SynthesisMedical care2011
Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials.
Synthesis in Medical care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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
13 citing papers in PubMed.
- Observational
- Article
- Time interval affects physical activity scores: a comparison of the Marx Activity Rating Scale and the Hospital for Special Surgery Pediatric Functional Activity Brief Scale.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2020Article
- Assessment and Measurement of Spasticity in MS: State of the Evidence.Current neurology and neuroscience reports · 2019Review
- State of the psychometric methods: patient-reported outcome measure development and refinement using item response theory.Journal of patient-reported outcomes · 2019Article
- Patient and observer reported outcome measures to evaluate health-related quality of life in inherited metabolic diseases: a scoping review.Orphanet journal of rare diseases · 2018Article
- Measurement properties of the Short Form-36 (SF-36) and the Functional Assessment of Cancer Therapy - Anemia (FACT-An) in patients with anemia associated with chronic kidney disease.Health and quality of life outcomes · 2018Article
- Responsiveness Comparison of the EQ-5D, PROMIS Global Health, and VR-12 Questionnaires in Knee Arthroscopy.Orthopaedic journal of sports medicine · 2016Article
- Patient involvement in clinical research: why, when, and how.Patient preference and adherence · 2016Review
- Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).Journal of epidemiology and global health · 2015Review
- Understanding and improving clinical trial outcome measures in acute respiratory failure.American journal of respiratory and critical care medicine · 2014Article
- Development of a new occupational balance-questionnaire: incorporating the perspectives of patients and healthy people in the design of a self-reported occupational balance outcome instrument.Health and quality of life outcomes · 2014Article
- Strengthening the assessment of factorial invariance across population subgroups: a commentary on Varni et al. (2013).Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundTo optimize the use of patient-reported outcomes (PROs) in clinical research, it is first necessary to review the current use of these outcomes in clinical trials to determine under what circumstances they are most useful, and to reveal current limitations. PURPOSE: To investigate current patterns of use of PROs in clinical trials. RESEARCH
designWe conducted a systematic literature review of all double-blind, placebo-controlled, randomized clinical trials using one or more PROs as a study outcome from 2004 to 2006. Data were abstracted and analyzed with descriptive statistics and logistic regression to characterize the use of PROs in clinical trials.
resultsThe 180 clinical trials that met the study inclusion criteria used 173 unique instruments to measure a total of 466 PROs. Most PRO measurements were obtained using relatively few PRO instruments, with one-third of PRO instruments applied in more than 1 trial. In multivariable analysis, tests of statistical significance were more often reported for PROs used as primary trial outcomes. Statistically significant PRO outcomes (P<0.05) were more likely among disease-specific PROs compared with general PROs, PROs with a discussion of minimally important difference, and larger trials.
conclusionsPRO instruments may be improved through efforts to provide centralized electronic administration, cross-validation, and standardized interpretation of clinically relevant outcomes. The majority of PROs used in current clinical trials come from relatively few, commonly used disease-specific PRO instruments within major therapeutic areas.
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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.