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.

Patient-Reported Outcome Measures for Hand and Wrist Trauma: Is There Sufficient Evidence of Reliability, Validity, and Responsiveness?

PubMed

Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

2016-03-01

Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology.

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…

Percent Grammatical Responses as a General Outcome Measure: Initial Validity

ERIC Educational Resources Information Center

Eisenberg, Sarita L.; Guo, Ling-Yu

2018-01-01

Purpose: This report investigated the validity of using percent grammatical responses (PGR) as a measure for assessing grammaticality. To establish construct validity, we computed the correlation of PGR with another measure of grammar skills and with an unrelated skill area. To establish concurrent validity for PGR, we computed the correlation of…

Assessment of Functional Rhinoplasty with Spreader Grafting Using Acoustic Rhinomanometry and Validated Outcome Measurements

PubMed Central

Paul, Marek A.; Kamali, Parisa; Chen, Austin D.; Ibrahim, Ahmed M. S.; Wu, Winona; Becherer, Babette E.; Medin, Caroline

2018-01-01

Background: Rhinoplasty is 1 of the most common aesthetic and reconstructive plastic surgical procedures performed within the United States. Yet, data on functional reconstructive open and closed rhinoplasty procedures with or without spreader graft placement are not definitive as only a few studies have examined both validated measurable objective and subjective outcomes of spreader grafting during rhinoplasty. The aim of this study was to utilize previously validated measures to assess objective, functional outcomes in patients who underwent open and closed rhinoplasty with spreader grafting. Methods: We performed a retrospective review of consecutive rhinoplasty patients. Patients with internal nasal valve insufficiency who underwent an open and closed approach rhinoplasty between 2007 and 2016 were studied. The Cottle test and Nasal Obstruction Symptom Evaluation survey was used to assess nasal obstruction. Patient-reported symptoms were recorded. Acoustic rhinometry was performed pre- and postoperatively. Average minimal cross-sectional area of the nose was measured. Results: One hundred seventy-eight patients were reviewed over a period of 8 years. Thirty-eight patients were included in this study. Of those, 30 patients underwent closed rhinoplasty and 8 open rhinoplasty. Mean age was 36.9 ± 18.4 years. The average cross-sectional area in closed and open rhinoplasty patients increased significantly (P = 0.019). There was a functional improvement in all presented cases using the Nasal Obstruction Symptom Evaluation scale evaluation. Conclusions: Closed rhinoplasty with spreader grafting may play a significant role in the treatment of nasal valve collapse. A closed approach rhinoplasty including spreader grafting is a viable option in select cases with objective and validated functional improvement. PMID:29707440

The French-Canadian validation of a disease-specific, patient-reported outcome measure for lupus.

PubMed

Bourré-Tessier, J; Clarke, A E; Kosinski, M; Mikolaitis-Preuss, R A; Bernatsky, S; Block, J A; Jolly, M

2014-12-01

The objective of this paper is to perform the cross-cultural validation of the French version of the LupusPRO, a disease-targeted patient-reported outcome measure, among systemic lupus erythematosus (SLE) patients in Canada. The French version of the LupusPRO and the MOS SF-36 were administered; demographic, clinical and serological characteristics were obtained. Disease activity (SELENA-SLEDAI and the Lupus Foundation of America definition of flare) and damage (SLICC/ACR SDI) were assessed. Physician disease activity and damage assessments were ascertained using visual analog scales. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity, damage or health status) and known group validity were tested. A total of 99 French-Canadian SLE patients participated (97% women, mean (SD) age 45.2 (14.5) years). The median (IQR) SELENA-SLEDAI and SDI were 3.5 (6.0) and 1.0 (2.0), respectively. The ICR of the LupusPRO domains ranged from 0.81 to 0.93 (except for lupus symptoms, procreation and coping), while TRT ranged from 0.72 to 0.95. Convergent and discriminant validity, criterion validity and known group validity against disease activity, damage and health status measures were observed. Confirmatory factor analysis showed a good fit. The LupusPRO has fair psychometric properties among French-Canadian patients with SLE. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Evaluation of the Validity and Response Burden of Patient Self-Report Measures of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR).

PubMed

Cook, Karon F; Kallen, Michael A; Buckenmaier, Chester; Flynn, Diane M; Hanling, Steven R; Collins, Teresa S; Joltes, Kristin; Kwon, Kyung; Medina-Torne, Sheila; Nahavandi, Parisa; Suen, Joshua; Gershon, Richard

2017-07-01

In 2009, the Army Pain Management Task Force was chartered. On the basis of their findings, the Department of Defense recommended a comprehensive pain management strategy that included development of a standardized pain assessment system that would collect patient-reported outcomes data to inform the patient-provider clinical encounter. The result was the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The purpose of this study was to assess the validity and response burden of the patient-reported outcome measures in PASTOR. Data for analyses were collected from 681 individuals who completed PASTOR at baseline and follow-up as part of their routine clinical care. The survey tool included self-report measures of pain severity and pain interference (measured using the National Institutes of Health Patient-Reported Outcome Measurement Information System [PROMIS] and the Defense and Veterans Pain Rating scale). PROMIS measures of pain correlates also were administered. Validation analyses included estimation of score associations among measures, comparison of scores of known groups, responsiveness, ceiling and floor effects, and response burden. Results of psychometric testing provided substantial evidence for the validity of PASTOR self-report measures in this population. Expected associations among scores largely supported the concurrent validity of the measures. Scores effectively distinguished among respondents on the basis of their self-reported impressions of general health. PROMIS measures were administered using computer adaptive testing and each, on average, required less than 1 minute to administer. Statistical and graphical analyses demonstrated the responsiveness of PASTOR measures over time. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

Cross-cultural adaptation and validation of the Dutch version of the core outcome measures index for low back pain.

PubMed

Van Lerbeirghe, J; Van Lerbeirghe, J; Van Schaeybroeck, P; Robijn, H; Rasschaert, R; Sys, J; Parlevliet, T; Hallaert, G; Van Wambeke, P; Depreitere, B

2018-01-01

The core outcome measures index (COMI) is a validated multidimensional instrument for assessing patient-reported outcome in patients with back problems. The aim of the present study is to translate the COMI into Dutch and validate it for use in native Dutch speakers with low back pain. The COMI was translated into Dutch following established guidelines and avoiding region-specific terminology. A total of 89 Dutch-speaking patients with low back pain were recruited from 8 centers, located in the Dutch-speaking part of Belgium. Patients completed a questionnaire booklet including the validated Dutch version of the Roland Morris disability questionnaire, EQ-5D, the WHOQoL-Bref, the Numeric Rating Scale (NRS) for pain, and the Dutch translation of the COMI. Two weeks later, patients completed the Dutch COMI translation again, with a transition scale assessing changes in their condition. The patterns of correlations between the individual COMI items and the validated reference questionnaires were comparable to those reported for other validated language versions of the COMI. The intraclass correlation for the COMI summary score was 0.90 (95% CI 0.84-0.94). It was 0.75 and 0.70 for the back and leg pain score, respectively. The minimum detectable change for the COMI summary score was 1.74. No significant differences were observed between repeated scores of individual COMI items or for the summary score. The reproducibility of the Dutch translation of the COMI is comparable to that of other validated spine outcome measures. The COMI items correlate well with the established item-specific scores. The Dutch translation of the COMI, validated by this work, is a reliable and valuable tool for spine centers treating Dutch-speaking patients and can be used in registries and outcome studies.

Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis

PubMed Central

Benedict, Ralph HB; DeLuca, John; Phillips, Glenn; LaRocca, Nicholas; Hudson, Lynn D; Rudick, Richard

2017-01-01

Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude. PMID:28206827

Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis.

PubMed

Benedict, Ralph Hb; DeLuca, John; Phillips, Glenn; LaRocca, Nicholas; Hudson, Lynn D; Rudick, Richard

2017-04-01

Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude.

Validation of the alcohol use item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS).

PubMed

Pilkonis, Paul A; Yu, Lan; Dodds, Nathan E; Johnston, Kelly L; Lawrence, Suzanne M; Daley, Dennis C

2016-04-01

The Patient-Reported Outcomes Measurement Information System (PROMIS) includes five item banks for alcohol use. There are limited data, however, regarding their validity (e.g., convergent validity, responsiveness to change). To provide such data, we conducted a prospective study with 225 outpatients being treated for substance abuse. Assessments were completed shortly after intake and at 1-month and 3-month follow-ups. The alcohol item banks were administered as computerized adaptive tests (CATs). Fourteen CATs and one six-item short form were also administered from eight other PROMIS domains to generate a comprehensive health status profile. After modeling treatment outcome for the sample as a whole, correlates of outcome from the PROMIS health status profile were examined. For convergent validity, the largest correlation emerged between the PROMIS alcohol use score and the Alcohol Use Disorders Identification Test (r=.79 at intake). Regarding treatment outcome, there were modest changes across the target problem of alcohol use and other domains of the PROMIS health status profile. However, significant heterogeneity was found in initial severity of drinking and in rates of change for both abstinence and severity of drinking during follow-up. This heterogeneity was associated with demographic (e.g., gender) and health-profile (e.g., emotional support, social participation) variables. The results demonstrated the validity of PROMIS CATs, which require only 4-6 items in each domain. This efficiency makes it feasible to use a comprehensive health status profile within the substance use treatment setting, providing important prognostic information regarding abstinence and severity of drinking. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group.

PubMed

Terslev, Lene; Gutierrez, Marwin; Schmidt, Wolfgang A; Keen, Helen I; Filippucci, Emilio; Kane, David; Thiele, Ralf; Kaeley, Gurjit; Balint, Peter; Mandl, Peter; Delle Sedie, Andrea; Hammer, Hilde Berner; Christensen, Robin; Möller, Ingrid; Pineda, Carlos; Kissin, Eugene; Bruyn, George A; Iagnocco, Annamaria; Naredo, Esperanza; D'Agostino, Maria Antonietta

2015-11-01

To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Working Group on the validation of US as a potential outcome measure in gout. Based on the lack of definitions, highlighted in a recent literature review on US as an outcome tool in gout, a series of iterative exercises were carried out to obtain consensus-based definitions on US elementary components in gout using a Delphi exercise and subsequently testing these definitions in static images and in patients with proven gout. Cohen's κ was used to test agreement, and values of 0-0.20 were considered poor, 0.20-0.40 fair, 0.40-0.60 moderate, 0.60-0.80 good, and 0.80-1 excellent. With an agreement of > 80%, consensus-based definitions were obtained for the 4 elementary lesions highlighted in the literature review: tophi, aggregates, erosions, and double contour (DC). In static images interobserver reliability ranged from moderate to almost perfect, and similar results were found for the intrareader reliability. In patients the intraobserver agreement was good for all lesions except DC (moderate). The interobserver agreement was poor for aggregates and DC but moderate for the other components. These first steps in evaluating the validity of US as an outcome measure for gout show that the reliability of the definitions ranged from moderate to excellent in static images and somewhat lower in patients, indicating that a standardized scanning technique may be needed, before testing the responsiveness of those definitions in a composite US score.

Measuring voice outcomes: state of the science review.

PubMed

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

2009-08-01

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

Systematic review of systemic sclerosis-specific instruments for the EULAR Outcome Measures Library: An evolutional database model of validated patient-reported outcomes.

PubMed

Ingegnoli, Francesca; Carmona, Loreto; Castrejon, Isabel

2017-04-01

The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML. A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist. From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements. Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted. Copyright © 2017 Elsevier Inc. All rights reserved.

Outward Bound Outcome Model Validation and Multilevel Modeling

ERIC Educational Resources Information Center

Luo, Yuan-Chun

2011-01-01

This study was intended to measure construct validity for the Outward Bound Outcomes Instrument (OBOI) and to predict outcome achievement from individual characteristics and course attributes using multilevel modeling. A sample of 2,340 participants was collected by Outward Bound USA between May and September 2009 using the OBOI. Two phases of…

Predictive Validity of Curriculum-Embedded Measures on Outcomes of Kindergarteners Identified as At Risk for Reading Difficulty

ERIC Educational Resources Information Center

Oslund, Eric L.; Hagan-Burke, Shanna; Simmons, Deborah C.; Clemens, Nathan H.; Simmons, Leslie E.; Taylor, Aaron B.; Kwok, Oi-man; Coyne, Michael D.

2017-01-01

This study examined the predictive validity of formative assessments embedded in a Tier 2 intervention curriculum for kindergarten students identified as at risk for reading difficulty. We examined when (i.e., months during the school year) measures could predict reading outcomes gathered at the end of kindergarten and whether the predictive…

Measuring spine fracture outcomes: common scales and checklists.

PubMed

Schoenfeld, Andrew J; Bono, Christopher M

2011-03-01

Although outcome instruments have been used extensively in spine surgical research, few studies at present specifically address their use in investigations regarding spine trauma. In this review we provide a summary of the outcome instruments used most frequently in spine trauma research, identify the unique challenges of studying outcomes of spine trauma patients, and propose an integrated approach that may be beneficial for future studies. We reviewed the use of outcome instruments applicable to spine trauma research, including generic health measures, inventories of back-specific function, pain scales, health related quality of life (HRQOL) instruments, and radiographic determinants of outcome. Several inventories have been utilised to measure clinical outcomes following spinal trauma. Excluding measures of neurological function (e.g. ASIA motor score), none have been specifically validated for use with spine fractures. The SF-36, RMDQ, and ODI are amongst the most commonly used instruments. Importantly, the use of validated functional outcome measures in spine trauma research is hampered by the fact that the pre-morbid state of patients who sustain spine trauma may not be accurately represented by normative values established for the general population. The VAS is used most frequently to assess degree of neck and back pain. Most studies have relied on non-validated measures to determine radiographic results of treatment, although more elegant radiographic metrics exist. Functional outcome measurement of traumatically injured spine patients is challenging because available generic and spine-specific instruments were not designed for or validated in this population. Furthermore, no single inventory is capable of capturing global data necessary to evaluate results following these injuries. Investigations seeking to quantify outcomes following spine trauma should consider the use of a combination of existing surveys in a complementary fashion that should include a

Reliability and validity of the Outcome Expectations for Exercise Scale-2.

PubMed

Resnick, Barbara

2005-10-01

Development of a reliable and valid measure of outcome expectations for exercise for older adults will help establish the relationship between outcome expectations and exercise and facilitate the development of interventions to increase physical activity in older adults. The purpose of this study was to test the reliability and validity of the Outcome Expectations for Exercise-2 Scale (OEE-2), a 13-item measure with two subscales: positive OEE (POEE) and negative OEE (NOEE). The OEE-2 scale was given to 161 residents in a continuing-care retirement community. There was some evidence of validity based on confirmatory factor analysis, Rasch-analysis INFIT and OUTFIT statistics, and convergent validity and test criterion relationships. There was some evidence for reliability of the OEE-2 based on alpha coefficients, person- and item-separation reliability indexes, and R(2)values. Based on analyses, suggested revisions are provided for future use of the OEE-2. Although ongoing reliability and validity testing are needed, the OEE-2 scale can be used to identify older adults with low outcome expectations for exercise, and interventions can then be implemented to strengthen these expectations and improve exercise behavior.

LC-PROM: Validation of a patient reported outcomes measure for liver cirrhosis patients.

PubMed

Zhang, Ying; Yang, Yuanyuan; Lv, Jing; Zhang, Yanbo

2016-05-10

The aim of the study is to develop a specific patient-reported scale of liver cirrhosis according to the Patient Reported Outcome guidelines of the Food and Drug Administration (FDA), and to examine its capacity to fill gaps in this field. A conceptual framework was developed and a preliminary item pool developed through literature review and interviews of 10 patients with liver cirrhosis. With the preliminary items, we performed a pilot survey that included a cognitive test with patients and interviews with experts; the focus was on content and language of the scale. In the item selection stage, seven statistical methods including discrete trends method, discrimination analysis, exploratory factor analysis, Cronbach's α coefficient, correlation coefficient, test-retest reliability, Item-Response Theory were applied to survey data from 200 subjects (150 liver cirrhosis patients and 50 controls). This produced the preliminary Liver Cirrhosis Patient-reported Outcome Measure (LC-PROM). In the next stage, we conducted the survey with 620 subjects (500 patients and 120 controls) to validate reliability, validity and acceptability of this scale. The 55 items and 13 dimensions addressed four domains: physical, psychological, social, and therapeutic. Cronbach's α coefficients were 0.921 for the total scale; the confirmatory factor analysis, t-tests and ANOVA supported scale validity; the model fit index as Root Mean Square Error of Approximation (RMSEA), Root Mean Square Residual (RMR), Normed Fit Index (NFI), Non-Normed Fit Index (NNFI), Comparative Fit Index (CFI) and Incremental Fit Index (IFI) met the criterion generally. The acceptance ratio and response rate indicated good feasibility. This study developed an accurate and stable patient-reported outcome scale of liver cirrhosis, which is able to evaluate clinical effects effectively, is helpful to patients in recognizing their health condition, and contributes to clinical decision making both for patients and

Health behavior in persons with spinal cord injury: development and initial validation of an outcome measure.

PubMed

Pruitt, S D; Wahlgren, D R; Epping-Jordan, J E; Rossi, A L

1998-10-01

To describe the development and initial psychometric properties of a new outcome measure for health behaviors that delay or prevent secondary impairments associated with spinal cord injury (SCI). Persons with SCI were surveyed during routine annual physical evaluations. Veterans Affairs Medical Center Spinal Cord Injury Unit, which specializes in primary care for persons with SCI. Forty-nine persons with SCI, aged 19-73 years, 1-50 years post-SCI. The newly developed Spinal Cord Injury Lifestyle Scale (SCILS). Internal consistency is high (alpha = 0.81). Correlations between clinicians' ratings of participants' health behavior and the new SCILS provide preliminary support for construct validity. The SCILS is a brief, self-report measure of health-related behavior in persons with SCI. It is a promising new outcome measure to evaluate the effectiveness of clinical and educational efforts for health maintenance and prevention of secondary impairments associated with SCI.

Development and validation of a patient-reported outcome measure for stroke patients.

PubMed

Luo, Yanhong; Yang, Jie; Zhang, Yanbo

2015-05-08

Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs. A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested. The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach's α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness. The Stroke

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

PubMed

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

2009-01-01

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

Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

PubMed

Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

2017-08-01

The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient

Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

PubMed

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

2017-08-01

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

Concurrent criterion validity of the safe driving behavior measure: a predictor of on-road driving outcomes.

PubMed

Classen, Sherrilene; Wang, Yanning; Winter, Sandra M; Velozo, Craig A; Lanford, Desiree N; Bédard, Michel

2013-01-01

We determined the concurrent criterion validity of the Safe Driving Behavior Measure (SDBM) for on-road outcomes (passing or failing the on-road test as determined by a certified driving rehabilitation specialist) among older drivers and their family members-caregivers. On the basis of ratings from 168 older drivers and 168 family members-caregivers, we calculated receiver operating characteristic curves. The drivers' area under the curve (AUC) was .620 (95% confidence interval [CI] = .514-.725, p = .043). The family members-caregivers' AUC was .726 (95% CI = .622-.829, p ≤ .01). Older drivers' ratings showed statistically significant yet poor concurrent criterion validity, but family members-caregivers' ratings showed good concurrent criterion validity for the criterion on-road driving test. Continuing research with a more representative sample is being pursued to confirm the SDBM's concurrent criterion validity. This screening tool may be useful for generalist practitioners to use in making decisions regarding driving. Copyright © 2013 by the American Occupational Therapy Association, Inc.

Concurrent Criterion Validity of the Safe Driving Behavior Measure: A Predictor of On-Road Driving Outcomes

PubMed Central

Wang, Yanning; Winter, Sandra M.; Velozo, Craig A.; Lanford, Desiree N.; Bédard, Michel

2013-01-01

We determined the concurrent criterion validity of the Safe Driving Behavior Measure (SDBM) for on-road outcomes (passing or failing the on-road test as determined by a certified driving rehabilitation specialist) among older drivers and their family members–caregivers. On the basis of ratings from 168 older drivers and 168 family members–caregivers, we calculated receiver operating characteristic curves. The drivers’ area under the curve (AUC) was .620 (95% confidence interval [CI] = .514–.725, p = .043). The family members–caregivers’ AUC was .726 (95% CI = .622–.829, p ≤ .01). Older drivers’ ratings showed statistically significant yet poor concurrent criterion validity, but family members–caregivers’ ratings showed good concurrent criterion validity for the criterion on-road driving test. Continuing research with a more representative sample is being pursued to confirm the SDBM’s concurrent criterion validity. This screening tool may be useful for generalist practitioners to use in making decisions regarding driving. PMID:23245789

Model testing for reliability and validity of the Outcome Expectations for Exercise Scale.

PubMed

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

2001-01-01

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

Predictive validity of callous-unemotional traits measured in early adolescence with respect to multiple antisocial outcomes.

PubMed

McMahon, Robert J; Witkiewitz, Katie; Kotler, Julie S

2010-11-01

This study investigated the predictive validity of youth callous-unemotional (CU) traits, as measured in early adolescence (Grade 7) by the Antisocial Process Screening Device (APSD; Frick & Hare, 2001), in a longitudinal sample (N = 754). Antisocial outcomes, assessed in adolescence and early adulthood, included self-reported general delinquency from 7th grade through 2 years post-high school, self-reported serious crimes through 2 years post-high school, juvenile and adult arrest records through 1 year post-high school, and antisocial personality disorder symptoms and diagnosis at 2 years post-high school. CU traits measured in 7th grade were highly predictive of 5 of the 6 antisocial outcomes-general delinquency, juvenile and adult arrests, and early adult antisocial personality disorder criterion count and diagnosis-over and above prior and concurrent conduct problem behavior (i.e., criterion counts of oppositional defiant disorder and conduct disorder) and attention-deficit/hyperactivity disorder (criterion count). Incorporating a CU traits specifier for those with a diagnosis of conduct disorder improved the positive prediction of antisocial outcomes, with a very low false-positive rate. There was minimal evidence of moderation by sex, race, or urban/rural status. Urban/rural status moderated one finding, with being from an urban area associated with stronger relations between CU traits and adult arrests. Findings clearly support the inclusion of CU traits as a specifier for the diagnosis of conduct disorder, at least with respect to predictive validity. PsycINFO Database Record (c) 2010 APA, all rights reserved

Using the bootstrap to establish statistical significance for relative validity comparisons among patient-reported outcome measures

PubMed Central

2013-01-01

Background Relative validity (RV), a ratio of ANOVA F-statistics, is often used to compare the validity of patient-reported outcome (PRO) measures. We used the bootstrap to establish the statistical significance of the RV and to identify key factors affecting its significance. Methods Based on responses from 453 chronic kidney disease (CKD) patients to 16 CKD-specific and generic PRO measures, RVs were computed to determine how well each measure discriminated across clinically-defined groups of patients compared to the most discriminating (reference) measure. Statistical significance of RV was quantified by the 95% bootstrap confidence interval. Simulations examined the effects of sample size, denominator F-statistic, correlation between comparator and reference measures, and number of bootstrap replicates. Results The statistical significance of the RV increased as the magnitude of denominator F-statistic increased or as the correlation between comparator and reference measures increased. A denominator F-statistic of 57 conveyed sufficient power (80%) to detect an RV of 0.6 for two measures correlated at r = 0.7. Larger denominator F-statistics or higher correlations provided greater power. Larger sample size with a fixed denominator F-statistic or more bootstrap replicates (beyond 500) had minimal impact. Conclusions The bootstrap is valuable for establishing the statistical significance of RV estimates. A reasonably large denominator F-statistic (F > 57) is required for adequate power when using the RV to compare the validity of measures with small or moderate correlations (r < 0.7). Substantially greater power can be achieved when comparing measures of a very high correlation (r > 0.9). PMID:23721463

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

Development and Validation of a Multifactorial Treatment Outcome Measure for Eating Disorders.

ERIC Educational Resources Information Center

Anderson, Drew A.; Williamson, Donald A.; Duchmann, Erich G.; Gleaves, David H.; Barbin, Jane M.

1999-01-01

Developed a brief self-report inventory to evaluate treatment outcome for anorexia and bulimia nervosa, the Multifactorial Assessment of Eating Disorders, and evaluated the instrument in a series of studies involving 1,054 women. Results support a stable factor structure and satisfactory reliability and validity, and establish normative data. (SLD)

Questionnaires for Measuring Refractive Surgery Outcomes.

PubMed

Kandel, Himal; Khadka, Jyoti; Lundström, Mats; Goggin, Michael; Pesudovs, Konrad

2017-06-01

To identify the questionnaires used to assess refractive surgery outcomes, assess the available questionnaires in regard to their psychometric properties, validity, and reliability, and evaluate the performance of the available questionnaires in measuring refractive surgery outcomes. An extensive literature search was done on PubMed, MEDLINE, Scopus, CINAHL, Cochrane, and Web of Science databases to identify articles that described or used at least one questionnaire to assess refractive surgery outcomes. The information on content quality, validity, reliability, responsiveness, and psychometric properties was extracted and analyzed based on an extensive set of quality criteria. Eighty-one articles describing 27 questionnaires (12 refractive error-specific, including 4 refractive surgery-specific, 7 vision-but-non-refractive, and 8 generic) were included in the review. Most articles (56, 69.1%) described refractive error-specific questionnaires. The Quality of Life Impact of Refractive Correction (QIRC), the Quality of Vision (QoV), and the Near Activity Visual Questionnaire (NAVQ) were originally constructed using Rasch analysis; others were developed using the Classical Test Theory. The National Eye Institute Refractive Quality of Life questionnaire was the most frequently used questionnaire, but it does not provide a valid measurement. The QoV, QIRC, and NAVQ are the three best existing questionnaires to assess visual symptoms, quality of life, and activity limitations, respectively. This review identified three superior quality questionnaires for measuring different aspects of quality of life in refractive surgery. Clinicians and researchers should choose a questionnaire based on the concept being measured with superior psychometric properties. [J Refract Surg. 2017;33(6):416-424.]. Copyright 2017, SLACK Incorporated.

The Content Validity of a Chemotherapy-Induced Peripheral Neuropathy Patient-Reported Outcome Measure

PubMed Central

Lavoie Smith, Ellen M.; Haupt, Rylie; Kelly, James P.; Lee, Deborah; Kanzawa-Lee, Grace; Knoerl, Robert; Bridges, Celia; Alberti, Paola; Prasertsri, Nusara; Donohoe, Clare

2018-01-01

Purpose/Objectives To test the content validity of a 16-item version of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20). Research Approach Cross-sectional, prospective, qualitative design. Setting Six outpatient oncology clinics within the University of Michigan Health System’s comprehensive cancer center in Ann Arbor. Participants 25 adults with multiple myeloma or breast, gynecologic, gastrointestinal, or head and neck malignancies experiencing peripheral neuropathy caused by neurotoxic chemotherapy. Methodologic Approach Cognitive interviewing methodology was used to evaluate the content validity of a 16-item version of the QLQ-CIPN20 instrument. Findings Minor changes were made to three questions to enhance readability. Twelve questions were revised to define unfamiliar terminology, clarify the location of neuropathy, and emphasize important aspects. One question was deleted because of clinical and conceptual redundancy with other items, as well as concerns regarding generalizability and social desirability. Interpretation Cognitive interviewing methodology revealed inconsistencies between patients’ understanding and researchers’ intent, along with points that required clarification to avoid misunderstanding. Implications for Nursing Patients’ interpretations of the instrument’s items were inconsistent with the intended meanings of the questions. One item was dropped and others were revised, resulting in greater consistency in how patients, clinicians, and researchers interpreted the items’ meanings and improving the instrument’s content validity. Following additional revision and psychometric testing, the QLQ-CIPN20 could evolve into a gold-standard CIPN patient-reported outcome measure. PMID:28820525

Physician outcome measurement: review and proposed model.

PubMed

Siha, S

1998-01-01

As health care moves from a free-for-service environment to a capitated arena, outcome measurements must change. ABC Children's Medical Center is challenged with developing comprehensive outcome measures for an employed physician group. An extensive literature review validates that physician outcomes must move beyond revenue production and measure all aspects of care delivery. The proposed measurement model for this physician group is a trilogy model. It includes measures of cost, quality, and service. While these measures can be examined separately, it is imperative to understand their integration in determining an organization's competitive advantage. The recommended measurements for the physician group must be consistent with the overall organizational goals. The long-term impact will be better utilization of resources. This will result in the most cost effective, quality care for the health care consumer.

Patient-Reported Outcome Measures in Dysphagia: A Systematic Review of Instrument Development and Validation

PubMed Central

Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.

2017-01-01

Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia

Validity and feasibility of the american college of surgeons colectomy composite outcome quality measure.

PubMed

Merkow, Ryan P; Hall, Bruce L; Cohen, Mark E; Wang, Xue; Adams, John L; Chow, Warren B; Lawson, Elise H; Bilimoria, Karl Y; Richards, Karen; Ko, Clifford Y

2013-03-01

To develop a reliable, robust, parsimonious, risk-adjusted 30-day composite colectomy outcome measure. A fundamental aspect in the pursuit of high-quality care is the development of valid and reliable performance measures in surgery. Colon resection is associated with appreciable morbidity and mortality and therefore is an ideal quality improvement target. From 2010 American College of Surgeons National Surgical Quality Improvement Program data, patients were identified who underwent colon resection for any indication. A composite outcome of death or any serious morbidity within 30 days of the index operation was established. A 6-predictor, parsimonious model was developed and compared with a more complex model with more variables. National caseload requirements were calculated on the basis of increasing reliability thresholds. From 255 hospitals, 22,346 patients were accrued who underwent a colon resection in 2010, most commonly for neoplasm (46.7%). A mortality or serious morbidity event occurred in 4461 patients (20.0%). At the hospital level, the median composite event rate was 20.7% (interquartile range: 15.8%-26.3%). The parsimonious model performed similarly to the full model (Akaike information criterion: 19,411 vs 18,988), and hospital-level performance comparisons were highly correlated (R = 0.97). At a reliability threshold of 0.4, 56 annual colon resections would be required and achievable at an estimated 42% of US and 69% of American College of Surgeons National Surgical Quality Improvement Program hospitals. This 42% of US hospitals performed approximately 84% of all colon resections in the country in 2008. It is feasible to design a measure with a composite outcome of death or serious morbidity after colon surgery that has a low burden for data collection, has substantial clinical importance, and has acceptable reliability.

The Chinese version of the Outcome Expectations for Exercise scale: validation study.

PubMed

Lee, Ling-Ling; Chiu, Yu-Yun; Ho, Chin-Chih; Wu, Shu-Chen; Watson, Roger

2011-06-01

Estimates of the reliability and validity of the English nine-item Outcome Expectations for Exercise (OEE) scale have been tested and found to be valid for use in various settings, particularly among older people, with good internal consistency and validity. Data on the use of the OEE scale among older Chinese people living in the community and how cultural differences might affect the administration of the OEE scale are limited. To test the validity and reliability of the Chinese version of the Outcome Expectations for Exercise scale among older people. A cross-sectional validation study was designed to test the Chinese version of the OEE scale (OEE-C). Reliability was examined by testing both the internal consistency for the overall scale and the squared multiple correlation coefficient for the single item measure. The validity of the scale was tested on the basis of both a traditional psychometric test and a confirmatory factor analysis using structural equation modelling. The Mokken Scaling Procedure (MSP) was used to investigate if there were any hierarchical, cumulative sets of items in the measure. The OEE-C scale was tested in a group of older people in Taiwan (n=108, mean age=77.1). There was acceptable internal consistency (alpha=.85) and model fit in the scale. Evidence of the validity of the measure was demonstrated by the tests for criterion-related validity and construct validity. There was a statistically significant correlation between exercise outcome expectations and exercise self-efficacy (r=.34, p<.01). An analysis of the Mokken Scaling Procedure found that nine items of the scale were all retained in the analysis and the resulting scale was reliable and statistically significant (p=.0008). The results obtained in the present study provided acceptable levels of reliability and validity evidence for the Chinese Outcome Expectations for Exercise scale when used with older people in Taiwan. Future testing of the OEE-C scale needs to be carried out

Neurocognition and community outcome in schizophrenia: long-term predictive validity.

PubMed

Fujii, Daryl E; Wylie, A Michael

2003-02-01

The present study examined the predictive validity of neuropsychological measures to functional outcome in 26 schizophrenic patients 15-plus year post-testing. Outcome measures included score on the Resource Associated Functional Level Scale (RAFLS), number of state hospital admissions, and total duration of state hospital inpatient stay. Results of several stepwise multiple regressions revealed that verbal memory significantly predicted RAFLS score, accounting for nearly half of the variance. Trails B significantly predicted duration of state hospital inpatient status. Discussion focused on the utility of these measures for clinicians and system planners. Copyright 2002 Elsevier Science B.V.

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

PubMed Central

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 and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables. Results A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling. Conclusions PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications. PMID:28030869

Measuring quality of life in cleft lip and palate patients: currently available patient-reported outcomes measures.

PubMed

Eckstein, Donna A; Wu, Rebecca L; Akinbiyi, Takintope; Silver, Lester; Taub, Peter J

2011-11-01

Patient-reported outcomes in cleft lip and palate treatment are critical for patient care. Traditional surgical outcomes focused on objective measures, such as photographs, anatomic measurements, morbidity, and mortality. Although these remain important, they leave many questions unanswered. Surveys that include aesthetics, speech, functionality, self-image, and quality of life provide more thorough outcomes assessment. It is vital that reliable, valid, and comprehensive questionnaires are available to craniofacial surgeons. The authors performed a literature review to identify questionnaires validated in cleft lip and palate patients. Qualifying instruments were assessed for adherence to guidelines for development and validation by the scientific advisory committee and for content. The authors identified 44 measures used in cleft lip and palate studies. After 15 ad hoc questionnaires, eight generic instruments, 11 psychiatric instruments, and one non-English language questionnaire were excluded, nine measures remained. Of these, four were never validated in the cleft population. Analysis revealed one craniofacial-specific measure (Youth Quality of Life-Facial Differences), two voice-related measures (Patient Voice-Related Quality of Life and Cleft Audit Protocol for Speech-Augmented), and two oral health-related measures (Child Oral Health Impact Profile and Child Oral Health Quality of Life). The Youth Quality of Life-Facial Differences, Child Oral Health Impact Profile, and Child Oral Health Quality of Life questionnaires were sufficiently validated. None was created specifically for clefts, resulting in content limitations. There is a lack of comprehensive, valid, and reliable questionnaires for cleft lip and palate surgery. For thorough assessment of satisfaction, further research to develop and validate cleft lip and palate surgery-specific instruments is needed.

Measurement properties of patient-reported outcome measures (PROMS) in Patellofemoral Pain Syndrome: a systematic review.

PubMed

Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G

2014-12-01

This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality. Copyright © 2014 Elsevier Ltd. All rights reserved.

Furthering the reliable and valid measurement of mental health screening, diagnoses, treatment and outcomes through health information technology.

PubMed

Haberer, Jessica E; Trabin, Tom; Klinkman, Michael

2013-01-01

Measurement of mental health is challenging; however, many solutions may be found through the use of health information technology. This article reviews current approaches to measuring mental health, focusing on screening, diagnosis, treatment, and outcomes. It then identifies several key areas in which health information technology may advance the field and provide reliable and valid measurements that are readily available to and manageable for providers, as well as acceptable, feasible, and sustainable for selected populations. Although new technologies must overcome many challenges, including privacy, efficiency, cost, and scalability, it is an exciting and fast-growing field with many potential applications and clinical benefit. Copyright © 2013 Elsevier Inc. All rights reserved.

Validation of Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs) in the Surgical Treatment of Lumbar Spinal Stenosis.

PubMed

Patel, Alpesh A; Dodwad, Shah-Nawaz M; Boody, Barrett S; Bhatt, Surabhi; Savage, Jason W; Hsu, Wellington K; Rothrock, Nan E

2018-03-19

Prospective, cohort study. Demonstrate validity of PROMIS physical function, pain interference, and pain behavior computer adaptive tests (CATs) in surgically treated lumbar stenosis patients. There has been increasing attention given to patient reported outcomes associated with spinal interventions. Historical patient outcome measures have inadequate validation, demonstrate floor/ceiling effects, and infrequently used due to time constraints. PROMIS is an adaptive, responsive NIH assessment tool that measures patient-reported health status. 98 consecutive patients were surgically treated for lumbar spinal stenosis and were assessed using PROMIS CATs, ODI, ZCQ and SF-12. Prior lumbar surgery, history of scoliosis, cancer, trauma, or infection were excluded. Completion time, preoperative assessment, 6 week and 3 month postoperative scores were collected. At baseline, 49%, 79%, and 81% of patients had PROMIS PB, PI, and PF scores greater than 1 SD worse than the general population. 50.6% were categorized as severely disabled, crippled, or bed bound by ODI. PROMIS CATs demonstrated convergent validity through moderate to high correlations with legacy measures (r = 0.35-0.73). PROMIS CATs demonstrated known groups validity when stratified by ODI levels of disability. ODI improvements of at least 10 points on average had changes in PROMIS scores in the expected direction (PI = -12.98, PB = -9.74, PF = 7.53). PROMIS CATs demonstrated comparable responsiveness to change when evaluated against legacy measures. PROMIS PB and PI decreased 6.66 and 9.62 and PROMIS PF increased 6.8 points between baseline and 3-months post-op (p < 0.001). Completion time for the PROMIS CATs (2.6 minutes) compares favorably to ODI, ZCQ, and SF-12 scores (3.1, 3.6, and 3.0 minutes). PROMIS CATs demonstrate convergent validity, known groups validity, and responsiveness for surgically treated patients with lumbar stenosis to detect change over time and are more efficient than

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.

Causal inference with measurement error in outcomes: Bias analysis and estimation methods.

PubMed

Shu, Di; Yi, Grace Y

2017-01-01

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

Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.

PubMed

Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O

2017-05-01

Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We

Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO.

