Search results for: patient reported outcomes

Authors: Hala Kama Ahmed Rashwan

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Ensuring the patient safety especially at intensive care units and those exposed to hospital tools and equipment is one of the most important challenges facing healthcare today. Outbreak of food poisoning as a result of food-borne pathogens has been reported in many hospitals and care homes all over the world due to hospital meals. Patient safety of eating hospital meals is a fundamental principle of healthcare; it is new healthcare disciplines that assure the food raw materials, food storage, meals processing, and control of kitchen errors that often lead to adverse healthcare events. The aim of this article is to promote any hospital in attaining the hygienic practices and better quality system during processing of the ready-to- eat meals for intensive care units patients according to the WHO safety guidelines.

Keywords: hospitals, meals, safety, intensive care

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Authors: Mani Mofidi, Neda Valizadeh, Ali Hashemaghaee, Mona Hashemaghaee, Soudabeh Shafiee Ardestani

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Background: Acute pain and its management remained the most complaint of emergency service admission. Diagnostic and therapeutic procedures add to patients’ pain. Diminishing the pain increases the quality of patient’s feeling and improves the patient-physician relationship. Aim: The aim of this study was to evaluate the outcomes and side effects of opioid administration in emergency patients. Material and Methods: patients admitted to ward II emergency service of Imam Khomeini hospital, who received one of the opioids: morphine, pethidine, methadone or fentanyl as an analgesic were evaluated. Their vital signs and general condition were examined before and after drug injection. Also, patient’s pain experience were recorded as numerical rating score (NRS) before and after analgesic administration. Results: 268 patients were studied. 34 patients were addicted to opioid drugs. Morphine had the highest rate of prescription (86.2%), followed by pethidine (8.5%), methadone (3.3%) and fentanyl (1.68). While initial NRS did not show significant difference between addicted patients and non-addicted ones, NRS decline and its score after drug injection were significantly lower in addicted patients. All patients had slight but statistically significant lower respiratory rate, heart rate, blood pressure and O2 saturation. There was no significant difference between different kind of opioid prescription and its outcomes or side effects. Conclusion: Pain management should be always in physicians’ mind during emergency admissions. It should not be assumed that an addicted patient complaining of pain is malingering to receive drug. Titration of drug and close monitoring must be in the curriculum to prevent any hazardous side effects.

Keywords: numerical rating score, opioid, pain, emergency department

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Authors: Anastasia Constantinou, Stephen Morris

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Background: The adoption of synchronous and asynchronous telemedicine modalities for primary care consultations has exponentially increased since the COVID-19 pandemic. However, there is limited understanding of how virtual consultations influence healthcare resource utilization and other quality measures including safety, timeliness, efficiency, patient and provider satisfaction, cost-effectiveness and environmental impact. Aim: Quantify the rate of follow-up visits, emergency department visits, hospitalizations, request for investigations and prescriptions and comment on the effect on different quality measures associated with different telemedicine modalities used for primary care services and primary care referrals to secondary care Design and setting: Systematic review in primary care Methods: A systematic search was carried out across three databases (Medline, PubMed and Scopus) between August and November 2023, using terms related to telemedicine, general practice, electronic referrals, follow-up, use and efficiency and supported by citation searching. This was followed by screening according to pre-defined criteria, data extraction and critical appraisal. Narrative synthesis and metanalysis of quantitative data was used to summarize findings. Results: The search identified 2230 studies; 50 studies are included in this review. There was a prevalence of asynchronous modalities in both primary care services (68%) and referrals from primary care to secondary care (83%), and most of the study participants were females (63.3%), with mean age of 48.2. The average follow-up for virtual consultations in primary care was 28.4% (eVisits: 36.8%, secure messages 18.7%, videoconference 23.5%) with no significant difference between them or F2F consultations. There was an average annual reduction of primary care visits by 0.09/patient, an increase in telephone visits by 0.20/patient, an increase in ED encounters by 0.011/patient, an increase in hospitalizations by 0.02/patient and an increase in out of hours visits by 0.019/patient. Laboratory testing was requested on average for 10.9% of telemedicine patients, imaging or procedures for 5.6% and prescriptions for 58.7% of patients. When looking at referrals to secondary care, on average 36.7% of virtual referrals required follow-up visit, with the average rate of follow-up for electronic referrals being higher than for videoconferencing (39.2% vs 23%, p=0.167). Technical failures were reported on average for 1.4% of virtual consultations to primary care. When using carbon footprint estimates, we calculate that the use of telemedicine in primary care services can potentially provide a net decrease in carbon footprint by 0.592kgCO2/patient/year. When follow-up rates are taken into account, we estimate that virtual consultations reduce carbon footprint for primary care services by 2.3 times, and for secondary care referrals by 2.2 times. No major concerns regarding quality of care, or patient satisfaction were identified. 5/7 studies that addressed cost-effectiveness, reported increased savings. Conclusions: Telemedicine provides quality, cost-effective, and environmentally sustainable care for patients in primary care with inconclusive evidence regarding the rates of subsequent healthcare utilization. The evidence is limited by heterogeneous, small-scale studies and lack of prospective comparative studies. Further research to identify the most appropriate telemedicine modality for different patient populations, clinical presentations, service provision (e.g. used to follow-up patients instead of initial diagnosis) as well as further education for patients and providers alike on how to make best use of this service is expected to improve outcomes and influence practice.

Keywords: telemedicine, healthcare utilisation, digital interventions, environmental impact, sustainable healthcare

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Authors: Ahmed Gendia, Waseem Kamran

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Objective: Total Laparoscopic hysterectomy (TLH) remains a common approach among laparoscopic surgeons. However, this approach depends on the use of uterine manipulator to facilitate the surgery. Although many studies reported the effectiveness of TLH with uterine manipulator, only few reported TLH without the use of any uterine or vaginal manipulation. the aim of this report is to demonstrate our Technique (kamran's TLH) in performing TLH without the use of any uterine or vaginal manipulation in benign conditions and report our intra- and post-operative outcomes. Methodology : surgical technique will be demonstrated through a short video highlighting the easy and safe to learn surgical steps. Additionally, the data of 86 patients who underwent KTLH for benign condition were retrospectively analyzed. the data included intra- and postoperative finding and complications. Results : A total of 86 hysterectomies were performed utilizing the Kamran's TLH ( KTHL). Mean age was 52.2 (±11) years old and BMI was 28.2(±7). Mean operative time was 64.7(±27.9) minutes and estimated bloods loss was 46.2(±54.6) ml. No intraoperative complications were recorded and there was no conversion to open surgery. Only one patient required readmission and surgery for vaginal vault dehiscence. Conclusion & Significance: Uterine manipulator is a key component in performing laparoscopic hysterectomy. However, our approach demonstrated that TLH can be safely performed without the use of any uterine or vaginal manipulation.

