Good Practice Standards Research Articles

The association of standardized patient educators (ASPE) gynecological teaching associate (GTA) and male urogenital teaching associate (MUTA) standards of best practice

Gynecological Teaching Associates (GTAs) and Male Urogenital Teaching Associates (MUTAs) instruct healthcare professional learners to perform accurate and respectful breast, speculum, bimanual vaginal, rectal, urogenital, and prostate examinations. During such sessions, the GTA/MUTA uses their own body to instruct while providing real-time feedback. While GTAs/MUTAs fall under the broader umbrella of Standardized Patient methodology, the specificity of their role indicates need for establishment of Standards of Best Practice (SOBP) for GTA/MUTA programs. On behalf of the Association of Standardized Patient Educators (ASPE), the Delphi process was utilized to reach international consensus identifying the Practices that comprise the ASPE GTA/MUTA SOBP. The original ASPE SOBP was used as the foundation for the iterative series of three surveys. Results were presented at the ASPE 2019 conference for additional feedback. Fifteen participants from four countries completed the Delphi process. Four of the original ASPE SOBP Domains were validated for GTA/MUTA programs: Safe Work Environment, Instructional Session Development, Training GTAs/MUTAs, and Program Management. Principles and Practices were shaped, and in some instances created, to best fit the distinct needs of GTA/MUTA programs. The ASPE GTA/MUTA SOBP apply to programs that engage GTAs/MUTAs in formative instructional sessions with learners. Programs that incorporate GTAs/MUTAs in simulation roles or in summative assessment are encouraged to reference the ASPE SOBP in conjunction with this document. The SOBP are aspirational and should be used to shape Practices within the program’s local context. The ASPE GTA/MUTA SOBP will continue to evolve as our knowledge-base and practice develop.

Collective scientific assessment as a relevant tool to inform public debate and policymaking: an illustration about the effects of plant protection products on biodiversity and ecosystem services.

Several sustainable development goals cannot be achieved without implementing a new generation of environmental measures to better preserve or restore biodiversity and ecosystem services. However, understanding and addressing biodiversity loss and ecosystem degradation is a challenging problem that is not solvable without integrating the best and latest science. It is crucial to enhance the legibility of this knowledge for decision-makers and policymakers following good-practice standards of scientific assessment. This is the main objective of collective scientific assessments (CSAs), as carried out by the French National Research Institute for Agriculture, Food and the Environment (INRAE) since the early 2000s following a documented procedure to inform public policy and foster public debate on complex interdisciplinary issues. This article describes the main steps of the CSA procedure designed by INRAE's Directorate for Collective Scientific Assessment, Foresight and Advanced Studies, from formulation of the initial question asked by public or para-public bodies (typically ministry divisions or environmental agencies) to wider dissemination of the results and conclusions. This process description is then illustrated through the example of a CSA recently commissioned by three French Ministries (for Ecology, for Research, and for Agriculture) regarding (i) contamination of terrestrial, freshwater, and marine ecosystems by plant protection products (PPPs); (ii) the resulting effects on biodiversity and ecosystem services; and (iii) possible prevention and mitigation strategies. The capacity of this kind of CSA to inform public debate and policymaking is then exemplified through a description of the main outcomes generated by the latest CSA dealing with the adverse effects of PPPs. We also provide a short overview of some key expectations from the current CSA, with a focus on the recent development of the ecosystem service approach in ecological risk assessments of PPPs in the European Union. This illustration demonstrates that CSAs, which are applicable to a wide variety of complex interdisciplinary questions that are not limited to environmental issues, are a relevant tool to inform public debate and policymaking.

GMP compliant isolation of mucosal epithelial cells and fibroblasts from biopsy samples for clinical tissue engineering

Engineered epithelial cell sheets for clinical replacement of non-functional upper aerodigestive tract mucosa are regulated as medicinal products and should be manufactured to the standards of good manufacturing practice (GMP). The current gold standard for growth of epithelial cells for research utilises growth arrested murine 3T3 J2 feeder layers, which are not available for use as a GMP compliant raw material. Using porcine mucosal tissue, we demonstrate a new method for obtaining and growing non-keratinised squamous epithelial cells and fibroblast cells from a single biopsy, replacing the 3T3 J2 with a growth arrested primary fibroblast feeder layer and using pooled Human Platelet lysate (HPL) as the media serum supplement to replace foetal bovine serum (FBS). The initial isolation of the cells was semi-automated using an Octodissociator and the resultant cell suspension cryopreservation for future use. When compared to the gold standard of 3T3 J2 and FBS containing medium there was no reduction in growth, viability, stem cell population or ability to differentiate to mature epithelial cells. Furthermore, this method was replicated with Human buccal tissue, providing cells of sufficient quality and number to create a tissue engineered sheet.

