Satish Chandrasekhar Nair

Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or Grandeur?

BACKGROUND Nearly 31% of the worlds clinical trials are conducted outside the US and 25% of the new drug applications include data from international sites. The high population growth, demand for medication, increased prevalence of life-style related and rare genetic diseases in the MENA countries should be associated with a consequent scale-up of clinical trials in these countries. However, the region sponsors under 1% of global clinical trials. METHODS Determinants including the regulatory environment, patient protection, physician-preparedness, types of diseases, costs of trials and pace of subject recruitment, were analyzed to identify critical factors that influence barriers to the conduct clinical trials in MENA. RESULTS Strategic planning by the CRO can help overcome challenges related to regulatory and oversight requirements. Barriers related to trial quality and subject protection can be mitigated by risk-based monitoring. Growing healthcare infrastructure and communication technologies provide clear advantages for subject recruitment. Low operating costs combined with the increase in pharmaceutical sales provide incentives for the future conduct of clinical trials. LIMITATIONS Although the opportunities and challenges cited are common to the MENA region, further studies are needed to assess other potential contributing variables for the conduct of clinical trials specific to each MENA country. CONCLUSION Challenges in drug importation and site oversight can be overcome with systematic interventions. Social media network and community awareness programs can assist reductions in barriers in obtaining effective informed consents. Increasing pharmaceutical sales, population growth, high prevalence of genetic and life-style related diseases and reduced clinical trial development costs offer expanding opportunities for future clinical trials in MENA.

Clinician-educators in emerging graduate medical education systems: description, roles and perceptions

Objectives To describe clinician-educators (CEs) in new graduate medical education (GME) systems and characterize perception of preparedness, roles and rewards, and factors affecting job satisfaction and retention. Methods A cross-sectional survey of all CEs of institutions using competency-based GME and accredited by the Accreditation Council for Graduate Medical Education-International (ACGME-I). Results 274 of 359 eligible participants (76.3%) responded, representing 47 residency programs across 17 specialties. CEs were predominantly married men aged in their 40s, employed at their current institution 9.3 years (±6.4 years). CEs judged themselves competent or expert in teaching skills (91.5%), trainee assessment (82%) and mentoring (75%); less so in curriculum development (44%) and educational research skills (32%). Clinical productivity was perceived by the majority (62%) as the item most valued by their institutions, with little or no perceived value for teaching or educational efforts. Overall, 58.3% were satisfied or very satisfied with their roles, and 77% expected to remain in academic medicine for 5 years. A strong negative correlation was found between being a program or associate program director and likelihood of staying in academic medicine (aOR 0.42; 0.22 to 0.80). Conclusions In the GME systems studied, CEs, regardless of country or programme, report working in environments that value clinical productivity over educational efforts. CEs feel competent and prepared for many aspects of their roles, have positive attitudes towards teaching, and report overall job satisfaction, with most likely to remain in academic medicine. As medical training advances internationally, the impact on and by CEs requires ongoing attention.

Assessing Subject Privacy and Data Confidentiality in an Emerging Region for Clinical Trials: United Arab Emirates

Pharmaceutical sponsored clinical trials, formerly conducted predominantly in the United States and Europe, have expanded to emerging regions, including the Middle East. Our study explores factors influencing clinical trial privacy and confidentiality in the United Arab Emirates. Factors including concept familiarity, informed consent compliance, data access, and preservation, were analyzed to assess current practices in the Arab world. As the UAE is an emerging region for clinical trials, there is a growing need for regulations related to data confidentiality and subject privacy. Informational and decisional privacy should be viewed within the realms of Arab culture and religious background.

Comparison of good clinical practice compliance and readability ease of the informed consents between observational and interventional clinical studies in the Emirates.

Background: Expansion of clinical trials activity into emerging regions has raised concerns regarding participant rights and research ethics. Increasing numbers of observational studies are now conducted in developing economies, including the United Arab Emirates. Materials and Methods: This study compares the content of information provided, Good Clinical Practice (GCP) guideline compliance, and readability of informed consent forms (ICFs) for observational compared to interventional studies. Results: GCP compliance for observational studies averaged at 79.5% + 6.8%, significantly (P < 0.001) lower than 92.2 + 5.0 percent for interventional studies. Readability ease and readability-grade level were assessed with Flesch-Kincaid scales. Results indicated higher readability grade-level 12.4 + 0.4 (P < 0.001) and lower readability Flesch-Kincaid reading ease score 35.7 + 3.6 for observational studies, as compared to 10.3 + 1.6 and 47.8 + 7.4 for interventional studies. Conclusion: Mandatory training for investigators is essential to provide readability ease and GCP compliance for the ICFs for the local population.

