Patient-entered data are immediately available in the ClinTrak EDC database. Patient profiles and reports may include this information, and are available to the Sponsor and other permitted users, including Investigators and medical monitors, on demand Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). Available at: www.goldcopd.org. Accessed on 6 Dec 2019.

Variety of Data Collection Solutions: Offers a variety of eCOA solutions, including: TEK eConsent, TEK eCOA Tablet, TEK eDiary, TEK Configurator and TEK Study Portal One stop solution for all the attractive and modern features required by an Institution under the umbrella of Lamda Infotech. Benefits of ePRO in Clinical Trials for Patients, Clinicians & Sponsors: Increased Safety for Participants Founded in 2011, Castor EDC has grown to become one of the largest and highest rated Electronic Data Capture systems for clinical trials.Beeh KM, Burgel PR, Franssen FME, Lopez-Campos JL, Loukides S, Hurst JR, Flezar M, Ulrik CS, Di Marco F, Stolz D, et al. How do dual long-acting bronchodilators prevent exacerbations of chronic obstructive pulmonary disease? Am J Respir Crit Care Med. 2017;196:139–49. Punekar YS, Shukla A, Mullerova H. COPD management costs according to the frequency of COPD exacerbations in UK primary care. Int J Chron Obstruct Pulmon Dis. 2014;9:65–73. Data from the FLAME study were used to perform this analysis. In the FLAME study, patients with ≥1 exacerbation in the past year were randomised to indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily or salmeterol/fluticasone (SFC) 50/500 μg twice daily [ 23] for 52 weeks ( ClinicalTrials.gov number, NCT01782326).

Patients were excluded if they had exacerbations requiring treatment with antibiotics and/or systemic corticosteroids and/or hospitalisation in the 6 weeks prior to screening. Patients with any history of asthma or a blood eosinophil count > 600/mm 3 at the start of the run-in period were also excluded. The majority of the patients included in the FLAME study were from group D according to global initiative for chronic obstructive lung disease (GOLD) 2016 criteria [ 23, 24]. The study design was presented in the primary publication [ 23] and in Supplementary Figure S1.Poor symptomatic control is associated with acute exacerbations, and this is a major challenge for physicians treating COPD patients. Exacerbations severely impair health status [ 5] and reduce life expectancy [ 1]. Previous reports suggest that patients with higher health status impairment, measured using CAT and SGRQ-C, are prone to exacerbations leading to death [ 27, 28, 29]. Outcomes of our analysis complement previous findings by confirming that patients with higher health status impairment, demonstrated by higher baseline SGRQ and CAT scores, had higher subsequent exacerbation frequency regardless of treatment received. Dyspnoea perception may also be an important factor in reporting of exacerbations and influencing exacerbation treatment [ 30, 31]. Prior studies have shown that increasing dyspnoea levels, as measured using the mMRC scale, are associated with increased risk of hospital readmission and mortality [ 32]; therefore, baseline mMRC score can be a good predictor of mortality [ 33]. Some moods are hard to describe with words in a diary, then you can choose mood diary symbols. Add your diary mood when you start writing private journals, and you can review your mood changes through the calendar. We wish you feel happy in your daily diary. Actually, keeping daily journals can also be a kind of joy. Design Patient and Staff ePRO Training: Another support service that WCG Clinical offers is helping you to design a training program for your staff and patients to give them the proper understanding required on how to use your customized ePRO solution. While it is hoped that the ePRO software is intuitive enough that it can be used with minimal training, depending on your particular study patient demographic, this additional service may prove to be helpful and worthwhile to ensure convenience and comfort for the patient, as well as accuracy in reported data.