Development of a Method for Converting Visual Analogue Scale (VAS) Scores for Pain and Mobility to EQ-5D Answers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lars Oddershede, Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01424683
First received: August 25, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

The objective of this study is to investigate how mobility and pain scores, measured on a Visual Analogue Scale (VAS), correspond to patients' EuroQol-5Dimensions-3Levels (EQ-5D-3L) answers on pain and mobility. In addition, the investigators want to evaluate patients' undergoing Coronary Artery Bypass Grafting (CABG) quality of life postoperatively, depending on the vein harvesting method used.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Method for Converting VAS Scores for Pain and Mobility to EQ-5D Answers

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • The distribution of answers to EQ-5D-3L sub-questions on a 100mm VAS for each sub-question. [ Time Frame: Approximately five days postoperatively ] [ Designated as safety issue: No ]
    The investigators wish to investigate how patients scoring "no pain or discomfort", "moderate pain or discomfort" and "extreme pain or discomfort" on the EQ-5D questionnaire score their pain on a 100mm VAS of pain. The same is done for the four other sub-questions in the EQ-5D, eg. how do patients score their mobility on a 100mm VAS of mobility if they score "no problems in walking about", "some problems in walking about" or "confined to bed" on the EQ-5D. (see citations for similar study setups)


Secondary Outcome Measures:
  • Quality of life (Qol) [ Time Frame: approximately 30 days ] [ Designated as safety issue: No ]
    The investigators will obtain 3 measurements from each patient and are therefore able to evaluate the change in Qol from baseline to approximately 30 days postoperatively in a group of elective bypass patients. Investigators hereby aim to find the incremental Qol. The patient group will be segmented on whether they underwent endoscopic or open vein harvest during their surgery.


Enrollment: 217
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endoscopic Vein Harvest (EVH)
A short saphenous vein segment is commonly used as a conduit for coronary artery bypass grafting (CABG), and clinicians must decide whether to obtain it by performing a traditional open vein harvest (OVH) or by performing an endoscopic vein harvest (EVH).
Open Vein Harvest (OVH)
A short saphenous vein segment is commonly used as a conduit for coronary artery bypass grafting (CABG), and clinicians must decide whether to obtain it by performing a traditional open vein harvest (OVH) or by performing an endoscopic vein harvest (EVH).

Detailed Description:

Many health economic researchers prefer that a treatments effect is measured in the quantity and quality of life (Qol) the treatment provides. This enables them to calculate effect in the generic Quality Adjusted Life-Years (QALYs). Patients' Qol can be estimates by having patients' answer the EQ-5D-3L questionnaire. However, when performing a post hoc health economic evaluation, data is often incomplete. Often there is no information available regarding the patients' Qol and some health economic researchers therefore resort to various conversions of other measurements of effect to Qol. Such conversions thereby enable them to calculate effect in QALYs even though they had incomplete information. However, no method has been developed for converting eg. VAS pain scores to Qol and the methods currently used are arbitrary. With this study the investigators wish to develop such a method and in the process evaluate our own arbitrary Qol conversion from a prior study by asking the same type of patients. The study is an observational study with no intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing CABG

Criteria

Inclusion Criteria:

  • Elective CABG patients
  • Use of a vein segment for conduit during CABG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424683

Locations
Denmark
Aalborg Hospital
Aalborg, Region Nord, Denmark, 9100
Sponsors and Collaborators
Lars Oddershede
Investigators
Study Director: Jan J Andreasen, MD, PhD Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
Principal Investigator: Lars Oddershede, MMSc Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
  More Information

Publications:
Responsible Party: Lars Oddershede, MMSc (master of medical science), Aalborg Universityhospital
ClinicalTrials.gov Identifier: NCT01424683     History of Changes
Other Study ID Numbers: Oddershede-1
Study First Received: August 25, 2011
Last Updated: June 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
Qol
Quality of life
VAS
Visual Analogue Scale
CABG
Coronary Artery Bypass Graft
Qol conversion
post hoc HTA

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014