Search results for: individual patient data

Authors: Hiroshi Kinoshita, Yasuto Nakanishi, Ryuhei Okuno, Toshio Higashi

Abstract:

Various kinds of pegboards have been developed and used widely in research and clinics of rehabilitation for evaluation and training of patient’s hand function. A common measure in these peg boards is a total time of performance execution assessed by a tester’s stopwatch. Introduction of electrical and automatic measurement technology to the apparatus, on the other hand, has been delayed. The present work introduces the development of a pegboard with an electric sensor to detect moments of individual peg’s insertion and removal. The work also gives fundamental data obtained from a group of healthy young individuals who performed peg transfer tasks using the pegboard developed. Through trails and errors in pilot tests, two 10-hole peg-board boxes installed with a small photo-reflector and a DC amplifier at the bottom of each hole were designed and built by the present authors. The amplified electric analogue signals from the 20 reflectors were automatically digitized at 500 Hz per channel, and stored in a PC. The boxes were set on a test table at different distances (25, 50, 75, and 125 mm) in parallel to examine the effect of hole-to-hole distance. Fifty healthy young volunteers (25 in each gender) as subjects of the study performed successive fast 80 time peg transfers at each distance using their dominant and non-dominant hands. The data gathered showed a clear-cut light interruption/continuation moment by the pegs, allowing accurately (no tester’s error involved) and precisely (an order of milliseconds) to determine the pull out and insertion times of each peg. This further permitted computation of individual peg movement duration (PMD: from peg-lift-off to insertion) apart from hand reaching duration (HRD: from peg insertion to lift-off). An accidental drop of a peg led to an exceptionally long ( < mean + 3 SD) PMD, which was readily detected from an examination of data distribution. The PMD data were commonly right-skewed, suggesting that the median can be a better estimate of individual PMD than the mean. Repeated measures ANOVA using the median values revealed significant hole-to-hole distance, and hand dominance effects, suggesting that these need to be fixed in the accurate evaluation of PMD. The gender effect was non-significant. Performance consistency was also evaluated by the use of quartile variation coefficient values, which revealed no gender, hole-to-hole, and hand dominance effects. The measurement reliability was further examined using interclass correlation obtained from 14 subjects who performed the 25 and 125 mm hole distance tasks at two 7-10 days separate test sessions. Inter-class correlation values between the two tests showed fair reliability for PMD (0.65-0.75), and for HRD (0.77-0.94). We concluded that a sensor peg board developed in the present study could provide accurate (excluding tester’s errors), and precise (at a millisecond rate) time information of peg movement separated from that used for hand movement. It could also easily detect and automatically exclude erroneous execution data from his/her standard data. These would lead to a better evaluation of hand dexterity function compared to the widely used conventional used peg boards.

Keywords: hand, dexterity test, peg movement time, performance consistency

Procedia PDF Downloads 104

Authors: Thitima Plejai

Abstract:

The practice in the operating room has been continually performed according to standards of services; however, undesirable incidents from surgical services are found such as surgical complications in the operating room. This participation action research aimed to develop practice guidelines for surgical safety management to reduce undesirable incidents from surgical services in the operating room of Songkhla Hospital. The target population was all 84 members of the multidisciplinary team who were involved in surgical services in the operating room consisting of 28 surgeons from five branches of surgery, 27 anesthetists and nurse anesthetists, and 29 surgical nurses. The data were collected through in-depth interviews, and non-participatory observations. The research instrument was tested by three experts, and the steps of the development consisted of four cycles, each consisting of assessment, planning, practice, practice reflection, and improvement until every step is practicable. The data were validated through triangulation research method, analyzed through content analysis and statistical analysis with number and percentage. The results of the development of practice guidelines surgical safety management to reduce undesirable incidents from surgical services could be concluded as follows. 1) The multidisciplinary team in surgery participated in the needs assessment for development of practice guidelines for surgical patient safety, and agreed on adapting the WHO Surgical Safety Checklists for use. 2) The WHO Surgical Safety Checklists was implemented, and meetings were held for the multidisciplinary team in surgery and the organizational risk committee to improve the practice guidelines to make them more practicable. 3) The multidisciplinary team consisting of surgeons from five branches of surgery, anesthetists, nurse anesthetists, surgical nurses, and the organizational risk committee announced policy on safety for surgical patients; the organizational risk committee designated the Surgical Safety Checklist as an instrument for surgical patient safety. The results of the safety management found that the surgical team members who could follow 100 percent of the guidelines were: professional nurses who checked patient identity and information before taking the patient to the operating room and kept complete records of data on the patients; surgical nurses who checked readiness of the patient before surgery; nurse anesthetists who assessed readiness before administering anesthetic drugs, and confirmed correctness of the patient; and circulating perioperative nurses who gave confirmation to the surgical team after completion of the surgery. The rates of undesirable incidents (surgical complications rates) before and after the implementation of the surgical safety management were 1.60 percent and 0.66 percent, respectively. The satisfaction of the surgery-related teams towards the use of the guidelines was 89 percent. The practice guidelines for surgical safety management to reduce undesirable incidents were taken as guidelines for surgical safety that the multidisciplinary team involved in the surgical process implemented correctly and in the same direction and clearly reduced undesirable incidents in surgical patients.

Keywords: practice guidelines, surgical safety management, reduce undesirable incidents, operating Room

Procedia PDF Downloads 272

Authors: Aziz Ikhlef

Abstract:

Most of multi-slices CT scanners are built with detectors composed of scintillator - photodiodes arrays. The photodiodes arrays are mainly based on front-illuminated technology for detectors under 64 slices and on back-illuminated photodiode for systems of 64 slices or more. The designs based on back-illuminated photodiodes were being investigated for CT machines to overcome the challenge of the higher number of runs and connection required in front-illuminated diodes. In backlit diodes, the electronic noise has already been improved because of the reduction of the load capacitance due to the routing reduction. This translated by a better image quality in low signal application, improving low dose imaging in large patient population. With the fast development of multi-detector-rows CT (MDCT) scanners and the increasing number of examinations, the clinical community has raised significant concerns on radiation dose received by the patient in both medical and regulatory community. In order to reduce individual exposure and in response to the recommendations of the International Commission on Radiological Protection (ICRP) which suggests that all exposures should be kept as low as reasonably achievable (ALARA), every manufacturer is trying to implement strategies and solutions to optimize dose efficiency and image quality based on x-ray emission and scanning parameters. The added demands on the CT detector performance also comes from the increased utilization of spectral CT or dual-energy CT in which projection data of two different tube potentials are collected. One of the approaches utilizes a technology called fast-kVp switching in which the tube voltage is switched between 80kVp and 140kVp in fraction of a millisecond. To reduce the cross-contamination of signals, the scintillator based detector temporal response has to be extremely fast to minimize the residual signal from previous samples. In addition, this paper will present an overview of detector technologies and image chain improvement which have been investigated in the last few years to improve the signal-noise ratio and the dose efficiency CT scanners in regular examinations and in energy discrimination techniques. Several parameters of the image chain in general and in the detector technology contribute in the optimization of the final image quality. We will go through the properties of the post-patient collimation to improve the scatter-to-primary ratio, the scintillator material properties such as light output, afterglow, primary speed, crosstalk to improve the spectral imaging, the photodiode design characteristics and the data acquisition system (DAS) to optimize for crosstalk, noise and temporal/spatial resolution.