PubMed

Watt, Torquil; Barbesino, Giuseppe; Bjorner, Jakob Bue; Bonnema, Steen Joop; Bukvic, Branka; Drummond, Russell; Groenvold, Mogens; Hegedüs, Laszlo; Kantzer, Valeska; Lasch, Kathryn E; Marcocci, Claudio; Mishra, Anjali; Netea-Maier, Romana; Ekker, Merel; Paunovic, Ivan; Quinn, Terence J; Rasmussen, Åse Krogh; Russell, Audrey; Sabaretnam, Mayilvaganan; Smit, Johannes; Törring, Ove; Zivaljevic, Vladan; Feldt-Rasmussen, Ulla

2015-03-01

Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification. For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for. The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in

Goal setting as an outcome measure: A systematic review.

PubMed

Hurn, Jane; Kneebone, Ian; Cropley, Mark

2006-09-01

Goal achievement has been considered to be an important measure of outcome by clinicians working with patients in physical and neurological rehabilitation settings. This systematic review was undertaken to examine the reliability, validity and sensitivity of goal setting and goal attainment scaling approaches when used with working age and older people. To review the reliability, validity and sensitivity of both goal setting and goal attainment scaling when employed as an outcome measure within a physical and neurological working age and older person rehabilitation environment, by examining the research literature covering the 36 years since goal-setting theory was proposed. Data sources included a computer-aided literature search of published studies examining the reliability, validity and sensitivity of goal setting/goal attainment scaling, with further references sourced from articles obtained through this process. There is strong evidence for the reliability, validity and sensitivity of goal attainment scaling. Empirical support was found for the validity of goal setting but research demonstrating its reliability and sensitivity is limited. Goal attainment scaling appears to be a sound measure for use in physical rehabilitation settings with working age and older people. Further work needs to be carried out with goal setting to establish its reliability and sensitivity as a measurement tool.

The Aphasia Communication Outcome Measure (ACOM): Dimensionality, Item Bank Calibration, and Initial Validation

ERIC Educational Resources Information Center

Hula, William D.; Doyle, Patrick J.; Stone, Clement A.; Hula, Shannon N. Austermann; Kellough, Stacey; Wambaugh, Julie L.; Ross, Katherine B.; Schumacher, James G.; St. Jacque, Ann

2015-01-01

Purpose: The purpose of this study is to investigate the structure and measurement properties of the Aphasia Communication Outcome Measure (ACOM), a patient-reported outcome measure of communicative functioning for persons with aphasia. Method: Three hundred twenty-nine participants with aphasia responded to 177 items asking about communicative…

Patient-reported outcome measures in reconstructive breast surgery: is there a role for generic measures?

PubMed

Korus, Lisa J; Cypel, Tatiana; Zhong, Toni; Wu, Albert W

2015-03-01

Patient-reported outcomes provide an invaluable tool in the assessment of outcomes in plastic surgery. Traditionally, patient-reported outcomes have consisted of either generic or ad hoc measures; however, more recently, there has been interest in formally constructed and validated questionnaires that are specifically designed for a particular patient population. The purpose of this systematic review was to determine whether generic measures still have a role in the evaluation of breast reconstruction outcomes, given the recent popularity and push for use of specific measures. A systematic review was performed to identify all articles using patient-reported outcomes in the assessment of postmastectomy breast reconstruction. Frequency of use was tabulated and the most frequently used tools were assessed for success of use, using criteria described previously by the Medical Outcomes Trust. To date, the most frequently used measures are still generic measures. The 36-Item Short-Form Health Survey was the most frequently used and most successfully applied showing evidence of responsiveness in multiple settings. Other measures such as the Hospital Anxiety and Depression Scale, the Hopwood Body Image Scale, and the Rosenberg Self-Esteem Scale were able to show responsiveness in certain settings but lacked evidence as universal tools for the assessment of outcomes in reconstructive breast surgery. Despite the recent advent of measures designed specifically to assess patient-reported outcomes in the breast reconstruction population, there still appears to be a role for the use of generic instruments. Many of these tools would benefit from undergoing formal validation in the breast reconstruction population.

Use of patient-reported outcome measures in foot and ankle research.

PubMed

Hunt, Kenneth J; Hurwit, Daniel

2013-08-21

In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will

[Reliability and validity of the Chinese version on Comprehensive Scores for Financial Toxicity based on the patient-reported outcome measures].

PubMed

Yu, H H; Bi, X; Liu, Y Y

2017-08-10

Objective: To evaluate the reliability and validity of the Chinese version on comprehensive scores for financial toxicity (COST), based on the patient-reported outcome measures. Methods: A total of 118 cancer patients were face-to-face interviewed by well-trained investigators. Cronbach's α and Pearson correlation coefficient were used to evaluate reliability. Content validity index (CVI) and exploratory factor analysis (EFA) were used to evaluate the content validity and construct validity, respectively. Results: The Cronbach's α coefficient appeared as 0.889 for the whole questionnaire, with the results of test-retest were between 0.77 and 0.98. Scale-content validity index (S-CVI) appeared as 0.82, with item-content validity index (I-CVI) between 0.83 and 1.00. Two components were extracted from the Exploratory factor analysis, with cumulative rate as 68.04% and loading>0.60 on every item. Conclusion: The Chinese version of COST scale showed high reliability and good validity, thus can be applied to assess the financial situation in cancer patients.

Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

PubMed Central

Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark

2017-01-01

Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (p<0.001). Conclusion The results of this multi-site outpatient study found that the Korean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

Patient-Reported Outcome Measures for Hand and Wrist Trauma

PubMed Central

Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

2016-01-01

Background: Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. Methods: A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. Results: The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. Conclusions: The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology. PMID:27418884

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.

[Cultural adaptation and content validation of the «Pain level» outcome of the Nursing Outcomes Classification].

PubMed

Bellido-Vallejo, José Carlos; Rodríguez-Torres, María Del Carmen; López-Medina, Isabel María; Pancorbo-Hidalgo, Pedro Luis

2013-01-01

To translate and culturally adapt the Pain Level outcome to the Spanish context to validate the contents of the Spanish version of the «Pain level» outcome. The original English version of the «Pain level» outcome was translated into Spanish (twice); then back-translated into English, and all the discrepancies were resolved after consulting with NOC authors. A panel consisting of 21 experts in pain care assessed this culturally adapted Spanish version, in order to score the content validity. In the first step, the experts scored the adequacy of each indicator to the concept «Pain level». In the second round, three new indicators were scored. The Statistical analysis included content validity index (CVI), probability of agreement by chance, and modified kappa statistic. A Spanish version was developed including label, definition, two groups of indicators, and two measurement scales. This version is fully adapted to the Spanish context and language. A set of 21 indicators (19 translated and two new) was selected, and 4 were deleted (three translated and one new). The CVI-average score was 0.83 and the CVI-universal agreement was 0.05. The Spanish-version of the outcome «Pain level» is semantically and culturally to adapted to a Spanish context and preserves equivalency with the original. Content validation has identified indicators useful for practice. The clinimetric properties (validity and reliability) of the adapted version could be tested in a clinical study with people suffering from acute pain. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

PubMed

de Souza, Jonas A; Yap, Bonnie J; Wroblewski, Kristen; Blinder, Victoria; Araújo, Fabiana S; Hlubocky, Fay J; Nicholas, Lauren H; O'Connor, Jeremy M; Brockstein, Bruce; Ratain, Mark J; Daugherty, Christopher K; Cella, David

2017-02-01

Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; P<.001), psychosocial distress (r = -0.26; P<.001), and HRQOL, as measured by the FACT-G (r = 0.42; P<.001) and by the EORTC QOL instruments (r = 0.33; P<.001). Independent factors found to be associated with financial toxicity were race (P = .04), employment status (P<.001), income (P = .003), number of inpatient admissions (P = .01), and psychological distress (P = .003). Willingness to discuss costs was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and

Private practice outcomes: validated outcomes data collection in private practice.

PubMed

Goldstein, Jack

2010-10-01

Improved patient care is related to validated outcome measures requiring the collection of three distinct data types: (1) demographics; (2) patient outcome measures; and (3) physician treatment. Previous impediments to widespread data collection have been: cost, office disruption, personnel requirements, physician motivation, data integration, and security. There are currently few means to collect data to be used for collaborative analysis. We therefore developed an inexpensive, patient-centric mechanism to reduce redundant data entry, limiting cost and personnel requirements. Using an intuitive touch-screen kiosk interface program, all data elements have been captured in a private practice setting since 2000. Developed for small to medium sized offices, this is scalable to larger organizations. Questionnaire navigation is patient driven, with demographics shared with EMR and billing systems. Integration of billing and EMR with outcomes minimizes cost and personnel time. Data are deidentified locally and may be centrally shared. Since data are entered by the patients, minimal personnel costs are incurred. Physician disincentives are minimized with cost reduction, time savings and ease of use. To date, we have collected high level data on most total joint patients, with excellent patient compliance. By addressing impediments to broad application, we may enable widespread local data collection in all practice settings. Data may be shared centrally, allowing comparative effectiveness research to become a reality. Future success will require broad physician participation, uniformity of data collected, and designation of a central site for receipt of data and its collaborative comparative analysis.

Outcome Measures Used in Clinical Trials for Behçet Syndrome: A Systematic Review

PubMed Central

Hatemi, Gulen; Merkel, Peter A.; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z.; Yazici, Hasan

2015-01-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology. PMID:24488418

Outcome measures used in clinical trials for Behçet syndrome: a systematic review.

PubMed

Hatemi, Gulen; Merkel, Peter A; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z; Yazici, Hasan

2014-03-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology.

A validation of the Nottingham Clavicle Score: a clavicle, acromioclavicular joint and sternoclavicular joint-specific patient-reported outcome measure.

PubMed

Charles, Edmund R; Kumar, Vinod; Blacknall, James; Edwards, Kimberley; Geoghegan, John M; Manning, Paul A; Wallace, W Angus

2017-10-01

Patients with acromioclavicular joint (ACJ) and sternoclavicular joint (SCJ) injuries and with clavicle fractures are typically younger and more active than those with other shoulder pathologies. We developed the Nottingham Clavicle Score (NCS) specifically for this group of patients to improve sensitivity for assessing the outcomes of treatment of these conditions compared with the more commonly used Constant Score (CS) and Oxford Shoulder Score (OSS). This was a cohort study in which the preoperative and 6-month postoperative NCS evaluations of outcome in 90 patients were compared with the CS, OSS, Imatani Score (IS), and the EQ-5D scores. Reliability was assessed using the Cronbach α. Reproducibility of the NCS was assessed using the test/retest method. Effect sizes were calculated for each score to assess sensitivity to change. Validity was examined by correlations between the NCS and the CS, OSS, IS, and EQ-5D scores obtained preoperatively and postoperatively. Significant correlations were demonstrated preoperatively with the OSS (P = .025) and all subcategories of the EQ-5D (P < .05) and postoperatively with the OSS (P < .001), CS (P = .008), IS (P < .001), and all subcategories of EQ-5D (P < .02). The NCS had the largest effect size (1.92) of the compared scores. Internal consistency was excellent (Cronbach α = 0.87). The NCS has been proven to be a valid, reliable and sensitive outcome measure that accurately measures the level of function and disability in the ACJ, SCJ and clavicle after traumatic injury and in degenerative disease. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Validity of a New Patient Engagement Measure: The Altarum Consumer Engagement (ACE) Measure.

PubMed

Duke, Christopher C; Lynch, Wendy D; Smith, Brad; Winstanley, Julie

2015-12-01

The objective of this study was to report on the validation of new scales [called the Altarum Consumer Engagement (ACE) Measure] that are indicative of an individual's engagement in health and healthcare decisions. The instrument was created to broaden the scope of how engagement is measured and understood, and to update the concept of engagement to include modern information sources, such as online health resources and ratings of providers and patient health. Data were collected through an online survey with a US population of 2079 participants. A combination of Principal Component Analysis (PCA) and detailed Rasch analyses were conducted to identify specific subscales of engagement. Results were compared to another commonly used survey instrument, and outcomes were compared for construct validity. The PCA identified a four-factor structure composed of 21 items. The factors were named Commitment, Informed Choice, Navigation, and Ownership. Rasch analyses confirmed scale stability. Relevant outcomes were correlated in the expected direction, such as health status, lifestyle behaviors, medication adherence, and observed expected group differences. This study confirmed the validity of the new ACE Measure and its utility in screening for and finding group differences in activities related to patient engagement and health consumerism, such as using provider comparison tools and asking about medical costs.

Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy.

PubMed

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

2013-10-15

Narrative review. To identify suitable outcome measures that can be used to quantify neurological and functional impairment in the management of cervical spondylotic myelopathy (CSM). CSM is the leading cause of acquired spinal cord disability, causing varying degrees of neurological impairment which impact on independence and quality of life. Because this impairment can have a heterogeneous presentation, a single outcome measure cannot define the broad range of deficits seen in this population. Therefore, it is necessary to define outcome measures that characterize the deficits with greater validity and sensitivity. This review was conducted in 3 stages. Stage I: To evaluate the current use of outcome measures in CSM, PubMed was searched using the name of the outcome measure and the common abbreviation combined with "CSM" or "myelopathy." Stage II: Having identified a lack of appropriate outcome measures, we constructed criteria by which measures appropriate for assessing the various aspects of CSM could be identified. Stage III: A second literature search was then conducted looking at specified outcomes that met these criteria. All literature was reviewed to determine specificity and psychometric properties of outcomes for CSM. Nurick grade, modified Japanese Orthopaedic Association Scale, visual analogue scale (VAS) for pain, Short Form (36) Health Survey (SF-36), and Neck Disability Index were the most commonly cited measures. The Short-Form 36 Health Survey and Myelopathy Disability Index have been validated in the CSM population with multiple studies, whereas the modified Japanese Orthopaedic Association Scale score, Nurick grade, and European Myelopathy Scale each had only one study assessing psychometric characteristics. No validity, reliability, or responsiveness studies were found for the VAS or Neck Disability Index in the CSM population. We recommend that the modified Japanese Orthopaedic Association Scale, Nurick grade, Myelopathy Disability Index

The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire.

PubMed

Aabenhus, Rune; Thorsen, Hanne; Siersma, Volkert; Brodersen, John

2013-01-01

Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure.

PubMed

Horn, Katyana Kowalchuk; Jennings, Sophie; Richardson, Gillian; Vliet, Ditte Van; Hefford, Cheryl; Abbott, J Haxby

2012-01-01

Systematic review of the literature. To summarize peer-reviewed literature on the reliability, validity, and responsiveness of the Patient-Specific Functional Scale (PSFS), and to identify its use as an outcome measure. Searches were performed of several electronic databases from 1995 to May 2010. Studies included were published articles containing (1) primary research investigating the psychometric and clinimetrics of the PSFS or (2) the implementation of the PSFS as an outcome measure. We assessed the methodological quality of studies included in the first category. Two hundred forty-two articles published from 1994 to May 2010 were identified. Of these, 66 met the inclusion criteria for this review, with 13 reporting the measurement properties of the PSFS, 55 implementing the PSFS as an outcome measure, and 2 doing both of the above. The PSFS was reported to be valid, reliable, and responsive in populations with knee dysfunction, cervical radiculopathy, acute low back pain, mechanical low back pain, and neck dysfunction. The PSFS was found to be reliable and responsive in populations with chronic low back pain. The PSFS was also reported to be valid, reliable, or responsive in individuals with a limited number of acute, subacute, and chronic conditions. This review found that the PSFS is also being used as an outcome measure in many other conditions, despite a lack of published evidence supporting its validity in these conditions. Although the use of the PSFS as an outcome measure is increasing in physiotherapy practice, there are gaps in the research literature regarding its validity, reliability, and responsiveness in many health conditions.

The validity of a simple outcome measure to assess stuttering therapy.

PubMed

Huinck, Wendy; Rietveld, Toni

2007-01-01

The validity of a simple and not time-consuming self-assessment (SA) Scale was tested to establish progress after or during stuttering therapy. The scores on the SA scale were related to (1) objective measures (percentage of stuttered syllables, and syllables per minute) and (2) (self-)evaluation tests (self-evaluation questionnaires and perceptual evaluations or judgments of disfluency, naturalness and comfort by naïve listeners). Data were collected from two groups of stutterers at four measurement times: pretherapy, posttherapy, 12 months after therapy and 24 months after therapy. The first group attended the Comprehensive Stuttering Program: an integrated program based on fluency shaping techniques, and the second group participated in a Dutch group therapy: the Doetinchem Method that focuses on emotions and cognitions related to stuttering. Results showed similar score patterns on the SA scale, the self-evaluation questionnaires, the objective measures over time, and significant correlations between the SA scale and syllables per minute, percentage of stuttered syllables, Struggle subscale of the Perceptions of Stuttering Inventory and judged fluency on the T1-T2 difference scores. We concluded that the validity of the SA measure was proved and therefore encourage the use of such an instrument when (stuttering) treatment efficacy is studied.

Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

PubMed

Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

2018-01-29

Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

Validation of Patient-Reported Outcomes Measurement Information System Short Forms for Use in Childhood-Onset Systemic Lupus Erythematosus.

PubMed

Jones, Jordan T; Carle, Adam C; Wootton, Janet; Liberio, Brianna; Lee, Jiha; Schanberg, Laura E; Ying, Jun; Morgan DeWitt, Esi; Brunner, Hermine I

2017-01-01

To validate the pediatric Patient-Reported Outcomes Measurement Information System short forms (PROMIS-SFs) in childhood-onset systemic lupus erythematosus (SLE) in a clinical setting. At 3 study visits, childhood-onset SLE patients completed the PROMIS-SFs (anger, anxiety, depressive symptoms, fatigue, physical function-mobility, physical function-upper extremity, pain interference, and peer relationships) using the PROMIS assessment center, and health-related quality of life (HRQoL) legacy measures (Pediatric Quality of Life Inventory, Childhood Health Assessment Questionnaire, Simple Measure of Impact of Lupus Erythematosus in Youngsters [SMILEY], and visual analog scales [VAS] of pain and well-being). Physicians rated childhood-onset SLE activity on a VAS and completed the Systemic Lupus Erythematosus Disease Activity Index 2000. Using a global rating scale of change (GRC) between study visits, physicians rated change of childhood-onset SLE activity (GRC-MD1: better/same/worse) and change of patient overall health (GRC-MD2: better/same/worse). Questionnaire scores were compared in support of validity and responsiveness to change (external standards: GRC-MD1, GRC-MD2). In this population-based cohort (n = 100) with a mean age of 15.8 years (range 10-20 years), the PROMIS-SFs were completed in less than 5 minutes in a clinical setting. The PROMIS-SF scores correlated at least moderately (Pearson's r ≥ 0.5) with those of legacy HRQoL measures, except for the SMILEY. Measures of childhood-onset SLE activity did not correlate with the PROMIS-SFs. Responsiveness to change of the PROMIS-SFs was supported by path, mixed-model, and correlation analyses. To assess HRQoL in childhood-onset SLE, the PROMIS-SFs demonstrated feasibility, internal consistency, construct validity, and responsiveness to change in a clinical setting. © 2016, American College of Rheumatology.

Outcome related to impact on daily living: preliminary validation of the ORIDL instrument.

PubMed

Reilly, David; Mercer, Stewart W; Bikker, Annemieke P; Harrison, Tansy

2007-09-02

The challenge of finding practical, patient-rated outcome measures is a key issue in the evaluation of health care systems and interventions. The ORIDL (Outcome in Relation to Impact on Daily Living) instrument (formerly referred to as the Glasgow Homoeopathic Hospital Outcomes Scale or GHHOS) has been developed to measure patient's views of the outcome of their care by asking about change, and relating this to impact on daily life. The aim of the present paper is to describe the background and potential uses of the ORIDL, and to report on its preliminary validation in a series of three studies in secondary and primary care. In the first study, 105 patients attending the Glasgow Homoeopathic Hospital (GHH) were followed-up at 12 months and changes in health status were measured by the EuroQol (EQOL) and the ORIDL. In the second study, 187 new patients at the GHH were followed-up at 3, 12, and 33 months, using the ORIDL, the Short Form 12 (SF-12), and the Measure Yourself Medical Outcome Profile (MYMOP). In study three, 323 patients in primary care were followed for 1 month post-consultation using the ORIDL and MYMOP. In all 3 studies the Patient Enablement Instrument (PEI) was also used as an outcome measure. Study 1 showed substantial improvements in main complaint and well-being over 12 months using the ORIDL, with two-thirds of patients reporting improvements in daily living. These improvements were not significantly correlated with changes in serial measures of the EQOL between baseline and 12 months, but were correlated with the EQOL transitions measure. Study 2 showed step-wise improvements in ORIDL scores between 3 and 33 months, which were only weakly associated with similar changes in SF-12 scores. However, MYMOP change scores correlated well with ORIDL scores at all time points. Study 3 showed similar high correlations between ORIDL scores and MYMOP scores. In all 3 studies, ORIDL scores were also significantly correlated with PEI-outcome scores. There is

Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire.

PubMed

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

2013-11-01

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

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.

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.

Are the Insomnia Severity Index and Pittsburgh Sleep Quality Index valid outcome measures for Cognitive Behavioral Therapy for Insomnia? Inquiry from the perspective of response shifts and longitudinal measurement invariance in their Chinese versions.

PubMed

Chen, Po-Yi; Jan, Ya-Wen; Yang, Chien-Ming

2017-07-01

The purpose of this study was to examine whether the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) are valid outcome measures for Cognitive Behavioral Therapy for Insomnia (CBT-I). Specifically, we tested whether the factorial parameters of the ISI and the PSQI could remain invariant against CBT-I, which is a prerequisite to using their change scores as an unbiased measure of the treatment outcome of CBT-I. A clinical data set including scores on the Chinese versions of the ISI and the PSQI obtained from 114 insomnia patients prior to and after a 6-week CBT-I program in Taiwan was analyzed. A series of measurement invariance (MI) tests were conducted to compare the factorial parameters of the ISI and the PSQI before and after the CBT-I treatment program. Most factorial parameters of the ISI remained invariant after CBT-I. However, the factorial model of the PSQI changed after CBT-I treatment. An extra loading with three residual correlations was added into the factorial model after treatment. The partial strong invariance of the ISI supports that it is a valid outcome measure for CBT-I. In contrast, various changes in the factor model of the PSQI indicate that it may not be an appropriate outcome measure for CBT-I. Some possible causes for the changes of the constructs of the PSQI following CBT-I are discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

Validity and reliability of a novel measure of activity performance and participation.

PubMed

Murgatroyd, Phil; Karimi, Leila

2016-01-01

To develop and evaluate an innovative clinician-rated measure, which produces global numerical ratings of activity performance and participation. Repeated measures study with 48 community-dwelling participants investigating clinical sensibility, comprehensiveness, practicality, inter-rater reliability, responsiveness, sensitivity and concurrent validity with Barthel Index. Important clinimetric characteristics including comprehensiveness and ease of use were rated >8/10 by clinicians. Inter-rater reliability was excellent on the summary scores (intraclass correlation of 0.95-0.98). There was good evidence that the new outcome measure distinguished between known high and low functional scoring groups, including both responsiveness to change and sensitivity at the same time point in numerous tests. Concurrent validity with the Barthel Index was fair to high (Spearman Rank Order Correlation 0.32-0.85, p > 0.05). The new measure's summary scores were nearly twice as responsive to change compared with the Barthel Index. Other more detailed data could also be generated by the new measure. The Activity Performance Measure is an innovative outcome instrument that showed good clinimetric qualities in this initial study. Some of the results were strong, given the sample size, and further trial and evaluation is appropriate. Implications for Rehabilitation The Activity Performance Measure is an innovative outcome measure covering activity performance and participation. In an initial evaluation, it showed good clinimetric qualities including responsiveness to change, sensitivity, practicality, clinical sensibility, item coverage, inter-rater reliability and concurrent validity with the Barthel Index. Further trial and evaluation is appropriate.

The HARM score for gastrointestinal surgery: Application and validation of a novel, reliable and simple tool to measure surgical quality and outcomes.

PubMed

Crawshaw, Benjamin P; Keller, Deborah S; Brady, Justin T; Augestad, Knut M; Schiltz, Nicholas K; Koroukian, Siran M; Navale, Suparna M; Steele, Scott R; Delaney, Conor P

2017-03-01

The HospitAl length of stay, Readmissions and Mortality (HARM) score is a simple, inexpensive quality tool, linked directly to patient outcomes. We assess the HARM score for measuring surgical quality across multiple surgical populations. Upper gastrointestinal, hepatobiliary, and colorectal surgery cases between 2005 and 2009 were identified from the Healthcare Cost and Utilization Project California State Inpatient Database. Composite and individual HARM scores were calculated from length of stay, 30-day readmission and mortality, correlated to complication rates for each hospital and stratified by operative type. 71,419 admissions were analyzed. Higher HARM scores correlated with higher complication rates for all cases after risk adjustment and stratification by operation type, elective or emergent status. The HARM score is a simple and valid quality measurement for upper gastrointestinal, hepatobiliary and colorectal surgery. The HARM score could facilitate benchmarking to improve patient outcomes and resource utilization, and may facilitate outcome improvement. Copyright © 2016 Elsevier Inc. All rights reserved.

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

Reliability and validity of two self-report measures of impairment and disability for MS. North American Research Consortium on Multiple Sclerosis Outcomes Study Group.

PubMed

Schwartz, C E; Vollmer, T; Lee, H

1999-01-01

To describe the results of a multicenter study that validated two new patient-reported measures of neurologic impairment and disability for use in MS clinical research. Self-reported data can provide a cost-effective means to assess patient functioning, and can be useful for screening patients who require additional evaluation. Thirteen MS centers from the United States and Canada implemented a cross-sectional validation study of two new measures of neurologic function. The Symptom Inventory is a measure of neurologic impairment with six subscales designed to correlate with localization of brain lesion. The Performance Scales measure disability in eight domains of function: mobility, hand function, vision, fatigue, cognition, bladder/bowel, sensory, and spasticity. Measures given for comparison included a neurologic examination (Expanded Disability Status Scale, Ambulation Index, Disease Steps) as well as the patient-reported Health Status Questionnaire and the Quality of Well-being Index. Participants included 274 MS patients and 296 healthy control subjects who were matched to patients on age, gender, and education. Both the Symptom Inventory and the Performance Scales showed high test-retest and internal consistency reliability. Correlational analyses supported the construct validity of both measures. Discriminant function analysis reduced the Symptom Inventory to 29 items without sacrificing reliability and increased its discriminant validity. The Performance Scales explained more variance in clinical outcomes and global quality of life than the Symptom Inventory, and there was some evidence that the two measures complemented each other in predicting Quality of Well-being Index scores. The Symptom Inventory and the Performance Scales are reliable and valid measures.

Evaluation of Internal Construct Validity and Unidimensionality of the Brachial Assessment Tool, A Patient-Reported Outcome Measure for Brachial Plexus Injury.

PubMed

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

2016-12-01

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

Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

PubMed Central

2014-01-01

Background Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. Methods A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. Results The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and

Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance.

PubMed

Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

2014-07-22

Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI

Quality of life after multiple trauma: validation and population norm of the Polytrauma Outcome (POLO) chart.

PubMed

Lefering, R; Tecic, T; Schmidt, Y; Pirente, N; Bouillon, B; Neugebauer, E

2012-08-01

Due to an increasing number of survivors after multiple injuries in Western countries, the health-related quality of life (QoL) is considered to be an important outcome parameter. Up to now, measuring instruments used in this field lacked validity and comparability. Within 6 years, our working group developed a new modular instrument, called the Polytrauma Outcome (POLO) chart. This study documents the validation of the trauma-specific module specifically designed for trauma patients, the Trauma Outcome Profile (TOP). A total of 172 multiply injured patients (mean Injury Severity Score [ISS] 26.7) recruited from eight trauma centres participating in the German Trauma Registry were compared with 166 marginally injured patients (mean ISS 3.9). The mean follow-up was 24.2 and 26.4 months, respectively. The validation questionnaires used were the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), Impact of Event Scale-Revised (IES-R), Social Support Questionnaire (F-SOZU-K-22), Barthel Index of Activities of Daily Living (ADL) and the Short Form Health Survey (SF-36). The internal consistency of the different dimensions of QoL assessed with the TOP was good. Factor analysis provides evidence of the construct validity of the questionnaire. Correlation with external measures gives evidence of criterion validity for the various dimensions of QoL and similar exceedance of proposed cut-off points within TOP and external measures is verified. The TOP module is a reliable and valid instrument to assess health-related QoL in patients with multiple injuries. It can be used stand-alone or as part of the POLO chart together with the Glasgow Outcome Scale (GOS), the EuroQoL and the SF-36 as a regular systematic follow-up instrument.

Validity of patient-reported swallowing and speech outcomes in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer.

PubMed

Rinkel, R N P M; Verdonck-de Leeuw, I M; de Bree, R; Aaronson, N K; Leemans, C R

2015-04-01

The objective of this study was to test the construct validity of the patient-reported outcomes Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI) in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer. The study sample consisted of patients treated for oral or oropharyngeal cancer. Outcome measures were the SWAL-QOL and the SHI, and the Functional Rehabilitation Outcomes Grade (FROG), a test to measure oral and shoulder function. Spearman's rank correlation coefficient was used to test associations between the SHI and SWAL-QOL scales, and the FROG scales. During a study period of 3 months, 38 patients (21 males, 17 females; mean age 54 years) were included who visited the outpatient clinic for follow-up care 6-155 months after surgical treatment (n = 14) or combined surgery and radiotherapy (n = 24) for oral (n = 21) or oropharyngeal cancer (n = 17). Most SWAL-QOL and SHI scales (except the SWAL-QOL Fatigue scale) correlated significantly with one or more FROG oral function scales. None of the SWAL-QOL and SHI scales correlated significantly with the FROG shoulder function scale. These results support the construct validity of the SWAL-QOL and SHI questionnaires for assessing speech and swallowing problems in daily life that are moderately but significantly related to oral function. A multidimensional assessment protocol is recommended for use in clinical practice and for research purposes for measuring oral function and swallowing- and speech-related problems in daily life among head and neck cancer patients.

Validation of the National Institutes of Health Patient-Reported Outcomes Measurement Information System Survey as a Quality-of-Life Instrument for Patients with Malignant Brain Tumors and Their Caregivers.

PubMed

Romero, Melissa M; Flood, Lisa Sue; Gasiewicz, Nanci K; Rovin, Richard; Conklin, Samantha

2015-12-01

At present there is a lack of well-validated surveys used to measure quality of life in patients with malignant brain tumors and their caregivers. The main objective of this pilot study was to validate the National Institutes of Health Patient-Reported Outcomes Measurement Information System (NIH PROMIS) survey for use as a quality-of-life measure in this population. This article presents the rationale for using the NIH PROMIS instrument as a quality-of-life measure for patients with malignant brain tumors and their caregivers. Copyright © 2015 Elsevier Inc. All rights reserved.

Recommendations for the Use of Common Outcome Measures in Pediatric Traumatic Brain Injury Research

PubMed Central

Wilde, Elisabeth A.; Anderson, Vicki A.; Bedell, Gary; Beers, Sue R.; Campbell, Thomas F.; Chapman, Sandra B.; Ewing-Cobbs, Linda; Gerring, Joan P.; Gioia, Gerard A.; Levin, Harvey S.; Michaud, Linda J.; Prasad, Mary R.; Swaine, Bonnie R.; Turkstra, Lyn S.; Wade, Shari L.; Yeates, Keith O.

2012-01-01

Abstract This article addresses the need for age-relevant outcome measures for traumatic brain injury (TBI) research and summarizes the recommendations by the inter-agency Pediatric TBI Outcomes Workgroup. The Pediatric Workgroup's recommendations address primary clinical research objectives including characterizing course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies. Consistent with other Common Data Elements (CDE) Workgroups, the Pediatric TBI Outcomes Workgroup adopted the standard three-tier system in its selection of measures. In the first tier, core measures included valid, robust, and widely applicable outcome measures with proven utility in pediatric TBI from each identified domain including academics, adaptive and daily living skills, family and environment, global outcome, health-related quality of life, infant and toddler measures, language and communication, neuropsychological impairment, physical functioning, psychiatric and psychological functioning, recovery of consciousness, social role participation and social competence, social cognition, and TBI-related symptoms. In the second tier, supplemental measures were recommended for consideration in TBI research focusing on specific topics or populations. In the third tier, emerging measures included important instruments currently under development, in the process of validation, or nearing the point of published findings that have significant potential to be superior to measures in the core and supplemental lists and may eventually replace them as evidence for their utility emerges. PMID:21644810

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

Using an evidence-based approach to measure outcomes in clinical practice.

PubMed

MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

2009-02-01

Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.

Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy.

PubMed

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

2017-03-01

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. This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. 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. 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. Muscle Nerve 55: 366-372, 2017. © 2016 Wiley Periodicals, Inc.

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

Donabedian's structure-process-outcome quality of care model: Validation in an integrated trauma system.

PubMed

Moore, Lynne; Lavoie, André; Bourgeois, Gilles; Lapointe, Jean

2015-06-01

According to Donabedian's health care quality model, improvements in the structure of care should lead to improvements in clinical processes that should in turn improve patient outcome. This model has been widely adopted by the trauma community but has not yet been validated in a trauma system. The objective of this study was to assess the performance of an integrated trauma system in terms of structure, process, and outcome and evaluate the correlation between quality domains. Quality of care was evaluated for patients treated in a Canadian provincial trauma system (2005-2010; 57 centers, n = 63,971) using quality indicators (QIs) developed and validated previously. Structural performance was measured by transposing on-site accreditation visit reports onto an evaluation grid according to American College of Surgeons criteria. The composite process QI was calculated as the average sum of proportions of conformity to 15 process QIs derived from literature review and expert opinion. Outcome performance was measured using risk-adjusted rates of mortality, complications, and readmission as well as hospital length of stay (LOS). Correlation was assessed with Pearson's correlation coefficients. Statistically significant correlations were observed between structure and process QIs (r = 0.33), and process and outcome QIs (r = -0.33 for readmission, r = -0.27 for LOS). Significant positive correlations were also observed between outcome QIs (r = 0.37 for mortality-readmission; r = 0.39 for mortality-LOS and readmission-LOS; r = 0.45 for mortality-complications; r = 0.34 for readmission-complications; 0.63 for complications-LOS). Significant correlations between quality domains observed in this study suggest that Donabedian's structure-process-outcome model is a valid model for evaluating trauma care. Trauma centers that perform well in terms of structure also tend to perform well in terms of clinical processes, which in turn has a favorable influence on patient outcomes

Is the Simple Shoulder Test a valid outcome instrument for shoulder arthroplasty?

PubMed

Hsu, Jason E; Russ, Stacy M; Somerson, Jeremy S; Tang, Anna; Warme, Winston J; Matsen, Frederick A

2017-10-01

The Simple Shoulder Test (SST) is a brief, inexpensive, and widely used patient-reported outcome tool, but it has not been rigorously evaluated for patients having shoulder arthroplasty. The goal of this study was to rigorously evaluate the validity of the SST for outcome assessment in shoulder arthroplasty using a systematic review of the literature and an analysis of its properties in a series of 408 surgical cases. SST scores, 36-Item Short Form Health Survey scores, and satisfaction scores were collected preoperatively and 2 years postoperatively. Responsiveness was assessed by comparing preoperative and 2-year postoperative scores. Criterion validity was determined by correlating the SST with the 36-Item Short Form Health Survey. Construct validity was tested through 5 clinical hypotheses regarding satisfaction, comorbidities, insurance status, previous failed surgery, and narcotic use. Scores after arthroplasty improved from 3.9 ± 2.8 to 10.2 ± 2.3 (P < .001). The change in SST correlated strongly with patient satisfaction (P < .001). The SST had large Cohen's d effect sizes and standardized response means. Criterion validity was supported by significant differences between satisfied and unsatisfied patients, those with more severe and less severe comorbidities, those with workers' compensation or Medicaid and other types of insurance, those with and without previous failed shoulder surgery, and those taking and those not taking narcotic pain medication before surgery (P < .005). These data combined with a systematic review of the literature demonstrate that the SST is a valid and responsive patient-reported outcome measure for assessing the outcomes of shoulder arthroplasty. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

The Online Social Support Scale: Measure development and validation.

PubMed

Nick, Elizabeth A; Cole, David A; Cho, Sun-Joo; Smith, Darcy K; Carter, T Grace; Zelkowitz, Rachel L

2018-05-21

A new measure, the Online Social Support Scale, was developed based on previous theory, research, and measurement of in-person social support. It includes four subscales: Esteem/Emotional Support, Social Companionship, Informational Support, and Instrumental Support. In college and community samples, factor analytic and item response theory results suggest that subtypes of in-person social support also pertain in the online world. Evidence of reliability, convergent validity, and discriminant validity provide excellent psychometric support for the measure. Construct validity accrues to the measure vis-à-vis support for three hypotheses: (a) Various broad types of Internet platforms for social interactions are differentially associated with online social support and online victimization; (b) similar to in-person social support, online social support offsets the adverse effect of negative life events on self-esteem and depression-related outcome; and (c) online social support counteracts the effects of online victimization in much the same way that in-person friends in one social niche counterbalance rejection in other social niches. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Patient Reported Outcome Measure of Spiritual Care as Delivered by Chaplains.

PubMed

Snowden, Austyn; Telfer, Iain

2017-01-01

Chaplains are employed by health organizations around the world to support patients in recognizing and addressing their spiritual needs. There is currently no generalizable measure of the impact of these interventions and so the clinical and strategic worth of chaplaincy is difficult to articulate. This article introduces the Scottish PROM, an original five-item patient reported outcome measure constructed specifically to address this gap. It describes the validation process from its conceptual grounding in the spiritual care literature through face and content validity cycles. It shows that the Scottish PROM is internally consistent and unidimensional. Responses to the Scottish PROM show strong convergent validity with responses to the Warwick and Edinburgh Mental Well-Being Scale, a generic well-being scale often used as a proxy for spiritual well-being. In summary, the Scottish PROM is fit for purpose. It measures the outcomes of spiritual care as delivered by chaplains in this study. This novel project introduces an essential and original breakthrough; the possibility of generalizable international chaplaincy research.

Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

PubMed

Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

2001-04-01

To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

How to measure the outcomes of chronic disease management.

PubMed

Lewis, Al

2009-02-01

The fastest-growing methodology for disease management outcomes measurement is valid, transparent, easy to apply, and freely available in the public domain and this article. It measures the actual goal of disease management, which is to reduce the rate of adverse events associated with the disease(s) being managed. Changes in this rate can be translated into a return on investment using some explicit assumptions about comorbidities and episode costs. Outcomes measured in this way show that in the health plan community as a whole, disease management in the broadest sense is working, as measured by the relative stability in the rate of adverse medical events closely associated with common chronic disease during this decade of increasing prevalence of most of the common chronic conditions.

The Toronto outcome measure for craniofacial prosthetics: reliability and validity of a condition-specific quality-of-life instrument.

PubMed

Anderson, James D; Johnston, Dennis A; Haugh, Gil S; Kiat-Amnuay, Sudarat; Gettleman, Lawrence

2013-01-01

The purpose of this study was to refine the Toronto Outcome Measure for Craniofacial Prosthetics (TOMCP), present evidence for its reliability and validity, and use the instrument to explore differences in quality of life between prostheses made with chlorinated polyethylene (CPE) (experimental) and silicone (control). As part of a multicenter prospective controlled randomized double-blind single-crossover clinical trial of the two materials, the TOMCP was administered at the start and end of two 4-month study arms, during which 42 patients wore prostheses made from one material then the other. Reliability was assessed at the crossover. To determine validity of the TOMCP, the Linear Analogue Self-Assessment (LASA-12) and the Short-Form 8 (SF-8) were also administered with the TOMCP. The TOMCP was reduced by removing items that were unreliable, had poorly distributed answers, showed increased internal consistency after their removal, or were too highly correlated with more than one other item. The tests of reliability and validity were then repeated. Finally, the reduced instrument was used to test for differences in quality of life between prostheses made of the two materials. The item reduction tactics pared the 52-item instrument down to 27 items. The correlations of both TOMCP versions with the LASA-12 and the SF-8 were found to be statistically significant, providing evidence of the validity of the TOMCP. The instrument revealed significantly better quality of life with silicone rather than CPE prostheses. Both versions of the TOMCP were found to be reliable and valid. The instrument was able to show differences in quality of life between two materials.

Psychometric properties of carer-reported outcome measures in palliative care: A systematic review

PubMed Central

Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele

2016-01-01

Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683

Tests examining skill outcomes in sport: a systematic review of measurement properties and feasibility.

PubMed

Robertson, Samuel J; Burnett, Angus F; Cochrane, Jodie

2014-04-01

A high level of participant skill is influential in determining the outcome of many sports. Thus, tests assessing skill outcomes in sport are commonly used by coaches and researchers to estimate an athlete's ability level, to evaluate the effectiveness of interventions or for the purpose of talent identification. The objective of this systematic review was to examine the methodological quality, measurement properties and feasibility characteristics of sporting skill outcome tests reported in the peer-reviewed literature. A search of both SPORTDiscus and MEDLINE databases was undertaken. Studies that examined tests of sporting skill outcomes were reviewed. Only studies that investigated measurement properties of the test (reliability or validity) were included. A total of 22 studies met the inclusion/exclusion criteria. A customised checklist of assessment criteria, based on previous research, was utilised for the purpose of this review. A range of sports were the subject of the 22 studies included in this review, with considerations relating to methodological quality being generally well addressed by authors. A range of methods and statistical procedures were used by researchers to determine the measurement properties of their skill outcome tests. The majority (95%) of the reviewed studies investigated test-retest reliability, and where relevant, inter and intra-rater reliability was also determined. Content validity was examined in 68% of the studies, with most tests investigating multiple skill domains relevant to the sport. Only 18% of studies assessed all three reviewed forms of validity (content, construct and criterion), with just 14% investigating the predictive validity of the test. Test responsiveness was reported in only 9% of studies, whilst feasibility received varying levels of attention. In organised sport, further tests may exist which have not been investigated in this review. This could be due to such tests firstly not being published in the peer

Systematic literature review of patient-reported outcome measures used in assessment and measurement of sleep disorders in chronic obstructive pulmonary disease.

PubMed

Garrow, Adam P; Yorke, Janelle; Khan, Naimat; Vestbo, Jørgen; Singh, Dave; Tyson, Sarah

2015-01-01

Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. The results highlight a need for existing non-disease-specific instruments to be validated in COPD populations and also a need for new disease-specific measures to assess the impact of sleep problems in COPD.

Validation of a Health Literacy Measure for Adolescents and Young Adults Diagnosed with Cancer.

PubMed

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

2016-03-01

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

Validation study of an electronic method of condensed outcomes tools reporting in orthopaedics.

PubMed

Farr, Jack; Verma, Nikhil; Cole, Brian J

2013-12-01

Patient-reported outcomes (PRO) instruments are a vital source of data for evaluating the efficacy of medical treatments. Historically, outcomes instruments have been designed, validated, and implemented as paper-based questionnaires. The collection of paper-based outcomes information may result in patients becoming fatigued as they respond to redundant questions. This problem is exacerbated when multiple PRO measures are provided to a single patient. In addition, the management and analysis of data collected in paper format involves labor-intensive processes to score and render the data analyzable. Computer-based outcomes systems have the potential to mitigate these problems by reformatting multiple outcomes tools into a single, user-friendly tool.The study aimed to determine whether the electronic outcomes system presented produces results comparable with the test-retest correlations reported for the corresponding orthopedic paper-based outcomes instruments.The study is designed as a crossover study based on consecutive orthopaedic patients arriving at one of two designated orthopedic knee clinics.Patients were assigned to complete either a paper or a computer-administered questionnaire based on a similar set of questions (Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee form, 36-Item Short Form survey, version 1, Lysholm Knee Scoring Scale). Each patient completed the same surveys using the other instrument, so that all patients had completed both paper and electronic versions. Correlations between the results from the two modes were studied and compared with test-retest data from the original validation studies.The original validation studies established test-retest reliability by computing correlation coefficients for two administrations of the paper instrument. Those correlation coefficients were all in the range of 0.7 to 0.9, which was deemed satisfactory. The present study computed correlation coefficients between

Validation of a pregnancy planning measure for Arabic-speaking women.

PubMed

Almaghaslah, Eman; Rochat, Roger; Farhat, Ghada

2017-01-01

The prevalence of unplanned pregnancy in Saudi Arabia has not been thoroughly investigated. To conduct a psychometric evaluation study of the Arabic version of the London Measure of Unplanned Pregnancy (LMUP). To evaluate the psychometric properties of the LMUP, we conducted a self-administered online survey among 796 ever-married Saudi women aged 20-49 years, and a re-test survey among 24 women. The psychometric properties evaluated included content validity measured by content validity index (CVI), structural validity assessed by exploratory factor analysis (EFA), substantive validity assessed by hypothesis testing, contextual stability for the test-retest assessed by weighted Kappa, and internal consistency assessed by Cronbach's alpha. The psychometric analysis of the Arabic version of LMUP exhibited valid and reliable properties. The CVIs for individual items and at the scale level were >0.7. EFA confirmed a unidimensional extraction of the scale item. Hypothesis testing confirmed expected associations. The tool was stable with weighted kappa = 0.78 and Cronbach's alpha = 0.88. In this study, the validity and reliability of the Arabic version of the LMUP were confirmed according to well-known psychometric criteria. This LMUP version can be used in research studies among Arabic-speaking women to measure unplanned pregnancy and investigate correlates and outcomes related to unplanned pregnancy.

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

Longitudinal evaluation of Patient Reported Outcomes Measurement Information Systems (PROMIS) measures in pediatric chronic pain

PubMed Central

Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R.; Sherry, David D.; Mara, Constance A.; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan

2015-01-01

The Patient Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of seven PROMIS domains for the assessment of children (ages 8-18) with chronic pain – Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function and Peer Relationships. PROMIS measures were administered at the initial visit and two follow-up visits at an outpatient chronic pain clinic (CPC; N=82) and at an intensive amplified pain day-treatment program (AMP; N= 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding “legacy” measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and AMP samples. Longitudinal growth models showed that PROMIS Pain Interference, Anxiety, Depression, Mobility, Upper Extremity and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All seven PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research. PMID:26447704

Reliability and Validity of the Self Efficacy Expectations and Outcome Expectations After ICD Implantation Scales

PubMed Central

Dougherty, Cynthia M.; Johnston, Sandra K.; Thompson, Elaine Adams

2009-01-01

The purpose of this study was to assess the reliability and validity characteristics of two new scales that measure self-efficacy expectations (SE-ICD) and outcome expectations (OE-ICD) in survivors (n=168) of sudden cardiac arrest (SCA), all of whom received an implantable cardioverter defibrillator (ICD). Cronbach's alpha reliability demonstrated good internal consistency (SE-ICD α = 0.93 and OE-ICD α = 0.81). Correlations with other self-efficacy instruments (general self-efficacy and social self-efficacy) were consistently high. The instruments were responsive to change across time with effect sizes of 0.46 for SE-ICD, and 0.26 for OE-ICD. These reliable, valid, and responsive instruments for measurement of self-efficacy expectations and outcome expectations after an ICD can be used in research and clinical settings. PMID:17693214

Reliability and validity analysis of the open-source Chinese Foot and Ankle Outcome Score (FAOS).

PubMed

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

2017-12-21

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

Young adult e-cigarette use outcome expectancies: Validity of a revised scale and a short scale.

PubMed

Pokhrel, Pallav; Lam, Tony H; Pagano, Ian; Kawamoto, Crissy T; Herzog, Thaddeus A

2018-03-01

The revised youth e-cigarette outcome expectancies measure adds new items informed by recent qualitative research with young adult e-cigarette users, especially in the domain of positive "smoking" experience. Positive "smoking" experience represents beliefs that use of e-cigarettes provides outcomes associated with a better "smoking" alternative: for example, an alternative that is more socially approved, more suitable for indoor use, and that provides a safer means of enjoying nicotine. In addition, we tested a short, 8-item version of the measure which may be more easily incorporated into surveys. We tested the validity of the revised measure, both long and short versions, in terms of factor structure and associations of the expectancy factors with current e-cigarette use, e-cigarette use susceptibility, and e-cigarette use dependence. Participants were young adults (N=470; 65% women; mean age=20.9, SD=2.1). Results replicated the findings of the previous study as well as highlighted the importance of the added domain of positive "smoking" experience and the validity of the short scale. Furthermore, results showed that positive outcome expectancies are strongly associated with e-cigarette use dependence. The long and short versions of the revised youth e-cigarette outcome expectancies scale appear to be valid and useful for application not only among cigarette smokers and e-cigarette users but also among never smokers and never e-cigarette users. Copyright © 2017 Elsevier Ltd. All rights reserved.

Corticospinal excitability measurements using transcranial magnetic stimulation are valid with intramuscular electromyography

PubMed Central

2017-01-01

Objectives Muscular targets that are deep or inaccessible to surface electromyography (sEMG) require intrinsic recording using fine-wire electromyography (fEMG). It is unknown if fEMG validly record cortically evoked muscle responses compared to sEMG. The purpose of this investigation was to establish the validity and agreement of fEMG compared to sEMG to quantify typical transcranial magnetic stimulation (TMS) measures pre and post repetitive TMS (rTMS). The hypotheses were that fEMG would demonstrate excellent validity and agreement compared with sEMG. Materials and methods In ten healthy volunteers, paired pulse and cortical silent period (CSP) TMS measures were collected before and after 1200 pulses of 1Hz rTMS to the motor cortex. Data were simultaneously recorded with sEMG and fEMG in the first dorsal interosseous. Concurrent validity (r and rho) and agreement (Tukey mean-difference) were calculated. Results fEMG quantified corticospinal excitability with good to excellent validity compared to sEMG data at both pretest (r = 0.77–0.97) and posttest (r = 0.83–0.92). Pairwise comparisons indicated no difference between sEMG and fEMG for all outcomes; however, Tukey mean-difference plots display increased variance and questionable agreement for paired pulse outcomes. CSP displayed the highest estimates of validity and agreement. Paired pulse MEP responses recorded with fEMG displayed reduced validity, agreement and less sensitivity to changes in MEP amplitude compared to sEMG. Change scores following rTMS were not significantly different between sEMG and fEMG. Conclusion fEMG electrodes are a valid means to measure CSP and paired pulse MEP responses. CSP displays the highest validity estimates, while caution is warranted when assessing paired pulse responses with fEMG. Corticospinal excitability and neuromodulatory aftereffects from rTMS may be assessed using fEMG. PMID:28231250

Corticospinal excitability measurements using transcranial magnetic stimulation are valid with intramuscular electromyography.

PubMed

Summers, Rebekah L S; Chen, Mo; Kimberley, Teresa J

2017-01-01

Muscular targets that are deep or inaccessible to surface electromyography (sEMG) require intrinsic recording using fine-wire electromyography (fEMG). It is unknown if fEMG validly record cortically evoked muscle responses compared to sEMG. The purpose of this investigation was to establish the validity and agreement of fEMG compared to sEMG to quantify typical transcranial magnetic stimulation (TMS) measures pre and post repetitive TMS (rTMS). The hypotheses were that fEMG would demonstrate excellent validity and agreement compared with sEMG. In ten healthy volunteers, paired pulse and cortical silent period (CSP) TMS measures were collected before and after 1200 pulses of 1Hz rTMS to the motor cortex. Data were simultaneously recorded with sEMG and fEMG in the first dorsal interosseous. Concurrent validity (r and rho) and agreement (Tukey mean-difference) were calculated. fEMG quantified corticospinal excitability with good to excellent validity compared to sEMG data at both pretest (r = 0.77-0.97) and posttest (r = 0.83-0.92). Pairwise comparisons indicated no difference between sEMG and fEMG for all outcomes; however, Tukey mean-difference plots display increased variance and questionable agreement for paired pulse outcomes. CSP displayed the highest estimates of validity and agreement. Paired pulse MEP responses recorded with fEMG displayed reduced validity, agreement and less sensitivity to changes in MEP amplitude compared to sEMG. Change scores following rTMS were not significantly different between sEMG and fEMG. fEMG electrodes are a valid means to measure CSP and paired pulse MEP responses. CSP displays the highest validity estimates, while caution is warranted when assessing paired pulse responses with fEMG. Corticospinal excitability and neuromodulatory aftereffects from rTMS may be assessed using fEMG.

Translation and linguistic validation of the Pediatric Patient-Reported Outcomes Measurement Information System measures into simplified Chinese using cognitive interviewing methodology.

PubMed

Liu, Yanyan; Hinds, Pamela S; Wang, Jichuan; Correia, Helena; Du, Shizheng; Ding, Jian; Gao, Wen Jun; Yuan, Changrong

2013-01-01

The Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) measures were developed using modern measurement theory and tested in a variety of settings to assess the quality of life, function, and symptoms of children and adolescents experiencing a chronic illness and its treatment. Developed in English, this set of measures had not been translated into Chinese. The objective of this study was to develop the Chinese version of the Pediatric PROMIS measures (C-Ped-PROMIS), specifically 8 short forms, and to pretest the translated measures in children and adolescents through cognitive interviewing methodology. The C-Ped-PROMIS was developed following the standard Functional Assessment of Chronic Illness Therapy Translation Methodology. Bilingual teams from the United States and China reviewed the translation to develop a provisional version, which was then pretested with cognitive interview by probing 10 native Chinese-speaking children aged 8 to 17 years in China. The translation was finalized by the bilingual teams. Most items, response options, and instructions were well understood by the children, and some revisions were made to address patient's comments during the cognitive interview. The results indicated that the C-Ped-PROMIS items were semantically and conceptually equivalent to the original. Children aged 8 to 17 years in China were able to comprehend these measures and express their experience and feelings about illness or their life. The C-Ped-PROMIS is available for psychometric validation. Future work will be directed at translating the rest of the item banks, calibrating them and creating a Chinese final version of the short forms.

Development and validation of the Pediatric Stroke Quality of Life Measure.

PubMed

Fiume, Andrea; Deveber, Gabrielle; Jang, Shu-Hyun; Fuller, Colleen; Viner, Shani; Friefeld, Sharon

2018-06-01

To develop and validate a disease-specific parent proxy and child quality of life (QoL) measure for patients aged 2 to 18 years surviving cerebral sinovenous thrombosis (CSVT) and arterial ischaemic stroke (AIS). Utilizing qualitative and quantitative methods, we developed a 75-item Pediatric Stroke Quality of Life Measure (PSQLM) questionnaire. We mailed the PSQLM and a standardized generic QoL measure, Pediatric Quality of Life Inventory (PedsQL), to 353 families. Stroke type, age at stroke, and neurological outcome on the Pediatric Stroke Outcome Measure were documented. We calculated the internal consistency, validity, and reliability of the PSQLM. The response rate was 29%, yielding a sample of 101 patients (mean age 9y 9mo [SD 4.30]; 69 AIS [68.3%], 32 CSVT [31.7%]). The internal consistency of the PSQLM was high (Cronbach's α=0.94-0.97). Construct validity for the PSQLM was moderately strong (r=0.3-0.4; p<0.003) and, as expected, correlation with the PedsQL was moderate, suggesting the PSQLM operationalizes QoL distinct from the PedsQL. Test-retest reliability at 2 weeks was very good (intraclass correlation coefficient [ICC] 0.85-0.95; 95% confidence interval 0.83-0.97) and good agreement was established between parent and child report (ICC 0.63-0.76). The PSQLM demonstrates sound psychometric properties. Further research will seek to increase its clinical utility by reducing length and establishing responsiveness for descriptive and longitudinal evaluative assessment. A pediatric stroke-specific quality of life (QoL) measurement tool for assessments based on perceptions of importance and satisfaction. Moderate-to-high reliability and validity established for a new clinical scale evaluating QoL among children with stroke. Perceived QoL measured using the Pediatric Stroke Quality of Life Measure appears lower in children with neurological impairment. © 2018 Mac Keith Press.

Analysis of subarachnoid hemorrhage using the Nationwide Inpatient Sample: the NIS-SAH Severity Score and Outcome Measure.

PubMed

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

2014-08-01

Studies using the Nationwide Inpatient Sample (NIS), a large ICD-9-based (International Classification of Diseases, Ninth Revision) administrative database, to analyze aneurysmal subarachnoid hemorrhage (SAH) have been limited by an inability to control for SAH severity and the use of unverified outcome measures. To address these limitations, the authors developed and validated a surrogate marker for SAH severity, the NIS-SAH Severity Score (NIS-SSS; akin to Hunt and Hess [HH] grade), and a dichotomous measure of SAH outcome, the NIS-SAH Outcome Measure (NIS-SOM; akin to modified Rankin Scale [mRS] score). Three separate and distinct patient cohorts were used to define and then validate the NIS-SSS and NIS-SOM. A cohort (n = 148,958, the "model population") derived from the 1998-2009 NIS was used for developing the NIS-SSS and NIS-SOM models. Diagnoses most likely reflective of SAH severity were entered into a regression model predicting poor outcome; model coefficients of significant factors were used to generate the NIS-SSS. Nationwide Inpatient Sample codes most likely to reflect a poor outcome (for example, discharge disposition, tracheostomy) were used to create the NIS-SOM. Data from 716 patients with SAH (the "validation population") treated at the authors' institution were used to validate the NIS-SSS and NIS-SOM against HH grade and mRS score, respectively. Lastly, 147,395 patients (the "assessment population") from the 1998-2009 NIS, independent of the model population, were used to assess performance of the NIS-SSS in predicting outcome. The ability of the NIS-SSS to predict outcome was compared with other common measures of disease severity (All Patient Refined Diagnosis Related Group [APR-DRG], All Payer Severity-adjusted DRG [APS-DRG], and DRG). RESULTS The NIS-SSS significantly correlated with HH grade, and there was no statistical difference between the abilities of the NIS-SSS and HH grade to predict mRS-based outcomes. As compared with the APR

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.

Outcome measures for oral health based on clinical assessments and claims data: feasibility evaluation in practice.

PubMed

Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert

2017-10-05

It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first

Checklist to operationalize measurement characteristics of patient-reported outcome measures.

PubMed

Francis, David O; McPheeters, Melissa L; Noud, Meaghan; Penson, David F; Feurer, Irene D

2016-08-02

The purpose of this study was to advance a checklist of evaluative criteria designed to assess patient-reported outcome (PRO) measures' developmental measurement properties and applicability, which can be used by systematic reviewers, researchers, and clinicians with a varied range of expertise in psychometric measure development methodology. A directed literature search was performed to identify original studies, textbooks, consensus guidelines, and published reports that propose criteria for assessing the quality of PRO measures. Recommendations from these sources were iteratively distilled into a checklist of key attributes. Preliminary items underwent evaluation through 24 cognitive interviews with clinicians and quantitative researchers. Six measurement theory methodological novices independently applied the final checklist to assess six PRO measures encompassing a variety of methods, applications, and clinical constructs. Agreement between novice and expert scores was assessed. The distillation process yielded an 18-item checklist with six domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (5) scoring and interpretation, and (6) respondent burden and presentation. With minimal instruction, good agreement in checklist item ratings was achieved between quantitative researchers with expertise in measurement theory and less experienced clinicians (mean kappa 0.70; range 0.66-0.87). We present a simplified checklist that can help guide systematic reviewers, researchers, and clinicians with varied measurement theory expertise to evaluate the strengths and weakness of candidate PRO measures' developmental properties and the appropriateness for specific applications.

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.

PubMed

Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

2012-09-01

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research. © 2012 John Wiley & Sons A/S.

Translation, adaptation and validation of the Coronary Revascularization Outcome Questionnaire into Greek.

PubMed

Takousi, Maria G; Schmeer, Stefanie; Manaras, Irene; Olympios, Christoforos D; Fakiolas, Constantine N; Makos, Georgios; Troop, Nick A

2016-04-01

Evaluating the impact of coronary revascularization on patients' health related quality of life with a patient-based and disease-specific tool is important for drawing conclusions about treatment and outcomes. This study reports on the translation, adaptation and psychometric evaluation of a Greek version of the Coronary Revascularization Outcome Questionnaire (CROQ-Gr). A total of 609 (81.7% male) patients who had undergone coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) were recruited from four hospitals in Athens. After translating the CROQ into Greek, a preliminary qualitative study and a pilot quantitative study were conducted. A full psychometric evaluation was carried out on the main study's data. The psychometric evaluation demonstrated that the CROQ-Gr is acceptable to patients (high response rate, low missing data) and has a good level of reliability (internal consistency >0.70, test-retest reliability >0.90) and validity (both content and construct validity). The results of this study show the CROQ-Gr to be a psychometrically rigorous patient-based measure of outcomes of coronary revascularization. It would be appropriate for use in evaluative research as well as a routine clinical tool to aid cardiologists in monitoring the outcomes of care. © The European Society of Cardiology 2015.

Measuring violence risk and outcomes among Mexican American adolescent females.

PubMed

Cervantes, Richard C; Duenas, Norma; Valdez, Avelardo; Kaplan, Charles

2006-01-01

Central to the development of culturally competent violence prevention programs for Hispanic youth is the development of psychometrically sound violence risk and outcome measures for this population. A study was conducted to determine the psychometric properties of two commonly used violence measures, in this case for Mexican American adolescent females. The Conflict Tactics Scales (CTS2) and the Past Feelings and Acts of Violence Scale (PFAV) were analyzed to examine their interitem reliability, criterion validity, and discriminant validity. A sample of 150 low-risk and 150 high-risk adolescent females was studied. Discriminant validity was indicated by the perpetrator negotiation scale and by the victim psychological aggression and sexual coercion scales of the CTS2 and the PFAV. Analysis indicates that the CTS2 scales and the PFAV demonstrate adequate reliability, whereas strong criterion validity was evidenced by eight of the CTS2 scales and the PFAV.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument.

PubMed

Mokkink, Lidwine B; Prinsen, Cecilia A C; Bouter, Lex M; Vet, Henrica C W de; Terwee, Caroline B

2016-01-19

COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

PubMed Central

Mokkink, Lidwine B.; Prinsen, Cecilia A. C.; Bouter, Lex M.; de Vet, Henrica C. W.; Terwee, Caroline B.

2016-01-01

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments. PMID:26786084

The Search for an Early Intervention Outcome Measurement Tool in Autism

ERIC Educational Resources Information Center

Fletcher-Watson, S.; McConachie, H.

2017-01-01

Evidence is accumulating that early intervention can be effective in improving the skills of young children with autism spectrum disorder. However, the science is hampered by the lack of agreed "gold standard" tools for the measurement of progress and outcome. What is required is a reliable, valid, and sensitive measure of change in the…

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.

Fit for purpose and modern validity theory in clinical outcomes assessment.

PubMed

Edwards, Michael C; Slagle, Ashley; Rubright, Jonathan D; Wirth, R J

2018-07-01

The US Food and Drug Administration (FDA), as part of its regulatory mission, is charged with determining whether a clinical outcome assessment (COA) is "fit for purpose" when used in clinical trials to support drug approval and product labeling. In this paper, we will provide a review (and some commentary) on the current state of affairs in COA development/evaluation/use with a focus on one aspect: How do you know you are measuring the right thing? In the psychometric literature, this concept is referred to broadly as validity and has itself evolved over many years of research and application. After a brief introduction, the first section will review current ideas about "fit for purpose" and how it has been viewed by FDA. This section will also describe some of the unique challenges to COA development/evaluation/use in the clinical trials space. Following this, we provide an overview of modern validity theory as it is currently understood in the psychometric tradition. This overview will focus primarily on the perspective of validity theorists such as Messick and Kane whose work forms the backbone for the bulk of high-stakes assessment in areas such as education, psychology, and health outcomes. We situate the concept of fit for purpose within the broader context of validity. By comparing and contrasting the approaches and the situations where they have traditionally been applied, we identify areas of conceptual overlap as well as areas where more discussion and research are needed.

Measuring production loss due to health and work environment problems: construct validity and implications.

PubMed

Karlsson, Malin Lohela; Bergström, Gunnar; Björklund, Christina; Hagberg, Jan; Jensen, Irene

2013-12-01

The aim was to validate two measures of production loss, health-related and work environment-related production loss, concerning their associations with health status and work environment factors. Validity was assessed by evaluating the construct validity. Health problems related and work environment-related problems (or factors) were included in separate analyses and evaluated regarding the significant difference in proportion of explained variation (R) of production loss. health problems production loss was not found to fulfill the criteria for convergent validity in this study; however, the measure of work environment-related production loss did fulfill the criteria that were set up. The measure of work environment-related production loss can be used to screen for production loss due to work environment problems as well as an outcome measure when evaluating the effect of organizational interventions.

The Benchmarking Capacity of a General Outcome Measure of Academic Language in Science and Social Studies

ERIC Educational Resources Information Center

Mooney, Paul; Lastrapes, Renée E.

2016-01-01

The amount of research evaluating the technical merits of general outcome measures of science and social studies achievement is growing. This study targeted criterion validity for critical content monitoring. Questions addressed the concurrent criterion validity of alternate presentation formats of critical content monitoring and the measure's…

Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue.

PubMed

Junghaenel, Doerte U; Schneider, Stefan; Stone, Arthur A; Christodoulou, Christopher; Broderick, Joan E

2014-04-01

This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. One-hundred women completed daily diaries and weekly PROMIS assessments over 4weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps<.0001) and post-menstrual (ps<.0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. Copyright © 2014 Elsevier Inc. All rights reserved.

Ecological Validity and Clinical Utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

PubMed Central

Junghaenel, Doerte U.; Schneider, Stefan; Stone, Arthur A.; Christodoulou, Christopher; Broderick, Joan E.

2014-01-01

Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. PMID:24630180

Patient-Reported Outcome Instruments for Surgical and Traumatic Scars: A Systematic Review of their Development, Content, and Psychometric Validation.

PubMed

Mundy, Lily R; Miller, H Catherine; Klassen, Anne F; Cano, Stefan J; Pusic, Andrea L

2016-10-01

Patient-reported outcomes (PROs) are of growing importance in research and clinical care and may be used as primary outcomes or as compliments to traditional surgical outcomes. In assessing the impact of surgical and traumatic scars, PROs are often the most meaningful. To assess outcomes from the patient perspective, rigorously developed and validated PRO instruments are essential. The authors conducted a systematic literature review to identify PRO instruments developed and/or validated for patients with surgical and/or non-burn traumatic scars. Identified instruments were assessed for content, development process, and validation under recommended guidelines for PRO instrument development. The systematic review identified 6534 articles. After review, we identified four PRO instruments meeting inclusion criteria: patient and observer scar assessment scale (POSAS), bock quality of life questionnaire for patients with keloid and hypertrophic scarring (Bock), patient scar assessment questionnaire (PSAQ), and patient-reported impact of scars measure (PRISM). Common concepts measured were symptoms and psychosocial well-being. Only PSAQ had a dedicated appearance domain. Qualitative data were used to inform content for the PSAQ and PRISM, and a modern psychometric approach (Rasch Measurement Theory) was used to develop PRISM and to test POSAS. Overall, PRISM demonstrated the most rigorous design and validation process, however, was limited by the lack of a dedicated appearance domain. PRO instruments to evaluate outcomes in scars exist but vary in terms of concepts measured and psychometric soundness. This review discusses the strengths and weaknesses of existing instruments, highlighting the need for future scar-focused PRO instrument development. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www

Parent-Reported Social Support for Child's Fruit and Vegetable Intake: Validity of Measures

ERIC Educational Resources Information Center

Dave, Jayna M.; Evans, Alexandra E.; Condrasky, Marge D.; Williams, Joel E.

2012-01-01

Objective: To develop and validate measures of parental social support to increase their child's fruit and vegetable (FV) consumption. Design: Cross-sectional study design. Setting: School and home. Participants: Two hundred three parents with at least 1 elementary school-aged child. Main Outcome Measure: Parents completed a questionnaire that…

Assessing educational outcomes in middle childhood: validation of the Teacher Academic Attainment Scale.

PubMed

Johnson, Samantha; Marlow, Neil; Wolke, Dieter

2012-06-01

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. Three hundred and forty three children in mainstream schools aged 10 to 11 years (144 males, 199 females; 190 extremely preterm and 153 term; mean age 10 y 9 mo, SD 5.5 mo, range 9 y 8 mo-12 y 3 mo) were assessed using the reading and mathematics scales of the criterion standard Wechsler Individual Achievement Test, 2nd (UK) edition (WIAT-II). Class teachers completed the TAAS, a seven-item questionnaire for assessing academic attainment. The TAAS was also completed at 6 years of age for 266 children. Cronbach's alpha 0.95 indicated excellent internal consistency, and the correlation between TAAS scores at 6 and 11 years indicated good test-retest reliability (r=0.77, p<0.001). Significantly higher TAAS scores for term vs preterm children demonstrated discriminative validity. TAAS scores at 6 and 11 years were significantly correlated with WIAT-II reading (r=0.69 and 0.75, p<0.001) and mathematics (r=0.75 and 0.82, p<0.001) scores, demonstrating good predictive and concurrent validity respectively. TAAS scores of <2.5 were good predictors of learning difficulties. The TAAS is a brief, psychometrically sound teacher-report of academic attainment that yields continuous and categorical outcomes. It provides a cost- and time-efficient outcome measure for large-scale studies. © The Authors. Developmental Medicine & Child Neurology © 2012 Mac Keith Press.

Outcomes assessment in rotator cuff pathology: what are we measuring?

PubMed

Makhni, Eric C; Steinhaus, Michael E; Morrow, Zachary S; Jobin, Charles M; Verma, Nikhil N; Cole, Brian J; Bach, Bernard R

2015-12-01

Assessments used to measure outcomes associated with rotator cuff pathology and after repair are varied. This lack of standardization leads to difficulty drawing comparisons across studies. We hypothesize that this variability in patient-reported outcome measures and objective metrics used in rotator cuff studies persists even in high-impact, peer reviewed journals. All studies assessing rotator cuff tear and repair outcomes in 6 orthopedic journals with a high impact factor from January 2010 to December 2014 were reviewed. Cadaveric and animal studies and those without outcomes were excluded. Outcome measures included range of motion (forward elevation, abduction, external rotation, and internal rotation), strength (in the same 4 planes), tendon integrity imaging, patient satisfaction, and functional assessment scores. Of the 156 included studies, 63% documented range of motion measurements, with 18% reporting range of motion in all 4 planes. Only 38% of studies reported quantitative strength measurements. In 65% of studies, tendon integrity was documented with imaging (38% magnetic resonance imaging/magnetic resonance anrhrogram, 31% ultrasound, and 8% computed tomography arthrogram). Finally, functional score reporting varied significantly, with the 5 most frequently reported scores ranging from 16% to 61% in studies, and 15 of the least reported outcomes were each reported in ≤6% of studies. Significant variability exists in outcomes reporting after rotator cuff tear and repair, making comparisons between clinical studies difficult. Creating a uniformly accepted, validated outcomes tool that assesses pain, function, patient satisfaction, and anatomic integrity would enable consistent outcomes assessment after operative and nonoperative management and allow comparisons across the literature. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

The validity of dependence as a health outcome measure in Alzheimer's disease.

PubMed

Spackman, D Eldon; Kadiyala, Srikanth; Neumann, Peter J; Veenstra, David L; Sullivan, Sean D

2013-05-01

Relating to Alzheimer's disease (AD), dependence has been defined as the increased need for assistance due to deterioration in cognition, physical functioning, and behavior. Our objective was to evaluate the association between dependence and measures of functional impairment. Data were compiled by the National Alzheimer's Coordinating Center. We used multinomial logistic regression to estimate the association between dependence and cognition, physical functioning, and behavior. The independent association with dependence was positive. Dependence was most strongly associated with physical functioning. A secondary analysis suggested a strong association of dependence with multiple impairments, as measured by the interaction terms, in more severe patients. We find that dependence is simultaneously associated with physical functioning, cognition, and behavior, which support the construct validity of dependence. Dependence might be a more simple measure to explain the multifaceted disease progression of AD and convey the increasing need for care.

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…

Validity and measurement precision of the PROMIS physical function item bank and a content validity-driven 20-item short form in rheumatoid arthritis compared with traditional measures.

PubMed

Oude Voshaar, Martijn A H; Ten Klooster, Peter M; Glas, Cees A W; Vonkeman, Harald E; Taal, Erik; Krishnan, Eswar; Bernelot Moens, Hein J; Boers, Maarten; Terwee, Caroline B; van Riel, Piet L C M; van de Laar, Mart A F J

2015-12-01

To evaluate the content validity and measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) physical function item bank and a 20-item short form in patients with RA in comparison with the HAQ disability index (HAQ-DI) and 36-item Short Form Health Survey (SF-36) physical functioning scale (PF-10). The content validity of the instruments was evaluated by linking their items to the International Classification of Functioning, Disability and Health (ICF) core set for RA. The measures were administered to 690 RA patients enrolled in the Dutch Rheumatoid Arthritis Monitoring registry. Measurement precision was evaluated using item response theory methods and construct validity was evaluated by correlating physical function scores with other clinical and patient-reported outcome measures. All 207 health concepts identified in the physical function measures referred to activities that are featured in the ICF. Twenty-three of 26 ICF RA core set domains are featured in the full PROMIS physical function item bank compared with 13 and 8 for the HAQ-DI and PF-10, respectively. As hypothesized, all three physical function instruments were highly intercorrelated (r 0.74-0.84), moderately correlated with disease activity measures (r 0.44-0.63) and weakly correlated with age (rs 0.07-0.14). Item response theory-based analysis revealed that a 20-item PROMIS physical function short form covered a wider range of physical function levels than the HAQ-DI or PF-10. The PROMIS physical function item bank demonstrated excellent measurement properties in RA. A content-driven 20-item short form may be a useful tool for assessing physical function in RA. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

PubMed

Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

2018-04-01

An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

Dutch translation and cross-cultural validation of the Adult Social Care Outcomes Toolkit (ASCOT).

PubMed

van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje Pd; Rand, Stacey E; Towers, Ann-Marie; Smith, Nick; Razik, Kamilla; Trukeschitz, Birgit; van Tulder, Maurits W; van der Horst, Henriette E; Ostelo, Raymond W

2015-05-13

The Adult Social Care Outcomes Toolkit was developed to measure outcomes of social care in England. In this study, we translated the four level self-completion version (SCT-4) of the ASCOT for use in the Netherlands and performed a cross-cultural validation. The ASCOT SCT-4 was translated into Dutch following international guidelines, including two forward and back translations. The resulting version was pilot tested among frail older adults using think-aloud interviews. Furthermore, using a subsample of the Dutch ACT-study, we investigated test-retest reliability and construct validity and compared response distributions with data from a comparable English study. The pilot tests showed that translated items were in general understood as intended, that most items were reliable, and that the response distributions of the Dutch translation and associations with other measures were comparable to the original English version. Based on the results of the pilot tests, some small modifications and a revision of the Dignity items were proposed for the final translation, which were approved by the ASCOT development team. The complete original English version and the final Dutch translation can be obtained after registration on the ASCOT website ( http://www.pssru.ac.uk/ascot ). This study provides preliminary evidence that the Dutch translation of the ASCOT is valid, reliable and comparable to the original English version. We recommend further research to confirm the validity of the modified Dutch ASCOT translation.

Development and validation of a Spanish diabetes-specific numeracy measure: DNT-15 Latino.

