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 generic health survey, a measure of back-specific function, and determinants of bodily pain and work-related disability. Copyright © 2010 Elsevier Ltd. All rights reserved.

Consequential Validity of an Assistive Technology Supplement for the School Function Assessment

ERIC Educational Resources Information Center

Silverman, Michelle Kaye; Smith, Roger O.

2006-01-01

Educators and therapists implement assistive technology to maximize educational outcomes of students with disabilities. However, few measure the outcomes of interventions because of a lack of valid measurement tools. This study investigated whether an assistive technology supplement for the School Function Assessment demonstrates an important…

Post-thrombotic syndrome in children: a systematic review of frequency of occurrence, validity of outcome measures, and prognostic factors

PubMed Central

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

2010-01-01

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

Multidimensional assessment of self-regulated learning with middle school math students.

PubMed

Callan, Gregory L; Cleary, Timothy J

2018-03-01

This study examined the convergent and predictive validity of self-regulated learning (SRL) measures situated in mathematics. The sample included 100 eighth graders from a diverse, urban school district. Four measurement formats were examined including, 2 broad-based (i.e., self-report questionnaire and teacher ratings) and 2 task-specific measures (i.e., SRL microanalysis and behavioral traces). Convergent validity was examined across task-difficulty, and the predictive validity was examined across 3 mathematics outcomes: 2 measures of mathematical problem solving skill (i.e., practice session math problems, posttest math problems) and a global measure of mathematical skill (i.e., standardized math test). Correlation analyses were used to examine convergent validity and revealed medium correlations between measures within the same category (i.e., broad-based or task-specific). Relations between measurement classes were not statistically significant. Separate regressions examined the predictive validity of the SRL measures. While controlling all other predictors, a SRL microanalysis metacognitive-monitoring measure emerged as a significant predictor of all 3 outcomes and teacher ratings accounted for unique variance on 2 of the outcomes (i.e., posttest math problems and standardized math test). Results suggest that a multidimensional assessment approach should be considered by school psychologists interested in measuring SRL. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The reporting of functional outcome instruments in the Journal of Orthopaedic Trauma over a 5-year period.

PubMed

Horwitz, Daniel S; Richard, Raveesh D; Suk, Michael

2014-01-01

Orthopaedic journals, such as the Journal of Orthopaedic Trauma, frequently publish studies reporting functional outcome instruments, but little information has been provided regarding the validity and overall strength of these instruments. This study analyzes the trends in reported functional outcome instruments in articles published in the Journal of Orthopaedic Trauma over a 5-year period and examines the utilization rate, "overall" strength, and validity of these functional outcome instruments for the populations being studied. Articles that were published in the Journal of Orthopaedic Trauma from January 2006 to December 2010 were reviewed, and each article was assigned to 1 of 4 different categories, based on the subspecialty focus and body region. The total number of articles reporting the use of functional outcome instruments, articles with at least 1 functional outcome instrument found in the AO Handbook, and the total number of functional outcome instruments reported were recorded. Each functional outcome instrument was assigned to 1 of 3 categories (generic, nonvalidated, validated), and each validated instrument was also examined to determine whether the category of interest for which it was used was one in which it was previously validated in. A total of 171 articles (34%) of the articles initially reviewed met the inclusion criteria. The average number of articles per year that reported functional outcome instruments was 56% (range, 47%-65%), and the average number of articles that reported at least 1 validated outcome instrument was 51% (range, 44%-61%). The average percentage of validated scores that were appropriately used within the category of interest was 23% (range, 13%-41%). Even though the 56% utilization rate of functional outcome instruments in The Journal of Orthopaedic Trauma is much higher than other journals, it is still low given the importance of measuring and attaining excellent functional outcomes. It is clear that future effort should be given to validating outcome measures for correct evaluation of orthopaedic trauma patients.

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…

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

Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways

PubMed Central

Hill, Jonathan C; Kang, Sujin; Benedetto, Elena; Myers, Helen; Blackburn, Steven; Smith, Stephanie; Hay, Elaine; Rees, Jonathan; Beard, David; Glyn-Jones, Sion; Barker, Karen; Ellis, Benjamin; Fitzpatrick, Ray; Price, Andrew

2016-01-01

Objectives Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ). Setting A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics. Participants Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570 participants (n=210 physiotherapy, n=150 hip, n=150 knee, n=60 shoulder patients). Outcome measures Outcomes included the MSK-HQ's acceptability, feasibility, comprehension, readability and responder burden. The validation cohort outcomes were the MSK-HQ's completion rate, test–retest reliability and convergent validity with reference standards (EQ-5D-5L, Oxford Hip, Knee, Shoulder Scores, and the Keele MSK-PROM). Results Musculoskeletal domains prioritised were pain severity, physical function, work interference, social interference, sleep, fatigue, emotional health, physical activity, independence, understanding, confidence to self-manage and overall impact. Patients reported MSK-HQ items to be ‘highly relevant’ and ‘easy to understand’. Completion rates were high (94.2%), with scores normally distributed, and no floor/ceiling effects. Test–retest reliability was excellent, and convergent validity was strong (correlations 0.81–0.88). Conclusions A new musculoskeletal outcome measure has been developed through a coproduction process with patients to capture prioritised outcomes for use throughout the pathway and with different musculoskeletal conditions. Four validation cohorts found that the MSK-HQ had high completion rates, excellent test–retest reliability and strong convergent validity with reference standards. Further validation studies are ongoing, including a cohort with rheumatoid/inflammatory arthritis. PMID:27496243

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

PubMed Central

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

2012-01-01

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

Physical functional outcome assessment of patients with major burns admitted to a UK Burn Intensive Care Unit.

PubMed

Smailes, Sarah T; Engelsman, Kayleen; Dziewulski, Peter

2013-02-01

Determining the discharge outcome of burn patients can be challenging and therefore a validated objective measure of functional independence would assist with this process. We developed the Functional Assessment for Burns (FAB) score to measure burn patients' functional independence. FAB scores were taken on discharge from ICU (FAB 1) and on discharge from inpatient burn care (FAB 2) in 56 patients meeting the American Burn Association criteria for major burn. We retrospectively analysed prospectively collected data to measure the progress of patients' physical functional outcomes and to evaluate the predictive validity of the FAB score for discharge outcome. Mean age was 38.6 years and median burn size 35%. Significant improvements were made in the physical functional outcomes between FAB 1 and FAB 2 scores (p<0.0001). 48 patients were discharged home, 8 of these with social care. 8 patients were transferred to another hospital for further inpatient rehabilitation. FAB 1 score (≤ 9) is strongly associated with discharge outcome (p<0.006) and as such can be used to facilitate early discharge planning. FAB 2 score (≤ 26) independently predicts discharge outcome (p<0.0001) and therefore is a valid outcome measure to determine discharge outcome of burn patients. Copyright © 2012 Elsevier Ltd and ISBI. 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 restoration', 'distribution of risk categories for dental caries', 'filled-and-missing score' and 'retreatment after restoration', were considered valid and relevant measures and a proxy for oral health status. As such, they improve the transparency of oral health services delivery that can be related to oral health outcomes, and with time may serve to improve these oral health outcomes.

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

PubMed Central

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

2008-01-01

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

The Brighton musculoskeletal Patient-Reported Outcome Measure (BmPROM): An assessment of validity, reliability, and responsiveness.

PubMed

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

2018-05-11

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

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

PubMed

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

2014-08-01

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

Validity and reliability of Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Osteoarthritis

PubMed Central

Broderick, Joan E.; Schneider, Stefan; Junghaenel, Doerte U.; Schwartz, Joseph E.; Stone, Arthur A.

2013-01-01

Objective Evaluation of known group validity, ecological validity, and test-retest reliability of four domain instruments from the Patient Reported Outcomes Measurement System (PROMIS) in osteoarthritis (OA) patients. Methods Recruitment of an osteoarthritis sample and a comparison general population (GP) through an Internet survey panel. Pain intensity, pain interference, physical functioning, and fatigue were assessed for 4 consecutive weeks with PROMIS short forms on a daily basis and compared with same-domain Computer Adaptive Test (CAT) instruments that use a 7-day recall. Known group validity (comparison of OA and GP), ecological validity (comparison of aggregated daily measures with CATs), and test-retest reliability were evaluated. Results The recruited samples matched (age, sex, race, ethnicity) the demographic characteristics of the U.S. sample for arthritis and the 2009 Census for the GP. Compliance with repeated measurements was excellent: > 95%. Known group validity for CATs was demonstrated with large effect sizes (pain intensity: 1.42, pain interference: 1.25, and fatigue: .85). Ecological validity was also established through high correlations between aggregated daily measures and weekly CATs (≥ .86). Test-retest validity (7-day) was very good (≥ .80). Conclusion PROMIS CAT instruments demonstrated known group and ecological validity in a comparison of osteoarthritis patients with a general population sample. Adequate test-retest reliability was also observed. These data provide encouraging initial data on the utility of these PROMIS instruments for clinical and research outcomes in osteoarthritis patients. PMID:23592494

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.

Development of a wheelchair mobility skills test for children and adolescents: combining evidence with clinical expertise.

PubMed

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

2017-02-13

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

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

Predicting reading outcomes with progress monitoring slopes among middle grade students

PubMed Central

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

2013-01-01

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

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 emerge as widely used and clinically meaningful. These data support the need for a paradigm shift toward the consistent use of valid and reliable outcome measures for foot and ankle clinical research.

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.

Are validated outcome measures used in distal radial fractures truly valid?

PubMed Central

Nienhuis, R. W.; Bhandari, M.; Goslings, J. C.; Poolman, R. W.; Scholtes, V. A. B.

2016-01-01

Objectives Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462. PMID:27132246

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…

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.

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…

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…

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.

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

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-review literature and secondly, not having their measurement properties (i.e., reliability or validity) examined formally. Of the 22 studies included in this review, items relating to test methodological quality were, on the whole, well addressed. Test-retest reliability was determined in all but one of the reviewed studies, whilst most studies investigated at least two aspects of validity (i.e., content, construct or criterion-related validity). Few studies examined predictive validity or responsiveness. While feasibility was addressed in over half of the studies, practicality and test limitations were rarely addressed. Consideration of study quality, measurement properties and feasibility components assessed in this review can assist future researchers when developing or modifying tests of sporting skill outcomes.

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.

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.

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

PubMed

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

2018-05-01

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

Advancing implementation science through measure development and evaluation: a study protocol.

PubMed

Lewis, Cara C; Weiner, Bryan J; Stanick, Cameo; Fischer, Sarah M

2015-07-22

Significant gaps related to measurement issues are among the most critical barriers to advancing implementation science. Three issues motivated the study aims: (a) the lack of stakeholder involvement in defining pragmatic measure qualities; (b) the dearth of measures, particularly for implementation outcomes; and (c) unknown psychometric and pragmatic strength of existing measures. Aim 1: Establish a stakeholder-driven operationalization of pragmatic measures and develop reliable, valid rating criteria for assessing the construct. Aim 2: Develop reliable, valid, and pragmatic measures of three critical implementation outcomes, acceptability, appropriateness, and feasibility. Aim 3: Identify Consolidated Framework for Implementation Research and Implementation Outcome Framework-linked measures that demonstrate both psychometric and pragmatic strength. For Aim 1, we will conduct (a) interviews with stakeholder panelists (N = 7) and complete a literature review to populate pragmatic measure construct criteria, (b) Q-sort activities (N = 20) to clarify the internal structure of the definition, (c) Delphi activities (N = 20) to achieve consensus on the dimension priorities, (d) test-retest and inter-rater reliability assessments of the emergent rating system, and (e) known-groups validity testing of the top three prioritized pragmatic criteria. For Aim 2, our systematic development process involves domain delineation, item generation, substantive validity assessment, structural validity assessment, reliability assessment, and predictive validity assessment. We will also assess discriminant validity, known-groups validity, structural invariance, sensitivity to change, and other pragmatic features. For Aim 3, we will refine our established evidence-based assessment (EBA) criteria, extract the relevant data from the literature, rate each measure using the EBA criteria, and summarize the data. The study outputs of each aim are expected to have a positive impact as they will establish and guide a comprehensive measurement-focused research agenda for implementation science and provide empirically supported measures, tools, and methods for accomplishing this work.

Guideline for translation and national validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

PubMed

Oosterhaven, Jart A F; Schuttelaar, Marie L A; Apfelbacher, Christian; Diepgen, Thomas L; Ofenloch, Robert F

2017-08-01

There is a need for well-developed and validated questionnaires to measure patient reported outcomes. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is such a validated instrument measuring disease-specific health-related quality of life in hand eczema patients. A re-validation of measurement properties is required before an instrument is used in a new population. With the objective of arriving at a guideline for translation and national validation of the QOLHEQ, we have developed the design of a reference study on how to adequately assess measurement properties of the QOLHEQ based on interdisciplinary discussions and current standards. We present a step-by-step guideline to assess translation (including cross-cultural adaptation), scale structure, validity, reproducibility, responsiveness, and interpretability. We describe which outcomes should be reported for each measurement property, and give advice on how to calculate these. It is also specified which sample size is needed, how to deal with missing data, and which cutoff values should be applied for the measurement properties assessed during the validation process. In conclusion, this guideline, presenting a reference validation study for the QOLHEQ, creates the possibility to harmonize the national validation of the various language versions of the QOLHEQ. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

Semi-structured Interview Measure of Stigma (SIMS) in psychosis: Assessment of psychometric properties.

PubMed

Wood, Lisa; Burke, Eilish; Byrne, Rory; Enache, Gabriela; Morrison, Anthony P

2016-10-01

Stigma is a significant difficulty for people who experience psychosis. To date, there have been no outcome measures developed to examine stigma exclusively in people with psychosis. The aim of this study was develop and validate a semi-structured interview measure of stigma (SIMS) in psychosis. The SIMS is an eleven item measure of stigma developed in consultation with service users who have experienced psychosis. 79 participants with experience of psychosis were recruited for the purposes of this study. They were administered the SIMS alongside a battery of other relevant outcome measures to examine reliability and validity. A one-factor solution was identified for the SIMS which encompassed all ten rateable items. The measure met all reliability and validity criteria and illustrated good internal consistency, inter-rater reliability, test retest reliability, criterion validity, construct validity, sensitivity to change and had no floor or ceiling effects. The SIMS is a reliable and valid measure of stigma in psychosis. It may be more engaging and acceptable than other stigma measures due to its semi-structured interview format. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

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 protocol aspires to assist in the advancement of the eLearning research field as well as in the development of high-quality healthcare professionals' digital education. PROSPERO CRD42017068427.

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

PubMed Central

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

2004-01-01

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

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.

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.springer.com/00266 .

Validity of clinical outcome measures to evaluate ankle range of motion during the weight-bearing lunge test.

PubMed

Hall, Emily A; Docherty, Carrie L

2017-07-01

To determine the concurrent validity of standard clinical outcome measures compared to laboratory outcome measure while performing the weight-bearing lunge test (WBLT). Cross-sectional study. Fifty participants performed the WBLT to determine dorsiflexion ROM using four different measurement techniques: dorsiflexion angle with digital inclinometer at 15cm distal to the tibial tuberosity (°), dorsiflexion angle with inclinometer at tibial tuberosity (°), maximum lunge distance (cm), and dorsiflexion angle using a 2D motion capture system (°). Outcome measures were recorded concurrently during each trial. To establish concurrent validity, Pearson product-moment correlation coefficients (r) were conducted, comparing each dependent variable to the 2D motion capture analysis (identified as the reference standard). A higher correlation indicates strong concurrent validity. There was a high correlation between each measurement technique and the reference standard. Specifically the correlation between the inclinometer placement at 15cm below the tibial tuberosity (44.9°±5.5°) and the motion capture angle (27.0°±6.0°) was r=0.76 (p=0.001), between the inclinometer placement at the tibial tuberosity angle (39.0°±4.6°) and the motion capture angle was r=0.71 (p=0.001), and between the distance from the wall clinical measure (10.3±3.0cm) to the motion capture angle was r=0.74 (p=0.001). This study determined that the clinical measures used during the WBLT have a high correlation with the reference standard for assessing dorsiflexion range of motion. Therefore, obtaining maximum lunge distance and inclinometer angles are both valid assessments during the weight-bearing lunge test. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

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.

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

PubMed Central

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

2014-01-01

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

A Correlational Study on Critical Thinking in Nursing as an Outcome Variable for Success

ERIC Educational Resources Information Center

Porter, Rebecca Jean

2018-01-01

Critical thinking is a required curricular outcome for nursing education; however, the literature shows a gap related to valid and reliable tools to measure critical thinking specific to nursing and relating that critical thinking measurement to meaningful outcomes. This study examined critical thinking scores, as measured by Assessment…

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

PubMed

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

2014-04-01

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

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

PubMed Central

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

2014-01-01

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

PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study.

PubMed

Katzan, Irene L; Lapin, Brittany

2018-01-01

The International Consortium for Health Outcomes Measurement recently included the 10-item PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) scale as part of their recommended Standard Set of Stroke Outcome Measures. Before collection of PROMIS GH is broadly implemented, it is necessary to assess its performance in the stroke population. The objective of this study was to evaluate the psychometric properties of PROMIS GH in patients with ischemic stroke and intracerebral hemorrhage. PROMIS GH and 6 PROMIS domain scales measuring same/similar constructs were electronically collected on 1102 patients with ischemic and hemorrhagic strokes at various stages of recovery from their stroke who were seen in a cerebrovascular clinic from October 12, 2015, through June 2, 2017. Confirmatory factor analysis was performed to evaluate the adequacy of 2-factor structure of component scores. Test-retest reliability and convergent validity of PROMIS GH items and component scores were assessed. Discriminant validity and responsiveness were compared between PROMIS GH and PROMIS domain scales measuring the same or related constructs. Analyses were repeated stratified by stroke subtype and modified Rankin Scale score <2 versus ≥2. There was moderate internal reliability (ordinal α, 0.82-0.88) and marginal model fit for the 2-factor solution for component scores (root mean square error of approximation, 0.11). Convergent validity was good with significant correlations between all PROMIS GH items and PROMIS domain scales ( P <0.001 for all). There was excellent discrimination for all PROMIS GH items and component scores across modified Rankin Scale levels. Good responsiveness (effect size, >0.5) was demonstrated for 8 of the 10 PROMIS GH items. Reliability and validity remained consistent across stroke subtype and disability level (modified Rankin Scale, <2 versus ≥2). PROMIS GH exhibits acceptable performance in patients with stroke. Our findings support International Consortium for Health Outcomes Measurement recommendation to use PROMIS GH as part of the standard set of outcome measures in stroke. © 2017 American Heart Association, Inc.

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.

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.

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

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.

Assessing the treatment effects in apraxia of speech: introduction and evaluation of the Modified Diadochokinesis Test.

PubMed

Hurkmans, Joost; Jonkers, Roel; Boonstra, Anne M; Stewart, Roy E; Reinders-Messelink, Heleen A

2012-01-01

The number of reliable and valid instruments to measure the effects of therapy in apraxia of speech (AoS) is limited. To evaluate the newly developed Modified Diadochokinesis Test (MDT), which is a task to assess the effects of rate and rhythm therapies for AoS in a multiple baseline across behaviours design. The consistency, accuracy and fluency of speech of 24 adults with AoS and 12 unaffected speakers matched for age, gender and educational level were assessed using the MDT. The reliability and validity of the instrument were considered and outcomes compared with those obtained with existing tests. The results revealed that MDT had a strong internal consistency. Scores were influenced by syllable structure complexity, while distinctive features of articulation had no measurable effect. The test-retest and intra- and inter-rater reliabilities were shown to be adequate, and the discriminant validity was good. For convergent validity different outcomes were found: apart from one correlation, the scores on tests assessing functional communication and AoS correlated significantly with the MDT outcome measures. The spontaneous speech phonology measure of the Aachen Aphasia Test (AAT) correlated significantly with the MDT outcome measures, but no correlations were found for the repetition subtest and the spontaneous speech articulation/prosody measure of the AAT. The study shows that the MDT has adequate psychometric properties, implying that it can be used to measure changes in speech motor control during treatment for apraxia of speech. The results demonstrate the validity and utility of the instrument as a supplement to speech tasks in assessing speech improvement aimed at the level of planning and programming of speech. © 2012 Royal College of Speech and Language Therapists.

DEVELOPMENT AND VALIDATION OF 'SURE': A PATIENT REPORTED OUTCOME MEASURE (PROM) FOR RECOVERY FROM DRUG AND ALCOHOL DEPENDENCE.

PubMed

Neale, Joanne; Vitoratou, Silia; Finch, Emily; Lennon, Paul; Mitcheson, Luke; Panebianco, Daria; Rose, Diana; Strang, John; Wykes, Til; Marsden, John

2016-08-01

Patient Reported Outcome Measures (PROMs) assess health status and health-related quality of life from the patient/service user perspective. Our study aimed to: i. develop a PROM for recovery from drug and alcohol dependence that has good face and content validity, acceptability and usability for people in recovery; ii. evaluate the psychometric properties and factorial structure of the new PROM ('SURE'). Item development included Delphi groups, focus groups, and service user feedback on draft versions of the new measure. A 30-item beta version was completed by 575 service users (461 in person [IP] and 114 online [OL]). Analyses comprised rating scale evaluation, assessment of psychometric properties, factorial structure, and differential item functioning. The beta measure had good face and content validity. Nine items were removed due to low stability, low factor loading, low construct validity or high complexity. The remaining 21 items were re-scaled (Rasch model analyses). Exploratory and confirmatory factor analyses revealed 5 factors: substance use, material resources, outlook on life, self-care, and relationships. The MIMIC model indicated 95% metric invariance across the IP and OL samples, and 100% metric invariance for gender. Internal consistency and test-retest reliability were granted. The 5 factors correlated positively with the corresponding WHOQOL-BREF and ARC subscales and score differences between participant sub-groups confirmed discriminative validity. 'SURE' is a psychometrically valid, quick and easy-to-complete outcome measure, developed with unprecedented input from people in recovery. It can be used alongside, or instead of, existing outcome tools. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

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.

TROPHI: development of a tool to measure complex, multi-factorial patient handling interventions.

PubMed

Fray, Mike; Hignett, Sue

2013-01-01

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

Development and validation of a VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G.

PubMed

Fearon, A M; Ganderton, C; Scarvell, J M; Smith, P N; Neeman, T; Nash, C; Cook, J L

2015-12-01

Greater trochanteric pain syndrome (GTPS) is common, resulting in significant pain and disability. There is no condition specific outcome score to evaluate the degree of severity of disability associated with GTPS in patients with this condition. To develop a reliable and valid outcome measurement capable of evaluating the severity of disability associated with GTPS. A phenomenological framework using in-depth semi structured interviews of patients and medical experts, and focus groups of physiotherapists was used in the item generation. Item and format clarification was undertaken via piloting. Multivariate analysis provided the basis for item reduction. The resultant VISA-G was tested for reliability with the inter class co-efficient (ICC), internal consistency (Cronbach's Alpha), and construct validity (correlation co-efficient) on 52 naïve participants with GTPS and 31 asymptomatic participants. The resultant outcome measurement tool is consistent in style with existing tendinopathy outcome measurement tools, namely the suite of VISA scores. The VISA-G was found to be have a test-retest reliability of ICC2,1 (95% CI) of 0.827 (0.638-0.923). Internal consistency was high with a Cronbach's Alpha of 0.809. Construct validity was demonstrated: the VISA-G measures different constructs than tools previously used in assessing GTPS, the Harris Hip Score and the Oswestry Disability Index (Spearman Rho:0.020 and 0.0205 respectively). The VISA-G did not demonstrate any floor or ceiling effect in symptomatic participants. The VISA-G is a reliable and valid score for measuring the severity of disability associated GTPS. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

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

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.

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

PubMed

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

2011-06-01

Estimates of the reliability and validity of the English nine-item Outcome Expectations for Exercise (OEE) scale have been tested and found to be valid for use in various settings, particularly among older people, with good internal consistency and validity. Data on the use of the OEE scale among older Chinese people living in the community and how cultural differences might affect the administration of the OEE scale are limited. To test the validity and reliability of the Chinese version of the Outcome Expectations for Exercise scale among older people. A cross-sectional validation study was designed to test the Chinese version of the OEE scale (OEE-C). Reliability was examined by testing both the internal consistency for the overall scale and the squared multiple correlation coefficient for the single item measure. The validity of the scale was tested on the basis of both a traditional psychometric test and a confirmatory factor analysis using structural equation modelling. The Mokken Scaling Procedure (MSP) was used to investigate if there were any hierarchical, cumulative sets of items in the measure. The OEE-C scale was tested in a group of older people in Taiwan (n=108, mean age=77.1). There was acceptable internal consistency (alpha=.85) and model fit in the scale. Evidence of the validity of the measure was demonstrated by the tests for criterion-related validity and construct validity. There was a statistically significant correlation between exercise outcome expectations and exercise self-efficacy (r=.34, p<.01). An analysis of the Mokken Scaling Procedure found that nine items of the scale were all retained in the analysis and the resulting scale was reliable and statistically significant (p=.0008). The results obtained in the present study provided acceptable levels of reliability and validity evidence for the Chinese Outcome Expectations for Exercise scale when used with older people in Taiwan. Future testing of the OEE-C scale needs to be carried out to see whether these results are generalisable to older Chinese people living in urban areas. Copyright © 2010 Elsevier Ltd. All rights reserved.

Updating the OMERACT filter: implications for imaging and soluble biomarkers.

PubMed

D'Agostino, Maria-Antonietta; Boers, Maarten; Kirwan, John; van der Heijde, Désirée; Østergaard, Mikkel; Schett, Georg; Landewé, Robert B; Maksymowych, Walter P; Naredo, Esperanza; Dougados, Maxime; Iagnocco, Annamaria; Bingham, Clifton O; Brooks, Peter M; Beaton, Dorcas E; Gandjbakhch, Frederique; Gossec, Laure; Guillemin, Francis; Hewlett, Sarah E; Kloppenburg, Margreet; March, Lyn; Mease, Philip J; Moller, Ingrid; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Wakefield, Richard J; Wells, George A; Tugwell, Peter; Conaghan, Philip G

2014-05-01

The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0.

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.

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

PubMed

Arbuckle, Rob; Abetz-Webb, Linda

2013-01-01

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

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

PubMed

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

2013-10-15

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

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)

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.

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

A Multimethod Multitrait Validity Assessment of Self-Construal in Japan, Korea, and the United States

ERIC Educational Resources Information Center

Bresnahan, Mary J.; Levine, Timothy R.; Shearman, Sachiyo Morinaga; Lee, Sun Young; Park, Cheong-Yi; Kiyomiya, Toru

2005-01-01

A large number of previous studies have used self-construal to predict communication outcomes. Recent evidence, however, suggests that validity problems may exist in self-construal measurement. The current study conducted a multimethod multitrait (Campbell & Fiske, 1959) validation study of self-construal measures with data (total N = 578)…

Evaluating information skills training in health libraries: a systematic review.

PubMed

Brettle, Alison

2007-12-01

Systematic reviews have shown that there is limited evidence to demonstrate that the information literacy training health librarians provide is effective in improving clinicians' information skills or has an impact on patient care. Studies lack measures which demonstrate validity and reliability in evaluating the impact of training. To determine what measures have been used; the extent to which they are valid and reliable; to provide guidance for health librarians who wish to evaluate the impact of their information skills training. Systematic review methodology involved searching seven databases, and personal files. Studies were included if they were about information skills training, used an objective measure to assess outcomes, and occurred in a health setting. Fifty-four studies were included in the review. Most outcome measures used in the studies were not tested for the key criteria of validity and reliability. Three tested for validity and reliability are described in more detail. Selecting an appropriate measure to evaluate the impact of training is a key factor in carrying out any evaluation. This systematic review provides guidance to health librarians by highlighting measures used in various circumstances, and those that demonstrate validity and reliability.

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.

Rasch Measurement Analysis of the Mayo-Portland Adaptability Inventory (MPAI-4) in a Community-Based Rehabilitation Sample

PubMed Central

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

2011-01-01

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

Rasch measurement analysis of the Mayo-Portland Adaptability Inventory (MPAI-4) in a community-based rehabilitation sample.

PubMed

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

2011-05-01

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

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.

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

PubMed Central

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

2011-01-01

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

Concurrent Validity of the International Family Quality of Life Survey.

PubMed

Samuel, Preethy S; Pociask, Fredrick D; DiZazzo-Miller, Rosanne; Carrellas, Ann; LeRoy, Barbara W

2016-01-01

The measurement of the social construct of Family Quality of Life (FQOL) is a parsimonious alternative to the current approach of measuring familial outcomes using a battery of tools related to individual-level outcomes. The purpose of this study was to examine the internal consistency and concurrent validity of the International FQOL Survey (FQOLS-2006), using cross-sectional data collected from 65 family caregivers of children with developmental disabilities. It shows a moderate correlation between the total FQOL scores of the FQOLS-2006 and the Beach Center's FQOL scale. The validity of five FQOLS-2006 domains was supported by the correlations between conceptually related domains.

The development and validation of the client expectations of massage scale.

PubMed

Boulanger, Karen T; Campo, Shelly; Glanville, Jennifer L; Lowe, John B; Yang, Jingzhen

2012-01-01

Although there is evidence that client expectations influence client outcomes, a valid and reliable scale for measuring the range of client expectations for both massage therapy and the behaviors of their massage therapists does not exist. Understanding how client expectations influence client outcomes would provide insight into how massage achieves its reported effects. To develop and validate the Client Expectations of Massage Scale (CEMS), a measure of clients' clinical, educational, interpersonal, and outcome expectations. Offices of licensed massage therapists in Iowa. A practice-based research methodology was used to collect data from two samples of massage therapy clients. For Sample 1, 21 volunteer massage therapists collected data from their clients before the massage. Factor analysis was conducted to test construct validity and coefficient alpha was used to assess reliability. Correlational analyses with the CEMS, previous measures of client expectations, and the Life Orientation Test-Revised were examined to test the convergent and discriminant validity of the CEMS. For Sample 2, 24 massage therapists distributed study materials for clients to complete before and after a massage therapy session. Structural equation modeling was used to assess the construct, discriminant, and predictive validity of the CEMS. Sample 1 involved 320 and Sample 2 involved 321 adult massage clients. Standard care provided by licensed massage therapists. Numeric Rating Scale for pain and Positive and Negative Affect Schedule-Revised (including the Serenity subscale). The CEMS demonstrated good construct, convergent, discriminant and predictive validity, and adequate reliability. Client expectations were generally positive toward massage and their massage therapists. Positive outcome expectations had a positive effect on clients' changes in pain and serenity. High interpersonal expectations had a negative effect on clients' changes in serenity. Client expectations contribute to the nonspecific effects of massage therapy.

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

The Development and Validation of the Client Expectations of Massage Scale

PubMed Central

Boulanger, Karen T.; Campo, Shelly; Glanville, Jennifer L.; Lowe, John B; Yang, Jingzhen

2012-01-01

Background: Although there is evidence that client expectations influence client outcomes, a valid and reliable scale for measuring the range of client expectations for both massage therapy and the behaviors of their massage therapists does not exist. Understanding how client expectations influence client outcomes would provide insight into how massage achieves its reported effects. Purpose: To develop and validate the Client Expectations of Massage Scale (CEMS), a measure of clients’ clinical, educational, interpersonal, and outcome expectations. Setting: Offices of licensed massage therapists in Iowa. Research Design: A practice-based research methodology was used to collect data from two samples of massage therapy clients. For Sample 1, 21 volunteer massage therapists collected data from their clients before the massage. Factor analysis was conducted to test construct validity and coefficient alpha was used to assess reliability. Correlational analyses with the CEMS, previous measures of client expectations, and the Life Orientation Test–Revised were examined to test the convergent and discriminant validity of the CEMS. For Sample 2, 24 massage therapists distributed study materials for clients to complete before and after a massage therapy session. Structural equation modeling was used to assess the construct, discriminant, and predictive validity of the CEMS. Participants: Sample 1 involved 320 and Sample 2 involved 321 adult massage clients. Intervention: Standard care provided by licensed massage therapists. Main Outcomes: Numeric Rating Scale for pain and Positive and Negative Affect Schedule–Revised (including the Serenity subscale). Results: The CEMS demonstrated good construct, convergent, discriminant and predictive validity, and adequate reliability. Client expectations were generally positive toward massage and their massage therapists. Positive outcome expectations had a positive effect on clients’ changes in pain and serenity. High interpersonal expectations had a negative effect on clients’ changes in serenity. Conclusions: Client expectations contribute to the nonspecific effects of massage therapy. PMID:23087774

Psycho-oncology assessment in Chinese populations: a systematic review of quality of life and psychosocial measures.

PubMed

Hyde, M K; Chambers, S K; Shum, D; Ip, D; Dunn, J

2016-09-01

This systematic review describes psychosocial and quality of life (QOL) measures used in psycho-oncology research with cancer patients and caregivers in China. Medline and PsycINFO databases were searched (1980-2014). Studies reviewed met the following criteria: English language; peer-reviewed; sampled Chinese cancer patients/caregivers; developed, validated or assessed psychometric properties of psychosocial or QOL outcome measures; and reported validation data. The review examined characteristics of measures and participants, translation and cultural adaptation processes and psychometric properties of the measures. Ninety five studies met review criteria. Common characteristics of studies reviewed were they: assessed primarily QOL measures, sampled patients with breast, colorectal, or head and neck cancer, and validated existing measures (>80%) originating in North America or Europe. Few studies reported difficulties translating measures. Regarding psychometric properties of the measures >50% of studies reported subscale reliabilities <α = 0.70, <50% reported test-retest reliability, and <30% reported divergent validity. Few reported sensitivity, specificity or responsiveness. Improved accuracy and transparency of reporting for translation, cultural adaptation and psychometric testing of psychosocial measures is needed. Developing support structures for translating and validating psychosocial measures would enable this and ensure Chinese psycho-oncology clinical practice and research keeps pace with international focus on patient reported outcome measures and data management. © 2015 John Wiley & Sons Ltd.

An international measure of awareness and beliefs about cancer: development and testing of the ABC

PubMed Central

Simon, Alice E; Forbes, Lindsay J L; Boniface, David; Warburton, Fiona; Brain, Kate E; Dessaix, Anita; Donnelly, Michael; Haynes, Kerry; Hvidberg, Line; Lagerlund, Magdalena; Petermann, Lisa; Tishelman, Carol; Vedsted, Peter; Vigmostad, Maria Nyre; Wardle, Jane; Ramirez, Amanda J

2012-01-01

Objectives To develop an internationally validated measure of cancer awareness and beliefs; the awareness and beliefs about cancer (ABC) measure. Design and setting Items modified from existing measures were assessed by a working group in six countries (Australia, Canada, Denmark, Norway, Sweden and the UK). Validation studies were completed in the UK, and cross-sectional surveys of the general population were carried out in the six participating countries. Participants Testing in UK English included cognitive interviewing for face validity (N=10), calculation of content validity indexes (six assessors), and assessment of test–retest reliability (N=97). Conceptual and cultural equivalence of modified (Canadian and Australian) and translated (Danish, Norwegian, Swedish and Canadian French) ABC versions were tested quantitatively for equivalence of meaning (≥4 assessors per country) and in bilingual cognitive interviews (three interviews per translation). Response patterns were assessed in surveys of adults aged 50+ years (N≥2000) in each country. Main outcomes Psychometric properties were evaluated through tests of validity and reliability, conceptual and cultural equivalence and systematic item analysis. Test–retest reliability used weighted-κ and intraclass correlations. Construction and validation of aggregate scores was by factor analysis for (1) beliefs about cancer outcomes, (2) beliefs about barriers to symptomatic presentation, and item summation for (3) awareness of cancer symptoms and (4) awareness of cancer risk factors. Results The English ABC had acceptable test–retest reliability and content validity. International assessments of equivalence identified a small number of items where wording needed adjustment. Survey response patterns showed that items performed well in terms of difficulty and discrimination across countries except for awareness of cancer outcomes in Australia. Aggregate scores had consistent factor structures across countries. Conclusions The ABC is a reliable and valid international measure of cancer awareness and beliefs. The methods used to validate and harmonise the ABC may serve as a methodological guide in international survey research. PMID:23253874

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.

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…

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.

Validation of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests in cervical spine surgery.

PubMed

Boody, Barrett S; Bhatt, Surabhi; Mazmudar, Aditya S; Hsu, Wellington K; Rothrock, Nan E; Patel, Alpesh A

2018-03-01

OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS), which is funded by the National Institutes of Health, is a set of adaptive, responsive assessment tools that measures patient-reported health status. PROMIS measures have not been validated for surgical patients with cervical spine disorders. The objective of this project is to evaluate the validity (e.g., convergent validity, known-groups validity, responsiveness to change) of PROMIS computer adaptive tests (CATs) for pain behavior, pain interference, and physical function in patients undergoing cervical spine surgery. METHODS The legacy outcome measures Neck Disability Index (NDI) and SF-12 were used as comparisons with PROMIS measures. PROMIS CATs, NDI-10, and SF-12 measures were administered prospectively to 59 consecutive tertiary hospital patients who were treated surgically for degenerative cervical spine disorders. A subscore of NDI-5 was calculated from NDI-10 by eliminating the lifting, headaches, pain intensity, reading, and driving sections and multiplying the final score by 4. Assessments were administered preoperatively (baseline) and postoperatively at 6 weeks and 3 months. Patients presenting for revision surgery, tumor, infection, or trauma were excluded. Participants completed the measures in Assessment Center, an online data collection tool accessed by using a secure login and password on a tablet computer. Subgroup analysis was also performed based on a primary diagnosis of either cervical radiculopathy or cervical myelopathy. RESULTS Convergent validity for PROMIS CATs was supported with multiple statistically significant correlations with the existing legacy measures, NDI and SF-12, at baseline. Furthermore, PROMIS CATs demonstrated known-group validity and identified clinically significant improvements in all measures after surgical intervention. In the cervical radiculopathy and myelopathic cohorts, the PROMIS measures demonstrated similar responsiveness to the SF-12 and NDI scores in the patients who self-identified as having postoperative clinical improvement. PROMIS CATs required a mean total of 3.2 minutes for PROMIS pain behavior (mean ± SD 0.9 ± 0.5 minutes), pain interference (1.2 ± 1.9 minutes), and physical function (1.1 ± 1.4 minutes) and compared favorably with 3.4 minutes for NDI and 4.1 minutes for SF-12. CONCLUSIONS This study verifies that PROMIS CATs demonstrate convergent and known-groups validity and comparable responsiveness to change as existing legacy measures. The PROMIS measures required less time for completion than legacy measures. The validity and efficiency of the PROMIS measures in surgical patients with cervical spine disorders suggest an improvement over legacy measures and an opportunity for incorporation into clinical practice.

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

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

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…

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

PubMed

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

2017-07-04

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

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.

Psychometric evaluation of the pediatric and parent-proxy Patient-Reported Outcomes Measurement Information System and the Neurology and Traumatic Brain Injury Quality of Life measurement item banks in pediatric traumatic brain injury.

PubMed

Bertisch, Hilary; Rivara, Frederick P; Kisala, Pamela A; Wang, Jin; Yeates, Keith Owen; Durbin, Dennis; Zonfrillo, Mark R; Bell, Michael J; Temkin, Nancy; Tulsky, David S

2017-07-01

The primary objective is to provide evidence of convergent and discriminant validity for the pediatric and parent-proxy versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, Depression, Anger, Peer Relations, Mobility, Pain Interference, and Fatigue item banks, the Neurology Quality of Life measurement system (Neuro-QOL) Cognition-General Concerns and Stigma item banks, and the Traumatic Brain Injury Quality of Life (TBI-QOL) Executive Function and Headache item banks in a pediatric traumatic brain injury (TBI) sample. Participants were 134 parent-child (ages 8-18 years) days. Children all sustained TBI and the dyads completed outcome ratings 6 months after injury at one of six medical centers across the United States. Ratings included PROMIS, Neuro-QOL, and TBI-QOL item banks, as well as the Pediatric Quality of Life inventory (PedsQL), the Health Behavior Inventory (HBI), and the Strengths and Difficulties Questionnaire (SDQ) as legacy criterion measures against which these item banks were validated. The PROMIS, Neuro-QOL, and TBI-QOL item banks demonstrated good convergent validity, as evidenced by moderate to strong correlations with comparable scales on the legacy measures. PROMIS, Neuro-QOL, and TBI-QOL item banks showed weaker correlations with ratings of unrelated constructs on legacy measures, providing evidence of discriminant validity. Our results indicate that the constructs measured by the PROMIS, Neuro-QOL, and TBI-QOL item banks are valid in our pediatric TBI sample and that it is appropriate to use these standardized scores for our primary study analyses.

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.

Construction and validation of the chronic acquired polyneuropathy patient-reported index, “CAP-PRI:” a disease-specific, health-related quality of life instrument

PubMed Central

Gwathmey, Kelly G.; Conaway, Mark R.; Seyedsadjadi, Reza; Joshi, Amruta; Barnett, Carolina; Bril, Vera; Ng, Eduardo; David, William; Gable, Karissa; Guptill, Jeffrey T.; Hobson-Webb, Lisa D.; Dineen, Jennifer; Hehir, Michael; Brannagan, Thomas H.; Byun, Esther; Adler, Margaret; Burns, Ted M.

2016-01-01

Introduction Generic health-related quality of life (HRQOL) patient-reported outcome measures have been used in patients with chronic immune-mediated polyneuropathies. We have created a disease-specific HRQOL instrument. Methods and Results The 15-item chronic acquired polyneuropathy patient-reported index (CAP-PRI) was developed and validated in multiple steps. Items were initially generated through patient and specialist input. The performance of the preliminary 20 items was analyzed from a prospective, 5-center study involving chronic immune-mediated polyneuropathy patients. Data analysis suggested modification to a 15-item scale with 3 response categories, rather than 5. The final CAP-PRI was then validated in another prospective, 5-center study. The CAP-PRI appeared to be a unidimensional outcome measure that fits the Rasch Partial Credit Model in our multicenter cohort. It correlated appropriately with the outcome measures commonly used in this patient population. Discussion The CAP-PRI is a simple, easy, disease-specific HRQOL measure that appears to be useful for clinical care and possibly also for clinical trials. PMID:26600438

[Benchmarking using different measurement instruments and the management of measurement variability].

