting outcomes. Given the current limitations associated with public reporting of quality and cost in orthopaedic surgery, valuable contributions can be made in developing specialty-specific evidence-based performance measures. We believe through leadership and involvement in policy formulation and development, orthopaedic surgeons are best equipped to accurately and comprehensively inform the quality reporting process and its application to improve the delivery and outcomes of orthopaedic care.

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).

The interdependence of behavioral and somatic health: implications for conceptualizing health and measuring treatment outcomes

PubMed Central

LaBrie, Richard A.; LaPlante, Debi A.; Peller, Allyson J.; Christensen, Donald E.; Greenwood, Kristina L.; Straus, John H.; Garmon, Michael S.; Browne, Cheryl; Shaffer, Howard J.

2007-01-01

Purpose The interdependence of behavioral and somatic aspects of various health conditions warrants greater emphasis on an integrated care approach. Theory We propose that integrated approaches to health and wellness require comprehensive and empirically-valid outcome measures to assess quality of care. Method We discuss the transition from independent to integrated treatment approaches and provide examples of new systems for integrated assessment of treatment outcome. Results Evidence suggests that support for an independent treatment approach is waning and momentum is building towards more integrated care. In addition, research evidence suggests integrated care improves health outcomes, and both physicians and patients have favorable impressions of integrated care. Conclusions As treatment goals in the integrated perspective expand to take into account the intimate relationships among mental illness, overall health, and quality of life, clinicians need to develop outcome measures that are similarly comprehensive. Discussion Increased recognition, by researchers, providers, and insurers, of the interdependence between behavioral and physical health holds great promise for innovative treatments that could significantly improve patients' lives. PMID:17627294

Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

PubMed

Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z; Bernhardt, Barbara A; Biesecker, Barbara B; Christensen, Kurt D; Joffe, Steven; Rini, Christine; Veenstra, David; McGuire, Amy L

2014-10-01

The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study

PubMed Central

Scheiman, Mitchell; Talasan, Henry; Mitchell, Gladys L; Alvarez, Tara L.

2016-01-01

Purpose To evaluate changes in objective measures of disparity vergence after office-based vision therapy (OBVT) for concussion-related convergence insufficiency (CI), and determine the feasibility of using this objective assessment as an outcome measure in a clinical trial. Methods This was a prospective, observational trial. All participants were treated with weekly OBVT with home reinforcement. Participants included two adolescents and three young adults with concussion-related, symptomatic CI. The primary outcome measure was average peak velocity for 4-degree symmetrical convergence steps. Other objective outcome measures of disparity vergence included time to peak velocity, latency, accuracy, settling time, and main sequence. We also evaluated saccadic eye movements using the same outcome measures. Changes in clinical measures (near point of convergence, positive fusional vergence at near, Convergence Insufficiency Symptom Survey (CISS) score) were evaluated. Results There were statistically significant and clinically meaningful changes in all clinical measures for convergence. Four of the five subjects met clinical success criteria. For the objective measures, we found a statistically significant increase in peak velocity, response accuracy to 4° symmetrical convergence and divergence step stimuli and the main sequence ratio for convergence step stimuli. Objective saccadic eye movements (5° and 10°) appeared normal pre-OBVT, and did not show any significant change after treatment. Conclusions This is the first report of the use of objective measures of disparity vergence as outcome measures for concussion-related convergence insufficiency. These measures provide additional information that is not accessible with clinical tests about underlying physiological mechanisms leading to changes in clinical findings and symptoms. The study results also demonstrate that patients with concussion can tolerate the visual demands (over 200 vergence and versional eye movements) during the 25-minute testing time and suggest that these measures could be used in a large-scale randomized clinical trial of concussion-related CI as outcome measures. PMID:27464574

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper

PubMed Central

Van de Heyning, Paul; Távora-Vieira, Dayse; Mertens, Griet; Van Rompaey, Vincent; Rajan, Gunesh P.; Müller, Joachim; Hempel, John Martin; Leander, Daniel; Polterauer, Daniel; Marx, Mathieu; Usami, Shin-ichi; Kitoh, Ryosuke; Miyagawa, Maiko; Moteki, Hideaki; Smilsky, Kari; Baumgartner, Wolf-Dieter; Keintzel, Thomas Georg; Sprinzl, Georg Mathias; Wolf-Magele, Astrid; Arndt, Susan; Wesarg, Thomas; Zirn, Stefan; Baumann, Uwe; Weissgerber, Tobias; Rader, Tobias; Hagen, Rudolf; Kurz, Anja; Rak, Kristen; Stokroos, Robert; George, Erwin; Polo, Ruben; Medina, María del Mar; Henkin, Yael; Hilly, Ohad; Ulanovski, David; Rajeswaran, Ranjith; Kameswaran, Mohan; Di Gregorio, Maria Fernanda; Zernotti, Mario E.

2017-01-01

Background While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL. Methods This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada. Results A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable. Conclusion A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. PMID:28319951

Evaluating the use of gas discharge visualization to measure massage therapy outcomes

PubMed Central

Haun, Jolie; Patel, Nitin; Schwartz, Gary; Ritenbaugh, Cheryl

2017-01-01

Background The purpose of this study was to evaluate the short-term effects of massage therapy using gas discharge visualization (GDV), a computerized biophysical electrophoton capture (EPC), in tandem with traditional self-report measures to evaluate the use of GDV measurement to assess the bioenergetic whole-person effects of massage therapy. Methods This study used a single treatment group, pre–post-repeated measures design with a sample of 23 healthy adults. This study utilized a single 50-min full-body relaxation massage with participants. GDV measurement method, an EPC, and traditional paper-based measures evaluating pain, stress, muscle tension, and well-being were used to assess intervention outcomes. Results Significant differences were found between pre- and post-measures of well-being, pain, stress, muscle tension, and GDV parameters. Pearson correlations indicate the GDV measure is correlated with pain and stress, variables that impact the whole person. Conclusions This study demonstrates that GDV parameters may be used to indicate significant bioenergetic change from pre- to post-massage. Findings warrant further investigation with a larger diverse sample size and control group to further explore GDV as a measure of whole-person bioenergetic effects associated with massage. PMID:26087069

Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome

PubMed Central

Schoenfeld, David A.; Brown, Samuel M.; Hough, Catherine L.; Yealy, Donald M.; Moss, Marc; Angus, Derek C.; Iwashyna, Theodore J.

2017-01-01

Rationale: After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT’s power to measure significant differences in these outcomes is poorly understood. Objectives: Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. Methods: We derived a general formula and Stata code for calculating an RCT’s power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress–like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT (www.clinicaltrials.gov identifier NCT02509078). Measurements and Main Results: On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Conclusions: Examining instruments’ power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities. PMID:27788018

Variations in the Quality of Care at Large Public Hospitals in Beijing, China: A Condition-Based Outcome Approach

PubMed Central

Xu, Ye; Liu, Yuanli; Shu, Ting; Yang, Wei; Liang, Minghui

2015-01-01

Background Public hospitals deliver over ninety percent of all outpatient and inpatient services in China. Their quality is graded into three levels (A, B, and C) largely based on structural resources, but empirical evidence on the quality of process and outcome of care is extremely scarce. As expectations for quality care rise with higher living standards and cost of care, such evidence is urgently needed and vital to improve care and to inform future health reforms. Methods We compiled and analyzed a multicenter database of over 4 million inpatient discharge summary records to provide a comprehensive assessment of the level and variations in clinical outcomes of hospitalization at 39 tertiary hospitals in Beijing. We assessed six outcome measures of clinical quality: in-hospital mortality rates (RSMR) for AMI, stroke, pneumonia and CABG, post-procedural complication rate (RS-CR), and failure-to-rescue rate (RS-FTR). The measures were adjusted for pre-admission patient case-mix using indirect standardization method with hierarchical linear mixed models. Results We found good overall quality with large variations by hospital and condition (mean/range, in %): RSMR-AMI: 6.23 (2.37–14.48), RSMR-stroke: 4.18 (3.58–4.44), RSMR-pneumonia: 7.78 (7.20–8.59), RSMR-CABG: 1.93 (1.55–2.23), RS-CR: 11.38 (9.9–12.88), and RS-FTR: 6.41 (5.17–7.58). Hospital grade was not significantly associated with any risk-adjusted outcome measures. Conclusions Going to a higher grade public hospital does not always lead to better patient outcome because hospital grade only contains information about hospital structural resources. A hospital report card with some outcome measures of quality would provide valuable information to patients in choosing providers, and for regulators to identify gaps in health care quality. Reducing the variations in clinical practice and patient outcome should be a focus for policy makers in the next round of health sector reforms in China. PMID:26430748

Music Appreciation after Cochlear Implantation in Adult Patients: A Systematic Review.

PubMed

Riley, Phoebe E; Ruhl, Douglas S; Camacho, Macario; Tolisano, Anthony M

2018-06-01

Objective The cochlear implant (CI) improves quality of life for people who are severely and profoundly deafened, allowing implantees to perceive speech at levels similar to those of individuals with normal hearing. However, patients with CIs generally report a reduced appreciation of music after implantation. We aimed to systematically review the English-language literature for studies evaluating music enjoyment and perception among adult patients with CIs. Data Sources A systematic review of PubMed/MEDLINE, Scopus, Embase, and the Cochrane Library. Review Methods The PRISMA statement was utilized to identify English-language studies reporting music appreciation among adults with CIs. Two independent reviewers performed searches through May 2017. Included studies investigated parameters related to music enjoyment and music perception, including (1) pitch and timbre perception, (2) noise-canceling algorithms, and (3) the presence of dissonant chords, lyrics, or visual cues. Results A total of 508 articles were screened for relevance. Forty-one full-text articles were evaluated, and 18 met final inclusion criteria. Studies used heterogeneous methods of outcome measurement for identifying music appreciation. The outcome measures suggest that rhythm and lyrics are important components of enjoyment. Patients with CIs had difficulty with pitch and timbre perception. Conclusion The heterogeneous outcome measures identified in this systematic review suggest that rhythm and lyrics are important components of enjoyment, while patients with CIs had difficulty with pitch and timbre perception. Because there is no standardized reporting metric for music appreciation among adult patients with CIs, a standardized validated outcome-measuring tool is warranted.

The use of qualitative methods in developing the descriptive systems of preference-based measures of health-related quality of life for use in economic evaluation.

PubMed

Stevens, Katherine; Palfreyman, Simon

2012-12-01

To describe how qualitative methods can be used in the development of descriptive systems of preference-based measures (PBMs) of health-related quality of life. The requirements of the National Institute for Health and Clinical Excellence and other agencies together with the increasing use of patient-reported outcome measures has led to an increase in the demand for PBMs. Recently, interest has grown in developing new PBMs and while previous research on PBMs has mainly focused on the methods of valuation, research into the methods of developing descriptive systems is an emerging field. Traditionally, descriptive systems of PBMs were developed by using top-down methods, where content was derived from existing measures, the literature, or health surveys. A contrasting approach is a bottom-up methodology, which takes the views of patients or laypeople on how their life is affected by their health. This approach generally requires the use of qualitative methods. Qualitative methods lend themselves well to the development of PBMs. They also ensure that the measure has appropriate language, content validity, and responsiveness to change. While the use of qualitative methods in the development of non-PBMs is fairly standard, their use in developing PBMs was until recently nonexistent. In this article, we illustrate the use of qualitative methods by presenting two case studies of recently developed PBMs, one generic and one condition specific. We outline the stages involved, discuss the strengths and weaknesses of the approach, and compare with the top-down approach used in the majority of PBMs to date. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Using qualitative and quantitative methods to evaluate small-scale disease management pilot programs.

PubMed

Esposito, Dominick; Taylor, Erin Fries; Gold, Marsha

2009-02-01

Interest in disease management programs continues to grow as managed care plans, the federal and state governments, and other organizations consider such efforts as a means to improve health care quality and reduce costs. These efforts vary in size, scope, and target population. While large-scale programs provide the means to measure impacts, evaluation of smaller interventions remains valuable as they often represent the early planning stages of larger initiatives. This paper describes a multi-method approach for evaluating small interventions that sought to improve the quality of care for Medicaid beneficiaries with multiple chronic conditions. Our approach relied on quantitative and qualitative methods to develop a complete understanding of each intervention. Quantitative data in the form of both process measures, such as case manager contacts, and outcome measures, such as hospital use, were reported and analyzed. Qualitative information was collected through interviews and the development of logic models to document the flow of intervention activities and how they were intended to affect outcomes. The logic models helped us to understand the underlying reasons for the success or lack thereof of each intervention. The analysis provides useful information on several fronts. First, qualitative data provided valuable information about implementation. Second, process measures helped determine whether implementation occurred as anticipated. Third, outcome measures indicated the potential for favorable results later, possibly suggesting further study. Finally, the evaluation of qualitative and quantitative data in combination helped us assess the potential promise of each intervention and identify common themes and challenges across all interventions.

Evaluating Change Processes: Assessing Extent of Implementation (Constructs, Methods and Implications)

ERIC Educational Resources Information Center

Hall, Gene E.

2013-01-01

Purpose: In far too many cases the initiatives to change schools by introducing new programs, processes and reforms has not resulted in obtainment of the desired outcomes. A major reason for limited outcomes suggested in this paper is that there has been a failure to learn from and apply constructs and measures related to understanding,…

Strengthening Families with First-Born Children: Exploratory Story of the Outcomes of a Home Visiting Intervention

ERIC Educational Resources Information Center

de la Rosa, Ivan A.; Perry, Joanne; Dalton, Lisa E.; Johnson, Victoria

2005-01-01

Objective: Using a theory of change framework, this study examines outcome measures of a home visitation program that provided services to first-born children and their parents living in southwestern New Mexico. Method: Home visitation workers conducted pretest and posttest assessments for prenatal and postpartum periods for 109 families receiving…

Personality, Cognitive Skills and Life Outcomes: Evidence from the Polish Follow-Up Study to PIAAC

ERIC Educational Resources Information Center

Palczynska, Marta; Swist, Karolina

2018-01-01

Background: There is a growing literature providing evidence on the importance of non-cognitive skills for life outcomes. However, to date there is limited evidence on the gains from incorporating such measures into large-scale competence surveys. Methods: We investigate the relationship between personality traits and eight important life…

Relationship between Course Length and Graduate Student Outcome Measures

ERIC Educational Resources Information Center

Carman, Carol A.; Bartsch, Robert A.

2017-01-01

One method to increase flexibility in class offerings is through the use of compressed courses, classes that have the same number of contact hours but over a shorter time period (e.g., 8 weeks vs. 15 weeks). Before offering these courses, it is important to determine whether they lead to equivalent or better student outcomes. This study examined…

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,…

Early Postimplant Speech Perception and Language Skills Predict Long-Term Language and Neurocognitive Outcomes Following Pediatric Cochlear Implantation

ERIC Educational Resources Information Center

Hunter, Cynthia R.; Kronenberger, William G.; Castellanos, Irina; Pisoni, David B.

2017-01-01

Purpose: We sought to determine whether speech perception and language skills measured early after cochlear implantation in children who are deaf, and early postimplant growth in speech perception and language skills, predict long-term speech perception, language, and neurocognitive outcomes. Method: Thirty-six long-term users of cochlear…

Evaluating the Wider Outcomes of Schools: Complex Systems Modelling for Leadership Decisioning

ERIC Educational Resources Information Center

Crick, Ruth Deakin; Barr, Steven; Green, Howard; Pedder, David

2017-01-01

A continuing challenge for the education system is how to evaluate the wider outcomes of schools. Wider measures of success--such as citizenship or lifelong learning--influence each other and emerge over time from complex interactions between students, teachers and leaders, and the wider community. Unless methods are found to evaluate these…

Using Response Ratios for Meta-Analyzing Single-Case Designs with Behavioral Outcomes

ERIC Educational Resources Information Center

Pustejovsky, James E.

2018-01-01

Methods for meta-analyzing single-case designs (SCDs) are needed to inform evidence-based practice in clinical and school settings and to draw broader and more defensible generalizations in areas where SCDs comprise a large part of the research base. The most widely used outcomes in single-case research are measures of behavior collected using…

The "Ins" and "Outs" of Physical Activity Policy Implementation: Inadequate Capacity, Inappropriate Outcome Measures, and Insufficient Funds

ERIC Educational Resources Information Center

Howie, Erin K.; Stevick, E. Doyle

2014-01-01

Background: Despite broad public support and legislative activity, policies intended to promote physical activity in schools have not produced positive outcomes in levels of physical activity or student health. What explains the broad failure of Physical Activity Policies (PAPs)? Thus far, PAP research has used limited quantitative methods to…

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

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.

Monitoring risk-adjusted medical outcomes allowing for changes over time.

PubMed

Steiner, Stefan H; Mackay, R Jock

2014-10-01

We consider the problem of monitoring and comparing medical outcomes, such as surgical performance, over time. Performance is subject to change due to a variety of reasons including patient heterogeneity, learning, deteriorating skills due to aging, etc. For instance, we expect inexperienced surgeons to improve their skills with practice. We propose a graphical method to monitor surgical performance that incorporates risk adjustment to account for patient heterogeneity. The procedure gives more weight to recent outcomes and down-weights the influence of outcomes further in the past. The chart is clinically interpretable as it plots an estimate of the failure rate for a "standard" patient. The chart also includes a measure of uncertainty in this estimate. We can implement the method using historical data or start from scratch. As the monitoring proceeds, we can base the estimated failure rate on a known risk model or use the observed outcomes to update the risk model as time passes. We illustrate the proposed method with an example from cardiac surgery. © The Author 2013. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

How do aggregated patient-reported outcome measures data stimulate health care improvement? A realist synthesis

PubMed Central

Dalkin, Sonia; Gibbons, Elizabeth; Wright, Judy; Valderas, Jose Maria; Meads, David; Black, Nick

2017-01-01

Objectives Internationally, there has been considerable debate about the role of data in supporting quality improvement in health care. Our objective was to understand how, why and in what circumstances the feedback of aggregated patient-reported outcome measures data improved patient care. Methods We conducted a realist synthesis. We identified three main programme theories underlying the use of patient-reported outcome measures as a quality improvement strategy and expressed them as nine ‘if then’ propositions. We identified international evidence to test these propositions through searches of electronic databases and citation tracking, and supplemented our synthesis with evidence from similar forms of performance data. We synthesized this evidence through comparing the mechanisms and impact of patient-reported outcome measures and other performance data on quality improvement in different contexts. Results Three programme theories were identified: supporting patient choice, improving accountability and enabling providers to compare their performance with others. Relevant contextual factors were extent of public disclosure, use of financial incentives, perceived credibility of the data and the practicality of the results. Available evidence suggests that patients or their agents rarely use any published performance data when selecting a provider. The perceived motivation behind public reporting is an important determinant of how providers respond. When clinicians perceived that performance indicators were not credible but were incentivized to collect them, gaming or manipulation of data occurred. Outcome data do not provide information on the cause of poor care: providers needed to integrate and interpret patient-reported outcome measures and other outcome data in the context of other data. Lack of timeliness of performance data constrains their impact. Conclusions Although there is only limited research evidence to support some widely held theories of how aggregated patient-reported outcome measures data stimulate quality improvement, several lessons emerge from interventions sharing the same programme theories to help guide the increasing use of these measures. PMID:29260592

Breastfeeding Outcomes After Oxytocin Use During Childbirth: An Integrative Review.

PubMed

Erickson, Elise N; Emeis, Cathy L

2017-07-01

Despite widespread use of exogenous synthetic oxytocin during the birth process, few studies have examined the effect of this drug on breastfeeding. Based on neuroscience research, endogenous oxytocin may be altered or manipulated by exogenous administration or by blocking normal function of the hormone or receptor. Women commonly cite insufficient milk production as their reason for early supplementation, jeopardizing breastfeeding goals. Researchers need to consider the role of birth-related medications and interventions on the production of milk. This article examines the literature on the role of exogenous oxytocin on breastfeeding in humans. Using the method described by Whittemore and Knafl, this integrative review of literature included broad search criteria within the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane, and Scopus databases. Studies published in English associating a breastfeeding outcome in relation to oxytocin use during the birth process were included. Twenty-six studies from 1978 to 2015 met the criteria. Studies were analyzed according to the purpose of the research, measures and methods used, results, and confounding variables. The 26 studies reported 34 measures of breastfeeding. Outcomes included initiation and duration of breastfeeding, infant behavior, and physiologic markers of lactation. Timing of administration of oxytocin varied. Some studies reported on low-risk birth, while others included higher-risk experiences. Fifty percent of the results (17 of 34 measures) demonstrated an association between exogenous oxytocin and less optimal breastfeeding outcomes, while 8 of 34 measures (23%) reported no association. The remaining 9 measures (26%) had mixed findings. Breastfeeding intentions, parity, birth setting, obstetric risk, and indications for oxytocin use were inconsistently controlled among the studies. Research on breastfeeding and lactation following exogenous oxytocin exposure is limited by few studies and heterogeneous methods. Despite the limitations, researchers and clinicians may benefit from awareness of this body of literature. Continued investigation is recommended given the prevalence of oxytocin use in clinical practice. © 2017 by the American College of Nurse-Midwives.

EXPOSURE ASSESSMENT METHODS DEVELOPMENT PILOTS FOR THE NATIONAL CHILDREN'S STUDY

EPA Science Inventory

Accurate exposure classification tools are needed to link exposure with health effects. EPA began methods development pilot studies in 2000 to address general questions about exposures and outcome measures. Selected pilot studies are highlighted in this poster. The “Literature Re...

Advancing current approaches to disease management evaluation: capitalizing on heterogeneity to understand what works and for whom.

PubMed

Elissen, Arianne M J; Adams, John L; Spreeuwenberg, Marieke; Duimel-Peeters, Inge G P; Spreeuwenberg, Cor; Linden, Ariel; Vrijhoef, Hubertus J M

2013-03-14

Evaluating large-scale disease management interventions implemented in actual health care settings is a complex undertaking for which universally accepted methods do not exist. Fundamental issues, such as a lack of control patients and limited generalizability, hamper the use of the 'gold-standard' randomized controlled trial, while methodological shortcomings restrict the value of observational designs. Advancing methods for disease management evaluation in practice is pivotal to learn more about the impact of population-wide approaches. Methods must account for the presence of heterogeneity in effects, which necessitates a more granular assessment of outcomes. This paper introduces multilevel regression methods as valuable techniques to evaluate 'real-world' disease management approaches in a manner that produces meaningful findings for everyday practice. In a worked example, these methods are applied to retrospectively gathered routine health care data covering a cohort of 105,056 diabetes patients who receive disease management for type 2 diabetes mellitus in the Netherlands. Multivariable, multilevel regression models are fitted to identify trends in clinical outcomes and correct for differences in characteristics of patients (age, disease duration, health status, diabetes complications, smoking status) and the intervention (measurement frequency and range, length of follow-up). After a median one year follow-up, the Dutch disease management approach was associated with small average improvements in systolic blood pressure and low-density lipoprotein, while a slight deterioration occurred in glycated hemoglobin. Differential findings suggest that patients with poorly controlled diabetes tend to benefit most from disease management in terms of improved clinical measures. Additionally, a greater measurement frequency was associated with better outcomes, while longer length of follow-up was accompanied by less positive results. Despite concerted efforts to adjust for potential sources of confounding and bias, there ultimately are limits to the validity and reliability of findings from uncontrolled research based on routine intervention data. While our findings are supported by previous randomized research in other settings, the trends in outcome measures presented here may have alternative explanations. Further practice-based research, perhaps using historical data to retrospectively construct a control group, is necessary to confirm results and learn more about the impact of population-wide disease management.

Characterizing smoking topography of cannabis in heavy users

PubMed Central

Stitzer, Maxine L.; Vandrey, Ryan

2013-01-01

Rationale Little is known about the smoking topography characteristics of heavy cannabis users. Such measures may be able to predict cannabis use-related outcomes and could be used to validate self-reported measures of cannabis use. Objectives The current study was conducted to measure cannabis smoking topography characteristics during periods of ad libitum use and to correlate topography assessments with measures of self-reported cannabis use, withdrawal and craving during abstinence, and cognitive task performance. Methods Participants (N=20) completed an inpatient study in which they alternated between periods of ad libitum cannabis use and abstinence. Measures of self-reported cannabis use, smoking topography, craving, withdrawal, and sleep measures were collected. Results Participants smoked with greater intensity (e.g., greater volume, longer duration) on initial cigarette puffs with a steady decline on subsequent puffs. Smoking characteristics were significantly correlated with severity of withdrawal, notably sleep quality and architecture, and craving during abstinence, suggesting dose-related effects of cannabis use on these outcomes. Smoking characteristics generally were not significantly associated with cognitive performance. Smoking topography measures were significantly correlated with self-reported measures of cannabis use, indicating validity of these assessments, but topography measures were more sensitive than self-report in predicting cannabis-related outcomes. Conclusions A dose–effect relationship between cannabis consumption and outcomes believed to be clinically important was observed. With additional research, smoking topography assessments may become a useful clinical tool. PMID:21922170

Historical perspective: The pros and cons of conventional outcome measures in Parkinson's disease.

PubMed

Lim, Shen-Yang; Tan, Ai Huey

2018-01-01

Conventional outcome measures (COMs) in Parkinson's disease (PD) refer to rating scales, questionnaires, patient diaries and clinically-based tests that do not require specialized equipment. It is timely at this juncture - as clinicians and researchers begin to grapple with the "invasion" of digital technologies - to review the strengths and weaknesses of these outcome measures. This paper discusses advances (including an enhanced understanding of PD itself, and the development of clinimetrics as a field) that have led to improvements in the COMs used in PD; their strengths and limitations; and factors to consider when selecting and using a measuring instrument. It is envisaged that in the future, a combination of COMs and technology-based objective measures will be utilized, with different methods having their own strengths and weaknesses. Judgement is required on the part of the clinician and researcher in terms of which instrument(s) are appropriate to use, depending on the particular clinical or research setting or question. Copyright © 2017 Elsevier Ltd. All rights reserved.

Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures.

PubMed

Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A; Tugwell, Peter S; Guillemin, Francis

2015-12-01

The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

Risk Factors for Physical Impairment after Acute Lung Injury in a National, Multicenter Study

PubMed Central

Wozniak, Amy W.; Hough, Catherine L.; Morris, Peter E.; Dinglas, Victor D.; Jackson, James C.; Mendez-Tellez, Pedro A.; Shanholtz, Carl; Ely, E. Wesley; Colantuoni, Elizabeth

2014-01-01

Rationale: Existing studies of risk factors for physical impairments in acute lung injury (ALI) survivors were potentially limited by single-center design or relatively small sample size. Objectives: To evaluate risk factors for three measures of physical impairments commonly experienced by survivors of ALI in the first year after hospitalization. Methods: A prospective, longitudinal study of 6- and 12-month physical outcomes (muscle strength, 6-minute-walk distance, and Short Form [SF]-36 Physical Function score) for 203 survivors of ALI enrolled from 12 hospitals participating in the ARDS Network randomized trials. Multivariable regression analyses evaluated the independent association of critical illness–related variables and intensive care interventions with impairments in each physical outcome measure, after adjusting for patient demographics, comorbidities, and baseline functional status. Measurements and Main Results: At 6 and 12 months, respectively, mean (± SD) values for strength (presented as proportion of maximum strength score evaluated using manual muscle testing) was 92% (± 8%) and 93% (± 9%), 6-minute-walk distance (as percent-predicted) was 64% (± 22%) and 67% (± 26%), and SF-36 Physical Function score (as percent-predicted) was 61% (± 36%) and 67% (± 37%). After accounting for patient baseline status, there was significant association and statistical interaction of mean daily dose of corticosteroids and intensive care unit length of stay with impairments in physical outcomes. Conclusions: Patients had substantial impairments, from predicted values, for 6-minute-walk distance and SF-36 Physical Function outcome measures. Minimizing corticosteroid dose and implementing existing evidence-based methods to reduce duration of intensive care unit stay and associated patient immobilization may be important interventions for improving ALI survivors’ physical outcomes. PMID:24716641

Intelligibility as a clinical outcome measure following intervention with children with phonologically based speech-sound disorders.

