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PURPOSE: Practical considerations precluding health-related quality of life (HRQOL) monitoring in population and clinical research have spawned development of improved items for more brief surveys of frequently measured HRQOL outcomes. The aim of this study was to validate the use of the Quality of Life General (QGEN-8), a shorter 8-item alternative to the longer 36-item short form (SF)-36 Health Survey for measuring the same eight HRQOL domains across groups of adults with varying severity of acute respiratory symptoms, such as cough and sore throat. METHODS: National Opinion Research Center (NORC) representative probability (N = 1,648) and supplemental opt-in (N = 5,915) U.S. adult samples were surveyed cross-sectionally online in 2020. Parallel analyses compared QGEN-8 and SF-36 estimates of group means for each of eight matching profile domains and summary physical and mental scores across groups differing in severity of acute symptoms and chronic respiratory conditions using analysis of covariance (ANCOVAs) controlling for socio-demographics and presence of chronic respiratory conditions. RESULTS: In support of discriminant validity, ANCOVA estimates of QGEN-8 means with SF-36 estimates revealed the same patterns of declining HRQOL with the presence and increasing severity of symptoms and chronic condition severity. CONCLUSION: QGEN-8® shows satisfactory validity and warrants further testing in cross-sectional and longitudinal population and clinical survey research as a more practical method for estimating group differences in SF-36 profile and summary component HRQOL scores.
Upper respiratory tract infections (URTI) with symptoms such as cough and sore throat are highly prevalent and negatively impact on health-related quality of life (HRQOL). Existing instruments that comprehensively measure HRQOL are lengthy, potentially increasing respondent burden and restricting their use in clinical studies and research. The aim of this study was to evaluate whether eight newly constructed survey items, the QGEN-8®, measure the same HRQOL outcomes as the 36-item SF-36 Health Survey well enough to serve as a more practical alternative for purposes of detecting the physical and mental HRQOL effects on differing severity of acute URTI symptoms, specifically cough and sore throat. The results showed that the QGEN-8® was psychometrically sound and able to differentiate between different levels of URTI symptoms, even in cases where respondents had chronic respiratory conditions. This indicates that the briefer QGEN-8® with 75% shorter response time is able to provide HRQOL measurements comparable to those derived from lengthier instruments thereby lending itself more readily to use in clinical studies and research of URTI symptoms, such as cough and sore throat.
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PURPOSE: Upper respiratory tract infections (URTI) and related symptoms are widespread and a common reason for visiting primary care with cough and sore throat being most prevalent. Despite their impact on daily activities, no studies have explored the impact on health-related quality of life (HRQOL) in representative general populations. We aimed to understand the short-term impact of the two most prevalent URTI symptoms on HRQOL. METHODS: Online 2020 surveys including acute (≤ 4 weeks) respiratory symptoms (sore throat and cough) and SF-36® health survey (all with 4-week recall) were analysed using analysis of covariance (ANCOVA) in comparison with adult US population norms. Linear T-score transformation of SF-6D utility (ranging from 0 to 1) enabled direct comparisons with SF-36. RESULTS: In total, 7563 US adults responded (average age: 52 years; range: 18-100 years). Sore throat and cough lasting at least several days were experienced by 14% and 22% participants, respectively. Chronic respiratory conditions were reported by 22% of the sample. A clear and consistent pattern of group HRQOL means declining significantly (p < 0.001) for acute cough and sore throat symptom presence and severity. Declines were observed on SF-36 physical (PCS) and mental component (MCS) and health utility (SF-6D) scores controlling for covariates. Those reporting respiratory symptoms 'most days' declined ≥ 0.5 standard deviation (minimal important difference [MID]) worse with averages at the 19th and 34th centiles for cough on the PCS and MCS, and 21st to 26th centile for sore throat. CONCLUSION: Declines in HRQOL with acute cough and sore throat symptoms consistently exceeded MID standards and should not be ignored as self-limiting without intervention. Future studies on early self-care for symptom relief and its implications on HRQOL and health economics would be valuable to understand the benefits on healthcare burden and need for updating treatment guidelines.
