Modeling and analysing quality of life data in clinical trials

Dipl.Stat. M. Olschewski IMBI
Dr. G. Schulgen IMBI
Prof. Dr. M. Schumacher IMBI/FDM
Prof. Dr. J. C. J. M. de Haes Medical Psychology, Amsterdam

• Previous work

In a comprehensive assessment of treatment efficacy in clinical research Quality of Life (QoL) is more and more considered an important endpoint additionally to classical endpoints like global or recurrence-free survival [1]. In the context of clinical trials conducted at the IMBI in the field of oncology or cardiology standardized measuring instruments for assessing patients' QoL were developed [2] and adapted [3]. These have been successfully applied in a number of trials [2,4].
Additionally, methodological overviews and critical appraisals of existing statistical analysis strategies of QoL data were performed [1,5]. Some problems specific to QoL data like multi-cultural aspects in international trials [4] or missing data [6] were considered.

• Actual and future projects

QoL data emerging from a number of ongoing trials is currently analysed. At the moment no further input from the FDM is necessary.

• Publications

(1)

Olschewski M, Schulgen G, Schumacher M, Altman DG: Quality of life assessment in clinical cancer research, British Journal of Cancer, 70, 1-5, 1994.

(2)

The German Breast Cancer Study Group (GBSG): Therapy of small breast cancer - Four-year results of a prospective non-randomized study, Breast Cancer Research and Treatment, 34, 1-13, 1995.

(3)

de Haes JCJM, Olschewski M, Fayers P et al.: The Rotterdam Symptom Checklist: a manual, Northern Centre for Healthcare Research series no. 9, Groningen, 1996.

(4)

de Haes JCJM, Olschewski M: Quality of life assessment in a cross-cultural context: use of the Rotterdam Symptom Checklist in a multinational randomized trial comparing CMF and Zoladex (Goserlin) treatment in early breast cancer, Annals of Oncology, 9, 745-50, 1998.

(5)

Olschewski M: Quality of life and survival analysis. In: Armitage P, Colton T (eds.), Encyclopedia of Biostatistics, Vol. 5, 3613-8, Wiley & Sons, Chichester, 1998.

(6)

Olschewski M: Compliance with QoL assessment in multi-centre German breast cancer trials, Statistics in Medicine, 17, 571-5, 1998.