Evidence map›Paper›PMID 19139138›Full record

SynthesisBMJ (Clinical research ed.)2009

Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review.

Despina G Contopoulos-Ioannidis, Anastasia Karvouni, Ioanna Kouri, John P A Ioannidis

2 registry-linked trialsAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 102 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 6 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.

NCT02469714 nacompletednot on this mapstarted 2015, after this paper: background citation

Integrated Care & Patient Navigators for Latinos With Serious Mental Illness

TypeinterventionalSponsorIllinois Institute of TechnologyRan2015 to 2016Enrolled110ConditionsMental DisordersArmsPeer Navigator Intervention
NCT06943703 completednot on this mapstarted 2018, after this paper: background citation

Safety, Efficacy, and Long-Term Outcomes of Intralesional Bleomycin Injection as an Adjunctive Therapy for Pediatric Lymphatic Malformations: A Retrospective Study on Cosmetic and Health-Related Quality of Life Improvements.

TypeobservationalSponsorNational Children's Hospital, VietnamRan2018 to 2025Enrolled809ConditionsLymphangioma, Lymphatic MalformationsArmsSclerotherapy with intralesional bleomycin injection
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  12. A dance intervention for cancer survivors and their partners (RHYTHM).Journal of cancer survivorship : research and practice · 2017
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42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Despina G Contopoulos-IoannidisDepartment of Paediatrics, University of Ioannina School of Medicine, Ioannina, Greece.
Anastasia Karvouni
Ioanna Kouri
John P A Ioannidis

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine how often health surveys and quality of life evaluations reach different conclusions from those of primary efficacy outcomes and whether discordant results make a difference in the interpretation of trial findings.

designSystematic review. DATA SOURCES: PubMed, contact with authors for missing information, and author survey for unpublished SF-36 data. STUDY SELECTION: Randomised trials with SF-36 outcomes (the most extensively validated and used health survey instrument for appraising quality of life) that were published in 2005 in 22 journals with a high impact factor. DATA EXTRACTION: Analyses on the two composite and eight subdomain SF-36 scores that corresponded to the time and mode of analysis of the primary efficacy outcome.

resultsOf 1057 screened trials, 52 were identified as randomised trials with SF-36 results (66 separate comparisons). Only eight trials reported all 10 SF-36 scores in the published articles. For 21 of the 66 comparisons, SF-36 results were discordant for statistical significance compared with the results for primary efficacy outcomes. Of 17 statistically significant SF-36 scores where primary outcomes were not also statistically significant in the same direction, the magnitude of effect was small in six, moderate in six, large in three, and not reported in two. Authors modified the interpretation of study findings based on SF-36 results in only two of the 21 discordant cases. Among 100 additional randomly selected trials not reporting any SF-36 information, at least five had collected SF-36 data but only one had analysed it.

conclusionsSF-36 measurements sometimes produce different results from those of the primary efficacy outcomes but rarely modify the overall interpretation of randomised trials. Quality of life and health related survey information should be utilised more systematically in randomised trials.

Indexed as

Health SurveysRandomized Controlled Trials as TopicHumansOutcome Assessment, Health CareSurveys and QuestionnairesTreatment Outcome

Identifiers

PMID19139138
PMCPMC2628302

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.