Good Practice Guidelines Research Articles

MRI in the assessment of cerebral injury and cerebroprotective effects of renal denervation in resistant hypertension

The purpose of this single-centre, prospective, comparative study was to evaluate the pattern and severity of the brain structural changes in patients with resistant hypertension based on MRI assessments and their changes one year after renal denervation.Material and Methods. The study comprised 53 patients with resistant hypertension (RH), aged 52.1 ± 9.1 years, who underwent renal denervation (RDN) following the Good Clinical Practice guidelines. Patients underwent office blood pressure measurements, 24-hour blood pressure monitoring (BPM), and brain MRI scanning. Using brain MRI, the cerebrospinal fluid (CSF) system measurements, the presence and severity of periventricular white matter lesion and focal changes in the brain white matter were evaluated.Results. Initially, patients with RH had a high incidence of the structural brain alterations: 43 (81%) patients with fine focal brain lesions, 43 (81%) patients with enlarged CSF spaces, and 48 (90%) patients with periventricular white matter lesions. After renal denervation, a significant hypotensive effect was noted. According to brain MRI, the number of patients without enlarged CSF spaces did not change significantly: 15 (25%) patients initially, and 12 (20%) patients a year later (χ2 = 0.63, р = 0.43 и χ2 = 0.72, р = 0.40). The incidence of periventricular white matter lesion did not significantly change one year after RDN; however, the incidence of fine focal brain lesions significantly decreased in 21 patients (81% to 60%, p = 0.02).Conclusion. Thus, it has been revealed that patients with resistant hypertension are characterised by a high incidence of structural brain alterations based on MRI assessments. Bilateral renal denervation is followed by a significant decrease in the incidence of fine focal brain lesions, without a significant change in the cerebrospinal fluid volume one year after the procedure.

AI and formative assessment: The train has left the station

AbstractIn response to Li, Reigh, He, and Miller's commentary, Can we and should we use artificial intelligence for formative assessment in science, we argue that artificial intelligence (AI) is already being widely employed in formative assessment across various educational contexts. While agreeing with Li et al.'s call for further studies on equity issues related to AI, we emphasize the need for science educators to adapt to the AI revolution that has outpaced the research community. We challenge the somewhat restrictive view of formative assessment presented by Li et al., highlighting the significant contributions of AI in providing formative feedback to students, assisting teachers in assessment practices, and aiding in instructional decisions. We contend that AI‐generated scores should not be equated with the entirety of formative assessment practice; no single assessment tool can capture all aspects of student thinking and backgrounds. We address concerns raised by Li et al. regarding AI bias and emphasize the importance of empirical testing and evidence‐based arguments in referring to bias. We assert that AI‐based formative assessment does not necessarily lead to inequity and can, in fact, contribute to more equitable educational experiences. Furthermore, we discuss how AI can facilitate the diversification of representational modalities in assessment practices and highlight the potential benefits of AI in saving teachers’ time and providing them with valuable assessment information. We call for a shift in perspective, from viewing AI as a problem to be solved to recognizing its potential as a collaborative tool in education. We emphasize the need for future research to focus on the effective integration of AI in classrooms, teacher education, and the development of AI systems that can adapt to diverse teaching and learning contexts. We conclude by underlining the importance of addressing AI bias, understanding its implications, and developing guidelines for best practices in AI‐based formative assessment.

O-081 A 10-year follow-up of reproductive outcomes in women returning after elective oocyte cryopreservation