Keywords: laparoscopic hystrectomy, TLH, uterine manipulator, surgery

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Authors: Soheila Zhaeentan, Anders Von Heijne, Elisabet Hagert, André Stark, Björn Salomonsson

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Recommended treatment for traumatic rotator cuff tear (TRCT) is surgery within a few weeks after injury if the diagnosis is made early, especially if a functional impairment of the shoulder exists. This may lead to the assumption that a poor outcome then can be expected in delayed surgical treatment, when the patient is diagnosed at a later stage. The aim of this study was to investigate if a surgical repair later than three months after injury may result in successful outcomes and patient satisfaction. There is evidence in literature that good results of treatment can be expected up to three months after the injury, but little is known of later treatment with cuff repair. 73 patients (75 shoulders), 58 males/17 females, mean age 59 (range 34-­‐72), who had undergone surgical intervention for TRCT between January 1999 to December 2011 at our clinic, were included in this study. Patients were assessed by MRI investigation, clinical examination, Western Ontario Rotator Cuff index (WORC), Oxford Shoulder Score, Constant-­‐Murley Score, EQ-­‐5D and patient subjective satisfaction at follow-­‐up. The patients treated surgically within three months ( < 12 weeks) after injury (39 cases) were compared with patients treated more than three months ( ≥ 12 weeks) after injury (36 cases). WORC was used as the primary outcome measure and the other variables as secondary. A senior consultant radiologist, blinded to patient category and clinical outcome, evaluated all MRI-­‐images. Rotator cuff integrity, presence of arthritis, fatty degeneration and muscle atrophy was evaluated in all cases. The average follow-­‐up time was 56 months (range 14-­‐149) and the average time from injury to repair was 16 weeks (range 3-­‐104). No statistically significant differences were found for any of the assessed parameters or scores between the two groups. The mean WORC score was 77 (early group, range 25-­‐ 100 and late group, range 27-­‐100) for both groups (p= 0.86), Constant-­‐Murley Score (p= 0.91), Oxford Shoulder Score (p= 0.79), EQ-­‐5D index (p= 0.86). Re-­‐tear frequency was 24% for both groups, and the patients with re-­‐tear reported less satisfaction with outcome. Discussion and conclusion: This study shows that surgical repair of TRCT performed later than three months after injury may result in good functional outcomes and patient satisfaction. However, this does not motivate an intentional delay in surgery when there is an indication for surgical repair as that delay may adversely affect the possibility to perform a repair. Our results show that surgeons may safely consider surgical repair even if a delay in diagnosis has occurred. A retrospective cohort study on 75 shoulders shows good functional result after traumatic rotator cuff tear (TRCT) treated surgically up to one year after the injury.

Keywords: traumatic rotator cuff injury, time to surgery, surgical outcome, retrospective cohort study

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Authors: Brooke Sweeney, David White, Felix Amparano, Nick A. Clark, Amy R. Beck, Mathew Lindquist, Lora Edwards, Julie Vandal, Jennifer Lisondra, Katie Cox, Renee Arensberg, Allen Cummins, Jazmine Cedeno, Jason D. Fraser, Kelsey Dean, Helena H. Laroche, Cristina Fernandez

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Background: National organizations call for standardized pre-surgical requirements and education to optimize postoperative outcomes. Since 2017 our surgery program has used defined protocols and educational curricula pre- and post-surgery. In response to patient outcomes, our educational content was refined to include quizzes to assess patient knowledge and surgical preparedness. We aim to optimize adolescent pre-bariatric surgery preparedness by improving overall aggregate pre-surgical assessment performance from 68% to 80% within 12 months. Methods: A multidisciplinary improvement team was developed within the weight management clinic (WMC) of our tertiary care, free-standing children’s hospital. A manual has been utilized since 2017, with limitations in consistent delivery and patient uptake of information. The curriculum has been improved to include quizzes administered during WMC visits prior to bariatric surgery. The initial outcome measure is the pre-surgical quiz score of adolescents preparing for bariatric surgery. Process measure was the number of questions answered correctly to test the questions. Baseline performance was determined by a patient assessment survey of pre-surgical preparedness at patient visits. Plan-Do-Study-Act cycles (PDSA) included: 1) creation and implementation of a refined curriculum, 2) development of 5 new quizzes based upon learning objectives, and 3) improving provider-lead teaching and quiz administration within clinic workflow. Run charts assessed impact over time. Results: A total of 346 quiz questions were administered to 34 adolescents. The outcome measure improved from a baseline mean of 68% to 86% following PDSA 2 cycles, and it was sustained. Conclusion/Implication: Patient/family comprehension of surgical preparedness improved with standardized education via team member-led teaching and assessment using quizzes during pre-surgical clinic visits. The next steps include launching redesigned teaching materials with modules correlated to quizzes and assessment of comprehension and outcomes post-surgically.

Keywords: bariatric surgery, adolescent, clinic, pre-bariatric training

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Authors: Gamith Mendis

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Even though the doctors are knowledgeable, there's a gap between knowing and being ethical. This is a barrier to establish an ethical doctor-patient relationship. Current health system has oriented in a way that gives a meaning to both the doctor and the patient through intermediate entities. For the doctor, the meaning of the doctor-patient relationship is given through the financial benefits, promotions, and social status. For the patient, the meaning is given through curing of the disease. It is obvious that both are independent entities between the doctor and the patient. As the philosophers like Husserl and Heidegger have pointed out, our subjective world will give the immediate meaningfulness to us. We should seek this immediate meaningfulness of the doctor-patient relationship. The present research has used the existential methodology as guided self-reflections on the lived experiences of a doctor and his students. In this approach, two important aspects have been understood. The first is, establishing the fact that being ethical is itself giving meaningfulness to the doctor’s being without any mediate entities. Simply, it is enjoying being an honest being. The second is by being-with-the-patient while treating the disease; both the doctor and the patient can enjoy the meaningfulness of their human relationship. The medical students and the doctors should focus on this meaningfulness. For that, this discussion should be actively incorporated into the medical curriculum with programs of practical guidance to medical students and should be discussed in patient-care reviews in the health setting within a satisfactory framework.

