Clinical trial NCT01424683: Development of a Method for Converting Visual Analogue Scale (VAS) Scores for Pain and Mobility to EQ-5D Answers
Official title: Development of a Method for Converting VAS Scores for Pain and Mobility to EQ-5D Answers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Qol
Quality of life
VAS
Visual Analogue Scale
CABG
Coronary Artery Bypass Graft
Qol conversion
post hoc HTA
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CABG

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.

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 criteria: Inclusion Criteria:

* Elective CABG patients
* Use of a vein segment for conduit during CABG

Primary outcomes:
measure: The distribution of answers to EQ-5D-3L sub-questions on a 100mm VAS for each sub-question.
timeFrame: Approximately five days postoperatively
Secondary outcomes:
measure: Quality of life (Qol)
timeFrame: approximately 30 days
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
state: Region Nord
Study officials:
affiliation: Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
name: Jan J Andreasen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
name: Lars Oddershede, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
citation: Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997 Aug;72(1-2):95-7. doi: 10.1016/s0304-3959(97)00005-5.