OBJECTIVES: The study aims to develop a questionnaire for analyze factors that influence adherence to inhaled bronchodilator medication in patients with Chronic Obstructive Pulmonary Disease (COPD) from Romania.

METHODS: A fixed dose combination of olodaterol and tiotropium was the inclusion criteria of patients with COPD in this study because it’s a new reimbursed therapy in Romania. Patients’ information that were entered from Jan to May, 2018 into the database were collected from 4 different counties (Dolj, Olt, Mehedinti, Valcea) and reviewed. Validity, reliability and reproducibility were measured. First, its flow, format, length and mode of administration were assessed. Second, we measured internal consistency reliability using Cronbach’s alpha and reproducibility using a Pearson correlation. We used also EQ-5D-5L for increasing sensibility and not failing to capture important aspects of quality of life for included patients. The adherence value was calculated as proportion of days covered (PDC).

RESULTS: The study included 51 patients with COPD. The mean age of patients was 65.29±11.99, 64.7% were male and the average baseline PDC was 91%. After reviewing, the final questionnaire had 9 statements. Validity was analyzed and significance levels were less than 5% for all 9 statements so the items are all valid. Regarding reliability, Cronbach’s alphas was 0.68, so the questionnaire items estimated consistency. The low correlations between total score of the statements and the degree of the disease (-0.12) suggest that there are no significant differences between groups classified by grade of severity of COPD and our questionnaire score.

CONCLUSIONS:

The questionnaire has good measurement properties and could be used as a valid and reliable measure for adherence’s assessment. The next step will be to correlate the factors included in our questionnaire with the value of patients’ adherence and the level of quality of life.