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

This study has been completed.
Sponsor:
Collaborator:
Adelante, Centre of Expertise in Rehabilitation and Audiology
Information provided by (Responsible Party):
Iris Maes, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01085409
First received: March 10, 2010
Last updated: May 6, 2013
Last verified: May 2013

March 10, 2010
May 6, 2013
April 2010
November 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01085409 on ClinicalTrials.gov Archive Site
Life satisfaction [ Time Frame: 2 times ] [ Designated as safety issue: No ]
Life satisfaction as mesured with te Satisfaction with Life Scale.
Same as current
Not Provided
Not Provided
 
The Q in the Quality Adjusted Life Years (QALY): Exploring New Methods
The Q in the QALY: Exploring New Methods

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

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Healthy
Not Provided
  • Tinnitus
    Patients with tinnitus
  • Artery disease
    Subjects with mobility constraints as a results of severe artery disease which in some cases led to leg amputation.
  • Anxiety
    Subjects with anxiety complaints
  • Controls
    Healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01085409
80-82500-98-9207
No
Iris Maes, Maastricht University Medical Center
Maastricht University Medical Center
Adelante, Centre of Expertise in Rehabilitation and Audiology
Principal Investigator: Iris Maes, MSc Maastricht Universitair Medical Centre
Principal Investigator: Manuela Joore, PhD Maastricht University Medical Centre
Maastricht University Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP