Hospitalization Endpoint in Clinical Trials of Outpatient Settings: using Anti-SARS-COV-2 Therapy as an Example

Alhanouf Yousef Alnafisah,1 Ahmed Fawaz Alkhalidi,1 Hanin Aljohani,1 Manal Almutairi,1 Adel Alharf,2 Hadeel Alkofide3 1Efficacy and Safety Evaluation Department, Benefit and Risk Evaluation Directorate, Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia; 2Drug Sector, Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia; 3Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaCorrespondence: Ahmed Fawaz Alkhalidi, Efficacy and Safety Evaluation Department, Benefit and Risk Evaluation Directorate, SFDA, Riyadh, 5163, Saudi Arabia, Tel +966555546169, Email [email protected]: In response to the COVID-19 pandemic, the World Health Organization (WHO) developed a set of outcome measures for trials primarily aimed at hospitalised patients. However, a gap exists in defining outcome standards for non-hospitalised patients. Therefore, this study aims to discuss hospitalisation as a primary outcome in outpatient trials and its potential pitfalls, specifically focusing on trials related to anti-SARS-COV-2 therapy.Methods: In this narrative review, researchers thoroughly searched MEDLINE and ClinicalTrials.gov from January 2020 to December 2022, targeting Phase III randomized controlled trials involving outpatients with mild-to-moderate COVID-19. The trials were specifically related to anti-SARS-COV-2 monoclonal antibodies or antiviral agents. The study collected essential data, including the type of intervention, comparator, primary objective, primary endpoint, and the use of estimands in the trial.Results: The search identified 12 trials that evaluated the efficacy of anti-SARS COV-2 therapies in a predefined population. Three studies used hospitalisation and death as primary endpoints in high-risk patients receiving monoclonal antibodies. Nine studies assessed the efficacy of several antiviral agents: four trials used hospitalisation and death as the main endpoints, while others used different measures such as virologic measures using the Reverse Transcription-Polymerase Chain Reaction test (RT-PCR), the eight-point WHO ordinal scale, symptom alleviation by Day 7 and time to clinical response.Conclusion: Choosing hospitalization as an endpoint may provide meaningful data such as the cost-effectiveness ratio of a drug. However, different hospital utilisation patterns and investigator decisions could bias clinical outcomes if no specific criteria are considered. Therefore, investigators should have clear criteria for determining variables that influence this measure.Keywords: COVID-19, outcome measures, non-hospitalized patients, monoclonal antibodies, antiviral agent

Erratum to: 36th International Symposium on Intensive Care and Emergency Medicine

[This corrects the article DOI: 10.1186/s13054-016-1208-6.]

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Prevalence of severe moral distress among healthcare providers in Saudi Arabia

Adel F Almutairi,1 Mahmoud Salam,1 Abdallah A Adlan,2 Abdullah S Alturki3 1Science and Technology Unit, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard health affairs, Riyadh, Saudi Arabia; 2Bioethics Section, King Abdullah International Medical Research center, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; 3Research operations, King Abdullah International Medical Research center, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia Background: Moral distress is a serious problem in healthcare environments that requires urgent attention and management. It occurs when healthcare providers are unable to provide the care that they feel is right or take, what they believe to be, ethically appropriate actions for their patients. Thus, this study aims to examine moral distress among nurses and physicians working in tertiary teaching hospitals in Saudi Arabia, as well as to evaluate the level of association between moral distress and turnover. Methods: This cross-sectional study, which employed an anonymous 21-item Moral Distress Scale, was undertaken at a large medical institution located in different regions of Saudi Arabia. The data were analyzed using bi-variate analyses, and logistic regression. Results: Of the 342 participants, 239 (69.9%) were nurses/staff physicians and 103 (30.1%) were fellows/consultants. Approximately 24.3% of respondents experienced severe moral distress, whereas 75.7% reported mild moral distress. There was no statistically significant difference between men and women in terms of moral distress. Age was found to be a notable factor: moral distress was significantly higher in those younger than 37 years compared to those 37 years and older (P=0.015). Less than half of the participants (137, 42.8%) indicated their willingness to leave their jobs. A significant association was observed between severe moral distress and leaving the career (OR=3.16; P<0.01). Job category was also an important factor: nurses/staff physicians were almost two times more likely (OR =1.95, P=0.038) to leave their positions compared to fellows/consultants. Conclusion: This study revealed that moral distress, which is a serious problem that compromises the well-being of caregivers, was a predictive variable for the intention of healthcare providers to leave their jobs. Therefore, it should be routinely examined, and efficient action plans should be implemented to alleviate its consequences. Keywords: burnout, MDS-R, organizational support, nurses, physician