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Faringitis , Infecciones del Sistema Respiratorio , Adulto , Humanos , Persona de Mediana Edad , Calidad de Vida/psicología , Tos/epidemiología , Faringitis/epidemiología , Infecciones del Sistema Respiratorio/epidemiología , Encuestas EpidemiológicasRESUMEN
BACKGROUND: Interpretation of health-related quality of life (QOL) outcomes requires improved methods to control for the effects of multiple chronic conditions (MCC). This study systematically compared legacy and improved method effects of aggregating MCC on the accuracy of predictions of QOL outcomes. METHODS: Online surveys administered generic physical (PCS) and mental (MCS) QOL outcome measures, the Charlson Comorbidity Index (CCI), an expanded chronic condition checklist (CCC), and individualized QOL Disease-specific Impact Scale (QDIS) ratings in a developmental sample (N = 5490) of US adults. Controlling for sociodemographic variables, regression models compared 12- and 35-condition checklists, mortality vs. population QOL-weighting, and population vs. individualized QOL weighting methods. Analyses were cross-validated in an independent sample (N = 1220) representing the adult general population. Models compared estimates of variance explained (adjusted R2) and model fit (AIC) for generic PCS and MCS across aggregation methods at baseline and nine-month follow-up. RESULTS: In comparison with sociodemographic-only regression models (MCS R2 = 0.08, PCS = 0.09) and Charlson CCI models (MCS R2 = 0.12, PCS = 0.16), increased variance was accounted for using the 35-item CCC (MCS R2 = 0.22, PCS = 0.31), population MCS/PCS QOL weighting (R2 = 0.31-0.38, respectively) and individualized QDIS weighting (R2 = 0.33 & 0.42). Model R2 and fit were replicated upon cross-validation. CONCLUSIONS: Physical and mental outcomes were more accurately predicted using an expanded MCC checklist, population QOL rather than mortality CCI weighting, and individualized rather than population QOL weighting for each reported condition. The 3-min combination of CCC and QDIS ratings (QDIS-MCC) warrant further testing for purposes of predicting and interpreting QOL outcomes affected by MCC.
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Afecciones Crónicas Múltiples , Calidad de Vida , Adulto , Enfermedad Crónica , Humanos , Multimorbilidad , Encuestas y CuestionariosRESUMEN
PURPOSE: Adults with autism spectrum disorder (ASD) consistently report worse functional health and well-being, compared to neurotypical (NT) peers. In a series of studies, we aimed to elucidated the effects of sex, age, and their interaction on health-related quality of life (HRQoL) and evaluated the effectiveness of mindfulness-based stress reduction (MBSR) for improving health-, disability-, and autism-related QoL, with possible sex and age outcome moderators, in adults with ASD. METHODS: Study 1 used the 36-Item Short Form Survey to compare mental and physical HRQoL composite scores in adults with ASD (n = 67) and matched NT adults (n = 66). Study 2 was a randomized pilot evaluation of the effect of MBSR, compared to an active control intervention with social support and relaxation education (support/education; n = 56), on the World Health Organization QoL BREF, Disability, and Autism-Specific scales in adults with ASD. RESULTS: In Study 1, we replicated findings that mental HRQoL is worse in both men and women with ASD, compared to NT counterparts, but physical HRQoL is only worse in women with ASD. We present novel findings that older age is associated with better mental HRQoL in women with ASD only. In Study 2, MBSR improved disability-related QoL in adults with ASD over and above the support/education intervention, but both interventions improved mental HRQoL. Lastly, both interventions were more effective for HRQoL improvements in women with ASD. CONCLUSION: Findings encourage precision medicine approaches tailored to age and sex groups for best HRQoL outcomes in adults with ASD. CLINICALTRIALS: gov Identifier: NCT04017793.
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Trastorno del Espectro Autista , Atención Plena , Adulto , Trastorno del Espectro Autista/terapia , Femenino , Humanos , Masculino , Proyectos Piloto , Calidad de Vida/psicología , Apoyo SocialRESUMEN
OBJECTIVE: The objective of this study was to develop the classification system for version of the SF-6D (SF-6Dv2) from the SF-36v2. SF-6Dv2 is an improved version of SF-6D, one of the most widely used generic measures of health for the calculation of quality-adjusted life years. STUDY DESIGN AND SETTING: A 3-step process was undertaken to generate a new classification system: (1) factor analysis to establish dimensionality; (2) Rasch analysis to understand item performance; and (3) tests of differential item function. To evaluate robustness, Rasch analyses were performed in multiple subsets of 2 large cross-sectional datasets from recently discharged hospital patients and online patient samples. RESULTS: On the basis of factor analysis, other psychometric evidence, cross-cultural considerations, and amenability to valuation, the 6-dimension classification used in SF-6D was maintained. SF-6Dv2 resulted in the following modifications to SF-6D: a simpler classification of physical function with clearer separation between levels; a more detailed 5-level description of role limitations; using negative wording to describe vitality; and using pain severity rather than pain interference. CONCLUSIONS: The SF-6Dv2 classification system describes more distinct levels of health than SF-6D, changes the descriptions used for a number of dimensions and provides clearer wording for health state valuation. The second stage of the study has developed a utility value set using discrete choice methods so that the measure can be used in health technology assessment. Further work should investigate the psychometric characteristics of the new instrument.
