scholarly journals Beyond visual acuity: Patient-relevant assessment measures of visual function in retinal diseases

2021 ◽  
pp. 112067212199062
Author(s):  
María Cinta Puell ◽  
Inés Contreras ◽  
Isabel Pinilla ◽  
José Juan Escobar ◽  
Antonio Soler-García ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Clinical Practice ◽  
Outcome Measures ◽  
Visual Function ◽  
Outcome Measure ◽  
Expert Panel ◽  
Reading Speed ◽  
Evidence Synthesis ◽  
Age Related Macular Degeneration ◽  
Patient Reported

Purpose: To identify patient-reported outcomes (PROs) and other clinical outcome measures (contrast sensitivity (CS), low-luminance visual acuity (LLVA) and reading acuity or reading speed (RA-RS)), relevant to patients with age-related macular degeneration (AMD) or diabetic retinopathy (DR), which would be recommended for use in clinical practice. Methods: The RAND/UCLA Appropriateness Method, based on the synthesis of the scientific evidence and the collective judgment of an expert panel using the two-round Delphi method, was applied. The evidence synthesis was performed by searching for articles on outcome measures for AMD and/or DR published between 2005 and 2018 in English or Spanish. The expert panel consisted of 14 Spanish ophthalmologists, who rated the recommendation degree for each outcome measure on a scale of 1 (extremely irrelevant) to 9 (maximum relevance). The recommended outcome measures were established according to the panel median score and the level of the panelists’ agreement. Results: Through the evidence search, 33 PRO-specific questionnaires (21 for visual function, six for AMD, three for DR, one for AMD and DR) and two treatment satisfaction questionnaires (one on AMD and one on DR) were identified. In addition, 21 methods were found for measuring CS, five for LLVA, and nine for RA-RS. According to the panel ratings, 11 of the 64 outcome measures evaluated for AMD, and seven of the 61 evaluated for DR were recommended. Conclusion: The AMD and DR outcome measures recommended will help ophthalmologists choose the outcome measure most appropriate for their patients. Furthermore, the use of PROs will contribute to shifting clinical practice towards patient-centered medicine.

scholarly journals The STArgardt Remofuscin Treatment Trial (STARTT): design and baseline characteristics of enrolled Stargardt patients

2021 ◽  
Vol 1 ◽  
pp. 96
Author(s):  
Patty P.A. Dhooge ◽  
Philipp T. Möller ◽  
Camiel J.F. Boon ◽  
Andrew J. Lotery ◽  
Philipp Herrmann ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Visual Function ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Reading Speed ◽  
Primary Outcome Measure ◽  
Treatment Trial ◽  
Patient Reported ◽  
Baseline Characteristics ◽  
Sd Oct

Background: This report describes the study design and baseline characteristics of patients with Stargardt disease (STGD1) enrolled in the STArgardt Remofuscin Treatment Trial (STARTT). Methods: In total, 87 patients with genetically confirmed STGD1 were randomized in a double-masked, placebo-controlled proof of concept trial to evaluate the safety and efficacy of 20 milligram oral remofuscin for 24 months. The primary outcome measure is change in mean quantitative autofluorescence value of an 8-segment ring centred on the fovea (qAF8). Secondary efficacy variables are best corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), mesopic microperimetry (mMP),  spectral domain optical coherence tomography (SD-OCT), reading speed on Radner reading charts, and patient-reported visual function as assessed by the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) and Functional Reading Independence (FRI) Index. Results: Mean age of participants was 35±11 years with 49 (56%) female. Median qAF8 value was 438 Units (range 210-729). Median BCVA and LLVA in decimal units were 0.50 (range 0.13-0.80) and 0.20 (range 0.06-0.63), respectively. The median of the mean retinal sensitivity with mMP was 20.4 dB (range 0.0-28.8). SD-OCT showed median central subfield retinal thickness of 142 µm (range 72-265) and median macular volume of 1.65 mm3 (range 1.13-2.19). Compared to persons without vision impairment, both reading performance and patient-reported visual function were significantly lower (p<0.001, one sample t-test). Mean reading speed was 108±39 words/minute with logRAD-score of 0.45±0.28. Mean VFQ-25 composite score was 72±13. Mean FRI Index score 2.8±0.6. Conclusions: This trial design may serve as reference for future clinical trials as it explores the utility of qAF8 as primary outcome measure. The baseline data represent the largest, multi-national, STGD1 cohort to date that underwent standardized qAF imaging, reading speed assessment and vision-related quality of life measures which all contribute to the characterization of STGD1. EudraCT registration: 2018-001496-20 (09/05/2019)

Core outcomes for geographic atrophy trials

2019 ◽  
pp. bjophthalmol-2019-314949
Author(s):  
Aniela Krystyna Krezel ◽  
Ruth Hogg ◽  
Lynne Lohfeld ◽  
Usha Chakravarthy ◽  
Augusto Azuara-Blanco
Keyword(s):  
Visual Acuity ◽  
Focus Groups ◽  
Reading Speed ◽  
Geographic Atrophy ◽  
Age Related Macular Degeneration ◽  
Outer Retina ◽  
Age Related ◽  
Patient Reported ◽  
Core Outcomes ◽  
Delphi Exercise

