Dataset Information

FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.

ABSTRACT: Research groups and funding agencies need a functional assessment suitable for an ultra-low vision population to evaluate the impact of new vision-restoration treatments. The purpose of this study was to develop a pilot assessment to capture the functional visual ability and well-being of subjects whose vision has been partially restored with the Argus II Retinal Prosthesis System.The Functional Low-Vision Observer Rated Assessment (FLORA) pilot assessment involved a self-report section, a list of functional visual tasks for observation of performance and a case narrative summary. Results were analysed to determine whether the interview questions and functional visual tasks were appropriate for this ultra-low vision population and whether the ratings suffered from floor or ceiling effects. Thirty subjects with severe to profound retinitis pigmentosa (bare light perception or worse in both eyes) were enrolled in a clinical trial and implanted with the Argus II System. From this population, 26 subjects were assessed with the FLORA. Seven different evaluators administered the assessment.All 14 interview questions were asked. All 35 tasks for functional vision were selected for evaluation at least once, with an average of 20 subjects being evaluated for each test item. All four rating options—impossible (33 per cent), difficult (23 per cent), moderate (24 per cent) and easy (19 per cent)—were used by the evaluators. Evaluators also judged the amount of vision they observed the subjects using to complete the various tasks, with 'vision only' occurring 75 per cent on average with the System ON, and 29 per cent with the System OFF.The first version of the FLORA was found to contain useful elements for evaluation and to avoid floor and ceiling effects. The next phase of development will be to refine the assessment and to establish reliability and validity to increase its value as an assessment tool for functional vision and well-being.

SUBMITTER: Geruschat DR

PROVIDER: S-EPMC4481161 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.

Geruschat Duane R DR Flax Marshall M Tanna Nilima N Bianchi Michelle M Fisher Andy A Goldschmidt Mira M Fisher Lynne L Dagnelie Gislin G Deremeik Jim J Smith Audrey A Anaflous Fatima F Dorn Jessy J

Clinical & experimental optometry 20150211 4

<h4>Background</h4>Research groups and funding agencies need a functional assessment suitable for an ultra-low vision population to evaluate the impact of new vision-restoration treatments. The purpose of this study was to develop a pilot assessment to capture the functional visual ability and well-being of subjects whose vision has been partially restored with the Argus II Retinal Prosthesis System.<h4>Methods</h4>The Functional Low-Vision Observer Rated Assessment (FLORA) pilot assessment invo ...[more]

PMID: 25675964

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Project description:BackgroundAchieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research.ObjectiveTo develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility.DesignA cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity.SettingParticipants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings.ParticipantsAdult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes.InterventionsNot applicable.Main outcome measuresCandidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents.ResultsA bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility.ConclusionThe PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.

Dataset Information

FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.

Publications

FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.

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