PubMed

Lousada, M; Jesus, Luis M T; Hall, A; Joffe, V

2014-01-01

The effectiveness of two treatment approaches (phonological therapy and articulation therapy) for treatment of 14 children, aged 4;0-6;7 years, with phonologically based speech-sound disorder (SSD) has been previously analysed with severity outcome measures (percentage of consonants correct score, percentage occurrence of phonological processes and phonetic inventory). Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility, it is curious that intervention studies focusing on children's phonology do not routinely use intelligibility as an outcome measure. It is therefore important that the impact of interventions on speech intelligibility is explored. This paper investigates the effectiveness of the two treatment approaches (phonological therapy and articulation therapy) using intelligibility measures, both in single words and in continuous speech, as the primary outcome. Fourteen children with phonologically based SSD participated in the intervention. The children were randomly assigned to phonological therapy or articulation therapy (seven children in each group). Two assessment methods were used for measuring intelligibility: a word identification task (for single words) and a rating scale (for continuous speech). Twenty-one unfamiliar adults listened and judged the children's intelligibility. Reliability analyses showed overall high agreement between listeners across both methods. Significant improvements were noted in intelligibility in both single words (paired t(6)=4.409, p=0.005) and continuous speech (asymptotic Z=2.371, p=0.018) for the group receiving phonology therapy pre- to post-treatment, but no differences in intelligibility were found for those receiving the articulation therapy pre- to post-treatment, either for single words (paired t(6)=1.763, p=0.128) or continuous speech (asymptotic Z=1.442, p=0.149). Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group. These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions. This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD. © 2014 Royal College of Speech and Language Therapists.

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

Gap-Balancing versus Measured Resection Technique in Total Knee Arthroplasty: A Comparison Study.

PubMed

Churchill, Jessica L; Khlopas, Anton; Sultan, Assem A; Harwin, Steven F; Mont, Michael A

2018-01-01

Proper femoral component alignment in the axial plane during total knee arthroplasty (TKA) depends on accurate bone cuts and soft tissue balancing. Two methods that are used to achieve this are "measured resection" and "gap balancing." However, a controversy exists as to which method is more accurate and leads to better outcomes. Therefore, the purpose of this study was to evaluate: (1) implant survivorship, (2) patient outcomes, (3) complications, and (4) radiographic analysis comparing patients who underwent TKA with either gap-balancing or measured resection techniques. A total of 214 consecutive patients (221 knees) underwent primary TKA by a single surgeon between 2011 and 2012. Component alignment was achieved by using measured resection in 116 knees and gap balancing was used in 105 knees. The patients had a mean age of 66 years (range, 44-86 years) and a mean body mass index of 32 kg/m 2 (range, 22-52 kg/m 2 ). Patient range-of-motion (ROM) and Knee Society (KS) function and pain scores, and radiographic assessment, were assessed preoperatively and postoperatively at ∼6 weeks, 3 months, 1 year, and then annually. The mean follow-up time was 3 years. A Kaplan-Meier's analysis was performed to calculate the survivorship. The aseptic survivorship was 98% in both the measured resection and gap-balancing groups. The mean ROM was not significantly different between the measured resection and gap-balancing groups (123 vs. 123 degrees, p  = 0.990). There were no significant differences between the two groups in terms of the KS function scores (86 vs. 85 points, p  = 0.829) or the KS pain scores (93 vs. 92 points, p  = 0.425). Otherwise, the radiographic evaluation at latest follow-up did not demonstrate any evidence of progressive radiolucencies or loosening, of any prosthesis. The results of this study found that at a mean follow-up of 3 years, both the measured resection and gap-balancing techniques achieved excellent survivorship and postoperative outcomes. This demonstrates that both methods can be used to achieve accurate femoral component alignment with similar short-term outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

PubMed

Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

2013-06-01

To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Development of indicators for measuring outcomes of water safety plans

PubMed Central

Lockhart, Gabriella; Oswald, William E.; Hubbard, Brian; Medlin, Elizabeth; Gelting, Richard J.

2015-01-01

Water safety plans (WSPs) are endorsed by the World Health Organization as the most effective method of protecting a water supply. With the increase in WSPs worldwide, several valuable resources have been developed to assist practitioners in the implementation of WSPs, yet there is still a need for a practical and standardized method of evaluating WSP effectiveness. In 2012, the Centers for Disease Control and Prevention (CDC) published a conceptual framework for the evaluation of WSPs, presenting four key outcomes of the WSP process: institutional, operational, financial and policy change. In this paper, we seek to operationalize this conceptual framework by providing a set of simple and practical indicators for assessing WSP outcomes. Using CDC’s WSP framework as a foundation and incorporating various existing performance monitoring indicators for water utilities, we developed a set of approximately 25 indicators of institutional, operational, financial and policy change within the WSP context. These outcome indicators hold great potential for the continued implementation and expansion of WSPs worldwide. Having a defined framework for evaluating a WSP’s effectiveness, along with a set of measurable indicators by which to carry out that evaluation, will help implementers assess key WSP outcomes internally, as well as benchmark their progress against other WSPs in their region and globally. PMID:26361540

Facilitators and Barriers to Employment Among Veterans with Spinal Cord Injury Receiving 12 Months of Evidence-Based Supported Employment Services

PubMed Central

Njoh, Eni N.; Trainor, John K.; O’Connor, Danielle R.; Barnett, Scott D.; Ottomanelli, Lisa

2015-01-01

Background: Return to work is associated with positive rehabilitation outcomes for persons with spinal cord injury (SCI); however, more research is needed on vocational support for persons with disabilities seeking employment. Objective: The association between facilitators and barriers of employment and employment outcome was examined among Veterans with SCI who participated in an evidence-based supported employment (EBSE) program. Methods: Using a mixed-methods, nested case-control design, data on facilitators and barriers to employment were extracted from qualitative interviews and quantitative measures administered in person to 34 Veterans with SCI who completed 12 months of an EBSE program. Participants who did (case) and did not (control) obtain competitive employment were matched on time since SCI. Facilitators and barriers to employment were compared between the groups. Results: Self-report measures administered at baseline were examined; there were no statistically significant factors that predicted employment outcomes after 12 months of EBSE program participation. Qualitative interview data revealed program-specific facilitators and Veteran characteristics that were associated with employment outcomes. Conclusions: Qualitative data illustrate how the integration of the vocational rehabilitation specialist on the medical team is helpful for addressing identified disability-specific barriers, including practical matters such as transportation and caregiving schedules, to facilitate employment outcomes. PMID:25762857

Exploration of time-course combinations of outcome scales for use in a global test of stroke recovery.

PubMed

Goldie, Fraser C; Fulton, Rachael L; Dawson, Jesse; Bluhmki, Erich; Lees, Kennedy R

2014-08-01

Clinical trials for acute ischemic stroke treatment require large numbers of participants and are expensive to conduct. Methods that enhance statistical power are therefore desirable. We explored whether this can be achieved by a measure incorporating both early and late measures of outcome (e.g. seven-day NIH Stroke Scale combined with 90-day modified Rankin scale). We analyzed sensitivity to treatment effect, using proportional odds logistic regression for ordinal scales and generalized estimating equation method for global outcomes, with all analyses adjusted for baseline severity and age. We ran simulations to assess relations between sample size and power for ordinal scales and corresponding global outcomes. We used R version 2·12·1 (R Development Core Team. R Foundation for Statistical Computing, Vienna, Austria) for simulations and SAS 9·2 (SAS Institute Inc., Cary, NC, USA) for all other analyses. Each scale considered for combination was sensitive to treatment effect in isolation. The mRS90 and NIHSS90 had adjusted odds ratio of 1·56 and 1·62, respectively. Adjusted odds ratio for global outcomes of the combination of mRS90 with NIHSS7 and NIHSS90 with NIHSS7 were 1·69 and 1·73, respectively. The smallest sample sizes required to generate statistical power ≥80% for mRS90, NIHSS7, and global outcomes of mRS90 and NIHSS7 combined and NIHSS90 and NIHSS7 combined were 500, 490, 400, and 380, respectively. When data concerning both early and late outcomes are combined into a global measure, there is increased sensitivity to treatment effect compared with solitary ordinal scales. This delivers a 20% reduction in required sample size at 80% power. Combining early with late outcomes merits further consideration. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

A comparison of 2 cesarean section methods, modified Misgav-Ladach and Pfannenstiel-Kerr: A randomized controlled study.

PubMed

Şahin, Nur; Genc, Mine; Turan, Gülüzar Arzu; Kasap, Esin; Güçlü, Serkan

2018-03-13

The modified Misgav-Ladach method (MML) is a minimally invasive cesarean section procedure compared with the classic Pfannenstiel-Kerr (PK) method. The aim of the study was to compare the MML method and the PK method in terms of intraoperative and short-term postoperative outcomes. This prospective, randomized controlled trial involved 252 pregnant women scheduled for primary emergency or elective cesarean section between October, 2014 and July, 2015. The primary outcome measures were the duration of surgery, extraction time, Apgar score, blood loss, wound complications, and number of sutures used. Secondary outcome measures were the wound infection, time of bowel restitution, visual analogue scale (VAS) scores at 6 h and 24 h after the operation, limitations in movement, and analgesic requirements. At 6 weeks after surgery, the patients were evaluated regarding late complications. There was a significant reduction in total operating and extraction time in the MML group (p < 0.001). Limitations in movement were lower at 24 h after the MML operation, and less analgesic was required in the MML group. There was no difference between the 2 groups in terms of febrile morbidity or the duration of hospitalization. At 6 weeks after the operation, no complaints and no additional complications from the surgery were noted. The MML method is a minimally invasive cesarean section. In the future, as surgeons' experience increases, MML will likely be chosen more often than the classic PK method.

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.

The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

PubMed Central

Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

2016-01-01

Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071

Measurement of the uterus and gestation sac by ultrasound in early normal and abnormal pregnancy.

PubMed

Chandra, M; Evans, L J; Duff, G B

1981-01-14

Uterine volumes measured by two different ultrasonic methods, and gestation sac volumes in early normal pregnancy are reported. The results obtained for uterine volume measurements are compared. Methods using measurements obtained from only a longitudinal scan were simpler but slightly less accurate. Uterine volumes were also calculated in a series of patients with pregnancy complicated by threatened abortion. The accuracy of the prediction of the outcome of the pregnancy, based solely on uterine volume was 71 percent. Uterine volume measurement is most useful in identifying cases of missed abortion where the period of gestation is known.

Scoring from Contests

PubMed Central

Penn, Elizabeth Maggie

2014-01-01

This article presents a new model for scoring alternatives from “contest” outcomes. The model is a generalization of the method of paired comparison to accommodate comparisons between arbitrarily sized sets of alternatives in which outcomes are any division of a fixed prize. Our approach is also applicable to contests between varying quantities of alternatives. We prove that under a reasonable condition on the comparability of alternatives, there exists a unique collection of scores that produces accurate estimates of the overall performance of each alternative and satisfies a well-known axiom regarding choice probabilities. We apply the method to several problems in which varying choice sets and continuous outcomes may create problems for standard scoring methods. These problems include measuring centrality in network data and the scoring of political candidates via a “feeling thermometer.” In the latter case, we also use the method to uncover and solve a potential difficulty with common methods of rescaling thermometer data to account for issues of interpersonal comparability. PMID:24748759

Health-Related Quality of Life after Cystectomy and Urinary Diversion for Bladder Cancer

PubMed Central

Shih, Cheryl; Porter, Michael P.

2011-01-01

With multiple options for urinary diversion after radical cystectomy for bladder cancer that have comparable cancer control and complication rates, health-related quality of life (HRQOL) has become an important consideration. This article reviews the methods for defining HRQOL, the challenges in measuring HRQOL in bladder cancer, and the literature comparing HRQOL after various methods of urinary diversion. Recent contributions include the validation of HRQOL instruments specific to bladder cancer and the publication of several prospective studies measuring HRQOL outcomes after cystectomy and urinary diversion. There is no convincing evidence from existing literature that any particular method of urinary diversion offers superior HRQOL outcomes. Rather, there is growing evidence that good HRQOL can be achieved with patient education and consideration of each patient's clinical and psychosocial situation. Future research should utilize the validated bladder cancer specific HRQOL instruments and perhaps explore the impact of preoperative counseling on postoperative HRQOL. PMID:21826139

High throughput estimation of functional cell activities reveals disease mechanisms and predicts relevant clinical outcomes

PubMed Central

Hidalgo, Marta R.; Cubuk, Cankut; Amadoz, Alicia; Salavert, Francisco; Carbonell-Caballero, José; Dopazo, Joaquin

2017-01-01

Understanding the aspects of the cell functionality that account for disease or drug action mechanisms is a main challenge for precision medicine. Here we propose a new method that models cell signaling using biological knowledge on signal transduction. The method recodes individual gene expression values (and/or gene mutations) into accurate measurements of changes in the activity of signaling circuits, which ultimately constitute high-throughput estimations of cell functionalities caused by gene activity within the pathway. Moreover, such estimations can be obtained either at cohort-level, in case/control comparisons, or personalized for individual patients. The accuracy of the method is demonstrated in an extensive analysis involving 5640 patients from 12 different cancer types. Circuit activity measurements not only have a high diagnostic value but also can be related to relevant disease outcomes such as survival, and can be used to assess therapeutic interventions. PMID:28042959

Assessing and improving health in the workplace: an integration of subjective and objective measures with the STress Assessment and Research Toolkit (St.A.R.T.) method.

PubMed

Panari, Chiara; Guglielmi, Dina; Ricci, Aurora; Tabanelli, Maria Carla; Violante, Francesco Saverio

2012-09-20

The aim of this work was to introduce a new combined method of subjective and objective measures to assess psychosocial risk factors at work and improve workers' health and well-being. In the literature most of the research on work-related stress focuses on self-report measures and this work represents the first methodology capable of integrating different sources of data. An integrated method entitled St.A.R.T. (STress Assessment and Research Toolkit) was used in order to assess psychosocial risk factors and two health outcomes. In particular, a self-report questionnaire combined with an observational structured checklist was administered to 113 workers from an Italian retail company. The data showed a correlation between subjective data and the rating data of the observational checklist for the psychosocial risk factors related to work contexts such as customer relationship management and customer queue. Conversely, the factors related to work content (workload and boredom) measured with different methods (subjective vs. objective) showed a discrepancy. Furthermore, subjective measures of psychosocial risk factors were more predictive of workers' psychological health and exhaustion than rating data. The different objective measures played different roles, however, in terms of their influence on the two health outcomes considered. It is important to integrate self-related assessment of stressors with objective measures for a better understanding of workers' conditions in the workplace. The method presented could be considered a useful methodology for combining the two measures and differentiating the impact of different psychological risk factors related to work content and context on workers' health.

The experience sampling method: Investigating students' affective experience

NASA Astrophysics Data System (ADS)

Nissen, Jayson M.; Stetzer, MacKenzie R.; Shemwell, Jonathan T.

2013-01-01

Improving non-cognitive outcomes such as attitudes, efficacy, and persistence in physics courses is an important goal of physics education. This investigation implemented an in-the-moment surveying technique called the Experience Sampling Method (ESM) [1] to measure students' affective experience in physics. Measurements included: self-efficacy, cognitive efficiency, activation, intrinsic motivation, and affect. Data are presented that show contrasts in students' experiences (e.g., in physics vs. non-physics courses).

Validity of the AusTOM scales: A comparison of the AusTOMs and EuroQol-5D

PubMed Central

Unsworth, Carolyn A; Duckett, Stephen J; Duncombe, Dianne; Perry, Alison; Skeat, Jemma; Taylor, Nicholas

2004-01-01

Background Clinicians require brief outcome measures in their busy daily practice to document global client outcomes. Based on the UK Therapy Outcome Measure, the Australian Therapy Outcome Measures were designed to capture global therapy outcomes of occupational therapy, physiotherapy and speech pathology in the Australian clinical context. The aim of this study was to investigate the construct (convergent) validity of the Australian Therapy Outcome Measures (AusTOMs) by comparing it with the EuroQuol-5D (EQ-5D). Methods The research was a prospective, longitudinal cohort study, with data collected over a seven month time period. The study was conducted at a total of 13 metropolitan and rural health-care sites including acute, sub-acute and community facilities. Two-hundred and five clients were asked to score themselves on the EQ-5D, and the same clients were scored by approximately 115 therapists (physiotherapists, speech pathologists and occupational therapists) using the AusTOMs at admission and discharge. Clients were consecutive admissions who agreed to participate in the study. Clients of all diagnoses, aged 18 years and over (a criteria of the EQ-5D), and able to give informed consent were scored on the measures. Spearman rank order correlation coefficients were used to analyze the relationships between scores from the two tools. The clients were scored on the AusTOMs and EQ-5D. Results There were many health care areas where correlations were expected and found between scores on the AusTOMs and the EQ-5D. Conclusion In the quest to measure the effectiveness of therapy services, managers, health care founders and clinicians are urgently seeking to undertake the first step by identifying tools that can measure therapy outcome. AusTOMs is one tool that can measure global client outcomes following therapy. In this study, it was found that on the whole, the AusTOMs and the EQ-5D measure similar constructs. Hence, although the validity of a tool is never 'proven', this study offers preliminary support for the construct validity of AusTOMs. PMID:15541181

Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach

PubMed Central

Baker, Karen; Stolar, Marilyn; Miller-Davis, Claiborne; Ames, Nancy; Yates, Jan; Bolle, Jacques; Pereira, Donna; St. Germain, Diane; Handel, Daniel; Berger, Ann

2012-01-01

Purpose To prospectively compare outcomes and processes of hospital-based early palliative care with standard care in surgical oncology patients (N = 152). Methods A randomized, mixed methods, longitudinal study evaluated the effectiveness of a hospital-based Pain and Palliative Care Service (PPCS). Interviews were conducted presurgically and at follow-up visits up to 1 year. Primary outcome measures included the Gracely Pain Intensity and Unpleasantness Scales and the Symptom Distress Scale. Qualitative interviews assessed social support, satisfaction with care, and communication with providers. Survival analysis methods explored factors related to treatment crossover and study discontinuation. Models for repeated measures within subjects over time explored treatment and covariate effects on patient-reported pain and symptom distress. Results None of the estimated differences achieved statistical significance; however, for those who remained on study for 12 months, the PPCS group performed better than their standard of care counterparts. Patients identified consistent communication, emotional support, and pain and symptom management as positive contributions delivered by the PPCS. Conclusions It is unclear whether lower pain perceptions despite greater symptom distress were clinically meaningful; however, when coupled with the patients’ perceptions of their increased resources and alternatives for pain control, one begins to see the value of an integrated PPCS. PMID:22101861

Results of clubfoot treatment after manipulation and casting using the Ponseti method: experience in Harare, Zimbabwe.

PubMed

Smythe, Tracey; Chandramohan, Daniel; Bruce, Jane; Kuper, Hannah; Lavy, Christopher; Foster, Allen

2016-10-01

The objective of this study was to evaluate the outcomes of the Ponseti manipulation and casting method for clubfoot in a tertiary hospital in Zimbabwe and explore predictors of these outcomes. A cohort study included children with idiopathic clubfoot managed from 2011 to 2013 at Parirenyatwa Hospital. Demographic data, clinical features and treatment outcomes were extracted from clinic records. The primary outcome measure was the final Pirani score (clubfoot severity measure) after manipulation and casting. Secondary outcomes included change in Pirani score (pre-treatment to end of casting), number of casts for correction, proportion receiving tenotomy and proportion lost to follow up. A total of 218 children (337 feet) were eligible for inclusion. The median age at treatment was 8 months; 173 children (268 feet) completed casting treatment within the study period. The mean length of time for corrective treatment was 10.2 weeks (9.5-10.9 weeks). Of the 45 children who did not complete treatment, 28 were under treatment and 17 were lost to follow up. A Pirani score of 1 or less was achieved in 85% of feet. Mean Pirani score at presentation was 3.80 (SD 1.15) and post-treatment 0.80 (SD 0.56, P-value <0.0001). Severity of deformity and being male were associated with a higher (worse) final Pirani score. Severity and age over two were associated with an increase in the number of casts required to correct deformity. This case series demonstrates that the majority (80%+) of children with clubfoot can achieve a good outcome with the Ponseti manipulation and casting method. © 2016 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

Validating Measures of Real-World Outcome: The Results of the VALERO Expert Survey and RAND Panel

PubMed Central

Leifker, Feea R.; Patterson, Thomas L.; Heaton, Robert K.; Harvey, Philip D.

2011-01-01

Background: People with schizophrenia demonstrate considerable discrepancy between self-reported functioning and informant reports. It is not clear whether these discrepancies originate from the instruments used or from the perspectives of different informants. The goal of the Validation of Everyday Real-World Outcomes (VALERO) Study is to enhance the measurement of real-world (RW) outcomes in the social, residential, and vocational domains through selection of optimal scales and informants using a multistep process similar to the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative. Methods: Forty-eight experts provided their opinion regarding the best scales measuring RW outcomes. Fifty-nine measures were nominated. The investigators selected the 11 scales that were the most highly nominated, had the most published validity data, and best represented the domains of interest. Information was provided to other experts who served as RAND panelists. Panelists rated each measure for its suitability across multiple a priori domains. Discrepant ratings were discussed until consensus was reached. Results: Following the RAND Panel, the 2 scales that scored highest across the various criteria for each of the classes of scales (hybrid, social functioning, and everyday living skills) were selected for use in the first substudy of VALERO. The scales selected were the Quality-of-Life Scale, Specific Levels of Functioning Scale, Social Behavior Schedule, Social Functioning Scale, Independent Living Skills Schedule, and Life Skills Profile. Discussion: The results show that although there are significant limitations with current scales used for the assessment of RW outcome in schizophrenia, a consensus is possible. Further, several existing instruments were rated as useful for measuring social, residential, and vocational outcomes. PMID:19525354

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

Measurement versus prediction in the construction of patient-reported outcome questionnaires: can we have our cake and eat it?

PubMed

Smits, Niels; van der Ark, L Andries; Conijn, Judith M

2017-11-02

Two important goals when using questionnaires are (a) measurement: the questionnaire is constructed to assign numerical values that accurately represent the test taker's attribute, and (b) prediction: the questionnaire is constructed to give an accurate forecast of an external criterion. Construction methods aimed at measurement prescribe that items should be reliable. In practice, this leads to questionnaires with high inter-item correlations. By contrast, construction methods aimed at prediction typically prescribe that items have a high correlation with the criterion and low inter-item correlations. The latter approach has often been said to produce a paradox concerning the relation between reliability and validity [1-3], because it is often assumed that good measurement is a prerequisite of good prediction. To answer four questions: (1) Why are measurement-based methods suboptimal for questionnaires that are used for prediction? (2) How should one construct a questionnaire that is used for prediction? (3) Do questionnaire-construction methods that optimize measurement and prediction lead to the selection of different items in the questionnaire? (4) Is it possible to construct a questionnaire that can be used for both measurement and prediction? An empirical data set consisting of scores of 242 respondents on questionnaire items measuring mental health is used to select items by means of two methods: a method that optimizes the predictive value of the scale (i.e., forecast a clinical diagnosis), and a method that optimizes the reliability of the scale. We show that for the two scales different sets of items are selected and that a scale constructed to meet the one goal does not show optimal performance with reference to the other goal. The answers are as follows: (1) Because measurement-based methods tend to maximize inter-item correlations by which predictive validity reduces. (2) Through selecting items that correlate highly with the criterion and lowly with the remaining items. (3) Yes, these methods may lead to different item selections. (4) For a single questionnaire: Yes, but it is problematic because reliability cannot be estimated accurately. For a test battery: Yes, but it is very costly. Implications for the construction of patient-reported outcome questionnaires are discussed.

Who Gets the Most Out of Cognitive-Behavioral Therapy for Anxiety Disorders?

PubMed Central

Glenn, Daniel; Golinelli, Daniela; Rose, Raphael D.; Roy-Byrne, Peter; Stein, Murray B.; Sullivan, Greer; Bystritksy, Alexander; Sherbourne, Cathy; Craske, Michelle G.

2013-01-01

Objective The present study explored treatment dose and patient engagement as predictors of treatment outcome in cognitive behavioral therapy (CBT) for anxiety disorders. Method Measures of high versus low treatment dose, and high versus low patient engagement in CBT were compared as predictors of 12 and 18 month outcomes for patients being treated for anxiety disorders with CBT (with or without concurrent pharmacotherapy) in primary care settings as part of a randomized controlled effectiveness trial of the Coordinated Anxiety Learning and Management (CALM) intervention. Measures of dose (attendance, exposure completion) and engagement in CBT (homework adherence, commitment) were collected throughout treatment, and blinded follow-up phone assessments of outcome measures (12-item Brief Symptom Inventory, Patient Health Questionnaire 8, Sheehan Disability Scale) were completed at 12 and 18 months. Propensity score weighting controlled for baseline differences in demographics and symptom severity between patients with high and low dose and engagement. These analyses included the 439 patients that selected CBT as treatment modality. Results Completing exposures, high attendance, and being more homework adherent predicted better outcomes across all measures at 12 and 18 months, and high CBT commitment predicted better outcomes on all measures at 18 months. Conclusions This study found that higher treatment dose and patient engagement in CBT for anxiety disorders were stable and robust predictors of greater reductions in anxiety symptoms, depression symptoms, and functional disability. PMID:23750465

Measuring Stress Before and During Pregnancy: A Review of Population-Based Studies of Obstetric Outcomes

PubMed Central

Witt, Whitney; Litzelman, Kristin; Cheng, Erika R; Wakeel, Fathima; Barker, Emily S.

2013-01-01

Objectives Mounting evidence from clinic and convenience samples suggests that stress is an important predictor of adverse obstetric outcomes. Using a proposed theoretical framework, this review identified and synthesized the population-based literature on the measurement of stress prior to and during pregnancy in relation to obstetric outcomes. Methods Population-based, peer-reviewed empirical articles that examined stress prior to or during pregnancy in relation to obstetric outcomes were identified in the PubMed and PsycInfo databases. Articles were evaluated to determine the domain(s) of stress (environmental, psychological, and/or biological), period(s) of stress (preconception and/or pregnancy), and strength of the association between stress and obstetric outcomes. Results Thirteen studies were evaluated. The identified studies were all conducted in developed countries. The majority of studies examined stress only during pregnancy (n=10); three examined stress during both the preconception and pregnancy periods (n=3). Most studies examined the environmental domain (e.g., life events) only (n=9), two studies examined the psychological domain only, and two studies examined both. No study incorporated a biological measure of stress. Environmental stressors before and during pregnancy were associated with worse obstetric outcomes, although some conflicting findings exist. Conclusions Few population-based studies have examined stress before or during pregnancy in relation to obstetric outcomes. Although considerable variation exists in the measurement of stress across studies, environmental stress increased the risk for poor obstetric outcomes. Additional work using a lifecourse approach is needed to fill the existing gaps in the literature and to develop a more comprehensive understanding of the mechanisms by which stress impacts obstetric outcomes. PMID:23447085

Prioritizing treatment outcomes: How people with acne vulgaris decide if their treatment is working.

PubMed

Layton, Alison M; Whitehouse, Heather; Eady, E Anne; Cowdell, Fiona; Warburton, Katharine L; Fenton, Mark

2017-08-01

To collect information about how people with acne make day-to-day decisions concerning the effectiveness of their treatment. Between May and August 2013, an optional question was embedded in the James Lind Alliance Acne Priority Setting Partnership's online survey to collect treatment uncertainties. The question asked people with acne to "Tell us in your own words how you decide if your treatment has been effective." A total of 742 respondents specified at least one outcome or means of assessing change (outcome measure). Fewer spots were the most commonly cited outcome, identified by 272 respondents (36.7%). Other frequently mentioned outcomes were in descending order: less redness (19.4%), reduction in spot size (12.1%), and less pain/discomfort (11.4%). Signs were much more commonly used than symptoms and surrogate outcomes such as changes in aspects of life quality were infrequently mentioned. Visual inspection of the skin was the most widely adopted outcome measure (16.3%). Although the most frequently used methods map well onto the outcome measures adopted in the majority of acne trials, namely physician-assessed changes in lesion counts and global acne severity, people with acne often take into account several factors that cannot be assessed by a third party at a single point in time. The minimal use of changes in psychosocial wellbeing and mood may reflect that these are regarded as secondary consequences of improvements in appearance. The robustness of these findings now requires independent evaluation. If confirmed, they could form the basis of a new patient-reported outcome measure. © 2017 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

PubMed Central

Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

2016-01-01

Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

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

Uranium Associations with Kidney Outcomes Vary by Urine Concentration Adjustment Method

PubMed Central

Shelley, Rebecca; Kim, Nam-Soo; Parsons, Patrick J.; Lee, Byung-Kook; Agnew, Jacqueline; Jaar, Bernard G.; Steuerwald, Amy J.; Matanoski, Genevieve; Fadrowski, Jeffrey; Schwartz, Brian S.; Todd, Andrew C.; Simon, David; Weaver, Virginia M.