Abstract Study question What are the reproductive treatment outcomes in women who underwent elective oocyte cryopreservation (EOC) returning to our clinic with a desire for a child? Summary answer Whether to warm oocytes or to first use fresh oocytes for ART depends on age upon returning, but both strategies resulted in favourable reproductive outcomes. What is known already Most affluent countries have observed a trend towards postponement of childbearing, and EOC is increasingly used in an attempt to extend the reproductive lifespan and mitigate age-related fertility decline. Although most follow-up studies after EOC have focused on women who requested oocyte warming, a substantial proportion of women who do not conceive naturally eventually embark for a fertility treatment without using their cryopreserved oocytes. Reports on reproductive outcomes in past EOC users are scarce, and the lack of reproductive treatment algorithms in this group of women hampers efficiency of clinical practice. Study design, size, duration This retrospective observational single-center study includes 843 women who had elective oocyte vitrification for non-medical reasons between 2009 and 2019, and describes the outcomes of the diverse reproductive treatment strategies that were performed in these women when they returned to the same clinic because of a desire for pregnancy until May 2022. Participants/materials, setting, methods Patient characteristics and data of ovarian stimulation of EOC cycles were analyzed, as well as data related to ovarian stimulation and laboratory data of ART in women who pursued fertility treatment with and/or without using their cryopreserved oocytes. The primary outcome was the live birth rate (LBR) per patient after oocyte warming and after ART using fresh oocytes. Secondary outcomes were laboratory outcomes and LBR per embryo transfer. Main results and the role of chance A total of 1353 EOC cycles (1.6 ± 0.9 per patient) were performed. Mean age was 36.5 ± 2.8 years. At the time of EOC 174 (20,6%) women had a partner. On average, 13.7 ± 9.2 mature oocytes were cryopreserved. After 39.9 ± 23.4 months, 231 (27.4%) women returned to the clinic. Upon returning, mean age was 40.4 ± 3.1 years, mean AMH 2.3 ± 2.0 ng/mL, and 150/231 (64,9%) patients had a partner. As a primary approach, 110/231 (47.6 %) past EOC women embarked on oocyte warming, 50/231 (21.6%) had intrauterine insemination, and 71/231 (30.7%) had ART using fresh oocytes. Cumulative LBR (CLBR) was 45.9 % (106/231) and miscarriage rate (MR) was 30.7% (51/166) in the entire cohort. A subset of 90/231 (39.0%) patients exclusively had oocyte warming, at 41.6 ± 3.0 years, with 10.0 ± 5.2 oocytes warmed per patient. 52/231 (22.5%) patients exclusively had ART using fresh oocytes, at a mean age of 39.0 ± 2.8 years, with 9.9 ± 7.4 mature oocytes retrieved per patient. CLBR was 37/90 (41.1%) in the oocyte warming-only group and 25/52 (48.1%) in the OS-only group. MR/transfer was 25.0% and 29.3% in the oocyte warming-only group and the OS-only group, respectively. Limitations, reasons for caution Both the small sample size and the retrospective design are limitations of this study. The decision to embark on a specific reproductive treatment strategy was based on patient preference, after counseling of treatment options. This precludes direct comparison of the efficacy of reproductive treatment options in past EOC users. Wider implications of the findings Reporting of clinical outcomes of women who underwent EOC and returned to the clinic to embark on divergent reproductive treatment strategies is mandatory to establish guidelines for best clinical practice in this growing patient population. Trial registration number Not applicable

Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision.

The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby-Mogensen et al., Acta Anaesthesiol Scand 1996, 40, 59-74); the guidelines were later revised and updated following the second consensus conference in Stockholm in 2005 (Fuchs-Buder et al., Acta Anaesthesiol Scand 2007, 51, 789-808). In view of new devices and further development of monitoring technologies that emerged since then, (e.g., electromyography, three-dimensional acceleromyography, kinemyography) as well as novel compounds (e.g., sugammadex) a review and update of these recommendations became necessary. The intent of these revised guidelines is to continue to help clinical researchers to conduct high-quality work and advance the field by enhancing the standards, consistency, and comparability of clinical studies. There is growing awareness of the importance of consensus-based reporting standards in clinical trials and observational studies. Such global initiatives are necessary in order to minimize heterogeneous and inadequate data reporting and to improve clarity and comparability between different studies and study cohorts. Variations in definitions of endpoints or outcome variables can introduce confusion and difficulties in interpretation of data, but more importantly, it may preclude building of an adequate body of evidence to achieve reliable conclusions and recommendations. Clinical research in neuromuscular pharmacology and physiology is no exception.