Assessing health literacy in the eastern and middle-eastern cultures

BackgroundHealth literacy is a term employed to assess the ability of people to meet the increasing demands related to health in a rapidly evolving society. Low health literacy can affect the social determinants of health, health outcomes and the use of healthcare services. The purpose of the study was to develop a survey construct to assess health literacy within the context of regional culture. Different socioeconomic status among the Eastern and Middle Eastern countries may restrict, health information access and utilization for those with low literacy.MethodsBy employing expert panel, Delphi technique, focus group methodologies, and pre-testing using participants (N = 900) from the UAE and India, a survey construct to the Eastern-Middle Eastern cultures was developed. Reliability was assessed using Cronbach’s α and validity using Factor analysis. Kiaser-Meyer-Olkin (KMO) sampling adequacy and Bartlett’s tests were used to assess the strength of the relationship among the variables.ResultsInclusion of non-health related items were found to be critical in the authentic assessment of health literacy in the Eastern and Middle Eastern population given the influence of social desirability. Thirty-two percentage of the original 19-item construct was eliminated by the focus group for reasons of relevance and impact for the local culture. Field pretesting participants from two countries, indicated overall construct reliability (Cronbach’s α =0.85), validity and consistency (KMO value of 0.92 and Bartlett’s test of sphericity was significant).ConclusionThe Eastern-Middle Eastern Adult Health Literacy (EMAHL13), screening instrument is brief, simple, a useful indicator of whether or not a patient can read. It assessespatients’ ability to comprehend by distinguishing between health and non-health related items. The EMAHL13 will be a useful too for the reliable assessment of health literacy in countries, where culture plays a significant impact. This will be the first steptowards providing equitable access to healthcare for countries that have large populations with low socioeconomic status.

Focus on international research strategy and teaching: the FIRST programme

Research, education and patient care are important missions of academic health centres and their respective teaching programmes. Yet, teaching hospitals struggle with ways to effectively support quality research initiatives. These issues are even more pronounced in countries with developing medical education systems where inconsistencies in training programme structure and quality, along with the lack of uniformity in the backgrounds and experience of the faculty, can hinder meaningful research activities. Hospital leaders recognized the need to inculcate both the desire and the ability to conduct quality research into every postgraduate training programme. Given the lack of global benchmarks, the institution developed and implemented the FIRST Programme (Focus on International Research Strategy and Teaching), a hospital-wide approach to research strategy training and support in 2010–2012. Over a 3-year period, the number of resident and faculty research activities has more than doubled. The types of research studies have also changed over the past few years, with an increase in basic science and randomized clinical trials. Our experience with implementing an institution-wide research initiative has been quite encouraging. Through leadership commitment, the institution has witnessed substantial increases in both trainee and faculty scholarship over a 3-year period.

Medical students’ perceptions of international accreditation

Objectives This study aimed to explore the perceptions of medical students in a developing medical education system towards international accreditation. Methods Applicants to an Internal Medicine residency program in an academic medical center in the United Arab Emirates (UAE) accredited by the Accreditation Council for Graduate Medical Education-International (ACGME-I) were surveyed between May and June 2014. The authors analysed responses using inductive qualitative thematic analysis to identify emergent themes. Results Seventy-eight of 96 applicants (81%) completed the survey. The vast majority of respondents 74 (95%) reported that ACGME-I accreditation was an important factor in selecting a residency program. Five major themes were identified, namely improving the quality of education, increasing opportunities, meeting high international standards, improving program structure, and improving patient care. Seven (10%) of respondents felt they would be in a position to pursue fellowship training or future employment in the United States upon graduation from an ACGME-I program. Conclusions UAE trainees have an overwhelmingly positive perception of international accreditation, with an emphasis on improving the quality of training provided. Misperceptions, however, exist about potential opportunities available to graduates of ACGME-I programs. As more countries adopt the standards of the ACGME-I or other international accrediting bodies, it is important to recognize and foster trainee “buy-in” of educational reform initiatives.