Keywords: doctor-patient relationship, medical education, medical ethics, medical humanities, qualitative health research

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Authors: Wan Nur'ashiqin Wan Mohamad, Zarina Othman, Mohd Azman Abas, Azizah Ya'acob, Rozmel Abdul Latiff

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Effective doctor-patient interaction is vital to both doctor and patient relationship. It is the cornerstone of good practice and an integral quality of a healthcare institution. This paper presented the hierarchy of the communication elements in doctor-patient interaction during medical consultations in a medical centre in Malaysia. This study adapted The Picker Patient Experience Questionnaire (2002) to obtain the information from patients. The questionnaire survey was responded by 100 patients between the ages of 20 and 50. Data collected were analysed using Rasch Measurement Model to yield the hierarchy of the communication elements in doctor-patient interaction. The findings showed that the three highest ranking on the doctor-patient interaction were doctor’s treatment, important information delivery and patient satisfaction of doctor’s responses. The results are valuable in developing the framework for communication ethics of doctors.

Keywords: communication elements, doctor-patient interaction, hierarchy, Rasch measurement model

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Authors: Qing Wu, Xuchun Ye, Kirsten Corazzini

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Objective: It is increasingly recognized that patients’ rational and meaningful engagement in healthcare could make important contributions to their health care and safety management. However, recent evidence indicated that patients' actual roles in healthcare didn’t match their desired roles, and many patients reported a less active role than desired, which suggested that patient engagement in healthcare may be influenced by various factors. This study aimed to analyze influencing factors on patient engagement and explore the influence mechanism, which will be expected to contribute to the strategy development of patient engagement in healthcare. Methods: On the basis of analyzing the literature and theory study, the research framework was developed. According to the research framework, a cross-sectional survey was employed using the behavior and willingness of patient engagement in healthcare questionnaire, Chinese version All Aspects of Health Literacy Scale, Facilitation of Patient Involvement Scale and Wake Forest Physician Trust Scale, and other influencing factor related scales. A convenience sample of 580 patients was recruited from 8 general hospitals in Shanghai, Jiangsu Province, and Zhejiang Province. Results: The results of the cross-sectional survey indicated that the mean score for the patient engagement behavior was (4.146 ± 0.496), and the mean score for the willingness was (4.387 ± 0.459). The level of patient engagement behavior was inferior to their willingness to be involved in healthcare (t = 14.928, P ＜ 0.01). The influencing mechanism model of patient engagement in healthcare was constructed by the path analysis. The path analysis revealed that patient attitude toward engagement, patients’ perception of facilitation of patient engagement and health literacy played direct prediction on the patients’ willingness of engagement, and standard estimated values of path coefficient were 0.341, 0.199, 0.291, respectively. Patients’ trust in physician and the willingness of engagement played direct prediction on the patient engagement, and standard estimated values of path coefficient were 0.211, 0.641, respectively. Patient attitude toward engagement, patients’ perception of facilitation and health literacy played indirect prediction on patient engagement, and standard estimated values of path coefficient were 0.219, 0.128, 0.187, respectively. Conclusions: Patients engagement behavior did not match their willingness to be involved in healthcare. The influencing mechanism model of patient engagement in healthcare was constructed. Patient attitude toward engagement, patients’ perception of facilitation of engagement and health literacy posed indirect positive influence on patient engagement through the patients’ willingness of engagement. Patients’ trust in physician and the willingness of engagement had direct positive influence on the patient engagement. Patient attitude toward engagement, patients’ perception of physician facilitation of engagement and health literacy were the factors influencing the patients’ willingness of engagement. The results of this study provided valuable evidence on guiding the development of strategies for promoting patient rational and meaningful engagement in healthcare.

Keywords: healthcare, patient engagement, influencing factor, the mechanism

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Authors: Carmen Silvia Gabriel, Dsniele Bernardi da Costa, Andrea Bernardes, Sabrina Elias Mikael, Daniele da Silva Ramos

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The goal of this quantitative study is to investigate patient safety culture from the perspective of professional from the hospital nursing team.It was conducted in two Brazilian hospitals,.The sample included 282 nurses Data collection occurred in 2013, through the questionnaire Hospital Survey on Patient Safety Culture.Based on the assessment of the dimensions is stressed that, in the dimension teamwork across hospital units, 69.4% of professionals agree that when a lot of work needs to be done quickly, they work together as a team; about the dimension supervisor/ manager expectations and actions promoting safety, 70.2% agree that their supervisor overlooks patient safety problems.Related to organizational learning and continuous improvement, 56.5% agree that there is evaluation of the effectiveness of the changes after its implementation.On hospital management support for patient safety, 52.8% refer that the actions of hospital management show that patient safety is a top priority.On the overall perception of patient safety, 57.2% disagree that patient safety is never compromised due to higher amount of work to be completed.In what refers to feedback and communication about error, 57.7% refer that always and usually receive such information. Relative to communication openness, 42.9% said they never or rarely feel free to question the decisions / actions of their superiors.On frequency of event reporting, 64.7% said often and always notify events with no damages to patients..About teamwork across hospital units is noted similarity between the percentages of agreement and disagreement, as on the item there is a good cooperation among hospital units that need to work together, that indicates 41.4% and 40.5% respectively.Related to adequacy of professionals, 77.8 % disagree on the existence of sufficient amount of employees to do the job, 52.4% agree that shift changes are problematic for patients. On nonpunitive response to errors, 71.7% indicate that when an event is reported it seems that the focus is on the person.On the patient safety grade of the institution, 41.6 % classified it as very good. it is concluded that there are positive points in the safety culture, and some weaknesses as a punitive culture and impaired patient safety due to work overload .

Keywords: quality of health care, health services evaluation, safety culture, patient safety, nursing team

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Authors: Sarah Gounden, Mukesh Dheda, Boikhutso Tlou, Elizabeth Ojewole, Frasia Oosthuizen

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Background: Antiretroviral therapy (ART) has been effective in the reduction of mortality and resulted in an improvement in the prognosis of HIV-infected patients. However, treatment with antiretrovirals (ARVs) has led to the development of many adverse drug reactions (ADRs). It is, therefore, necessary to determine the safety profile of these medicines in a South African population in order to ensure safe and optimal medicine use. Objectives: The aim of this study was to quantify ADRs experienced with the different ARVs currently used in South Africa, to determine the safety profile of ARV medicine in South Africa based on reported ADRs, and to determine the ARVs with the lowest risk profile based on specific patient populations. Methodology: This was a quantitative study. Individual case safety reports for the period January 2010 – December 2013 were obtained from the National Pharmacovigilance Center; these reports contained information on ADRs, ARV medicine, and patient demographics. Data was analysed to find associations that may exist between ADRs experienced, ARV medicines used and patient demographics. Results: A total of 1916 patient reports were received of which 1534 met the inclusion criteria for the study. The ARV with the lowest risk of ADRs were found to be lamivudine (0.51%, n=12), followed by lopinavir/ritonavir combination (0.8%, n=19) and abacavir (0.64%, n=15). A higher incidence of ADRs was observed in females compared to males. The age group 31–50 years and the weight group 61–80 kg had the highest incidence of ADRs reported. Conclusion: This study found that the safest ARVs to be used in a South African population are lamivudine, abacavir, and the lopinavir/ritonavir combination. Gender differences play a significant role in the occurrence of ADRs and both anatomical and physiological differences account for this. An increased BMI (body mass index) in both men and women showed an increase in the incidence of ADRs associated with ARV therapy.

