Dataset Information

Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure.

ABSTRACT: Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ? correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach ?) coefficients ranged from 0.52 to 0.96, with ??0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ?0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/?>0.60) and divergent validity ( r/?<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.

SUBMITTER: Ahmad FS

PROVIDER: S-EPMC6711378 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure.

Ahmad Faraz S FS Kallen Michael A MA Schifferdecker Karen E KE Carluzzo Kathleen L KL Yount Susan E SE Gelow Jill M JM McCullough Peter A PA Kimmel Stephen E SE Fisher Elliot S ES Cella David D

Circulation. Heart failure 20190605 6

Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®- ...[more]

PMID: 31163985

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Project description:AimsHeart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®-Plus-HF (PROMIS+HF) profile measure, including universal and HF-specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use.Methods and resultsCandidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF-27 and PROMIS+HF-10 profiles with summary scores (0-100) for overall, physical, mental, and social health. In a cross-sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman-Brown), test-retest reliability (intraclass coefficient; n = 100), known-groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow-up scores by calculating mean differences and Cohen's d and comparing with paired t-tests. Internal consistency was good to excellent (α 0.82-0.94) for all PROMIS+HF-27 scores and acceptable to good (α/Spearman-Brown 0.60-0.85) for PROMIS+HF-10 scores. Test-retest intraclass coefficients were acceptable to excellent (0.75-0.97). Both profiles demonstrated known-groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF-27 and PROMIS+HF-10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group-based increase of 7.6-8.3 points represented a small to medium change (Cohen's d = 0.40-0.42). For the PROMIS+HF physical summary scores, a group-based increase of 5.0-5.9 points represented a small to medium change (Cohen's d = 0.29-0.35).ConclusionsThe PROMIS+HF-27 and PROMIS+HF-10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient-centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision-making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline-directed medical therapy.

Project description:BackgroundActivation of a family member refers to their desire, knowledge, confidence, and skills that can inform engagement in healthcare. Family activation combined with opportunity can lead to engagement in care. No tool currently exists to measure family activation in acute care. Therefore, we aimed to develop and validate a tool to measure family activation in acute care.MethodsAn interdisciplinary team of content experts developed the FAMily Activation Measure (FAM-Activate) through an iterative process. The FAM-Activate tool is a 4-item questionnaire with 5 Likert-type response options (ranging from strongly agree to strongly disagree). Scale scores are converted to a 0-100 point scoring range so that higher FAM-Activate scores indicate increased family activation. An overall FAM-Activate score (range 0-100) is calculated by adding the scores for each item and dividing by 4. We conducted reliability and predictive validity assessments to validate the instrument by administering the FAM-Activate tool to family members of patients in an acute cardiac unit at a tertiary care hospital. We obtained preliminary estimates of family engagement and satisfaction with care.ResultsWe surveyed 124 family participants (age 54.1±14.4; 73% women; 34% non-white). Participants were predominantly the adult child (38%) or spouse/partner (36%) of patients. The mean FAM-Activate score during hospitalization was 84.1±16.1. FAM-Activate had acceptable internal consistency (Cronbach's a = 0.74) and showed test-retest responsiveness. FAM-Activate was moderately correlated with engagement behavior (Pearson's correlation r = 0.47, P <0.0001). The FAM-Activate score was an independent predictor of family satisfaction, after adjusting for age, gender, relationship, and living status.ConclusionThe FAM-Activate tool was reliable and had predictive validity in the acute cardiac population. Further research is needed to explore whether improving family activation can lead to improved family engagement in care.

Project description:Assessment environment, synonymous with climate or atmosphere, is multifaceted. Although there are valid and reliable instruments for measuring the educational environment, there is no validated instrument for measuring the assessment environment in medical programs. This study aimed to develop an instrument for measuring students' perceptions of the assessment environment in an undergraduate medical program and to examine the psychometric properties of the new instrument.The Assessment Environment Questionnaire (AEQ), a 40-item, four-point (1=Strongly Disagree to 4=Strongly Agree) Likert scale instrument designed by the authors, was administered to medical undergraduates from the authors' institution. The response rate was 626/794 (78.84%). To establish construct validity, exploratory factor analysis (EFA) with principal component analysis and varimax rotation was conducted. To examine the internal consistency reliability of the instrument, Cronbach's α was computed. Mean scores for the entire AEQ and for each factor/subscale were calculated. Mean AEQ scores of students from different academic years and sex were examined.Six hundred and eleven completed questionnaires were analysed. EFA extracted four factors: feedback mechanism (seven items), learning and performance (five items), information on assessment (five items), and assessment system/procedure (three items), which together explained 56.72% of the variance. Based on the four extracted factors/subscales, the AEQ was reduced to 20 items. Cronbach's α for the 20-item AEQ was 0.89, whereas Cronbach's α for the four factors/subscales ranged from 0.71 to 0.87. Mean score for the AEQ was 2.68/4.00. The factor/subscale of 'feedback mechanism' recorded the lowest mean (2.39/4.00), whereas the factor/subscale of 'assessment system/procedure' scored the highest mean (2.92/4.00). Significant differences were found among the AEQ scores of students from different academic years.The AEQ is a valid and reliable instrument. Initial validation supports its use to measure students' perceptions of the assessment environment in an undergraduate medical program.

Project description:PurposeFibromyalgia (FM) is characterized by myriad symptoms and problems. Fatigue is one of the most common, distressing, and disabling symptoms in FM. The purpose of this study was to use fatigue item banks that were developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) to devise a self-report measure of fatigue for use in individuals with FM.MethodsA sample of 532 adults with FM (age range = 18-77, 96.1 % female) completed the PROMIS fatigue item bank. Factor analyses and item response theory analyses were used to identify dimensionality and optimally performing items. These data were used in combination with clinical input to select items for a fatigue self-report measure for use in FM.ResultsFactor analyses revealed four distinct factors in the PROMIS fatigue item bank; items for each univariate subscale were identified by selecting four items with high item information values. A 16-item measure, the PROMIS FatigueFM Profile, consisting of four 4-item short forms reflecting fatigue experience ("intensity") and fatigue impact in three subdomains-social, cognitive, and motivation-was created. The new PROMIS FatigueFM Profile short forms showed excellent internal reliability, low ceiling and floor effects, and equivalent or higher test information compared to the standard 4- and 7-item PROMIS fatigue short forms.ConclusionsThe newly developed PROMIS FatigueFM Profile, a 16-item measure consisting of four 4-item short forms of self-reported fatigue severity, shows early evidence of good psychometric characteristics, provides the ability to use short forms that assess distinct aspects of fatigue experience and fatigue impact, and demonstrates equivalent or higher levels of test information compared to standard PROMIS fatigue short forms with similar number of items. The PROMIS FatigueFM Profile indicated fatigue experience and impact levels approximately 1.5 standard deviations above the normative sample mean across all short forms. Future work to evaluate the validity and reliability of this new measure in individuals with FM is needed.

Dataset Information

Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure.

Publications

Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure.

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