PubMed

White, Richard O; Osborn, Chandra Y; Gebretsadik, Tebeb; Kripalani, Sunil; Rothman, Russell L

2011-09-01

Although deficits in health literacy and numeracy have been described among Latinos, the impact of low numeracy on diabetes outcomes has not been studied. Study objectives were (1) to establish the reliability and validity of a 15-item Spanish, diabetes-specific numeracy measure (Diabetes Numeracy Test [DNT]-15 Latino) and (2) to examine the relationship between diabetes-specific numeracy and diabetes-related outcomes among a sample of Latino adults with diabetes. Data collection included patient demographics, health literacy, general numeracy, diabetes-specific numeracy, acculturation, self-efficacy, self-care behaviors, and most recent glycosylated hemoglobin (HbA1c). Participants (n=144) were on average 47.8 years old (SD=12.1). The majority were female (62%), uninsured (81%), and of Mexican nationality (78%) and reported low levels of acculturation (96%). The DNT-15 Latino had high internal reliability (Kruder-Richardson 20=0.78). The DNT-15 Latino demonstrated construct validity, correlating with measures of health literacy (ρ=0.291), general numeracy (ρ=0.500), education (ρ=0.361), and income (ρ=0.270) (P<0.001 for each). The DNT-15 Latino was significantly associated with acculturation but unrelated to self-efficacy, self-care behaviors, insulin use, and HbA1c. The DNT-15 Latino is a reliable and valid measure of diabetes-specific numeracy for Latino patients with diabetes; however, additional studies are needed to further explore the association between diabetes-specific numeracy and acculturation and their impact on diabetes-related outcomes for Latinos.

Neurological Outcome Scale for Traumatic Brain Injury: III. Criterion-Related Validity and Sensitivity to Change in the NABIS Hypothermia-II Clinical Trial

PubMed Central

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

2013-01-01

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

A critical appraisal of instruments to measure outcomes of interprofessional education.

PubMed

Oates, Matthew; Davidson, Megan

2015-04-01

Interprofessional education (IPE) is believed to prepare health professional graduates for successful collaborative practice. A range of instruments have been developed to measure the outcomes of IPE. An understanding of the psychometric properties of these instruments is important if they are to be used to measure the effectiveness of IPE. This review set out to identify instruments available to measure outcomes of IPE and collaborative practice in pre-qualification health professional students and to critically appraise the psychometric properties of validity, responsiveness and reliability against contemporary standards for instrument design. Instruments were selected from a pool of extant instruments and subjected to critical appraisal to determine whether they satisfied inclusion criteria. The qualitative and psychometric attributes of the included instruments were appraised using a checklist developed for this review. Nine instruments were critically appraised, including the widely adopted Readiness for Interprofessional Learning Scale (RIPLS) and the Interdisciplinary Education Perception Scale (IEPS). Validity evidence for instruments was predominantly based on test content and internal structure. Ceiling effects and lack of scale width contribute to the inability of some instruments to detect change in variables of interest. Limited reliability data were reported for two instruments. Scale development and scoring protocols were generally reported by instrument developers, but the inconsistent application of scoring protocols for some instruments was apparent. A number of instruments have been developed to measure outcomes of IPE in pre-qualification health professional students. Based on reported validity evidence and reliability data, the psychometric integrity of these instruments is limited. The theoretical test construction paradigm on which instruments have been developed may be contributing to the failure of some instruments to detect change in

Review of patient-reported outcome measures in chronic hepatitis C

PubMed Central

2012-01-01

Background Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. Methods A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. Results This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. Conclusions This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to

Translation, cross-cultural adaptation and validation of SinoNasal Outcome Test (SNOT): 22 to Brazilian Portuguese.

PubMed

Kosugi, Eduardo Macoto; Chen, Vitor Guo; Fonseca, Viviane Maria Guerreiro da; Cursino, Milena Martins Pellogia; Mendes Neto, José Arruda; Gregório, Luís Carlos

2011-01-01

Quality of life questionnaires have been increasingly used in clinical trials to help establish the impact of medical intervention or to assess the outcome of health care services. Among disease-specific outcome measures, SNOT-22 was considered the most suitable tool for assessing chronic rhinosinusitis and patients with nasal polyps. To perform translation, cross-cultural adaptation and validation of the SNOT-22 to Brazilian Portuguese. Prospective study involving eighty-nine patients with chronic rhinosinusitis or nasal polyps submitted to functional endoscopic sinus surgery, who answered the questionnaire before and after surgery. Furthermore, 113 volunteers without sinonasal disease also answered the questionnaire. Internal consistency, test-retest reliability, measure validity, responsiveness and clinical interpretability were assessed. Mean preoperative, postoperative and no sinonasal disease scores were 62.39, 23.09 and 11.42, respectively (p<0.0001); showing validity and responsiveness. Internal consistency was high (Cronbach's alpha = 0.9276). Reliability was sufficiently good, considering inter-interviewers (r=0.81) and intra-interviewers within a 10 to 14 day-interval (r=0.72). Surgery effect size was 1.55. Minimally important difference was 14 points; and scores up to 10 points were considered normal. The Brazilian Portuguese SNOT-22 version is a valid instrument to assess patients with chronic rhinosinusitis and nasal polyps.

Assessment of postoperative outcomes of hypospadias repair with validated questionnaires.

PubMed

Liu, Mona M Y; Holland, Andrew J A; Cass, Danny T

2015-12-01

A standardized assessment for the optimal repair of hypospadias remains elusive. This study utilized validated questionnaires to assess the postoperative functional, cosmetic, and psychosocial outcomes of hypospadias repair. 172 patients who underwent hypospadias repair under the care of a single surgeon were identified. 25 agreed for follow-up using the validated questionnaires of Hypospadias Objective Scoring Evaluation (HOSE), Pediatric Penile Perception Scale (PPPS), and Pediatric Quality of Life Inventory (PedsQL™4.0). Mean follow-up was 59months postoperatively (range 7-113months). Techniques used included tubularized incised plate urethroplasty, meatal advancement and glanuloplasty, and a 2-stage repair. 23 of 25 patients achieved a HOSE score of 14 or more (maximum of 16). The PPPS scores correlated with severity of the hypospadias. Those with glanular hypospadias (mean score=10) scored higher than those with coronal (mean score=9) and penile/penoscrotal hypospadias (mean score=7). There was no correlation between PedsQL™4.0 scores and the severity of hypospadias or procedure used. Validated questionnaires revealed generally good functional, cosmetic, and early psychosocial outcomes after hypospadias repair. The use of validated questionnaires in routine follow-up sessions may facilitate objective assessment of both functional outcomes and patient satisfaction. Copyright © 2015 Elsevier Inc. All rights reserved.

Validity of the Medical College Admission Test for Predicting MD-PhD Student Outcomes

ERIC Educational Resources Information Center

Bills, James L.; VanHouten, Jacob; Grundy, Michelle M.; Chalkley, Roger; Dermody, Terence S.

2016-01-01

The Medical College Admission Test (MCAT) is a quantitative metric used by MD and MD-PhD programs to evaluate applicants for admission. This study assessed the validity of the MCAT in predicting training performance measures and career outcomes for MD-PhD students at a single institution. The study population consisted of 153 graduates of the…

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

PubMed

Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

2016-01-01

The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Outcome Measures in Spinal Cord Injury

PubMed Central

Alexander, Marcalee S.; Anderson, Kim; Biering-Sorensen, Fin; Blight, Andrew R.; Brannon, Ruth; Bryce, Thomas; Creasey, Graham; Catz, Amiram; Curt, Armin; Donovan, William; Ditunno, John; Ellaway, Peter; Finnerup, Nanna B.; Graves, Daniel E.; Haynes, Beth Ann; Heinemann, Allen W.; Jackson, Amie B.; Johnston, Mark; Kalpakjian, Claire Z.; Kleitman, Naomi; Krassioukov, Andrei; Krogh, Klaus; Lammertse, Daniel; Magasi, Susan; Mulcahey, MJ; Schurch, Brigitte; Sherwood, Arthur; Steeves, John D.; Stiens, Steven; Tulsky, David S.; van Hedel, Hubertus J.A.; Whiteneck, Gale

2009-01-01

Study Design review by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. Results imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain, and psycho-social tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. Conclusion significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial. PMID:19381157

Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism.

PubMed

Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A

2016-04-01

Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

Evidence of Validity for the Japanese Version of the Foot and Ankle Ability Measure

PubMed Central

Uematsu, Daisuke; Suzuki, Hidetomo; Sasaki, Shogo; Nagano, Yasuharu; Shinozuka, Nobuyuki; Sunagawa, Norihiko; Fukubayashi, Toru

2015-01-01

Context: The Foot and Ankle Ability Measure (FAAM) is a valid, reliable, and self-reported outcome instrument for the foot and ankle region. Objective: To provide evidence for translation, cross-cultural adaptation, validity, and reliability of the Japanese version of the FAAM (FAAM-J). Design: Cross-sectional study. Setting: Collegiate athletic training/sports medicine clinical setting. Patients or Other Participants: Eighty-three collegiate athletes. Main Outcome Measure(s): All participants completed the Activities of Daily Living and Sports subscales of the FAAM-J and the Physical Functioning and Mental Health subscales of the Japanese version of the Short Form-36v2 (SF-36). Also, 19 participants (23%) whose conditions were expected to be stable completed another FAAM-J 2 to 6 days later for test-retest reliability. We analyzed the scores of those subscales for convergent and divergent validity, internal consistency, and test-retest reliability. Results: The Activities of Daily Living and Sports subscales of the FAAM-J had correlation coefficients of 0.86 and 0.75, respectively, with the Physical Functioning section of the SF-36 for convergent validity. For divergent validity, the correlation coefficients with Mental Health of the SF-36 were 0.29 and 0.27 for each subscale, respectively. Cronbach α for internal consistency was 0.99 for the Activities of Daily Living and 0.98 for the Sports subscale. A 95% confidence interval with a single measure was ±8.1 and ±14.0 points for each subscale. The test-retest reliability measures revealed intraclass correlation coefficient values of 0.87 for the Activities of Daily Living and 0.91 for the Sports subscales with minimal detectable changes of ±6.8 and ±13.7 for the respective subscales. Conclusions: The FAAM was successfully translated for a Japanese version, and the FAAM-J was adapted cross-culturally. Thus, the FAAM-J can be used as a self-reported outcome measure for Japanese-speaking individuals; however

Prediction of Outcome after Moderate and Severe Traumatic Brain Injury: External Validation of the IMPACT and CRASH Prognostic Models

PubMed Central

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

2012-01-01

Objective The International Mission on Prognosis and Analysis of Clinical Trials (IMPACT) and Corticoid Randomisation After Significant Head injury (CRASH) prognostic models predict outcome after traumatic brain injury (TBI) but have not been compared in large datasets. The objective of this is study is to validate externally and compare the IMPACT and CRASH prognostic models for prediction of outcome after moderate or severe TBI. Design External validation study. Patients We considered 5 new datasets with a total of 9036 patients, comprising three randomized trials and two observational series, containing prospectively collected individual TBI patient data. Measurements Outcomes were mortality and unfavourable outcome, based on the Glasgow Outcome Score (GOS) at six months after injury. To assess performance, we studied the discrimination of the models (by AUCs), and calibration (by comparison of the mean observed to predicted outcomes and calibration slopes). Main Results The highest discrimination was found in the TARN trauma registry (AUCs between 0.83 and 0.87), and the lowest discrimination in the Pharmos trial (AUCs between 0.65 and 0.71). Although differences in predictor effects between development and validation populations were found (calibration slopes varying between 0.58 and 1.53), the differences in discrimination were largely explained by differences in case-mix in the validation studies. Calibration was good, the fraction of observed outcomes generally agreed well with the mean predicted outcome. No meaningful differences were noted in performance between the IMPACT and CRASH models. More complex models discriminated slightly better than simpler variants. Conclusions Since both the IMPACT and the CRASH prognostic models show good generalizability to more recent data, they are valid instruments to quantify prognosis in TBI. PMID:22511138

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

PubMed

Driban, Jeffrey B; Morgan, Nani; Price, Lori Lyn; Cook, Karon F; Wang, Chenchen

2015-09-14

The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population. We conducted a secondary analysis of baseline data from a randomized trial comparing Tai Chi and physical therapy. Participants completed four PROMIS static short-form instruments (i.e., Anxiety, Depression, Physical Function, and Pain Interference) as well as six well-validated (legacy) measures that assess pain, function, and psychological health. We calculated descriptive statistics and percentages of participants scoring the minimum (floor) and maximum (ceiling) possible scores for PROMIS and legacy measures. We also estimated the association between PROMIS scores and scores on legacy measures using Spearman's rank correlations coefficients. Data from 204 participants were analyzed. Mean age of the sample was 60 years; 70% were female. The PROMIS Anxiety and Depression had floor effects with 17 and 24% of participants scoring the minimum, respectively. PROMIS Anxiety and Depression scores had strongest associations with general mental health, including stress (Perceived Stress Scale, r ≥ 0.65) and depression (Beck Depression Index-II, r = 0.70). PROMIS Pain Interference scores correlated most strongly with measures of whole body pain (Short-Form 36 Bodily Pain, r = -0.73) and physical health (Short-Form 36 Physical-Component Summary, r = -0.73); their correlations were lower with other legacy measures, including with the WOMAC knee-specific pain (r = 0.47). PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function (r = 0.79) than with

The PU-PROM: A patient-reported outcome measure for peptic ulcer disease.

PubMed

Liu, Na; Lv, Jing; Liu, Jinchun; Zhang, Yanbo

2017-12-01

Patient-reported outcome measure (PROM) conceived to enable description of treatment-related effects, from the patient perspective, bring the potential to improve in clinical research, and to provide patients with accurate information. Therefore, the aim of this study was to develop a patient-centred peptic ulcer patient-reported outcome measure (PU-PROM) and evaluate its reliability, validity, differential item functioning (DIF) and feasibility. To develop a conceptual framework and item pool for the PU-PROM, we performed a literature review and consulted other measures created in China and other countries. Beyond that, we interviewed 10 patients with peptic ulcers, and consulted six key experts to ensure that all germane parameters were included. In the first item selection phase, classical test theory and item response theory were used to select and adjust items to shape the preliminary measure completed by 130 patients and 50 controls. In the next phase, the measure was evaluated used the same methods with 492 patients and 124 controls. Finally, we used the same population in the second item reselection to assess the reliability, validity, DIF and feasibility of the final measure. The final peptic ulcer PRO measure comprised four domains (physiology, psychology, society and treatment), with 11 subdomains, and 54 items. The Cronbach's α coefficient of each subdomain for the measure was >0.800. Confirmatory factory analysis indicated that the construct validity fulfilled expectations. Model fit indices, such as RMR, RMSEA, NFI, NNFI, CFI and IFI, showed acceptable fit. The measure showed a good response rate. The peptic ulcer PRO measure had good reliability, validity, DIF and feasibility, and can be used as a clinical research evaluation instrument with patients with peptic ulcers to assess their condition focus on treatment. This measure may also be applied in other health areas, especially in clinical trials of new drugs, and may be helpful in clinical

Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

PubMed

Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H

2016-01-01

Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

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

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

PubMed

Varghese, M; Lamb, J; Rambani, R; Venkateswaran, B

2014-11-01

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. 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. 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.

Validation of the Economic and Health Outcomes Model of Type 2 Diabetes Mellitus (ECHO-T2DM).

PubMed

Willis, Michael; Johansen, Pierre; Nilsson, Andreas; Asseburg, Christian

2017-03-01

The Economic and Health Outcomes Model of Type 2 Diabetes Mellitus (ECHO-T2DM) was developed to address study questions pertaining to the cost-effectiveness of treatment alternatives in the care of patients with type 2 diabetes mellitus (T2DM). Naturally, the usefulness of a model is determined by the accuracy of its predictions. A previous version of ECHO-T2DM was validated against actual trial outcomes and the model predictions were generally accurate. However, there have been recent upgrades to the model, which modify model predictions and necessitate an update of the validation exercises. The objectives of this study were to extend the methods available for evaluating model validity, to conduct a formal model validation of ECHO-T2DM (version 2.3.0) in accordance with the principles espoused by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Society for Medical Decision Making (SMDM), and secondarily to evaluate the relative accuracy of four sets of macrovascular risk equations included in ECHO-T2DM. We followed the ISPOR/SMDM guidelines on model validation, evaluating face validity, verification, cross-validation, and external validation. Model verification involved 297 'stress tests', in which specific model inputs were modified systematically to ascertain correct model implementation. Cross-validation consisted of a comparison between ECHO-T2DM predictions and those of the seminal National Institutes of Health model. In external validation, study characteristics were entered into ECHO-T2DM to replicate the clinical results of 12 studies (including 17 patient populations), and model predictions were compared to observed values using established statistical techniques as well as measures of average prediction error, separately for the four sets of macrovascular risk equations supported in ECHO-T2DM. Sub-group analyses were conducted for dependent vs. independent outcomes and for microvascular vs. macrovascular vs. mortality

Cross-cultural adaptation and validation of the Arabic version of the knee outcome survey-activities for daily living scale.

PubMed

Bouzubar, Fawzi F; Aljadi, Sameera H; Alotaibi, Naser M; Irrgang, James J

2018-07-01

The purpose of this study is to cross-culturally adapt the Knee Outcome Survey-Activities of Daily Living Scale into Arabic and to assess its psychometric properties (internal consistency, reliability, validity, and responsiveness) in patients with knee disorders. The cross-cultural adaptation process for the Knee Outcome Survey-Activities of Daily Living Scale into Arabic was performed consistent with the published guidelines. The psychometric properties of this Arabic version were then evaluated. Participants completed this version three times: at baseline, 2-4 days later, and 4 weeks later. Correlations between the Arabic version of Knee Outcome Survey-Activities of Daily Living Scale and the Arabic version of the Short Form-36 Health Survey, Get Up and Go, and Ascending/Descending stairs tests were evaluated. Linguistic and cultural issues were addressed. The Arabic version of the Knee Outcome Survey-Activities of Daily Living Scale demonstrated excellent internal consistency (Cronbach's alpha = 0.97) and excellent test-retest reliability (intraclass correlation coefficient = 0.97). Construct validity of the Arabic version of the Knee Outcome Survey-Activities of Daily Living Scale with the Arabic version of Short Form-36 Health Survey subscales ranged from r = 0.28 to 0.53, p < 0.001. Criterion validity with the Get Up and Go and Ascending/Descending stairs tests ranged from r = -0.47 to -0.60, p < 0.01. This Arabic version was able to detect changes 4 weeks later (effect size = 1.12 and minimum clinically important difference = 14 points). The Arabic version of the Knee Outcome Survey-Activities of Daily Living Scale is a reliable, valid and responsive measure for assessing knee-related symptoms and functional limitations Implications for rehabilitation The Knee Outcome Survey-Activities of Daily Living Scale-Arabic is a reliable, valid and responsive measure for assessing knee-related functional limitations. This Arabic

Definitions and Outcome Measures in Pediatric Functional Upper Gastrointestinal Tract Disorders: A Systematic Review.

PubMed

Nassar-Sheikh Rashid, Amara; Taminiau, Jan A; Benninga, Marc A; Saps, Miguel; Tabbers, Merit M

2016-04-01

Functional disorders of the upper gastrointestinal tract are frequently diagnosed in children. Four different clinical entities are addressed by the Rome III committee: functional dyspepsia (FD), cyclic vomiting syndrome (CVS), adolescent rumination syndrome (ARS), and aerophagia. Management of these disorders is often difficult leading to a wide variety in therapeutic interventions. We hypothesize that definitions and outcome measures in these studies are heterogeneous as well. Our aim is to systematically assess how these disorders and outcomes are defined in therapeutic randomized controlled trials (RCTs). CENTRAL, Embase, and MEDLINE/PubMed were searched from inception to February 25, 2015. Search terms were FD, CVS, ARS, and aerophagia. Therapeutic RCTs, or systematic reviews of RCTs, in English language including subjects ages 4 to 18 years (0-18 years for CVS) were evaluated. Quality was assessed using the Delphi list. A total of 1398 articles were found of which 8 articles were included. Seven concerned FD and 1 concerned CVS. In all of the studies, Rome criteria or similar definitions were used; all the studies however used different outcome measures. Seventy-five percent of the trials were of good methodological quality. Only 57% used validated pain scales. Different outcome measures are used in therapeutic trials on functional disorders of the upper gastrointestinal tract. There is a clear paucity of trials evaluating different treatment regimens regarding CVS, ARS, and aerophagia. Uniform definitions, outcome measures, and validated instruments are needed to make a comparison between intervention studies possible.

Validation of a contemporary prostate cancer grading system using prostate cancer death as outcome.

PubMed

Berney, Daniel M; Beltran, Luis; Fisher, Gabrielle; North, Bernard V; Greenberg, David; Møller, Henrik; Soosay, Geraldine; Scardino, Peter; Cuzick, Jack

2016-05-10

Gleason scoring (GS) has major deficiencies and a novel system of five grade groups (GS⩽6; 3+4; 4+3; 8; ⩾9) has been recently agreed and included in the WHO 2016 classification. Although verified in radical prostatectomies using PSA relapse for outcome, it has not been validated using prostate cancer death as an outcome in biopsy series. There is debate whether an 'overall' or 'worst' GS in biopsies series should be used. Nine hundred and eighty-eight prostate cancer biopsy cases were identified between 1990 and 2003, and treated conservatively. Diagnosis and grade was assigned to each core as well as an overall grade. Follow-up for prostate cancer death was until 31 December 2012. A log-rank test assessed univariable differences between the five grade groups based on overall and worst grade seen, and using univariable and multivariable Cox proportional hazards. Regression was used to quantify differences in outcome. Using both 'worst' and 'overall' GS yielded highly significant results on univariate and multivariate analysis with overall GS slightly but insignificantly outperforming worst GS. There was a strong correlation with the five grade groups and prostate cancer death. This is the largest conservatively treated prostate cancer cohort with long-term follow-up and contemporary assessment of grade. It validates the formation of five grade groups and suggests that the 'worst' grade is a valid prognostic measure.

Sino-Nasal Outcome Test-22: Translation, Cross-cultural Adaptation, and Validation in Hebrew-Speaking Patients.

PubMed

Shapira Galitz, Yael; Halperin, Doron; Bavnik, Yosef; Warman, Meir

2016-05-01

To perform the translation, cross-cultural adaptation, and validation of the Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire to the Hebrew language. A single-center prospective cross-sectional study. Seventy-three chronic rhinosinusitis (CRS) patients and 73 patients without sinonasal disease filled the Hebrew version of the SNOT-22 questionnaire. Fifty-one CRS patients underwent endoscopic sinus surgery, out of which 28 filled a postoperative questionnaire. Seventy-three healthy volunteers without sinonasal disease also answered the questionnaire. Internal consistency, test-retest reproducibility, validity, and responsiveness of the questionnaire were evaluated. Questionnaire reliability was excellent, with a high internal consistency (Cronbach's alpha coefficient, 0.91-0.936) and test-retest reproducibility (Spearman's coefficient, 0.962). Mean scores for the preoperative, postoperative, and control groups were 50.44, 29.64, and 13.15, respectively (P < .0001 for CRS vs controls, P < .001 for preoperative vs postoperative), showing validity and responsiveness of the questionnaire. The Hebrew version of SNOT-22 questionnaire is a valid outcome measure for patients with CRS with or without nasal polyps. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Development and validation of a preference based measure derived from the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for use in cost utility analyses.

PubMed

McKenna, Stephen P; Ratcliffe, Julie; Meads, David M; Brazier, John E

2008-08-21

Pulmonary Hypertension is a severe and incurable disease with poor prognosis. A suite of new disease-specific measures--the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - was recently developed for use in this condition. The purpose of this study was to develop and validate a preference based measure from the CAMPHOR that could be used in cost-utility analyses. Items were selected that covered major issues covered by the CAMPHOR QoL scale (activities, travelling, dependence and communication). These were used to create 36 health states that were valued by 249 people representative of the UK adult population, using the time trade-off (TTO) technique. Data from the TTO interviews were analysed using both aggregate and individual level modelling. Finally, the original CAMPHOR validation data were used to validate the new preference based model. The predicted health state values ranged from 0.962 to 0.136. The mean level model selected for analyzing the data had good explanatory power (0.936), did not systematically over- or underestimate the observed mean health state values and showed no evidence of auto correlation in the prediction errors. The value of less than 1 reflects a background level of ill health in state 1111, as judged by the respondents. Scores derived from the new measure had excellent test-retest reliability (0.85) and construct validity. The CAMPHOR utility score appears better able to distinguish between WHO functional classes (II and III) than the EQ-5D and SF-6D. The tariff derived in this study can be used to classify an individual into a health state based on their responses to the CAMPHOR. The results of this study widen the evidence base for conducting economic evaluations of interventions designed to improve QoL for patients with PH.

Updating the OMERACT filter: implications of filter 2.0 to select outcome instruments through assessment of "truth": content, face, and construct validity.

PubMed

Tugwell, Peter; Boers, Maarten; D'Agostino, Maria-Antonietta; Beaton, Dorcas; Boonen, Annelies; Bingham, Clifton O; Choy, Ernest; Conaghan, Philip G; Dougados, Maxime; Duarte, Catia; Furst, Daniel E; Guillemin, Francis; Gossec, Laure; Heiberg, Turid; van der Heijde, Désirée M; Hewlett, Sarah; Kirwan, John R; Kvien, Tore K; Landewé, Robert B; Mease, Philip J; Østergaard, Mikkel; Simon, Lee; Singh, Jasvinder A; Strand, Vibeke; Wells, George

2014-05-01

The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity. Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved. The case studies showed that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address. These issues will require resolution to reach consensus on how Truth will be assessed for the proposed Filter 2.0 framework, for instruments to be endorsed by OMERACT.

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.

Measurement properties of patient reported outcome measures for spondyloarthritis: A systematic review.

PubMed

Png, Kelly; Kwan, Yu Heng; Leung, Ying Ying; Phang, Jie Kie; Lau, Jia Qi; Lim, Ka Keat; Chew, Eng Hui; Low, Lian Leng; Tan, Chuen Seng; Thumboo, Julian; Fong, Warren; Østbye, Truls

2018-03-21

This systematic review aimed to identify studies investigating measurement properties of patient reported outcome measures (PROMs) for spondyloarthritis (SpA), and to evaluate their methodological quality and level of evidence relating to the measurement properties of PROMs. This systematic review was guided by the preferred reporting items for systematic review and meta-analysis (PRISMA). Articles published before 30 June 2017 were retrieved from PubMed ® , Embase ® , and PsychINFO ® (Ovid). Methodological quality and level of evidence were evaluated according to recommendations from the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). We identified 60 unique PROMs from 125 studies in 39 countries. Twenty-one PROMs were validated for two or more SpA subtypes. The literature examined hypothesis testing (82.4%) most frequently followed by reliability (60.0%). A percentage of 77.7% and 42.7% of studies that assessed PROMs for hypothesis testing and reliability, respectively had "fair" or better methodological quality. Among the PROMs identified, 41.7% were studied in ankylosing spondylitis (AS) only and 23.3% were studied in psoriatic arthritis (PsA) only. The more extensively assessed PROMs included the ankylosing spondylitis quality of life (ASQoL) and bath ankylosing spondylitis functional index (BASFI) for ankylosing spondylitis, and the psoriatic arthritis quality of life questionnaire (VITACORA-19) for psoriatic arthritis. This study identified 60 unique PROMs through a systematic review and synthesized evidence of the measurement properties of the PROMs. There is a lack of validation of PROMs for use across SpA subtypes. Future studies may consider validating PROMs for use across different SpA subtypes. Copyright © 2018 Elsevier Inc. All rights reserved.

Development and Validation of Participation and Positive Psychologic Function Measures for Stroke Survivors

PubMed Central

Bode, Rita K.; Heinemann, Allen W.; Butt, Zeeshan; Stallings, Jena; Taylor, Caitlin; Rowe, Morgan; Roth, Elliot J.

2013-01-01

Bode RK, Heinemann AW, Butt Z, Stallings J, Taylor C, Rowe M, Roth EJ. Development and validation of participation and positive psychologic function measures for stroke survivors. Objective To evaluate the reliability and validity of Neurologic Quality of Life (NeuroQOL) item banks that assess quality-of-life (QOL) domains not typically included in poststroke measures. Design Secondary analysis of item responses to selected NeuroQOL domains. Setting Community. Participants Community-dwelling stroke survivors (n=111) who were at least 12 months poststroke. Interventions Not applicable. Main Outcome Measures Five measures developed for 3 NeuroQoL domains: ability to participate in social activities, satisfaction with participation in social activities, and positive psychologic function. Results A single bank was developed for the positive psychologic function domain, but 2 banks each were developed for the ability-to-participate and satisfaction-with-participation domains. The resulting item banks showed good psychometric properties and external construct validity with correlations with the legacy instruments, ranging from .53 to .71. Using these measures, stroke survivors in this sample reported an overall high level of QOL. Conclusions The NeuroQoL-derived measures are promising and valid methods for assessing aspects of QOL not typically measured in this population. PMID:20801251

Validation of the Perception of Change Scale - Family Version (EMP-F) as a treatment outcome measure in mental health services.

PubMed

Bandeira, Marina; Felicio, Cynthia Mara; Cesari, Luciana

2010-09-01

This study aimed to validate the Perception of Change Scale - Family Version, which evaluates the perception of family caregivers in regard to the treatment outcomes of psychiatric patients in mental health services. Family caregivers (N = 300) of psychiatric patients attending mental health services completed the Perception of Change Scale - Family Version. The scale has 19 items rated in a three-point Likert scale that evaluate changes perceived in the patient's life as a result of treatment. The factorial analysis revealed a four-factor structure, with the following dimensions: 1) occupation, 2) psychological factors, 3) relationships, and 4) physical health. In the internal consistency analysis, Cronbach's alpha coefficient was 0.85. The test-retest temporal stability analysis yielded a significant intraclass correlation coefficient (r = 0.96; p < 0.005). The convergent validity analysis revealed a positive significant correlation with another scale evaluating a distinct but theoretically related construct of family satisfaction with services (r = 0.41; p < 0.05). The Perception of Change Scale - Family Version has adequate reliability and construct and convergent validity. It can be used to evaluate treatment outcome in mental health services from the perspective of family caregivers, indicating targets to improve treatment.

Constructing, Quantifying, and Validating an Adverse Outcome Pathway for Vascular Developmental Toxicity

EPA Science Inventory

Constructing, Quantifying, and Validating an Adverse Outcome Pathway for Vascular Developmental Toxicity The adverse outcome pathway (AOP) for embryonic vascular disruption1 leading to a range of adverse prenatal outcomes was recently entered into the AOP wiki and accepted as par...

Measuring eating competence: psychometric properties and validity of the ecSatter Inventory.

PubMed

Lohse, Barbara; Satter, Ellyn; Horacek, Tanya; Gebreselassie, Tesfayi; Oakland, Mary Jane

2007-01-01

Assess validity of the ecSatter Inventory (ecSI) to measure eating competence (EC). Concurrent administration of ecSI with validated measures of eating behaviors using on-line and paper-pencil formats. The on-line survey was completed by 370 participants; 462 completed the paper version. Participants included 863 adults with 832 usable surveys from respondents (mean age 36.2 +/- 13.4 years) without eating disorders, mostly female, white, educated, overweight, physically active, and food secure. Of those indicating intent to complete the on-line survey, 80.3% did so; 54% of mailed surveys were returned. Eating and food behaviors compared among EC tertiles and between dichotomous EC categories; internal consistency of ecSI. Analysis of variance, independent t tests, chi-square, factor analysis, logistic regression. Significance level was P < .05. Mean ecSI score was 31.1 +/- 7.5. ecSI included 4 subscales with internal reliability and content validity. Construct validity was supported by specific behavioral profiles for ecSI tertiles and ecSI dichotomized categories. Persons unsatisfied with weight were 54% less likely to be EC; unit increase in the food like index was associated with nearly 3 times greater likelihood of being EC. The ecSatter Inventory is a valid measure of EC and can be used for descriptive and outcome measurements.

Reliability and concurrent and construct validity of the Strategies for Weight Management measure for adults.

PubMed

Kolodziejczyk, Julia K; Norman, Gregory J; Rock, Cheryl L; Arredondo, Elva M; Roesch, Scott C; Madanat, Hala; Patrick, Kevin

2016-01-01

This study evaluates the reliability and validity of the strategies for weight management (SWM) measure, a questionnaire that assesses weight management strategies for adults. The SWM includes 20 items that are categorized within the following subscales: (1) energy intake, (2) energy expenditure, (3) self-monitoring, and (4) self-regulation. Baseline and 6-month data were collected from 404 overweight/obese adults (mean age=22±3.8 years, 68% ethnic minority) enrolled in a randomized controlled trial aiming to reduce weight by improving diet and physical activity behaviours. Reliability and validity were assessed for each subscale separately. Cronbach alpha was conducted to assess reliability. Concurrent, construct I (sensitivity to the study treatment condition), and construct II (relationship to the outcomes) validity were assessed using linear regressions with the following outcome measures: weight, self-reported diet, and weekly energy expenditure. All subscales showed strong internal consistency. The strength of the validity evidence depended on subscale and validity type. The strongest validity evidence was concurrent validity of the energy intake and energy expenditure subscales; construct I validity of the energy intake and self-monitoring subscales; and construct II validity of the energy intake, energy expenditure, and self-regulation subscales. Results indicate that the SWM can be used to assess weight management strategies among an ethnically diverse sample of adults as each subscale showed evidence of reliability and select types of validity. As validity is an accumulation of evidence over multiple studies, this study provides initial reliability and validity evidence in one population segment. Copyright © 2015 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

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

Patient-reported outcome measures in arthroplasty registries

PubMed Central

Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill

2016-01-01

The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175

A concise, content valid, gender invariant measure of workplace incivility.

PubMed

Matthews, Russell A; Ritter, Kelsey-Jo

2016-07-01

The authors present a short, valid, gender invariant measure of workplace incivility that should have a high degree of utility in a variety of research designs, especially those concerned with reducing participant burden such as experience sampling and multiwave longitudinal designs. Given ongoing concerns about the psychometric properties of workplace mistreatment constructs, they validated a 4-item measure of experienced incivility based on series of 3 independent field studies (N = 2,636). In addition to retaining items on the basis of employee rated conceptual alignment (i.e., judgmental criteria) with a standard incivility definition (i.e., ambiguous intent to harm), items were also chosen based on external criteria in terms of their ability to explain incremental variance in outcomes of interest (e.g., role overload, interpersonal deviance). Items with large systematic relationships with other mistreatment constructs (i.e., abusive supervision, supervisor undermining) were excluded. In turn, the authors demonstrated that the 4-item measure is gender invariant, a critical issue that has received limited attention in the literature to date. They also experimentally investigated the effect of recall window (2 weeks, 1 month, 1 year) and found a differential pattern of effect sizes for various outcomes of interest. A fourth independent field study was conducted as a practical application of the measure within a longitudinal framework. An autoregressive model examining experienced incivility and counterproductive work behaviors was tested. Data was collected from a sample of 278 respondents at 3 time points with 1 month between assessments. Implications of these findings are discussed. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Ranking Surgical Residency Programs: Reputation Survey or Outcomes Measures?

PubMed

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

2015-01-01

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

Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis.

PubMed

Sebastião, Emerson; Sandroff, Brian M; Learmonth, Yvonne C; Motl, Robert W

2016-07-01

To examine the validity of the timed Up and Go (TUG) test as a measure of functional mobility in persons with multiple sclerosis (MS) by using a comprehensive framework based on construct validity (ie, convergent and divergent validity). Cross-sectional study. Hospital setting. Community-residing persons with MS (N=47). Not applicable. Main outcome measures included the TUG test, timed 25-foot walk test, 6-minute walk test, Multiple Sclerosis Walking Scale-12, Late-Life Function and Disability Instrument, posturography evaluation, Activities-specific Balance Confidence scale, Symbol Digits Modalities Test, Expanded Disability Status Scale, and the number of steps taken per day. The TUG test was strongly associated with other valid outcome measures of ambulatory mobility (Spearman rank correlation, rs=.71-.90) and disability status (rs=.80), moderately to strongly associated with balance confidence (rs=.66), and weakly associated with postural control (ie, balance) (rs=.31). The TUG test was moderately associated with cognitive processing speed (rs=.59), but not associated with other nonambulatory measures (ie, Late-Life Function and Disability Instrument-upper extremity function). Our findings support the validity of the TUG test as a measure of functional mobility. This warrants its inclusion in patients' assessment alongside other valid measures of functional mobility in both clinical and research practice in persons with MS. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Development and Psychometric Validation of the Family Outcomes Survey-Revised

ERIC Educational Resources Information Center

Bailey, Donald B., Jr.; Raspa, Melissa; Olmsted, Murrey G.; Novak, Scott P.; Sam, Ann M.; Humphreys, Betsy P.; Nelson, Robin; Robinson, Nyle; Guillen, Chelsea

2011-01-01

Few psychometrically valid scales exist to assess family outcomes and the helpfulness of early intervention. This article describes the development and psychometric properties of the Family Outcomes Survey-Revised. The revision was prompted by the need to (a) create a new format that would be easier for parents to understand, (b) revise and expand…

Choice of outcomes and measurement instruments in randomised trials on eLearning in medical education: a systematic mapping review protocol.

PubMed

Law, Gloria C; Apfelbacher, Christian; Posadzki, Pawel P; Kemp, Sandra; Tudor Car, Lorainne

2018-05-17

There will be a lack of 18 million healthcare workers by 2030. Multiplying the number of well-trained healthcare workers through innovative ways such as eLearning is highly recommended in solving this shortage. However, high heterogeneity of learning outcomes in eLearning systematic reviews reveals a lack of consistency and agreement on core learning outcomes in eLearning for medical education. In addition, there seems to be a lack of validity evidence for measurement instruments used in these trials. This undermines the credibility of these outcome measures and affects the ability to draw accurate and meaningful conclusions. The aim of this research is to address this issue by determining the choice of outcomes, measurement instruments and the prevalence of measurement instruments with validity evidence in randomised trials on eLearning for pre-registration medical education. We will conduct a systematic mapping and review to identify the types of outcomes, the kinds of measurement instruments and the prevalence of validity evidence among measurement instruments in eLearning randomised controlled trials (RCTs) in pre-registration medical education. The search period will be from January 1990 until August 2017. We will consider studies on eLearning for health professionals' education. Two reviewers will extract and manage data independently from the included studies. Data will be analysed and synthesised according to the aim of the review. Appropriate choice of outcomes and measurement tools is essential for ensuring high-quality research in the field of eLearning and eHealth. The results of this study could have positive implications for other eHealth interventions, including (1) improving quality and credibility of eLearning research, (2) enhancing the quality of digital medical education and (3) informing researchers, academics and curriculum developers about the types of outcomes and validity evidence for measurement instruments used in eLearning studies. The

Validity and reliability of the Turkish version of the Optimality Index-US (OI-US) to assess maternity care outcomes.