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Análisis Costo-Beneficio/métodos , Estado de Salud , Salud Mental , Rendimiento Físico Funcional , Encuestas y Cuestionarios/normas , Adolescente , Adulto , Anciano , Análisis Costo-Beneficio/normas , Estudios Transversales , Competencia Cultural , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/epidemiología , Psicometría , Años de Vida Ajustados por Calidad de Vida , Reproducibilidad de los Resultados , Participación Social , Factores Socioeconómicos , Adulto JovenRESUMEN
BACKGROUND: Patient-reported outcome measures that are more practical and clinically useful are needed for patients with CKD. We compared a new CKD-specific quality-of-life impact scale (CKD-QOL) with currently used measures. METHODS: Patients (n=485) in different treatment groups (nondialysis stages 3-5, on dialysis, or post-transplant) completed the kidney-specific CKD-QOL and Kidney Disease Quality of Life-36 (KDQOL-36) forms and the generic SF-12 Health Survey at baseline and 3 months. New items summarizing quality of life (QOL) impact attributed to CKD across six QOL domains yielded single impact scores from a six-item static (fixed-length) form and from computerized adaptive tests (CATs) with three to six items. Validity tests compared the CKD-QOL, KDQOL-36 (Burden, Effects, and Symptoms/Problems subscales), and generic SF-12 measures across groups in four tests of clinical status and clinician assessment of change (CKD-specific tests), and number of comorbidities. ANOVA was used to test for group mean differences, variances in each measure explained by groups, and relative validity (RV) in comparison with the referent KDQOL-36 Burden subscale. RESULTS: KDQOL-36 and CKD-QOL measures generally discriminated better than generic SF-12v2 measures. The pattern of variances across CKD-specific tests comparing validity favored CKD-QOL two-fold over KDQOL-36. Two RV test results confirmed CKD-QOL improvements over the referent KDQOL scale. Results for static and CAT CKD-QOL forms were similar. SF-12 Physical and KDQOL-36 Symptoms scores worsened with increasing comorbid condition counts. CONCLUSIONS: Overall, compared with the KDQOL-36, the new approach to summarizing CKD-specific QOL impact performed better across multiple tests of validity. CAT surveys were more efficient than static surveys.
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Medición de Resultados Informados por el Paciente , Calidad de Vida , Insuficiencia Renal Crónica , Adolescente , Adulto , Anciano , Estudios Transversales , Femenino , Estado de Salud , Humanos , Relaciones Interpersonales , Trasplante de Riñón , Masculino , Persona de Mediana Edad , Diálisis Renal , Insuficiencia Renal Crónica/fisiopatología , Insuficiencia Renal Crónica/psicología , Insuficiencia Renal Crónica/terapia , Adulto JovenRESUMEN
BACKGROUND: To document the development and evaluation of the Quality of life Disease Impact Scale (QDIS®), a measure that standardizes item content and scoring across chronic conditions and provides a summary, norm-based QOL impact score for each disease. METHODS: A bank of 49 disease impact items was constructed from previously-used descriptions of health impact to represent ten frequently-measured quality of life (QOL) content areas and operational definitions successfully utilized in generic QOL surveys. In contrast to health in general, all items were administered with attribution to a specific disease (osteoarthritis, rheumatoid arthritis, angina, myocardial infarction, congestive heart failure, chronic kidney disease (CKD), diabetes, asthma, or COPD). Responses from 5418 adults were analyzed as five disease groups: arthritis, cardiovascular, CKD, diabetes, and respiratory. Unidimensionality, item parameter and scale-level invariance, reliability, validity and responsiveness to change during 9-month follow-up were evaluated by disease group and for all groups combined using multi-group confirmatory factor analysis (MGCFA), item response theory (IRT) and analysis of variance methods. QDIS was normed in an independent chronically ill US population sample (N = 4120). RESULTS: MGCFA confirmed a 1-factor model, justifying a summary score estimated using equal parameters for each item across disease groups. In support of standardized IRT-based scoring, correlations were very high between disease-specific and standardized IRT item slopes (r = 0.88-0.96), thresholds (r = 0.93-0.99) and person-level scores (r ≥ 0.99). Internal consistency, test-retest and person-level IRT reliability were consistently satisfactory across groups. In support of interpreting QDIS as a disease-specific measure, in comparison with generic measures, QDIS consistently discriminated markedly better across disease severity levels, correlated higher with other disease-specific measures in cross-sectional tests, and was more responsive in comparisons of groups with better, same or worse evaluations of disease-specific outcomes at the 9-month follow-up. CONCLUSIONS: Standardization of content and scoring across diseases was shown to be justified psychometrically and enabled the first summary measure of disease-specific QOL impact normed in the chronically ill population. This disease-specific approach substantially improves discriminant validity and responsiveness over generic measures and provides a basis for better understanding the relative QOL impact of multiple chronic conditions in research and clinical practice.
