Quality of Life in Patients With Multiple Myeloma
Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. In the
absence of curative treatment, the aim of the therapy is not only to induce an objective
response and a prolongation of survival but also to improve the patients quality of life.
This project will raise two problems which make QoL-data hard to interpret
1. In a clinical trial where many patients are included, statistically significant
differences are obtained. However, there is widespread agreement that p-values do not
indicate whether a particular finding has clinical significance because statistical
significance does not necessarily equate to a meaningful difference or change in QoL. A
crucial task for clinicians in interpreting trial-based QoL results is to determine if
the observed change is clinically important to the patient.
2. When measuring changes in QoL in a pretest-posttest design,response shift can affect
results. Patients with advanced disease can report surprisingly good QoL.Including
response shift into quality of life research would allow a better understanding of
changes in the QoL that patients report.
Observational Model: Case-Only, Time Perspective: Prospective
Finn Wisløff, MD, PhD
Ullevål University Hospital, Norway
Norway:National Committee for Medical and Health Research Ethics