Halah Ibrahim

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.

The transition to competency-based pediatric training in the United Arab Emirates

Although competency-based medical education has become the standard for physician training in the West, many developing countries have not yet adopted competency-based training. In 2009 in the United Arab Emirates, the government regulatory and operational authorities for healthcare in Abu Dhabi mandated a wide-scale reform of the emirate’s postgraduate residency programs to the competency-based framework of the newly formed Accreditation Council for Graduate Medical Education-International (ACGME-I). This article briefly describes the rationale for competency-based medical education and provides an overview of the transition from traditional, time-based residency training to competency-based postgraduate medical education for the Pediatrics residency programs in Abu Dhabi. We will provide data on the initial impact of this transition on resident performance and patient outcomes in a Pediatrics residency program in an academic medical center in the United Arab Emirates.

Creating a Framework for Medical Professionalism: An Initial Consensus Statement From an Arab Nation

Background Medical professionalism has received increased worldwide attention, yet there is limited information on the applicability and utility of established Western professionalism frameworks in non-Western nations. Objective We developed a locally derived consensus definition of medical professionalism for the United Arab Emirates (UAE), which reflects the cultural and social constructs of the UAE and the Middle East. Methods We used a purposive sample of 14 physicians working in the UAE as clinical and education leaders. This expert panel used qualitative methods, including the world café, nominal group technique, the Delphi method, and an interpretive thematic analysis to develop the consensus statement. Results The expert panel defined 9 attributes of medical professionalism. There was considerable overlap with accepted Western definitions, along with important differences in 3 aspects: (1) the primacy of social justice and societal rights; (2) the role of the physicians personal faith and spirituality in guiding professional practices; and (3) societal expectations for professional attributes of physicians that extend beyond the practice of medicine. Conclusions Professionalism is a social construct influenced by cultural and religious contexts. It is imperative that definitions of professionalism used in the education of physicians in training and in the assessment of practicing physicians be formulated locally and encompass specific competencies relevant to the local, social, and cultural context for medical practice. Our goal was to develop a secular consensus statement that encompasses culture and values relevant to professionalism for the UAE and the Arab region.

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.

Gender and international clinician educators

Objectives To describe gender differences of international clinician educators (CEs) and leaders, and CEs’ perceptions by gender of preparation, roles, rewards and factors affecting job satisfaction and retention in emerging international competency-based residency programmes. Methods Cross-sectional surveys of CEs and leadership were conductedJune 2013–June 2014 at institutions that had adopted competency-based graduate medical education and were accredited by the Accreditation Council for Graduate Medical Education-International. Results 274 (76.3%) of 359 eligible participants responded; 69 (25.2%) were female. Two (18%) of 11 chief executive officers and 1 (9%) of 11 chief medical officers were women. Female CEs were younger, more likely to be single and childless. They were less likely to hold academic appointments, despite no gender differences in length of time at current institution or in current position. A greater proportion of female CEs felt they were ‘never’ rewarded by academic promotion. Satisfaction rates were similar between the genders. Single female CEs were five times as likely to report being ‘extremely likely’ to stay in the country. Female CEs with children <21 were less likely to report high likelihood of staying in academia. Marital status and children were not associated with outcomes for male CEs. Conclusions In the international academic medicine programmes studied, there were fewer female CEs in the pipeline and they perceived a gender gap in appointment and advancement. Stakeholders at international programmes need to develop contextualised strategies to expand entry and decrease attrition of women into CE tracks, and promote gender equity.

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.