Using Failure Mode, Effect and Criticality Analysis to improve safety in the cancer treatment prescription and administration process.

BACKGROUND: Administering cancer drugs is a high-risk process, and mistakes can have fatal consequences. Failure Mode, Effect and Criticality Analysis (FMECA) is a widely recognized method for identifying and preventing potential risks, applied in various settings, including healthcare. The aim of this study was to recognize potential failures in cancer treatment prescription and administration, with a view to enabling the adoption of measures to prevent them. METHODS: This study consists of a FMECA. A team of resident doctors in public health at the University of Padua examined the cancer chemotherapy process with the support of a multidisciplinary team from the Veneto Institute of Oncology (an acknowledged comprehensive cancer center), and two other provincial hospitals. A diagram was drafted to illustrate 9 different phases of chemotherapy, from the adoption of a treatment plan to its administration, and to identify all possible failure modes. Criticality was ascertained by rating severity, frequency and likelihood of a failure being detected, using adapted versions of already published scales. Safety strategies were identified and summarized. RESULTS: Twenty-two failure modes came to light, distributed over the various phases of the cancer treatment process, and seven of them were classified as high risk. All phases of the cancer chemotherapy process were defined as potentially critical and at least one action was identified for a single high-risk failure mode. To reduce the likelihood of the cause, or to improve the chances of a failure mode being detected, a total of 10 recommendations have been identified. CONCLUSIONS: FMECA can be useful for identifying potential failures in a process considered to be at high risk. Safety strategies were devised for each high-risk failure mode identified.

Surveillance of Outbreaks of SARS-CoV-2 Infections at School in the Veneto Region: Methods and Results of the Public Health Response during the Second and Third Waves of the Pandemic between January and June 2021.

During the COVID-19 pandemic, many countries adopted various non-pharmacological interventions to contain the number of infections. The most often used policy was school closures. We describe the strategy adopted by the Veneto Regional Authority to contain transmission in school settings. This included a detailed school surveillance system, strict contact tracing, and maintaining school attendance with self-monitoring for symptoms whenever possible. All analyzed COVID-19 cases among children, adolescents (0-19 years old), and school staff were registered using a web-based application between 4 January 2021 and 13 June 2021. During the study period, 6272 episodes of infection in schools were identified; 87% were linked to a student index case and 13% to school staff; 69% generated no secondary cases; 24% generated one or two; and only 7% caused more than two. Our data may help to clarify the role of school closures, providing useful input for decisions in the months to come. Good practice in public health management needs tools that provide a real-time interpretation of phenomena like COVID-19 outbreaks. The proposed measures should be easy to adopt and accessible to policymakers.

Prevalence of Asymptomatic SARS-CoV-2 Infection in the General Population of the Veneto Region: Results of a Screening Campaign with Third-Generation Rapid Antigen Tests in the Pre-Vaccine Era.

The aim of our study was to ascertain the prevalence of SARS-CoV-2 infection in the general population during a period of moderate risk, just before Italy started to implement its vaccination campaign. A third-generation antigenic nasal swab sample was collected by a healthcare provider, and all individuals testing positive subsequently had a nasopharyngeal swab for molecular testing; the result was used to calculate the positive predictive value. The population consisted of 4467 asymptomatic adults with a mean age of 46.8 ± 16.00 years. The 62.2% tested for the first time, while 37.8% had previously undergone a mean 2.2 tests for SARS-CoV-2. With 77 of our overall sample reporting they had previously tested positive for COVID-19 and 14 found positive on our screening test, the overall estimated prevalence of the infection was 0.31%. Nine of the 14 cases were confirmed on molecular testing with a PPV of 64.3%. The mean age of the individuals testing positive was 38.1 ± 17.4. Based on the timing of symptom onset, six of the above cases were classified as false negatives, and the adjusted estimated prevalence was 0.34%. Describing levels of infection in a general population seems to be very difficult to achieve, and the universal screening proved hugely expensive particularly in a low-prevalence situation. Anyway, it is only thanks to mass screening efforts that epidemiological data have been collected. This would support the idea that routine screening may have an impact on mitigating the spread of the virus in higher-risk environments, where people come into contact more frequently, as in the workplace.