Attitudes toward mental illness, mentally ill persons, and help-seeking among the Saudi public and sociodemographic correlates

Mostafa A Abolfotouh,1 Adel F Almutairi,2 Zainab Almutairi,3 Mahmoud Salam,2 Anwar Alhashem,1 Abdallah A Adlan,4 Omar Modayfer5 1Research Training and Development Section, King Abdullah International Medical Research Center/ King Saud bin-Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 2Science and Technology Unit, King Abdullah International Medical Research Center/ King Saud bin-Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 3Stem Cells Donor Registry, King Abdullah International Medical Research Center/ King Saud bin-Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 4Bioethics Section, King Abdullah International Medical Research Center/ King Saud bin-Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 5Division of Mental Health, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia Background: It has been reported that the majority of individuals with mental illnesses (MIs) do not seek help. Few studies have focused on correlates of a positive attitude toward professional help-seeking for MI. This study aimed to determine levels of knowledge, perception, and attitudes toward MI, determine attitudes toward mental health help-seeking, and identify sociodemographic predictors of correct knowledge and favorable attitudes among the Saudi public. Methods: A cross-sectional survey was conducted on 650 Saudi adults aged >18 years who attended the Saudi Jenadriyah annual cultural and heritage festival during February 2016. The previously validated Attitudes to Mental Illness Questionnaire was used. Attitude to professional help-seeking was also assessed, using a tool retrieved from the World Mental Health Composite International Diagnostic Interview part II. Multiple regression analyses were applied, and statistical significance considered at P<0.05. Results: The majority of the Saudi public reported lack of knowledge about the nature of MI (87.5%, percentage mean score [PMS] 45.02±19.98), negative perception (59%, PMS 59.76±9.16), negative attitudes to MI (66.5%, PMS 65.86±7.77), and negative attitudes to professional help-seeking (54.5%, PMS 62.45±8.54). Marital status was a predictor of knowledge (t=–3.12, P=0.002), attitudes to MI (t=2.93, P=0.003), and attitudes to help-seeking (t=2.20, P=0.03). Attitudes to help-seeking were also predicted by sex (t=–2.72, P=0.007), employment (t=3.05, P=0.002), and monthly income (t=2.79, P=0.005). Perceptions toward the mentally ill were not predicted by these socioeconomic characteristics (P>0.05). Conclusion: The Saudi public reported lack of knowledge of MI and stigmatizing attitudes toward people with MI in relation to treatment, work, marriage, and recovery and toward professional help-seeking. Sociodemographic characteristics predicted correct knowledge and favorable attitudes, while Saudi culture was the likely factor behind negative judgments about mentally ill persons. Efforts to challenge this negative publicity and stigma through antistigma campaigns and public education through schools and media are recommended. Keywords: psychiatric illness, discrimination, people with mental illness, PWMI, stigma, antistigma, negative publicity, judgment of mental issues, professional help-seeking, social distanc

Relationship between early menarche, obesity, and disordered eating behaviors: a school-based cross-sectional survey in Northern Saudi Arabia

