Development of an Instrument for Measuring Self-Care Behaviors After Left Ventricular Assist Device Implantation

Abstract

Background:Successful long-term left ventricular assist device (LVAD) therapy necessitates a high degree of self-care. We aimed to develop an instrument that measures self-care behaviors in adult patients living with an LVAD.Methods:We used the method to develop patient-reported outcomes recommended by the US Food and Drug Administration. Prior to developing the instrument, a literature review was conducted to generate items using the middle-range theory of self-care of chronic illness as a guiding framework. A 2-round Delphi method, involving 17 clinicians with expertise in heart failure and assist devices from the Netherlands, Israel, United States, Canada, and Japan, was used to generate and select items. In the first Delphi survey, the levels of importance, relevance, and clarity of items in the instrument were evaluated. The second Delphi survey was performed to gain consensus on the final selection of items. We also examined face validity.Results:A preliminary 37-item version of the Self-Care Behavior Scale was produced. The first panel judged 33 items as important and relevant, taking out 4 items due to vague wording and duplication and adding in 4 items. In the final 33-item version, 19 items address self-care maintenance behaviors, 10 items address self-care monitoring behaviors, and 4 items address self-care management behaviors. Patients (N = 25) did not have any difficulties understanding items and report any missing items.Conclusion:The 33-item Self-Care Behavior Scale for patients with heart failure having an LVAD has been developed and is ready for further psychometric testing.

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

“…In the present study, we performed initial psychometric testing and further refinement of the LVAD self-care behaviour scale. We previously developed a 33-item scale based on a qualitative and quantitative literature review, guidelines and discussions among the research team (including clinical experts on heart failure and LVAD [15]), and the Middle Range Theory of Self-Care of Chronic Illness [16]. We demonstrated that the 20-item LVAD self-care behaviour scale is a valid and reliable instrument to measure self-care behaviour for LVAD supported patients in research and clinical practice.…”

“…The 33-item version of an instrument for measuring self-care behaviour after LVAD implantation was developed on the basis of a literature review including qualitative studies, quantitative studies, and LVAD guidelines, as well as a 2-round Delphi method involving 17 clinicians with expertise in heart failure and LVAD from 5 countries [9,15,18]. The middle-range theory of self-care of chronic illness was used as the fundamental theory of the scale [16].…”

“…Because we developed the 33-item version of the LVAD self-care behaviour scale [15] and we were the owner of the original scale, we did not have to obtain the permission to modify it.…”

“…Based on the instrument's theoretical perspective [15], we hypothesised a three-factor model of the LVAD self-care behaviour scale consisting of selfcare maintenance, self-care monitoring, and self-care management. To test how well the measured variables fit the theory-derived model, confirmatory factor analysis was performed.…”

“…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].…”