Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02244060 |
| Other study ID # |
vignette2014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 14, 2014 |
| Last updated |
April 5, 2015 |
| Start date |
September 2014 |
| Est. completion date |
October 2014 |
Study information
| Verified date |
April 2015 |
| Source |
Harvard School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
China: Ministry of Health |
| Study type |
Interventional
|
Clinical 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. 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.
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:
1. Better than Zhang's
2. The same as Zhang's
3. 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:
1. Excellent,
2. Good,
3. Fair,
4. Poor, or
5. 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.
