Impact of COVID-19 pandemic on care of maintenance hemodialysis patients: a multicenter study.

BACKGROUND: The COVID-19 pandemic posed a challenge to hemodialysis (HD) patients. While most outpatient and elective medical services stopped during lockdown, HD patients continued to visit their dialysis centers. We aimed to assess how the initial phase of the pandemic affected patient care by comparing dialysis adequacy and other parameters of patient care before and during the first 10 months of the COVID-19 pandemic. METHODS: In a retrospective multi-center observational study, all adult dialysis patients in five dialysis centers in Alexandria, Egypt were included. Dialysis adequacy, missed sessions, laboratory parameters and hospitalization were recorded. Data of the 10 months before and the 10 months after the pandemic were compared and predictors of adequacy were determined. RESULTS: In the 388 HD patients included in the study, the number of missed sessions was higher during the pandemic with peaks during the first and second wave of the pandemic. The ratio of patients to nurses, phosphorus and parathormone levels were significantly higher during the pandemic, while urea reduction ratio, Kt/V, hemoglobin, calcium and albumin levels were significantly lower. In patients who reported difficult accessibility, missed HD sessions were higher during lockdown. Hospital admissions doubled during the pandemic, with COVID-19 infection being the main cause (45.5%). Number of patients per nurse and interdialytic weight gain were predictors of inadequate dialysis. CONCLUSION: The COVID-19 pandemic and its related lockdown negatively affected multiple aspects of dialysis patient care. Continued access of optimum care in dialysis patients should be a priority in any future mass events.

The ERA Registry Annual Report 2021: a summary.

Background: The European Renal Association (ERA) Registry collects data on kidney replacement therapy (KRT) in patients with end-stage kidney disease (ESKD). This paper is a summary of the ERA Registry Annual Report 2021, including a comparison across treatment modalities. Methods: Data was collected from 54 national and regional registries from 36 countries, of which 35 registries from 18 countries contributed individual patient data and 19 registries from 19 countries contributed aggregated data. Using this data, incidence and prevalence of KRT, kidney transplantation rates, survival probabilities and expected remaining lifetimes were calculated. Result: In 2021, 533.2 million people in the general population were covered by the ERA Registry. The incidence of KRT was 145 per million population (pmp). In incident patients, 55% were 65 years or older, 64% were male, and the most common primary renal disease (PRD) was diabetes (22%). The prevalence of KRT was 1040 pmp. In prevalent patients, 47% were 65 years or older, 62% were male, and the most common PRDs were diabetes and glomerulonephritis/sclerosis (both 16%). On 31 December 2021, 56% of patients received haemodialysis, 5% received peritoneal dialysis, and 39% were living with a functioning graft. The kidney transplantation rate in 2021 was 37 pmp, a majority coming from deceased donors (66%). For patients initiating KRT between 2012-2016, 5-year survival probability was 52%. Compared to the general population, life expectancy was 65% and 68% shorter for males and females receiving dialysis, and 40% and 43% shorter for males and females living with a functioning graft.

Researchers' Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region.

Background: The recent expansion of genomic biobank research in the Arab region in the Middle East North Africa has raised complex ethical and regulatory issues. However, there is a lack of studies regarding the views of Arab researchers involved in such research. We aimed to assess the perceptions and attitudes of Arab researchers regarding these issues in biobank research. Methods: We developed a questionnaire to assess the perceptions and attitudes regarding genetic research of researchers from Egypt, Sudan, Morocco, and Jordan. The questionnaire requested demographic data, perceptions, and attitudes regarding the collection, storage, and use of biospecimens and data, the use of broad consent, data security, data sharing, and community engagement. We used multiple linear regressions to identify predictors of perceptions and attitudes. Results: We recruited 383 researchers. Researchers favored equally the use of broad and tiered consent (44.1% and 39.1%, respectively). Most respondents agreed with the importance of confidentiality protections to ensure data security (91.8%). However, lower percentages were seen regarding the importance of community engagement (64.5%), data sharing with national colleagues and international partners (60.9% and 41.1%, respectively), and biospecimen sharing with national colleagues and international partners (59.9% and 36.2%, respectively). Investigators were evenly split on whether the return of individual research results should depend on the availability or not of a medical intervention that can be offered to address the genetic anomaly (47.5% and 46.4%, respectively). Predictors of attitudes toward biospecimen research included serving on Research Ethics Committees, prior research ethics training, and affiliation with nonacademic institutions. Conclusions: We recommend further exploratory research with researchers regarding the importance of community engagement and to address their concerns about data sharing, with researchers within and outside their countries.

