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COMS-QOLS Report No. 2

The Collaborative Ocular Melanoma Study–Quality of Life Study Group*

Arch Ophthalmol. 2003;121:1010-1020.

Objective  To develop and validate scales measuring common concerns of patients with choroidal melanoma: perception of appearance, concern about cancer recurrence, and difficulty with vision-dependent activities requiring stereopsis or binocularity.

Design  Cross-sectional study within a randomized multicenter clinical trial.

Methods  Eight-hundred forty-two of 1317 patients with choroidal melanoma enrolled in the Collaborative Ocular Melanoma Study (COMS) for medium-sized tumors and randomized to receive iodine 125 brachytherapy or enucleation were interviewed. Scale reliability was evaluated using Cronbach's , and validity was investigated through correlation with existing scales and with data collected during COMS clinical examinations.

Results  All 3 proposed scales had good internal consistency reliability. The appearance and recurrence scales had low to moderate correlation with the 36-Item Short-Form Health Survey mental health scale (r = 0.26 and 0.31, respectively) and with the the Hospital Anxiety and Depression Scale depression (r = -0.22 and -0.19) and anxiety (r = -0.27 and -0.42) scales. Appearance scores were significantly associated with occurrence of appearance-altering complications and conditions, recurrence scores were associated with recent removal of the brachytherapy-treated eye, and stereopsis/binocularity scores were higher in patients with good visual acuity in both eyes than in those with good visual acuity in one eye and an enucleated fellow eye.

Conclusions  All 3 proposed scales have good internal consistency, range, and SDs of measurement in the tested population. Based on clinical data, there is evidence of good construct validity for all 3 scales, although there also is evidence that the stereopsis/binocularity scale is sensitive to other aspects of vision in addition to stereopsis and binocularity. The appearance and recurrence scales capture clinically relevant information not available from standard mental health scales.

*Members of the writing team who signed authorship responsibility, financial disclosure, and copyright transfer statements for the group are as follows: Michele Melia, ScM; Claudia S. Moy, PhD, Sandra M. Reynolds, MA, David Cella, PhD, Timothy G. Murray, MD, Kenneth R. Hovland, MD, James A. Hayman, MD, and Carol M. Mangione, MD, MSPH. From the Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, Md (Dr Moy and Mss Melia and Reynolds); the Center on Outcomes Research and Education, Evanston Northwestern Healthcare, Evanston, Ill (Dr Cella); Bascom Palmer Eye Institute, University of Miami, Miami, Fla (Dr Murray); Department of Ophthalmology, Porter Adventist Hospital, Denver, Colo (Dr Hovland); the Department of Radiation Oncology, University of Michigan, Ann Arbor (Dr Hayman); and the Division of General Internal Medicine, David Geffen School of Medicine at UCLA, Los Angeles, Calif (Dr Mangione). Dr Moy is now with the National Institute of Neurological Disease and Stroke, Bethesda, Md.

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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Quality of Life After Iodine 125 Brachytherapy vs Enucleation for Choroidal Melanoma: 5-Year Results From the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.
Collaborative Ocular Melanoma Study-Quality of Lif
Arch Ophthalmol 2006;124:226-238.
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