Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00678860|
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : July 2, 2017
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.)
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||147 participants|
|Official Title:||Pilot Validation Study of Computer Administration of Vision Targeted Quality of Life Instruments|
|Study Start Date :||May 9, 2008|
|Study Completion Date :||October 31, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678860
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|