Responsiveness of PROMIS® to change in chronic obstructive pulmonary disease.

BackgroundChronic obstructive pulmonary disease (COPD) is a progressive chronic disease characterized by airflow obstruction that leads to shortness of breath and substantial negative impacts on health-related quality of life (HRQL). The course of COPD includes periodic acute exacerbations that require changes in treatment and/or hospitalizations. This study was designed to examine the responsiveness of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures to changes associated with COPD exacerbation recovery.MethodsA longitudinal analysis using mixed-effects models was conducted of people who were enrolled while stable (n = 100) and those who experienced an acute exacerbation (n = 85). PROMIS (physical function, pain interference, pain behavior, fatigue, anxiety, depression, anger, social roles, discretionary social activities, Global Health, dyspnea severity and dyspnea functional limitations) and COPD-targeted HRQL measures were completed at baseline and at 12 weeks.ResultsWe administered PROMIS measures using computer adaptive testing (CAT), followed by administration of any remaining short form (SF) items that had not yet been administered by CAT. Examination of the difference between group differences from baseline to 12 weeks in the stable and exacerbation groups revealed that the exacerbation group changed (improved) significantly more than the stable group in anxiety (p < .001 to p < .01; f2 effect size [ES] = 0.023/0.021), fatigue (p < .0001; ES = 0.036/0.047) and social roles (p < .001 to p < .05; ES = 0.035/0.024). All effect sizes were small in magnitude and smaller than hypothesized. Depression was also statistically significant (p < .05, SF only) but the ES was trivial. For all other PROMIS domains, the differences were not significant and ES were trivial.ConclusionsThis longitudinal study provides some support for the validity of the PROMIS fatigue, anxiety, and social roles domains in COPD, but further evaluation of responsiveness is warranted

Known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS®) in adolescents and young adults with special healthcare needs

To examine known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Forms (SFs) for adolescents and young adults with special health care needs (SHCN) using data collected from the PROMIS Linking Study

Evaluation of Item Candidates: The PROMIS Qualitative Item Review

One of the PROMIS (Patient-Reported Outcome Measurement Information System) network's primary goals is the development of a comprehensive item bank for patient-reported outcomes of chronic diseases. For its first set of item banks, PROMIS chose to focus on pain, fatigue, emotional distress, physical function, and social function. An essential step for the development of an item pool is the identification, evaluation, and revision of extant questionnaire items for the core item pool. In this work, we also describe the systematic process wherein items are classified for subsequent statistical processing by the PROMIS investigators. Six phases of item development are documented: identification of extant items, item classification and selection, item review and revision, focus group input on domain coverage, cognitive interviews with individual items, and final revision before field testing. Identification of items refers to the systematic search for existing items in currently available scales. Expert item review and revision was conducted by trained professionals who reviewed the wording of each item and revised as appropriate for conventions adopted by the PROMIS network. Focus groups were used to confirm domain definitions and to identify new areas of item development for future PROMIS item banks. Cognitive interviews were used to examine individual items. Items successfully screened through this process were sent to field testing and will be subjected to innovative scale construction procedures

Development of a proxy-reported pulmonary outcome scale for preterm infants with bronchopulmonary dysplasia

<p>Abstract</p> <p>Background</p> <p>To develop an accurate, proxy-reported bedside measurement tool for assessment of the severity of bronchopulmonary dysplasia (also called chronic lung disease) in preterm infants to supplement providers' current biometric measurements of the disease.</p> <p>Methods</p> <p>We adapted Patient-Reported Outcomes Measurement Information System (PROMIS) methodology to develop the Proxy-Reported Pulmonary Outcomes Scale (PRPOS). A multidisciplinary group of registered nurses, nurse practitioners, neonatologists, developmental specialists, and feeding specialists at five academic medical centers participated in the PRPOS development, which included five phases: (1) identification of domains, items, and responses; (2) item classification and selection using a modified Delphi process; (3) focus group exploration of items and response options; (4) cognitive interviews on a preliminary scale; and (5) final revision before field testing.</p> <p>Results</p> <p>Each phase of the process helped us to identify, classify, review, and revise possible domains, questions, and response options. The final items for field testing include 26 questions or observations that a nurse assesses before, during, and after routine care time and feeding.</p> <p>Conclusions</p> <p>We successfully created a prototype scale using modified PROMIS methodology. This process can serve as a model for the development of proxy-reported outcomes scales in other pediatric populations.</p

Significance of Medicare and Medicaid Programs for the Practice of Medicine

The 1965 legislation that established Medicare and Medicaid declared that the Federal Government would not interfere in clinical medicine. Despite the original intent, Medicare and Medicaid have had tremendous influence on medical practice. In this article, we focus on four policy areas that illustrate the influence of CMS (and its predecessor agencies) on medical practice. We discuss the implications of the relationship between CMS and clinical medicine and how this relationship has changed over time. We conclude with thoughts about potential future efforts at CMS

Are children with asthma overconfident that they are using their inhalers correctly?

The objectives of this study were to quantify the extent to which children with asthma are overconfident that they are using their inhalers correctly and determine whether demographic and clinical characteristics are associated with children being overconfident

An item-level response shift study on the change of health state with the rating of asthma-specific quality of life: a report from the PROMIS® Pediatric Asthma Study

To examine item-level response shift associated with the change in asthma-related health state (i.e., change in asthma control status and global rating of change (GRC) in breathing problems)

Responsiveness to Change in PROMIS

AbstractObjectiveTo compare the responsiveness to change of the Patient-Reported Outcomes Measurement Information System (PROMIS®) asthma impact, pain interference, fatigue, depressive symptoms, mobility, and peer relationship scales to a legacy scale, the Paediatric Asthma Quality of Life Questionnaire (PAQLQ).MethodsTwo hundred and twenty-nine child-parent dyads from public insurance programs were enrolled. PROMIS pediatric short forms (SFs) and the PAQLQ were used to measure health-related quality of life across four time points (T1–T4) over 2 years. The Asthma Control and Communication Instrument was used to measure the change in asthma control, and the Global Rating of Change (GRC) Index for breathing problems and overall health was used to measure the change in health status. Responsiveness was tested by comparing the changes in health-related quality of life with the changes in asthma control and health status over time using t tests, generalized estimating equations, and relative validity approaches. Magnitudes of the responsiveness between the Pediatric PROMIS and PAQLQ were assessed through statistical significance, Cohen's d effect size (ES), and standardized response mean (SRM).ResultsThe PROMIS asthma impact scale and all PAQLQ scales exhibited significant responsiveness (p'sConclusionsThe PROMIS asthma impact SF indicated similar responsiveness to the PAQLQ scales. Due to its brevity and responsiveness, the PROMIS asthma impact SF is useful for clinical practice or research