Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Compliance With Clinical Guidelines and Effect on Patient Outcome of Real-life Treatment of Hospitalised Exacerbations of COPD: a Nationwide Study in Spain
Rationale. Currently there are well-established guidelines for the management of stable COPD.
However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on
observational studies and low-quality clinical trials. In addition, there are some
controversial aspects, such as treatment with systemic steroids. On the other hand, the
available information on the adherence to the recommendations of the clinical practice
guidelines (CPG) and its impact on the outcome of patients is scarce.
Main objectives. (1) To examine the appropriateness of two clinical guidelines (GOLD and
GesEPOC) of the current management of hospitalized exacerbations of COPD; (2) To determine in
real-life clinical practice the impact of adherence to CPG recommendations for management of
COPD exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days
post-discharge readmissions and mortality); (3) To examine the appropriateness of two
clinical guidelines (GOLD and GesEPOC) of the treatment of stable COPD at admission and after
discharge in patients hospitalized with exacerbated COPD; (4) To determinate in real-life
clinical practice the impact of the suitability to CPG recommendations for treatment of
stable COPD on 90-day post-discharge mortality and readmission of COPD.
Method. National, multicenter, observational and longitudinal study of the first consecutive
20 patients hospitalized for exacerbations of COPD between December 10 and 23, 2019 in the
Internal Medicine Services of the participating Centers. Patients will be followed 90 days
after discharge. A total of 400 patients will be recruited in 20 Spanish hospitals (20 per
center). Independent variables: age, sex, admission service, body mass index, dyspnea (mMRC),
obstruction (FEV¬₁), exacerbations in the previous year, comorbidities, bronchodilator
treatment prior to admission, criteria of adequacy to the CPG in the clinical evaluation and
treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia
and bronchodilator treatment at discharge. Outcomes: in-hospital mortality, mortality at 90
days, re-admission at 90 days. Statistical analysis: Parametric and non-parametric tests,
Kaplan-Meier and ROC curves and multiple logistic regression.
n/a
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