Symposium on Quality of Life in Cancer Patients
Assessing Clinical Significance in Measuring Oncology Patient Quality of Life: Introduction to the Symposium, Content Overview, and Definition of Terms

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The Clinical Significance Consensus Meeting Group of the Symposium on the Clinical Significance of Quality-of-Life Measures in Cancer Patients produced 6 articles regarding the clinical significance of quality of life (QOL) assessments in oncology. The 6 articles deal with the methods used to date: group-vs-individual clinical significance; single items vs summated scores; patient, clinician, and population perspectives; assessment of changes over time; and communication of results. The articles were produced by a team of 30 QOL research experts assembled in a consensus writing meeting held at the Mayo Clinic, Rochester, Minn, October 6 and 7, 2000. This introduction describes the need for the articles, definitions of key terms, and plans for the future. It is hoped that this series of articles will serve as a resource for individuals conducting cancer QOL research and for clinicians considering incorporation of QOL assessment in the treatment of patients with neoplastic diseases. A secondary goal is to stimulate further discussion and research in the interpretation of QOL assessments.

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WHY DO WE NEED A SERIES OF ARTICLES ON QOL CLINICAL SIGNIFICANCE?

There has been an explosion of QOL publications in recent years. However, the literature on QOL research is scattered and not easily accessible. Much of what we now call QOL literature is spread out in the nursing, social science (eg, psychology), and medical literature. Gaps exist between the research literature and clinicians themselves in terms of language and communication. Regulatory agencies are searching for guidelines to handle QOL data. To date there have not been unified guidelines

HOW DID THIS EFFORT COME TOGETHER?

Investigators, regulators, and clinicians have accepted QOL as an end point in clinical research.2, 4 A mechanism for easy incorporation in clinical practice or trials is still pending. Clinicians may become frustrated with an inability to understand how to integrate these “soft” measures into clinical research and practice. If such mechanisms are not clarified with a strong and unified voice from the QOL research community, there is a danger that QOL will be marginalized in such endeavors.

WHO IS THE INTENDED AUDIENCE?

This series of articles is aimed at oncology clinical researchers and clinicians. The target audience includes those who are familiar with QOL research and those who have seen QOL assessment as a barrier to clinical research. The audience includes clinicians who may want to incorporate QOL assessment into their clinical practice but do not know how or who are concerned that doing so may involve an inordinate burden for them, their practice, and their patients. While the series is intended to be

HOW DID THE WRITING PROCESS PROCEED?

Each team included a clinician, an experienced QOL researcher, and a methodologist. The remainder of the team members were chosen to achieve a balance of interests and experience. Teams were given the topic they were to address, and the group leader was asked to initiate communication via e-mail, telephone, and/or teleconference prior to the formal 2000 conference. This optimized efficiency for the writing tasks during the time of the meeting. At the consensus meeting, each topic was given a

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A complete list of other Clinical Significance Consensus Meeting Group contributors to this article appears at the end of the article.

This project was supported in part by Public Health Service grants CA25224, CA37404, CA15083, CA35269, CA35113, CA35272, CA52352, CA35103, CA37417, CA63849, CA35448, CA35101, CA35195, CA35415, and CA35103.

Individual reprints of this article are not available. The entire Symposium on the Clinical Significance of Quality-of-Life Measures in Cancer Patients will be available for purchase as a bound booklet from the Proceedings Editorial Office at a later date

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