Outcomes by Mode of Transport of ST Elevation MI Patients in the United Arab Emirates

Introduction The purpose of this multicenter study was to assess differences in demographics, medical history, treatment times, and follow-up status among patients with ST-elevation myocardial infarction (STEMI), who were transported to the hospital by emergency medical services (EMS) or by private vehicle, or were transferred from other medical facilities. Methods This multicenter study involved the collection of both retrospective and prospective data from 455 patients admitted to four hospitals in Abu Dhabi. We collected electronic medical records from EMS and hospitals, and conducted interviews with patients in person or via telephone. Chi-square tests and Kruskal–Wallis tests were used to examine differences in variables by mode of transportation. Results Results indicated significant differences in modes of transportation when considering symptom-onset-to-balloon time (p < 0.001), door-to-balloon time (p < 0.001), and health status at six-month and one-year follow-up (p < 0.001). Median times (interquartile range) for patients transported by EMS, private vehicle, or transferred from an outside facility were as follows: symptom-onset-to-balloon time in hours, 3.1 (1.8–4.3), 3.2 (2.1–5.3), and 4.5 (3.0–7.5), respectively; door-to-balloon time in minutes, 70 (48–78), 81 (64–105), and 62 (46–77), respectively. In all cases, EMS transportation was associated with a shorter time to treatment than other modes of transportation. However, the EMS group experienced greater rates of in-hospital events, including cardiac arrest and mortality, than the private transport group. Conclusion Our results contribute data supporting EMS transportation for patients with acute coronary syndrome. Although a lack of follow-up data made it difficult to draw conclusions about long-term outcomes, our findings clearly indicate that EMS transportation can speed time to treatment, including time to balloon inflation, potentially reducing readmission and adverse events. We conclude that future efforts should focus on encouraging the use of EMS and improving transfer practices. Such efforts could improve outcomes for patients presenting with STEMI.

Utilizations and perceptions of emergency medical services by patients with st-segments elevation acute myocardial infarction in Abu Dhabi: A multicenter study

Background: Data on the use of emergency medical services (EMS) by patients with cardiac conditions in the Gulf region are scarce, and prior studies have suggested underutilization. Patient perception and knowledge of EMS care is critical to proper utilization of such services. Objectives: To estimate utilization, knowledge, and perceptions of EMS among patients with ST-elevation myocardial infarction (STEMI) in the Emirate of Abu Dhabi. Methods: We conducted a multicenter prospective study of consecutive patients admitted with STEMI in four government-operated hospitals in Abu Dhabi. Semi-structured interviews were conducted with patients to assess the rationale for choosing their prehospital mode of transport and their knowledge of EMS services. Results: Of 587 patients with STEMI (age 51 ± 11 years, male 95%), only 15% presented through EMS, and the remainder came via private transport. Over half of the participants (55%) stated that they did not know the telephone number for EMS. The most common reasons stated for not using EMS were that private transport was quicker (40%) or easier (11%). A small percentage of participants (7%) did not use EMS because they did not think their symptoms were cardiac-related or warranted an EMS call. Stated reasons for not using EMS did not significantly differ by age, gender, or primary language of the patients. Conclusions: EMS care for STEMI is grossly underutilized in Abu Dhabi. Patient knowledge and perceptions may contribute to underutilization, and public education efforts are needed to raise their perception and knowledge of EMS.

Reducing the physician workforce crisis: Career choice and graduate medical education reform in an emerging Arab country

Background: In today′s interdependent world, issues of physician shortages, skill imbalances and maldistribution affect all countries. In the United Arab Emirates (UAE), a nation that has historically imported its physician manpower, there is sustained investment in educational infrastructure to meet the population′s healthcare needs. However, policy development and workforce planning are often hampered by limited data regarding the career choice of physicians-in-training. The purpose of this study was to determine the specialty career choice of applicants to postgraduate training programs in the UAE and factors that influence their decisions, in an effort to inform educational and health policy reform. To our knowledge, this is the first study of career preferences for UAE residency applicants. Methods: All applicants to residency programs in the UAE in 2013 were given an electronic questionnaire, which collected demographic data, specialty preference, and factors that affected their choice. Differences were calculated using the t-test statistic. Results: Of 512 applicants, 378 participated (74%). The most preferred residency programs included internal medicine, pediatrics, emergency medicine and family medicine. A variety of clinical experience, academic reputation of the hospital, and international accreditation were leading determinants of career choice. Potential future income was not a significant contributing factor. Discussion: Applicants to UAE residency programs predominantly selected primary care careers, with the exception of obstetrics. The results of this study can serve as a springboard for curricular and policy changes throughout the continuum of medical education, with the ultimate goal of training future generations of primary care clinicians who can meet the country′s healthcare needs. As 65% of respondents trained in medical schools outside of the UAE, our results may be indicative of medical student career choice in countries throughout the Arab world.