GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF) compliance with Good Clinical Practice (GCP) guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants′ rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE

Assessing health literacy in the eastern and middle-eastern cultures

Abstract 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

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

Estimation of health literacy levels in patients with cardiovascular diseases in a Gulf country

Abstract Introduction Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide. In the United Arab Emirates (UAE), the prevalence of deaths associated with CVD is higher than the global average, and the incidence of premature coronary heart disease is 10–15 years earlier than in Western nations. In patients with CVD, inadequate health literacy (HL) is significantly associated with poor health outcomes. The goal of this study is to assess HL levels among patients with CVD in the UAE to develop effective health system strategies for disease prevention and management. Methods A nationwide cross-sectional survey to assess HL levels in patients with CVD was conducted between January 2019 and May 2020 in the UAE. The association between health literacy level with patient age, gender, nationality, and education was determined using the Chi-Square test. The significant variables were further analyzed by ordinal regression. Results Of 336 participants (86.5% response rate), approximately half 51.5% (173/336) of the respondents were women, and 46% (146/336) of them attained high school level of education. More than 75% (268/336) of the participants were above the age of 50 years. Overall, 39.3% (132/336) of respondents possessed inadequate HL, and 46.4% (156/336) and 14.3% (48/336) demonstrated marginal and adequate HL, respectively. Inadequate health literacy was more prevalent among women, as compared to men. Age was significantly associated with HL levels. Participants under age 50 had higher adequate HL levels 45.6% (31/68), (95% CI (3.8–57.4), P < 0.001). There was no correlation between education and health literacy levels. Conclusion The inadequate HL levels found in outpatients with CVD is a major health concern in the UAE. To improve population health outcomes, health system interventions, including targeted educational and behavioral programs for the older population are necessary

Addressing research barriers and facilitators in medical residency

Objective: To develop and implement an instrument to identify contributing factors and obstacles to resident research participation. Materials and Methods: Clinical Research Excellence Development in Innovation and Technology (CREDIT-20), a 20-point questionnaire, was developed through a four-stage methodology to measure opportunities and challenges to enhance participation of medical residents in research. The study was distributed to all medical residents at three Joint Commission–accredited academic medical centers in the emirate of Abu Dhabi between March 2017 and July 2018. Participant responses were analyzed and represented as mean ± standard error of mean, and subgroup analysis was conducted using Fisher's exact test. Results: In all, 314 of 380 residents completed the survey (83% response rate). Resident interest in research was high, with the majority of trainees responding that research will enhance their critical thinking (93%) and add to their knowledge of medicine (92%). Lack of protected time and lack of research methodology training were the most significant barriers. Over half of the residents cited the lack of a dedicated research budget as a program organization challenge. Age significantly correlated with resident perceptions of the benefits for conducting research, with trainees age 27 years or less indicating that they would be more likely to benefit from conducting research than their older counterparts (164 vs 128, P < 0.05). Conclusion: Improving research methodology training and dedicating structured-protected time for the scholarship are strategies to increase research output in international academic medical centers. The CREDIT-20 survey can identify specific barriers faced by trainees and assist medical educational leaders in implementing targeted interventions

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

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

Introduction. The purpose of this multicenter, prospective 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), privately, or transferred from other medical facilities.Methods. Our sample consisted of 455 patients admitted to 4 hospitals in “blinded for peer review.” 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 &lt; 0.001), door-to-balloon time (p &lt; 0.001), and health status at 6-month and 1-year follow-up (p &lt; 0.001). 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