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QUALITY OF LIFE

Assessing the Usefulness of Health-Related Quality-of-Life Trials: A Clinician's Perspective Using Two COPD Examples

Outcomes Research Fellow, University of Connecticut/Hartford Hospital Evidence-Based Practice Center, Hartford, CT

C Michael White, PharmD FCP FCCP

Professor of Pharmacy Practice, School of Pharmacy, University of Connecticut, Storrs, CT; Director, University of Connecticut/Hartford Hospital Evidence-Based Practice Center

William L Baker, PharmD BCPS

Senior Research Scientist, University of Connecticut/Hartford Hospital Evidence-Based Practice Center

Craig I Coleman, PharmD

Associate Professor of Pharmacy Practice, School of Pharmacy, University of Connecticut; Program Director and Methods Chief, University of Connecticut/Hartford Hospital Evidence-Based Practice Center

Reprints: Dr. Coleman, University of Connecticut/Hartford Hospital Evidence-Based Practice Center, 80 Seymour St., CB309, Hartford, CT 06102, fax 860/545-2277, ccolema{at}harthosp.org

OBJECTIVE: To empower clinicians to discern when health-related quality-of-life (HRQoL) evidence from a single trial, or from constituent trials within a systematic review or meta-analysis, is compelling enough to alter clinical practice.

DATA SOURCES: To determine the criteria that would be most useful in assessing the quality of HRQoL data, recommendation statements or consensus guidelines that offer guidance to those conducting HRQoL trials were located through a MEDLINE search (1950-April 2009) using the search terms health-related quality of life and recommendations or guidelines.

STUDY SELECTION AND DATA EXTRACTION: Recommendation statements or consensus guidelines that offer guidance to investigators conducting HRQoL trials were evaluated to determine what criteria would be the most useful in assessing the quality of HRQoL data.

DATA SYNTHESIS: We discuss how quality of HRQoL data may be assessed by evaluating the following broad questions: (1) Is the HRQoL analysis hypothesis-driven? (2) How is HRQoL being measured? (3) Are the HRQoL data being collected adequately and analyzed correctly? and (4) To what extent do investigators discuss the results of HRQoL analyses? Using select examples from the literature on chronic obstructive pulmonary disease, we applied the 4 broad questions in the assessment of their quality. Also, the use of scoring systems for quality rating for HRQoL data is discussed and applied to the example cases.

CONCLUSIONS: HRQoL data are an important outcome because they capture treatment impact on physical, social, and psychological well-being. Assessing the quality and usefulness of HRQoL data requires an understanding of the advantages, limitations, and caveats of their use. Because of the potential lack of quality in HRQoL outcomes, clinicians should thoroughly assess the validity and usefulness of the evaluation. Tools are available to aid clinicians and decision-makers in the assessment of HRQoL outcomes, but additional research needs to be conducted on the topic of quality assessment of HRQoL studies to improve the usefulness of these evaluations to clinicians.

Key Words: health-related quality-of-life, patient-reported outcomes, systematic review, validity assessment

Published Online, August 18, 2009. www.theannals.com, DOI 10.1345/aph.1M211