ArticleRespiratory research2016
Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy.
Article in Respiratory research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis 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
30 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Joint longitudinal model-based meta-analysis of FEVJournal of pharmacokinetics and pharmacodynamics · 2023Pooled it
- Follow-up interviews from The Salford Lung Study (COPD) and analyses per treatment and exacerbations.NPJ primary care respiratory medicine · 2019Trial
- Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD): follow-up interviews on patient-centred outcomes.NPJ primary care respiratory medicine · 2017Trial
- The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.Therapeutic advances in respiratory diseaseTrial
- Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study.BMJ (Clinical research ed.) · 2024Article
- Eligibility of patients with chronic obstructive pulmonary disease for inclusion in randomised control trials investigating triple therapy: a study using routinely collected data.Respiratory research · 2024Article
- Budesonide/Glycopyrrolate/Formoterol for the Management of COPD in a UK Primary Care Population: Real-World Use and Early Medication Success.International journal of chronic obstructive pulmonary disease · 2024Observational
- Real-World Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy for Symptomatic COPD: The ELLITHE Non-Interventional Trial.International journal of chronic obstructive pulmonary disease · 2024Article
- Clinical Management of COPD in the Real World: Can Studies Reveal Errors in Management and Pathways to Improve Patient Care?Pragmatic and observational research · 2023Review
- Prognosis of Patients with Chronic Obstructive Pulmonary Disease Not Eligible for Major Clinical Trials.American journal of respiratory and critical care medicine · 2022Article
- Understanding the People Excluded from Chronic Obstructive Pulmonary Disease Clinical Trials.American journal of respiratory and critical care medicine · 2022Article
- Impact of baseline clinical features on outcomes of nebulized glycopyrrolate therapy in COPD.NPJ primary care respiratory medicine · 2021Review
- Heterogeneity within and between physician-diagnosed asthma and/or COPD: NOVELTY cohort.The European respiratory journal · 2021Observational
- INTREPID: single-ERJ open research · 2021Article
- A Real World Study to Assess the Effectiveness of Switching to Once Daily Closed Triple Therapy from Mono/Dual Combination or Open Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2021Article
- Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2021Article
- Real-life effectiveness of first-line anticancer treatments in stage IIIB/IV NSCLC patients: Data from the Czech TULUNG Registry.Thoracic cancer · 2020Article
- Real-World Data and Randomised Controlled Trials: The Salford Lung Study.Advances in therapy · 2020Review
- Extrafine Beclometasone Dipropionate/Formoterol Fumarate vs Double Bronchodilation Therapy in Patients with COPD: A Historical Real-World Non-Inferiority Study.International journal of chronic obstructive pulmonary disease · 2020Article
- Adequacy of Therapy for People with Both COPD and Heart Failure in the UK: Historical Cohort Study.Pragmatic and observational research · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundManagement guidelines of chronic obstructive pulmonary disease (COPD) are mainly based on results of randomised controlled trials (RCTs), but some authors have suggested limited representativeness of patients included in these trials. No previous studies have applied the full range of selection criteria to a broad COPD patient population in a real-life setting.
methodsWe identified all RCTs of inhaled long-acting bronchodilator therapy, during 1999-2013, at ClinicalTrials.gov and translated trial selection criteria into definitions compatible with electronic medical records. Eligibility was calculated for each RCT by applying these criteria to a uniquely representative, well-characterised population of patients with COPD from the Optimum Patient Care Research Database (OPCRD).
resultsMedian eligibility of 36 893 patients with COPD for participation in 31 RCTs was 23 % (interquartile range 12-38). Two studies of olodaterol showed the highest eligibility of 55 and 58 %. Conversely, the lowest eligibility was observed in two studies that required a history of exacerbations in the past year (3.5 and 3.9 %). For the patient subgroup with modified Medical Research Council score ≥2, the overall median eligibility was 27 %.
conclusionsBy applying an extensive range of RCT selection criteria to a large, representative COPD patient population, this study highlights that the interpretation of results from RCTs must take into account that RCT participants are variably, but generally more representative of patients in the community than previously believed.
Indexed as
Identifiers
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.