Using ClinicalTrials.gov to Understand the State of Clinical Research in Pulmonary, Critical Care, and Sleep Medicine.

Ann Am Thorac Soc. 2013 Aug 29;

Authors: Todd JL, White KR, Chiswell K, Tasneem A, Palmer SM

Abstract
Rationale: ClinicalTrials.gov is the largest trial registry in the world. Strengthened registration requirements, including federal mandates in 2007, have increased study representation. A systematic evaluation of all registered studies has been limited by the absence of an aggregate dataset and specialty-specific search terms. Objective: We leveraged a newly transformed database containing annotated data from ClinicalTrials.gov to define the portfolio of interventional clinical research in pulmonary, critical care, and sleep medicine. Methods: Analysis was restricted to studies registered after September 2007 through September 2010 and defined as "interventional" (n=40,970). A specialty-specific study dataset (n= 2,226) was created using disease condition terms provided by data submitters and medical subject heading terms generated by a National Library of Medicine algorithm. Trial characteristics were extracted and summarized using descriptive statistics. Measurements and Main Results: Pulmonary, critical care, and sleep medicine trials composed 5.4% of all interventional studies registered over the 3-year period. In contrast, oncology and cardiovascular disease comprised 21.9% and 8.4% of trials respectively. Within pulmonary trials, asthma and chronic obstructive pulmonary disease were the most studied conditions (27.4% and 21.8% of studies), and measures of lung function or safety were the most frequent primary outcomes. Nearly two-thirds of trials indicated enrollment of 100 patients or fewer, and a majority of studies were phase II or III trials. The single largest funding source (43.5%) was industry and study characteristics varied by funding source. Conclusions: We applied a novel approach to describe the portfolio of interventional clinical research in pulmonary medicine. Our results indicate a disparity between trial representation and the burden of respiratory disease. Resources should be targeted across the spectrum of pulmonary research to address this discrepancy.

PMID: 23987571 [PubMed - as supplied by publisher]

Related Articles

Prediction of unsuccessful treatment in patients with severe acute asthma.

Emerg Med J. 2013 Aug 29;

Authors: Goodacre S, Bradburn M, Cohen J, Gray A, Benger J, Coats T, on behalf of the 3Mg Research Team

Abstract
BACKGROUND: Clinical assessment can be used to identify which patients with acute asthma are at risk of unsuccessful initial treatment.
OBJECTIVE: To determine which elements of clinical assessment predict unsuccessful treatment, defined as needing critical care or any unplanned additional treatment.
METHODS: We analysed data from a large multicentre trial (the 3Mg trial). Adults with severe acute asthma underwent standardised clinical assessment, including peak expiratory flow rate (PEFR), up to 2 h after initiation of treatment. Standard care was provided other than blinded random allocation to trial treatment or placebo. Patients were followed up by record review up to 30 days. Unsuccessful treatment was defined as needing (1) critical care or (2) critical care or any unplanned additional treatment within 7 days of presentation. Logistic regression was used to identify predictors and derive a prediction model for each outcome.
RESULTS: Out of 1084 patients analysed, 81 (7%) received critical care and 157 (14%) received critical care or unplanned additional treatment. Baseline PEFR (p=0.017), baseline heart rate (p<0.001), other serious illness (p=0.019), PEFR change (p=0.015) and heart rate change (p<0.001) predicted need for critical care. Baseline PEFR (p=0.010), baseline heart rate (p<0.001), baseline respiratory rate (p=0.017), other serious illness (p=0.023), PEFR change (p=0.003) and heart rate change (p=0.001) predicted critical care or additional treatment. Models based on these characteristics had c-statistics of 0.77 and 0.69, respectively.
CONCLUSIONS: PEFR, heart rate and other serious illnesses are the best predictors of unsuccessful treatment, but models based on these variables provide modest predictive value.

PMID: 23988398 [PubMed - as supplied by publisher]

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Asthma increases pulmonary thromboembolism risk: a nationwide population cohort study.

Eur Respir J. 2013 Aug 29;

Authors: Chung WS, Lin CL, Ho FM, Li RY, Sung FC, Kao CH, Yeh JJ

Abstract
Studies on the association between asthma and pulmonary thromboembolism (PE) are considerably limited. We investigated whether PE is associated with asthma using a nationwide cohort study.We identified 31356 patients with asthma newly diagnosed in 2002-2008 and 125157 individuals without asthma randomly selected from the general population, frequency-matched by age, sex, and index year using the National Health Insurance Research Database. Both cohorts were followed up until the end of 2010 to measure the incidence of PE. Cox proportional hazards regression analysis was used to measure the hazard ratio (HR) of PE for the asthmatic cohort, compared with the non-asthmatic cohort.We followed 186182 person-years for asthmatic patients and 743374 person-years for non-asthmatic persons, respectively. The HR of PE was 3.24 for the asthmatic cohort, compared with non-asthmatic cohort after adjusting for sex, age, comorbidities and oestrogen supplement. The risk of developing PE significantly increased with the increased frequency of asthma exacerbation and hospitalization.This nationwide cohort study suggests that the risk of developing PE significantly increased in asthmatic patients compared to those of the general population. Frequent asthma exacerbation and hospitalization are significantly associated with PE risk.

PMID: 23988762 [PubMed - as supplied by publisher]

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Inhaled Corticosteroids and the Risk of Pneumonia in people with Asthma: A case control study.

Chest. 2013 Aug 29;

Authors: McKeever T, Harrison TW, Hubbard R, Shaw D

Abstract
BACKGROUND In clinical trials the use of inhaled corticosteroids is associated with an increased risk of pneumonia in people with chronic obstructive pulmonary disease but whether the same is true for people with asthma is not known. METHODS Using primary care data from The Health Improvement Network we identified people with asthma and from this cohort we identified cases with pneumonia/ lower respiratory tract infection, and age and sex matched controls. Conditional logistic regression was used to determine the association between the dose and type of inhaled corticosteroid and risk of pneumonia or LRTI. RESULTS There was a dose response relationship between strength of dose of inhaled corticosteroid and risk of pneumonia or lower respiratory tract infection (p-trend &lt;0∙001), such that after adjusting for confounders people receiving the highest strength of inhaled corticosteroid (≥1000mcg) had a 2.04 (95% CI 1∙59 to 2∙64) increased risk of pneumonia or lower respiratory infection when compared to people with asthma who did not have a prescription for inhaled corticosteroids within the previous 90 days. CONCLUSION People with asthma receiving inhaled corticosteroids are at an increased risk of pneumonia or lower respiratory infection with people receiving higher doses at greater risk. Pneumonia should be considered as a possible side effect of inhaled corticosteroids and the lowest dose of inhaled corticosteroids possible should be used in the management of asthma.

PMID: 23990003 [PubMed - as supplied by publisher]