Implementing out of hours MDT safety huddles at the Ladywell Unit, Lewisham, South London and the Maudsley (SLAM) NHS Foundation Trust

Aims•For 100% of patients admitted OOH (Friday 5pm – Sunday 9am) to have a multi-disciplinary review of their treatment•For 100% of patients with deteriorating physical and mental health to be discussed•To improve multi-disciplinary team (MDT) morale, working relationships and team cohesiveness OOHBackgroundIn most specialties, the standard of best practice is that patients admitted to the ward out of hours (OOH) receive a senior review over the weekend. However this does not usually take place in Psychiatry, and patients routinely wait until Monday to be seen by the ward team. This has been highlighted as problematic in cases where patients are agitated and not receiving any treatment for > 24 hours.We trialled a weekend teleconference safety huddle in Lewisham involving the on call consultant, registrar (SpR), core trainee (CT) and duty senior nurse (DSN).MethodThe weekend huddles were through a teleconference line, with participants dialling in at 9.45am.Issues discussed: 1)Management plan for newly admitted patients OOH.2)Plan for patients with deteriorating mental health or escalating level of aggression.3)Plan for patients with deteriorating physical health.Feedback was collected from CTs, SpRs and consultants focusing on whether the huddle made any difference to the speed of care, cohesiveness of the OOH team, and whether it was generally helpful or not.Result54% of CTs (n = 11) felt that patients admitted OOH had an MDT review, and 90% felt that patients with deteriorating mental and physical health were discussed and a plan put in place. 80% of CTs, 63% of SpRs (n = 8) and 67% of consultants (n = 6) agreed it improved team cohesiveness. 90% of DSNs felt safer and more supported in decision-making OOH.80% of CTs, 63% of SpRs and 83% of consultants found weekend huddles helpful.Data were also collected on violent incidents OOH, and there was a slight reduction in the number of violent incidents in the weeks following introduction of the huddle.ConclusionIntroducing safety huddles in Lewisham has facilitated the prompt discussion of the management of patients admitted OOH, and of those with deteriorating mental and physical health. It has also fostered a greater sense of cohesiveness in the MDT team.In light of this feedback, safety huddles have now been established as part of the weekend schedule in Lewisham, and are being rolled out to other boroughs within SLaM.

Use of a Structured Approach to Develop Best Practices in Interprofessional Education.

Providing interprofessional education (IPE) is mandated by accrediting agencies for health professions education; however, pedagogical, logistical, and financial challenges exist in implementing and sustaining high-quality IPE. After executing several IPE activities, an IPE team developed a structured approach for organizing, sustaining, and ensuring high-quality IPE. This article introduces the Design-Implement-Assess-Modify (DIAM) Model. A portfolio spreadsheet was developed and includes components from each of the DIAM phases. The team documented characteristics from five IPE activities conducted annually for 5 years and tracked progress. The DIAM approach has allowed the team to develop a detailed and living portfolio to design, implement, assess, and modify several IPE activities across different professions. This approach has led to the intentional planning and development of multiple IPE activities that include the integration of standards of best practice and accreditation, while preparing practitioners for collaborative practice. [J Nurs Educ. 2021;60(6):309-316.].

Improving patient access to medication information: a quality improvement project on patient-centred prescribing