The ERA Registry Annual Report 2020: a summary.

Background: The European Renal Association (ERA) Registry collects data on kidney replacement therapy (KRT) in patients with ESKD. This paper is a summary of the ERA Registry Annual Report 2020, also including comparisons among primary renal disease (PRD) groups. Methods: Data were collected from 52 national and regional registries from 34 European countries and countries bordering the Mediterranean Sea: 35 registries from 18 countries providing individual level data and 17 registries from 17 countries providing aggregated data. Using this data, KRT incidence and prevalence, kidney transplantation rates, expected remaining lifetimes and survival probabilities were calculated. Results: A general population of 654.9 million people was covered by the ERA Registry in 2020. The overall incidence of KRT was 128 per million population (p.m.p.). In incident KRT patients, 54% were older than 65 years, 63% were men and the most common PRD was diabetes mellitus (21%). Regarding initial treatment modality in incident patients, 85% received haemodialysis (HD), 11% received peritoneal dialysis (PD) and 4% received a pre-emptive kidney transplant. On 31 December 2020, the prevalence of KRT was 931 p.m.p. In prevalent patients, 45% were older than 65 years, 60% were men and glomerulonephritis was the most common PRD (18%). Of these patients, 58% were on HD, 5% on PD and 37% were living with a kidney transplant. The overall kidney transplantation rate in 2020 was 28 p.m.p., with a majority of kidney grafts from deceased donors (71%). The unadjusted 5-year survival, based on incident dialysis patient from 2011-15, was 41.8%. For patients having received a deceased donor transplant, the unadjusted 5-year survival probability was 86.2% and for patients having received a living donor transplant it was 94.4%. When comparing data by PRD group, differences were found regarding the distribution of age groups, sex and treatment modality received.

Assessing disparities in medical students' knowledge and attitude about monkeypox: a cross-sectional study of 27 countries across three continents.

Background and aims: The recent monkeypox (Mpox) outbreak confirmed by the World Health Organization (WHO) underscores the importance of evaluating the knowledge and attitude of medical students toward emerging diseases, given their potential roles as healthcare professionals and sources of public information during outbreaks. This study aimed to assess medical students' knowledge and attitude about Mpox and to identify factors affecting their level of knowledge and attitude in low-income and high-income countries. Methods: A cross-sectional study was conducted on 11,919 medical students from 27 countries. A newly-developed validated questionnaire was used to collect data on knowledge (14 items), attitude (12 items), and baseline criteria. The relationship between a range of factors with knowledge and attitude was studied using univariate and multivariate analyses. Results: 46% of the study participants were males; 10.7% were in their sixth year; 54.6% knew about smallpox; 84% received the coronavirus disease 2019 (COVID-19) vaccine; and 12.5% had training on Mpox. 55.3% had good knowledge of Mpox and 51.7% had a positive attitude towards it. Medical students in their third, fifth, or sixth year high- income countries who obtained information on Mpox from friends, research articles, social media and scientific websites were positive predictors for good knowledge. Conversely, being male or coming from high-income countries showed a negative relation with good knowledge about Mpox. Additionally, a positive attitude was directly influenced by residing in urban areas, being in the fifth year of medical education, having knowledge about smallpox and a history of receiving the coronavirus disease 2019 (COVID-19) vaccine. Receiving information about Mpox from social media or scientific websites and possessing good knowledge about Mpox were also predictors of a positive attitude. On the other hand, being male, employed, or receiving a training program about Mpox were inversely predicting positive attitude about Mpox. Conclusion: There were differences in knowledge and attitude towards Mpox between medical students in low and high-income countries, emphasizing the need for incorporating epidemiology of re-emerging diseases like Mpox into the medical curriculum to improve disease prevention and control.

