Clinical investigations: Outcomes, health policy, and managed care
Clinically important differences in health status for patients with heart disease: an expert consensus panel report

Presented at the Eighth Annual Meeting of the International Society for Quality of Life Research, November 9, 2001, in Amsterdam, The Netherlands, and at the Annual Meeting of the Academy of Health Services Research and Health Policy, June 23–25, 2002.
https://doi.org/10.1016/j.ahj.2003.10.039Get rights and content

Abstract

Background

The purpose of the study was to develop clinically important difference (CID) standards for patients with coronary artery disease and congestive heart failure that identify small, moderate, and large intraindividual changes with time in a modified version of the Chronic Heart Failure Questionnaire (CHQ) and the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, version 2). Prior work in ascertaining important difference standards for the CHQ have centered on patient-perceived changes. No important difference standards for the SF-36 have been published for patients with heart disease. This development of CIDs would facilitate the use of health status measures in daily clinical decision-making.

Methods

We used a modification of the RAND Appropriateness Method to assemble and guide a 9-member consensus panel of physicians with substantial experience in using the CHQ or the SF-36 among patients with heart disease.

Results

On the basis of their own experience using these measures and an extensive review of articles describing the development and use of these instruments, the expert panel achieved consensus on small, medium, and large clinically relevant changes in scores for the CHQ and SF-36. The CID standards established by this panel were slightly higher than the minimal important difference standards previously established for the CHQ using patient-perceived changes.

Conclusions

The CID standards established by this expert panel provide an important and useful tool for determining whether routine clinical health status assessments will benefit patients and enhance physicians' decision-making capacity in clinical settings.

Section snippets

Methods

The RAND Appropriateness Method served as the model for the development and implementation of our consensus panel process. In its original form, the method involved a systematic review of relevant literature, a procedure for expert panelists' selection, a detailed clinical indications list, and then a 2-fold process for consensus building among the expert panelists that integrated current evidence when recommending the appropriateness of surgical and medical procedures.16 With minor

Results

The CAD/CHF expert consensus panel (see Acknowledgments for panelist names) convened in St. Louis, Mo, on May 16, 2000. After initial introductions, the panelists engaged in discussion on their objective to establish small, moderate, and large intraindividual CID standards for both improvements and declines in the CHQ and the SF-36. The panel chair launched the CID dialogue by asking each panelist to give a description of the method he used to determine the CID standards in the Delphi rounds.

Discussion

The RAND Appropriateness Method was used to provide a structured mechanism for convening an expert panel of physicians familiar with the use of the CHQ and the SF-36 in patients with heart disease and to recommend CID standards for these health status measures. The standards recommended by the expert panel for the CHQ were slightly higher than the small, moderate, and large important difference standards ascertained by Jaeschke et al in 1989 of 2.5, 2.0, and 3.5 in the dyspnea, fatigue, and

Acknowledgements

We thank the members of Heart Disease Expert Panel: John A. Spertus, MD, panel chair; Kirkwood F. Adams, MD; Ronald S. Baigrie, MD; Marshall H. Chin, MD; Donald J. Mertens, MD; Michael W. Rich, MD; Kenneth Rockwood, MD; Roy J. Shephard, MD; and Robert J. Zalenski, MD. We also thank Kelli Norton and Joe Kesterson for coordinating the data and chart searches required to create the clinical change scenarios, Janet Bafia and Sharon Fryer for transcribing the audio and videotapes from the panel

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    Supported by grants from the Agency for Healthcare Research and Quality to Dr Wolinsky (R01 HS10234) and Dr Wyrwich (K02 HS11635).

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