AimsWard rounds are sometimes the only opportunity for patients to discuss medication. Patient and professional feedback on an acute male inpatient ward in South London highlighted a demand for more medication information outside the formal ward round setting. We aimed to have 100% of patients meet our criteria for “Patient-Centred Prescribing” on the ward by March 2021. To fulfil criteria, all patients are offered: (1) ward round discussion, (2) written patient information leaflets (PILs), (3) informal discussion groups, all regarding medication.The principles of this quality improvement project (QIP) were drawn from definitions of patient-centred care and standards of good practice; patients should have access to a variety of information formats, relevant to the individual, and the knowledge gained empowers patients.Patient experience data revealed that 30% of clients answered passively to the question, “Do you feel involved in your care?” We hypothesized that medication discussion groups positively impact patients’ wellbeing, by providing a safe space that facilitates conversation surrounding medication issues.MethodWe conducted weekly audits on patients whose admission duration was >7 days, and recorded fulfilment of the above criteria. At week 1, we introduced a program of weekly medication discussion groups led by members of the wider multi-disciplinary team covering a broad topic range. At week 6, we developed a rolling rota of the discussion groups and posters were displayed in advance. At week 14, all patients were offered PILs through a 1:1 interaction and this continued as routine practice. Medication discussion group feedback was obtained via questionnaires and “The Blob Tree”, a psycho-emotional assessment tool commonly used in healthcare settings.ResultIn 19 weeks, the median percentage of patients who fulfilled our criteria for Patient-Centred Prescribing was 92.86%. After 11 medication discussion groups, 79.3% of questionnaire responders wanted further sessions. 88% of “The Blob Tree” responses collected inferred a positive emotional response after the group discussions and half of those noticed an improvement in their emotional state.ConclusionThis QIP was overall a success; it fulfilled a requirement to meet good standards in information sharing and became embedded in the fabric of the ward, continuing to run as part of the activities program. It demonstrated the impact of education on patients’ mental wellbeing through empowerment and peer support. As a by-product it established multidisciplinary connections and improved therapeutic relationships. Challenges included patient engagement secondary to acute mental illness or negative symptoms and maintaining project momentum following a COVID-19 outbreak.

MSC Manufacturing for Academic Clinical Trials: From a Clinical-Grade to a Full GMP-Compliant Process.

Following European regulation 1394/2007, mesenchymal stromal cell (MSCs) have become an advanced therapy medicinal product (ATMP) that must be produced following the good manufacturing practice (GMP) standards. We describe the upgrade of our existing clinical-grade MSC manufacturing process to obtain GMP certification. Staff organization, premises/equipment qualification and monitoring, raw materials management, starting materials, technical manufacturing processes, quality controls, and the release, thawing and infusion were substantially reorganized. Numerous studies have been carried out to validate cultures and demonstrate the short-term stability of fresh or thawed products, as well their stability during long-term storage. Detailed results of media simulation tests, validation runs and early MSC batches are presented. We also report the validation of a new variant of the process aiming to prepare fresh MSCs for the treatment of specific lesions of Crohn’s disease by local injection. In conclusion, we have successfully ensured the adaptation of our clinical-grade MSC production process to the GMP requirements. The GMP manufacturing of MSC products is feasible in the academic setting for a limited number of batches with a significant cost increase, but moving to large-scale production necessary for phase III trials would require the involvement of industrial partners.

Implementation and utilization of gynecological teaching associate and male urogenital teaching associate programs: a scoping review

BackgroundGynecological Teaching Associates (GTAs) and Male Urogenital Teaching Associates (MUTAs) are individuals trained to instruct health professional learners with their own body to conduct accurate, patient-centered breast, pelvic, urogenital, rectal, and/or prostate examinations. Evidence indicates that this results in improvements in technical competence and communication skills, but there is wide variability to how such programs are implemented and engaged within the curriculum. In this scoping review, we mapped evidence regarding (1) how GTA/MUTA programs are utilized with health professional learners, (2) how GTA/MUTA programs are implemented using the Association of Standardized Patient Educators (ASPE) Standards of Best Practice (SOBP) as a framework, and (3) what broad outcomes are addressed in publications.MethodsPubMed, ERIC, PsychINFO, CINAHL, and Sociological s were searched for all publications addressing instruction of physical examinations with a GTA/MUTA and/or administration of GTA/MUTA programs. Studies were charted in tandem until consensus was identified and then charted individually, using an iterative process. The scoping review protocol was registered prospectively.ResultsOne hundred and one articles were identified, and nearly all highlighted positive results regarding GTA/MUTA programs. Most studies addressed medical students within the USA and Europe. During instructional sessions, three (SD=1.4) learners worked with each GTA/MUTA and an average of 32 min (SD=17) was allocated per learner. GTAs/MUTA instructed both independently (n=33) and in pairs (n=51). Thirty-eight articles provided detailed information consistent with one or more of the Domains of the ASPE SOBP, with six providing specific information regarding safe work environments.ConclusionsWhile studies demonstrate consistently positive outcomes for learners, there is wide variability in implementation patterns. This variability may impact learning outcomes and impact both physical and psychological safety for GTAs/MUTAs and learners. Terminology used to refer to GTAs/MUTAs is inconsistent and may obscure relevant publications. Additional research is indicated to explore the pedagogical variables that result in positive learning outcomes and examine methods to ensure physical and psychological safety of GTAs/MUTAs and learners.Trial registrationhttps://osf.io/x9w2u/.

Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents

Producing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also, for product quality and safety. However, the large-scale production of clinical-grade MSCs possesses unique regulatory challenges and hurdles related to the heterogeneous nature of MSC cultures as well as the complex manufacturing process. Following is a compilation of the major issues encountered in the manufacturing of MSCs for clinical use, and our views on the optimal characteristics of the final MSC product.

233 Concomitant Surgical Atrial Fibrillation Ablation Follow-Up Against Best-Practice Standards at A Tertiary Cardiac Surgery Centre in Brighton

Abstract Introduction Best-practice as per JCTVS 2006 meta-analysis recommends following patients who undergo concomitant surgical Atrial Fibrillation (AF) ablation at 3-months, 1, 2 and 3 years to ensure AF resolution. A dedicated nurse-led arrythmia clinic managed these patients at Royal Sussex County Hospital (RSCH), Brighton but was relinquished. Follow-up was incorporated into routine cardiothoracic/cardiology clinics. This audit compares current practice at RSCH against best-practice (JCTVS). Method Patients who underwent surgical AF ablation between 2016-2017 at RSCH notes were interrogated for demographic, clinical and outcome data. Survival, freedom from AF at 3-years and post-operative anticoagulation/rate-control medications at follow-up data were extracted. Results Sixty-two patients underwent surgical AF ablation; 21 were followed up locally at RSCH and included in the final analysis. 53% had post-surgical AF resolution. At 3-years, 48% were free from AF; all patients survived. Only 38% patients had 4 follow-up appointments as per best-practice standards. 62% and 66% continued anticoagulation and rate-control medications, respectively. Conclusions Best-practice standards were poorly met. Patients inappropriately followed-up could incur severe AF-related complications including longer hospital stay, treatment and poorer quality of life. A nurse-led arrhythmia clinic can prevent AF-related hospital admissions and sequalae by ensuring cost-effective review, optimal anticoagulation, and rate/rhythm control.

Rasch Analysis of the Listening Effort Questionnaire-Cochlear Implant.

Listening effort may be defined as the attentional and cognitive resources needed to understand an auditory message, modulated by motivation. Despite the use of hearing devices such as hearing aids or cochlear implants (CIs), the requirement for high listening effort remains a challenge for individuals with hearing loss. The Listening Effort Questionnaire-Cochlear Implant (LEQ-CI) is a hearing-specific patient-reported outcome measure (PROM), which has been designed for use in the CI candidacy and rehabilitation process to assess perceived listening effort in everyday life in adults with severe-profound hearing loss. The LEQ-CI has been developed in line with international consensus-based standards for best practice in PROM construction. The aim of this study was to improve the measurement precision of the LEQ-CI and to assess its psychometric measurement properties. A field test was undertaken with 330 CI patients from five National Health Service auditory implant centers in the United Kingdom. Participants were adults (≥18 years of age), had a severe-profound hearing loss, and met the UK candidacy criteria for cochlear implantation specified by the National Institute for Health and Care Excellence (NICE). Participants completed and returned an anonymized 29-item (each with a 5- or 7-point response option), draft version of the LEQ-CI (LEQ-CI29) and a demographic questionnaire. Rasch analysis was undertaken using Winsteps software and the partial credit model to assess rating scale function and item fit. Results informed refinements to produce a 21-item version (LEQ-CI21), which underwent a further Rasch analysis. The sample was predominantly female: 60.3% (n = 191). Median age of participants was 66 (range 21 to 89) years, with 7.3% (n = 24) of respondents being CI candidates and 92.7% (n = 306) being CI recipients. Mean duration of implantation was 3.8 (SD = 4.8) years. Initial Rasch analysis of the LEQ-CI29 revealed poor rating scale functioning. Collapsing the 5- and 7-point rating scales to 3- and 4-point scales and removing eight items produced a 21-item PROM (LEQ-CI21). Rasch analysis of the LEQ-CI21 showed good fit to the Rasch measurement model. No items showed misfit and dimensionality analysis supported the existence of a single Rasch dimension, defined as perceived listening effort in daily life. Person reliability was 0.91 and the person separation index was 3.28, establishing four levels of person ability. The item separation index was 9.69, confirming the item hierarchy. No items showed differential item functioning for gender or age. The item difficulty range was -0.81 to 1.05, the person ability range for nonextreme persons was -3.54 to 2.49, and the mean person ability was -0.31. Overall, the LEQ-CI21 was found to meet the Rasch model criteria for interval-level measurement. The LEQ-CI21 is the first PROM to be developed specifically for the measurement of perceived listening effort and one of the first patient-reported outcome measures for use with CI patients to be developed using Rasch analysis. The LEQ-CI21 has the potential to be used as a research tool and in clinical practice to evaluate perceived listening effort in daily life. Further psychometric evaluation of the LEQ-CI21 is planned.