Keywords: computed tomography, X-ray detector, medical imaging, image quality, artifacts

Procedia PDF Downloads 231

Authors: Volker Koch, Sigrid Swobodnik, Bernd M. Zunk

Abstract:

The success of companies on globalized markets is significantly influenced by the performance of purchasing departments and, of course, the individuals employed as professional purchasers. Nonetheless, this is generally accepted in practice, in literature as well as in empirical research, only insufficient attention was given to the assessment of this relationship between the personality of professional purchasers and their individual performance. This paper aims to describe the relationship against the background of the 'Big Five Inventory'. Based on the five dimensions of a personality (openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism) a research model was designed. The research model divides the individual performance of professional purchasers into two major dimensions: operational and strategic. The operational dimension consists of the items 'cost', 'quality delivery' and 'flexibility'; the strategic dimension comprises the positions 'innovation', 'supplier satisfaction' as wells as 'purchasing and supply management integration in the organization'. To test the research model, a survey study was performed, and an online questionnaire was sent out to purchasing professionals in Austrian companies. The data collected from 78 responses was used to test the research model applying a group comparison. The comparison points out that there is (i) an influence of the purchasers’ personality on the individual performance of professional purchasers and (ii) a link between purchasers’ personality to a high or a low individual performance of professional purchasers. The findings of this study may help human resource managers during staff recruitment processes to identify the 'right performing personality' for an operational and/or a strategic position in purchasing departments.

Keywords: big five inventory, individual performance, personality, purchasing professionals

Procedia PDF Downloads 144

Authors: Yun-Tsuen Chen, Shih-Ting Huang, Pi-Fen Cheng, Yu-Ting Su, Joffrey Hsu, Hui-Zhu Chen

Abstract:

Acute intestinal obstruction is one of the differentials of acute abdomen and requires timely alleviation of intestinal distention and abdominal pain to avoid perforation, intra-abdominal infection, and peritonitis. Investigation to identify the cause of obstruction will direct treatment planning and allow for more effective management. In this study, we present a 71-year-old female presenting with symptoms of acute intestinal obstruction for five days. After extensive history taking, physical exam, medical imaging, and pathology, the patient was diagnosed with colon cancer with lung metastasis and acute intestinal obstruction. The patient was placed on nil per os status with intravenous fluid support, intravenous antibiotics, and a decompression nasogastric tube was placed. The patient received decompression with colostomy creation surgery. After assessing the patient’s clinical condition and tumor staging, a multidisciplinary healthcare team created an individualized treatment plan, which included plans to prepare the patient for home self-care and maintain good mental health with regular monitoring in the clinic setting. This case demonstrates the importance of early diagnosis, effective treatment, and a multidisciplinary approach to the management of acute intestinal obstruction secondary to colon cancer.

Keywords: acute intestinal obstruction, colostomy surgery, metastatic colon cancer, multidisciplinary healthcare team

Procedia PDF Downloads 79

Authors: Babu Shersad, Partha Banerjee

Abstract:

Reduction in haemoglobin levels has been implicated to be a cause for reduced exercise tolerance and cardiovascular complications of chronic renal diseases. Trends of hemoglobin levels in patients on haemodialysis could be an indicator of efficacy of hemodialysis and an indicator of quality of life in haemodialysis patients. In the UAE, the rate of growth (of patients on dialysis) is 10 to 15 per cent per year. The primary mode of haemodialysis in the region is based on in-patient hospital-based hemodialysis units. The increase in risk of cardiovascular and cerebrovascular morbidity as well as mortality in pre-dialysis Chronic Renal Disease has been reported. However, data on the health burden on haemodialysis in standalone dialysis facilities is very scarce. This is mainly due to the paucity of ambulatory centres for haemodialysis in the region. AMSA is the first center to offer standalone dialysis in the UAE and a study over a one year period was performed. Patient data was analyzed using a questionnaire for 45 patients with an average of 2.5 dialysis sessions per week. All patients were on chronic haemodialysis as outpatients. The trends of haemoglobin levels as an independent variable were evaluated. These trends were interpreted in comparison with other parameters of renal function (creatinine, uric acid, blood pressure and ferritin). Trends indicate an increase in hemoglobin levels with increased supplementation of iron and erythropoietin over time. The adequacy of hemodialysis shows improvement concomitantly. This, in turn, correlates with better patient outcomes and has a direct impact on morbidity and mortality. This study is a pilot study and further studies are indicated so that objective parameters can be studied and validated for hemodialysis in the region.

Keywords: haemodialysis, haemoglobin in haemodialysis, haemodialysis parameters, erythropoietic agents in haemodialysis

Procedia PDF Downloads 252

Authors: Esra Danaci, Tugba Kavalali Erdogan, Sevil Masat, Selin Keskin Kiziltepe, Tugba Cinarli, Zeliha Koc

Abstract:

This study was conducted in a descriptive and cross-sectional manner to determine that factors that influence the self-efficacy and self-sufficiency levels among oncology patients. The research was conducted between January 24, 2017 and September 24, 2017 in the oncology and hematology departments of a university hospital in Turkey with 179 voluntary inpatients. The data were collected through the Self-Sufficiency/Self-Efficacy Scale and a 29-question survey, which was prepared in order to determine the sociodemographic and clinical properties of the patients. The Self-Sufficiency/Self-Efficacy Scale is a Likert-type scale with 23 articles. The scale scores range between 23 and 115. A high final score indicates a good self-sufficiency/self-efficacy perception for the individual. The data were analyzed using percentage analysis, one-way ANOVA, Mann Whitney U-test, Kruskal Wallis test and Tukey test. The demographic data of the subjects were as follows: 57.5% were male and 42.5% were female, 82.7% were married, 46.4% were primary school graduate, 36.3% were housewives, 19% were employed, 93.3% had social security, 52.5% had matching expenses and incomes, 49.2% lived in the center of the city. The mean age was 57.1±14.6. It was determined that 22.3% of the patients had lung cancer, 19.6% had leukemia, and 43.6% had a good overall condition. The mean self-sufficiency/self-efficacy score was 83,00 (41-115). It was determined that the patients' self-sufficiency/self-efficacy scores were influenced by some of their socio-demographic and clinical properties. This study has found that the patients had high self-sufficiency/self-efficacy scores. It is recommended that the nursing care plans should be developed to improve their self-sufficiency/self-efficacy levels in the light of the patients' sociodemographic and clinical properties.