PubMed

Blankers, M; Barendregt, M; Dekker, J J M

2016-01-01

In mental health care centres in the Netherlands outcome data are collected using a variety of outcome instruments. This may have implications for the comparability of outcome results between different centres. To discuss recent findings regarding the extent to which the eight instruments currently used in clinical practice report comparable results. Our study is based on a combination of literature review and empirical research. The results obtained with the eight instruments are not equivalent. Patients symptom reductions appear larger with some instruments than with others. The current practice of benchmarking in the Dutch mental health system would have greater validity if the number of different instruments would be reduced. State-of-the-art calibration studies are necessary to validate the comparability of the remaining instruments. Ideally, all mental health centres will soon use one instrument per care domain to measure treatment outcome.

Translation and validation of the German version of the Bournemouth Questionnaire for Neck Pain.

PubMed

Soklic, Marina; Peterson, Cynthia; Humphreys, B Kim

2012-01-25

Clinical outcome measures are important tools to monitor patient improvement during treatment as well as to document changes for research purposes. The short-form Bournemouth questionnaire for neck pain patients (BQN) was developed from the biopsychosocial model and measures pain, disability, cognitive and affective domains. It has been shown to be a valid and reliable outcome measure in English, French and Dutch and more sensitive to change compared to other questionnaires. The purpose of this study was to translate and validate a German version of the Bournemouth questionnaire for neck pain patients. German translation and back translation into English of the BQN was done independently by four persons and overseen by an expert committee. Face validity of the German BQN was tested on 30 neck pain patients in a single chiropractic practice. Test-retest reliability was evaluated on 31 medical students and chiropractors before and after a lecture. The German BQN was then assessed on 102 first time neck pain patients at two chiropractic practices for internal consistency, external construct validity, external longitudinal construct validity and sensitivity to change compared to the German versions of the Neck Disability Index (NDI) and the Neck Pain and Disability Scale (NPAD). Face validity testing lead to minor changes to the German BQN. The Intraclass Correlation Coefficient for the test-retest reliability was 0.99. The internal consistency was strong for all 7 items of the BQN with Cronbach α's of .79 and .80 for the pre and post-treatment total scores. External construct validity and external longitudinal construct validity using Pearson's correlation coefficient showed statistically significant correlations for all 7 scales of the BQN with the other questionnaires. The German BQN showed greater responsiveness compared to the other questionnaires for all scales. The German BQN is a valid and reliable outcome measure that has been successfully translated and culturally adapted. It is shorter, easier to use, and more responsive to change than the NDI and NPAD.

Outcome expectations for exercise scale: utility and psychometrics.

PubMed

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

2000-11-01

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

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

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.

A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review.

PubMed

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

2018-02-01

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

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.

Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways.

PubMed

Hill, Jonathan C; Kang, Sujin; Benedetto, Elena; Myers, Helen; Blackburn, Steven; Smith, Stephanie; Dunn, Kate M; Hay, Elaine; Rees, Jonathan; Beard, David; Glyn-Jones, Sion; Barker, Karen; Ellis, Benjamin; Fitzpatrick, Ray; Price, Andrew

2016-08-05

Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ). A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics. Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570 participants (n=210 physiotherapy, n=150 hip, n=150 knee, n=60 shoulder patients). Outcomes included the MSK-HQ's acceptability, feasibility, comprehension, readability and responder burden. The validation cohort outcomes were the MSK-HQ's completion rate, test-retest reliability and convergent validity with reference standards (EQ-5D-5L, Oxford Hip, Knee, Shoulder Scores, and the Keele MSK-PROM). Musculoskeletal domains prioritised were pain severity, physical function, work interference, social interference, sleep, fatigue, emotional health, physical activity, independence, understanding, confidence to self-manage and overall impact. Patients reported MSK-HQ items to be 'highly relevant' and 'easy to understand'. Completion rates were high (94.2%), with scores normally distributed, and no floor/ceiling effects. Test-retest reliability was excellent, and convergent validity was strong (correlations 0.81-0.88). A new musculoskeletal outcome measure has been developed through a coproduction process with patients to capture prioritised outcomes for use throughout the pathway and with different musculoskeletal conditions. Four validation cohorts found that the MSK-HQ had high completion rates, excellent test-retest reliability and strong convergent validity with reference standards. Further validation studies are ongoing, including a cohort with rheumatoid/inflammatory arthritis. 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/

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.

Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity.

PubMed

Hawkins, Melanie; Elsworth, Gerald R; Osborne, Richard H

2018-07-01

Data from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context. This paper proposes the application of contemporary validity theory and methodology to PROM validity testing. The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ). Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector.

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…

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.

The development and validation of the Perceived Health Competence Scale.

PubMed

Smith, M S; Wallston, K A; Smith, C A

1995-03-01

A sense of competence or self-efficacy is associated with many positive outcomes, particularly in the area of health behavior. A measure of a sense of competence in the domain of health behavior has not been developed. Most measures are either general measures of a general sense of self-efficacy or are very specific to a particular health behavior. The Perceived Health Competence Scale (PHCS), a domain-specific measure of the degree to which an individual feels capable of effectively managing his or her health outcomes, was developed to provide a measure of perceived competence at an intermediate level of specificity. Five studies using three different types of samples (students, adults and persons with a chronic illness) provide evidence for the reliability and validity of the PHCS. The eight items of the PHCS combine both outcome and behavioral expectancies. Results from the five studies indicate that the scale has good internal consistency and test-retest reliability. The construct validity of the scale is demonstrated through the support obtained for substantive hypotheses regarding the correlates of perceived health competence, such as health behavior intentions, general sense of competence and health locus of control.

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

Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures.

PubMed

Cappelleri, Joseph C; Jason Lundy, J; Hays, Ron D

2014-05-01

The US Food and Drug Administration's guidance for industry document on patient-reported outcomes (PRO) defines content validity as "the extent to which the instrument measures the concept of interest" (FDA, 2009, p. 12). According to Strauss and Smith (2009), construct validity "is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity" (p. 7). Hence, both qualitative and quantitative information are essential in evaluating the validity of measures. We review classical test theory and item response theory (IRT) 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. If a researcher has few qualitative data and wants to get preliminary information about the content validity of the instrument, then descriptive assessments using classical test theory should be the first step. As the sample size grows during subsequent stages of instrument development, confidence in the numerical estimates from Rasch and other IRT models (as well as those of classical test theory) would also grow. Classical test theory and IRT can be useful in providing a quantitative assessment of items and scales during the content-validity phase of PRO-measure development. Depending on the particular type of measure and the specific circumstances, the classical test theory and/or the IRT should be considered to help maximize the content validity of PRO measures. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

[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.

Reliability and Validity of the Alcohol Consequences Expectations Scale

ERIC Educational Resources Information Center

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

2009-01-01

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

Readability of Self-Report Measures of Depression and Anxiety

ERIC Educational Resources Information Center

McHugh, R. Kathryn; Behar, Evelyn

2009-01-01

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

A need for an augmented review when reviewing rehabilitation research.

PubMed

Gerber, Lynn H; Nava, Andrew; Garfinkel, Steven; Goel, Divya; Weinstein, Ali A; Cai, Cindy

2016-10-01

There is a need for additional strategies for performing systematic reviews (SRs) to improve translation of findings into practice and to influence health policy. SRs critically appraise research methodology and determine level of evidence of research findings. The standard type of SR identifies randomized controlled trials (RCTs) as providing the most valid data and highest level of evidence. RCTs are not among the most frequently used research design in disability and health research. RCTs usually measure impairments for the primary research outcome rather than improved function, participation or societal integration. It forces a choice between "validity" and "utility/relevance." Other approaches have effectively been used to assess the validity of alternative research designs, whose outcomes focus on function and patient-reported outcomes. We propose that utilizing existing evaluation tools that measure knowledge, dissemination and utility of findings, may help improve the translation of findings into practice and health policy. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of the ProPublica Surgeon Scorecard "Adjusted Complication Rate" Measure Specifications.

PubMed

Ban, Kristen A; Cohen, Mark E; Ko, Clifford Y; Friedberg, Mark W; Stulberg, Jonah J; Zhou, Lynn; Hall, Bruce L; Hoyt, David B; Bilimoria, Karl Y

2016-10-01

The ProPublica Surgeon Scorecard is the first nationwide, multispecialty public reporting of individual surgeon outcomes. However, ProPublica's use of a previously undescribed outcome measure (composite of in-hospital mortality or 30-day related readmission) and inclusion of only inpatients have been questioned. Our objectives were to (1) determine the proportion of cases excluded by ProPublica's specifications, (2) assess the proportion of inpatient complications excluded from ProPublica's measure, and (3) examine the validity of ProPublica's outcome measure by comparing performance on the measure to well-established postoperative outcome measures. Using ACS-NSQIP data (2012-2014) for 8 ProPublica procedures and for All Operations, the proportion of cases meeting all ProPublica inclusion criteria was determined. We assessed the proportion of complications occurring inpatient, and thus not considered by ProPublica's measure. Finally, we compared risk-adjusted performance based on ProPublica's measure specifications to established ACS-NSQIP outcome measure performance (eg, death/serious morbidity, mortality). ProPublica's inclusion criteria resulted in elimination of 82% of all operations from assessment (range: 42% for total knee arthroplasty to 96% for laparoscopic cholecystectomy). For all ProPublica operations combined, 84% of complications occur during inpatient hospitalization (range: 61% for TURP to 88% for total hip arthroplasty), and are thus missed by the ProPublica measure. Hospital-level performance on the ProPublica measure correlated weakly with established complication measures, but correlated strongly with readmission (R = 0.834, P < 0.001). ProPublica's outcome measure specifications exclude 82% of cases, miss 84% of postoperative complications, and correlate poorly with well-established postoperative outcomes. Thus, the validity of the ProPublica Surgeon Scorecard is questionable.

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 significant agreement between patient outcomes assessed by the ORIDL and the EQOL transition scale, the MYMOP, and the PEI-outcome instrument, suggesting that the ORIDL may be a valid and sensitive tool for measuring change in relation to impact on life.

Nursing Outcomes for Patients with Risk of Perioperative Positioning Injury.

PubMed

de Lima, Luciana Bjorklund; E Cardozo, Michelle Cardoso; Bernardes, Daniela de Souza; Rabelo-Silva, Eneida Rejane

2018-04-16

To select and refine the outcomes and indicators of Nursing Outcomes Classification for the diagnosis of risk for perioperative positioning injury. Validation study on expert consensus and refinement through pilot study. Eight outcomes and 35 indicators were selected in consensus. After clinical testing was performed, in which 10 patients were assessed at five different times. Eight outcomes and 33 indicators remained in the protocol. This study made it possible to select the most relevant outcomes and indicators to be measured for this diagnosis in clinical practice. Validation studies by consensus and clinical testing are important to promote the accuracy, creating opportunities to legitimize, and improve the concepts of taxonomies. © 2018 NANDA International, Inc.

Convergent Validity of the CORE Measures with Measures of Depression for Clients in Cognitive Therapy for Depression

ERIC Educational Resources Information Center

Cahill, Jane; Barkham, Michael; Stiles, William B.; Twigg, Elspeth; Hardy, Gillian E.; Rees, Anne; Evans, Chris

2006-01-01

Clients (N = 77) undergoing cognitive therapy for depression were assessed before treatment with the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), which encompasses domains of subjective well-being, problems, functioning, and risk of harming self or others, along with the Beck Depression Inventory-II (BDIII), the Hamilton…

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

ERIC Educational Resources Information Center

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

2017-01-01

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

The 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…

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 version can be used in clinical practice and for research purposes to assess symptoms and functional limitations in Arabic-speaking patients with knee disorders. This scale is responsive to track therapeutic outcome of Arabic-speaking patients with knee disorders.

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.

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.

Conceptual and measurement issues in early parenting practices research: an epidemiologic perspective.

PubMed

Walker, Lorraine O; Kirby, Russell S

2010-11-01

Early parenting practices are significant to public health because of their linkages to child health outcomes. This paper focuses on the current state of the science regarding conceptual frameworks that incorporate early parenting practices in epidemiologic research and evidence supporting reliability and validity of self-report measures of such practices. Guided by a provisional definition of early parenting practices, literature searches were conducted using PubMed and Sociological Abstracts. Twenty-five published studies that included parent-report measures of early parenting practices met inclusion criteria. Findings on conceptual frameworks were analyzed qualitatively, whereas evidence of reliability and validity were organized into four domains (safety, feeding and oral health, development promotion, and discipline) and summarized in tabular form. Quantitative estimates of measures of reliability and validity were extracted, where available. We found two frameworks incorporating early parenting: one a program theory and the other a predictive model. We found no reported evidence of the reliability or validity of parent-report measures of safety or feeding and oral health practices. Evidence for reliability and validity were reported with greater frequency for development promotion and discipline practices, but report of the most pertinent type of reliability estimation, test-retest reliability, was rare. Failure to examine associations of early parenting practices with any child outcomes within most studies resulted in missed opportunities to indirectly estimate validity of parenting practice measures. Stronger evidence concerning specific measurement properties of early parenting practices is important to advancing maternal-child research, surveillance, and practice.

The Social Meaning in Life Events Scale (SMILES): A preliminary psychometric evaluation in a bereaved sample.

PubMed

Bellet, Benjamin W; Holland, Jason M; Neimeyer, Robert A

2018-06-05

A mourner's success in making meaning of a loss has proven key in predicting a wide array of bereavement outcomes. However, much of this meaning-making process takes place in an interpersonal framework that is hypothesized to either aid or obstruct this process. To date, a psychometrically validated measure of the degree to which a mourner successfully makes meaning of a loss in a social context has yet to be developed. The present study examines the factor structure, reliability, and validity of a new measure called the Social Meaning in Life Events Scale (SMILES) in a sample of bereaved college students (N = 590). The SMILES displayed a two-factor structure, with one factor assessing the extent to which a mourner's efforts at making meaning were invalidated (Social Invalidation subscale), and the other assessing the extent to which a mourner's meaning-making process was validated (Social Validation subscale). The subscales displayed good reliability and construct validity in reference to several outcome variables of interest (complicated grief, general health, and post-loss growth), as well as related but different variables (social support and meaning made). The subscales also demonstrated group differences according to two demographic variables associated with complications in the mourning process (age and mode of loss), as well as incremental validity in predicting adverse bereavement outcomes over and above general social support. Clinical and research implications involving the use of this new measure are discussed.

Supervisor Health and Safety Support: Scale Development and Validation

PubMed Central

Butts, Marcus M.; Hurst, Carrie S.; Eby, Lillian T.

2013-01-01

Executive Summary Two studies were conducted to develop a psychometrically sound measure of supervisor health and safety support (SHSS). We identified three dimensions of supervisor support (physical health, psychological health, safety) and used Study 1 to develop items and establish content validity. Study 2 was used to establish the dimensionality of the new measure and provide criterion-related and discriminant validity evidence of the measure using supervisor and subordinate data. The measure had incremental validity in predicting employee performance and psychological strain outcomes above and beyond general work support variables. Implications of these findings and for workplace support theory and practice are discussed. PMID:24771991

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.

Urbanisation, urbanicity, and health: a systematic review of the reliability and validity of urbanicity scales.

PubMed

Cyril, Sheila; Oldroyd, John C; Renzaho, Andre

2013-05-28

Despite a plethora of studies examining the effect of increased urbanisation on health, no single study has systematically examined the measurement properties of scales used to measure urbanicity. It is critical to distinguish findings from studies that use surrogate measures of urbanicity (e.g. population density) from those that use measures rigorously tested for reliability and validity. The purpose of this study was to assess the measurement reliability and validity of the available urbanicity scales and identify areas where more research is needed to facilitate the development of a standardised measure of urbanicity. Databases searched were MEDLINE with Full Text, CINAHL with Full Text, and PsycINFO (EBSCOhost) as well as Embase (Ovid) covering the period from January 1970 to April 2012. Studies included in this systematic review were those that focused on the development of an urbanicity scale with clearly defined items or the adoption of an existing scale, included at least one outcome measure related to health, published in peer-reviewed journals, the full text was available in English and tested for validity and reliability. Eleven studies met our inclusion criteria which were conducted in Sri Lanka, Austria, China, Nigeria, India and Philippines. They ranged in size from 3327 to 33,404 participants. The number of scale items ranged from 7 to 12 items in 5 studies. One study measured urban area socioeconomic disadvantage instead of urbanicity. The emerging evidence is that increased urbanisation is associated with deleterious health outcomes. It is possible that increased urbanisation is also associated with access and utilisation of health services. However, urbanicity measures differed across studies, and the reliability and validity properties of the used scales were not well established. There is an urgent need for studies to standardise measures of urbanicity. Longitudinal cohort studies to confirm the relationship between increased urbanisation and health outcomes are urgently needed.

Urbanisation, urbanicity, and health: a systematic review of the reliability and validity of urbanicity scales

PubMed Central

2013-01-01

Background Despite a plethora of studies examining the effect of increased urbanisation on health, no single study has systematically examined the measurement properties of scales used to measure urbanicity. It is critical to distinguish findings from studies that use surrogate measures of urbanicity (e.g. population density) from those that use measures rigorously tested for reliability and validity. The purpose of this study was to assess the measurement reliability and validity of the available urbanicity scales and identify areas where more research is needed to facilitate the development of a standardised measure of urbanicity. Methods Databases searched were MEDLINE with Full Text, CINAHL with Full Text, and PsycINFO (EBSCOhost) as well as Embase (Ovid) covering the period from January 1970 to April 2012. Studies included in this systematic review were those that focused on the development of an urbanicity scale with clearly defined items or the adoption of an existing scale, included at least one outcome measure related to health, published in peer-reviewed journals, the full text was available in English and tested for validity and reliability. Results Eleven studies met our inclusion criteria which were conducted in Sri Lanka, Austria, China, Nigeria, India and Philippines. They ranged in size from 3327 to 33,404 participants. The number of scale items ranged from 7 to 12 items in 5 studies. One study measured urban area socioeconomic disadvantage instead of urbanicity. The emerging evidence is that increased urbanisation is associated with deleterious health outcomes. It is possible that increased urbanisation is also associated with access and utilisation of health services. However, urbanicity measures differed across studies, and the reliability and validity properties of the used scales were not well established. Conclusion There is an urgent need for studies to standardise measures of urbanicity. Longitudinal cohort studies to confirm the relationship between increased urbanisation and health outcomes are urgently needed. PMID:23714282

Validation of the organizational culture assessment instrument.

PubMed

Heritage, Brody; Pollock, Clare; Roberts, Lynne

2014-01-01

Organizational culture is a commonly studied area in industrial/organizational psychology due to its important role in workplace behaviour, cognitions, and outcomes. Jung et al.'s [1] review of the psychometric properties of organizational culture measurement instruments noted many instruments have limited validation data despite frequent use in both theoretical and applied situations. The Organizational Culture Assessment Instrument (OCAI) has had conflicting data regarding its psychometric properties, particularly regarding its factor structure. Our study examined the factor structure and criterion validity of the OCAI using robust analysis methods on data gathered from 328 (females = 226, males = 102) Australian employees. Confirmatory factor analysis supported a four factor structure of the OCAI for both ideal and current organizational culture perspectives. Current organizational culture data demonstrated expected reciprocally-opposed relationships between three of the four OCAI factors and the outcome variable of job satisfaction but ideal culture data did not, thus indicating possible weak criterion validity when the OCAI is used to assess ideal culture. Based on the mixed evidence regarding the measure's properties, further examination of the factor structure and broad validity of the measure is encouraged.

Validation of the Organizational Culture Assessment Instrument

PubMed Central

Heritage, Brody; Pollock, Clare; Roberts, Lynne

2014-01-01

Organizational culture is a commonly studied area in industrial/organizational psychology due to its important role in workplace behaviour, cognitions, and outcomes. Jung et al.'s [1] review of the psychometric properties of organizational culture measurement instruments noted many instruments have limited validation data despite frequent use in both theoretical and applied situations. The Organizational Culture Assessment Instrument (OCAI) has had conflicting data regarding its psychometric properties, particularly regarding its factor structure. Our study examined the factor structure and criterion validity of the OCAI using robust analysis methods on data gathered from 328 (females = 226, males = 102) Australian employees. Confirmatory factor analysis supported a four factor structure of the OCAI for both ideal and current organizational culture perspectives. Current organizational culture data demonstrated expected reciprocally-opposed relationships between three of the four OCAI factors and the outcome variable of job satisfaction but ideal culture data did not, thus indicating possible weak criterion validity when the OCAI is used to assess ideal culture. Based on the mixed evidence regarding the measure's properties, further examination of the factor structure and broad validity of the measure is encouraged. PMID:24667839

Understanding Health-related Quality of Life in Caregivers of Civilians and Service Members/Veterans with Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Mental Health Measures.

PubMed

Carlozzi, Noelle E; Hanks, Robin; Lange, Rael T; Brickell D Psych, Tracey A; Ianni, Phillip A; Miner, Jennifer A; French Psy D, Louis M; Kallen, Michael A; Sander, Angelle M

2018-06-19

To provide important reliability and validity data to support the use of the PROMIS Mental Health measures in caregivers of civilians or service members/veterans with traumatic brain injury (TBI). Patient-reported outcomes surveys administered through an electronic data collection platform. Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. 560 caregivers of individuals with a documented TBI (344 civilians and 216 military) INTERVENTION: Not Applicable MAIN OUTCOME MEASURES: PROMIS Anxiety, Depression, and Anger Item Banks RESULTS: Internal consistency for all of the PROMIS Mental Health item banks was very good (all α > .86) and three-week test retest reliability was good to adequate (ranged from .65 to .85). Convergent validity and discriminant validity of the PROMIS measures was also supported. Caregivers of individuals that were low functioning had worse emotional HRQOL (as measured by the three PROMIS measures) than caregivers of high functioning individuals, supporting known groups validity. Finally, levels of distress, as measured by the PROMIS measures, were elevated for those caring for low-functioning individuals in both samples (rates ranged from 26.2% to 43.6% for caregivers of low-functioning individuals). Results support the reliability and validity of the PROMIS Anxiety, Depression, and Anger item banks in caregivers of civilians and service members/veterans with TBI. Ultimately, these measures can be used to provide a standardized assessment of HRQOL as it relates to mental health in these caregivers. Copyright © 2018. Published by Elsevier Inc.

Characteristics of clinical shoulder research over the last decade: a review of shoulder articles in The Journal of Bone & Joint Surgery from 2004 to 2014.

PubMed

Gartsman, Gary M; Morris, Brent J; Unger, R Zackary; Laughlin, Mitzi S; Elkousy, Hussein A; Edwards, T Bradley

2015-03-04

The purpose of this study was to determine characteristics and trends in published shoulder research over the last decade in a leading orthopaedic journal. We examined all clinical shoulder articles published in The Journal of Bone & Joint Surgery from 2004 to 2014. The number of citations, authorship, academic degrees of the authors, country and institution of origin, topic, level of evidence, positive or nonpositive outcome, and inclusion of validated patient-reported outcome measures were assessed for each article. Shoulder articles that included an author with an advanced research degree (MD [Doctor of Medicine] with a PhD [Doctor of Philosophy] or other advanced degree) increased during the study period (p = 0.047). Level-I, II, and III studies were more likely to have an author with an advanced research degree, and Level-IV studies were more likely to have MDs only (p = 0.03). Overall, there was great variability of outcome measures, with at least thirty-nine different validated or nonvalidated outcome measures reported. Over the last decade, there was an improvement in the level of evidence of shoulder articles published in The Journal of Bone & Joint Surgery that corresponds with recent emphasis on evidence-based medicine. A consensus is needed in shoulder research for more consistent application of validated patient-reported outcome measurement tools. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Correlation of PROMIS Physical Function and Pain CAT Instruments With Oswestry Disability Index and Neck Disability Index in Spine Patients.

PubMed

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

2016-07-15

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

Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity.

PubMed

Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C

2017-01-01

Advances from pharmacogenetics (PGx) have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

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 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 legacy instruments. 2.

Measurement of COPD Severity Using a Survey-Based Score

PubMed Central

Omachi, Theodore A.; Katz, Patricia P.; Yelin, Edward H.; Iribarren, Carlos; Blanc, Paul D.

2010-01-01

Background: A comprehensive survey-based COPD severity score has usefulness for epidemiologic and health outcomes research. We previously developed and validated the survey-based COPD Severity Score without using lung function or other physiologic measurements. In this study, we aimed to further validate the severity score in a different COPD cohort and using a combination of patient-reported and objective physiologic measurements. Methods: Using data from the Function, Living, Outcomes, and Work cohort study of COPD, we evaluated the concurrent and predictive validity of the COPD Severity Score among 1,202 subjects. The survey instrument is a 35-point score based on symptoms, medication and oxygen use, and prior hospitalization or intubation for COPD. Subjects were systemically assessed using structured telephone survey, spirometry, and 6-min walk testing. Results: We found evidence to support concurrent validity of the score. Higher COPD Severity Score values were associated with poorer FEV1 (r = −0.38), FEV1% predicted (r = −0.40), Body mass, Obstruction, Dyspnea, Exercise Index (r = 0.57), and distance walked in 6 min (r = −0.43) (P < .0001 in all cases). Greater COPD severity was also related to poorer generic physical health status (r = −0.49) and disease-specific health-related quality of life (r = 0.57) (P < .0001). The score also demonstrated predictive validity. It was also associated with a greater prospective risk of acute exacerbation of COPD defined as ED visits (hazard ratio [HR], 1.31; 95% CI, 1.24-1.39), hospitalizations (HR, 1.59; 95% CI, 1.44-1.75), and either measure of hospital-based care for COPD (HR, 1.34; 95% CI, 1.26-1.41) (P < .0001 in all cases). Conclusion: The COPD Severity Score is a valid survey-based measure of disease-specific severity, both in terms of concurrent and predictive validity. The score is a psychometrically sound instrument for use in epidemiologic and outcomes research in COPD. PMID:20040611

The development and preliminary psychometric properties of two positive psychology outcome measures for people with dementia: the PPOM and the EID-Q.

PubMed

Stoner, Charlotte R; Orrell, Martin; Long, Maria; Csipke, Emese; Spector, Aimee

2017-03-21

Positive psychology research in dementia care has largely been confined to the qualitative literature because of the lack of robust outcome measures. The aim of this study was to develop positive psychology outcome measures for people with dementia. Two measures were each developed in four stages. Firstly, literature reviews were conducted to identify and operationalise salient positive psychology themes in the qualitative literature and to examine existing measures of positive psychology. Secondly, themes were discussed within a qualitative study to add content validity for identified concepts (n = 17). Thirdly, draft measures were submitted to a panel of experts for feedback (n = 6). Finally, measures were used in a small-scale pilot study (n = 33) to establish psychometric properties. Salient positive psychology themes were identified as hope, resilience, a sense of independence and social engagement. Existing measures of hope and resilience were adapted to form the Positive Psychology Outcome Measure (PPOM). Due to the inter-relatedness of independence and engagement for people with dementia, 28 items were developed for a new scale of Engagement and Independence in Dementia Questionnaire (EID-Q) following extensive qualitative work. Both measures demonstrated acceptable internal consistency (α = .849 and α = .907 respectively) and convergent validity. Two new positive psychology outcome measures were developed using a robust four-stage procedure. Preliminary psychometric data was adequate and the measures were easy to use, and acceptable for people with dementia.

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

ERIC Educational Resources Information Center

Lee, Chul-Joo; Kim, Daniel

2013-01-01

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

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…

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…

Background, College Experiences, and the ACT-COMP Exam: Using Construct Validity to Evaluate Assessment Instruments.

ERIC Educational Resources Information Center

Pike, Gary R.

1989-01-01

A study investigated the appropriateness of the American College Testing Program's College Outcome Measures Program, conducted at the University of Tennessee, Knoxville, by applying the criterion of construct validity. Results indicated that while the test primarily measures individual differences, it is also sensitive to the effects of higher…

The Development, Evaluation, and Validation of a Financial Stress Scale for Undergraduate Students

ERIC Educational Resources Information Center

Northern, Jebediah J.; O'Brien, William H.; Goetz, Paul W.

2010-01-01

Financial stress is commonly experienced among college students and is associated with adverse academic, mental health, and physical health outcomes. Surprisingly, no validated measures of financial stress have been developed for undergraduate populations. The present study was conducted to generate and evaluate a measure of financial stress for…

The Halpern Critical Thinking Assessment and Real-World Outcomes: Cross-National Applications

ERIC Educational Resources Information Center

Butler, Heather A.; Dwyer, Christopher P.; Hogan, Michael J.; Franco, Amanda; Rivas, Silvia F.; Saiz, Carlos; Almeida, Leandro S.

2012-01-01

The Halpern Critical Thinking Assessment (HCTA) is a reliable measure of critical thinking that has been validated with numerous qualitatively different samples and measures of academic success (Halpern, 2010a). This paper presents several cross-national applications of the assessment, and recent work to expand the validation of the HCTA with…

A systematic review of instruments for assessing parent satisfaction with family-centred care in neonatal intensive care units.

PubMed

Dall'Oglio, Immacolata; Mascolo, Rachele; Gawronski, Orsola; Tiozzo, Emanuela; Portanova, Anna; Ragni, Angela; Alvaro, Rosaria; Rocco, Gennaro; Latour, Jos M

2018-03-01

This systematic review synthesised and described instruments measuring parent satisfaction with the increasing standard practice of family-centred care (FCC) in neonatal intensive care units. We evaluated 11 studies published from January 2006 to March 2016: two studies validated a parent satisfaction questionnaire, and nine developed or modified previous questionnaires to use as outcome measures in their local settings. Most instruments were not tested on reliability and validity. Only two validated instruments included all six of the FCC principles and could assess parent satisfaction with FCC in neonatal intensive care units and be considered as outcome indicators for further research. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Patient-reported outcome instruments that evaluate adherence behaviours in adults with asthma: A systematic review of measurement properties.

PubMed

Gagné, Myriam; Boulet, Louis-Philippe; Pérez, Norma; Moisan, Jocelyne

2018-04-30

To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong). We screened 6,068 records and included 15 studies (14 PROs). No studies evaluated measurement error or responsiveness. Based on methodological and measurement property quality assessments, we found limited positive evidence of: (a) internal consistency of the Adherence Questionnaire, Refined Medication Adherence Reason Scale (MAR-Scale), Medication Adherence Report Scale for Asthma (MARS-A), and Test of the Adherence to Inhalers (TAI); (b) reliability of the TAI; and (c) structural validity of the Adherence Questionnaire, MAR-Scale, MARS-A, and TAI. We also found limited negative evidence of: (d) hypotheses testing of Adherence Questionnaire; (e) reliability of the MARS-A; and (f) criterion validity of the MARS-A and TAI. Our results highlighted the need to conduct further high-quality studies that will positively evaluate the reliability, validity, and responsiveness of the available PROs. This article is protected by copyright. All rights reserved.

Understanding health-related quality of life in caregivers of civilians and service members/veterans with traumatic brain injury: Establishing the reliability and validity of PROMIS Fatigue and Sleep Disturbance item banks.

PubMed

Carlozzi, Noelle E; Ianni, Phillip A; Tulsky, David S; Brickell, Tracey A; Lange, Rael T; French, Louis M; Cella, David; Kallen, Michael A; Miner, Jennifer A; Kratz, Anna L

2018-06-19

To examine the reliability and validity of Patient Reported Outcomes Measurement Information System (PROMIS) measures of sleep disturbance and fatigue in TBI caregivers and to determine the severity of fatigue and sleep disturbance in these caregivers. Cross-sectional survey data collected through an online data capture platform. Four rehabilitation hospitals and Walter Reed National Military Medical Center. Caregivers (N=560) of civilians (n=344) and service member/veterans (n=216) with TBI. Not Applicable MAIN OUTCOME MEASURES: PROMIS sleep and fatigue measures administered as both computerized adaptive tests (CATs) and 4-item short forms (SFs). For both samples, floor and ceiling effects for the PROMIS measures were low (<11%), internal consistency was very good (all alphas ≥0.80), and test-retest reliability was acceptable (all r≥0.70 except for the fatigue CAT in the service member/veteran sample r=0.63). Convergent validity was supported by moderate correlations between the PROMIS and related measures. Discriminant validity was supported by low correlations between PROMIS measures and measures of dissimilar constructs. PROMIS scores indicated significantly worse sleep and fatigue for those caring for someone with high levels versus low levels of impairment. Findings support the reliability and validity of the PROMIS CAT and SF measures of sleep disturbance and fatigue in caregivers of civilians and service members/veterans with TBI. Copyright © 2018. Published by Elsevier Inc.

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.

Measuring Critical Education Processes and Outcomes: Illustration from a Cluster Randomized Trial in the Democratic Republic of the Congo

ERIC Educational Resources Information Center

Halpin, Peter F.; Torrente, Catalina

2014-01-01

Using reliable and valid measures of students' outcomes which are sensitive to change is critical for obtaining interpretable and therefore useful results from evaluations of school-based interventions. While measurement development for use in experimental evaluations receives a great deal of attention in the U.S., it lags behind in low-income…

Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder.

PubMed

Anagnostou, Evdokia; Jones, Nancy; Huerta, Marisela; Halladay, Alycia K; Wang, Paul; Scahill, Lawrence; Horrigan, Joseph P; Kasari, Connie; Lord, Cathy; Choi, Dennis; Sullivan, Katherine; Dawson, Geraldine

2015-07-01

Social communication impairments are a core deficit in autism spectrum disorder. Social communication deficit is also an early indicator of autism spectrum disorder and a factor in long-term outcomes. Thus, this symptom domain represents a critical treatment target. Identifying reliable and valid outcome measures for social communication across a range of treatment approaches is essential. Autism Speaks engaged a panel of experts to evaluate the readiness of available measures of social communication for use as outcome measures in clinical trials. The panel held monthly conference calls and two face-to-face meetings over 14 months. Key criteria used to evaluate measures included the relevance to the clinical target, coverage of the symptom domain, and psychometric properties (validity and reliability, as well as evidence of sensitivity to change). In all, 38 measures were evaluated and 6 measures were considered appropriate for use, with some limitations. This report discusses the relative strengths and weaknesses of existing social communication measures for use in clinical trials and identifies specific areas in need of further development. © The Author(s) 2014.

Candidate Quality Measures for Hand Surgery.

PubMed

2017-11-01

Quality measures are tools used by physicians, health care systems, and payers to evaluate performance, monitor the outcomes of interventions, and inform quality improvement efforts. A paucity of quality measures exist that address hand surgery care. We completed a RAND/UCLA (University of California Los Angeles) Delphi Appropriateness process with the goal of developing and evaluating candidate hand surgery quality measures to be used for national quality measure development efforts. A consortium of 9 academic upper limb surgeons completed a RAND/UCLA Delphi Appropriateness process to evaluate the importance, scientific acceptability, usability, and feasibility of 44 candidate quality measures. These addressed hand problems the panelists felt were most appropriate for quality measure development. Panelists rated the measures on an ordinal scale between 1 (definitely not valid) and 9 (definitely valid) in 2 rounds (preliminary round and final round) with an intervening face-to-face discussion. Ratings from 1 to 3 were considered not valid, 4 to 6 as equivocal or uncertain, and 7 to 9 as valid. If no more than 2 of the 9 ratings were outside the 3-point range that included the median (1-3, 4-6, or 7-9), the panelists were considered to be in agreement. If 3 or more of the panelists' ratings of a measure were within the 1 to 3 range and 3 or more ratings were in the 7 to 9 range, the panelists were considered to be in disagreement. There was agreement on 43% (19) of the measures as important, 27% (12) as scientifically sound, 48% (21) as usable, and 59% (26) as feasible to complete. Ten measures met all 4 of these criteria and were, therefore, considered valid measurements of quality. Quality measures that were developed address outcomes (patient-reported outcomes for assessment and improvement of function) and processes of care (utilization rates of imaging, antibiotics, occupational therapy, ultrasound, and operative treatment). The consortium developed 10 measures of hand surgery quality using a validated methodology. These measures merit further development. Quality measures can be used to evaluate the quality of care provided by physicians and health systems and can inform quality and value-based reimbursement models. Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Evaluating a measure of social health derived from two mental health recovery measures: the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program Consumer Survey (MHSIP).

PubMed

Carlson, Jordan A; Sarkin, Andrew J; Levack, Ashley E; Sklar, Marisa; Tally, Steven R; Gilmer, Todd P; Groessl, Erik J

2011-08-01

Social health is important to measure when assessing outcomes in community mental health. Our objective was to validate social health scales using items from two broader commonly used measures that assess mental health outcomes. Participants were 609 adults receiving psychological treatment services. Items were identified from the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program (MHSIP) outcome measures by their conceptual correspondence with social health and compared to the Social Functioning Questionnaire (SFQ) using correlational analyses. Pearson correlations for the identified CA-QOL and MSHIP items with the SFQ ranged from .42 to .62, and the identified scale scores produced Pearson correlation coefficients of .56, .70, and, .70 with the SFQ. Concurrent validity with social health was supported for the identified scales. The current inclusion of these assessment tools allows community mental health programs to include social health in their assessments.

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.

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.

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…

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.

Reliability and validity of the Tilburg Frailty Indicator (TFI) among Chinese community-dwelling older people.

PubMed

Dong, Lijuan; Liu, Na; Tian, Xiaoyu; Qiao, Xiaoxia; Gobbens, Robbert J J; Kane, Robert L; Wang, Cuili

2017-11-01

To translate the Tilburg Frailty Indicator (TFI) into Chinese and assess its reliability and validity. A sample of 917 community-dwelling older people, aged ≥60 years, in a Chinese city was included between August 2015 and March 2016. Construct validity was assessed using alternative measures corresponding to the TFI items, including self-rated health status (SRH), unintentional weight loss, walking speed, timed-up-and-go tests (TUGT), making telephone calls, grip strength, exhaustion, Short Portable Mental Status Questionnaire (SPMSQ), Geriatric Depression scale (GDS-15), emotional role, Adaptability Partnership Growth Affection and Resolve scale (APGAR) and Social Support Rating Scale (SSRS). Fried's phenotype and frailty index were measured to evaluate criterion validity. Adverse health outcomes (ADL and IADL disability, healthcare utilization, GDS-15, SSRS) were used to assess predictive (concurrent) validity. The internal consistency reliability was good (Cronbach's α=0.71). The test-retest reliability was strong (r=0.88). Kappa coefficients showed agreements between the TFI items and corresponding alternative measures. Alternative measures correlated as expected with the three domains of TFI, with an exclusion that alternative psychological measures had similar correlations with psychological and physical domains of the TFI. The Chinese TFI had excellent criterion validity with the AUCs regarding physical phenotype and frailty index of 0.87 and 0.86, respectively. The predictive (concurrent) validities of the adverse health outcomes and healthcare utilization were acceptable (AUCs: 0.65-0.83). The Chinese TFI has good validity and reliability as an integral instrument to measure frailty of older people living in the community in China. Copyright © 2017 Elsevier B.V. All rights reserved.

Confirmatory Factor Analysis of a Family Quality of Life Scale for Taiwanese Families of Children with Intellectual Disability/Developmental Delay

ERIC Educational Resources Information Center

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

2017-01-01

The Beach Center Family Quality of Life Scale is an internationally validated instrument for measuring family outcomes. To revise the scale for better alignment with the Family Quality of Life theory, the authors excluded non-outcome items in this revision. In this study, we examined reliability and validity of the revised scale (i.e., the FQoL…

Psychometric evaluation of dietary self-efficacy and outcome expectation scales in female college freshmen.

PubMed

Kedem, Leia E; Evans, Ellen M; Chapman-Novakofski, Karen

2014-11-01

Lifestyle interventions commonly measure psychosocial beliefs as precursors to positive behavior change, but often overlook questionnaire validation. This can affect measurement accuracy if the survey has been developed for a different population, as differing behavioral influences may affect instrument validity. The present study aimed to explore psychometric properties of self-efficacy and outcome expectation scales-originally developed for younger children-in a population of female college freshmen (N = 268). Exploratory principal component analysis was used to investigate underlying data patterns and assess validity of previously published subscales. Composite scores for reliable subscales (Cronbach's α ≥ .70) were calculated to help characterize self-efficacy and outcome expectation beliefs in this population. The outcome expectation factor structure clearly comprised of positive (α = .81-.90) and negative outcomes (α = .63-.67). The self-efficacy factor structure included themes of motivation and effort (α = .75-.94), but items pertaining to hunger and availability cross-loaded often. Based on cross-loading patterns and low Cronbach's alpha values, respectively, self-efficacy items regarding barriers to healthy eating and negative outcome expectation items should be refined to improve reliability. Composite scores suggested that eating healthfully was associated with positive outcomes, but self-efficacy to do so was lower. Thus, dietary interventions for college students may be more successful by including skill-building activities to enhance self-efficacy and increase the likelihood of behavior change. © The Author(s) 2014.

The London handicap scale: a re-evaluation of its validity using standard scoring and simple summation.

PubMed

Jenkinson, C; Mant, J; Carter, J; Wade, D; Winner, S

2000-03-01

To assess the validity of the London handicap scale (LHS) using a simple unweighted scoring system compared with traditional weighted scoring 323 patients admitted to hospital with acute stroke were followed up by interview 6 months after their stroke as part of a trial looking at the impact of a family support organiser. Outcome measures included the six item LHS, the Dartmouth COOP charts, the Frenchay activities index, the Barthel index, and the hospital anxiety and depression scale. Patients' handicap score was calculated both using the standard procedure (with weighting) for the LHS, and using a simple summation procedure without weighting (U-LHS). Construct validity of both LHS and U-LHS was assessed by testing their correlations with the other outcome measures. Cronbach's alpha for the LHS was 0.83. The U-LHS was highly correlated with the LHS (r=0.98). Correlation of U-LHS with the other outcome measures gave very similar results to correlation of LHS with these measures. Simple summation scoring of the LHS does not lead to any change in the measurement properties of the instrument compared with standard weighted scoring. Unweighted scores are easier to calculate and interpret, so it is recommended that these are used.

