Correction: The Development of a Clinical Research Model Complementing Medical Residency and the Assessment of Research Productivity.

[This corrects the article DOI: 10.7759/cureus.48684.].

The Development of a Clinical Research Model Complementing Medical Residency and the Assessment of Research Productivity.

BACKGROUND AND OBJECTIVE: Despite modern healthcare infrastructure, there is a paucity of information about the clinical research framework supporting healthcare in the United Arab Emirates (UAE). Therefore, this study aimed to assess research performance productivity, and the clinical research framework, complementing medical residency, at the nation's hub for clinical research. METHODS: A cross-sectional retrospective review of records from the research database of the institution was conducted to assess productivity, and framework development, and data analyzed. RESULTS:  The migration of global healthcare providers, and the pharmaceutical industry offices, the adoption of the International Conference on Harmonization (ICH) guidelines, and electronic medical records established a research culture. Following the development of the governance framework, a total of 1,328 research projects were submitted to the ethics committee until 2023. Approximately 63% of the total studies were of minimal risk, followed by industry-sponsored clinical trials (4.9%, 58/1,163), and prospective interventional studies (3.5%, 39/1,163). Almost half (48.3%, 28/58) of the total industry-sponsored clinical trials were phase II and phase III. The number of peer-reviewed indexed publications, a measure of research productivity, indicated that the periods between 2011 and 2015, 2016 and 2020, and 2021 and 2023 witnessed a 3.8-, 9.3-, and 7.9-fold increase compared to the baseline period (1995-2005). The implementation of the Focus on International Research Strategy, Teaching, Evaluation, and Mentoring (FIRSTEM) strategy, to accommodate mandatory research activity requirements for residents by the physician licensing boards, observed substantial increases in output. The number of international peer-reviewed indexed publications/resident projects doubled from 10.8% (2010-2015) to 24% (2016-2020) and reached 40.1% in 2023. CONCLUSION: This is the first research governance model established in the UAE, a country with an increasing prevalence of diabetes, and cardiovascular and genetic diseases. The model indicates that the medical trainees differentiate the best research evidence in making decisions about the clinical care of patients. The study outcomes may potentially be useful for other countries in developing a clinical research framework.

Assessment of mortality from COVID-19 in a multicultural multi-ethnic patient population.

BACKGROUND: Studies indicate that ethnicity and socioeconomic disparity are significant facilitators for COVID-19 mortality. The United Arab Emirates, distinctly has a population of almost 12% citizens and the rest, immigrants, are mainly unskilled labourers. The disparate socio-economic structure, crowded housing conditions, and multi-ethnic population offer a unique set of challenges in COVID-19 management. METHODS: Patient characteristics, comorbidities, and clinical outcomes data from the electronic patient medical records were retrospectively extracted from the hospital information system of the two designated public COVID-19 referral hospitals. Chi-square test, logistic regression, and odds ratio were used to analyse the variables. RESULTS: From, the total of 3072 patients, less than one-fifth were females; the Asian population (71.2%);followed by Middle Eastern Arabs (23.3%) were the most infected by the virus. Diabetes Mellitus (26.8%), hypertension (25.7%) and heart disease (9.6%) were the most prevalent comorbidities observed among COVID-19 patients. Kidney disease as comorbidity significantly diminished the survival rates (Crude OR 9.6, 95% CI (5.6-16.6), p < 0.001) and (Adjusted OR 5.7 95% CI (3.0 - 10.8), p < 0.001), as compared to those patients without kidney disease. Similarly, the higher age of patients between 51 and 65 years, significantly decreased the odds for survival (Crude OR 14.1 95% CI (3.4-58.4), p < 0.001) and (Adjusted OR 12.3 95% CI (2.9 - 52.4), p < 0.001). Patient age beyond 66 years, further significantly decreased the odds for survival (Crude OR 36.1 95% CI (8.5-154.1), p < 0.001), and (Adjusted OR 26.6 95% CI (5.7 - 123.8), p < 0.001). CONCLUSION: Our study indicates that older ages above 51 years and kidney disease increased mortality significantly in COVID-19 patients. Ethnicity was not significantly associated with mortality in the UAE population. Our findings are important in the management of the COVID-19 disease in the region with similar economic, social, cultural, and ethnic backgrounds.

Covid-19 pandemic research opportunity: Is the Middle East & North Africa (MENA) missing out?