Corrigendum: Factors influencing participation in COVID-19 clinical trials: a multinational study.

[This corrects the article DOI: 10.3389/fmed.2021.608959.].

Psychological Antecedents of Healthcare Workers towards Monkeypox Vaccination in Nigeria.

The ongoing monkeypox (MPX) outbreak has been declared a public health emergency of international concern. People in close contact with active MPX cases, including healthcare workers (HCWs), are at higher risk of virus acquisition since the MPX virus can be transmitted by skin contact or respiratory secretions. In this study, we aimed to assess the psychological antecedents of MPX vaccination among Nigerian HCWs using the 5C scale. We used an anonymous online cross-sectional survey to recruit potential participants using snowball sampling. The questionnaire aimed to assess the geo/socioeconomic features and the 5C psychological antecedents of vaccine acceptance (confidence, complacency, constraints, calculation, and collective responsibility). A total of 389 responses were included, with a median age of 37 years (IQR: 28−48), 55.5% males, and 60.7% married participants. Among the studied Nigerian HCWs, only 31.1% showed confidence in MPX vaccination, 58.4% expressed complacency towards vaccination, 63.8% perceived constraints towards MPX vaccination, 27.2% calculated the benefits and risks of vaccination, and 39.2% agreed to receive MPX vaccination to protect others. The determinants of MPX vaccine confidence were being single (OR = 5.07, 95% CI: 1.26−20.34, p = 0.022), a higher education level (with pre-college/high school as a reference, professional/technical: OR = 4.12, 95% CI: 1.57−10.73, p = 0.004, undergraduate: OR = 2.94, 95% CI: 1.32−6.55, p = 0.008, and postgraduate degree (OR = 3.48, 95% CI: 1.51−8.04, p = 0.003), and absence of chronic disease (OR = 2.57, 95% CI: 1.27−5.22, p = 0.009). The significant complacency predictors were having a middle-income (OR = 0.53, 95% CI: 0.33−0.89, p = 0.008), having a bachelor's degree (OR = 2.37, 95% CI: 1.10−5.11, p = 0.027), and knowledge of someone who died due to MPX (OR = 0.20, 95% CI: 0.05−0.93, p = 0.040). Income was associated with perceived vaccination constraints (OR = 0.62, 95% CI: 0.39−0.99, p = 0.046). Participants aged 46−60 years had decreased odds in the calculation domain (OR = 0.52, 95% CI: 0.27−0.98, p = 0.044). Middle-income and bachelor degree/postgraduate education significantly influenced the collective responsibility domain (OR = 2.10, 95% CI: 1.19−3.69, p = 0.010; OR = 4.17, 95% CI: 1.85−9.38, p < 0.001; and OR = 3.45, 95% CI: 1.50−7.90, p = 0.003, respectively). An investigation of the 5C pattern-based psychological antecedents of MPX vaccination in a sample of Nigerian HCWs revealed low levels of vaccine confidence and collective responsibility with high levels of constraints and complacency. These psychological factors are recommended to be considered in any efforts aiming to promote MPX vaccination needed in a country where MPX is endemic.

Translation and cultural adaptation of the WHO generic tuberculosis patient cost survey to an Egyptian context.

Background: Tuberculosis (TB) represents a major health problem having serious financial impact on a substantial proportion of patients. This has necessitated the development of a valid tool for measuring TB-related expenditure by patients and their households so that appropriate measures can be taken to reduce the financial burden. Aims: To translate and culturally validate the generic WHO tuberculosis patient cost survey within the Egyptian context. Methods: The instrument was translated and culturally adapted using forward-translation, back-translation, expert panel assessment, pretesting, cognitive interviewing, and appraisal by the developer. Results: A final Arabic version with modifications to 35 descriptors of the original tool was produced after review by an expert committee and cognitive interviews with patients. Twelve questions were modified, 13 response options were changed, 6 questions were added, and 4 questions were removed. Pretesting of the tool ensured that the final version is culturally sensitive and fit for assessing the costs incurred by TB patients in an Egyptian context. Conclusion: Policymakers are encouraged to use the WHO tuberculosis patient cost survey tool for assessing the expenditure of TB patients with a view to developing appropriate policies to reduce the financial burden of patients.