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Enfermedad Crónica/psicología , Costo de Enfermedad , Calidad de Vida , Índice de Severidad de la Enfermedad , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Comorbilidad , Estudios Transversales , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psicometría , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
BACKGROUND: Assessment of health-related quality of life (HRQoL) is well established in clinical research, but ceiling effects in validated tools might prevent detection of changes in well respondents. Tobacco Quality of Life Impact Tool (TQOLITv1) uses conceptual and psychometric advances to enhance detection of HRQoL changes. METHODS: In a 6-month, forced-switch study, the German TQOLITv1 was assessed in healthy adult (age 23-55 years) current and matched former-smokers. At baseline, smokers were switched to reduced toxicant prototype (RTP) or conventional cigarette for 6 months. TQOLITv1 responses were collected at baseline, 3 and 6 months from current smokers whilst former smokers completed it at the latter two time points. TQOLITv1 includes SF-36v2 and new smoking-specific, physical and general-health measures. RESULTS: Reliability at baseline was good (Cronbach's coefficient alpha > 0.70) for all measures. The baseline percentage with the best possible score (ceiling effect) for former and current smokers was substantially better for the new physical function than SF-36 physical function measure (35% vs. 59% at ceiling, respectively). New smoking-specific measures discriminated current from former smokers better than general health measures. Smoking-specific symptoms (r = 0.73) were more stable from baseline to 6 months than other measures (r = 0.38-0.54) particularly more than the SF-36 mental component score (r = 0.24). Although both product smoking groups worsened in most HRQoL measures, changes in general and smoking-specific HRQoL impact measures favored RTP smokers. CONCLUSIONS: The German TQOLITv1 is sufficiently reliable and valid to assess HRQoL and may be more useful than SF-36v2 in evaluation of interventions in well smoking populations including those consuming RTPs.
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Indicadores de Salud , Calidad de Vida/psicología , Fumar/psicología , Encuestas y Cuestionarios/normas , Dispositivos para Dejar de Fumar Tabaco , Traducción , Adulto , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Psicometría , Reproducibilidad de los Resultados , Método Simple Ciego , Fumar/epidemiología , Prevención del Hábito de Fumar , Nicotiana , Productos de Tabaco/toxicidadRESUMEN
BACKGROUND: Health-related quality of life (QOL) surveys include generic measures that enable comparisons across conditions and measures that focus more specifically on one disease or condition. We evaluated the psychometric properties of German- and English-language versions of survey scales representing both types of measures in samples of current and former smokers. METHODS: TQOLIT(™)v1 integrates new measures of smoking-specific symptoms and QOL impact attributed to smoking with generic SF-36 Health Survey measures. For purposes of evaluation, cross-sectional data were analyzed for two independent samples. Disease-free (otherwise healthy) adults ages 23-55 used a tablet to complete surveys in a clinical trial in Germany (125 current and 54 former smokers). Online general population surveys were completed in the US by otherwise healthy current and former smokers (N = 149 and 110, respectively). Evaluations included psychometric tests of assumptions underlying scale construction and scoring, score distributions, and reliability. Tests of validity included cross-sectional correlations and analyses of variance based on a conceptual framework and hypotheses for groups differing in self-reported smoking behavior (current versus former smoker, cigarettes per day (CPD)) and severity of smoking symptoms in both samples and, in the German trial only, clinical parameters of biomarkers of exposure. RESULTS: Tests of scaling assumptions and internal consistency reliability (alpha = 0.71-0.79) of the smoking-specific measures were satisfactory, although ceiling effects attenuated correlations for former smokers in both samples. Correlational evidence supporting validity of smoking-specific symptom and impact measures included their substantial inter-correlation and higher correlations (than generic measures) with smoking behavior (favoring former over current groups) and CPD in both samples. In the German trial, both smoking-specific measures correlated significantly (p < 0.05) with all four biomarkers. QOL impact attributed to smoking correlated with the SF-36 mental but not physical summary measures in both samples. CONCLUSIONS: German- and English-language TQOLITv1 surveys have comparable and satisfactory psychometric properties. Cross-sectional tests, including correlations with four biomarkers, support the validity of the new smoking-specific measures for use in studies of otherwise healthy smokers. Smoking-specific measures consistently performed better than generic QOL measures in all tests of validity.