Mashael Almuhlafi,1 Khalil Abu Jamilah,1 Adel F Almutairi,2 Mahmoud Salam2 1Department of Family Medicine, North West Armed Forces Hospital, Tabuk, Saudi Arabia; 2Science and Technology Unit, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia Background: Obesity and disordered eating (DE) behaviors are serious health concerns, regularly observed among female adolescents, which could progress to adverse psychological and nutritional sequels. Aim: The aim of this study was to determine the prevalence of obesity and the self-reported DE behaviors among high school female students and to evaluate their self-perception of body image, peer pressures, and need for dietary consultation. Methods: This is a school-based cross-sectional study conducted in 2018. Self-administered surveys and anthropometric measurements were obtained from adolescent females, randomly selected from eight schools in northern Saudi Arabia. Sample characteristics were age, menarche, and DE behaviors (binge eating, self-induced vomiting, and usage of laxatives). Body mass index was converted to percentiles using the age-to-gender scale. Self-perception of body image, perceived peer pressures, and the Eating Attitude Test-26 (EAT-26) were scored, summated, and then presented in percentage mean scores (PMSs) and mean scores (MSs). Results: Sample comprised 399 participants. One hundred twenty-eight (32.1%) participants reported early age of menarche (≤12 years). Sixty-five (16.3%) participants reported the prevalence of overweight/obesity, 123 (30.8%) participants reported binge eating, 28 (7.0%) participants reported self-induced vomiting, and 21 (5.3%) participants reported usage of laxatives. The PMS of self-perception of body weight and peer pressure was 68.7±27.1 and 41.9±23.5, respectively. One hundred ninety-two (48.1%) participants needed professional dietary help. Students with early age of menarche were 1.7 times more likely to be overweight/obese (adjusted [adj] P=0.018) compared to others. Overweight/obese participants had significantly poorer self-perception of body image (PMS =47.4±25.0) and higher perceived peer pressure (PMS =49.5±23.1) compared to underweight/normal weight students (PMS =72.8±25.6 [P<0.001] and PMS =40.5±23.3 [P=0.005], respectively). Participants with early age of menarche complained of higher perceived peer pressure compared to others (P=0.045). Participants with DE behaviors had higher peer pressure (PMS =46.8±23.5) and higher scores on E-26 (MS =22.2±11.4) compared to their counter groups (P=0.002 and 0.016, respectively). Conclusion: The high rate of overweight/obesity and DE behaviors among female adolescents is alarming. Special consideration should be made for those with early menarche who were more prone to overweight/obesity. Keywords: adolescent, peer, E-26, body image, binge, self-induced vomitin

The public’s risk perception of blood transfusion in Saudi Arabia

Adel F Almutairi, Mahmoud Salam, Oraynab Abou Abbas, Maliha Nasim, Abdallah A Adlan King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia Background: Human beings may face many circumstances, such as surgery, trauma, and ­anemia, in which they could require an urgent blood transfusion. However, only a few ­studies have examined people’s risk perception of blood transfusion. Therefore, this study aims to evaluate the public’s risk perception of blood transfusion in Saudi Arabia, and to identify factors associated with their risk perception.Methods: Self-reported questionnaires on blood transfusion risk perception were distributed to the public during a Saudi national festival in Riyadh. Data were analyzed using mean, SD, Student’s t-test, and linear regression.Results: The overall percentage mean score±SD of risk perception was 59.8±16.1. Male participants were significantly more likely to perceive blood transfusion negatively, both in terms of the dread/severity domain (β=−0.23, p=0.003) and their overall risk perception score (β=−0.17, p=0.028). Older participants were considerably more likely to have a more negative perception (β=0.12, p=0.041) of the benefits of blood transfusion compared with younger participants. Study participants who received blood in the past had a significantly better perception (β=−0.13, p=0.029) of the benefits of transfusion. Additionally, participants who had previously donated blood had a considerably more positive perception in the dread/severity domain (β=−0.18, p=0.017) and their overall score (β=−0.15, p=0.045).Conclusion: Saudi males are more likely to perceive blood transfusion as a high-risk procedure. Similarly, older Saudis will probably have a more negative perception of the benefits of blood transfusion. Previous recipients and donors will likely have a better perception of the benefits of blood transfusion and a more positive overall risk perception. Keywords: blood transfusion, perception, risk, knowledge, benefit, Saud

Impact of help-seeking behavior and partner support on postpartum depression among Saudi women