Fundamentals and Applications of the Receiver Operating Characteristic Curve Analysis in the Research of Endothelial Dysfunction in Chronic Kidney Disease.

Endothelial dysfunction (ED) starts early in chronic kidney disease (CKD) and is the hallmark of atherosclerosis in these patients. During recent years, numerous markers have emerged, aiming to predict the onset of ED in CKD patients. Therefore, there is a need to evaluate and assess the discriminatory ability (or diagnostic accuracy) of such a marker (i.e., the ability to correctly classify individuals as having a given disease or not) and identify the optimal cut-off value. A receiver operating characteristic (ROC) curve analysis has been used in the majority of the research papers evaluating the predictive ability of a marker of ED. It is a graphical plot combining pairs of sensitivity (true positive rate) on the y axis and the complement of specificity (1-specificity, false positive rate) in the x axis, corresponding to several of the cut-off values covering the complete range of possible values that this test/marker might take. Herein, using a series of practical examples derived from clinical studies on ED in the special population of CKD, we address the principles, fundamentals, advantages and limitations regarding the interpretation of the ROC analysis.

Reliability and validation of an attitude scale regarding responsible conduct in research.

BACKGROUND: Several studies reveal a problematic prevalence of research misbehaviors. There are several potential causes of research misconduct but ensuring that scientists hold attitudes that reflect norms of acceptable behaviors is fundamental. AIM: Our aim was to evaluate the psychometric properties (factor structure and reliability) of an "attitude" scale that we adopted from a questionnaire we previously used to investigate the prevalence of research misbehaviors in the Middle East. METHODS: We used data from participants (n = 254) who were involved in our prior questionnaire study to determine the validity of an attitude scale that we adapted from this previous study. We performed exploratory factor analysis (EFA) to determine the factor structure of the attitude scale followed by measures of convergent and concurrent validity. We assessed reliability by computing the Cronbach's alphas of each construct of the attitude scale. RESULTS: EFA indicated that the attitude scale consists of two factors (constructs). Convergent validity was demonstrated by significant correlations of item-item and item-total. Correlation analysis revealed that the attitude constructs were significantly correlated with the Research Misbehavior Severity Score, thereby demonstrating concurrent validity. Cronbach's alphas were greater than 0.75 for both constructs. CONCLUSION: We demonstrated a valid and reliable 20-item attitude scale with two factors related to "acceptability of practices in responsible conduct in research" and "general attitudes regarding scientific misconduct". The use of a validated attitude scale can help assess the effectiveness of educational programs that focus on participants acquiring attitudes that are instrumental in responsible conduct in research.

A systematic review and meta-analysis of the catastrophic costs incurred by tuberculosis patients.

One of the strategies of the World Health Organization End Tuberculosis (TB) was to reduce the catastrophic costs incurred by TB-affected families to 0% by 2020.Catastrophic cost is defined by the total cost related to TB management exceeding 20% of the annual pre-TB household income. This study aimed to estimate the pooled proportion of TB affected households who incurred catastrophic costs. We searched PubMed, SciELO, Scopus, Embase, Google Scholar, ProQuest, SAGE, and Web of Science databases according to Preferred Reporting Items of the Systematic Reviews and Meta-Analysis (PRISMA) guidelines till November 20, 2020. Eligible studies were identified and data on catastrophic costs due to TB were extracted. We performed a meta-analysis to generate the pooled proportion of patients with TB facing catastrophic costs. From 5114 studies identified, 29 articles were included in the final analysis. The pooled proportion of patients faced catastrophic costs was (43%, 95% CI [34-51]). Meta-regression revealed that country, drug sensitivity, and Human immune-deficiency Virus (HIV) co-infection were the main predictors of such costs. Catastrophic costs incurred by drug sensitive, drug resistant, and HIV co-infection were 32%, 81%, and 81%, respectively. The catastrophic costs incurred were lower among active than passive case findings (12% vs. 30%). Half (50%) of TB-affected households faced catastrophic health expenditure at 10% cut-off point. The financial burden of patients seeking TB diagnosis and treatment continues to be a worldwide impediment. Therefore, the End TB approach should rely on socioeconomic support and cost-cutting initiatives.PROSPERO registration: CRD42020221283.

