Self ReportNCT02244060
Eye Examinations as a Gold Standard to Evaluating Survey Instruments
A study testing Priming effect from vignette in people with Self Report and Questionnaire Design, run by Harvard School of Public Health (HSPH) at 1 site in China.
Trial summary
Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued to be subjective and not comparable. A middle ground approach is to apply the frontier work of vignette methods. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Self Report, Questionnaire Design
- What is being tested?
- Priming effect from vignette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,320 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Oct 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Middle school students (i.e., Grade 7 to Grade12) in Jingning County.
Who cannot join
- Primary school students (i.e., Grade 1 to Grade 6) in Jingning County.
Trial locations and contacts
1 site in 1 country.
About this study
Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued to be subjective and not comparable. A middle ground approach is to apply the frontier work of vignette methods. The aim of the survey experiment is to explore the validity of survey instruments to identify students who need glasses, using objectively measured visual acuity as a gold standard. It is hypothesized that direct comparison against vignette (DCV) is significantly different from indirect comparison against vignette (ICV); meanwhile, self-assessment of vision (SAV) is significantly different from primed self-assessment of vision (PSAV). It is also hypothesized that DCV is a more valid survey instrument than ICV to classify students who need glasses, using objective visual acuity as a gold standard. Lastly, it is hypothesized that priming effect from vignettes improves the validity of self-assessment. It is planned to enroll 3,755 subjects in the survey experiment.
Read the detailed description
The schools will be visited to announce this project on survey experiment and measuring visual acuity, for which all participants will receive free eye examinations. After receiving consent/assent, two data collection strategies will be applied in this survey - DCV and ICV, to identify individual perceptions of vision. In the arm of ICV, the self-assessment of vision (SAV) is listed before the vignette questions; however, in the arm of DCV, the self-assessed vision (PSAV) is listed after the vignette questions to estimate priming effect. With randomization prior to administration of survey, 50% of the students will be enrolled in "direct comparison against vignettes" (DCV) and another 50% for "implied comparison against vignettes" (ICV). Each participant will self-administer the survey. The objective measure of vision will be set up in a vacant classroom with assistance from members of the Health Center Jingning County. DCV, ICV, SAV, and PSAV are estimated from randomized survey questionnaires. Objectively measured vision is from simplified Snellen chart.
Measures - All subjects will be asked to respond to the questions about vision acuity without glasses or contact lenses for themselves and these hypothetical scenarios. Information collected through the survey includes self-assessed vision, vignettes, clusters (school, grade, and class), whether the subjects wear glasses or contact lenses, and two demographic variables (age and sex).
Self-assessed vision - Data of self-assessed vision is collected by asking students to think about their own vision without glasses or contact lenses. Specifically, each student was asked to respond to this question: "at the present time, would you say your distance eyesight is excellent, good, fair, poor, or very poor?" Vignettes - The DCV questionnaire asks subjects to jointly evaluate their own vision and vignette situations; meanwhile, the ICV questionnaire asks subjects to conduct single evaluation of vignette questions. Even though subjects in ICV questionnaires were not asked to compare their visual acuity with the hypothetical person Zhang, the experimenter could conduct the comparison through data analysis. Accordingly this approach is named the "indirect comparison against vignettes" (ICV).
For example, in the DCV questionnaire, the subjects will be asked to respond to the following question:
Sitting in the last row in the classroom, [Xiao Zhang] does recognize teacher's faces clearly but cannot identify small hand writing on the blackboard clearly. Would you say your distance eyesight is:
- Better than Zhang's
- The same as Zhang's
- Worse than Zhang's Comparatively, in the ICV questionnaire, the subjects will be asked to respond to the following question instead.
Sitting in the last row in the classroom, [Xiao Zhang] does recognize teacher's faces clearly but cannot identify small hand writing on the blackboard clearly. Would you say [Zhang]'s distance eyesight is:
- Excellent,
- Good,
- Fair,
- Poor, or
- Very poor.
Two vignettes are designed in this study. More specifically, two hypothetical persons with common Chinese names, Xiao Wang and Xiao Zhang will be introduced in the survey, who would be mentioned as V1 and V2 in the following discussion.
V1: In the dining hall, [Xiao Wang] has no difficulty to see students on the same table clearly but he cannot not see students on next tables clearly.
V2: Sitting in the last row in the classroom, [Xiao Zhang] does recognize teacher's faces clearly but cannot identify small hand writing on the blackboard clearly.
The two vignettes is designed in the ascending level of visual acuity and the vignettes is arranged in the questionnaires in this way: V1 and V2.
The question in DCV is, "Would you say your distance eyesight is better than Wang's, the same as Wang's, or worse than Wang's?" and the question in ICV was, "Would you say Wang's distance eyesight is excellent, good, fair, poor, or very poor?" respectively.
Objective visual acuity - The simplified Snellen chart only consists of letter "E" with different directions, which was approved by the National Bureau of Standards in China to be a national standard in testing visual acuity (GB115331989). It was approved by the Ministry of Health to be used nationwide in China on March 27th, 1989. The simplified Snellen chart is used to estimate visual acuity with the respondent standing at 5 meters. The measurement ranges from 4.0 to 5.3, an arithmetic sequence with 0.1 progression. The larger the number is, the better the respondent's vision is.
