An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits, and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depending on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

The Diet Adherence in Cardiovascular Disease Risk Factors Patients in the North of Iran Based on the Mediterranean Diet Adherence

Background and objectives: Before any nutritional intervention, it is necessary to have the prospect of eating habits of people with cardiovascular risk factors. In this study, we assessed the adherence of healthy diet based on Mediterranean dietary pattern and related factors in adults in the north of Iran. Methods: This study was conducted on 550 men and women with cardiovascular risk factors that referred to Heshmat hospital in Rasht, northern Iran. Information was collected by interview and reading medical history and measuring anthropometric indexes. The Mediterranean Diet Adherence Screener was used for assessing dietary adherence, this screener was modified according to religious beliefs and culture of Iran. Results: The mean age of participants was 58±0.38 years. The mean of body mass index was 27±0.01 kg/m2, and the mean of waist circumference was 98±0.2 cm. The mean of dietary adherence was 5.76±0.07. 45% of participants had low adherence, and just 4% had suitable adherence. The mean of dietary adherence in men was significantly higher than women (p=0. 07). Participants in rural area and high educational participants insignificantly had an unsuitable dietary Adherence. There was no significant association between some cardiovascular disease risk factors and dietary adherence. Conclusion: Education to different group about dietary intake correction and using a Mediterranean dietary pattern that is similar to dietary intake in the north of Iran, for controlling cardiovascular disease is necessary.

Metallic Coating for Carbon Fiber Reinforced Polymer Matrix Composite Substrate

This paper investigates the application of metallic coatings on high fiber volume fraction carbon/epoxy polymer matrix composites. For the grip of the metallic layer, a method of modifying the surface of the composite by introducing a mixture of copper and steel powder (filler powders) which can reduce the impact of thermal spray particles. The powder was introduced to the surface at the time of the forming. Arc spray was used to project the zinc coating layer. The substrate was grit blasted to avoid poor adherence. The porosity, microstructure, and morphology of layers are characterized by optical microscopy, SEM and image analysis. The samples were studied also in terms of hardness and erosion resistance. This investigation did not reveal any visible evidence damage to the substrates. The hardness of zinc layer was about 25.94 MPa and the porosity was around (∼6.70%). The erosion test showed that the zinc coating improves the resistance to erosion. Based on the results obtained, we can conclude that thermal spraying allows the production of protective coating on PMC. Zinc coating has been identified as a compatible material with the substrate. The filler powders layer protects the substrate from the impact of hot particles and allows avoiding the rupture of brittle carbon fibers.

Service Blueprint for Improving Clinical Guideline Adherence via Mobile Health Technology

Background: To improve the delivery of paediatric healthcare in low resource settings, Community Health Workers (CHW) have been provided with a paper-based set of protocols known as Community Case Management (CCM). Yet research has shown that CHW adherence to CCM guidelines is poor, ultimately impacting health service delivery. Digitising the CCM guidelines via mobile technology is argued in extant literature to improve CHW adherence. However, little research exist which outlines how (a) this process can be digitised and (b) adherence could be improved as a result. Aim: To explore how an electronic mobile version of CCM (eCCM) can overcome issues associated with the paper-based CCM protocol (inadequate adherence to guidelines) vis-à-vis service blueprinting. This service blueprint will outline how (a) the CCM process can be digitised using mobile Clinical Decision Support Systems software to support clinical decision-making and (b) adherence can be improved as a result. Method: Development of a single service blueprint for a standalone application which visually depicts the service processes (eCCM) when supporting the CHWs, using an application known as Supporting LIFE (SL eCCM app) as an exemplar. Results: A service blueprint is developed which illustrates how the SL eCCM app can be utilised by CHWs to assist with the delivery of healthcare services to children. Leveraging smartphone technologies can (a) provide CHWs with just-in-time data to assist with their decision making at the point-of-care and (b) improve CHW adherence to CCM guidelines. Conclusions: The development of the eCCM opens up opportunities for the CHWs to leverage the inherent benefit of mobile devices to assist them with health service delivery in rural settings. To ensure that benefits are achieved, it is imperative to comprehend the functionality and form of the eCCM service process. By creating such a service blueprint for an eCCM approach, CHWs are provided with a clear picture regarding the role of the eCCM solution, often resulting in buy-in from the end-users.