The quest for fragile X biomarkers.

PubMed

Westmark, Cara J

2014-12-01

Fragile X is the most common form of inherited intellectual disability and the leading known genetic cause of autism. There is currently no cure or approved medication for fragile X although various drugs target specific disease symptoms and a large number of therapeutics are in various stages of clinical development. Multiple recent clinical trials have failed on their primary endpoints indicating that there is a compelling need for validated biomarkers and outcome measures in fragile X. There are currently no validated blood-based biomarkers to assess disease severity or to monitor drug efficacy in fragile X syndrome. Herein, we review candidate blood protein biomarkers including extracellular-regulated kinase, phosphoinositide 3-kinase, matrix metalloproteinase 9, amyloid-beta and amyloid-beta protein precursor. Bench-to-bedside plans for fragile X syndrome are severely limited by the lack of validated outcome measures. The reviewed candidate biomarkers are at early stages of validation and deserve further investigation.

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

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

Elbow-specific clinical rating systems: extent of established validity, reliability, and responsiveness.

PubMed

The, Bertram; Reininga, Inge H F; El Moumni, Mostafa; Eygendaal, Denise

2013-10-01

The modern standard of evaluating treatment results includes the use of rating systems. Elbow-specific rating systems are frequently used in studies aiming at elbow-specific pathology. However, proper validation studies seem to be relatively sparse. In addition, these scoring systems might not always be used for appropriate populations of interest. Both of these issues might give rise to invalid conclusions being reported in the literature. Our aim was to investigate the extent to which the available elbow-specific outcome measurement tools have been validated and the quality of the validation itself. We also aimed to provide characteristics of the populations used for validation of these scales to enable clinicians to use them appropriately. A literature search identified 17 studies of 12 different elbow-specific scoring systems. These were assessed for validity, reliability, and responsiveness characteristics. The quality of these assessments was rated according to the Consensus Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist criteria, a standardized and validated tool developed specifically for this purpose. Currently, the only elbow-specific rating system that is validated using high-quality methodology is the Oxford Elbow Score, a patient-administered outcome measure tool that has been validated on heterogeneous study populations. Other rating systems still have to be proven in the future to be as good as the Oxford Elbow Score for clinical or research purposes. Additional validation studies are needed. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

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 provide a standardized way to assess maternity care process and outcomes of maternity care in Turkey which can inform future research aimed at improving maternity care outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Parent- and Self-Reported Dimensions of Oppositionality in Youth: Construct Validity, Concurrent Validity, and the Prediction of Criminal Outcomes in Adulthood

ERIC Educational Resources Information Center

Aebi, Marcel; Plattner, Belinda; Metzke, Christa Winkler; Bessler, Cornelia; Steinhausen, Hans-Christoph

2013-01-01

Background: Different dimensions of oppositional defiant disorder (ODD) have been found as valid predictors of further mental health problems and antisocial behaviors in youth. The present study aimed at testing the construct, concurrent, and predictive validity of ODD dimensions derived from parent- and self-report measures. Method: Confirmatory…

Measuring conflict management, emotional self-efficacy, and problem solving confidence in an evaluation of outdoor programs for inner-city youth in Baltimore, Maryland.

PubMed

Caldas, Stephanie V; Broaddus, Elena T; Winch, Peter J

2016-08-01

Substantial evidence supports the value of outdoor education programs for promoting healthy adolescent development, yet measurement of program outcomes often lacks rigor. Accurately assessing the impacts of programs that seek to promote positive youth development is critical for determining whether youth are benefitting as intended, identifying best practices and areas for improvement, and informing decisions about which programs to invest in. We generated brief, customized instruments for measuring three outcomes among youth participants in Baltimore City Outward Bound programs: conflict management, emotional self-efficacy, and problem solving confidence. Measures were validated through exploratory and confirmatory factor analyses of pilot-testing data from two groups of program participants. We describe our process of identifying outcomes for measurement, developing and adapting measurement instruments, and validating these instruments. The finalized measures support evaluations of outdoor education programs serving urban adolescent youth. Such evaluations enhance accountability by determining if youth are benefiting from programs as intended, and strengthen the case for investment in programs with demonstrated success. Copyright © 2016 Elsevier Ltd. All rights reserved.

Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment.

PubMed

Dobler, Claudia C; Morgan, Rebecca L; Falck-Ytter, Yngve; Montori, Victor M; Murad, M Hassan

2018-04-01

Surrogate endpoints are often used in clinical trials, as they allow for indirect measures of outcomes (eg, shorter trials with less participants). Improvements in surrogate endpoints (eg, reduction in low density lipoprotein cholesterol, normalisation of glycated haemoglobin) achieved with an intervention are, however, not always associated with improvements in patient-important outcomes. The common tendency in evidence-based medicine is to view results based on surrogate endpoints as less certain than results based on long term, final patient-important outcomes and rate them as 'lower quality evidence'. However, careful appraisal of the validity of a surrogate endpoint as a measure of the final, patient-important outcome is more useful than an automatic judgement. In this guide, we use a contemporary and currently highly debated example of the surrogate endpoint 'sustained viral response' (ie, viral eradication considered to represent successful treatment) in patients treated for chronic hepatitis C virus. We demonstrate how the validity of a surrogate endpoint can be critically appraised to assess the quality of the evidence (ie, the certainty in estimates) and the implications for decision-making. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Validation of the Focus on the Outcomes of Communication under Six outcome measure

PubMed Central

Thomas-Stonell, Nancy; Oddson, Bruce; Robertson, Bernadette; Rosenbaum, Peter

2013-01-01

Aim The aim of this study was to establish the construct validity of the Focus on the Outcomes of Communication Under Six (FOCUS©),a tool designed to measure changes in communication skills in preschool children. Method Participating families' children (n=97; 68 males, 29 females; mean age 2y 8mo; SD 1.04y, range 10mo–4y 11mo) were recruited through eight Canadian organizations. The children were on a waiting list for speech and language intervention. Parents completed the Ages and Stages Questionnaire – Social/Emotional (ASQ-SE) and the FOCUS three times: at assessment and at the start and end of treatment. A second sample (n=28; 16 males 12 females) was recruited from another organization to correlate the FOCUS scores with speech, intelligibility and language measures. Second sample participants ranged in age from 3 years 1 month to 4 years 9 months (mean 3y 11mo; SD 0.41y). At the start and end of treatment, children were videotaped to obtain speech and language samples. Parents and speech–language pathologists (SLPs) independently completed the FOCUS tool. SLPs who were blind to the pre/post order of the videotapes analysed the samples. Results The FOCUS measured significantly more change (p<0.01) during treatment than during the waiting list period. It demonstrated both convergent and discriminant validity against the ASQ-SE. The FOCUS change corresponded to change measured by a combination of clinical speech and language measures (κ=0.31, p<0.05). Conclusion The FOCUS shows strong construct validity as a change-detecting instrument. PMID:23461266

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.

A systematic review of measures of mental health and emotional wellbeing in parents of children aged 0-5.

PubMed

Webb, Rebecca; Ayers, Susan; Rosan, Camilla

2018-01-01

A significant proportion of women with young children experience mental health problems and recent research suggests fathers may also be affected. This may have a long term negative impact on the child's development with significant costs to society. Appropriate measures are therefore needed to identify parents and children at risk. This literature review aimed to identify the most reliable, evidence based global measures of mental health for parents of infants from pregnancy to 5 years postpartum (0-5 years). Literature searches were conducted on online databases and hand searches of reference lists were also carried out. Studies were included in the review if they reported information on measures of global psychological distress or wellbeing from 0 to 5 years postpartum. A total of 183 studies were included in the review, 19 of which directly examined the psychometric validity of an outcome measure. These studies reported information on 23 outcome measures, 4 of which had been validated in parents of children from 1 to 5. These were: the General Health Questionnaire (GHQ), the Symptom Checklist (SCL), the Self-Reporting Questionnaire (SRQ) and the Kessler scale (K10/6). Reliability and validity varied across studies. Only a small number of studies included fathers and examined psychometric validity across the entire period of early childhood. The GHQ was the most frequently validated but results suggest poor reliability and validity. The SRQ and K10/6 were the most promising measures in terms of psychometric properties and clinical utility. Copyright © 2017 Elsevier B.V. All rights reserved.

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 outcomes in foot and ankle research through improved precision and reduced respondent burden. Level II, prospective comparative study.

Overcoming redundancies in bedside nursing assessments by validating a parsimonious meta-tool: findings from a methodological exercise study.

PubMed

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

2016-10-01

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

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.

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.

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.

Why Measure Outcomes?

PubMed

Kuhn, John E

2016-01-01

The concept of measuring the outcomes of treatment in health care was promoted by Ernest Amory Codman in the early 1900s, but, until recently, his ideas were generally ignored. The forces that have advanced outcome measurement to the forefront of health care include the shift in payers for health care from the patient to large insurance companies or government agencies, the movement toward assessing the care of populations not individuals, and the effort to find value (or cost-effective treatments) amid rising healthcare costs. No ideal method exists to measure outcomes, and the information gathered depends on the reason the outcome information is required. Outcome measures used in research are best able to answer research questions. The methods for assessing physician and hospital performance include process measures, patient-experience measures, structure measures, and measures used to assess the outcomes of treatment. The methods used to assess performance should be validated, be reliable, and reflect a patient's perception of the treatment results. The healthcare industry must measure outcomes to identify which treatments are most effective and provide the most benefit to patients.

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.

Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer.

PubMed

Flynn, Kathryn E; Lin, Li; Cyranowski, Jill M; Reeve, Bryce B; Reese, Jennifer Barsky; Jeffery, Diana D; Smith, Ashley Wilder; Porter, Laura S; Dombeck, Carrie B; Bruner, Deborah Watkins; Keefe, Francis J; Weinfurt, Kevin P

2013-02-01

We describe the development and validation of the Patient-Reported Outcomes Measurement Information System(®) Sexual Function and Satisfaction (PROMIS(®) SexFS; National Institutes of Health) measures, version 1.0, for cancer populations. To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS Network. Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient-reported outcome measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item-response theory and evaluated for reliability and validity. The PROMIS SexFS measures, version 1.0, include 81 items in 11 domains: Interest in Sexual Activity, Lubrication, Vaginal Discomfort, Erectile Function, Global Satisfaction with Sex Life, Orgasm, Anal Discomfort, Therapeutic Aids, Sexual Activities, Interfering Factors, and Screener Questions. In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different) and convergent validity (strong correlations between scores on PROMIS and scores on conceptually similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (interclass correlations from two administrations of the instrument, 1 month apart). The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study. © 2013 International Society for Sexual Medicine.

Development of the NIH PROMIS® Sexual Function and Satisfaction Measures in Patients with Cancer

PubMed Central

Flynn, Kathryn E.; Lin, Li; Cyranowski, Jill M.; Reeve, Bryce B.; Reese, Jennifer Barsky; Jeffery, Diana D.; Smith, Ashley Wilder; Porter, Laura S.; Dombeck, Carrie B.; Bruner, Deborah Watkins; Keefe, Francis J.; Weinfurt, Kevin P.

2013-01-01

Introduction We describe the development and validation of the PROMIS Sexual Function and Satisfaction (PROMIS SexFS) measures version 1.0 for cancer populations. Aim To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS® Network. Methods Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient reported outcome (PRO) measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item response theory and evaluated for reliability and validity. Main Outcome Measures The PROMIS Sexual Function and Satisfaction (PROMIS SexFS) measures version 1.0 include 79 items in 11 domains: interest in sexual activity, lubrication, vaginal discomfort, erectile function, global satisfaction with sex life, orgasm, anal discomfort, therapeutic aids, sexual activities, interfering factors, and screener questions. Results In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different), convergent validity (strong correlations between scores on PROMIS and scores on conceptually-similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (inter-class correlations from 2 administrations of the instrument, 1 month apart). Conclusions The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study. PMID:23387911

Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

PubMed

Palmieri, Gaspare; Evans, Chris; Hansen, Vidje; Brancaleoni, Greta; Ferrari, Silvia; Porcelli, Piero; Reitano, Francesco; Rigatelli, Marco

2009-01-01

The Clinical Outcomes in Routine Evaluation--Outcome Measure (CORE-OM) was translated into Italian and tested in non-clinical (n = 263) and clinical (n = 647) samples. The translation showed good acceptability, internal consistency and convergent validity in both samples. There were large and statistically significant differences between clinical and non-clinical datasets on all scores. The reliable change criteria were similar to those for the UK referential data. Some of the clinically significant change criteria, particularly for the men, were moderately different from the UK cutting points. The Italian version of the CORE-OM showed respectable psychometric parameters. However, it seemed plausible that non-clinical and clinical distributions of self-report scores on psychopathology and functioning measures may differ by language and culture. *A good quality Italian translation of the CORE-OM, and hence the GP-CORE, CORE-10 and CORE-5 measures also, is now available for use by practitioners and anyone surveying or exploring general psychological state. The measures can be obtained from CORE-IMS or yourself and practitioners are encouraged to share anonymised data so that good clinical and non-clinical referential databases can be established for Italy.

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.

Risk prediction in the community: A systematic review of case-finding instruments that predict adverse healthcare outcomes in community-dwelling older adults.

PubMed

O'Caoimh, Rónán; Cornally, Nicola; Weathers, Elizabeth; O'Sullivan, Ronan; Fitzgerald, Carol; Orfila, Francesc; Clarnette, Roger; Paúl, Constança; Molloy, D William

2015-09-01

Few case-finding instruments are available to community healthcare professionals. This review aims to identify short, valid instruments that detect older community-dwellers risk of four adverse outcomes: hospitalisation, functional-decline, institutionalisation and death. Data sources included PubMed and the Cochrane library. Data on outcome measures, patient and instrument characteristics, and trial quality (using the Quality In Prognosis Studies [QUIPS] tool), were double-extracted for derivation-validation studies in community-dwelling older adults (>50 years). Forty-six publications, representing 23 unique instruments, were included. Only five were externally validated. Mean patient age range was 64.2-84.6 years. Most instruments n=18, (78%) were derived in North America from secondary analysis of survey data. The majority n=12, (52%), measured more than one outcome with hospitalisation and the Probability of Repeated Admission score the most studied outcome and instrument respectively. All instruments incorporated multiple predictors. Activities of daily living n=16, (70%), was included most often. Accuracy varied according to instruments and outcomes; area under the curve of 0.60-0.73 for hospitalisation, 0.63-0.78 for functional decline, 0.70-0.74 for institutionalisation and 0.56-0.82 for death. The QUIPS tool showed that 5/23 instruments had low potential for bias across all domains. This review highlights the present need to develop short, reliable, valid instruments to case-find older adults at risk in the community. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

The perceived personal control (PPC) questionnaire: reliability and validity in a sample from the United Kingdom.

PubMed

McAllister, Marion; Wood, Alex M; Dunn, Graham; Shiloh, Shoshana; Todd, Chris

2012-02-01

Outcome measures are important assessment tools to evaluate clinical genetics services. Research suggests that perceived personal control (PPC) is an outcome valued by clinical genetics patients and clinicians. The PPC scale was developed in Hebrew to capture three dimensions of PPC: Cognitive, decisional, and behavioral control. This article reports on the first psychometric validation of the English translation of the PPC scale. Previous research has shown that the Hebrew and Dutch translations have good psychometric properties. However, the psychometric properties of the English translation have not been tested, and there is disagreement about the factor structure, with implications for how to score the measure. A total of 395 patients attending a clinical genetics appointment in the United Kingdom completed several measures at baseline, and a further 241 also completed measures at 2-4 weeks follow-up. The English language PPC has (a) a one-factor structure, (b) convergent validity with internal health locus of control (IHLC), satisfaction with life (SWL), depression, and authenticity, (c) high internal consistency (α = 0.83), and (d) sensitivity to change, being able to identify moderate changes in PPC following clinic attendance (Cohen's d = 0.40). These properties suggest the English language PPC measure is a useful tool for both clinical genetics research and for use as a Patient Reported Outcome Measure (PROM) in service evaluation. Copyright © 2011 Wiley Periodicals, Inc.

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.

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.

Development and validation of the Simulation Learning Effectiveness Inventory.

PubMed

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

2015-10-01

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

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

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.

The Well-Being 5: Development and Validation of a Diagnostic Instrument to Improve Population Well-being

PubMed Central

Sears, Lindsay E.; Agrawal, Sangeeta; Sidney, James A.; Castle, Patricia H.; Coberley, Carter R.; Witters, Dan; Pope, James E.; Harter, James K.

2014-01-01

Abstract Building upon extensive research from 2 validated well-being instruments, the objective of this research was to develop and validate a comprehensive and actionable well-being instrument that informs and facilitates improvement of well-being for individuals, communities, and nations. The goals of the measure were comprehensiveness, validity and reliability, significant relationships with health and performance outcomes, and diagnostic capability for intervention. For measure development and validation, questions from the Well-being Assessment and Wellbeing Finder were simultaneously administered as a test item pool to over 13,000 individuals across 3 independent samples. Exploratory factor analysis was conducted on a random selection from the first sample and confirmed in the other samples. Further evidence of validity was established through correlations to the established well-being scores from the Well-Being Assessment and Wellbeing Finder, and individual outcomes capturing health care utilization and productivity. Results showed the Well-Being 5 score comprehensively captures the known constructs within well-being, demonstrates good reliability and validity, significantly relates to health and performance outcomes, is diagnostic and informative for intervention, and can track and compare well-being over time and across groups. With this tool, well-being deficiencies within a population can be effectively identified, prioritized, and addressed, yielding the potential for substantial improvements to the health status, performance, and quality of life for individuals and cost savings for stakeholders. (Population Health Management 2014;17:357–365) PMID:24892873

Development and validation of the French-Canadian Chronic Pain Self-efficacy Scale

PubMed Central

Lacasse, Anaïs; Bourgault, Patricia; Tousignant-Laflamme, Yannick; Courtemanche-Harel, Roxanne; Choinière, Manon

2015-01-01

BACKGROUND: Perceived self-efficacy is a non-negligible outcome when measuring the impact of self-management interventions for chronic pain patients. However, no validated, chronic pain-specific self-efficacy scales exist for studies conducted with French-speaking populations. OBJECTIVES: To establish the validity of the use of the French-Canadian Chronic Pain Self-efficacy Scale (FC-CPSES) among chronic pain patients. METHODS: The Chronic Disease Self-Efficacy Scale is a validated 33-item self-administered questionnaire that measures perceived self-efficacy to perform self-management behaviours, manage chronic disease in general and achieve outcomes (a six-item version is also available). This scale was adapted to the context of chronic pain patients following cross-cultural adaptation guidelines. The FC-CPSES was administered to 109 fibromyalgia and 34 chronic low back pain patients (n=143) who participated in an evidence-based self-management intervention (the PASSAGE program) offered in 10 health care centres across the province of Quebec. Cronbach’s alpha coefficients (α) were calculated to determine the internal consistency of the 33- and six-item versions of the FC-CPSES. With regard to convergent construct validity, the association between the FC-CPSES baseline scores and related clinical outcomes was examined. With regard to the scale’s sensitivity to change, pre- and postintervention FC-CPSES scores were compared. RESULTS: Internal consistency was high for both versions of the FC-CPSES (α=0.86 to α=0.96). Higher self-efficacy was significantly associated with higher mental health-related quality of life and lower pain intensity and catastrophizing (P<0.05), supporting convergent validity of the scale. There was a statistically significant increase in FC-CPSES scores between pre- and postintervention measures for both versions of the FC-CPSES (P<0.003), which supports their sensitivity to clinical change during an intervention. CONCLUSIONS: These data suggest that both versions of the FC-CPSES are reliable and valid for the measurement of pain management self-efficacy among chronic pain patients. PMID:25848845

Measuring Social Communication Behaviors as a Treatment Endpoint in Individuals with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Anagnostou, Evdokia; Jones, Nancy; Huerta, Marisela; Halladay, Alycia K.; Wang, Paul; Scahill, Lawrence; Horrigan, Joseph P.; Kasari, Connie; Lord, Cathy; Choi, Dennis; Sullivan, Katherine; Dawson, Geraldine

2015-01-01

Social communication impairments are a core deficit in autism spectrum disorder. Social communication deficit is also an early indicator of autism spectrum disorder and a factor in long-term outcomes. Thus, this symptom domain represents a critical treatment target. Identifying reliable and valid outcome measures for social communication across a…

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…

[Measurement properties of self-report questionnaires published in Korean nursing journals].

PubMed

Lee, Eun-Hyun; Kim, Chun-Ja; Kim, Eun Jung; Chae, Hyun-Ju; Cho, Soo-Yeon

2013-02-01

The purpose of this study was to evaluate measurement properties of self-report questionnaires for studies published in Korean nursing journals. Of 424 Korean nursing articles initially identified, 168 articles met the inclusion criteria. The methodological quality of the measurements used in the studies and interpretability were assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. It consists of items on internal consistency, reliability, measurement error, content validity, construct validity including structural validity, hypothesis testing, cross-cultural validity, and criterion validity, and responsiveness. For each item of the COSMIN checklist, measurement properties are rated on a four-point scale: excellent, good, fair, and poor. Each measurement property is scored with worst score counts. All articles used the classical test theory for measurement properties. Internal consistency (72.6%), construct validity (56.5%), and content validity (38.2%) were most frequently reported properties being rated as 'excellent' by COSMIN checklist, whereas other measurement properties were rarely reported. A systematic review of measurement properties including interpretability of most instruments warrants further research and nursing-focused checklists assessing measurement properties should be developed to facilitate intervention outcomes across Korean studies.

Assessing the quality of the volume-outcome relationship in uro-oncology.

PubMed

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

2009-02-01

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

Preliminary validation of the Review of Musculoskeletal System (ROMS) questionnaire.

PubMed

Bershadsky, Boris; Kane, Robert L; Wuerz, Thomas; Jones, Morgan; Brighton, Brian; Stitzlein, Russell; Parker, Richard; Iannotti, Joseph P

2015-04-01

Measurement of clinical outcomes is necessary to define best practice. It requires a validated tool that can be easily applied as part of clinical practice. We present the preliminary validation of a brief self-reported Review of Musculoskeletal System (ROMS) questionnaire that captures functional limitations due to musculoskeletal problems and other medical and emotional conditions. Data were derived from a clinical outcomes database (Orthopaedic Minimal Data Set [OrthoMiDaS]) that combines patient-reported data collected as part of routine care and secondary data extracted from electronic medical records. The study utilized 82,873 encounters collected from 24,116 consecutive patients with problems in the upper and lower extremities. In addition to the ROMS, the study used version 2 of the Short Form-12 (SF-12v2), the Penn Shoulder Score (PSS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Fifteen cross-sectional samples were used to evaluate the floor and ceiling effects as well as the construct and content validity. Five longitudinal cohorts were used to measure test-retest reliability and responsiveness. Standard statistical tests were applied. The floor and ceiling effects of the ROMS questionnaire in patients with shoulder, hip, and knee problems ranged from 1.3% to 8.5%. Construct-validity tests confirmed convergent and divergent validity of the ROMS. The tests also justified its additional value when the ROMS was used with joint-specific tools. When measuring test-retest reliability of the ROMS scales, intraclass correlation ranged from 0.80 to 0.90 at approximately one week and from 0.71 to 0.87 at approximately four weeks. Responsiveness of the ROMS was greater than that of the SF-12 and less than that of the joint-specific questionnaires. The ROMS is compatible with routine clinical process and has good psychometric properties in patients with shoulder, hip, and knee disorders. It can be used as a primary outcome tool for large observational studies and can supplement more specific tools in controlled studies. The ROMS was developed as a tool to measure and monitor the clinical status of the musculoskeletal system in a population of patients during and after treatment as well as over time. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

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 decision making. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

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

PubMed

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

2017-07-20

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

Characterizing smoking topography of cannabis in heavy users

PubMed Central

Stitzer, Maxine L.; Vandrey, Ryan

2013-01-01

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

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

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

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.

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.

Measuring teamwork in health care settings: a review of survey instruments.

PubMed

Valentine, Melissa A; Nembhard, Ingrid M; Edmondson, Amy C

2015-04-01

Teamwork in health care settings is widely recognized as an important factor in providing high-quality patient care. However, the behaviors that comprise effective teamwork, the organizational factors that support teamwork, and the relationship between teamwork and patient outcomes remain empirical questions in need of rigorous study. To identify and review survey instruments used to assess dimensions of teamwork so as to facilitate high-quality research on this topic. We conducted a systematic review of articles published before September 2012 to identify survey instruments used to measure teamwork and to assess their conceptual content, psychometric validity, and relationships to outcomes of interest. We searched the ISI Web of Knowledge database, and identified relevant articles using the search terms team, teamwork, or collaboration in combination with survey, scale, measure, or questionnaire. We found 39 surveys that measured teamwork. Surveys assessed different dimensions of teamwork. The most commonly assessed dimensions were communication, coordination, and respect. Of the 39 surveys, 10 met all of the criteria for psychometric validity, and 14 showed significant relationships to nonself-report outcomes. Evidence of psychometric validity is lacking for many teamwork survey instruments. However, several psychometrically valid instruments are available. Researchers aiming to advance research on teamwork in health care should consider using or adapting one of these instruments before creating a new one. Because instruments vary considerably in the behavioral processes and emergent states of teamwork that they capture, researchers must carefully evaluate the conceptual consistency between instrument, research question, and context.

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

ERIC Educational Resources Information Center

Johnson, Samantha; Marlow, Neil; Wolke, Dieter

2012-01-01

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

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, the scores must be interpreted with caution, especially when applied to different populations and other types of injury than those included in this study. PMID:25310247

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…

Development and Validation of the International Baccalaureate Learner Profile Questionnaire (IBLPQ)

ERIC Educational Resources Information Center

Walker, Allan; Lee, Moosung; Bryant, Darren A.

2016-01-01

The Learner Profile (LP) frames International Baccalaureate (IB) learning outcomes across the three programme levels and, as such, plays a key role in measuring the success of the rapidly growing number of IB schools in the Asia-Pacific Region. Our aim was to develop an instrument to measure the IBLP and validate the instrument through a series of…

The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability

PubMed Central

Altmann, Tobias; Roth, Marcus

2018-01-01

Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studies (total N = 826), we describe the development of the SESS and present evidence for its validity with respect to individual outcomes (life satisfaction, neuroticism, and vulnerable narcissism) and dyadic outcomes (relationship satisfaction in self- and partner ratings) through direct comparisons with existing measures. The new SESS proved to be a stronger predictor than the existing scales and had incremental validity over and above self-esteem level. The results also showed that all cross-sectional measures of self-esteem stability were only moderately associated with variability in self-esteem levels assessed longitudinally with multiple administrations of the Rosenberg Self-Esteem Scale. We discuss this validity issue, arguing that direct and indirect assessment approaches measure relevant, yet different aspects of self-esteem stability. PMID:29487551

The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability.

PubMed

Altmann, Tobias; Roth, Marcus

2018-01-01

Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studies (total N = 826), we describe the development of the SESS and present evidence for its validity with respect to individual outcomes (life satisfaction, neuroticism, and vulnerable narcissism) and dyadic outcomes (relationship satisfaction in self- and partner ratings) through direct comparisons with existing measures. The new SESS proved to be a stronger predictor than the existing scales and had incremental validity over and above self-esteem level. The results also showed that all cross-sectional measures of self-esteem stability were only moderately associated with variability in self-esteem levels assessed longitudinally with multiple administrations of the Rosenberg Self-Esteem Scale. We discuss this validity issue, arguing that direct and indirect assessment approaches measure relevant, yet different aspects of self-esteem stability.

Construct, Concurrent and Predictive Validity of the URICA: Data from Two Multi-site Clinical Trials

PubMed Central

Field, Craig A.; Adinoff, Bryon; Harris, T. Robert; Ball, Samuel A.; Carroll, Kathleen M.

2011-01-01

Background A better understanding of how to measure motivation to change and how it relates to behavior change in patients with drug and alcohol dependence would broaden our understanding of the role of motivation in addiction treatment. Methods Two multi-site, randomized clinical trials comparing brief motivational interventions with standard care were conducted in the National Institute on Drug Abuse Clinical Trials Network. Patients with primary drug dependence and alcohol dependence entering outpatient treatment participated in a study of either Motivational Enhancement Therapy (n=431) or Motivational Interviewing (n=423). The construct, concurrent, and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committed Action (CA) were evaluated. Results Confirmatory factor analysis confirmed the a priori factor structure of the URICA. RTC was significantly associated with measures of addiction severity at baseline (r=.12-.52, p<.05). Although statistically significant (p<.01), the correlations between treatment outcomes and RTC were low (r=-.15 and -18). Additional analyses did not support a moderating or mediating effect of motivation on treatment retention or substance use. Conclusions The construct validity of the URICA was confirmed separately in a large sample of drug- and alcohol-dependent patients. However, evidence for the predictive validity of composite scores was very limited and there were no moderating or mediating effects of either measure on treatment outcome. Thus, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome. PMID:19157723

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 approximating the expectations the patients hold to their actual experience. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

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.

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.

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.

Validation of the CMT Pediatric Scale as an outcome measure of disability

PubMed Central

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

2012-01-01

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

Generalizability and Validity of a Mathematics Performance Assessment.

ERIC Educational Resources Information Center

Lane, Suzanne; And Others

1996-01-01

Evidence from test results of 3,604 sixth and seventh graders is provided for the generalizability and validity of the Quantitative Understanding: Amplifying Student Achievement and Reasoning (QUASAR) Cognitive Assessment Instrument, which is designed to measure program outcomes and growth in mathematics. (SLD)

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.

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.

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.

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.

Group power through the lens of the 21st century and beyond: further validation of the Sieloff-King Assessment of Group Power within Organizations.

PubMed

Sieloff, Christina L; Bularzik, Anne M

2011-11-01

The purpose was to determine the content validity of a semantic revision of items on a reliable and valid instrument, the Sieloff-King Assessment of Group Power within Organizations (SKAGPO). Research participants expressed negative perceptions regarding the use of the concept of 'power' in SKAGPO items. The SKAGPO is the only instrument measuring a nursing group's power or outcome attainment. Using a survey method, the instrument and grading scale were sent to 12 expert judges. Six participants completed the grading scale. The Content Validity Index (CVI) for seven questions was at or above 83% agreement. Overall, the CVI for the eight revised questions was 93.75%. Subsequently, the instrument was renamed the Sieloff-King Assessment of Group Outcome Attainment within Organizations (SKAGOAO). The semantic revision demonstrated content validity for the revised SKAGOAO. When used by nursing groups to assess their level of outcome attainment, the instrument should continue to be psychometrically evaluated. A nursing group of any size can use the SKAGOAO to both assess the group's level of outcome attainment or empowerment and direct plans to further improve that level. © 2011 Blackwell Publishing Ltd.

General Education Courses at the University of Botswana: Application of the Theory of Reasoned Action in Measuring Course Outcomes

ERIC Educational Resources Information Center

Garg, Deepti; Garg, Ajay K.

2007-01-01

This study applied the Theory of Reasoned Action and the Technology Acceptance Model to measure outcomes of general education courses (GECs) under the University of Botswana Computer and Information Skills (CIS) program. An exploratory model was validated for responses from 298 students. The results suggest that resources currently committed to…

Confirmatory Factor Analysis of a Family Quality of Life Scale for Families of Kindergarten Children without Disabilities

ERIC Educational Resources Information Center

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

2009-01-01

Recently, within the field of special education, attention has been accorded to the conceptualization and measurement of family outcomes. The Family Quality of Life (FQOL) Scale is an instrument that can be used to measure family outcomes for families who have children with disabilities, and it has been demonstrated to have psychometric validity.…

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/

The multiple sclerosis work difficulties questionnaire: translation and cross-cultural adaptation to Turkish and assessment of validity and reliability.

PubMed

Kahraman, Turhan; Özdoğar, Asiye Tuba; Honan, Cynthia Alison; Ertekin, Özge; Özakbaş, Serkan

2018-05-09

To linguistically and culturally adapt the Multiple Sclerosis Work Difficulties Questionnaire-23 (MSWDQ-23) for use in Turkey, and to examine its reliability and validity. Following standard forward-back translation of the MSWDQ-23, it was administered to 124 people with multiple sclerosis (MS). Validity was evaluated using related outcome measures including those related to employment status and expectations, disability level, fatigue, walking, and quality of life. Randomly selected participants were asked to complete the MSWDQ-23 again to assess test-retest reliability. Confirmatory factor analysis on the MSWDQ-23 demonstrated a good fit for the data, and the internal consistency of each subscale was excellent. The test-retest reliability for the total score, psychological/cognitive barriers, physical barriers, and external barriers subscales were high. The MSWDQ-23 and its subscales were positively correlated with the employment, disability level, walking, and fatigue outcome measures. This study suggests that the Turkish version of MSWDQ-23 has high reliability and adequate validity, and it can be used to determine the difficulties faced by people with multiple sclerosis in workplace. Moreover, the study provides evidence about the test-retest reliability of the questionnaire. Implications for rehabilitation Multiple sclerosis affects young people of working age. Understanding work-related problems is crucial to enhance people with multiple sclerosis likelihood of maintaining their job. The Multiple Sclerosis Work Difficulties Questionnaire-23 (MSWDQ-23) is a valid and reliable measure of perceived workplace difficulties in people with multiple sclerosis: we presented its validation to Turkish. Professionals working in the field of vocational rehabilitation may benefit from using the MSWDQ-23 to predict the current work outcomes and future employment expectations.

Measurement properties of quality-of-life measurement instruments for infants, children and adolescents with eczema: a systematic review.

PubMed

Heinl, D; Prinsen, C A C; Sach, T; Drucker, A M; Ofenloch, R; Flohr, C; Apfelbacher, C

2017-04-01

Quality of life (QoL) is one of the core outcome domains identified by the Harmonising Outcome Measures for Eczema (HOME) initiative to be assessed in every eczema trial. There is uncertainty about the most appropriate QoL instrument to measure this domain in infants, children and adolescents. To systematically evaluate the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in infants, children and adolescents with eczema. A systematic literature search in PubMed and Embase, complemented by a thorough hand search of reference lists, retrieved studies on measurement properties of eczema QoL instruments for infants, children and adolescents. For all eligible studies, we judged the adequacy of the measurement properties and the methodological study quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Results from different studies were summarized in a best-evidence synthesis and formed the basis to assign four degrees of recommendation. Seventeen articles, three of which were found by hand search, were included. These 17 articles reported on 24 instruments. No instrument can be recommended for use in all eczema trials because none fulfilled all required adequacy criteria. With adequate internal consistency, reliability and hypothesis testing, the U.S. version of the Childhood Atopic Dermatitis Impact Scale (CADIS), a proxy-reported instrument, has the potential to be recommended depending on the results of further validation studies. All other instruments, including all self-reported ones, lacked significant validation data. Currently, no QoL instrument for infants, children and adolescents with eczema can be highly recommended. Future validation research should primarily focus on the CADIS, but also attempt to broaden the evidence base for the validity of self-reported instruments. © 2016 British Association of Dermatologists.

The UKCAT-12 study: educational attainment, aptitude test performance, demographic and socio-economic contextual factors as predictors of first year outcome in a cross-sectional collaborative study of 12 UK medical schools.

PubMed

McManus, I C; Dewberry, Chris; Nicholson, Sandra; Dowell, Jonathan S

2013-11-14

Most UK medical schools use aptitude tests during student selection, but large-scale studies of predictive validity are rare. This study assesses the United Kingdom Clinical Aptitude Test (UKCAT), and its four sub-scales, along with measures of educational attainment, individual and contextual socio-economic background factors, as predictors of performance in the first year of medical school training. A prospective study of 4,811 students in 12 UK medical schools taking the UKCAT from 2006 to 2008 as a part of the medical school application, for whom first year medical school examination results were available in 2008 to 2010. UKCAT scores and educational attainment measures (General Certificate of Education (GCE): A-levels, and so on; or Scottish Qualifications Authority (SQA): Scottish Highers, and so on) were significant predictors of outcome. UKCAT predicted outcome better in female students than male students, and better in mature than non-mature students. Incremental validity of UKCAT taking educational attainment into account was significant, but small. Medical school performance was also affected by sex (male students performing less well), ethnicity (non-White students performing less well), and a contextual measure of secondary schooling, students from secondary schools with greater average attainment at A-level (irrespective of public or private sector) performing less well. Multilevel modeling showed no differences between medical schools in predictive ability of the various measures. UKCAT sub-scales predicted similarly, except that Verbal Reasoning correlated positively with performance on Theory examinations, but negatively with Skills assessments. This collaborative study in 12 medical schools shows the power of large-scale studies of medical education for answering previously unanswerable but important questions about medical student selection, education and training. UKCAT has predictive validity as a predictor of medical school outcome, particularly in mature applicants to medical school. UKCAT offers small but significant incremental validity which is operationally valuable where medical schools are making selection decisions based on incomplete measures of educational attainment. The study confirms the validity of using all the existing measures of educational attainment in full at the time of selection decision-making. Contextual measures provide little additional predictive value, except that students from high attaining secondary schools perform less well, an effect previously shown for UK universities in general.

The UKCAT-12 study: educational attainment, aptitude test performance, demographic and socio-economic contextual factors as predictors of first year outcome in a cross-sectional collaborative study of 12 UK medical schools

PubMed Central

2013-01-01

Background Most UK medical schools use aptitude tests during student selection, but large-scale studies of predictive validity are rare. This study assesses the United Kingdom Clinical Aptitude Test (UKCAT), and its four sub-scales, along with measures of educational attainment, individual and contextual socio-economic background factors, as predictors of performance in the first year of medical school training. Methods A prospective study of 4,811 students in 12 UK medical schools taking the UKCAT from 2006 to 2008 as a part of the medical school application, for whom first year medical school examination results were available in 2008 to 2010. Results UKCAT scores and educational attainment measures (General Certificate of Education (GCE): A-levels, and so on; or Scottish Qualifications Authority (SQA): Scottish Highers, and so on) were significant predictors of outcome. UKCAT predicted outcome better in female students than male students, and better in mature than non-mature students. Incremental validity of UKCAT taking educational attainment into account was significant, but small. Medical school performance was also affected by sex (male students performing less well), ethnicity (non-White students performing less well), and a contextual measure of secondary schooling, students from secondary schools with greater average attainment at A-level (irrespective of public or private sector) performing less well. Multilevel modeling showed no differences between medical schools in predictive ability of the various measures. UKCAT sub-scales predicted similarly, except that Verbal Reasoning correlated positively with performance on Theory examinations, but negatively with Skills assessments. Conclusions This collaborative study in 12 medical schools shows the power of large-scale studies of medical education for answering previously unanswerable but important questions about medical student selection, education and training. UKCAT has predictive validity as a predictor of medical school outcome, particularly in mature applicants to medical school. UKCAT offers small but significant incremental validity which is operationally valuable where medical schools are making selection decisions based on incomplete measures of educational attainment. The study confirms the validity of using all the existing measures of educational attainment in full at the time of selection decision-making. Contextual measures provide little additional predictive value, except that students from high attaining secondary schools perform less well, an effect previously shown for UK universities in general. PMID:24229380

The Achilles tendon total rupture score: a study of responsiveness, internal consistency and convergent validity on patients with acute Achilles tendon ruptures

PubMed Central

2012-01-01

Background The Achilles tendon Total Rupture Score was developed by a research group in 2007 in response to the need for a patient reported outcome measure for this patient population. Beyond this original development paper, no further validation studies have been published. Consequently the purpose of this study was to evaluate internal consistency, convergent validity and responsiveness of this newly developed patient reported outcome measure within patients who have sustained an isolated acute Achilles tendon rupture. Methods Sixty-four eligible patients with an acute rupture of their Achilles tendon completed the Achilles tendon Total Rupture Score alongside two further patient reported outcome measures (Disability Rating Index and EQ 5D). These were completed at baseline, six weeks, three months, six months and nine months post injury. The Achilles tendon Total Rupture Score was evaluated for internal consistency, using Cronbach's alpha, convergent validity, through correlation analysis and responsiveness, by analysing floor and ceiling effects and calculating its relative efficiency in comparison to the Disability Rating Index and EQ 5D scores. Results The Achilles tendon Total Rupture Score demonstrated high internal consistency (Cronbachs alpha > 0.8) and correlated significantly (p < 0.001) with the Disability Rating Index at five time points (pre-injury, six weeks, three, six and nine months) with correlation coefficients between -0.5 and -0.9. However, the confidence intervals were wide. Furthermore, the ability of the new score to detect clinically important changes over time (responsiveness) was shown to be greater than the Disability Rating Index and EQ 5D. Conclusions A universally accepted outcome measure is imperative to allow comparisons to be made across practice. This is the first study to evaluate aspects of validity of this newly developed outcome measure, outside of the developing centre. The ATRS demonstrated high internal consistency and responsiveness, with limited convergent validity. This research provides further support for the use of this outcome measure, however further research is required to advocate its universal use in patients with acute Achilles tendon ruptures. Such areas include inter-rater reliability and research to determine the minimally clinically important difference between scores. All authors have read and concur with the content of this manuscript. The material presented has not been and will not be submitted for publication elsewhere, except as an abstract. All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content and (3) final approval of the submitted version. This research has been funded by Arthritis Research UK, no conflicts of interests have been declared by the authors. Kind Regards Rebecca Kearney (corresponding author) Research Physiotherapist PMID:22376047

Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review.

PubMed

Gerbens, L A A; Prinsen, C A C; Chalmers, J R; Drucker, A M; von Kobyletzki, L B; Limpens, J; Nankervis, H; Svensson, Å; Terwee, C B; Zhang, J; Apfelbacher, C J; Spuls, P I

2017-01-01

Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Patient-reported outcomes in borderline personality disorder.

PubMed

Hasler, Gregor; Hopwood, Christopher J; Jacob, Gitta A; Brändle, Laura S; Schulte-Vels, Thomas

2014-06-01

Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes.

Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties.

