Evidence map›Paper›PMID 32571121›Full record

ArticleOphthalmic genetics2020

Content generation for patient-reported outcome measures for retinal degeneration therapeutic trials.

Gabrielle D Lacy, Maria Fernanda Abalem, Lilia T Popova, Erin P Santos, Gina Yu, Hanan Y Rakine, Julie M Rosenthal, Joshua R Ehrlich, David C Musch, K Thiran Jayasundera

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmic genetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
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  5. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Gabrielle D LacyDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0002-3746-9326
Maria Fernanda AbalemDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0002-4194-9314
Lilia T PopovaDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.
Erin P SantosDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0002-6796-4889
Gina YuDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.
Hanan Y RakineDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0001-7836-9711
Julie M RosenthalDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0002-8447-0477
Joshua R EhrlichDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0002-0607-3564
David C MuschDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0002-4164-3841
K Thiran JayasunderaDepartment of Ophthalmology and Visual Sciences, University of Michigan Medical School , Ann Arbor, Michigan, USA.ORCID 0000-0003-4895-4818

Funding

NRSA Training CoreTL1TR002242 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HOLINSTAT, MICHAEL ALLAN · 2017 to 2021
$2.8M
Targeted functional testing for retinal diseases based on patient reported outcomesK23EY026985 · NEI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI JAYASUNDERA, KANISHKA THIRAN · 2016 to 2020
$1.2M
Addressing Low Vision due to Severe Peripheral Field Loss: Development and Validation of a Patient-Centered Outcome MeasureK23EY027848 · NEI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI EHRLICH, JOSHUA ROBERT · 2017 to 2021
$1.2M
NCATS NIH HHS TL1 TR002242NEI NIH HHS K23 EY026985NEI NIH HHS K23 EY027848
6 · The paper itself

Abstract

purposeGenerate content for a patient-reported outcome (PRO) measure for use in future clinical trials for inherited retinal degenerations.

methodsPatients at the University of Michigan Kellogg Eye Center with a clinical diagnosis of inherited retinal degeneration with varying phenotypes were recruited for interviews. First, in-depth interviews were performed to solicit a wide range of patient experiences pertaining to visual function. Coders qualitatively analyzed the transcripts from these interviews using Atlas.ti software (Version 8.1.3 (522)) to draft questionnaire items. Next, the questionnaire was tested and refined based on participant feedback in cognitive interviews and administrator feedback in the pilot survey administration (pilot interviews).

resultsA total of 55 participants with a clinical diagnosis of inherited retinal degeneration were interviewed throughout the three study phases: in-depth interviews (n = 26), cognitive interviews (n = 16), and pilot interviews (n = 13). Coded items were analyzed for frequency of occurrence and related themes, then organized into common domains. Within each domain, PRO items were drafted to address the functional limitations or adaptations experienced by patients.

conclusionsItems for a PRO measure have been drafted and evaluated for interpretability in the target inherited retinal degeneration patient population. Content validity for the items was established through a process of in-depth interviews, cognitive interviews, and pilot interviews.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdultAgedClinical Trials as TopicFemaleHumansMaleMiddle AgedPilot ProjectsRetinal DegenerationSurveys and Questionnairesgene therapyinherited retinal degenerationMichigan retinal degeneration questionnairePatient-reported outcomesretinal dystrophy

Identifiers

PMID32571121
PMCPMC7503769

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.