Keywords: oncology, patient, self-efficacy, self-sufficiency

Procedia PDF Downloads 145

Authors: Fenni Sim

Abstract:

Objectives: The purpose of the study is to examine the relationship between family functioning and level of self-efficacy: how family functioning can potentially affect self-efficacy which will eventually lead to better clinical outcomes. The hypothesis was ‘Patients on haemodialysis with perceived higher family functioning are more likely to have higher perceived level of self-efficacy’. Methods: The study was conducted with a mixed methodology of quantitative and qualitative data collection of survey and semi-structured interview respectively. The General Self-Efficacy scale and SCORE-15 were self-administered by participants. The data will be analysed with correlation analysis method using Microsoft Excel. 79 patients were recruited for the study through random sampling. 6 participants whose results did not reflect the hypothesis were then recruited for the qualitative study. Interpretive phemenological analysis was then used to analyse the qualitative data. Findings: The hypothesis was accepted that higher family functioning leads to higher perceived self-efficacy. The correlation coefficient of -0.21 suggested a mild correlation between the two variables. However, only 4.6% of the variation in perceived self-efficacy is accounted by the variation in family functioning. The qualitative study extrapolated three themes that might explain the variations in the outliers: (1) level of physical functioning affects perceived self-efficacy, (2) instrumental support from family influenced perceived level of family functioning, and self-efficacy, (3) acceptance of illness reflects higher level of self-efficacy. Conclusion: While family functioning does have an impact on perceived self-efficacy, there are many intrapersonal and physical factors that may affect self-efficacy. The concepts of family functioning and self-efficacy are more appropriately seen as complementing each other to help a patient in managing his illness. Healthcare social workers can look at how family functioning is supporting the individual needs of patients with different trajectory of ESRD and the support we can provide to improve one’s self-efficacy.

Keywords: chronic kidney disease, coping of illness, family functioning, self efficacy

Procedia PDF Downloads 149

Authors: H. A. Algahtani, A. S. Khan, O. Alzahrani, N. Hussein, M. A. Khan, Loudhi Y. I. Soliman

Abstract:

Objective: To report on the Saudi experience (developing country) of neurological complications from bariatric surgery. The literature on the subject is reviewed. Method: This is a cross sectional study done in King Abdul Aziz Medical City Jeddah, WR, where we reviewed all charts of the patients who underwent bariatric surgery between January 1st, 2009 to December 31st , 2014. Personal and clinical data including age, sex, BMI, comorbidities, type of procedure, duration of stay in hospital, complications and postoperative follow up were collected. In addition follow up visit and remote complication if present were collected. All patients with neurological complications were reviewed in details including their clinical examination, laboratory and imaging results, treatment and prognosis. This report is essentially descriptive with no statistical analysis performed. Results: Fifteen cases were collected in this study (3%). Axonal polyneuropathy was the most frequent neurological complica¬tion, but cases of Wernicke syndrome, vitamin B12 deficiency, Guillain-Barre syndrome and cupper deficiency were also identified. Fourteen patients (93.3%) had full recovery from the neurological signs and symptoms but unfortunately one patient died. Conclusion: Bariatric surgery, a procedure that is continuously increasing in popularity, is not free of potential neurological complications. A clear education, guidelines and follow-up program should be planned and practiced. Facts should be clearly presented to the individual undergoing this type of surgery. Although a clear cause-effect relation cannot be established for the present cases, the cumulative literature on the subject makes it important to warn the patient of the potential risks of this procedure.

Keywords: bariatric surgery, neurological complications, neuropathy, Wenicke syndrome

Procedia PDF Downloads 304

Authors: Mohammed Saeed Jawad

Abstract:

Metaverse involves the convergence of three major technologies trends of AI, VR, and AR. Together these three technologies can provide an entirely new channel for delivering healthcare with great potential to lower costs and improve patient outcomes on a larger scale. Telepresence is the technology that allows people to be together even if they are physically apart. Medical doctors can be symbolic as interactive avatars developed to have smart conversations and medical recommendations for patients at the different stages of the treatment. Medical digital assets such as Medical IoT for real-time remote healthcare monitoring as well as the symbolic doctors’ avatars as well as the hospital and clinical physical constructions and layout can be immersed in extended realities 3D metaverse environments where doctors, nurses, and patients can interact and socialized with the related digital assets that facilitate the data analytics of the sensed and collected personal medical data with visualized interaction of the digital twin of the patient’s body as well as the medical doctors' smart conversation and consultation or even in a guided remote-surgery operation.

Keywords: personal healthcare, metaverse, telemedicine, telepresence, avatar, medical consultation, remote-surgery

Procedia PDF Downloads 106

Authors: Khachen Kongpakwattana, Nathorn Chaiyakunapruk

Abstract:

