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EDIARY COLLECTION OF DIARY

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Schumann DM, Tamm M, Kostikas K, Stolz D. Stability of the blood Eosinophilic phenotype in stable and exacerbated COPD. Chest. 2019;156:456–65. Some vendors will offer 24/7 technical support for their solution for both patients and clinicians. This is not a common feature across ePRO solutions, although it may prove to be valuable as it does happen that technical issues occur. Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, Guasconi A, Montagna I, Vezzoli S, Petruzzelli S, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018;391:1076–84. your can put in them, and no inc will fade over time. E-diaries have become popular the last few years, Full size table Impact of baseline health status measured via CAT and SGRQ-C scores on moderate/severe exacerbation rate

If you are running a global clinical trial, it is likely that you will be working with a patient population that needs to be serviced in a variety of languages. The majority of ePRO vendors offer multilingual support, as it is a necessity for working with sponsors running international trials. Alerts & Notifications: Able to limit missing data and protocol non-compliance through the use of helpful alerts and reminders to patients.

Founded in 2017 and based in the San Francisco Bay Area, Curebase offers decentralized clinical trials software solutions to sponsors, clinicians and patients. Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;157:1418–22. In online diaries, people write about their day-to-day experiences, social commentary, complaints, poems, prose, illicit thoughts and any content that might be found in a traditional paper diary or journal. They often allow readers to contribute through comments or community posting. Exacerbations were defined symptomatically using the eDiary data according to the criteria of Anthonisen et al. [ 25] and based on healthcare resource utilisation [ 26]. In brief, COPD exacerbations were defined as a worsening of ≥2 major symptoms (dyspnoea, sputum purulence or sputum volume) or as a worsening of any one major symptom and a minor symptom (sore throat, colds [nasal discharge and/or nasal congestion], fever without other cause, cough or wheeze) for at least 2 consecutive days. Only moderate or severe healthcare resource utilisation events were included in this analysis. If an exacerbation required treatment with oral corticosteroids and/or antibiotics, it was considered as moderate, whereas, an exacerbation leading to hospitalisation within 7 days from the onset was considered as severe. Hypothetical total symptom burden (measured using the eDiary data) at the onset and during an exacerbation is graphically represented in Supplementary Figure S2. Statistical analyses

Kim V, Criner GJ. The chronic bronchitis phenotype in chronic obstructive pulmonary disease: features and implications. Curr Opin Pulm Med. 2015;21:133–41. In this post hoc analysis, regardless of treatment, patients from the full analysis set of the FLAME study were divided into groups based on baseline symptoms, presence of disease, clinical characteristics and smoking status. Flexible Device Support: Patients are able to use any device to access the OpenClinica ePRO platform and submit their diary entries. The presence of bronchitis is common in patients with COPD, which is characterised by chronic cough and excessive sputum production leading to a higher symptom burden [ 11, 12]. Higher symptom burden and chronic mucus hypersecretion are also associated with a higher risk of accelerated decline in lung function, exacerbations and hospitalisations [ 13, 14, 15]. An electronic diary (eDiary) enables the evaluation of individual and collective symptoms, including dyspnoea and bronchitis symptoms. Recent reports have indicated that daily symptoms captured by an eDiary may predict long-term response to bronchodilators [ 16, 17]. Party Data Integration: Offers capabilities for third party data and workflow integrations, allowing you to build and deploy integrated study forms with data drawn from patients, EDC, CMTS, and third party sources.

In fact, monkkee is funded exclusively through donations from its users and through the ongoing support of the monkkee founders. monkkee was born out of passion for the cause and the desire to create great software. It is the work of a few passionate individuals, not one of large internet companies. With its client-side encryption, we’re convinced that monkkee is a unique product and we want to make the software accessible to any person wishing to use it. Patients included were aged ≥40 years, with symptomatic COPD (modified Medical Research Council [mMRC] scale ≥2), a post-bronchodilator forced expiratory volume in 1 s (FEV 1) of ≥25 to < 60% of the predicted value, and a post-bronchodilator FEV 1/forced vital capacity < 0.70. Customizable & Complex ePRO surveys: Sponsors are able to use the Castor ePRO software independently (via interactive dashboard) to create customizable surveys.

Josephs L, Culliford D, Johnson M, Thomas M. Improved outcomes in ex-smokers with COPD: a UK primary care observational cohort study. Eur Respir J. 2017;49:1602114. While generally all ePRO/eCOA vendors will provide training and support with using their solution, some vendors offer an additional service of creating training materials for your customized ePRO solution.

droidreport.com said:

Founded in 2011, Castor EDC has grown to become one of the largest and highest rated Electronic Data Capture systems for clinical trials.

Headquartered in France, Kayentis also has offices in the US (Boston) and in Japan (Tokyo). Kayentis was founded in 2004, and since then has grown to over 150 employees. The company specializes in clinical research data capture, and helps to bring simplicity, quality and efficiency in the clinical data management processes for sponsors and CROs. Kayentis’ main product offering is their Clin’from eCOA solution.In recent years in the eCOA/ePRO space, vendors have started to offer a BYOD option, which allows patients to use their personal devices to complete diary entries via an iOS or Android smartphone, tablet, or a computer. This has helped to lower costs associated with providing patients with a provisioned ePRO device, and has become an important and must-have ePRO feature for budget-conscious sponsors. 2. Vendor Platform Ecosystem

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