User-Centered Design Groups to Engage Patients and Caregivers with a Personalized Health Information Technology Tool.

Health information technology (IT) has opened exciting avenues for capturing, delivering and sharing data, and offers the potential to develop cost-effective, patient-focused applications. In recent years, there has been a proliferation of health IT applications such as outpatient portals. Rigorous evaluation is fundamental to ensure effectiveness and sustainability, as resistance to more widespread adoption of outpatient portals may be due to lack of user friendliness. Health IT applications that integrate with the existing electronic health record and present information in a condensed, user-friendly format could improve coordination of care and communication. Importantly, these applications should be developed systematically with appropriate methodological design and testing to ensure usefulness, adoption, and sustainability. Based on our prior work that identified numerous information needs and challenges of HCT, we developed an experimental prototype of a health IT tool, the BMT Roadmap. Our goal was to develop a tool that could be used in the real-world, daily practice of HCT patients and caregivers (users) in the inpatient setting. Herein, we examined the views, needs, and wants of users in the design and development process of the BMT Roadmap through user-centered Design Groups. Three important themes emerged: 1) perception of core features as beneficial (views), 2) alerting the design team to potential issues with the user interface (needs); and 3) providing a deeper understanding of the user experience in terms of wider psychosocial requirements (wants). These findings resulted in changes that led to an improved, functional BMT Roadmap product, which will be tested as an intervention in the pediatric HCT population in the fall of 2015 (ClinicalTrials.govNCT02409121).

Transformation of health care and the new model of care in Saudi Arabia: Kingdom's Vision 2030.

The Kingdom of Saudi Arabia espoused "Vision 2030" as a strategy for economic development and national growth. The vision demonstrated the Kingdom's objectives to become a pioneer nation globally by achieving three main goals: a vibrant society, a thriving economy, and an ambitious nation. To fulfill this, the Kingdom launched a national transformation program (NTP) as outlined in "vision 2030" in June 2016. The health care transformation is one of the eight themes of the NTP's. The history of health care facilities in the Kingdom is almost a century. Although the Kingdom has made notable progress in improving its population's health over recent decades, it needs to modernize the health care system to reach the "vision 2030" goal. This article aims to describe the new Model of Care (MOC) according to the recent Saudi health care transformation under the Kingdom's vision 2030. The MOC concept started with understanding the current state and collecting learnings. It is based on the six systems of care (SOC)- keeping well, planned procedure, women & children, urgent problems, chronic conditions, and the last phase of life. The SOC is cut across different "service layers" to support people's stay well and efficiently get them healthy again when they need care. The new MOC describes a total of forty-two interventions, of which twenty-seven split across the six SOC and the rest fifteen cut-across the multiple SOC. Implementation of all MOC interventions will streamline the Saudi health care system to embrace the Kingdom's "vision 2030".

Bayesian group sequential designs for phase III emergency medicine trials: a case study using the PARAMEDIC2 trial.

BACKGROUND: Phase III trials often require large sample sizes, leading to high costs and delays in clinical decision-making. Group sequential designs can improve trial efficiency by allowing for early stopping for efficacy and/or futility and thus may decrease the sample size, trial duration and associated costs. Bayesian approaches may offer additional benefits by incorporating previous information into the analyses and using decision criteria that are more practically relevant than those used in frequentist approaches. Frequentist group sequential designs have often been used for phase III studies, but the use of Bayesian group sequential designs is less common. The aim of this work was to explore how Bayesian group sequential designs could be constructed for phase III trials conducted in emergency medicine. METHODS: The PARAMEDIC2 trial was a phase III randomised controlled trial that compared the use of adrenaline to placebo in out-of-hospital cardiac arrest patients on 30-day survival rates. It used a frequentist group sequential design to allow early stopping for efficacy or harm. We constructed several alternative Bayesian group sequential designs and studied their operating characteristics via simulation. We then virtually re-executed the trial by applying the Bayesian designs to the PARAMEDIC2 data to demonstrate what might have happened if these designs had been used in practice. RESULTS: We produced three alternative Bayesian group sequential designs, each of which had greater than 90% power to detect the target treatment effect. A Bayesian design which performed interim analyses every 500 patients recruited produced the lowest average sample size. Using the alternative designs, the PARAMEDIC2 trial could have declared adrenaline superior for 30-day survival with approximately 1500 fewer patients. CONCLUSIONS: Using the PARAMEDIC2 trial as a case study, we demonstrated how Bayesian group sequential designs can be constructed for phase III emergency medicine trials. The Bayesian framework enabled us to obtain efficient designs using decision criteria based on the probability of benefit or harm. It also enabled us to incorporate information from previous studies on the treatment effect via the prior distributions. We recommend the wider use of Bayesian approaches in phase III clinical trials. TRIAL REGISTRATION: PARAMEDIC2 Trial registration ISRCTN, ISRCTN73485024. Registered 13 March 2014, http://www.isrctn.com/ISRCTN73485024.

Development of Palliative and End of Life Care: The Current Situation in Saudi Arabia.

As part of the health care reforms and transformation project of the Vision 2030, a group of expert healthcare professionals was tasked with the development of a model of care for patients with life-shortening illnesses in Saudi Arabia. This Care Design Group (CDG 1-3) held a series of workshops and conducted surveys and online discussions to systematically document and develop a model of care. These interventions were aimed at achieving a national standard of care. This short article is a description of this very successful process of development.

Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs.

PURPOSE: The aim of this study was to evaluate an intervention designed to assist after-school programs (ASPs) in meeting snack nutrition policies that specify that a fruit or vegetable be served daily and sugar-sweetened beverages/foods and artificially flavored foods eliminated. DESIGN: The study used a 1-year group-randomized controlled trial. SETTING: The study took place in ASPs operating in South Carolina, United States. SUBJECTS: Twenty ASPs serving over 1700 children were recruited, match-paired postbaseline on enrollment size and days fruits/vegetables were served per week, and randomized to either intervention (n = 10) or control (n = 10) groups. INTERVENTION: The study used Strategies To Enhance Practice for Healthy Eating (STEPs-HE), a multistep adaptive intervention framework that assists ASP leaders and staff to serve snacks that meet nutrition policies while maintaining cost. MEASURES: Direct observation of snacks served and consumed and monthly snack expenditures as determined by receipts were used. ANALYSIS: The study used nonparametric and mixed-model repeated measures. RESULTS: By postassessment, intervention ASPs increased serving of fruits/vegetables to 3.9 ± 2.1 vs. 0.7 ± 1.7 d/wk and decreased serving sugar-sweetened beverages to 0.1 ± 0.7 vs. 1.8 ± 2.4 d/wk and sugar-sweetened foods to 0.3 ± 1.1 vs. 2.7 ± 2.5 d/wk compared to controls, respectively. Cost of snacks increased by $0.02/snack in the intervention ASPs ($0.36 to $0.38) compared to a $0.01 per snack decrease in the control group ($0.39 to $0.38). Across both assessments and groups, 80% to 100% of children consumed FVs. CONCLUSIONS: The STEPs-HE intervention can assist ASPs in meeting nationally endorsed nutrition policies with marginal increases in cost.