Parkinson's disease: current assessment methods and wearable devices for evaluation of movement disorder motor symptoms - a patient and healthcare professional perspective.

BACKGROUND: Parkinson's disease is the second most common long-term chronic, progressive, neurodegenerative disease, affecting more than 10 million people worldwide. There has been a rising interest in wearable devices for evaluation of movement disorder diseases such as Parkinson's disease due to the limitations in current clinic assessment methods such as Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr (HY) scale. However, there are only a few commercial wearable devices available, which, in addition, have had very limited adoption and implementation. This inconsistency may be due to a lack of users' perspectives in terms of device design and implementation. This study aims to identify the perspectives of healthcare professionals and patients linked to current assessment methods and to identify preferences, and requirements of wearable devices. METHODS: This was a qualitative study using semi-structured interviews followed by focus groups. Transcripts from sessions were analysed using an inductive thematic approach. RESULTS: It was noted that the well-known assessment process such as Unified Parkinson's Disease Rating Scale (UPDRS) was not used routinely in clinics since it is time consuming, subjective, inaccurate, infrequent and dependent on patients' memories. Participants suggested that objective assessment methods are needed to increase the chance of effective treatment. The participants' perspectives were positive toward using wearable devices, particularly if they were involved in early design stages. Patients emphasized that the devices should be comfortable, but they did not have any concerns regarding device visibility or data privacy transmitted over the internet when it comes to their health. In terms of wearing a monitor, the preferable part of the body for all participants was the wrist. Healthcare professionals stated a need for an economical solution that is easy to interpret. Some design aspects identified by patients included clasps, material choice, and form factor. CONCLUSION: The study concluded that current assessment methods are limited. Patients' and healthcare professionals' involvement in wearable devices design process has a pivotal role in terms of ultimate user acceptance. This includes the provision of additional functions to the wearable device, such as fall detection and medication reminders, which could be attractive features for patients.

Proof-of-Concept Study: a Mobile Application to Derive Clinical Outcome Measures from Expression and Speech for Mental Health Status Evaluation.

This proof-of-concept study aimed to assess the ability of a mobile application and cloud analytics software solution to extract facial expression information from participant selfie videos. This is one component of a solution aimed at extracting possible health outcome measures based on expression, voice acoustics and speech sentiment from video diary data provided by patients. Forty healthy volunteers viewed 21 validated images from the International Affective Picture System database through a mobile app which simultaneously captured video footage of their face using the selfie camera. Images were intended to be associated with the following emotional responses: anger, disgust, sadness, contempt, fear, surprise and happiness. Both valence and arousal scores estimated from the video footage associated with each image were adequate predictors of the IAPS image scores (p < 0.001 and p = 0.04 respectively). 12.2% of images were categorised as containing a positive expression response in line with the target expression; with happiness and sadness responses providing the greatest frequency of responders: 41.0% and 21.4% respectively. 71.2% of images were associated with no change in expression. This proof-of-concept study provides early encouraging findings that changes in facial expression can be detected when they exist. Combined with voice acoustical measures and speech sentiment analysis, this may lead to novel measures of health status in patients using a video diary in indications including depression, schizophrenia, autism spectrum disorder and PTSD amongst other conditions.

Mechanical behaviour of 3D printed vs thermoformed clear dental aligner materials under non-linear compressive loading using FEM.

