OBJECTIVE: To summarise the protocol and statistical analysis plan for the Mega-ROX HIE trial.
DESIGN SETTING AND PARTICIPANTS: Mega-ROX HIE is an international randomised clinical trial that will be conducted within an overarching 40,000-participant registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We expect to enrol approximately 4000 participants with suspected HIE following a cardiac arrest who are receiving invasive mechanical ventilation in the ICU.
MAIN OUTCOME MEASURES: The primary outcome is in-hospital all-cause mortality up to 90 days from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and the proportion of participants discharged home.
RESULTS AND CONCLUSIONS: Mega-ROX HIE will compare the effect of conservative vs. liberal oxygen therapy regimens on day-90 in-hospital mortality in adults in the ICU with suspected HIE following a cardiac arrest. The protocol and planned analyses are reported here to mitigate analysis bias.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).
DESIGN: An online survey was conducted.
SETTING AND PARTICIPANTS: An online survey was distributed to intensive care doctors in sites participating in a large-scale international randomised clinical trial evaluating oxygen therapy targets in 15 countries and to additional intensive care clinicians from Canada.
MAIN OUTCOME MEASURES: Outcomes included the expressed level of support for a large pragmatic trial to evaluate minimum MAP targets in critically ill adults and stated current practice and acceptability of minimum MAP for specific scenarios.
RESULTS: The response rate to our survey for respondents who work in sites participating in the mega randomised registry trial research program was 265 out of 701 (37.8%), with an additional 56 out of 256 (21.8%) responses obtained from a direct email containing a link to the survey sent to intensive care clinicians in Canada. A total of 309 of 321 respondents (96.3%) were supportive, in principle, of conducting a very large pragmatic trial to evaluate MAP targets in intensive care unit patients receiving noradrenaline. The commonest response in all scenarios was to agree that the optimal minimum MAP target was uncertain. In all scenarios, except for active bleeding, the most common reported minimum MAP target was 65 mmHg; for patients who were actively bleeding, the most common reported target was 60 mmHg.
CONCLUSIONS: Our data suggest that intensive care clinicians are broadly supportive of a large-scale pragmatic minimum MAP targets in intensive care unit patients receiving noradrenaline.
OBJECTIVE: To evaluate the risk of EDs and its associated factors among medical students in the Middle East and North Africa (MENA) region.
METHODS: A web-based cross-sectional study was conducted among medical students in the MENA region during the months of June and July 2024. The primary data collection instrument was a comprehensive questionnaire that contained the Eating Attitudes Test (EAT-26) and sociodemographic and clinical features and designed using Google Forms and distributed via social media platforms.
RESULTS: The total number of participants was 5061. The mean age in our population was 22.58 ± 3.27. Our population's average EAT-26 score was 13.87 ± 10.7, with ranges varying from 0 to 72. Based on their EAT-26 scores being 20 or above, 1254 people (24.8%) were deemed to be at risk of EDs. Among the participants, 8% were underweight. The multivariable logistic regression model revealed several eating disorder risk factors such as T1DM, schizophrenia, autism, female gender, IBD, and daily exposure to thin body ideal. Regular sports practice and weight satisfaction were protective factors.
CONCLUSION: There exists a higher prevalence of individuals at risk for the development of EDs in the MENA region especially females, students with comorbidities, and those having conflictual relationships with their parents. Regular sports practice and weight satisfaction are protective factors.
METHODS: Muslim people with diabetes and CKD were surveyed in 13 countries shortly after the end of Ramadan 2020, using a simple Survey Monkey questionnaire.
RESULTS: This survey recruited 6736 people with diabetes, of which 707 (10.49%) had CKD. There were 118 (16.69%) people with type1 diabetes (T1D), and 589 (83.31%) were with type2 diabetes (T2D). 62 (65.24%) people with T1D and 448 (76.06%) people with T2D had fasted with CKD. Episodes of hypoglycaemia and hyperglycaemia were more frequent among people with T1D compared to T2D, 64.52% and 43.54% vs 25.22% and 22.32% respectively. Visits to the emergency department and hospitalization were more frequent among people with CKD, however no significant difference was found between people with T1D and T2D.
CONCLUSION: The COVID-19 pandemic had only a minor effect on the intention to fast during Ramadan in people with diabetes and CKD. However, hypoglycaemia and hyperglycaemia were found to be more frequent, as well as emergency visits and hospital admissions among people with diabetic kidney disease. Prospective studies are needed in future to evaluate the risk indicators of hypoglycaemia and hyperglycaemia among fasting people with CKD, especially in the context of different stages of kidney disease.
Objective: The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM's working group in colorectal cancer.
Evidence Review: The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015).
Findings: After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals.
Conclusions: A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.
METHODS: We performed exome sequencing (ES) in 237 families, including 183 with SRNS and 54 with SSNS/SDNS.
RESULTS: A (likely) pathogenic variant in a known SRNS gene was identified in 29/183 individuals with SRNS (15.8%). Additionally, 6/183 (3.3%) individuals with SRNS carried pathogenic variants in phenocopy genes-genes associated with diseases that clinically mimic SRNS. The diagnostic yield was significantly higher in individuals with ≥ 50 Mb homozygosity-by-descent (HBD) (44.7% vs. 8.5%) and in those with SRNS disease onset before 1 year of age (41.9%). In individuals with SSNS/SDNS, we found a likely causative variant in only 1 of 54 probands.
CONCLUSIONS: A genetic cause was established in 19.1% of SRNS patients (15.8% in known SRNS genes and 3.3% in phenocopy genes), but only 1.9% of non-steroid-resistant cases.