ReviewPloS one2009
Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity.
Review in PloS one, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled 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.
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.
Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Inclusion of participants from low-income and middle-income countries in core outcome sets development: a systematic review.BMJ open · 2021Pooled it
- Pooled it
- Core outcomes in neonatology: development of a core outcome set for neonatal research.Archives of disease in childhood. Fetal and neonatal edition · 2020Pooled it
- Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.Journal of clinical epidemiology · 2015Pooled it
- Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies.PLoS medicine · 2011Pooled it
- Review
- Clinical trials and outcome reporting in congenital diaphragmatic hernia overlook long-term health and functional outcomes-A plea for core outcomes.Acta paediatrica (Oslo, Norway : 1992) · 2022Review
- Outcomes reported in trials of childhood fractures: a systematic review.Bone & joint open · 2020Article
- Article
- Under-utilisation of reproducible, child appropriate or patient reported outcome measures in childhood uveitis interventional research.Orphanet journal of rare diseases · 2019Review
- Outcomes Reported After Surgery for Cauda Equina Syndrome: A Systematic Literature Review.Spine · 2018Review
- Parent, patient and clinician perceptions of outcomes during and following neonatal care: a systematic review of qualitative research.BMJ paediatrics open · 2018Article
- Article
- Article
- The COMET Handbook: version 1.0.Trials · 2017Review
- Developing, implementing and disseminating a core outcome set for neonatal medicine.BMJ paediatrics open · 2017Article
- Systematic review of outcome measures in pediatric eosinophilic esophagitis treatment trials.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2016Article
- Article
- When will research measure up to our need to know how steroids affect childhood growth?The Cochrane database of systematic reviews · 2014Article
- Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
backgroundLittle work has been done to determine which outcomes should be measured in randomised controlled trials (RCTs) in children with asthma. Drug regulatory authorities require that short term disease activity is measured, but other outcome domains are not mandatory for licensing and marketing purposes. We aimed to identify whether any domains were underrepresented in RCTs of regular therapies for children with asthma over a 20 year period, and to examine what consistency there was between RCTs in the outcomes used to assess the domains. METHODOLOGY/PRINCIPAL
findingsBy searching the Cochrane Central Register of Controlled Trials in January 2008, we identified all parallel-group RCTs, published between January 1988 and December 2007, which assessed inhaled corticosteroids (ICS) as regular therapy for children with asthma. We evaluated how frequently RCTs measured the following pre-defined domains: disease activity; disease damage; functional status; quality of life; health resource utilisation; and adverse effects of therapy. Our initial search identified 1668 abstracts, of which 412 were retrieved in full. 159 RCTs, of which 115 involved only children and 44 involved children and adults, were included in the review. Disease activity was measured in 157 RCTs, adverse effects of ICS in 135, functional status in 25, quality of life in 21, and health resource utilisation in 17. No RCT measured long term disease damage, although two used FEV1 as a measure of 'lung growth'. RCTs were inconsistent in the outcomes used to measure the domains.
conclusionsShort term disease activity is the most frequently measured outcome domain in RCTs in children with asthma. Effects of regular therapies on functional status, quality of life, and long term consequences of asthma are infrequently assessed. A core set of outcomes, developed using consensus techniques, would standardise the measurement of appropriate outcomes in these RCTs. Involving patients would identify outcomes which are most relevant from their perspective.
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What OpenQuestion holds
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.