Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19” AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.

Necrotizing fasciitis (NF) is a devastating soft tissue infection associated with potentially poor outcomes. The Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) score has been introduced as a diagnostic tool for NF. We aimed to evaluate the prognostic value of LRINEC scoring in NF patients. A retrospective analysis was conducted for patients who were admitted with NF between 2000 and 2013. Based on LRINEC points, patients were classified into (Group 1: LRINEC < 6 and Group 2: LRINEC ≥ 6). The 2 groups were analyzed and compared. Primary outcomes were hospital length of stay, septic shock and hospital death. A total of 294 NF cases were identified with a mean age 50.9 ± 15 years. When compared to Group1, patients in Group 2 were 5 years older (p = 0.009), more likely to have diabetes mellitus (61 vs 41%, p < 0.001), Pseudomonas aeruginosa infection (p = 0.004), greater Sequential Organ Failure Assessment (SOFA) score (11.5 ± 3 vs 8 ± 2, p = 0.001), and prolonged intensive care (median 7 vs 5 days) and hospital length of stay (22 vs 11 days, p = 0.001). Septic shock (37 vs. 15%, p = 0.001) and mortality (28.8 vs. 15.0%, p = 0.005) were also significantly higher in Group 2 patients. Using Receiver operating curve, cutoff LRINEC point for mortality was 8.5 with area under the curve of 0.64. Pearson correlation analysis showed a significant correlation between LRINEC and SOFA scorings (r = 0.51, p < 0.002). Early diagnosis, simplified risk stratification and on-time management are vital to achieve better outcomes in patients with NF. Beside its diagnostic role, LRINEC scoring could predict worse hospital outcomes in patients with NF and simply identify the high-risk patients. However, further prospective studies are needed to support this finding.

Globally, frequent flooding causes higher magnitude of disaster among the developing and developed nations. Particularly, the Indian subcontinent is considered as highly vulnerable area for natural disaster and is affected most because of limited resources and coping strategies for post-disaster rehabilitation. Apart from the great impact on human health, floods have considerable impact on mental health. The most frequently diagnosed psychological illness in flood affected population is post-traumatic stress disorder (PTSD). In India, the incidence of PTSD in major natural disasters varies considerably depending upon the magnitude of event, with the highest rates reported of around 70%. Studies conducted during initial few months post-disaster, showed a higher occurrence of psychiatric manifestations. On the other hand, some reports suggested contrary results under similar circumstances. Notably, extreme age (children and elderly), female gender, socioeconomic status, pre-existing mental health issues and financial crisis post-disaster are the potential predisposing factors influencing the vulnerability of PTSD. In Indian context, the variability in the magnitude of psychiatric illness is mainly attributed to the ethnic diversity (vulnerable population), severity and type of flood event and social support. Still there is more to explore regarding the long-term sequelae of catastrophic floods on physical and mental trauma on disaster-affected populations.

Trauma remains one of the leading causes of morbidity and mortality worldwide. Generally, the incidence of traumatic injuries is disproportionately high in males. However, trauma in females is underreported.

Background: Globally, post traumatic stress disorder (PTSD) is one of the most common psychiatric illnesses following a disaster. We aimed to evaluate the relationship between the socio-economic and flood exposure factors with PTSD, depression and anxiety among the flood-affected populations in Kerala, India. Methods: A cross-sectional household survey was conducted from November 2019 to January 2020 in Kozhikode district of Kerala, India. Adults (≥ 18 years), who were permanent residents and had been directly exposed to the flood, were invited to take part in the study. Individuals with a history of mental health issues and those who had other stressful situations in the past were excluded. The survey questionnaire was based on three screening tools: (1) PTSD Checklist for DSM-5 (PCL-5); (2) patient health questionnaire (PHQ-9); and (3) generalized anxiety disorder (GAD-7). Data included sociodemographic factors and flood exposure variables. The primary outcome variable was psychiatric morbidity (PTSD, anxiety and depression). Results: A total of 276 respondents (150 males/126 females) participated in the study. A significant correlation was observed between total score on PCL-5 and GAD-7 (r=0.339, p=0.001) and PHQ-9 (r=0.262, p=0.001). Females had significantly higher total PTSD symptom severity scores (8.24±5.88 vs. 6.07±5.22; p=0.001), severity of symptoms of intrusion (4.66±3.60 vs. 3.69±3.20; p=0.04), increased level of anxiety (2.54±1.94 vs. 1.79±1.53; p=0.001) and depression (3.02±2.26 vs. 2.04±1.67; p=0.001) compared to males. However, the gender difference for PTSD symptoms disappeared when controlling for age. Conclusion: The findings of this survey revealed that the vast majority of respondents (92 percent females and 87 percent males) still had subclinical psychiatric symptoms one year after the flood. Therefore, tailored psychological interventions are warranted to counter the long-lasting impact of flooding on the mental health of individuals.