scholarly journals Development of a Patient Reported Measure of Experimental Transplants with HIV and Ethics in the United States (PROMETHEUS)

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Shanti Seaman ◽  
Diane Brown ◽  
Ann Eno ◽  
Sile Yu ◽  
Allan B. Massie ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Reliability And Validity ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cronbach’S Alpha ◽  
Cronbach's Alpha ◽  
Patient Reported ◽  
Decision Satisfaction

Abstract Background Transplantation of HIV-positive (HIV+) donor organs for HIV+ recipients (HIV D+/R+) is now being performed as research in the United States, but raises ethical concerns. While patient-reported outcome measures are increasingly used to evaluate clinical interventions, there is no published measure to aptly capture patients’ experiences in the unique context of experimental HIV D+/R+ transplantation. Therefore, we developed PROMETHEUS (patient-reported measure of experimental transplants with HIV and ethics in the United States). To do so, we created a conceptual framework, drafted a pilot battery using existing and new measures related to this context, and refined it based on cognitive and pilot testing. PROMETHEUS was administered 6-months post-transplant in a clinical trial evaluating these transplants. We analyzed data from the first 20 patient-participants for reliability and validity by calculating Cronbach’s alpha and reviewing item performance characteristics. Results PROMETHEUS 1.0 consisted of 29 items with 5 putative subscales: Emotions; Trust; Decision Making; Transplant; and Decision Satisfaction. Overall, responses were positive. Cronbach’s alpha was > 0.8 for all subscales except Transplant, which was 0.38. Two Transplant subscale items were removed due to poor reliability and construct validity. Conclusions We developed PROMETHEUS to systematically capture patient-reported experiences with this novel experimental transplantation program, nested it in an actual clinical trial, and obtained preliminary data regarding its performance.

scholarly journals Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Theresa M. Coles ◽  
Adrian F. Hernandez ◽  
Bryce B. Reeve ◽  
Karon Cook ◽  
Michael C. Edwards ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Contextual Factors ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Think Tank ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

Psychometric Properties of the Abbreviated Multidimensional Acculturation Scale and the Multigroup Ethnic Identity Measure With Japanese Sojourners

Assessment ◽  
2016 ◽  
Vol 24 (1) ◽  
pp. 104-114 ◽  
Author(s):  
Makoto Miyoshi ◽  
Kimberly Asner-Self ◽  
Sheng Yanyan ◽  
Jennifer M. Koran
Keyword(s):  
United States ◽  
Ethnic Identity ◽  
Construct Validity ◽  
Psychometric Properties ◽  
Factor Structure ◽  
Japanese Version ◽  
The United States ◽  
Cronbach’S Alpha ◽  
Cronbach's Alpha ◽  
Multigroup Ethnic Identity Measure

The current study examined psychometric properties of the Japanese version of Abbreviated Multidimensional Acculturation Scale (AMAS-ZABB-JP) and the 20-item Multigroup Ethnic Identity Measure (MEIM-JP) with 273 Japanese sojourners and immigrants to the United States. The theoretical six-factor structure for the AMAS-JP and two-factor structure for the MEIM-JP was consistent with the literature. The subscales of the AMAS and MEIM showed expected patterns of correlation with each other and with additional variables (i.e., number of years in the United States), providing evidence for construct validity. Cronbach’s alpha reflected high levels of reliability for both scales. Despite strong psychometric findings, there were translational and cultural-based findings that suggest the need for further research.

scholarly journals A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010

2012 ◽  
Vol 15 (3) ◽  
pp. 437-442 ◽  
Author(s):  
Ari Gnanasakthy ◽  
Margaret Mordin ◽  
Marci Clark ◽  
Carla DeMuro ◽  
Sheri Fehnel ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Patient Reported Outcome ◽  
Patient Reported

scholarly journals What Is Sufficient Evidence for the Reliability and Validity of Patient-Reported Outcome Measures?