The ODMAP protocol: a new tool for standardized reporting that could revolutionize species distribution modeling

Several recent papers have highlighted best practices, defined metadata standards and proposed checklists for reproducibility of species distribution models (SDMs). A new paper by Zurell et al. (2020) formalizes, extends and implements many of these ideas in a standardized protocol for reporting SDMs called ODMAP (Overview, Data, Model, Assessment, Prediction). ODMAP has the potential to revolutionize species distribution modeling, not through the development of new methods, but rather by providing a long overdue system to document, communicate and reproduce methods. ODMAP could lead to improved basic and applied science outcomes by increasing comprehension and transparency, and by guiding implementation of best practices. However, the impact that ODMAP has on SDMs depends in large part on the extent to which journals, reviewers and funding agencies encourage its use and whether mentors introduce it to the next generation of biodiversity scientists. Important next steps include formalizing mechanisms for the broader research community to participate in future development of ODMAP and related standards for best practices in biodiversity modeling.

Analysis of the use of podcasts to enhance student learning in a visual dependent course

Background Interest in podcasting as a learning tool has increased amongst educators in light of the push to online/virtual learning. Studies investigating the efficacy of podcasting have had mixed results and varying parameters. As the use of podcasting for educational purposes is still in its infancy, standards for best practices are underdeveloped. One of the most commonly cited drawbacks of podcasts is the lack of student participation in the podcast production. Here we develop a podcast exam review created directly from student inquiries. We believe that providing a podcast that answers student inquiries directly will improve student engagement, increase short-term retention, and allow the efficacy of podcasting after one episode to be assessed. Methods Students enrolled in histology and neuroanatomy were asked to submit questions for each podcast exam review one week prior to the exam. The podcast narrators answered the student inquiries during each podcast episode. On each exam, questions related to content covered in the podcasts were tagged as podcast-multiple choice (P-MCQs) or podcast-short answer (SA-Ps). Questions relating to content only reviewed in class were labeled as class-MCQs (C-MCQs) or class short answer (SA-C). With each exam, students were asked to complete a survey relating to their utilization of the podcast. Based on self-reported usage, consenting students were divided into two groups, podcast users (PUs) and non-users (NPUs). Results from one exam were excluded as all of the students who completed the survey also listened to the podcast. At the end of Fall semester, a follow-up survey about the utility of the podcast was sent to the students. Results Performances on the P-MCQs or SA-Ps between PUs and NPUs were not significantly different (p=0.6). During the Neuroanatomy course, PUs tended to score higher on SA-Ps but this was not significant (p=0.53). Based on student comments, we extrapolated three themes: length, helpful, and engaging. Many students wished the podcasts were longer. Podcast listeners found it helpful to hear concepts repeated or described from a different perspective. Students also commented that they would listen to the podcast and draw or take notes to link to other concepts. Conclusion Overall, there was not a significant difference in performance on tagged MCQs or SAs between students who listened to or did not listen to the podcast, which was contradictory to our hypothesis but not unexpected based on adult learning theories. We did reveal that single episodes of podcasts are perceived to be beneficial based on student comments, which should help inform best-practices for educational podcasting. Student comments also suggested that they were linking various course concepts, which we believe is significant benefit of podcasting. Due to the extreme circumstances of the previous year, we were unable to obtain sufficient student feedback or responses post-semester. In the future, we believe that longer podcasts, that go beyond the questions posted by the students, can be created and still perceived as useful based on themes derived from student comments.

