Promise of Real-World Evidence for Patient Centricity in Gulf Cooperation Council Countries: Call to Action.

Presently, Gulf Cooperation Council countries are lagging in the generation of real-world data and use of real-world evidence for patient-centered care compared with the global average. In a collaborative effort, experts from multiple domains of the healthcare environment from the Gulf Cooperation Council countries came together to present their views and recommended key action points for the generation of robust real-world data and leveraging real-world evidence in the countries. The opinions of the experts are presented, along with existing barriers to the effective generation of real-world evidence in the countries. The Gulf Cooperation Council countries are undergoing transformative changes paving the way for improved healthcare measures; however, the challenges in generating reliable, robust, accessible, and secure real-world evidence are persistent. Hence, ongoing public-private engagements, as well as collaborations between regulators, policymakers, healthcare professionals, insurance and pharmaceutical companies, and patients, are warranted. A few notable examples of real-world evidence studies highlighting the benefits of real-world evidence for gaining valuable insights into patient-centric decision making are also discussed. The actionable steps identified for successful real-world evidence generation would provide long-term, real-world evidence-based patient-centric benefits for the countries.

Pituitary apoplexy and panhypopituitarism following acute leptospirosis.

Leptospirosis is a common tropical febrile illness which may manifest with the hepatorenal syndrome and systemic hemorrhagic manifestations. Pituitary apoplexy is a rare but life-threatening condition characterized by a hemorrhage within the pituitary gland or a pituitary adenoma. Apoplexy is very rarely associated with some inducing events such as infectious diseases such as dengue hemorrhagic fever, Hantaan virus, Puumala virus have also been reported to cause pituitary apoplexy. We present the first case of pituitary apoplexy in a patient who was being treated for leptospirosis and discuss the possible mechanisms of apoplexy in the scenario presented. We also review other reports of infectious causes that may result in pituitary apoplexy.

Estimation of lung cancer burden in Australia, the Philippines, and Singapore: an evaluation of disability adjusted life years.

OBJECTIVE: Lung cancer is one of the leading cancers and major causes of cancer mortality worldwide. The economic burden associated with the high mortality of lung cancer is high, which accounts for nearly $180 billion on a global scale in 2008. This paper aims to understand the economic burden of lung cancer in terms of disability adjusted life years (DALY) in Australia, the Philippines, and Singapore. METHODS: The years of life lost (YLL) and years lost due to disability (YLD) were calculated using the formula developed by Murray and Lopez in 1996 as part of a comprehensive assessment of mortality and disability for diseases, injuries and risk factors in 1990 and projected to 2020. The same formula is represented in the Global Burden of Disease template provided by the World Health Organization. Appropriate assumptions were made when data were unavailable and projections were performed using regression analysis to obtain data for 2015. RESULTS: The total DALYs due to lung cancer in Australia, the Philippines, and Singapore were 91,695, 38,584, and 12,435, respectively, and the corresponding DALY rates per a population of 1,000 were 4.0, 0.4, and 2.2, respectively, with a discount rate of 3%. When researchers calculated DALYs without the discount rate, the burden of disease increased substantially; the DALYs were 117,438 in Australia, 50,977 in the Philippines, and 16,379 in Singapore. Overall, YLL or premature death accounted for more than 95% of DALYs in these countries. CONCLUSIONS: Strategies for prevention, early diagnosis, and prompt treatment must be devised for diseases where the major burden is due to mortality.

The Challenges and Recommendations for Gestational Diabetes Mellitus Care in India: A Review.