Keywords: adverse drug reaction, antiretrovirals, HIV/AIDS, pharmacovigilance, South Africa

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Authors: Ronak Mishra, Sachin Kale

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Background: The clinical outcome of a new fixation device (femoral neck system, FNS) for femoral neck fractures is not described properly. The main purpose of this study was to evaluate the functional outcome of the patients of femoral neck fractures treated with FNS. Methods: A retrospective study was done among patients aged 60 years or less. On the basis of inclusion and exclusion criteria a final sample size of 30 was considered. Blood loss, type of fracture internal fixation, and length of clinical follow-up were all acquired from patient records. The volume of blood loss was calculated. The mean and standard deviation of continuous variables were reported (with range). Harris Hip score (HHS) And Post op xrays at intervals(6 weeks, 6 months ,12 months ) we used to clinically asses the patient. Results: Out of all 60% were females and 40% were males. The mean age of the patients was. 44.12(+-) years The comparison of functional outcomes of the patients treated with FNS using Harris Hip Score. It showed a highly significant comparison between the patients at post operatively , 6 weeks and 3 months and 12 months . There were no postoperative complications seen among the patients. Conclusion: FNS offers superior biomechanical qualities and greatly improved overall build stability. It allows for a significant reduction in operation time, potentially lowering risks and consequences associated with surgery.

Keywords: FNS, trauma, hip, neck femur fracture, minimally invasive surgery

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Authors: Alessandro Marano

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Aim: The author describes a strategy for choosing between two different rhinoplasty approaches for outcomes treatment. Methods: Series of the case study. There are advantages and disadvantages on both approaches for rhinoplasty. On the side of the open approach, we are be able to better manage the techniques for shaping and restoring nasal structures in rhinoplasty outcomes; on the other side, the closed approach requires more practice and experience to achieve good results. Results: Author’s choice is the closed approach on rhinoplasty outcomes. Anyway, the open approach is most commonly preferred due to superior management and better vision on nasal structures. Conclusions: Both approaches are valid for the treatment of rhinoplasty outcomes, author's preferred approach is closed, with minimally invasive modification focused on restoring outcomes in nasal function and aesthetics.

Keywords: rhinoplasty, aesthetic, face, outcomes

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Authors: Hilary P. Stevenson, Alexander J. Hayek, Amie Dereczyk

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In this case report, we provide an example of an asymptomatic COVID-19 positive patient who presented with new-onset psychosis with severe paranoid delusions. He was seen in our ED after ingesting isopropyl alcohol which he reported was an attempt to escape presumed attackers, which at the time was logical to the patient. The patient’s family had COVID-19 symptoms that corresponded to those typically observed from the Omicron variant. The patient was treated successfully, within ten days, with Risperdal twice-daily dosing resulting in the resolution of the patient’s delusions and improved insight regarding the events that led to his hospitalization. In this work, we examine possible contributing factors to new-onset psychosis in the context of COVID-19, a phenomenon that is becoming increasingly notable in the literature. One area of importance is the already established inflammatory hypothesis of psychosis in which defects in the innate immune system, which result in its overactivation, may play a role in a typical first-episode psychosis, in addition to subsequent episodes. Given that COVID-19 is known to cause derangements in the innate immune system, such as cytokine storm reactions, this link may be critical in further understanding the etiologies of new-onset COVID-19 psychosis and its risk factors. Also included in this work is a brief review of antipsychotic interventions that have been described in the literature to date for the first episode of COVID-19-related psychosis. This will explore the potential of some antipsychotics to innately diminish the production of pro-inflammatory cytokines, further enhancing their usefulness in COVID-19 first-episode psychosis patients.

Keywords: COVID-19, first break psychosis, inflammatory hypothesis of psychosis, Risperdal

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Authors: Ana Ferraz, Martim Santos, M. Graça Pereira

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Distress among parents of children with acute lymphoblastic leukemia (ALL) is common during treatment and can persist several years post-diagnosis, impacting the adjustment of children and parents themselves. Current evidence is needed to examine the scope and nature of parental distress in childhood ALL. This review focused on associated variables, predictors, and outcomes of parental distress following their ALL diagnosis of their child. PubMed, Web of Science, and PsycINFO databases were searched for English and Spanish papers published from 1983 to 2021. PRISMA statement was followed, and papers were evaluated through a standardized methodological quality assessment tool (NHLBI). Of the 28 papers included, 16 were evaluated as fair, eight as good, and four as poor. Regarding results, 11 papers reported subgroup differences, and 15 found potential predictors of parental distress, including sociodemographic, psychosocial, psychological, family, health, and ALL-specific variables. Significant correlations were found between parental distress, social support, illness cognitions, and resilience, as well as contradictory results regarding the impact of sociodemographic variables on parental distress. Family cohesion and caregiver burden were associated with distress, and the use of healthy coping strategies was associated with less anxiety. Caregiver strain contributed to distress, and the overall impact of illness positively predicted anxiety in mothers and somatization in fathers. Differences in parental distress were found regarding group risk, time since diagnosis, and treatment phases. Thirteen papers explored the outcomes of parental distress on psychological, family, health, and social/education outcomes. Parental distress was the most important predictor of family strain. Significant correlations were found between parental distress at diagnosis and further psychological adjustment of parents themselves and their children. Most papers reported correlations between parental distress on children’s adjustment and quality of life, although few studies reported no association. Correlations between maternal depression and child participation in education and social life were also found. Longitudinal studies are needed to better understand parental distress and its consequences on health outcomes, in particular. Future interventions should focus mainly on parents on distress reduction and psychological adjustment, both in parents and children over time.

