Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2008 |
| End Date: | October 2011 |
Pilot Validation Study of Computer Administration of Vision Targeted Quality of Life Instruments
This study will test and compare computerized and paper versions of eye questionnaires.
Questionnaires are used in medicine to gain a better understanding of how a disease can
impact a person's quality of life. Computerized versions of such questionnaires are often as
good as or better than paper versions, but there has been no direct comparison of the two.
This study may help in the development of eye questionnaires used to understand symptoms and
monitor patients in clinical trials.
People 21 years of age and older with ocular surface disease (OSD) and matched control
subjects without OSD may be eligible for this study. All participants undergo the following
procedures:
- Medical and eye history.
- Vision test and examination of the front part of the eye.
- Tear measurement: A small piece of paper is placed on the surface of the eye to measure
the amount of tears produced. The consistency of the tears is measured by looking at
how fast they evaporate from the surface of the eye.
- Completion of either paper-based or computer-based version of a questionnaire 15
minutes after the eye examination and completion of the other version within 1 week at
home. (Subjects who complete the paper version in the clinic are told how to access the
computer version online at home or on a library computer; those who complete the
computer version in the clinic are given a paper version to take home.)
Questionnaires are used in medicine to gain a better understanding of how a disease can
impact a person's quality of life. Computerized versions of such questionnaires are often as
good as or better than paper versions, but there has been no direct comparison of the two.
This study may help in the development of eye questionnaires used to understand symptoms and
monitor patients in clinical trials.
People 21 years of age and older with ocular surface disease (OSD) and matched control
subjects without OSD may be eligible for this study. All participants undergo the following
procedures:
- Medical and eye history.
- Vision test and examination of the front part of the eye.
- Tear measurement: A small piece of paper is placed on the surface of the eye to measure
the amount of tears produced. The consistency of the tears is measured by looking at
how fast they evaporate from the surface of the eye.
- Completion of either paper-based or computer-based version of a questionnaire 15
minutes after the eye examination and completion of the other version within 1 week at
home. (Subjects who complete the paper version in the clinic are told how to access the
computer version online at home or on a library computer; those who complete the
computer version in the clinic are given a paper version to take home.)
The purpose of this protocol is to compare the health-related quality of life (visual
function) reported by participants when using web-based questionnaires versus their
responses obtained when using standard paper versions of the questionnaires. This comparison
will be performed in a population of patients diagnosed with ocular surface disease (OSD)
and in age- and gender-matched controls by using a randomized, cross-over study design. This
type of comparative study of patient-reported outcomes has been reported for rheumatology,
cardiology, psychiatry, asthma, alcoholism, pain assessment, gastrointestinal disease,
diabetes, and allergy populations; however, to our knowledge there have been no reports of
such a study from patients with ocular disease. The study will evaluate the agreement
between scores reported via two modes of administration: a web-based version and a
paper-and-pencil version. Components of three questionnaires commonly used to evaluate
visual function, symptoms, and vision-related quality of life in OSD will be included: the
initial 5 questions of the Ocular Surface Index (OSDI), question #15 of the National Eye
Institute Visual Functioning Questionnaire - 25 (VFQ-25), and specified domains of the
National Eye Institute Refractive Error Quality Of Life Instrument-42 (RQL-42) (clarity of
vision, near vision, far vision, glare, symptoms, worry, and satisfaction with correction).
The study will also evaluate whether there are differences in mean overall score by age,
gender, order of administration, or disease severity.
Ocular surface disease, which includes dry eye disease secondary to a variety of etiologies,
is an ophthalmic condition which places a burden not just on functional vision, but also on
overall health related quality of life (HRQoL), with an impact similar to that of moderate
angina3. This study will add to the body of knowledge in the field of patient-reported
outcome measures (PROs), and will be the first to compare the computerized, web-based and
paper-based versions of previously validated questionnaires used to assess QoL in subjects
with ocular disease.
