Chronic RhinosinusitisNCT01391910
Response Shift in Sinus Surgery Outcomes
An observational study of Chronic Rhinosinusitis, run by Greg Davis at 1 site in United States.
Trial summary
The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the significance of response shift on treatment effect. This is a prospective cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 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: Subjects will be surgery patients from Dr. Davis' clinic at the University of Washington. They will have undergone FESS for treatment of CRS.
Who may be able to join
- age greater than 18 years
- ICD 9 code for CRS and CPT code for FESS
- completed a pre-operative SNOT-20 questionnaire
- within 6 months of surgical treatment
- pts. of PI
Who cannot join
- unable to give informed consent or complete questionnaires written in English due to cognitive impairment, language barriers or severe medical conditions
- CRS secondary to malignancy
- incomplete or incorrectly completed pre-operative SNOT-20
Trial locations and contacts
1 site in 1 country.
About this study
The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the significance of response shift on treatment effect.
This is a prospective cohort study. The investigators will recruit patients who are within a 6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20 forms and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled "pre" and "post" operative. The "pre" should be completed based on subject's memory of their condition prior to surgery and "post" based on how they feel now.
Read the detailed description
Introduction The most common goal of functional endoscopic sinus surgery (FESS) is to improve quality of life (QOL). Changes in QOL or treatment effect can be measured using validated instruments completed by patients. One's perception of QOL is often a dynamic experience and has been shown to be affected by current medical and emotional state. This phenomenon is known as response shift in QOL research and can be measured by using the Then-test. This test asks patients to complete the same pre-operative survey of their symptoms during the post-operative period. This test aims to characterize any changes in one's perception of the pre-operative condition. The aim of this study is to assess the significance of response shift on sinus surgery outcomes measured using the sino-nasal outcome test (SNOT-20), a validated questionnaire used to assess the severity of symptoms related to chronic rhinosinusitis.
Methods This was a prospective cohort study approved by the University of Washington IRB. We approached all patients who underwent FESS for chronic rhinosinusitis from 2010-2012 who completed a pre-operative SNOT-20. We aimed to recruit 30 patients. Patients were mailed 2 SNOT-20 forms and a transition QOL scale at least 6 months after surgery. Patients were instructed to complete 1 SNOT-20 according to their pre-operative symptoms (then-test) and the other according to their post-operative symptoms. The difference between the pre- and post-operative SNOT-20 was calculated which represents the treatment effect, while the difference between the pre-operative SNOT-20 and then-test represents the response shift. A student t-test was used to compare these differences.
Results A total of 32 complete responses were obtained. Using a 0 to 5 SNOT-20 scale, the average treatment effect was -0.96 (p=0.00) and the average response shift was +0.42 (p=0.01). The negative treatment effect signifies an improvement in QOL. The positive response shift signifies that on average, patients thought they were even more symptomatic prior to surgery. The actual treatment effect is the sum of treatment effect and response shift which was -1.38.
Discussion Response shift exists and can be quantified in FESS outcomes. The actual treatment effect was more profound when taking into account response shift, therefore future studies should account for this often unmeasured, potential change in QOL.
- Conditions
- Chronic Rhinosinusitis
- Keywords
- rhinosinusitis
- Medical subject headings
- Rhinosinusitis
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 |
|---|---|---|
| post endoscopic sinus surgery for chronic rhinosinusitis | Patients who have undergone functional endoscopic sinus surgery for treatment of chronic rhinosinusitis and completed a pre-surgery SNOT-20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sino-Nasal Outcome 20 (SNOT-20)
The SNOT-20 "pre" and "post" surgery will be compared to the pre-surgery SNOT-20
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greg Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Greg Davis, University of Washington
- Investigators
- Greg E Davis, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391910
- Sponsor's protocol ID
- 40578-E/A
- Status last verified
- Dec 2013
- First submitted
- 8 Jul 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Shift in Sinus Surgery Outcomes
- ClinicalTrials.gov ID
- NCT01391910
- Acronym / sponsor ID
- 40578-E/A
- Conditions
- Chronic Rhinosinusitis
- Keywords
- rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Greg DavisUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Jul 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 aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the significance of response shift on treatment effect.