2017-01-01

Uranium is a ubiquitous metal that is nephrotoxic at high doses. Few epidemiologic studies have examined the kidney filtration impact of chronic environmental exposure. In 684 lead workers environmentally exposed to uranium, multiple linear regression was used to examine associations of uranium measured in a four-hour urine collection with measured creatinine clearance, serum creatinine- and cystatin-C-based estimated glomerular filtration rates, and N-acetyl-β-D-glucosaminidase (NAG). Three methods were utilized, in separate models, to adjust uranium levels for urine concentration - μg uranium/g creatinine; μg uranium/L and urine creatinine as separate covariates; and μg uranium/4 hr. Median urine uranium levels were 0.07 μg/g creatinine and 0.02 μg/4 hr and were highly correlated (rs =0.95). After adjustment, higher ln-urine uranium was associated with lower measured creatinine clearance and higher NAG in models that used urine creatinine to adjust for urine concentration but not in models that used total uranium excreted (μg/4 hr). These results suggest that, in some instances, associations between urine toxicants and kidney outcomes may be statistical, due to the use of urine creatinine in both exposure and outcome metrics, rather than nephrotoxic. These findings support consideration of non-creatinine-based methods of adjustment for urine concentration in nephrotoxicant research. PMID:23591699

A Method of Measuring Inequality within a Selection Process

ERIC Educational Resources Information Center

Bulle, Nathalie

2016-01-01

To explain the inequalities in access to a discrete good G across two populations, or across time in a single national context, it is necessary to distinguish, for each population or period of time, the effect of the diffusion of G from that of unequal outcomes of underlying micro-social processes. The inequality of outcomes of these micro-social…

An Assessment of Learning Outcomes in Short-Term Study Abroad and Human Rights Education

ERIC Educational Resources Information Center

Nagengast, Emil

2017-01-01

How does short-term study abroad affect students' attitudes toward human rights? What role does study abroad play in human rights education? This study assesses the learning outcomes of two study abroad programs that aimed to promote human rights education. I applied a mixed methods approach to measure the changes in the opinions of students who…

The Other Side of Method Bias: The Perils of Distinct Source Research Designs

ERIC Educational Resources Information Center

Kammeyer-Mueller, John; Steel, Piers D. G.; Rubenstein, Alex

2010-01-01

Common source bias has been the focus of much attention. To minimize the problem, researchers have sometimes been advised to take measurements of predictors from one observer and measurements of outcomes from another observer or to use separate occasions of measurement. We propose that these efforts to eliminate biases due to common source…

Measuring Cognitive Load with Electroencephalography and Self-Report: Focus on the Effect of English-Medium Learning for Korean Students

ERIC Educational Resources Information Center

Lee, Hyunjeong

2014-01-01

This study investigated a reliable and valid method for measuring cognitive load during learning through comparing various types of cognitive load measurements: electroencephalography (EEG), self-reporting, and learning outcome. A total of 43 college-level students underwent watching a documentary delivered in English or in Korean. EEG was…

The use of computer adaptive tests in outcome assessments following upper limb trauma.

PubMed

Jayakumar, P; Overbeek, C; Vranceanu, A-M; Williams, M; Lamb, S; Ring, D; Gwilym, S

2018-06-01

Aims Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to "CATs", "orthopaedics", "trauma", and "anatomical regions". Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg istered (PROSPERO: CRD42016053886). Results A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures. Cite this article: Bone Joint J 2018;100-B:693-702.

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

Advancing current approaches to disease management evaluation: capitalizing on heterogeneity to understand what works and for whom

PubMed Central

2013-01-01

Background Evaluating large-scale disease management interventions implemented in actual health care settings is a complex undertaking for which universally accepted methods do not exist. Fundamental issues, such as a lack of control patients and limited generalizability, hamper the use of the ‘gold-standard’ randomized controlled trial, while methodological shortcomings restrict the value of observational designs. Advancing methods for disease management evaluation in practice is pivotal to learn more about the impact of population-wide approaches. Methods must account for the presence of heterogeneity in effects, which necessitates a more granular assessment of outcomes. Methods This paper introduces multilevel regression methods as valuable techniques to evaluate ‘real-world’ disease management approaches in a manner that produces meaningful findings for everyday practice. In a worked example, these methods are applied to retrospectively gathered routine health care data covering a cohort of 105,056 diabetes patients who receive disease management for type 2 diabetes mellitus in the Netherlands. Multivariable, multilevel regression models are fitted to identify trends in clinical outcomes and correct for differences in characteristics of patients (age, disease duration, health status, diabetes complications, smoking status) and the intervention (measurement frequency and range, length of follow-up). Results After a median one year follow-up, the Dutch disease management approach was associated with small average improvements in systolic blood pressure and low-density lipoprotein, while a slight deterioration occurred in glycated hemoglobin. Differential findings suggest that patients with poorly controlled diabetes tend to benefit most from disease management in terms of improved clinical measures. Additionally, a greater measurement frequency was associated with better outcomes, while longer length of follow-up was accompanied by less positive results. Conclusions Despite concerted efforts to adjust for potential sources of confounding and bias, there ultimately are limits to the validity and reliability of findings from uncontrolled research based on routine intervention data. While our findings are supported by previous randomized research in other settings, the trends in outcome measures presented here may have alternative explanations. Further practice-based research, perhaps using historical data to retrospectively construct a control group, is necessary to confirm results and learn more about the impact of population-wide disease management. PMID:23497125

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.

Providing Evidence in the Moral Domain

ERIC Educational Resources Information Center

Cooper, Diane L.; Liddell, Debora L.; Davis, Tiffany J.; Pasquesi, Kira

2012-01-01

In this era of increased accountability, it is important to consider how student affairs researches and assesses the outcomes of efforts to increase moral competence. This article examines both qualitative and quantitative inquiry methods for measuring moral development. The authors review the instrumentation and methods typically used to measure…

Meaningful Engagement in Facebook Learning Environments: Merging Social and Academic Lives

ERIC Educational Resources Information Center

Wang, Jenny; Lin, Chun-Fu C.; Yu, Wei-Chieh W.; Wu, Emily

2013-01-01

This study compared the effectiveness of different learning environments between interactive Facebook instructional method and non-Facebook instructional method for undergraduate students. Two outcome dimensions were measured: student grades and learning engagement. A pre-test-posttest control group experimental design was used. The experimental…

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

PubMed

Tonetti, Maurizio; Palmer, Richard

2012-02-01

The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research. © 2012 John Wiley & Sons A/S.

The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease.

PubMed

Pohl, Petra; Dizdar, Nil; Hallert, Eva

2013-01-01

To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson's disease (PD). Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility). Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed. In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD. The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD. The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation. Most measurements were feasible except for Timed-Up-and-Go.

Individual Prognosis of Symptom Burden and Functioning in Chronic Diseases: A Generic Method Based on Patient-Reported Outcome (PRO) Measures

PubMed Central

2017-01-01

Background Information to the patient about the long-term prognosis of symptom burden and functioning is an integrated part of clinical practice, but relies mostly on the clinician’s personal experience. Relevant prognostic models based on patient-reported outcome (PRO) data with repeated measurements are rarely available. Objective The aim was to describe a generic method for individual long-term prognosis of symptom burden and functioning that implied few statistical presumptions, to evaluate an implementation for prognosis of depressive symptoms in stroke patients and to provide open access to a Web-based prototype of this implementation for individual use. Methods The method used to describe individual prognosis of a PRO outcome was based on the selection of a specific subcohort of patients who have the same score as the patient in question at the same time (eg, after diagnosis or treatment start), plus or minus one unit of minimal clinically important difference. This subcohort’s experienced courses were then used to provide quantitative measures of prognosis over time. A cohort of 1404 stroke patients provided data for a simulation study and a prototype for individual use. Members of the cohort answered questionnaires every 6 months for 3.5 years. Depressive symptoms were assessed by the Hospital Anxiety and Depression Scale (HADS) and a single item from the SF-12 (MH4) health survey. Four approaches were compared in a simulation study in which the prognosis for each member of the cohort was individually assessed. Results The mean standard deviations were 40% to 70% higher in simulated scores. Mean errors were close to zero, and mean absolute errors were between 0.46 and 0.66 SD in the four approaches. An approach in which missing HADS scores were estimated from the single-item SF-12 MH4 performed marginally better than methods restricted to questionnaires with a genuine HADS score, which indicates that data collected with shorter questionnaires (eg, in clinical practice) may be used together with longer versions with the full scale, given that the design includes at least two simultaneous measurements of the full scale and the surrogate measure. Conclusions This is the first description and implementation of a nonparametric method for individual PRO-based prognosis. Given that relevant PRO data have been collected longitudinally, the method may be applied to other patient groups and to any outcome related to symptom burden and functioning. This initial implementation has been deliberately made simple, and further elaborations as well as the usability and clinical validity of the method will be scrutinized in clinical practice. An implementation of the prototype is available online at www.prognosis.dk. PMID:28765099

Psychosocial adjustment and life satisfaction until 5 years after severe brain damage.

PubMed

Sörbo, Ann K; Blomqvist, Maritha; Emanuelsson, Ingrid M; Rydenhag, Bertil

2009-06-01

The objectives of this study were to describe psychosocial adjustment and outcome over time for severely brain-injured patients and to find suitable outcome measures for clinical practice during the rehabilitation process and for individual rehabilitation planning after discharge from hospital. The methods include a descriptive, prospective, population-based study. The participants were assessed at 6 months and annually until 5 years after traumatic brain injury or nontraumatic subarachnoid haemorrhage. Inclusion criteria were age 16-65 years, severe traumatic brain injury or nontraumatic subarachnoid haemorrhage defined as Glasgow Coma Scale 8 or worse and need for neurointensive care for at least 5 days. The main outcome measures were Head Injury Evaluation Chart, Glasgow Outcome Scale Extended (GOSE) and Life Satisfaction Questionnaire (LiSat)-11 checklist. Change over time for the group and the individuals, as measured with the GOSE, was analyzed by a statistical method that is suitable for small datasets and takes into account the nonmetric properties of the data. Eighteen patients were included. Three died and one was excluded for the long-term follow-up (n=14). The group had a good outcome with no participant remaining in a vegetative state, 93% (12 of 13) went home and 60% (six of 10) returned to work. Eighty percent (eight of 10) of participants rated 'life as a whole' as satisfactory 5 years after the injury. The change at group level was significant (GOSE) until 1 year after the injury. The GOSE and the LiSat-11 were most clinically useful as they were easy to use for the rater/participants.

From clinically relevant outcome measures to quality of life in epilepsy: A time trade-off study.

PubMed

de Kinderen, Reina J A; Wijnen, Ben F M; van Breukelen, Gerard; Postulart, Debby; Majoie, Marian H J M; Aldenkamp, Albert P; Evers, Silvia M A A

2016-09-01

A proposed method for bridging the gap between clinically relevant epilepsy outcome measures and quality-adjusted life years is to derive utility scores for epilepsy health states. The aim of this study is to develop such a utility-function and to investigate the impact of the epilepsy outcome measures on utility. Health states, based on clinically important epilepsy attributes (e.g. seizure frequency, seizure severity, side-effects), were valued by a sample of the Dutch population (N=525) based on the time trade-off method. In addition to standard demographics, every participant was asked to rate 10 or 11 different health state scenarios. A multilevel regression analysis was performed to account for the nested structure of the data. Results show that the best health state (no seizures and no side-effects) is estimated at 0.89 and the worst state (seizures type 5 twice a day plus severe side-effects) at 0.22 (scale: 0-1). An increase in seizure frequency, occurrence of side-effects, and seizure severity were all significantly associated with lower utility values. Furthermore, seizure severity has the largest impact on quality of life compared with seizure frequency and side-effects. This study provides a utility-function for transforming clinically relevant epilepsy outcome measures into utility estimates. We advise using our utility-function in economic evaluations, when quality of life is not directly measured in a study and hence, no health state utilities are available, or when there is convincing empirical evidence of the insensitivity of a generic quality-of-life-instrument within epilepsy. Copyright © 2016 Elsevier B.V. All rights reserved.

Association between women's autonomy and family planning outcome in couples residing in Isfahan.

PubMed

Kohan, Shahnaz; Talebian, Ferdos; Ehsanpour, Soheila

2014-09-01

One of the important factors in the prediction of family planning outcome is paying attention to women's role in decision making concerning fertility and household affairs. With the improvement of women's status and autonomy, their control over fertility is expected to increase. The present study aimed to investigate the association between women's autonomy and family planning outcome of the couples residing in Isfahan. This is cross-sectional study. Two hundred and seventy women of childbearing age, eligible for family planning and residing in Isfahan, were selected through random cluster sampling and they filled a researcher-made questionnaire. Women's autonomy was measured with the questions on their decision-making autonomy concerning household affairs and physical mobility autonomy. The association between women's autonomy and family planning outcome was analyzed through statistical methods. The results showed that the mean of women's decision-making, physical mobility, and general autonomy was 50. Women's autonomy had a direct significant association with the type of contraception method (P = 0.01) and the length of usage of their present contraception method (P = 0.04) as well as where they received family planning services (P = 0.02). Analysis of data revealed women with higher autonomy used a more efficient contraception method and continued their contraception method for a longer time, which leads to improvement of couples' family planning outcome. Therefore, family planning services should be planned and provided with women's autonomy under consideration.

Accuracy of a Computer-Aided Surgical Simulation (CASS) Protocol for Orthognathic Surgery: A Prospective Multicenter Study

PubMed Central

Hsu, Sam Sheng-Pin; Gateno, Jaime; Bell, R. Bryan; Hirsch, David L.; Markiewicz, Michael R.; Teichgraeber, John F.; Zhou, Xiaobo; Xia, James J.

2012-01-01

Purpose The purpose of this prospective multicenter study was to assess the accuracy of a computer-aided surgical simulation (CASS) protocol for orthognathic surgery. Materials and Methods The accuracy of the CASS protocol was assessed by comparing planned and postoperative outcomes of 65 consecutive patients enrolled from 3 centers. Computer-generated surgical splints were used for all patients. For the genioplasty, one center utilized computer-generated chin templates to reposition the chin segment only for patients with asymmetry. Standard intraoperative measurements were utilized without the chin templates for the remaining patients. The primary outcome measurements were linear and angular differences for the maxilla, mandible and chin when the planned and postoperative models were registered at the cranium. The secondary outcome measurements were: maxillary dental midline difference between the planned and postoperative positions; and linear and angular differences of the chin segment between the groups with and without the use of the template. The latter was measured when the planned and postoperative models were registered at mandibular body. Statistical analyses were performed, and the accuracy was reported using root mean square deviation (RMSD) and Bland and Altman's method for assessing measurement agreement. Results In the primary outcome measurements, there was no statistically significant difference among the 3 centers for the maxilla and mandible. The largest RMSD was 1.0mm and 1.5° for the maxilla, and 1.1mm and 1.8° for the mandible. For the chin, there was a statistically significant difference between the groups with and without the use of the chin template. The chin template group showed excellent accuracy with largest positional RMSD of 1.0mm and the largest orientational RSMD of 2.2°. However, larger variances were observed in the group not using the chin template. This was significant in anteroposterior and superoinferior directions, as in pitch and yaw orientations. In the secondary outcome measurements, the RMSD of maxillary dental midline positions was 0.9mm. When registered at the body of the mandible, the linear and angular differences of the chin segment between the groups with and without the use of the chin template were consistent with the results found in the primary outcome measurements. Conclusion Using the CASS protocol, the computerized plan can be accurately and consistently transferred to the patient to position the maxilla and mandible at the time of surgery. The computer-generated chin template provides more accuracy in repositioning the chin segment than the intraoperative measurements. PMID:22695016

The use of rapid review methods in health technology assessments: 3 case studies.

PubMed

Kaltenthaler, Eva; Cooper, Katy; Pandor, Abdullah; Martyn-St James, Marrissa; Chatters, Robin; Wong, Ruth

2016-08-26

Rapid reviews are of increasing importance within health technology assessment due to time and resource constraints. There are many rapid review methods available although there is little guidance as to the most suitable methods. We present three case studies employing differing methods to suit the evidence base for each review and outline some issues to consider when selecting an appropriate method. Three recently completed systematic review short reports produced for the UK National Institute for Health Research were examined. Different approaches to rapid review methods were used in the three reports which were undertaken to inform the commissioning of services within the NHS and to inform future trial design. We describe the methods used, the reasoning behind the choice of methods and explore the strengths and weaknesses of each method. Rapid review methods were chosen to meet the needs of the review and each review had distinctly different challenges such as heterogeneity in terms of populations, interventions, comparators and outcome measures (PICO) and/or large numbers of relevant trials. All reviews included at least 10 randomised controlled trials (RCTs), each with numerous included outcomes. For the first case study (sexual health interventions), very diverse studies in terms of PICO were included. P-values and summary information only were presented due to substantial heterogeneity between studies and outcomes measured. For the second case study (premature ejaculation treatments), there were over 100 RCTs but also several existing systematic reviews. Data for meta-analyses were extracted directly from existing systematic reviews with new RCT data added where available. For the final case study (cannabis cessation therapies), studies included a wide range of interventions and considerable variation in study populations and outcomes. A brief summary of the key findings for each study was presented and narrative synthesis used to summarise results for each pair of interventions compared. Rapid review methods need to be chosen to meet both the nature of the evidence base of a review and the challenges presented by the included studies. Appropriate methods should be chosen after an assessment of the evidence base.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

PubMed

Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan

2016-10-01

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

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

Early Postimplant Speech Perception and Language Skills Predict Long-Term Language and Neurocognitive Outcomes Following Pediatric Cochlear Implantation

PubMed Central

Kronenberger, William G.; Castellanos, Irina; Pisoni, David B.

2017-01-01

Purpose We sought to determine whether speech perception and language skills measured early after cochlear implantation in children who are deaf, and early postimplant growth in speech perception and language skills, predict long-term speech perception, language, and neurocognitive outcomes. Method Thirty-six long-term users of cochlear implants, implanted at an average age of 3.4 years, completed measures of speech perception, language, and executive functioning an average of 14.4 years postimplantation. Speech perception and language skills measured in the 1st and 2nd years postimplantation and open-set word recognition measured in the 3rd and 4th years postimplantation were obtained from a research database in order to assess predictive relations with long-term outcomes. Results Speech perception and language skills at 6 and 18 months postimplantation were correlated with long-term outcomes for language, verbal working memory, and parent-reported executive functioning. Open-set word recognition was correlated with early speech perception and language skills and long-term speech perception and language outcomes. Hierarchical regressions showed that early speech perception and language skills at 6 months postimplantation and growth in these skills from 6 to 18 months both accounted for substantial variance in long-term outcomes for language and verbal working memory that was not explained by conventional demographic and hearing factors. Conclusion Speech perception and language skills measured very early postimplantation, and early postimplant growth in speech perception and language, may be clinically relevant markers of long-term language and neurocognitive outcomes in users of cochlear implants. Supplemental materials https://doi.org/10.23641/asha.5216200 PMID:28724130

Global measures of outcome in a controlled comparison of pharmacological and psychological treatment of panic disorder and agoraphobia in primary care.

PubMed Central

Sharp, D M; Power, K G; Simpson, R J; Swanson, V; Anstee, J A

1997-01-01

BACKGROUND: Panic disorder, with and without agoraphobia, is a prevalent condition which presents primarily in general practice. Previous clinical outcome studies have been conducted mainly in specialist university departments or hospital settings, and have tended to employ complex rating scales that are not well suited for use as outcome measures in primary care. AIM: To evaluate the outcome, in a primary care setting, of fluvoxamine versus cognitive behaviour therapy, each used alone and in combination in a double-blind placebo-controlled framework, balanced for therapist contact. METHOD: A total of 149 patients satisfying DSMIII-R criteria for panic disorder were randomly allocated to receive one of the following: fluvoxamine, placebo, fluvoxamine plus cognitive behaviour therapy, placebo plus cognitive behaviour therapy, and cognitive behaviour therapy alone. These five treatment groups represent the minimum number acceptable for such a comparison to be made. All patients received an identical schedule of contact over 13 weeks. Measures of symptom severity, general health and social disruption were taken at entry point and end point; measures of change in symptoms were taken at end point only. Outcome was reported in terms of brief global ratings of severity of illness and change in symptoms, and of ratings of general health and social disruption that are suitable for use in general practice. RESULTS: All active treatment groups showed statistically significant advantages over placebo over a range of outcome ratings. The groups employing cognitive behaviour therapy showed the most robust and consistent response. CONCLUSION: The brief global measures reported here proved adequate to the task of assessing treatment outcome. Results indicate that treatments including cognitive behaviour therapy can be effective in the treatment of panic disorder and agoraphobia in primary care. PMID:9167318

Update on Outcome Measure Development for Large Vessel Vasculitis: Report from OMERACT 12

PubMed Central

Aydin, Sibel Zehra; Direskeneli, Haner; Sreih, Antoine; Alibaz-Oner, Fatma; Gul, Ahmet; Kamali, Sevil; Hatemi, Gulen; Kermani, Tanaz; Mackie, Sarah L.; Mahr, Alfred; Meara, Alexa; Milman, Nataliya; Nugent, Heidi; Robson, Joanna; Tomasson, Gunnar; Merkel, Peter A.

2015-01-01

Objective The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group’s research agenda. Methods The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group’s LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients’ perspectives and that patients have input into the research agenda and process. Results The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. Conclusion The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV. PMID:26077399

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

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

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

Association between women's autonomy and family planning outcome in couples residing in Isfahan

PubMed Central

Kohan, Shahnaz; Talebian, Ferdos; Ehsanpour, Soheila

2014-01-01

Background: One of the important factors in the prediction of family planning outcome is paying attention to women's role in decision making concerning fertility and household affairs. With the improvement of women's status and autonomy, their control over fertility is expected to increase. The present study aimed to investigate the association between women's autonomy and family planning outcome of the couples residing in Isfahan. Materials and Methods: This is cross-sectional study. Two hundred and seventy women of childbearing age, eligible for family planning and residing in Isfahan, were selected through random cluster sampling and they filled a researcher-made questionnaire. Women's autonomy was measured with the questions on their decision-making autonomy concerning household affairs and physical mobility autonomy. The association between women's autonomy and family planning outcome was analyzed through statistical methods. Results: The results showed that the mean of women's decision-making, physical mobility, and general autonomy was 50. Women's autonomy had a direct significant association with the type of contraception method (P = 0.01) and the length of usage of their present contraception method (P = 0.04) as well as where they received family planning services (P = 0.02). Conclusions: Analysis of data revealed women with higher autonomy used a more efficient contraception method and continued their contraception method for a longer time, which leads to improvement of couples’ family planning outcome. Therefore, family planning services should be planned and provided with women's autonomy under consideration. PMID:25400671

Randomized Placebo-Controlled Double-Blind Clinical Trial of Cannabis-Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy

PubMed Central

Selvarajah, Dinesh; Gandhi, Rajiv; Emery, Celia J.; Tesfaye, Solomon

2010-01-01

OBJECTIVE To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN). RESEARCH DESIGN AND METHODS In this randomized controlled trial, 30 subjects with painful DPN received daily Sativex or placebo. The primary outcome measure was change in mean daily pain scores, and secondary outcome measures included quality-of-life assessments. RESULTS There was significant improvement in pain scores in both groups, but mean change between groups was not significant. There were no significant differences in secondary outcome measures. Patients with depression had significantly greater baseline pain scores that improved regardless of intervention. CONCLUSIONS This first-ever trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful DPN. Depression was a major confounder and may have important implications for future trials on painful DPN. PMID:19808912

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.

“It's The Skin You're In”: African-American Women Talk About Their Experiences of Racism. An Exploratory Study to Develop Measures of Racism for Birth Outcome Studies

PubMed Central

Nuru-Jeter, Amani; Dominguez, Tyan Parker; Hammond, Wizdom Powell; Leu, Janxin; Skaff, Marilyn; Egerter, Susan; Jones, Camara P.; Braveman, Paula

2011-01-01

Objectives Stress due to experiences of racism could contribute to African-American women's adverse birth outcomes, but systematic efforts to measure relevant experiences among childbearing women have been limited. We explored the racism experiences of childbearing African-American women to inform subsequent development of improved measures for birth outcomes research. Methods Six focus groups were conducted with a total of 40 socioeconomically diverse African-American women of childbearing age in four northern California cities. Results Women reported experiencing racism (1) throughout the lifecourse, with childhood experiences seeming particularly salient and to have especially enduring effects (2) directly and vicariously, particularly in relation to their children; (3) in interpersonal, institutional, and internalized forms; (4) across different life domains; (5) with active and passive responses; and (6) with pervasive vigilance, anticipating threats to themselves and their children. Conclusions This exploratory study's findings support the need for measures reflecting the complexity of childbearing African-American women's racism experiences. In addition to discrete, interpersonal experiences across multiple domains and active/passive responses, which have been measured, birth outcomes research should also measure women's childhood experiences and their potentially enduring impact, perceptions of institutionalized racism and internalized negative stereotypes, vicarious experiences related to their children, vigilance in anticipating future racism events, as well as the pervasiveness and chronicity of racism exposure, all of which could be sources of ongoing stress with potentially serious implications for birth outcomes. Measures of racism addressing these issues should be developed and formally tested. PMID:18463971

Lack of knowledge and training are the major obstacles in application of the Spinal Cord Independence Measure (SCIM) in China.

PubMed

Liu, Nan; Xing, Huayi; Zhou, Mouwang; Biering-Sørensen, Fin

2018-03-29

Objective To investigate the use of functional outcome measurements after spinal cord injury (SCI) in current clinical practice and to explore the knowledge about the Spinal Cord Independence Measure (SCIM) among SCI physicians in China, and to find facilitators for a broader utilization of SCIM. Design A survey-based study. Setting SCI workshops at Peking University. Participants 125 Chinese SCI physicians attending annual workshops in two consecutive years. Interventions Not applicable. Outcome measures A questionnaire was administered. The following items were included: whether functional outcome measurement for SCI individuals was performed and with which assessment tool(s); what items should be included in the assessment; whether they knew about the SCIM, its latest version, the Chinese translation, and if so from what source; the possible reasons why SCIM was not implemented in clinical practice; and whether training before using the SCIM was needed, and the training method preferred. Results Among these physicians, 84.8% performed functional outcome measurement for individuals with SCI, but only 29.6% of attendees were aware of the SCIM and 20.8% had used it. Lack of training was the major reason why SCIM was not used in clinical practice. Furthermore, 74.4% of the physicians felt they needed formal training before using the SCIM. Conclusion The use of SCIM is limited in clinical practice in China, which is mainly attributed to lack of knowledge and training. Formal training on the use of the SCIM is essential for its dissemination and will improve functional SCI outcome measurement in China.

Examining the Bricks and Mortar of Socioeconomic Status: An Empirical Comparison of Measurement Methods

ERIC Educational Resources Information Center

Markle, Ross Edward

2010-01-01

The impact of socioeconomic status (SES) on educational outcomes has been widely demonstrated in the fields of sociology, psychology, and educational research. Across these fields however, measurement models of SES vary, including single indicators (parental income, education, and occupation), multiple indicators, hierarchical models, and most…

Reliability and Validity of the Alcohol Consequences Expectations Scale

ERIC Educational Resources Information Center

Arriola, Kimberly R. Jacob; Usdan, Stuart; Mays, Darren; Weitzel, Jessica Aungst; Cremeens, Jennifer; Martin, Ryan J.; Borba, Christina; Bernhardt, Jay M.

2009-01-01

Objectives: To examine the reliability and validity of a new measure of alcohol outcome expectations for college students, the Alcohol Consequences Expectations Scale (ACES). Methods: College students (N = 169) completed the ACES and several other measures. Results: Results support the existence of 5 internally consistent subscales. Additionally,…

Readability of Self-Report Measures of Depression and Anxiety

ERIC Educational Resources Information Center

McHugh, R. Kathryn; Behar, Evelyn

2009-01-01

As the demand for accountability in service provision settings increases, the need for valid methods for assessing clinical outcomes is of particular importance. Self-report measures of functioning are particularly useful in the assessment of psychological functioning, but a vital factor in their validity and transportability is the reading level…

Guide to the assessment of physical activity: Clinical and research applications: a scientific statement from the American Heart Association.