Keywords: childhood acute lymphoblastic leukemia, family, parental distress, psychological adjustment, quality of life

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Authors: Ramanish Ravishankar, Azar Hussain, Mahmoud Loubani, Mubarak Chaudhry

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Background and Aims: Currently, there are no strict guidelines in cardiopulmonary bypass temperature management in cardiac surgery not involving the aortic arch. This study aims to compare patient outcomes undergoing mild hypothermia and normothermia. The aim of this study was to compare patient outcomes between mild hypothermia and normothermia undergoing on-pump cardiac surgery not involving the aortic arch. Methods: This was a retrospective cohort study from January 2015 until May 2023. Patients who underwent cardiac surgery with cardiopulmonary bypass temperatures ≥32oC were included and stratified into mild hypothermia (32oC – 35oC) and normothermia (>35oC) cohorts. Propensity matching was applied through the nearest neighbour method (1:1) using the risk factors detailed in the EuroScore using RStudio. The primary outcome was mortality. Secondary outcomes included post-op stay, intensive care unit readmission, re-admission, stroke, and renal complications. Patients who had major aortic surgery and off-pump operations were excluded. Results: Each cohort had 1675 patients. There was a significant increase in overall mortality with the mild hypothermia cohort (3.59% vs. 2.32%; p=0.04912). There was also a greater stroke incidence (2.09% vs. 1.13%; p=0.0396) and transient ischaemic attack (TIA) risk (3.1% vs. 1.49%; p=0.0027). There was no significant difference in renal complications (9.13% vs. 7.88%; p=0.2155). Conclusions: Patient’s who underwent mild hypothermia during cardiopulmonary bypass have a significantly greater mortality, stroke, and transient ischaemic attack incidence. Mild hypothermia does not appear to provide any benefit over normothermia and does not appear to provide any neuroprotective benefits. This shows different results to that of other major studies; further trials and studies need to be conducted to reach a consensus.

Keywords: cardiac surgery, therapeutic hypothermia, neuroprotection, cardiopulmonary bypass

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Authors: Jiyoung Kim, Chae Weon Chung

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Labor pain is one of the most common concerns of pregnant women, thus women are in need of possible options they could take to control the pain. So, this study aimed to explore maternal perception of epidural anesthesia and to compare the childbirth outcomes according to the use of epidural anesthesia. For this descriptive study, women who were over 36 weeks of pregnancy were recruited from an out-patient obstetric clinic in a public hospital in Seoul. Women were included in the study if agreed to participate, were pregnant singleton, without pregnancy complication, and expecting a natural birth. Data collection was done twice, the first one at the prenatal care visit and the second one at an in-patient ward on 2nd day postpartum. The instrument of the beliefs about epidural anesthesia, one item of asking intention to use epidural anesthesia, demographics, and obstetrical characteristics were incorporated into a questionnaire. One nurse researcher performed data collection with the structured questionnaire after the approval of the institutional review board. At the initial data collection 133 women were included, while 117 were retained at the second point after excluded 13 women due to the occurrence of complications. Analyses were done by chi-square, t-test, and ANOVA using the SPSS program. Women were aged 32.5 years old, 22.2% were over 35 years old. The average gestational age was 38.5 weeks, and 67.5% were nulliparous. Out of 38 multiparous women, 20 women (52.6%) had received epidural anesthesia in the previous delivery. At the initial interview, 62.6% (n=73) of women wanted to receive epidural anesthesia while 22.4% answered not decided and 15.4% did not want to take the procedure. However, there were changes in proportions between women’s intention to take it and actual procedures done, particularly, two-thirds of women (n=26) who had been undecided were found to receive epidural anesthesia during labor. There was a significant difference in the perception of epidural anesthesia measured before delivery between women who received and not received it (t=3.68, p < .001). Delivery outcomes were statistically different between the two groups in delivery mode (chi-square=8.64, p=.01), O₂ supply during labor (chi-square =5.01, p=.03), duration of 2nd stage of labor (t=3.70, p < .001), and arterial cord blood pH (t=2.64, p=.01). Interestingly, there was no difference in labor pain perceived between women with and without epidural anesthesia. Considering the preference and use of epidural anesthesia, health professionals need to assess coping ability of women undergoing delivery and to provide accurate information about pain control to support their decision making and eventually to enhance delivery outcomes for mothers and neonates.

Keywords: epidural anesthesia, delivery outcomes, labor pain, perception

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Authors: Bin Mohamed Ebrahim, Aminesh Singla, Henry Pleass

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Aim: There is an ongoing gap in renal transplantation between organs available for donation and recipients on the waiting list. Live donors with pre-existing or a history of renal calculi were thought to be a relative contraindication due to safety concerns for donors. We aim to review current literature assessing outcomes of donors who were found to have a history of renal calculi. Methods: Ovid and Embase were searched between 1960 to 2021 using key terms and Medical Subject Headings (MeSH) – nephrolithiasis, renal stones, renal transplantation and renal graft. Articles included conference proceedings and journal articles and were not excluded based on patient numbers. Studies were excluded if the specific organ was not identified, duplicated reports found or if post-transplant outcomes were not recorded. Outcomes were donor’s renal function or renal calculi recurrence postoperatively. Results: Upon reviewing 344 articles, 14 manuscripts met inclusion criteria. A total of 152 live donors were identified as having pre-existing or with a history of renal calculi at pre-operative workup. The mean stone size was 2.6 4mm (1 – 16) with a mean follow-up duration of 31.8 months (1 – 96). Seven studies had both outcomes. None showed renal complications or stone recurrence. The remaining studies contained 2 out of 84 patients having recurrent nephrolithiasis. Conclusion: Data suggests minimal morbidity involved for live renal donors with a history of nephrolithiasis. This should encourage surgeons to continue recruiting such donors for kidney transplantation.

Keywords: renal transplantation, renal graft, nephrolithiasis, renal calculi, live donor

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Authors: Kailin K. Zhang, Anne W. Thompson

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Electronic learning for continuing professional education (CPE) and interprofessional education (IPE) in healthcare have been shown to improve learners’ satisfaction, attitudes, and performance. Yet, their impact on behavior change in healthcare professionals through continuing interprofessional education (CIPE) is less known. A scoping review of 32 articles from 2010 to 2020 was conducted using the Arksey and O’Malley framework across all healthcare settings. It focused on evaluating the effectiveness of CIPE on behavior change of healthcare professionals, as well as identifying course features of electronic CIPE programs facilitating behavior change. Eight different types of electronic learning methods, including online programs, tele-education, and social media, were identified as interventions. More than 35,542 healthcare professionals participated in the interventions. Electronic learning for CIPE led to positive behavior outcomes in 30 out of 32 studies, especially through a change in patient care practices. The most successful programs provided interactive and authentic learning experiences tailored to learners’ needs while promoting the direct application of what was learned in their clinical settings. Future research should include monitoring of sustained behavior changes and their resultant patient outcomes.

