Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial

BackgroundThe reporting of adverse drug reactions (ADR) by patients represents an interesting challenge in the field of pharmacovigilance, but the reporting system is not adequately implemented in France. In 2015, only 20 MS patients in France reported ADR due to first-line disease-modifying drugs (DMD), while more than 3000 patients were initiated on DMD.The aim of this study is to validate a proof-of-concept as to whether the use of a mobile application (App) increases ADR reporting among patients with relapsing-remitting multiple sclerosis (RR-MS) receiving DMD.Methods/designWe designed a multi-centric, open cluster-randomized controlled trial, called the Vigip-SEP study (NCT03029897), using the App My eReport France® to report ADR to the appropriate authorities in E2B language, in accordance with European regulations. RR-MS patients who were initiated on, or switched, first-line DMD will be included. In the experimental arm, a neurologist will introduce the patient to the App to report ADR to the appropriate French authorities. In the control arm, the patient will be informed of the existence of the App but will not be introduced to its use and will then report ADR according to the usual reporting procedures. Primary assessment criteria are defined as the average number of ADR per patient and per center. We assume that the App will increase patient reporting by 10-fold. Therefore, we will require 24 centers (12 per arm: 6 MS academic expert centers, 3 general hospitals, 3 private practice neurologists), allowing for an expected enrollment of 180 patients (alpha risk 5%, power 90% and standard deviation 4%).DiscussionIncreasing patient reporting of ADR in a real-life setting is extremely important for therapeutic management of RR-MS, particularly for monitoring newly approved DMD to gain better knowledge of their safety profiles. To increase patient involvement, teaching patients to use tools, such as mobile applications, should be encouraged, and these tools should be tested rigorously

Checking the moderating effect of perceived control on the relationship between anxiety and postoperative hospital length of stay among coronary artery bypass graft patients

Mohannad Eid AbuRuz, Ghadeer Al-Dweik, Hekmat Yousef Al-Akash Clinical Nursing Department, Faculty of Nursing, Applied Science Private University, Amman 11934, Jordan Background: Coronary artery disease (CAD) is the most common cardiovascular disease (CVD). Coronary artery bypass graft (CABG) surgery is the most common treatment used for CAD. Patients undergoing this surgery are always anxious, which might increase complications in the postoperative period, especially prolongation of postoperative length of stay (LOS). It has been shown that perceived control (PC) moderated the relationship between anxiety and complications in a cardiac population, but its effect has not been studied in post-CABG. Aim: The aim of this study was to check if there is a moderating effect for the PC on the relationship between anxiety and LOS post-CABG. Patients and methods: A non-experimental, prospective, observational study was conducted with a consecutive sample of 250 patients who underwent elective CABG from four hospitals in Amman, Jordan. PC was measured by the Arabic version of the Control Attitude Scale-Revised (CAS-R), and anxiety was measured by the Arabic version of the anxiety subscale of Hospital Anxiety and Depression Scale. LOS and other needed information were obtained from patients’ medical records. Results: Preoperative anxiety was significantly higher than postoperative anxiety (mean [SD]: 12.80 [6.70] vs 11.01 [6.74], P<0.001). Female patients were more anxious and had longer LOS compared to male patients. In stepwise regression, anxiety and PC scores were independent predictors for LOS. Every unit increase in preoperative anxiety increased LOS by 0.381 days, and every unit increase in PC decreased the postoperative LOS by 0.210 days. Moderating effect was checked by simple slope analysis for high (+1 SD) and low (−1 SD) levels of PC. Patients with high anxiety and low PC had the longest LOS, and patients with low anxiety and high PC had the shortest LOS, indicating the moderating effect of PC on the relationship between anxiety and LOS. Conclusion: High levels of anxiety were associated with longer LOS after CABG. PC moderates this relationship. Enhancing PC in this population can improve outcomes and decrease LOS and morbidity. Keywords: anxiety, perceived control, length of stay, coronary artery bypass graf

A Review to Innovative Ventilation Techniques Used in Historical Hospitals in Middle East and Europe

Historically, natural ventilation has been an important factor to achieve thermal comfort and reduce energy consumption in healthcare buildings. Since the recent century, there has been an increasing change and scientific advancement that led to the reliance of mechanical ventilation systems in commercial buildings and especially in hospitals and healthcare settings. However, the fully mechanical system approaches have changed gradually after global warming and the lack of energy sources. In this context, this study investigated systematically, passive ventilation techniques used in medieval near eastern hospitals ”Bimaristans” and historical hospitals in Europe. The study traced the roots of natural ventilation in a sample of historical healthcare buildings. It also investigated ventilation techniques used in historical hospitals in Middle East and Europe. This study is looking forward to discover the architectural design parameters’ effects of historical hospitals on ventilation, to make a better environment for patients’ health by learning from past lessons in traditional architecture, and how could we adapt these techniques in our nowadays healthcare buildings. This step will allow further research on the adaption and integration of passive techniques inherited from the past in our contemporary hospital design