Journal of Patient-Reported Outcomes最新文献

Background: Pelvic floor disorders (PFDs) affect women's physical, psychological, and social well-being, particularly in low- and middle-income countries. The PFIQ-7, a key patient-reported outcome (PROM) measure, assesses symptom severity and quality of life but lacks an Urdu adaptation. This study aims to translate, culturally adapt, and validate the PFIQ-7 for Urdu-speaking women to improve its clinical and research utility.

Methodology: This cross-sectional, observational study was conducted in two phases: Phase 1 focused on translating and culturally adapting the PFIQ-7, while Phase 2 assessed its psychometric properties. A total of 108 Urdu-literate women participated. The PFIQ-7 underwent rigorous translation following international guidelines, including forward and backward translation, consensus meetings, and pilot testing. The study evaluated reliability (Cronbach's alpha, interclass correlation) and validity (content, criterion, and construct validity) through expert review, S-POP-Q correlation, and known-group comparisons.

Results: The Urdu PFIQ-7 demonstrated excellent internal consistency (Cronbach's alpha = 0.884) and test-retest reliability (ICC = 0.995). Strong criterion validity was evidenced by significant correlations between PFIQ-7 scores and S-POP-Q findings (SCC = 0.67; p < 0.005). Construct validity was confirmed, as patients with higher S-POP-Q stages and urinary incontinence reported significantly higher PFIQ-7 scores compared to asymptomatic participants (p < 0.0005). Pilot testing confirmed the questionnaire's clarity, cultural relevance, and feasibility, with a completion time of approximately four to five minutes.

Conclusions: The Urdu PFIQ-7 is a reliable and valid tool for assessing PFD's impact on quality of life, supporting its use in clinical and research settings in Pakistan. Future research should explore its utility in rural and community-based settings to enhance generalizability.

Background: Terheyden et al. recently described a compelling vision for large language model-enabled patient-reported outcome measures (LLM-PROMs).

Main text: We support Terheyden et al.'s vision and offer complementary observations about the potential for generative artificial intelligence (GenAI) in assessing patient-centered outcomes. GenAI has the potential to improve the quality and efficiency of developing traditional PROMs and collecting patient experience data. Traditional PROMs rely on standardized questions and responses, which may introduce ambiguity about the health concept being assessed. Yet, interviewers who are trained in the meaning of the concepts can tailor questions to the respondent's experience and conversation style and have a back-and-forth clarification of meaning to ensure that both the interviewer's and respondent's meanings are aligned. The shortcoming of this approach is that it cannot be done at scale with human interviewers. However, trained GenAI interviewers could make such an assessment a reality for large samples of patients. The technology is already available to train GenAI interviewers in interview technique, the intent of each item, and a consistent approach toward coding the respondent's answer based on the conversation.

Conclusion: The health outcomes research field should actively inquire into what patient experience data can be collected via GenAI and rigorously evaluate the quality of the assessments obtained.

Background: Dysphagia in a family member may negatively influence caregivers and may disrupt their quality of life. Thus, it is crucial to understand caregiver perspectives as an integral component of holistic dysphagia treatment. Hence, the present study aimed to cross-culturally adapt, translate, and pre-test the Caregiver's Analysis of Reported Experiences with Swallowing Disorders (CARES) into the Kannada language, a structural screening tool for assessing caregiver burden associated with dysphagia.

Methods: The Kannada version of the CARES screening tool was cross-culturally adapted using the ISPOR Principles of Good Practice for Patient-Reported Outcome Measures and was pre-tested on 48 dysphagia caregivers of adult dysphagia cancer survivors. The internal consistency of each item was assessed using Cronbach's alpha.

Results: The results revealed that the Kannada version of the CARES screening tool had good internal consistency for each subscale, Part A-Checklist of Behavioral and Functional Changes", and Part B-Measures of Subjective Caregiver Stress, with α = 0.763 and α = 0.852, respectively. The item-total correlation of each item of the subscale was greater than 0.8, indicating that each item of the tool significantly contributed to the tool.

Conclusions: The Kannada CARES was found to have good internal consistency. Hence, it can be considered a linguistically equivalent tool for identifying caregiver burdens associated with dysphagia care.

Background: Self-swabs and digital patient-reported outcomes (PROs) offer innovative tools for decentralized monitoring of infectious diseases. The DANFLU-2 HomeSwab PRO substudy evaluated the feasibility of using these methods for tracking influenza-like illness (ILI) within a large-scale, pragmatic, randomized trial.

Methods: During the 2023/2024 influenza season, adults aged ≥ 65 years were recruited from the DANFLU-2 trial, which evaluates the relative effectiveness of high-dose influenza vaccine compared to standard-dose. Participants were instructed to self-swab at home upon ILI symptom onset and complete the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) for 14 days. Swabs were registered via QR code in a webapp and mailed for centralized PCR testing. Compliance was defined as completing all 14 days of RiiQ™ reporting.

Results: Among 1,976 enrolled participants, 208 (10.5%) completed at least one RiiQ™, and 171 (82.2%) met the ILI case definition. Most participants found self-swabbing easy (66.1%) and more practical than visiting a clinic (78.6%). Compliance with daily RiiQ™ symptom tracking was 85.7%. Among those with ILI, 89.4% performed a self-swab within 1 day [IQR: 0; 3] of symptom onset; 65.8% of swabs were correctly registered in the webapp, and 96.5% were RNaseP-positive. Thirty-six participants (1.8%) withdrew, mainly due to weekly reminders; allowing reduced reminder frequency improved retention.

Conclusion: The study confirmed the feasibility of using home-based self-swabs for remote disease diagnosis and digital PRO tracking for symptoms during ILI events in a large-scale, pragmatic randomized trial. While the approach proved viable, the findings also highlighted areas for improvement in participant engagement and data collection efficiency.

Clinicaltrials:

Gov id: NCT05517174.