Keywords: behavior change, continuing interprofessional education, distance learning, electronic learning

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Authors: Yasar Samet Gokceoglu, Ayse Nur Incesu, Furkan Okatar, Berk Nimetoglu, Serkan Bayram, Turgut Akgul

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Ankle syndesmosis injuries pose a significant challenge in orthopedic practice due to their potential for prolonged recovery and chronic ankle dysfunction. Accurate diagnosis and management of these injuries are essential for achieving optimal patient outcomes. The use of radiological methods, such as X-ray, computed tomography (CT), and magnetic resonance imaging (MRI), plays a vital role in the accurate diagnosis of syndesmosis injuries in the context of ankle fractures. Treatment options for ankle syndesmosis injuries vary, with surgical interventions such as screw fixation and suture-button implantation being commonly employed. The choice of treatment is influenced by the severity of the injury and the presence of associated fractures. Additionally, the mechanism of injury, such as pure syndesmosis injury or specific fracture types, can impact the stability and management of syndesmosis injuries. Ankle fractures with syndesmosis injury present a complex clinical scenario, requiring accurate diagnosis, appropriate reduction, and tailored management strategies. The interplay between the mechanism of injury, associated fractures, and treatment modalities significantly influences the outcomes of these challenging injuries. The long-term outcomes and patient satisfaction following ankle fractures with syndesmosis injury are crucial considerations in the field of orthopedics. Patient-reported outcome measures, such as the Foot and Ankle Outcome Score (FAOS), provide essential information about functional recovery and quality of life after these injuries. When diagnosing syndesmosis injuries, standard measurements, such as the medial clear space, tibiofibular overlap, tibiofibular clear space, anterior tibiofibular ratio (ATFR), and the anterior-posterior tibiofibular ratio (APTF), are assessed through radiographs and computed tomography (CT) scans. These parameters are critical in evaluating the presence and severity of syndesmosis injuries, enabling clinicians to choose the most appropriate treatment approach. Despite advancements in diagnostic imaging, challenges remain in accurately diagnosing and treating ankle syndesmosis injuries. Traditional diagnostic parameters, while beneficial, may not capture the full extent of the injury or provide sufficient information to guide therapeutic decisions. This gap highlights the need for exploring additional diagnostic parameters that could enhance the accuracy of syndesmosis injury diagnoses and inform treatment strategies more effectively. The primary goal of this research is to evaluate the usefulness of traditional radiographic measurements in comparison to new CT-based measurements for diagnosing ankle syndesmosis injuries. Specifically, this study aims to assess the accuracy of conventional parameters, including medial clear space, tibiofibular overlap, tibiofibular clear space, ATFR, and APTF, in contrast with the recently proposed CT-based measurements such as the delta and gamma angles. Moreover, the study intends to explore the relationship between these diagnostic parameters and functional outcomes, as measured by the Foot and Ankle Outcome Score (FAOS). Establishing a correlation between specific diagnostic measurements and FAOS scores will enable us to identify the most reliable predictors of functional recovery following syndesmosis injuries. This comparative analysis will provide valuable insights into the accuracy and dependability of CT-based measurements in diagnosing ankle syndesmosis injuries and their potential impact on predicting patient outcomes. The results of this study could greatly influence clinical practices by refining diagnostic criteria and optimizing treatment planning for patients with ankle syndesmosis injuries.

Keywords: ankle syndesmosis injury, diagnostic accuracy, computed tomography, radiographic measurements, Tibiofibular syndesmosis distance

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Authors: Jemini Vyas, Oluwatobi Adeyoe, Jenny Branagan, Chandran Tanabalan, John Beatty, Aakash Pai

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Introduction: The development of robotic surgery has accelerated centralisation to tertiary centres, where robotic radical prostatectomy (RP) is offered. The purpose of concentrating treatment in high volume specialist centres is to improve the quality of care and patient outcomes. The aim of this study was to assess the impact on clinical outcomes of centralisation for locally diagnosed patients undergoing RP. Methods: Clinical outcomes for 169 consecutive laparoscopic & open RP pre-centralisation were retrospectively compared with 50 consecutive robotic RP conducted over a similar period post-centralisation. Preoperative risk stratification and time to surgery were collected. Perioperative outcomes, including length of stay (LOS) and complications, were collated. Post-operative outcomes, including erectile dysfunction (ED), biochemical recurrence (BCR), and urinary continence, were assessed. Results: Preoperative risk stratification showed no difference between the two groups. The median time from diagnosis to treatment was similar between the two groups (pre-centralisation, 121 days, post-centralisation, 117 days). The mean length of stay (pre-centralisation, 2.1 days, post-centralisation, 1.6 days) showed no significant difference (p=0.073). Proportion of overall complications (pre-centralisation, 11.4%, post-centralisation, 8.7%) and complications, above Clavien-Dindo 2, were similar between the two groups (pre-centralisation1.2%, post-centralisation 2.2%). Post operative functional parameters, including continence and ED, were comparable. Five-year BCR free rate was 78% for the pre-centralisation group and 79% for the post centralisation group. Conclusion: For our cohort of patients, clinical outcomes have remained static during centralisation. It is imperative that centralisation is accompanied by increased capacity, streamlining of pathways, and training to ensure that improved quality of care is achieved. Our institution has newly acquired a robot, and prospectively studying this data may support the reversal of centralisation for RP surgery.

Keywords: prostate, cancer, prostatectomy, clinical

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Authors: Kingkan Chumjamras

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There are permanent and temporary tracheostomies, and in a permanent tracheostomy, care giver are important persons to know and be able to care for the tracheostomy patient. The objective of this quasi-experimental study was to evaluate outcomes of educating care giver in tracheostomy wound care for discharge planning of tracheostomy patients. The subjects of the study were relatives who directly cared for tracheostomy patients. Thirty subjects were selected according to specified criteria. The research instruments consisted of practice guidelines, manual for relatives in caring for the tracheostomy wound, an assisted model with a tracheostomy wound, a test, an observation form, and a patient’s relative satisfaction questionnaire. The instrument validity was tested by three experts, and the questionnaire reliability was tested with Cronbach’s alpha, and the reliability coefficient was 0.83; the data were analyzed using descriptive statistics, and paired t-test. The results of the study on educating relatives in tracheostomy wound care for discharge planning of tracheostomy patients revealed that the score for knowledge and ability in caring for the tracheostomy wound before receiving the education was at a low level (M= 19.23, SD= 1.57) compared with the very high score (M= 36.40, SD= 19.23) after receiving the education. The difference was statistically significant (p < .05), and relatives’ satisfaction was at a high level (80 percent). Knowledge and ability in caring for tracheostomy patients among patients’ relatives could cause tracheostomy wound complications for tracheostomy patients. One way to control such complications and returns to hospital from infection, in addition to care by the health care team, is educating relatives in tracheostomy wound care for discharge planning of tracheostomy patients.