Background/AimsOngoing and recent clinical trials for geographic atrophy (GA) have used different outcomes. The goal of this study was to identify a core outcome set (COS) important for patients, clinicians and researchers, and to propose the use of COS in the design of future GA trials.MethodsFive-component project including: Delphi method with patients and experts, focus groups and interviews with patients, relatives and workers supporting patients. Three hundred and one patients (301) with age-related macular degeneration participated in round 1 of a Delphi exercise. Most subjects had GA; 183 patients (61%) were females and the median (range) age was 77 (50–99) years. In round 2, of the 301 of the first round, 100 participants were randomly selected of whom 76 agreed to take part. In a parallel Delphi exercise, panellists comprised a mix of non-clinical scientists and clinicians (43 in the initial and 21 in the final round). In addition, interviews and focus groups consisting of patients (n=20), family members (n=4) and support workers (n=5) were undertaken.ResultsCore outcomes identified as important for age-related macular degeneration trials were the health of the outer retina, multimodal estimation of lesion size, reading speed, best corrected distance and near acuity, low luminance visual acuity, patient reported visual performance and safety.ConclusionThis study identified a set of core outcomes that should be used in GA trials. The COS include patient-reported outcome measures, near visual acuity, reading speed and assessment of the outer retina.

scholarly journals Measuring the Contrast Sensitivity Function in Non-Neovascular and Neovascular Age-Related Macular Degeneration: The Quantitative Contrast Sensitivity Function Test

2021 ◽  
Vol 10 (13) ◽  
pp. 2768
Author(s):  
Filippos Vingopoulos ◽  
Karen M. Wai ◽  
Raviv Katz ◽  
Demetrios G. Vavvas ◽  
Leo A. Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Visual Acuity ◽  
Clinical Practice ◽  
Contrast Sensitivity ◽  
Visual Function ◽  
Sensitivity Function ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Test Retest Reliability

Age-related macular degeneration (AMD) affects various aspects of visual function compromising patients’ functional vision and quality of life. Compared to visual acuity, contrast sensitivity correlates better with vision-related quality of life and subjectively perceived visual impairment. It may also be affected earlier in the course of AMD than visual acuity. However, lengthy testing times, coarse sampling and resolution, and poor test–retest reliability of the existing contrast testing methods have limited its widespread adoption into routine clinical practice. Using active learning principles, the qCSF can efficiently measure contrast sensitivity across multiple spatial frequencies with both high sensitivity in detecting subtle changes in visual function and robust test–retest reliability, emerging as a promising visual function endpoint in AMD both in clinical practice and future clinical trials.

The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA LV VFQ-48): Performance of the Italian version

2019 ◽  
Vol 30 (5) ◽  
pp. 1014-1018
Author(s):  
Ilaria Di Maggio ◽  
Gianni Virgili ◽  
Giovanni Giacomelli ◽  
Vittoria Murro ◽  
Giovanni Sato ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Visual Information ◽  
Low Vision ◽  
Reading Speed ◽  
Veterans Affairs ◽  
Age Related Macular Degeneration ◽  
Italian Version ◽  
Visual Functioning ◽  
Age Related ◽  
Patient Reported

Purpose: The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 is among the most validated tools to collect patient-reported outcomes in a low-vision population. We have aimed to conduct a pilot validation of the Italian version of the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48. Methods: The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 was translated using a standardized procedure and then administered to consecutive low-vision patients attending rehabilitation services in three centers. Patients were interviewed by a trained psychologist regarding the individual items of the tool. Results: We included 131 patients with a mean visual acuity of 0.91 logMAR (standard deviation: 0.42 logMAR), mostly affected by age-related macular degeneration. The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 showed high internal consistency (Cronbach’s alpha: 0.98) and good item-test and item-rest correlation (median: 0.73 and 0.71, respectively). Both the overall score and the subscale (reading, visual motor, mobility and visual information) scores significantly correlated with visual acuity, reading acuity and speed. Reading speed achieved the best absolute correlation with the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 scores (Spearman r: 0.39–0.49). Conclusion: The Italian version of the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 is a valid tool to assess patients attending low-vision services. Revising a few items may further improve the tool.