PubMed

Collins, N J; Prinsen, C A C; Christensen, R; Bartels, E M; Terwee, C B; Roos, E M

2016-08-01

To conduct a systematic review and meta-analysis to synthesize evidence regarding measurement properties of the Knee injury and Osteoarthritis Outcome Score (KOOS). A comprehensive literature search identified 37 eligible papers evaluating KOOS measurement properties in participants with knee injuries and/or osteoarthritis (OA). Methodological quality was evaluated using the COSMIN checklist. Where possible, meta-analysis of extracted data was conducted for all studies and stratified by age and knee condition; otherwise narrative synthesis was performed. KOOS has adequate internal consistency, test-retest reliability and construct validity in young and old adults with knee injuries and/or OA. The ADL subscale has better content validity for older patients and Sport/Rec for younger patients with knee injuries, while the Pain subscale is more relevant for painful knee conditions. The five-factor structure of the original KOOS is unclear. There is some evidence that the KOOS subscales demonstrate sufficient unidimensionality, but this requires confirmation. Although measurement error requires further evaluation, the minimal detectable change for KOOS subscales ranges from 14.3 to 19.6 for younger individuals, and ≥20 for older individuals. Evidence of responsiveness comes from larger effect sizes following surgical (especially total knee replacement) than non-surgical interventions. KOOS demonstrates adequate content validity, internal consistency, test-retest reliability, construct validity and responsiveness for age- and condition-relevant subscales. Structural validity, cross-cultural validity and measurement error require further evaluation, as well as construct validity of KOOS Physical function Short form. Suggested order of subscales for different knee conditions can be applied in hierarchical testing of endpoints in clinical trials. PROSPERO (CRD42011001603). Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Updating the OMERACT Filter: Implications for imaging and soluble biomarkers

PubMed Central

D’Agostino, Maria-Antonietta; Boers, Maarten; Kirwan, John; van der Heijde, Desirée; Østergaard, Mikkel; Schett, Georg; Landewé, Robert B.M.; Maksymowych, Walter P.; Naredo, Esperanza; Dougados, Maxime; Iagnocco, Annamaria; Bingham, Clifton O.; Brooks, Peter; Beaton, Dorcas; Gandjbakhch, Frederique; Gossec, Laure; Guillemin, Francis; Hewlett, Sarah; Kloppenburg, Margreet; March, Lyn; Mease, Philip J; Moller, Ingrid; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Wakefield, Richard J; Wells, George; Tugwell, Peter; Conaghan, Philip G

2014-01-01

Objective The OMERACT Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges due to their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. Methods A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient or disease centred-variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis and knee osteoarthritis were then evaluated using the original OMERACT filter and the newly proposed structure. Break-out groups critically reviewed the extent to which the candidate biomarkers complied with the proposed step-wise approach, as a way of examining the utility of the proposed 3 dimensional structure. Results Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. Conclusion General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0. PMID:24584916

Validation of an Instrument for Measuring Students' Understanding of Interdisciplinary Science in Grades 4-8 over Multiple Semesters: A Rasch Measurement Study

ERIC Educational Resources Information Center

Yang, Yang; He, Peng; Liu, Xiufeng

2018-01-01

So far, not enough effort has been invested in developing reliable, valid, and engaging assessments in school science, especially assessment of interdisciplinary science based on the new Next Generation Science Standards (NGSS). Furthermore, previous tools rely mostly on multiple-choice items and evaluation of student outcome is linked only to…

Dimensions of Academic Growth and Development During College: Using Alumni Reports to Evaluate Education Programs. ASHE Annual Meeting Paper.

ERIC Educational Resources Information Center

Pike, Gary R.

This study attempted to validate the use of academic growth and development items from Tennessee alumni surveys as measures of program quality and effectiveness at the University of Tennessee (UTK), Knoxville. The argument is made that it is essential that the instruments used to assess students educational outcomes be valid measures of the goals…

Concordance of the Mini-Psychiatric Assessment Schedule for Adults Who Have Developmental Disabilities (PASADD) and the Brief Symptom Inventory

ERIC Educational Resources Information Center

Beail, N.; Mitchell, K.; Vlissides, N.; Jackson, T.

2015-01-01

Background: When assessing the mental health needs of people who have intellectual disabilities (ID) it is important to use measures that have good validity and reliability to ensure accurate case recognition and reliable and valid outcome data. Measures developed for this purpose tend to be self-report or by informant report. Multi-trait…

[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.

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

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. Prognostic study, level III.

Open-Minded Cognition.

PubMed

Price, Erika; Ottati, Victor; Wilson, Chase; Kim, Soyeon

2015-11-01

The present research conceptualizes open-minded cognition as a cognitive style that influences how individuals select and process information. An open-minded cognitive style is marked by willingness to consider a variety of intellectual perspectives, values, opinions, or beliefs-even those that contradict the individual's opinion. An individual's level of cognitive openness is expected to vary across domains (such as politics and religion). Four studies develop and validate a novel measure of open-minded cognition, as well as two domain-specific measures of religious and political open-minded cognition. Exploratory and confirmatory factor analysis (controlling for acquiescence bias) are used to develop the scales in Studies 1 to 3. Study 4 demonstrates that these scales possess convergent and discriminant validity. Study 5 demonstrates the scale's unique predictive validity using the outcome of Empathic Concern (Davis, 1980). Study 6 demonstrates the scale's unique predictive validity using the outcomes of warmth toward racial, religious, and sexual minorities. © 2015 by the Society for Personality and Social Psychology, Inc.

Creation and Initial Validation of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale

PubMed Central

Steele, Catriona M.; Namasivayam-MacDonald, Ashwini M.; Guida, Brittany T.; Cichero, Julie A.; Duivestein, Janice; MRSc; Hanson, Ben; Lam, Peter; Riquelme, Luis F.

2018-01-01

Objective To assess consensual validity, interrater reliability, and criterion validity of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale, a new functional outcome scale intended to capture the severity of oropharyngeal dysphagia, as represented by the degree of diet texture restriction recommended for the patient. Design Participants assigned International Dysphagia Diet Standardisation Initiative Functional Diet Scale scores to 16 clinical cases. Consensual validity was measured against reference scores determined by an author reference panel. Interrater reliability was measured overall and across quartile subsets of the dataset. Criterion validity was evaluated versus Functional Oral Intake Scale (FOIS) scores assigned by survey respondents to the same case scenarios. Feedback was requested regarding ease and likelihood of use. Setting Web-based survey. Participants Respondents (NZ170) from 29 countries. Interventions Not applicable. Main Outcome Measures Consensual validity (percent agreement and Kendall t), criterion validity (Spearman rank correlation), and interrater reliability (Kendall concordance and intraclass coefficients). Results The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed strong consensual validity, criterion validity, and interrater reliability. Scenarios involving liquid-only diets, transition from nonoral feeding, or trial diet advances in therapy showed the poorest consensus, indicating a need for clear instructions on how to score these situations. The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed greater sensitivity than the FOIS to specific changes in diet. Most (>70%) respondents indicated enthusiasm for implementing the International Dysphagia Diet Standardisation Initiative Functional Diet Scale. Conclusions This initial validation study suggests that the International Dysphagia Diet Standardisation Initiative Functional Diet Scale has strong consensual and criterion validity and can be used reliably by clinicians to capture diet texture restriction and progression in people with dysphagia. PMID:29428348

The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice.

PubMed

Patrick, Donald L; Giuliano, François; Ho, Kai Fai; Gagnon, Dennis D; McNulty, Pauline; Rothman, Margaret

2009-02-01

To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. Data were from men participating in observational studies in the USA (PE, 207 men; non-PE, 1380) and Europe (PE, 201; non-PE, 914) and from men with PE (1238) participating in a phase III randomized, placebo-controlled clinical trial of dapoxetine. The PEP contains four measures: perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty related to ejaculation, each assessed on five-point response scales. Test-retest reliability, known-groups validity, and ability to detect a patient-reported global impression of change (PGI) in condition were evaluated for the individual PEP measures and a PEP index score (the mean of all four measures). Profile analysis was conducted using multivariate analysis of variance. All PEP measures showed acceptable reliability (intraclass correlation coefficients ranged from 0.66 to 0.83) and mean scores for all measures differed significantly between PE and non-PE groups (P < 0.001). Men who reported a reduction in PE with treatment in the phase III trial had significantly greater scores on each of the four measures. The PEP profiles of men with and without PE differed significantly (P < 0.001) in both observational studies; higher levels of PGI were associated with higher PEP profiles (P < 0.001). The PEP index score also showed acceptable reliability and was significantly different between the PE and non-PE groups (P < 0.001). Men who reported an improvement in PE with treatment in the phase III trial had significantly greater PEP index scores. In the phase III trial, nausea was the most common adverse event with dapoxetine. The PEP provides a reliable, valid, and interpretable measure for use in monitoring outcomes of men with PE.

Factor structure, validity and reliability of the Cambridge Worry Scale in a pregnant population.

PubMed

Green, Josephine M; Kafetsios, Konstantinos; Statham, Helen E; Snowdon, Claire M

2003-11-01

This article presents the Cambridge Worry Scale (CWS), a content-based measure for assessing worries, and discusses its psychometric properties based on a longitudinal study of 1,207 pregnant women. Principal components analysis revealed a four-factor structure of women's concerns during pregnancy: socio-medical, own health, socio-economic and relational. The measure demonstrated good reliability and validity. Total CWS scores were strongly associated with state and trait anxiety (convergent validity) but also had significant and unique predictive value for mood outcomes (discriminant validity). The CWS discriminated better between women with different reproductive histories than measures of state and trait anxiety. We conclude that the CWS is a reliable and valid tool for assessing the extent and content of worries in specific situations.

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

PubMed

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

2015-11-01

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

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.

Parent and family impact of raising a child with perinatal stroke

PubMed Central

2014-01-01

Background Perinatal stroke is a leading cause of early brain injury, cerebral palsy, and lifelong neurological morbidity. No study to date has examined the impact of raising a child with perinatal stroke on parents and families. However, a large breadth of research suggests that parents, especially mothers, may be at increased risk for psychological concerns. The primary aim of this study was to examine the impact of raising a child with perinatal stroke on mothers’ wellbeing. A secondary aim was to examine how caring for a child with perinatal stroke differentially affects mothers and fathers. Methods In Study I, a matched case-control design was used to compare the wellbeing of mothers of children with perinatal stroke and mothers of children with typical development. In Study II, a matched case-control design was used to compare mother-father dyads. Participants completed validated measures of anxiety and depression, stress, quality of life and family functioning, marital satisfaction, and marital distress. Parents of children with perinatal stroke also completed a recently validated measure of the psychosocial impact of perinatal stroke including guilt and blame outcomes. Disease severity was categorized by parents, validated by the Pediatric Stroke Outcome Measure (PSOM), and compared across the above outcomes in Study I. Results A total of 112 mothers participated in Study I (n = 56 per group; mean child age = 7.42 years), and 56 parents participated in Study II (n = 28 per group; mean child age = 8.25 years). In Study I, parent assessment of disease severity was correlated with PSOM scores (γ = 0.75, p < .001) and associated with parent outcomes. Mothers of children with mild conditions were indistinguishable from controls on the outcome measures. However, mothers of children with moderate/severe conditions had poorer outcomes on measures of depression, marital satisfaction, quality of life, and family functioning. In Study II, mothers and fathers had similar outcomes except mothers demonstrated a greater burden of guilt and higher levels of anxiety. Conclusions Although most mothers of children with perinatal stroke adapt well, mothers of children with moderate/severe conditions appear to be at higher risk for psychological concerns. PMID:25018138

Parent and family impact of raising a child with perinatal stroke.

PubMed

Bemister, Taryn B; Brooks, Brian L; Dyck, Richard H; Kirton, Adam

2014-07-14

Perinatal stroke is a leading cause of early brain injury, cerebral palsy, and lifelong neurological morbidity. No study to date has examined the impact of raising a child with perinatal stroke on parents and families. However, a large breadth of research suggests that parents, especially mothers, may be at increased risk for psychological concerns. The primary aim of this study was to examine the impact of raising a child with perinatal stroke on mothers' wellbeing. A secondary aim was to examine how caring for a child with perinatal stroke differentially affects mothers and fathers. In Study I, a matched case-control design was used to compare the wellbeing of mothers of children with perinatal stroke and mothers of children with typical development. In Study II, a matched case-control design was used to compare mother-father dyads. Participants completed validated measures of anxiety and depression, stress, quality of life and family functioning, marital satisfaction, and marital distress. Parents of children with perinatal stroke also completed a recently validated measure of the psychosocial impact of perinatal stroke including guilt and blame outcomes. Disease severity was categorized by parents, validated by the Pediatric Stroke Outcome Measure (PSOM), and compared across the above outcomes in Study I. A total of 112 mothers participated in Study I (n = 56 per group; mean child age = 7.42 years), and 56 parents participated in Study II (n = 28 per group; mean child age = 8.25 years). In Study I, parent assessment of disease severity was correlated with PSOM scores (γ = 0.75, p < .001) and associated with parent outcomes. Mothers of children with mild conditions were indistinguishable from controls on the outcome measures. However, mothers of children with moderate/severe conditions had poorer outcomes on measures of depression, marital satisfaction, quality of life, and family functioning. In Study II, mothers and fathers had similar outcomes except mothers demonstrated a greater burden of guilt and higher levels of anxiety. Although most mothers of children with perinatal stroke adapt well, mothers of children with moderate/severe conditions appear to be at higher risk for psychological concerns.

Gait assessment using the Microsoft Xbox One Kinect: Concurrent validity and inter-day reliability of spatiotemporal and kinematic variables.

PubMed

Mentiplay, Benjamin F; Perraton, Luke G; Bower, Kelly J; Pua, Yong-Hao; McGaw, Rebekah; Heywood, Sophie; Clark, Ross A

2015-07-16

The revised Xbox One Kinect, also known as the Microsoft Kinect V2 for Windows, includes enhanced hardware which may improve its utility as a gait assessment tool. This study examined the concurrent validity and inter-day reliability of spatiotemporal and kinematic gait parameters estimated using the Kinect V2 automated body tracking system and a criterion reference three-dimensional motion analysis (3DMA) marker-based camera system. Thirty healthy adults performed two testing sessions consisting of comfortable and fast paced walking trials. Spatiotemporal outcome measures related to gait speed, speed variability, step length, width and time, foot swing velocity and medial-lateral and vertical pelvis displacement were examined. Kinematic outcome measures including ankle flexion, knee flexion and adduction and hip flexion were examined. To assess the agreement between Kinect and 3DMA systems, Bland-Altman plots, relative agreement (Pearson's correlation) and overall agreement (concordance correlation coefficients) were determined. Reliability was assessed using intraclass correlation coefficients, Cronbach's alpha and standard error of measurement. The spatiotemporal measurements had consistently excellent (r≥0.75) concurrent validity, with the exception of modest validity for medial-lateral pelvis sway (r=0.45-0.46) and fast paced gait speed variability (r=0.73). In contrast kinematic validity was consistently poor to modest, with all associations between the systems weak (r<0.50). In those measures with acceptable validity, the inter-day reliability was similar between systems. In conclusion, while the Kinect V2 body tracking may not accurately obtain lower body kinematic data, it shows great potential as a tool for measuring spatiotemporal aspects of gait. Copyright © 2015 Elsevier Ltd. All rights reserved.

Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.

PubMed

Smith, Shannon M; Paillard, Florence; McKeown, Andrew; Burke, Laurie B; Edwards, Robert R; Katz, Nathaniel P; Papadopoulos, Elektra J; Rappaport, Bob A; Slagle, Ashley; Strain, Eric C; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

2015-05-01

Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and nonopioid prescription medications to identify any that meet U.S. and European regulatory agencies' rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the life span rather than current use, including items that did not directly assess inappropriate use (eg, questions about anger), or failing to capture information pertinent to inappropriate use events (eg, intention and route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, nonstandardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. This systematic review evaluates the measurement properties of inappropriate medication use (eg, abuse or misuse) instruments to determine whether any meet regulatory standards for clinical trial outcome measures to assess abuse potential. Copyright © 2015 American Pain Society. All rights reserved.

Factor Analysis of the Modified Sexual Adjustment Questionnaire-Male

PubMed Central

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

2015-01-01

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

Selection into medical school: from tools to domains.

PubMed

Wilkinson, Tom M; Wilkinson, Tim J

2016-10-03

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

Publishing nutrition research: validity, reliability, and diagnostic test assessment in nutrition-related research.

PubMed

Gleason, Philip M; Harris, Jeffrey; Sheean, Patricia M; Boushey, Carol J; Bruemmer, Barbara

2010-03-01

This is the sixth in a series of monographs on research design and analysis. The purpose of this article is to describe and discuss several concepts related to the measurement of nutrition-related characteristics and outcomes, including validity, reliability, and diagnostic tests. The article reviews the methodologic issues related to capturing the various aspects of a given nutrition measure's reliability, including test-retest, inter-item, and interobserver or inter-rater reliability. Similarly, it covers content validity, indicators of absolute vs relative validity, and internal vs external validity. With respect to diagnostic assessment, the article summarizes the concepts of sensitivity and specificity. The hope is that dietetics practitioners will be able to both use high-quality measures of nutrition concepts in their research and recognize these measures in research completed by others. Copyright 2010 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Author Response to Sabour (2018), "Comment on Hall et al. (2017), 'How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial'".

PubMed

Hall, Deborah A; Mehta, Rajnikant L; Fackrell, Kathryn

2018-03-08

The authors respond to a letter to the editor (Sabour, 2018) concerning the interpretation of validity in the context of evaluating treatment-related change in tinnitus loudness over time. The authors refer to several landmark methodological publications and an international standard concerning the validity of patient-reported outcome measurement instruments. The tinnitus loudness rating performed better against our reported acceptability criteria for (face and convergent) validity than did the tinnitus loudness matching test. It is important to distinguish between tests that evaluate the validity of measuring treatment-related change over time and tests that quantify the accuracy of diagnosing tinnitus as a case and non-case.

Validity of surveys to assess safe routes to school programs

USDA-ARS?s Scientific Manuscript database

Safe Routes to School programs are designed to make walking and bicycling to school safe and accessible for children. These programs promote children's physical activity and show promise for obesity prevention. However, there are few validated surveys to measure important outcomes such as student tr...

Validity of instruments to assess students' travel and pedestrian safety

USDA-ARS?s Scientific Manuscript database

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school,safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research...

Validity and Utility of the Parent--Teacher Relationship Scale-II

ERIC Educational Resources Information Center

Dawson, Anne E.; Wymbs, Brian T.

2016-01-01

Preliminary findings indicate that positive relations between parents and teachers are associated with successful school outcomes for children. However, measures available to assess parent-teacher relations are scant. The current study examined validity evidence for the Parent-Teacher Relationship Scale-I (PTRS). Specifically, the internal…

Revision, Criterion Validity, and Multi-group Assessment of the Reactions to Homosexuality Scale

PubMed Central

Smolenski, Derek J.; Diamond, Pamela M.; Ross, Michael W.; Simon Rosser, B. R.

2010-01-01

Internalized homonegativity encompasses negative attitudes toward one’s own sexual orientation, and is associated with negative mental and physical health outcomes. The Reactions to Homosexuality scale (Ross & Rosser, 1996), an instrument used to measure internalized homonegativity, has been criticized for including content irrelevant to the construct of internalized homonegativity. We revised the scale using exploratory and confirmatory factor analyses, and identified a seven-item, three-factor reduced version that demonstrated measurement invariance across racial/ethnic categorizations and between English and Spanish versions. We also investigated criterion validity by estimating correlations with hypothesized outcomes associated with outness, relationship status, sexual orientation, and gay community affiliation. The evidence of measurement invariance suggests that this scale is appropriate for pluralistic treatment or study groups. PMID:20954058

Why not procrastinate? Development and validation of a new active procrastination scale.

PubMed

Choi, Jin Nam; Moran, Sarah V

2009-04-01

Procrastination has been studied as a dysfunctional, self-effacing behavior that ultimately results in undesirable outcomes. However, A. H. C. Chu and J. N. Choi (2005) found a different form of procrastination (i.e., active procrastination) that leads to desirable outcomes. The construct of active procrastination has a high potential to expand the time management literature and is likely to be adopted by researchers in multiple areas of psychology. To facilitate the research on this new construct and its further integration into the literature, the authors developed and validated a new, expanded measure of active procrastination that reliably assesses its four dimensions. Using this new measure of active procrastination, they further examined its nomological network. The new 16-item measure is a critical step toward further empirical investigation of active procrastination.

Attitudes of Austrian Psychotherapists Towards Process and Outcome Monitoring.

PubMed

Kaiser, Tim; Schmutzhart, Lisa; Laireiter, Anton-Rupert

2018-03-08

While monitoring systems in psychotherapy have become more common, little is known about the attitudes that mental health practitioners have towards these systems. In an online survey among 111 Austrian psychotherapists and trainees, attitudes towards therapy monitoring were measured. A well-validated questionnaire measuring attitudes towards outcome monitoring, the Outcome Measurement Questionnaire, was used. Clinicians' theoretical orientations as well as previous knowledge and experience with monitoring systems were associated with positive attitudes towards monitoring. Possible factors that may have led to these findings, like the views of different theoretical orientations or obstacles in Austrian public health care, are discussed.

Further Validation of the Pathways Housing First Fidelity Scale.

PubMed

Goering, Paula; Veldhuizen, Scott; Nelson, Geoffrey B; Stefancic, Ana; Tsemberis, Sam; Adair, Carol E; Distasio, Jino; Aubry, Tim; Stergiopoulos, Vicky; Streiner, David L

2016-01-01

This study examined whether Housing First fidelity ratings correspond to program operation descriptions from administrative data and predict client outcomes. A multisite, randomized controlled trial (At Home/Chez Soi) in five Canadian cities included two assessments of 12 programs over two years. Outcomes for 1,158 clients were measured every six months. Associations between fidelity ratings and administrative data (Spearman correlations) and participant outcomes (mixed-effects modeling) were examined. Fidelity ratings were generally good (mean ± SD=136.6 ± 10.3 out of a possible range of 38-152; 87% of maximum value). Fidelity was significantly associated with three of four measures of program operation, with correlations between .55 and .60. Greater program fidelity was associated with improvement in housing stability, community functioning, and quality of life. Variation in program fidelity was associated with operations and outcomes, supporting scale validity and intervention effectiveness. These findings reinforced the value of using fidelity monitoring to conduct quality assurance and technical assistance activities.

The development and pilot testing of an instrument to measure nurses' working environment: the Nursing Context Index.

PubMed

Slater, Paul; McCormack, Brendan; Bunting, Brendan

2009-01-01

Evidence shows that adopting a person-centered approach to nursing alters the work environment, reduces anxiety levels among nurses in the long term, promotes teamwork among staff, and increases job satisfaction. However, few studies have attempted to quantify the outcomes from the adoption of person-centered nursing. The lack of outcome measurement is in part influenced by the lack of a standardized instrument to measure person-centered nursing. The aim of this study was to develop an instrument (the Nursing Context Index) to inform the development of person-centered nursing and outcomes arising. The Nursing Context Index (NCI) was developed through three stages. Stage 1 involved a systematic literature review to identify the key characteristics that needed to be considered in the instrument. Stage 2 involved the identification and selection of items for inclusion in the instrument identified through focus group discussions. A 19-construct instrument was developed. Face validity and content validity were gauged. In Stage 3, a pilot study (n = 23) was conducted to test the instrument. Measures of internal consistency were ensured using Cronbach's alpha. Criterion-related validity of the instrument was ensured through comparison between factors contained in the instrument. Findings show that the NCI is an accurate representation of the factors influenced by a clinical setting's progression to person-centered nursing. The factors were deemed appropriate to the clinical settings, and possessed face and content validity. Initial statistical findings confirm the validity and usability of the NCI. The process used for the development and testing of the instrument was found to be effective. The NCI was deemed to be an effective measure of factors influenced by the implementation of person-centered nursing and would help in redressing a scarcity of quantitative evidence to examine the benefits of nurses working in a person-centered manner.

Patient-Reported Outcomes of Quality of Life, Functioning, and GI/Psychiatric Symptom Severity in Patients with Inflammatory Bowel Disease (IBD).

PubMed

IsHak, Waguih W; Pan, Dana; Steiner, Alexander J; Feldman, Edward; Mann, Amy; Mirocha, James; Danovitch, Itai; Melmed, Gil Y

2017-05-01

Patients with inflammatory bowel disease (IBD) are at risk for psychiatric disorders that impact symptom experience and health-related quality of life (HRQOL). Therefore, comprehensive biopsychosocial assessments should be considered in ambulatory care settings. Patient-Reported Outcomes Measurement Information System (PROMIS) measures created by the National Institutes of Health have shown construct validity in a large IBD internet-based cohort, but their validity in ambulatory settings has not been examined. We sought to validate PROMIS patient-reported measures of HRQOL, functioning, and psychiatric symptom severity at a tertiary IBD clinic. Adult patients (n = 110) completed the PROMIS Global Health scale, PROMIS-29, SF-12, and WHODAS 2.0. Pearson's correlation coefficients (r) determined the relationships between scores to validate the PROMIS Global Health Physical and Mental metrics, compared with the SF-12 and WHODAS 2.0. We compared these measures by disease subtype of Crohn's disease or ulcerative colitis. PROMIS measures were highly correlated (r range = 0.64-0.82) with standard measures of HRQOL and functioning. On the PROMIS Global Health measures, 20.9% had impaired physical health, and 13.7% had impaired mental health. Impairments were reported in pain interference (20% of patients), anxiety (18.2%), satisfaction with social role (15.5%), physical functioning (10.9%), fatigue (10%), depression (7.3%), and sleep disturbance (5.5%). Patients with Crohn's disease had worse scores than those with ulcerative colitis on measures of the global physical health (P = 0.027), physical functioning (P = 0.047), and pain interference (P = 0.0009). PROMIS instruments provide valid assessment of HRQOL and functioning in ambulatory adults with IBD. Of note, patients with Crohn's disease demonstrated significantly worse impairments than those with ulcerative colitis.

Relationship of patient characteristics and rehabilitation services to outcomes following spinal cord injury: The SCIRehab Project

PubMed Central

Whiteneck, Gale; Gassaway, Julie; Dijkers, Marcel P.; Heinemann, Allen W.; Kreider, Scott E. D.

2012-01-01

Background/objective To examine associations of patient characteristics along with treatment quantity delivered by seven clinical disciplines during inpatient spinal cord injury (SCI) rehabilitation with outcomes at rehabilitation discharge and 1-year post-injury. Methods Six inpatient SCI rehabilitation centers enrolled 1376 patients during the 5-year SCIRehab study. Clinicians delivering standard care documented details of treatment. Outcome data were derived from SCI Model Systems Form I and II and a project-specific interview conducted at approximately 1-year post-injury. Regression modeling was used to predict outcomes; models were cross-validated by examining relative shrinkage of the original model R2 using 75% of the dataset to the R2 for the same outcome using a validation subsample. Results Patient characteristics are strong predictors of outcome; treatment duration adds slightly more predictive power. More time in physical therapy was associated positively with motor Functional Independence Measure at discharge and the 1-year anniversary, CHART Physical Independence, Social Integration, and Mobility dimensions, and smaller likelihood of rehospitalization after discharge and reporting of pressure ulcer at the interview. More time in therapeutic recreation also had multiple similar positive associations. Time spent in other disciplines had fewer and mixed relationships. Seven models validated well, two validated moderately well, and four validated poorly. Conclusion Patient characteristics explain a large proportion of variation in multiple outcomes after inpatient rehabilitation. The total amount of treatment received during rehabilitation from each of seven disciplines explains little additional variance. Reasons for this and the phenomenon that sometimes more hours of service predict poorer outcome, need additional study. Note This is the first of nine articles in the SCIRehab series. PMID:23318033

Validity, Reliability, and the Questionable Role of Psychometrics in Plastic Surgery

PubMed Central

2014-01-01

Summary: This report examines the meaning of validity and reliability and the role of psychometrics in plastic surgery. Study titles increasingly include the word “valid” to support the authors’ claims. Studies by other investigators may be labeled “not validated.” Validity simply refers to the ability of a device to measure what it intends to measure. Validity is not an intrinsic test property. It is a relative term most credibly assigned by the independent user. Similarly, the word “reliable” is subject to interpretation. In psychometrics, its meaning is synonymous with “reproducible.” The definitions of valid and reliable are analogous to accuracy and precision. Reliability (both the reliability of the data and the consistency of measurements) is a prerequisite for validity. Outcome measures in plastic surgery are intended to be surveys, not tests. The role of psychometric modeling in plastic surgery is unclear, and this discipline introduces difficult jargon that can discourage investigators. Standard statistical tests suffice. The unambiguous term “reproducible” is preferred when discussing data consistency. Study design and methodology are essential considerations when assessing a study’s validity. PMID:25289354

Reducing, Maintaining, or Escalating Uncertainty? The Development and Validation of Four Uncertainty Preference Scales Related to Cancer Information Seeking and Avoidance.

PubMed

Carcioppolo, Nick; Yang, Fan; Yang, Qinghua

2016-09-01

Uncertainty is a central characteristic of many aspects of cancer prevention, screening, diagnosis, and treatment. Brashers's (2001) uncertainty management theory details the multifaceted nature of uncertainty and describes situations in which uncertainty can both positively and negatively affect health outcomes. The current study extends theory on uncertainty management by developing four scale measures of uncertainty preferences in the context of cancer. Two national surveys were conducted to validate the scales and assess convergent and concurrent validity. Results support the factor structure of each measure and provide general support across multiple validity assessments. These scales can advance research on uncertainty and cancer communication by providing researchers with measures that address multiple aspects of uncertainty management.

Modified stoke ankylosing spondylitis spinal score as an outcome measure to assess the impact of treatment on structural progression in ankylosing spondylitis.

PubMed

van der Heijde, Désirée; Braun, Jürgen; Deodhar, Atul; Baraliakos, Xenofon; Landewé, Robert; Richards, Hanno B; Porter, Brian; Readie, Aimee

2018-05-30

In ankylosing spondylitis (AS), structural damage that occurs as a result of syndesmophyte formation and ankylosis of the vertebral column is irreversible. Structural damage is currently assessed by conventional radiography and scoring systems that reliably assess radiographic structural damage are needed to capture the differential effects of drugs on structural damage progression. The validity of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) as a primary outcome measure in evaluating the effect of AS treatments on radiographic progression rates was assessed in this review. The mSASSS has not been used, to date, as a primary outcome measure in a prospective randomized controlled clinical trial of biologic therapy in AS. This review of the medical literature confirmed that the mSASSS is the most validated and widely used method for assessing radiographic progression in AS, correlating with worsening measures of disease signs and symptoms, spinal mobility and physical function, with a 2-year interval being required to ensure sufficient sensitivity to change.

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 variables of interest following an IPE intervention. These limitations should be considered in any future research on instrument design. © 2015 John Wiley & Sons Ltd.

Comparative validity of brief to medium-length Big Five and Big Six Personality Questionnaires.

PubMed

Thalmayer, Amber Gayle; Saucier, Gerard; Eigenhuis, Annemarie

2011-12-01

A general consensus on the Big Five model of personality attributes has been highly generative for the field of personality psychology. Many important psychological and life outcome correlates with Big Five trait dimensions have been established. But researchers must choose between multiple Big Five inventories when conducting a study and are faced with a variety of options as to inventory length. Furthermore, a 6-factor model has been proposed to extend and update the Big Five model, in part by adding a dimension of Honesty/Humility or Honesty/Propriety. In this study, 3 popular brief to medium-length Big Five measures (NEO Five Factor Inventory, Big Five Inventory [BFI], and International Personality Item Pool), and 3 six-factor measures (HEXACO Personality Inventory, Questionnaire Big Six Scales, and a 6-factor version of the BFI) were placed in competition to best predict important student life outcomes. The effect of test length was investigated by comparing brief versions of most measures (subsets of items) with original versions. Personality questionnaires were administered to undergraduate students (N = 227). Participants' college transcripts and student conduct records were obtained 6-9 months after data was collected. Six-factor inventories demonstrated better predictive ability for life outcomes than did some Big Five inventories. Additional behavioral observations made on participants, including their Facebook profiles and cell-phone text usage, were predicted similarly by Big Five and 6-factor measures. A brief version of the BFI performed surprisingly well; across inventory platforms, increasing test length had little effect on predictive validity. Comparative validity of the models and measures in terms of outcome prediction and parsimony is discussed.

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.

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.

Patient-reported outcomes in borderline personality disorder

PubMed Central

Hasler, Gregor; Hopwood, Christopher J.; Jacob, Gitta A.; Brändle, Laura S.; Schulte-Vels, Thomas

2014-01-01

Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes. PMID:25152662

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-reported symptoms, long-term control and health-related quality of life. What does this study add? Progress was made towards developing a core outcome set for measuring eczema in clinical trials. The group established the essential items to be included in the outcome measure for the clinical signs of eczema and was able to recommend a scale for the core set. The remaining three domains of patient-reported symptoms, long-term control and health-related quality of life require further work and meetings to determine the core outcome measures. PMID:24980543

The Utility of the Mayo-Portland Adaptability Inventory Participation Index (M2PI) in US Military Veterans With a History of Mild Traumatic Brain Injury.

PubMed

OʼRourke, Justin; Critchfield, Edan; Soble, Jason; Bain, Kathleen; Fullen, Chrystal; Eapen, Blessen

2018-05-31

To examine the utility of the Mayo-Portland Adaptability Inventory-4th Edition Participation Index (M2PI) as a self-report measure of functional outcome following mild traumatic brain injury (mTBI) in US Military veterans. Department of Veterans Affairs Polytrauma Rehabilitation Center specialty hospital. On hundred thirty-nine veterans with a history of self-reported mTBI. Retrospective cross-sectional examination of data collected from regular clinical visits. M2PI, Neurobehavioral Symptoms Inventory with embedded validity measures, Posttraumatic Stress Disorder Checklist-Military Version. Forty-one percent of the sample provided symptom reports that exceeded established cut scores on embedded symptom validity tests. Invalid responders had higher levels of unemployment and endorsed significantly greater functional impairment, posttraumatic stress symptoms, and postconcussive complaints. For valid responders, regression analyses revealed that self-reported functioning was primarily related to posttraumatic stress complaints, followed by postconcussive cognitive complaints. For invalid responders, posttraumatic stress complaints also predicted self-reported functioning. Caution is recommended when utilizing the M2PI to measure functional outcome following mTBI in military veterans, particularly in the absence of symptom validity tests.

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.

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

The Predictive Validity of the Tilburg Frailty Indicator: Disability, Health Care Utilization, and Quality of Life in a Population at Risk

ERIC Educational Resources Information Center

Gobbens, Robbert J. J.; van Assen, Marcel A. L. M.; Luijkx, Katrien G.; Schols, Jos M. G. A.

2012-01-01

Purpose: To assess the predictive validity of frailty and its domains (physical, psychological, and social), as measured by the Tilburg Frailty Indicator (TFI), for the adverse outcomes disability, health care utilization, and quality of life. Design and Methods: The predictive validity of the TFI was tested in a representative sample of 484…

"Hits" (Not "Discussion Posts") Predict Student Success in Online Courses: A Double Cross-Validation Study

ERIC Educational Resources Information Center

Ramos, Cheryl; Yudko, Errol

2008-01-01

The efficacy of individual components of an online course on positive course outcome was examined via stepwise multiple regression analysis. Outcome was measured as the student's total score on all exams given during the course. The predictors were page hits, discussion posts, and discussion reads. The vast majority of the variance of outcome was…

Validation of the Worry about Sexual Outcomes Scale for Use in STI/HIV Prevention Interventions for Adolescent Females

ERIC Educational Resources Information Center

Sales, Jessica M.; Spitalnick, Josh; Milhausen, Robin R.; Wingood, Gina M.; Diclemente, Ralph J.; Salazar, Laura F.; Crosby, Richard A.

2009-01-01

This study examined the psychometric properties of a new scale to measure adolescents' worry regarding outcomes of risky sexual behavior (i.e. sexually transmitted infections, including HIV [STI/HIV], and unintended pregnancy). The 10-item worry about sexual outcomes (WASO) scale, resulting in two subscales STI/HIV worry and pregnancy worry, was…

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

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

PubMed

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

2016-12-01

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

Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.

PubMed

Bodien, Yelena G; McCrea, Michael; Dikmen, Sureyya; Temkin, Nancy; Boase, Kim; Machamer, Joan; Taylor, Sabrina R; Sherer, Mark; Levin, Harvey; Kramer, Joel H; Corrigan, John D; McAllister, Thomas W; Whyte, John; Manley, Geoffrey T; Giacino, Joseph T

Traumatic brain injury (TBI) is a global public health problem that affects the long-term cognitive, physical, and psychological health of patients, while also having a major impact on family and caregivers. In stark contrast to the effective trials that have been conducted in other neurological diseases, nearly 30 studies of interventions employed during acute hospital care for TBI have failed to identify treatments that improve outcome. Many factors may confound the ability to detect true and meaningful treatment effects. One promising area for improving the precision of intervention studies is to optimize the validity of the outcome assessment battery by using well-designed tools and data collection strategies to reduce variability in the outcome data. The Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the United States, implemented a multidimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to 1 year postinjury. In parallel, through the TBI Endpoints Development (TED) Initiative, federal agencies and investigators have partnered to identify the most valid, reliable, and sensitive outcome assessments for TBI. Here, we present lessons learned from the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome assessment in TBI.

Wound-healing outcomes using standardized assessment and care in clinical practice.

PubMed

Bolton, Laura; McNees, Patrick; van Rijswijk, Lia; de Leon, Jean; Lyder, Courtney; Kobza, Laura; Edman, Kelly; Scheurich, Anne; Shannon, Ron; Toth, Michelle

2004-01-01

Wound-healing outcomes applying standardized protocols have typically been measured within controlled clinical trials, not natural settings. Standardized protocols of wound care have been validated for clinical use, creating an opportunity to measure the resulting outcomes. Wound-healing outcomes were explored during clinical use of standardized validated protocols of care based on patient and wound assessments. This was a prospective multicenter study of wound-healing outcomes management in real-world clinical practice. Healing outcomes from March 26 to October 31, 2001, were recorded on patients in 3 long-term care facilities, 1 long-term acute care hospital, and 12 home care agencies for wounds selected by staff to receive care based on computer-generated validated wound care algorithms. After diagnosis, wound dimensions and status were assessed using a tool adapted from the Pressure Sore Status Toolfor use on all wounds. Wound, ostomy, and continence nursing professionals accessed consistent protocols of care, via telemedicine in home care or paper forms in long-term care. A physician entered assessments into a desktop computer in the wound clinic. Based on evidence that healing proceeds faster with fewer infections in environments without gauze, the protocols generally avoided gauze dressings. Most of the 767 wounds selected to receive the standardized-protocols of care were stage III-IV pressure ulcers (n = 373; mean healing time 62 days) or full-thickness venous ulcers (n = 124; mean healing time 57 days). Partial-thickness wounds healed faster than same-etiology full-thickness wounds. These results provide benchmarks for natural-setting healing outcomes and help to define and address wound care challenges. Outcomes primarily using nongauze protocols of care matched or surpassed best previously published results on similar wounds using gauze-based protocols of care, including protocols applying gauze impregnated with growth factors or other agents.

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.

Dynamic Assessment of Algebraic Learning in Predicting Third Graders’ Development of Mathematical Problem Solving

PubMed Central

Fuchs, Lynn S.; Compton, Donald L.; Fuchs, Douglas; Hollenbeck, Kurstin N.; Craddock, Caitlin F.; Hamlett, Carol L.

2008-01-01

Dynamic assessment (DA) involves helping students learn a task and indexing responsiveness to that instruction as a measure of learning potential. The purpose of this study was to explore the utility of a DA of algebraic learning in predicting 3rd graders’ development of mathematics problem solving. In the fall, 122 3rd-grade students were assessed on language, nonverbal reasoning, attentive behavior, calculations, word-problem skill, and DA. On the basis of random assignment, students received 16 weeks of validated instruction on word problems or received 16 weeks of conventional instruction on word problems. Then, students were assessed on word-problem measures proximal and distal to instruction. Structural equation measurement models showed that DA measured a distinct dimension of pretreatment ability and that proximal and distal word-problem measures were needed to account for outcome. Structural equation modeling showed that instruction (conventional vs. validated) was sufficient to account for math word-problem outcome proximal to instruction; by contrast, language, pretreatment math skill, and DA were needed to forecast learning on word-problem outcomes more distal to instruction. Findings are discussed in terms of responsiveness-to-intervention models for preventing and identifying learning disabilities. PMID:19884957

Validation of a Spanish version of the Spine Functional Index.

PubMed

Cuesta-Vargas, Antonio I; Gabel, Charles P

2014-06-27

The Spine Functional Index (SFI) is a recently published, robust and clinimetrically valid patient reported outcome measure. The purpose of this study was the adaptation and validation of a Spanish-version (SFI-Sp) with cultural and linguistic equivalence. A two stage observational study was conducted. The SFI was cross-culturally adapted to Spanish through double forward and backward translation then validated for its psychometric characteristics. Participants (n = 226) with various spine conditions of >12 weeks duration completed the SFI-Sp and a region specific measure: for the back, the Roland Morris Questionnaire (RMQ) and Backache Index (BADIX); for the neck, the Neck Disability Index (NDI); for general health the EQ-5D and SF-12. The full sample was employed to determine internal consistency, concurrent criterion validity by region and health, construct validity and factor structure. A subgroup (n = 51) was used to determine reliability at seven days. The SFI-Sp demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96). The factor structure was one-dimensional and supported construct validity. Criterion specific validity for function was high with the RMQ (r = 0.79), moderate with the BADIX (r = 0.59) and low with the NDI (r = 0.46). For general health it was low with the EQ-5D and inversely correlated (r = -0.42) and fair with the Physical and Mental Components of the SF-12 and inversely correlated (r = -0.56 and r = -0.48), respectively. The study limitations included the lack of longitudinal data regarding other psychometric properties, specifically responsiveness. The SFI-Sp was demonstrated as a valid and reliable spine-regional outcome measure. The psychometric properties were comparable to and supported those of the English-version, however further longitudinal investigations are required.