Methods to Analyze Time-to-Event Data: The Cox Regression Analysis.

The Cox model is a regression technique for performing survival analyses in epidemiological and clinical research. This model estimates the hazard ratio (HR) of a given endpoint associated with a specific risk factor, which can be either a continuous variable like age and C-reactive protein level or a categorical variable like gender and diabetes mellitus. When the risk factor is a continuous variable, the Cox model provides the HR of the study endpoint associated with a predefined unit of increase in the independent variable (e.g., for every 1-year increase in age, 2 mg/L increase in C-reactive protein). A fundamental assumption underlying the application of the Cox model is proportional hazards; in other words, the effects of different variables on survival are constant over time and additive over a particular scale. The Cox regression model, when applied to etiological studies, also allows an adjustment for potential confounders; in an exposure-outcome pathway, a confounder is a variable which is associated with the exposure, is not an effect of the exposure, does not lie in the causal pathway between the exposure and the outcome, and represents a risk factor for the outcome.

Methods to Analyse Time-to-Event Data: The Kaplan-Meier Survival Curve.

Studies performed in the field of oxidative medicine and cellular longevity frequently focus on the association between biomarkers of cellular and molecular mechanisms of oxidative stress as well as of aging, immune function, and vascular biology with specific time to event data, such as mortality and organ failure. Indeed, time-to-event analysis is one of the most important methodologies used in clinical and epidemiological research to address etiological and prognostic hypotheses. Survival data require adequate methods of analyses. Among these, the Kaplan-Meier analysis is the most used one in both observational and interventional studies. In this paper, we describe the mathematical background of this technique and the concept of censoring (right censoring, interval censoring, and left censoring) and report some examples demonstrating how to construct a Kaplan-Meier survival curve and how to apply this method to provide an answer to specific research questions.

Arabic validation and cross-cultural adaptation of the 5C scale for assessment of COVID-19 vaccines psychological antecedents.

BACKGROUND: In the Arab countries, there has not been yet a specific validated Arabic questionnaire that can assess the psychological antecedents of COVID-19 vaccine among the general population. This study, therefore, aimed to translate, culturally adapt, and validate the 5C scale into the Arabic language. METHODS: The 5C scale was translated into Arabic by two independent bilingual co-authors, and then translated back into English. After reconciling translation disparities, the final Arabic questionnaire was disseminated into four randomly selected Arabic countries (Egypt, Libya, United Arab Emirates (UAE), and Saudi Arabia). Data from 350 Arabic speaking adults (aged ≥18 years) were included in the final analysis. Internal consistency was assessed by Cronbach's alpha. Construct validity was determined by concurrent, convergent, discriminant, exploratory and confirmatory factor analyses. RESULTS: Age of participants ranged between 18 to 73 years; 57.14% were females, 37.43% from Egypt, 36.86%, from UAE, 30% were healthcare workers, and 42.8% had the intention to get COVID-19 vaccines. The 5 sub-scales of the questionnaire met the criterion of internal consistency (Cronbach's alpha ≥0.7). The predictors of intention to get COVID-19 vaccines (concurrent validity) were young age and the 5C sub-scales. Convergent validity was identified by the significant inter-item and item-mean score of the sub-scale correlation (P<0.001). Discriminant validity was reported as inter-factor correlation matrix (<0.7). Kaiser-Meyer-Olkin sampling adequacy measure was 0.80 and Bartlett's sphericity test was highly significant (P<0.001). Exploratory factor analysis indicated that the 15 items of the questionnaire could be summarized into five factors. Confirmatory factor analysis confirmed that the hypothesized five-factor model of the 15-item questionnaire was satisfied with adequate psychometric properties and fit with observed data (RMSEA = 0.060, GFI = 0.924, CFI = 0.957, TLI = 0.937, SRMR = 0.076 & NFI = 906). CONCLUSION: The Arabic version of the 5C scale is a valid and reliable tool to assess the psychological antecedents of COVID-19 vaccine among Arab population.

Development and Validation of a Biobank Questionnaire Intended for the Public in the Arab Region.