PubMed

Strath, Scott J; Kaminsky, Leonard A; Ainsworth, Barbara E; Ekelund, Ulf; Freedson, Patty S; Gary, Rebecca A; Richardson, Caroline R; Smith, Derek T; Swartz, Ann M

2013-11-12

The deleterious health consequences of physical inactivity are vast, and they are of paramount clinical and research importance. Risk identification, benchmarks, efficacy, and evaluation of physical activity behavior change initiatives for clinicians and researchers all require a clear understanding of how to assess physical activity. In the present report, we have provided a clear rationale for the importance of assessing physical activity levels, and we have documented key concepts in understanding the different dimensions, domains, and terminology associated with physical activity measurement. The assessment methods presented allow for a greater understanding of the vast number of options available to clinicians and researchers when trying to assess physical activity levels in their patients or participants. The primary outcome desired is the main determining factor in the choice of physical activity assessment method. In combination with issues of feasibility/practicality, the availability of resources, and administration considerations, the desired outcome guides the choice of an appropriate assessment tool. The decision matrix, along with the accompanying tables, provides a mechanism for this selection that takes all of these factors into account. Clearly, the assessment method adopted and implemented will vary depending on circumstances, because there is no single best instrument appropriate for every situation. In summary, physical activity assessment should be considered a vital health measure that is tracked regularly over time. All other major modifiable cardiovascular risk factors (diabetes mellitus, hypertension, hypercholesterolemia, obesity, and smoking) are assessed routinely. Physical activity status should also be assessed regularly. Multiple physical activity assessment methods provide reasonably accurate outcome measures, with choices dependent on setting-specific resources and constraints. The present scientific statement provides a guide to allow professionals to make a goal-specific selection of a meaningful physical activity assessment method.

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study

PubMed Central

2012-01-01

Background A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Methods Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. Results The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Conclusion Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity. PMID:22510227

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

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

Neural activity during affect labeling predicts expressive writing effects on well-being: GLM and SVM approaches

PubMed Central

Memarian, Negar; Torre, Jared B.; Haltom, Kate E.; Stanton, Annette L.

2017-01-01

Abstract Affect labeling (putting feelings into words) is a form of incidental emotion regulation that could underpin some benefits of expressive writing (i.e. writing about negative experiences). Here, we show that neural responses during affect labeling predicted changes in psychological and physical well-being outcome measures 3 months later. Furthermore, neural activity of specific frontal regions and amygdala predicted those outcomes as a function of expressive writing. Using supervised learning (support vector machines regression), improvements in four measures of psychological and physical health (physical symptoms, depression, anxiety and life satisfaction) after an expressive writing intervention were predicted with an average of 0.85% prediction error [root mean square error (RMSE) %]. The predictions were significantly more accurate with machine learning than with the conventional generalized linear model method (average RMSE: 1.3%). Consistent with affect labeling research, right ventrolateral prefrontal cortex (RVLPFC) and amygdalae were top predictors of improvement in the four outcomes. Moreover, RVLPFC and left amygdala predicted benefits due to expressive writing in satisfaction with life and depression outcome measures, respectively. This study demonstrates the substantial merit of supervised machine learning for real-world outcome prediction in social and affective neuroscience. PMID:28992270

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.

Evaluating the Impact of the U.S. National Toxicology Program: A Case Study on Hexavalent Chromium.

PubMed

Xie, Yun; Holmgren, Stephanie; Andrews, Danica M K; Wolfe, Mary S

2017-02-01

Evaluating the impact of federally funded research with a broad, methodical, and objective approach is important to ensure that public funds advance the mission of federal agencies. We aimed to develop a methodical approach that would yield a broad assessment of National Toxicology Program's (NTP's) effectiveness across multiple sectors and demonstrate the utility of the approach through a case study. A conceptual model was developed with defined activities, outputs (products), and outcomes (proximal, intermediate, distal) and applied retrospectively to NTP's research on hexavalent chromium (CrVI). Proximal outcomes were measured by counting views of and requests for NTP's products by external stakeholders. Intermediate outcomes were measured by bibliometric analysis. Distal outcomes were assessed through Web and LexisNexis searches for documents related to legislation or regulation changes. The approach identified awareness of NTP's work on CrVI by external stakeholders (proximal outcome) and citations of NTP's research in scientific publications, reports, congressional testimonies, and legal and policy documents (intermediate outcome). NTP's research was key to the nation's first-ever drinking water standard for CrVI adopted by California in 2014 (distal outcome). By applying this approach to a case study, the utility and limitations of the approach were identified, including challenges to evaluating the outcomes of a research program. This study identified a broad and objective approach for assessing NTP's effectiveness, including methodological needs for more thorough and efficient impact assessments in the future. Citation: Xie Y, Holmgren S, Andrews DMK, Wolfe MS. 2017. Evaluating the impact of the U.S. National Toxicology Program: a case study on hexavalent chromium. Environ Health Perspect 125:181-188; http://dx.doi.org/10.1289/EHP21.

Designing and Evaluating an Interprofessional Experiential Course Series Involving Medical and Pharmacy Students

PubMed Central

Dueñas, Gladys G.; Zanoni, Aileen; Grover, Anisha B.

2016-01-01

Objective. To prepare first-year and second-year pharmacy and medical students to build effective collaborative health care teams by participating in an interprofessional experiential 6-semester course series. Design. An interprofessional experiential course series was designed using a variety of teaching methods to achieve both interprofessional and experiential learning outcomes. A standardized objective behavioral assessment was developed to measure team performance of interprofessional communication and teamwork. In addition, student perceptions were measured using a validated instrument. Assessment. A majority of teams demonstrated appropriate competence with respect to interprofessional communication and teamwork. Additionally, a majority of students expressed positive perceptions of interprofessional collaboration with respect to teamwork, roles and responsibilities, and patient outcomes. Conclusion. An interprofessional experiential course series can be successfully implemented to achieve both interprofessional and experiential learning outcomes. Highly collaborative teams and positive student perceptions provide evidence of achievement of interprofessional education learning outcomes. PMID:27402988

Building a bridge for integrating Chinese medicine into conventional healthcare: observations drawn from the development of the Chinese quality of life instrument.

PubMed

Zhao, Li; Chan, Kelvin

2005-01-01

This paper describes the methods and theories of patient-reported outcomes, in particular to the health-related quality of life recently applied in Chinese medicine research. It begins with an investigation of the reasons for a patient-reported outcomes measure for Chinese medicine and the development of a new health-related quality of life instrument based on Chinese culture and Chinese medicine. Discussions on the importance and application of patient-reported outcomes as well as the relationship between quality of life and Chinese medicine are at the focus of this paper. Through a description of the Chinese Quality of Life Instrument and its development, the present work demonstrates an evidence-based approach using patient-reported outcomes or health-related quality of life measures to evaluate treatment efficacy of Chinese medicine, and thereby build a bridge for the integration of Chinese medicine into mainstream health care.

The Positive Effect of Resilience on Stress and Business Outcomes in Difficult Work Environments

PubMed Central

Shatté, Andrew; Perlman, Adam; Smith, Brad; Lynch, Wendy D.

2017-01-01

Objective: To examine whether resilience has a protective effect in difficult work environments. Methods: A survey of 2063 individuals measured individual resilience, stress, burnout, sleep problems, likelihood of depression, job satisfaction, intent to quit, absences, and productivity. It also measured work characteristics: job demands, job influence, and social support. Multivariate and logistic regression models examined the main effects and interactions of resilience and job characteristics. Results: High strain work environments (high demand, low influence, and low support) have an unfavorable effect on all outcomes. Resilience has a protective effect on all outcomes. For stress, burnout, and sleep, higher resilience has a more protective effect under low-strain conditions. For depression, absence and productivity, resilience has a more protective effect when job strain is high. Conclusions: Workers with high resilience have better outcomes in difficult work environments. PMID:28002352

Multiple imputation for assessment of exposures to drinking water contaminants: evaluation with the Atrazine Monitoring Program.

PubMed

Jones, Rachael M; Stayner, Leslie T; Demirtas, Hakan

2014-10-01

Drinking water may contain pollutants that harm human health. The frequency of pollutant monitoring may occur quarterly, annually, or less frequently, depending upon the pollutant, the pollutant concentration, and community water system. However, birth and other health outcomes are associated with narrow time-windows of exposure. Infrequent monitoring impedes linkage between water quality and health outcomes for epidemiological analyses. To evaluate the performance of multiple imputation to fill in water quality values between measurements in community water systems (CWSs). The multiple imputation method was implemented in a simulated setting using data from the Atrazine Monitoring Program (AMP, 2006-2009 in five Midwestern states). Values were deleted from the AMP data to leave one measurement per month. Four patterns reflecting drinking water monitoring regulations were used to delete months of data in each CWS: three patterns were missing at random and one pattern was missing not at random. Synthetic health outcome data were created using a linear and a Poisson exposure-response relationship with five levels of hypothesized association, respectively. The multiple imputation method was evaluated by comparing the exposure-response relationships estimated based on multiply imputed data with the hypothesized association. The four patterns deleted 65-92% months of atrazine observations in AMP data. Even with these high rates of missing information, our procedure was able to recover most of the missing information when the synthetic health outcome was included for missing at random patterns and for missing not at random patterns with low-to-moderate exposure-response relationships. Multiple imputation appears to be an effective method for filling in water quality values between measurements. Copyright © 2014 Elsevier Inc. All rights reserved.

Recommendations for a mixed methods approach to evaluating the patient-centered medical home.

PubMed

Goldman, Roberta E; Parker, Donna R; Brown, Joanna; Walker, Judith; Eaton, Charles B; Borkan, Jeffrey M

2015-03-01

There is a strong push in the United States to evaluate whether the patient-centered medical home (PCMH) model produces desired results. The explanatory and contextually based questions of how and why PCMH succeeds in different practice settings are often neglected. We report the development of a comprehensive, mixed qualitative-quantitative evaluation set for researchers, policy makers, and clinician groups. To develop an evaluation set, the Brown Primary Care Transformation Initiative convened a multidisciplinary group of PCMH experts, reviewed the PCMH literature and evaluation strategies, developed key domains for evaluation, and selected or created methods and measures for inclusion. The measures and methods in the evaluation set (survey instruments, PCMH meta-measures, patient outcomes, quality measures, qualitative interviews, participant observation, and process evaluation) are meant to be used together. PCMH evaluation must be sufficiently comprehensive to assess and explain both the context of transformation in different primary care practices and the experiences of diverse stakeholders. In addition to commonly assessed patient outcomes, quality, and cost, it is critical to include PCMH components integral to practice culture transformation: patient and family centeredness, authentic patient activation, mutual trust among practice employees and patients, and transparency, joy, and collaboration in delivering and receiving care in a changing environment. This evaluation set offers a comprehensive methodology to enable understanding of how PCMH transformation occurs in different practice settings. This approach can foster insights about how transformation affects critical outcomes to achieve meaningful, patient-centered, high-quality, and cost-effective sustainable change among diverse primary care practices. © 2015 Annals of Family Medicine, Inc.

Outcomes in pediatric neurology: a review of conceptual issues and recommendationsThe 2010 Ronnie Mac Keith Lecture.

PubMed

Ronen, Gabriel M; Fayed, Nora; Rosenbaum, Peter L

2011-04-01

This paper discusses how to evaluate whether, and in what ways, treatments affect the lives of children with neurological conditions and their families. We argue that professionals should incorporate perspectives from patients and families to help them make decisions about what 'outcomes' are important, and we discuss how those outcomes might be assessed. A case vignette illustrates the differences and complementarity between the perspectives of clinicians and those of children and their parents. We recommend methods for expanding the range of relevant health outcomes in child neurology to include those that reflect the ways patients and families view their conditions and our interventions. We explore the added value of a 'non-categorical' approach to the choice of outcomes. The International Classification of Functioning, Disability and Health is a useful biopsychosocial framework to 'rule in' relevant aspects of child and family issues to create a dynamic system of possible influences on outcomes. We examine the meaning of 'health', 'health-related quality of life', and 'quality of life' as related but conceptually distinct outcomes. Specific issues are discussed about the construction, validation, and appraisal of outcome measures, as well as practical recommendations on how to select outcome measures in the clinical setting and research. © The Authors. Developmental Medicine & Child Neurology © 2011 Mac Keith Press.

Developing a Framework to Generate Evidence of Health Outcomes From Social Media Use in Chronic Disease Management

PubMed Central

Gray, Kathleen; Martin-Sanchez, Fernando

2013-01-01

Background While there is an abundance of evidence-based practice (EBP) recommendations guiding management of various chronic diseases, evidence suggesting best practice for using social media to improve health outcomes is inadequate. The variety of social media platforms, multiple potential uses, inconsistent definitions, and paucity of rigorous studies, make it difficult to measure health outcomes reliably in chronic disease management. Most published investigations report on an earlier generation of online tools, which are not as user-centered, participatory, engaging, or collaborative, and thus may work differently for health self-management. Objective The challenge to establish a sound evidence base for social media use in chronic disease starts with the need to define criteria and methods to generate and evaluate evidence. The authors’ key objective is to develop a framework for research and practice that addresses this challenge. Methods This paper forms part of a larger research project that presents a conceptual framework of how evidence of health outcomes can be generated from social media use, allowing social media to be utilized in chronic disease management more effectively. Using mixed methods incorporating a qualitative literature review, a survey and a pilot intervention, the research closely examines the therapeutic affordances of social media, people with chronic pain (PWCP) as a subset of chronic disease management, valid outcome measurement of patient-reported (health) outcomes (PRO), the individual needs of people living with chronic disease, and finally translation of the combined results to improve evidence-based decision making about social media use in this context. Results Extensive review highlights various affordances of social media that may prove valuable to understanding social media’s effect on individual health outcomes. However, without standardized PRO instruments, we are unable to definitively investigate these effects. The proposed framework that we offer outlines how therapeutic affordances of social media coupled with valid and reliable PRO measurement may be used to generate evidence of improvements in health outcomes, as well as guide evidence-based decision making in the future about social media use as part of chronic disease self-management. Conclusions The results will (1) inform a framework for conducting research into health outcomes from social media use in chronic disease, as well as support translating the findings into evidence of improved health outcomes, and (2) inform a set of recommendations for evidence-based decision making about social media use as part of chronic disease self-management. These outcomes will fill a gap in the knowledge and resources available to individuals managing a chronic disease, their clinicians and other researchers in chronic disease and the field of medicine 2.0. PMID:25075238

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

PubMed

Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

2018-02-01

The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Quantifying Genome Editing Outcomes at Endogenous Loci using SMRT Sequencing

PubMed Central

Clark, Joseph; Punjya, Niraj; Sebastiano, Vittorio; Bao, Gang; Porteus, Matthew H

2014-01-01

SUMMARY Targeted genome editing with engineered nucleases has transformed the ability to introduce precise sequence modifications at almost any site within the genome. A major obstacle to probing the efficiency and consequences of genome editing is that no existing method enables the frequency of different editing events to be simultaneously measured across a cell population at any endogenous genomic locus. We have developed a novel method for quantifying individual genome editing outcomes at any site of interest using single molecule real time (SMRT) DNA sequencing. We show that this approach can be applied at various loci, using multiple engineered nuclease platforms including TALENs, RNA guided endonucleases (CRISPR/Cas9), and ZFNs, and in different cell lines to identify conditions and strategies in which the desired engineering outcome has occurred. This approach facilitates the evaluation of new gene editing technologies and permits sensitive quantification of editing outcomes in almost every experimental system used. PMID:24685129

Comparison of CTT and Rasch-based approaches for the analysis of longitudinal Patient Reported Outcomes.

PubMed

Blanchin, Myriam; Hardouin, Jean-Benoit; Le Neel, Tanguy; Kubis, Gildas; Blanchard, Claire; Mirallié, Eric; Sébille, Véronique

2011-04-15

Health sciences frequently deal with Patient Reported Outcomes (PRO) data for the evaluation of concepts, in particular health-related quality of life, which cannot be directly measured and are often called latent variables. Two approaches are commonly used for the analysis of such data: Classical Test Theory (CTT) and Item Response Theory (IRT). Longitudinal data are often collected to analyze the evolution of an outcome over time. The most adequate strategy to analyze longitudinal latent variables, which can be either based on CTT or IRT models, remains to be identified. This strategy must take into account the latent characteristic of what PROs are intended to measure as well as the specificity of longitudinal designs. A simple and widely used IRT model is the Rasch model. The purpose of our study was to compare CTT and Rasch-based approaches to analyze longitudinal PRO data regarding type I error, power, and time effect estimation bias. Four methods were compared: the Score and Mixed models (SM) method based on the CTT approach, the Rasch and Mixed models (RM), the Plausible Values (PV), and the Longitudinal Rasch model (LRM) methods all based on the Rasch model. All methods have shown comparable results in terms of type I error, all close to 5 per cent. LRM and SM methods presented comparable power and unbiased time effect estimations, whereas RM and PV methods showed low power and biased time effect estimations. This suggests that RM and PV methods should be avoided to analyze longitudinal latent variables. Copyright © 2010 John Wiley & Sons, Ltd.

Measuring continuous baseline covariate imbalances in clinical trial data

PubMed Central

Ciolino, Jody D.; Martin, Renee’ H.; Zhao, Wenle; Hill, Michael D.; Jauch, Edward C.; Palesch, Yuko Y.

2014-01-01

This paper presents and compares several methods of measuring continuous baseline covariate imbalance in clinical trial data. Simulations illustrate that though the t-test is an inappropriate method of assessing continuous baseline covariate imbalance, the test statistic itself is a robust measure in capturing imbalance in continuous covariate distributions. Guidelines to assess effects of imbalance on bias, type I error rate, and power for hypothesis test for treatment effect on continuous outcomes are presented, and the benefit of covariate-adjusted analysis (ANCOVA) is also illustrated. PMID:21865270

Comparison of two- and three-dimensional assessment methods of nasolabial appearance in cleft lip and palate patients: Do the assessment methods measure the same outcome?

PubMed

Mosmuller, David G M; Maal, Thomas J; Prahl, Charlotte; Tan, Robin A; Mulder, Frans J; Schwirtz, Roderic M F; de Vet, Henrica C W; Bergé, Stefaan J; Don Griot, J P W

2017-08-01

For the assessment of the nasolabial appearance in cleft patients, a widely accepted, reliable scoring system is not available. In this study four different methods of assessment are compared, including 2D and 3D asymmetry and aesthetic assessments. The data and ratings from an earlier study using the Asher-McDade aesthetic index on 3D photographs and the outcomes of 3D facial distance mapping were compared to a 2D aesthetic assessment, the Cleft Aesthetic Rating Scale, and to SymNose, a computerized 2D asymmetry assessment technique. The reliability and correlation between the four assessment techniques were tested using a sample of 79 patients. The 3D asymmetry assessment had the highest reliability and could be performed by just one observer (Intraclass correlation coefficient (ICC): 0.99). The 2D asymmetry assessment of the nose was highly reliable when performed by just one observer (ICC: 0.89). However, for the 2D asymmetry assessment of the lip more observers were needed. For the 2D aesthetic assessments 3 observers were needed. The 3D aesthetic assessment had the lowest single-observer reliability (ICC: 0.38-0.56) of all four techniques. The agreement between the different assessment methods is poor to very poor. The highest correlation (R: 0.48) was found between 2D and 3D aesthetic assessments. Remarkably, the lowest correlations were found between 2D and 3D asymmetry assessments (0.08-0.17). Different assessment methods are not in agreement and seem to measure different nasolabial aspects. More research is needed to establish exactly what each assessment technique measures and which measurements or outcomes are relevant for the patients. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Age estimation by assessment of pulp chamber volume: a Bayesian network for the evaluation of dental evidence.

PubMed

Sironi, Emanuele; Taroni, Franco; Baldinotti, Claudio; Nardi, Cosimo; Norelli, Gian-Aristide; Gallidabino, Matteo; Pinchi, Vilma

2017-11-14

The present study aimed to investigate the performance of a Bayesian method in the evaluation of dental age-related evidence collected by means of a geometrical approximation procedure of the pulp chamber volume. Measurement of this volume was based on three-dimensional cone beam computed tomography images. The Bayesian method was applied by means of a probabilistic graphical model, namely a Bayesian network. Performance of that method was investigated in terms of accuracy and bias of the decisional outcomes. Influence of an informed elicitation of the prior belief of chronological age was also studied by means of a sensitivity analysis. Outcomes in terms of accuracy were adequate with standard requirements for forensic adult age estimation. Findings also indicated that the Bayesian method does not show a particular tendency towards under- or overestimation of the age variable. Outcomes of the sensitivity analysis showed that results on estimation are improved with a ration elicitation of the prior probabilities of age.

Botulinum Toxin Type A Injections in the Psoas Muscle of Children with Cerebral Palsy: Muscle Atrophy after Motor End Plate-Targeted Injections

ERIC Educational Resources Information Center

Van Campenhout, Anja; Verhaegen, Ann; Pans, Steven; Molenaers, Guy

2013-01-01

MEP targeting during BoNT-A injections has been demonstrated to improve outcome. Two injection techniques of the psoas muscle--proximal MEP targeting versus a widely used more distal injection technique--are compared using muscle volume assessment by digital MRI segmentation as outcome measure. Method: 7 spastic diplegic children received…

Development and Validation of the Delinquency Reduction Outcome Profile (DROP) in a Sample of Incarcerated Juveniles: A Multiconstruct/Multisituational Scoring Approach

ERIC Educational Resources Information Center

Barbot, Baptiste; Haeffel, Gerald J.; Macomber, Donna; Hart, Lesley; Chapman, John; Grigorenko, Elena L.

2012-01-01

The "Delinquency Reduction Outcome Profile" ("DROP") is a novel situational-judgment test (SJT) designed to measure social decision making in delinquent youth. The DROP includes both a typical SJT scoring method, which captures the deviation of an individual response from an "ideal" expert-based response pattern, as well as a novel…

Brief Report: Do Service Dog Providers Placing Dogs with Children with Developmental Disabilities Use Outcome Measures and, if So, What Are They?

ERIC Educational Resources Information Center

Butterly, Felicity; Percy, Carol; Ward, Gillian

2013-01-01

The aim of this study was to identify the outcomes expected and assessed by those providing service dogs to children with developmental disabilities. Seventeen registered service dog providers were invited to complete a mixed methods online survey. Five providers, who prepared dogs to work with a wide range of conditions and behaviours, mainly…

An International Standard Set of Patient-Centered Outcome Measures After Stroke.

PubMed

Salinas, Joel; Sprinkhuizen, Sara M; Ackerson, Teri; Bernhardt, Julie; Davie, Charlie; George, Mary G; Gething, Stephanie; Kelly, Adam G; Lindsay, Patrice; Liu, Liping; Martins, Sheila C O; Morgan, Louise; Norrving, Bo; Ribbers, Gerard M; Silver, Frank L; Smith, Eric E; Williams, Linda S; Schwamm, Lee H

2016-01-01

Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings. © 2015 The Authors.

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

Toward the Development of Integrative Risk-Adjusted Measures of Quality Using Large Clinical Data Bases: The Case of Anesthesia Services.

ERIC Educational Resources Information Center

Fleming, Steven T.

1992-01-01

The concept of risk-adjusted measures of quality is discussed, and a methodology is proposed for risk-adjusting and integrating multiple adverse outcomes of anesthesia services into measures for quality assurance and quality improvement programs. Although designed for a new anesthesiology database, the methods should apply to other health…

Review: A Systematic Review of Quality of Life Measures for People with Intellectual Disabilities and Challenging Behaviours

ERIC Educational Resources Information Center

Townsend-White, C.; Pham, A. N. T.; Vassos, M. V.

2012-01-01

Background: The quality of life (QOL) construct is proposed as a method to assess service outcomes for people utilising disability services. With this in mind, the aim of this study was to conduct a systematic review of available QOL measures for people with intellectual disability (ID) to pinpoint psychometrically sound measures that can be…

Exploring Outcome Measures for Exercise Intervention in People with Parkinson's Disease

PubMed Central

King, L. A.; Salarian, A.; Mancini, M.; Priest, K. C.; Nutt, J.; Serdar, A.; Wilhelm, J.; Schlimgen, J.; Smith, M.; Horak, F. B.

2013-01-01

Background. It is widely believed that exercise improves mobility in people with Parkinson's disease (PD). However, it is difficult to determine whether a specific type of exercise is the most effective. The purpose of this study was to determine which outcome measures were sensitive to exercise intervention and to explore the effects of two different exercise programs for improving mobility in patients with PD. Methods. Participants were randomized into either the Agility Boot Camp (ABC) or treadmill training; 4x/week for 4 weeks. Outcome measures were grouped by the International Classification of Function/Disability (ICF). To determine the responsiveness to exercise, we calculated the standardized response means. t-tests were used to compare the relative benefits of each exercise program. Results. Four of five variables at the structure/function level changed after exercise: turn duration (P = 0.03), stride velocity (P = 0.001), peak arm speed (P = 0.001), and horizontal trunk ROM during gait (P = 0.02). Most measures improved similarly for both interventions. The only variable that detected a difference between groups was postural sway in ABC group (F = 4.95; P = 0.03). Conclusion. Outcome measures at ICF body structure/function level were most effective at detecting change after exercise and revealing differences in improvement between interventions. PMID:23738230

Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse

PubMed Central

2013-01-01

Background Involving patients in treatment is becoming increasingly popular in mental health [Sales & Alves: Personalized evaluation of psychological treatments: A review of tools and research designs, submitted]. However, in substance misuse treatment settings, the patient perspective about treatment tends to be overlooked. This has been cited as a key priority by Orford et al. [Addiction, 103: 875-885, 2008] who included patient feedback about treatment as one of ten areas requiring an urgent paradigm shift in addiction research and practice. This project will apply an innovative method to involve substance misuse patients in psychological therapies, by asking them to suggest topics to evaluate their treatment. These topics suggested by patients can be written as a list of personalised items, so-called as patient-generated outcome measures (PGOM). Despite its patient-friendly features, PGOM’s have never been used in this population, which is what this project aims to overcome. Methods/design This project is part of an International Exchange Platform on Personalising Addiction Treatment. Data will be collected in two phases (pre-post study and focus groups with patients) to explore the following: 1). How reliable and sensitive to change are PGOM’s and standardised measures in substance misuse treatment? 2). Do PGOM’s add relevant information to standardised measures? 3). What are the views of substance misuse patients about personalised outcome assessment? 4). Development of guidelines on using PGOM’s in this population Discussion This research will potentially demonstrate the diversity of personal problems among patients seeking substance misuse treatment, suggesting the relevance of PGOM as a method to personalise outcome measurement and, ultimately, guiding treatment provision. It is expected that, as in previous studies, PGOM’s will be perceived as helpful and patient-friendly tools, where patients may express their own concerns in a semi-structured setting. Similarly to other populations, we also expect PGOM’s to be reliable, valid and sensitive to clinical changes in substance misuse treatment, as well as more content informative than their standardised counterparts. If these results are achieved, we might hypothesize that PGOM’s are a potentially valid supplement to traditional standardised scales, by providing a closer insight to what motivates patients to participate in substance misuse treatment programmes. PMID:24341378

HRM and its effect on employee, organizational and financial outcomes in health care organizations

PubMed Central

2014-01-01

Background One of the main goals of Human Resource Management (HRM) is to increase the performance of organizations. However, few studies have explicitly addressed the multidimensional character of performance and linked HR practices to various outcome dimensions. This study therefore adds to the literature by relating HR practices to three outcome dimensions: financial, organizational and employee (HR) outcomes. Furthermore, we will analyze how HR practices influence these outcome dimensions, focusing on the mediating role of job satisfaction. Methods This study uses a unique dataset, based on the ‘ActiZ Benchmark in Healthcare’, a benchmark study conducted in Dutch home care, nursing care and care homes. Data from autumn 2010 to autumn 2011 were analyzed. In total, 162 organizations participated during this period (approximately 35% of all Dutch care organizations). Employee data were collected using a questionnaire (61,061 individuals, response rate 42%). Clients were surveyed using the Client Quality Index for long-term care, via stratified sampling. Financial outcomes were collected using annual reports. SEM analyses were conducted to test the hypotheses. Results It was found that HR practices are - directly or indirectly - linked to all three outcomes. The use of HR practices is related to improved financial outcomes (measure: net margin), organizational outcomes (measure: client satisfaction) and HR outcomes (measure: sickness absence). The impact of HR practices on HR outcomes and organizational outcomes proved substantially larger than their impact on financial outcomes. Furthermore, with respect to HR and organizational outcomes, the hypotheses concerning the full mediating effect of job satisfaction are confirmed. This is in line with the view that employee attitudes are an important element in the ‘black box’ between HRM and performance. Conclusion The results underscore the importance of HRM in the health care sector, especially for HR and organizational outcomes. Further analyses of HRM in the health care sector will prove to be a productive endeavor for both scholars and HR managers. PMID:24938460

Measuring team factors thought to influence the success of quality improvement in primary care: a systematic review of instruments

PubMed Central

2013-01-01

Background Measuring team factors in evaluations of Continuous Quality Improvement (CQI) may provide important information for enhancing CQI processes and outcomes; however, the large number of potentially relevant factors and associated measurement instruments makes inclusion of such measures challenging. This review aims to provide guidance on the selection of instruments for measuring team-level factors by systematically collating, categorizing, and reviewing quantitative self-report instruments. Methods Data sources: We searched MEDLINE, PsycINFO, and Health and Psychosocial Instruments; reference lists of systematic reviews; and citations and references of the main report of instruments. Study selection: To determine the scope of the review, we developed and used a conceptual framework designed to capture factors relevant to evaluating CQI in primary care (the InQuIRe framework). We included papers reporting development or use of an instrument measuring factors relevant to teamwork. Data extracted included instrument purpose; theoretical basis, constructs measured and definitions; development methods and assessment of measurement properties. Analysis and synthesis: We used qualitative analysis of instrument content and our initial framework to develop a taxonomy for summarizing and comparing instruments. Instrument content was categorized using the taxonomy, illustrating coverage of the InQuIRe framework. Methods of development and evidence of measurement properties were reviewed for instruments with potential for use in primary care. Results We identified 192 potentially relevant instruments, 170 of which were analyzed to develop the taxonomy. Eighty-one instruments measured constructs relevant to CQI teams in primary care, with content covering teamwork context (45 instruments measured enabling conditions or attitudes to teamwork), team process (57 instruments measured teamwork behaviors), and team outcomes (59 instruments measured perceptions of the team or its effectiveness). Forty instruments were included for full review, many with a strong theoretical basis. Evidence supporting measurement properties was limited. Conclusions Existing instruments cover many of the factors hypothesized to contribute to QI success. With further testing, use of these instruments measuring team factors in evaluations could aid our understanding of the influence of teamwork on CQI outcomes. Greater consistency in the factors measured and choice of measurement instruments is required to enable synthesis of findings for informing policy and practice. PMID:23410500

Risk measures for power failures in transmission systems

NASA Astrophysics Data System (ADS)

Cassidy, Alex; Feinstein, Zachary; Nehorai, Arye

2016-11-01

We present a novel framework for evaluating the risk of failures in power transmission systems. We use the concept of systemic risk measures from the financial mathematics literature with models of power system failures in order to quantify the risk of the entire power system for design and comparative purposes. The proposed risk measures provide the collection of capacity vectors for the components in the system that lead to acceptable outcomes. Keys to the formulation of our measures of risk are two elements: a model of system behavior that provides the (distribution of) outcomes based on component capacities and an acceptability criterion that determines whether a (random) outcome is acceptable from an aggregated point of view. We examine the effects of altering the line capacities on energy not served under a variety of networks, flow manipulation methods, load shedding schemes, and load profiles using Monte Carlo simulations. Our results provide a quantitative comparison of the performance of these schemes, measured by the required line capacity. These results provide more complete descriptions of the risks of power failures than the previous, one-dimensional metrics.