PubMed

Yucel, Cigdem; Taskin, Lale; Low, Lisa Kane

2015-12-01

Although obstetrical interventions are used commonly in Turkey, there is no standardized evidence-based assessment tool to evaluate maternity care outcomes. The Optimality Index-US (OI-US) is an evidence-based tool that was developed for the purpose of measuring aggregate perinatal care processes and outcomes against an optimal or best possible standard. This index has been validated and used in Netherlands, USA and UK until now. The objective of this study was to adapt the OI-US to assess maternity care outcomes in Turkey. Translation and back translation were used to develop the Optimality Index-Turkey (OI-TR) version. To evaluate the content validity of the OI-TR, an expert panel group (n=10) reviewed the items and evidence-based quality of the OI-TR for application in Turkey. Following the content validity process, the OI-TR was used to assess 150 healthy and 150 high-risk pregnant women who gave birth at a high volume, urban maternity hospital in Turkey. The scores between the two groups were compared to assess the discriminant validity of the OI-TR. The percentage of agreement between two raters and the Kappa statistic were calculated to evaluate the reliability. Content validity was established for the OI-TR by an expert group. Discriminant validity was confirmed by comparing the OI scores of healthy pregnant women (mean OI score=77.65%) and those of high-risk pregnant women (mean OI score=78.60%). The percentage of agreement between the two raters was 96.19, and inter-rater agreement was provided for each item in the OI-TR. OI-TR is a valid and reliable tool that can be used to assess maternity care outcomes in Turkey. The results of this study indicate that although the risk statuses of the women differed, the type of care they received was essentially the same, as measured by the OI-TR. Care was not individualised based on risk and for a majority of items was inconsistent with evidence based practice, which is not optimal. Use of the OI-TR will help to

Outcome measures for adult critical care: a systematic review.

PubMed

Hayes, J A; Black, N A; Jenkinson, C; Young, J D; Rowan, K M; Daly, K; Ridley, S

2000-01-01

1. To identify generic and disease specific measures of impairment, functional status and health-related quality of life that have been used in adult critical care (intensive and high-dependency care) survivors. 2. To review the validity, reliability and responsiveness of the measures in adult critical care survivors. 3. To consider the implications for future policy and to make recommendations for further methodological research. 4. To review what is currently known of the outcome of adult critical care. Searches of electronic databases (MEDLINE, EMBASE, CINAHL, PsycLIT, The Cochrane Library and SIGLE) from 1970 to August 1998. Manual searches of five journals (1985-98) not indexed in electronic databases and relevant conference proceedings (1993-98). Reference lists of six existing reviews, plus snowballing from reference lists of all relevant articles identified. Randomised trials, non-randomised trials (cohort studies) and case series that included data on outcomes after discharge from adult (16 years and over) critical care. If reported, the following data were extracted from each paper: patient characteristics (age, gender, severity of illness, diagnostic category) number of patients eligible for study, follow-up period, number of deaths before follow-up, number and proportion of survivors included in follow-up method of presentation of outcome data - proportion normal as defined by reference values, or aggregate value (e.g. mean or median), or aggregate values plus an indication of variance (e.g. standard deviation or inter-quartile range). Evidence for three measurement properties was sought for each outcome measure that had been used in at least two studies - their validity, reliability and responsiveness in adult critical care. If the authors did not report these aspects explicitly, an attempt was made to use the data provided to provide these measurement properties. For measures that were used in at least ten studies, information on actual reported

Spanish Adaptation and Validation of the Outcome Questionnaire OQ-30.2

PubMed Central

Errázuriz, Paula; Opazo, Sebastián; Behn, Alex; Silva, Oscar; Gloger, Sergio

2017-01-01

This study assessed the psychometric properties of a Spanish version of the Shortened Outcome Questionnaire (OQ-30.2, Lambert et al., 2004) validated with a sample of 546 patients in an outpatient mental health clinic and 100 non-clinical adults in Chile. Our results show that this measure has similar normative data to the original measure, with a cutoff score for the Chilean population set at 43.36, and the reliable change index at 14. This Spanish OQ-30.2 has good internal consistency (α = 0.90), has concurrent validity with the Depressive, Anxious, and Somatoform disorders measuring scale (Alvarado and Vera, 1991), and is sensitive to change during psychotherapy. Consistent with previous studies, factorial analyses showed that both, the one-factor solution for a general scale and the three-factor solution containing three theoretical scales yielded poor fit estimates. Overall, our results are similar to past research on the OQ-45 and the OQ-30. The short version has adequate psychometric properties, comparable to those of the OQ-45, but provides a gain in application time that could be relevant in the setting of psychotherapy research with large samples, frequent assessments over time, and/or samples that may require more assistance completing items (e.g., low-literacy). We conclude that this measure will be a valuable instrument for research and clinical practice. PMID:28559857

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.

The medial tibial stress syndrome score: a new patient-reported outcome measure.

PubMed

Winters, Marinus; Moen, Maarten H; Zimmermann, Wessel O; Lindeboom, Robert; Weir, Adam; Backx, Frank Jg; Bakker, Eric Wp

2016-10-01

At present, there is no validated patient-reported outcome measure (PROM) for patients with medial tibial stress syndrome (MTSS). Our aim was to select and validate previously generated items and create a valid, reliable and responsive PROM for patients with MTSS: the MTSS score. A prospective cohort study was performed in multiple sports medicine, physiotherapy and military facilities in the Netherlands. Participants with MTSS filled out the previously generated items for the MTSS score on 3 occasions. From previously generated items, we selected the best items. We assessed the MTSS score for its validity, reliability and responsiveness. The MTSS score was filled out by 133 participants with MTSS. Factor analysis showed the MTSS score to exhibit a single-factor structure with acceptable internal consistency (α=0.58) and good test-retest reliability (intraclass correlation coefficient=0.81). The MTSS score ranges from 0 to 10 points. The smallest detectable change in our sample was 0.69 at the group level and 4.80 at the individual level. Construct validity analysis showed significant moderate-to-large correlations (r=0.34-0.52, p<0.01). Responsiveness of the MTSS score was confirmed by a significant relation with the global perceived effect scale (β=-0.288, R(2)=0.21, p<0.001). The MTSS score is a valid, reliable and responsive PROM to measure the severity of MTSS. It is designed to evaluate treatment outcomes in clinical studies. 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/

Item bank development, calibration and validation for patient-reported outcomes in female urinary incontinence

PubMed Central

Sung, Vivian W.; Griffith, James W.; Rogers, Rebecca G.; Raker, Christina A.; Clark, Melissa A.

2016-01-01

Purpose Current patient-reported outcomes for female urinary incontinence (UI) are limited by their inability to be tailored. Our objective is to describe the development and field-testing of 7 item banks designed to measure domains identified as important UI in females (UIf). We also describe the calibration and validation properties of the UIf-item banks, which allow for more efficient computerized-adaptive testing (CAT) in the future. METHODS The UIf-measures included 168 items covering 7 domains: Stress UI (SUI), Overactive Bladder (OAB), Urinary Frequency, Physical, Social and Emotional Health Impact, and Adaptation. Items underwent rigorous qualitative development and psychometric testing across 2 sites. Items were calibrated using item response theory and evaluated for internal consistency, construct validity and responsiveness. RESULTS 750 women (249 SUI, 249 OAB, and 252 mixed UI) participated. Mean age was 55±14 years ,23% were Hispanic, 80% white. In addition to face and content validity, the measures demonstrated good internal consistency (coefficient alpha 0.92-0.98) and unidimensionality. There was evidence for construct validity with moderate to strong correlations with the UDI (r’s ≥ 0.6) and IIQ (r’s = ≥ 0.6) scales. The measures were responsive to change for SUI treatment (paired t-test p <.001, ES range=1.3 to 2.9; SRM range=1.3 to 2.5) and OAB treatment (paired t-test p <.05 for all domains except Social Health Impact and Adaptation, ES range=.3 to 1.5, SRM range=0.4 to 1.0). The measures were responsive based on concurrent changes with the UDI and IIQ (p < 0.05). CAT versions were developed and pilot tested. CONCLUSIONS The UIf-item banks demonstrate good psychometric characteristics and are a sufficiently valid set of customizable tools for measuring UI symptoms and life impact. PMID:26732514

The Validity of Dependence as a Health Outcome Measure in Alzheimer’s Disease

PubMed Central

Spackman, D. Eldon; Kadiyala, Srikanth; Neumann, Peter J.; Veenstra, David L.; Sullivan, Sean D.

2013-01-01

Background Relating to Alzheimer’s disease (AD), dependence has been defined as the increased need for assistance due to deterioration in cognition, physical functioning, and behavior. Our objective was to evaluate the association between dependence and measures of functional impairment. Methods Data were compiled by the National Alzheimer’s Coordinating Center. We used multinomial logistic regression to estimate the association between dependence and cognition, physical functioning, and behavior. Results The independent association with dependence was positive. Dependence was most strongly associated with physical functioning. A secondary analysis suggested a strong association of dependence with multiple impairments, as measured by the interaction terms, in more severe patients. Conclusions We find that dependence is simultaneously associated with physical functioning, cognition, and behavior, which support the construct validity of dependence. Dependence might be a more simple measure to explain the multifaceted disease progression of AD and convey the increasing need for care. PMID:23512996

Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials.

PubMed

Xiao, Lan; Lv, Nan; Rosas, Lisa G; Au, David; Ma, Jun

2017-02-01

To validate clinic weights in electronic health records against researcher-measured weights for outcome assessment in weight loss trials. Clinic and researcher-measured weights from a published trial (BE WELL) were compared using Lin's concordance correlation coefficient, Bland and Altman's limits of agreement, and polynomial regression model. Changes in clinic and researcher-measured weights in BE WELL and another trial, E-LITE, were analyzed using growth curve modeling. Among BE WELL (n = 330) and E-LITE (n = 241) participants, 96% and 90% had clinic weights (mean [SD] of 5.8 [6.1] and 3.7 [3.9] records) over 12 and 15 months of follow-up, respectively. The concordance correlation coefficient was 0.99, and limits of agreement plots showed no pattern between or within treatment groups, suggesting overall good agreement between researcher-measured and nearest-in-time clinic weights up to 3 months. The 95% confidence intervals for predicted percent differences fell within ±3% for clinic weights within 3 months of the researcher-measured weights. Furthermore, the growth curve slopes for clinic and researcher-measured weights by treatment group did not differ significantly, suggesting similar inferences about treatment effects over time, in both trials. Compared with researcher-measured weights, close-in-time clinic weights showed high agreement and inference validity. Clinic weights could be a valid pragmatic outcome measure in weight loss studies. © 2017 The Obesity Society.

Outcome measurement of hand function following mirror therapy for stroke rehabilitation: A systematic review.

PubMed

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

2018-02-28

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

Validation of a contemporary prostate cancer grading system using prostate cancer death as outcome

PubMed Central

Berney, Daniel M; Beltran, Luis; Fisher, Gabrielle; North, Bernard V; Greenberg, David; Møller, Henrik; Soosay, Geraldine; Scardino, Peter; Cuzick, Jack

2016-01-01

Background: Gleason scoring (GS) has major deficiencies and a novel system of five grade groups (GS⩽6; 3+4; 4+3; 8; ⩾9) has been recently agreed and included in the WHO 2016 classification. Although verified in radical prostatectomies using PSA relapse for outcome, it has not been validated using prostate cancer death as an outcome in biopsy series. There is debate whether an ‘overall' or ‘worst' GS in biopsies series should be used. Methods: Nine hundred and eighty-eight prostate cancer biopsy cases were identified between 1990 and 2003, and treated conservatively. Diagnosis and grade was assigned to each core as well as an overall grade. Follow-up for prostate cancer death was until 31 December 2012. A log-rank test assessed univariable differences between the five grade groups based on overall and worst grade seen, and using univariable and multivariable Cox proportional hazards. Regression was used to quantify differences in outcome. Results: Using both ‘worst' and ‘overall' GS yielded highly significant results on univariate and multivariate analysis with overall GS slightly but insignificantly outperforming worst GS. There was a strong correlation with the five grade groups and prostate cancer death. Conclusions: This is the largest conservatively treated prostate cancer cohort with long-term follow-up and contemporary assessment of grade. It validates the formation of five grade groups and suggests that the ‘worst' grade is a valid prognostic measure. PMID:27100731

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

Validation of a photography-based goniometry method for measuring joint range of motion.

PubMed

Blonna, Davide; Zarkadas, Peter C; Fitzsimmons, James S; O'Driscoll, Shawn W

2012-01-01

A critical component of evaluating the outcomes after surgery to restore lost elbow motion is the range of motion (ROM) of the elbow. This study examined if digital photography-based goniometry is as accurate and reliable as clinical goniometry for measuring elbow ROM. Instrument validity and reliability for photography-based goniometry were evaluated for a consecutive series of 50 elbow contractures by 4 observers with different levels of elbow experience. Goniometric ROM measurements were taken with the elbows in full extension and full flexion directly in the clinic (once) and from digital photographs (twice in a blinded random manner). Instrument validity for photography-based goniometry was extremely high (intraclass correlation coefficient: extension = 0.98, flexion = 0.96). For extension and flexion measurements by the expert surgeon, systematic error was negligible (0° and 1°, respectively). Limits of agreement were 7° (95% confidence interval [CI], 5° to 9°) and -7° (95% CI, -5° to -9°) for extension and 8° (95% CI, 6° to 10°) and -7° (95% CI, -5° to -9°) for flexion. Interobserver reliability for photography-based goniometry was better than that for clinical goniometry. The least experienced observer's photographic goniometry measurements were closer to the reference measurements than the clinical goniometry measurements. Photography-based goniometry is accurate and reliable for measuring elbow ROM. The photography-based method relied less on observer expertise than clinical goniometry. This validates an objective measure of patient outcome without requiring doctor-patient contact at a tertiary care center, where most contracture surgeries are done. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. 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

Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement.

PubMed

Spuls, P I; Gerbens, L A A; Simpson, E; Apfelbacher, C J; Chalmers, J R; Thomas, K S; Prinsen, C A C; von Kobyletzki, L B; Singh, J A; Williams, H C; Schmitt, J

2017-04-01

The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. © 2016 British Association of Dermatologists.

Portuguese Adaptation and Input for the Validation of the Views on Inpatient Care (VOICE) Outcome Measure to Assess Service Users'Perceptions of Inpatient Psychiatric Care.

PubMed

Palha, João; Palha, Filipa; Dias, Pedro; Gonçalves-Pereira, Manuel

2017-11-29

Patient satisfaction is an important measure of health care quality. Patients' views have seldom been considered in the construction of measures addressing satisfaction with inpatient facilities in psychiatry. The Views on Inpatient Care - VOICE - is a first service-user generated outcome measure relying solely on their perceptions of acute care, representing a valuable indicator of service users' perceived quality of care. The present study aimed to contribute to the validation of the Portuguese version of VOICE. The questionnaire was translated into Portuguese and applied to a sample of eighty-five female inpatients of a psychiatric institution. Data analysis focused on assessing reliability and exploring the impact of demographic and clinical variables on participants' satisfaction. Internal consistency of the questionnaire was high (α = 0.87). Participants' age and marital status were associated with differences in scores, with older patients and patients who were married or involved in a close relationship presenting higher satisfaction levels. The questionnaire demonstrated good internal consistency and acceptability, as well as construct validity. Further studies should expand the analysis of the psychometric properties of this measure e.g., test-retest reliability. The Portuguese version of VOICE is a promising tool to assess service users' perceptions of inpatient psychiatric care in Portugal.

The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS?

PubMed Central

Garratt, A M; Ruta, D A; Abdalla, M I; Buckingham, J K; Russell, I T

1993-01-01

OBJECTIVE--To assess the validity, reliability, and acceptability of the short form 36 (SF 36) health survey questionnaire (a shortened version of a battery of 149 health status questions) as a measure of patient outcome in a broad sample of patients suffering from four common clinical conditions. DESIGN--Postal questionnaire, followed up by two reminders at two week intervals. SETTING--Clinics and four training practices in north east Scotland. SUBJECTS--Over 1700 patients aged 16-86 with one of four conditions--low back pain, menorrhagia, suspected peptic ulcer, or varicose veins--and a comparison sample of 900 members of the general population. MAIN OUTCOME MEASURES--The eight scales within the SF36 health profile. RESULTS--The response rate exceeded 75% in the patient population (1310 respondents). The SF36 satisfied rigorous psychometric criteria for validity and internal consistency. Clinical validity was shown by the distinctive profiles generated for each condition, each of which differed from that in the general population in a predictable manner. Furthermore, SF36 scores were lower in referred patients than in patients not referred and were closely related to general practitioners' perceptions of severity. CONCLUSIONS--These results provide support for the SF36 as a potential measure of patient outcome within the NHS. The SF36 seems acceptable to patients, internally consistent, and a valid measure of the health status of a wide range of patients. Before it can be used in the new health service, however, its sensitivity to changes in health status over time must also be tested. PMID:8518640

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

PubMed

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

2015-12-01

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). During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. 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. 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.

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

Outcome Rating Scale and Session Rating Scale in Psychological Practice: Clinical Utility of Ultra-Brief Measures

ERIC Educational Resources Information Center

Campbell, Alistair; Hemsley, Samantha

2009-01-01

The validity and reliability of the Outcome Rating Scale (ORS) and the Session Rating Scale (SRS) were evaluated against existing longer measures, including the Outcome Questionnaire-45, Working Alliance Inventory, Depression Anxiety Stress Scale-21, Quality of Life Scale, Rosenberg Self-Esteem Scale and General Self-efficacy Scale. The measures…

Measuring treatment outcomes in gambling disorders: a systematic review.

PubMed

Pickering, Dylan; Keen, Brittany; Entwistle, Gavin; Blaszczynski, Alex

2018-03-01

Considerable variation of outcome variables used to measure recovery in the gambling treatment literature has precluded effective cross-study evaluations and hindered the development of best-practice treatment methodologies. The aim of this systematic review was to describe current diffuse concepts of recovery in the gambling field by mapping the range of outcomes and measurement strategies used to evaluate treatments, and to identify more commonly accepted indices of recovery. A systematic search of six academic databases for studies evaluating treatments (psychological and pharmacological) for gambling disorders with a minimum 6-month follow-up. Data from eligible studies were tabulated and analysis conducted using a narrative approach. Guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were adhered to. Thirty-four studies were reviewed systematically (RCTs = 17, comparative designs = 17). Sixty-three different outcome measures were identified: 25 (39.7%) assessed gambling-specific constructs, 36 (57.1%) assessed non-gambling specific constructs, and two instruments were used across both categories (3.2%). Self-report instruments ranged from psychometrically validated to ad-hoc author-designed questionnaires. Units of measurement were inconsistent, particularly in the assessment of gambling behaviour. All studies assessed indices of gambling behaviour and/or symptoms of gambling disorder. Almost all studies (n = 30; 88.2%) included secondary measures relating to psychiatric comorbidities, psychological processes linked to treatment approach, or global functioning and wellbeing. In research on gambling disorders, the incorporation of broader outcome domains that extend beyond disorder-specific symptoms and behaviours suggests a multi-dimensional conceptualization of recovery. Development of a single comprehensive scale to measure all aspects of gambling recovery could help to facilitate uniform reporting practices

Psychometrics of the Personal Questionnaire: A client-generated outcome measure.

PubMed

Elliott, Robert; Wagner, John; Sales, Célia M D; Rodgers, Brian; Alves, Paula; Café, Maria J

2016-03-01

We present a range of evidence for the reliability and validity of data generated by the Personal Questionnaire (PQ), a client-generated individualized outcome measure, using 5 data sets from 3 countries. Overall pretherapy mean internal consistency (alpha) across clients was .80, and within-client alphas averaged .77; clients typically had 1 or 2 items that did not vary with the other items. Analyses of temporal structure indicated high levels of between-clients variance (58%), moderate pretherapy test-retest correlation (r = .57), and high session-to-session Lag-1 autocorrelation (.82). Scores on the PQ provided clear evidence of convergence with a range of outcome measures (within-client r = .41). Mean pre-post effects were large (d = 1.25). The results support a revised caseness cutoff of 3.25 and a reliable change index interval of 1.67. We conclude that PQ data meet criteria for evidence-based, norm-referenced measurement of client psychological distress for supporting psychotherapy practice and research. (c) 2016 APA, all rights reserved).

Assessing Workplace Emotional Intelligence: Development and Validation of an Ability-based Measure.

PubMed

Krishnakumar, Sukumarakurup; Hopkins, Kay; Szmerekovsky, Joseph G; Robinson, Michael D

2016-01-01

Existing measures of Emotional Intelligence (EI), defined as the ability to perceive, understand, and manage emotions for productive purposes, have displayed limitations in predicting workplace outcomes, likely in part because they do not target this context. Such considerations led to the development of an ability EI measure with work-related scenarios in which respondents infer the likely emotions (perception) and combinations of emotion (understanding) that would occur to protagonists while rating the effectiveness of ways of responding (management). Study 1 (n = 290 undergraduates) used item-total correlations to select scenarios from a larger pool and Study 2 (n = 578) reduced the measure-termed the NEAT-to 30 scenarios on the basis of structural equation modeling. Study 3 (n = 96) then showed that the NEAT had expected correlations with personality and cognitive ability and Study 4 (n = 85) demonstrated convergent validity with other ability EI measures. Last, study 5 (n = 91) established that the NEAT had predictive validity with respect to job satisfaction, job stress, and job performance. The findings affirm the importance of EI in the workplace in the context of a valid new instrument for assessing relevant skills.

Clinical validation of nursing outcome mobility in patients with cerebrovascular accidents.

PubMed

Moreira, Rafaella Pessoa; Araujo, Thelma Leite de; Lopes, Marcos Venicios de Oliveira; Cavalcante, Tahissa Frota; Guedes, Nirla Gomes; Chaves, Emília Soares; Portela, Regiane Campos; Holanda, Rose-Eloise

2016-12-15

To clinically validate the nursing outcome Mobility in patients with cerebrovascular accidents. Descriptive study, conducted in July 2011, with 38 outpatients, in northeastern Brazil. Data collection took place by evaluating two pairs of specialist nurses, where one pair used the instrument containing the constitutive and operational definitions of the indicators and magnitudes of the Mobility Outcome and the other pair without such definitions. When analyzing the evaluations among nurses, all indicators showed significant differences by the Friedman test (p <0.05). The constitutive and operational definitions submitted to the validation process provide greater accuracy in assessing the cerebrovascular accident patient's mobility state.

Actigraphy scoring for sleep outcome measures in chronic obstructive pulmonary disease.

PubMed

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

2017-09-01

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

Reliability and validity of the cross-culturally adapted Turkish version of the Core Outcome Measures Index for low back pain.

PubMed

Çetin, Engin; Çelik, Evrim Coşkun; Acaroğlu, Emre; Berk, Haluk

2018-01-01

To produce a cross-culturally adapted and validated Turkish version of The Core Outcome Measure Index (COMI) Back questionnaire. Ninety-six Turkish-speaking patients with non-specific low back pain (LBP) were recruited from orthopedic and physical therapy outpatient clinics in a public hospital. They completed a booklet of questionnaires containing Turkish version of COMI, adjectival pain scale, Roland Morris disability questionnaire, European 5 Dimension Questionnaire and brief version of World Health Organization Quality of Life Questionnaire. Within following 7-14 days, 67 patients, reported no or minimal changes in their back pain status, completed the Turkish COMI again to assess reproducibility. Data quality was good with very few missing answers. COMI summary index score displayed 3% floor effects and no ceiling effects. The correlations between the COMI summary index score and each of the full instrument whole scores were found to be excellent to very good (ρ = - 0.81 to 0.74). Reliability expressed as intraclass correlation coefficient (ICC) was 0.95 (95% CI 0.91-0.97). Standard error of measurement (SEM agreement ) was acceptable at 0.41 and the minimum detectable change (MDC 95% ) was 1.14. Turkish version of the COMI has acceptable psychometric properties. It is a valid and reliable instrument and cross-culturally adapted, in accordance with established guidelines, for the use by Turkish-speaking patients. It can be recommended for use in evaluation of patients with chronic LBP in daily practice, in international multicenter studies and in spine registry systems.

Creating a Novel Video Vignette Stroke Preparedness Outcome Measure Using a Community-Based Participatory Approach.

PubMed

Skolarus, Lesli E; Murphy, Jillian B; Dome, Mackenzie; Zimmerman, Marc A; Bailey, Sarah; Fowlkes, Sophronia; Morgenstern, Lewis B

2015-07-01

Evaluating the efficacy of behavioral interventions for rare outcomes is a challenge. One such topic is stroke preparedness, defined as inteventions to increase stroke symptom recognition and behavioral intent to call 911. Current stroke preparedness intermediate outcome measures are centered on written vignettes or open-ended questions and have been shown to poorly reflect actual behavior. Given that stroke identification and action requires aural and visual processing, video vignettes may improve on current measures. This article discusses an approach for creating a novel stroke preparedness video vignette intermediate outcome measure within a community-based participatory research partnership. A total of 20 video vignettes were filmed of which 13 were unambiguous (stroke or not stroke) as determined by stroke experts and had test discrimination among community participants. Acceptable reliability, high satisfaction, and cultural relevance were found among the 14 community respondents. A community-based participatory approach was effective in creating a video vignette intermediate outcome. Future projects should consider obtaining expert and community feedback prior to filming all the video vignettes to improve the proportion of vignettes that are usable. While content validity and preliminary reliability were established, future studies are needed to confirm the reliability and establish construct validity. © 2014 Society for Public Health Education.

Creating a Novel Video Vignette Stroke Preparedness Outcome Measure using a Community Based Participatory Approach

PubMed Central

Skolarus, Lesli E.; Murphy, Jillian B.; Dome, Mackenzie; Zimmerman, Marc A.; Bailey, Sarah; Fowlkes, Sophronia; Morgenstern, Lewis B.

2015-01-01

Evaluating the efficacy of behavioral interventions for rare outcomes is a challenge. One such topic is stroke preparedness, defined as inteventions to increase stroke symptom recognition and behavioral intent to call 911. Current stroke preparedness intermediate outcome measures are centered on written vignettes or open ended questions and have been shown to poorly reflect actual behavior. Given that stroke identification and action requires aural and visual processing, video vignettes may improve upon current measures. This article discusses an approach for creating a novel stroke preparedness video vignette intermediate outcome measure within a community based participatory research partnership. A total of 20 video vignettes were filmed of which 13 were unambiguous (stroke or not stroke) as determined by stroke experts and had test discrimination among community participants. Acceptable reliability, high satisfaction and cultural relevance were found among the 14 community respondents. A community based participatory approach was effective in creating a video vignette intermediate outcome. Future projects should consider obtaining expert and community feedback prior to filming all the video vignettes to improve the proportion of vignettes that are usable. While content validity and preliminary reliability were established, future studies are needed to confirm the reliability and establish construct validity. PMID:25367896

Reliability and validity of non-radiographic methods of thoracic kyphosis measurement: a systematic review.

PubMed

Barrett, Eva; McCreesh, Karen; Lewis, Jeremy

2014-02-01

A wide array of instruments are available for non-invasive thoracic kyphosis measurement. Guidelines for selecting outcome measures for use in clinical and research practice recommend that properties such as validity and reliability are considered. This systematic review reports on the reliability and validity of non-invasive methods for measuring thoracic kyphosis. A systematic search of 11 electronic databases located studies assessing reliability and/or validity of non-invasive thoracic kyphosis measurement techniques. Two independent reviewers used a critical appraisal tool to assess the quality of retrieved studies. Data was extracted by the primary reviewer. The results were synthesized qualitatively using a level of evidence approach. 27 studies satisfied the eligibility criteria and were included in the review. The reliability, validity and both reliability and validity were investigated by sixteen, two and nine studies respectively. 17/27 studies were deemed to be of high quality. In total, 15 methods of thoracic kyphosis were evaluated in retrieved studies. All investigated methods showed high (ICC ≥ .7) to very high (ICC ≥ .9) levels of reliability. The validity of the methods ranged from low to very high. The strongest levels of evidence for reliability exists in support of the Debrunner kyphometer, Spinal Mouse and Flexicurve index, and for validity supports the arcometer and Flexicurve index. Further reliability and validity studies are required to strengthen the level of evidence for the remaining methods of measurement. This should be addressed by future research. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

PubMed

Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

2014-10-01

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Construct validity of the PROMIS® sexual function and satisfaction measures in patients with cancer

PubMed Central

2013-01-01

Background With data from a diverse sample of patients either in treatment for cancer or post-treatment for cancer, we examine inter-domain and cross-domain correlations among the core domains of the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction measures (PROMIS® SexFS) and the corresponding domains from conceptually-similar measures of sexual function, the International Index of Erectile Function and the Female Sexual Function Index. Findings Men (N=389) and women (N=430) were recruited from a tumor registry, oncology clinics, and an internet panel. The PROMIS SexFS, International Index of Erectile Function, and Female Sexual Function Index were used to collect participants’ self-reported sexual function. The domains shared among the measures include desire/interest in sexual activity, lubrication and vaginal discomfort/pain (women), erectile function (men), orgasm, and satisfaction. We examined correlations among different domains within the same instrument (discriminant validity) and correlations among similar domains measured by different instruments (convergent validity). Correlations demonstrating discriminant validity ranged from 0.38 to 0.73 for men and 0.48 to 0.74 for women, while correlations demonstrating convergent validity ranged from 0.62 to 0.83 for men and 0.71 to 0.92 for women. As expected, correlations demonstrating convergent validity were higher than correlations demonstrating discriminant validity, with one exception (orgasm for men). Conclusions Construct validity was supported by convergent and discriminant validity in a diverse sample of patients with cancer. For patients with cancer who may or may not have sexual dysfunction, the PROMIS SexFS measures provide a comprehensive assessment of key domains of sexual function and satisfaction. PMID:23497200

Reference values for developing responsive functional outcome measures across the lifespan.

PubMed

McKay, Marnee J; Baldwin, Jennifer N; Ferreira, Paulo; Simic, Milena; Vanicek, Natalie; Burns, Joshua

2017-04-18

To generate a reference dataset of commonly performed functional outcome measures in 1,000 children and adults and investigate the influence of demographic, anthropometric, strength, and flexibility characteristics. Twelve functional outcome measures were collected from 1,000 healthy individuals aged 3-101 years: 6-minute walk test, 30-second chair stand test, timed stairs test, long jump, vertical jump, choice stepping reaction time, balance (Star Excursion Balance Test, tandem stance eyes open and closed, single-leg stance eyes closed), and dexterity (9-hole peg test, Functional Dexterity Test). Correlation and multiple regression analyses were performed to identify factors independently associated with each measure. Age- and sex-stratified reference values for functional outcome measures were generated. Functional performance increased through childhood and adolescence, plateaued during adulthood, and declined in older adulthood. While balance did not differ between the sexes, male participants generally performed better at gross motor tasks while female participants performed better at dexterous tasks. Height was the most consistent correlate of functional performance in children, while lower limb muscle strength was a major determinant in adolescents and adults. In older adults, age, lower limb strength, and joint flexibility explained up to 63% of the variance in functional measures. These normative reference values provide a framework to accurately track functional decline associated with neuromuscular disorders and assist development and validation of responsive outcome measures for therapeutic trials. © 2017 American Academy of Neurology.

Measuring Instructional Practice in Science Using Classroom Artifacts: Lessons Learned from Two Validation Studies

ERIC Educational Resources Information Center

Martinez, Jose Felipe; Borko, Hilda; Stecher, Brian M.

2012-01-01

With growing interest in the role of teachers as the key mediators between educational policies and outcomes, the importance of developing good measures of classroom processes has become increasingly apparent. Yet, collecting reliable and valid information about a construct as complex as instruction poses important conceptual and technical…

Development and validation of measures to assess prevention and control of AMR in hospitals.

PubMed

Flanagan, Mindy; Ramanujam, Rangaraj; Sutherland, Jason; Vaughn, Thomas; Diekema, Daniel; Doebbeling, Bradley N

2007-06-01

The rapid spread of antimicrobial resistance (AMR) in the US hospitals poses serious quality and safety problems. Expert panels, identifying strategies for optimizing antibiotic use and preventing AMR spread, have recommended hospitals undertake efforts to implement specific evidence-based practices. To develop and validate a measurement scale for assessing hospitals' efforts to implement recommended AMR prevention and control measures. Surveys were mailed to infection control professionals in a national sample of 670 US hospitals stratified by geographic region, bedsize, teaching status, and VA affiliation. : Four hundred forty-eight infection control professionals participated (67% response rate). Survey items measured implementation of guideline recommendations, practices for AMR monitoring and feedback, AMR-related outcomes (methicillin-resistant Staphylococcus aureus prevalence and outbreaks [MRSA]), and organizational features. "Derivation" and "validation" samples were randomly selected. Exploratory factor analysis was performed to identify factors underlying AMR prevention and control efforts. Multiple methods were used for validation. We identified 4 empirically distinct factors in AMR prevention and control: (1) practices for antimicrobial prescription/use, (2) information/resources for AMR control, (3) practices for isolating infected patients, and (4) organizational support for infection control policies. The Prevention and Control of Antimicrobial Resistance scale was reliable and had content and construct validity. MRSA prevalence was significantly lower in hospitals with higher resource/information availability and broader organizational support. The Prevention and Control of Antimicrobial Resistance scale offers a simple yet discriminating assessment of AMR prevention and control efforts. Use should complement assessment methods based exclusively on AMR outcomes.

Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.

PubMed

Boers, Maarten; Kirwan, John R; Wells, George; Beaton, Dorcas; Gossec, Laure; d'Agostino, Maria-Antonietta; Conaghan, Philip G; Bingham, Clifton O; Brooks, Peter; Landewé, Robert; March, Lyn; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Tugwell, Peter

2014-07-01

Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n=125) at the OMERACT 11 consensus conference endorsed this model and process. The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

The Cambridge Otology Quality of Life Questionnaire: an otology-specific patient-recorded outcome measure. A paper describing the instrument design and a report of preliminary reliability and validity.

PubMed

Martin, T P C; Moualed, D; Paul, A; Ronan, N; Tysome, J R; Donnelly, N P; Cook, R; Axon, P R

2015-04-01

The Cambridge Otology Quality of Life Questionnaire (COQOL) is a patient-recorded outcome measurement (PROM) designed to quantify the quality of life of patients attending otology clinics. Item-reduction model. A systematically designed long-form version (74 items) was tested with patient focus groups before being presented to adult otology patients (n. 137). Preliminary item analysis tested reliability, reducing the COQOL to 24 questions. This was then presented in conjunction with the SF-36 (V1) questionnaire to a total of 203 patients. Subsequently, these were re-presented at T + 3 months, and patients recorded whether they felt their condition had improved, deteriorated or remained the same. Non-responders were contacted by post. A correlation between COQOL scores and patient perception of change was examined to analyse content validity. Teaching hospital and university psychology department. Adult patients attending otology clinics with a wide range of otological conditions. Item reliability measured by item–total correlation, internal consistency and test– retest reliability. Validity measured by correlation between COQOL scores and patient-reported symptom change. Reliability: the COQOL showed excellent internal consistency at both initial presentation (a = 0.90) and 3 months later (a = 0.93). Validity: One-way analysis of variance showed a significant difference between groups reporting change and those reporting no change in quality of life (F(2, 80) = 5.866, P < 0.01). The COQOL is the first otology-specific PROM. Initial studies demonstrate excellent reliability and encouraging preliminary criterion validity: further studies will allow a deeper validation of the instrument.

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 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.

Satellite stratospheric aerosol measurement validation

NASA Technical Reports Server (NTRS)

Russell, P. B.; Mccormick, M. P.

1984-01-01

The validity of the stratospheric aerosol measurements made by the satellite sensors SAM II and SAGE was tested by comparing their results with each other and with results obtained by other techniques (lider, dustsonde, filter, and impactor). The latter type of comparison required the development of special techniques that convert the quantity measured by the correlative sensor (e.g. particle backscatter, number, or mass) to that measured by the satellite sensor (extinction) and quantitatively estimate the uncertainty in the conversion process. The results of both types of comparisons show agreement within the measurement and conversion uncertainties. Moreover, the satellite uncertainty is small compared to aerosol natural variability (caused by seasonal changes, volcanoes, sudden warmings, and vortex structure). It was concluded that the satellite measurements are valid.

Voice disorder outcome profile (V-DOP)-translation and validation in Tamil language.

PubMed

Mahalingam, Shenbagavalli; Boominathan, Prakash; Subramaniyan, Balasubramaniyan

2014-11-01

This study sought to translate and validate the voice disorder outcome profile (V-DOP) for Tamil-speaking populations. It was implemented in two phases: the English language V-DOP developed for an Indian population was first translated into Tamil, a south Indian Dravidian language. Five Tamil language experts verified the translated version for exactness of meaning and usage. The expert's comments and suggestions were used to select the questions for the final V-DOP, thus establishing content validity. Then the translated V-DOP was administered to 95 subjects (75 in clinical and 20 in nonclinical group) for reliability (item-total correlation) and validity (construct) measures. The overall Cronbach coefficient α for V-DOP was 0.89 whereas the mean total V-DOP score was zero for the nonclinical group and 104.28 for the clinical group (standard deviation = 64.71). The emotional and functional domains indicated a statistically significant correlation (r = 0.91 and r = 0.90 respectively), followed by the physical domain (r = 0.82) with the total scores. A significant, but moderate correlation was obtained across V-DOP domains (r = 0.50 to 0.60; P < 0.05 and 0.01) and between total score and overall severity of V-DOP (r = 0.62; P < 0.01). Thus the self-perception measuring V-DOP in Tamil is a valid and reliable tool for evaluating the impact of voice disorders in Tamil-speaking population. Copyright © 2014 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Homework Stress: Construct Validation of a Measure

ERIC Educational Resources Information Center

Katz, Idit; Buzukashvili, Tamara; Feingold, Liat

2012-01-01

This article presents 2 studies aimed at validating a measure of stress experienced by children and parents around the issue of homework, applying Benson's program of validation (Benson, 1998). Study 1 provides external validity of the measure by supporting hypothesized relations between stress around homework and students' and parents' positive…

Patient reported outcome measures in septorhinoplasty surgery.