Keratoconic patient profile and management at public sector facilities in South Africa

Background: Keratoconus (KC) is a condition marked by thinning and protrusion of the cornea resulting in high myopia and irregular astigmatism. Knowledge of KC patients’ profiles and management approaches used can help to predict the needs of public hospitals to improve patient care.Aim: This study aimed to describe the profiles and management of KC patients.Setting: Capricorn district, Limpopo Province, South Africa.Methods: Medical records of 188 KC patients attending public hospitals of Capricorn District from January 2017 to December 2020 were reviewed. Data on patient profile and their management were collected and analysed.Results: The mean age of KC patients was 20.64 ± 6.82 years and the majority (56.9%) were males. Clinical findings were mean unaided visual acuity (UVA) of 0.19 ± 0.18, best corrected VA of 0.53 ± 0.24, spherical equivalence of -4.89 ± 9.17 dioptre (D), mean K of 57.37 ± 17 D and corneal astigmatism of -6.24 ± 4.27 D. A total of 54.5% of patients had severe KC. Bilateral KC was found in almost all patients (97.3%) and a mean K difference of 7.59 ± 6.08 D (p 0.001) between the better and the worse eye. The study found no significant difference in KC severity by age (p = 0.451) and gender (p = 0.819). Patients fitted with scleral lenses had the highest VA improvement of 0.44 ± 0.17.Conclusion: Most patients presented with bilateral and severe KC. Scleral lenses provided higher VA improvement than other methods.Contribution: The study aimed to present the clinical profile and management of keratoconic patients attending public sector facilities. Knowledge of the patterns of KC presentation may assist in the development of intervention strategies and guidelines for best practice in the management of KC, especially in public sector facilities.

Prioritization of vegetable-borne biological hazards in Argentina using a multicriteria decision analysis tool.

Vegetables, especially those eaten raw, have been implicated in several foodborne disease outbreaks. Since multiple vegetable matrices and hazards are involved, risk managers have to prioritize those with the greatest impact on public health to design control strategies. In this study, a scientific-based risk ranking of foodborne pathogens transmitted by leafy green vegetables in Argentina was performed. The prioritization process included hazard identification, evaluation criteria identification and definition, criteria weighting, expert survey design and selection and call for experts, hazard score calculation, hazard ranking and variation coefficient, and result analysis. Regression tree analysis determined four risk clusters: high (Cryptosporidum spp., Toxoplasma gondii, Norovirus), moderate (Giardia spp., Listeria spp., Shigella sonnei), low (Shiga toxin-producing Escherichia coli, Ascaris spp., Entamoeba histolytica, Salmonella spp., Rotavirus, Enterovirus) and very low (Campylobacter jejuni, hepatitis A virus and Yersinia pseudotuberculosis). Diseases caused by Norovirus, Cryptosporidium spp. and T. gondii do not require mandatory notification. Neither viruses nor parasites are included as microbiological criteria for foodstuff. The lack of outbreak studies did not allow to accurately identify vegetables as a source of Norovirus disease. Information on listeriosis cases or outbreaks due to vegetable consumption was not available. Shigella spp. was the main responsible for bacterial diarrhea, but it has not been epidemiologically associated with vegetable consumption. The quality of the available information for all hazards studied was very low and low. The implementation of good practice guidelines throughout the entire vegetable production chain could prevent the presence of the identified hazards. The current study allowed the identification of vacancy areas and could help reinforce the need for performing epidemiological studies on foodborne diseases potentially associated with vegetable consumption in Argentina.

