Claudette Varricchio

The clinical significance of quality of life assessments in oncology: a summary for clinicians

BackgroundA series of six manuscripts with an introduction appeared in the Mayo Clinic Proceedings, based upon the collective effort of 30 individuals with an interest and expertise in assessing the clinical significance of quality of life (QOL) assessments. The series of manuscripts described the state of the science of QOL assessments in oncology clinical research and practice and included extensive literature and theoretical justification for the continued inclusion of QOL in oncology clinical research and practice.ObjectivesThe purpose of this paper is to produce a summary of these articles and to supplement these works with additional information that was gleaned from subsequent meetings and discussions of this material. The primary aim of this paper is to present a cogent and concise description for clinicians to facilitate the incorporation of QOL assessments into oncology clinical research and practice. The theoretical discussion is supplemented with an example of how the various ideas can be operationalized in an oncology clinical trial.

Exploration of the Value of Health-Related Quality-of-Life Information From Clinical Research and Into Clinical Practice

Quality-of-life (QOL) instruments used in clinical research can provide important evidence to inform decisions about alternative treatments. This is particularly true when patients, such as those with cancer who are contemplating toxic chemotherapy, face tradeoffs between quantity of life and QOL or when the primary goal of therapy is to improve how patients feel. Surrogate measures (cardiac function, exercise capacity, bone density, tumor size) are inadequate substitutes for direct measurement of QOL. Quality-of-life measures will be most valuable when they comprehensively measure aspects of QOL that are both important to patients and likely to be influenced by therapy, when the QOL measurement instruments are valid (measuring what is intended) and responsive (able to detect all important changes, even if small), and when the results are readily interpretable (determining whether treatment-related changes are trivial, small but important, or large). Researchers are finding new, imaginative ways to help clinicians understand the magnitude of treatment impact on QOL. Additionally, QOL measures may be useful in clinical practice. Recent results from well-designed randomized controlled trials suggest that information on patient QOL provided to clinicians might, in some circumstances, result in benefits for these patients. Further investigation is warranted to confirm these observations and to define the particular combination of methods and settings most likely to yield important benefits.

Applying Quality-of-Life Data Formally and Systematically Into Clinical Practice

The systematic integration of quality-of-life (QOL) assessment into the clinical setting, although deemed important, infrequently occurs. Barriers include the need for a practical approach perceived as useful and efficient by patients and clinicians and the inability of clinicians to readily identify the value of integrating QOL assessments into the clinical setting. We discuss the use of QOL data in patient care and review approaches used to integrate QOL assessment into the clinical setting. Additionally, we highlight select QOL measures that have been successfully applied in the clinical setting. These measures have been shown to identify key QOL issues, improve patient-clinician communications, and improve and enhance patient care. However, the work done to date requires continued development. Continued research is needed that provides information about benefits and addresses limitations of current approaches.

Assessing the clinical significance of single items relative to summated scores

How many items are needed to measure an individuals quality of life (QOL)? This article describes the strengths and weaknesses of single items and summated scores (from multiple items) as QOL measures. We also address the use of single global measures vs multiple subindices as measures of QOL. The primary themes that recur throughout this article are the relationships between well-defined research objectives, the research setting, and the choice single item vs summated scores to measure QOL. The conceptual framework of the study, the conceptual fit with the measure, and the purpose of the assessment should all be considered when choosing a measure of QOL. No gold standard QOL measure can be recommended because no one size fits all. Single items have the advantage of simplicity at the cost of detail. Multiple-item indices have the advantage of providing a complete profile of QOL component constructs at the cost of increased burden and of asking potentially irrelevant questions. The 2 types of indices are not mutually exclusive and can be used together in a single research study or in the clinical setting.

Quality of Life Assessments in Clinical Practice

OBJECTIVES To provide information about the value of quality of life (QOL) assessments to improve clinical care. DATA SOURCES Published articles, web resources, clinical practice. CONCLUSION Clinical assessment of QOL can lead to improved patient outcomes and provide a means of evaluating the effectiveness of interventions. IMPLICATIONS FOR NURSING PRACTICE QOL assessment provides nurses with a more holistic view of the patient and improves communication between the patient and health care providers.

Quality of life endpoints in prostate chemoprevention trials

Although the ultimate goal of any chemoprevention study is to extend life by preventing cancer, it is also important that in doing so, the quality of life is not reduced. Hence, quality of life (QOL) endpoints are secondary only in importance to survival as an endpoint for prostate chemoprevention trials. One can conceptualize QOL endpoints as just another surrogate endpoint biomarker. QOL can be administered and collected in a valid and reliable fashion from cancer patients as demonstrated by numerous clinical trials. To date more than 25 prostate cancer QOL tools have been developed with over 700 different items. However, patients may be asymptomatic, leaving the sensitivity and specificity of the QOL instrumentation in question. Judicious use of a global QOL measure supplemented by protocol-specific or disease-specific instruments is an efficient approach for prostate chemoprevention trials. Clinical significance and missing data considerations need to be elucidated a priori in definitive terms so that results are directly interpretable from the data obtained. The effect of chemopreventive agents on QOL needs to be sufficiently modest to be practical to justify administration in a healthy population. As such, great care needs to be given to a priori determination of the QOL constructs that are most likely to change.