PubMed

Biggs, T C; Fraser, L R; Ward, M J; Sunkaraneni, V S; Harries, P G; Salib, R J

2015-01-01

Surgical procedures incorporating a cosmetic element such as septorhinoplasty and otoplasty are currently under threat in the National Health Service (NHS) as they are deemed to be procedures of 'limited clinical benefit' by many primary care providers. Patient reported outcome measures (PROMs), which assess the quality of care delivered from the patients' perspective, are becoming increasingly important in documenting the effectiveness of such procedures. The Rhinoplasty Outcomes Evaluation (ROE) questionnaire, a validated PROM tool, was used to assess patient satisfaction in 141 patients undergoing septorhinoplasty surgery over a 90-month period at the University Hospital Southampton NHS Foundation Trust. Overall, 100 patients with a mean follow-up period of 36 months completed the study. The mean ROE score was 73.3%. In addition, 75% of patients questioned were happy with the final result of their operation and 83% would undergo the procedure again if required. These benefits occurred irrespective of age, sex and primary versus revision surgery, and were maintained for up to 71 months following surgery. This study has shown that patients are generally satisfied with their functional and cosmetic outcomes following septorhinoplasty surgery. These results help support the case for septorhinoplasty surgery to continue being funded as an NHS procedure.

Content Validity for the VVSymQ® Instrument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms.

PubMed

Paty, Jean; Elash, Celeste A; Turner-Bowker, Diane M

2017-02-01

Varicose veins are common and can impact patients' quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations. This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ ® instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials. The development of the VVSymQ ® instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients' ability to understand and use the VVSymQ ® instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument. Five symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI™]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ ® instrument queries patients on the HASTI™ symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from "None of the time" to "All of the time," and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients' understanding of and their ability to use the final version of the VVSymQ ® instrument. Content validity was established for the VVSymQ ® instrument, which assesses the five HASTI™ symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice.

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

PubMed

Orsi, Rebecca

2017-02-01

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

Reliability and Validity of an Internet-based Questionnaire Measuring Lifetime Physical Activity

PubMed Central

De Vera, Mary A.; Ratzlaff, Charles; Doerfling, Paul; Kopec, Jacek

2010-01-01

Lifetime exposure to physical activity is an important construct for evaluating associations between physical activity and disease outcomes, given the long induction periods in many chronic diseases. The authors' objective in this study was to evaluate the measurement properties of the Lifetime Physical Activity Questionnaire (L-PAQ), a novel Internet-based, self-administered instrument measuring lifetime physical activity, among Canadian men and women in 2005–2006. Reliability was examined using a test-retest study. Validity was examined in a 2-part study consisting of 1) comparisons with previously validated instruments measuring similar constructs, the Lifetime Total Physical Activity Questionnaire (LT-PAQ) and the Chasan-Taber Physical Activity Questionnaire (CT-PAQ), and 2) a priori hypothesis tests of constructs measured by the L-PAQ. The L-PAQ demonstrated good reliability, with intraclass correlation coefficients ranging from 0.67 (household activity) to 0.89 (sports/recreation). Comparison between the L-PAQ and the LT-PAQ resulted in Spearman correlation coefficients ranging from 0.41 (total activity) to 0.71 (household activity); comparison between the L-PAQ and the CT-PAQ yielded coefficients of 0.58 (sports/recreation), 0.56 (household activity), and 0.50 (total activity). L-PAQ validity was further supported by observed relations between the L-PAQ and sociodemographic variables, consistent with a priori hypotheses. Overall, the L-PAQ is a useful instrument for assessing multiple domains of lifetime physical activity with acceptable reliability and validity. PMID:20876666

Reliability and validity of an internet-based questionnaire measuring lifetime physical activity.

PubMed

De Vera, Mary A; Ratzlaff, Charles; Doerfling, Paul; Kopec, Jacek

2010-11-15

Lifetime exposure to physical activity is an important construct for evaluating associations between physical activity and disease outcomes, given the long induction periods in many chronic diseases. The authors' objective in this study was to evaluate the measurement properties of the Lifetime Physical Activity Questionnaire (L-PAQ), a novel Internet-based, self-administered instrument measuring lifetime physical activity, among Canadian men and women in 2005-2006. Reliability was examined using a test-retest study. Validity was examined in a 2-part study consisting of 1) comparisons with previously validated instruments measuring similar constructs, the Lifetime Total Physical Activity Questionnaire (LT-PAQ) and the Chasan-Taber Physical Activity Questionnaire (CT-PAQ), and 2) a priori hypothesis tests of constructs measured by the L-PAQ. The L-PAQ demonstrated good reliability, with intraclass correlation coefficients ranging from 0.67 (household activity) to 0.89 (sports/recreation). Comparison between the L-PAQ and the LT-PAQ resulted in Spearman correlation coefficients ranging from 0.41 (total activity) to 0.71 (household activity); comparison between the L-PAQ and the CT-PAQ yielded coefficients of 0.58 (sports/recreation), 0.56 (household activity), and 0.50 (total activity). L-PAQ validity was further supported by observed relations between the L-PAQ and sociodemographic variables, consistent with a priori hypotheses. Overall, the L-PAQ is a useful instrument for assessing multiple domains of lifetime physical activity with acceptable reliability and validity.

Validity of the Medical College Admission Test for predicting MD-PhD student outcomes.

PubMed

Bills, James L; VanHouten, Jacob; Grundy, Michelle M; Chalkley, Roger; Dermody, Terence S

2016-03-01

The Medical College Admission Test (MCAT) is a quantitative metric used by MD and MD-PhD programs to evaluate applicants for admission. This study assessed the validity of the MCAT in predicting training performance measures and career outcomes for MD-PhD students at a single institution. The study population consisted of 153 graduates of the Vanderbilt Medical Scientist Training Program (combined MD-PhD program) who matriculated between 1963 and 2003 and completed dual-degree training. This population was divided into three cohorts corresponding to the version of the MCAT taken at the time of application. Multivariable regression (logistic for binary outcomes and linear for continuous outcomes) was used to analyze factors associated with outcome measures. The MCAT score and undergraduate GPA (uGPA) were treated as independent variables; medical and graduate school grades, time-to-PhD defense, USMLE scores, publication number, and career outcome were dependent variables. For cohort 1 (1963-1977), MCAT score was not associated with any assessed outcome, although uGPA was associated with medical school preclinical GPA and graduate school GPA (gsGPA). For cohort 2 (1978-1991), MCAT score was associated with USMLE Step II score and inversely correlated with publication number, and uGPA was associated with preclinical GPA (mspGPA) and clinical GPA (mscGPA). For cohort 3 (1992-2003), the MCAT score was associated with mscGPA, and uGPA was associated with gsGPA. Overall, MCAT score and uGPA were inconsistent or weak predictors of training metrics and career outcomes for this population of MD-PhD students.

Developing measures of community-relevant outcomes for violence prevention programs: a community-based participatory research approach to measurement.

PubMed

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

2013-12-01

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

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.

Creation of a computer self-efficacy measure: analysis of internal consistency, psychometric properties, and validity.

PubMed

Howard, Matt C

2014-10-01

Computer self-efficacy is an often studied construct that has been shown to be related to an array of important individual outcomes. Unfortunately, existing measures of computer self-efficacy suffer from several deficiencies, including criterion contamination, outdated wording, and/or inadequate psychometric properties. For this reason, the current article presents the creation of a new computer self-efficacy measure. In Study 1, an over-representative item list is created and subsequently reduced through exploratory factor analysis to create an initial measure, and the discriminant validity of this initial measure is tested. In Study 2, the unidimensional factor structure of the initial measure is supported through confirmatory factor analysis and further reduced into a final, 12-item measure. In Study 3, the convergent and criterion validity of the 12-item measure is tested. Overall, this three study process demonstrates that the new computer self-efficacy measure has superb psychometric properties and internal reliability, and demonstrates excellent evidence for several aspects of validity. It is hoped that the 12-item computer self-efficacy measure will be utilized in future research on computer self-efficacy, which is discussed in the current article.

Adaptation and Validation of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for Use in Spain.

PubMed

Aguirre-Camacho, Aldo; Stepanous, Jessica; Blanco-Donoso, Luis M; Moreno-Jiménez, Bernardo; Wilburn, Jeanette; González-Saiz, Laura; McKenna, Stephen P

2017-06-01

The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a patient-reported outcome measure of health-related quality of life and quality of life specific to individuals with pulmonary hypertension (PH). This questionnaire has demonstrated superiority over other instruments assessing similar domains. The objective of the present study was to adapt and validate the Spanish version of the questionnaire. The adaptation consisted of 3 stages: translation from English to Spanish using bilingual and lay panels, cognitive debriefing interviews with patients, and assessment of psychometric properties by means of a postal validation survey. The translation panels produced a version of the CAMPHOR that was considered suitable for use by Spanish PH patients. The relevance, comprehensiveness, and acceptability of this version were confirmed in interviews with PH patients. Finally, the validation survey (n = 70) revealed that the 3 CAMPHOR scales (Symptoms, Activities, and Quality of life) showed strong psychometric properties. The internal consistency (Cronbach α) coefficients of the scales were above 0.89, and the test-retest reliability was above 0.87. The convergent and known group validity of the CAMPHOR scales was also demonstrated. The Spanish version of the CAMPHOR is a valid and reliable instrument for the assessment of health-related quality of life and quality of life in Spanish PH patients. Therefore, it is recommended for use in future research and clinical practice in the Spanish population of PH patients. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Measurement Development and Validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF)

PubMed Central

Hammer, Leslie B.; Kossek, Ellen Ernst; Bodner, Todd; Crain, Tori

2013-01-01

Recently, scholars have demonstrated the importance of Family Supportive Supervisor Behaviors (FSSB), defined as behaviors exhibited by supervisors that are supportive of employees’ family roles, in relation to health, well-being, and organizational outcomes. FSSB was originally conceptualized as a multidimensional, superordinate construct with four subordinate dimensions assessed with 14 items: emotional support, instrumental support, role modeling behaviors, and creative work-family management. Retaining one item from each dimension, two studies were conducted to support the development and use of a new FSSB-Short Form (FSSB-SF). Study 1 draws on the original data from the FSSB validation study of retail employees to determine if the results using the 14-item measure replicate with the shorter 4-item measure. Using data from a sample of 823 information technology professionals and their 219 supervisors, Study 2 extends the validation of the FSSB-SF to a new sample of professional workers and new outcome variables. Results from multilevel confirmatory factor analyses and multilevel regression analyses provide evidence of construct and criterion-related validity of the FSSB-SF, as it was significantly related to work-family conflict, job satisfaction, turnover intentions, control over work hours, obligation to work when sick, perceived stress, and reports of family time adequacy. We argue that it is important to develop parsimonious measures of work-family specific support to ensure supervisor support for work and family is mainstreamed into organizational research and practice. PMID:23730803

Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF).

PubMed

Hammer, Leslie B; Ernst Kossek, Ellen; Bodner, Todd; Crain, Tori

2013-07-01

Recently, scholars have demonstrated the importance of Family Supportive Supervisor Behaviors (FSSB), defined as behaviors exhibited by supervisors that are supportive of employees' family roles, in relation to health, well-being, and organizational outcomes. FSSB was originally conceptualized as a multidimensional, superordinate construct with four subordinate dimensions assessed with 14 items: emotional support, instrumental support, role modeling behaviors, and creative work-family management. Retaining one item from each dimension, two studies were conducted to support the development and use of a new FSSB-Short Form (FSSB-SF). Study 1 draws on the original data from the FSSB validation study of retail employees to determine whether the results using the 14-item measure replicate with the shorter 4-item measure. Using data from a sample of 823 information technology professionals and their 219 supervisors, Study 2 extends the validation of the FSSB-SF to a new sample of professional workers and new outcome variables. Results from multilevel confirmatory factor analyses and multilevel regression analyses provide evidence of construct and criterion-related validity of the FSSB-SF, as it was significantly related to work-family conflict, job satisfaction, turnover intentions, control over work hours, obligation to work when sick, perceived stress, and reports of family time adequacy. We argue that it is important to develop parsimonious measures of work-family specific support to ensure supervisor support for work and family is mainstreamed into organizational research and practice. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Validity and Responsiveness of the Two-Minute Walk Test for Measuring Functional Recovery After Total Knee Arthroplasty.

PubMed

Unnanuntana, Aasis; Ruangsomboon, Pakpoom; Keesukpunt, Worawut

2018-06-01

The 2-minute walk test (2mwt) is a performance-based test that evaluates functional recovery after total knee arthroplasty (TKA). This study evaluated its validity compared with the modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS), modified Knee Score, Numerical Pain Rating Scale, and Timed Up and Go test, and its responsiveness in assessing functional recovery in TKA patients. This prospective cohort study included 162 patients undergoing primary TKA between 2013 and 2015. We used patient-reported outcome measures (modified WOMAC, OKS, modified Knee Score, Numerical Pain Rating Scale) and performance-based tests (2mwt and Timed Up and Go test) at baseline and 3, 6, and 12 months postoperatively. The construct validity of 2mwt was determined between the 2mwt distances walked and other outcome measurements. To assess responsiveness, effect size and standardized response mean were analyzed. Minimal clinically important difference of 2mwt at 12 months after TKA was also calculated. All outcome measurements improved significantly from baseline to 3, 6, and 12 months postoperatively. Bivariate analysis revealed mild to moderate associations between the 2mwt and modified WOMAC function subscales, and moderate to strong associations with OKS. Mild to moderate correlations were found for pain and stiffness between 2mwt and other outcome measurements. The effect size and standardized response mean at 12 months were large, with a minimal clinically important difference of 12.7 m. 2mwt is a validated performance-based test with responsiveness properties. Being simple and easy to perform, it can be used routinely in clinical practice to evaluate functional recovery after TKA. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Validation of a scale to measure parental psychological empowerment in the vaccination decision.

PubMed

Marta, Fadda; Elisa, Galimberti; Luisa, Romanò; Marino, Faccini; Sabrina, Senatore; Alessandro, Zanetti; Peter J, Schulz

2017-09-21

Parents' empowerment is advocated to promote and preserve an informed and autonomous decision regarding their children' immunization. The scope of this study is to develop and evaluate the psychometric properties of an instrument to measure parents' psychological empowerment in their children's vaccination decision and propose a context-specific definition of this construct. Grounding in previous qualitative data, we generated an initial pool of items which was later content and face validated by a panel of experts. A pretest allowed us to reduce the initial pool to 9 items. Convergent and discriminant validity measures included the General Self-Efficacy Scale, a Psychological Empowerment Scale, and the Control Preference Scale. Vaccination-related outcomes such as attitude and intention were also included. Principal Component Analysis revealed a 2-factor structure, with each factor composed of 2 items. The first factor concerns the perceived influence of one's personal and family experience with vaccination, while the second factor represents the desire not to ask other parents about their experience with vaccination and their lack of interest in other parents' vaccination opinion. In light of its association with positive immunization-related outcomes, public health efforts should be directed to reinforce parents' empowerment.

Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome.

PubMed

Vork, L; Keszthelyi, D; Mujagic, Z; Kruimel, J W; Leue, C; Pontén, I; Törnblom, H; Simrén, M; Albu-Soda, A; Aziz, Q; Corsetti, M; Holvoet, L; Tack, J; Rao, S S; van Os, J; Quetglas, E G; Drossman, D A; Masclee, A A M

2018-03-01

End-of-day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS), are influenced by recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments in the natural state and environment of a subject, and herewith overcomes these limitations. This report describes the development of a patient-reported outcome measure (PROM) based on the ESM principle, taking into account content validity and cross-cultural adaptation. Focus group interviews with IBS patients and expert meetings with international experts in the fields of neurogastroenterology & motility and pain were performed in order to select the items for the PROM. Forward-and-back translation and cognitive interviews were performed to adapt the instrument for the use in different countries and to assure on patients' understanding with the final items. Focus group interviews revealed 42 items, categorized into five domains: physical status, defecation, mood and psychological factors, context and environment, and nutrition and drug use. Experts reduced the number of items to 32 and cognitive interviewing after translation resulted in a few slight adjustments regarding linguistic issues, but not regarding content of the items. An ESM-based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow. © 2017 John Wiley & Sons Ltd.

Positive psychology outcome measures for family caregivers of people living with dementia: a systematic review.

PubMed

Stansfeld, Jacki; Stoner, Charlotte R; Wenborn, Jennifer; Vernooij-Dassen, Myrra; Moniz-Cook, Esme; Orrell, Martin

2017-08-01

Family caregivers of people living with dementia can have both positive and negative experiences of caregiving. Despite this, existing outcome measures predominately focus on negative aspects of caregiving such as burden and depression. This review aimed to evaluate the development and psychometric properties of existing positive psychology measures for family caregivers of people living with dementia to determine their potential utility in research and practice. A systematic review of positive psychology outcome measures for family caregivers of people with dementia was conducted. The databases searched were as follows: PsychINFO, CINAHL, MEDLINE, EMBASE, and PubMed. Scale development papers were subject to a quality assessment to appraise psychometric properties. Twelve positive outcome measures and six validation papers of these scales were identified. The emerging constructs of self-efficacy, spirituality, resilience, rewards, gain, and meaning are in line with positive psychology theory. There are some robust positive measures in existence for family caregivers of people living with dementia. However, lack of reporting of the psychometric properties hindered the quality assessment of some outcome measures identified in this review. Future research should aim to include positive outcome measures in interventional research to facilitate a greater understanding of the positive aspects of caregiving and how these contribute to well-being.

Assessing participation in the ACL injured population: Selecting a patient reported outcome measure on the basis of measurement properties.

PubMed

Letchford, Robert; Sparkes, Valerie; van Deursen, Robert W M

2015-06-01

A return to pre injury activity participation remains a common but often elusive goal following ACL injury. Investigations to improve our understanding of participation restrictions are limited by inconsistent use of insufficiently investigated measurement tools. The aim of this study was to follow the consensus based standards for the selection of health measurement instruments (COSMIN) guideline to provide a comparative evaluation of four patient reported outcomes (PROMs) on the basis of measurement properties. This will inform recommendations for measuring participation of ACL injured subjects, particularly in the United Kingdom (UK) National Health Service (NHS). Thirteen criteria were compiled from the COSMIN guideline. These included reliability, measurement error, content validity, construct validity, responsiveness and interpretability. Data from 51 subjects collected as part of a longitudinal observational study of recovery over the first year following ACLR was used in the analysis. Of the thirteen criteria, the required standard was met in 11 for Tegner, 11 for International Knee Documentation Committee (IKDC), 6 for Cincinnati Sports Activity Scale (CSAS) and 6 for Marx. The two weaknesses identified for the Tegner are more easily compensated for during interpretation than those in the IKDC; for this reason the Tegner is the recommended PROM. The Tegner activity rating scale performed consistently well in respect of all measurement properties in this sample, with clear benefits over the other PROMs. The measurement properties presented should be used to inform implementation and interpretation of this outcome measure in clinical practice and research. Level II prospective study. Copyright © 2015 Elsevier B.V. All rights reserved.

A child chronic cough-specific quality of life measure: development and validation.

PubMed

Newcombe, Peter A; Sheffield, Jeanie K; Petsky, Helen L; Marchant, Julie M; Willis, Carol; Chang, Anne B

2016-08-01

Quality of life (QoL) measures are an important patient-relevant outcome measure for clinical studies. Cough is the most common symptom that results in new medical consultations. Although adult and parent-proxy cough-specific QoL instruments have been shown to be a useful cough outcome measure, no suitable cough-specific QoL measure for children with chronic cough exists. We report on the statistical properties of a chronic cough-specific QoL (CC-QoL) questionnaire for children. 130 children (median age 10 years, IQR 8-12 years; 65 girls) participated. A preliminary 37-item version was developed from conversations with children with chronic cough (>4 weeks). Children also completed generic QoL questionnaires (Pediatric QoL Inventory 4.0 (PedsQL4.0), Spence Children's Anxiety Scale (SCAS)) and cough diary scores. The clinical impact method of item reduction resulted in 16 items that had excellent internal consistency (Cronbach's α=0.94) among these items and also within each domain. Evidence for construct and criterion validity was established with significant correlations between CC-QoL subscales with cough scores, PedsQL and SCAS scores. CC-QoL scores were sensitive to change following an intervention and significant differences were noted between those children coughing and those who had ceased coughing. Minimum important difference (MID) for overall and domain CC-QoL ranged from 0.37-1.36 (distribution-based approach) to 1.11-1.58 (anchor-based approach). Chronic cough significantly impacts the QoL of children. The CC-QoL is a reliable, valid and sensitive to change outcome measure that assesses QoL from the child's perspective. Pending data from a confirmatory cohort, a MID for the CC-QoL of 1.1 is recommended when evaluating health status change. 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/

Patient-reported outcome measures for patients with meniscal tears: a systematic review of measurement properties and evaluation with the COSMIN checklist

PubMed Central

Middleton, Robert; Beard, David J; Price, Andrew J; Hopewell, Sally

2017-01-01

Objective Meniscal tears occur frequently in the population and the most common surgical treatment, arthroscopic partial meniscectomy, is performed in approximately two million cases worldwide each year. The purpose of this systematic review is to summarise and critically appraise the evidence for the use of patient-reported outcome measures (PROMs) in patients with meniscal tears. Design A systematic review was undertaken. Data on reported measurement properties were extracted and the quality of the studies appraised according to Consensus-based Standards for the Selection of Health Measurement Instruments. Data sources A search of MEDLINE, Embase, AMED and PsycINFO, unlimited by language or publication date (last search 20 February 2017). Eligibility criteria for selecting studies Development and validation studies reporting the measurement properties of PROMs in patients with meniscal tears were included. Results 11 studies and 10 PROMs were included. The overall quality of studies was poor. For measurement of symptoms and functional status, there is only very limited evidence supporting the selection of either the Lysholm Knee Scale, International Knee Documentation Committee Subjective Knee Form or the Dutch version of the Knee injury and Osteoarthritis Outcome Score. For measuring health-related quality of life, only limited evidence supports the selection of the Western Ontario Meniscal Evaluation Tool (WOMET). Of all the PROMs evaluated, WOMET has the strongest evidence for content validity. Conclusion For patients with meniscal tears, there is poor quality and incomplete evidence regarding the validity of the currently available PROMs. Further research is required to ensure these PROMs truly reflect the symptoms, function and quality of life of patients with meniscal tears. PROSPERO registration number CRD42017056847. PMID:29030413

Language-based Measures of Mindfulness: Initial Validity and Clinical Utility

PubMed Central

Collins, Susan E.; Chawla, Neharika; Hsu, Sharon H.; Grow, Joel; Otto, Jacqueline M.; Marlatt, G. Alan

2009-01-01

This study examined relationships among language use, mindfulness, and substance-use treatment outcomes in the context of an efficacy trial of mindfulness-based relapse prevention (MBRP) for adults with alcohol and other drug use (AOD) disorders (see Bowen, Chawla, Collins et al., in press). An expert panel generated two categories of mindfulness language (ML) describing the mindfulness state and the more encompassing “mindfulness journey,” which included words describing challenges of developing a mindfulness practice. MBRP participants (n=48) completed baseline sociodemographic and AOD measures, and participated in the 8-week MBRP program. AOD data were collected during the 4-month follow-up. A word count program assessed the frequency of ML and other linguistic markers in participants’ responses to open-ended questions about their postintervention impressions of mindfulness practice and MBRP. Findings supported concurrent validity of ML categories: ML words appeared more frequently in the MBRP manual compared to the 12-step Big Book. Further, ML categories correlated with other linguistic variables related to the mindfulness construct. Finally, predictive validity was supported: greater use of ML predicted fewer AOD use days during the 4-month follow-up. This study provided initial support for ML as a valid, clinically useful mindfulness measure. If future studies replicate these findings, ML could be used in conjunction with self-report to provide a more complete picture of the mindfulness experience. PMID:20025383

Further Evidence of the Utility and Validity of a Measure of Outcome for Children and Adolescents

ERIC Educational Resources Information Center

Turchik, Jessica A.; Karpenko, Veronika; Ogles, Benjamin M.

2007-01-01

The "Ohio Youth Problems, Functioning, and Satisfaction Scales" (Ohio Scales) are a recently developed set of measures designed to be a brief, practical assessment of changes in behavior over time in children and adolescents. The authors explored the convergent validity of the Ohio Scales by examining the relationship between the scales and…

Reliability and validity of the Pragmatics Observational Measure (POM): a new observational measure of pragmatic language for children.

PubMed

Cordier, Reinie; Munro, Natalie; Wilkes-Gillan, Sarah; Speyer, Renée; Pearce, Wendy M

2014-07-01

There is a need for a reliable and valid assessment of childhood pragmatic language skills during peer-peer interactions. This study aimed to evaluate the psychometric properties of a newly developed pragmatic assessment, the Pragmatic Observational Measure (POM). The psychometric properties of the POM were investigated from observational data of two studies - study 1 involved 342 children aged 5-11 years (108 children with ADHD; 108 typically developing playmates; 126 children in the control group), and study 2 involved 9 children with ADHD who attended a 7-week play-based intervention. The psychometric properties of the POM were determined based on the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) taxonomy of psychometric properties and definitions for health-related outcomes; the Pragmatic Protocol was used as the reference tool against which the POM was evaluated. The POM demonstrated sound psychometric properties in all the reliability, validity and interpretability criteria against which it was assessed. The findings showed that the POM is a reliable and valid measure of pragmatic language skills of children with ADHD between the age of 5 and 11 years and has clinical utility in identifying children with pragmatic language difficulty. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Validity of the Digital Inclinometer and iPhone When Measuring Thoracic Spine Rotation.

PubMed

Bucke, Jonathan; Spencer, Simon; Fawcett, Louise; Sonvico, Lawrence; Rushton, Alison; Heneghan, Nicola R

2017-09-01

  Spinal axial rotation is required for many functional and sporting activities. Eighty percent of axial rotation occurs in the thoracic spine. Existing measures of thoracic spine rotation commonly involve laboratory equipment, use a seated position, and include lumbar motion. A simple performance-based outcome measure would allow clinicians to evaluate isolated thoracic spine rotation. Currently, no valid measure exists.   To explore the criterion and concurrent validity of a digital inclinometer (DI) and iPhone Clinometer app (iPhone) for measuring thoracic spine rotation using the heel-sit position.   Controlled laboratory study.   University laboratory.   A total of 23 asymptomatic healthy participants (14 men, 9 women; age = 25.82 ± 4.28 years, height = 170.26 ± 8.01 cm, mass = 67.50 ± 9.46 kg, body mass index = 23.26 ± 2.79) were recruited from a student population.   We took DI and iPhone measurements of thoracic spine rotation in the heel-sit position concurrently with dual-motion analysis (laboratory measure) and ultrasound imaging of the underlying bony tissue motion (reference standard). To determine the criterion and concurrent validity, we used the Pearson product moment correlation coefficient (r, 2 tailed) and Bland-Altman plots.   The DI (r = 0.88, P < .001) and iPhone (r = 0.88, P < .001) demonstrated strong criterion validity. Both also had strong concurrent validity (r = 0.98, P < .001). Bland-Altman plots illustrated mean differences of 5.82° (95% confidence interval [CI] = 20.37°, -8.73°) and 4.94° (95% CI = 19.23°, -9.35°) between the DI and iPhone, respectively, and the reference standard and 0.87° (95% CI = 6.79°, -5.05°) between the DI and iPhone.   The DI and iPhone provided valid measures of thoracic spine rotation in the heel-sit position. Both can be used in clinical practice to assess thoracic spine rotation, which may be valuable when evaluating thoracic dysfunction.

Parents' self-efficacy, outcome expectations, and self-reported task performance when managing atopic dermatitis in children: instrument reliability and validity.

PubMed

Mitchell, Amy E; Fraser, Jennifer A

2011-02-01

Support and education for parents faced with managing a child with atopic dermatitis is crucial to the success of current treatments. Interventions aiming to improve parent management of this condition are promising. Unfortunately, evaluation is hampered by lack of precise research tools to measure change. To develop a suite of valid and reliable research instruments to appraise parents' self-efficacy for performing atopic dermatitis management tasks; outcome expectations of performing management tasks; and self-reported task performance in a community sample of parents of children with atopic dermatitis. The Parents' Eczema Management Scale (PEMS) and the Parents' Outcome Expectations of Eczema Management Scale (POEEMS) were developed from an existing self-efficacy scale, the Parental Self-Efficacy with Eczema Care Index (PASECI). Each scale was presented in a single self-administered questionnaire, to measure self-efficacy, outcome expectations, and self-reported task performance related to managing child atopic dermatitis. Each was tested with a community sample of parents of children with atopic dermatitis, and psychometric evaluation of the scales' reliability and validity was conducted. A community-based convenience sample of 120 parents of children with atopic dermatitis completed the self-administered questionnaire. Participants were recruited through schools across Australia. Satisfactory internal consistency and test-retest reliability was demonstrated for all three scales. Construct validity was satisfactory, with positive relationships between self-efficacy for managing atopic dermatitis and general perceived self-efficacy; self-efficacy for managing atopic dermatitis and self-reported task performance; and self-efficacy for managing atopic dermatitis and outcome expectations. Factor analyses revealed two-factor structures for PEMS and PASECI alike, with both scales containing factors related to performing routine management tasks, and managing the

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

[Validation of the Spanish version of the Palliative Care Outcome Scale].

PubMed

Serra-Prat, Mateu; Nabal, Maria; Santacruz, Víctor; Picaza, Josep M; Trelis, Jordi

2004-10-02

The objective of this study was to translate the Palliative Care Outcome Scale (POS) into Spanish and to validate it. The translation and adaptation was based on the conceptual equivalence of the terms used. In order to study the psychometric properties, 200 patients receiving palliative care were asked to fill out the POS questionnaire, the European Organization for Research on Cancer Treatment Quality of Life Questionnaire (EORCT QLQ C-30), the Barthel Index and the Karnofsky Index on their first visit. The Spanish version of the POS questionnaire was given to the patients again, a week later, to measure the intra-observer reliability. There were no major problems with the translation and adaptation process. The Spanish POS adapted very well for both the staff and the patients versions. Inter- and intra-observer reliability was good, with intraclass correlation coefficients of between 0.61 and 0.93 according to the item. Internal consistency analysis showed a Cronbach's alpha of 0.62 for the staff version and 0.64 for the patients version. Most of the Spanish POS correlated with the EORTC QLQ C-30 emotional function scale and quality of life scale. The Spanish POS is a valid and reliable instrument for measuring the quality of life of patients receiving palliative care. It is useful in research as well as in everyday clinical practice.

Validation Theory and Research for a Population-Level Measure of Children's Development, Wellbeing, and School Readiness

ERIC Educational Resources Information Center

Guhn, Martin; Zumbo, Bruno D.; Janus, Magdalena; Hertzman, Clyde

2011-01-01

This paper delineates general validity and research questions that are underlying an ongoing program of research pertaining to the Early Development Instrument (EDI, Janus and Offord 2007), a population-level measure, on which teachers rate kindergarten children's developmental outcomes in the social, emotional, physical, cognitive, and…

Development and Validation of an Empiric Tool to Predict Favorable Neurologic Outcomes Among PICU Patients.

PubMed

Gupta, Punkaj; Rettiganti, Mallikarjuna; Gossett, Jeffrey M; Daufeldt, Jennifer; Rice, Tom B; Wetzel, Randall C

2018-01-01

To create a novel tool to predict favorable neurologic outcomes during ICU stay among children with critical illness. Logistic regression models using adaptive lasso methodology were used to identify independent factors associated with favorable neurologic outcomes. A mixed effects logistic regression model was used to create the final prediction model including all predictors selected from the lasso model. Model validation was performed using a 10-fold internal cross-validation approach. Virtual Pediatric Systems (VPS, LLC, Los Angeles, CA) database. Patients less than 18 years old admitted to one of the participating ICUs in the Virtual Pediatric Systems database were included (2009-2015). None. A total of 160,570 patients from 90 hospitals qualified for inclusion. Of these, 1,675 patients (1.04%) were associated with a decline in Pediatric Cerebral Performance Category scale by at least 2 between ICU admission and ICU discharge (unfavorable neurologic outcome). The independent factors associated with unfavorable neurologic outcome included higher weight at ICU admission, higher Pediatric Index of Morality-2 score at ICU admission, cardiac arrest, stroke, seizures, head/nonhead trauma, use of conventional mechanical ventilation and high-frequency oscillatory ventilation, prolonged hospital length of ICU stay, and prolonged use of mechanical ventilation. The presence of chromosomal anomaly, cardiac surgery, and utilization of nitric oxide were associated with favorable neurologic outcome. The final online prediction tool can be accessed at https://soipredictiontool.shinyapps.io/GNOScore/. Our model predicted 139,688 patients with favorable neurologic outcomes in an internal validation sample when the observed number of patients with favorable neurologic outcomes was among 139,591 patients. The area under the receiver operating curve for the validation model was 0.90. This proposed prediction tool encompasses 20 risk factors into one probability to predict

A validated model for the 22-item Sino-Nasal Outcome Test subdomain structure in chronic rhinosinusitis.

PubMed

Feng, Allen L; Wesely, Nicholas C; Hoehle, Lloyd P; Phillips, Katie M; Yamasaki, Alisa; Campbell, Adam P; Gregorio, Luciano L; Killeen, Thomas E; Caradonna, David S; Meier, Josh C; Gray, Stacey T; Sedaghat, Ahmad R

2017-12-01

Previous studies have identified subdomains of the 22-item Sino-Nasal Outcome Test (SNOT-22), reflecting distinct and largely independent categories of chronic rhinosinusitis (CRS) symptoms. However, no study has validated the subdomain structure of the SNOT-22. This study aims to validate the existence of underlying symptom subdomains of the SNOT-22 using confirmatory factor analysis (CFA) and to develop a subdomain model that practitioners and researchers can use to describe CRS symptomatology. A total of 800 patients with CRS were included into this cross-sectional study (400 CRS patients from Boston, MA, and 400 CRS patients from Reno, NV). Their SNOT-22 responses were analyzed using exploratory factor analysis (EFA) to determine the number of symptom subdomains. A CFA was performed to develop a validated measurement model for the underlying SNOT-22 subdomains along with various tests of validity and goodness of fit. EFA demonstrated 4 distinct factors reflecting: sleep, nasal, otologic/facial pain, and emotional symptoms (Cronbach's alpha, >0.7; Bartlett's test of sphericity, p < 0.001; Kaiser-Meyer-Olkin >0.90), independent of geographic locale. The corresponding CFA measurement model demonstrated excellent measures of fit (root mean square error of approximation, <0.06; standardized root mean square residual, <0.08; comparative fit index, >0.95; Tucker-Lewis index, >0.95) and measures of construct validity (heterotrait-monotrait [HTMT] ratio, <0.85; composite reliability, >0.7), again independent of geographic locale. The use of the 4-subdomain structure for SNOT-22 (reflecting sleep, nasal, otologic/facial pain, and emotional symptoms of CRS) was validated as the most appropriate to calculate SNOT-22 subdomain scores for patients from different geographic regions using CFA. © 2017 ARS-AAOA, LLC.

A Comparative Analysis of the Validity of US State- and County-Level Social Capital Measures and Their Associations with Population Health

PubMed Central

Lee, Chul-joo; Kim, Daniel

2014-01-01

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

Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout.

PubMed

Taylor, William J; Redden, David; Dalbeth, Nicola; Schumacher, H Ralph; Edwards, N Lawrence; Simon, Lee S; John, Markus R; Essex, Margaret N; Watson, Douglas J; Evans, Robert; Rome, Keith; Singh, Jasvinder A

2014-03-01

To determine the extent to which instruments that measure core outcome domains in acute gout fulfill the Outcome Measures in Rheumatology (OMERACT) filter requirements of truth, discrimination, and feasibility. Patient-level data from 4 randomized controlled trials of agents designed to treat acute gout and 1 observational study of acute gout were analyzed. For each available measure, construct validity, test-retest reliability, within-group change using effect size, between-group change using the Kruskall-Wallis statistic, and repeated measures generalized estimating equations were assessed. Floor and ceiling effects were also assessed and minimal clinically important difference was estimated. These analyses were presented to participants at OMERACT 11 to help inform voting for possible endorsement. There was evidence for construct validity and discriminative ability for 3 measures of pain [0 to 4 Likert, 0 to 10 numeric rating scale (NRS), 0 to 100 mm visual analog scale (VAS)]. Likewise, there appears to be sufficient evidence for a 4-point Likert scale to possess construct validity and discriminative ability for physician assessment of joint swelling and joint tenderness. There was some evidence for construct validity and within-group discriminative ability for the Health Assessment Questionnaire as a measure of activity limitations, but not for discrimination between groups allocated to different treatment. There is sufficient evidence to support measures of pain (using Likert, NRS, or VAS), joint tenderness, and swelling (using Likert scale) as fulfilling the requirements of the OMERACT filter. Further research on a measure of activity limitations in acute gout clinical trials is required.

Mapping health outcome measures from a stroke registry to EQ-5D weights.

PubMed

Ghatnekar, Ola; Eriksson, Marie; Glader, Eva-Lotta

2013-03-07

To map health outcome related variables from a national register, not part of any validated instrument, with EQ-5D weights among stroke patients. We used two cross-sectional data sets including patient characteristics, outcome variables and EQ-5D weights from the national Swedish stroke register. Three regression techniques were used on the estimation set (n=272): ordinary least squares (OLS), Tobit, and censored least absolute deviation (CLAD). The regression coefficients for "dressing", "toileting", "mobility", "mood", "general health" and "proxy-responders" were applied to the validation set (n=272), and the performance was analysed with mean absolute error (MAE) and mean square error (MSE). The number of statistically significant coefficients varied by model, but all models generated consistent coefficients in terms of sign. Mean utility was underestimated in all models (least in OLS) and with lower variation (least in OLS) compared to the observed. The maximum attainable EQ-5D weight ranged from 0.90 (OLS) to 1.00 (Tobit and CLAD). Health states with utility weights <0.5 had greater errors than those with weights ≥ 0.5 (P<0.01). This study indicates that it is possible to map non-validated health outcome measures from a stroke register into preference-based utilities to study the development of stroke care over time, and to compare with other conditions in terms of utility.

Validity of a Measure of Assertiveness

ERIC Educational Resources Information Center

Galassi, John P.; Galassi, Merna D.

1974-01-01

This study was concerned with further validation of a measure of assertiveness. Concurrent validity was established for the College Self-Expression Scale using the method of contrasted groups and through correlations of self-and judges' ratings of assertiveness. (Author)

Patient reported outcomes in GNE myopathy: incorporating a valid assessment of physical function in a rare disease.

PubMed

Slota, Christina; Bevans, Margaret; Yang, Li; Shrader, Joseph; Joe, Galen; Carrillo, Nuria

2018-05-01

The aim of this analysis was to evaluate the psychometric properties of three patient reported outcome (PRO) measures characterizing physical function in GNE myopathy: the Human Activity Profile, the Inclusion Body Myositis Functional Rating Scale, and the Activities-specific Balance Confidence scale. This analysis used data from 35 GNE myopathy subjects participating in a natural history study. For construct validity, correlational and known-group analyses were between the PROs and physical assessments. Reliability of the PROs between baseline and 6 months was evaluated using the intra-class correlation coefficient model; internal consistency was tested with Cronbach's alpha. The hypothesized moderate positive correlations for construct validity were supported; the strongest correlation was between the human activity profile adjusted activity score and the adult myopathy assessment endurance subscale score (r = 0.81; p < 0.0001). The PROs were able to discriminate between known high and low functioning groups for the adult myopathy assessment tool. Internal consistency of the PROs was high (α > 0.8) and there was strong reliability (ICC >0.62). The PROs are valid and reliable measures of physical function in GNE myopathy and should be incorporated in investigations to better understand the impact of progressive muscle weakness on physical function in this rare disease population. Implications for Rehabilitation GNE myopathy is a rare muscle disease that results in slow progressive muscle atrophy and weakness, ultimately leading to wheelchair use and dependence on a caregiver. There is limited knowledge on the impact of this disease on the health-related quality of life, specifically physical function, of this rare disease population. Three patient reported outcomes have been shown to be valid and reliable in GNE myopathy subjects and should be incorporated in future investigations to better understand how progressive muscle weakness impacts physical

Development and validation of a questionnaire to measure moral distress in community pharmacists.

PubMed

Astbury, Jayne L; Gallagher, Cathal T

2017-02-01

Background Pharmacists work within a highly-regulated occupational sphere, and are bound by strict legal frameworks and codes of professional conduct. This regulatory environment creates the potential for moral distress to occur due to the limitations it places on acting in congruence with moral judgements. Very little research regarding this phenomenon has been undertaken in pharmacy: thus, prominent research gaps have arisen for the development of a robust tool to measure and quantify moral distress experienced in the profession. Objective The aim of this study was to develop an instrument to measure moral distress in community pharmacists. Setting Community pharmacies in the United Kingdom. Method This study adopted a three-phase exploratory sequential mixed-method design. Three semi-structured focus groups were then conducted to allow pharmacists to identify and explore scenarios that cause moral distress. Each of the identified scenarios were developed into a statement, which was paired with twin seven-point Likert scales to measure the frequency and intensity of the distress, respectively. Content validity, reliability, and construct validity were all tested, and the questionnaire was refined. Main outcome measure The successful development of the valid instrument for use in the United Kingdom. Results This research has led to the development of a valid and reliable instrument to measure moral distress in community pharmacists in the UK. The questionnaire has already been distributed to a large sample of community pharmacists. Conclusion Results from this distribution will be used to inform the formulation of coping strategies for dealing with moral distress.

Validation of a new measure of availability and accommodation of health care that is valid for rural and urban contexts.

PubMed

Haggerty, Jeannie L; Levesque, Jean-Frédéric

2017-04-01

Patients are the most valid source for evaluating the accessibility of services, but a previous study observed differential psychometric performance of instruments in rural and urban respondents. To validate a measure of organizational accessibility free of differential rural-urban performance that predicts consequences of difficult access for patient-initiated care. Sequential qualitative-quantitative study. Qualitative findings used to adapt or develop evaluative and reporting items. Quantitative validation study. Primary data by telephone from 750 urban, rural and remote respondents in Quebec, Canada; follow-up mailed questionnaire to a subset of 316. Items were developed for barriers along the care trajectory. We used common factor and confirmatory factor analysis to identify constructs and compare models. We used item response theory analysis to test for differential rural-urban performance; examine individual item performance; adjust response options; and exclude redundant or non-discriminatory items. We used logistic regression to examine predictive validity of the subscale on access difficulty (outcome). Initial factor resolution suggested geographic and organizational dimensions, plus consequences of access difficulty. After second administration, organizational accommodation and geographic indicators were integrated into a 6-item subscale of Effective Availability and Accommodation, which demonstrates good variability and internal consistency (α = 0.84) and no differential functioning by geographic area. Each unit increase predicts decreased likelihood of consequences of access difficulties (unmet need and problem aggravation). The new subscale is a practical, valid and reliable measure for patients to evaluate first-contact health services accessibility, yielding valid comparisons between urban and rural contexts. © 2016 The Authors. Health Expectations published by John Wiley & Sons Ltd.

PRION-1 scales analysis supports use of functional outcome measures in prion disease

PubMed Central

Mead, S.; Ranopa, M.; Gopalakrishnan, G.S.; Thompson, A.G.B.; Rudge, P.; Wroe, S.; Kennedy, A.; Hudson, F.; MacKay, A.; Darbyshire, J.H.; Walker, A.S.

2011-01-01

Objectives: Human prion diseases are heterogeneous but invariably fatal neurodegenerative disorders with no known effective therapy. PRION-1, the largest clinical trial in prion disease to date, showed no effect of the potential therapeutic quinacrine on survival. Although there are several limitations to the usefulness of survival as an outcome measure, there have been no comprehensive studies of alternatives. Methods: To address this we did comparative analyses of neurocognitive, psychiatric, global, clinician-rated, and functional scales, focusing on validity, variability, and impact on statistical power over 77 person-years follow-up in 101 symptomatic patients in PRION-1. Results: Quinacrine had no demonstrable benefit on any of the 8 scales (p > 0.4). All scales had substantial numbers of patients with the worst possible score at enrollment (Glasgow Coma Scale score being least affected) and were impacted by missing data due to disease progression. These effects were more significant for cognitive/psychiatric scales than global, clinician-rated, or functional scales. The Barthel and Clinical Dementia Rating scales were the most valid and powerful in simulated clinical trials of an effective therapeutic. A combination of selected subcomponents from these 2 scales gave somewhat increased power, compared to use of survival, to detect clinically relevant effects in future clinical trials of feasible size. Conclusions: Our findings have implications for the choice of primary outcome measure in prion disease clinical trials. Prion disease presents the unusual opportunity to follow patients with a neurodegenerative disease through their entire clinical course, and this provides insights relevant to designing outcome measures in related conditions. PMID:22013183

Linguistic validation and reliability properties are weak investigated of most dementia-specific quality of life measurements-a systematic review.

PubMed

Dichter, Martin Nikolaus; Schwab, Christian G G; Meyer, Gabriele; Bartholomeyczik, Sabine; Halek, Margareta

2016-02-01

For people with dementia, the concept of quality of life (Qol) reflects the disease's impact on the whole person. Thus, Qol is an increasingly used outcome measure in dementia research. This systematic review was performed to identify available dementia-specific Qol measurements and to assess the quality of linguistic validations and reliability studies of these measurements (PROSPERO 2013: CRD42014008725). The MEDLINE, CINAHL, EMBASE, PsycINFO, and Cochrane Methodology Register databases were systematically searched without any date restrictions. Forward and backward citation tracking were performed on the basis of selected articles. A total of 70 articles addressing 19 dementia-specific Qol measurements were identified; nine measurements were adapted to nonorigin countries. The quality of the linguistic validations varied from insufficient to good. Internal consistency was the most frequently tested reliability property. Most of the reliability studies lacked internal validity. Qol measurements for dementia are insufficiently linguistic validated and not well tested for reliability. None of the identified measurements can be recommended without further research. The application of international guidelines and quality criteria is strongly recommended for the performance of linguistic validations and reliability studies of dementia-specific Qol measurements. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation of the PROMIS® measures of self-efficacy for managing chronic conditions.

PubMed

Gruber-Baldini, Ann L; Velozo, Craig; Romero, Sergio; Shulman, Lisa M

2017-07-01

The Patient-Reported Outcomes Measurement Information System ® (PROMIS ® ) was designed to develop, validate, and standardize item banks to measure key domains of physical, mental, and social health in chronic conditions. This paper reports the calibration and validation testing of the PROMIS Self-Efficacy for Managing Chronic Conditions measures. PROMIS Self-Efficacy for Managing Chronic Conditions item banks comprise five domains, Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. Banks were calibrated in 1087 subjects from two data sources: 837 patients with chronic neurologic conditions (epilepsy, multiple sclerosis, neuropathy, Parkinson disease, and stroke) and 250 subjects from an online Internet sample of adults with general chronic conditions. Scores were compared with one legacy scale: Self-Efficacy for Managing Chronic Disease 6-Item scale (SEMCD6) and five PROMIS short forms: Global Health (Physical and Mental), Physical Function, Fatigue, Depression, and Anxiety. The sample was 57% female, mean age = 53.8 (SD = 14.7), 76% white, 21% African American, 6% Hispanic, and 76% with greater than high school education. Full-item banks were created for each domain. All measures had good internal consistency and correlated well with SEMCD6 (r  = 0.56-0.75). Significant correlations were seen between the Self-Efficacy measures and other PROMIS short forms (r  > 0.38). The newly developed PROMIS Self-Efficacy for Managing Chronic Conditions measures include five domains of self-efficacy that were calibrated across diverse chronic conditions and show good internal consistency and cross-sectional validity.

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.

Parent outcome expectancies for purchasing fruit and vegetables: a validation.

PubMed

Baranowski, Tom; Watson, Kathy; Missaghian, Mariam; Broadfoot, Alison; Baranowski, Janice; Cullen, Karen; Nicklas, Theresa; Fisher, Jennifer; O'Donnell, Sharon

2007-03-01

To validate four scales -- outcome expectancies for purchasing fruit and for purchasing vegetables, and comparative outcome expectancies for purchasing fresh fruit and for purchasing fresh vegetables versus other forms of fruit and vegetables (F&V). Survey instruments were administered twice, separated by 6 weeks. Recruited in front of supermarkets and grocery stores; interviews conducted by telephone. One hundred and sixty-one food shoppers with children (18 years or younger). Single dimension scales were specified for fruit and for vegetable purchasing outcome expectancies, and for comparative (fresh vs. other) fruit and vegetable purchasing outcome expectancies. Item Response Theory parameter estimates revealed easily interpreted patterns in the sequence of items by difficulty of response. Fruit and vegetable purchasing and fresh fruit comparative purchasing outcome expectancy scales were significantly correlated with home F&V availability, after controlling for social desirability of response. Comparative fresh vegetable outcome expectancy scale was significantly bivariately correlated with home vegetable availability, but not after controlling for social desirability. These scales are available to help better understand family F&V purchasing decisions.

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.

CHoice of Outcome In Cbt for psychosEs (CHOICE): The Development of a New Service User–Led Outcome Measure of CBT for Psychosis

PubMed Central

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

2010-01-01

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

The Reliability and Validity of Measures of Gait Variability in Community-Dwelling Older Adults

PubMed Central

Brach, Jennifer S.; Perera, Subashan; Studenski, Stephanie; Newman, Anne B.

2009-01-01

Objective To examine the test-retest reliability and concurrent validity of variability of gait characteristics. Design Cross-sectional study. Setting Research laboratory. Participants Older adults (N=558) from the Cardiovascular Health Study. Interventions Not applicable. Main Outcome Measures Gait characteristics were measured using a 4-m computerized walkway. SD determined from the steps recorded were used as the measures of variability. Intraclass correlation coefficients (ICC) were calculated to examine test-retest reliability of a 4-m walk and two 4-m walks. To establish concurrent validity, the measures of gait variability were compared across levels of health, functional status, and physical activity using independent t tests and analysis of variances. Results Gait variability measures from the two 4-m walks demonstrated greater test-retest reliability than those from the single 4-m walk (ICC=.22–.48 and ICC=.40–.63, respectively). Greater step length and stance time variability were associated with poorer health, functional status and physical activity (P<.05). Conclusions Gait variability calculated from a limited number of steps has fair to good test-retest reliability and concurrent validity. Reliability of gait variability calculated from a greater number of steps should be assessed to determine if the consistency can be improved. PMID:19061741

The international Hip Outcome Tool-33 (iHOT-33): multicenter validation and translation to Spanish.

PubMed

Ruiz-Ibán, Miguel Angel; Seijas, Roberto; Sallent, Andrea; Ares, Oscar; Marín-Peña, Oliver; Muriel, Alfonso; Cuéllar, Ricardo

2015-05-20

The international Hip Outcome Tool-33 (iHOT-33) is a 33-item self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The aim of the present study is to translate and validate the iHOT-33 into Spanish. 97 patients undergoing hip arthroscopy were included in this prospective and multicenter study performed between January 2012 and May 2014. Crosscultural adaptation was used to translate iHOT-33 into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 48 years old. Feasibility: 41.2 % patients had no blank questions, and 71.3 % of patients had fulfilled all but one or two questions. Reliability: ICC for the global questionnaire was 0.97, showing that the questionnaire is highly reproducible. Internal consistency: Cronbach's alpha was 0.98 for the global questionnaire. Construct validity: there was a high correlation with WOMAC (correlation coefficient >0.5). The Ceiling effect (taking into account the minimum detectable change) was 12.1 % and the floor effect was 21.6 %, for the global questionnaire. Large sensitivity to change was shown. the Spanish version of iHOT-33 has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of iHOT-33 allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

Measuring outcomes in children's rehabilitation: a decision protocol.

PubMed

Law, M; King, G; Russell, D; MacKinnon, E; Hurley, P; Murphy, C

1999-06-01

To develop and test the feasibility and clinical utility of a computerized self-directed software program designed to enable service providers in children's rehabilitation to make decisions about the most appropriate outcome measures to use in client and program evaluation. A before-and-after design was used to test the feasibility and initial impact of the decision-making outcome software in improving knowledge and use of clinical outcome measures. A children's rehabilitation center in a city of 50,000. All service providers in the children's rehabilitation center. Disciplines represented included early childhood education, occupational therapy, physical therapy, speech and language pathology, audiology, social work, and psychology. Using a conceptual framework based on the International Classification of Impairment, Disability, and Handicap (ICIDH), an outcome measurement decision-making protocol was developed. The decision-making protocol was computerized in an educational software program with an attached database of critically appraised measures. Participants learned about outcome measures through the program and selected outcome measures that met their specifications. The computer software was tested for feasibility in the children's rehabilitation center for 6 months. Knowledge and use of clinical outcome measures were determined before and after the feasibility testing using a survey of all service providers currently at the centre and audits of 30 randomly selected rehabilitation records (at pretest, posttest, and follow-up). Service providers indicated that the outcomes software was easy to follow and believed that the use of the ICIDH framework helped them in making decisions about selecting outcome measures. Results of the survey indicated that there were significant changes in the service providers' level of comfort with selecting measures and knowing what measures were available. Use of outcome measures as identified through the audit did not change

Development and validation of the Surgical Outcome Risk Tool (SORT)

PubMed Central

Protopapa, K L; Simpson, J C; Smith, N C E; Moonesinghe, S R

2014-01-01

Background Existing risk stratification tools have limitations and clinical experience suggests they are not used routinely. The aim of this study was to develop and validate a preoperative risk stratification tool to predict 30-day mortality after non-cardiac surgery in adults by analysis of data from the observational National Confidential Enquiry into Patient Outcome and Death (NCEPOD) Knowing the Risk study. Methods The data set was split into derivation and validation cohorts. Logistic regression was used to construct a model in the derivation cohort to create the Surgical Outcome Risk Tool (SORT), which was tested in the validation cohort. Results Prospective data for 19 097 cases in 326 hospitals were obtained from the NCEPOD study. Following exclusion of 2309, details of 16 788 patients were analysed (derivation cohort 11 219, validation cohort 5569). A model of 45 risk factors was refined on repeated regression analyses to develop a model comprising six variables: American Society of Anesthesiologists Physical Status (ASA-PS) grade, urgency of surgery (expedited, urgent, immediate), high-risk surgical specialty (gastrointestinal, thoracic, vascular), surgical severity (from minor to complex major), cancer and age 65 years or over. In the validation cohort, the SORT was well calibrated and demonstrated better discrimination than the ASA-PS and Surgical Risk Scale; areas under the receiver operating characteristic (ROC) curve were 0·91 (95 per cent c.i. 0·88 to 0·94), 0·87 (0·84 to 0·91) and 0·88 (0·84 to 0·92) respectively (P < 0·001). Conclusion The SORT allows rapid and simple data entry of six preoperative variables, and provides a percentage mortality risk for individuals undergoing surgery. PMID:25388883

Measuring outcomes of community aged care programs: challenges, opportunities and the Australian Community Outcomes Measurement ACCOM tool.

PubMed

Cardona, Beatriz

2018-05-29

Measuring health and wellbeing outcomes of community aged care programs is a complex task given the diverse settings in which care takes place and the intersection of numerous factors affecting an individual's quality of life outcomes. Knowledge of a strong causal relationship between services provided and the final outcome enables confidence in assuming the care provided was largely responsible for the outcome achieved (Courtney et al., Aust J Adv Nurs 26:49-57, 2009). The Department of Health has recently reported on the findings of The National Aged Care Quality Indicator Program - Home Care Pilot (KPMG, National Aged Care Quality Indicator Program - Home Care Pilot, 2017). The Program sought to test various tools to measure quality of life outcomes of their community aged care programs. Some of the key issues raised in the study reiterate the findings from The Australian Community Care Outcome Measurement (ACCOM) pilot study (Cardona et al., Australas J Ageing 36: 69-71, 2017), including the value of the ASCOT SCT4 tool (Adult Social care Outcomes Toolkit, http://www.pssru.ac.uk/ascot/downloads/questionnaires/sct4.pdf ) to measure social care related quality of life (SCRQoL) in community aged care programs in the Australian context, the collection of additional data to map the relationship of various variables such as functional ability, demographic characteristics and quality of life scores and the governance and administration of measurement tools for the purpose of quality reporting and consumer choice.

Measurement properties of outcome measures for vitiligo. A systematic review.

PubMed

Vrijman, Charlotte; Linthorst Homan, May W; Limpens, Jacqueline; van der Veen, Wietze; Wolkerstorfer, Albert; Terwee, Caroline B; Spuls, Phyllis I

2012-11-01

OBJECTIVE To summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes, measuring any construct of interest in patients with all types of vitiligo. DATA SOURCES Electronic databases including PubMed (1948 to July 2011), OVID EMBASE (1980 to July 2011), and CINAHL (EBSCOhost) (1982 to July 2011) were searched. STUDY SELECTION Two authors independently screened all records for eligibility. For inclusion, the study population had to include patients with vitiligo, for which outcome measures were developed or evaluated on their measurement properties. The initial search retrieved 1249 records, of which 14 articles met the inclusion criteria. DATA EXTRACTION Characteristics of the included instruments, study population, and results of the measurement properties were extracted. The Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) 4-point checklist, combined with quality criteria for measurement properties, was used to calculate the overall level of evidence per measurement property of each instrument. Independent extraction and assessment was performed by 2 authors. DATA SYNTHESIS Eleven different measurement instruments were identified. Strong evidence was found for a positive internal consistency of the Dermatology Life Quality Index. For other instruments, the evidence of measurement properties was limited or unknown. CONCLUSIONS Recommendations on the use of specific outcome measures for vitiligo should be formulated with caution because current evidence is insufficient owing to a low number of studies with poor methodological quality and unclear clinical relevance. To recommend outcome measures for vitiligo, further research on measurement properties of clinical relevant outcome measures for vitiligo according to COSMIN quality criteria is needed.

The multi-dimensional measure of informed choice: a validation study.

PubMed

Michie, Susan; Dormandy, Elizabeth; Marteau, Theresa M

2002-09-01

The aim of this prospective study is to assess the reliability and validity of a multi-dimensional measure of informed choice (MMIC). Participants were 225 pregnant women in two general hospitals in the UK, women receiving low-risk results following serum screening for Down syndrome. The MMIC was administered before testing and the Ottawa Decisional Conflict Scale was administered 6 weeks later. The component scales of the MMIC, knowledge and attitude, were internally consistent (alpha values of 0.68 and 0.78, respectively). Those who made a choice categorised as informed using the MMIC rated their decision 6 weeks later as being more informed, better supported and of higher quality than women whose choice was categorised as uninformed. This provides evidence of predictive validity, whilst the lack of association between the MMIC and anxiety shows construct (discriminant) validity. Thus, the MMIC has been shown to be psychometrically robust in pregnant women offered the choice to undergo prenatal screening for Down syndrome and receiving a low-risk result. Replication of this finding in other groups, facing other decisions, with other outcomes, should be assessed in future research.

Neuro-QoL health-related quality of life measurement system: Validation in Parkinson's disease.

PubMed

Nowinski, Cindy J; Siderowf, Andrew; Simuni, Tanya; Wortman, Catherine; Moy, Claudia; Cella, David

2016-05-01

Neuro-QoL is a multidimensional patient-reported outcome measurement system assessing aspects of physical, mental, and social health identified by neurology patients and caregivers as important. One of the first neurology-specific patient-reported outcome measure systems created using modern test development methods, Neuro-Qol enables brief, yet precise, assessment and the ability to conduct both PD-specific and cross-disease comparisons. We present results of Neuro-QoL clinical validation using a sample of PD patients. A total of 120 PD patients recruited from academic medical centers were assessed at baseline, 1 week, and 6 months. Assessments included Neuro-QoL and general and PD-specific validity measures. Participants were 62% male and 95% white (average age = 66); H & Y stages were 1 (16%), 2 (61%), 3 (18%), and 4 (5%). Internal consistency and test-retest reliability of Neuro-QoL ranged from Cronbach's alphas = 0.81 to 0.94 with intraclass correlation coefficients = 0.66 to 0.80. Pearson's correlations between Neuro-QoL and legacy measures were generally moderate and in expected directions. UPDRS Part 2 was moderately correlated with Neuro-QoL Upper Extremity and Mobility, respectively (r's = -0.44; -0.59). Parkinson's Disease Questionnaire-39 and Neuro-QoL measures of similar constructs showed strong-to-moderate correlations (r's = 0.70-0.44). Neuro-QoL measures of fatigue, mobility, positive emotion, and emotional/behavioral control showed responsiveness to self-reported change. Neuro-QoL is valid for use in PD clinical research. Reliability for all but two measures is sufficient for group comparisons, with some evidence supporting responsiveness to change. Neuro-QoL possesses characteristics, such as brevity, flexibility in administration, and suitability, for cross-disease comparisons that may be advantageous to users in a variety of settings. © 2016 Movement Disorder Society. © 2016 International Parkinson and Movement Disorder

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

A "Learning Platform" Approach to Outcome Measurement in Fragile X Syndrome: A Preliminary Psychometric Study

ERIC Educational Resources Information Center

Hall, S. S.; Hammond, J. L.; Hirt, M.; Reiss, A. L.

2012-01-01

Background: Clinical trials of medications to alleviate the cognitive and behavioural symptoms of individuals with fragile X syndrome (FXS) are now underway. However, there are few reliable, valid and/or sensitive outcome measures available that can be directly administered to individuals with FXS. The majority of assessments employed in clinical…

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

PubMed Central

Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

2014-01-01

Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient

Development of a measure of hypodontia patients' expectations of the process and outcome of combined orthodontic and restorative treatment.

PubMed

Gassem, Afnan Ben; Foxton, Richard; Bister, Dirk; Newton, Tim

2016-12-01

To devise and assess the psychometric properties of a measure that investigates hypodontia patients' expectations of the process and outcome of combined orthodontic/restorative treatment. Specialised secondary care facility for individuals with hypodontia. Mixed research design with three phases: (a) Thematic analysis of data from individual interviews with 25 hypodontia patients/16 parents to generate the questionnaire items. (b) Questionnaire design, assessment of readability and face/content validity with 10 patients. (c) Survey of 32 new hypodontia patients to determine the internal consistency of the measure. Three main themes related to the treatment process emerged from the qualitative data: 'hypodontia clinic', 'orthodontic treatment' and 'restorative treatment'. Three main themes were also revealed relating to treatment outcome: 'changes in appearance', 'psychosocial changes' and 'functional changes'. A 28 item questionnaire was constructed using a mix of visual analogue scale (VAS) and categorical response format. The Flesch reading ease score of the measure was 78, equivalent to a reading age of 9-10 years. Face and content validity were good. The overall Cronbach's alpha was 0.80 while for the treatment process and treatment outcome subscales it was 0.71 and 0.88 respectively. A patient-based measure of the process and outcome of combined orthodontic/restorative treatment for hypodontia patients has been developed which has good face and construct validity and satisfactory internal consistency. Patient expectations of treatment are important in determining not only their satisfaction with treatment outcomes but also their engagement with the clinical process. This questionnaire is a first step in operationalising the expectations of hypodontia patients through assessment tools that can then determine whether pre-treatment counselling is required and aid the consent and treatment planning process, thus improving the quality of treatment provided by

Reliability and validity of the self-efficacy for exercise and outcome expectations for exercise scales with minority older adults.

PubMed

Resnick, Barbara; Luisi, Daria; Vogel, Amanda; Junaleepa, Piyatida

2004-01-01

Older African Americans and Latinos tend to exercise less than older Whites and are more likely to have chronic diseases that could benefit from exercise. Measurement of self-efficacy of exercise and exercise outcome expectations in this older population is required if exercise is to be monitored carefully and enhanced in this population. The purpose of this study was to test the reliability and validity of the Self-Efficacy for Exercise Scale (SEE) and Outcome Expectations for Exercise Scale (OEE) in a sample of African American and Latino older adults. A total of 166 individuals, 32 males (19%) and 134 females (81%) with an average age of 72.8 +/- 8.4 years participated in the study. The SEE and OEE scales were completed using face-to-face interviews. There was evidence of internal consistency for both scales with alphas of .89 and .90 for the SEE scale and .72 and .88 for the OEE scale. There was some evidence of validity for both scales based on confirmatory factor analysis and hypothesis testing, because factor loadings were greater than .50 in all but two items in the OEE, and there were significant relationships between self-efficacy and outcome expectations and exercise behavior at all testing time-points. The measurement models showed a fair fit of the data to the models. The study provided some evidence for the reliability and validity of the SEE and OEE when used with minority older adults, and it provides some guidelines for future scale revisions and use.

Concurrent validity of single-item measures of emotional exhaustion and depersonalization in burnout assessment.

PubMed

West, Colin P; Dyrbye, Liselotte N; Satele, Daniel V; Sloan, Jeff A; Shanafelt, Tait D

2012-11-01

Burnout is a common problem among physicians and physicians-in-training. The Maslach Burnout Inventory (MBI) is the gold standard for burnout assessment, but the length of this well-validated 22-item instrument can limit its feasibility for survey research. To evaluate the concurrent validity of two questions relative to the full MBI for measuring the association of burnout with published outcomes. DESIGN, PARTICIPANTS, AND MAIN MEASURES: The single questions "I feel burned out from my work" and "I have become more callous toward people since I took this job," representing the emotional exhaustion and depersonalization domains of burnout, respectively, were evaluated in published studies of medical students, internal medicine residents, and practicing surgeons. We compared predictive models for the association of each question, versus the full MBI, using longitudinal data on burnout and suicidality from 2006 and 2007 for 858 medical students at five United States medical schools, cross-sectional data on burnout and serious thoughts of dropping out of medical school from 2007 for 2222 medical students at seven United States medical schools, and cross-sectional data on burnout and unprofessional attitudes and behaviors from 2009 for 2566 medical students at seven United States medical schools. We also assessed results for longitudinal data on burnout and perceived major medical errors from 2003 to 2009 for 321 Mayo Clinic Rochester internal medicine residents and cross-sectional data on burnout and both perceived major medical errors and suicidality from 2008 for 7,905 respondents to a national survey of members of the American College of Surgeons. Point estimates of effect for models based on the single-item measures were uniformly consistent with those reported for models based on the full MBI. The single-item measures of emotional exhaustion and depersonalization exhibited strong associations with each published outcome (all p ≤ 0.008). No conclusion regarding

Reliability and validity of a measure of role functioning among people with psychiatric disabilities.

PubMed

Harris, Meredith; Gladman, Beverley; Hennessy, Nicole; Lloyd, Chris; Mowry, Bryan; Waghorn, Geoffrey

2011-06-01

The aim was to investigate the reliability and validity of the Socially Valued Role Classification Scale (SRCS), a domain-specific measure of role functioning designed for use with community residents with psychiatric disabilities. Test-retest reliability, concurrent validity, face validity, consumer and clinician acceptability and utility were examined. Sixty community residents with schizophrenia or schizoaffective disorder participated in this study where the SRCS was administered by telephone. Test-retest reliability showed good or very good agreement for subscale scores (intraclass correlations (ICCs): 0.78-0.89) and for items capturing amount of participation in domain-specific activities (ICC: 0.67-1.00). Greater variation was observed for items capturing assistance required with activities (κ: 0.40-0.75), and standard of activities performed (κ: 0.43-1.00). Concurrent validity was supported by moderate to very good associations in the directions expected. Face validity, user acceptability and utility in telephone interviews were adequate. These findings add to previous psychometric evidence and support the continued development of the SRCS for use in community mental health settings. The SRCS has promising utility for occupational therapists involved in psychiatric rehabilitation outcome measurement. © 2011 Queensland Health - QCMHR. Australian Occupational Therapy Journal © 2011 Australian Association of Occupational Therapists.

Validity and reliability of the Dutch version of the Copenhagen Hip And Groin Outcome Score (HAGOS-NL) in patients with hip pathology.

PubMed

Giezen, Hilde; Stevens, Martin; van den Akker-Scheek, Inge; Reininga, Inge H F

2017-01-01

The Copenhagen Hip And Groin Outcome Score (HAGOS) was developed to assess disease-specific consequences in young to middle-aged, physically active hip and/or groin patients. The study aimed to determine validity and reliability of the Dutch version of the HAGOS (HAGOS-NL) for middle-aged patients with hip complaints. To assess validity, 117 participants completed five questionnaires: HAGOS-NL, international Hip Outcome Tool (iHOT-12NL), Hip disability and Osteoarthritis Outcome Score (HOOS), RAND-36 Health Survey and Tegner activity scale. Structural validity was determined by conducting confirmatory factor analysis. Construct validity was analyzed by formulating predefined hypotheses regarding relationships between the HAGOS-NL and subscales of the iHOT-12NL, HOOS, RAND-36 and Tegner activity scale. The HAGOS-NL was filled out again by 67 patients to explore test-retest reliability. Reliability was assessed in terms of Cronbach's alpha, Intraclass Correlation Coefficient (ICC), Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC). The Bland and Altman method was used to explore absolute agreement. Factor analysis confirmed that the HAGOS-NL consists of six subscales. All hypotheses were confirmed, indicating good construct validity. Internal consistency was good, with Cronbach's alpha values ranging from 0.89 to 0.98. Test-retest reliability was considered good, with ICC values of 0.80 and higher. The SEM ranged from 6.6 to 12.3, and MDC at individual level from 18.3 to 34.1 and at group level from 2.3 to 4.4. Bland and Altman analyses showed no bias. The HAGOS-NL is a reliable and valid instrument for measuring pain, physical functioning and quality of life in middle-aged patients with hip complaints.

Validation of Functional Reaching Volume as an Outcome Measure across the Spectrum of Abilities in Muscular Dystrophy

DTIC Science & Technology

2017-09-01

interactive video game regardless of ambulatory status. The objective of this project is to produce a trial ready outcome measure that will enable clinical...custom-designed video game using the Microsoft Kinect camera, measures functional reaching volume (FRV) across the spectrum of the disease in DMD...Kinect, video game , clinical trial readiness, neuromuscular disease, Soliton, functional reaching volume 3. ACCOMPLISHMENTS: The PI is reminded

What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures.

PubMed

Frost, Rachael; Levati, Sara; McClurg, Doreen; Brady, Marian; Williams, Brian

2017-06-01

To systematically review methods for measuring adherence used in home-based rehabilitation trials and to evaluate their validity, reliability, and acceptability. In phase 1 we searched the CENTRAL database, NHS Economic Evaluation Database, and Health Technology Assessment Database (January 2000 to April 2013) to identify adherence measures used in randomized controlled trials of allied health professional home-based rehabilitation interventions. In phase 2 we searched the databases of MEDLINE, Embase, CINAHL, Allied and Complementary Medicine Database, PsycINFO, CENTRAL, ProQuest Nursing and Allied Health, and Web of Science (inception to April 2015) for measurement property assessments for each measure. Studies assessing the validity, reliability, or acceptability of adherence measures. Two reviewers independently extracted data on participant and measure characteristics, measurement properties evaluated, evaluation methods, and outcome statistics and assessed study quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. In phase 1 we included 8 adherence measures (56 trials). In phase 2, from the 222 measurement property assessments identified in 109 studies, 22 high-quality measurement property assessments were narratively synthesized. Low-quality studies were used as supporting data. StepWatch Activity Monitor validly and acceptably measured short-term step count adherence. The Problematic Experiences of Therapy Scale validly and reliably assessed adherence to vestibular rehabilitation exercises. Adherence diaries had moderately high validity and acceptability across limited populations. The Borg 6 to 20 scale, Bassett and Prapavessis scale, and Yamax CW series had insufficient validity. Low-quality evidence supported use of the Joint Protection Behaviour Assessment. Polar A1 series heart monitors were considered acceptable by 1 study. Current rehabilitation adherence measures are limited. Some possess

Measuring School Climate for Gauging Principal Performance: A Review of the Validity and Reliability of Publicly Accessible Measures. A Quality School Leadership Issue Brief

ERIC Educational Resources Information Center

Clifford, Matthew; Menon, Roshni; Gangi, Tracy; Condon, Christopher; Hornung, Katie

2012-01-01

This policy brief provides principal evaluation system designers information about the technical soundness and cost (i.e., time requirements) of publicly available school climate surveys. The authors focus on the technical soundness of school climate surveys because they believe that using validated and reliable surveys as an outcomes measure can…

Anxiety measures validated in perinatal populations: a systematic review.

PubMed

Meades, Rose; Ayers, Susan

2011-09-01

Research and screening of anxiety in the perinatal period is hampered by a lack of psychometric data on self-report anxiety measures used in perinatal populations. This paper aimed to review self-report measures that have been validated with perinatal women. A systematic search was carried out of four electronic databases. Additional papers were obtained through searching identified articles. Thirty studies were identified that reported validation of an anxiety measure with perinatal women. Most commonly validated self-report measures were the General Health Questionnaire (GHQ), State-Trait Anxiety Inventory (STAI), and Hospital Anxiety and Depression Scales (HADS). Of the 30 studies included, 11 used a clinical interview to provide criterion validity. Remaining studies reported one or more other forms of validity (factorial, discriminant, concurrent and predictive) or reliability. The STAI shows criterion, discriminant and predictive validity and may be most useful for research purposes as a specific measure of anxiety. The Kessler 10 (K-10) may be the best short screening measure due to its ability to differentiate anxiety disorders. The Depression Anxiety Stress Scales 21 (DASS-21) measures multiple types of distress, shows appropriate content, and remains to be validated against clinical interview in perinatal populations. Nineteen studies did not report sensitivity or specificity data. The early stages of research into perinatal anxiety, the multitude of measures in use, and methodological differences restrict comparison of measures across studies. There is a need for further validation of self-report measures of anxiety in the perinatal period to enable accurate screening and detection of anxiety symptoms and disorders. Copyright © 2010 Elsevier B.V. All rights reserved.

Mapping health outcome measures from a stroke registry to EQ-5D weights

PubMed Central

2013-01-01

Purpose To map health outcome related variables from a national register, not part of any validated instrument, with EQ-5D weights among stroke patients. Methods We used two cross-sectional data sets including patient characteristics, outcome variables and EQ-5D weights from the national Swedish stroke register. Three regression techniques were used on the estimation set (n = 272): ordinary least squares (OLS), Tobit, and censored least absolute deviation (CLAD). The regression coefficients for “dressing“, “toileting“, “mobility”, “mood”, “general health” and “proxy-responders” were applied to the validation set (n = 272), and the performance was analysed with mean absolute error (MAE) and mean square error (MSE). Results The number of statistically significant coefficients varied by model, but all models generated consistent coefficients in terms of sign. Mean utility was underestimated in all models (least in OLS) and with lower variation (least in OLS) compared to the observed. The maximum attainable EQ-5D weight ranged from 0.90 (OLS) to 1.00 (Tobit and CLAD). Health states with utility weights <0.5 had greater errors than those with weights ≥0.5 (P < 0.01). Conclusion This study indicates that it is possible to map non-validated health outcome measures from a stroke register into preference-based utilities to study the development of stroke care over time, and to compare with other conditions in terms of utility. PMID:23496957

An Electronic Patient-Reported Outcome Measures System in UK Chiropractic Practices: A Feasibility Study of Routine Collection of Outcomes and Costs.

