Multiple Myeloma Clinical Trial
Official title:
Quality of Life in Patients With Multiple Myeloma
The purpose of this study is to determine Clinically important difference and Response shift in 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.
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Observational Model: Case-Only, Time Perspective: Prospective
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Recruiting |
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