Clear dental aligners are commonly manufactured using thermoplastic materials such as Duran and Durasoft. Using conventional thermoforming methods there are inherent disadvantages including time consumption and poor geometrical accuracies that often occur. The use of digital technologies and 3D printing techniques for producing dental aligners is often preferred where possible. Innovation in 3D printing has resulted in bio-compatible materials becoming more readily available, including Formlabs Dental LT Clear resin, which is a 3D printable and Class IIa bio-compatible material. In this paper, we investigate the difference between thermoplastic materials such as Scheu-Dental Duran and Durasoft and 3D printed Dental LT using Finite Element Analysis (FEA)/Finite Element Modelling (FEM) in a dental aligner case based on an analysis of von Mises stress distribution at molars, incisors and canines for a total of 33161 nodes using Finite Element Analysis (FEA). Maximum von Mises stress distribution at all of the sections under the action of non-linear compressive forces equivalent to human biting force (up to 600 N) were discovered to vary within a range of 0.2-7.7% for Dental LT resin. The Duran and Durasoft cases were comparable, thereby widening the scope for the use of Dental LT in various dentistry applications, including clear aligners.

Mechanical and geometric properties of thermoformed and 3D printed clear dental aligners.

INTRODUCTION: The aim of this research was to compare compressive mechanical properties and geometric inaccuracies between conventionally manufactured thermoformed Duran clear dental aligners and 3D printed Dental Long Term (LT) resin-based clear aligners using 3D modeling and printing techniques. METHODS: Impressions of the patient's dentition were scanned and using 3D modeling software, dental models were designed and 3D printed. These printed models then underwent vacuum thermoforming to thermoform a clear Duran thermoplastic sheet of 0.75-mm thickness into clear dental aligners of the same thickness of 0.75 mm. For the same dental model, aligners were also designed and 3D printed to 0.75-mm thickness creating biocompatible clear dental aligners using Dental LT resin utilizing a Formlabs 3D printing machine for direct usage by the patients. Five observers calculated teeth height for both types of aligners for evaluation of geometric deviations. Both types of aligners were subjected to compression loading of 1000 N to evaluate their load vs displacement behavior. RESULTS: 3D printed cured clear dental aligners were found to be geometrically more accurate with an average relative difference in tooth height of 2.55% in comparison with thermoformed aligners (4.41%). Low standard deviations (0.03-0.09 mm) were observed for tooth height measurements taken by all the observers for both types of aligners. 3D printed aligners could resist a maximum load of nearly 662 N for a low displacement of 2.93 mm; whereas, thermoformed aligners could resist a load on only 105 N for 2.93-mm displacement. Thermoformed aligners deformed plastically and irreversibly for large displacements; whereas, 3D printed aligners deformed elastically with reversibility for lower displacements. CONCLUSIONS: 3D printed and suitably cured Dental LT resin-based clear dental aligners are suggested to be more suitable for patient use as they are geometrically more accurate; this presents an opportunity to make processing time savings while ensuring an aligner is mechanically stronger and elastic in comparison with the conventionally produced thermoplastic-based thermoformed clear dental aligners.

Utilising the Intel RealSense Camera for Measuring Health Outcomes in Clinical Research.

Applications utilising 3D Camera technologies for the measurement of health outcomes in the health and wellness sector continues to expand. The Intel® RealSense™ is one of the leading 3D depth sensing cameras currently available on the market and aligns itself for use in many applications, including robotics, automation, and medical systems. One of the most prominent areas is the production of interactive solutions for rehabilitation which includes gait analysis and facial tracking. Advancements in depth camera technology has resulted in a noticeable increase in the integration of these technologies into portable platforms, suggesting significant future potential for pervasive in-clinic and field based health assessment solutions. This paper reviews the Intel RealSense technology's technical capabilities and discusses its application to clinical research and includes examples where the Intel RealSense camera range has been used for the measurement of health outcomes. This review supports the use of the technology to develop robust, objective movement and mobility-based endpoints to enable accurate tracking of the effects of treatment interventions in clinical trials.

Evaluation of anti-desmoglein-1 and anti-desmoglein-3 autoantibody titers in pemphigus patients at the time of the initial diagnosis and after clinical remission.