Lameness recovery rates following treatment of dairy cattle with claw horn lameness in the Waikato region of New Zealand

ABSTRACT Aims To describe the time in days for lame dairy cows to recover after diagnosis and treatment of claw horn lameness, and to investigate whether cure rates differed between farms. Methods Five dairy farms in the Waikato region were conveniently enrolled into a descriptive epidemiological study. Three of these farms had dairy cattle enrolled over two consecutive seasons, while two farms enrolled for one year. Lame cattle diagnosed by the farmers were enrolled into the study if they had a lameness score (LS ≥ 2 on a 0–3 scale) and claw horn lesions. All enrolled animals were treated by a single veterinarian following a consistent methodology, and subsequently assessed for LS at a median frequency of 4 days from enrolment until they were sound (LS = 0). The times (days) taken for animals to become sound and non-lame (LS < 2) were reported for all animals, and Kaplan–Meier survival curves used to present the results. A Cox-proportional hazard model was used to assess if the hazard of soundness was associated with farm, age, breed, lesion, number of limbs involved, and LS at enrolment. Results A total of 241 lame cattle with claw horn lesions were enrolled across the five farms. White line disease was the predominant pain-causing lesion in 225 (93%) animals, and blocks were applied to 205 (85%) of enrolled animals. The overall median days from enrolment to becoming sound was 18 (95% CI = 14–21) days, and 7 (95% CI = 7–8) days to become non-lame. A difference in the hazards of lameness cure between farms was identified (p = 0.007), with median days to lameness cure between farms ranging from 11 to 21 days. No associations were identified between age, breed, limb, or LS at enrolment on the lameness cure rates. Conclusions Treatment of claw horn lameness following industry-standard guidelines in dairy cattle on five New Zealand dairy farms resulted in rapid cure, although cure rates differed between farms. Clinical relevance Following industry best-practice lameness treatment guidelines, including frequent use of blocks, can result in rapid lameness cure rates in New Zealand dairy cows. This study also suggests that management of lame cattle on pasture can positively benefit their welfare and recovery times. The reported cure rates provide veterinarians with benchmarks on the length of time after which a lame animal should be re-examined, and in the investigation of poor treatment response rates at the herd level.

Lineage segregation in human pre-implantation embryos is specified by YAP1 and TEAD1.

Lineage segregation in human pre-implantation embryos is specified by YAP1 and TEAD1.

Inferior Vena Cava Filters and Complications: A Systematic Review.

Inferior vena cava(IVC) filters have been used since the 1960s to treat patients with acute risk of pulmonary embolism (PE) to prevent migration of thrombus by trapping it within the filter. Traditional usage has been in patients with contraindication to anticoagulation that carry a significant mortality risk. In this systematic review, we sought to evaluate complications associated with placement of inferior vena cava filters based on published data from the past 20 years. A search was performed on October 6th, 2022, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews, using three databases (ProQuest, PubMed and ScienceDirect) for articles published between the dates of February 1, 2002 and October 1, 2022. Results were filtered to include full-text, clinical studies, and randomized trials written in English pertaining to keywords "IVC filter AND complications", "Inferior Vena Cava Filter AND complications", "IVC filter AND thrombosis" and "Inferior Vena Cava Filter AND thrombosis". Articles identified by the three databases were pooled and further screened for relevance based on inclusion and exclusion criteria. Initial search results yielded 33,265 hits from all three databases combined. Screening criteria were applied, with 7721 results remaining. After further manual screening, including removal of duplicate hits, a total of 117 articles were selected for review.While there are no consensus guidelines for best practice, there is compelling evidence that IVC filters can provide significant protection against PE with minimal complications if the treatment window is appropriate. Increase in the variety of filter models has led to broader availability, but skepticism remains about their efficacy and safety, with ongoing controversy surrounding appropriate indications. Further research is needed to establish clear guidelines on appropriate indications for IVC placement and to determine time course of complications versus benefits for indwelling filters.

Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial

Improving exercise tolerance is indisputably beneficial for long-term survival in patients treated with percutaneous coronary intervention (PCI). Although previous studies suggested that Yangxinshi tablets effectively improve exercise tolerance in patients with coronary heart disease, the evidence is limited due to the lack of high-quality randomized trials. The Effects of Yangxinshi Tablets on Exercise Tolerance Compared with Trimetazidine in Patients after PCI (HEARTRIP) trial is a multicenter, double-blind, double-dummy, active drug-controlled, randomized trial designed to test if the effects of Yangxinshi tablets on exercise tolerance are non-inferior to those of trimetazidine in patients undergoing PCI. A total of 668 patients who have undergone PCI for the first time and completed a cardiopulmonary exercise test (CPET) will be enrolled and randomly assigned, in a 1:1 ratio, to receive Yangxinshi tablets (3 tablets, 3 times/d) plus trimetazidine-placebo or trimetazidine (20 mg, 3 times/d) plus Yangxinshi-placebo for 24 weeks. The primary endpoint is metabolic equivalent of tasks (METs) measured by CPET at 24 weeks after randomization. The secondary endpoints include comprehensive CPET indicators, incidence of major adverse cardiac and cerebrovascular events, and depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and quality of life (Seattle Angina Questionnaire) scores. This study will appraise current clinical evidence on the beneficial effect of Yangxinshi tablets on improving exercise tolerance after PCI and may substantiate their use as an effective pharmacological option for cardiac rehabilitation patients. The HEARTRIP study protocol received approval from the ethics committee of the General Hospital of Northern Theater Command (Shenyang, China). The procedures set out in this protocol are in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be published following the guidelines of the CONSORT statement in a peer-reviewed scientific journal (Trial registration number: NCT03809273).

Embedded System for the Simultaneous Study of SAHS and Cardiac Arrhythmia

This paper presents a proposed embedded system for the simultaneous study of Sleep Apnea/Hypopnea Syndrome (SAHS) and related cardiac arrhythmias, which can affect about 1 billion people worldwide. Its objective is to become a tool to research the relational causes of these disruptions. It can record biomedical signals and vital parameters related to cardiac and respiratory activity commonly used in clinical practice. The system is designed to be used in sleep studies, providing greater comfort to users by integrating two devices into one. The proposed system is battery-powered and has Bluetooth wireless communication for remote studies. The design is based on specific electronic components such as Analog Front-End and System on Chips, and best-practice guidelines for PCB design were followed. A hybrid-scheduler was selected as software architecture to ensure the task execution at specific intervals. The systems signal quality recording sub-system was tested using a multiparametric simulator, commercial holter device and acquired real records. The results are similar to other works.

Consensus-Based Best Practice Guidelines for the Management of Spinal Deformity and Associated Tumors in Pediatric Neurofibromatosis Type 1: Screening and Surveillance, Surgical Intervention, and Medical Therapy.

Spinal conditions, such as scoliosis and spinal tumors, are prevalent in neurofibromatosis type 1 (NF1). Despite the recognized importance of their early detection and treatment, there remain knowledge gaps in how to approach these manifestations. The purpose of this study was to utilize the experience of a multidisciplinary committee of experts to establish consensus-based best practice guidelines (BPGs) for spinal screening and surveillance, surgical intervention, and medical therapy in pediatric patients with NF1. Using the results of a prior systematic review, 10 key questions that required further assessment were first identified. A committee of 20 experts across medical specialties was then chosen based on their clinical experience with spinal deformity and tumors in NF1. These were 9 orthopaedic surgeons, 4 neuro-oncologists/oncologists, 3 neurosurgeons, 2 neurologists, 1 pulmonologist, and 1 clinical geneticist. An initial online survey on current practices and opinions was conducted, followed by 2 additional surveys via a formal consensus-based modified Delphi method. The final survey involved voting on agreement or disagreement with 35 recommendations. Items reaching consensus (≥70% agreement or disagreement) were included in the final BPGs. Consensus was reached for 30 total recommendations on the management of spinal deformity and tumors in NF1. These were 11 recommendations on screening and surveillance, 16 on surgical intervention, and 3 on medical therapy. Five recommendations did not achieve consensus and were excluded from the BPGs. We present a set of consensus-based BPGs comprised of 30 recommendations for spinal screening and surveillance, surgical intervention, and medical therapy in pediatric NF1.