This is a prospective cohort study. The investigators will recruit patients who are within a 6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20 forms and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled "pre" and "post" operative. The "pre" should be completed based on subject's memory of their condition prior to surgery and "post" based on how they feel now.
Detailed description
Introduction The most common goal of functional endoscopic sinus surgery (FESS) is to improve quality of life (QOL). Changes in QOL or treatment effect can be measured using validated instruments completed by patients. One's perception of QOL is often a dynamic experience and has been shown to be affected by current medical and emotional state. This phenomenon is known as response shift in QOL research and can be measured by using the Then-test. This test asks patients to complete the same pre-operative survey of their symptoms during the post-operative period. This test aims to characterize any changes in one's perception of the pre-operative condition. The aim of this study is to assess the significance of response shift on sinus surgery outcomes measured using the sino-nasal outcome test (SNOT-20), a validated questionnaire used to assess the severity of symptoms related to chronic rhinosinusitis.
Methods This was a prospective cohort study approved by the University of Washington IRB. We approached all patients who underwent FESS for chronic rhinosinusitis from 2010-2012 who completed a pre-operative SNOT-20. We aimed to recruit 30 patients. Patients were mailed 2 SNOT-20 forms and a transition QOL scale at least 6 months after surgery. Patients were instructed to complete 1 SNOT-20 according to their pre-operative symptoms (then-test) and the other according to their post-operative symptoms. The difference between the pre- and post-operative SNOT-20 was calculated which represents the treatment effect, while the difference between the pre-operative SNOT-20 and then-test represents the response shift. A student t-test was used to compare these differences.
Results A total of 32 complete responses were obtained. Using a 0 to 5 SNOT-20 scale, the average treatment effect was -0.96 (p=0.00) and the average response shift was +0.42 (p=0.01). The negative treatment effect signifies an improvement in QOL. The positive response shift signifies that on average, patients thought they were even more symptomatic prior to surgery. The actual treatment effect is the sum of treatment effect and response shift which was -1.38.
Discussion Response shift exists and can be quantified in FESS outcomes. The actual treatment effect was more profound when taking into account response shift, therefore future studies should account for this often unmeasured, potential change in QOL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post endoscopic sinus surgery for chronic rhinosinusitis | – | –Patients who have undergone functional endoscopic sinus surgery for treatment of chronic rhinosinusitis and completed a pre-surgery SNOT-20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be surgery patients from Dr. Davis' clinic at the University of Washington. They will have undergone FESS for treatment of CRS.
Key inclusion criteria (5 listed)
- age greater than 18 years
- ICD 9 code for CRS and CPT code for FESS
- completed a pre-operative SNOT-20 questionnaire
- within 6 months of surgical treatment
- pts. of PI
Key exclusion criteria (3 listed)
- unable to give informed consent or complete questionnaires written in English due to cognitive impairment, language barriers or severe medical conditions
- CRS secondary to malignancy
- incomplete or incorrectly completed pre-operative SNOT-20
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
Sino-Nasal Outcome 20 (SNOT-20)
Time frame: 6 months post surgery
The SNOT-20 "pre" and "post" surgery will be compared to the pre-surgery SNOT-20
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 12 Dec 2013.
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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.
Greg E Davis, MD, MPH principal investigator
University of Washington
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 Chronic Rhinosinusitis, run by Greg Davis at 1 site in United States.
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 5 inclusion and 3 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 12 Dec 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 United States. 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?
Sino-Nasal Outcome 20 (SNOT-20) (time frame: 6 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2013; AzTrials last refreshed its copy on 27 Oct 2026.