Background: Decision-analytic models for Alzheimer’s disease (AD) have been advanced to discrete-event simulation (DES), in which individual-level modelling of disease progression across continuous severity spectra and incorporation of key parameters such as treatment persistence into the model become feasible. This study aimed to apply the DES to perform a cost-effectiveness analysis of treatment for AD in Thailand. Methods: A dataset of Thai patients with AD, representing unique demographic and clinical characteristics, was bootstrapped to generate a baseline cohort of patients. Each patient was cloned and assigned to donepezil, galantamine, rivastigmine, memantine or no treatment. Throughout the simulation period, the model randomly assigned each patient to discrete events including hospital visits, treatment discontinuation and death. Correlated changes in cognitive and behavioral status over time were developed using patient-level data. Treatment effects were obtained from the most recent network meta-analysis. Treatment persistence, mortality and predictive equations for functional status, costs (Thai baht (THB) in 2017) and quality-adjusted life year (QALY) were derived from country-specific real-world data. The time horizon was 10 years, with a discount rate of 3% per annum. Cost-effectiveness was evaluated based on the willingness-to-pay (WTP) threshold of 160,000 THB/QALY gained (4,994 US$/QALY gained) in Thailand. Results: Under a societal perspective, only was the prescription of donepezil to AD patients with all disease-severity levels found to be cost-effective. Compared to untreated patients, although the patients receiving donepezil incurred a discounted additional costs of 2,161 THB, they experienced a discounted gain in QALY of 0.021, resulting in an incremental cost-effectiveness ratio (ICER) of 138,524 THB/QALY (4,062 US$/QALY). Besides, providing early treatment with donepezil to mild AD patients further reduced the ICER to 61,652 THB/QALY (1,808 US$/QALY). However, the dominance of donepezil appeared to wane when delayed treatment was given to a subgroup of moderate and severe AD patients [ICER: 284,388 THB/QALY (8,340 US$/QALY)]. Introduction of a treatment stopping rule when the Mini-Mental State Exam (MMSE) score goes below 10 to a mild AD cohort did not deteriorate the cost-effectiveness of donepezil at the current treatment persistence level. On the other hand, none of the AD medications was cost-effective when being considered under a healthcare perspective. Conclusions: The DES greatly enhances real-world representativeness of decision-analytic models for AD. Under a societal perspective, treatment with donepezil improves patient’s quality of life and is considered cost-effective when used to treat AD patients with all disease-severity levels in Thailand. The optimal treatment benefits are observed when donepezil is prescribed since the early course of AD. With healthcare budget constraints in Thailand, the implementation of donepezil coverage may be most likely possible when being considered starting with mild AD patients, along with the stopping rule introduced.

Keywords: Alzheimer's disease, cost-effectiveness analysis, discrete event simulation, health technology assessment

Procedia PDF Downloads 101

Authors: Aziz Ikhlef

Abstract:

Most of multi-slices Computed Tomography (CT) scanners are built with detectors composed of scintillator - photodiodes arrays. The photodiodes arrays are mainly based on front-illuminated technology for detectors under 64 slices and on back-illuminated photodiode for systems of 64 slices or more. The designs based on back-illuminated photodiodes were being investigated for CT machines to overcome the challenge of the higher number of runs and connection required in front-illuminated diodes. In backlit diodes, the electronic noise has already been improved because of the reduction of the load capacitance due to the routing reduction. This is translated by a better image quality in low signal application, improving low dose imaging in large patient population. With the fast development of multi-detector-rows CT (MDCT) scanners and the increasing number of examinations, the clinical community has raised significant concerns on radiation dose received by the patient in both medical and regulatory community. In order to reduce individual exposure and in response to the recommendations of the International Commission on Radiological Protection (ICRP) which suggests that all exposures should be kept as low as reasonably achievable (ALARA), every manufacturer is trying to implement strategies and solutions to optimize dose efficiency and image quality based on x-ray emission and scanning parameters. The added demands on the CT detector performance also comes from the increased utilization of spectral CT or dual-energy CT in which projection data of two different tube potentials are collected. One of the approaches utilizes a technology called fast-kVp switching in which the tube voltage is switched between 80 kVp and 140 kVp in fraction of a millisecond. To reduce the cross-contamination of signals, the scintillator based detector temporal response has to be extremely fast to minimize the residual signal from previous samples. In addition, this paper will present an overview of detector technologies and image chain improvement which have been investigated in the last few years to improve the signal-noise ratio and the dose efficiency CT scanners in regular examinations and in energy discrimination techniques. Several parameters of the image chain in general and in the detector technology contribute in the optimization of the final image quality. We will go through the properties of the post-patient collimation to improve the scatter-to-primary ratio, the scintillator material properties such as light output, afterglow, primary speed, crosstalk to improve the spectral imaging, the photodiode design characteristics and the data acquisition system (DAS) to optimize for crosstalk, noise and temporal/spatial resolution.

Keywords: computed tomography, X-ray detector, medical imaging, image quality, artifacts

Procedia PDF Downloads 169

Authors: Pippa Sipanoun, Jo Wray, Kate Oulton, Faith Gibson

Abstract:

Background: With rapidly evolving digital health innovation, there is a need for digital health transformation that is accessible and sustainable, that demonstrates utility for all stakeholders while maintaining data safety. Great Ormond Street Hospital for Children aimed to future-proof the hospital by transitioning to an electronic patient record (EPR) system with a tethered patient portal (MyGOSH) in April 2019. MyGOSH patient portal enables patients 12 years or older (with their parent's consent) to access their digital health data. This includes access to results, documentation, and appointments that facilitate communication with their care team. As part of the Going Digital Study conducted between 2018-2021, data were collected from a sample of all relevant stakeholders before and after EPR and MyGOSH implementation. Data collection reach was wide and included the hospital legal and ethics teams. Aims: This study aims to understand the ethical and legal implications of young people and their parents accessing their digital health data. Methods: A focus group was conducted. Recruited participants were members of the Great Ormond Street Hospital Paediatric Bioethics Centre. Participants included expert and lay members from the Committee from a variety of professional or academic disciplines. Written informed consent was provided by all participants (n=7). The focus group was recorded, transcribed verbatim, and analyzed using thematic analysis. Results: Six themes were identified: access, competence and capacity - granting access to the system; inequalities in access resulting in inequities; burden, uncertainty and responding to change - managing expectations; documenting, risks and data safety; engagement, empowerment and understanding – how to use and manage personal information; legal considerations and obligations. Discussion: If healthcare professionals are to empower young people to be more engaged in their care, the importance of including them in decisions about their health is paramount, especially when they are approaching the age of becoming the consenter for treatment. Complexities exist in assessing competence or capacity when granting system access, when disclosing sensitive information, and maintaining confidentiality. Difficulties are also present in managing clinician burden, managing user expectations whilst providing an equitable service, and data management that meets professional and legal requirements. Conclusion: EPR and tethered-portal implementation at Great Ormond Street Hospital for Children was not only timely, due to the need for a rapid transition to remote consultations during the COVID-19 pandemic, which would not have been possible had EPR/MyGOSH not been implemented, but also integral to the digital health revolution required in healthcare today. This study is highly relevant in understanding the complexities around young people and their parents accessing their digital health data and, although the focus of this research related to portal use and access, the findings translate to young people in the wider digital health context. Ongoing support is required for all relevant stakeholders following MyGOSH patient portal implementation to navigate the ethical and legal complexities. Continued commitment is needed to balance the benefits and burdens, promote inclusion and equity, and ensure portal utility for patient benefit, whilst maintaining an individualized approach to care.