Optimising the prescribing of drugs that may cause dependency: An evidence and gap map of systematic reviews.

We set out to map the quantitative and qualitative systematic review evidence available to inform the optimal prescribing of drugs that can cause dependency (benzodiazepines, opioids, non-benzodiazepine hypnotics, gabapentinoids and antidepressants). We also consider how this evidence can be used to inform decision-making in the patient care pathway for each type of medication. Eight bibliographic databases were searched for the period 2010 to 2020. All included reviews were initially appraised using four items from the Collaboration for Environmental Evidence Synthesis Assessment Tool, with reviews that scored well on all items proceeding to full quality appraisal. Key characteristics of the reviews were tabulated, and each review was incorporated into an evidence and gap map based on a patient care pathway. The care pathway was based upon an amalgamation of existing NICE guidelines and feedback from clinical and patient stakeholders. We identified 80 relevant reviews and displayed them in an evidence and gap map. The evidence included in these reviews was predominantly of low overall quality. Areas where systematic reviews have been conducted include barriers and facilitators to the deprescribing of drugs that may cause dependency, although we identified little evidence exploring the experiences or evaluations of specific interventions to promote deprescribing. All medications of interest, apart from gabapentinoids, were included in at least one review. The evidence and gap map provides an interactive resource to support (i) policy developers and service commissioners to use evidence in the development and delivery of services for people receiving a prescription of drugs that may cause dependency, where withdrawal of medication may be appropriate, (ii) the clinical decision-making of prescribers and (iii) the commissioning of further research. The map can also be used to inform the commissioning of further systematic reviews. To address the concerns regarding the quality of the existing evidence based raised in this report, future reviews should be conducted according to best-practice guidelines. Systematic reviews focusing on evaluating interventions to promote deprescribing would be particularly beneficial, as would reviews focusing on addressing the paucity of evidence regarding the deprescription of gabapentinoids.

DeapSea: Workflow-Supported Serious Game Design for Stroke Rehabilitation

The design and development of a serious game are complex due to different and often numerous stakeholders involved. Different guidelines for general best practices exist, but those are not specific and often do not include therapists or patients as essential stakeholders especially in the context of individualisation of a serious games. Although there are a lot of serious games in the area of (stroke) rehabilitation, design guidelines and indications of what is important are quite scarce. Identifying individualisation possibilities to adapt a serious game to the specific needs of patients was identified to support and improve the design and outcome of serious game development. A literature research and the analysis of previously designed serious games created the foundation for this research. The identified configuration possibilities, additional requirements, and the developed workflow were then evaluated with the gathered insights of therapists trough an online survey. 20 generic configuration possibilities for therapists, as well as seven requirements, were identified and are presented, which can be used when designing a serious game in the context of stroke. In addition a workflow, called “DeapSea” is proposed for supporting the design as well. These results should be used as an addition to already established design recommendations to deliver an adaptable and flexible serious game in the area of stroke—helping to fulfill individual patient needs from the point of therapists and other involved medical stakeholders within the rehabilitation process.

(064) “Condoms and Sexual Health Practices, Knowledge, Attitudes, and Beliefs of Cal Poly San Luis Obispo Students”