Assessing cosmetic results after breast conserving surgery.

PubMed

Cardoso, Maria João; Oliveira, Helder; Cardoso, Jaime

2014-07-01

"Taking less treating better" has been one of the major improvements of breast cancer surgery in the last four decades. The application of this principle translates into equivalent survival of breast cancer conserving treatment (BCT) when compared to mastectomy, with a better cosmetic outcome. While it is relatively easy to evaluate the oncological results of BCT, the cosmetic outcome is more difficult to measure due to the lack of an effective and consensual procedure. The assessment of cosmetic outcome has been mainly subjective, undertaken by a panel of expert observers or/and by patient self-assessment. Unfortunately, the reproducibility of these methods is low. Objective methods have higher values of reproducibility but still lack the inclusion of several features considered by specialists in BCT to be fundamental for cosmetic outcome. The recent addition of volume information obtained with 3D images seems promising. Until now, unfortunately, no method is considered to be the standard of care. This paper revises the history of cosmetic evaluation and guides us into the future aiming at a method that can easily be used and accepted by all, caregivers and caretakers, allowing not only the comparison of results but the improvement of performance. © 2014 Wiley Periodicals, Inc.

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

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

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

Neonatal and maternal outcomes of successful manual rotation to correct malposition of the fetal head; A retrospective and prospective observational study

PubMed Central

Tempest, Nicola; McGuinness, Naomi; Lane, Steven; Hapangama, Dharani K.

2017-01-01

Objective To evaluate the neonatal and maternal outcomes associated with successful operative vaginal births assisted by manual rotation. Design Prospective and retrospective observational study. Setting Delivery suite in a tertiary referral teaching hospital in England. Population A cohort of 2,426 consecutive operative births, in the second stage of labour, complicated with malposition of the fetal head during 2006–2013. Methods Outcomes of all births successfully assisted by manual rotation followed by direct traction instruments were compared with other methods of operative birth for fetal malposition in the second stage of labour (rotational ventouse, Kielland forceps and caesarean section). Main outcome measures Associated neonatal outcomes (admission to the special care baby unit, low cord pH, low Apgar and shoulder dystocia) and maternal outcomes (massive obstetric haemorrhage (blood loss of >1500ml) and obstetric anal sphincter injury). Results Births successfully assisted with manual rotation followed by direct traction instruments, resulted in 10% (36/346) of the babies being admitted to the Special Care Baby Unit, 4.9% (17/349) shoulder dystocia, 2% (7/349) massive obstetric haemorrhage and 1.7% (6/349) obstetric anal sphincter injury, similar to other methods of rotational births. Conclusions Adverse neonatal and maternal outcomes associated with successful manual rotations followed by direct traction instruments were comparable to traditional methods of operative births. There is an urgent need to standardise the practice (guidance, training) and documentation of manual rotation followed by direct traction instrumental deliveries that will enable assessment of its efficacy and the absolute safety in achieving a vaginal birth. PMID:28489924

Comparing Prognostic Strength of Acute Corticospinal Tract Injury Measured by a New Diffusion Tensor Imaging Based Template Approach Versus Common Approaches

PubMed Central

Hirai, Kelsi K.; Groisser, Benjamin N.; Copen, William A.; Singhal, Aneesh B.; Schaechter, Judith D.

2015-01-01

Background Long-term motor outcome of acute stroke patients with severe motor impairment is difficult to predict. While measure of corticospinal tract (CST) injury based on diffusion tensor imaging (DTI) in subacute stroke patients strongly predicts motor outcome, its predictive value in acute stroke patients is unclear. Using a new DTI-based, density-weighted CST template approach, we demonstrated recently that CST injury measured in acute stroke patients with moderately-severe to severe motor impairment of the upper limb strongly predicts motor outcome of the limb at 6 months. New Method The current study compared the prognostic strength of CST injury measured in 10 acute stroke patients with moderately-severe to severe motor impairment of the upper limb by the new density-weighted CST template approach versus several variants of commonly used DTI-based approaches. Results and Comparison with Existing Methods Use of the density-weighted CST template approach yielded measurements of acute CST injury that correlated most strongly, in absolute magnitude, with 6-month upper limb strength (rs = 0.93), grip (rs = 0.94) and dexterity (rs = 0.89) compared to all other 11 approaches. Formal statistical comparison of correlation coefficients revealed that acute CST injury measured by the density-weighted CST template approach correlated significantly more strongly with 6-month upper limb strength, grip and dexterity than 9, 10 and 6 of the 11 alternative measurements, respectively. Conclusions Measurements of CST injury in acute stroke patients with substantial motor impairment by the density-weighted CST template approach may have clinical utility for anticipating healthcare needs and improving clinical trial design. PMID:26386285

Measurement equivalence and differential item functioning in family psychology.

PubMed

Bingenheimer, Jeffrey B; Raudenbush, Stephen W; Leventhal, Tama; Brooks-Gunn, Jeanne

2005-09-01

Several hypotheses in family psychology involve comparisons of sociocultural groups. Yet the potential for cross-cultural inequivalence in widely used psychological measurement instruments threatens the validity of inferences about group differences. Methods for dealing with these issues have been developed via the framework of item response theory. These methods deal with an important type of measurement inequivalence, called differential item functioning (DIF). The authors introduce DIF analytic methods, linking them to a well-established framework for conceptualizing cross-cultural measurement equivalence in psychology (C.H. Hui and H.C. Triandis, 1985). They illustrate the use of DIF methods using data from the Project on Human Development in Chicago Neighborhoods (PHDCN). Focusing on the Caregiver Warmth and Environmental Organization scales from the PHDCN's adaptation of the Home Observation for Measurement of the Environment Inventory, the authors obtain results that exemplify the range of outcomes that may result when these methods are applied to psychological measurement instruments. (c) 2005 APA, all rights reserved

Periodontal Research: Basics and beyond – Part II (Ethical issues, sampling, outcome measures and bias)

PubMed Central

Avula, Haritha

2013-01-01

A good research beginning refers to formulating a well-defined research question, developing a hypothesis and choosing an appropriate study design. The first part of the review series has discussed these issues in depth and this paper intends to throw light on other issues pertaining to the implementation of research. These include the various ethical norms and standards in human experimentation, the eligibility criteria for the participants, sampling methods and sample size calculation, various outcome measures that need to be defined and the biases that can be introduced in research. PMID:24174747

Improving Evaluation of Dental Hygiene Students' Cultural Competence with a Mixed-Methods Approach.

PubMed

Flynn, Priscilla; Sarkarati, Nassim

2018-02-01

Most dental hygiene educational programs include cultural competence education, but may not evaluate student outcomes. The aim of this study was to design and implement a mixed-methods evaluation to measure dental hygiene students' progression toward cultural competence. Two cohorts consisting of consecutive classes in one U.S. dental hygiene program participated in the study. A total of 47 dental hygiene students (100% response rate) completed self-assessments to measure their attitudes and knowledge at three time points between 2014 and 2016. Mean scores were calculated for three domains: Physical Environment, Communication, and Values. Qualitative analysis of the students' cultural diversity papers was also conducted to further evaluate students' knowledge and skills. Bennett's five-level conceptual framework was used to code phrases or sentences to place students in the general categories of ethnocentric or ethno-relative. The quantitative and qualitative results yielded different outcomes for Cohort 1, but not for Cohort 2. The Cohort 1 students assessed themselves statistically significantly lower over time in one of the three measured domains. However, the Cohort 2 students assessed themselves as statistically significantly more culturally competent in all three domains. Qualitative results placed 72% of Cohort 1 students and 83% of Cohort 2 students in the more desirable ethno-relative category. Since quantitative methods consisting of student self-assessments may not adequately measure students' cultural competence, adding qualitative methods to measure skills specific to patient care in this study added a robust dimension to evaluating this complex dental hygiene student competence.

Quality Measures for the Care of Patients with Insomnia

PubMed Central

Edinger, Jack D.; Buysse, Daniel J.; Deriy, Ludmila; Germain, Anne; Lewin, Daniel S.; Ong, Jason C.; Morgenthaler, Timothy I.

2015-01-01

The American Academy of Sleep Medicine (AASM) commissioned five Workgroups to develop quality measures to optimize management and care for patients with common sleep disorders including insomnia. Following the AASM process for quality measure development, this document describes measurement methods for two desirable outcomes of therapy, improving sleep quality or satisfaction, and improving daytime function, and for four processes important to achieving these goals. To achieve the outcome of improving sleep quality or satisfaction, pre- and post-treatment assessment of sleep quality or satisfaction and providing an evidence-based treatment are recommended. To realize the outcome of improving daytime functioning, pre- and post-treatment assessment of daytime functioning, provision of an evidence-based treatment, and assessment of treatment-related side effects are recommended. All insomnia measures described in this report were developed by the Insomnia Quality Measures Workgroup and approved by the AASM Quality Measures Task Force and the AASM Board of Directors. The AASM recommends the use of these measures as part of quality improvement programs that will enhance the ability to improve care for patients with insomnia. Citation: Edinger JD, Buysse DJ, Deriy L, Germain A, Lewin DS, Ong JC, Morgenthaler TI. Quality measures for the care of patients with insomnia. J Clin Sleep Med 2015;11(3):311–334. PMID:25700881

Achieving Goal-Concordant Care: A Conceptual Model and Approach to Measuring Serious Illness Communication and Its Impact.

PubMed

Sanders, Justin J; Curtis, J Randall; Tulsky, James A

2018-03-01

High-quality care for seriously ill patients aligns treatment with their goals and values. Failure to achieve "goal-concordant" care is a medical error that can harm patients and families. Because communication between clinicians and patients enables goal concordance and also affects the illness experience in its own right, healthcare systems should endeavor to measure communication and its outcomes as a quality assessment. Yet, little consensus exists on what should be measured and by which methods. To propose measurement priorities for serious illness communication and its anticipated outcomes, including goal-concordant care. We completed a narrative review of the literature to identify links between serious illness communication, goal-concordant care, and other outcomes. We used this review to identify gaps and opportunities for quality measurement in serious illness communication. Our conceptual model describes the relationship between communication, goal-concordant care, and other relevant outcomes. Implementation-ready measures to assess the quality of serious illness communication and care include (1) the timing and setting of serious illness communication, (2) patient experience of communication and care, and (3) caregiver bereavement surveys that include assessment of perceived goal concordance of care. Future measurement priorities include direct assessment of communication quality, prospective patient or family assessment of care concordance with goals, and assessment of the bereaved caregiver experience. Improving serious illness care necessitates ensuring that high-quality communication has occurred and measuring its impact. Measuring patient experience and receipt of goal-concordant care should be our highest priority. We have the tools to measure both.

Functional Recovery Measures for Spinal Cord Injury: An Evidence-Based Review for Clinical Practice and Research

PubMed Central

Anderson, Kim; Aito, Sergio; Atkins, Michal; Biering-Sørensen, Fin; Charlifue, Susan; Curt, Armin; Ditunno, John; Glass, Clive; Marino, Ralph; Marshall, Ruth; Mulcahey, Mary Jane; Post, Marcel; Savic, Gordana; Scivoletto, Giorgio; Catz, Amiram

2008-01-01

Background/Objective: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome measures designed to assess functional status relevant to SCI are important to develop. Method: Evaluation of currently available SCI functional outcome measures by a multinational work group. Results: The 4 measures that fit the prespecified inclusion criteria were the Modified Barthel Index (MBI), the Functional Independence Measure (FIM), the Quadriplegia Index of Function (QIF), and the Spinal Cord Independence Measure (SCIM). The MBI and the QIF were found to have minimal evidence for validity, whereas the FIM and the SCIM were found to be reliable and valid. The MBI has little clinical utility for use in the SCI population. Likewise, the FIM applies mainly when measuring burden of care, which is not necessarily a reflection of functional recovery. The QIF is useful for measuring functional recovery but only in a subpopulation of people with SCI, and substantial validity data are still required. The SCIM is the only functional recovery outcome measure designed specifically for SCI. Conclusions: The multinational work group recommends that the latest version of the SCIM (SCIM III) continue to be refined and validated and subsequently implemented worldwide as the primary functional recovery outcome measure for SCI. The QIF may continue to be developed and validated for use as a supplemental tool for the nonambulatory tetraplegic population. PMID:18581660

QUEST+: A general multidimensional Bayesian adaptive psychometric method.

PubMed

Watson, Andrew B

2017-03-01

QUEST+ is a Bayesian adaptive psychometric testing method that allows an arbitrary number of stimulus dimensions, psychometric function parameters, and trial outcomes. It is a generalization and extension of the original QUEST procedure and incorporates many subsequent developments in the area of parametric adaptive testing. With a single procedure, it is possible to implement a wide variety of experimental designs, including conventional threshold measurement; measurement of psychometric function parameters, such as slope and lapse; estimation of the contrast sensitivity function; measurement of increment threshold functions; measurement of noise-masking functions; Thurstone scale estimation using pair comparisons; and categorical ratings on linear and circular stimulus dimensions. QUEST+ provides a general method to accelerate data collection in many areas of cognitive and perceptual science.

Variation in population levels of physical activity in European children and adolescents according to cross-European studies: a systematic literature review within DEDIPAC.

PubMed

Van Hecke, Linde; Loyen, Anne; Verloigne, Maïté; van der Ploeg, Hidde P; Lakerveld, Jeroen; Brug, Johannes; De Bourdeaudhuij, Ilse; Ekelund, Ulf; Donnelly, Alan; Hendriksen, Ingrid; Deforche, Benedicte

2016-06-28

Regular physical activity is associated with physical, social and mental health benefits, whilst insufficient physical activity is associated with several negative health outcomes (e.g. metabolic problems). Population monitoring of physical activity is important to gain insight into prevalence of compliance to physical activity recommendations, groups at risk and changes in physical activity patterns. This review aims to provide an overview of all existing studies that measure physical activity in youth, in cross-European studies, to describe the variation in population levels of physical activity and to describe and define challenges regarding assessment methods that are used. A systematic search was performed on six databases (PubMed, EMBASE, CINAHL, PsycINFO, SportDiscus and OpenGrey), supplemental forward- and backward tracking was done and authors' and experts' literature databases were searched to identify relevant articles. Journal articles or reports that reported levels of physical activity in the general population of youth from cross-European studies were included. Data were reviewed, extracted and assessed by two researchers, with disagreements being resolved by a third researcher. The review protocol of this review is published under registration number CRD42014010684 in the PROSPERO database. The search resulted in 9756 identified records of which 30 articles were included in the current review. This review revealed large differences between countries in prevalence of compliance to physical activity recommendations (i.e. 60 min of daily moderate- to vigorous-intensity physical activity (MVPA)) measured subjectively (5-47%) and accelerometer measured minutes of MVPA (23-200 min). Overall boys and children were more active than girls and adolescents. Different measurement methods (subjective n = 12, objective n = 18) and reported outcome variables (n = 17) were used in the included articles. Different accelerometer intensity thresholds used to define MVPA resulted in substantial differences in MVPA between studies conducted in the same countries when assessed objectively. Reported levels of physical activity and prevalence of compliance to physical activity recommendations in youth showed large variation across European countries. This may reflect true variation in physical activity as well as variation in assessment methods and reported outcome variables. Standardization across Europe, of methods to assess physical activity in youth and reported outcome variables is warranted, preferably moving towards a pan-European surveillance system combining objective and self-report methods.

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

Accountability for the Quality of Care Provided to People with Serious Illness

PubMed Central

Hudson Scholle, Sarah; Briefer French, Jessica

2018-01-01

Abstract Background: Care for patients with serious illness is an emerging practice area that has gained attention as value-based purchasing has increased. While the number of programs is growing, their impact on care quality and outcomes is unknown. Objective: With support from the Gordon and Betty Moore Foundation, the National Committee for Quality Assurance (NCQA) is assessing the feasibility of creating an accountability program focused on serious illness care. Methods: This article describes the process of developing an accountability program, findings from our initial work, and our plans to develop measures for a serious illness care accountability program. We focused on three questions: 1. What patient populations should be targeted for measurement?2. What entities have accountability for ensuring high-quality care for serious illness?3. What structures, processes, and outcomes should be evaluated in an accountability program for serious illness care? Results: Our environmental scan showed that the evidence base for specific patient populations or care models is not sufficiently mature to justify traditional structure and process measures. In visits to serious illness care programs, we observed different staffing models, care models, care settings, and payment structures. We found a gap between recommended inclusion criteria and services when compared to inclusion criteria and services offered by existing programs. Conclusions: To address the challenges, NCQA intends to develop outcome measures driven by patient and family priorities. Structure and process measures will focus on building organizations' capacity to measure outcomes, including patient engagement and outcomes, linked to patient goals. PMID:29313755

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Measurement of Sexual Health in the U.S.: An Inventory of Nationally Representative Surveys and Surveillance Systems

PubMed Central

Ivankovich, Megan B.; Leichliter, Jami S.; Douglas, John M.

2013-01-01

Objectives To identify opportunities within nationally representative surveys and surveillance systems to measure indicators of sexual health, we reviewed and inventoried existing data systems that include variables relevant to sexual health. Methods We searched for U.S. nationally representative surveys and surveillance systems that provided individual-level sexual health data. We assessed the methods of each data system and catalogued them by their measurement of the following domains of sexual health: knowledge, communication, attitudes, service access and utilization, sexual behaviors, relationships, and adverse health outcomes. Results We identified 18 U.S.-focused, nationally representative data systems: six assessing the general population, seven focused on special populations, and five addressing health outcomes. While these data systems provide a rich repository of information from which to assess national measures of sexual health, they present several limitations. Most importantly, apart from data on service utilization, routinely gathered, national data are currently focused primarily on negative aspects of sexual health (e.g., risk behaviors and adverse health outcomes) rather than more positive attributes (e.g., healthy communication and attitudes, and relationship quality). Conclusion Nationally representative data systems provide opportunities to measure a broad array of domains of sexual health. However, current measurement gaps indicate the need to modify existing surveys, where feasible and appropriate, and develop new tools to include additional indicators that address positive domains of sexual health of the U.S. population across the life span. Such data can inform the development of effective policy actions, services, prevention programs, and resource allocation to advance sexual health. PMID:23450886

COMMUNICATING PROBABILISTIC RISK OUTCOMES TO RISK MANAGERS

EPA Science Inventory

Increasingly, risk assessors are moving away from simple deterministic assessments to probabilistic approaches that explicitly incorporate ecological variability, measurement imprecision, and lack of knowledge (collectively termed "uncertainty"). While the new methods provide an...

Automated cerebral infarct volume measurement in follow-up noncontrast CT scans of patients with acute ischemic stroke.

PubMed

Boers, A M; Marquering, H A; Jochem, J J; Besselink, N J; Berkhemer, O A; van der Lugt, A; Beenen, L F; Majoie, C B

2013-08-01

Cerebral infarct volume as observed in follow-up CT is an important radiologic outcome measure of the effectiveness of treatment of patients with acute ischemic stroke. However, manual measurement of CIV is time-consuming and operator-dependent. The purpose of this study was to develop and evaluate a robust automated measurement of the CIV. The CIV in early follow-up CT images of 34 consecutive patients with acute ischemic stroke was segmented with an automated intensity-based region-growing algorithm, which includes partial volume effect correction near the skull, midline determination, and ventricle and hemorrhage exclusion. Two observers manually delineated the CIV. Interobserver variability of the manual assessments and the accuracy of the automated method were evaluated by using the Pearson correlation, Bland-Altman analysis, and Dice coefficients. The accuracy was defined as the correlation with the manual assessment as a reference standard. The Pearson correlation for the automated method compared with the reference standard was similar to the manual correlation (R = 0.98). The accuracy of the automated method was excellent with a mean difference of 0.5 mL with limits of agreement of -38.0-39.1 mL, which were more consistent than the interobserver variability of the 2 observers (-40.9-44.1 mL). However, the Dice coefficients were higher for the manual delineation. The automated method showed a strong correlation and accuracy with the manual reference measurement. This approach has the potential to become the standard in assessing the infarct volume as a secondary outcome measure for evaluating the effectiveness of treatment.

What Is Nursing Home Quality and How Is It Measured?

ERIC Educational Resources Information Center

Castle, Nicholas G.; Ferguson, Jamie C.

2010-01-01

Purpose: In this commentary, we examine nursing home quality and indicators that have been used to measure nursing home quality. Design and Methods: A brief review of the history of nursing home quality is presented that provides some context and insight into currently used quality indicators. Donabedian's structure, process, and outcome (SPO)…

Stability of Teacher Value-Added Rankings across Measurement Model and Scaling Conditions

ERIC Educational Resources Information Center

Hawley, Leslie R.; Bovaird, James A.; Wu, ChaoRong

2017-01-01

Value-added assessment methods have been criticized by researchers and policy makers for a number of reasons. One issue includes the sensitivity of model results across different outcome measures. This study examined the utility of incorporating multivariate latent variable approaches within a traditional value-added framework. We evaluated the…

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.

Disparities at the intersection of marginalized groups

PubMed Central

Jackson, John W.; Williams, David R.; VanderWeele, Tyler J.

2016-01-01

Mental health disparities exist across several dimensions of social inequality, including race/ethnicity, socioeconomic status and gender. Most investigations of health disparities focus on one dimension. Recent calls by researchers argue for studying persons who are marginalized in multiple ways, often from the perspective of intersectionality, a theoretical framework applied to qualitative studies in law, sociology, and psychology. Quantitative adaptations are emerging but there is little guidance as to what measures or methods are helpful. Here, we consider the concept of a joint disparity and its composition, show that this approach can illuminate how outcomes are patterned for social groups that are marginalized across multiple axes of social inequality, and compare the insights gained with that of other measures of additive interaction. We apply these methods to a cohort of males from the National Longitudinal Survey of Youth, examining disparities for black males with low early life SES vs. white males with high early life SES across several outcomes that predict mental health, including unemployment, wages, and incarceration. We report striking disparities in each outcome, but show that the contribution of race, SES, and their intersection varies. PMID:27531592

Disparities at the intersection of marginalized groups.

PubMed

Jackson, John W; Williams, David R; VanderWeele, Tyler J

2016-10-01

Mental health disparities exist across several dimensions of social inequality, including race/ethnicity, socioeconomic status and gender. Most investigations of health disparities focus on one dimension. Recent calls by researchers argue for studying persons who are marginalized in multiple ways, often from the perspective of intersectionality, a theoretical framework applied to qualitative studies in law, sociology, and psychology. Quantitative adaptations are emerging but there is little guidance as to what measures or methods are helpful. Here, we consider the concept of a joint disparity and its composition, show that this approach can illuminate how outcomes are patterned for social groups that are marginalized across multiple axes of social inequality, and compare the insights gained with that of other measures of additive interaction. We apply these methods to a cohort of young men from the National Longitudinal Survey of Youth, examining disparities for black men with low early life SES vs. white men with high early life SES across several outcomes that predict mental health, including unemployment, wages, and incarceration. We report striking disparities in each outcome, but show that the contribution of race, SES, and their intersection varies.

Multicriteria Selection of Optimal Location of TCSC in a Competitive Energy Market

NASA Astrophysics Data System (ADS)

Alomoush, Muwaffaq I.

2010-05-01

The paper investigates selection of the best location of thyristor-controlled series compensator (TCSC) in a transmission system from many candidate locations in a competitive energy market such that the TCSC causes a net valuable impact on congestion management outcome, transmission utilization, transmission losses, voltage stability, degree of fulfillment of spot market contracts, and system security. The problem is treated as a multicriteria decision-making process such that the candidate locations of TCSC are the alternatives and the conflicting objectives are the outcomes of the dispatch process, which may have different importance weights. The paper proposes some performance indices that the dispatch decision-making entity can use to measure market dispatch outcomes of each alternative. Based on agreed-upon preferences, the measures presented may help the decision maker compare and rank dispatch scenarios to ultimately decide which location is the optimal one. To solve the multicriteria decision, we use the preference ranking organization method for enrichment evaluations (PROMETHEE), which is a multicriteria decision support method that can handle complex conflicting-objective decision-making processes.

Assessment of Primary Site Response in Children With High-Risk Neuroblastoma: An International Multicenter Study

PubMed Central

McHugh, Kieran; Naranjo, Arlene; Van Ryn, Collin; Kirby, Chaim; Brock, Penelope; Lyons, Karen A.; States, Lisa J.; Rojas, Yesenia; Miller, Alexandra; Volchenboum, Sam L.; Simon, Thorsten; Krug, Barbara; Sarnacki, Sabine; Valteau-Couanet, Dominique; von Schweinitz, Dietrich; Kammer, Birgit; Granata, Claudio; Pio, Luca; Park, Julie R.; Nuchtern, Jed

2016-01-01

Purpose The International Neuroblastoma Response Criteria (INRC) require serial measurements of primary tumors in three dimensions, whereas the Response Evaluation Criteria in Solid Tumors (RECIST) require measurement in one dimension. This study was conducted to identify the preferred method of primary tumor response assessment for use in revised INRC. Patients and Methods Patients younger than 20 years with high-risk neuroblastoma were eligible if they were diagnosed between 2000 and 2012 and if three primary tumor measurements (antero-posterior, width, cranio-caudal) were recorded at least twice before resection. Responses were defined as ≥ 30% reduction in longest dimension as per RECIST, ≥ 50% reduction in volume as per INRC, or ≥ 65% reduction in volume. Results Three-year event-free survival for all patients (N = 229) was 44% and overall survival was 58%. The sensitivity of both volume response measures (ability to detect responses in patients who survived) exceeded the sensitivity of the single dimension measure, but the specificity of all response measures (ability to identify lack of response in patients who later died) was low. In multivariable analyses, none of the response measures studied was predictive of outcome, and none was predictive of the extent of resection. Conclusion None of the methods of primary tumor response assessment was predictive of outcome. Measurement of three dimensions followed by calculation of resultant volume is more complex than measurement of a single dimension. Primary tumor response in children with high-risk neuroblastoma should therefore be evaluated in accordance with RECIST criteria, using the single longest dimension. PMID:26755515

Assessing the effects of employee assistance programs: a review of employee assistance program evaluations.

