Concept Mapping to Develop a Framework for Characterizing Electronic Data Capture (EDC) Systems

CTSAs have brought about a push to find better EDC systems, which facilitate translational research. Based on the data management needs of a specific clinical/translational research lab, concept mapping was used to create a framework to evaluate EDCs. After refinement based on a spiral model, including consultations with the UW CTSA and a survey of other CTSAs, the tool was used to characterize EDCs used at CTSA sites across the country

Guide to Low Cost Electronic Data Capture Systems for Clinical Trials

There are many ways to use computer systems to record the information generated during the course of clinical trials. The Electronic Data Capture, or EDC, systems have a range of features from a simple basic functionality to sophisticated and complex specialty systems. The costs of these systems also vary from very expensive proprietary products to a recent trend of Open Source software that is distributed without a license fee. Traditionally, academic projects have made use of existing software resources like spreadsheets and Microsoft Access databases. This guide will present information on the low cost options using existing software or Open Source systems that are supported by the Institute for Translational Health Sciences. The description of the features of each option is intended to help an investigator select appropriate software. Additional proprietary and free software options will be described on in future reports

Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial

Background: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). Methods: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. Results: Of 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. Conclusions: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking

Smoking Patterns and Receipt of Cessation Services Among Pregnant Women in Argentina and Uruguay

Introduction: The 5A’s (Ask, Advise, Assess, Assist, and Arrange) strategy, a best-practice approach for cessation counseling, has been widely implemented in high-income countries for pregnant women; however, no studies have evaluated implementation in middle-income countries. The study objectives were to assess smoking patterns and receipt of 5A’s among pregnant women in Buenos Aires, Argentina and Montevideo, Uruguay. Methods: Data were collected through administered questionnaires to women at delivery hospitalizations during October 2011–May 2012. Eligible women attended one of 12 maternity hospitals or 21 associated prenatal care clinics. The questionnaire included demographic data, tobacco use/cessation behaviors, and receipt of the 5A’s. Self-reported cessation was verified with saliva cotinine. Results: Overall, of 3400 pregnant women, 32.8% smoked at the beginning of pregnancy; 11.9% quit upon learning they were pregnant or later during pregnancy, and 20.9% smoked throughout pregnancy. Smoking prevalence varied by country with 16.1% and 26.7% who smoked throughout pregnancy in Argentina and Uruguay, respectively. Among pregnant smokers in Argentina, 23.8% reported that a provider asked them about smoking at more than one prenatal care visit; 18.5% were advised to quit; 5.3% were assessed for readiness to quit, 4.7% were provided assistance, and 0.7% reported follow-up was arranged. In Uruguay, those percentages were 36.3%, 27.9%, 5.4%, 5.6%, and 0.2%, respectively. Conclusions: Approximately, one in six pregnant women smoked throughout pregnancy in Buenos Aires and one in four in Montevideo. However, a low percentage of smokers received any cessation assistance in both countries. Healthcare providers are not fully implementing the recommended 5A’s intervention to help pregnant women quit smoking.Fil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Morello, Paola. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Alemán, Alicia. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Tong, Van T.. Centers for Disease Control and Prevention; Estados UnidosFil: Johnson, Carolyn. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Dietz, Patricia M.. Centers for Disease Control and Prevention; Estados UnidosFil: Farr, Sherry L.. Centers for Disease Control and Prevention; Estados UnidosFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Colomar, Mercedes. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Ciganda, Alvaro. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Llambi, Laura. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Becú, Ana. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Smith, Ruben A.. Centers for Disease Control and Prevention; Estados UnidosFil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentin

Vascular Function Intervention Trial in sickle cell disease (V-FIT): Trial Protocol

This protocol outlines procedures for capturing participant information as part of the V-FIT study. The protocol should not be used as a guide for the treatment of other participants; every care was taken in its drafting, but corrections or amendments may be necessary. This trial adheres to the principles outlined in the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines, protocol and all applicable local regulations

The Role of Free/Libre and Open Source Software in Learning Health Systems

OBJECTIVE: To give an overview of the role of Free/Libre and Open Source Software (FLOSS) in the context of secondary use of patient data to enable Learning Health Systems (LHSs). METHODS: We conducted an environmental scan of the academic and grey literature utilising the MedFLOSS database of open source systems in healthcare to inform a discussion of the role of open source in developing LHSs that reuse patient data for research and quality improvement. RESULTS: A wide range of FLOSS is identified that contributes to the information technology (IT) infrastructure of LHSs including operating systems, databases, frameworks, interoperability software, and mobile and web apps. The recent literature around the development and use of key clinical data management tools is also reviewed. CONCLUSIONS: FLOSS already plays a critical role in modern health IT infrastructure for the collection, storage, and analysis of patient data. The nature of FLOSS systems to be collaborative, modular, and modifiable may make open source approaches appropriate for building the digital infrastructure for a LHS.</p