Negative relationship behavior is more important than positive: Correlates of outcomes during stressful life events.

PubMed

Rivers, Alannah Shelby; Sanford, Keith

2018-04-01

When people who are married or cohabiting face stressful life situations, their ability to cope may be associated with two separate dimensions of interpersonal behavior: positive and negative. These behaviors can be assessed with the Couple Resilience Inventory (CRI). It was expected that scales on this instrument would correlate with outcome variables regarding life well-being, stress, and relationship satisfaction. It was also expected that effects for negative behavior would be larger than effects for positive and that the effects might be curvilinear. Study 1 included 325 married or cohabiting people currently experiencing nonmedical major life stressors and Study 2 included 154 married or cohabiting people with current, serious medical conditions. All participants completed an online questionnaire including the CRI along with an alternate measure of couple behavior (to confirm scale validity), a measure of general coping style (to serve as a covariate), and measures of outcome variables regarding well-being, quality of life, perceived stress, and relationship satisfaction. The effects for negative behavior were larger than effects for positive in predicting most outcomes, and many effects were curvilinear. Notably, results remained significant after controlling for general coping style, and scales measuring positive and negative behavior demonstrated comparable levels of validity. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation.

PubMed

Kirsch, Monika; Mitchell, Sandra A; Dobbels, Fabienne; Stussi, Georg; Basch, Ethan; Halter, Jorg P; De Geest, Sabina

2015-02-01

The aim of this sequential mixed methods study was to develop a PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)-based measure of the symptom experience of late effects in German speaking long-term survivors of allogeneic stem cell transplantation (SCT), and to examine its content validity. The US National Cancer Institute's PRO-CTAE item library was translated into German and linguistically validated. PRO-CTCAE symptoms prevalent in ≥50% of survivors (n = 15) and recognized in its importance by SCT experts (n = 9) were identified. Additional concepts relevant to the symptom experience and its consequences were elicited. Content validity of the PROVIVO (Patient-Reported Outcomes of long-term survivors after allogeneic SCT) instrument was assessed through an additional round of cognitive debriefing in 15 patients, and item and scale content validity indices by 9 experts. PROVIVO is comprised of a total of 49 items capturing the experience of physical, emotional and cognitive symptoms. To improve the instrument's utility for clinical decision-making, questions soliciting limitations in activities of daily living, frequent infections, and overall well-being were added. Cognitive debriefings demonstrated that items were well understood and relevant to the SCT survivor experience. Scale Content Validity Index (CVI) (0.94) and item CVI (median = 1; range 0.75-1) were very high. Qualitative and quantitative data provide preliminary evidence supporting the content validity of PROVIVO and identify a PRO-CTCAE item bundle for use in SCT survivors. A study to evaluate the measurement properties of PROVIVO and to examine its capacity to improve survivorship care planning is underway. Copyright © 2014 Elsevier Ltd. All rights reserved.

Psychometric properties including reliability, validity and responsiveness of the Majeed pelvic score in patients with chronic sacroiliac joint pain.

PubMed

Bajada, Stefan; Mohanty, Khitish

2016-06-01

The Majeed scoring system is a disease-specific outcome measure that was originally designed to assess pelvic injuries. The aim of this study was to determine the psychometric properties of the Majeed scoring system for chronic sacroiliac joint pain. Internal consistency, content validity, criterion validity, construct validity and responsiveness to change was assessed prospectively for the Majeed scoring system in a cohort of 60 patients diagnosed with sacroiliac joint pain. This diagnosis was confirmed with CT-guided sacroiliac joint anaesthetic block. The overall Majeed score showed acceptable internal consistency (Cronbach alpha = 0.63). Similarly, it showed acceptable floor (0 %) and ceiling (0 %) effects. On the other hand, the domains of pain, work, sitting and sexual intercourse had high (>30 %) floor effects. Significant correlation with the physical component of the Short Form-36 (p = 0.005) and Oswestry disability index (p ≤ 0.001) was found indicating acceptable criterion validity. The overall Majeed score showed acceptable construct validity with all five developed hypotheses showing significance (p ≤ 0.05). The overall Majeed score showed acceptable responsiveness to change with a large (≥0.80) effect size and standardized response mean. Overall the Majeed scoring system demonstrated acceptable psychometric properties for outcome assessment in chronic sacroiliac joint pain. Thus, its use in this condition is adequate. However, some domains demonstrated suboptimal performance indicating that improvement might be achieved with the development of an outcome measure specific for sacroiliac joint dysfunction and degeneration.

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.

Reliability and Validity of the IKDC, KOOS, and WOMAC for Patients With Meniscal Injuries.

PubMed

van de Graaf, Victor A; Wolterbeek, Nienke; Scholtes, Vanessa A B; Mutsaerts, Eduard L A R; Poolman, Rudolf W

2014-06-01

Several patient-reported outcome measurements are used to measure functional outcome after treatment of meniscal injuries. However, for comparison of study results, there is a need for a uniform and standardized approach of measuring functional outcome. Selection of the instrument should be based on the quality of its measurement properties, and only the best instrument can be justified to be used. This study aimed to determine and compare the measurement properties of the Dutch-language versions of the International Knee Documentation Committee (IKDC) Subjective Knee Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) in a homogeneous group of patients with meniscal tears. Cohort study (design); Level of evidence, 2. Patients on the waiting list for meniscal surgery and patients between 6 weeks and 6 months after meniscal surgery were included (n = 75). Patients were excluded if they received an arthroplasty or had surgery on the anterior cruciate ligament. Internal consistency (Cronbach alpha), test-retest reliability (intraclass correlation coefficient [ICC]), measurement error (SEM), smallest detectable difference (SDD), content validity, construct validity (factor analysis and hypothesis testing), and floor and ceiling effects were determined. Results for the IKDC, KOOS dimensions, and WOMAC dimensions, respectively, were as follows: Cronbach alpha = .90, .72-.95, and .84-.95; ICC = 0.93, 0.84-0.89, and 0.77-0.89; SEM = 5.3, 7.0-12.6, and 7.3-12.2; SDD = 14.6, 19.4-35.0, and 20.2-33.9; hypotheses testing confirmation = 100%, 86%, and 85%. Floor effects within the SDD from the minimum score were found for the KOOS Sports/Recreation and Quality of Life dimensions. Ceiling effects within the SDD from the maximum score were found for the KOOS Activities of Daily Living and for all WOMAC dimensions. The IKDC showed the best performance on all measurement properties, implying that the IKDC, rather than the KOOS or WOMAC, should be used to assess functional outcome in patients with meniscal tears. © 2014 The Author(s).

Development and validation of the Neonatal Mortality Score-9 Mexico to predict mortality in critically ill neonates.

PubMed

Márquez-González, Horacio; Jiménez-Báez, María Valeria; Muñoz-Ramírez, C Mireya; Yáñez-Gutiérrez, Lucelli; Huelgas-Plaza, Ana C; Almeida-Gutiérrez, Eduardo; Villa-Romero, Antonio Rafael

2015-06-01

Prognostic scales or scores are useful for physicians who work in neonatal intensive care units. There are several validated neonatal scores but they are mostly applicable to low birth weight infants. The aim of this study was to develop and validate a mortality prognostic score in newborn infants, that would include new prognostic outcome measures. The study was conducted in a mother and child hospital in the city of Mexico, part of the Instituto Mexicano del Seguro Social (Mexican Institute of Social Security). In the first phase of the study, a nested case-control study was designed (newborn infants admitted on the basis of severity criteria during the first day of life), in which a scale was identified and developed with gradual parameters of cumulative score consisting of nine independent outcome measures to predict death, as follows: weight, metabolic acidemia, lactate, PaO2/FiO2, p(A-a) O2, A/a, platelets and serum glucose.Validation was performed in a matched prospective cohort, using 7-day mortality as an endpoint. The initial cohort consisted of 424 newborn infants. Twenty-two cases and 132 controls were selected; and 9 outcome measures were identified, making up the scale named neonatal mortality score-9 Mexico. The validation cohort consisted of 227 newborn infants. Forty-four (19%) deaths were recorded, with an area under the curve (AUC) of 0.92. With a score between 16 and 18, an 85 (11-102) hazard ratio, 99% specificity, 71% positive predictive value and 90% negative predictive value were reported. Conclusions .The proposed scale is a reliable tool to predict severity in newborn infants.

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

PubMed Central

2012-01-01

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

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

Instruments for measuring meaningful learning in healthcare students: a systematic psychometric review.

PubMed

Cadorin, Lucia; Bagnasco, Annamaria; Tolotti, Angela; Pagnucci, Nicola; Sasso, Loredana

2016-09-01

To identify, evaluate and describe the psychometric properties of instruments that measure learning outcomes in healthcare students. Meaningful learning is an active process that enables a wider and deeper understanding of concepts. It is the result of an interaction between new and prior knowledge and produces a long-standing change in knowledge and skills. In the field of education, validated and reliable instruments for assessing meaningful learning are needed. A psychometric systematic review. MEDLINE CINAHL, SCOPUS, ERIC, Cochrane Library, Psychology & Behavioural Sciences Collection Database from 1990-December 2013. Using pre-determined inclusion criteria, three reviewers independently identified studies for full-text review. Then they extracted data for quality appraisal and graded instrument validity using the Consensus-based Standards for the selection of the health status Measurement INstruments checklist and the Psychometric Grading Framework. Of the 57 studies identified for full-text review, 16 met the inclusion criteria and 13 different instruments were assessed. Following quality assessment, only one instrument was considered of good quality but it measured meaningful learning only in part; the others were either fair or poor. The Psychometric Grading Framework indicated that one instrument was weak, while the others were very weak. No instrument displayed adequate validity. The systematic review produced a synthesis of the psychometric properties of tools that measure learning outcomes in students of healthcare disciplines. Measuring learning outcomes is very important when educating health professionals. The identified tools may constitute a starting point for the development of other assessment tools. © 2016 John Wiley & Sons Ltd.

A pilot validation of a modified Illness Perceptions Questionnaire designed to predict response to cognitive therapy for psychosis.

PubMed

Marcus, Elena; Garety, Philippa; Weinman, John; Emsley, Richard; Dunn, Graham; Bebbington, Paul; Freeman, Daniel; Kuipers, Elizabeth; Fowler, David; Hardy, Amy; Waller, Helen; Jolley, Suzanne

2014-12-01

Clinical responsiveness to cognitive behavioural therapy for psychosis (CBTp) varies. Recent research has demonstrated that illness perceptions predict active engagement in therapy, and, thereby, better outcomes. In this study, we aimed to investigate the psychometric properties of a modification of the Illness Perceptions Questionnaire (M-IPQ) designed to predict response following CBTp. Fifty-six participants with persistent, distressing delusions completed the M-IPQ; forty before a brief CBT intervention targeting persecutory ideation and sixteen before and after a control condition. Additional predictors of outcome (delusional conviction, symptom severity and belief inflexibility) were assessed at baseline. Outcomes were assessed at baseline and at follow-up four to eight weeks later. The M-IPQ comprised two factors measuring problem duration and therapy-specific perceptions of Cure/Control. Associated subscales, formed by summing the relevant items for each factor, were reliable in their structure. The Cure/Control subscale was also reliable over time; showed convergent validity with other predictors of outcome; predicted therapy outcomes; and differentially predicted treatment effects. We measured outcome without an associated measure of engagement, in a small sample. Findings are consistent with hypothesis and existing research, but require replication in a larger, purposively recruited sample. The Cure/Control subscale of the M-IPQ shows promise as a predictor of response to therapy. Specifically targeting these illness perceptions in the early stages of cognitive behavioural therapy may improve engagement and, consequently, outcomes. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

PubMed

Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

2014-02-01

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

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.

Asthma Outcomes: Healthcare Utilization and Costs

PubMed Central

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

2014-01-01

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

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.

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

PubMed Central

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

2014-01-01

Objective To determine the extent to which instruments that measure core outcome domains in acute gout fulfil the OMERACT filter requirements of truth, discrimination and feasibility. Methods Patient-level data from four randomised controlled trials of agents designed to treat acute gout and one observational study of acute gout were analysed. 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 generalised estimating equations were assessed. Floor and ceiling effects were also assessed and MCID was estimated. These analyses were presented to participants at OMERACT 11 to help inform voting for possible endorsement. Results There was evidence for construct validity and discriminative ability for 3 measures of pain (0 to 4 Likert, 0 to 10 numeric rating scale, 0 to 100 mm visual analogue scale). 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. Conclusions There is sufficient evidence to support measures of pain (using Likert, numeric rating scale or visual analogue scales), 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. PMID:24429178

Beliefs about penis size: validation of a scale for men ashamed about their penis size.

PubMed

Veale, David; Eshkevari, Ertimiss; Read, Julie; Miles, Sarah; Troglia, Andrea; Phillips, Rachael; Echeverria, Lina Maria Carmona; Fiorito, Chiara; Wylie, Kevan; Muir, Gordon

2014-01-01

No measures are available for understanding beliefs in men who experience shame about the perceived size of their penis. Such a measure might be helpful for treatment planning, and measuring outcome after any psychological or physical intervention. Our aim was to validate a newly developed measure called the Beliefs about Penis Size Scale (BAPS). One hundred seventy-three male participants completed a new questionnaire consisting of 18 items to be validated and developed into the BAPS, as well as various other standardized measures. A urologist also measured actual penis size. The BAPS was validated against six psychosexual self-report questionnaires as well as penile size measurements. Exploratory factor analysis reduced the number of items in the BAPS from 18 to 10, which was best explained by one factor. The 10-item BAPS had good internal consistency and correlated significantly with measures of depression, anxiety, body image quality of life, social anxiety, erectile function, overall satisfaction, and the importance attached to penis size. The BAPS was not found to correlate with actual penis size. It was able to discriminate between those who had concerns or were dissatisfied about their penis size and those who were not. This is the first study to develop a scale for measurement of beliefs about penis size. It may be used as part of an assessment for men who experience shame about the perceived size of their penis and as an outcome measure after treatment. The BAPS measures various manifestations of masculinity and shame about their perceived penis size including internal self-evaluative beliefs; negative evaluation by others; anticipated consequences of a perceived small penis, and extreme self-consciousness. © 2013 International Society for Sexual Medicine.

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.

Measuring Certified Registered Nurse Anesthetist Organizational Climate: Instrument Adaptation.

PubMed

Boyd, Donald; Poghosyan, Lusine

2017-08-01

No tool exists measuring certified registered nurse anesthetist (CRNA) organizational climate. The study's purpose is to adapt a validated tool to measure CRNA organizational climate. Content validity of the Certified Registered Nurse Anesthetist Organizational Climate Questionnaire (CRNA-OCQ) was established. Pilot testing was conducted to determine internal reliability consistency of the subscales. Experts rated the tool as content valid. The subscales had high internal consistency reliability (with respective Cronbach's alphas): CRNA-Anesthesiologist Relations (.753), CRNA-Physician Relations (.833), CRNA-Administration Relations (.895), Independent Practice (.830), Support for CRNA Practice (.683), and Professional Visibility (.772). Further refinement of the CRNA-OCQ is necessary. Measurement and assessment of CRNA organizational climate may produce evidence needed to improve provider and patient outcomes.

Perceived match or mismatch on the Gottman conflict styles: associations with relationship outcome variables.

PubMed

Busby, Dean M; Holman, Thomas B

2009-12-01

Gottman has proposed that there are 3 functional styles of conflict management in couple relationships, labeled Avoidant, Validating, and Volatile, and 1 dysfunctional style, labeled Hostile. Using a sample of 1,983 couples in a committed relationship, we test the association of perceived matches or mismatches on these conflict styles with relationship outcome variables. The results indicate that 32% of the participants perceive there is a mismatch with their conflict style and that of their partner. The Volatile-Avoidant mismatch was particularly problematic and was associated with more stonewalling, relationship problems, and lower levels of relationship satisfaction and stability than the Validating matched style and than other mismatched styles. The most problematic style was the Hostile style. Contrary to existing assumptions by Gottman, the 3 matched functional styles were not equivalent, as the Validating Style was associated with substantially better results on relationship outcome measures than the Volatile and Avoidant styles.

Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma

PubMed Central

Medeiros, Felipe A.

2017-01-01

With the recent progress in imaging technologies for assessment of structural damage in glaucoma, a debate has emerged on whether these measurements can be used as valid surrogate endpoints in clinical trials evaluating new therapies for the disease. A discussion of surrogates should be grounded on knowledge acquired from their use in other areas of medicine as well as regulatory requirements. This article reviews the conditions for valid surrogacy in the context of glaucoma clinical trials and critically evaluates the role of biomarkers such as IOP and imaging measurements as potential surrogates for clinically relevant outcomes. Valid surrogate endpoints must be able to predict a clinically relevant endpoint, such as loss of vision or decrease in quality of life. In addition, the effect of a proposed treatment on the surrogate must capture the effect of the treatment on the clinically relevant endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has yet been conducted for any class of IOP-lowering treatments. Although strong evidence has accumulated about imaging measurements as predictors of relevant functional outcomes in glaucoma, there is still insufficient evidence to support their use as valid surrogate endpoints. However, imaging biomarkers could potentially be used as part of composite endpoints in glaucoma trials, overcoming weaknesses of the use of structural or functional endpoints in isolation. Efforts should be taken to properly design and conduct studies that can provide proper validation of potential biomarkers in glaucoma clinical trials. PMID:28475699

Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma.

PubMed

Medeiros, Felipe A

2017-05-01

With the recent progress in imaging technologies for assessment of structural damage in glaucoma, a debate has emerged on whether these measurements can be used as valid surrogate endpoints in clinical trials evaluating new therapies for the disease. A discussion of surrogates should be grounded on knowledge acquired from their use in other areas of medicine as well as regulatory requirements. This article reviews the conditions for valid surrogacy in the context of glaucoma clinical trials and critically evaluates the role of biomarkers such as IOP and imaging measurements as potential surrogates for clinically relevant outcomes. Valid surrogate endpoints must be able to predict a clinically relevant endpoint, such as loss of vision or decrease in quality of life. In addition, the effect of a proposed treatment on the surrogate must capture the effect of the treatment on the clinically relevant endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has yet been conducted for any class of IOP-lowering treatments. Although strong evidence has accumulated about imaging measurements as predictors of relevant functional outcomes in glaucoma, there is still insufficient evidence to support their use as valid surrogate endpoints. However, imaging biomarkers could potentially be used as part of composite endpoints in glaucoma trials, overcoming weaknesses of the use of structural or functional endpoints in isolation. Efforts should be taken to properly design and conduct studies that can provide proper validation of potential biomarkers in glaucoma clinical trials.

Cost-Value Analysis and the SAVE: A Work in Progress, But an Option for Localised Decision Making?

PubMed

Karnon, Jonathan; Partington, Andrew

2015-12-01

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

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

Validation of sleep-2-Peak: A smartphone application that can detect fatigue-related changes in reaction times during sleep deprivation.

PubMed

Brunet, Jean-François; Dagenais, Dominique; Therrien, Marc; Gartenberg, Daniel; Forest, Geneviève

2017-08-01

Despite its high sensitivity and validity in the context of sleep loss, the Psychomotor Vigilance Test (PVT) could be improved. The aim of the present study was to validate a new smartphone PVT-type application called sleep-2-Peak (s2P) by determining its ability to assess fatigue-related changes in alertness in a context of extended wakefulness. Short 3-min versions of s2P and of the classic PVT were administered at every even hour during a 35-h total sleep deprivation protocol. In addition, subjective measures of sleepiness were collected. The outcomes on these tests were then compared using Pearson product-moment correlations, t tests, and repeated measures within-groups analyses of variance. The results showed that both tests significantly correlated on all outcome variables, that both significantly distinguished between the alert and sleepy states in the same individual, and that both varied similarly through the sleep deprivation protocol as sleep loss accumulated. All outcome variables on both tests also correlated significantly with the subjective measures of sleepiness. These results suggest that a 3-min version of s2P is a valid tool for differentiating alert from sleepy states and is as sensitive as the PVT for tracking fatigue-related changes during extended wakefulness and sleep loss. Unlike the PVT, s2P does not provide feedback to subjects on each trial. We discuss how this feature of s2P raises the possibility that the performance results measured by s2P could be less impacted by motivational confounds, giving this tool added value in particular clinical and/or research settings.

Using Optimal Test Assembly Methods for Shortening Patient-Reported Outcome Measures: Development and Validation of the Cochin Hand Function Scale-6: A Scleroderma Patient-Centered Intervention Network Cohort Study.

PubMed

Levis, Alexander W; Harel, Daphna; Kwakkenbos, Linda; Carrier, Marie-Eve; Mouthon, Luc; Poiraudeau, Serge; Bartlett, Susan J; Khanna, Dinesh; Malcarne, Vanessa L; Sauve, Maureen; van den Ende, Cornelia H M; Poole, Janet L; Schouffoer, Anne A; Welling, Joep; Thombs, Brett D

2016-11-01

To develop and validate a short form of the Cochin Hand Function Scale (CHFS), which measures hand disability, for use in systemic sclerosis, using objective criteria and reproducible techniques. Responses on the 18-item CHFS were obtained from English-speaking patients enrolled in the Scleroderma Patient-Centered Intervention Network Cohort. CHFS unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit to CHFS items. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible form length between 1 and 17 items. The final short form selected was the form with the least number of items that maintained statistically equivalent convergent validity, compared to the full-length CHFS, with the Health Assessment Questionnaire (HAQ) disability index (DI) and the physical function domain of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29). There were 601 patients included. A 6-item short form of the CHFS (CHFS-6) was selected. The CHFS-6 had a Cronbach's alpha of 0.93. Correlations of the CHFS-6 summed score with HAQ DI (r = 0.79) and PROMIS-29 physical function (r = -0.54) were statistically equivalent to the CHFS (r = 0.81 and r = -0.56). The correlation with the full CHFS was high (r = 0.98). The OTA procedure generated a valid short form of the CHFS with minimal loss of information compared to the full-length form. The OTA method used was based on objective, prespecified criteria, but should be further studied for viability as a general procedure for shortening patient-reported outcome measures in health research. © 2016, American College of Rheumatology.

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 validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

Validating the Patient Experience with Treatment and Self-Management (PETS), a patient-reported measure of treatment burden, in people with diabetes

PubMed Central

Rogers, Elizabeth A; Yost, Kathleen J; Rosedahl, Jordan K; Linzer, Mark; Boehm, Deborah H; Thakur, Azra; Poplau, Sara; Anderson, Roger T; Eton, David T

2017-01-01

Aims To validate a comprehensive general measure of treatment burden, the Patient Experience with Treatment and Self-Management (PETS), in people with diabetes. Methods We conducted a secondary analysis of a cross-sectional survey study with 120 people diagnosed with type 1 or type 2 diabetes and at least one additional chronic illness. Surveys included established patient-reported outcome measures and a 48-item version of the PETS, a new measure comprised of multi-item scales assessing the burden of chronic illness treatment and self-care as it relates to nine domains: medical information, medications, medical appointments, monitoring health, interpersonal challenges, health care expenses, difficulty with health care services, role activity limitations, and physical/mental exhaustion from self-management. Internal reliability of PETS scales was determined using Cronbach’s alpha. Construct validity was determined through correlation of PETS scores with established measures (measures of chronic condition distress, medication satisfaction, self-efficacy, and global well-being), and known-groups validity through comparisons of PETS scores across clinically distinct groups. In an exploratory test of predictive validity, step-wise regressions were used to determine which PETS scales were most associated with outcomes of chronic condition distress, overall physical and mental health, and medication adherence. Results Respondents were 37–88 years old, 59% female, 29% non-white, and 67% college-educated. PETS scales showed good reliability (Cronbach’s alphas ≥0.74). Higher PETS scale scores (greater treatment burden) were correlated with more chronic condition distress, less medication convenience, lower self-efficacy, and worse general physical and mental health. Participants less (versus more) adherent to medications and those with more (versus fewer) health care financial difficulties had higher mean PETS scores. Medication burden was the scale that was most consistently associated with well-being and patient-reported adherence. Conclusion The PETS is a reliable and valid measure for assessing perceived treatment burden in people coping with diabetes. PMID:29184456

Validating the Patient Experience with Treatment and Self-Management (PETS), a patient-reported measure of treatment burden, in people with diabetes.

PubMed

Rogers, Elizabeth A; Yost, Kathleen J; Rosedahl, Jordan K; Linzer, Mark; Boehm, Deborah H; Thakur, Azra; Poplau, Sara; Anderson, Roger T; Eton, David T

2017-01-01

To validate a comprehensive general measure of treatment burden, the Patient Experience with Treatment and Self-Management (PETS), in people with diabetes. We conducted a secondary analysis of a cross-sectional survey study with 120 people diagnosed with type 1 or type 2 diabetes and at least one additional chronic illness. Surveys included established patient-reported outcome measures and a 48-item version of the PETS, a new measure comprised of multi-item scales assessing the burden of chronic illness treatment and self-care as it relates to nine domains: medical information, medications, medical appointments, monitoring health, interpersonal challenges, health care expenses, difficulty with health care services, role activity limitations, and physical/mental exhaustion from self-management. Internal reliability of PETS scales was determined using Cronbach's alpha. Construct validity was determined through correlation of PETS scores with established measures (measures of chronic condition distress, medication satisfaction, self-efficacy, and global well-being), and known-groups validity through comparisons of PETS scores across clinically distinct groups. In an exploratory test of predictive validity, step-wise regressions were used to determine which PETS scales were most associated with outcomes of chronic condition distress, overall physical and mental health, and medication adherence. Respondents were 37-88 years old, 59% female, 29% non-white, and 67% college-educated. PETS scales showed good reliability (Cronbach's alphas ≥0.74). Higher PETS scale scores (greater treatment burden) were correlated with more chronic condition distress, less medication convenience, lower self-efficacy, and worse general physical and mental health. Participants less (versus more) adherent to medications and those with more (versus fewer) health care financial difficulties had higher mean PETS scores. Medication burden was the scale that was most consistently associated with well-being and patient-reported adherence. The PETS is a reliable and valid measure for assessing perceived treatment burden in people coping with diabetes.

Assessment of the psychometric properties of the Short-Form Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) following surgical placement of Prolift+M: a transvaginal partially absorbable mesh system for the treatment of pelvic organ prolapse.

PubMed

Roy, Sanjoy; Mohandas, Anita; Coyne, Karin; Gelhorn, Heather; Gauld, Judi; Sikirica, Vanja; Milani, Alfredo L

2012-04-01

Impairment of sexual function is a significant problem among women suffering from pelvic organ prolapse (POP). Because anatomical measures of POP do not always correspond with patients' subjective reports of their condition, patient-reported outcome measures may provide additional valuable information regarding the experiences of women who have undergone surgery. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated, widely used condition-specific questionnaire focused on sexual function among patients with POP or urinary incontinence. This study aims to report sexual function outcomes as measured by PISQ-12 and to evaluate the psychometric characteristics of the questionnaire following surgical mesh implant for the treatment of POP. The PISQ-12 was used to measure sexual function, while a set of other measures, namely, Pelvic Organ Prolapse Quantification, Patient Global Impression of Change, Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Surgical Satisfaction Questionnaire, was used for validation. Data for the study were collected from a prospective multicenter, single-arm study of surgical POP repair via the transvaginal placement of a partially absorbable mesh system. For baseline, month 3, and month 12 following POP surgery, several psychometric properties of the PISQ-12 were evaluated, including internal consistency (Cronbach's alpha), concurrent validity, discriminant validity, and responsiveness. As measured by the PISQ-12 questionnaire, statistically significant improvements were observed in the composite summary score as well as all three subscale scores at 1 year. The PISQ-12 generally demonstrated good psychometric properties including internal consistency reliability, validity, and responsiveness. The PISQ-12 items had good distributional properties at baseline, with substantial ceiling effects at follow-up visits reflecting improvements experienced by the patients. The PISQ-12 is a valid measure of sexual function in studies involving patients with POP. © 2012 International Society for Sexual Medicine.

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.

Let's Stop Trying to Quantify Household Vulnerability: The Problem With Simple Scales for Targeting and Evaluating Economic Strengthening Programs.

PubMed

Moret, Whitney M

2018-03-21

Economic strengthening practitioners are increasingly seeking data collection tools that will help them target households vulnerable to HIV and poor child well-being outcomes, match households to appropriate interventions, monitor their status, and determine readiness for graduation from project support. This article discusses efforts in 3 countries to develop simple, valid tools to quantify and classify economic vulnerability status. In Côte d'Ivoire, we conducted a cross-sectional survey with 3,749 households to develop a scale based on the definition of HIV-related economic vulnerability from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for the purpose of targeting vulnerable households for PEPFAR-funded programs for orphans and vulnerable children. The vulnerability measures examined did not cluster in ways that would allow for the creation of a small number of composite measures, and thus we were unable to develop a scale. In Uganda, we assessed the validity of a vulnerability index developed to classify households according to donor classifications of economic status by measuring its association with a validated poverty measure, finding only a modest correlation. In South Africa, we developed monitoring and evaluation tools to assess economic status of individual adolescent girls and their households. We found no significant correlation with our validation measures, which included a validated measure of girls' vulnerability to HIV, a validated poverty measure, and subjective classifications generated by the community, data collector, and respondent. Overall, none of the measures of economic vulnerability used in the 3 countries varied significantly with their proposed validation items. Our findings suggest that broad constructs of economic vulnerability cannot be readily captured using simple scales to classify households and individuals in a way that accounts for a substantial amount of variance at locally defined vulnerability levels. We recommend that researchers and implementers design monitoring and evaluation instruments to capture narrower definitions of vulnerability based on characteristics programs intend to affect. We also recommend using separate tools for targeting based on context-specific indicators with evidence-based links to negative outcomes. Policy makers and donors should avoid reliance on simplified metrics of economic vulnerability in the programs they support. © Moret.

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

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.

An empirical comparison of the measurement properties of the EQ-5D-5L, DEMQOL-U and DEMQOL-Proxy-U for older people in residential care.

PubMed

Easton, Tiffany; Milte, Rachel; Crotty, Maria; Ratcliffe, Julie

2018-05-01

This study aimed to empirically compare the measurement properties of self-reported and proxy-reported (in cases of severe cognitive impairment) generic (EQ-5D-5L) and condition-specific (DEMQOL-U and DEMQOL-Proxy-U) preference-based HRQoL instruments in residential care, where the population is characterised by older people with high rates of cognitive impairment, dementia and disability. Participants were recruited from seventeen residential care facilities across four Australian states. One hundred and forty-three participants self-completed the EQ-5D-5L and the DEMQOL-U while three hundred and eight-seven proxy completed (due to the presence of severe dementia) the EQ-5D-5L and DEMQOL-Proxy-U. The convergent validity of the outcome measures and known group validity relative to a series of clinical outcome measures were assessed. Results satisfy convergent validity among the outcome measures. EQ-5D-5L and DEMQOL-U utilities were found to be significantly correlated with each other (p < 0.01) as were EQ-5D-5L and DEMQOL-Proxy-U utilities (p < 0.01). Both self-reported and proxy-reported EQ-5D-5L utilities demonstrated strong known group validity in relation to clinically recognised thresholds of cognition and physical functioning, while in contrast neither DEMQOL-U nor DEMQOL-Proxy-U demonstrated this association. The findings suggest that the EQ-5D-5L, DEMQOL-U and DEMQOL-Proxy-U capture distinct aspects of HRQoL for this population. The measurement and valuation of HRQoL form an essential component of economic evaluation in residential care. However, high levels of cognitive impairment may preclude self-completion for a majority. Further research is needed to determine cognition thresholds beyond which an individual is unable to reliably self-report their own health-related quality of life.

The development of an instrument to measure the self-efficacy of students participating in VEX robotics competitions

NASA Astrophysics Data System (ADS)

Robinson, Trevor P.

The number of robotics competitions has steadily increased over the past 30 years. Schools are implementing robotics competitions to increase student content knowledge and interest in science, technology, engineering, and mathematics (STEM). Companies in STEM-related fields are financially supporting robotics competitions to help increase the number of students pursuing careers in STEM among other reasons. These financial supporters and school administrations are asking what the outcomes of students participating in competitive robotics are. Few studies have been conducted to investigate these outcomes. The studies that have been conducted usually compare students in robotics to students not in robotics. There have not been any studies that compare students to themselves before and after participating in robotics competitions. This may be due to the lack of available instruments to measure student outcomes. This study developed an instrument to measure the self-efficacy of students participating in VEX Robotics Competitions (VRC). The VRC is the world's largest and fastest growing robotics competition available for middle and high school students. Self-efficacy was measured because of its importance to the education community. Students with higher self-efficacy tend to persevere through difficult tasks more frequently than students with low self-efficacy. A person's self-efficacy has major influence over what interests, activities, classes, college majors, and careers he or she will pursue in life. The self-efficacy survey instrument created through this study was developed through an occupational and task analysis (OTA), and initial content and face validity was established through the OTA process. Exploratory and confirmatory factor analyses were also conducted to assist in instrument validation. The reliability was calculated using Cronbach's alpha. Face validity was established through the OTA process. Construct validity was established through the factor analyses. The processes of the OTA and factor analyses have created an instrument that results indicate is reliable and valid to use in further research studies.

Reliability and validation of the Dutch Achilles tendon Total Rupture Score.

PubMed

Opdam, K T M; Zwiers, R; Wiegerinck, J I; Kleipool, A E B; Haverlag, R; Goslings, J C; van Dijk, C N

2018-03-01

Patient-reported outcome measures (PROMs) have become a cornerstone for the evaluation of the effectiveness of treatment. The Achilles tendon Total Rupture Score (ATRS) is a PROM for outcome and assessment of an Achilles tendon rupture. The aim of this study was to translate the ATRS to Dutch and evaluate its reliability and validity in the Dutch population. A forward-backward translation procedure was performed according to the guidelines of cross-cultural adaptation process. The Dutch ATRS was evaluated for reliability and validity in patients treated for a total Achilles tendon rupture from 1 January 2012 to 31 December 2014 in one teaching hospital and one academic hospital. Reliability was assessed by the intraclass correlation coefficients (ICC), Cronbach's alpha and minimal detectable change (MDC). We assessed construct validity by calculation of Spearman's rho correlation coefficient with domains of the Foot and Ankle Outcome Score (FAOS), Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A) and Numeric Rating Scale (NRS) for pain in rest and during running. The Dutch ATRS had a good test-retest reliability (ICC = 0.852) and a high internal consistency (Cronbach's alpha = 0.96). MDC was 30.2 at individual level and 3.5 at group level. Construct validity was supported by 75 % of the hypothesized correlations. The Dutch ATRS had a strong correlation with NRS for pain during running (r = -0.746) and all the five subscales of the Dutch FAOS (r = 0.724-0.867). There was a moderate correlation with the VISA-A-NL (r = 0.691) and NRS for pain in rest (r = -0.580). The Dutch ATRS shows an adequate reliability and validity and can be used in the Dutch population for measuring the outcome of treatment of a total Achilles tendon rupture and for research purposes. Diagnostic study, Level I.

Assessment of generalizability, applicability and predictability (GAP) for evaluating external validity in studies of universal family-based prevention of alcohol misuse in young people: systematic methodological review of randomized controlled trials.

PubMed

Fernandez-Hermida, Jose Ramon; Calafat, Amador; Becoña, Elisardo; Tsertsvadze, Alexander; Foxcroft, David R

2012-09-01

To assess external validity characteristics of studies from two Cochrane Systematic Reviews of the effectiveness of universal family-based prevention of alcohol misuse in young people. Two reviewers used an a priori developed external validity rating form and independently assessed three external validity dimensions of generalizability, applicability and predictability (GAP) in randomized controlled trials. The majority (69%) of the included 29 studies were rated 'unclear' on the reporting of sufficient information for judging generalizability from sample to study population. Ten studies (35%) were rated 'unclear' on the reporting of sufficient information for judging applicability to other populations and settings. No study provided an assessment of the validity of the trial end-point measures for subsequent mortality, morbidity, quality of life or other economic or social outcomes. Similarly, no study reported on the validity of surrogate measures using established criteria for assessing surrogate end-points. Studies evaluating the benefits of family-based prevention of alcohol misuse in young people are generally inadequate at reporting information relevant to generalizability of the findings or implications for health or social outcomes. Researchers, study authors, peer reviewers, journal editors and scientific societies should take steps to improve the reporting of information relevant to external validity in prevention trials. © 2012 The Authors. Addiction © 2012 Society for the Study of Addiction.

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

Clinimetric properties of the Tinetti Mobility Test, Four Square Step Test, Activities-specific Balance Confidence Scale, and spatiotemporal gait measures in individuals with Huntington's disease

PubMed Central

Kloos, Anne D.; Fritz, Nora E.; Kostyk, Sandra K.; Young, Gregory S.; Kegelmeyer, Deb A.

2014-01-01

Background and purpose Individuals with Huntington's disease (HD) experience balance and gait problems that lead to falls. Clinicians currently have very little information about the reliability and validity of outcome measures to determine the efficacy of interventions that aim to reduce balance and gait impairments in HD. This study examined the reliability and concurrent validity of spatiotemporal gait measures, the Tinetti Mobility Test (TMT), Four Square Step Test (FSST), and Activities-specific Balance Confidence (ABC) Scale in individuals with HD. Methods Participants with HD [n = 20; mean age ± SD = 50.9 ± 13.7; 7 male] were tested on spatiotemporal gait measures the TMT, FSST, and ABC Scale before and after a six week period to determine test–retest reliability and minimal detectable change (MDC) values. Linear relationships between gait and clinical measures were estimated using Pearson's correlation coefficients. Results Spatiotemporal gait measures, the TMT total and the FSST showed good to excellent test–retest reliability (ICC > 0.75). MDC values were 0.30 m/s and 0.17 m/s for velocity in forward and backward walking respectively, four points for the TMT, and 3 s for the FSST. The TMT and FSST were highly correlated with most spatiotemporal measures. The ABC Scale demonstrated lower reliability and less concurrent validity than other measures. Conclusions The high test–retest reliability over a six week period and concurrent validity between the TMT, FSST, and spatiotemporal gait measures suggest that the TMT and FSST may be useful outcome measures for future intervention studies in ambulatory individuals with HD. PMID:25128156

Clinimetric properties of the Tinetti Mobility Test, Four Square Step Test, Activities-specific Balance Confidence Scale, and spatiotemporal gait measures in individuals with Huntington's disease.

PubMed

Kloos, Anne D; Fritz, Nora E; Kostyk, Sandra K; Young, Gregory S; Kegelmeyer, Deb A

2014-09-01

Individuals with Huntington's disease (HD) experience balance and gait problems that lead to falls. Clinicians currently have very little information about the reliability and validity of outcome measures to determine the efficacy of interventions that aim to reduce balance and gait impairments in HD. This study examined the reliability and concurrent validity of spatiotemporal gait measures, the Tinetti Mobility Test (TMT), Four Square Step Test (FSST), and Activities-specific Balance Confidence (ABC) Scale in individuals with HD. Participants with HD [n = 20; mean age ± SD=50.9 ± 13.7; 7 male] were tested on spatiotemporal gait measures and the TMT, FSST, and ABC Scale before and after a six week period to determine test-retest reliability and minimal detectable change (MDC) values. Linear relationships between gait and clinical measures were estimated using Pearson's correlation coefficients. Spatiotemporal gait measures, the TMT total and the FSST showed good to excellent test-retest reliability (ICC > 0.75). MDC values were 0.30 m/s and 0.17 m/s for velocity in forward and backward walking respectively, four points for the TMT, and 3s for the FSST. The TMT and FSST were highly correlated with most spatiotemporal measures. The ABC Scale demonstrated lower reliability and less concurrent validity than other measures. The high test-retest reliability over a six week period and concurrent validity between the TMT, FSST, and spatiotemporal gait measures suggest that the TMT and FSST may be useful outcome measures for future intervention studies in ambulatory individuals with HD. Copyright © 2014 Elsevier B.V. All rights reserved.

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

PubMed Central

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

2008-01-01

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

The cervical dystonia impact profile (CDIP-58): can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

PubMed

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

2008-08-06

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

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.

An Investigation of the Relationship Between the Alliance Negotiation Scale and Psychotherapy Process and Outcome.

PubMed

Doran, Jennifer M; Safran, Jeremy D; Muran, J Christopher

2017-04-01

This study examines the validity of the Alliance Negotiation Scale (ANS) in a psychotherapy research program. Analyses were designed to evaluate the relationship between the ANS and psychotherapy process and outcome variables. Data were collected in a metropolitan psychotherapy research program. Participants completed 30 sessions of therapy, postsession assessments, and a battery of measures at intake and termination. Relationships were found between the ANS and session outcome, working alliance, and the presence of ruptures and their resolution. Relationships emerged between the ANS and treatment outcome on measures of psychiatric distress and interpersonal problems. The ANS demonstrated relationships with several psychotherapy process and outcome variables. The ANS was the most differentiated from the working alliance on measures of interpersonal functioning and in discriminating personality disorder pathology. These results extend previous findings on the ANS' psychometric integrity, and offer new data on the relationship between negotiation and treatment outcome. © 2016 Wiley Periodicals, Inc.

Impact of cooking and home food preparation interventions among adults: outcomes and implications for future programs

PubMed Central

Reicks, Marla; Trofholz, Amanda C.; Stang, Jamie S; Laska, Melissa N.

2014-01-01

Objective Cooking programs are growing in popularity; however an extensive review has not examined overall impact. Therefore, this study reviewed previous research on cooking/home food preparation interventions and diet and health-related outcomes among adults and identified implications for practice and research. Design Literature review and descriptive summative method. Main outcome measures Dietary intake, knowledge/skills, cooking attitudes and self-efficacy/confidence, health outcomes. Analysis Articles evaluating effectiveness of interventions that included cooking/home food preparation as the primary aim (January 1980 through December 2011) were identified via OVID MEDLINE, Agricola and Web of Science databases. Studies grouped according to design and outcomes were reviewed for validity using an established coding system. Results were summarized for several outcome categories. Results Of 28 studies identified, 12 included a control group with six as non-randomized and six as randomized controlled trials. Evaluation was done post-intervention for five studies, pre- and post-intervention for 23 and beyond post-intervention for 15. Qualitative and quantitative measures suggested a positive influence on main outcomes. However, non-rigorous study designs, varying study populations, and use of non-validated assessment tools limited stronger conclusions. Conclusions and Implications Well-designed studies are needed that rigorously evaluate long-term impact on cooking behavior, dietary intake, obesity and other health outcomes. PMID:24703245

Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

2017-06-09

Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve clinical trial quality. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis: a systematic review.