Adel F Almutairi,1,2 Mahmoud Salam,1,2 Samiyah Alanazi,1 Manal Alweldawi,1 Najad Alsomali,1 Najla Alotaibi1 1King Saud Bin Abdulaziz University of Health Sciences, 2Science and Technology Unit, King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia Background: Many studies have discovered a number of factors that can contribute to the risk of developing postpartum depression (PPD), including, but not limited to, life stressors, lack of social support, low economic status, and quality of the marital relationship. However, these studies were conducted in various countries with participants from different cultural backgrounds.Purpose: This study aimed to examine the impact of general help-seeking behavior (GHSB) and partner support (PS) on PPD among Saudi women in primary health care clinics in Riyadh city.Methods: Data were collected by using self-administered measures of the Edinburgh Postnatal Depression Scale (EPDS), General Help-Seeking Questionnaire (GHSQ), and Partner Support Scale (PSS). Frequency distribution was used to analyze the categorical data, and Student’s t-test and one-way analysis of variance were employed to compare the numerical data. Linear regression analysis was used to control for all confounders.Results: The findings showed that 9% and 28% of women had good and poor GHSB, respectively, 16% had poor PS, and 25.7% could be classified as probably depressed. Negative relationships between GHSB versus PPD and PS versus PPD were observed. Adjusting by mode of delivery and controlling for confounders in linear regression showed that women who underwent normal vaginal delivery, with higher para rates (β=0.250, t=2.063) and lower PS scores (β=-0.238, t=-2.038), were more likely to suffer higher depression scores (adj P=0.043 and adj P=0.045, respectively). Women who underwent cesarean-section, with postpartum duration ≥6 weeks (β=0.374, t=2.082), were more likely to suffer higher depression scores (adj P=0.045) compared to those with <6 weeks of postpartum duration.Conclusion: The prevalence of PPD among the study participants was high, especially among higher para women who underwent normal delivery and women ≥6 weeks post cesarean-section, in comparison with the results in other studies. PPD is reduced by enhancing women’s GHSB and PS. Keywords: postpartum depression, partner support, help-seeking, women, Saudi Arabi

Prevalence and outcomes of Guillain-Barré syndrome among pediatrics in Saudi Arabia: a 10-year retrospective study

Safiyyah Asiri,1 Waleed A Altwaijri,1,2 Duaa Ba-Armah,1 Ahmed Al Rumayyan,1,2 Muhammad T Alrifai,1,2 Mahmoud Salam,3 Adel F Almutairi3 1Pediatric Neurology, Pediatric Department, King Abdullah Specialist Children’s Hospital, Ministry of National Guard-Health Affairs (MNGHA), Riyadh, Saudi Arabia; 2College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 3Science and Technology Unit, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia Background: Guillain-Barré syndrome (GBS) is a progressive acute form of paralysis most probably secondary to an immune-mediated process. GBS among Saudis has been seldom investigated, which leaves both clinicians and researchers with scarcity in knowledge. Therefore, this study aims to assess the prevalence and clinical prognosis of GBS among pediatrics admitted with acute paralysis at a large healthcare facility in Riyadh, Saudi Arabia. Methods: This retrospective study reviewed patients’ medical records between 2005 and 2015. Eligible cases were children (<14 years old) admitted to the hospital complaining of acute paralysis and later diagnosed with one form or variant of GBS. Pearson’s chi-square, Fisher’s exact test, and binary logistic regression were employed to analyze the collected data. Results: The prevalence of GBS was 49%. The male-to-female ratio was 1.45:1. The mean ± standard deviation age was 7±3.7 years. There were 34 (69.4%) cases with progression to maximum paralysis in ≤2 weeks, while 15 (30.6%) cases occurred beyond 2 weeks. Males (n=24, 82.8%) were more likely to endure progression to maximum paralysis in ≤2 weeks after the disease onset, compared to females (n=10, 50%), P=0.014. All cases complaining of respiratory problems exhibited a progression to maximum paralysis in ≤2 weeks, compared to those with no respiratory problems, P=0.027. Residual paralysis at 60 days post disease onset was highly associated with GBS patients of age 8–14 years (n=15, 65.2%), compared to younger patients (n=8, 30.8%), P=0.016. Patients admitted in colder seasons (n=14, 63.6%) were more likely to suffer residual paralysis too, compared to those in warmer seasons (n=9, 33.3%), P=0.035. GBS cases who complained of facial weakness (n=9, 75%) and ocular abnormalities (n=10, 71.4%) were also more likely to endure residual paralysis at 60 days post disease onset, P=0.025 and P=0.03, respectively. Conclusion: Male gender could be a determinant of rapid progression to maximum paralysis, while the older age group in pediatrics is expected to endure residual paralysis at 60 days post disease onset. GBS can be accounted as a rare disease, especially in pediatrics, so confirmed cases should be investigated comprehensively for research purposes. Keywords: GBS, factors, prognosis, residual, paralysis, neur