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Encuestas Epidemiológicas , Calidad de Vida/psicología , Fumar/psicología , Adulto , Estudios Transversales , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Psicometría , Reproducibilidad de los Resultados , Autoinforme , Estados Unidos , Adulto JovenRESUMEN
PURPOSE: Vitality is an important domain reflecting both the physical and emotional components of health-related quality of life. Because of its complexity, it has been defined and measured both broadly and narrowly. We explored the dimensionality of a very comprehensive item bank hypothesized to measure vitality and its related concepts. METHODS: Secondary analyses were conducted using the responses of 1,343 adults representative of the US general population to Internet-based surveys including 42 items compiled from multiple scales (e.g., SF-36 Vitality, PROMIS-Fatigue), covering a broad range of vitality-related content areas (energy, fatigue, and their interference with physical, mental, social activities, and quality of life). Exploratory and confirmatory factor models were evaluated independently using split-half samples. Bifactor model was used to assess the essential unidimensionality of the items, in comparison with traditional unidimensional, multidimensional, and hierarchical models. Method effects of a common scale or phrase were modeled via correlating errors. RESULTS: The exploratory factor analysis identified one dominant factor. The confirmatory factor analysis identified a best-fitting (CFI = 0.964, RMSEA = 0.084) bifactor model with one general (vitality) and two group (energy and fatigue) factors, explaining 69, 3, and 4 % of total variance. Correlating errors accounting for the method effects were important in identifying the substantive dimensionality of the items. CONCLUSIONS: The bifactor model proved to be useful for evaluating the dimensionality of a complex construct. Results supported conceptualizing and measuring vitality as a unidimensional energy-fatigue construct. We encourage future studies comparing practical implications of measures based on the broader and narrower conceptualizations of vitality.
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Análisis Factorial , Fatiga/etiología , Calidad de Vida , Proyectos de Investigación/estadística & datos numéricos , Anciano , Formación de Concepto , Emociones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Modelos Teóricos , Encuestas y CuestionariosRESUMEN
PURPOSE: The Quality-of-life (QOL) Disease Impact Scale (QDIS(®)) standardizes the content and scoring of QOL impact attributed to different diseases using item response theory (IRT). This study examined the IRT invariance of the QDIS-standardized IRT parameters in an independent sample. METHOD: The differential functioning of items and test (DFIT) of a static short-form (QDIS-7) was examined across two independent sources: patients hospitalized for acute coronary syndrome (ACS) in the TRACE-CORE study (N = 1,544) and chronically ill US adults in the QDIS standardization sample. "ACS-specific" IRT item parameters were calibrated and linearly transformed to compare to "standardized" IRT item parameters. Differences in IRT model-expected item, scale and theta scores were examined. The DFIT results were also compared in a standard logistic regression differential item functioning analysis. RESULTS: Item parameters estimated in the ACS sample showed lower discrimination parameters than the standardized discrimination parameters, but only small differences were found for thresholds parameters. In DFIT, results on the non-compensatory differential item functioning index (range 0.005-0.074) were all below the threshold of 0.096. Item differences were further canceled out at the scale level. IRT-based theta scores for ACS patients using standardized and ACS-specific item parameters were highly correlated (r = 0.995, root-mean-square difference = 0.09). Using standardized item parameters, ACS patients scored one-half standard deviation higher (indicating greater QOL impact) compared to chronically ill adults in the standardization sample. CONCLUSION: The study showed sufficient IRT invariance to warrant the use of standardized IRT scoring of QDIS-7 for studies comparing the QOL impact attributed to acute coronary disease and other chronic conditions.
