Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
260 participants
OBSERVATIONAL
2006-01-31
2008-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Informed consent
Exclusion Criteria
* Unable to fill in a questionnaire in norwegian
18 Years
ALL
No
Sponsors
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Ullevaal University Hospital
OTHER
Principal Investigators
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Finn Wisløff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ullevål University Hospital, Norway
Locations
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Ullevaal University Hospital
Oslo, , Norway
Countries
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References
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Kvam AK, Wisloff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health Qual Life Outcomes. 2010 Aug 3;8:79. doi: 10.1186/1477-7525-8-79.
Other Identifiers
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1.2005.1269
Identifier Type: -
Identifier Source: org_study_id
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