Keywords: patient portal, young people and their parents, ethical, legal

Procedia PDF Downloads 91

Authors: Yasuyuki Takahashi, Maya Yamashita, Kyoko Saito

Abstract:

In general, dynamic SPECT data acquisition needs a few minutes for one rotation. Thus, the time-activity curve (TAC) derived from the dynamic SPECT is relatively coarse. In order to effectively shorten the interval, between data points, we adopted a 180-degree interpolation method. This method is already used for reconstruction of the X-ray CT data. In this study, we applied this 180-degree interpolation method to SPECT and investigated its effectiveness.To briefly describe the 180-degree interpolation method: the 180-degree data in the second half of one rotation are combined with the 180-degree data in the first half of the next rotation to generate a 360-degree data set appropriate for the time halfway between the first and second rotations. In both a phantom and a patient study, the data points from the interpolated images fell in good agreement with the data points tracking the accumulation of 99mTc activity over time for appropriate region of interest. We conclude that data derived from interpolated images improves the apparent time resolution of dynamic SPECT.

Keywords: dynamic SPECT, time resolution, 180-degree interpolation method, 99mTc-GSA.

Procedia PDF Downloads 476

Authors: Eunhwa Jun

Abstract:

This case report describes the misdiagnosis of a patient who presented with right arm pain as cervical disc herniation. The patient had several underlying conditions, including hypertension, diabetes mellitus, liver cirrhosis, a history of lung cancer with left lower lobe lobectomy, and adjuvant chemoradiotherapy. An external cervical spine MRI revealed central protruding discs at the C4-5-6-7 levels. Despite treatment with medication and epidural blocks, the patient's pain persisted. A C-RACZ procedure was planned, but the patient's pain had worsened before admission. Using ultrasound, a brachial plexus block was attempted, but the brachial plexus eluded clear visualization, hinting at underlying neurological complexities. Chest CT revealed a new, large soft tissue mass in the right supraclavicular region with adjacent right axillary lymphadenopathy, leading to the diagnosis of metastatic squamous cell carcinoma. Palliative radiation therapy and chemotherapy were initiated as part of the treatment plan, and the patient's pain score decreased to 3 out of 10 on the Numeric Rating Scale (NRS), revealing the pain was due to metastatic lung cancer.

Keywords: supraclavicula brachial plexus metastasis, cervical disc herniation, brachial plexus block, metastatic lung cancer

Procedia PDF Downloads 16

Authors: Catharina Lindberg, Cecilia Fagerstrom, Ania Willman

Abstract:

Patients in high-tech care environments are usually dependent on both formal/informal caregivers and technology, highlighting their vulnerability and challenging their autonomy. Autonomy presumes that a person has education, experience, self-discipline and decision-making capacity. Reference to autonomy in relation to patients in high-tech care environments could, therefore, be considered paradoxical, as in most cases these persons have impaired physical and/or metacognitive capacity. Therefore, to understand the prerequisites for patients to experience autonomy in high-tech care environments and to support them, there is a need to enhance knowledge and understanding of the concept of patient autonomy in this care context. The development of concepts and theories in a practice discipline such as nursing helps to improve both nursing care and nursing education. Theoretical development is important when clarifying a discipline, hence, a theoretical framework could be of use to nurses in high-tech care environments to support and defend the patient’s autonomy. A meta-synthesis was performed with the intention to be interpretative and not aggregative in nature. An amalgamation was made of the results from three previous studies, carried out by members of the same research group, focusing on the phenomenon of patient autonomy from a patient perspective within a caring context. Three basic approaches to theory development: derivation, synthesis, and analysis provided an operational structure that permitted the researchers to move back and forth between these approaches during their work in developing a theoretical framework. The results from the synthesis delineated that patient autonomy in a high-tech care context is: To be in control though trust, co-determination, and transition in everyday life. The theoretical framework contains several components creating the prerequisites for patient autonomy. Assumptions and propositional statements that guide theory development was also outlined, as were guiding principles for use in day-to-day nursing care. Four strategies used by patients to remain or obtain patient autonomy in high-tech care environments were revealed: the strategy of control, the strategy of partnership, the strategy of trust, and the strategy of transition. This study suggests an extended knowledge base founded on theoretical reasoning about patient autonomy, providing an understanding of the strategies used by patients to achieve autonomy in the role of patient, in high-tech care environments. When possessing knowledge about the patient perspective of autonomy, the nurse/carer can avoid adopting a paternalistic or maternalistic approach. Instead, the patient can be considered to be a partner in care, allowing care to be provided that supports him/her in remaining/becoming an autonomous person in the role of patient.

Keywords: autonomy, caring, concept development, high-tech care, theory development

Procedia PDF Downloads 184

Authors: Eduardo Costa

Abstract:

Hospital strikes in the Portuguese National Health Service (NHS) are becoming increasingly frequent, raising concerns in what respects patient safety. In fact, data shows that mortality rates for patients admitted during strikes are up to 30% higher than for patients admitted in other days. This paper analyses the effects of hospital strikes on patients’ outcomes. Specifically, it analyzes the impact of different strikes (physicians, nurses and other health professionals), on in-hospital mortality rates, readmission rates and length of stay. The paper uses patient-level data containing all NHS hospital admissions in mainland Portugal from 2012 to 2017, together with a comprehensive strike dataset comprising over 250 strike days (19 physicians-strike days, 150 nurses-strike days and 50 other health professionals-strike days) from 135 different strikes. The paper uses a linear probability model and controls for hospital and regional characteristics, time trends, and changes in patients’ composition and diagnoses. Preliminary results suggest a 6-7% increase in in-hospital mortality rates for patients exposed to physicians’ strikes. The effect is smaller for patients exposed to nurses’ strikes (2-5%). Patients exposed to nurses strikes during their stay have, on average, higher 30-days urgent readmission rates (4%). Length of stay also seems to increase for patients exposed to any strike. Results – conditional on further testing, namely on non-linear models - suggest that hospital operations and service levels are partially disrupted during strikes.

