Evidence map›Paper›PMID 34350566›Full record

ReviewQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2022

Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review.

Guro Lindviksmoen Astrup, Gudrun Rohde, Stein Arne Rimehaug, Marit Helen Andersen, Tomm Bernklev, Kristin Bjordal, Ragnhild Sørum Falk, Nina Marie Høyning Jørgensen, Knut Stavem, Anita Tollisen and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

12 authors.

Guro Lindviksmoen AstrupResearch support services, Oslo University Hospital, Oslo, Norway. gurol@ous-hf.no.ORCID http://orcid.org/0000-0002-2579-3161
Gudrun RohdeDepartment of Clinical Research, Sørlandet Hospital, Kristiansand, Norway.ORCID http://orcid.org/0000-0002-8538-7237
Stein Arne RimehaugSunnaas Rehabilitation Hospital, Nesoddtangen, Norway.ORCID http://orcid.org/0000-0003-4811-2688
Marit Helen AndersenDepartment of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-6115-3268
Tomm BernklevFaculty of Medicine, University of Oslo, Oslo, Norway.
Kristin BjordalResearch support services, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-1914-494X
Ragnhild Sørum FalkResearch support services, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0001-8398-3492
Nina Marie Høyning JørgensenMedical Library at Ullevål Hospital, University of Oslo Library, Oslo, Norway.
Knut StavemFaculty of Medicine, University of Oslo, Oslo, Norway.ORCID http://orcid.org/0000-0003-4512-8000
Anita TollisenUnger-Vetlesens Institute, Lovisenberg Diaconal Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-4776-9808
Cecilie Delphin AmdalResearch support services, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0001-8422-8085
on behalf of PROMiNET

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSeveral guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted.

methodsA literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist.

resultsThe search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue.

conclusionThe number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years.

Indexed as

NeoplasmsQuality of LifeEuropeHumansPatient Reported Outcome MeasuresResearch DesignClinical studiesCONSORT-PROPatient-reported outcomePatient-reported outcome measureReview

Identifiers

PMID34350566
PMCPMC8921066

What OpenQuestion holds

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LicenceCC BY
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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.