PubMed

Colantonio, A

1989-01-01

Employee assistance programs have grown at a dramatic rate, yet the effectiveness of these programs has been called into question. The purpose of this paper was to assess the effectiveness of employee assistance programs (EAPs) by reviewing recently published EAP evaluations. All studies evaluating EAPs published since 1975 from peer-reviewed journals in the English language were included in this analysis. Each of the articles was assessed in the following areas: (a) program description (subjects, setting, type of intervention, format), (b) evaluation design (research design, variables measured, operational methods), and (c) program outcomes. Results indicate numerous methodological and conceptual weaknesses and issues. These weaknesses included lack of controlled research designs and short time lags between pre- and post-test measures. Other problems identified are missing information regarding subjects, type of intervention, how variables are measured (operational methods), and reliability and validity of evaluation instruments. Due to the aforementioned weaknesses, positive outcomes could not be supported. Recommendations are made for future EAP evaluations.

Assessing the effects of employee assistance programs: a review of employee assistance program evaluations.

PubMed Central

Colantonio, A.

1989-01-01

Employee assistance programs have grown at a dramatic rate, yet the effectiveness of these programs has been called into question. The purpose of this paper was to assess the effectiveness of employee assistance programs (EAPs) by reviewing recently published EAP evaluations. All studies evaluating EAPs published since 1975 from peer-reviewed journals in the English language were included in this analysis. Each of the articles was assessed in the following areas: (a) program description (subjects, setting, type of intervention, format), (b) evaluation design (research design, variables measured, operational methods), and (c) program outcomes. Results indicate numerous methodological and conceptual weaknesses and issues. These weaknesses included lack of controlled research designs and short time lags between pre- and post-test measures. Other problems identified are missing information regarding subjects, type of intervention, how variables are measured (operational methods), and reliability and validity of evaluation instruments. Due to the aforementioned weaknesses, positive outcomes could not be supported. Recommendations are made for future EAP evaluations. PMID:2728498

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

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.

Comparing two correlated C indices with right-censored survival outcome: a one-shot nonparametric approach

PubMed Central

Kang, Le; Chen, Weijie; Petrick, Nicholas A.; Gallas, Brandon D.

2014-01-01

The area under the receiver operating characteristic (ROC) curve (AUC) is often used as a summary index of the diagnostic ability in evaluating biomarkers when the clinical outcome (truth) is binary. When the clinical outcome is right-censored survival time, the C index, motivated as an extension of AUC, has been proposed by Harrell as a measure of concordance between a predictive biomarker and the right-censored survival outcome. In this work, we investigate methods for statistical comparison of two diagnostic or predictive systems, of which they could either be two biomarkers or two fixed algorithms, in terms of their C indices. We adopt a U-statistics based C estimator that is asymptotically normal and develop a nonparametric analytical approach to estimate the variance of the C estimator and the covariance of two C estimators. A z-score test is then constructed to compare the two C indices. We validate our one-shot nonparametric method via simulation studies in terms of the type I error rate and power. We also compare our one-shot method with resampling methods including the jackknife and the bootstrap. Simulation results show that the proposed one-shot method provides almost unbiased variance estimations and has satisfactory type I error control and power. Finally, we illustrate the use of the proposed method with an example from the Framingham Heart Study. PMID:25399736

Faculty Perceptions of Formative Assessment and Implementation Practices in Preclinical Medical Edcuation: A Q Method Study

ERIC Educational Resources Information Center

Close, Brandy

2017-01-01

This study describes faculty perceptions of formative assessment and the influence their perceptions have on implementation practices. Assessment is often misunderstood and too often becomes an afterthought in the teaching process. Measuring curricular success by overall student outcomes means instructional and assessment methods have a…

Convergent Evidence Scaling for Multiple Assessment Indicators: Conceptual Issues, Applications, and Technical Challenges

ERIC Educational Resources Information Center

Busse, R. T.; Elliott, Stephen N.; Kratochwill, Thomas R.

2010-01-01

The purpose of this article is to present Convergent Evidence Scaling (CES) as an emergent method for combining data from multiple assessment indicators. The CES method combines single-case assessment data by converging data gathered across multiple persons, settings, or measures, thereby providing an overall criterion-referenced outcome on which…

Evaluations of Structural Interventions for HIV Prevention: A Review of Approaches and Methods.

PubMed

Iskarpatyoti, Brittany S; Lebov, Jill; Hart, Lauren; Thomas, Jim; Mandal, Mahua

2018-04-01

Structural interventions alter the social, economic, legal, political, and built environments that underlie processes affecting population health. We conducted a systematic review of evaluations of structural interventions for HIV prevention in low- and middle-income countries (LMICs) to better understand methodological and other challenges and identify effective evaluation strategies. We included 27 peer-reviewed articles on interventions related to economic empowerment, education, and substance abuse in LMICs. Twenty-one evaluations included clearly articulated theories of change (TOCs); 14 of these assessed the TOC by measuring intermediary variables in the causal pathway between the intervention and HIV outcomes. Although structural interventions address complex interactions, no evaluation included methods designed to evaluate complex systems. To strengthen evaluations of structural interventions, we recommend clearly articulating a TOC and measuring intermediate variables between the predictor and outcome. We additionally recommend adapting study designs and analytic methods outside traditional epidemiology to better capture complex results, influences external to the intervention, and unintended consequences.

Body composition changes in pregnancy: measurement, predictors and outcomes

PubMed Central

Widen, EM; Gallagher, D

2014-01-01

Prevalence of overweight and obesity has risen in the United States over the past few decades. Concurrent with this rise in obesity has been an increase in pregravid body mass index and gestational weight gain affecting maternal body composition changes in pregnancy. During pregnancy, many of the assumptions inherent in body composition estimation are violated, particularly the hydration of fat-free mass, and available methods are unable to disentangle maternal composition from fetus and supporting tissues; therefore, estimates of maternal body composition during pregnancy are prone to error. Here we review commonly used and available methods for assessing body composition changes in pregnancy, including: (1) anthropometry, (2) total body water, (3) densitometry, (4) imaging, (5) dual-energy X-ray absorptiometry, (6) bioelectrical impedance and (7) ultrasound. Several of these methods can measure regional changes in adipose tissue; however, most of these methods provide only whole-body estimates of fat and fat-free mass. Consideration is given to factors that may influence changes in maternal body composition, as well as long-term maternal and offspring outcomes. Finally, we provide recommendations for future research in this area. PMID:24667754

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

Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study.

PubMed

Blackwood, Bronagh; Ringrow, Suzanne; Clarke, Mike; Marshall, John; Rose, Louise; Williamson, Paula; McAuley, Danny

2015-08-20

Among clinical trials of interventions that aim to modify time spent on mechanical ventilation for critically ill patients there is considerable inconsistency in chosen outcomes and how they are measured. The Core Outcomes in Ventilation Trials (COVenT) study aims to develop a set of core outcomes for use in future ventilation trials in mechanically ventilated adults and children. We will use a mixed methods approach that incorporates a randomised trial nested within a Delphi study and a consensus meeting. Additionally, we will conduct an observational cohort study to evaluate uptake of the core outcome set in published studies at 5 and 10 years following core outcome set publication. The three-round online Delphi study will use a list of outcomes that have been reported previously in a review of ventilation trials. The Delphi panel will include a range of stakeholder groups including patient support groups. The panel will be randomised to one of three feedback methods to assess the impact of the feedback mechanism on subsequent ranking of outcomes. A final consensus meeting will be held with stakeholder representatives to review outcomes. The COVenT study aims to develop a core outcome set for ventilation trials in critical care, explore the best Delphi feedback mechanism for achieving consensus and determine if participation increases use of the core outcome set in the long term.

Physical Therapists as Providers of Care: Exercise Prescriptions and Resultant Outcomes in Cardiac and Pulmonary Rehabilitation Programs in New York State

PubMed Central

Scott, Lisa Benz

2008-01-01

Purpose: Physical therapists have engaged in cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) for decades, but the extent of their current involvement in this practice area is unclear. This study surveyed directors of CR and PR programs on a statewide level to ascertain what type of provider is writing the prescription, which methods of exercise formulation are used, which outcome measures are used and their congruency with established guidelines. Methods: A convenience sample of outpatient CR and PR directors (n=31) representing 38 CR and/or PR programs located in New York completed a survey in spring 2005 (29 CR and 9 PR). Results: Results showed that only 2 physical therapists were responsible for writing exercise prescriptions in CR and PR programs. Most program directors were registered nurses (53%), who also wrote the majority of CR exercise prescriptions. Exercise intensity was most frequently determined using formulae and data that were highly patient-specific. Clinical outcomes most frequently included Quality of Life scales and stress tests. Conclusions: Physical therapists are minimally involved in directing programs and writing exercise prescriptions. Exercise prescriptions are individualized to the patient. Outcome measures most frequently used by participating CR and PR program directors are consistent with nationally-recognized best practice. PMID:20467497

Speckle tracking as a method to measure hemidiaphragm excursion.

PubMed

Goutman, Stephen A; Hamilton, James D; Swihart, Blake; Foerster, Bradley; Feldman, Eva L; Rubin, Jonathan M

2017-01-01

Diaphragm excursion measured via ultrasound may be an important imaging outcome measure of respiratory function. We developed a new method for measuring diaphragm movement and compared it to the more traditional M-mode method. Ultrasound images of the right and left hemidiaphragms were collected to compare speckle tracking and M-mode measurements of diaphragm excursion. Speckle tracking was performed using EchoInsight (Epsilon Imaging, Ann Arbor, Michigan). Six healthy subjects without a history of pulmonary diseases were included in this proof-of-concept study. Speckle tracking of the diaphragm is technically possible. Unlike M-mode, speckle tracking carries the advantage of reliable visualization and measurement of the left hemidiaphragm. Speckle tracking accounted for diaphragm movement simultaneously in the cephalocaudad and mediolateral directions, unlike M-mode, which is 1-dimensional. Diaphragm speckle tracking may represent a novel, more robust method for measuring diaphragm excursion, especially for the left hemidiaphragm. Muscle Nerve 55: 125-127, 2017. © 2016 Wiley Periodicals, Inc.

Outcome methods used in clinical studies of Chiari malformation Type I: a systematic review.

PubMed

Greenberg, Jacob K; Milner, Eric; Yarbrough, Chester K; Lipsey, Kim; Piccirillo, Jay F; Smyth, Matthew D; Park, Tae Sung; Limbrick, David D

2015-02-01

Chiari malformation Type I (CM-I) is a common and often debilitating neurological disease. Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes. To understand current approaches and lay a foundation for future research, the authors conducted a systematic review of the methods used in original published research articles to evaluate clinical outcomes in patients treated for CM-I. The authors searched PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov , and Cochrane databases to identify publications between January 2003 and August 2013 that met the following criteria: 1) reported clinical outcomes in patients treated for CM-I; 2) were original research articles; 3) included at least 10 patients or, if a comparative study, at least 5 patients per group; and 4) were restricted to patients with CM-I. Among the 74 papers meeting inclusion criteria, there was wide variation in the outcome methods used. However, all approaches were broadly grouped into 3 categories: 1) "gestalt" impression of overall symptomatic improvement (n=45 papers); 2) postoperative change in specific signs or symptoms (n=20); or 3) results of various standardized assessment scales (n=22). Among standardized scales, 11 general function measures were used, compared with 6 disease-specific tools. Only 3 papers used scales validated in patients with CM-I. To facilitate a uniform comparison of these heterogeneous approaches, the authors appraised articles in multiple domains defined a priori as integral to reporting clinical outcomes in CM-I. Notably, only 7 articles incorporated patient-response instruments when reporting outcome, and only 22 articles explicitly assessed quality of life. The methods used to evaluate clinical outcomes in CM-I are inconsistent and frequently not comparable, complicating efforts to analyze results across studies. Development, validation, and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients.

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

PubMed

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

2017-01-01

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

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

PubMed Central

Miller, Rosalie J.; Shotwell, Mary P.

2017-01-01

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

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

PubMed

Taylor, Ann M; Phillips, Kristine; Patel, Kushang V; Turk, Dennis C; Dworkin, Robert H; Beaton, Dorcas; Clauw, Daniel J; Gignac, Monique A M; Markman, John D; Williams, David A; Bujanover, Shay; Burke, Laurie B; Carr, Daniel B; Choy, Ernest H; Conaghan, Philip G; Cowan, Penney; Farrar, John T; Freeman, Roy; Gewandter, Jennifer; Gilron, Ian; Goli, Veeraindar; Gover, Tony D; Haddox, J David; Kerns, Robert D; Kopecky, Ernest A; Lee, David A; Malamut, Richard; Mease, Philip; Rappaport, Bob A; Simon, Lee S; Singh, Jasvinder A; Smith, Shannon M; Strand, Vibeke; Tugwell, Peter; Vanhove, Gertrude F; Veasley, Christin; Walco, Gary A; Wasan, Ajay D; Witter, James

2016-09-01

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

Evidence on the Effectiveness of Water, Sanitation, and Hygiene (WASH) Interventions on Health Outcomes in Humanitarian Crises: A Systematic Review

PubMed Central

Ramesh, Anita; Blanchet, Karl; Ensink, Jeroen H. J.; Roberts, Bayard

2015-01-01

Background Water, sanitation, and hygiene (WASH) interventions are amongst the most crucial in humanitarian crises, although the impact of the different WASH interventions on health outcomes remains unclear. Aim To examine the quantity and quality of evidence on WASH interventions on health outcomes in humanitarian crises, as well as evaluate current evidence on their effectiveness against health outcomes in these contexts. Methods A systematic literature review was conducted of primary and grey quantitative literature on WASH interventions measured against health outcomes in humanitarian crises occurring from 1980–2014. Populations of interest were those in resident in humanitarian settings, with a focus on acute crisis and early recovery stages of humanitarian crises in low and middle-income countries. Interventions of interest were WASH-related, while outcomes of interest were health-related. Study quality was assessed via STROBE/CONSORT criteria. Results were analyzed descriptively, and PRISMA reporting was followed. Results Of 3963 studies initially retrieved, only 6 published studies measured a statistically significant change in health outcome as a result of a WASH intervention. All 6 studies employed point-of-use (POU) water quality interventions, with 50% using safe water storage (SWS) and 35% using household water treatment (HWT). All 6 studies used self-reported diarrhea outcomes, 2 studies also reported laboratory confirmed outcomes, and 2 studies reported health treatment outcomes (e.g. clinical admissions). 1 study measured WASH intervention success in relation to both health and water quality outcomes; 1 study recorded uptake (use of soap) as well as health outcomes. 2 studies were unblinded randomized-controlled trials, while 4 were uncontrolled longitudinal studies. 2 studies were graded as providing high quality evidence; 3 studies provided moderate and 1 study low quality evidence. Conclusion The current evidence base on the impact of WASH interventions on health outcomes in humanitarian crises is extremely limited, and numerous methodological limitations limit the ability to determine associative, let alone causal, relationships. PMID:26398228

Developing, implementing and disseminating a core outcome set for neonatal medicine.

PubMed

Webbe, James; Brunton, Ginny; Ali, Shohaib; Duffy, James Mn; Modi, Neena; Gale, Chris

2017-01-01

In high resource settings, 1 in 10 newborn babies require admission to a neonatal unit. Research evaluating neonatal care involves recording and reporting many different outcomes and outcome measures. Such variation limits the usefulness of research as studies cannot be compared or combined. To address these limitations, we aim to develop, disseminate and implement a core outcome set for neonatal medicine. A steering group that includes parents and former patients, healthcare professionals and researchers has been formed to guide the development of the core outcome set. We will review neonatal trials systematically to identify previously reported outcomes. Additionally, we will specifically identify outcomes of importance to parents, former patients and healthcare professionals through a systematic review of qualitative studies. Outcomes identified will be entered into an international, multi-perspective eDelphi survey. All key stakeholders will be invited to participate. The Delphi method will encourage individual and group stakeholder consensus to identify a core outcome set. The core outcome set will be mapped to existing, routinely recorded data where these exist. Use of a core set will ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research. Embedding the core outcome set within future clinical studies will extend the usefulness of research to inform practice, enhance patient care and ultimately improve outcomes. Using routinely recorded electronic data will facilitate implementation with minimal addition burden. Core Outcome Measures in Effectiveness Trials (COMET) database: 842 (www.comet-initiative.org/studies/details/842).

Overview of Classical Test Theory and Item Response Theory for Quantitative Assessment of Items in Developing Patient-Reported Outcome Measures

PubMed Central

Cappelleri, Joseph C.; Lundy, J. Jason; Hays, Ron D.

2014-01-01

Introduction The U.S. Food and Drug Administration’s patient-reported outcome (PRO) guidance document defines content validity as “the extent to which the instrument measures the concept of interest” (FDA, 2009, p. 12). “Construct validity is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity” (Strauss & Smith, 2009, p. 7). Hence both qualitative and quantitative information are essential in evaluating the validity of measures. Methods We review classical test theory and item response theory approaches to evaluating PRO measures including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized “difficulty” (severity) order of items is represented by observed responses. Conclusion Classical test theory and item response theory can be useful in providing a quantitative assessment of items and scales during the content validity phase of patient-reported outcome measures. Depending on the particular type of measure and the specific circumstances, either one or both approaches should be considered to help maximize the content validity of PRO measures. PMID:24811753

Design and baseline data from the Gratitude Research in Acute Coronary Events (GRACE) study

PubMed Central

Huffman, Jeff C.; Beale, Eleanor E.; Beach, Scott R.; Celano, Christopher M.; Belcher, Arianna M.; Moore, Shannon V.; Suarez, Laura; Gandhi, Parul U.; Motiwala, Shweta R.; Gaggin, Hanna; Januzzi, James L.

2015-01-01

Background Positive psychological constructs, especially optimism, have been linked with superior cardiovascular health. However, there has been minimal study of positive constructs in patients with acute coronary syndrome (ACS), despite the prevalence and importance of this condition. Furthermore, few studies have examined multiple positive psychological constructs and multiple cardiac-related outcomes within the same cohort to determine specifically which positive construct may affect a particular cardiac outcome. Materials and methods The Gratitude Research in Acute Coronary Events (GRACE) study examines the association between optimism/gratitude 2 weeks post-ACS and subsequent clinical outcomes. The primary outcome measure is physical activity at 6 months, measured via accelerometer, and key secondary outcome measures include levels of prognostic biomarkers and rates of nonelective cardiac rehospitalization at 6 months. These relationships will be analyzed using multivariate linear regression, controlling for sociodemographic, medical, and negative psychological factors; associations between baseline positive constructs and subsequent rehospitalizations will be assessed via Cox regression. Results Overall, 164 participants enrolled and completed the baseline 2-week assessment; the cohort had a mean age of 61.5 +/− 10.5 years and was 84% men; this was the first ACS for 58% of participants. Conclusion The GRACE study will determine whether optimism and gratitude are prospectively and independently associated with physical activity and other critical outcomes in the 6 months following an ACS. If these constructs are associated with superior outcomes, this may highlight the importance of these constructs as independent prognostic factors post-ACS. PMID:26166171

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

The cervical dystonia impact profile (CDIP-58): can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

PubMed

Cano, Stefan J; Warner, Thomas T; Thompson, Alan J; Bhatia, Kailash P; Fitzpatrick, Ray; Hobart, Jeremy C

2008-08-06

The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data < or = 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha > or = 0.92, test-retest intraclass correlations > or = 0.83); and 5) validity was supported. This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis.

Outcomes of Moral Case Deliberation - the development of an evaluation instrument for clinical ethics support (the Euro-MCD)

PubMed Central

2014-01-01

Background Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. Methods A multi-item instrument for assessing outcomes of Moral Case Deliberation (MCD) was constructed through an iterative process, founded on a literature review and modified through a multistep review by ethicists and health care providers. The instrument measures perceived importance of outcomes before and after MCD, as well as experienced outcomes during MCD and in daily work. A purposeful sample of 86 European participants contributed to a Delphi panel and content validity testing. The Delphi panel (n = 13), consisting of ethicists and ethics researchers, participated in three Delphi-rounds. Health care providers (n = 73) participated in the content validity testing through ‘think-aloud’ interviews and a method using Content Validity Index. Results The development process resulted in the European Moral Case Deliberation Outcomes Instrument (Euro-MCD), which consists of two sections, one to be completed before a participant’s first MCD and the other after completing multiple MCDs. The instrument contains a few open-ended questions and 26 specific items with a corresponding rating/response scale representing various MCD outcomes. The items were categorised into the following six domains: Enhanced emotional support, Enhanced collaboration, Improved moral reflexivity, Improved moral attitude, Improvement on organizational level and Concrete results. Conclusions A tentative instrument has been developed that seems to cover main outcomes of Moral Case Deliberation. The next step will be to test the Euro-MCD in a field study. PMID:24712735

Validation of PROMIS ® Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research.

PubMed

Hung, Man; Baumhauer, Judith F; Latt, L Daniel; Saltzman, Charles L; SooHoo, Nelson F; Hunt, Kenneth J

2013-11-01

In 2012, the American Orthopaedic Foot & Ankle Society(®) established a national network for collecting and sharing data on treatment outcomes and improving patient care. One of the network's initiatives is to explore the use of computerized adaptive tests (CATs) for patient-level outcome reporting. We determined whether the CAT from the NIH Patient Reported Outcome Measurement Information System(®) (PROMIS(®)) Physical Function (PF) item bank provides efficient, reliable, valid, precise, and adequately covered point estimates of patients' physical function. After informed consent, 288 patients with a mean age of 51 years (range, 18-81 years) undergoing surgery for common foot and ankle problems completed a web-based questionnaire. Efficiency was determined by time for test administration. Reliability was assessed with person and item reliability estimates. Validity evaluation included content validity from expert review and construct validity measured against the PROMIS(®) Pain CAT and patient responses based on tradeoff perceptions. Precision was assessed by standard error of measurement (SEM) across patients' physical function levels. Instrument coverage was based on a person-item map. Average time of test administration was 47 seconds. Reliability was 0.96 for person and 0.99 for item. Construct validity against the Pain CAT had an r value of -0.657 (p < 0.001). Precision had an SEM of less than 3.3 (equivalent to a Cronbach's alpha of ≥ 0.90) across a broad range of function. Concerning coverage, the ceiling effect was 0.32% and there was no floor effect. The PROMIS(®) PF CAT appears to be an excellent method for measuring outcomes for patients with foot and ankle surgery. Further validation of the PROMIS(®) item banks may ultimately provide a valid and reliable tool for measuring patient-reported outcomes after injuries and treatment.

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

Food environments and dietary intakes among adults: does the type of spatial exposure measurement matter? A systematic review.

PubMed

Bivoltsis, Alexia; Cervigni, Eleanor; Trapp, Gina; Knuiman, Matthew; Hooper, Paula; Ambrosini, Gina Leslie

2018-06-09

The relationships between food environments and dietary intake have been assessed via a range of methodologically diverse measures of spatial exposure to food outlets, resulting in a largely inconclusive body of evidence, limiting informed policy intervention. This systematic review aims to evaluate the influence of methodological choice on study outcomes by examining the within-study effect of availability (e.g., counts) versus accessibility (e.g., proximity) spatial exposure measures on associations with diet. (PROSPERO registration: CRD42018085250). PubMed, Web of Science, Scopus and ScienceDirect databases were searched for empirical studies from 1980 to 2017, in the English language, involving adults and reporting on the statistical association between a dietary outcome and spatial exposure measures of both availability and accessibility. Studies were appraised using an eight-point quality criteria with a narrative synthesis of results. A total of 205 associations and 44 relationships (i.e., multiple measures of spatial exposure relating to a particular food outlet type and dietary outcome) were extracted from 14 eligible articles. Comparative measures were dominated by counts (availability) and proximity (accessibility). Few studies compared more complex measures and all counts were derived from place-based measures of exposure. Sixteen of the 44 relationships had a significant effect involving an availability measure whilst only 8 had a significant effect from an accessibility measure. The largest effect sizes in relationships were mostly for availability measures. After stratification by scale, availability measure had the greatest effect size in 139 of the 176 pairwise comparisons. Of the 33% (68/205) of associations that reached significance, 53/68 (78%) were from availability measures. There was no relationship between study quality and reported study outcomes. The limited evidence suggests that availability measures may produce significant and greater effect sizes than accessibility measures. However, both availability and accessibility measures may be important concepts of spatial exposure depending on the food outlet type and dietary outcome examined. More studies reporting on multi-method effects are required to differentiate findings by the type of spatial exposure assessment and build an evidence base regarding the appropriateness and robustness of measures under different circumstances.

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.

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

Using Patient Reported Outcomes and PROMIS in Research and Clinical Applications: Experiences from the PCORI Pilot Projects

PubMed Central

Bingham, Clifton O.; Bartlett, Susan J.; Merkel, Peter A.; Mielenz, Thelma J.; Pilkonis, Paul A.; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K.

2016-01-01

Purpose The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes, and in particular, the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Methods Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects’ experiences. Results Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. Conclusions The PCORI Pilot Projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders. PMID:26914103

Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results

PubMed Central

Valera-Garrido, Fermín; Minaya-Muñoz, Francisco; Medina-Mirapeix, Francesc

2014-01-01

Background Ultrasound (US)-guided percutaneous needle electrolysis (PNE) is a novel minimally invasive approach which consists of the application of a galvanic current through an acupuncture needle. Objective To evaluate the clinical and ultrasonographic effectiveness of a multimodal programme (PNE, eccentric exercise (EccEx) and stretching) in the short term for patients with chronic lateral epicondylitis, and to determine whether the clinical outcomes achieved decline over time. Methods A one-way repeated measures study was performed in a clinical setting in 36 patients presenting with lateral epicondylitis. The patients received one session of US-guided PNE per week over 4–6 weeks, associated with a home programme of EccEx and stretching. The main outcome measures were severity of pain, disability (Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire), structural tendon changes (US), hypervascularity and patients’ perceptions of overall outcome. Measurements at 6, 26 and 52 weeks follow-up included recurrence rates (increase in severity of pain or disability compared with discharge), perception of overall outcome and success rates. Results All outcome measures registered significant improvements between pre-intervention and discharge. Most patients (n=30, 83.3%) rated the overall outcome as ‘successful’ at 6 weeks. The ultrasonographic findings showed that the hypoechoic regions and hypervascularity of the extensor carpi radialis brevis changed significantly. At 26 and 52 weeks, all participants (n=32) perceived a ‘successful’ outcome. Recurrence rates were null after discharge and at follow-up at 6, 26 and 52 weeks. Conclusions Symptoms and degenerative structural changes of chronic lateral epicondylitis are reduced after US-guided PNE associated with EccEx and stretching, with encouragingly low recurrences in the mid to long term. Trial registration number ClinicalTrials.gov identifier: NCT02085928. PMID:25122629

Pressure garment design tool to monitor exerted pressures.

PubMed

Macintyre, Lisa; Ferguson, Rhona

2013-09-01

Pressure garments are used in the treatment of hypertrophic scarring following serious burns. The use of pressure garments is believed to hasten the maturation process, reduce pruritus associated with immature hypertrophic scars and prevent the formation of contractures over flexor joints. Pressure garments are normally made to measure for individual patients from elastic fabrics and are worn continuously for up to 2 years or until scar maturation. There are 2 methods of constructing pressure garments. The most common method, called the Reduction Factor method, involves reducing the patient's circumferential measurements by a certain percentage. The second method uses the Laplace Law to calculate the dimensions of pressure garments based on the circumferential measurements of the patient and the tension profile of the fabric. The Laplace Law method is complicated to utilise manually and no design tool is currently available to aid this process. This paper presents the development and suggested use of 2 new pressure garment design tools that will aid pressure garment design using the Reduction Factor and Laplace Law methods. Both tools calculate the pressure garment dimensions and the mean pressure that will be exerted around the body at each measurement point. Monitoring the pressures exerted by pressure garments and noting the clinical outcome would enable clinicians to build an understanding of the implications of particular pressures on scar outcome, maturation times and patient compliance rates. Once the optimum pressure for particular treatments is known, the Laplace Law method described in this paper can be used to deliver those average pressures to all patients. This paper also presents the results of a small scale audit of measurements taken for the fabrication of pressure garments in two UK hospitals. This audit highlights the wide range of pressures that are exerted using the Reduction Factor method and that manual pattern 'smoothing' can dramatically change the actual Reduction Factors used. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Development and application of the RE-AIM QuEST mixed methods framework for program evaluation.

