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

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ClinicalTrials.gov Identifier: NCT01424683
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Lars Oddershede, Aalborg Universitetshospital

Brief Summary:
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 or disease
Cardiovascular Diseases

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.

Study Type : Observational
Actual Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Method for Converting VAS Scores for Pain and Mobility to EQ-5D Answers
Study Start Date : August 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Group/Cohort
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).



Primary Outcome Measures :
  1. The distribution of answers to EQ-5D-3L sub-questions on a 100mm VAS for each sub-question. [ Time Frame: Approximately five days postoperatively ]
    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 :
  1. Quality of life (Qol) [ Time Frame: approximately 30 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Lars Oddershede, MMSc (master of medical science), Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT01424683     History of Changes
Other Study ID Numbers: Oddershede-1
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Cardiovascular Diseases