BACKGROUND: The Covid-19 pandemic has caused fear and panic worldwide, forcing healthcare systems to disregard conventional practices and adopt innovation to contain the infection and death. Globally, there has been a rapid proliferation of research studies and clinical trials assessing risks, infectivity and treatment. METHODS: This review assesses the opportunities and challenges in the Middle East North Africa (MENA) region to engage in the conduct of high quality clinical trials during the Covid-19 pandemic. RESULTS: Opportunities are abundant for conducting clinical trials in MENA countries, including substantial cost savings, academic health centers, integrated health information systems, international accreditation, and international collaborations. Yet, the MENA region has missed out on opportunities to advance patient research during prior infectious disease outbreaks caused by the Severe Acute Respiratory Syndrome, Ebola, and the Middle East Respiratory Syndrome, as evidenced by the lack of concerted research and clinical trials from the region. A large vulnerable population, especially the poor expatriate work force, the current isolation of the health centers, and the lack of an expert network or field trained task force, all contribute to challenges preventing the formation of a pan Arab research enterprise for epidemics. CONCLUSION: Quality clinical research is critical during public health emergencies to identify treatments and solutions. The efficient conduct of clinical trials requires innovative strategies in research design, approval, and dissemination. Many countries in the MENA region have an opportunity to quickly ramp up research capacity and contribute significantly to the fight against the Covid-19 global threat.

Should I stay or should I go now? The impact of "pull" factors on physician decisions to remain in a destination country.

BACKGROUND: The recruitment and retention of a competent health care workforce is a worldwide problem. Globalization and increased mobility have provided skilled clinicians the freedom to offer their services in an interconnected global employment market, with multiple studies revealing a pattern of migration from low- and middle-income countries to high-income countries in North America, Western Europe, and more recently, the Middle East. The purpose of this study is to review the United Arab Emirates health care man power strategy and to assess the impact of pull factors on physician retention plans. METHODS: The study employed a mixed-method comparative approach, comprising a comprehensive review of the literature on human resources for health issues and physician migration patterns, along with a cross sectional survey of expatriate physicians working in private and public sectors in the United Arab Emirates (UAE) between November 2018 and March 2019. RESULTS: Of 479 physicians, 374 participated (79% response rate). Issues related to family and social life encouraged remaining in the UAE, including close proximity to extended family, social environment, and spouse's employment opportunities. The government's new policy to provide 10-year visas to health professionals was perceived as an important factor encouraging retention. Only 35% of respondents felt that their income was an important factor in deciding to remain in the UAE. Significant gender differences exist in physician migration decisions. CONCLUSION: Factors influencing retention of the UAE's expatriate physician workforce are primarily lifestyle-related. Physicians also report positive perceptions of newly implemented visa policies.

Developing a clinical trial governance framework for pharmaceutical industry-funded clinical trials.

Rising concerns relating to pharmaceutical sponsor bias in the conduct of clinical trials have compelled the need to develop a clinical trial governance framework. This article describes the development of the Conflict of Interest in Research (COIR), a clinical trial governance framework. The COIR, consisting of three process phases (initiation, concurrent, and ongoing), developed following a needs assessment, using a four-stage methodology, and evaluated against the International Conference on Harmonization--Good Clinical Practice (ICH-GCP) guidelines. The Conflict of Interest Resolution algorithm, the backbone of COIR, enables constant surveillance to detect/resolve conflicts at all stages of the clinical trial life-cycle. COIR promotes interaction between the regulatory system and the sponsors, independent of individuals. COIR enables rapid detection of scientific and financial conflicts, to prevent subject harm and, to assure optimal funds utilization, the latter feature helped to reduce a significant burden for the ethics committee, as it lacks financial expertise. COIR is a semi-automated Oracle system, requires manpower, and is affected by human expertise and subjectivity. Complete automation to overcome this limitation will still need human expertise to scale changing trial regulations. Nevertheless, the COIR has won the distinction of the "most favored site" from pharmaceutical sponsors and is anticipated to be adopted by other clinical trial sites.

Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.

Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

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.

Assessing health literacy in the eastern and middle-eastern cultures.

BACKGROUND: Health 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. METHODS: By 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. RESULTS: Inclusion 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). CONCLUSION: The 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.

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.

Comparison of the use of silastic with titanium prefabricated implant in type I thyroplasty.