Keywords: health sector strikes, in-hospital mortality rate, length of stay, readmission rate

Procedia PDF Downloads 115

Authors: Suchart Tripopsakul

Abstract:

This paper uses data from the Global Entrepreneurship Monitor (GEM) to investigate the difference of attitudes towards entrepreneurial intention (EI). EI is generally assumed to be the single most relevant predictor of entrepreneurial behavior. The aim of this paper is to examine a range of attitudes effect on individual’s intent to start a new venture. A cross-cultural comparison between Asia and Europe is used to further investigate the possible differences between potential entrepreneurs from these distinct national contexts. The empirical analysis includes a GEM data set of 10 countries (n = 10,306) which was collected in 2013. Logistic regression is used to investigate the effect of individual’s attitudes on EI. Independent variables include individual’s perceived capabilities, the ability to recognize business opportunities, entrepreneurial network, risk perceptions as well as a range of socio-cultural attitudes. Moreover, a cross-cultural comparison of the model is conducted including six ASEAN (Malaysia, Indonesia, Philippines, Singapore, Vietnam and Thailand) and four European nations (Spain, Sweden, Germany, and the United Kingdom). The findings support the relationship between individual’s attitudes and their entrepreneurial intention. Individual’s capability, opportunity recognition, networks and a range of socio-cultural perceptions all influence EI significantly. The impact of media attention on entrepreneurship and was found to influence EI in ASEAN, but not in Europe. On the one hand, Fear of failure was found to influence EI in Europe, but not in ASEAN. The paper develops and empirically tests attitudes toward Entrepreneurial Intention between ASEAN and Europe. Interestingly, fear of failure was found to have no significant effect in ASEAN, and the impact of media attention on entrepreneurship and was found to influence EI in ASEAN. Moreover, the resistance of ASEAN entrepreneurs to the otherwise high rates of fear of failure and high impact of media attention are proposed as independent variables to explain the relatively high rates of entrepreneurial activity in ASEAN as reported by GEM. The paper utilizes a representative sample of 10,306 individuals in 10 countries. A range of attitudes was found to significantly influence entrepreneurial intention. Many of these perceptions, such as the impact of media attention on entrepreneurship can be manipulated by government policy. The paper also suggests strategies by which Asian economy in particular can benefit from their apparent high impact of media attention on entrepreneurship.

Keywords: an entrepreneurial intention, attitude, GEM, ASEAN and Europe

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Authors: Dana Mohammed, Fatemah Abdullah, Hawraa Ali, Najat Al-Shaer, Rawan Al-Awadhi, , Magdy Helal

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We study the patient service performance at the emergency department of a major Kuwaiti public hospital, using discrete simulation and lean concepts. In addition to the common problems in such health care systems (over crowdedness, facilities planning and usage, scheduling and staffing, capacity planning) the emergency department suffered from several cultural and patient behavioural issues. Those contributed significantly to the system problems and constituted major obstacles in maintaining the performance in control. This led to overly long waiting times and the potential of delaying providing help to critical cases. We utilized the visual management tools to mitigate the impact of the patients’ behaviours and attitudes and improve the logistics inside the system. In addition a proposal is made to automate the date collection and communication within the department using RFID-based barcoding system. Discrete event simulation models were developed as decision support systems; to study the operational problems and assess achieved improvements. The simulation analysis resulted in cutting the patient delays to about 35% of their current values by reallocating and rescheduling the medical staff. Combined with the application of the visual management concepts, this provided the basis to improving patient service without any major investments.

Keywords: simulation, visual management, health care system, patient

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Authors: Stefaan Carpentier, Aya Al Masri, Fabrice Leroy, Thibault Julien, Safoin Aktaou, Malorie Martin, Fouad Maaloul

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Introduction: During an 'Interventional Radiology (IR)' procedure, the patient's skin-dose may become very high for a burn, necrosis, and ulceration to appear. In order to prevent these deterministic effects, a prediction of the peak skin-dose for the patient is important in order to improve the post-operative care to be given to the patient. The objective of this study is to estimate, before the intervention, the patient dose for ‘Chronic Total Occlusion (CTO)’ procedures by selecting relevant clinical indicators. Materials and methods: 103 procedures were performed in the ‘Interventional Cardiology (IC)’ department using a Siemens Artis Zee image intensifier that provides the Air Kerma of each IC exam. Peak Skin Dose (PSD) was measured for each procedure using radiochromic films. Patient parameters such as sex, age, weight, and height were recorded. The complexity index J-CTO score, specific to each intervention, was determined by the cardiologist. A correlation method applied to these indicators allowed to specify their influence on the dose. A predictive model of the dose was created using multiple linear regressions. Results: Out of 103 patients involved in the study, 5 were excluded for clinical reasons and 2 for placement of radiochromic films outside the exposure field. 96 2D-dose maps were finally used. The influencing factors having the highest correlation with the PSD are the patient's diameter and the J-CTO score. The predictive model is based on these parameters. The comparison between estimated and measured skin doses shows an average difference of 0.85 ± 0.55 Gy for doses of less than 6 Gy. The mean difference between air-Kerma and PSD is 1.66 Gy ± 1.16 Gy. Conclusion: Using our developed method, a first estimate of the dose to the skin of the patient is available before the start of the procedure, which helps the cardiologist in carrying out its intervention. This estimation is more accurate than that provided by the Air-Kerma.

Keywords: chronic total occlusion procedures, clinical experimentation, interventional radiology, patient's peak skin dose

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Authors: Nashalla Gwyn Nyinda

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The ancient system of Tibetan Medicine, known as Sowa Rigpa across the Himalayan regions, is a systematic system of healing encouraging balance primarily through diet and behavior modifications. With the rise of the popularity of Tibetan Medicine, compliance is critical to successful treatment outcomes. As patients learn more about who they are as individuals and how their elemental balances or imbalances affect disorders and mental-emotional balance, they develop faith and dedication to their healing process. Specifically, regarding diet and behavior and the basic principles of the medical system, patient compliance increases dramatically in all treatment areas when they understand why a treatment or dietary prescription guidance is effective. Successful responses to Tibetan treatment rely on a buy-in from the patient. Trust between the slower process of Traditional medicine treatments, the Tibetan physician and the patient is a cornerstone of treatment. The resulting decrease in the use of allopathic medicine and better health outcomes for acute and chronic disorders are well documented. This paper addresses essential points of the Tibetan Medicine system, dialogue between doctor and patient focused on appropriate and seasonal changing dietetics. Such fluctuating treatment approaches, based on external elemental factors, dramatically increase treatment outcomes. Specifically, this work addresses why allopathic medicine models may need more trust development between practitioner and patient.

