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Introduction Telemonitoring is a promising self-management strategy to improve health care outcomes. This study evaluated real-world adoption of the chronic obstructive pulmonary disease (COPD) Co-Pilot daily symptom monitoring tool by patients and primary care providers (PCPs). Methods An open-label, 6-month, single-arm, multicenter, noninterventional feasibility study enrolled 97 patients aged ≥ 40 years with symptomatic or poorly controlled COPD and ≥ 10 pack-year smoking history. Patients received smartphones and training to use the COPD Co-Pilot application. During the study, patients tracked symptoms daily; an increase in symptom score of ≥ 1.0 point from baseline (symptom alert) prompted patients to contact their PCP via toll-free number. The primary endpoint was time to clinical recommendation (TTCR) from a symptom alert; adherence to completing daily symptom reports through the COPD Co-Pilot application and patient satisfaction were also measured. Results Overall, 87 of 96 patients (90.6%) received 2142 symptom alerts; 42 alerts (equivalent to 2% of all symptom alerts) resulted in 23 patients contacting their PCP. Median TTCR was 7.1 h (interquartile range [IQR]: 4.0–29.9). Among 15 patients using the toll-free number, median TTCR was 2.1 h (IQR 0.0–7.2) versus 19.6 h (IQR 4.5–45.2) for eight patients using other contact methods. Average COPD Co-Pilot adherence overall was 75.2% (95% CI 74.6–75.9). Patients responded favorably regarding the application’s ease of use, functionality, and information provided. Conclusions The COPD Co-Pilot tool was associated with relatively high levels of adherence, suggesting patients’ willingness to monitor symptoms daily. Although a limited number of patients initiated PCP contact, patients who used the study-provided toll-free number had substantially shorter median TTCR, suggesting that this tool could help empower patients to better manage their COPD. Supplementary Information The online version contains supplementary material available at 10.1007/s41030-021-00168-3.

Gerard J Criner,1 Therese Cole,2 Kristen A Hahn,3 Kari Kastango,3 James Eudicone,4 Ileen Gilbert4 1Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Hospital, Philadelphia, PA, USA; 2IQVIA, Rockville, MD, USA; 3IQVIA, Cambridge, MA, USA; 4AstraZeneca, Wilmington, DE, USACorrespondence: Gerard J CrinerDepartment of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Hospital, Philadelphia, PA, 19140, USATel +1 215 707 8113Email gerard.criner@tuhs.temple.eduPurpose: Among patients with chronic obstructive pulmonary disease (COPD), adherence to inhaled medication leads to fewer exacerbations and improved health status. The goal of the present study was to evaluate the effects of medication reminders via the BreatheMate device on adherence in patients with COPD.Patients and Methods: A 6-month, phase 4, randomized, multicenter, open-label US study (NCT02864342) enrolled 138 patients aged ≥ 40 years with moderate to very severe COPD and ≥ 10 pack-year smoking history. Patients in the intervention (n = 68) and control (n = 70) groups received the BreatheMate device, smartphone application, and vouchers to redeem pressurized metered-dose inhalers (pMDIs) for the prescribed 2 puffs of budesonide/formoterol 160/4.5 μg twice daily. The intervention group also received twice-daily electronic reminders to take budesonide/formoterol. The primary endpoint was the mean number of sets of adherent puffs/day (4 puffs: 2 puffs within 60 minutes, twice daily) over 6 months. Secondary endpoints included adherence by three 60-day intervals, usage days, prescription refills, and Clinical COPD Questionnaire (CCQ) score. Study enrollment terminated early due to issues with inconsistent syncing.Results: A higher mean proportion of adherent days (77.6% vs 60.2%; P < 0.001) and sets of adherent puffs/day (1.61 vs 1.33; P < 0.001) were recorded for the intervention group versus the control group. Intervention group adherence was higher than that of the control group for each 60-day interval (P < 0.001); the intervention group was 3.07 (95% confidence interval: 1.49– 6.52) times more likely than the control group to be adherent for ≥ 80% of study days. Overuse (> 2 sets of 2 puffs/day), underuse (< 2 sets of 2 puffs/day), and no use days were lower in the intervention group versus control (P < 0.05). Patients aged ≥ 65 years had higher adherence (P < 0.001).Conclusion: Medication reminders through the BreatheMate device and application produced greater adherence to inhaled therapy in patients with COPD.Keywords: chronic obstructive pulmonary disease, telemedicine, adherence, pressurized metered-dose inhaler

This multicenter, observational drug utilization (DU) study ({"type":"clinical-trial","attrs":{"text":"NCT01594996","term_id":"NCT01594996"}}NCT01594996) investigated the profile of patients and specialist providers who prescribed extended release quetiapine fumarate (quetiapine XR) for treatment of major depressive disorder (MDD) across five European countries (Germany, Italy, Romania, Spain, and Sweden). A DU data abstraction form captured information on the characteristics of physicians, patients, and drugs utilized in the medical management of depressive episodes in MDD, where the therapeutic regimen included quetiapine XR. Data were reported descriptively. This analysis included 811 patients. Psychiatric histories indicated a burden of severe MDD in these patients. Patient demographics were similar across countries; however, those in Sweden had a younger mean age. Physicians’ ratings of the therapeutic effect of prior treatment with antidepressants suggested the need for an add-on treatment for most patients. Overall, 15.7% of patients initiated quetiapine XR treatment as monotherapy. Presence of psychotic symptoms during depressive episodes predicted treatment with higher than recommended doses of quetiapine XR (odds ratio=3.11; 95% confidence interval: 1.6–6.0). This analysis demonstrated similarities in DU across the countries analyzed, largely in accordance with the recommended dose of quetiapine XR as an adjunctive therapy to antidepressants in MDD (50–300 mg/day).

Introduction: Medication adherence improves symptoms and reduces exacerbation risk for COPD patients. Aims: To assess the impact of electronic reminders on adherence in COPD patients. Methods: The 6mo, open-label, randomized, multicenter, phase 4 study (NCT02864342) enrolled 137 patients aged ≥40y with ≥10 pack-year smoking history and moderate-to-very severe COPD in the US. Patients received BUD/FM pMDI 2 puffs of 160/4.5μg twice daily, BreatheMate device, and smartphone app (intervention group [INT, n=67] had audiovisual reminders; control group [CTRL, n=70] did not). The primary endpoint was the mean number of sets of adherent puffs/day (2 sets of 2 puffs/day, both puffs of a set within 60min, 4 puffs total) for 6mo. Secondary endpoints were Clinical COPD Questionnaire (CCQ) score, adherence for each 60d interval, usage days, and prescription refills. The study terminated early due to smartphone syncing issues. Results: INT had significantly more sets of adherent puffs/day (1.61 vs 1.33, P 2 sets of 2 puffs/day) days vs CTRL (P Conclusions: Use of the BreatheMate application with reminders resulted in significantly higher adherence to inhaled therapy in COPD patients. Funded by AstraZeneca