ArticleAnnals of the American Thoracic Society2016
Acute Respiratory Distress Syndrome Measurement Error. Potential Effect on Clinical Study Results.
Article in Annals of the American Thoracic Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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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
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Electronic "Sniffer" Systems to Identify the Acute Respiratory Distress Syndrome.Annals of the American Thoracic Society · 2019Pooled it
- Nudging implementation of low tidal volume ventilation: a stepped wedge, cluster randomized trial.Implementation science : IS · 2026Trial
- Trial
- Development and External Validation of a Detection Model to Retrospectively Identify Patients With Acute Respiratory Distress Syndrome.Critical care medicine · 2025Article
- Exercise interventions for pulmonary function impairment: rehabilitation strategies from the acute phase to long-term sequelae.Frontiers in physiology · 2025Review
- Incidence and Outcomes of Acute Respiratory Distress Syndrome in Brain-Injured Patients Receiving Invasive Ventilation: A Secondary Analysis of the ENIO Study.Journal of intensive care medicine · 2024Article
- Advantages and disadvantages of treatment of experimental ARDS by M2-polarized RAW 264.7 macrophages.Heliyon · 2023Article
- Joint classification and segmentation for an interpretable diagnosis of acute respiratory distress syndrome from chest x-rays.Journal of medical imaging (Bellingham, Wash.) · 2023Article
- Pediatric prognostic models predicting inhospital child mortality in resource-limited settings: An external validation study.Health science reports · 2023Article
- Pulse oximetry for the diagnosis and management of acute respiratory distress syndrome.The Lancet. Respiratory medicine · 2022Review
- A comparison of traditional diarrhoea measurement methods with microbiological and biochemical indicators: A cross-sectional observational study in the Cox's Bazar displaced persons camp.EClinicalMedicine · 2021Article
- Implementing nudges to promote utilization of low tidal volume ventilation (INPUT): a stepped-wedge, hybrid type III trial of strategies to improve evidence-based mechanical ventilation management.Implementation science : IS · 2021Article
- The relationship of tidal volume and driving pressure with mortality in hypoxic patients receiving mechanical ventilation.PloS one · 2021Article
- External validation of the RISC, RISC-Malawi, and PERCH clinical prediction rules to identify risk of death in children hospitalized with pneumonia.Journal of global health · 2021Article
- Differences between Patients in Whom Physicians Agree and Disagree about the Diagnosis of Acute Respiratory Distress Syndrome.Annals of the American Thoracic Society · 2019Article
- Accounting for Label Uncertainty in Machine Learning for Detection of Acute Respiratory Distress Syndrome.IEEE journal of biomedical and health informatics · 2019Article
- Surviving sepsis campaign: research priorities for sepsis and septic shock.Intensive care medicine · 2018Article
- Sample size implications of mortality definitions in sepsis: a retrospective cohort study.Trials · 2018Article
- Article
- Translating evidence into practice in acute respiratory distress syndrome: teamwork, clinical decision support, and behavioral economic interventions.Current opinion in critical care · 2017Review
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4 authors.
Funding
Abstract
rationaleIdentifying patients with acute respiratory distress syndrome (ARDS) is a recognized challenge. Experts often have only moderate agreement when applying the clinical definition of ARDS to patients. However, no study has fully examined the implications of low reliability measurement of ARDS on clinical studies.
objectivesTo investigate how the degree of variability in ARDS measurement commonly reported in clinical studies affects study power, the accuracy of treatment effect estimates, and the measured strength of risk factor associations.
methodsWe examined the effect of ARDS measurement error in randomized clinical trials (RCTs) of ARDS-specific treatments and cohort studies using simulations. We varied the reliability of ARDS diagnosis, quantified as the interobserver reliability (κ-statistic) between two reviewers. In RCT simulations, patients identified as having ARDS were enrolled, and when measurement error was present, patients without ARDS could be enrolled. In cohort studies, risk factors as potential predictors were analyzed using reviewer-identified ARDS as the outcome variable. MEASUREMENTS AND MAIN
resultsLower reliability measurement of ARDS during patient enrollment in RCTs seriously degraded study power. Holding effect size constant, the sample size necessary to attain adequate statistical power increased by more than 50% as reliability declined, although the result was sensitive to ARDS prevalence. In a 1,400-patient clinical trial, the sample size necessary to maintain similar statistical power increased to over 1,900 when reliability declined from perfect to substantial (κ = 0.72). Lower reliability measurement diminished the apparent effectiveness of an ARDS-specific treatment from a 15.2% (95% confidence interval, 9.4-20.9%) absolute risk reduction in mortality to 10.9% (95% confidence interval, 4.7-16.2%) when reliability declined to moderate (κ = 0.51). In cohort studies, the effect on risk factor associations was similar.
conclusionsARDS measurement error can seriously degrade statistical power and effect size estimates of clinical studies. The reliability of ARDS measurement warrants careful attention in future ARDS clinical studies.
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