Development of a Mobile Image-Based Reminder Application to Support Tuberculosis Treatment in Africa

This paper presents the design, development and evaluation of an application prototype developed to support tuberculosis (TB) patients’ treatment adherence. The system makes use of graphics and voice reminders as opposed to text messaging to encourage patients to follow their medication routine. To evaluate the effect of the prototype applications, participants were given mobile phones on which the reminder system was installed. Thirty-eight people, including TB health workers and patients from Zanzibar, Tanzania, participated in the evaluation exercises. The results indicate that the participants found the mobile image-based application is useful to support TB treatment. All participants understood and interpreted the intended meaning of every image correctly. The study findings revealed that the use of a mobile visualbased application may have potential benefit to support TB patients (both literate and illiterate) in their treatment processes.

Patient’s Knowledge and Use of Sublingual Glyceryl Trinitrate Therapy in Taiping Hospital, Malaysia

Background: The objectives of this study were to assess patient’s knowledge of appropriate sublingual glyceryl trinitrate (GTN) use as well as to investigate how patients commonly store and carry their sublingual GTN tablets. Methodology: This was a cross-sectional survey, using a validated researcher-administered questionnaire. The study involved cardiac patients receiving sublingual GTN attending the outpatient and inpatient departments of Taiping Hospital, a non-academic public care hospital. The minimum calculated sample size was 92, but 100 patients were conveniently sampled. Respondents were interviewed on 3 areas, including demographic data, knowledge and use of sublingual GTN. Eight items were used to calculate each subject’s knowledge score and six items were used to calculate use score. Results: Of the 96 patients who consented to participate, majority (96.9%) were well aware of the indication of sublingual GTN. With regards to the mechanism of action of sublingual GTN, 73 (76%) patients did not know how the medication works. Majority of the patients (66.7%) knew about the proper storage of the tablet. In relation to the maximum number of sublingual GTN tablets that can be taken during each angina episode, 36.5% did not know that up to 3 tablets of sublingual GTN can be taken during each episode of angina. Fifty four (56.2%) patients were not aware that they need to replace sublingual GTN every 8 weeks after receiving the tablets. Majority (69.8%) of the patients demonstrated lack of knowledge with regards to the use of sublingual GTN as prevention of chest pain. Conclusion: Overall, patients’ knowledge regarding the self-administration of sublingual GTN is still inadequate. The findings support the need for more frequent reinforcement of patient education, especially in the areas of preventive use, storage and drug stability.

Predictor Factors for Treatment Failure among Patients on Second Line Antiretroviral Therapy

Second line antiretroviral therapy (ART) regimen is used when patients fail their first line regimen. There are many factors such as non-adherence, drug resistance as well as virological and immunological failure that lead to second line highly active antiretroviral therapy (HAART) regimen treatment failure. This study was aimed at determining predictor factors to treatment failure with second line HAART and analyzing median survival time. An observational, retrospective study was conducted in Sungai Buloh Hospital (HSB) to assess current status of HIV patients treated with second line HAART regimen. Convenience sampling was used and 104 patients were included based on the study’s inclusion and exclusion criteria. Data was collected for six months i.e. from July until December 2013. Data was then analysed using SPSS version 18. Kaplan-Meier and Cox regression analyses were used to measure median survival times and predictor factors for treatment failure. The study population consisted mainly of male subjects, aged 30- 45 years, who were heterosexual, and had HIV infection for less than 6 years. The most common second line HAART regimen given was lopinavir/ritonavir (LPV/r)-based combination. Kaplan-Meier analysis showed that patients on LPV/r demonstrated longer median survival times than patients on indinavir/ritonavir (IDV/r) based combination (p

Contributory Factors to Diabetes Dietary Regimen Non Adherence in Adults with Diabetes

A cross sectional survey design was used to collect data from 370 diabetic patients. Two instruments were used in obtaining data; in-depth interview guide and researchers- developed questionnaire. Fisher's exact test was used to investigate association between the identified factors and nonadherence. Factors identified were: socio-demographic factors such as: gender, age, marital status, educational level and occupation; psychosocial obstacles such as: non-affordability of prescribed diet, frustration due to the restriction, limited spousal support, feelings of deprivation, feeling that temptation is inevitable, difficulty in adhering in social gatherings and difficulty in revealing to host that one is diabetic; health care providers obstacles were: poor attitude of health workers, irregular diabetes education in clinics , limited number of nutrition education sessions/ inability of the patients to estimate the desired quantity of food, no reminder post cards or phone calls about upcoming patient appointments and delayed start of appointment / time wasting in clinics.