2007 ◽  
Vol 10 ◽  
pp. S94-S105 ◽  
Author(s):  
Marlene H. Frost ◽  
Bryce B. Reeve ◽  
Astra M. Liepa ◽  
Joseph W. Stauffer ◽  
Ron D. Hays
Keyword(s):  
Outcome Measures ◽  
Reliability And Validity ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Sufficient Evidence ◽  
Patient Reported

scholarly journals Perceptions of Patients, Caregivers, and Healthcare Providers of Idiopathic Inflammatory Myopathies: An International OMERACT Study

2018 ◽  
Vol 46 (1) ◽  
pp. 106-111 ◽  
Author(s):  
Christopher A. Mecoli ◽  
Jin Kyun Park ◽  
Helene Alexanderson ◽  
Malin Regardt ◽  
Merrilee Needham ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Qualitative Content Analysis ◽  
Healthcare Providers ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Idiopathic Inflammatory Myopathies ◽  
Inflammatory Myopathies ◽  
Patient Reported ◽  
Initial List

Objective.Patient-reported outcome measures (PROM) that incorporate the patient perspective have not been well established in idiopathic inflammatory myopathies (IIM). As part of our goal to develop IIM-specific PROM, the Outcome Measures in Rheumatology (OMERACT) Myositis special interest group sought to determine which aspects of disease and its effects are important to patients and healthcare providers (HCP).Methods.Based on a prior qualitative content analysis of focus groups, an initial list of 24 candidate domains was constructed. We subsequently conducted an international survey to identify the importance of each of the 24 domains to be assessed in clinical research. Patients with IIM, their caregivers, and HCP treating IIM completed the survey.Results.In this survey, a total of 638 respondents completed the survey, consisting of 510 patients, 101 HCP, and 27 caregivers from 48 countries. Overall, patients were more likely to rank “fatigue,” “cognitive impact,” and “difficulty sleeping” higher compared with HCP, who ranked “joint symptoms,” “lung symptoms,” and “dysphagia” higher. Both patients and providers rated muscle symptoms as their top domain. In general, patients from different countries were in agreement on which domains were most important. One notable exception was that patients from Sweden and the Netherlands ranked lung symptoms significantly higher compared to other countries including the United States and Australia (mean weighted rankings of 2.86 and 2.04 vs 0.76 and 0.80, respectively; p < 0.0001).Conclusion.Substantial differences exist in how IIM is perceived by patients compared to HCP, with different domains prioritized. In contrast, patients’ ratings across the world were largely similar.

The Myositis Activities Profile — Initial Validation for Assessment of Polymyositis/Dermatomyositis in the USA

2012 ◽  
Vol 39 (11) ◽  
pp. 2134-2141 ◽  
Author(s):  
HELENE ALEXANDERSON ◽  
ANN M. REED ◽  
STEVEN R. YTTERBERG
Keyword(s):  
United States ◽  
Disease Activity ◽  
Weighted Kappa ◽  
Well Being ◽  
The United States ◽  
Measurement Properties ◽  
Cronbach’S Alpha ◽  
Cronbach's Alpha ◽  
Initial Validation ◽  
Disease Effect

Objective.To evaluate some measurement properties of the Myositis Activities Profile (MAP) in adult patients with polymyositis (PM) and dermatomyositis (DM) in the United States.Methods.To assess content validity, patients with PM/DM rated difficulty and importance of items of the MAP using a visual analog scale (VAS), range 0–10. For construct validity, consecutive patients with PM/DM performed the 6-item core set for disease activity including the manual muscle test (MMT) and the Health Assessment Questionnaire (HAQ), the Functional Index-2 (FI-2; muscle endurance), and the MAP plus disease effect on well-being on a VAS. Item fit within subscales was analyzed by Cronbach’s alpha. Patients with stable disease activity filled out the MAP again 1 week later.Results.The median combined difficulty and importance, 0–10, of the 31 items was 5.00 (range 2.10–5.95). One item was added, giving a 32-item MAP. Correlations between the median of subscales/single items of the MAP and the HAQ and disease effect on well-being were rs = 0.69 and rs = 0.68, respectively, with lower correlations to the MMT (rs = −0.35), and the FI-2 (rs = −0.29 to −0.47) and disease activity measures (rs = 0.36–0.41). Cronbach’s alpha coefficients for the 4 subscales varied between 0.85 and 0.95. Weighted kappa coefficients (Kw) ranged between 0.77 and 0.93 for the 4 subscales and between 0.74 and 0.83 for the 4 single items without systematic variations (p > 0.05).Conclusion.This initial validation of the MAP indicates promising measurement properties for assessing limitations in activities of daily living and participation in patients with PM/DM in the United States.

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