A Novel Orthoplastic Reconstruction of Relapsed Clubfoot With Total Ankle Arthroplasty.

Congenital clubfoot is addressed in infancy and rarely persists into adulthood. Ankle arthroplasty is an increasingly popular surgical intervention for patients with ankle arthritis since it allows a natural ankle range of motion and completely replaces a degenerative hindfoot. Here, we describe the first successful total ankle arthroplasty (TAA) for a patient with previously treated congenital clubfoot that reverted later in life. To address the patient's poor soft-tissue integument and reduce the likelihood of post-surgical complications, a perioperative latissimus muscle-free flap was performed. This two-staged, novel orthoplastic intervention addressed our patient's ankle issues and appears to be a viable option for clubfoot patients.

Intellectual Property and Royalty Payments Among Foot and Ankle Surgery Fellowship Faculty.

Faculty of the American College of Foot and Ankle Surgeons and American Orthopedic Foot and Ankle Society fellowship programs are uniquely positioned to provide advanced clinical and surgical training to fellows. One aspect of this training may include product design and mentorship through the associated intellectual property (IP) and patent timeline. This study describes the payments received and IP held among foot and ankle surgery fellowship faculty. A review of foot and ankle surgeons with royalties or license payments disclosed on the CMS Open Payments Database from 2014 to 2020 was conducted. Members with payments were then cross-referenced with the US Patent Full-Text Database to identify patents held. Fellowship affiliation, practice location, patent office, number of patents, citations, patent h-index, type of patent, and yearly payment values were recorded. Among the 2801 surgeons, 53 fellowship affiliates and 46 nonaffiliates maintained at least 1 patent and royalty/license payment. A total of 576 patents and 19,191 citations were assessed. The median number of patents and citations held by fellowship faculty was 3 and 60, respectively, while the median total payment value reached $165,197.09. Fixation devices comprised most of the patents and citations. Payment value positively correlated with number of patents held (p = .01), citations (p = .007), and patent h-index (p = .01) among fellowship-affiliated surgeons. Foot and ankle surgery fellowship faculty payments for IP are associated with the number and citability of patents held. While a small proportion of faculty were paid for intellectual property, the number of patents held and citations was comparable to other specialties.

Floating solar panels on reservoirs impact phytoplankton populations: A modelling experiment.

Floating solar photovoltaic (FPV) deployments are increasing globally as the switch to renewable energy intensifies, representing a considerable water surface transformation. FPV installations can potentially impact aquatic ecosystem function, either positively or negatively. However, these impacts are poorly resolved given the challenges of collecting empirical data for field or modelling experiments. In particular, there is limited evidence on the response of phytoplankton to changes in water body thermal dynamics and light climate with FPV. Given the importance of understanding phytoplankton biomass and species composition for managing ecosystem services, we use an uncertainty estimation approach to simulate the effect of FPV coverage and array siting location on a UK reservoir. FPV coverage was modified in 10% increments from a baseline with 0% coverage to 100% coverage for three different FPV array siting locations based on reservoir circulation patterns. Results showed that FPV coverage significantly impacted thermal properties, resulting in highly variable impacts on phytoplankton biomass and species composition. The impacts on phytoplankton were often dependent on array siting location as well as surface coverage. Changes to phytoplankton species composition were offset by the decrease in phytoplankton biomass associated with increasing FPV coverage. We identified that similar phytoplankton biomass reductions could be achieved with less FPV coverage by deploying the FPV array on the water body's faster-flowing area than the central or slower flowing areas. The difference in response dependent on siting location could be used to tailor phytoplankton management in water bodies. Simulation of water body-FPV interactions efficiently using an uncertainty approach is an essential tool to rapidly develop understanding and ultimately inform FPV developers and water body managers looking to minimise negative impacts and maximise co-benefits.

Adaptive forecasting of phytoplankton communities.

The global proliferation of harmful algal blooms poses an increasing threat to water resources, recreation and ecosystems. Predicting the occurrence of these blooms is therefore needed to assist water managers in making management decisions to mitigate their impact. Evaluation of the potential for forecasting of algal blooms using the phytoplankton community model PROTECH was undertaken in pseudo-real-time. This was achieved within a data assimilation scheme using the Ensemble Kalman Filter to allow uncertainties and model nonlinearities to be propagated to forecast outputs. Tests were made on two mesotrophic lakes in the English Lake District, which differ in depth and nutrient regime. Some forecasting success was shown for chlorophyll a, but not all forecasts were able to perform better than a persistence forecast. There was a general reduction in forecast skill with increasing forecasting period but forecasts for up to four or five days showed noticeably greater promise than those for longer periods. Associated forecasts of phytoplankton community structure were broadly consistent with observations but their translation to cyanobacteria forecasts was challenging owing to the interchangeability of simulated functional species.