Keywords: compliancy in treatment, diet and lifestyle medicine, nature and elements as medicine, seasonal diets, Sowa Rigpa, traditional Tibetan medicine, treatment outcomes

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Authors: Loveneet Kaur

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Introduction: Osteoarthritis (OA) is one of the leading causes of disability, and the knee is the most commonly affected joint in the body. The last resort for treatment of knee OA is Total Knee Replacement (TKR) surgery. Despite numerous advances in prosthetic design, patients do not reach normal function after surgery. Current surgical decisions are made on 2D radiographs and patient interviews. Aims: The aim of this study was to compare knee kinematics pre and post-TKR surgery using computer-animated images of patient-specific models under everyday conditions. Methods: 7 subjects were recruited for the study. Subjects underwent 3D gait analysis during 4 everyday activities and medical imaging of the knee joint pre- and one-month post-surgery. A 3D model was created from each of the scans, and the kinematic gait analysis data was used to animate the images. Results: Improvements were seen in a range of motion in all 4 activities 1-year post-surgery. The preoperative 3D images provide detailed information on the anatomy of the osteoarthritic knee. The postoperative images demonstrate potential future problems associated with the implant. Although not accurate enough to be of clinical use, the animated data can provide valuable insight into what conditions cause damage to both the osteoarthritic and prosthetic knee joints. As the animated data does not require specialist training to view, the images can be utilized across the fields of health professionals and manufacturing in the assessment and treatment of patients pre and post-knee replacement surgery. Future improvements in the collection and processing of data may yield clinically useful data. Conclusion: Although not yet of clinical use, the potential application of 3D animations of the knee joint pre and post-surgery is widespread.

Keywords: Orthoporosis, Ortharthritis, knee replacement, TKR

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Authors: Aidan N. Smallwood, Celestine R. Weegenaar, Jack N. Evans

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The intensive care unit (ICU) is a particularly resource heavy environment, in terms of staff, drugs and equipment required. Whilst many areas of the hospital are attempting to cut down on plastic use and minimise their impact on the environment, this has proven challenging within the confines of intensive care. Concurrently, as globalization has progressed over recent decades, there has been a tendency towards centralised manufacturing with international distribution networks for products, often covering large distances. In this study, we have modelled the standard consumption of plastic single-use items over the course of the first 24-hours of an average individual patient’s stay in a 12 bed ICU in the United Kingdom (UK). We have identified the country of manufacture and calculated the minimum possible distance travelled by each item from factory to patient. We have assumed direct transport via the shortest possible straight line from country of origin to the UK and have not accounted for transport within either country. Assuming an intubated patient with invasive haemodynamic monitoring and central venous access, there are a total of 52 distincts, largely plastic, disposable products which would reasonably be required in the first 24-hours after admission. Each product type has only been counted once to account for multiple items being shipped as one package. Travel distances from origin were summed to give the total distance combined for all 52 products. The minimum possible total distance travelled from country of origin to the UK for all types of product was 273,353 km, equivalent to 6.82 circumnavigations of the globe, or 71% of the way to the moon. The mean distance travelled was 5,256 km, approximately the distance from London to Mecca. With individual packaging for each item, the total weight of consumed products was 4.121 kg. The CO2 produced shipping these items by air freight would equate to 30.1 kg, however doing the same by sea would produce 0.2 kg CO2. Extrapolating these results to the 211,932 UK annual ICU admissions (2018-2019), even with the underestimates of distance and weight of our assumptions, air freight would account for 6586 tons CO2 emitted annually, approximately 130 times that of sea freight. Given the drive towards cost saving within the UK health service, and the decline of the local manufacturing industry, buying from intercontinental manufacturers is inevitable However, transporting all consumables by sea where feasible would be environmentally beneficial, as well as being less costly than air freight. At present, the NHS supply chain purchases from medical device companies, and there is no freely available information as to the transport mode used to deliver the product to the UK. This must be made available to purchasers in order to give a fuller picture of life cycle impact and allow for informed decision making in this regard.

Keywords: CO2, intensive care, plastic, transport

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Authors: Julius Lenaerts, Ahmed Elsaadawy, Mohammed Bashir

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Background Sedated and paralyzed patients have an impaired blink reflex leading to ophthalmic complications such as conjunctivitis, epithelial defects, bacterial keratitis, and more. These are entirely preventable complications through regular eye care. Methods Patients at level 3 or above (intubated/paralyzed) care in the Intensive Care Unit (ICU) were reviewed between February and April. Data was pulled from Metavision and adherence was compared to Royal College of Ophthalmology (RCOphth) recommendations[4]. Using a multi-pronged approach through posters, individual teaching sessions and faculty teaching, we aimed to educate staff about eye care in the ICU. Patients were reaudited in the period July to August. Results Out of 40 patients, only 23% were assessed for eye care needs on admission compared to 77% after teaching; eye care was only delivered 59% of the time it was due, compared to 61%; 2.5% of patients had eyedrops prescribed compared to 41%. This shows an overall increase in meeting RCOphth standards. Key messages Eye care is an overlooked aspect of patient care in the ICU, associated with avoidable ocular complications. Healthcare staff need further rigorous education on the provision and importance of eye care to reduce avoidable complications.

Keywords: ICU, eye care, risk, QIP

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Authors: Nazura Abdul Manap, Siti Nur Farah Atiqah Salleh

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For decades, the misuse of personal data has been a critical issue. Malaysia has accepted responsibility by implementing the Malaysian Personal Data Protection Act 2010 to secure personal data (PDPA 2010). After more than a decade, this legislation is set to be revised by the current PDPA 2023 Amendment Bill to align with the world's key personal data protection regulations, such as the European Union General Data Protection Regulations (GDPR). Among the other suggested adjustments is the Data User's appointment of a Data Protection Officer (DPO) to ensure the commercial entity's compliance with the PDPA 2010 criteria. The change is expected to be enacted in parliament fairly soon; nevertheless, based on the experience of the Personal Data Protection Department (PDPD) in implementing the Act, it is projected that there will be a slew of additional concerns associated with the DPO mandate. Consequently, the goal of this article is to highlight the issues that the DPO will encounter and how the Personal Data Protection Department should respond to this subject. The study result was produced using a qualitative technique based on an examination of the current literature. This research reveals that there are probable obstacles experienced by the DPO, and thus, there should be a definite, clear guideline in place to aid DPO in executing their tasks. It is argued that appointing a DPO is a wise measure in ensuring that the legal data security requirements are met.

