Subjective symptoms and quality of life in healthy subjects during a phase I study

Abstract

A careful exploration of the baseline symptoms is necessary even in healthy subjects to avoid observation bias. The symptom course differs greatly from individual to individual; therefore in a phase I study only group scores of wellbeing should be used to assess the possible effects of trial-related factors. A setting like the one used in our study does not impair the quality of life of healthy subjects and as such can be regarded as a fairly neutral means of measuring wellbeing.

Modulation of clinical expression of plaque‐induced gingivitis: effects of personality traits, social support and stress

“…For the Hardiness Scale and the CEC-S, the total score as well as the score from each single sub-scale were calculated. For the LES, the raw number of events and the Impact Score were determined (Sarason et al 1985, Schuppel et al 1996, Leserman et al 1998 subscales and VAS-TD). Multiple regression analysis was used to determine whether psychological measures could be independent predictors for plaque accumulation or gingival inflammatory variables.…”

“…For the Hardiness Scale and the CEC‐S, the total score as well as the score from each single sub‐scale were calculated. For the LES, the raw number of events and the Impact Score were determined (Sarason et al 1985, Schuppel et al 1996, Leserman et al 1998). Reliability test (Cronbach α ), Pearson's correlation test and anova were used, when appropriate, on psychological measures.…”

The Experience of Older Patients With Cancer in Phase 1 Clinical Trials: A Qualitative Case Series

“…Biomedical research on phase 1 clinical trials focuses on the rates of therapeutic response and frequency of adverse events, yet other contextual and quality-of-life factors related to procedural burden, physical symptoms, and psychosocial function are equally important to our understanding of the patient experience of trial participation. [1][2][3][4] Although previous research on clinical trial participation from the perspective of the patients with cancer is informative, 1,2,5,6 there has been little inquiry into the experience of older adults with advanced cancer enrolled in phase 1 chemotherapy protocols. This may stem from lower rates of trial participation among this age cohort.…”