Validity and reliability of the left ventricular assist device self-care behaviour scale

PLOS ONE RESEARCH ARTICLE Validity and reliability of the left ventricular assist device self-care behaviour scale Naoko P. Kato ID1,2*, Semyon Melnikov3, Quin E. Denfeld ID4, Jesus Casida5, Anna Strömberg1, Tuvia Ben-Gal6, Christopher S. Lee7,8, Tiny Jaarsma1 a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 Department of Health, Division of Nursing Sciences and Reproductive Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden, 2 Department of Therapeutic Strategy for Heart Failure, The University of Tokyo Hospital, Tokyo, Japan, 3 Sackler Faculty of Medicine, Department of Nursing, Stanley Steyer School of Health Professions, Tel Aviv University, Tel Aviv, Israel, 4 School of Nursing & Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon, United States of America, 5 Eleanor Mann School of Nursing, The University of Arkansas, Fayetteville, Arkansas, United States of America, 6 Sackler Faculty of Medicine, Heart Failure Unit, Cardiology Department, Rabin Medical Center, Petah Tikva, Tel Aviv University, Tel Aviv, Israel, 7 The Boston College William F. Connell School of Nursing, Chestnut Hill, Massachusetts, United States of America, 8 Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia * Abstract OPEN ACCESS Background Citation: Kato NP, Melnikov S, Denfeld QE, Casida J, Strömberg A, Ben-Gal T, et al. (2023) Validity and reliability of the left ventricular assist device self-care behaviour scale. PLoS ONE 18(2): e0275465. https://doi.org/10.1371/journal. pone.0275465 Adequate self-care behaviour is essential for patients with a left ventricular assist device (LVAD) to prevent complications, prolong life, and optimise quality of life. However, there were no valid and reliable measurements available to assess self-care behaviour among patients with LVAD. We have previously developed the 33-item LVAD self-care behaviour scale. Editor: Mustafa M. Ahmed, University of Florida, UNITED STATES Objectives Received: June 7, 2022 To evaluate psychometric properties of the 33-item LVAD self-care behaviour scale. Accepted: September 18, 2022 Methods and results Published: February 10, 2023 Data on 127 patients with a LVAD in Israel, Japan, and the USA were analysed (mean age 51±14.3, 81% male). Exploratory factor analysis extracted three factors, and 13 items were excluded from the scale. Internal consistency assessed by Cronbach’s alpha was acceptable for the total scale (α = 0.80) and the three subscales: Factor 1: Monitoring (α = 0.81), Factor 2: Heart failure self-care (α = 0.67), and Factor 3: LVAD self-care (α = 0.63). The 20item version of the LVAD self-care behaviour scale had sufficient convergent validity with another scale that assessed self-care related to the driveline of LVAD (r = 0.47, p<0.001). Test–retest reliability was adequate (intraclass correlation coefficient = 0.58). Copyright: © 2023 Kato et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: This research was supported in part by a Grant-in-Aid for a Young Scientist (B) to N.P.K. from the Japan Society for the Promotion Science KAKENHI (JP15K20693). Competing interests: The authors have declared that no competing interests exist. Conclusions The 20-item version of the LVAD self-care behaviour scale showed adequate validity and reliability. The scale is ready for use in clinical practice and research. Additional testing might further optimise the scale. PLOS ONE | https://doi.org/10.1371/journal.pone.0275465 February 10, 2023 1 / 16 PLOS ONE Psychometric testing of the LVAD self-care behaviour scale Introduction With the growing number of heart failure (HF) patients and improved medical management, the prevalence of patients with advanced HF is increasing [1]. The gold standard treatment of patients with advanced HF is heart transplantation, but the supply of donor organs is limited. During the past two decades, mechanical circulatory support, primarily using a left ventricular assist device (LVAD), has emerged as a major alternative treatment option for patients with advanced HF. LVAD devices have been increasingly used worldwide, not only as a bridge to heart transplantation, but also as a destination therapy [2]. More than 22 000 devices have been implanted to date in the USA, and at least 2500 new implants occur annually [3]. Many studies have shown that LVAD treatment improves the patients´ prognosis and quality of life [4,5]. Successful long-term LVAD support requires a high degree of self-care by the patients and their caregivers [6,7]. For example, LVAD-supported patients need to take care of the driveline exit site, monitor for signs of infection as well as worsening heart failure, and respond appropriately to emergency situations. Good self-care at home for LVAD-supported patients may be associated with good prognosis and better quality of life because it may decrease the risk of infection and other LVAD-related complications [8–12]. To identify possible deficits in LVAD self-care behaviour and evaluate the effectiveness of educational support to improve self-care, the patient’s self-care behaviour needs to be measured appropriately using a valid and reliable instrument. There was only one instrument to measure self-care behaviour in patients after LVAD implantation. This LVAD Patient Home Management Adherence Scale consists of 9 LVADspecific self-care behaviours, related to the equipment and driveline [13]. However, patients also need to perform more self-care behaviours, such as daily weight monitoring, regular exercise, and fluid intake. A single instrument that could comprehensively measure self-care behaviours would be of great value. To address this need, we developed a 33-item LVAD self-care behaviour scale based on the method for developing patient-reported outcomes recommended by the US Food and Drug Administration [14,15]. The scale items were generated on the basis of a literature review and 2-round Delphi method with expertise in HF and LVAD, guided by the Middle-Range Theory of Self-care of Chronic Illness [16]. Further refinement is needed to use it in research as well as in clinical practice. The purpose of the study was therefore to assess validity and reliability of the 33-item version of the LVAD self-care behaviour scale. Method 1. Study design A cross-sectional survey using a self-administered questionnaire was performed in Japan, Israel, and the United States. Measurement properties of the LVAD self-care behaviour scale were evaluated in reference to the COSMIN Study Design Checklist [17]. Construct validity and internal consistency (...truncated)