METHODS FOR ASSESSING QUALITY OF LIFE IN CANCER PATIENTS EXPERIENCING COMPLICATIONS- OSTEONECROSIS OF THE JAW PILOT STUDY

Author(s)

Rebecca Miksad, MD, MPH, Clinical Oncology Attending Physician/ Program in Cancer Outcomes Research Training Fellow1, Sook-Bin Woo, DMD, Attending Dentist/Assistant Professor, Harvard School of Dental Medicine2, Thomas Dodson, DMD, MPH, Attending Oral Surgeon/Associate Professor of Oral and Maxillofacial Surgery3, Nathaniel Simon Treister, DMD, DMSc, Associate Surgeon/ Instructor in Oral Medicine2, Guy Maytal, MD, Psychiatry Attending Physician/Assistant Professor of Psychiatry3, Meredith August, MD, DMD, Attending Oral Surgeon/Associate Professor of Oral and Maxillofacial Surgery3, Omosalewa Akinyemi, MD, MPH, Research Scientist3, Marian Moore Bihrle, BA, Research Scientist4, J Shannon Swan, MD, Senior Scientist/Associate Radiologist / Assistant Professor, Harvard Medical School31Beth Israel Deaconess Medical Center / Institute for Technology Assessment / Harvard University, Boston, MA, USA; 2 Brigham and Women's Hospital/ Harvard University, Boston, MA, USA; 3 Massachusetts General Hospital/ Harvard University, Boston, MA, USA; 4 Massachusetts General Hospital/ Beth Israel Deaconess Medical Center/ Harvard University, Boston, MA, USA

Objectives: Intravenous bisphosphonate use in cancer patients is associated with exposed and necrotic jaw bone, called Osteonecrosis of the Jaw (ONJ). The overall aim of this pilot study was to develop a survey that captured the oral health-specific and the global health related quality of life (HRQoL) impact of ONJ, to test the feasibility of survey instruments and to assess subject distress. Methods: A 30 minute phone survey was created with multi-disciplinary collaboration. Four standardized ONJ health states were developed and subjects' preferences (utility) for each state were obtained using the Visual Analogue Scale (VAS), the EQ5D and time-tradeoff (TTO) questions. A Visual Basic Interface was constructed to guide the interviewer through TTO questions designed for the survey. The subject's life before and after ONJ was evaluated with the Oral Health Impact Profile (OHIP). Emotional discomfort during and after survey was evaluated on a five point Likert scale. Subjects were randomly identified from a cohort of 80 cancer patients with ONJ. Results: The pilot study included five patients (response rate=100%). Utility decreased with increasing ONJ stage for all HRQoL instruments: 0.76, 0.97, 0.86 (Cancer and No ONJ), 0.72, 0.88, 0.83 (Cancer and Stage 1 ONJ), 0.43, 0.52, 0.63 (Cancer and Stage 2 ONJ) and 0.34, 0.39, 0.56 (Cancer and Stage 3 ONJ) for VAS, EQ5D and TTO respectively. With a baseline mean of 1.6, the OHIP score increased to 7.2 after ONJ (0-28 scale). Two subjects ranked 2 (“a little”) for the level of emotional discomfort during the survey, but none were upset afterwards. Conclusions: Based on preliminary results, the study design was feasible and both oral health-specific and global HRQoL instruments were sensitive to QoL changes associated with ONJ. All HRQoL instrument performance showed appropriate rank ordering and consistent relationship by ONJ stage. There was minimal subject distress.

Conference/Value in Health Info

2008-05, ISPOR 2008, Toronto, Ontario, Canada

Value in Health, Vol. 11, No. 3 (May/June 2008)

Code

PCN79

Disease

Oncology

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