Evidence map›Paper›PMID 22987144›Full record

SynthesisQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2013

Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards.

Michael Brundage, Jane Blazeby, Dennis Revicki, Brenda Bass, Henrica de Vet, Helen Duffy, Fabio Efficace, Madeleine King, Cindy L K Lam, David Moher and 5 more

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 24 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

97 citing papers in PubMed, 24 syntheses or guidelines pooled it.

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  4. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
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  9. Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
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  13. Reporting of health-related quality of life in randomized controlled trials involving palliative systemic therapy for esophagogastric cancer: a systematic review.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2018
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37 more citing papers are in PubMed but not listed here.

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

15 authors.

Michael BrundageQueen's University, Kingston, ON, Canada.
Jane Blazeby
Dennis Revicki
Brenda Bass
Henrica de Vet
Helen Duffy
Fabio Efficace
Madeleine King
Cindy L K Lam
David Moher
Jane Scott
Jeff Sloan
Claire Snyder
Susan Yount
Melanie Calvert

Funding

Medical Research Council G0800800Medical Research Council G0800808
6 · The paper itself

Abstract

purposeTo develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs.

methodsA Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance.

resultsForty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors.

conclusionsISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.

Indexed as

ConsensusDecision MakingAdvisory CommitteesConsensus Statements as TopicHealth StatusHumansOutcome Assessment, Health CarePatient Outcome AssessmentQuality of LifeRandomized Controlled Trials as Topic

Identifiers

PMID22987144
PMCPMC3731511

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.