Evidence map›Paper›PMID 35441987›Full record

ArticleJournal of patient-reported outcomes2022

Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations.

Sophia T Matts, Christina M Webber, Fraser D Bocell, Brittany Caldwell, Allen L Chen, Michelle E Tarver

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of patient-reported outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Trial
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  8. The Role of Patient-Reported Outcomes in Cirrhosis.The American journal of gastroenterology · 2025
    Review
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  10. Review
  11. A Narrative Review of Patient-Reported Outcome Measures and Their Application in Recent Pediatric Surgical Research: Advancing Knowledge and Offering New Perspectives to the Field.European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie · 2024
    Review
  12. Review
  13. 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

6 authors.

Sophia T MattsOak Ridge Institute for Science and Education (ORISE) Research Participation Program, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Christina M WebberCenter for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Fraser D BocellCenter for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Brittany CaldwellCenter for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Allen L ChenCenter for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Michelle E TarverCenter for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. michelle.tarver@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe U.S. Food and Drug Administration encourages the incorporation of the patient voice throughout the medical device total product lifecycle. This study examined the incorporation of patient-reported outcome (PRO) instruments in the evaluation of medical devices over a six-year period. PRO instruments used to inform study endpoints were extracted from the summary documents and clinical trial data of premarket authorizations posted on publicly available FDA databases between October 1, 2014-September 30, 2020.

resultsPROs were included in 53% of authorizations, with 34% using PROs as primary and secondary endpoints. This study found that PRO instruments were used in each type of marketing authorization and in all medical specialties examined in this study.

conclusionsExpanding the current collaborative efforts to develop and modify PRO instruments may help to improve use of PROs in medical device evaluations.

Identifiers

PMID35441987
PMCPMC9021347

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Registered trials

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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.