PubMed

Kroman, S L; Roos, E M; Bennell, K L; Hinman, R S; Dobson, F

2014-01-01

To systematically appraise the evidence on measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis (OA). Electronic searches were performed in MEDLINE, CINAHL, Scopus and SPORTDiscus in May 2013. Two reviewers independently rated the measurement properties using the 4-point COSMIN checklist. Best evidence synthesis was made using COSMIN quality, consistency and direction of findings and sample size. Twenty of 2736 papers were eligible for inclusion and 24 different performance-based outcome measures knee or obese populations were evaluated. No tests related to hip populations were included. Twenty-five measurement properties including reliability (nine studies), construct validity (hypothesis testing) (nine studies), measurement error (three studies), structural validity (two studies), interpretability (one study) and responsiveness (one study) were evaluated. A positive rating was given to 12.5% (30/240) of all possible measurement ratings. Tests were grouped into two categories based on the population characteristics. The one-legged hop for distance, followed by the 6-m timed hop and cross over hop for distance were the best-rated tests for the knee-injured population. Whereas the 6-min walk test was the only included test for the obese population. This review highlights the many gaps in knowledge about the measurement properties of performance-based outcome measures for young and middle-aged people known to be at high risk of hip and/or knee OA. There is a need for consensus on which outcome measures should be used and/or combined when assessing physical function in this population. Further good quality research is required. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Evaluating cognition in individuals with Huntington disease: Neuro-QoL cognitive functioning measures.

PubMed

Lai, Jin-Shei; Goodnight, Siera; Downing, Nancy R; Ready, Rebecca E; Paulsen, Jane S; Kratz, Anna L; Stout, Julie C; McCormack, Michael K; Cella, David; Ross, Christopher; Russell, Jenna; Carlozzi, Noelle E

2018-03-01

Cognitive functioning impacts health-related quality of life (HRQOL) for individuals with Huntington disease (HD). The Neuro-QoL includes two patient-reported outcome (PRO) measures of cognition-Executive Function (EF) and General Concerns (GC). These measures have not previously been validated for use in HD. The purpose of this analysis is to evaluate the reliability and validity of the Neuro-QoL Cognitive Function measures for use in HD. Five hundred ten individuals with prodromal or manifest HD completed the Neuro-QoL Cognition measures, two other PRO measures of HRQOL (WHODAS 2.0 and EQ5D), and a depression measure (PROMIS Depression). Measures of functioning The Total Functional Capacity and behavior (Problem Behaviors Assessment) were completed by clinician interview. Objective measures of cognition were obtained using clinician-administered Symbol Digit Modalities Test and the Stroop Test (Word, Color, and Interference). Self-rated, clinician-rated, and objective composite scores were developed. We examined the Neuro-QoL measures for reliability, convergent validity, discriminant validity, and known-groups validity. Excellent reliabilities (Cronbach's alphas ≥ 0.94) were found. Convergent validity was supported, with strong relationships between self-reported measures of cognition. Discriminant validity was supported by less robust correlations between self-reported cognition and other constructs. Prodromal participants reported fewer cognitive problems than manifest groups, and early-stage HD participants reported fewer problems than late-stage HD participants. The Neuro-QoL Cognition measures provide reliable and valid assessments of self-reported cognitive functioning for individuals with HD. Findings support the utility of these measures for assessing self-reported cognition.

Construction and Validation of the Student-Athlete Environmental and Academic Orientation Survey (SEAOS)

ERIC Educational Resources Information Center

Mullenbach, Lauren E.; Green, Gary T.

2016-01-01

Many surveys exist that measure environmental orientations, yet few measure learning outcomes, such as self-efficacy, and even fewer specifically target student-athletes. Hence, this study created a survey, named the Student-Athlete Environmental and Academic Orientation Survey (SEAOS), which measured student-athletes' environmental attitudes,…

Measures of Self-Care Independence for Children with Osteochondrodysplasia: A Clinimetric Review

ERIC Educational Resources Information Center

Ireland, Penelope; Johnston, Leanne M.

2012-01-01

This systematic review evaluates the validity, reliability, and clinical utility of outcome measures used to assess self-care skills among children with congenital musculoskeletal conditions and assesses the applicability of these measures for children with osteochondrodysplasia aged 0-12 years. Electronic databases were searched to identify…

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.

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 child's symptoms and behaviour. Factor analysis was also applied to POEEMS resulting in a three-factor structure. Factors relating to independent management of atopic dermatitis by the parent, involving healthcare professionals in management, and involving the child in the management of atopic dermatitis were found. Parents' self-efficacy and outcome expectations had a significant influence on self-reported task performance. Findings suggest that PEMS and POEEMS are valid and reliable instruments worthy of further psychometric evaluation. Likewise, validity and reliability of PASECI was confirmed. Copyright © 2010 Elsevier Ltd. All rights reserved.

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.

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

PubMed

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

2018-02-01

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

SAGES quality initiative: an introduction.

PubMed

Lidor, Anne; Telem, Dana; Bower, Curtis; Sinha, Prashant; Orlando, Rocco; Romanelli, John

2017-08-01

The Medicare program has transitioned to paying healthcare providers based on the quality of care delivered, not on the quantity. In May 2015, SAGES held its first ever Quality Summit. The goal of this meeting was to provide us with the information necessary to put together a strategic plan for our Society over the next 3-5 years, and to participate actively on a national level to help develop valid measures of quality of surgery. The transition to value-based medicine requires that providers are now measured and reimbursed based on the quality of services they provide rather than the quantity of patients in their care. As of 2014, quality measures must cover 3 of the 6 available National Quality domains. Physician quality reporting system measures are created via a vigorous process which is initiated by the proposal of the quality measure and subsequent validation. Commercial, non-profit, and governmental agencies have now been engaged in the measurement of hospital performance through structural measures, process measures, and increasingly with outcomes measures. This more recent focus on outcomes measures have been linked to hospital payments through the Value-Based Purchasing program. Outcomes measures of quality drive CMS' new program, MACRA, using two formats: Merit-based incentive programs and alternative payment models. But, the quality of information now available is highly variable and difficult for the average consumer to use. Quality metrics serve to guide efforts to improve performance and for consumer education. Professional organizations such as SAGES play a central role in defining the agenda for improving quality, outcomes, and safety. The mission of SAGES is to improve the quality of patient care through education, research, innovation, and leadership, principally in gastrointestinal and endoscopic surgery.

Cultural and linguistic transferability of the multi-dimensional OxCAP-MH capability instrument for outcome measurement in mental health: the German language version.

PubMed

Simon, Judit; Łaszewska, Agata; Leutner, Eva; Spiel, Georg; Churchman, David; Mayer, Susanne

2018-06-05

Mental health conditions affect aspects of people's lives that are often not captured in common health-related outcome measures. The OxCAP-MH self-reported, quality of life questionnaire based on Sen's capability approach was developed in the UK to overcome these limitations. The aim of this study was to develop a linguistically and culturally valid German version of the questionnaire. Following forward and back translations, the wording underwent cultural and linguistic validation with input from a sample of 12 native German speaking mental health patients in Austria in 2015. Qualitative feedback from patients and carers was obtained via interviews and focus group meetings. Feedback from mental health researchers from Germany was incorporated to account for cross-country differences. No significant item modifications were necessary. However, changes due to ambiguous wordings, possibilities for differential interpretations, politically unacceptable expressions, cross-country language differences and differences in political and social systems, were needed. The study confirmed that all questions are relevant and understandable for people with mental health conditions in a German speaking setting and transferability of the questionnaire from English to German speaking countries is feasible. Professional translation is necessary for the linguistic accuracy of different language versions of patient-reported outcome measures but does not guarantee linguistic and cultural validity and cross-country transferability. Additional context-specific piloting is essential. The time and resources needed to achieve valid multi-lingual versions should not be underestimated. Further research is ongoing to confirm the psychometric properties of the German version.

The EULAR Outcome Measures Library: development and an example from a systematic review for systemic lupus erythematous instruments.

PubMed

Castrejon, I; Carmona, L; Agrinier, N; Andres, M; Briot, K; Caron, M; Christensen, R; Consolaro, A; Curbelo, R; Ferrer, Montserrat; Foltz, Violaine; Gonzalez, C; Guillemin, F; Machado, P M; Prodinger, Birgit; Ravelli, A; Scholte-Voshaar, M; Uhlig, T; van Tuyl, L H D; Zink, A; Gossec, L

2015-01-01

Patient reported outcomes (PROs) are relevant in rheumatology. Variable accessibility and validity of commonly used PROs are obstacles to homogeneity in evidence synthesis. The objective of this project was to provide a comprehensive library of "validated PROs". A launch meeting with rheumatologists, PROs methodological experts, and patients, was held to define the library's aims and scope, and basic requirements. To feed the library we performed systematic reviews on selected diseases and domains. Relevant information on PROs was collected using standardised data collection forms based on the COSMIN checklist. The EULAR Outcomes Measures Library (OML), whose aims are to provide and to advise on PROs on a user-friendly manner albeit based on scientific grounds, has been launched and made accessible to all. PROs currently included cover any domain and, are generic or specifically target to the following diseases: rheumatoid arthritis, osteoarthritis, spondyloarthritis, low back pain, systemic lupus erythematosus, gout, osteoporosis, juvenile idiopathic arthritis, and fibromyalgia. Up to 236 instruments (106 generic and 130 specific) have been identified, evaluated, and included. The systematic review for SLE, which yielded 10 specific instruments, is presented here as an example. The OML website includes, for each PRO, information on the construct being measured and the extent of validation, recommendations for use, and available versions; it also contains a glossary on common validation terms. The OML is an in progress library led by rheumatologists, related professionals and patients, that will help to better understand and apply PROs in rheumatic and musculoskeletal diseases.

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 ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness. PMID:22871087

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.

Toddlers' Expressive Vocabulary Outcomes after One Year of Parent-Child Home Program Services

ERIC Educational Resources Information Center

Manz, Patricia H.; Bracaliello, Catherine B.; Pressimone, Vanessa J.; Eisenberg, Rachel A.; Gernhart, Amanda C.; Fu, Qiong; Zuniga, Cesar

2016-01-01

This quasi-experimental study examined expressive vocabulary outcomes for Parent-Child Home Program (PCHP) toddlers, after one year of home-visiting services. First, this study applied Rasch modelling to establish the construct validity and reliability of a widely used expressive vocabulary measure, as modified for a sample of ethnic and…

Coloniality and a Global Testing Regime in Higher Education: Unpacking the OECD's AHELO Initiative

ERIC Educational Resources Information Center

Shahjahan, Riyad A.

2013-01-01

The Organization for Economic Cooperation and Development (OECD) is currently engaging in a worldwide feasibility study entitled International Assessment of Higher Education Learning Outcomes (AHELO). This feasibility study seeks to develop measures that would assess student learning outcomes that would be valid across different languages,…

The benefits of using bluetooth accessories with hearing aids.

PubMed

Smith, Pauline; Davis, Adrian

2014-10-01

To investigate the benefits in reported outcomes after providing bluetooth accessories for established hearing aid users. Prospective observational study using validated quantitative outcome measures and detailed patient narrative before and two months after patients were provided with bluetooth accessories. Twelve patients with bilateral NHS hearing aids participated. They had a wide range of ages and hearing loss. After two months, 10 patients reported substantial additional benefit and kept the accessories; two returned them for various reasons. Statistically significant changes were seen in two validated outcome measures: the Glasgow Hearing Aid Benefit Profile and the International Outcome Inventory - Hearing Aids, but not in the Speech, Spatial and Qualities of Hearing Scale. Two notable benefits were reported: some described hearing the emotion and mood in a voice for the first time; others were amazed to report an improved ability to hear film or to hold conversations over the telephone. The provision of bluetooth accessories can give additional reported benefit for some patients - we need better knowledge about who benefits, and whether further support/training to individuals would make a difference.

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.

Measurement properties of adult quality-of-life measurement instruments for eczema: a systematic review.

PubMed

Heinl, D; Prinsen, C A C; Deckert, S; Chalmers, J R; Drucker, A M; Ofenloch, R; Humphreys, R; Sach, T; Chamlin, S L; Schmitt, J; Apfelbacher, C

2016-03-01

The Harmonising Outcome Measures for Eczema (HOME) initiative has identified quality of life (QoL) as a core outcome domain to be evaluated in every eczema trial. It is unclear which of the existing QoL instruments is most appropriate for this domain. Thus, the aim of this review was to systematically assess the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in adult eczema. We conducted a systematic literature search in PubMed and Embase identifying studies on measurement properties of adult eczema QoL instruments. For all eligible studies, we assessed the adequacy of the measurement properties and the methodological quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis summarizing findings from different studies was the basis to assign four degrees of recommendation (A-D). A total of 15 articles reporting on 17 instruments were included. No instrument fulfilled the criteria for category A. Six instruments were placed in category B, meaning that they have the potential to be recommended depending on the results of further validation studies. Three instruments had poor adequacy in at least one required adequacy criterion and were therefore put in category C. The remaining eight instruments were minimally validated and were thus placed in category D. Currently, no QoL instrument can be recommended for use in adult eczema. The Quality of Life Index for Atopic Dermatitis (QoLIAD) and the Dermatology Life Quality Index (DLQI) are recommended for further validation research. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale; translation and validation of the Dutch language version for ankle fractures.

PubMed

de Boer, A Siebe; Tjioe, Roderik J C; Van der Sijde, Fleur; Meuffels, Duncan E; den Hoed, Pieter T; Van der Vlies, Cornelis H; Tuinebreijer, Wim E; Verhofstad, Michael H J; Van Lieshout, Esther M M

2017-08-03

The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale is among the most commonly used instruments for measuring outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It consists of a patient-reported and a physician-reported part. A validated, Dutch version of this instrument is currently not available. The aim of this study was to translate the instrument into Dutch and to determine the measurement properties of the AOFAS Ankle-Hindfoot Scale Dutch language version (DLV) in patients with a unilateral ankle fracture. Multicentre (two Dutch hospitals), prospective observational study. In total, 142 patients with a unilateral ankle fracture were included. Ten patients were lost to follow-up. Patients completed the subjective (patient-reported) part of the AOFAS Ankle-Hindfoot Scale-DLV. A physician or trained physician-assistant completed the physician-reported part. For comparison and evaluation of the measuring characteristics, the Foot Function Index and the Short Form-36 were completed by the patient. Descriptive statistics (including floor and ceiling effects), reliability (ie, internal consistency), construct validity, reproducibility (ie, test-retest reliability, agreement and smallest detectable change) and responsiveness were determined. The AOFAS-DLV and its subscales showed good internal consistency (Cronbach's α >0.90). Construct validity and longitudinal validity were proven to be adequate (76.5% of predefined hypotheses were confirmed). Floor effects were not present. Ceiling effects were present from 6 months onwards, as expected. Responsiveness was adequate, with a smallest detectable change of 12.0 points. The AOFAS-DLV is a reliable, valid and responsive measurement instrument for evaluating functional outcome in patients with a unilateral ankle fracture. This implies that the questionnaire is suitable to compare different treatment modalities within this population or to compare outcome across hospitals. The Netherlands Trial Register (NTR5613; 05-jan-2016). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Validating a measure to assess factors that affect assistive technology use by students with disabilities in elementary and secondary education.

PubMed

Zapf, Susan A; Scherer, Marcia J; Baxter, Mary F; H Rintala, Diana

2016-01-01

The purpose of this study was to measure the predictive validity, internal consistency and clinical utility of the Matching Assistive Technology to Child & Augmentative Communication Evaluation Simplified (MATCH-ACES) assessment. Twenty-three assistive technology team evaluators assessed 35 children using the MATCH-ACES assessment. This quasi-experimental study examined the internal consistency, predictive validity and clinical utility of the MATCH-ACES assessment. The MATCH-ACES assessment predisposition scales had good internal consistency across all three scales. A significant relationship was found between (a) high student perseverance and need for assistive technology and (b) high teacher comfort and interest in technology use (p = (0).002). Study results indicate that the MATCH-ACES assessment has good internal consistency and validity. Predisposition characteristics of student and teacher combined can influence the level of assistive technology use; therefore, assistive technology teams should assess predisposition factors of the user when recommending assistive technology. Implications for Rehabilitation Educational and medical professionals should be educated on evidence-based assistive technology assessments. Personal experience and psychosocial factors can influence the outcome use of assistive technology. Assistive technology assessments must include an intervention plan for assistive technology service delivery to measure effective outcome use.

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.

Development and validation of the Single Item Trait Empathy Scale (SITES).

PubMed

Konrath, Sara; Meier, Brian P; Bushman, Brad J

2018-04-01

Empathy involves feeling compassion for others and imagining how they feel. In this article, we develop and validate the Single Item Trait Empathy Scale (SITES), which contains only one item that takes seconds to complete. In seven studies (N=5,724), the SITES was found to be both reliable and valid. It correlated in expected ways with a wide variety of intrapersonal outcomes. For example, it is negatively correlated with narcissism, depression, anxiety, and alexithymia. In contrast, it is positively correlated with other measures of empathy, self-esteem, subjective well-being, and agreeableness. The SITES also correlates with a wide variety of interpersonal outcomes, especially compassion for others and helping others. The SITES is recommended in situations when time or question quantity is constrained.

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.

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

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 endpoints. All stress tests were passed. ECHO-T2DM replicated the National Institutes of Health cost-effectiveness application with numerically similar results. In external validation of ECHO-T2DM, model predictions agreed well with observed clinical outcomes. For all sets of macrovascular risk equations, the results were close to the intercept and slope coefficients corresponding to a perfect match, resulting in high R 2 and failure to reject concordance using an F test. The results were similar for sub-groups of dependent and independent validation, with some degree of under-prediction of macrovascular events. ECHO-T2DM continues to match health outcomes in clinical trials in T2DM, with prediction accuracy similar to other leading models of T2DM.

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

Cross-cultural adaptation, reliability and validity of the Turkish version of the Lower Limb Functional Index.

PubMed

Duruturk, Neslihan; Tonga, Eda; Gabel, Charles Philip; Acar, Manolya; Tekindal, Agah

2015-07-26

This study aims to adapt culturally a Turkish version of the Lower Limb Functional Index (LLFI) and to determine its validity, reliability, internal consistency, measurement sensitivity and factor structure in lower limb problems. The LLFI was translated into Turkish and cross-culturally adapted with a double forward-backward protocol that determined face and content validity. Individuals (n = 120) with lower limb musculoskeletal disorders completed the LLFI and Short Form-36 questionnaires and the Timed Up and Go physical test. The psychometric properties were evaluated for the all participants from patient-reported outcome measures made at baseline and repeated at day 3 to determine criterion between scores (Pearson's r), internal consistency (Cronbachs α) and test-retest reliability (intraclass correlation coefficient - ICC 2.1 ). Error was determined using standard error of the measurement (SEM) and minimal detectable change at the 90% level (MDC 90 ), while factor structure was determined using exploratory factor analysis with maximum likelihood extraction and Varimax rotation. The psychometric characteristics showed strong criterion validity (r = 0.74-0.76), high internal consistency (α = 0.82) and high test-retest reability (ICC 2.1  = 0.97). The SEM of 3.2% gave an MDC 90  = 5.8%. The factor structure was uni-dimensional. Turkish version of LLFI was found to be valid and reliable for the measurement of lower limb function in a Turkish population. Implications for Rehabilitation Lower extremity musculoskeletal disorders are common and greatly impact activities among the affected individuals pertaining to daily living, work, leisure and quality of life. Patient-reported outcome (PRO) measures have advantages as they are practical, cost-effective and clinically convenient for use in patient-centered care. The Lower Limb Functional Index is a recently validated PRO measure shown to have strong clinimetric properties.

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 Validity of the Child and Adolescent Needs and Strengths Assessment

ERIC Educational Resources Information Center

Dilley, Joseph B.; Weiner, Dana A.; Lyons, John S.; Martinovich, Zoran

2007-01-01

The Child and Adolescent Needs and Strengths (CANS) is a functional assessment used in approximately 27 states to evaluate youth service outcomes. The CANS purports to measure both the youth's risk and protective factors, but its validity is largely un-researched. This study compares ratings of 304 delinquent youth on the CANS and ratings on a…

The Volunteer Satisfaction Index: A Validation Study in the Chinese Cultural Context

ERIC Educational Resources Information Center

Wong, Lok Ping; Chui, Wing Hong; Kwok, Yan Yuen

2011-01-01

Using a Hong Kong-sourced sample of 261 participants, this study set out to validate the Volunteer Satisfaction Index (VSI) in the Chinese cultural context and to evaluate its psychometric properties. The VSI was originally developed by Galindo-Kuhn and Guzley (2001) to measure the outcomes of volunteer experiences. In this study, exploratory…

Predicting Curriculum and Test Performance at Age 7 Years from Pupil Background, Baseline Skills and Phonological Awareness at Age 5

ERIC Educational Resources Information Center

Savage, R.; Carless, S.

2004-01-01

Background: Phonological awareness tests are known to be amongst the best predictors of literacy; however their predictive validity alongside current school screening practice (baseline assessment, pupil background data) and to National Curricular outcome measures is unknown. Aim: We explored the validity of phonological awareness and orthographic…

Assessing Parenting Behaviors in Euro-Canadian and East Asian Immigrant Mothers: Limitations to Observations of Responsiveness

ERIC Educational Resources Information Center

Chan, Kathy; Penner, Kailee; Mah, Janet W. T.; Johnston, Charlotte

2010-01-01

The use of parenting measures that are developed for use with Western families without testing their validity among families from non-Western cultural backgrounds may not be appropriate. Similar parenting behaviors may affect child outcomes in different ways across different cultures. This study examined the cross-cultural validity of an…

How Can We Improve Outcomes for Patients and Families Under Palliative Care? Implementing Clinical Audit for Quality Improvement in Resource Limited Settings

PubMed Central

Selman, Lucy; Harding, Richard

2010-01-01

Palliative care in India has made enormous advances in providing better care for patients and families living with progressive disease, and many clinical services are well placed to begin quality improvement initiatives, including clinical audit. Clinical audit is recognized globally to be essential in all healthcare, as a way of monitoring and improving quality of care. However, it is not common in developing country settings, including India. Clinical audit is a cyclical activity involving: identification of areas of care in need of improvement, through data collection and analysis utilizing an appropriate questionnaire; setting measurable quality of care targets in specific areas; designing and implementing service improvement strategies; and then re-evaluating quality of care to assess progress towards meeting the targets. Outcome measurement is an important component of clinical audit that has additional advantages; for example, establishing an evidence base for the effectiveness of services. In resource limited contexts, outcome measurement in clinical audit is particularly important as it enables service development to be evidence-based and ensures resources are allocated effectively. Key success factors in conducting clinical audit are identified (shared ownership, training, managerial support, inclusion of all members of staff and a positive approach). The choice of outcome measurement tool is discussed, including the need for a culturally appropriate and validated measure which is brief and simple enough to incorporate into clinical practice and reflects the holistic nature of palliative care. Support for clinical audit is needed at a national level, and development and validation of an outcome measurement tool in the Indian context is a crucial next step. PMID:20859465

Lower Anogenital Tract Disease Therapy Outcomes, COMET, and CROWN: Call for Research Submissions.

PubMed

Andrews, Jeffrey

2015-10-01

There is a problem of inconsistent and inappropriate outcome selection for research studies. We can improve the relevance of research results for women and for their physicians and clinicians by encouraging researchers to critically evaluate outcome measures, and use valid, appropriate, standardized measures. To this purpose, and to facilitate synthesis of the evidence, outcomes reported by clinical studies should be standardized for different disease conditions through the development of core outcome sets (COS). There is an international effort for reaching consensus on outcome measures and establishing COS that represent agreed-upon standardized collections of outcome measures that will be reported in all studies within a clinical area. Across clinical specialties, the Core Outcome Measures in Effectiveness Trials (COMET) initiative launched in 2010. In 2014, the editors of women's health journals answered the challenge of COMET and formed the Core Outcomes in Women's Health initiative. The Journal of Lower Genital Tract Diseases is a participating member of the Core Outcomes in Women's Health consortium. There is broad inconsistency in outcome measures and reporting in the field of lower anogenital tract diseases. No core outcome sets currently exist. Suggested target conditions in anogenital disease are vulvar dermatoses, cervical intraepithelial neoplasia, and vulvodynia. Investigators are encouraged to conduct secondary systematic research to determine previously reported primary outcome measures and suggest domains for COS. Core Outcomes in Women's health initiative and COMET encourage the formation of consensus panels of stakeholders (researchers, health care providers, patients, and others) to recommend outcome domains and COS and then publish their report.

AFSS: athlete's foot severity score. A proposal and validation.

PubMed

Cohen, A D; Wolak, A; Alkan, M; Shalev, R; Vardy, D A

2002-04-01

We developed a simple scoring system to evaluate the severity of tinea pedis (Athlete's foot severity score, AFSS). The AFSS consists of a clinical evaluation, using a three-point scale, of erythema and scaling in the plantar and interdigital spaces of the feet, and counts of interdigital spaces involved. Each foot is evaluated separately. The validity of the AFSS was assessed in 224 soldiers of the Israel Defense Force using mycological cultures as the main outcome measure and subjective assessment of pruritus as the secondary outcome measure. Mycological examinations were performed in 106 patients who had clinical evidence of tinea pedis. AFSS was significantly associated with culture results (P<0.0001), as well as with the presence of pruritus (P=0.002), and pruritus scores (P=0.025). We conclude the AFSS is valid for the clinical evaluation of tinea pedis severity in military settings. The application of AFSS to civilian morbidity should be subjected to further evaluation. AFSS: Schweregrad-Beurteilung des Athletenfusses. Ein Vorschlag

Cultural differences in functional status measurement: analyses of person fit according to the Rasch model.

PubMed

Custers, J W; Hoijtink, H; van der Net, J; Helders, P J

2000-01-01

For many reasons it is preferable to use established health related outcome instruments. The validity of an instrument, however, can be affected when used in another culture or language other than what it was originally developed. In this paper, the outcome on functional status measurement using a preliminary version of the Dutch translated 'Pediatric Evaluation of Disability Inventory' (PEDI) was studied involving a sample of 20 non-disabled Dutch children and American peers, to see if a cross-cultural validation procedure is needed before using the instrument in the Netherlands. The Rasch model was used to analyse the Dutch data. Score profiles were not found to be compatible with the score profiles of American children. In particular, ten items were scored differently with strong indications that these were based on inter-cultural differences. Based on our study, it is argued that cross-cultural validation of the PEDI is necessary before using the instrument in the Netherlands.

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

ICRS Recommendation Document

PubMed Central

Roos, Ewa M.; Engelhart, Luella; Ranstam, Jonas; Anderson, Allen F.; Irrgang, Jay J.; Marx, Robert G.; Tegner, Yelverton; Davis, Aileen M.

2011-01-01

Objective: The purpose of this article is to describe and recommend patient-reported outcome instruments for use in patients with articular cartilage lesions undergoing cartilage repair interventions. Methods: Nonsystematic literature search identifying measures addressing pain and function evaluated for validity and psychometric properties in patients with articular cartilage lesions. Results: The knee-specific instruments, titled the International Knee Documentation Committee Subjective Knee Form and the Knee injury and Osteoarthritis and Outcome Score, both fulfill the basic requirements for reliability, validity, and responsiveness in cartilage repair patients. A major difference between them is that the former results in a single score and the latter results in 5 subscores. A single score is preferred for simplicity’s sake, whereas subscores allow for evaluation of separate constructs at all levels according to the International Classification of Functioning. Conclusions: Because there is no obvious superiority of either instrument at this time, both outcome measures are recommended for use in cartilage repair. Rescaling of the Lysholm Scoring Scale has been suggested, and confirmatory longitudinal studies are needed prior to recommending this scale for use in cartilage repair. Inclusion of a generic measure is feasible in cartilage repair studies and allows analysis of health-related quality of life and health economic outcomes. The Marx or Tegner Activity Rating Scales are feasible and have been evaluated in patients with knee injuries. However, activity measures require age and sex adjustment, and data are lacking in people with cartilage repair. PMID:26069575

Confirmatory Factor Analysis of a Family Quality of Life Scale for Taiwanese Families of Children With Intellectual Disability/Developmental Delay.

PubMed

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

2017-04-01

The Beach Center Family Quality of Life Scale is an internationally validated instrument for measuring family outcomes. To revise the scale for better alignment with the Family Quality of Life theory, the authors excluded non-outcome items in this revision. In this study, we examined reliability and validity of the revised scale (i.e., the FQoL Scale-21) and its scores for Taiwanese families of children and youth with intellectual disability and developmental delay (age 0-18). Results from 400 Taiwanese respondents suggested that the FQoL Scale-21 has the potential to be used as an indicator of positive outcomes in intervention evaluation, policy making, and service delivery.

MRI-based modeling for radiocarpal joint mechanics: validation criteria and results for four specimen-specific models.

PubMed

Fischer, Kenneth J; Johnson, Joshua E; Waller, Alexander J; McIff, Terence E; Toby, E Bruce; Bilgen, Mehmet

2011-10-01

The objective of this study was to validate the MRI-based joint contact modeling methodology in the radiocarpal joints by comparison of model results with invasive specimen-specific radiocarpal contact measurements from four cadaver experiments. We used a single validation criterion for multiple outcome measures to characterize the utility and overall validity of the modeling approach. For each experiment, a Pressurex film and a Tekscan sensor were sequentially placed into the radiocarpal joints during simulated grasp. Computer models were constructed based on MRI visualization of the cadaver specimens without load. Images were also acquired during the loaded configuration used with the direct experimental measurements. Geometric surface models of the radius, scaphoid and lunate (including cartilage) were constructed from the images acquired without the load. The carpal bone motions from the unloaded state to the loaded state were determined using a series of 3D image registrations. Cartilage thickness was assumed uniform at 1.0 mm with an effective compressive modulus of 4 MPa. Validation was based on experimental versus model contact area, contact force, average contact pressure and peak contact pressure for the radioscaphoid and radiolunate articulations. Contact area was also measured directly from images acquired under load and compared to the experimental and model data. Qualitatively, there was good correspondence between the MRI-based model data and experimental data, with consistent relative size, shape and location of radioscaphoid and radiolunate contact regions. Quantitative data from the model generally compared well with the experimental data for all specimens. Contact area from the MRI-based model was very similar to the contact area measured directly from the images. For all outcome measures except average and peak pressures, at least two specimen models met the validation criteria with respect to experimental measurements for both articulations. Only the model for one specimen met the validation criteria for average and peak pressure of both articulations; however the experimental measures for peak pressure also exhibited high variability. MRI-based modeling can reliably be used for evaluating the contact area and contact force with similar confidence as in currently available experimental techniques. Average contact pressure, and peak contact pressure were more variable from all measurement techniques, and these measures from MRI-based modeling should be used with some caution.

Outcomes of Moral Case Deliberation - the development of an evaluation instrument for clinical ethics support (the Euro-MCD)

PubMed Central

2014-01-01

Background Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. Methods A multi-item instrument for assessing outcomes of Moral Case Deliberation (MCD) was constructed through an iterative process, founded on a literature review and modified through a multistep review by ethicists and health care providers. The instrument measures perceived importance of outcomes before and after MCD, as well as experienced outcomes during MCD and in daily work. A purposeful sample of 86 European participants contributed to a Delphi panel and content validity testing. The Delphi panel (n = 13), consisting of ethicists and ethics researchers, participated in three Delphi-rounds. Health care providers (n = 73) participated in the content validity testing through ‘think-aloud’ interviews and a method using Content Validity Index. Results The development process resulted in the European Moral Case Deliberation Outcomes Instrument (Euro-MCD), which consists of two sections, one to be completed before a participant’s first MCD and the other after completing multiple MCDs. The instrument contains a few open-ended questions and 26 specific items with a corresponding rating/response scale representing various MCD outcomes. The items were categorised into the following six domains: Enhanced emotional support, Enhanced collaboration, Improved moral reflexivity, Improved moral attitude, Improvement on organizational level and Concrete results. Conclusions A tentative instrument has been developed that seems to cover main outcomes of Moral Case Deliberation. The next step will be to test the Euro-MCD in a field study. PMID:24712735

Outcomes of moral case deliberation--the development of an evaluation instrument for clinical ethics support (the Euro-MCD).

PubMed

Svantesson, Mia; Karlsson, Jan; Boitte, Pierre; Schildman, Jan; Dauwerse, Linda; Widdershoven, Guy; Pedersen, Reidar; Huisman, Martijn; Molewijk, Bert

2014-04-08

Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers' experiences and perceived importance of outcomes of Moral Case Deliberation. A multi-item instrument for assessing outcomes of Moral Case Deliberation (MCD) was constructed through an iterative process, founded on a literature review and modified through a multistep review by ethicists and health care providers. The instrument measures perceived importance of outcomes before and after MCD, as well as experienced outcomes during MCD and in daily work. A purposeful sample of 86 European participants contributed to a Delphi panel and content validity testing. The Delphi panel (n = 13), consisting of ethicists and ethics researchers, participated in three Delphi-rounds. Health care providers (n = 73) participated in the content validity testing through 'think-aloud' interviews and a method using Content Validity Index. The development process resulted in the European Moral Case Deliberation Outcomes Instrument (Euro-MCD), which consists of two sections, one to be completed before a participant's first MCD and the other after completing multiple MCDs. The instrument contains a few open-ended questions and 26 specific items with a corresponding rating/response scale representing various MCD outcomes. The items were categorised into the following six domains: Enhanced emotional support, Enhanced collaboration, Improved moral reflexivity, Improved moral attitude, Improvement on organizational level and Concrete results. A tentative instrument has been developed that seems to cover main outcomes of Moral Case Deliberation. The next step will be to test the Euro-MCD in a field study.

Validating a Measure of Patient Self-efficacy in Disease Self-management Using a Population-based IBD Cohort: The IBD Self-efficacy Scale.

PubMed

Graff, Lesley A; Sexton, Kathryn A; Walker, John R; Clara, Ian; Targownik, Laura E; Bernstein, Charles N

2016-09-01

Self-efficacy describes a person's confidence in their ability to manage demands, and is predictive of health outcomes in chronic disease such as hospitalization and health status. However, meaningful measurement must be domain (e.g., disease) specific. This study aims to provide validation of the Inflammatory Bowel Disease Self-Efficacy scale (IBD-SE), using a population-based IBD sample. Manitoba IBD Cohort Study participants completed a survey and clinical interview at a mean of 12 years postdiagnosis (n = 121 Crohn's disease; n = 108 ulcerative colitis), which included validated measures of psychological functioning, disability, disease-specific quality of life, perceived health, and current and recent disease activity, in addition to the IBD-SE. The IBD-SE had high internal consistency (Cronbach's α = 0.97), and a 4-factor structure was confirmed. Construct validity was demonstrated as follows: the IBD-SE was strongly correlated with mastery (r = 0.53), highly correlated in the expected directions with measures of psychological well-being (r = 0.70), stress (r = -0.78), distress (r = -0.71), disability (r = -0.48), disease-specific quality of life (r = 0.68), and overall perceived health (r = 0.52) (all P < 0.001). Those with currently inactive disease had higher self-efficacy than the active disease group (Crohn's disease: mean = 232 versus 195, P < 0.001; ulcerative colitis: mean = 233 versus 202, P < 0.01), with similar findings for recent symptomatic disease activity. The IBD-SE is a reliable, valid, and sensitive measure as demonstrated in this population-based sample, supporting its utility in IBD. Because self-efficacy is a modifiable psychological characteristic that can contribute to positive health outcomes, the IBD-SE may prove to be a valuable instrument for research and in targeted intervention with IBD patients.

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.

OA Go Away: Development and Preliminary Validation of a Self-Management Tool to Promote Adherence to Exercise and Physical Activity for People with Osteoarthritis of the Hip or Knee

PubMed Central

Toupin April, Karine; Backman, Catherine; Tugwell, Peter

2016-01-01

Purpose: To determine the face and content validity, construct validity, and test–retest reliability of the OA Go Away (OGA), a personalized self-management tool to promote adherence to exercise and physical activity for people with osteoarthritis (OA) of the hip or knee. Methods: The face and content validity of OGA version 1.0 were determined via interviews with 10 people with OA of the hip or knee and 10 clinicians. A revised OGA version 2.0 was then tested for construct validity and test–retest reliability with a new sample of 50 people with OA of the hip or knee by comparing key items in the OGA journal with validated outcome measures assessing similar health outcomes and comparing scores on key items of the journal 4–7 days apart. Face and content validity were then confirmed with a new sample of 5 people with OA of the hip or knee and 5 clinicians. Results: Eighteen of 30 items from the OGA version 1.0 and 41 of 43 items from the OGA version 2.0 journal, goals and action plan, and exercise log had adequate content validity. Construct validity and test–retest reliability were acceptable for the main items of the OGA version 2.0 journal. The OGA underwent modifications based on results and participant feedback. Conclusion: The OGA is a novel self-management intervention and assessment tool for people with OA of the hip or knee that shows adequate preliminary measurement properties. PMID:27909359

Developing and validating a model to predict the success of an IHCS implementation: the Readiness for Implementation Model.

PubMed

Wen, Kuang-Yi; Gustafson, David H; Hawkins, Robert P; Brennan, Patricia F; Dinauer, Susan; Johnson, Pauley R; Siegler, Tracy

2010-01-01

To develop and validate the Readiness for Implementation Model (RIM). This model predicts a healthcare organization's potential for success in implementing an interactive health communication system (IHCS). The model consists of seven weighted factors, with each factor containing five to seven elements. Two decision-analytic approaches, self-explicated and conjoint analysis, were used to measure the weights of the RIM with a sample of 410 experts. The RIM model with weights was then validated in a prospective study of 25 IHCS implementation cases. Orthogonal main effects design was used to develop 700 conjoint-analysis profiles, which varied on seven factors. Each of the 410 experts rated the importance and desirability of the factors and their levels, as well as a set of 10 different profiles. For the prospective 25-case validation, three time-repeated measures of the RIM scores were collected for comparison with the implementation outcomes. Two of the seven factors, 'organizational motivation' and 'meeting user needs,' were found to be most important in predicting implementation readiness. No statistically significant difference was found in the predictive validity of the two approaches (self-explicated and conjoint analysis). The RIM was a better predictor for the 1-year implementation outcome than the half-year outcome. The expert sample, the order of the survey tasks, the additive model, and basing the RIM cut-off score on experience are possible limitations of the study. The RIM needs to be empirically evaluated in institutions adopting IHCS and sustaining the system in the long term.

Refining and validating a conceptual model of Clinical Nurse Leader integrated care delivery.

PubMed

Bender, Miriam; Williams, Marjory; Su, Wei; Hites, Lisle

2017-02-01

To empirically validate a conceptual model of Clinical Nurse Leader integrated care delivery. There is limited evidence of frontline care delivery models that consistently achieve quality patient outcomes. Clinical Nurse Leader integrated care delivery is a promising nursing model with a growing record of success. However, theoretical clarity is necessary to generate causal evidence of effectiveness. Sequential mixed methods. A preliminary Clinical Nurse Leader practice model was refined and survey items developed to correspond with model domains, using focus groups and a Delphi process with a multi-professional expert panel. The survey was administered in 2015 to clinicians and administrators involved in Clinical Nurse Leader initiatives. Confirmatory factor analysis and structural equation modelling were used to validate the measurement and model structure. Final sample n = 518. The model incorporates 13 components organized into five conceptual domains: 'Readiness for Clinical Nurse Leader integrated care delivery'; 'Structuring Clinical Nurse Leader integrated care delivery'; 'Clinical Nurse Leader Practice: Continuous Clinical Leadership'; 'Outcomes of Clinical Nurse Leader integrated care delivery'; and 'Value'. Sample data had good fit with specified model and two-level measurement structure. All hypothesized pathways were significant, with strong coefficients suggesting good fit between theorized and observed path relationships. The validated model articulates an explanatory pathway of Clinical Nurse Leader integrated care delivery, including Clinical Nurse Leader practices that result in improved care dynamics and patient outcomes. The validated model provides a basis for testing in practice to generate evidence that can be deployed across the healthcare spectrum. © 2016 John Wiley & Sons Ltd.

The Motivation and Pleasure Scale-Self-Report (MAP-SR): reliability and validity of a self-report measure of negative symptoms.

PubMed

Llerena, Katiah; Park, Stephanie G; McCarthy, Julie M; Couture, Shannon M; Bennett, Melanie E; Blanchard, Jack J

2013-07-01

The Clinical Assessment Interview for Negative Symptoms (CAINS) is an empirically developed interview measure of negative symptoms. Building on prior work, this study examined the reliability and validity of a self-report measure based on the CAINS-the Motivation and Pleasure Scale-Self-Report (MAP-SR)-that assesses the motivation and pleasure domain of negative symptoms. Thirty-seven participants with schizophrenia or schizoaffective disorder completed the 18-item MAP-SR, the CAINS, and other measures of functional outcome. Item analyses revealed three items that performed poorly. The revised 15-item MAP-SR demonstrated good internal consistency and convergent validity with the clinician-rated Motivation and Pleasure scale of the CAINS, as well as good discriminant validity, with little association with psychotic symptoms or depression/anxiety. MAP-SR scores were related to social anhedonia, social closeness, and clinician-rated social functioning. The MAP-SR is a promising self-report measure of severity of negative symptoms. Copyright © 2013 Elsevier Inc. 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 clinician report measures appeared less well developed. It would be of value if new measures defined the construct of interest and, that the construct, be part of theoretical model. By ensuring measures are both theoretically and empirically valid then improvements in subjective health outcome measures should be possible. PMID:17343739

Quantifying Media Literacy: Development, Reliability, and Validity of a New Measure

ERIC Educational Resources Information Center

Arke, Edward T.; Primack, Brian A.

