The Q in the Quality Adjusted Life Years (QALY): Exploring New Methods (MOMENTUM)
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| First Received Date ICMJE | March 10, 2010 | ||||||||
| Last Updated Date | May 6, 2013 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Quality of Life [ Time Frame: During 1 week ] [ Designated as safety issue: No ] The primary outcome measure of this study is quality of life as measured with a Visual Analogue Scale (VAS), the EuroQol, the Experience Sampling Method, the Day Reconstruction Method and the Time trade-off. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01085409 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Life satisfaction [ Time Frame: 2 times ] [ Designated as safety issue: No ] Life satisfaction as mesured with te Satisfaction with Life Scale. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Q in the Quality Adjusted Life Years (QALY): Exploring New Methods | ||||||||
| Official Title ICMJE | The Q in the QALY: Exploring New Methods | ||||||||
| Brief Summary | Aim: The aim of this proposal is to investigate the potential use and value of experienced utility, as measured by the Experience Sampling Method and the Day Reconstruction Method, in the economic evaluation of health care. Methods: Three samples of 46 patients with different conditions one sample of 46 healthy controls will be included in the study. The Experience Sampling Method (ESM) and the Day Reconstruction Method (DRM) will be adapted and subsequently used to measure experienced utility. Decision utilities will be elicited by traditional preference based methods. Expected results: The expected results of this study are threefold. First, unified versions of the ESM and DRM for use in the economic evaluation of health care will be developed and applied. Second, a rich dataset will allow us to investigate the differences between the results of experienced utilities derived from these methods, with the traditional preference based measures. Third, the normative implications of the use of QALYs based on either decision utilities, experienced utilities, or a combination of the two, for health care resource allocation decisions, will be examined. Keywords: experienced utility, decision utility, subjective well-being, experience sampling method, day reconstruction method |
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| Detailed Description | This study explores new methodology regarding the measurement of health state utilities. A new pharmaceutical is nowadays only reimbursed if there is evidence of cost-effectiveness. This can be determined by different types of economic evaluations, of which cost-utility analysis (CUA) is preferred in most guidelines. In CUA the health outcome of a technology is measured in quality adjusted life years (QALY). Utilities to calculate QALYs should be based on decisions under uncertainty (decision utilities). However, the health care literature describes several problems that lead to bias in the measurement of decision utilities. These biases lead to an inaccurate estimation of the value of a health state and can therefore cause policy makers to allocate resources inefficiently. To solve some of these problems, it was suggested to determine experiences associated with different health states by measuring well-being moment-to-moment (experienced utility) by the Experience Sampling Method or the Day Reconstruction Method. Differences between the utilities measured using traditional preference based measures (decision utility), and using the new state-of-art methods ESM and DRM (experienced utility) in a range of populations with differing conditions and severity of health state will be investigated. Since somatic, psychosomatic and psychological conditions are likely to differ in the way they experience and affect well-being, we will involve patient groups from each category in this study as well as healthy controls. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients will be recruited from the Maastricht University Medical Hospital or Adelante centre of expertise in rehabilitation and audiology. Healthy controls will be recruited by advertisement in local newspapers and flyers. |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 139 | ||||||||
| Completion Date | December 2012 | ||||||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01085409 | ||||||||
| Other Study ID Numbers ICMJE | 80-82500-98-9207 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Iris Maes, Maastricht University Medical Center | ||||||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||
| Collaborators ICMJE | Adelante, Centre of Expertise in Rehabilitation and Audiology | ||||||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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