Keywords: guideline, law, data protection officer, personal data

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Authors: Fiona Lourenco, William Allen

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Dentofacial deformities are primarily surgically treated via orthognathic surgery. Health-related quality of life is concerned with aspects of quality of life that relate specifically to an individual’s health. Design and Setting: Retrospective analysis of patients who had orthognathic surgery from January 2018 - December 2022 at the trust using the previously validated Orthognathic Quality of Life questionnaire (OQoL). Materials and Methods: 32 Patient questionnaires (which included pre-operative and post-operative separate sections) were obtained via telephone survey. The data was analysed using the two-tailed paired t-test and Wilcoxon signed-rank test. Results: The change in perception post-surgery was highly significant (both tests resulted in p<0.001 for overall analysis as well as for each domain). Overall, a 74% improvement in QoL was seen following orthognathic surgery. Reports of improvement in each domain were as follows: 71% in the social aspect of the deformity domain, 76% in facial aesthetics, 60% in function, and 57% improvement in awareness of facial deformity. Conclusion: The assessment of QoL is becoming progressively imperative in clinical research. The above data shows that orthognathic surgery has a significant improvement in the QoL of patients post-operatively. The results demonstrate improvement in all domains, with perceptions in facial aesthetics seeing the highest change post-operatively.

Keywords: dentofacial, oral, facial asymmetry, orthognathic surgery, quality of life

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Authors: Khaja Moiduddin, Sherif Mohammed Elseufy, Hisham Alkhalefah

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Recent advances in three-dimensional (3D) printing, medical imaging, and implant design may alter how craniomaxillofacial surgeons construct individualized treatments using patient data. By utilizing medical image data, medical professionals can obtain detailed information about a patient's injuries, enabling them to conduct a thorough preoperative assessment while ensuring the implant's accuracy. However, selecting the right implant material requires careful consideration of various mechanical properties. This study aims to compare the two commonly used implant material for cranial reconstruction which includes titanium (Ti6Al4V) and Polyetheretherketone (PEEK). Biomechanical analysis was performed to study the implant behavior, by keeping the implant design and fixation constant in both cases. A finite element model was created and analyzed under loading conditions. The finite element analysis proves that although Ti6Al4V is stronger than PEEK but, its mechanical strength is adequate to bear the loads of the adjacent bone tissue.

Keywords: cranial reconstruction, titanium implants, PEEK, finite element model

Procedia PDF Downloads 45

Authors: Muhammad Faizan Butt, Maria Ambreen Tahir, Joshua James Pilkington, A. A. Warsi

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Background: Total parenteral nutrition (TPN) use within the NHS is crucial in the prevention of malnourishment. TPN prescriptions are tailored to an individual patient’s needs. TPN bags come in fixed sizes, and minimizing wastage has financial and sustainability implications for the health service. The aim of the study is to assess current prescribing practices, look at the volume of TPN wastage and identify reasons for it. Methodology: A retrospective cohort study on TPN prescriptions over a period of 1 year (Jan-Dec 2022) was performed. All patients prescribed TPN that had been admitted under a general surgery consultant in a small district hospital were included. Data were extracted from hospital electronic records and dietician charts. Data were described, and reasons for TPN wastage were explored. Results: 49 patients were identified. The average length of TPN prescription was 8 days (median). This totaled 608 prescriptions. Of the bags prescribed, 258, 169, and 181 were 10g (2500ml), 14g (2000ml), and 18g (2000ml), respectively. The mean volume wasted from each type of bag was 634ml, 634ml, and 648ml, respectively. Reasons for TPN wastage identified were: no loss (25%), smaller bags not available (53.6%), step-down regime (8.1%), and other (12.2%). Conclusion: This study has identified that the current stocking and prescribing of TPN within a district general hospital leads to a significant wastage of 638.2ml (average). The commonest reason for wastage is the non-availability of a more appropriate sized bag.

Keywords: general surgery, TPN, sustainability, wastage

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Authors: Lateefat Amao, Misagh Faezipour

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Implementing electronic health records (EHR) in healthcare is a pivotal transition aimed at digitizing and optimizing patient health information management. The expectations associated with this transition are high, even towards other health information systems (HIS) and health technology. This multifaceted process involves careful planning and execution to improve the quality and efficiency of patient care, especially as healthcare technology is a sensitive niche. Key considerations include a thorough needs assessment, judicious vendor selection, robust infrastructure development, and training and adaptation of healthcare professionals. Comprehensive training programs, data migration from legacy systems and models, interoperability, as well as security and regulatory compliance are imperative for healthcare staff to navigate EHR systems adeptly. The purpose of this work is to offer a comprehensive review of the literature on EHR implementation. It explores the impact of this health technology on health practices, highlights challenges and barriers to its successful utility, and offers practical strategies that can impact its success in healthcare. This paper provides a thorough review of studies on the adoption of EHRs, emphasizing the wide range of experiences and results connected to EHR use in the medical field, especially across different types of healthcare organizations.

Keywords: healthcare, electronic health records, EHR implementation, patient care, interoperability

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Authors: Kevin Yeo, Christine Hall, Babinchak Tim

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BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] anti-toxin is a mixture of equine immune globulin fragments indicated for the treatment of symptomatic botulism in adult and pediatric patients. The effectiveness of BAT anti-toxin is based on efficacy studies conducted in animal models. A general explanation of the pivotal animal studies, post market surveillance and outcomes of an observational patient registry for patients treated with BAT product distributed in the USA is briefly discussed. Overall it took 20 animal studies for two well-designed and appropriately powered pivotal efficacy studies – one in which the effectiveness of BAT was assessed against all 7 serotypes in the guinea pig, and the other where efficacy is confirmed in the Rhesus macaque using Serotype A. Clinical Experience for BAT to date involves approximately 600 adult and pediatric patients with suspected botulism. In pre-licensure, patient data was recorded under the US CDC expanded access program (259 adult and pediatric patients between 10 days to 88 years of age). In post licensure, greater than 350 patients to date have received BAT and been followed up by enhanced expanded access program. The analysis of the post market surveillance data provided a unique opportunity to demonstrate clinical benefit in the field study required by the animal rule. While the animal rule is applied because human efficacy studies are not ethical or feasible, a post-marketing requirement is to conduct a study to evaluate safety and clinical benefit when circumstances arise and demonstrate the favourable benefit-risk profile that supported licensure.

Keywords: botulism, threat, clinical benefit, observational patient registry

Procedia PDF Downloads 150