Integrating Safety, Security and Human Factors Engineering in Rail Infrastructure Design and Evaluation.

With the new emerging dependency towards the rail industry, there have been growing concerns on how to make this critical infrastructure more adaptable in this technological era of cyber attacks. Currently, the rail infrastructure is built around safety and human factors, but one important factor which has less attention is cyber security. In order to satisfy the security needs of rail stakeholders, there is a need to put together knowledge in the form of design framework by combining safety and human factors, with cyber security. The research problem this PhD thesis addresses is how the process-techniques and tool- support available in safety, security and human factors engineering can be integrated to provide design solutions in rail infrastructure. This PhD thesis claims that proposed design framework is an exemplar by making three significant contributions. Firstly, it identifies the integration of concepts between safety, security and human factors engineering. Secondly, based on integration it pro- vides an integrated design framework where Integrating Requirements and Information Security (IRIS), use-case specifications informed Task Analysis (TA) using Cognitive Task Analysis (CTA) and Hierarchical Task Analysis (HTA), Human Factors Analysis and Clas- sification System (HFACS) frameworks are used to inform Systems-Theoretic Process Analysis (STPA). This integrated design framework is tool-supported using the open- source Computer Aided Integrating Requirements and Information Security (CAIRIS) platform. Thirdly, the proposed design framework in the form of process-techniques and tool-support is implemented by rail infrastructure to determine the safe, secure and us- able design solutions. This PhD thesis is validated by applying the design framework to three case studies. In the first, preliminary evaluation is carried out by applying it to a case study of ‘Polish Tram Incident’, where inter-dependencies between safety, security, and human factors engineering are present. In the second, the results are used to inform TA using use-case specifications format by prototyping the role of European Railway Traffic Management System (ERTMS) - Signaller, which provides human factors experts a chance to work in collaboration with safety and security design experts. In the final case study, with the support of representative rail stakeholders from Ricardo Rail is used to implement STPA on case study of ’Cambrian Railway Incident’

Frequency of Post-Operative Wound Contamination in Bakhtawar General Hospital, Jamshoro

Background: Surgical site wound infection (SSI) imposes a great challenge worldwide. It is the third most commonly reported nosocomial infection. The objective of the study was to assess the frequency of postoperative wound infections in a newly developed health organization.Material and Methods: This cross-sectional study was conducted from June 2017 to May 2018 in Bakhtawar General Hospital, Jamshoro. A total of 364 cases of surgery, from Obstetrics and Gynecology and General Surgery department were included. Surgical interventions involving an incision were assessed. Infection (SSI) rate was noticed and data was analyzed by SPSS version 18.Results: Healthy discharge rate was 97%. The overall surgical site wound infection rate was 3.1%. These infections were high in genitourinary surgeries (9.09%). Among Obstetrics & Gynecology surgeries, maximum number of SSIs were reported in cases of emergency Lower Segment Cesarean Section (LSCS).Conclusions: The overall rate of SSI for different types of surgeries performed at Bakhtawar General Hospital, Jamshoro was only 3.1%. Frequency of SSI was highest in genitourinary surgeries followed by gastrointestinal and obstetrics and gynecology surgeries, respectively.Key words: General Surgery, Genitourinary surgery, Obstetrics & Gynecology surgery, Post-operative wound contaminatio

Prevalence of Sleep Paralysis in the Medical Students of a Local Medical College

Abstract Objective: To find out the prevalence of sleep paralysis among the medical students of a local Pakistani medical college. Methodology: This cross-sectional study was conducted on 107 medical students from, Karachi Institute of Medical Sciences (KIMS), Karachi, Pakistan. Non-probability Convenient Sampling Technique was utilized for this study. Students suffering from any psychiatric illness were excluded from this study. The study was performed after taking permission from the Institutional Ethical Review Committee. Written informed consent was taken from all the students. The data were collected using a pretested predesigned Questionnaire which was consisted of 10 questions related to the common10 happening and symptoms of sleep paralysis. Data were recorded in the form of frequency and percentages and analyzed using SPSS 24. Results: 52% (56 out of 107) participants have had an experience of sleep paralysis. Most of the participants (76.6%) described their experience as an Inability to move. Frequency of experience ranged from 0 to 20 times in the last year. Age at first experience ranged between 10-20 years. Conclusion: We found a high prevalence of sleep paralysis (47.2%) among the medical students at a local Pakistani medical college. Majority of the students experienced the phenomenon multiple times in their life. The students associated the symptoms the factors such as academic stress, anxiety, workload, emotional experiences, sleep deprivation, work routine, sleep pattern, sleep deprivation, fatigue, mental disturbance, studies and routine stress. 37.3% of the students also related the phenomenon to their position of sleep (lying on back). The participants described the experience as a source of great distress. Sleep paralysis needs to be studied, investigated and addressed in context of mental health of the students

Comparing Different Routes of Vitamin D Administration: A Randomized Interventional Trial

Background: Vitamin D maintains overall good health by boosting up of the immune system through proper function of lungs, heart, muscles, brain and bones. The goal of the study was to determine and compare different routes and formulation of vitamin D3 that was per oral, injectable formulation given orally and intramuscular injection in patients of different groups. Methods: This was a randomized clinical trial designed for vitamin D deficient patients. Patients were randomly assigned to three routes of administration i.e. orally, injection formulation given orally andintramuscular injection group. For mild deficiency, 2 doses of 200,000 IU, for moderate deficiency, 3 doses of 200,000 IU and for severe deficiency, 4 doses of 200,000 IU, 25[OH] D was prescribed. Chi-Square (χ2 ) test was used to evaluate the significant association . Results: A total of 150 patients were enrolled in the study. The mean age ±SD of patients was 48.29 ± 4.65 years. At 4 and 12 weeks after completion of vitamin D3 replacement, levels of 25-hydroxycholecalciferol were measured. In the majority of participants of all three groups, the levels of vitamin D were increased to normal range by week 4 after the final dose of vitamin D3. However, the majority of patients failed to maintain their Vitamin D3 levels within the normal range 12 weeks after the final dose. All three routes of administration of Vitamin D were found equally effective with no significant difference between the routes (p>0.05). Conclusion: All three routes of administration of vitamin D supplements had equal efficacy with no significant advantage over one another

Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation &lt;92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p&lt;0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p&lt;0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research