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

A Person-Centered Interdisciplinary Plan-of-Care Program for Dialysis: Implementation and Preliminary Testing

RATIONALE & OBJECTIVE: Despite growing interest in individualizing care, routine dialysis processes, including the interdisciplinary plan of care, often fail to account for patient-identified priorities. To better align dialysis care with patient priorities and improve care planning experiences, we implemented a person-centered care plan program at a single clinic. We also sought to gain insight into key implementation considerations and areas for program improvement. STUDY DESIGN: 6-month quality improvement project with research substudy. SETTING & PARTICIPANTS: 49 hemodialysis patients and 14 care team members at a North Carolina dialysis clinic. QUALITY IMPROVEMENT ACTIVITIES: Implementation of My Dialysis Plan, a person-centered care plan program. OUTCOMES: Participant perspectives and care plan meeting characteristics (quality improvement); pre- to postprogram change in patient-reported autonomy support, patient-centeredness of care, and dialysis care individualization (research). ANALYTICAL APPROACH: We used the Consolidated Framework for Implementation Research to guide implementation and evaluation. We conducted pre-, intra-, and post-project interviews with clinic stakeholders (patients, clinic personnel, and medical providers) to identify implementation barriers, facilitators, and perceptions. We compared pre- and post-project care plan meeting content and patient-reported outcome survey scores. RESULTS: We conducted 54 care plans with 49 patients. Overall, care teams successfully used My Dialysis Plan to elicit and link patient priorities to actionable aspects of dialysis care. Participants identified interdisciplinary team commitment, accountability, and the structured yet flexible meeting approach as key implementation elements. Throughout the project, stakeholder input guided program modifications (eg, implementation practices and resources) to better meet clinic needs, but follow-up on care plan-identified action items remained challenging. Among the 28 substudy participants, there was no difference in pre- to post-project patient-reported outcome survey scores. LIMITATIONS: Single clinic implementation. CONCLUSIONS: My Dialysis Plan has the potential to enhance dialysis care individualization and care plan experiences. Evaluation of program impact on patient-reported and clinical outcomes is needed

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 and content validity of a hemodialysis symptom patient-reported outcome measure

PurposeTo describe the process and preliminary qualitative development of a new symptom-based patient-reported outcome measure (PROM) intended to assess hemodialysis treatment-related physical symptoms.MethodsExperienced interviewers conducted concept elicitation and cognitive debriefing interviews with individuals receiving in-center hemodialysis in the United States. Concept elicitation interviews involved eliciting spontaneous reports of symptom experiences and probing to further explore and confirm concepts. We used patient-reported concepts to generate a preliminary symptom PROM. We conducted 3 rounds of cognitive debriefing interviews to evaluate symptom relevance, item interpretability, and draft item structure. We iteratively refined the measure based on cognitive interview findings.ResultsForty-two adults receiving in-center hemodialysis participated in the concept elicitation interviews. A total of 12 symptoms were reported by >10% of interviewees. We developed a 13-item initial draft instrument for testing in 3 rounds of cognitive interviews with an additional 52 hemodialysis patients. Participant responses and feedback during cognitive interviews led to changes in symptom descriptions, division of the single item "nausea/vomiting" into 2 distinct items, removal of daily activity interference items, addition of instructions, and clarification about the recall period, among other changes.ConclusionsSymptom Monitoring on Renal Replacement Therapy-Hemodialysis (SMaRRT-HD™) is a 14-item PROM intended for use in hemodialysis patents. SMaRRT-HD™ uses a single treatment recall period and a 5-point Likert scale to assess symptom severity. Qualitative interview data provide evidence of its content validity. SMaRRT-HD™ is undergoing additional testing to assess measurement properties and inform measure scoring

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