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

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

Study Overview

• Status: Completed
• Conditions: Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Hoensbroek, Limburg, Netherlands, 6430AB
      • Adelante
    • Maastricht, Limburg, Netherlands, 6227 AZ
      • Maastricht University Medical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	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.	During 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life satisfaction	Life satisfaction as mesured with te Satisfaction with Life Scale.	2 times

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Adelante, Centre of Expertise in Rehabilitation and Audiology
• Investigators: Principal Investigator: Iris Maes, MSc, Maastricht Universitair Medical Centre; Principal Investigator: Manuela Joore, PhD, Maastricht University Medical Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; experienced utility; decision utility; subjective well-being; experience sampling method; day reconstruction method
• Other Study ID Numbers: 80-82500-98-9207