PubMed

Newell, Dave; Diment, Emily; Bolton, Jenni E

2016-01-01

The purpose of this study was to test the feasibility of collecting valid and widely used health outcomes, including information concerning cost of care, using a Web-based patient-driven patient-reported outcome measure (PROM) collection process within a cohort of UK chiropractic practices. A Web-based PROM system (Care Response) was used. Patients with low back and neck pain were recruited from a group of chiropractic practices located in the United Kingdom. Information collected included demographic data, generic and condition-specific PROMs at the initial consultation and 90 days later, patient-reported experience measures, and additional health seeking to estimate costs of care. A group of 33 clinics provided information from a total of 1895 patients who completed baseline questionnaires with 844 (45%) completing the measures at 90-day follow-up. Subsequent outcomes suggest that more than 70% of patients improved over the course of treatment regardless of the outcome used. Using the baseline as a virtual counterfactual with respect to follow-up, we calculated quality-adjusted life years and the cost thereof resulting in a mean quality-adjusted life years gained of 0.8 with an average cost of £895 per quality-adjusted life year. Routine collection of PROMs, including information about cost, is feasible and can be achieved using an online system within a clinical practice environment. We describe a Web-based collection system and discuss the choice of measures leading to a comprehensive understanding of outcomes and costs in routine practice. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

Dental neglect and adverse birth outcomes: a validation and observational study.

PubMed

Acharya, S; Pentapati, K C; Bhat, P V

2013-05-01

The objectives of this study were to validate the Indian translation of the Dental Neglect Scale (DNS) among a sample of parturient Indian women and to investigate dental neglect as a possible risk indicator in adverse birth outcomes. Three hundred and sixteen parturient women were administered the DNS and the Modified Dental Beliefs Scale (MDBS) and were also clinically examined for oral health status. Information regarding socio-economic status, weeks of gestation and birth weight was also collected. A gestation period of less than 37 weeks was considered as preterm and a birth weight of less than 2500 gm as 'low birth weight'. The Indian version of the DNS was found to be reliable (Cronbach's Alpha = 0.72) and valid for assessing dental neglect among the women. Factor analysis of the DNS revealed a two-factor structure accounting for 56% variance. Dental neglect was higher among those with poorer oral health status, lower socio-economic and educational status. Multinomial logistic regression showed high dental neglect and negative dental beliefs and not poor oral health, as significant risk indicators for occurrence of adverse birth outcomes. The finding of an association of adverse birth outcomes with dental neglect and beliefs, but not with poor oral health could be due to the influence of other more important general factors which had a direct bearing on birth outcomes. There is a need for further research to assess the role of behavioural factors like dental neglect as risk indicators for adverse birth outcomes. © 2012 John Wiley & Sons A/S.

A user's survey of the clinical application and content validity of the DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure.

PubMed

Kennedy, Carol A; Beaton, Dorcas E

Survey. To elicit feedback on the clinical use and content validity of the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure from frontline users of the instrument. A cross-sectional survey was administered to registered DASH users and inquired about how the DASH was being used and to identify the informational value of items of the DASH (content validity). About 172 completed the survey. One or both of the DASH and/or QuickDASH were consistently (89.5%) being used. About 90% were using it in adults (21-65 years), and at least 70% were using it across the entire extremity, and to a lesser extent, 10% reported using it in isolated neck injuries. Most respondents (66.9%-75.8%) were using the DASH in musculoskeletal (MSK) disorders, with some applying it for other more unique or non-MSK conditions (2.5%-16.6%). All but 1 of the 30 DASH items had at least 10% endorsement as being informative, and 4 items were identified as being problematic by greater than 20%. The DASH is being used as intended (whole extremity and MSK conditions), and in addition, it is being used in different body regions and diverse conditions. Not applicable (descriptive survey). Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Measuring awareness of financial skills: reliability and validity of a new measure.

PubMed

Cramer, K; Tuokko, H A; Mateer, C A; Hultsch, D F

2004-03-01

This paper examines the psychometric properties of a three-part (participant, informant, and performance) Measure for assessing Awareness of Financial Skills (MAFS). The MAFS was administered to 10 seniors with dementia and 25 well-functioning seniors, and their informants. Measures of cognitive functioning, social desirability, neuroticism, and perceived control were administered to each participant to allow for an assessment of validity. Internal consistency estimates for the participant and informant questionnaires were found to be 0.92 and 0.97, respectively. Convergent validity analysis indicated that performance on this measure was related to level of cognitive functioning, with higher level of unawareness associated with decreased cognitive ability. Discriminant validity analysis showed that performance on this measure was not related to social desirability or neuroticism. This study provides evidence that the MAFS is a reliable and valid tool for assessing awareness of financial skills in older adults.

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

Functional outcomes assessment in shoulder surgery

PubMed Central

Wylie, James D; Beckmann, James T; Granger, Erin; Tashjian, Robert Z

2014-01-01

The effective evaluation and management of orthopaedic conditions including shoulder disorders relies upon understanding the level of disability created by the disease process. Validated outcome measures are critical to the evaluation process. Traditionally, outcome measures have been physician derived objective evaluations including range of motion and radiologic evaluations. However, these measures can marginalize a patient’s perception of their disability or outcome. As a result of these limitations, patient self-reported outcomes measures have become popular over the last quarter century and are currently primary tools to evaluate outcomes of treatment. Patient reported outcomes measures can be general health related quality of life measures, health utility measures, region specific health related quality of life measures or condition specific measures. Several patients self-reported outcomes measures have been developed and validated for evaluating patients with shoulder disorders. Computer adaptive testing will likely play an important role in the arsenal of measures used to evaluate shoulder patients in the future. The purpose of this article is to review the general health related quality-of-life measures as well as the joint-specific and condition specific measures utilized in evaluating patients with shoulder conditions. Advances in computer adaptive testing as it relates to assessing dysfunction in shoulder conditions will also be reviewed. PMID:25405091

A systematic review of patient-reported outcome measures in clinical vestibular research

PubMed Central

Fong, Eric; Li, Carol; Aslakson, Rebecca; Agrawal, Yuri

2014-01-01

Objective To identify the most commonly-used patient-reported outcome (PRO) measures in clinical vestibular research, and assess their test characteristics and applicability to study age-related vestibular loss (ARVL) in clinical trials. Data Sources We performed a systematic review of the PubMed, CINAHL, and PsycINFO databases from 1950 to August 13, 2013. Study Selection PRO measures were defined as outcomes that capture the subjective experience of the patient, such as symptoms, functional status, health perceptions, and quality of life. Two independent reviewers selected studies that used PRO measures in clinical vestibular research. Disparities were resolved with consensus between the reviewers. Of 2260 articles initially found on literature search, 255 full-text articles were retrieved for assessment. One-hundred and four studies met inclusion criteria for data collection. Data Extraction PRO measures were identified by two independent reviewers. The four most commonly used PROs were evaluated for their applicability to the condition of ARVL. Specifically, for these four PROs, data were collected pertaining to instrument test-retest reliability, item domains, and target population of the instrument. Data Synthesis A total of 50 PRO instruments were identified. The four most frequently utilized PROs were the Dizziness Handicap Inventory (DHI), the Activities-specific Balance Confidence (ABC) scale, the Vertigo Symptom Scale (VSS), and the Visual Analogue Scale (VAS). Of these four PROs, three were validated for use in patients with vestibular disease, and one was validated in community-dwelling older individuals with balance impairments. Items across the four PROs were categorized into three domains based on the International Classification of Functioning, Disability and Health: Activity, Participation, and Body Functions and Structures. Conclusions None of the most commonly-used PRO instruments were validated for use in community-dwelling older adults

The development and evaluation of content validity of the Zambia Spina Bifida Functional Measure: Preliminary studies

PubMed Central

Amosun, Seyi L.; Shilalukey-Ngoma, Mary P.; Kafaar, Zuhayr

2017-01-01

Background Very little is known on outcome measures for children with spina bifida (SB) in Zambia. If rehabilitation professionals managing children with SB in Zambia and other parts of sub-Saharan Africa are to instigate measuring outcomes routinely, a tool has to be made available. The main objective of this study was to develop an appropriate and culturally sensitive instrument for evaluating the impact of the interventions on children with SB in Zambia. Methods A mixed design method was used for the study. Domains were identified retrospectively and confirmation was done through a systematic review study. Items were generated through semi-structured interviews and focus group discussions. Qualitative data were downloaded, translated into English, transcribed verbatim and presented. These were then placed into categories of the main domains of care deductively through the process of manifest content analysis. Descriptive statistics, alpha coefficient and index of content validity were calculated using SPSS. Results Self-care, mobility and social function were identified as main domains, while participation and communication were sub-domains. A total of 100 statements were generated and 78 items were selected deductively. An alpha coefficient of 0.98 was computed and experts judged the items. Conclusions The new functional measure with an acceptable level of content validity titled Zambia Spina Bifida Functional Measure (ZSBFM) was developed. It was designed to evaluate effectiveness of interventions given to children with SB from the age of 6 months to 5 years. Psychometric properties of reliability and construct validity were tested and are reported in another study. PMID:28951850

Construct validity of the canadian occupational performance measure in participants with tendon injury and Dupuytren disease.

PubMed

van de Ven-Stevens, Lucelle A W; Graff, Maud J L; Peters, Marlijn A M; van der Linde, Harmen; Geurts, Alexander C H

2015-05-01

In patient-centered practice, instruments need to assess outcomes that are meaningful to patients with hand conditions. It is unclear which assessment tools address these subjective perspectives best. The aim of this study was to establish the construct validity of the Canadian Occupational Performance Measure (COPM) in relation to the Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire and the Michigan Hand Outcomes Questionnaire (MHQ) in people with hand conditions. It was hypothesized that COPM scores would correlate with DASH and MHQ total scores only to a moderate degree and that the COPM, DASH questionnaire, and MHQ would all correlate weakly with measures of hand impairments. This was a validation study. The COPM, DASH questionnaire, and MHQ were scored, and then hand impairments were measured (pain [numerical rating scale], active range of motion [goniometer], grip strength [dynamometer], and pinch grip strength [pinch meter]). People who had received postsurgery rehabilitation for flexor tendon injuries, extensor tendon injuries, or Dupuytren disease were eligible. Seventy-two participants were included. For all diagnosis groups, the Pearson coefficient of correlation between the DASH questionnaire and the MHQ was higher than .60, whereas the correlation between the performance scale of the COPM and either the DASH questionnaire or the MHQ was lower than .51. Correlations of these assessment tools with measures of hand impairments were lower than .46. The small sample sizes may limit the generalization of the results. The results supported the hypotheses and, thus, the construct validity of the COPM after surgery in people with hand conditions. © 2015 American Physical Therapy Association.

Development and validation of brief scales to measure emotional and behavioural problems among Chinese adolescents

PubMed Central

Shen, Minxue; Hu, Ming; Sun, Zhenqiu

2017-01-01

Objectives To develop and validate brief scales to measure common emotional and behavioural problems among adolescents in the examination-oriented education system and collectivistic culture of China. Setting Middle schools in Hunan province. Participants 5442 middle school students aged 11–19 years were sampled. 4727 valid questionnaires were collected and used for validation of the scales. The final sample included 2408 boys and 2319 girls. Primary and secondary outcome measures The tools were assessed by the item response theory, classical test theory (reliability and construct validity) and differential item functioning. Results Four scales to measure anxiety, depression, study problem and sociality problem were established. Exploratory factor analysis showed that each scale had two solutions. Confirmatory factor analysis showed acceptable to good model fit for each scale. Internal consistency and test–retest reliability of all scales were above 0.7. Item response theory showed that all items had acceptable discrimination parameters and most items had appropriate difficulty parameters. 10 items demonstrated differential item functioning with respect to gender. Conclusions Four brief scales were developed and validated among adolescents in middle schools of China. The scales have good psychometric properties with minor differential item functioning. They can be used in middle school settings, and will help school officials to assess the students’ emotional/behavioural problems. PMID:28062469

Measuring Psychobiosocial States in Sport: Initial Validation of a Trait Measure

PubMed Central

Bertollo, Maurizio; Ruiz, Montse C.; Bortoli, Laura

2016-01-01

We examined the item characteristics, the factor structure, and the concurrent validity of a trait measure of psychobiosocial states. In Study 1, Italian athletes (N = 342, 228 men, 114 women, Mage = 23.93, SD = 6.64) rated the intensity, the frequency, and the perceived impact dimensions of a psychobiosocial states scale, trait version (PBS-ST), which is composed of 20 items (10 functional and 10 dysfunctional) referring to how they usually felt before an important competition. In Study 2, the scale was cross validated in an independent sample (N = 251, 181 men, 70 women, Mage = 24.35, SD = 7.25). The concurrent validity of the PBS-ST scale scores were also examined in comparison with two sport-specific emotion-related measures and a general measure of affect. Exploratory structural equation modeling and confirmatory factor analysis of the data of Study 1 showed that a 2-factor, 15-item solution of the PBS-ST scale (8 functional items and 7 dysfunctional items) reached satisfactory fit indices for the three dimensions (i.e., intensity, frequency, and perceived impact). Results of Study 2 provided evidence of substantial measurement and structural invariance of all dimensions across samples. The low association of the PBS-ST scale with other measures suggests that the scale taps unique constructs. Findings of the two studies offer initial validity evidence for a sport-specific tool to measure psychobiosocial states. PMID:27907111

Measurement of fatigue: Comparison of the reliability and validity of single-item and short measures to a comprehensive measure.

PubMed

Kim, Hee-Ju; Abraham, Ivo

2017-01-01

Evidence is needed on the clinicometric properties of single-item or short measures as alternatives to comprehensive measures. We examined whether two single-item fatigue measures (i.e., Likert scale, numeric rating scale) or a short fatigue measure were comparable to a comprehensive measure in reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, concurrent, and predictive validity) in Korean young adults. For this quantitative study, we selected the Functional Assessment of Chronic Illness Therapy-Fatigue for the comprehensive measure and the Profile of Mood States-Brief, Fatigue subscale for the short measure; and constructed two single-item measures. A total of 368 students from four nursing colleges in South Korea participated. We used Cronbach's alpha and item-total correlation for internal consistency reliability and intraclass correlation coefficient for test-retest reliability. We assessed Pearson's correlation with a comprehensive measure for convergent validity, with perceived stress level and sleep quality for concurrent validity and the receiver operating characteristic curve for predictive validity. The short measure was comparable to the comprehensive measure in internal consistency reliability (Cronbach's alpha=0.81 vs. 0.88); test-retest reliability (intraclass correlation coefficient=0.66 vs. 0.61); convergent validity (r with comprehensive measure=0.79); concurrent validity (r with perceived stress=0.55, r with sleep quality=0.39) and predictive validity (area under curve=0.88). Single-item measures were not comparable to the comprehensive measure. A short fatigue measure exhibited similar levels of reliability and validity to the comprehensive measure in Korean young adults. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Predicting functional outcomes among college drinkers: reliability and predictive validity of the Young Adult Alcohol Consequences Questionnaire.

PubMed

Read, Jennifer P; Merrill, Jennifer E; Kahler, Christopher W; Strong, David R

2007-11-01

Heavy drinking and associated consequences are widespread among U.S. college students. Recently, Read et al. (Read, J. P., Kahler, C. W., Strong, D., & Colder, C. R. (2006). Development and preliminary validation of the Young Adult Alcohol Consequences Questionnaire. Journal of Studies on Alcohol, 67, 169-178) developed the Young Adult Alcohol Consequences Questionnaire (YAACQ) to assess the broad range of consequences that may result from heavy drinking in the college milieu. In the present study, we sought to add to the psychometric validation of this measure by employing a prospective design to examine the test-retest reliability, concurrent validity, and predictive validity of the YAACQ. We also sought to examine the utility of the YAACQ administered early in the semester in the prediction of functional outcomes later in the semester, including the persistence of heavy drinking, and academic functioning. Ninety-two college students (48 females) completed a self-report assessment battery during the first weeks of the Fall semester, and approximately one week later. Additionally, 64 subjects (37 females) participated at an optional third time point at the end of the semester. Overall, the YAACQ demonstrated strong internal consistency, test-retest reliability, and concurrent and predictive validity. YAACQ scores also were predictive of both drinking frequency, and "binge" drinking frequency. YAACQ total scores at baseline were an early indicator of academic performance later in the semester, with greater number of total consequences experienced being negatively associated with end-of-semester grade point average. Specific YAACQ subscale scores (Impaired Control, Dependence Symptoms, Blackout Drinking) showed unique prediction of persistent drinking and academic outcomes.

The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity.

PubMed

Varni, James W; Burwinkle, Tasha M; Seid, Michael; Skarr, Douglas

2003-01-01

The application of health-related quality of life (HRQOL) as a pediatric population health measure may facilitate risk assessment and resource allocation, the tracking of community health, the identification of health disparities, and the determination of health outcomes from interventions and policy decisions. To determine the feasibility, reliability, and validity of the 23-item PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales as a measure of pediatric population health for children and adolescents. Mail survey in February and March 2001 to 20 031 families with children ages 2-16 years throughout the State of California encompassing all new enrollees in the State's Children's Health Insurance Program (SCHIP) for those months and targeted language groups. The PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by 10 241 families through a statewide mail survey to evaluate the HRQOL of new enrollees in SCHIP. The PedsQL 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha =.89 child;.92 parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQL 4.0 was also related to indicators of health care access, days missed from school, days sick in bed or too ill to play, and days needing care. The results demonstrate the feasibility, reliability, and validity of the PedsQL 4.0 as a pediatric population health outcome. Measuring pediatric HRQOL may be a way to evaluate the health outcomes of SCHIP.

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review

PubMed Central

Kyte, Derek; Cockwell, Paul; Marshall, Tom; Gheorghe, Adrian; Keeley, Thomas; Slade, Anita; Calvert, Melanie

2017-01-01

Background Patient-reported outcome measures (PROMs) can provide valuable information which may assist with the care of patients with chronic kidney disease (CKD). However, given the large number of measures available, it is unclear which PROMs are suitable for use in research or clinical practice. To address this we comprehensively evaluated studies that assessed the measurement properties of PROMs in adults with CKD. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the methodological quality of the included studies and to inform a best evidence synthesis for each PROM. Results The search strategy retrieved 3,702 titles/abstracts. After 288 duplicates were removed, 3,414 abstracts were screened and 71 full-text articles were retrieved for further review. Of these, 24 full-text articles were excluded as they did not meet the eligibility criteria. Following reference list and citation searching, 19 articles were retrieved bringing the total number of papers included in the final analysis to 66. There was strong evidence supporting internal consistency and moderate evidence supporting construct validity for the Kidney Disease Quality of Life-36 (KDQOL-36) in pre-dialysis patients. In the dialysis population, the KDQOL-Short Form (KDQOL-SF) had strong evidence for internal consistency and structural validity and moderate evidence for test-retest reliability and construct validity while the KDQOL-36 had moderate evidence of internal consistency, test-retest reliability and construct validity. The End Stage Renal Disease-Symptom Checklist Transplantation Module (ESRD-SCLTM) demonstrated strong evidence for internal consistency and moderate evidence for test-retest reliability, structural and construct validity in renal transplant recipients. Conclusions We suggest considering the

Reliability and Validity of Survey Instruments to Measure Work-Related Fatigue in the Emergency Medical Services Setting: A Systematic Review.

PubMed

Patterson, P Daniel; Weaver, Matthew D; Fabio, Anthony; Teasley, Ellen M; Renn, Megan L; Curtis, Brett R; Matthews, Margaret E; Kroemer, Andrew J; Xun, Xiaoshuang; Bizhanova, Zhadyra; Weiss, Patricia M; Sequeira, Denisse J; Coppler, Patrick J; Lang, Eddy S; Higgins, J Stephen

2018-02-15

This study sought to systematically search the literature to identify reliable and valid survey instruments for fatigue measurement in the Emergency Medical Services (EMS) occupational setting. A systematic review study design was used and searched six databases, including one website. The research question guiding the search was developed a priori and registered with the PROSPERO database of systematic reviews: "Are there reliable and valid instruments for measuring fatigue among EMS personnel?" (2016:CRD42016040097). The primary outcome of interest was criterion-related validity. Important outcomes of interest included reliability (e.g., internal consistency), and indicators of sensitivity and specificity. Members of the research team independently screened records from the databases. Full-text articles were evaluated by adapting the Bolster and Rourke system for categorizing findings of systematic reviews, and the rated data abstracted from the body of literature as favorable, unfavorable, mixed/inconclusive, or no impact. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology was used to evaluate the quality of evidence. The search strategy yielded 1,257 unique records. Thirty-four unique experimental and non-experimental studies were determined relevant following full-text review. Nineteen studies reported on the reliability and/or validity of ten different fatigue survey instruments. Eighteen different studies evaluated the reliability and/or validity of four different sleepiness survey instruments. None of the retained studies reported sensitivity or specificity. Evidence quality was rated as very low across all outcomes. In this systematic review, limited evidence of the reliability and validity of 14 different survey instruments to assess the fatigue and/or sleepiness status of EMS personnel and related shift worker groups was identified.

Using standardised patients to measure physicians' practice: validation study using audio recordings

PubMed Central

Luck, Jeff; Peabody, John W

2002-01-01

Objective To assess the validity of standardised patients to measure the quality of physicians' practice. Design Validation study of standardised patients' assessments. Physicians saw unannounced standardised patients presenting with common outpatient conditions. The standardised patients covertly tape recorded their visit and completed a checklist of quality criteria immediately afterwards. Their assessments were compared against independent assessments of the recordings by a trained medical records abstractor. Setting Four general internal medicine primary care clinics in California. Participants 144 randomly selected consenting physicians. Main outcome measures Rates of agreement between the patients' assessments and independent assessment. Results 40 visits, one per standardised patient, were recorded. The overall rate of agreement between the standardised patients' checklists and the independent assessment of the audio transcripts was 91% (κ=0.81). Disaggregating the data by medical condition, site, level of physicians' training, and domain (stage of the consultation) gave similar rates of agreement. Sensitivity of the standardised patients' assessments was 95%, and specificity was 85%. The area under the receiver operator characteristic curve was 90%. Conclusions Standardised patients' assessments seem to be a valid measure of the quality of physicians' care for a variety of common medical conditions in actual outpatient settings. Properly trained standardised patients compare well with independent assessment of recordings of the consultations and may justify their use as a “gold standard” in comparing the quality of care across sites or evaluating data obtained from other sources, such as medical records and clinical vignettes. What is already known on this topicStandardised patients are valid and reliable reporters of physicians' practice in the medical education settingHowever, validating standardised patients' measurements of quality of care in

The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population-based study.

PubMed

Thyø, A; Emmertsen, K J; Pinkney, T D; Christensen, P; Laurberg, S

2017-01-01

The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Validating Dimensions of Psychosis Symptomatology: Neural Correlates and 20-year Outcomes

PubMed Central

Kotov, Roman; Foti, Dan; Li, Kaiqiao; Bromet, Evelyn J.; Hajcak, Greg; Ruggero, Camilo J.

2016-01-01

Heterogeneity of psychosis presents significant challenges for classification. Between two and 12 symptom dimensions have been proposed, and consensus is lacking. The present study sought to identify uniquely informative models by comparing the validity of these alternatives. An epidemiologic cohort of 628 first-admission inpatients with psychosis was interviewed 6 times over two decades and completed an electrophysiological assessment of error processing at year 20. We first analyzed a comprehensive set of 49 symptoms rated by interviewers at baseline, progressively extracting from one to 12 factors. Next, we compared the ability of resulting factor solutions to (a) account for concurrent neural dysfunction and (b) predict 20-year role, social, residential, and global functioning, and life satisfaction. A four-factor model showed incremental validity with all outcomes, and more complex models did not improve explanatory power. The four dimensions—reality distortion, disorganization, inexpressivity, and apathy/asociality—were replicable in 5 follow-ups, internally consistent, stable across assessments, and showed strong discriminant validity. These results reaffirm the value of separating disorganization and reality distortion, are consistent with recent findings distinguishing inexpressivity and apathy/asociality, and suggest that these four dimensions are fundamental to understanding neural abnormalities and long-term outcomes in psychosis. PMID:27819471

Validating dimensions of psychosis symptomatology: Neural correlates and 20-year outcomes.

PubMed

Kotov, Roman; Foti, Dan; Li, Kaiqiao; Bromet, Evelyn J; Hajcak, Greg; Ruggero, Camilo J

2016-11-01

Heterogeneity of psychosis presents significant challenges for classification. Between 2 and 12 symptom dimensions have been proposed, and consensus is lacking. The present study sought to identify uniquely informative models by comparing the validity of these alternatives. An epidemiologic cohort of 628 first-admission inpatients with psychosis was interviewed 6 times over 2 decades and completed an electrophysiological assessment of error processing at year 20. We first analyzed a comprehensive set of 49 symptoms rated by interviewers at baseline, progressively extracting from 1 to 12 factors. Next, we compared the ability of resulting factor solutions to (a) account for concurrent neural dysfunction and (b) predict 20-year role, social, residential, and global functioning, and life satisfaction. A four-factor model showed incremental validity with all outcomes, and more complex models did not improve explanatory power. The 4 dimensions-reality distortion, disorganization, inexpressivity, and apathy/asociality-were replicable in 5 follow-ups, internally consistent, stable across assessments, and showed strong discriminant validity. These results reaffirm the value of separating disorganization and reality distortion, are consistent with recent findings distinguishing inexpressivity and apathy/asociality, and suggest that these 4 dimensions are fundamental to understanding neural abnormalities and long-term outcomes in psychosis. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Web-based questionnaires to assess perinatal outcome proved to be valid.

PubMed

van Gelder, Marleen M H J; Vorstenbosch, Saskia; Derks, Lineke; Te Winkel, Bernke; van Puijenbroek, Eugène P; Roeleveld, Nel

2017-10-01

The objective of this study was to validate a Web-based questionnaire completed by the mother to assess perinatal outcome used in a prospective cohort study. For 882 women with an estimated date of delivery between February 2012 and February 2015 who participated in the PRegnancy and Infant DEvelopment (PRIDE) Study, we compared data on pregnancy outcome, including mode of delivery, plurality, gestational age, birth weight and length, head circumference, birth defects, and infant sex, from Web-based questionnaires administered to the mothers 2 months after delivery with data from obstetric records. For continuous variables, we calculated intraclass correlation coefficients (ICCs) with 95% confidence intervals (CIs), whereas sensitivity and specificity were determined for categorical variables. We observed only very small differences between the two methods of data collection for gestational age (ICC, 0.91; 95% CI, 0.90-0.92), birth weight (ICC, 0.96; 95% CI, 0.95-0.96), birth length (ICC, 0.90; 95% CI, 0.87-0.92), and head circumference (ICC, 0.88; 95% CI, 0.80-0.93). Agreement between the Web-based questionnaire and obstetric records was high as well, with sensitivity ranging between 0.86 (termination of pregnancy) and 1.00 (four outcomes) and specificity between 0.96 (term birth) and 1.00 (nine outcomes). Our study provides evidence that Web-based questionnaires could be considered as a valid complementary or alternative method of data collection. Copyright © 2017 Elsevier Inc. All rights reserved.

The International Dermatology Outcome Measures Group: formation of patient-centered outcome measures in dermatology.

PubMed

Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W; Abernethy, April; Duffin, Kristina Callis; Bhushan, Reva; Garg, Amit; Merola, Joseph F; Maccarone, Mara; Christensen, Robin

2015-02-01

As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Competency measurements: testing convergent validity for two measures.

PubMed

Cowin, Leanne S; Hengstberger-Sims, Cecily; Eagar, Sandy C; Gregory, Linda; Andrew, Sharon; Rolley, John

2008-11-01

This paper is a report of a study to investigate whether the Australian National Competency Standards for Registered Nurses demonstrate correlations with the Finnish Nurse Competency Scale. Competency assessment has become popular as a key regulatory requirement and performance indicator. The term competency, however, does not have a globally accepted definition and this has the potential to create controversy, ambiguity and confusion. Variations in meaning and definitions adopted in workplaces and educational settings will affect the interpretation of research findings and have implications for the nursing profession. A non-experimental cross-sectional survey design was used with a convenience sample of 116 new graduate nurses in 2005. The second version of the Australian National Competency Standards and the Nurse Competency Scale was used to elicit responses to self-assessed competency in the transitional year (first year as a Registered Nurse). Correlational analysis of self-assessed levels of competence revealed a relationship between the Australian National Competency Standards (ANCI) and the Nurse Competency Scale (NCS). The correlational relation between ANCI domains and NCS factors suggests that these scales are indeed used to measure related dimensions. A statistically significant relationship (r = 0.75) was found between the two competency measures. Although the finding of convergent validity is insufficient to establish construct validity for competency as used in both measures in this study, it is an important step towards this goal. Future studies on relationships between competencies must take into account the validity and reliability of the tools.

Validity and repeatability of inertial measurement units for measuring gait parameters.

PubMed

Washabaugh, Edward P; Kalyanaraman, Tarun; Adamczyk, Peter G; Claflin, Edward S; Krishnan, Chandramouli

2017-06-01

Inertial measurement units (IMUs) are small wearable sensors that have tremendous potential to be applied to clinical gait analysis. They allow objective evaluation of gait and movement disorders outside the clinic and research laboratory, and permit evaluation on large numbers of steps. However, repeatability and validity data of these systems are sparse for gait metrics. The purpose of this study was to determine the validity and between-day repeatability of spatiotemporal metrics (gait speed, stance percent, swing percent, gait cycle time, stride length, cadence, and step duration) as measured with the APDM Opal IMUs and Mobility Lab system. We collected data on 39 healthy subjects. Subjects were tested over two days while walking on a standard treadmill, split-belt treadmill, or overground, with IMUs placed in two locations: both feet and both ankles. The spatiotemporal measurements taken with the IMU system were validated against data from an instrumented treadmill, or using standard clinical procedures. Repeatability and minimally detectable change (MDC) of the system was calculated between days. IMUs displayed high to moderate validity when measuring most of the gait metrics tested. Additionally, these measurements appear to be repeatable when used on the treadmill and overground. The foot configuration of the IMUs appeared to better measure gait parameters; however, both the foot and ankle configurations demonstrated good repeatability. In conclusion, the IMU system in this study appears to be both accurate and repeatable for measuring spatiotemporal gait parameters in healthy young adults. Copyright © 2017 Elsevier B.V. All rights reserved.

Perceived Health Outcomes of Recreation Scale (PHORS): Reliability, Validity and Invariance

ERIC Educational Resources Information Center

Gómez, Edwin; Hill, Eddie; Zhu, Xihe; Freidt, Barbara

2016-01-01

This study examined the psychometric properties of the Perceived Health Outcomes of Recreation Scale (PHORS). Data for PHORS were collected from three different trail sites (Appalachian Trail, Pacific Crest Trail, and First Landing State Park) during three separate time periods, allowing for cross-validation and invariance testing. Exploratory…

Assessing reliability and validity measures in managed care studies.

PubMed

Montoya, Isaac D

2003-01-01

To review the reliability and validity literature and develop an understanding of these concepts as applied to managed care studies. Reliability is a test of how well an instrument measures the same input at varying times and under varying conditions. Validity is a test of how accurately an instrument measures what one believes is being measured. A review of reliability and validity instructional material was conducted. Studies of managed care practices and programs abound. However, many of these studies utilize measurement instruments that were developed for other purposes or for a population other than the one being sampled. In other cases, instruments have been developed without any testing of the instrument's performance. The lack of reliability and validity information may limit the value of these studies. This is particularly true when data are collected for one purpose and used for another. The usefulness of certain studies without reliability and validity measures is questionable, especially in cases where the literature contradicts itself

Patients' Experience of Myositis and Further Validation of a Myositis-specific Patient Reported Outcome Measure - Establishing Core Domains and Expanding Patient Input on Clinical Assessment in Myositis. Report from OMERACT 12.

PubMed

Regardt, Malin; Basharat, Pari; Christopher-Stine, Lisa; Sarver, Catherine; Björn, Anita; Lundberg, Ingrid E; Wook Song, Yeong; Bingham, Clifton O; Alexanderson, Helene

2015-12-01

The Outcome Measures in Rheumatology (OMERACT) myositis working group was established to examine patient-reported outcomes (PRO) as well as to validate patient-reported outcome measures (PROM) in myositis. Qualitative studies using focus group interviews and cognitive debriefing of the myositis-specific Myositis Activities Profile (MAP) were used to explore the experience of adults living with polymyositis (PM) and dermatomyositis (DM). Preliminary results underscore the importance of patient input in the development of PROM to ensure content validity. Results from multicenter focus groups indicate the range of symptoms experienced including pain, fatigue, and impaired cognitive function, which are not currently assessed in myositis. Preliminary cognitive debriefing of the MAP indicated that while content was deemed relevant and important, several activities were not included; and that questionnaire construction and wording may benefit from revision. A research agenda was developed to continue work toward optimizing PRO assessment in myositis with 2 work streams. The first would continue to conduct and analyze focus groups until saturation in the thematic analysis was achieved to develop a framework that encompassed the patient-relevant aspects of myositis. The second would continue cognitive debriefing of the MAP to identify potential areas for revision. There was agreement that further work would be needed for inclusion body myositis and juvenile dermatomyositis, and that the inclusion of additional contributors such as caregivers and individuals from the pharmaceutical/regulatory spheres would be desirable. The currently used PROM do not assess symptoms or the effects of disease that are most important to patients; this emphasizes the necessity of patient involvement. Our work provides concrete examples for PRO identification.

Development and validation of a continuous measure of patient condition using the Electronic Medical Record.

PubMed

Rothman, Michael J; Rothman, Steven I; Beals, Joseph

2013-10-01

Patient condition is a key element in communication between clinicians. However, there is no generally accepted definition of patient condition that is independent of diagnosis and that spans acuity levels. We report the development and validation of a continuous measure of general patient condition that is independent of diagnosis, and that can be used for medical-surgical as well as critical care patients. A survey of Electronic Medical Record data identified common, frequently collected non-static candidate variables as the basis for a general, continuously updated patient condition score. We used a new methodology to estimate in-hospital risk associated with each of these variables. A risk function for each candidate input was computed by comparing the final pre-discharge measurements with 1-year post-discharge mortality. Step-wise logistic regression of the variables against 1-year mortality was used to determine the importance of each variable. The final set of selected variables consisted of 26 clinical measurements from four categories: nursing assessments, vital signs, laboratory results and cardiac rhythms. We then constructed a heuristic model quantifying patient condition (overall risk) by summing the single-variable risks. The model's validity was assessed against outcomes from 170,000 medical-surgical and critical care patients, using data from three US hospitals. Outcome validation across hospitals yields an area under the receiver operating characteristic curve(AUC) of ≥0.92 when separating hospice/deceased from all other discharge categories, an AUC of ≥0.93 when predicting 24-h mortality and an AUC of 0.62 when predicting 30-day readmissions. Correspondence with outcomes reflective of patient condition across the acuity spectrum indicates utility in both medical-surgical units and critical care units. The model output, which we call the Rothman Index, may provide clinicians with a longitudinal view of patient condition to help address known

Systematic Review of Treatment Outcome Measures for Vulvodynia.

PubMed

Sadownik, Leslie A; Yong, Paul J; Smith, Kelly B

2018-07-01

To systematically evaluate the literature regarding vulvodynia treatment outcome measures. A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition. Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT. Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.

Development and initial validation of a measure of work, family, and school conflict.

PubMed

Olson, Kristine J

2014-01-01

This study reports the development and initial validation of a theoretically based measure of conflict between work, family, and college student roles. The measure was developed through the assessment of construct definitions and an assessment of measurement items by subject matter experts. Then, the measurement items were assessed with data from 500 college students who were engaged in work and family responsibilities. The results indicate that conflict between work, family, and school are effectively measured by 12 factors assessing the direction of conflict (e.g., work-to-school conflict, and school-to-work conflict) as well as the form of conflict (i.e., time, strain, and behavior based conflict). Sets of exploratory and confirmatory factor analyses demonstrated that the 12 factors of the new measure are distinct from the 6 factors of the Carlson, Kacmar, and Williams (2000) work-family conflict measure. Criterion validity of the measure was established through a series of regression analyses testing hypothesized relationships between antecedent and outcome variables with role conflict. Results indicate that role demand was a robust predictor of role conflict. To extend the literature, core self-evaluations and emotional stability were established as predictors of role conflict. Further, work, family, and school role satisfaction were significantly impacted with the presence of role conflict between work, family, and school. PsycINFO Database Record (c) 2014 APA, all rights reserved.

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.

A Comparison of Three Job Engagement Measures: Examining their Factorial and Criterion-Related Validity.

PubMed

Wefald, Andrew J; Mills, Maura J; Smith, Michael R; Downey, Ronald G

2012-03-01

Engagement is an emerging job attitude that purports to measure employees' psychological presence at and involvement in their work. This research compares three academic approaches to engagement, and makes recommendations regarding the most appropriate conceptualisation and measurement of the construct in future research. The current research also investigates whether any of these three approaches to engagement contribute unique variance to the prediction of turnover intentions above and beyond the predictive capacity of alternative constructs. An online survey was taken by 382 employees and managers from a mid-sized financial institution. Results failed to support either a multi- or unidimensional factor structure for the Utrecht Work Engagement Scale (UWES) engagement measure. For the Shirom-Melamed Vigor Measure (SMVM), a multi-dimensional structure was identified as a good fit, while a unidimensional structure fit poorly. The uni-factorial structure of Britt's engagement measure was confirmed. The Schaufeli measure of engagement was a strong predictor of work outcomes; however, when controlling for job satisfaction and affective commitment, that measure lost its ability to predict intentions to leave. Two components of the Shirom vigor measure held their predictive validity. Collectively, these findings suggest that the Shirom vigor measure may provide better insight into whether and how much a person is 'into' his or her job. The Schaufeli measure was a good predictor of important work outcomes, but when job satisfaction and affective commitment were controlled, it lost its predictive validity. We were not able to confirm the three-factor structure of the Schaufeli measure. Two components of the Shirom vigor measure predicted turnover intentions after controlling for job satisfaction and affective commitment, suggesting less overlap with those constructs than the Schaufeli measure of engagement. This research adds important information on the nature of