Evaluation of an immunosuppressant side effect instrument

Progress in Transplantation, Sep 2004 by Winsett, Rebecca P, Arheart, Kris, Stratta, Robert J, Alloway, Rita, Et al

Background-Clinicians continue to be compelled to evaluate the impact of immunosuppressive medication side effects on the quality of life of transplant recipients. We were asked to develop an instrument to measure side effects in immunosuppressed transplant recipients.

Objective-To construct an instrument that measures the impact and severity of side effects of immunosuppressive medications used in transplantation and to assess the reliability and validity of the newly developed instrument called the Memphis Survey.

Design-The instrument was constructed by a panel of physicians, nurses, and pharmacists with experience in treating transplant recipients. A small group of kidney transplant recipients (n= 13) provided pilot data for refining and testing the instrument. A national sample of kidney, liver, and heart transplant recipients (n = 505) provided data that were used to further develop the instrument.

Analysis-Factor analysis was used to determine the psychological dimensions underlying the instrument and to guide the construction of scales from the survey items. The instrument scales were then computed from the dataset of 505 transplant recipients to quantify the impact of immunosuppressant side effects on the quality of life of transplant recipients.

Results and Conclusion-Analyses showed the final instrument scales to be valid and reliable. Exploratory analysis suggests the need for further testing of the instrument to determine gender differences. (Progress in Transplantation. 2004;14:210-216,240)

The current paradigm shift from short-to long-term outcomes after transplantation emphasizes the excellent survival rates and improved quality of life (QOL) achieved for most solid-organ recipients. With the improvement in survival rates, transplant clinicians can now focus on promoting long-term health and QOL. Transplant clinicians are particularly concerned about the long-term effects of immunosuppwssive agents. A review of the literature indicates that 2 psychometrically sound instruments have been developed specifically for heart and lung transplant recipients.1,2 At the time we undertook the development of the instrument presented in this article, psychometric properties for

the 2 known instruments had not been published. A third instrument to evaluate symptom distress has not been published nor psychometric properties examined,1 We chose to develop and test an instrument specific to immunosuppresslve medications that may cross organ lransplanl types, thus providing an additional transplant-specific instrument. This article outlines the steps undertaken to develop and evaluate such an instrument.

Problem

To maintain graft function, transplant recipients must take immunosuppressive medications to protect the transplanted organ from rejection. Yet these medications are not without adverse side effects, and these side effects are believed to be associated with medication nonadherence. Nonadherenee to medications has been identified as the third leading cause of graft failure after acute rejection and infection.4 Furthermore, healthcare providers perceive disturbing side effects to be an influential factor in nonadherence.5 Therefore, clinicians continue to question the effect of the immunosuppressive medications on short- and longterm outcomes. The framework for the development of this instrument is based on the clinicians' perception that side effects of medications, particularly immunosuppressive medications, influence long-term health and QOL outcomes. It is because of the strength of that belief that we agreed to undertake the enormous task of developing a transplant-specific side effect instrument. This does not discount the conceptualization of patient symptom distress of which the literature supports.6-11 The combined effort of seeking clinician input in patient side effects coupled with recipients' perceptions of side effect severity would provide empirical data for us to examine the effects of immunosuppressive drugs on QOL in the future.

Using a psychometrically sound instrument to measure the impact of side effects may assist clinicians in identifying patients at risk of medication nonadherence and may facilitate the use of tailored medication maintenance protocols to balance optimal immune suppression while minimizing drug-related side effects. Currently, only 1 instrument has been developed to assess the effect of immunosuppressive drugs on QOL.12 This instrument measured frequency and distress in the precyclosporine era. Because this instrument was developed in the early cyclosporine era, it has recently been revised to include side effects associated with new immunosuppressive drugs used in transplantation.11 Symptom distress has also been addressed in another instrument3,7,13,14; however, the psychometric properties of the instrument have not been published.

Purpose of Study

The purpose of this study was to construct and to assess the psychometric properties of a newly developed instrument to measure the impact of immunosuppressive treatment. The institutional review board at the University of Tennessee Health Science Center in Memphis, Tenn, approved the study protocol with regard to the protection of human subjects.