Harmonized outcome measures for use in degenerative lumbar spondylolisthesis patient registries and clinical practice

2021 ◽  
pp. 1-9
Author(s):  
Robert E. Harbaugh ◽  
Clinton Devin ◽  
Michelle B. Leavy ◽  
Zoher Ghogawala ◽  
Kristin R. Archer ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Research Data ◽  
Patient Registries ◽  
Data Infrastructure ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Patient Reported ◽  
Research Questions ◽  
Lumbar Spondylolisthesis

OBJECTIVE The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality’s Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

Minimal Important Difference in Patient Reported Outcome Measures in Persons with Severe Mental Illness, a Post-hoc Pre-Post Analysis

2020 ◽  
Author(s):  
Titus Beentjes ◽  
Steven Teerenstra ◽  
Hester Vermeulen ◽  
Maria W.G. Nijhuis-van der Sanden ◽  
Betsie G.I. van Gaal ◽  
...  
Keyword(s):  
Mental Illness ◽  
Severe Mental Illness ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Minimal Important Difference ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Illness Management And Recovery ◽  
Patient Reported ◽  
Complementary Intervention

Abstract Background: Complementary interventions for persons with severe mental illness (SMI) provide broad strategies for recovery and illness self-management. It is not known which outcome measure can be considered to be relevant for persons with SMI. This knowledge can motivate a professional to offer and stimulate a person to participate in that intervention. This paper aimed to identify the outcome measures that determine the most relevant and meaningful change and capture the benefits of a complementary intervention. Methods: By using anchor-based and distribution-based methods, we estimated the minimal important difference (MID) to determine which outcome measure persons improved in beyond the MID to reflect a relevant change in pre-post effect of a complementary intervention, in casu the Illness Management and Recovery programme (IMR).Results: The anchor MID was based on the results of the measure Rand General Health Perception (Rand-GHP). On all MIDs, the Mental Health Recovery Measure (MHRM) had the highest score on the effect compared to its MIDs, and also on all MIDs the MHRM had the highest percentages of participants that scored above the MID. Conclusion: The Rand-GHP is considered to be an excellent measure for investigating the MID as a result of an intervention. The results of our study can be used in shared decision-making processes to determine which intervention is suitable for a person with SMI. A person who desires a recovery outcome, as measured by the MHRM, can be recommended to do the IMR programme.

scholarly journals Patient-reported outcome measures in systemic sclerosis–related interstitial lung disease for clinical practice and clinical trials

2020 ◽  
Vol 5 (2_suppl) ◽  
pp. 48-60
Author(s):  
Lesley Ann Saketkoo ◽  
Mary Beth Scholand ◽  
Matthew R. Lammi ◽  
Anne-Marie Russell
Keyword(s):  
Clinical Practice ◽  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Outcome Measures ◽  
Symptom Burden ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Science Methodology

Systemic sclerosis (SSc) is a progressive vasculopathic, fibrosing autoimmune condition, portending significant mortality; wherein interstitial lung disease (ILD) is the leading cause of death. Although lacking a definitive cure, therapeutics for (SSc-ILD) that stave progression exist with further promising primary and adjuvant compounds in development, as well as interventions to reduce symptom burden and increase quality of life. To date, there has been a significant but varied history related to systemic sclerosis–related interstitial lung disease trial design and endpoint designation. This is especially true of endpoints measuring patient-reported perceptions of efficacy and tolerability. This article describes the underpinnings and complexity of the science, methodology, and current state of patient-reported outcome measures used in (SSc-ILD) systemic sclerosis–related interstitial lung disease in clinical practice and trials.

scholarly journals Feasibility of using patient-reported outcome measures with visually impaired children/young people attending paediatric ophthalmology clinics

2020 ◽  
pp. archdischild-2020-318991
Author(s):  
Alexandra O Robertson ◽  
Valerija Tadić ◽  
Mario Cortina-Borja ◽  
Jugnoo Rahi
Keyword(s):  
Visual Acuity ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Young Person ◽  
Patient Reported Outcome ◽  
Department Of Ophthalmology ◽  
Patient Reported ◽  
Paper And Pencil ◽  
Paediatric Ophthalmology ◽  
At Home

ABSTRACTObjectiveTo explore feasibility of using child/young person patient-reported outcome measures (PROMs) routinely in practice, using vision-specific instruments and paediatric ophthalmology as the exemplar.MethodsParticipants comprised patients aged 8–17 years, with visual impairment or low vision (visual acuity of the logarithm of the minimum angle of resolution (logMAR) worse than 0.3 in the better eye), attending the Department of Ophthalmology at Great Ormond Street Hospital, London, UK. All participants completed age-appropriate PROMs before attending their outpatient appointment. Half were randomly assigned to completion at home, with the choice of paper-and-pencil or electronic format. The other half were invited to complete PROMs during their hospital appointment, and randomly assigned to completion format. All participants completed a face-to-face survey exploring their attitudes and preferences. Analysis comprised survival analysis, and direct comparisons of proportions, with complementary qualitative data analysis.Results93 patients participated. 48 (98%) completing PROMs at home chose the paper-and-pencil format. Completion at home took longer than at hospital (median=20, vs 14 min, p<0.001). Visual acuity was associated with completion time (p=0.007) and missing data (p=0.03). Overall, 52 (60%) reported a preference for completion at home but there was no clear preference for format (37 (43%) preferred either format).ConclusionPROM completion at home ahead of hospital appointments may be preferable for collecting complete, high-quality datasets. Despite equipoise on preference for format, the majority of those completing at home chose the traditional paper-and-pencil format, despite impaired sight. These findings should inform implementation of child/young person PROMs into routine practice.

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