PubMed

Forman, Jane; Heisler, Michele; Damschroder, Laura J; Kaselitz, Elizabeth; Kerr, Eve A

2017-06-01

To increase the likelihood of successful implementation of interventions and promote dissemination across real-world settings, it is essential to evaluate outcomes related to dimensions other than Effectiveness alone. Glasgow and colleagues' RE-AIM framework specifies four additional types of outcomes that are important to decision-makers: Reach, Adoption, Implementation (including cost), and Maintenance. To further strengthen RE-AIM, we propose integrating qualitative assessments in an expanded framework: RE-AIM Qualitative Evaluation for Systematic Translation (RE-AIM QuEST), a mixed methods framework. RE-AIM QuEST guides formative evaluation to identify real-time implementation barriers and explain how implementation context may influence translation to additional settings. RE-AIM QuEST was used to evaluate a pharmacist-led hypertension management intervention at 3 VA facilities in 2008-2009. We systematically reviewed each of the five RE-AIM dimensions and created open-ended companion questions to quantitative measures and identified qualitative and quantitative data sources, measures, and analyses. To illustrate use of the RE-AIM QuEST framework, we provide examples of real-time, coordinated use of quantitative process measures and qualitative methods to identify site-specific issues, and retrospective use of these data sources and analyses to understand variation across sites and explain outcomes. For example, in the Reach dimension, we conducted real-time measurement of enrollment across sites and used qualitative data to better understand and address barriers at a low-enrollment site. The RE-AIM QuEST framework may be a useful tool for improving interventions in real-time, for understanding retrospectively why an intervention did or did not work, and for enhancing its sustainability and translation to other settings.

Using Optimal Test Assembly Methods for Shortening Patient-Reported Outcome Measures: Development and Validation of the Cochin Hand Function Scale-6: A Scleroderma Patient-Centered Intervention Network Cohort Study.

PubMed

Levis, Alexander W; Harel, Daphna; Kwakkenbos, Linda; Carrier, Marie-Eve; Mouthon, Luc; Poiraudeau, Serge; Bartlett, Susan J; Khanna, Dinesh; Malcarne, Vanessa L; Sauve, Maureen; van den Ende, Cornelia H M; Poole, Janet L; Schouffoer, Anne A; Welling, Joep; Thombs, Brett D

2016-11-01

To develop and validate a short form of the Cochin Hand Function Scale (CHFS), which measures hand disability, for use in systemic sclerosis, using objective criteria and reproducible techniques. Responses on the 18-item CHFS were obtained from English-speaking patients enrolled in the Scleroderma Patient-Centered Intervention Network Cohort. CHFS unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit to CHFS items. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible form length between 1 and 17 items. The final short form selected was the form with the least number of items that maintained statistically equivalent convergent validity, compared to the full-length CHFS, with the Health Assessment Questionnaire (HAQ) disability index (DI) and the physical function domain of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29). There were 601 patients included. A 6-item short form of the CHFS (CHFS-6) was selected. The CHFS-6 had a Cronbach's alpha of 0.93. Correlations of the CHFS-6 summed score with HAQ DI (r = 0.79) and PROMIS-29 physical function (r = -0.54) were statistically equivalent to the CHFS (r = 0.81 and r = -0.56). The correlation with the full CHFS was high (r = 0.98). The OTA procedure generated a valid short form of the CHFS with minimal loss of information compared to the full-length form. The OTA method used was based on objective, prespecified criteria, but should be further studied for viability as a general procedure for shortening patient-reported outcome measures in health research. © 2016, American College of Rheumatology.

How large must a treatment effect be before it matters to practitioners? An estimation method and demonstration.

PubMed

Miller, William R; Manuel, Jennifer Knapp

2008-09-01

Treatment research is sometimes criticised as lacking in clinical relevance, and one potential source of this friction is a disconnection between statistical significance and what clinicians regard to be a meaningful difference in outcomes. This report demonstrates a novel methodology for estimating what substance abuse practitioners regard to be clinically important differences. To illustrate the estimation method, we surveyed 50 substance abuse treatment providers participating in the National Institute on Drug Abuse (NIDA) Clinical Trials Network. Practitioners identified thresholds for clinically meaningful differences on nine common outcome variables, indicated the size of effect that would justify their learning a new treatment method and estimated current outcomes from their services. Clinicians judged a difference between two treatments to be meaningful if outcomes were improved by about 10 - 12 points on the percentage of patients totally abstaining, arrested for driving while intoxicated, employed or having abnormal liver enzymes. A 5 percentage-point reduction in patient mortality was regarded as clinically significant. On continuous outcome measures (such as percentage of days abstinent or drinks per drinking day), practitioners judged an outcome to be significant when it doubled or halved the base rate. When a new treatment meets such criteria, practitioners were interested in learning it. Effects that are statistically significant in clinical trials may be unimpressive to practitioners. Clinicians' judgements of meaningful differences can inform the powering of clinical trials.

Covariate selection with group lasso and doubly robust estimation of causal effects

PubMed Central

Koch, Brandon; Vock, David M.; Wolfson, Julian

2017-01-01

Summary The efficiency of doubly robust estimators of the average causal effect (ACE) of a treatment can be improved by including in the treatment and outcome models only those covariates which are related to both treatment and outcome (i.e., confounders) or related only to the outcome. However, it is often challenging to identify such covariates among the large number that may be measured in a given study. In this paper, we propose GLiDeR (Group Lasso and Doubly Robust Estimation), a novel variable selection technique for identifying confounders and predictors of outcome using an adaptive group lasso approach that simultaneously performs coefficient selection, regularization, and estimation across the treatment and outcome models. The selected variables and corresponding coefficient estimates are used in a standard doubly robust ACE estimator. We provide asymptotic results showing that, for a broad class of data generating mechanisms, GLiDeR yields a consistent estimator of the ACE when either the outcome or treatment model is correctly specified. A comprehensive simulation study shows that GLiDeR is more efficient than doubly robust methods using standard variable selection techniques and has substantial computational advantages over a recently proposed doubly robust Bayesian model averaging method. We illustrate our method by estimating the causal treatment effect of bilateral versus single-lung transplant on forced expiratory volume in one year after transplant using an observational registry. PMID:28636276

Covariate selection with group lasso and doubly robust estimation of causal effects.

PubMed

Koch, Brandon; Vock, David M; Wolfson, Julian

2018-03-01

The efficiency of doubly robust estimators of the average causal effect (ACE) of a treatment can be improved by including in the treatment and outcome models only those covariates which are related to both treatment and outcome (i.e., confounders) or related only to the outcome. However, it is often challenging to identify such covariates among the large number that may be measured in a given study. In this article, we propose GLiDeR (Group Lasso and Doubly Robust Estimation), a novel variable selection technique for identifying confounders and predictors of outcome using an adaptive group lasso approach that simultaneously performs coefficient selection, regularization, and estimation across the treatment and outcome models. The selected variables and corresponding coefficient estimates are used in a standard doubly robust ACE estimator. We provide asymptotic results showing that, for a broad class of data generating mechanisms, GLiDeR yields a consistent estimator of the ACE when either the outcome or treatment model is correctly specified. A comprehensive simulation study shows that GLiDeR is more efficient than doubly robust methods using standard variable selection techniques and has substantial computational advantages over a recently proposed doubly robust Bayesian model averaging method. We illustrate our method by estimating the causal treatment effect of bilateral versus single-lung transplant on forced expiratory volume in one year after transplant using an observational registry. © 2017, The International Biometric Society.

Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

PubMed

Anderson, Jennifer J; Bolognese, James A; Felson, David T

2003-11-01

Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. The simulation studies demonstrate that data-driven outcome definitions can provide better sensitivity to change than does the ACR20 or DDAS. Using such methods would improve power, but at the expense of trial standardization. The studies also show how patient population and treatment characteristics affect the power of specific outcome measures in RA clinical trials, and provide quantification of those effects.

Assessing resident's knowledge and communication skills using four different evaluation tools.

PubMed

Nuovo, Jim; Bertakis, Klea D; Azari, Rahman

2006-07-01

This study assesses the relationship between 4 Accreditation Council for Graduate Medical Education (ACGME) outcome project measures for interpersonal and communication skills and medical knowledge; specifically, monthly performance evaluations, objective structured clinical examinations (OSCEs), the American Board of Family Practice in-training examination (ABFP-ITE) and the Davis observation code (DOC) practice style profiles. Based on previous work, we have DOC scoring for 29 residents from the University of California, Davis Department of Family and Community Medicine. For all these residents we also had the results of monthly performance evaluations, 2 required OSCE exercises, and the results of 3 American Board of Family Medicine (ABFM) ITEs. Data for each of these measures were abstracted for each resident. The Pearson correlation coefficient was used to assess the presence or lack of correlation between each of these evaluation methods. There is little correlation between various evaluation methods used to assess medical knowledge, and there is also little correlation between various evaluation methods used to assess communication skills. The outcome project remains a 'work in progress', with the need for larger studies to assess the value of different assessment measures of resident competence. It is unlikely that DOC will become a useful evaluation tool.

The Effect of New Cooperative Medical Scheme on Health Outcomes and Alleviating Catastrophic Health Expenditure in China: A Systematic Review

PubMed Central

Liang, Xiaoyun; Guo, Hong; Jin, Chenggang; Peng, Xiaoxia; Zhang, Xiulan

2012-01-01

Background In 2002, the Chinese government launched a new rural health financing policy to provide health insurance (New Cooperative Medical Scheme, NCMS) for its rural population. NCMS, jointly financed by governments and individual households, aims to protect households from impoverishment due to catastrophic health expenditure. In 2011, NCMS covered more than 96% of the rural population. We have systematically searched and reviewed available evidence to estimate the effects of NCMS on health outcomes and on alleviating catastrophic health expenditure. Methods PubMed, Web of Science with Conference Proceedings, ProQuest Digital Dissertations, CMCI, CNKI, and VIP were searched. We also obtained literature from colleague communications. Quasi-experimental studies regarding the effect of NCMS on health outcomes and catastrophic health expenditure were included. Two independent reviewers screened the literature, extracted the data, and assessed the study quality. Results Fifteen studies out of the 6123 studies in the literature fulfilled criteria and were included in this review. Twelve studies identified the relationship between NCMS and health outcomes, among which six studies measured sickness or injury in the past four weeks, four measured sickness or injury in the past two weeks, and five measured self-reported health status. Four studies focused on the relationship between NCMS and alleviating catastrophic health expenditure. However, the results from these studies were in conflict: individual studies indicated that NCMS had positive, negative, or no effect on health outcomes and/or the incidence of catastrophic health payments, respectively. Conclusions We still have no clear evidence that NCMS improves the health outcomes and decreases the alleviating catastrophic health expenditure of the China’s rural population. In addition, the heterogeneity among individual studies reminds us that provider payment method reforms, benefit package and information systems around NCMS should be improved in the future. PMID:22916098

Family structure and risk behaviors: the role of the family meal in assessing likelihood of adolescent risk behaviors.

PubMed

Goldfarb, Samantha; Tarver, Will L; Sen, Bisakha

2014-01-01

Previous literature has asserted that family meals are a key protective factor for certain adolescent risk behaviors. It is suggested that the frequency of eating with the family is associated with better psychological well-being and a lower risk of substance use and delinquency. However, it is unclear whether there is evidence of causal links between family meals and adolescent health-risk behaviors. The purpose of this article is to review the empirical literature on family meals and adolescent health behaviors and outcomes in the US. A SEARCH WAS CONDUCTED IN FOUR ACADEMIC DATABASES: Social Sciences Full Text, Sociological Abstracts, PsycINFO®, and PubMed/MEDLINE. We included studies that quantitatively estimated the relationship between family meals and health-risk behaviors. Data were extracted on study sample, study design, family meal measurement, outcomes, empirical methods, findings, and major issues. Fourteen studies met the inclusion criteria for the review that measured the relationship between frequent family meals and various risk-behavior outcomes. The outcomes considered by most studies were alcohol use (n=10), tobacco use (n=9), and marijuana use (n=6). Other outcomes included sexual activity (n=2); depression, suicidal ideation, and suicide attempts (n=4); violence and delinquency (n=4); school-related issues (n=2); and well-being (n=5). The associations between family meals and the outcomes of interest were most likely to be statistically significant in unadjusted models or models controlling for basic family characteristics. Associations were less likely to be statistically significant when other measures of family connectedness were included. Relatively few analyses used sophisticated empirical techniques available to control for confounders in secondary data. More research is required to establish whether or not the relationship between family dinners and risky adolescent behaviors is an artifact of underlying confounders. We recommend that researchers make more frequent use of sophisticated methods to reduce the problem of confounders in secondary data, and that the scope of adolescent problem behaviors also be further widened.

Comparing exposure assessment methods for traffic-related air pollution in an adverse pregnancy outcome study

PubMed Central

Wu, Jun; Wilhelm, Michelle; Chung, Judith; Ritz, Beate

2011-01-01

Background Previous studies reported adverse impacts of traffic-related air pollution exposure on pregnancy outcomes. Yet, little information exists on how effect estimates are impacted by the different exposure assessment methods employed in these studies. Objectives To compare effect estimates for traffic-related air pollution exposure and preeclampsia, preterm birth (gestational age less than 37 weeks), and very preterm birth (gestational age less than 30 weeks) based on four commonly-used exposure assessment methods. Methods We identified 81,186 singleton births during 1997–2006 at four hospitals in Los Angeles and Orange Counties, California. Exposures were assigned to individual subjects based on residential address at delivery using the nearest ambient monitoring station data [carbon monoxide (CO), nitrogen dioxide (NO2), nitric oxide (NO), nitrogen oxides (NOx), ozone (O3), and particulate matter less than 2.5 (PM2.5) or less than 10 (PM10) μm in aerodynamic diameter], both unadjusted and temporally-adjusted land-use regression (LUR) model estimates (NO, NO2, and NOx), CALINE4 line-source air dispersion model estimates (NOx and PM2.5), and a simple traffic-density measure. We employed unconditional logistic regression to analyze preeclampsia in our birth cohort, while for gestational age-matched risk sets with preterm and very preterm birth we employed conditional logistic regression. Results We observed elevated risks for preeclampsia, preterm birth, and very preterm birth from maternal exposures to traffic air pollutants measured at ambient stations (CO, NO, NO2, and NOx) and modeled through CALINE4 (NOx and PM2.5) and LUR (NO2 and NOx). Increased risk of preterm birth and very preterm birth were also positively associated with PM10 and PM2.5 air pollution measured at ambient stations. For LUR-modeled NO2 and NOx exposures, elevated risks for all the outcomes were observed in Los Angeles only – the region for which the LUR models were initially developed. Unadjusted LUR models often produced odds ratios somewhat larger in size than temporally-adjusted models. The size of effect estimates was smaller for exposures based on simpler traffic density measures than the other exposure assessment methods. Conclusion We generally confirmed that traffic-related air pollution was associated with adverse reproductive outcomes regardless of the exposure assessment method employed, yet the size of the estimated effect depended on how both temporal and spatial variations were incorporated into exposure assessment. The LUR model was not transferable even between two contiguous areas within the same large metropolitan area in Southern California. PMID:21453913

Neural activity during affect labeling predicts expressive writing effects on well-being: GLM and SVM approaches.

PubMed

Memarian, Negar; Torre, Jared B; Haltom, Kate E; Stanton, Annette L; Lieberman, Matthew D

2017-09-01

Affect labeling (putting feelings into words) is a form of incidental emotion regulation that could underpin some benefits of expressive writing (i.e. writing about negative experiences). Here, we show that neural responses during affect labeling predicted changes in psychological and physical well-being outcome measures 3 months later. Furthermore, neural activity of specific frontal regions and amygdala predicted those outcomes as a function of expressive writing. Using supervised learning (support vector machines regression), improvements in four measures of psychological and physical health (physical symptoms, depression, anxiety and life satisfaction) after an expressive writing intervention were predicted with an average of 0.85% prediction error [root mean square error (RMSE) %]. The predictions were significantly more accurate with machine learning than with the conventional generalized linear model method (average RMSE: 1.3%). Consistent with affect labeling research, right ventrolateral prefrontal cortex (RVLPFC) and amygdalae were top predictors of improvement in the four outcomes. Moreover, RVLPFC and left amygdala predicted benefits due to expressive writing in satisfaction with life and depression outcome measures, respectively. This study demonstrates the substantial merit of supervised machine learning for real-world outcome prediction in social and affective neuroscience. © The Author (2017). Published by Oxford University Press.

Diabetes Self-Management Care via Cell Phone: A Systematic Review

PubMed Central

Krishna, Santosh; Boren, Suzanne Austin

2008-01-01

Background The objective of this study was to evaluate the evidence on the impact of cell phone interventions for persons with diabetes and/or obesity in improving health outcomes and/or processes of care for persons with diabetes and/or obesity. Methods We searched Medline (1966–2007) and reviewed reference lists from included studies and relevant reviews to identify additional studies. We extracted descriptions of the study design, sample size, patient age, duration of study, technology, educational content and delivery environment, intervention and control groups, process and outcome measures, and statistical significance. Results In this review, we included 20 articles, representing 18 studies, evaluating the use of a cell phone for health information for persons with diabetes or obesity. Thirteen of 18 studies measured health outcomes and the remaining 5 studies evaluated processes of care. Outcomes were grouped into learning, behavior change, clinical improvement, and improved health status. Nine out of 10 studies that measured hemoglobin A1c reported significant improvement among those receiving education and care support. Cell phone and text message interventions increased patient–provider and parent–child communication and satisfaction with care. Conclusions Providing care and support with cell phones and text message interventions can improve clinically relevant diabetes-related health outcomes by increasing knowledge and self-efficacy to carry out self-management behaviors. PMID:19885219

A pragmatic comparison of two diabetes education programs in improving type 2 diabetes mellitus outcomes.

PubMed

Dorland, Katherine; Liddy, Clare

2014-03-28

Although it is clear that education programs constitute key elements of improved diabetes management, uncertainty exists regarding the optimal method of delivering that education. In addition to the lack of consensus regarding the most appropriate delivery methods for these programs, there is a paucity of research which evaluates these methods in terms of specific clinical outcomes. This pragmatic study compares the effectiveness of two distinct diabetes education programs in improving clinical outcomes in patients with type 2 diabetes mellitus in a primary care setting. The two diabetes education classes (n = 80 enrolled) retrospectively evaluated were 'the ABC's of Diabetes' (one 2-hour didactic teaching session) and 'Conversation Maps' (3 highly interactive weekly classes, 6 hours in total). Eligible participants (n = 32) had their charts reviewed and outcome measures (i.e., glycosylated hemoglobin levels (HbA1c), low density lipoprotein (LDL), systolic blood pressure (SBP), diastolic blood pressure (DBP), and weight) recorded 1 year prior to and 6 months following the class. Pre- and post-class outcome measures were compared. A trend towards lower HbA1c was observed after completion of both classes, with an average reduction of 0.2%, and 0.6% after 6 months in the 'ABC's of Diabetes' class and 'Conversation Maps' class respectively. A significant decrease in weight was observed 6 months after the 'ABC's of Diabetes' class (p = 0.028), and in LDL after the 'Conversation Maps' class (p = 0.049). Patients with HbA1c ≥ 8% showed a drop of 1.1% in HbA1c 3 months after either class (p = 0.004). No significant difference in outcomes was found between the two diabetes education classes assessed. There was a trend towards improved glycemic control after both classes, and patients with high HbA1c levels demonstrated statistically significant improvements. This indicates that shorter sessions using didactic teaching methods may be equally effective in producing improvements in diabetes self-management as more intensive course formats.

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

Prognosis of constipation: clinical factors and colonic transit time

PubMed Central

de Lorijn, F; van Wijk, M P; Reitsma, J; van Ginkel, R; Taminiau, J; Benninga, M

2004-01-01

Background: Measurement of colonic transit time (CTT) is sometimes used in the evaluation of patients with chronic constipation. Aim: To investigate the relation between symptoms and CTT, and to assess the importance of symptoms and CTT in predicting outcome. Methods: Between 1995 and 2000, 169 consecutive patients (median age 8.4 years, 65% boys) fulfilling the criteria for constipation were enrolled. During the intervention and follow up period, all kept a diary to record symptoms. CTT was measured at entry to the study. Results: At entry, defecation frequency was lower in girls than in boys, while the frequency of encopresis episodes was higher in boys. CTT values were significantly higher in those with a low defecation frequency (⩽1/week) and a high frequency of encopresis (⩾2/day). However, 50% had CTT values within the normal range. Successful outcome occurred more often in those with a rectal impaction. CTT results <100 hours were not predictive of outcome. However, those with CTT >100 hours were less likely to have had a successful outcome. Conclusion: The presence of a rectal impaction at presentation is associated with a better outcome at one year. A CTT >100 hours is associated with a poor outcome at one year. PMID:15269069

Transfer of learning and patient outcome in simulated crisis resource management: a systematic review.

PubMed

Boet, Sylvain; Bould, M Dylan; Fung, Lillia; Qosa, Haytham; Perrier, Laure; Tavares, Walter; Reeves, Scott; Tricco, Andrea C

2014-06-01

Simulation-based learning is increasingly used by healthcare professionals as a safe method to learn and practice non-technical skills, such as communication and leadership, required for effective crisis resource management (CRM). This systematic review was conducted to gain a better understanding of the impact of simulation-based CRM teaching on transfer of learning to the workplace and subsequent changes in patient outcomes. Studies on CRM, crisis management, crew resource management, teamwork, and simulation published up to September 2012 were searched in MEDLINE(®), EMBASE™, CINAHL, Cochrane Central Register of Controlled Trials, and ERIC. All studies that used simulation-based CRM teaching with outcomes measured at Kirkpatrick Level 3 (transfer of learning to the workplace) or 4 (patient outcome) were included. Studies measuring only learners' reactions or simple learning (Kirkpatrick Level 1 or 2, respectively) were excluded. Two authors independently reviewed all identified titles and abstracts for eligibility. Nine articles were identified as meeting the inclusion criteria. Four studies measured transfer of simulation-based CRM learning into the clinical setting (Kirkpatrick Level 3). In three of these studies, simulation-enhanced CRM training was found significantly more effective than no intervention or didactic teaching. Five studies measured patient outcomes (Kirkpatrick Level 4). Only one of these studies found that simulation-based CRM training made a clearly significant impact on patient mortality. Based on a small number of studies, this systematic review found that CRM skills learned at the simulation centre are transferred to clinical settings, and the acquired CRM skills may translate to improved patient outcomes, including a decrease in mortality.

Six-Month Changes in Spirituality and Religiousness in Alcoholics Predict Drinking Outcomes at Nine Months*

PubMed Central

Robinson, Elizabeth A. R.; Krentzman, Amy R.; Webb, Jon R.; Brower, Kirk J.

2011-01-01

Objective: Although spiritual change is hypothesized to contribute to recovery from alcohol dependence, few studies have used prospective data to investigate this hypothesis. Prior studies have also been limited to treatment-seeking and Alcoholics Anonymous (AA) samples. This study included alcohol-dependent individuals, both in treatment and not, to investigate the effect of spiritual and religious (SR) change on subsequent drinking outcomes, independent of AA involvement. Method: Alcoholics (N = 364) were recruited for a panel study from two abstinence-based treatment centers, a moderation drinking program, and untreated individuals from the local community. Quantitative measures of SR change between baseline and 6 months were used to predict 9-month drinking outcomes, controlling for baseline drinking and AA involvement. Results: Significant 6-month changes in 8 of 12 SR measures were found, which included private SR practices, beliefs, daily spiritual experiences, three measures of forgiveness, negative religious coping, and purpose in life. Increases in private SR practices and forgiveness of self were the strongest predictors of improvements in drinking outcomes. Changes in daily spiritual experiences, purpose in life, a general measure of forgiveness, and negative religious coping also predicted favorable drinking outcomes. Conclusions: SR change predicted good drinking outcomes in alcoholics, even when controlling for AA involvement. SR variables, broadly defined, deserve attention in fostering change even among those who do not affiliate with AA or religious institutions. Last, future research should include SR variables, particularly various types of forgiveness, given the strong effects found for forgiveness of self. PMID:21683048

Abbreviated neuropsychological assessment in schizophrenia

PubMed Central

Harvey, Philip D.; Keefe, Richard S. E.; Patterson, Thomas L.; Heaton, Robert K.; Bowie, Christopher R.

2008-01-01

The aim of this study was to identify the best subset of neuropsychological tests for prediction of several different aspects of functioning in a large (n = 236) sample of older people with schizophrenia. While the validity of abbreviated assessment methods has been examined before, there has never been a comparative study of the prediction of different elements of cognitive impairment, real-world outcomes, and performance-based measures of functional capacity. Scores on 10 different tests from a neuropsychological assessment battery were used to predict global neuropsychological (NP) performance (indexed with averaged scores or calculated general deficit scores), performance-based indices of everyday-living skills and social competence, and case-manager ratings of real-world functioning. Forward entry stepwise regression analyses were used to identify the best predictors for each of the outcomes measures. Then, the analyses were adjusted for estimated premorbid IQ, which reduced the magnitude, but not the structure, of the correlations. Substantial amounts (over 70%) of the variance in overall NP performance were accounted for by a limited number of NP tests. Considerable variance in measures of functional capacity was also accounted for by a limited number of tests. Different tests constituted the best predictor set for each outcome measure. A substantial proportion of the variance in several different NP and functional outcomes can be accounted for by a small number of NP tests that can be completed in a few minutes, although there is considerable unexplained variance. However, the abbreviated assessments that best predict different outcomes vary across outcomes. Future studies should determine whether responses to pharmacological and remediation treatments can be captured with brief assessments as well. PMID:18720182

Guidelines for competency development and measurement in rehabilitation psychology postdoctoral training.

PubMed

Stiers, William; Barisa, Mark; Stucky, Kirk; Pawlowski, Carey; Van Tubbergen, Marie; Turner, Aaron P; Hibbard, Mary; Caplan, Bruce

2015-05-01

This study describes the results of a multidisciplinary conference (the Baltimore Conference) that met to develop consensus guidelines for competency specification and measurement in postdoctoral training in rehabilitation psychology. Forty-six conference participants were chosen to include representatives of rehabilitation psychology training and practice communities, representatives of psychology accreditation and certification bodies, persons involved in medical education practice and research, and consumers of training programs (students). Consensus education and training guidelines were developed that specify the key competencies in rehabilitation psychology postdoctoral training, and structured observation checklists were developed for their measurement. This study continues the development of more than 50 years of thinking about education and training in rehabilitation psychology and builds on the existing work to further advance the development of guidelines in this area. The conference developed aspirational guidelines for competency specification and measurement in rehabilitation psychology postdoctoral training (i.e., for studying the outcomes of these training programs). Structured observation of trainee competencies allows examination of actual training outcomes in relation to intended outcomes and provides a methodology for studying how program outcomes are related to program structures and processes so that program improvement can occur. Best practices in applying program evaluation research methods to the study of professional training programs are discussed. (c) 2015 APA, all rights reserved).

Frailty and Intellectual and Developmental Disabilities: a Scoping Review

PubMed Central

McKenzie, Katherine; Martin, Lynn; Ouellette-Kuntz, Hélène

2016-01-01

Background Individuals with intellectual and developmental disabilities (IDD) are both living longer than in previous generations and experiencing premature aging. Improved understanding of frailty in this aging population may inform community supports and avoid negative outcomes. Methods The objective of this study was to review the literature on frailty and IDD and determine areas for future research and application. The methodological framework for a scoping review as developed by H. Arksey and L. O’Malley was applied to identify and select original studies published since 2000. Results Seventeen studies were identified; these were based on the work of researchers from four research programs. The studies utilized six measures of frailty, including two frailty indices, the VFQ-ID(-R), the frailty phenotype, and the frailty marker. Frailty was equally studied as an outcome and as predictor for other outcomes (e.g., mobility, falls, care intensity, institutionalization, and survival). Conclusions There is evidence of a growing interest in the measurement of frailty in aging adults with IDD. As in the general population, frailty in this group is associated with many negative outcomes. While a few measures have emerged, more work is required to replicate results, validate tools, and test the feasibility of applying frailty measures in practice and to inform policy. PMID:27729949

Measuring animal personality for use in population management in zoos: suggested methods and rationale.

PubMed

Watters, Jason V; Powell, David M

2012-01-01

The concept that animals have personalities is gaining traction in the scientific community and is well established in zoos and aquariums. Applying knowledge of animal personalities has occurred more slowly and is most often only considered informally. However, animal personalities are likely to affect the welfare animals experience in captivity and thus should be of primary concern to zoo managers. In addition, animal personality likely affects the outcomes of zoo guest experiences and potentially guests' conservation-related behavior. With over 1,000,000 animals in the care of zoos internationally and hundreds of millions of visitors annually, it would be prudent and beneficial to maximize our use of animal personality data in zoos to effect positive conservation outcomes. Understanding how to broaden population planning techniques to include measures of animal personality and the important outcomes of welfare and education value is of prime importance to the zoo industry. In order to succeed, it is necessary to employ techniques that reliably assess animal personalities and provide measures that can easily be used in population planning models. We discuss the outcomes of recent workshops designed to determine the best techniques for measuring animal personalities in the zoo setting with the goal of incorporating personality into population planning. © 2011 Wiley Periodicals, Inc.