Background: Assessing the public perspectives regarding donation of biospecimens to biobanks would be helpful with the establishment of biobanks in the Arab region. Objective: To develop a biobanking questionnaire in Arabic and assess its psychometric properties. Design: Multicenter cross-sectional study. Methods: We used a two-step process for questionnaire development. First, we decided on the important constructs for a questionnaire followed by development of an item pool through review of the scientific literature and published questionnaires. The questionnaire was refined through cognitive interviews and translation. An expert panel assessed content validity. The final questionnaire included five domains: perceptions; aspects important to participation in biobank research; preferences for type of biobank; attitudes toward biobanking; and willingness to participate in biobank research. Second, we distributed the questionnaire to 250 members of the public from Egypt, Jordan, Sudan, and Morocco to assess the questionnaire's psychometric properties, including reliability (internal consistency and Cronbach's alpha) and construct validity (convergent and divergent validity and exploratory factor analysis [EFA]). Results: Internal consistency yielded a range of Cronbach's alpha for the five domains from 0.62 to 0.80. EFA showed a 12-factorial solution. Kaiser-Meyer-Olkin measure of sampling adequacy was 0.907 and Bartlett's test of sphericity was significant (p < 0.005). Attitudes were positively correlated with willingness to donate (r = 0.30; p < 0.001). Conclusions: The final biobank Arabic language questionnaire showed excellent reliability and acceptable validity parameters. The newly developed Arabic questionnaire is the first psychometrically tested tool that can be used in the Arab region to assess the public perspectives on participation in biobanking research.

Clinical triage of patients on kidney replacement therapy presenting with COVID-19: an ERACODA registry analysis.

BACKGROUND: Patients on kidney replacement therapy (KRT) are at very high risk of coronavirus disease 2019 (COVID-19). The triage pathway for KRT patients presenting to hospitals with varying severity of COVID-19 illness remains ill-defined. We studied the clinical characteristics of patients at initial and subsequent hospital presentations and the impact on patient outcomes. METHODS: The European Renal Association COVID-19 Database (ERACODA) was analysed for clinical and laboratory features of 1423 KRT patients with COVID-19 either hospitalized or non-hospitalized at initial triage and those re-presenting a second time. Predictors of outcomes (hospitalization, 28-day mortality) were then determined for all those not hospitalized at initial triage. RESULTS: Among 1423 KRT patients with COVID-19 [haemodialysis (HD), n = 1017; transplant, n = 406), 25% (n = 355) were not hospitalized at first presentation due to mild illness (30% HD, 13% transplant). Of the non-hospitalized patients, only 10% (n = 36) re-presented a second time, with a 5-day median interval between the two presentations (interquartile range 2-7 days). Patients who re-presented had worsening respiratory symptoms, a decrease in oxygen saturation (97% versus 90%) and an increase in C-reactive protein (26 versus 73 mg/L) and were older (72 vs 63 years) compared with those who did not return a second time. The 28-day mortality between early admission (at first presentation) and deferred admission (at second presentation) was not significantly different (29% versus 25%; P = 0.6). Older age, prior smoking history, higher clinical frailty score and self-reported shortness of breath at first presentation were identified as risk predictors of mortality when re-presenting after discharge at initial triage. CONCLUSIONS: This study provides evidence that KRT patients with COVID-19 and mild illness can be managed effectively with supported outpatient care and with vigilance of respiratory symptoms, especially in those with risk factors for poor outcomes. Our findings support a risk-stratified clinical approach to admissions and discharges of KRT patients presenting with COVID-19 to aid clinical triage and optimize resource utilization during the ongoing pandemic.

Determining the Cutoff Points of the 5C Scale for Assessment of COVID-19 Vaccines Psychological Antecedents among the Arab Population: A Multinational Study.