2009-01-01

Media literacy has the potential to alter outcomes in various fields, including education, communication, and public health. However, measurement of media literacy remains a critical challenge in advancing this field of inquiry. In this manuscript, we describe the development and testing of a pilot measure of media literacy. Items were formed…

The development of the Nurse Workplace Scale: self-advocating behaviors and beliefs in the professional workplace.

PubMed

DeMarco, Rosanna; Roberts, Susan Jo; Norris, Anne; McCurry, Mary K

2008-01-01

This project developed and tested the Nurse Workplace Scale (NWS) using data from a random sample of registered nurses in Massachusetts (n = 904). The NWS was adapted from an earlier checklist that measured group behaviors and beliefs in the workplace of a variety of nurses. Nurses have been thought to display non-self-advocating behaviors and beliefs that have contributed to disempowering their contribution in health care systems, but no tool has been available to assist nurse managers or clinical nurse leaders to test outcomes that measure progress toward changing these behaviors. A cross-validation procedure was used to establish the reliability and validity of the NWS to measure behaviors in nurses that are counterproductive in the workplace. Two components, "internalized sexism" and "minimization of self" behaviors, were established. Scores on the scales were shown to vary with the age and practice settings of the nurses. The NWS can be used in professional development settings and nurse workplace intervention studies to measure outcomes congruent with nurse empowerment.

Validation of the Yale Food Addiction Scale among a weight-loss surgery population.

PubMed

Clark, Shannon M; Saules, Karen K

2013-04-01

The Yale Food Addiction Scale (YFAS), recently validated in college students and binge eaters, is a means to assess "food addiction" in accordance with DSM-IV criteria for substance dependence. Using online survey methodology, we aimed to validate the use of the YFAS among weight loss surgery (WLS) patients. Participants completed measures about pre-WLS food addiction (YFAS), emotional and binge eating, behavioral activation and inhibition, and pre- and post-WLS substance use. A sample of 67 WLS patients (59.7% Roux-en-Y) was recruited; participants were 62.7% female, 86.6% Caucasian, had a mean age of 42.7; and 53.7% met the criteria for pre-WLS food addiction. Convergent validity was found between the YFAS and measures of emotional eating (r=.368, p<.05) and binge eating (r=.469, p<.05). Discriminant validity was supported in that problematic substance use, behavioral activation, and behavioral inhibition were not associated with YFAS scores. Incremental validity was supported in that the YFAS explained a significant proportion of additional variance in binge eating scores, beyond that predicted by emotional eating (EES) and disordered eating behavior (EAT-26). Those meeting the food addiction criteria had poorer percent total weight loss outcomes (32% vs. 27%). There was a nonsignificant trend towards those with higher food addiction being more likely to admit to post-WLS problematic substance use (i.e., potential "addiction transfer"; 53% vs. 39%). Results support the use of the YFAS as a valid measure of food addiction among WLS patients. Future research with a larger sample may shed light on potentially important relationships between pre-surgical food addiction and both weight and substance use outcomes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation.

PubMed

Chen, Poyu; Lin, Keh-Chung; Liing, Rong-Jiuan; Wu, Ching-Yi; Chen, Chia-Ling; Chang, Ku-Chou

2016-06-01

To examine the criterion validity, responsiveness, and minimal clinically important difference (MCID) of the EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L) and visual analog scale (EQ-VAS) in people receiving rehabilitation after stroke. The EQ-5D-5L, along with four criterion measures-the Medical Research Council scales for muscle strength, the Fugl-Meyer assessment, the functional independence measure, and the Stroke Impact Scale-was administered to 65 patients with stroke before and after 3- to 4-week therapy. Criterion validity was estimated using the Spearman correlation coefficient. Responsiveness was analyzed by the effect size, standardized response mean (SRM), and criterion responsiveness. The MCID was determined by anchor-based and distribution-based approaches. The percentage of patients exceeding the MCID was also reported. Concurrent validity of the EQ-Index was better compared with the EQ-VAS. The EQ-Index has better power for predicting the rehabilitation outcome in the activities of daily living than other motor-related outcome measures. The EQ-Index was moderately responsive to change (SRM = 0.63), whereas the EQ-VAS was only mildly responsive to change. The MCID estimation of the EQ-Index (the percentage of patients exceeding the MCID) was 0.10 (33.8 %) and 0.10 (33.8 %) based on the anchor-based and distribution-based approaches, respectively, and the estimation of EQ-VAS was 8.61 (41.5 %) and 10.82 (32.3 %). The EQ-Index has shown reasonable concurrent validity, limited predictive validity, and acceptable responsiveness for detecting the health-related quality of life in stroke patients undergoing rehabilitation, but not for EQ-VAS. Future research considering different recovery stages after stroke is warranted to validate these estimations.

Translation and cross-cultural adaptation of the lower extremity functional scale into a Brazilian Portuguese version and validation on patients with knee injuries.

PubMed

Metsavaht, Leonardo; Leporace, Gustavo; Riberto, Marcelo; Sposito, Maria Matilde M; Del Castillo, Letícia N C; Oliveira, Liszt P; Batista, Luiz Alberto

2012-11-01

Clinical measurement. To translate and culturally adapt the Lower Extremity Functional Scale (LEFS) into a Brazilian Portuguese version, and to test the construct and content validity and reliability of this version in patients with knee injuries. There is no Brazilian Portuguese version of an instrument to assess the function of the lower extremity after orthopaedic injury. The translation of the original English version of the LEFS into a Brazilian Portuguese version was accomplished using standard guidelines and tested in 31 patients with knee injuries. Subsequently, 87 patients with a variety of knee disorders completed the Brazilian Portuguese LEFS, the Medical Outcomes Study 36-Item Short-Form Health Survey, the Western Ontario and McMaster Universities Osteoarthritis Index, and the International Knee Documentation Committee Subjective Knee Evaluation Form and a visual analog scale for pain. All patients were retested within 2 days to determine reliability of these measures. Validation was assessed by determining the level of association between the Brazilian Portuguese LEFS and the other outcome measures. Reliability was documented by calculating internal consistency, test-retest reliability, and standard error of measurement. The Brazilian Portuguese LEFS had a high level of association with the physical component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.82), the Western Ontario and McMaster Universities Osteoarthritis Index (r = 0.87), the International Knee Documentation Committee Subjective Knee Evaluation Form (r = 0.82), and the pain visual analog scale (r = -0.60) (all, P<.05). The Brazilian Portuguese LEFS had a low level of association with the mental component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.38, P<.05). The internal consistency (Cronbach α = .952) and test-retest reliability (intraclass correlation coefficient = 0.957) of the Brazilian Portuguese version of the LEFS were high. The standard error of measurement was low (3.6) and the agreement was considered high, demonstrated by the small differences between test and retest and the narrow limit of agreement, as observed in Bland-Altman and survival-agreement plots. The translation of the LEFS into a Brazilian Portuguese version was successful in preserving the semantic and measurement properties of the original version and was shown to be valid and reliable in a Brazilian population with knee injuries.

Subtyping attention-deficit/hyperactivity disorder using temperament dimensions: toward biologically based nosologic criteria

PubMed Central

Karalunas, Sarah L.; Fair, Damien; Musser, Erica D.; Aykes, Kamari; Iyer, Swathi P.; Nigg, Joel T.

2014-01-01

Importance Psychiatric nosology is limited by behavioral and biological heterogeneity within existing disorder categories. The imprecise nature of current nosological distinctions limits both mechanistic understanding and clinical prediction. Here, we demonstrate an approach consistent with the NIMH Research Domain Criteria (RDoC) initiative to identifying superior, neurobiologically-valid subgroups with better predictive capacity than existing psychiatric categories for childhood Attention-Deficit Hyperactivity Disorder (ADHD). Objective Refine subtyping of childhood ADHD by using biologically-based behavioral dimensions (i.e. temperament), novel classification algorithms, and multiple external validators. In doing so, we demonstrate how refined nosology is capable of improving on current predictive capacity of long-term outcomes relative to current DSM-based nosology. Design, Setting, Participants 437 clinically well-characterized, community-recruited children with and without ADHD participated in an on-going longitudinal study. Baseline data were used to classify children into subgroups based on temperament dimensions and to examine external validators including physiological and MRI measures. One-year longitudinal follow-up data are reported for a subgroup of the ADHD sample to address stability and clinical prediction. Main Outcome Measures Parent/guardian ratings of children on a measure of temperament were used as input features in novel community detection analyses to identify subgroups within the sample. Groups were validated using three widely-accepted external validators: peripheral physiology (cardiac measures of respiratory sinus arrhythmia and pre-ejection period), central nervous system functioning (via resting-state functional connectivity MRI), and clinical outcomes (at one-year longitudinal follow-up). Results The community detection algorithm suggested three novel types of ADHD, labeled as “Mild” (normative emotion regulation); “Surgent” (extreme levels of positive approach-motivation); and “Irritable” (extreme levels of negative emotionality, anger, and poor soothability). Types were independent of existing clinical demarcations, including DSM-5 presentations or symptom severity. These types showed stability over time and were distinguished by unique patterns of cardiac physiological response, resting-state functional brain connectivity, and clinical outcome one year later. Conclusions and Relevance Results suggest that a biologically-informed temperament-based typology, developed with a discovery-based community detection algorithm, provided a superior description of heterogeneity in the ADHD population than any current clinical nosology. This demonstration sets the stage for more aggressive attempts at a tractable, biologically-based nosology. PMID:25006969

Validity and cross-cultural adaptation of the persian version of the oxford elbow score.

PubMed

Ebrahimzadeh, Mohammad H; Kachooei, Amir Reza; Vahedi, Ehsan; Moradi, Ali; Mashayekhi, Zeinab; Hallaj-Moghaddam, Mohammad; Azami, Mehran; Birjandinejad, Ali

2014-01-01

Oxford Elbow Score (OES) is a patient-reported questionnaire used to assess outcomes after elbow surgery. The aim of this study was to validate and adapt the OES into Persian language. After forward-backward translation of the OES into Persian, a total number of 92 patients after elbow surgeries completed the Persian OES along with the Persian DASH and SF-36. To assess test-retest reliability, 31 randomly selected patients (34%) completed the Persian OES again after three days while abstaining from all forms of therapeutic regimens. Reliability of the Persian OES was assessed by measuring intraclass correlation coefficient (ICC) for test-retest reliability and Cronbach's alpha for internal consistency. Spearman's correlation coefficient was used to test the construct validity. Cronbach's alpha coefficient was 0.92 showing excellent reliability. Cronbach's alpha for function, pain, and social-psychological subscales was 0.95, 0.86, and 0.85, respectively. Intraclass correlation coefficient (ICC) was 0.85 for the overall questionnaire and 0.90, 0.76, and 0.75 for function, pain, and social-psychological subscales, respectively. Construct validity was confirmed as the Spearman correlation between OES and DASH was 0.80. Persian OES is a valid and reliable patient-reported outcome measure to assess postsurgical elbow status in Persian speaking population.

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 Incremental Validity of the MMPI-2: When Does Therapist Access Not Enhance Treatment Outcome?

ERIC Educational Resources Information Center

Lima, Elizabeth N.; Stanley, Sheila; Kaboski, Beth; Reitzel, Lorraine R.; Richey, Anthony; Castro, Yezzennya; Williams, Foluso M.; Tannenbaum, Kendra R.; Stellrecht, Nadia E.; Jakobsons, Lara J.; Wingate, LaRicka R.; Joiner, Thomas E.

2005-01-01

The present study examined whether therapist access to the Minnesota Multiphasic Personality Inventory (MMPI-2) predicted favorable treatment outcome, above and beyond other assessment measures. A manipulated assessment design was used, in which patients were randomly assigned either to a group in which therapists had access to their MMPI-2 data…

The Triangulation Algorithmic: A Transformative Function for Designing and Deploying Effective Educational Technology Assessment Instruments

ERIC Educational Resources Information Center

Osler, James Edward

2013-01-01

This paper discusses the implementation of the Tri-Squared Test as an advanced statistical measure used to verify and validate the research outcomes of Educational Technology software. A mathematical and epistemological rational is provided for the transformative process of qualitative data into quantitative outcomes through the Tri-Squared Test…

Teacher Interpersonal Behaviour and Secondary Students' Cognitive, Affective and Moral Outcomes in Hong Kong

ERIC Educational Resources Information Center

Sivan, Atara; Chan, Dennis W. K.

2013-01-01

This study validated the Chinese version of the Questionnaire on Teacher Interaction (QTI) in the Hong Kong context as well as examined the relationship between students' perceptions of interpersonal teacher behaviour and their cognitive, affective and moral learning outcomes. Data were collected with the QTI and four other measures of student…

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Excellent Patient Care Processes in Poor Hospitals? Why Hospital-Level and Patient-Level Care Quality-Outcome Relationships Can Differ.

PubMed

Finney, John W; Humphreys, Keith; Kivlahan, Daniel R; Harris, Alex H S

2016-04-01

Studies finding weak or nonexistent relationships between hospital performance on providing recommended care and hospital-level clinical outcomes raise questions about the value and validity of process of care performance measures. Such findings may cause clinicians to question the effectiveness of the care process presumably captured by the performance measure. However, one cannot infer from hospital-level results whether patients who received the specified care had comparable, worse or superior outcomes relative to patients not receiving that care. To make such an inference has been labeled the "ecological fallacy," an error that is well known among epidemiologists and sociologists, but less so among health care researchers and policy makers. We discuss such inappropriate inferences in the health care performance measurement field and illustrate how and why process measure-outcome relationships can differ at the patient and hospital levels. We also offer recommendations for appropriate multilevel analyses to evaluate process measure-outcome relationships at the patient and hospital levels and for a more effective role for performance measure bodies and research funding organizations in encouraging such multilevel analyses.

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.

Preliminary data on validity of the Drug Addiction Treatment Efficacy Questionnaire.

PubMed

Kastelic, Andrej; Mlakar, Janez; Pregelj, Peter

2013-09-01

This study describes the validation process for the Slovenian version of the Drug Addiction Treatment Efficacy Questionnaire (DATEQ). DATEQ was constructed from the questionnaires used at the Centre for the Treatment of Drug Addiction, Ljubljana University Psychiatric Hospital, and within the network of Centres for the Prevention and Treatment of Drug Addiction in Slovenia during the past 14 years. The Slovenian version of the DATEQ was translated to English using the 'forward-backward' procedure by its authors and their co-workers. The validation process included 100 male and female patients with established addiction to illicit drugs who had been prescribed opioid substitution therapy. The DATEQ questionnaire was used in the study, together with clinical evaluation to measure psychological state and to evaluate the efficacy of treatment in the last year. To determinate the validity of DATEQ the correlation with the clinical assessments of the outcome was calculated using one-way ANOVA. The F value was 44.4, p<0.001 (sum of squares: between groups 210.4, df=2, within groups 229.7, df=97, total 440.1, df=99). At the cut-off 4 the sensitivity is 81% and specificity 83%. The validation process for the Slovenian DATEQ version shows metric properties similar to those found in international studies of similar questionnaires, suggesting that it measures the same constructs, in the same way and as similar questionnaires. However, the relatively low sensitivity and specificity suggests caution when using DATEQ as the only measure of outcome.

Development of a tool to measure person-centered maternity care in developing settings: validation in a rural and urban Kenyan population.

PubMed

Afulani, Patience A; Diamond-Smith, Nadia; Golub, Ginger; Sudhinaraset, May

2017-09-22

Person-centered reproductive health care is recognized as critical to improving reproductive health outcomes. Yet, little research exists on how to operationalize it. We extend the literature in this area by developing and validating a tool to measure person-centered maternity care. We describe the process of developing the tool and present the results of psychometric analyses to assess its validity and reliability in a rural and urban setting in Kenya. We followed standard procedures for scale development. First, we reviewed the literature to define our construct and identify domains, and developed items to measure each domain. Next, we conducted expert reviews to assess content validity; and cognitive interviews with potential respondents to assess clarity, appropriateness, and relevance of the questions. The questions were then refined and administered in surveys; and survey results used to assess construct and criterion validity and reliability. The exploratory factor analysis yielded one dominant factor in both the rural and urban settings. Three factors with eigenvalues greater than one were identified for the rural sample and four factors identified for the urban sample. Thirty of the 38 items administered in the survey were retained based on the factors loadings and correlation between the items. Twenty-five items load very well onto a single factor in both the rural and urban sample, with five items loading well in either the rural or urban sample, but not in both samples. These 30 items also load on three sub-scales that we created to measure dignified and respectful care, communication and autonomy, and supportive care. The Chronbach alpha for the main scale is greater than 0.8 in both samples, and that for the sub-scales are between 0.6 and 0.8. The main scale and sub-scales are correlated with global measures of satisfaction with maternity services, suggesting criterion validity. We present a 30-item scale with three sub-scales to measure person-centered maternity care. This scale has high validity and reliability in a rural and urban setting in Kenya. Validation in additional settings is however needed. This scale will facilitate measurement to improve person-centered maternity care, and subsequently improve reproductive outcomes.

Validity, Reliability, and Feasibility of Durometer Measurements of Scleroderma Skin Disease in a Multicenter Treatment Trial

PubMed Central

MERKEL, PETER A.; SILLIMAN, NANCY P.; DENTON, CHRISTOPHER P.; FURST, DANIEL E.; KHANNA, DINESH; EMERY, PAUL; HSU, VIVIEN M.; STREISAND, JAMES B.; POLISSON, RICHARD P.; ÅKESSON, ANITA; COPPOCK, JOHN; van den HOOGEN, FRANK; HERRICK, ARIANE; MAYES, MAUREEN D.; VEALE, DOUGLAS; SEIBOLD, JAMES R.; BLACK, CAROL M.; KORN, JOSEPH H.

2013-01-01

Objective To determine the validity, reliability, and feasibility of durometer measurements of skin hardness as an outcome measure in clinical trials of scleroderma. Methods Skin hardness was measured during a multicenter treatment trial for scleroderma using handheld digital durometers with a continuous scale. Skin thickness was measured by modified Rodnan skin score (MRSS). Other outcome data collected included the Scleroderma Health Assessment Questionnaire. In a reliability exercise in advance of the trial, 9 investigators examined the same 5 scleroderma patients by MRSS and durometry. Results Forty-three patients with early diffuse cutaneous systemic sclerosis were studied at 11 international centers (mean age 49 years [range 24–76], median disease duration 6.4 months [range 0.3–23], and median baseline MRSS 22 [range 11–38]). The reliability of durometer measurements was excellent, with high interobserver intraclass correlation coefficients (ICCs) (0.82–0.92), and each result was greater than the corresponding skin site ICCs for MRSS (0.54–0.85). Baseline durometer scores correlated well with MRSS (r = 0.69, P < 0.0001), patient self-assessments of skin disease (r = 0.69, P < 0.0001), and Health Assessment Questionnaire (HAQ) disability scores (r = 0.34, P = 0.03). Change in durometer scores correlated with change in MRSS (r = 0.70, P < 0.0001), change in patient self-assessments of skin disease (r = 0.52, P = 0.003), and change in HAQ disability scores (r = 0.42, P = 0.017). The effect size was greater for durometry than for MRSS or patient self-assessment. Conclusion Durometer measurements of skin hardness in patients with scleroderma are reliable, simple, accurate, demonstrate good sensitivity to change compared with traditional skin scoring, and reflect patients' self-assessments of their disease. Durometer measurements are valid, objective, and scalable, and should be considered for use as a complementary outcome measure to skin scoring in clinical trials of scleroderma. PMID:18438905

Development and psychometric validation of a cystic fibrosis knowledge scale.

PubMed

Balfour, Louise; Armstrong, Michael; Holly, Crystal; Gaudet, Ena; Aaron, Shawn; Tasca, George; Cameron, William; Pakhale, Smita

2014-11-01

Well-developed and validated measures of cystic fibrosis (CF) knowledge are scarce. The purpose of the present study is to develop and validate a CF knowledge scale that is brief, easy to use, self-administered and demonstrates clinical utility. A comprehensive literature search generated a pool of scale items; an expert panel of CF team members reviewed and provided recommendations for item inclusion. A focus group of CF patients and family members (n = 12) then reviewed the items for face validity and reading clarity. To evaluate the validity and reliability of the newly developed CF knowledge scale, it was administered to several different samples including CF patients (n = 45), respirology patients (n = 100), health-care providers (n = 74) and university student samples (psychology students, n = 71; medical students, n = 36). Internal consistency of the scale was high, with an alpha coefficient for the overall sample of .95 (n = 326). The scale also demonstrated excellent construct validity. This study is an important first step in a line of research that aims to develop and empirically validate a psycho-educational adherence intervention for improving quality of life and treatment outcomes among adult CF patients. The CF knowledge scale has potential applications as a clinical teaching tool with patients and health-care providers and could be used as an outcome measure in CF educational intervention studies aimed at optimizing CF treatment knowledge, adherence and quality of life among CF patients. © 2014 Asian Pacific Society of Respirology.

Evaluation of a word recognition instrument to test health literacy in dentistry: the REALD-99.

PubMed

Richman, Julia A; Lee, Jessica Y; Rozier, R Gary; Gong, Debra A; Pahel, Bhavna T; Vann, William F

2007-01-01

This study aims to evaluate a dental health literacy word recognition instrument. Based on a reading recognition test used in medicine, the Rapid Estimate of Adult Literacy in Medicine (REALM), we developed the Rapid Estimate of Adult Literacy in Dentistry (REALD-99). Parents of pediatric dental patients were recruited from local dental clinics and asked to read aloud words in both REALM and REALD-99. REALD-99 scores had a possible range of 0 (low literacy) to 99 (high literacy); REALM scores ranged from 0 to 66. Outcome measures included parents' perceived oral health for themselves and of their children, and oral health-related quality of life of the parent as measured by the short-form Oral Health Impact Profile (OHIP-14). To determine the validity, we tested bivariate correlations between REALM and REALD-99, REALM and perceived dental outcomes, and REALD-99 and perceived dental outcomes. We used ordinary least squares regression and logit models to further examine the relationship between REALD-99 and dental outcomes. We determined internal reliability using Cronbach's alpha. One hundred two parents of children were interviewed. The average REALD-99 and REALM-66 scores were high (84 and 62, respectively). REALD-99 was positively correlated with REALM (PCC = 0.80). REALM was not related to dental outcomes. REALD-99 was associated with parents' OHIP-14 score in multivariate analysis. REALD-99 had good reliability (Cronbach's alpha = 0.86). REALD-99 has promise for measuring dental health literacy because it demonstrated good reliability and is quick and easy to administer. Additional studies are needed to examine the validity of REALD-99 using objective clinical oral health measures and more proximal outcomes such as behavior and compliance to specific health instructions.

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.

Validity and test-retest reliability in assessing current body size with figure drawings in Chinese adolescents.

PubMed

Lo, Wing-Sze; Ho, Sai-Yin; Wong, Bonny Yee-Man; Mak, Kwok-Kei; Lam, Tai-Hing

2011-06-01

The reliability and validity of Stunkard's Figure Rating Scale (FRS) as a measure of current body size (CBS) was established in Western adolescent girls but not in non-Western population. We examined the validity and test-retest reliability of Stunkard's FRS in assessing CBS among Chinese adolescents. Methods. In a school-based survey in Hong Kong, 5666 adolescents (boys: 45.1%; mean age 14.7 years) provided data on self-reported height and weight, CBS, perceived weight status, and health-related quality of life using the Medical Outcomes Study Short-Form version 2 (SF-12v2). Height and weight were also objectively measured. Spearman's correlation was used to assess construct validity, concurrent validity and test-retest reliability. Convergent and discriminant validity were good: CBS correlated strongly with weight and self-reported/measured BMI, but only weakly with SF-12v2. CBS correlated strongly with perceived weight status, showing concurrent validity. Spearman's correlation (r) for CBS was 0.78 for girls and 0.72 for boys indicating good test-retest reliability. Validity and reliability results did not differ significantly between senior and junior grade adolescents. Our findings support the use of Stunkard's FRS to measure body size among Chinese adolescents.

Measuring Educational Outcomes for At-Risk Children and Youth: Issues with the Validity of Self-Reported Data

ERIC Educational Resources Information Center

Teye, Amanda Cleveland; Peaslee, Liliokanaio

2015-01-01

Background: Youth programs often rely on self-reported data without clear evidence as to the accuracy of these reports. Although the validity of self-reporting has been confirmed among some high school and college age students, one area that is absent from extant literature is a serious investigation among younger children. Moreover, there is…

Concurrent Validity of LibQUAL+[TM] Scores: What Do LibQUAL+[TM] Scores Measure?

ERIC Educational Resources Information Center

Thompson, Bruce; Cook, Colleen; Kyrillidou, Martha

2005-01-01

The present study investigated the validity of LibQUAL+[TM] scores, and specifically how total and subscale LibQUAL+[TM] scores are associated with self-reported, library-related satisfaction and outcomes scores. Participants included 88,664 students and faculty who completed the American English (n[AE] = 69,494) or the British English (n[BE] =…

Moving toward a standard for spinal fusion outcomes assessment.

PubMed

Blount, Kevin J; Krompinger, W Jay; Maljanian, Rose; Browner, Bruce D

2002-02-01

Previous spinal fusion outcomes assessment studies have been complicated by inconsistencies in evaluative criteria and consequent variations in results. As a result, a general consensus is lacking on how to achieve comprehensive outcomes assessment for spinal fusion surgeries. The purpose of this article is to report the most validated and frequently used assessment measures to facilitate comparable outcomes studies in the future. Twenty-seven spinal fusion outcomes studies published between 1990 and 2000 were retrospectively reviewed. Study characteristics such as design, evaluative measures, and assessment tools were recorded and analyzed. Based on the reviewed literature, an outcomes assessment model is proposed including the Short Form-36 Health Survey, the Oswestry Disability Questionnaire, the North American Spine Society Patient Satisfaction Index, the Prolo Economic Scale, a 0-10 analog pain scale, medication use, radiographically assessed fusion status, and a generalized complication rate.

Do treatment quality indicators predict cardiovascular outcomes in patients with diabetes?

PubMed

Sidorenkov, Grigory; Voorham, Jaco; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M; Denig, Petra

2013-01-01

Landmark clinical trials have led to optimal treatment recommendations for patients with diabetes. Whether optimal treatment is actually delivered in practice is even more important than the efficacy of the drugs tested in trials. To this end, treatment quality indicators have been developed and tested against intermediate outcomes. No studies have tested whether these treatment quality indicators also predict hard patient outcomes. A cohort study was conducted using data collected from >10.000 diabetes patients in the Groningen Initiative to Analyze Type 2 Treatment (GIANTT) database and Dutch Hospital Data register. Included quality indicators measured glucose-, lipid-, blood pressure- and albuminuria-lowering treatment status and treatment intensification. Hard patient outcome was the composite of cardiovascular events and all-cause death. Associations were tested using Cox regression adjusting for confounding, reporting hazard ratios (HR) with 95% confidence intervals. Lipid and albuminuria treatment status, but not blood pressure lowering treatment status, were associated with the composite outcome (HR = 0.77, 0.67-0.88; HR = 0.75, 0.59-0.94). Glucose lowering treatment status was associated with the composite outcome only in patients with an elevated HbA1c level (HR = 0.72, 0.56-0.93). Treatment intensification with glucose-lowering but not with lipid-, blood pressure- and albuminuria-lowering drugs was associated with the outcome (HR = 0.73, 0.60-0.89). Treatment quality indicators measuring lipid- and albuminuria-lowering treatment status are valid quality measures, since they predict a lower risk of cardiovascular events and mortality in patients with diabetes. The quality indicators for glucose-lowering treatment should only be used for restricted populations with elevated HbA1c levels. Intriguingly, the tested indicators for blood pressure-lowering treatment did not predict patient outcomes. These results question whether all treatment indicators are valid measures to judge quality of health care and its economics.

An acute cough-specific quality-of-life questionnaire for children: Development and validation.

PubMed

Anderson-James, Sophie; Newcombe, Peter A; Marchant, Julie M; O'Grady, Kerry-Ann F; Acworth, Jason P; Stone, D Grant; Turner, Catherine T; Chang, Anne B

2015-05-01

Patient-relevant outcome measures are essential for high-quality clinical research, and quality-of-life (QoL) tools are the current standard. Currently, there is no validated children's acute cough-specific QoL questionnaire. The objective of this study was to develop and validate the Parent-proxy Children's Acute Cough-specific QoL Questionnaire (PAC-QoL). Using focus groups, a 48-item PAC-QoL questionnaire was developed and later reduced to 16 items by using the clinical impact method. Parents of children with a current acute cough (<2 weeks) at enrollment completed 2 validated cough score measures, the preliminary 48-item PAC-QoL, and 3 other questionnaires (the State Trait Anxiety Inventory [STAI], the Short-Form 8-item 24-hour recall Health Survey [SF-8], and the Depression, Anxiety, and Stress 21-item Scale [DASS21]). All measures were repeated on days 3 and 14. The median age of the 155 children enrolled was 2.3 years (interquartile range, 1.3-4.6). Median cough duration at enrollment was 3 days (interquartile range, 2-5). The reduced 16-item scale had high internal consistency (Cronbach α = 0.95). Evidence for repeatability and criterion validity was shown by significant correlations between the domains and total PAC-QoL scores and the SF-8 (r = -0.36 and -0.51), STAI (r = -0.27 and -0.39), and DASS21 (r = -0.32 and -0.41) scales on days 0 and 3, respectively. The final PAC-QoL questionnaire was sensitive to change over time, with changes significantly relating to changes in cough score measures (P < .001). The 16-item PAC-QoL is a reliable and valid outcome measure that assesses QoL related to childhood acute cough at a given time point and reflects changes in acute cough-specific QoL over time. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Development and Validation of a Daily Pain Catastrophizing Scale.

PubMed

Darnall, Beth D; Sturgeon, John A; Cook, Karon F; Taub, Chloe J; Roy, Anuradha; Burns, John W; Sullivan, Michael; Mackey, Sean C

2017-09-01

To date, there is no validated measure for pain catastrophizing at the daily level. The Pain Catastrophizing Scale (PCS) is widely used to measure trait pain catastrophizing. We sought to develop and validate a brief, daily version of the PCS for use in daily diary studies to facilitate research on mechanisms of catastrophizing treatment, individual differences in self-regulation, and to reveal the nuanced relationships between catastrophizing, correlates, and pain outcomes. After adapting the PCS for daily use, we evaluated the resulting 14 items using 3 rounds of cognitive interviews with 30 adults with chronic pain. We refined and tested the final daily PCS in 3 independent, prospective, cross-sectional, observational validation studies conducted in a combined total of 519 adults with chronic pain who completed online measures daily for 14 consecutive days. For study 1 (N = 131), exploratory factor analysis revealed adequate fit and-unexpectedly-unidimensionality for item responses to the daily PCS. Study 2 (N = 177) correlations indicated adequate association with related constructs (anger, anxiety, pain intensity, depression). Similarly, results for study 3 (N = 211) revealed expected correlations for daily PCS and measures of daily constructs including physical activity, sleep, energy level, and positive affect. Results from complex/multilevel confirmatory factor analysis confirmed good fit to a unidimensional model. Scores on the daily PCS were statistically comparable with and more parsimonious than the full 14-item version. Next steps include evaluation of score validity in populations with medical diagnoses, greater demographic diversity, and in patients with acute pain. This article describes the development and validation of a daily PCS. This daily measure may facilitate research that aims to characterize pain mechanisms, individual differences in self-regulation, adaptation, and nuanced relationships between catastrophizing, correlates, and pain outcomes. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

Psychometric Evaluation of the PROMIS Fatigue-Short Form Across Diverse Populations

PubMed Central

Ameringer, Suzanne; Elswick, R. K.; Menzies, Victoria; Robins, Jo Lynne; Starkweather, Angela; Walter, Jeanne; Gentry, Amanda Elswick; Jallo, Nancy

2016-01-01

Background The need for reliable, valid tools to measure patient-reported outcomes (PROs) is critical for both research and for evaluating treatment effects in practice. The Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form v1.0 –Fatigue 7a (PROMIS F-SF) has had limited psychometric evaluation in various populations. Objectives The aim of the study is to examine psychometric properties of PROMIS F-SF item responses across various populations. Methods Data from five studies with common data elements were used in this secondary analysis. Samples from patients with fibromyalgia, sickle cell disease, cardiometabolic risk, pregnancy, and healthy controls were used. Reliability was estimated using Cronbach’s alpha. Dimensionality was evaluated with confirmatory factor analysis. Concurrent validity was evaluated by examining Pearson’s correlations between scores from the PROMIS F-SF, the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), and the Brief Fatigue Inventory (BFI). Discriminant validity was evaluated by examining Pearson’s correlations between scores on the PROMIS F-SF and measures of stress and depressive symptoms. Known groups validity was assessed by comparing PROMIS F-SH scores in the clinical samples to healthy controls. Results Reliability of PROMIS F-SF scores was adequate across samples, ranging from .72 in the pregnancy sample to .88 in healthy controls. Unidimensionality was supported in each sample. Concurrent validity was strong; across the groups, correlations with scores on the MFSI-SF and BFI ranged from .60–.85. Correlations of the PROMIS-SF with measures of stress and depressive mood were moderate to strong, ranging from .37–.64. PROMIS F-SF scores were significantly higher in clinical samples, compared to healthy controls. Discussion Reliability and validity of the PROMIS F-SF were acceptable. The PROMIS F-SF is a suitable measure of fatigue across the four diverse clinical populations included in the analysis. PMID:27362514

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.

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 the relationship between burnout and any outcome variable was altered by the use of the single-item measures rather than the full MBI. Relative to the full MBI, single-item measures of emotional exhaustion and depersonalization exhibit strong and consistent associations with key outcomes in medical students, internal medicine residents, and practicing surgeons.

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 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.

The Profile of Emotional Competence (PEC): development and validation of a self-reported measure that fits dimensions of emotional competence theory.

PubMed

Brasseur, Sophie; Grégoire, Jacques; Bourdu, Romain; Mikolajczak, Moïra

2013-01-01

Emotional Competence (EC), which refers to individual differences in the identification, understanding, expression, regulation and use of one's own emotions and those of others, has been found to be an important predictor of individuals' adaptation to their environment. Higher EC is associated with greater happiness, better mental and physical health, more satisfying social and marital relationships and greater occupational success. While it is well-known that EC (as a whole) predicts a number of important outcomes, it is unclear so far which specific competency(ies) participate(s) in a given outcome. This is because no measure of EC distinctly measures each of the five core emotional competences, separately for one's own and others' emotions. This lack of information is problematic both theoretically (we do not understand the processes at stake) and practically (we cannot develop customized interventions). This paper aims to address this issue. We developed and validated in four steps a complete (albeit short: 50 items) self-reported measure of EC: the Profile of Emotional Competence. Analyses performed on a representative sample of 5676 subjects revealed promising psychometric properties. The internal consistency of scales and subscales alike was satisfying, factorial structure was as expected, and concurrent/discriminant validity was good.

Psychometric properties of the Finnish version of the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) questionnaire.

PubMed

Gergov, Vera; Lahti, Jari; Marttunen, Mauri; Lipsanen, Jari; Evans, Chris; Ranta, Klaus; Laitila, Aarno; Lindberg, Nina

2017-05-01

An increasing need exists for suitable measures to evaluate treatment outcome in adolescents. YP-CORE is a pan-theoretical brief questionnaire developed for this purpose, but it lacks studies in different cultures or languages. To explore the acceptability, factor structure, reliability, validity, and sensitivity to change of the Finnish translation of YP-CORE. The study was conducted at the Department of Adolescent Psychiatry, Helsinki University Central Hospital. A Finnish translation was prepared by a team of professionals and adolescents. A clinical sample of 104 patients was asked to complete the form together with BDI-21 and BAI, and 92 of them filled the forms again after a 3-month treatment. Analysis included acceptability, confirmatory factor analysis, internal and test-re-test reliability, concurrent validity, influence of gender and age, and criteria for reliable change. YP-CORE was well accepted, and the rate of missing values was low. Internal consistency (α = 0.83-.92) and test-re-test reliability were good (r = 0.69), and the results of CFA supported a one-factor model. YP-CORE showed good concurrent validity against two widely used symptom-specific measures (r = 0.62-0.87). Gender had a moderately strong effect on the scores (d = 0.67), but the effect of age was not as evident. The measure was sensitive to change, showing a larger effect size (d = 0.55) than in the BDI-21 and BAI (d = 0.31-0.50). The results show that the translation of YP-CORE into Finnish has been successful, the YP-CORE has good psychometric properties, and the measure could be taken into wider use in clinical settings for outcome measurement in adolescents.

Translation, Cross Cultural Adaptation and Validation of the Lee Chronic Graft-versus-Host Disease (GVHD) Symptom Scale in a Brazilian Population

PubMed Central

de Souza, Clarissa Vasconcellos; Vigorito, Afonso Celso; Miranda, Eliana C M; Garcia, Celso; Colturato, Vergílio Antonio Rensi; Mauad, Marcos Augusto; Moreira, Maria Cláudia Rodrigues; da Silva Bouzas, Luis Fernando; Lermontov, Simone; Hamerschlak, Nelson; Rodrigues, Morgani; de Almeida Barros, Jose Carlos; Chiattone, Ricardo; Lee, Stephanie J; Flowers, Mary ED

2017-01-01

The Lee chronic graft-versus-disease (cGVHD) Symptom Scale is a patient-reported instrument developed and validated in English to measure symptoms and functional impact of cGVHD. This tool has not been validated in a Latin America population. The Brazil-Seattle Chronic GVHD Consortium conducted a multicenter study at five Brazilian institutions to validate the Lee cGVHD Symptom Scale in adults with chronic GVHD. Study objectives included the translation and validation of the instrument in Brazilian Portuguese and evaluation of the correlation with other quality of life (QoL) tools (i.e., Medical Outcomes Study Short Form 36 [SF-36] and the Functional Assessment of Chronic Illness Therapy with Bone Marrow Transplant subscale [FACT-BMT]). Translation and validation were according to the American Association of Orthopedic Surgeons Outcome Committee guideline. Spearman’s correlation coefficient was used to measure construct validity. Reliability was assessed using Cronbach’s alpha and intraclass correlation coefficients. Between April 2011 and August 2012, 47 patients with cGVHD by the 2005 NIH criteria were enrolled in this study. Cohort median age was 48 (23–69) years and 29 (62%) were male. Lee cGVHD Symptom Scale reliability was adequate (Cronbach’s alpha 0.62–0.83). The correlations between similar domains of the Lee cGVHD Symptom Scale, SF-36 and FACT-BMT were moderate to high. The Brazilian Portuguese version of the Lee cGVHD Symptom Scale is valid and reliable and can be used in clinical trials of cGVHD in Brazil. PMID:27058616

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.

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.

Reliability, validity and responsiveness of the German self-reported foot and ankle score (SEFAS) in patients with foot or ankle surgery.

PubMed

Arbab, Dariusch; Kuhlmann, Katharina; Schnurr, Christoph; Bouillon, Bertil; Lüring, Christian; König, Dietmar

2017-10-10

Patient-reported outcome measures are a critical tool in evaluating the efficacy of orthopedic procedures and are increasingly used in clinical trials to assess outcomes of health care. The intention of this study was to develop and culturally adapt a German version of the Self-reported Foot and Ankle Score (SEFAS) and to evaluate reliability, validity and responsiveness. According to Cross Cultural Adaptation of Self-Reported Measure guidelines forward and backward translation has been performed. The German SEFAS was investigated in 177 consecutive patients. 177 Patients completed the German SEFAS, Foot and Ankle Outcome Score (FAOS), Short-Form 36 and numeric scales for pain and disability (NRS) before and 118 patients 6 months after foot or ankle surgery. Test-Retest reliability, internal consistency, floor and ceiling effects, construct validity and minimal important change were analyzed. The German SEFAS demonstrated excellent test-retest reliability with ICC values of 0.97. Cronbach's alpha (α) value of 0.89 demonstrated strong internal consistency. No floor or ceiling effects were observed for the German version of the SEFAS. As hypothesized SEFAS correlated strongly with FAOS and SF-36 domains. It showed moderate (ES/SRM > 0.5) responsiveness between preoperative assessment and postoperative follow-up. The German version of the SEFAS demonstrated good psychometric properties. It proofed to be a valid and reliable instrument for use in foot and ankle patients. DRKS00007585.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

PubMed

Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by 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

PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions.

PubMed

Cook, Karon F; Jensen, Sally E; Schalet, Benjamin D; Beaumont, Jennifer L; Amtmann, Dagmar; Czajkowski, Susan; Dewalt, Darren A; Fries, James F; Pilkonis, Paul A; Reeve, Bryce B; Stone, Arthur A; Weinfurt, Kevin P; Cella, David

2016-05-01

To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations. Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model. The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions. The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

The reliability and validity of patient-reported chronic obstructive pulmonary disease exacerbations.

PubMed

Mohan, Arjun; Sethi, Sanjay

2014-03-01

Despite the increasing awareness of their pathogenesis and clinical consequences, research on and clinical management of acute exacerbations of chronic obstructive lung disease (AECOPDs) have been hindered by the lack of a consistent and reliable definition. Symptom-based definitions of exacerbations are sensitive to events and account for unreported exacerbations. Event (healthcare utilization)-based definitions are somewhat more definitive but miss unreported events. Objective quantification of symptoms in AECOPD is now possible with the development of the Exacerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT-PRO), a patient-reported outcome (PRO) measure. Several studies have revealed that unreported AECOPDs are more frequent than reported events and are associated with long-term adverse consequences. New antibiotic development for AECOPD has been hampered by the lack of validated measures for resolution of exacerbations. As a result of these observations, a unique collaborative effort between academia, industry and regulatory agencies resulted in the development of the EXACT-PRO. It consists of 14 questions that generate a score between 0 and 100, and it has been shown to have excellent reliability and validity. In the absence of a reliable biomarker, the definition and measurement of exacerbations has been subjective and imprecise. PRO measures such as EXACT can provide much needed objectivity in assessing symptom-defined exacerbations, which may translate into a uniform outcome measure in clinical trials. With further development and validation, it may have a role in clinical practice in the earlier detection of exacerbations, stratification of an exacerbation severity and the assessment of clinical response to treatment.