Keywords: outcomes, educating, care giver, Tracheostomy Wound Care, discharge planning

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Authors: S. Ayeko, J. Milton, C. Hughes, K. Anderson, R. G. Middleton

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Background: Periprosthetic femoral fractures (PFF) in association with hip hemiarthroplasty or total hip arthroplasty is a common and serious complication. In the Vancouver Classification system algorithm, B1 fractures should be treated with Open Reduction and Internal Fixation (ORIF) and preferentially revised in combination with ORIF if B2 or B3. This study aims to assess patient outcomes after plate osteosynthesis alone for Vancouver B1 and B2 fractures. The main outcome is the 1-year re-revision rate, and secondary outcomes are 30-day and 1-year mortality. Method: This is a retrospective single-centre case-series review from January 2016 to June 2021. Vancouver B1 and B2, non-malignancy fractures in adults over 18 years of age treated with polyaxial Non-Contact Bridging plate osteosynthesis, have been included. Outcomes were gathered from electronic notes and radiographs. Results: There were 50 B1 and 64 B2 fractures. 26 B2 fractures were managed with ORIF and revision, 39 ORIF alone. Of the revision group, one died within 30 days (3.8%), one at one year (3.8%), and two were revised within one year (7.7). Of the B2 ORIF group, three died within 30-day mortality (7.96%), eight at one year (21.1%), and 0 were revised in 1 year. Conclusion: This study has demonstrated that satisfactory outcomes can be achieved with ORIF, excluding revision in the management of B2 fractures.

Keywords: arthroplasty, bridging plate, periprosthetic fracture, revision surgery

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Authors: Kristin Thooft

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— Increasing pressure to manage healthcare costs has resulted in shifting care towards ambulatory settings and is driving a focus on cost transparency. There are few nurse staffing to workload models developed for ambulatory settings, less for multi-specialty clinics. Of the existing models, few have been evaluated against outcomes to understand any impact. This evaluation took place after the AWARD model for nurse staffing to workload was implemented in a multi-specialty clinic at a regional healthcare system in the Midwest. The multi-specialty clinic houses 26 medical and surgical specialty practices. The AWARD model was implemented in two specialty practices in October 2020. Donabedian’s Structure-Process-Outcome (SPO) model was used to evaluate outcomes based on changes to the structure and processes of care provided. The AWARD model defined and quantified the processes, recommended changes in the structure of day-to-day nurse staffing. Cost of care per patient visit, total visits, a total nurse performed visits used as structural and process measures, influencing the outcomes of cost of care and access to care. Independent t-tests were used to compare the difference in variables pre-and post-implementation. The SPO model was useful as an evaluation tool, providing a simple framework that is understood by a diverse care team. No statistically significant changes in the cost of care, total visits, or nurse visits were observed, but there were differences. Cost of care increased and access to care decreased. Two weeks into the post-implementation period, the multi-specialty clinic paused all non-critical patient visits due to a second surge of the COVID-19 pandemic. Clinic nursing staff was re-allocated to support the inpatient areas. This negatively impacted the ability of the Nurse Manager to utilize the AWARD model to plan daily staffing fully. The SPO framework could be used for the ongoing assessment of nurse staffing performance. Additional variables could be measured, giving a complete picture of the impact of nurse staffing. Going forward, there must be a continued focus on the outcomes of care and the value of nursing

Keywords: ambulatory, clinic, evaluation, outcomes, staffing, staffing model, staffing to workload

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Authors: Lucia Liu, Matthew Koziol

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Obsessive-compulsive disorder (OCD), a long-lasting anxiety disorder involving recurrent, intrusive thoughts, affects over 2 million adults in the United States. Transcranial magnetic stimulation (TMS) stands out as a noninvasive, cutting-edge therapy that has been shown to reduce symptoms in patients with treatment-resistant OCD. The Food and Drug Administration (FDA) approved protocol pairs TMS sessions with individualized symptom provocation, aiming to improve the susceptibility of brain circuits to stimulation. However, limited standardization or guidance exists on how to conduct symptom provocation and which methods are most effective. This study aims to compare the effect of internal versus external techniques to induce obsessional stress in a clinical setting during TMS therapy. Two symptom provocation methods, (i) Asking patients thought-provoking questions about their obsessions (internal) and (ii) Requesting patients to perform obsession-related tasks (external), were employed in a crossover design with repeated measurement. Thirty-six treatments of NeuroStar TMS were administered to each of two patients over 8 weeks in an outpatient clinic. Patient One received 18 sessions of internal provocation followed by 18 sessions of external provocation, while Patient Two received 18 sessions of external provocation followed by 18 sessions of internal provocation. The primary outcome was the level of self-reported obsessional stress on a visual analog scale from 1 to 10. The secondary outcome was self-reported OCD severity, collected biweekly in a four-level Likert-scale (1 to 4) of bad, fair, good and excellent. Outcomes were compared and tested between provocation arms through repeated measures ANOVA, accounting for intra-patient correlations. Ages were 42 for Patient One (male, White) and 57 for Patient Two (male, White). Both patients had similar moderate symptoms at baseline, as determined through the Yale-Brown Obsessive Compulsive Scale (YBOCS). When comparing obsessional stress induced across the two arms of internal and external provocation methods, the mean (SD) was 6.03 (1.18) for internal and 4.01 (1.28) for external strategies (P=0.0019); ranges were 3 to 8 for internal and 2 to 8 for external strategies. Internal provocation yielded 5 (31.25%) bad, 6 (33.33%) fair, 3 (18.75%) good, and 2 (12.5%) excellent responses for OCD status, while external provocation yielded 5 (31.25%) bad, 9 (56.25%) fair, 1 (6.25%) good, and 1 (6.25%) excellent responses (P=0.58). Internal symptom provocation tactics had a significantly stronger impact on inducing obsessional stress and led to better OCD status (non-significant). This could be attributed to the fact that answering questions may prompt patients to reflect more on their lived experiences and struggles with OCD. In the future, clinical trials with larger sample sizes are warranted to validate this finding. Results support the increased integration of internal methods into structured provocation protocols, potentially reducing the time required for provocation and achieving greater treatment response to TMS.

