Cardiovascular DiseasesNCT01424683
Development of a Method for Converting Visual Analogue Scale (VAS) Scores for Pain and Mobility to EQ-5D Answers
An observational study of Cardiovascular Diseases, run by Lars Oddershede at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 217 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing CABG
Who may be able to join
- Elective CABG patients
- Use of a vein segment for conduit during CABG
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Method for Converting VAS Scores for Pain and Mobility to EQ-5D Answers
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Qol, Quality of life, VAS, Visual Analogue Scale, CABG, Coronary Artery Bypass Graft, Qol conversion, post hoc HTA
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of answers to EQ-5D-3L sub-questions on a 100mm VAS for each sub-question.
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)
Measured: Approximately five days postoperatively
Secondary outcomes (1)
Quality of life (Qol)
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.
Measured: approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Oddershede
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Oddershede, Aalborg University Hospital
- Investigators
- Jan J Andreasen, MD, PhD, Study director, Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University HospitalLars Oddershede, MMSc, Principal investigator, Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424683
- Sponsor's protocol ID
- Oddershede-1
- Status last verified
- Jun 2013
- First submitted
- 25 Aug 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14622683Collins 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.
PubMed 9272792
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Method for Converting VAS Scores for Pain and Mobility to EQ-5D Answers
- ClinicalTrials.gov ID
- NCT01424683
- Acronym / sponsor ID
- Oddershede-1
- Conditions
- Cardiovascular Diseases
- Keywords
- Qol, Quality of life, VAS, Visual Analogue Scale, CABG, Coronary Artery Bypass Graft, Qol conversion, post hoc HTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Lars OddershedeUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing CABG
Key inclusion criteria (2 listed)
- Elective CABG patients
- Use of a vein segment for conduit during CABG
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Quality of life (Qol)
Time frame: approximately 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Background: PubMed 14622683Jensen 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.
- Background: PubMed 9272792Collins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan J Andreasen, MD, PhD study director
Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
Lars Oddershede, MMSc principal investigator
Department of Cardiothoracic Surgery, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Lars Oddershede at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distribution of answers to EQ-5D-3L sub-questions on a 100mm VAS for each sub-question. (time frame: Approximately five days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.