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Síndrome Coronario Agudo/psicología , Calidad de Vida , Adulto , Anciano , Calibración , Enfermedad Crónica/psicología , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psicometría , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To evaluate the responsiveness of the SF-36 Health Survey in drug trials and to determine how often clinically efficacious treatments produce meaningful functional health changes across medical conditions. RESEARCH DESIGN: We conducted a systematic review of randomized, double-blind, placebo-controlled drug trials published from 1995 to 2011 that documented results for primary clinical endpoints and SF-36 outcomes. PubMed and a database of SF-36 publications were searched. We evaluated responsiveness as concordance (both statistically significant or both nonsignificant) between primary clinical and SF-36 outcomes. To determine how often SF-36 physical and mental component summary (PCS, MCS) score changes were of meaningful magnitude, mean net of placebo changes with treatment were compared against the developer's recommended 3-point threshold for a minimal important difference (MID) across groups of medical conditions. RESULTS: Of 805 screened trials, 185 met eligibility criteria. Primary clinical and SF-36 outcomes were concordant in 151 trials (82%). Among clinically efficacious trials, 58% reported net mean SF-36 improvements ≥MID threshold; however, SF-36 changes were often modest (PCS IQR, 1.6-4.1; MCS IQR, 0.8-3.5). Variations in treatment impact were apparent across conditions. Clinically efficacious therapies for rheumatoid arthritis, psoriatic arthritis, and psoriasis consistently achieved the largest SF-36 improvements, with 87% exceeding MID, whereas no efficacious therapies for peripheral arterial disease or chronic obstructive pulmonary disease achieved MID threshold. CONCLUSIONS: The SF-36 responds to treatment impact, distinguishing drug therapies that, on average, produce meaningful functional health benefits. Overall, just over half of clinically efficacious trials report meaningful functional health improvements, and results vary widely by medical condition.
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Quimioterapia/estadística & datos numéricos , Encuestas Epidemiológicas/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Autoinforme , Resultado del Tratamiento , Método Doble Ciego , Estado de Salud , Humanos , Satisfacción Personal , Calidad de Vida , Reproducibilidad de los ResultadosRESUMEN
PURPOSE: To test the impact of method of administration (MOA) on the measurement characteristics of items developed in the Patient-Reported Outcomes Measurement Information System (PROMIS). METHODS: Two non-overlapping parallel 8-item forms from each of three PROMIS domains (physical function, fatigue, and depression) were completed by 923 adults (age 18-89) with chronic obstructive pulmonary disease, depression, or rheumatoid arthritis. In a randomized cross-over design, subjects answered one form by interactive voice response (IVR) technology, paper questionnaire (PQ), personal digital assistant (PDA), or personal computer (PC) on the Internet, and a second form by PC, in the same administration. Structural invariance, equivalence of item responses, and measurement precision were evaluated using confirmatory factor analysis and item response theory methods. RESULTS: Multigroup confirmatory factor analysis supported equivalence of factor structure across MOA. Analyses by item response theory found no differences in item location parameters and strongly supported the equivalence of scores across MOA. CONCLUSIONS: We found no statistically or clinically significant differences in score levels in IVR, PQ, or PDA administration as compared to PC. Availability of large item response theory-calibrated PROMIS item banks allowed for innovations in study design and analysis.