INTRODUCTION: Type I thyroplasty is the treatment of choice for unilateral vocal cord palsy with no spontaneous recovery. OBJECTIVES: To compare the use of silastic implant with titanium vocal fold medializing implant (TVFMI®) in type I thyroplasty for unilateral vocal cord palsy with respect to subjective and objective improvement in voice, endoscopic changes in vocal cords, surgical time, and cost effectiveness. METHODOLOGY: This was a prospective study conducted on 40 patients with unilateral vocal cord paralysis who underwent type I thyroplasty with either silastic implant or TVFMI®. Pre-operative and four-week post-operative assessment and statistical comparison were performed by videolaryngoscopy, stroboscopy, perceptual assessment (GRBAS), subjective (voice handicap index) analysis of voice, and computer-assisted acoustic and electroglottographic assessment. The duration of surgery and cost of implant were also recorded. RESULTS: Although both implants showed improvement in quality of voice following thyroplasty, TVFMI® presents slightly better results in objective voice analysis. The surgery time for TVFMI®insertion was shorter, but the costs were higher. CONCLUSION: TVFMI® may be preferred for medialization thyroplasty as it presents better voice results and demands less surgical time; however, it is costlier than silastic implant.

Comparação do uso de implante de Silastic(r) com titânio pré-fabricado na tireoplastia tipo I / Comparison of the use of silastic with titanium prefabricated implant in type I thyroplasty

Introdução: A tireoplastia tipo I é o tratamento de escolha nas paralisias unilaterais das pregas Análise de custo-bene-vocais que não se recuperam espontaneamente. fício. Objetivos: Comparar o uso de implante de Silastic® com o uso de titânio pré-fabricado TVFMI® (Titanium Vocal Fold Medializing Implant) na tireoplastia tipo I para o tratamento da paralisia unilateral das pregas vocais com relação à melhora subjetiva e objetiva da voz, às alterações endoscópicas nas pregas vocais, ao tempo de cirurgia e à relação custo-benefício. Método: Trata-se de um estudo prospectivo com 40 pacientes portadores de paralisia unilateral das pregas vocais submetidos à tireoplastia tipo I com implante de silastic® ou TVFMI®. A avaliação e comparação estatística foram realizadas antes e quatro semanas depois da cirurgia por meio de videolaringoscopia, estroboscopia, análise perceptiva (escala GRBAS-Grade, Roughness, Breathiness, Asthenia, Strain) e subjetiva (IDV-índice de desvantagem vocal) da voz e avaliação eletroglotográfica e avaliação acústica computadorizada. Também foram observados o tempo de cirurgia e o custo do implante. Resultados: Embora os dois implantes mostrem melhora na qualidade da voz após a tireoplastia, o TVFMI® teve um resultado ligeiramente melhor na análise objetiva da voz. O TVFMI® levou menos tempo de cirurgia para ser inserido, porém foi mais caro. Conclusão: O TVFMI® poderá ser preferencial na tireoplastia de medialização, já que possui melhores resultados vocais e leva menos tempo de cirurgia, porém é mais caro que o implante de Silastic®. .

Introduction: Type I thyroplasty is the treatment of choice for unilateral vocal cord palsy with no spontaneous recovery. Objectives: To compare the use of silastic implant with titanium vocal fold medializing implant (TVFMI®) in type I thyroplasty for unilateral vocal cord palsy with respect to subjective and objective improvement in voice, endoscopic changes in vocal cords, surgical time, and cost effectiveness. Methodology: This was a prospective study conducted on 40 patients with unilateral vocal cord paralysis who underwent type I thyroplasty with either silastic implant or TVFMI®. Pre-operative and four-week post-operative assessment and statistical comparison were performed by videolaryngoscopy, stroboscopy, perceptual assessment (GRBAS), subjective (voice handicap index) analysis of voice, and computer-assisted acoustic and electroglottographic assessment. The duration of surgery and cost of implant were also recorded. Results: Although both implants showed improvement in quality of voice following thyroplasty, TVFMI® presents slightly better results in objective voice analysis. The surgery time for TVFMI®insertion was shorter, but the costs were higher. Conclusion: TVFMI® may be preferred for medialization thyroplasty as it presents better voice results and demands less surgical time; however, it is costlier than silastic implant. .

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

BACKGROUND: Nearly 31% of the world's 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.