Abstract Introduction Sexual wellbeing is a large aspect of college students’ health that continues to be minimally addressed on university campuses. Considering the topic of STIs, it is estimated that people ages 15-24 accounted for almost half of the 26 million new sexually transmitted infections that occurred in the United States in 2018 (CDC, 2018). While there is information on condom and contraceptive usage for college students, there is not much data on the usage and beliefs surrounding condoms and sexual health practices. To further explore the sexual health practices at a university, a mixed-method study was conducted by the Sexual and Reproductive Health Lab during the 2020-21 school year. The study included a survey (n=580) and focus group discussions (n = 16) designed to answer the research questions 1) to what extent are condoms being used by students and 2) what are students’ knowledge, attitudes, and beliefs about condoms and sexual health? Results from the study indicated that while 69% of students engage in sexual activity, sex-based differences are apparent in the desire to use condoms, condoms are only used for vaginal sex, and barrier methods other than external condoms are not being used. Further, conversations prior to sex surrounding STI status and testing are limited. Future interventions are necessary to ensure that current limitations to best safe sex practices are improved through more inclusive sexual education and access to sexual health resources. Objective 1. Describe the factors that students consider when electing whether to use a condom by examining scenarios in which they are used frequently, which partner uses one, and why these scenarios elicit use. 2. Identify what type(s) of sexual acts condoms are currently being used for within the Cal Poly student population in comparison to guidelines for best sexual health practice by asking directly about patterns of use for penetrative vaginal, penetrative anal, and oral sex. 3. Discuss the ways in which health services at the University can better support the specific needs of Cal Poly students by gauging knowledge and certain perceptions on sexual health behaviors and contraceptive use, ultimately using the data to identify areas in which university services can target informative and preventive campaigns and provide access to relevant resources. Methods One-on-one in person or virtual interviews were conducted and asked students about their sexual histories to reveal their experiences using protection, initiating STI status conversations, and circumstances where protection is or is not used. Questions were then asked to evaluate student perceptions of “cleanliness” and clean status conversations. After, the interviews were transcribed via Microsoft Word and NVIVO is being used to code the data. Open coding of the data was first done to create codes and themes of the data and once codes were created, axial coding was done to interpret the data. Results Emerging data from the ongoing study reveals some important trends. Perhaps the most notable emerging finding centralizes on the role of trust in influencing a student’s decision to use a condom, engage in an STI status conversation, and ask for proof of status. Many participants also mentioned trust as a key factor. Another emerging finding reveals that students do not share a universal definition of the word “clean”, but instead the semantic value ranges from the physical environment to personal hygiene habits, to STI status. Furthermore, the use of the word “clean” to describe STI status was nor preferred by the general student population as they believe it propagates the stigma surrounding sex and STIs and implies people are dirty. Conclusions As we have uncovered, students do seem to have some understanding of safe sex practices. In addition, plenty of free barrier methods like condoms and dental dams are available across campus. Therefore, the issues related to lack of conversation and condom use, and subsequent rising rates of transmission, cannot be attributed to lack of knowledge or resources. Other factors, then, appear to be impeding adherence to sexual health best practices. Disclosure Yes, this is sponsored by industry/sponsor: Cal Poly San Luis Obispo. Clarification: Industry funding only - investigator initiated and executed study.

Identification of monoclonal antibody drug substances using non-destructive Raman spectroscopy

Monoclonal antibodies provide highly specific and effective therapies for the treatment of chronic diseases. These protein-based therapeutics, or drug substances, are transported in single used plastic packaging to fill finish sites. According to good manufacturing practice guidelines, each drug substance needs to be identified before manufacturing of the drug product. However, considering their complex structure, it is challenging to correctly identify therapeutic proteins in an efficient manner. Common analytical techniques for therapeutic protein identification are SDS-gel electrophoresis, enzyme linked immunosorbent assays, high performance liquid chromatography and mass spectrometry-based assays. Although effective in correctly identifying the protein therapeutic, most of these techniques need extensive sample preparation and removal of samples from their containers. This step not only risks contamination but the sample taken for the identification is destroyed and cannot be re-used. Moreover, these techniques are often time consuming, sometimes taking several days to process. Here, we address these challenges by developing a rapid and non-destructive identification technique for monoclonal antibody-based drug substances. Raman spectroscopy in combination with chemometrics were used to identify three monoclonal antibody drug substances. This study explored the impact of laser exposure, time out of refrigerator and multiple freeze thaw cycles on the stability of monoclonal antibodies. and demonstrated the potential of using Raman spectroscopy for the identification of protein-based drug substances in the biopharmaceutical industry.