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Recolección de Datos/métodos , Sistemas de Información , Autoinforme , Perfil de Impacto de Enfermedad , Encuestas y Cuestionarios , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/psicología , Estudios Cruzados , Trastorno Depresivo/diagnóstico , Trastorno Depresivo/psicología , Discriminación en Psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/psicología , Calidad de Vida , Adulto JovenRESUMEN
BACKGROUND: Immunocompromised individuals are known to respond inadequately to SARS-CoV-2 vaccines, placing them at high risk of severe or fatal COVID-19. Thus, immunocompromised individuals and their caregivers may still practice varying degrees of social or physical distancing to avoid COVID-19. However, the association between physical distancing to avoid COVID-19 and quality of life has not been comprehensively evaluated in any study. OBJECTIVE: We aim to measure physical distancing behaviors among immunocompromised individuals and the association between those behaviors and person-centric outcomes, including health-related quality of life (HRQoL) measures, health state utilities, anxiety and depression, and work and school productivity impairment. METHODS: A patient-informed protocol was developed to conduct the EAGLE Study, a large cross-sectional, observational study, and this paper describes that protocol. EAGLE is designed to measure distancing behaviors and outcomes in immunocompromised individuals, including children (aged ≥6 mo) and their caregivers, and nonimmunocompromised adults in the United States and United Kingdom who report no receipt of passive immunization against COVID-19. We previously developed a novel self- and observer-reported instrument, the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19), to measure physical distancing behavior levels cross-sectionally and retrospectively. Using an interim or a randomly selected subset of the study population, the PDS-C19 psychometric properties will be assessed, including structural validity, internal consistency, known-group validity, and convergent validity. Associations (correlations) will be assessed between the PDS-C19 and validated HRQoL-related measures and utilities. Structural equation modeling and regression will be used to assess these associations, adjusting for potential confounders. Participant recruitment and data collection took place from December 2022 to June 2023 using direct-to-patient channels, including panels, clinician referral, patient advocacy groups, and social media, with immunocompromising diagnosis confirmation collected and assessed for a randomly selected 25% of immunocompromised participants. The planned total sample size is 3718 participants and participant-caregiver pairs. Results will be reported by immunocompromised status, immunocompromising condition category, country, age group, and other subgroups. RESULTS: All data analyses and reporting were planned to be completed by December 2023. Results are planned to be submitted for publication in peer-reviewed journals in 2024-2025. CONCLUSIONS: This study will quantify immunocompromised individuals' physical distancing behaviors to avoid COVID-19 and their association with HRQoL as well as health state utilities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/52643.
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COVID-19 , Huésped Inmunocomprometido , Distanciamiento Físico , Calidad de Vida , Humanos , COVID-19/prevención & control , COVID-19/epidemiología , Estudios Transversales , Huésped Inmunocomprometido/inmunología , Adulto , Masculino , Femenino , Estados Unidos/epidemiología , Reino Unido/epidemiología , NiñoRESUMEN
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).
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Modelos Estadísticos , Evaluación de Resultado en la Atención de Salud , Insuficiencia Renal Crónica/psicología , Adulto , Análisis de Varianza , Intervalos de Confianza , Femenino , Estado de Salud , Humanos , Masculino , Calidad de Vida , Insuficiencia Renal Crónica/diagnóstico , AutoinformeRESUMEN
BACKGROUND: To prepare for a longitudinal study of the effects of potassium-lowering treatment on quality of life (QOL), we quantified the validity of a new disease-specific instrument for measuring QOL, using data from patients who had hyperkalemia (HK) due to chronic kidney disease (CKD) or chronic heart failure, and were also being treated with potassium binders (PBs). METHODS: In this cross-sectional study, the participants were 98 patients at five outpatient clinics in Japan. The outcome measures were the Medical Outcomes Study 36-item short-form (SF-36), a widely used generic measure of QOL, and the Quality of Life Disease-specific Impact Scale (QDIS-7), a recently-developed disease-specific measure of QOL. Internal-consistency reliability was quantified, and factor analysis was done to confirm hypothesized QOL dimensions. Validation tests used two external criteria: CKD stage, and PB formulation. PB formulation was used because different formulations are associated with different degrees of patients' burden. Using a previously-described method, we computed the relative validity (RV) of the two measures. RESULTS: Two factor scoring of the SF-36 and one factor scoring of the QDIS-7, as standardized from previous studies, were confirmed. The RVs showed that the QDIS-7 was much more valid than the SF-36, for discriminating between groups defined clinically (by CKD stage), and also between groups defined by PB formulation. Reliability was satisfactory: 0.73-0.95 for the SF-36 and 0.86 for the QDIS-7. CONCLUSIONS: The QDIS-7 with CKD or PB attributions was more valid than the SF-36 for measuring the effects of CKD and of PB formulation on QOL.
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INTRODUCTION: Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin-angiotensin-aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients' quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient's QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient's QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient's QOL, in patients with HK. METHODS AND ANALYSIS: This is a prospective cohort study with 6 months of follow-up in 30-40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients' characteristics. To assess the impact of treatment on a patient's QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient's QOL. ETHICS AND DISSEMINATION: Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals. TRIAL REGISTRATION NUMBER: NCT05297409.