There has been an increasing interest in assessing PROs in many fields of medicine,
especially in the context of clinical trials where HRQoL is an important component of the
overall evaluation of an intervention or treatment. As the use of computers increases and
accessibility to the internet broadens, there is a tremendous potential in harnessing this
technology in the future as a cost-effective, efficient way to gather clinical data on PROs
for future ophthalmic clinical trials and studies.
function) reported by participants when using web-based questionnaires versus their
responses obtained when using standard paper versions of the questionnaires. This comparison
will be performed in a population of patients diagnosed with ocular surface disease (OSD)
and in age- and gender-matched controls by using a randomized, cross-over study design. This
type of comparative study of patient-reported outcomes has been reported for rheumatology,
cardiology, psychiatry, asthma, alcoholism, pain assessment, gastrointestinal disease,
diabetes, and allergy populations; however, to our knowledge there have been no reports of
such a study from patients with ocular disease. The study will evaluate the agreement
between scores reported via two modes of administration: a web-based version and a
paper-and-pencil version. Components of three questionnaires commonly used to evaluate
visual function, symptoms, and vision-related quality of life in OSD will be included: the
initial 5 questions of the Ocular Surface Index (OSDI), question #15 of the National Eye
Institute Visual Functioning Questionnaire - 25 (VFQ-25), and specified domains of the
National Eye Institute Refractive Error Quality Of Life Instrument-42 (RQL-42) (clarity of
vision, near vision, far vision, glare, symptoms, worry, and satisfaction with correction).
The study will also evaluate whether there are differences in mean overall score by age,
gender, order of administration, or disease severity.
Ocular surface disease, which includes dry eye disease secondary to a variety of etiologies,
is an ophthalmic condition which places a burden not just on functional vision, but also on
overall health related quality of life (HRQoL), with an impact similar to that of moderate
angina3. This study will add to the body of knowledge in the field of patient-reported
outcome measures (PROs), and will be the first to compare the computerized, web-based and
paper-based versions of previously validated questionnaires used to assess QoL in subjects
with ocular disease.
There has been an increasing interest in assessing PROs in many fields of medicine,
especially in the context of clinical trials where HRQoL is an important component of the
overall evaluation of an intervention or treatment. As the use of computers increases and
accessibility to the internet broadens, there is a tremendous potential in harnessing this
technology in the future as a cost-effective, efficient way to gather clinical data on PROs
for future ophthalmic clinical trials and studies.
- INCLUSION CRITERIA:
The study cohort will be comprised of eighty (80) participants diagnosed with OSD and 40
controls without OSD comprised of similar numbers of men and women.
INCLUSION CRITERIA FOR OSD GROUP:
- Patients greater than or equal to 18 years of age with a diagnosis of ocular surface
disease confirmed by investigator.
- Schirmer I less than 10 mm wetting over 5 minutes OR tear breakup time less than or
equal to 5 seconds.
- Binocular visual acuity at near equal to or greater than 20/40 (Jaeger 3) with
habitual correction.
- Literacy and fluency in English sufficient to follow study instructions and likely to
be able to comprehend the questionnaires.
- Ability and willingness to complete the study protocol.
EXCLUSION CRITERIA FOR OSD GROUP:
- Ocular surgery or infection within 3 months of study enrollment.
- Inability to obtain appropriate consent.
- Allergy or sensitivity to any medication used in study.
- Subject has a situation or condition, which in the investigator's opinion, may put
the subject at a significant risk, may confound the study result, or may interfere
significantly with the participation in the study.
- Uncontrolled systemic disease.
- Active ocular disease other than ocular surface disease which in the investigator's
opinion may put the subject at a significant risk, may confound the study result, or
may interfere significantly with the participation in the study.
- Any disability preventing timely, efficient completion of writing or keyboarding
tasks.
- Incapable of providing informed consent.
- Monocular vision (legal blindness in one eye).
INCLUSION CRITERIA FOR CONTROL GROUP:
- Age greater than or equal to 18 years.
- Schirmer I test greater than or equal to 10 mm wetting over 5 minutes OR tear breakup
time greater than 5 seconds.
- Binocular visual acuity at near equal to or greater than 20/40 (Jaeger 3) with
habitual correction
- Literacy and fluency in English sufficient to follow study instructions and likely to
be able to comprehend the questionnaire
- Ability and willingness to complete the study protocol
EXCLUSION CRITERIA FOR CONTROL GROUP:
- A diagnosis of ocular surface disease made by a clinician
- Ocular surgery or infection within 6 months of study enrollment
- Pupillary, motility, convergence or accommodative ocular disorder judged by
investigator to have potential to negatively impact ease of near and intermediate
binocular visual function
- Inability to obtain appropriate consent
- Allergy or sensitivity to any medication used in study.
- Monocular vision (legal blindness in one eye) or subject has a situation or
condition, which in the investigator's opinion, may put the subject at a significant
risk, may confound the study results, or may interfere significantly with the
participation in the study.
- Uncontrolled systemic disease
- Active ocular disease which in the investigator's opinion may put the subject at a
significant risk, may confound the study result, or may interfere significantly with
the participation in the study
- Any disability preventing timely, efficient completion of writing or keyboarding
tasks
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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