Does performance-based remuneration improve outcomes in the treatment of hip fracture?

AimsThe aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients.MethodsThis was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients.ResultsA total of 6,532 patients provided both baseline and four-month EQ-5D-5L, of whom 1,060 participants had died at follow-up. Best practice was achieved in the care of 57% of participants; there was no difference in age, cognitive ability, and mobility at baseline for the overall attainment and non-attainment groups. Attaining at least ‘joint care by surgeon and orthogeriatrician’, ‘delirium assessment’, and ‘falls assessment’ was associated with a large, clinically relevant increase in four months EQ-5D-5L of 0.094 (bootstrapped 95% confidence interval (CI) 0.046 to 0.146).ConclusionNational standards with enhanced remuneration in hip fracture care results in improvement in individual patients’ HRQoL.Cite this article: Bone Joint J 2021;103-B(5):881–887.

Common Limitations and Challenges of Dietary Clinical Trials for Translation into Clinical Practices.

The progressive development of clinical and public health nutrition has long relied on dietary clinical trials (DCTs), investigating the causal relationship between diet and multiple risk factors of non-communicable and chronic diseases. DCTs are also hallmarks for establishing dietary requirements and promoting overall nutritional health among the population. Despite their critical importance in translation into public health strategies and practices, DCTs have several limitations and challenges for study design, implementation and finding interpretation. The complex nature of nutrition interventions, collinearity between diet components, multi-target effects of the interventions, diverse dietary behaviors, and food culture are the most challenging issues. Furthermore, baseline exposure and dietary status, appropriate control groups, blinding, randomization, and poor adherence undermine the effectiveness of DCTs in translation into practices. Disruptive factors will be minimized if researchers are committed to following good clinical practice (GCP) standards available for common designs of clinical trials. Planning DCTs, however, needs careful considerations for hypothesis generation, study design development, the definition of primary and secondary outcome measures, and target population.

Systems Exercise Genetics Research Design Standards.

It is clear, based on a deep scientific literature base, that genetic and genomic factors play significant roles in determining a wide range of sport and exercise characteristics including exercise endurance capacity, strength, daily physical activity levels, and trainability of both endurance and strength. Although the research field of exercise systems genetics has rapidly expanded over the past two decades, many researchers publishing in this field are not extensively trained in molecular biology or genomics techniques, sometimes creating gaps in generating high-quality and cutting-edge research for publication. As current or former Associate Editors for Medicine and Science in Sports and Exercise that have handled the majority of exercise genetics articles for Medicine and Science in Sports and Exercise in the past 15 yr, we have observed a large number of scientific manuscripts submitted for publication review that have exhibited significant flaws preventing their publication; flaws that often directly stem from a lack of knowledge regarding the "state-of-the-art" methods and accepted literature base that is rapidly changing as the field evolves. The purpose of this commentary is to provide researchers-especially those coming from a nongenetics background attempting to publish in the exercise system genetics area-with recommendations regarding best-practice research standards and data analysis in the field of exercise systems genetics, to strengthen the overall literature in this important and evolving field of research.

The Bow Jubail Oiled Wildlife Incident: Success Factors of an International Tiered Response on the Basis of Standards of Good Practice