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Insuficiencia Cardíaca , Hiperpotasemia , Insuficiencia Renal Crónica , Humanos , Hiperpotasemia/tratamiento farmacológico , Hiperpotasemia/etiología , Calidad de Vida , Estudios Prospectivos , Japón , Insuficiencia Renal Crónica/terapia , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/tratamiento farmacológico , Enfermedad Crónica , PotasioRESUMEN
BACKGROUND: Computerized adaptive tests (CATs) have abundant theoretical advantages over established static instruments, which could improve ambulatory monitoring of patient-reported outcomes (PROs). However, an empirical demonstration of their practical benefits is warranted. METHODS: We reviewed the literature and evaluated existing data to discuss the potential of CATs for use in ambulatory monitoring outside clinical facilities. RESULTS: Computerized adaptive tests are not being used for ambulatory monitoring, but initial results from their use in health care research allow for discussion of some issues relevant to ambulatory care. Evidence shows that CATs can capture the most relevant health outcomes as well as established static tools, with substantially decreased respondent burden. They can be more precise than static tools of similar length and can reduce floor and ceiling effects. Computerized adaptive tests can reliably measure a construct over time with different items, which yields the potential of introducing item exposure control in ambulatory monitoring. Studies have shown that CATs can be at least as valid as well-designed static tools in group comparisons, but further investigation is needed to determine whether psychometric advantages lead to increased responsiveness of CATs. CONCLUSIONS: Ambulatory monitoring of PROs demands short, yet very precise measurements, which can be repeated up to many times a day. Computerized adaptive tests may address several present shortcomings in ambulatory monitoring of PROs efficiently. However, most CAT developments have primarily focused on psychometric improvements. To use the full potential of CATs for ambulatory monitoring purposes, content must also be carefully considered.
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Monitoreo Ambulatorio/métodos , Evaluación de Resultado en la Atención de Salud/métodos , Psicometría , Autoinforme , Programas Informáticos , Interfaz Usuario-Computador , Computadoras de Mano , Humanos , Monitoreo Ambulatorio/instrumentación , Satisfacción del PacienteRESUMEN
OBJECTIVES: Role functioning (RF) is a key component of health and well-being and an important outcome in health research. The aim of this study was to develop an item bank to measure impact of health on role functioning. METHODS: A set of different instruments including 75 newly developed items asking about the impact of health on role functioning was completed by 2,500 participants. Established item response theory methods were used to develop an item bank based on the generalized partial credit model. Comparison of group mean bank scores of participants with different self-reported general health status and chronic conditions was used to test the external validity of the bank. RESULTS: After excluding items that did not meet established requirements, the final item bank consisted of a total of 64 items covering three areas of role functioning (family, social, and occupational). Slopes in the bank ranged between .93 and 4.37; the mean threshold range was -1.09 to -2.25. Item bank-based scores were significantly different for participants with and without chronic conditions and with different levels of self-reported general health. CONCLUSIONS: An item bank assessing health impact on RF across three content areas has been successfully developed. The bank can be used for development of short forms or computerized adaptive tests to be applied in the assessment of role functioning as one of the common denominators across applications of generic health assessment.
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Actividades Cotidianas/psicología , Estado de Salud , Salud Mental , Evaluación de Resultado en la Atención de Salud/métodos , Psicometría/métodos , Autoinforme , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Intervalos de Confianza , Evaluación Educacional , Escolaridad , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Satisfacción Personal , Teoría Psicológica , Calidad de Vida , Adulto JovenRESUMEN
PURPOSE: Role functioning (RF) is an important part of health-related quality of life, but is hard to measure due to the wide definition of roles and fluctuations in role participation. This study aims to explore the dimensionality of a newly developed item bank assessing the impact of health on RF. METHODS: A battery of measures with skip patterns including the new RF bank was completed by 2,500 participants answering only questions on social roles relevant to them. Confirmatory factor analyses were conducted for the participants answering items from all conceptual domains (N = 1193). Conceptually based dimensionality and method effects reflecting positively and negatively worded items were explored in a series of models. RESULTS: A bi-factor model (CFI = .93, RMSEA = .08) with one general and four conceptual factors (social, family, occupation, generic) was retained. Positively worded items were excluded from the final solution due to misfit. While a single factor model with methods factors had a poor fit (CFI = .88, RMSEA = .13), high loadings on the general factor in the bi-factor model suggest that the RF bank is sufficiently unidimensional for IRT analysis. CONCLUSIONS: The bank demonstrated sufficient unidimensionality for IRT-based calibration of all the items on a common metric and development of a computerized adaptive test.