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Better Understanding of Quality of Life Assessments

Intent on incorporating the patient’s voice into cancer research and care, Mayo Clinic Cancer Center investigators have sought out the best //practices, promising techniques and novel applications for quality of life (QOL) assessment. Their findings were published as a monograph in two issues of Current Problems in Cancer.

QOL assessments capture the patient's perspective of how their physical, psychological, emotional, social and spiritual well-being are affected by their disease and treatment.

“Patients with cancer face many quality of life challenges, and many efforts are taken to alleviate those burdens,” says Jeff Sloan, Ph.D., Mayo Clinic oncology researcher. “We have found that clinicians collect a wide variety of QOL data and use it in numerous ways; but there is a great degree of variability. We hope our discussions will further the understanding of the QOL assessment and be used to improve patient care.”

Dr. Sloan says that the team chose to study QOL assessments with the intent of moving towards standardization recommendations. He says that because no standard criteria existed, and general understanding remains vague, the need was obvious. “Without a complete understanding of the value of QOL data, physicians are unable to address the totality of a patient’s physical and emotional well-being,” he says.

Since beginning their research, the Mayo team partnered with the U.S. Food and Drug Administration (FDA) to host a patient-reported outcome forum, during which researchers and clinicians from around the world gathered to help codify the FDA’s draft guidance for incorporating patient-reported outcomes into research. The team was also instrumental in subsequent symposiums designed to address this QOL issue, but they say that a need for overall guidance still exists.

The authors say QOL refers to all aspects of a cancer patient’s well-being, other than survival or tumor response. They review genetic imp lications, philosophical issues, and the necessity of statistical relevance and simplicity of data collection. Additionally, they discuss ways to evaluate and choose the right methods for individual studies, reviewing current options.

Issues addressed in the second published report include:

? Does QOL Provide the Same Information as Toxicity Data?
? Genetics and Quality of Life
? Is the Use of QOL Data Really Any Different than Other Medical Testing?
? Choosing the “Correct” Assessment Tool
? Analyzing the “Correct” Endpoint
? Dealing with Multiple Endpoints
? Integrating QOL Assessments for Clinical and Research Purposes

A significant number of QOL assessments are available, and Dr. Sloan and his coauthors say that choosing the right ones to use can be difficult, as can the proper data for a study or treatment regimen. Requiring the patient to submit excessive amounts of data, such as daily reports or lengthy questionnaires, contributes to a lessened quality of life, say the authors, but not enough information may result in inaccurate assessments by the clinician and or inadequate adjustment of treatment strategies. As a result, patients may choose to cease participation in a clinical study or course of treatment. To be useful, QOL assessments must merge the researcher’s data requirements, the clinician’s goals, and the patient’s needs.

The researchers found significant evidence for the idea that genetics affects QOL. This research, in which several of the QOL team members were involved, was conducted through the North Central Cancer Treatment Group, a National Cancer Institute-sponsored clinical research group with its research base at Mayo Clinic. “It is not difficult to understand why there would be a link between an individual’s genetic makeup and his or her reaction to the stresses of cancer diagnosis and treatment,” says Dr. Sloan. “While much evidence is preliminary, we in the North Central Cancer Treatment Group just completed a study that adds credence to the idea of a genetic link to QOL responses from patients.” The team hopes that other researchers will continue to add to the body of research surrounding QOL, and strive to incorporate best practices across the medical field.

“We expect that QOL assessments will someday become as routine as having your blood pressure checked,” says Dr. Sloan. “After all, if the best interests of the patient are what we seek, incorporating their needs into regular care is imperative.”

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