Evidence map›Paper›PMID 33606595›Full record

ReviewHuman vaccines & immunotherapeutics2022

Patient-reported outcomes in vaccines research: relevance for decision-making.

Desmond Curran, Eliazar Sabater Cabrera, Linda Nelsen

Abstract readReview
In one paragraph

Review in Human vaccines & immunotherapeutics, 2022. 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. Article
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  4. Review
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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

3 authors.

Desmond CurranValue Evidence, GSK, Wavre, Belgium.ORCID 0000-0002-7423-0111
Eliazar Sabater CabreraValue Evidence, GSK, Wavre, Belgium.ORCID 0000-0002-3184-2855
Linda NelsenValue Evidence, GSK, Upper Providence, PA, USA.ORCID 0000-0002-3929-4064

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development and demand for effective vaccines have witnessed an exponential growth over the last century. In the meantime, the vaccine market involves more knowledgeable stakeholders, with a shift in emphasis by regulatory agencies on understanding the patient perception and experience. The Food and Drug Administration's publication of the patient-reported outcomes (PRO) guidance has elevated the discipline of PROs and has resulted in a transition from clinician reports of patient outcomes to PROs. This review reports various research methods, which utilize PROs, including qualitative and quantitative research, clinical trials, and patient preference studies. With the advancement of electronic PRO data capture, additional advantages of PROs are being observed and utilized (e.g. as a trigger for clinical endpoints). We discuss uses and advantages of including PROs into the clinical trial program to improve efficiencies, clinical relevance and overall validity of the program in the vaccine field. (See Plain Language Summary).

Indexed as

Patient Reported Outcome MeasuresVaccinesHumansResearch DesignVaccinesclinical outcomes assessmentscomparative effectivenesselectronic PROhealth-related quality of lifehealth technology assessmentPatient-reported outcomesPRO instrumentspublic health benefitqualitative researchvaccines

Identifiers

PMID33606595
PMCPMC8920246

What OpenQuestion holds

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LicenceCC BY
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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.