Assessing quality of life (QL) and patient reported outcomes (PROs) in clinical trials and clinical practice: A study using a hand-held computerized form of the validated LCSS instrument in patients with non-small cell lung cancer (NSCLC)
Kuruvilla, P.G.; Krieger, H.; Zibdawi, L.; Meharchand, J.; Solow, H.; Leighl, N.; Chin, C.; Stewart, J.A.; Hollen, P.J.; Gralla, R.J.
Journal of Clinical Oncology 23(16_Suppl): 8067-8067
NlmCategory="UNASSIGNED">8067 Background: Improving survival, QL, and PROs are key goals in cancer treatment. Valid QL instruments are available; however, low feasibility in treatment settings remains a barrier to QL assessment. The LCSS was converted into a computerized format for inexpensive hand-held devices (pocket pc), providing an immediate graphic report of current scores and change over time. All data are automatically recorded without transcription. This study documents ease of use and psychometrics with this new approach, comparing the LCSS paper form with the electronic (LCSS-QL). The objectives were to: a) determine correlation of the LCSS-QL with the paper version; b) measure completion times; and c) assess acceptability of the LCSS-QL by patients, nurses, and physicians. Patients were entered at 9 COMET clinics in Ontario. All had: a) stage III or IV NSCLC, b) KPS ≥ 60, 3) no prior chemotherapy, and 4) received initial courses of docetaxel + platinum. 48 patients completed both the paper and electronic forms (pretreatment, and with the next 4 chemotherapy cycles - paper version with every other cycle). Characteristics: 58% men; KPS (median 80%; range 60% - 100%); age (median 71; range 47-81); Stage IV: 73%. The LCSS-QL had excellent acceptance by patients, nurses, and physicians. Patients required a mean of only 2.1 minutes (SD 1.58 min) to complete the LCSS-QL. Reliability coefficients using Cronbach's alpha were high for the paper (0.83) and electronic (0.88) versions. Correlation coefficients between paper and electronic forms were in near agreement (0.93, 0.92, 0.92 for each of 3 methods used: Pearson r, Intraclass Correlation Coefficient, Lin's concordance, respectively) for the total score. 1) The high acceptance rate by patients and professionals, the rapid completion time, good feasibility, reliability, and validity confirm that the electronic LCSS is practical for evaluating QL and PRO endpoints in clinical trials and in patient management; and 2) both the paper and electronic LCSS versions provide the same score for quality of life. [Table: see text].