Evidence map›Paper›PMID 36855175›Full record

ReviewHealth and quality of life outcomes2023

Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure.

Carla DeMuro Romano, Lyn Finelli, Sandy Lewis, Valerie Williams, Emily Martin, Matthew Phillips, Todd L Saretsky, Josephine Norquist

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Health and quality of life outcomes, 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
1.1field-weighted citation impact, top 23% of its field
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, 5 citations in OpenAlex.

  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 at 3 institutions in 1 country.

Carla DeMuro RomanoRTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194 Research Triangle Park, Durham, NC, 27709-2194, USA. demuromercon@rti.org.
Lyn FinelliCenter for Observational and Real-World Evidence, Merck and Co., Inc, Rahway, NJ, USA.
Sandy LewisRTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194 Research Triangle Park, Durham, NC, 27709-2194, USA.
Valerie WilliamsRTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194 Research Triangle Park, Durham, NC, 27709-2194, USA.
Emily MartinSchool of Public Health, University of Michigan, Ann Arbor, MI, USA.
Matthew PhillipsCenter for Observational and Real-World Evidence, Merck and Co., Inc, Rahway, NJ, USA.
Todd L SaretskyBiostatistics and Research Data Sciences, Patient-Centered Endpoints and Strategy Group, Merck and Co., Inc, Rahway, NJ, USA.
Josephine NorquistBiostatistics and Research Data Sciences, Patient-Centered Endpoints and Strategy Group, Merck and Co., Inc, Rahway, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USRTI Health Solutions · USUniversity of Michigan–Ann Arbor · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure.

methodsA targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes.

resultsIn-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined.

conclusionsThe RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.

Indexed as

Influenza, HumanInfluenza VaccinesRespiratory Syncytial Virus InfectionsAgedHumansPatient Reported Outcome MeasuresQuality of LifeUnited StatesInfluenza VaccinesDisease burdenImpactRespiratory syncytial virus (RSV)RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ)Symptoms

Identifiers

PMID36855175
PMCPMC9976435
OpenAlexW4322625236

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.