Let's Stop Trying to Quantify Household Vulnerability: The Problem With Simple Scales for Targeting and Evaluating Economic Strengthening Programs

PubMed Central

Moret, Whitney M

2018-01-01

Introduction: Economic strengthening practitioners are increasingly seeking data collection tools that will help them target households vulnerable to HIV and poor child well-being outcomes, match households to appropriate interventions, monitor their status, and determine readiness for graduation from project support. This article discusses efforts in 3 countries to develop simple, valid tools to quantify and classify economic vulnerability status. Methods and Findings: In Côte d'Ivoire, we conducted a cross-sectional survey with 3,749 households to develop a scale based on the definition of HIV-related economic vulnerability from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for the purpose of targeting vulnerable households for PEPFAR-funded programs for orphans and vulnerable children. The vulnerability measures examined did not cluster in ways that would allow for the creation of a small number of composite measures, and thus we were unable to develop a scale. In Uganda, we assessed the validity of a vulnerability index developed to classify households according to donor classifications of economic status by measuring its association with a validated poverty measure, finding only a modest correlation. In South Africa, we developed monitoring and evaluation tools to assess economic status of individual adolescent girls and their households. We found no significant correlation with our validation measures, which included a validated measure of girls' vulnerability to HIV, a validated poverty measure, and subjective classifications generated by the community, data collector, and respondent. Overall, none of the measures of economic vulnerability used in the 3 countries varied significantly with their proposed validation items. Conclusion: Our findings suggest that broad constructs of economic vulnerability cannot be readily captured using simple scales to classify households and individuals in a way that accounts for a substantial amount of variance at locally defined vulnerability levels. We recommend that researchers and implementers design monitoring and evaluation instruments to capture narrower definitions of vulnerability based on characteristics programs intend to affect. We also recommend using separate tools for targeting based on context-specific indicators with evidence-based links to negative outcomes. Policy makers and donors should avoid reliance on simplified metrics of economic vulnerability in the programs they support. PMID:29496734

The individual therapy process questionnaire: development and validation of a revised measure to evaluate general change mechanisms in psychotherapy.

PubMed

Mander, Johannes

2015-01-01

There is a dearth of measures specifically designed to assess empirically validated mechanisms of therapeutic change. To fill in this research gap, the aim of the current study was to develop a measure that covers a large variety of empirically validated mechanisms of change with corresponding versions for the patient and therapist. To develop an instrument that is based on several important change process frameworks, we combined two established change mechanisms instruments: the Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP) and the Scale of the Therapeutic Alliance-Revised (STA-R). In our study, 457 psychosomatic inpatients completed the SACiP and the STA-R and diverse outcome measures in early, middle and late stages of psychotherapy. Data analyses were conducted using factor analyses and multilevel modelling. The psychometric properties of the resulting Individual Therapy Process Questionnaire were generally good to excellent, as demonstrated by (a) exploratory factor analyses on both patient and therapist ratings, (b) CFA on later measuring times, (c) high internal consistencies and (d) significant outcome predictive effects. The parallel forms of the ITPQ deliver opportunities to compare the patient and therapist perspectives for a broader range of facets of change mechanisms than was hitherto possible. Consequently, the measure can be applied in future research to more specifically analyse different change mechanism profiles in session-to-session development and outcome prediction. Key Practitioner Message This article describes the development of an instrument that measures general mechanisms of change in psychotherapy from both the patient and therapist perspectives. Post-session item ratings from both the patient and therapist can be used as feedback to optimize therapeutic processes. We provide a detailed discussion of measures developed to evaluate therapeutic change mechanisms. Copyright © 2014 John Wiley & Sons, Ltd.

Effect of ethnicity on disease activity and physical function in psoriatic arthritis in a multiethnic Asian population.

PubMed

Leung, Ying Ying; Fong, Warren; Lui, Nai Lee; Thumboo, Julian

2017-01-01

Geographic differences in manifestation of psoriatic arthritis (PsA) could be related to differences in genetic or environmental factors. We aimed to compare the disease activity and functional status using validated outcome measures among patients with PsA of different ethnicities living in the same environment. We performed a cross-sectional study on consecutive patients with PsA classified by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria from a single center. Sociodemographic data, clinical variables, and patient-reported outcomes were collected using a standardized protocol. Disease activities were assessed by validated composite scores: clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), Composite Psoriatic Disease Activity Index (CPDAI), and minimal disease activity (MDA). Physical function was assessed with Health Assessment Questionnaire (HAQ) and the Medical Outcome Study Short-Form 36 (SF36) physical function subscales. Linear regression analyses were performed to identify variables associated with disease activities and physical function. Ninety-eight patients (51.5%, men) with mean (±SD) age and duration of PsA of 51.5 ± 13.8 and 5.5 ± 8.4 years were recruited. Indian was overrepresented compared with the national distribution of ethnicities. Compared to Chinese, Indian patients were more likely to be using biological therapies, have higher tender joint count, and worse enthesitis. Higher proportion of Indians had higher disease activity categories measured by cDAPSA, CPDAI, and MDA and had poorer physical function. In the multivariable analysis, ethnicity was significantly associated with HAQ and SF36-PF. Compared to Chinese, Indians with PsA living in the same environment had worse disease activity and physical function measured by validated outcomes.

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.

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.

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

Typical Intellectual Engagement, Big Five Personality Traits, Approaches to Learning and Cognitive Ability Predictors of Academic Performance

ERIC Educational Resources Information Center

Furnham, Adrian; Monsen, Jeremy; Ahmetoglu, Gorkan

2009-01-01

Background: Both ability (measured by power tests) and non-ability (measured by preference tests) individual difference measures predict academic school outcomes. These include fluid as well as crystalized intelligence, personality traits, and learning styles. This paper examines the incremental validity of five psychometric tests and the sex and…

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

ERIC Educational Resources Information Center

Lee, Hyunjeong

2014-01-01

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

An Algorithm for Converting Ordinal Scale Measurement Data to Interval/Ratio Scale

ERIC Educational Resources Information Center

Granberg-Rademacker, J. Scott

2010-01-01

The extensive use of survey instruments in the social sciences has long created debate and concern about validity of outcomes, especially among instruments that gather ordinal-level data. Ordinal-level survey measurement of concepts that could be measured at the interval or ratio level produce errors because respondents are forced to truncate or…

Measurement of organizational culture and climate in healthcare.

PubMed

Gershon, Robyn R M; Stone, Patricia W; Bakken, Suzanne; Larson, Elaine

2004-01-01

Although there is increasing interest in the relationship between organizational constructs and health services outcomes, information on the reliability and validity of the instruments measuring these constructs is sparse. Twelve instruments were identified that may have applicability in measuring organizational constructs in the healthcare setting. The authors describe and characterize these instruments and discuss the implications for nurse administrators.

The Meriden School Climate Survey-Student Version: Preliminary Evidence of Reliability and Validity

ERIC Educational Resources Information Center

Gage, Nicholas A.; Larson, Alvin; Chafouleas, Sandra M.

2016-01-01

School climate has been linked with myriad positive student outcomes and the measurement of school climate is widely advocated at the national and state level. However, districts have little guidance about how to define and measure school climate. This study examines the psychometric properties of a district-developed school climate measure that…

Measuring Social Relationships in Different Social Systems: The Construction and Validation of the Evaluation of Social Systems (EVOS) Scale

PubMed Central

Aguilar-Raab, Corina; Grevenstein, Dennis; Schweitzer, Jochen

2015-01-01

Social interactions have gained increasing importance, both as an outcome and as a possible mediator in psychotherapy research. Still, there is a lack of adequate measures capturing relational aspects in multi-person settings. We present a new measure to assess relevant dimensions of quality of relationships and collective efficacy regarding interpersonal interactions in diverse personal and professional social systems including couple partnerships, families, and working teams: the EVOS. Theoretical dimensions were derived from theories of systemic family therapy and organizational psychology. The study was divided in three parts: In Study 1 (N = 537), a short 9-item scale with two interrelated factors was constructed on the basis of exploratory factor analysis. Quality of relationship and collective efficacy emerged as the most relevant dimensions for the quality of social systems. Study 2 (N = 558) confirmed the measurement model using confirmatory factor analysis and established validity with measures of family functioning, life satisfaction, and working team efficacy. Measurement invariance was assessed to ensure that EVOS captures the same latent construct in all social contexts. In Study 3 (N = 317), an English language adaptation was developed, which again confirmed the original measurement model. The EVOS is a theory-based, economic, reliable, and valid measure that covers important aspects of social relationships, applicable for different social systems. It is the first instrument of its kind and an important addition to existing measures of social relationships and related outcome measures in therapeutic and other counseling settings involving multiple persons. PMID:26200357

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 KDQOL-36 for use in pre-dialysis patients; the KDQOL-SF or KDQOL-36 for dialysis patients and the ESRD-SCLTM for use in transplant recipients. However, further research is required to evaluate the measurement error, structural validity, responsiveness and patient acceptability of PROMs used in CKD. PMID:28636678

Clinical prediction models for mortality and functional outcome following ischemic stroke: A systematic review and meta-analysis

PubMed Central

Crayton, Elise; Wolfe, Charles; Douiri, Abdel

2018-01-01

Objective We aim to identify and critically appraise clinical prediction models of mortality and function following ischaemic stroke. Methods Electronic databases, reference lists, citations were searched from inception to September 2015. Studies were selected for inclusion, according to pre-specified criteria and critically appraised by independent, blinded reviewers. The discrimination of the prediction models was measured by the area under the curve receiver operating characteristic curve or c-statistic in random effects meta-analysis. Heterogeneity was measured using I2. Appropriate appraisal tools and reporting guidelines were used in this review. Results 31395 references were screened, of which 109 articles were included in the review. These articles described 66 different predictive risk models. Appraisal identified poor methodological quality and a high risk of bias for most models. However, all models precede the development of reporting guidelines for prediction modelling studies. Generalisability of models could be improved, less than half of the included models have been externally validated(n = 27/66). 152 predictors of mortality and 192 predictors and functional outcome were identified. No studies assessing ability to improve patient outcome (model impact studies) were identified. Conclusions Further external validation and model impact studies to confirm the utility of existing models in supporting decision-making is required. Existing models have much potential. Those wishing to predict stroke outcome are advised to build on previous work, to update and adapt validated models to their specific contexts opposed to designing new ones. PMID:29377923

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

Validation and reliability of the VF-14 questionnaire in a German population.

PubMed

Chiang, Peggy Pei-Chia; Fenwick, Eva; Marella, Manjula; Finger, Robert; Lamoureux, Ecosse

2011-11-21

To evaluate the validity, reliability, and measurement characteristics of the Visual Function 14 (VF-14) in a German sample using Rasch analysis. This was a clinic-based, cross-sectional study with 184 patients with low vision recruited from an outpatient clinic at a German eye hospital. Participants underwent a clinical examination and completed the German VF-14 scale. The validity of the VF-14 scale was assessed using Rasch analysis. The main outcome measure was the overall functional score provided by the VF-14. After collapsing two response categories for items 13 and 14, the VF-14 scale satisfied fundamental criteria to achieve fit to the Rasch model, namely, ordered thresholds, the ability to distinguish between different strata of participant ability, absence of misfitting items, no evidence of unidimensionality, and no significant differential item functioning for key sociodemographic covariates. The VF-14 is able to discriminate between participants with different levels of vision impairment and across different cultural groups. The VF-14 is a valid, reliable, and unidimensional questionnaire for use in a German population. These findings contribute to the growing evidence base for second generation patient reported outcome measures in ophthalmology, and support the use of the German VF-14 in tertiary eye clinics in Germany to capture the impact of visual impairment on visual function from the patient's perspective and to inform low vision rehabilitation and interventions.

Instruments and Scoring Guide of the Experiential Education Evaluation Project.

ERIC Educational Resources Information Center

Conrad, Dan; Hedin, Diane

As a result of the Experiential Education Evaluation Project the publication identifies instruments used to measure and assess experiential learning programs. The following information is given for each instrument: rationale for its inclusion in the study; precise issues or outcomes designed to measure, validity and reliability data; and…

Teaching Young Children Effectively

ERIC Educational Resources Information Center

Brophy, Jere E.; Evertson, Carolyn M.

2010-01-01

Process-product research in which the investigator observes in teachers' classrooms and tries to relate process measures of teaching behavior to product measures of student outcome has face validity appeal and common sense logic. This research approach appears to be the simplest and most direct way to identify teaching behaviors which discriminate…

Accuracy of the DIBELS Oral Reading Fluency Measure for Predicting Third Grade Reading Comprehension Outcomes

ERIC Educational Resources Information Center

Roehrig, Alysia D.; Petscher, Yaacov; Nettles, Stephen M.; Hudson, Roxanne F.; Torgesen, Joseph K.

2008-01-01

We evaluated the validity of DIBELS ("Dynamic Indicators of Basic Early Literacy Skills") ORF ("Oral Reading Fluency") for predicting performance on the "Florida Comprehensive Assessment Test" (FCAT-SSS) and "Stanford Achievement Test" (SAT-10) reading comprehension measures. The usefulness of previously…

Assessment of sexual difficulties associated with multi-modal treatment for cervical or endometrial cancer: A systematic review of measurement instruments.

PubMed

White, Isabella D; Sangha, Amrit; Lucas, Grace; Wiseman, Theresa

2016-12-01

Practitioners and researchers require an outcome measure that accurately identifies the range of common treatment-induced changes in sexual function and well-being experienced by women after cervical or endometrial cancer. This systematic review critically appraised the measurement properties and clinical utility of instruments validated for the measurement of female sexual dysfunction (FSD) in this clinical population. A bibliographic database search for questionnaire development or validation papers was completed and methodological quality and measurement properties of selected studies rated using the Consensus-based Standards for the selection of health Measurement Instrument (COSMIN) checklist. 738 articles were screened, 13 articles retrieved for full text assessment and 7 studies excluded, resulting in evaluation of 6 papers; 2 QoL and 4 female sexual morbidity measures. Five of the six instruments omitted one or more dimension of female sexual function and only one instrument explicitly measured distress associated with sexual changes as per DSM V (APA 2013) diagnostic criteria. None of the papers reported measurement error, responsiveness data was available for only two instruments, three papers failed to report on criterion validity, and test-retest reliability reporting was inconsistent. Heterosexual penile-vaginal intercourse remains the dominant sexual activity focus for sexual morbidity PROMS terminology and instruments lack explicit reference to solo or non-coital sexual expression or validation in a non-heterosexual sample. Four out of six instruments included mediating treatment or illness items such as vaginal changes, menopause or altered body image. Findings suggest that the Female Sexual Function Index (FSFI) remains the most robust sexual morbidity outcome measure, for research or clinical use, in sexually active women treated for cervical or endometrial cancer. Development of an instrument that measures sexual dysfunction in women who are infrequently/not sexually active due to treatment consequences is still required to identify women in need of sexual rehabilitation. Copyright © 2016 Elsevier Inc. All rights reserved.

Idiopathic Pulmonary Fibrosis: Clinically Meaningful Primary Endpoints in Phase 3 Clinical Trials

PubMed Central

Collard, Harold R.; Anstrom, Kevin J.; Flaherty, Kevin R.; Fleming, Thomas R.; King, Talmadge E.; Martinez, Fernando J.; Brown, Kevin K.

2012-01-01

Definitive evidence of clinical efficacy in a Phase 3 trial is best shown by a beneficial impact on a clinically meaningful endpoint—that is, an endpoint that directly measures how a patient feels (symptoms), functions (the ability to perform activities in daily life), or survives. In idiopathic pulmonary fibrosis (IPF), we believe the endpoints that best meet these criteria are all-cause mortality and all-cause nonelective hospitalization. There are no validated measures of symptoms or broader constructs such as health status or funtional status in IPF. A surrogate endpoint is defined as an indirect measure that is intended to substitute for a clinically meaningful endpoint. Surrogate endpoints can be appropriate outcome measures if validated. However, validation requires substantial evidence that the effect of an intervention on a clinically meaningful endpoint is reliably predicted by the effect of an intervention on the surrogate endpoint. For patients with IPF, there are currently no validated surrogate endpoints. PMID:22505745

Severity of anxiety and work-related outcomes of patients with anxiety disorders.

PubMed

Erickson, Steven R; Guthrie, Sally; Vanetten-Lee, Michelle; Himle, Joseph; Hoffman, Jody; Santos, Susana F; Janeck, Amy S; Zivin, Kara; Abelson, James L

2009-01-01

This study examined associations between anxiety and work-related outcomes in an anxiety disorders clinic population, examining both pretreatment links and the impact of anxiety change over 12 weeks of treatment on work outcomes. Four validated instruments were used to also allow examination of their psychometric properties, with the goal of improving measurement of work-related quality of life in this population. Newly enrolled adult patients seeking treatment in a university-based anxiety clinic were administered four work performance measures: Work Limitations Questionnaire (WLQ), Work Productivity and Activity Impairment Questionnaire (WPAI), Endicott Work Productivity Scale (EWPS), and Functional Status Questionnaire Work Performance Scale (WPS). Anxiety severity was determined using the Beck Anxiety Inventory (BAI). The Clinical Global Impressions, Global Improvement Scale (CGI-I) was completed by patients to evaluate symptom change at a 12-week follow-up. Two severity groups (minimal/mild vs. moderate/severe, based on baseline BAI score) were compared to each other on work measures. Eighty-one patients provided complete baseline data. Anxiety severity groups did not differ in job type, time on job, job satisfaction, or job choice. Patients with greater anxiety generally showed lower work performance on all instruments. Job advancement was impaired for the moderate/severe group. The multi-item performance scales demonstrated better validity and internal consistency. The WLQ and the WPAI detected change with symptom improvement. Level of work performance was generally associated with severity of anxiety. Of the instruments tested, the WLQ and the WPAI questionnaire demonstrated acceptable validity and internal reliability.

Development and Validation of A Scheduled Shifts Staffing (ASSiST) Measure of Unit-Level Staffing in Nursing Homes.

PubMed

Cummings, Greta G; Doupe, Malcolm; Ginsburg, Liane; McGregor, Margaret J; Norton, Peter G; Estabrooks, Carole A

2017-06-01

To (a) describe A Scheduled Shifts Staffing measure (ASSiST) to derive care aide worked hours per resident day (HCA WHRD) at facility and unit levels in nursing homes, (b) report reliability through comparisons to administrative staffing data; (c) report validity by examining associations between HCA WHRD, staff outcomes (job satisfaction, emotional exhaustion), and resident quality indicators (QIs) (e.g. falls, delirium, stage 2+ pressure ulcers), and (d) explore intrafacility variation in staffing intensity levels related to unit-level variation in resident and staff outcomes. We used data from 40 care units in 12 Canadian nursing homes between 2007 and 2012. Descriptive statistics and tests of association and difference described relationships of two measures of staffing with resident and staff outcomes. Annualized rates of HCA WHRD from both data sources compared well at the facility level (Pearson Product Correlation; R = 0.847, p < .001), and were correlated similarly to staff work life and many QIs. Using ASSiST data, we show that staffing levels can vary by up to 40% at the unit-level within nursing homes. ASSiST is easy to collect, more timely to retrieve than administrative data, has good criterion and construct validity, and reflects intrafacility variation in health care aide staffing levels. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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

PubMed

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

2018-02-28

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

Telepressure and College Student Employment: The Costs of Staying Connected Across Social Contexts.

PubMed

Barber, Larissa K; Santuzzi, Alecia M

2017-02-01

Telepressure is a psychological state consisting of the preoccupation and urge to respond quickly to message-based communications from others. Telepressure has been linked with negative stress and health outcomes, but the existing measure focuses on experiences specific to the workplace. The current study explores whether an adapted version of the workplace telepressure measure is relevant to general social interactions that rely on information and communication technologies. We validated a general telepressure measure in a sample of college students and found psychometric properties similar to the original workplace measure. Also, general telepressure was related to, but distinct from, the fear of missing out, self-control and technology use. Using a predictive validity design, we also found that telepressure at the beginning of the semester was related to student reports of burnout, perceived stress and poor sleep hygiene 1 month later (but not work-life balance or general life satisfaction). Moreover, telepressure was more strongly related to more negative outcomes (burnout, stress and poor sleep hygiene) and less positive outcomes (work-life balance and life satisfaction) among employed compared with non-employed students. Thus, the costs of staying connected to one's social network may be more detrimental to college students with additional employment obligations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Predictors of assistive technology use: the importance of personal and psychosocial factors.

PubMed

Scherer, Marcia J; Sax, Caren; Vanbiervliet, Alan; Cushman, Laura A; Scherer, John V

2005-11-15

To validate an assistive technology (AT) baseline and outcomes measure and to quantify the measure's value in determining the best match of consumer and AT considering consumer ratings of their subjective quality of life, mood, support from others, motivation for AT use, program/therapist reliance, and self-determination/self-esteem. Prospective multi-cohort study. Vocational rehabilitation offices and community. Over 150 vocational rehabilitation counselors in 25 U.S. states with one consumer each receiving new AT. Counselor training in the Matching Person and Technology (MPT) Model and consumer completion of the MPT measure, Assistive Technology Device Predisposition Assessment (ATD PA). Total and subscale scores on the ATD PA as well as counselor-completed questionnaires. ATD PA items differentiated consumer predispositions to AT use as well as AT and user match. There were no significant differences due to gender, physical locality, or age within this sample of working-age adult consumers. Vocational rehabilitation counselors exposed to training in the MPT Model achieved enhanced AT service delivery outcomes. The ATD PA is a valid measure of predisposition to use an AT and the subsequent match of AT and user. Rehabilitation practitioners who use the ATD PA will achieve evidence-based practice and can expect to see enhanced AT service delivery outcomes.

Systematic review of middle ear implants: do they improve hearing as much as conventional hearing AIDS?

PubMed

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

2010-12-01

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

Development and Validation of the "iCAN!"--A Self-Administered Questionnaire Measuring Outcomes/Competences and Professionalism of Medical Graduates

ERIC Educational Resources Information Center

Dimoliatis, Ioannis D. K.; Lyrakos, Georgios N.; Tseretopoulou, Xanthippi; Tzamalis, Theodoros; Bazoukis, George; Benos, Alexis; Gogos, Charalambos; Malizos, Konstantinos; Pneumatikos, Ioannis; Thermos, Kyriaki; Kaldoudi, Eleni; Tzaphlidou, Margaret; Papadopoulos, Iordanis N.; Jelastopulu, Eleni

2014-01-01

The Tuning-Medicine Project produced a set of "level one" and "level two" learning outcomes/competences to be met by European medical graduates. In the learner-centered era self-assessment becomes more and more important. Our aim was to develop a self-completion questionnaire ("iCAN!") evaluating graduates' learning…

Development and validation of the Australian version of the Birth Satisfaction Scale-Revised (BSS-R).

PubMed

Jefford, Elaine; Hollins Martin, Caroline J; Martin, Colin R

2018-02-01

The 10-item Birth Satisfaction Scale-Revised (BSS-R) has recently been endorsed by international expert consensus for global use as the birth satisfaction outcome measure of choice. English-language versions of the tool include validated UK and US versions; however, the instrument has not, to date, been contextualised and validated in an Australian English-language version. The current investigation sought to develop and validate an English-language version of the tool for use within the Australian context. A two-stage study. Following review and modification by expert panel, the Australian BSS-R (A-BSS-R) was (Stage 1) evaluated for factor structure, internal consistency, known-groups discriminant validity and divergent validity. Stage 2 directly compared the A-BSS-R data set with the original UK data set to determine the invariance characteristics of the new instrument. Participants were a purposive sample of Australian postnatal women (n = 198). The A-BSS-R offered a good fit to data consistent with the BSS-R tridimensional measurement model and was found to be conceptually and measurement equivalent to the UK version. The A-BSS-R demonstrated excellent known-groups discriminant validity, generally good divergent validity and overall good internal consistency. The A-BSS-R represents a robust and valid measure of the birth satisfaction concept suitable for use within Australia and appropriate for application to International comparative studies.

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.

[Systematic development of a scale for determination of health-related quality of life in multiple trauma patients. The Polytrauma Outcome (POLO) Chart].

PubMed

Pirente, N; Bouillon, B; Schäfer, B; Raum, M; Helling, H J; Berger, E; Neugebauer, E

2002-05-01

Even years after having sustained multiple injuries patients often suffer from its sequelae. These comprise restrictions in physical function, but also pain, social and psychological impairments. Although the Meran Consensus Conference in 1990 defined the contents of "quality of life" (QoL) measures in surgery, still no instrument is available for the valid assessment of all relevant QoL domains in multiple injured patients. This paper describes the systematic development of a modular instrument for the assessment of health related QoL. Within three phases (phase I: generation of items, phase II: item reduction, phase III: pre-testing in 70 multiple injured and control patients) a questionnaire of 57 items was developed, which measures all relevant trauma-related aspects of QoL after acute hospital care. In combination with the Glascow Outcome Scale (GOS), the EUROQOL and the SF-36, the newly developed instrument builds the Polytrauma Outcome Chart (POLO-Chart) which will also be used as "Part E" for outcome assessment within the "Trauma registry" of the German Society for Trauma Surgery. In phase IV, the POLO-Chart will finally be validated in five trauma centres (Celle, Essen, Hanover, Cologne und Munich).

Combined Medication and CBT for Generalized Anxiety Disorder with African American Participants: Reliability and Validity of Assessments and Preliminary Outcomes

PubMed Central

Markell, Hannah M.; Newman, Michelle G.; Gallop, Robert; Gibbons, Mary Beth Connolly; Rickels, Karl; Crits-Christoph, Paul

2014-01-01

Using data from a study of combined cognitive behavioral therapy (CBT) and venlafaxine XR in the treatment of generalized anxiety disorder (GAD), the current article examines the reliability and convergent validity of scales, and preliminary outcomes, for African American compared to European American patients. Internal consistency and short-term stability coefficients for African Americans (n=42) were adequate and similar or higher compared to those found for European Americans (n=164) for standard scales used in GAD treatment research. Correlations among outcome measures among African Americans were in general not significantly different for African Americans compared to European Americans. A subset of patients with DSM-IV–diagnosed GAD (n = 24 African Americans; n = 52 European Americans) were randomly selected to be offered the option of adding 12 sessions of CBT to venlafaxine XR treatment. Of those offered CBT, 33.3% (n = 8) of the African Americans, and 32.6% (n = 17) of the European Americans accepted and attended at least one CBT treatment session. The outcomes for African Americans receiving combined treatment were not significantly different from European Americans receiving combined treatment on primary or secondary efficacy measures. PMID:24912462

Transcultural and psychometric validation of the Dispositional Resilience Scale (DRS-15) in Chinese adult women.

PubMed

Wong, Janet Yuen-Ha; Fong, Daniel Yee-Tak; Choi, Anna Wai-Man; Chan, Claudia Kor-Yee; Tiwari, Agnes; Chan, Ko Ling; Lai, Vincent; Logan, Tk; Bartone, Paul

2014-11-01

The aim of this study was to report translation and transcultural adaptation of the 15-item Dispositional Resilience Scale in traditional Chinese (C-DRS-15) and evaluate its psychometric properties. The DRS is a self-report instrument that measures psychological hardiness. We followed an international standard of cross-cultural translation and validation of patient-reported outcome measures to create the Chinese version. Then, the translated C-DRS-15 was validated on 542 Chinese women from a population-based sample in Hong Kong. The internal consistency and criterion-related validity were investigated. Exploratory and confirmatory factor analysis revealed that the C-DRS-15 was supported by a modified three-factor structure in our Chinese sample (RMSEA = .06, CFI = .94, TLI = .92, and SRMR = .06). The reliability (Cronbach's α coefficient = .78) and validity were satisfactory. Total resilience score was negatively correlated with depression (p < .001), with non-depressed women scoring higher on the C-DRS-15. The C-DRS-15 was demonstrated to be a reliable and valid measurement to assess hardiness in Chinese women.

Measuring factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures

PubMed Central

2013-01-01

Background Two of the current methodological barriers to implementation science efforts are the lack of agreement regarding constructs hypothesized to affect implementation success and identifiable measures of these constructs. In order to address these gaps, the main goals of this paper were to identify a multi-level framework that captures the predominant factors that impact implementation outcomes, conduct a systematic review of available measures assessing constructs subsumed within these primary factors, and determine the criterion validity of these measures in the search articles. Method We conducted a systematic literature review to identify articles reporting the use or development of measures designed to assess constructs that predict the implementation of evidence-based health innovations. Articles published through 12 August 2012 were identified through MEDLINE, CINAHL, PsycINFO and the journal Implementation Science. We then utilized a modified five-factor framework in order to code whether each measure contained items that assess constructs representing structural, organizational, provider, patient, and innovation level factors. Further, we coded the criterion validity of each measure within the search articles obtained. Results Our review identified 62 measures. Results indicate that organization, provider, and innovation-level constructs have the greatest number of measures available for use, whereas structural and patient-level constructs have the least. Additionally, relatively few measures demonstrated criterion validity, or reliable association with an implementation outcome (e.g., fidelity). Discussion In light of these findings, our discussion centers on strategies that researchers can utilize in order to identify, adapt, and improve extant measures for use in their own implementation research. In total, our literature review and resulting measures compendium increases the capacity of researchers to conceptualize and measure implementation-related constructs in their ongoing and future research. PMID:23414420

Developing a measure of medication-related quality of life for people with polypharmacy.

PubMed

Tseng, Hsu-Min; Lee, Chia-Hui; Chen, Yin-Jen; Hsu, Hsiang-Hao; Huang, Li-Yueh; Huang, Jing-Long

2016-05-01

To develop a measure of medication-related quality of life (MRQoL) and to validate the measure in a hospital-based population of patients with polypharmacy. The Medication-Related Quality of Life Scale version 1.0 (MRQoLS-v1.0) included 14 items developed on the basis of interviews with elderly patients with polypharmacy, defined as taking five or more medications simultaneously. This scale was tested in 219 outpatients (99 with polypharmacy and 120 without polypharmacy). Two measures were used to establish construct validity the Psychological Distress Checklist, for convergent validity, and the Medication Adherence Behavior Scale (MABS), for discriminant validity. The 14-item scale was found to be both reliable and valid. Internal consistency reliability evaluated using Cronbach's alpha for this scale was 0.91. Scores on the MRQoLS-v1.0 correlated statistically significantly and negatively with those on the Psychological Distress Checklist. Discriminant validity was demonstrated by low correlation with MABS, indicating that the MRQoLS-v1.0 measured concepts different from medication adherence. Significant differences in the MRQoLS-v1.0 between patients with polypharmacy and those without polypharmacy provided evidence for known-group validity. The study presents a psychometric evaluation of a measure used to assess MRQoL of patients with polypharmacy. The instrument is practical to administer in clinics and provides a valuable adjunct to the outcome measurement for patients with polypharmacy. Further research on the sensitivity of this instrument to medication change in multi-medicated patients is warranted.

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.

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.

The validity of health-related quality of life questionnaires in bronchiectasis: a systematic review and meta-analysis.

PubMed

Spinou, Arietta; Fragkos, Konstantinos C; Lee, Kai K; Elston, Caroline; Siegert, Richard J; Loebinger, Michael R; Wilson, Robert; Garrod, Rachel; Birring, Surinder S

2016-08-01

A range of questionnaires have been used to assess health-related quality of life (HRQOL) in bronchiectasis. A systematic review was conducted to evaluate their psychometric properties and assess associations between HRQOL and clinical measures. Five electronic databases were searched. Studies eligible for inclusion were those that investigated the validity of HRQOL questionnaires and/or their association with other outcomes in adults with bronchiectasis. Patients with cystic fibrosis were excluded. The identified questionnaires were assessed for convergent, discriminant and cross-cultural translation validity; missing data, floor and ceiling effects, internal consistency, responsiveness and test-retest reliability. A meta-analysis was conducted to estimate the strength of associations between HRQOL and clinical measures. From 1918 studies identified, 43 studies were included in the systematic review, of which 38 were suitable for the meta-analysis. Nine HRQOL questionnaires were identified, with the most widely used being: St George's Respiratory Questionnaire, Leicester Cough Questionnaire, Quality of Life-Bronchiectasis and Short Form-36. HRQOL questionnaires had moderate to good internal consistency and good test-retest reliability. Only 8 of 18 studies that used translated HRQOL questionnaires reported or referred to the validity of the translated questionnaire. There was a stronger correlation (mean r (95% CI)) between HRQOL and subjective outcome measures, such as dyspnoea (0.55 (0.41 to 0.68)) and fatigue (0.42 (0.23 to 0.58)) compared with objective measures; exercise capacity (-0.41 (-0.54 to -0.24)), FEV1% predicted (-0.31 (-0.40 to -0.23)) and extent of bronchiectasis on CT scan (0.35 (0.03 to 0.61)); all p<0.001. This review supports most HRQOL questionnaires used in bronchiectasis have good psychometric properties. There was a weak to moderate association between HRQOL and objective outcome measures. This suggests that HRQOL questionnaires assess a unique aspect of health not captured by objective measures. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Flexibility Scale: Development and Preliminary Validation of a Cognitive Flexibility Measure in Children with Autism Spectrum Disorders.

PubMed

Strang, John F; Anthony, Laura G; Yerys, Benjamin E; Hardy, Kristina K; Wallace, Gregory L; Armour, Anna C; Dudley, Katerina; Kenworthy, Lauren

2017-08-01

Flexibility is a key component of executive function, and is related to everyday functioning and adult outcomes. However, existing informant reports do not densely sample cognitive aspects of flexibility; the Flexibility Scale (FS) was developed to address this gap. This study investigates the validity of the FS in 221 youth with ASD and 57 typically developing children. Exploratory factor analysis indicates a five-factor scale: Routines/rituals, transitions/change, special interests, social flexibility, and generativity. The FS demonstrated convergent and divergent validity with comparative domains of function in other measures, save for the Generativity factor. The FS discriminated participants with ASD and controls. Thus, this study suggests the FS may be a viable, comprehensive measure of flexibility in everyday settings.

Variables influencing wearable sensor outcome estimates in individuals with stroke and incomplete spinal cord injury: a pilot investigation validating two research grade sensors.

PubMed

Jayaraman, Chandrasekaran; Mummidisetty, Chaithanya Krishna; Mannix-Slobig, Alannah; McGee Koch, Lori; Jayaraman, Arun

2018-03-13

Monitoring physical activity and leveraging wearable sensor technologies to facilitate active living in individuals with neurological impairment has been shown to yield benefits in terms of health and quality of living. In this context, accurate measurement of physical activity estimates from these sensors are vital. However, wearable sensor manufacturers generally only provide standard proprietary algorithms based off of healthy individuals to estimate physical activity metrics which may lead to inaccurate estimates in population with neurological impairment like stroke and incomplete spinal cord injury (iSCI). The main objective of this cross-sectional investigation was to evaluate the validity of physical activity estimates provided by standard proprietary algorithms for individuals with stroke and iSCI. Two research grade wearable sensors used in clinical settings were chosen and the outcome metrics estimated using standard proprietary algorithms were validated against designated golden standard measures (Cosmed K4B2 for energy expenditure and metabolic equivalent and manual tallying for step counts). The influence of sensor location, sensor type and activity characteristics were also studied. 28 participants (Healthy (n = 10); incomplete SCI (n = 8); stroke (n = 10)) performed a spectrum of activities in a laboratory setting using two wearable sensors (ActiGraph and Metria-IH1) at different body locations. Manufacturer provided standard proprietary algorithms estimated the step count, energy expenditure (EE) and metabolic equivalent (MET). These estimates were compared with the estimates from gold standard measures. For verifying validity, a series of Kruskal Wallis ANOVA tests (Games-Howell multiple comparison for post-hoc analyses) were conducted to compare the mean rank and absolute agreement of outcome metrics estimated by each of the devices in comparison with the designated gold standard measurements. The sensor type, sensor location, activity characteristics and the population specific condition influences the validity of estimation of physical activity metrics using standard proprietary algorithms. Implementing population specific customized algorithms accounting for the influences of sensor location, type and activity characteristics for estimating physical activity metrics in individuals with stroke and iSCI could be beneficial.

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 challenges in caregiver communication, continuity of care, and earlier detection of acuity trends. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

The Feasibility of First Step to Success with Preschoolers.

PubMed

Frey, Andy J; Small, Jason; Feil, Edward; Seeley, John; Walker, Hill; Golly, Annemieke

2013-07-01

The primary purpose of this study was to examine feasibility of the preschool version of the First Step to Success (FSS) intervention. Toward this end, the following four research questions were addressed: (1) To what extent was the intervention implemented with integrity? (2) To what extent do teachers and parents perceive the intervention to be socially valid? (3) To what extent were teachers and parents satisfied with the intervention? and (4) To what extent was the intervention effective in reducing problem behavior and improving social skills? Twelve students participated in the study. Treatment integrity, social validity, and satisfaction results were analyzed at the aggregate level, and a reliable change index was calculated at the case level for primary outcome measures to assess the potential efficacy of the intervention. Fidelity data suggest the preschool version of the intervention can be implemented with acceptable integrity by coaches and teachers in preschool settings. Social validity outcomes suggest parents' perceptions of the program's goals, procedures, and outcomes were extremely favorable, and social validity from the teacher perspective was acceptable. The results provide initial evidence that participating in the preschool version of the FSS intervention improves children's social skills and decreases problem behavior.

The Feasibility of First Step to Success with Preschoolers

PubMed Central

Frey, Andy J.; Small, Jason; Feil, Edward; Seeley, John; Walker, Hill; Golly, Annemieke

2017-01-01

The primary purpose of this study was to examine feasibility of the preschool version of the First Step to Success (FSS) intervention. Toward this end, the following four research questions were addressed: (1) To what extent was the intervention implemented with integrity? (2) To what extent do teachers and parents perceive the intervention to be socially valid? (3) To what extent were teachers and parents satisfied with the intervention? and (4) To what extent was the intervention effective in reducing problem behavior and improving social skills? Twelve students participated in the study. Treatment integrity, social validity, and satisfaction results were analyzed at the aggregate level, and a reliable change index was calculated at the case level for primary outcome measures to assess the potential efficacy of the intervention. Fidelity data suggest the preschool version of the intervention can be implemented with acceptable integrity by coaches and teachers in preschool settings. Social validity outcomes suggest parents’ perceptions of the program’s goals, procedures, and outcomes were extremely favorable, and social validity from the teacher perspective was acceptable. The results provide initial evidence that participating in the preschool version of the FSS intervention improves children’s social skills and decreases problem behavior. PMID:29225519

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.

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.

[Development of the Portuguese version of MOS SF-36. Part I. Cultural and linguistic adaptation].

PubMed

Ferreira, P L

2000-01-01

No one aims at applying generic measures as substitutes for other more traditional clinical procedures. The whole history of the evolution of these types of measures has been based on comparisons with clinical measures, always seen by researchers as ways to validate health outcome measures and as a process to be recognized by clinicians as a way to detect changes in time not always detected by the usual measures. The measurement instrument presented in this paper is the Portuguese version of the MOS SF-36, originally a result of the Medical Outcomes Study, a study carried out by Rand Corporation researchers in the 80's. One of the objectives of these researchers was precisely to develop instruments to be used in continuous monitoring of outcomes. This paper describes the first time MOS SF-36 was culturally adapted to Portuguese, validated and implemented. The first part mentions some of the foundations and developments of the original instrument as well as some results obtained from some specific applications. The second part introduces operational definitions for each of the eight scales and describes the SF-36 measurement model as well as the factor structure with two dimensions. Next, we present the design used by us to transform the data from the time they are collected from the respondents to the time they are ready to be further used. Finally, the methodology used to culturally adapt the MOS SF-36 and create a Portuguese version which is culturally equivalent are presented.

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 the paper and electronic modes of administration. These correlation coefficients demonstrated similar results with an overall value of 0.86.On the basis of the correlation coefficients, the electronic application of commonly used knee outcome scores compare variably to the traditional paper variants with a high rate of test-retest correlation. This equivalence supports the use of the condensed electronic outcomes system and validates comparison of scores between electronic and paper modes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Criterion validity study of the cervical range of motion (CROM) device for rotational range of motion on healthy adults.

PubMed

Tousignant, Michel; Smeesters, Cécil; Breton, Anne-Marie; Breton, Emilie; Corriveau, Hélène

2006-04-01

This study compared range of motion (ROM) measurements using a cervical range of motion device (CROM) and an optoelectronic system (OPTOTRAK). To examine the criterion validity of the CROM for the measurement of cervical ROM on healthy adults. Whereas measurements of cervical ROM are recognized as part of the assessment of patients with neck pain, few devices are available in clinical settings. Two papers published previously showed excellent criterion validity for measurements of cervical flexion/extension and lateral flexion using the CROM. Subjects performed neck rotation, flexion/extension, and lateral flexion while sitting on a wooden chair. The ROM values were measured by the CROM as well as the OPTOTRAK. The cervical rotational ROM values using the CROM demonstrated a good to excellent linear relationship with those using the OPTOTRAK: right rotation, r = 0.89 (95% confidence interval, 0.81-0.94), and left rotation, r = 0.94 (95% confidence interval, 0.90-0.97). Similar results were also obtained for flexion/extension and lateral flexion ROM values. The CROM showed excellent criterion validity for measurements of cervical rotation. We propose using ROM values measured by the CROM as outcome measures for patients with neck pain.

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.

Measuring Meaningful Outcomes in Consequential Contexts: Searching for a Happy Medium in Educational Technology Research (Phase II)

ERIC Educational Resources Information Center

Ross, Steven M.; Morrison, Jennifer R.

2014-01-01

In a paper published 25 years ago, Ross and Morrison ("Educ Technol Res Dev" 37(1):19-33, 1989) called for a "happy medium" in educational technology research, to be achieved by balancing high rigor of studies (internal validity) with relevance to real-world applications (external validity). In this paper, we argue that,…