It has been suggested that anti-desmoglein autoantibody titers could be helpful in follow-up and therapeutic management of pemphigus patients. However, there is no consensus regarding the relationship between anti-desmoglein autoantibody titers and clinical activity of pemphigus.The aim of our study was to evaluate if clinical remission of pemphigus relates to the presence of anti-desmoglein autoantibodies.Thirty patients with pemphigus vulgaris and 7 patients with pemphigus foliaceous were included in the study. Assessment of autoantibody titers was carried out at the time of the initial diagnosis and after the clinical remission using an enzyme-linked immunosorbent assay-based assay.Our results indicate that pemphigus clinical remission did not necessarily imply a serological remission, and consequently it is necessary to establish if withdrawal of the immunosuppressive regimen in pemphigus should be based exclusively on the achievement of clinical remission or also on the serological findings.

Flexural resistance of Cerec CAD/CAM system ceramic blocks. Part 2: Outsourcing materials.

PURPOSE: To test different Cerec CAD/CAM system ceramic blocks, comparing mean flexural strength (sigma), Weibull modulus (m), and Weibull characteristic strength (sigma0) in an ISO standardized set-up. METHODS: Following the recent ISO Standard (ISO 6872:2008), 11 types of ceramic blocks were tested: IPS e.max CAD MO, IPS e.max CAD LT and IPS e.max CAD HT (lithium disilicate glass-ceramic); In-Ceram SPINELL, In-Ceram Alumina and In-Ceram Zirconia (glass-infiltrated materials); inCoris AL and In-Ceram AL (densely sintered alumina); In-Ceram YZ, IPS e.max Zir-CAD and inCoris ZI (densely sintered zirconia). Specimens were cut out from ceramic blocks, finished, crystallized/infiltrated/sintered, polished, and tested in a three-point bending test apparatus. Flexural strength, Weibull characteristic strength, and Weibull modulus were obtained. RESULTS: A statistically significant difference was found (P < 0.001) among lithium disilicate glass-ceramic (sigma = 272.6 +/- 376.8 MPa, m = 6.2 +/- 11.3, sigma0 = 294.0 +/- 394.1 MPa) and densely sintered alumina (sigma = 441.8 +/- 541.6 MPa, m = 11.9 +/- 19.0, sigma0 = 454.2 +/- 565.2 MPa). No statistically significant difference was found (P = 0.254) in glass infiltrated materials (sigma = 376.9 +/- 405.5 MPa, m = 7.5 +/- 11.5, sigma0 = 393.7 +/- 427.0 MPa). No statistically significant difference was found (P = 0.160) in densely sintered zirconia (sigma = 1,060.8 +/- 1,227.8 MPa, m = 5.8 +/- 7.4, sigma0 = 1,002.4 +/- 1,171.0 MPa). Not all the materials tested fulfilled the requirements for the clinical indications recommended by the manufacturer.

Flexural resistance of Cerec CAD/CAM system ceramic blocks. Part 1: Chairside materials.

PURPOSE: This study tested the materials available on the market for Cerec CAD/CAM, comparing the mean flexural strength in an ISO standardized set-up, since the ISO standard for testing such materials was issued later than the marketing of the materials tested. METHODS: Following the recent Standard ISO 6872:2008, eight types of ceramic blocks were tested: Paradigm C, IPS Empress CAD LT, IPS Empress CAD Multi, Cerec Blocs, Cerec Blocs PC, Triluxe, Triluxe Forte, Mark II. Specimens were cut out from ceramic blocks, finished, polished, and tested in a three-point bending test apparatus until failure. Flexural strength, Weibull characteristic strength, and Weibull modulus, were calculated. RESULTS: The results obtained from the materials for flexural strength were IPS Empress CAD (125.10 +/- 13.05), Cerec Blocs (112.68 +/- 7.97), Paradigm C (109.14 +/- 10.10), Cerec Blocs PC (105.40 +/- 5.39), Triluxe Forte (105.06 +/- 4.93), Mark II (102.77 +/- 3.60), Triluxe (101.95 +/- 7.28) and IPS Empress CAD Multi (100.86 +/- 15.82). All the tested materials had a flexural strength greater than 100 MPa, thereby satisfying the requirements of the ISO standard for the clinical indications of the materials tested. In all tested materials the Weibull characteristic strength was greater than 100 MPa.