BACKGROUND: One of the newly faced challenges during the COVID-19 is vaccine hesitancy (VH). The validated 5C scale, that assesses 5 psychological antecedents of vaccination, could be effective in exploring COVID-19 VH. This study aimed to determine a statistically valid cutoff points for the 5C sub-scales among the Arab population. METHODS: A cross-sectional study was conducted among 446 subjects from 3 Arab countries (Egypt, United Arab Emirates (UAE), and Jordan). Information regarding sociodemographics, clinical history, COVID-19 infection and vaccination history, and 5C scale were collected online. The 5C scores were analyzed to define the cutoff points using the receiver operating characteristic curve (ROC) and to verify the capability of the questionnaire to differentiate whether responders are hesitant or non-hesitant to accept vaccination. ROC curve analysis was conducted for previous vaccine administration as a response, with the predictors being the main 5 domains of the 5C questionnaire. The mean score of each sub-scale was compared with COVID-19 vaccine intake. RESULTS: The mean age of the studied population was 37 ± 11, 42.9% were males, 44.8% from Egypt, 21.1% from Jordan, and 33.6% from the UAE. Statistically significant differences between vaccinated and unvaccinated participants, respectively, were detected in the median score of confidence [6.0(1.3) versus 4.7(2.0)], complacency [(2.7(2.0) versus 3.0(2.0)], constraints [1.7(1.7) versus 3.7(2.3)], and collective responsibility [6.7(1.7) versus 5.7(1.7)]. The area under the curve of the 5 scales was 0.72, 0.60, 0.76, 0.66, 0.66 for confidence, complacency, constraints, calculation, and collective responsibility at cutoff values of 5.7, 4.7, 6.0, 6.3, and 6.2, respectively. CONCLUSION: The Arabic validated version of the 5C scale has a good discriminatory power to predict COVID-19 vaccines antecedent.

Factors Influencing Participation in COVID-19 Clinical Trials: A Multi-National Study.

In 2020, the World Health Organization has characterized COVID-19, a disease caused by infection with the SARS-CoV-2 virus, as a pandemic. Although a few vaccines and drugs have been approved to, respectively, prevent or treat the disease, several clinical trials are still ongoing to test new vaccines or drugs to mitigate the burden of the pandemic. Few studies have shown the role of host genetics in disease prognosis and drug response highlighting the importance of diverse participation in COVID-19 clinical trials. The goal of this study is to assess public attitudes in Egypt, Saudi Arabia, and Jordan toward participating in COVID-19 clinical trials and to identify the factors that may influence their attitude. An online questionnaire was developed and distributed among the target group through social media platforms. The number of responses was 1,576. Three quarters (74.9%) of participants heard about clinical trials before, 57.6% of them had a positive attitude toward participation in COVID-19 clinical trials. The conduct of clinical trials in accordance with the scientific, research, and ethical guidelines was a strong predictor of willingness to participate in clinical trials. Other positive factors also included protection of family from COVID-19 and contributing to the return to normal community life as well as receiving additional healthcare benefit was the fourth significant predictor. On the other hand, the thought that clinical trials can have a negative impact on the health of participants strongly predicted the unwillingness of individuals to participate in such trials. This was followed by having limited information about the novel coronavirus and COVID-19 and the lack of trust in physicians and hospitals. In general, Arab citizens are accepting the concept and have a positive attitude toward COVID-19 clinical trials. Increasing awareness of COVID-19 and clinical trials, enforcing the concept of altruism, and placing clear policies in conducting clinical trials are needed to increase participation in clinical trials among Arabs.

Be careful with ecological associations.

Ecological studies are observational studies commonly used in public health research. The main characteristic of this study design is that the statistical analysis is based on pooled (i.e., aggregated) rather than on individual data. Thus, patient-level information such as age, gender, income and disease condition are not considered as individual characteristics but as mean values or frequencies, calculated at country or community level. Ecological studies can be used to compare the aggregated prevalence and incidence data of a given condition across different geographical areas, to assess time-related trends of the frequency of a pre-defined disease/condition, to identify factors explaining changes in health indicators over time in specific populations, to discriminate genetic from environmental causes of geographical variation in disease, or to investigate the relationship between a population-level exposure and a specific disease or condition. The major pitfall in ecological studies is the ecological fallacy, a bias which occurs when conclusions about individuals are erroneously deduced from results about the group to which those individuals belong. In this paper, by using a series of examples, we provide a general explanation of the ecological studies and provide some useful elements to recognize or suspect ecological fallacy in this type of studies.