The Predictive Utility of a Brief Kindergarten Screening Measure of Child Behavior Problems

PubMed Central

Racz, Sarah Jensen; King, Kevin M.; Wu, Johnny; Witkiewitz, Katie; McMahon, Robert J.

2013-01-01

Objective Kindergarten teacher ratings, such as those from the Teacher Observation of Classroom Adaptation–Revised (TOCA-R), are a promising cost- and time-effective screening method to identify children at risk for later problems. Previous research with the TOCA-R has been mainly limited to outcomes in a single domain measured during elementary school. The goal of the current study was to examine the ability of TOCA-R sum scores to predict outcomes in multiple domains across distinct developmental periods (i.e., late childhood, middle adolescence, late adolescence). Method We used data from the Fast Track Project, a large multisite study with children at risk for conduct problems (n = 752; M age at start of study = 6.55 years; 57.7% male; 49.9% Caucasian, 46.3% African American). Kindergarten TOCA-R sum scores were used as the predictor in regression analyses; outcomes included school difficulties, externalizing diagnoses and symptom counts, and substance use. Results TOCA-R sum scores predicted school outcomes at all time points, diagnosis of ADHD in 9th grade, several externalizing disorder symptom counts, and cigarette use in 12th grade. Conclusions The findings demonstrate the predictive utility of the TOCA-R when examining outcomes within the school setting. Therefore, these results suggest the 10-item TOCA-R may provide a quick and accurate screening of children at risk for later problems. Implications for prevention and intervention programs are discussed. PMID:23544679

Relative Risk Reduction as a Metric to Standardize Effect Size for Public Heath Interventions for Translational Research: Methods and Applications

PubMed Central

Mirzazadeh, A; Malekinejad, M; Kahn, JG

2018-01-01

Objective Heterogeneity of effect measures in intervention studies undermines the use of evidence to inform policy. Our objective was to develop a comprehensive algorithm to convert all types of effect measures to one standard metric, relative risk reduction (RRR). Study Design and Setting This work was conducted to facilitate synthesis of published intervention effects for our epidemic modeling of the health impact of HIV Testing and Counseling (HTC). We designed and implemented an algorithm to transform varied effect measures to RRR, representing the proportionate reduction in undesirable outcomes. Results Our extraction of 55 HTC studies identified 473 effect measures representing unique combinations of intervention-outcome-population characteristics, using five outcome metrics: pre-post proportion (70.6%), odds ratio (14.0%), mean difference (10.2%), risk ratio (4.4%), and RRR (0.9%). Outcomes were expressed as both desirable (29.5%, e.g., consistent condom use) and undesirable (70.5% e.g., inconsistent condom use). Using four examples, we demonstrate our algorithm for converting varied effect measures to RRR, and provide the conceptual basis for advantages of RRR over other metrics. Conclusion Our review of the literature suggests that RRR, an easily understood and useful metric to convey risk reduction associated with an intervention, is underutilized by original and review studies. PMID:25726522

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

Teaching interprofessional teamwork skills to health professional students: A scoping review.

PubMed

Fox, Lanae; Onders, Robert; Hermansen-Kobulnicky, Carol J; Nguyen, Thanh-Nga; Myran, Leena; Linn, Becky; Hornecker, Jaime

2018-03-01

An expanding body of literature is examining interprofessional teamwork and its effect in healthcare. To produce capable healthcare professionals prepared to participate in interprofessional roles, teamwork training must begin early in health professional students' training. The focus of this scoping review was to explore interprofessional education (IPE) studies designed to teach and/or assess interprofessional teamwork skills to students from two or more different health professions, to find and describe effective pedagogy and assessment strategies. Using a scoping review methodology, 1,106 abstracts were reviewed by three teams of investigators. Eligibility criteria were inclusion of students in interprofessional teams, an intervention to improve interprofessional teamwork skills and assessment of outcomes related to teamwork. Thirty-three studies met the criteria for inclusion. The literature was varied in terms of study design, teaching methods and assessment measures for interprofessional teamwork. The lack of rigorous, comparable studies in this area makes recommending one teaching method or assessment measure over another difficult. Regardless of teaching method, it appears that most learning activities where interprofessional teams interact result in positive changes in student perceptions and attitudes towards IPE and practice. As health education programs seek to incorporate more interprofessional activities into their respective programs, it is important to review methods and measures that would best fit their individual program. This review highlights the importance of standardising the reporting of methods and outcomes for those who wish to incorporate the studied methods into their curricula.

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

Modified stoke ankylosing spondylitis spinal score as an outcome measure to assess the impact of treatment on structural progression in ankylosing spondylitis.

PubMed

van der Heijde, Désirée; Braun, Jürgen; Deodhar, Atul; Baraliakos, Xenofon; Landewé, Robert; Richards, Hanno B; Porter, Brian; Readie, Aimee

2018-05-30

In ankylosing spondylitis (AS), structural damage that occurs as a result of syndesmophyte formation and ankylosis of the vertebral column is irreversible. Structural damage is currently assessed by conventional radiography and scoring systems that reliably assess radiographic structural damage are needed to capture the differential effects of drugs on structural damage progression. The validity of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) as a primary outcome measure in evaluating the effect of AS treatments on radiographic progression rates was assessed in this review. The mSASSS has not been used, to date, as a primary outcome measure in a prospective randomized controlled clinical trial of biologic therapy in AS. This review of the medical literature confirmed that the mSASSS is the most validated and widely used method for assessing radiographic progression in AS, correlating with worsening measures of disease signs and symptoms, spinal mobility and physical function, with a 2-year interval being required to ensure sufficient sensitivity to change.

Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative.

PubMed

Garcia, Sofia F; Cella, David; Clauser, Steven B; Flynn, Kathryn E; Lad, Thomas; Lai, Jin-Shei; Reeve, Bryce B; Smith, Ashley Wilder; Stone, Arthur A; Weinfurt, Kevin

2007-11-10

Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

A nonparametric multiple imputation approach for missing categorical data.

PubMed

Zhou, Muhan; He, Yulei; Yu, Mandi; Hsu, Chiu-Hsieh

2017-06-06

Incomplete categorical variables with more than two categories are common in public health data. However, most of the existing missing-data methods do not use the information from nonresponse (missingness) probabilities. We propose a nearest-neighbour multiple imputation approach to impute a missing at random categorical outcome and to estimate the proportion of each category. The donor set for imputation is formed by measuring distances between each missing value with other non-missing values. The distance function is calculated based on a predictive score, which is derived from two working models: one fits a multinomial logistic regression for predicting the missing categorical outcome (the outcome model) and the other fits a logistic regression for predicting missingness probabilities (the missingness model). A weighting scheme is used to accommodate contributions from two working models when generating the predictive score. A missing value is imputed by randomly selecting one of the non-missing values with the smallest distances. We conduct a simulation to evaluate the performance of the proposed method and compare it with several alternative methods. A real-data application is also presented. The simulation study suggests that the proposed method performs well when missingness probabilities are not extreme under some misspecifications of the working models. However, the calibration estimator, which is also based on two working models, can be highly unstable when missingness probabilities for some observations are extremely high. In this scenario, the proposed method produces more stable and better estimates. In addition, proper weights need to be chosen to balance the contributions from the two working models and achieve optimal results for the proposed method. We conclude that the proposed multiple imputation method is a reasonable approach to dealing with missing categorical outcome data with more than two levels for assessing the distribution of the outcome. In terms of the choices for the working models, we suggest a multinomial logistic regression for predicting the missing outcome and a binary logistic regression for predicting the missingness probability.

Parks and people: An environmental justice inquiry in Baltimore, Maryland

Treesearch

Christopher G. Boone; Geoffrey L. Buckley; J. Morgan Grove; Chona Sister

2009-01-01

This article examines the distribution of parks in Baltimore, Maryland, as an environmental justice issue. In addition to established methods for measuring distribution of and access to parks, we employ a novel park service area approach that uses Thiessen polygons and dasymetric reapportioning of census data to measure potential park congestion as an equity outcome...

Generalizability of the Differential Coursework Methodology: Relationships between Self-Reported Coursework and Performance on the ACT-COMP Exam.

ERIC Educational Resources Information Center

Pike, Gary R.; Phillippi, Raymond H.

1989-01-01

Measures of student achievement must be linked to the characteristics of academic programs. The Differential Coursework Patterns Project at Iowa State University was used by the University of Tennessee at Knoxville as a method of linking outcome measures to program data. Results are discussed. (Author/MLW)

Reliability of the Colorado Family Support Assessment: A Self-Sufficiency Matrix for Families

ERIC Educational Resources Information Center

Richmond, Melissa K.; Pampel, Fred C.; Zarcula, Flavia; Howey, Virginia; McChesney, Brenda

2017-01-01

Purpose: Family support programs commonly use self-sufficiency matrices (SSMs) to measure family outcomes, however, validation research on SSMs is sparse. This study examined the reliability of the Colorado Family Support Assessment 2.0 (CFSA 2.0) to measure family self-reliance across 14 domains (e.g., employment). Methods: Ten written case…

The Influence of Epoch Length on Physical Activity Patterns Varies by Child's Activity Level

ERIC Educational Resources Information Center

Nettlefold, Lindsay; Naylor, P. J.; Warburton, Darren E. R.; Bredin, Shannon S. D.; Race, Douglas; McKay, Heather A.

2016-01-01

Purpose: Patterns of physical activity (PA) and sedentary time, including volume of bouted activity, are important health indicators. However, the effect of accelerometer epoch length on measurement of these patterns and associations with health outcomes in children remain unknown. Method: We measured activity patterns in 308 children (52% girls,…

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…

Improved Body Mass Index Measures Following a Middle School-Based Obesity Intervention--The MATCH Program

ERIC Educational Resources Information Center

Lazorick, Suzanne; Fang, Xiangming; Hardison, George T.; Crawford, Yancey

2015-01-01

Background: Motivating Adolescents with Technology to CHOOSE Health™ (MATCH) is an educational and behavioral intervention in seventh grade. Methods: Teachers in 2 schools delivered the MATCH curriculum, with 1 control school. Using a quasi-experimental design, outcome measures included lessons completed, body mass index (BMI), BMI z-score (zBMI),…

The Impact of Advanced Greenhouse Gas Measurement Science on Policy Goals and Research Strategies

NASA Astrophysics Data System (ADS)

Abrahams, L.; Clavin, C.; McKittrick, A.

2016-12-01

In support of the Paris agreement, accurate characterizations of U.S. greenhouse gas (GHG) emissions estimates have been area of increased scientific focus. Over the last several years, the scientific community has placed significant emphasis on understanding, quantifying, and reconciling measurement and modeling methods that characterize methane emissions from petroleum and natural gas sources. This work has prompted national policy discussions and led to the improvement of regional and national methane emissions estimates. Research campaigns focusing on reconciling atmospheric measurements ("top-down") and process-based emissions estimates ("bottom-up") have sought to identify where measurement technology advances could inform policy objectives. A clear next step is development and deployment of advanced detection capabilities that could aid U.S. emissions mitigation and verification goals. The breadth of policy-relevant outcomes associated with advances in GHG measurement science are demonstrated by recent improvements in the petroleum and natural gas sector emission estimates in the EPA Greenhouse Gas Inventory, ambitious efforts to apply inverse modeling results to inform or validate national GHG inventory, and outcomes from federal GHG measurement science technology development programs. In this work, we explore the variety of policy-relevant outcomes impacted by advances in GHG measurement science, with an emphasis on improving GHG inventory estimates, identifying emissions mitigation strategies, and informing technology development requirements.

The Role of Theory-Specific Techniques and Therapeutic Alliance in Promoting Positive Outcomes: Integrative Psychotherapy for World Trade Center Responders.

PubMed

Haugen, Peter Tejas; Werth, Aditi Sinha; Foster, Alyce Lauren; Owen, Jesse

2016-12-01

World Trade Center responders demonstrate high symptom burden, underscoring the importance of refining treatment approaches for this cohort. One method is examining the impact of therapy techniques on outcomes, and the interactions between technique and alliance on outcomes. This study a) examined the interaction of early treatment techniques on integrative psychotherapy outcomes and b) explored whether associations differed at varying levels of alliance. Twenty-nine adult responders diagnosed with partial or full posttraumatic stress disorder received outpatient psychotherapy and completed weekly measures of alliance, technique, and symptom distress. Analyses indicated significant interactions between 1) alliance and psychodynamic interventions on outcomes and 2) alliance and cognitive behavioral (CB) interventions on outcomes. Clients with high alliance had better outcomes when their therapist used fewer CB techniques. No meaningful differences were found between technique and outcomes for clients with lower alliance. These findings reiterate the critical roles technique and responsiveness to the alliance play in engendering successful outcomes.

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

PubMed

Kluetz, Paul G; O'Connor, Daniel J; Soltys, Katherine

2018-05-01

The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process. Copyright © 2018 Elsevier Ltd. All rights reserved.

Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes.

PubMed

Kirwan, John R; Fries, James F; Hewlett, Sarah E; Osborne, Richard H; Newman, Stanton; Ciciriello, Sabina; van de Laar, Mart A; Dures, Emma; Minnock, Patricia; Heiberg, Turid; Sanderson, Tessa C; Flurey, Caroline A; Leong, Amy L; Montie, Pamela; Richards, Pam

2011-08-01

The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.

Feasibility of a Sensory-Adapted Dental Environment for Children With Autism

PubMed Central

Stein Duker, Leah I.; Williams, Marian E.; Lane, Christianne Joy; Dawson, Michael E.; Borreson, Ann E.; Polido, José C.

2015-01-01

OBJECTIVE. To provide an example of an occupational therapy feasibility study and evaluate the implementation of a randomized controlled pilot and feasibility trial examining the impact of a sensory-adapted dental environment (SADE) to enhance oral care for children with autism spectrum disorder (ASD). METHOD. Twenty-two children with ASD and 22 typically developing children, ages 6–12 yr, attended a dental clinic in an urban hospital. Participants completed two dental cleanings, 3–4 mo apart, one in a regular environment and one in a SADE. Feasibility outcome measures were recruitment, retention, accrual, dropout, and protocol adherence. Intervention outcome measures were physiological stress, behavioral distress, pain, and cost. RESULTS. We successfully recruited and retained participants. Parents expressed satisfaction with research study participation. Dentists stated that the intervention could be incorporated in normal practice. Intervention outcome measures favored the SADE condition. CONCLUSION. Preliminary positive benefit of SADE in children with ASD warrants moving forward with a large-scale clinical trial. PMID:25871593

The Virtual Research Lab: Research Outcome Expectations, Research Knowledge, and the Graduate Student Experience

ERIC Educational Resources Information Center

Stadtlander, Lee; Giles, Martha; Sickel, Amy

2013-01-01

This paper examines the complexities of working with student researchers in a virtual lab setting, logistics, and methods to resolve issues. To demonstrate the feasibility of a virtual lab, a mixed-methods study consisting of quantitative surveys and qualitative data examined changes in doctoral students' confidence as measured by research outcome…

Unpacking Trauma Exposure Risk Factors and Differential Pathways of Influence: Predicting Postwar Mental Distress in Bosnian Adolescents

ERIC Educational Resources Information Center

Layne, Christopher M.; Olsen, Joseph A.; Baker, Aaron; Legerski, John-Paul; Isakson, Brian; Pasalic, Alma; Durakovic-Belko, Elvira; Dapo, Nermin; Campara, Nihada; Arslanagic, Berina; Saltzman, William R.; Pynoos, Robert S.

2010-01-01

Methods are needed for quantifying the potency and differential effects of risk factors to identify at-risk groups for theory building and intervention. Traditional methods for constructing war exposure measures are poorly suited to "unpack" differential relations between specific types of exposure and specific outcomes. This study of…

The Relationship between Method of Clinical Instruction in Radiography and Scores on the American Registry of Radiologic Technologists Certification Examination.

ERIC Educational Resources Information Center

Dowd, Steven B.

An examination was made of the relationship between clinical grade based on simulation and a subsequent outcome measurement, the national certification examination in radiography. Although the new "Essentials" developed by the Joint Review Committee in Education in Radiologic Technology discouraged use of simulation, the method had…

A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

PubMed

Kirkham, Jamie J; Clarke, Mike; Williamson, Paula R

2017-05-17

Objective  To assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries. Design  Review of randomised trials. Setting  ClinicalTrials.gov. Subjects  273 randomised trials of drug interventions for the treatment of rheumatoid arthritis and registered in ClinicalTrials.gov between 2002 and 2016. Full publications were identified for completed studies from information in the trial registry or from an internet search using Google and the citation database Web of Science. Main outcome measure  The percentage of trials reporting or planning to measure the rheumatoid arthritis core outcome set calculated from the information presented in the trial registry and compared with the percentage reporting the rheumatoid arthritis core outcome set in the resulting trial publications. Results  The full rheumatoid arthritis core outcome set was reported in 81% (116/143) of trials identified on the registry as completed (or terminated) for which results were found in either the published literature or the registry. For trials identified on the registry as completed (or terminated), using information only available in the registry gives an estimate for uptake of 77% (145/189). Conclusions  The uptake of the rheumatoid arthritis core outcome set in clinical trials has continued to increase over time. Using the information on outcomes listed for completed or terminated studies in a trial registry provides a reasonable estimate of the uptake of a core outcome set and is a more efficient and up-to-date approach than examining the outcomes in published trial reports. The method proposed may provide an efficient approach for an up-to-date assessment of the uptake of the 300 core outcome sets already published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

How Can Value-Added Measures Be Used for Teacher Improvement? What We Know Series: Value-Added Methods and Applications. Knowledge Brief 13

ERIC Educational Resources Information Center

Loeb, Susanna

2013-01-01

The question for this brief is whether education leaders can use value-added measures as tools for improving schooling and, if so, how to do this. Districts, states, and schools can, at least in theory, generate gains in educational outcomes for students using value-added measures in three ways: creating information on effective programs, making…

Newcomer adjustment during organizational socialization: a meta-analytic review of antecedents, outcomes, and methods.

PubMed

Bauer, Talya N; Bodner, Todd; Erdogan, Berrin; Truxillo, Donald M; Tucker, Jennifer S

2007-05-01

The authors tested a model of antecedents and outcomes of newcomer adjustment using 70 unique samples of newcomers with meta-analytic and path modeling techniques. Specifically, they proposed and tested a model in which adjustment (role clarity, self-efficacy, and social acceptance) mediated the effects of organizational socialization tactics and information seeking on socialization outcomes (job satisfaction, organizational commitment, job performance, intentions to remain, and turnover). The results generally supported this model. In addition, the authors examined the moderating effects of methodology on these relationships by coding for 3 methodological issues: data collection type (longitudinal vs. cross-sectional), sample characteristics (school-to-work vs. work-to-work transitions), and measurement of the antecedents (facet vs. composite measurement). Discussion focuses on the implications of the findings and suggestions for future research. 2007 APA, all rights reserved

Medical Staff Involvement in Nursing Homes: Development of a Conceptual Model and Research Agenda

PubMed Central

Shield, Renée; Rosenthal, Marsha; Wetle, Terrie; Tyler, Denise; Clark, Melissa; Intrator, Orna

2013-01-01

Medical staff (physicians, nurse practitioners, physicians’ assistants) involvement in nursing homes (NH) is limited by professional guidelines, government policies, regulations, and reimbursements, creating bureaucratic burden. The conceptual NH Medical Staff Involvement Model, based on our mixed methods research, applies the Donabedian structure-process-outcomes framework to the NH identifying measures for a coordinated research agenda. Quantitative surveys and qualitative interviews conducted with medical directors, administrators and directors of nursing, other experts, residents and family members and Minimum Data Set, the Online Certification and Reporting System and Medicare Part B claims data related to NH structure, process and outcomes were analyzed. NH control of medical staff, or structure, affects medical staff involvement in care processes and is associated with better outcomes (e.g. symptom management, appropriate transitions, satisfaction). The Model identifies measures clarifying the impact of NH medical staff involvement on care processes and resident outcomes and has strong potential to inform regulatory policies. PMID:24652944

Bimodal Benefits on Objective and Subjective Outcomes for Adult Cochlear Implant Users

PubMed Central

Heo, Ji-Hye; Lee, Won-Sang

2013-01-01

Background and Objectives Given that only a few studies have focused on the bimodal benefits on objective and subjective outcomes and emphasized the importance of individual data, the present study aimed to measure the bimodal benefits on the objective and subjective outcomes for adults with cochlear implant. Subjects and Methods Fourteen listeners with bimodal devices were tested on the localization and recognition abilities using environmental sounds, 1-talker, and 2-talker speech materials. The localization ability was measured through an 8-loudspeaker array. For the recognition measures, listeners were asked to repeat the sentences or say the environmental sounds the listeners heard. As a subjective questionnaire, three domains of Korean-version of Speech, Spatial, Qualities of Hearing scale (K-SSQ) were used to explore any relationships between objective and subjective outcomes. Results Based on the group-mean data, the bimodal hearing enhanced both localization and recognition regardless of test material. However, the inter- and intra-subject variability appeared to be large across test materials for both localization and recognition abilities. Correlation analyses revealed that the relationships were not always consistent between the objective outcomes and the subjective self-reports with bimodal devices. Conclusions Overall, this study supports significant bimodal advantages on localization and recognition measures, yet the large individual variability in bimodal benefits should be considered carefully for the clinical assessment as well as counseling. The discrepant relations between objective and subjective results suggest that the bimodal benefits in traditional localization or recognition measures might not necessarily correspond to the self-reported subjective advantages in everyday listening environments. PMID:24653909

The Effect Of Different Corrective Feedback Methods on the Outcome and Self Confidence of Young Athletes

PubMed Central

Tzetzis, George; Votsis, Evandros; Kourtessis, Thomas

2008-01-01

This experiment investigated the effects of three corrective feedback methods, using different combinations of correction, or error cues and positive feedback for learning two badminton skills with different difficulty (forehand clear - low difficulty, backhand clear - high difficulty). Outcome and self-confidence scores were used as dependent variables. The 48 participants were randomly assigned into four groups. Group A received correction cues and positive feedback. Group B received cues on errors of execution. Group C received positive feedback, correction cues and error cues. Group D was the control group. A pre, post and a retention test was conducted. A three way analysis of variance ANOVA (4 groups X 2 task difficulty X 3 measures) with repeated measures on the last factor revealed significant interactions for each depended variable. All the corrective feedback methods groups, increased their outcome scores over time for the easy skill, but only groups A and C for the difficult skill. Groups A and B had significantly better outcome scores than group C and the control group for the easy skill on the retention test. However, for the difficult skill, group C was better than groups A, B and D. The self confidence scores of groups A and C improved over time for the easy skill but not for group B and D. Again, for the difficult skill, only group C improved over time. Finally a regression analysis depicted that the improvement in performance predicted a proportion of the improvement in self confidence for both the easy and the difficult skill. It was concluded that when young athletes are taught skills of different difficulty, different type of instruction, might be more appropriate in order to improve outcome and self confidence. A more integrated approach on teaching will assist coaches or physical education teachers to be more efficient and effective. Key pointsThe type of the skill is a critical factor in determining the effectiveness of the feedback types.Different instructional methods of corrective feedback could have beneficial effects in the outcome and self-confidence of young athletesInstructions focusing on the correct cues or errors increase performance of easy skills.Positive feedback or correction cues increase self-confidence of easy skills but only the combination of error and correction cues increase self confidence and outcome scores of difficult skills. PMID:24149905

Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

PubMed Central

Saketkoo, Lesley Ann; Mittoo, Shikha; Huscher, Dörte; Khanna, Dinesh; Dellaripa, Paul F; Distler, Oliver; Flaherty, Kevin R; Frankel, Sid; Oddis, Chester V; Denton, Christopher P; Fischer, Aryeh; Kowal-Bielecka, Otylia M; LeSage, Daphne; Merkel, Peter A; Phillips, Kristine; Pittrow, David; Swigris, Jeffrey; Antoniou, Katerina; Baughman, Robert P; Castelino, Flavia V; Christmann, Romy B; Christopher-Stine, Lisa; Collard, Harold R; Cottin, Vincent; Danoff, Sonye; Highland, Kristin B; Hummers, Laura; Shah, Ami A; Kim, Dong Soon; Lynch, David A; Miller, Frederick W; Proudman, Susanna M; Richeldi, Luca; Ryu, Jay H; Sandorfi, Nora; Sarver, Catherine; Wells, Athol U; Strand, Vibeke; Matteson, Eric L; Brown, Kevin K; Seibold, James R

2014-01-01

Rationale Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. Methods The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). Results A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Conclusion Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field. PMID:24368713

Functional Performance Testing and Patient Reported Outcomes following ACL Reconstruction: A Systematic Scoping Review

PubMed Central

Herrington, Lee

2014-01-01

Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that are increasingly being used for ACL reconstruction throughout the last decade. PMID:27379330

Evaluating Willingness-to-Pay Thresholds for Dementia Caregiving Interventions: Application to the Tailored Activity Program

PubMed Central

Jutkowitz, Eric; Gitlin, Laura N.; Pizzi, Laura T.

2017-01-01

Objectives The study aims to apply willingness-to-pay (WTP) values derived from the literature to inform decision-makers of the cost-effectiveness of the Tailored Activity Program (TAP), an intervention proven to reduce caregiver burden. Methods TAP and other caregiver interventions employ an individual perspective and non–quality-adjusted life-year (QALY) outcome measure where the primary objective is to determine caregiver burden from an individual perspective. Therefore, standard cost/QALY thresholds are not appropriate. To identify relevant WTP values, we searched for studies that: 1) were published in the past 5 years and used contingent valuation methodology to identify WTP; 2) assessed WTP for a dementia-related intervention requiring out-of-pocket expenditure; and 3) asked caregivers their WTP for an outcome related to reducing caregiver burden. Three studies were identified utilizing four WTP values. We also assessed potential financial savings that caregivers could achieve from purchasing TAP. To assess the probability of TAP being cost-effective, we built a Monte Carlo simulation to test the four WTP values applied to two TAP outcome measures: reduction in caregiver hours “on duty;” and “doing things.” Results For outcome measure “on duty,” WTP varied between $1.06/hour and $4.58/hour. For outcome measure “doing things,” WTP varied between $2.21/hour and $9.57/hour. Applying the four identified WTP values from the literature to TAP outcomes resulted in TAP cost-effectiveness varying between 50% and 80% for both outcome measures. Conclusions When WTP data are not collected prospectively or conventional metrics cannot be applied, retrospectively assessing literature-derived WTP may be acceptable for informing decision-makers of potential cost-effectiveness of a proven program. Application of WTP to TAP shows potential cost-effectiveness that can be expected under the tested WTP scenarios. PMID:20561331

The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

PubMed Central

Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

2016-01-01

Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

A simple ERP method for quantitative analysis of cognitive workload in myoelectric prosthesis control and human-machine interaction.

PubMed

Deeny, Sean; Chicoine, Caitlin; Hargrove, Levi; Parrish, Todd; Jayaraman, Arun

2014-01-01

Common goals in the development of human-machine interface (HMI) technology are to reduce cognitive workload and increase function. However, objective and quantitative outcome measures assessing cognitive workload have not been standardized for HMI research. The present study examines the efficacy of a simple event-related potential (ERP) measure of cortical effort during myoelectric control of a virtual limb for use as an outcome tool. Participants trained and tested on two methods of control, direct control (DC) and pattern recognition control (PRC), while electroencephalographic (EEG) activity was recorded. Eighteen healthy participants with intact limbs were tested using DC and PRC under three conditions: passive viewing, easy, and hard. Novel auditory probes were presented at random intervals during testing, and significant task-difficulty effects were observed in the P200, P300, and a late positive potential (LPP), supporting the efficacy of ERPs as a cognitive workload measure in HMI tasks. LPP amplitude distinguished DC from PRC in the hard condition with higher amplitude in PRC, consistent with lower cognitive workload in PRC relative to DC for complex movements. Participants completed trials faster in the easy condition using DC relative to PRC, but completed trials more slowly using DC relative to PRC in the hard condition. The results provide promising support for ERPs as an outcome measure for cognitive workload in HMI research such as prosthetics, exoskeletons, and other assistive devices, and can be used to evaluate and guide new technologies for more intuitive HMI control.