Capability to respond to this eye chart is most likely to be independent from educational level. Furthermore, simplified Snellen chart also rules out of the difficulties of Snellen letters and common misidentifications(Mathew, Shah et al. 2011). Therefore, it is less likely than a standard Snellen chart to underestimate true vision due to low literacy rate. In the line with vision 4.0, only one letter "E" is presented, and in the line with vision 4.1, there are two "E"s. Except those two lines, the probability to overestimate true vision by 0.1 due to chance alone is smaller than 6.25% (i.e., 1/64), since a correct response to at least three "E"s in each line is required in this survey experiment. More specifically, the probability to guess the direction of one letter "E" correctly by chance is 1/4 and the probability to guess the directions of three "E"s correctly by chance is only 1/64. Using eye examination as a gold standard, the empirical research addressed the validity of vignette methods.
- Conditions
- Self Report, Questionnaire Design
- Being tested
- Priming effect from vignette
- Keywords
- Vignette, Priming effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Priming effect from vignetteOther
Also called primed self-assessed vision, primed self-assessment of vision
In the arm of DCV, the self-assessed vision (PSAV) is listed after the vignette questions; however, in the arm of ICV, the self-assessment of vision (SAV) is listed before the vignette questions. Priming effect from vignette will be estimated by comparing those two randomized variables (i.e., SAV and PSAV).
| Study group | Role | What they receive |
|---|---|---|
| Direct comparison | Experimental | The Direct comparison against vignette (DCV) questionnaire asks subjects to estimate their own vision against vignette situations.Priming effect from vignette is designed in the arm of DCV. Receives: Other: Priming effect from vignette |
| Indirect comparison | No intervention | The Indirect comparison against vignette (ICV) questionnaire asks self-assessed vision and single evaluation of vignettes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed vision
Measured: One and half months
Direct comparison against vignette (DCV)
Measured: One and half months
Indirect comparison against vignette (ICV)
Measured: One and half months
Primed self-assessed vision
Measured: One and half months
Secondary outcomes (1)
Objectively measured vision
Measured: One and half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self ReportStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Jingning County in Zhejiang Province in China
- Responsible party
- Principal investigator, Yanfang Su, Harvard School of Public Health (HSPH)
- Investigators
- Linyu Su, Study director, Jingning Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244060
- Sponsor's protocol ID
- vignette2014
- Status last verified
- Apr 2015
- First submitted
- 14 Sep 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Examinations as a Gold Standard to Evaluating Survey Instruments
- ClinicalTrials.gov ID
- NCT02244060
- Acronym / sponsor ID
- vignette2014
- Conditions
- Self Report, Questionnaire Design
- Keywords
- Vignette, Priming effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,320 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Jingning County in Zhejiang Province in China
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Sep 2014 (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.
Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued to be subjective and not comparable. A middle ground approach is to apply the frontier work of vignette methods. The aim of the survey experiment is to explore the validity of survey instruments to identify students who need glasses, using objectively measured visual acuity as a gold standard. It is hypothesized that direct comparison against vignette (DCV) is significantly different from indirect comparison against vignette (ICV); meanwhile, self-assessment of vision (SAV) is significantly different from primed self-assessment of vision (PSAV). It is also hypothesized that DCV is a more valid survey instrument than ICV to classify students who need glasses, using objective visual acuity as a gold standard. Lastly, it is hypothesized that priming effect from vignettes improves the validity of self-assessment. It is planned to enroll 3,755 subjects in the survey experiment.
Detailed description
The schools will be visited to announce this project on survey experiment and measuring visual acuity, for which all participants will receive free eye examinations. After receiving consent/assent, two data collection strategies will be applied in this survey - DCV and ICV, to identify individual perceptions of vision. In the arm of ICV, the self-assessment of vision (SAV) is listed before the vignette questions; however, in the arm of DCV, the self-assessed vision (PSAV) is listed after the vignette questions to estimate priming effect. With randomization prior to administration of survey, 50% of the students will be enrolled in "direct comparison against vignettes" (DCV) and another 50% for "implied comparison against vignettes" (ICV). Each participant will self-administer the survey. The objective measure of vision will be set up in a vacant classroom with assistance from members of the Health Center Jingning County. DCV, ICV, SAV, and PSAV are estimated from randomized survey questionnaires. Objectively measured vision is from simplified Snellen chart.
Measures - All subjects will be asked to respond to the questions about vision acuity without glasses or contact lenses for themselves and these hypothetical scenarios. Information collected through the survey includes self-assessed vision, vignettes, clusters (school, grade, and class), whether the subjects wear glasses or contact lenses, and two demographic variables (age and sex).
