Evidence map›Paper›PMID 36848017›Full record

ReviewAdvances in therapy2023

Development and Preliminary Validation of an Instrument to Measure Symptoms and Impacts in Patients with Proliferative Diabetic Retinopathy.

Diana Rofail, Steven Sherman, Christopher Hartford, Adele Levine, Jessica Baldasaro, Patrick Marquis, Rohini Rao, Diana V Do

Abstract readReview
In one paragraph

Review in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Diana RofailRegeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA. diana.rofail@regeneron.com.ORCID http://orcid.org/0000-0002-2125-4734
Steven ShermanRegeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA.
Christopher HartfordRegeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA.
Adele LevineModus Outcomes, a Division of THREAD, Cambridge, MA, USA.
Jessica BaldasaroModus Outcomes, a Division of THREAD, Cambridge, MA, USA.
Patrick MarquisModus Outcomes, a Division of THREAD, Cambridge, MA, USA.
Rohini RaoRegeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA.
Diana V DoByers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFollowing a review of patient-reported outcome (PRO) instruments in the literature, existing PRO instruments may not adequately capture the experience of receiving treatment for proliferative diabetic retinopathy (PDR). Therefore, this study aimed to develop a de novo instrument to comprehensively assess the patient experience of PDR.

methodsThis qualitative, mixed-methods study comprised item generation for the Diabetic Retinopathy-Patient Experience Questionnaire (DR-PEQ), content validation in patients with PDR, and preliminary Rasch measurement theory (RMT) analyses. Adult patients with diabetes mellitus and PDR who received aflibercept and/or panretinal photocoagulation within 6 months of study initiation were eligible for participation. The preliminary DR-PEQ comprised four scales: Daily Activities, Emotional Impact, Social Impact, and Vision Problems. DR-PEQ items were generated using existing knowledge of patient experiences in PDR and conceptual gaps identified from existing PRO instruments. Patients indicated the level of difficulty conducting daily activities and frequency experiencing emotional impacts, social impacts, and vision problems attributed to diabetic retinopathy and its treatment in the past 7 days. Content validity was evaluated in two rounds of in-depth, semi-structured patient interviews. Measurement properties were investigated via RMT analyses.

resultsThe preliminary DR-PEQ comprised 72 items. Overall, mean (SD) patient age was 53.7 (14.7) years. Forty patients completed the first interview; of these, 30 completed the second interview. Patients reported that the DR-PEQ was easily understood and relevant to their experience. Minor revisions, including removal of the Social Impact scale and addition of a Treatment Experience scale, were implemented to generate 85 items spanning four scales: Daily Activities, Emotional Impact, Vision Problems, and Treatment Experience. RMT analyses provided preliminary evidence that the DR-PEQ performed as intended.

conclusionThe DR-PEQ evaluated a broad spectrum of symptoms, functional impacts, and treatment experiences relevant to patients with PDR. Additional analyses are warranted to evaluate psychometric properties in a larger patient population.

Indexed as

Diabetes MellitusDiabetic RetinopathyAdultHumansLaser CoagulationMiddle AgedPatient Reported Outcome MeasuresRetinaSurveys and QuestionnairesAfliberceptClinical benefitDiabetic retinopathyMixed methodsPatient-reported outcomePhotocoagulationPsychometricsRasch measurement theorySymptomsTreatment

Identifiers

PMID36848017
PMCPMC9969934

What OpenQuestion holds

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LicenceCC BY-NC
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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.