Keywords: obsessive-compulsive disorder, transcranial magnetic stimulation, mental health, symptom provocation

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Authors: Amira A. Alshowkan, Aleya M. Gamal

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Background: Patient safety is a vital element in providing high quality health care. In psychiatric wards, numerous of physical and emotional factors have been found to affect patient safety. In addition, organization, healthcare provider and patients were identified to be significant factors in patient safety. Aim: This study aims to discover nurses' perception of patient safety in psychiatric wards in Saudi Arabian. Method: Date will be collected through semi-structure face to face interview with nurses who are working at psychiatric wards. Data will be analysed thought the used of thematic analysis. Results: The results of this study will help in understanding the psychiatric nurses' perception of patient safety in Saudi Arabia. Several suggestions will be recommended for formulation of policies and strategies for psychiatric wards. In addition, recommendation to nursing education and training will be tailored in order to improve patient safety culture.

Keywords: patient safety culture, psychiatric, qualitative, Saudi Arabia

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Authors: Gerard Bray, Derek Mao, Arya Bahadori, Sachinka Ranasinghe

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The EAU currently recommends partial nephrectomy as the preferred management for localised cT1 renal tumours, irrespective of surgical approach. With the advent of robotic assisted partial nephrectomy, there is growing evidence that warm ischaemia time may be reduced compared to the traditional laparoscopic approach. There is still no clear differences between the two approaches with regards to other peri-operative and oncological outcomes. Current limitations in the field denote the lack of single surgeon series to compare the two approaches as other studies often include multiple operators of different experience levels. To the best of our knowledge, this study is the first single surgeon series comparing peri-operative outcomes of robotic assisted and laparoscopic PN. The current study aims to reduce intra-operator bias while maintaining an adequate sample size to assess the differences in outcomes between the two approaches. We retrospectively compared patient demographics, peri-operative outcomes, and renal function derangements of all partial nephrectomies undertaken by a single surgeon with experience in both laparoscopic and robotic surgery. Warm ischaemia time, length of stay, and acute renal function deterioration were all significantly reduced with robotic partial nephrectomy, compared to laparoscopic nephrectomy. This study highlights the benefits of robotic partial nephrectomy. Further prospective studies with larger sample sizes would be valuable additions to the current literature.

Keywords: partial nephrectomy, robotic assisted partial nephrectomy, warm ischaemia time, peri-operative outcomes

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Authors: Ya-Chu May Tsai, Ibrahim Yacoub, Eoin Casey

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The Australian and New Zealand College of Anaesthetists (ANZCA) advises that smoking should not be permitted within 12 hours of surgery. There is little information in the medical literature regarding patients awareness of perioperative smoking cessation recommendations nor their appreciation of how smoking might negatively impact their perioperative course. The aim of the study is to assess the prevalence of current smokers presenting to Werribee Mercy Hospital (WMH) and to evaluate if pre-operative provision of both written and verbal pre-operative advice was, 1: Effective in improving patient awareness of the benefits of pre-operative smoking cessation, 2: Associated with an increase in the number of elective surgical patients who stop smoking at least 12 hours pre-operatively. Methods: The initial survey included all patients who presented to WMH for elective surgical procedures from 19 – 30 September 2016 using a standardized questionnaire focused on patients’ smoking history and their awareness of smoking cessation preoperatively. The intervention consisted of a standard pre-operative phone call to all patients advising them of the increased perioperative risks associated with smoking, and advised patients to cease 12 hours prior. In addition, written information on smoking cessation strategies were sent out in mail at least 1 week prior to planned procedure date to all patients. Questionnaire-based study after the intervention was conducted on day of elective procedure from 10 – 21 October 2016 inclusive. Primary outcomes measured were patient’s awareness of smoking cessation and proportion of smokers who quit >12 hours, considered a clinically meaning duration to reduce anaesthetics complications. Comparison of pre and post intervention results were made using SPSS 21.0. Results: In the pre-intervention group (n=156), 36 (22.4%) patients were current smokers, 46 were ex-smokers (29.5%) and 74 were non-smokers (48.1%). Of the smokers, 12 (33%) reported having been informed of smoking cessation prior to operation and 8 (22%) were aware of increased intra- and perioperative adverse events associated with smoking. In the post-intervention group n= 177, 38 (21.5%) patients were current smokers, 39 were ex-smokers (22.0%) and 100 were non-smokers (56.5%). Of the smokers, 32 (88.9%) reported having been informed of smoking cessation prior to operation and 35 (97.2%) reported being aware of increased intra- and perioperative adverse events associated with smoking. The median time since last smoke in the pre-intervention group was 5.5 hours (Q1-Q3 = 2-14) compared with 13 hours (Q1-Q3 = 5-24) in post intervention group. Amongst the smokers, smoking cessation at least 12 hours prior to surgery significantly increased from 27.8% pre-intervention to 52.6% post intervention (P=0.03). Conclusion: A standard preoperative phone call and written instruction on smoking cessation guidelines at time of waitlist placement increase preoperative smoking cessation rates by almost 2-fold.

Keywords: anaesthesia, audit, perioperative medicine, smoking cessation

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Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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Authors: Hasan Frookh Jamal

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This is a case of a 36-year-old Bahraini gentleman diagnosed to have Cushing's Syndrome with a large anterior mediastinal mass. He was sent abroad to the Speciality hospital in Jordan, where he underwent diagnostic video-assisted thoracoscopy, partial thymectomy and pericardial fat excision. Histopathology of the mass was reported to be an Atypical carcinoid tumor with a low Ki67 proliferation index of 5%, the mitotic activity of 4 MF/10HPF and pathological stage classification(pTNM): pT1aN1. MRI of the pituitary gland showed an ill-defined non-enhancing focus of about 3mm on the Rt side of the pituitary on coronal images, with a similar but smaller one on the left side, which could be due to enhancing pattern rather than a real lesion as reported. The patient underwent Ga68 Dotate PET/CT scan post-operatively, which showed multiple somatostatin receptor-positive lesions seen within the tail, body and head of the pancreas and positive somatostatin receptor lymph nodes located between the pancreatic head and IVC. There was no uptake detected at the anterior mediastinum nor at the site of thymic mass resection. There was no evidence of any positive somatostatin uptake at the soft tissue or lymph nodes. The patient underwent IPSS, which proved that the source is, in fact, an ectopic source of ACTH secretion. Unfortunately, the patient's serum cortisol remained elevated after surgery and failed to be suppressed by 1 mg ODST and by 2 days LLDST with a high ACTH value. The patient was started on Osilodrostat for treatment of hypercortisolism for the time being and his future treatment plan with Lutetium-177 Dotate therapy vs. bilateral adrenalectomy is to be considered in an MDT meeting.

Keywords: cushing syndrome, neuroendocrine tumur, carcinoid tumor, Thymoma

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