Self-assessed vision - Data of self-assessed vision is collected by asking students to think about their own vision without glasses or contact lenses. Specifically, each student was asked to respond to this question: "at the present time, would you say your distance eyesight is excellent, good, fair, poor, or very poor?" Vignettes - The DCV questionnaire asks subjects to jointly evaluate their own vision and vignette situations; meanwhile, the ICV questionnaire asks subjects to conduct single evaluation of vignette questions. Even though subjects in ICV questionnaires were not asked to compare their visual acuity with the hypothetical person Zhang, the experimenter could conduct the comparison through data analysis. Accordingly this approach is named the "indirect comparison against vignettes" (ICV).
For example, in the DCV questionnaire, the subjects will be asked to respond to the following question:
Sitting in the last row in the classroom, [Xiao Zhang] does recognize teacher's faces clearly but cannot identify small hand writing on the blackboard clearly. Would you say your distance eyesight is:
- Better than Zhang's
- The same as Zhang's
- Worse than Zhang's Comparatively, in the ICV questionnaire, the subjects will be asked to respond to the following question instead.
Sitting in the last row in the classroom, [Xiao Zhang] does recognize teacher's faces clearly but cannot identify small hand writing on the blackboard clearly. Would you say [Zhang]'s distance eyesight is:
- Excellent,
- Good,
- Fair,
- Poor, or
- Very poor.
Two vignettes are designed in this study. More specifically, two hypothetical persons with common Chinese names, Xiao Wang and Xiao Zhang will be introduced in the survey, who would be mentioned as V1 and V2 in the following discussion.
V1: In the dining hall, [Xiao Wang] has no difficulty to see students on the same table clearly but he cannot not see students on next tables clearly.
V2: Sitting in the last row in the classroom, [Xiao Zhang] does recognize teacher's faces clearly but cannot identify small hand writing on the blackboard clearly.
The two vignettes is designed in the ascending level of visual acuity and the vignettes is arranged in the questionnaires in this way: V1 and V2.
The question in DCV is, "Would you say your distance eyesight is better than Wang's, the same as Wang's, or worse than Wang's?" and the question in ICV was, "Would you say Wang's distance eyesight is excellent, good, fair, poor, or very poor?" respectively.
Objective visual acuity - The simplified Snellen chart only consists of letter "E" with different directions, which was approved by the National Bureau of Standards in China to be a national standard in testing visual acuity (GB115331989). It was approved by the Ministry of Health to be used nationwide in China on March 27th, 1989. The simplified Snellen chart is used to estimate visual acuity with the respondent standing at 5 meters. The measurement ranges from 4.0 to 5.3, an arithmetic sequence with 0.1 progression. The larger the number is, the better the respondent's vision is.
Capability to respond to this eye chart is most likely to be independent from educational level. Furthermore, simplified Snellen chart also rules out of the difficulties of Snellen letters and common misidentifications(Mathew, Shah et al. 2011). Therefore, it is less likely than a standard Snellen chart to underestimate true vision due to low literacy rate. In the line with vision 4.0, only one letter "E" is presented, and in the line with vision 4.1, there are two "E"s. Except those two lines, the probability to overestimate true vision by 0.1 due to chance alone is smaller than 6.25% (i.e., 1/64), since a correct response to at least three "E"s in each line is required in this survey experiment. More specifically, the probability to guess the direction of one letter "E" correctly by chance is 1/4 and the probability to guess the directions of three "E"s correctly by chance is only 1/64. Using eye examination as a gold standard, the empirical research addressed the validity of vignette methods.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct comparison | Experimental | Other: Priming effect from vignetteThe Direct comparison against vignette (DCV) questionnaire asks subjects to estimate their own vision against vignette situations.Priming effect from vignette is designed in the arm of DCV. |
| Indirect comparison | No intervention | –The Indirect comparison against vignette (ICV) questionnaire asks self-assessed vision and single evaluation of vignettes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Middle school students (i.e., Grade 7 to Grade12) in Jingning County.
Key exclusion criteria (1 listed)
- Primary school students (i.e., Grade 1 to Grade 6) in Jingning County.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Priming effect from vignetteAlso: primed self-assessed vision, primed self-assessment of visionIn the arm of DCV, the self-assessed vision (PSAV) is listed after the vignette questions; however, in the arm of ICV, the self-assessment of vision (SAV) is listed before the vignette questions. Priming effect from vignette will be estimated by comparing those two randomized variables (i.e., SAV and PSAV). | Other | Direct comparison |
Primary outcome
Self-assessed vision
Time frame: One and half months
Direct comparison against vignette (DCV)
Time frame: One and half months
Indirect comparison against vignette (ICV)
Time frame: One and half months
Primed self-assessed vision
Time frame: One and half months
1 secondary outcome
Objectively measured vision
Time frame: One and half months
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 7 Apr 2015.
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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.
Linyu Su study director
Jingning Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Priming effect from vignette in people with Self Report and Questionnaire Design, run by Harvard School of Public Health (HSPH) at 1 site in China.
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 1 inclusion and 1 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 7 Apr 2015. 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 China. 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?
Self-assessed vision (time frame: One and half months). The study lists 4 primary outcomes in all. 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 7 Apr 2015.