Cross-Sectional Patient-Reported Outcomes in Chronic Lymphocytic Leukemia Patients
Real-world health-related quality of life (HRQoL) and treatment satisfaction data of patients with CLL. This study was completed in two parts. The first portion (Norming Study) was a US online survey conducted to serve as a reference population. The Norming Study included a total of 139 patients with CLL, excluding those treated with ibrutinib. The second portion (CLL Ibrutinib Study). Respondents completed online or phone surveys to collect demographic and clinical information and HRQoL instruments. Higher scores indicate better HRQoL/treatment satisfaction.
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The following surveys were licensed for this study: Functional Assessment of Cancer Therapy-General [FACT-G], FACT-Leukemia [FACT-Leu] Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, and Cancer Therapy Satisfaction Questionnaire [CTSQ], Short Form-12v2® Health Survey [SF-12v2]. Descriptive analyses were used to understand patient demographics, comorbidities, and PROs and summarized using proportions, means and standard deviations, where appropriate. The results of validated instruments were scored according to the appropriate algorithm. Effect sizes of the difference in HRQoL and treatment satisfaction scores at the group level between the CLL Norming and CLL Ibrutinib studies were calculated using Hedges' g, which provides a measure of effect size weighted according to the relative size of each sample, given the different sample sizes among the groups. An effect size of 0.2 is considered a small effect, 0.5 is a medium effect, and 0.8 is a large effect and the sign of the effect indicates the direction of the effect.