Gestational diabetes mellitus (GDM) is a primary concern in India affecting approximately five million women each year. Existing literature indicate that prediabetes and diabetes affect approximately six million births in India alone, of which 90% are due to GDM. Studies reveal that there is no consensus among physicians and health-care providers in India regarding management of GDM prepartum and postpartum despite available guidelines. Also, there is no consensus among physicians as to when a woman should undergo oral glucose tolerance test after delivery. This clearly shows that management of GDM is challenging and controversial in India due to conflicting guidelines and treatment protocols, despite availability of straightforward protocols for screening and management. Also, a collaborative approach remains a key for GDM management, as patient compliance and proper educational interventions promote better pregnancy outcomes. Management of GDM plays a pivotal role, as women with GDM have an increased chance of developing diabetes mellitus 5-10 years after pregnancy. Also, children born in GDM pregnancies face an increased risk for obesity and type 2 diabetes. The cornerstone for the management of GDM is glycemic control and quality nutritional intake. GDM management is complex in India, and existing challenges are multifactorial. However, there are little published data outlining these challenges. This review gives an account of some of the key challenges from self-management and health-care provider perspective. The recommendations in this review provide insights for building a more structured model for GDM care in India. This research has several practical applications. First, it points out to reaching a consensus on approaches for screening, diagnosis, and treatment of care across clinical practices in the nation that can aid in overcoming certain challenges observed. Second, it highlights the importance to build capacities and capabilities, especially in resource-limited settings. Health education among pregnant women remains a priority to resolve issues related to self-management. More broadly, further research, specifically qualitative is vital to determine forthcoming challenges with respect to patients, caregivers, providers, and policy makers and to provide solutions fitted to practice setting and demographic background.

An overview of Compassionate Use Programs in the European Union member states.

The past decade witnessed rapid development of novel drugs and therapeutic biological agents. The marketing authorization for novel therapies is often time consuming and distressing for patients. Earlier clinical trials were the only way to access new drugs under development. However, not every patient meets the enrolment criteria, and participation is difficult for patients with life-threatening, long-lasting or seriously debilitating diseases like rare diseases. Early access programs like "Compassionate Use Program (CUP)" have generated alternative channels for such patients. The European Medical Agency provides regulations and recommendations for compassionate use, upon which every European Union (EU) member state has developed its own rules and regulations. Despite previous reviews and studies, the available information is limited and gaps exist. This literature review explores CUP in 28 EU member states. Data was collected through literature review and use of country-specific search terms from the healthcare domain. Data sources were not limited to databases and articles published in journals, but also included grey literature. The results implied that CUP was present in 20 EU member states (71%). Of 28 EU states, 18 (∼64%) had nationalized regulations and processes were well-defined. Overall, this review identified CUP and its current status and legislation in 28 EU member states. The established legislation for CUP in the EU member states suggest their willingness to adopt processes that facilitate earlier and better access to new medicines. Further research and periodic reviews are warranted to understand the contemporary and future regulatory trends in early access programs.

mHealth Intervention to Improve Diabetes Risk Behaviors in India: A Prospective, Parallel Group Cohort Study.

BACKGROUND: In low/middle income countries like India, diabetes is prevalent and health care access limited. Most adults have a mobile phone, creating potential for mHealth interventions to improve public health. To examine the feasibility and initial evidence of effectiveness of mDiabetes, a text messaging program to improve diabetes risk behaviors, a global nonprofit organization (Arogya World) implemented mDiabetes among one million Indian adults. OBJECTIVE: A prospective, parallel cohort design was applied to examine whether mDiabetes improved fruit, vegetable, and fat intakes and exercise. METHODS: Intervention participants were randomly selected from the one million Nokia subscribers who elected to opt in to mDiabetes. Control group participants were randomly selected from non-Nokia mobile phone subscribers. mDiabetes participants received 56 text messages in their choice of 12 languages over 6 months; control participants received no contact. Messages were designed to motivate improvement in diabetes risk behaviors and increase awareness about the causes and complications of diabetes. Participant health behaviors (exercise and fruit, vegetable, and fat intake) were assessed between 2012 and 2013 via telephone surveys by blinded assessors at baseline and 6 months later. Data were cleaned and analyzed in 2014 and 2015. RESULTS: 982 participants in the intervention group and 943 in the control group consented to take the phone survey at baselne. At the end of the 6-month period, 611 (62.22%) in the intervention and 632 (67.02%) in the control group completed the follow-up telephone survey. Participants receiving texts demonstrated greater improvement in a health behavior composite score over 6 months, compared with those who received no messages F(1, 1238) = 30.181, P<.001, 95% CI, 0.251-0.531. Fewer intervention participants demonstrated health behavior decline compared with controls. Improved fruit, vegetable, and fat consumption (P<.01) but not exercise were observed in those receiving messages, as compared with controls. CONCLUSIONS: A text messaging intervention was feasible and showed initial evidence of effectiveness in improving diabetes-related health behaviors, demonstrating the potential to facilitate population-level behavior change in a low/middle income country. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN): 12615000423516; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367946&isReview=true (Archived by WebCite at http://www.webcitation.org/6j5ptaJgF).