Key factors in the choice of appropriate outcomes for clinical trials

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Possible outcomes in a bronchial asthma study.
Outcome adjudicatorMeasured outcome
Laboratory

Pre-bronchodilator FEV1 value in spirometry.

Serum IgE levels.

Clinical professional

Wheezing or other alterations in pulmonary auscultation.

Pathological findings in chest X-ray or computed tomography: hyperinflation, atelectasis, and/or bronchial wall thickening.

Histological remodeling of the lower airway through bronchial lavage or biopsy.

Family member or caregiver

Subjective perception of relatives or caregivers regarding the patient’s quality of life.

Caregiver stress.

Patient

Quality of life: subjective assessment or through standardized surveys.

Intensity and frequency of symptoms (dyspnea, cough, retrosternal tightness).

Exercise tolerance.

Weekly use of salbutamol as rescue medication.

Adverse effects of pharmacological treatment.

FEV1, forced expiratory volume in the first second. IgE, immunoglobulin E.

Source: Prepared by the authors.