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The Q in the Quality Adjusted Life Years (QALY): Exploring New Methods (MOMENTUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085409
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : May 7, 2013
Adelante, Centre of Expertise in Rehabilitation and Audiology
Information provided by (Responsible Party):
Iris Maes, Maastricht University Medical Center

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

Condition or disease

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 : Observational
Actual Enrollment : 139 participants
Time Perspective: Prospective
Official Title: The Q in the QALY: Exploring New Methods
Study Start Date : April 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Patients with tinnitus
Artery disease
Subjects with mobility constraints as a results of severe artery disease which in some cases led to leg amputation.
Subjects with anxiety complaints
Healthy controls

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: During 1 week ]
    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.

Secondary Outcome Measures :
  1. Life satisfaction [ Time Frame: 2 times ]
    Life satisfaction as mesured with te Satisfaction with Life Scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

  • Diagnose on one of the diseases under investigation
  • 18 years or older

Exclusion Criteria:

  • not being able to read in Dutch
  • not able to handle the ESM device because of impaired motor skills

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01085409

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Hoensbroek, Limburg, Netherlands, 6430AB
Maastricht University Medical Hospital
Maastricht, Limburg, Netherlands, 6227 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Adelante, Centre of Expertise in Rehabilitation and Audiology
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Principal Investigator: Iris Maes, MSc Maastricht Universitair Medical Centre
Principal Investigator: Manuela Joore, PhD Maastricht University Medical Centre

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Responsible Party: Iris Maes, MSc, Maastricht University Medical Center Identifier: NCT01085409     History of Changes
Other Study ID Numbers: 80-82500-98-9207
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by Iris Maes, Maastricht University Medical Center:
experienced utility
decision utility
subjective well-being
experience sampling method
day reconstruction method
Quality of life