Time to Deterioration in Quality of Life Score as a Modality of Longitudinal Analysis in Patients with Breast Cancer

Abstract

Purpose. This prospective multicenter study explored different definitions of time to deterioration (TTD) in quality of life (QoL) scores, according to different cutoffs of the minimal clinically important difference (MCID) as a modality for longitudinal QoL assessment in breast cancer patients.Methods. QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and BR-23 before surgery, after surgery, and 6 and 12 months later. The global health score, arm symptoms score (BRAS), and breast symptoms score were analyzed. For a given baseline score, QoL was considered to have deteriorated if this score decreased by >5 points at any time point after baseline. Analyses were repeated using an MCID of 10 points and taking the score after surgery as the reference score (to explore the occurrence of response shift). TTD was calculated using the Kaplan-Meier method and Cox regression was used to identify independent factors associated with TTD.Results. Two hundred thirty-five patients underwent axillary lymph node dissection (ALND), 222 underwent sentinel lymph node biopsy (SLNB), and 61 underwent SLNB plus ALND. Patients who underwent SLNB had a significantly longer TTD for the BRAS dimension than those who underwent ALND. Cox multivariate analyses showed that treatment using SLNB and age >59 years were independently associated with longer TTD for the

Cancer-related fatigue management: evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study

“…The time to fatigue severity level deterioration (TTD) was defined as the time from baseline to a first deterioration of 1 point at least of the VAS measure of fatigue severity as compared to the baseline measure (Hamidou et al , 2011). Patients with the baseline fatigue severity measure and at least one follow-up measure were retained (mITT3).…”

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial

“…Burden, coping and HADS will also be modeled as time-dependent covariables in another model. Time to HRQoL score deterioration will be estimated using the definitions of both Bonnetain et al [51] and Hamidou et al [52]. Item Response Theory, cluster analyses, structural equation modeling as well as classical factorial analyses will be conducted as complementary analyses to define and validate longitudinal profiles of caregivers.…”

QoLR: An R Package for the Longitudinal Analysis of Health-Related Quality of Life in Oncology

“…The most widely used is the linear mixed model (Diggle 1988). Survival analysis approaches, like the time to deterioration in a HRQOL score, have recently been proposed as a modality of longitudinal HRQOL analysis in cancer patients (Bonnetain et al 2010;Hamidou et al 2011).…”

“…Contrary to the linear mixed model, "time to deterioration" (TTD) models can propose clinically meaningful results with hazard ratios and log-rank tests (Bonnetain et al 2010;Hamidou et al 2011). Moreover, these models can handle the presence of missing data: when intermittent missing data occur for one patient, we can consider that the patient's HRQOL level remains unchanged since the previous available measure; whereas monotone missing data can be due to a deterioration of the patient's health status in case of advanced/metastatic setting.…”

“…The event definition can be defined according to the reference score, the MCID, missing scores, including death or not. The most intuitive definition is the time from inclusion in the study to a first deterioration of the score with a MCID of at least k points as compared to the baseline score (Hamidou et al 2011). Patients with no deterioration before drop-out from the study are censored at the time of last HRQOL questionnaire completion or last follow-up.…”