Abstract In June 2018, about 218 metric tons of heavy fuel oil gushed into the harbor of Rotterdam (NL) following the rupturing of the hull of the Bow Jubail at a jetty. Due to tidal activity, the oil from the unloaded chemical tanker quickly spread out over a 30+ km waterway where many hundreds of Mute swans were moulting at the time. A citizen's initiative quickly led to the capture of over 200 swans from the water and shores, and their transport to some bird rehab centers in the immediate neighborhood. For the authorities this massive impact that overwhelmed the available resources of the permanent centers was the trigger to activate the national oiled wildlife response plan. The activation of the national plan goes hand in hand with the decision to build a large temporary facility that needs to be fully operational within 48 hours to receive the impacted live animals for treatment. The building of the such a facility, but also the staffing that is needed to care for 600 impacted swans is a challenging task and needs fast decision taking by experts who can oversee the particular needs of swans, and are able to inform logistics about equipment and materials needed. In parallel, a large number of experts must be mobilized who can lead and process the impacted animals once the temporary facility is ready for operations. For some part these resources were available in the Netherlands, but many more experts needed to be mobilized from abroad. The mobilization procedures of both EUROWA network and the GOWRS network were activated, leading to a large number of experts who indicated their availability. Meanwhile, the authorities took decisions on the authorization of the international mobilization, and when green lighted, the experts were asked to come over. This paper describes the decision making in the early days, and the way that arriving experts were deployed in the facility. The use of international guidelines for this process and the ease by which international experts could work together thanks to many years of investments into local and international preparedness will be highlighted. The rehabilitation of 522 mute swans took a full month (30 days), after which 97.5% of the animals had been successfully released.

Effectiveness of antenatal corticosteroids at term: Can we trust the data that ‘inform’ us?

Randomized controlled trials (RCTs) are a cornerstone for the assessment of the effectiveness of interventions. Appropriate randomization, design, sample size, statistical analyses, and conduct that reduces the risk of bias, enhance the chance they will deliver true research findings.The credibility of RCTs is difficult to assess without objective evidence of compliance with Good Clinical Practice standards. Remarkably, no mechanisms are in place both in the initial peer review process and during meta-analysis to assess these, and little guidance on how to assess data where research integrity cannot be confirmed (e.g. where data originated from a setting without established infrastructure or an era preceding current standards).We describe the case of the use of antenatal steroids. When these drugs are used in early preterm birth, their benefits outweigh the harms. However, later in pregnancy, and specifically at term, this balance is less clear. We describe that the four randomised clinical trials that inform clinical practice through the Cochrane meta-analysis, for various reasons, lack clear governance which makes it difficult to verify provenance and reliability of the data. We conclude that transparency and assessment of data credibility need to be inbuilt both at the time of publication and at the time of meta-analysis. This will drive up standards and encourage appropriate interpretation of results and the context from which they were derived.

Oncology Clinical Trials in Africa: Partnering for Quality.

Oncology clinical trials are requisite for testing the safety and effectiveness of promising treatments and deciphering new knowledge into concrete benefits for patients. They present opportunities to innovate promising, novel cancer remedies. A dearth of local evidence to guide cancer treatment in Africans is creating an increased interest in oncology clinical trials to improve patient care. This is primarily because of limitations in pathology, surgery, medical oncology, radiation, and palliation that are leading to worse cancer outcomes on the continent.Investment in oversight of Human Research Ethics committees and Medicines Regulatory Authorities in Africa has improved the potential for many countries to host clinical trials. However, the distribution of cancer trials remains poor across the continent, resulting in inadequate treatment options for patients with cancer.There are some initiatives aimed at developing research capacity to host trials in Africa. However, there is now a need to establish strategic partnerships whose aim should be to achieve harmonized, accredited Clinical Trials Units capable of running trials to meet Good Clinical Practice standards. This article discusses what has been achieved and proposes a model for quality oversight of Clinical Trials Units in Africa.

Accurate Quantification of AAV Vector Genomes by Quantitative PCR.

The ability to accurately determine the dose of an adeno-associated viral (AAV) therapeutic vector is critical to the gene therapy process. Quantitative PCR (qPCR) is one of the common methods to quantify the AAV vector titre, but different variables can lead to inconsistent results. The aim of this study was to analyze the influence of the conformation of the DNA used as the standard control, and the enzymatic digestion was performed to release the viral genome from the protein capsid on the physical genome titration of a clinically relevant AAV8.RPGR vector, made to good laboratory practice standards in an academic setting. The results of this study showed that the conformation of the DNA used as standard has a significant impact on the accuracy of absolute quantification by qPCR. The use of supercoiled undigested plasmid DNA template generated a higher apparent titer, as compared to the use of linearized plasmid as the standard. In contrast to previous studies, the pre-treatment of the samples with Proteinase K, in addition to the high temperature step used after DNase I digestion, resulted in a reduction on AAV titers. Ideally, all AAV documentation should state which form of reference plasmid and which pre-treatment of the samples have been used to calculate titers, so that appropriate comparisons relating to dose toxicity and transduction efficacy can be made in the clinical scenario.