CHF-PROM: validation of a patient-reported outcome measure for patients with chronic heart failure

Abstract

BackgroundDue to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.MethodsAccording to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients’ responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.ResultsThe final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach’s alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.ConclusionsThe final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.Electronic supplementary materialThe online version of this article (10.1186/s12955-018-0874-2) contains supplementary material, which is available to authorized users.

A Nomogram based on a Patient-reported Outcomes Measure: Predicting the Risk of Readmission for Patients with Chronic Heart Failure

“…First, PROM used in our study is a questionnaire in Chinese based on the different cultural and societal value systems of mainland China as well as the medical and economic environments of the country. The reliability and validity of the scale have been verified by Tian et al, [25] and they were further verified and screened in this study.…”

“…The study uses a Chinese questionnaire related to mainland China -CHF-PROM. [25] The CHF-PROM is divided into four domains which are further divided into 12 subdomains, including a total of 57 items.…”

Influence of self-management on patient-reported outcomes for individuals with chronic heart failure: a multilevel model approach from a longitudinal study

“…Among these strategies, a regular schedule was defined as maintaining relatively fixed sleep and wake times, and LSD intake < 5 g of salt per day. All participants were followed-up at 1, 3, and 6 months after discharge in face-to-face consultations or telephone follow-up to obtain information regarding the selfadministered questionnaire and CHF-PRO scores [9]. To ensure quality, all questionnaires were administered by professionally trained individuals.…”

“…The CHF-PRO was developed by the authors' research group and adopted in this study. This questionnaire contains 57 items, 12 subdomains, and 4 domains, which consisted of physical, psychological, social, and therapeutic domains [9]. Patients responded to each item on a 5-point Likert scale to reflect how often they had experienced each issue.…”

“…Patient-reported outcome (PRO), recommended by the United States Food & Drug Administration to evaluate QoL, was adopted in the present study [8]. To better evaluate patients in China, we used a Chinese questionnaire known as the "CHF-PRO", which is specifically relevant to the population of mainland China [9]. Therefore, this study focused on self-management after discharge and applied multilevel models in an attempt to determine effective self-management strategies to improve CHF-PRO scores.…”