Integrating Environmental and Social Dimensions with Science-Based Knowledge for a Sustainable Pesticides Management—A Project of Lombardy Region in Italy

Achieving a change towards the sustainable use and management of pesticides requires a multiple perspective approach that combines traditional knowledge, experience of different local stakeholders, scientific expertise, and context-specific data to provide useful and understandable information for the target farmers. In this paper, the incorporation of the information on environmental and social dimensions into a “science-based” pesticide management practice is presented as an example of a replicable multidisciplinary approach. This approach depicts the importance of the context-specific scenario analysis and of the involvement of farmers starting from their practices and their knowledge. A diverse range of engagement initiatives have been adopted to consult, inform, and involve the community. Tools as target guidelines of good practices, self-evaluation checklists, and a user-friendly indicator that considers social, environmental, and territorial parameters of the specific area, gained a lot of interest and trust and have proven to be useful in disseminating the methodology of environmental risk assessment to farmers, supporting and assisting them in the comparison of different phytosanitary strategies at farm scale to identify weaknesses in their current pesticide management at farm level and to find corresponding corrective actions. The experience also highlighted the importance of the role of properly trained and informed advisors.

Heat and carbon uptake in the Southern Ocean: the state of the art and future priorities.

Heat and carbon uptake in the Southern Ocean: the state of the art and future priorities.

Ethical perspectives on surgical video recording for patients, surgeons and society: systematic review.

Operating-room audiovisual recording is increasingly proposed, although its ethical implications need elucidation. The aim of this systematic review was to examine the published literature on ethical aspects regarding operating-room recording. MEDLINE (via PubMed), Embase, and Cochrane databases were systematically searched for articles describing ethical aspects regarding surgical (both intracorporeal and operating room) recording from database inception to the present (the last search was undertaken in July 2022). Medical subject headings used in the search included 'operating room', 'surgery', 'video recording', 'black box', 'ethics', 'consent', 'confidentiality', 'privacy', and more. Title, abstract, and full-text screening determined relevance. The quality of studies was assessed using Centre for Evidence-Based Medicine grading and no formal assessment of risk of bias was attempted given the theoretical nature of the data collected. From 1048 citations, 22 publications met the inclusion criteria, with three more added from their references. There was evident geographical (21 were from North America/Europe) and recency (all published since 2010) bias and an exclusive patient/clinician perspective (25 of 25). The varied methodology (including ten descriptive reviews, seven opinion pieces, five surveys, two case reports, and one RCT) and evidence level (14 level V and 10 level III/IV) prevented meaningful systematic grading/meta-analysis. Publications were narratively analysed for ethical thematic content (mainly education, performance, privacy, consent, and ownership) that was then grouped by the four principles of biomedical ethics of Beauchamp and Childress, accounting for 63 distinct considerations concerning beneficence (22 of 63; 35 per cent), non-maleficence (17 of 63; 27 per cent), justice (14 of 63; 22 per cent), and autonomy (10 of 63; 16 per cent). From this, a set of proposed guidelines on the use of operative data is presented. For a surgical video to be a truly valuable resource, its potential benefits must be more fully weighed against its potential disadvantages, so that any derived instruments have a solid ethical foundation. Universal, ethical, best-practice guidelines are needed to protect clinicians, patients, and society.

The Politics of Environmental Consensus: The Case of the World Commission on Dams

Abstract Recent discussion of global environmental assessment processes suggests that the process of consensus creation is central to understanding the way knowledge is produced and conclusions are reached. Here we contribute to this literature by providing a case study of the World Commission on Dams, which brought together supporters and opponents of large dams, at the height of controversy about dams in the 1990s. The Commission reviewed evidence and formulated guidelines for best practice, finding a way through a political stalemate. The article draws on interviews with those involved in the Commission and discusses the historical context, form of stakeholder representation, time horizon, and leadership style as consensus-enabling conditions. We conclude that an ambitious consensual process was successful within the life of the Commission, but at the cost of carrying external actors with it, leading to challenges with dissemination and uptake of consensual recommendations.