Effects of seasonal meteorological variables on E. coli persistence in livestock faeces and implications for environmental and human health.

Agriculture contributes significant volumes of livestock faeces to land. Understanding how faecal microbes respond to shifts in meteorological patterns of contrasting seasons is important in order to gauge how environmental (and human health) risks may alter under a changing climate. The aim of this study was to: (i) quantify the temporal pattern of E. coli growth within dairy faeces post defecation; and (ii) derive E. coli seasonal population change profiles associated with contrasting environmental drivers. Evaluation of the die-off dynamics of E. coli revealed that a treatment mimicking drought and warming conditions significantly enhanced persistence relative to E. coli in faeces that were exposed to field conditions, and that this pattern was consistent across consecutive years. The internal temperature of faeces was important in driving the rate of change in the E. coli population in the immediate period post defecation, with most E. coli activity (as either die-off or growth) occurring at low dry matter content. This study highlighted that the use of seasonal E. coli persistence profiles should be approached with caution when modelling environmental and human health risks given the increased likelihood of atypical seasonal meteorological variables impacting on E. coli growth and die-off.

Predicting microbial water quality with models: Over-arching questions for managing risk in agricultural catchments.

The application of models to predict concentrations of faecal indicator organisms (FIOs) in environmental systems plays an important role for guiding decision-making associated with the management of microbial water quality. In recent years there has been an increasing demand by policy-makers for models to help inform FIO dynamics in order to prioritise efforts for environmental and human-health protection. However, given the limited evidence-base on which FIO models are built relative to other agricultural pollutants (e.g. nutrients) it is imperative that the end-user expectations of FIO models are appropriately managed. In response, this commentary highlights four over-arching questions associated with: (i) model purpose; (ii) modelling approach; (iii) data availability; and (iv) model application, that must be considered as part of good practice prior to the deployment of any modelling approach to predict FIO behaviour in catchment systems. A series of short and longer-term research priorities are proposed in response to these questions in order to promote better model deployment in the field of catchment microbial dynamics.

Equipment and Analytical Companies Meeting Continuous Challenges May 20-21 2014 Continuous Manufacturing Symposium.

This white paper focuses on equipment, and analytical manufacturers' perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

This white paper focuses on equipment, and analytical manufacturers' perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales.

Determining E. coli burden on pasture in a headwater catchment: combined field and modelling approach.

Empirical monitoring studies of catchment-scale Escherichia coli burden to land from agriculture are scarce. This is not surprising given the complexity associated with the temporal and spatial heterogeneity in the excretion of livestock faecal deposits and variability in microbial content of faeces. However, such information is needed to appreciate better how land management and landscape features impact on water quality draining agricultural landscapes. The aim of this study was to develop and test a field-based protocol for determining the burden of E. coli in a small headwater catchment in the UK. Predictions of E. coli burden using an empirical model based on previous best estimates of excretion and shedding rates were also evaluated against observed data. The results indicated that an empirical model utilising key parameters was able to satisfactorily predict E. coli burden on pasture most of the time, with 89% of observed values falling within the minimum and maximum range of predicted values. In particular, the overall temporal pattern of E. coli burden on pasture is captured by the model. The observed and predicted values recorded a disagreement of >1 order of magnitude on only one of the nine sampling dates throughout an annual period. While a first approximation of E. coli burden to land, this field-based protocol represents one of the first comprehensive approaches for providing a real estimate of a dynamic microbial reservoir at the headwater catchment scale and highlights the utility of a simple dynamic empirical model for a more economical prediction of catchment-scale E. coli burden.

Re-shaping models of E. coli population dynamics in livestock faeces: increased bacterial risk to humans?

Dung-pats excreted directly on pasture from grazing animals can contribute a significant burden of faecal microbes to agricultural land. The aim of this study was to use a combined field and modelling approach to determine the importance of Escherichia coli growth in dung-pats when predicting faecal bacteria accumulation on grazed grassland. To do this an empirical model was developed to predict the dynamics of an E. coli reservoir within 1ha plots each grazed by four beef steers for six months. Published first-order die-off coefficients were used within the model to describe the expected decline of E. coli in dung-pats. Modelled estimates using first-order kinetics led to an underestimation of the observed E. coli land reservoir, when using site-specific die-off coefficients. A simultaneous experiment determined the die-off profiles of E. coli within fresh faeces of beef cattle under field relevant conditions and suggested that faecal bacteria may experience growth and re-growth in the period post defecation when exposed to a complex interaction of environmental drivers such as variable temperature, UV radiation and moisture levels. This growth phase in dung-pats is not accounted for in models based on first-order die-off coefficients. When the model was amended to incorporate the growth of E. coli, equivalent to that observed in the field study, the prediction of the E. coli reservoir was improved with respect to the observed data and produced a previously unquantified step-change improvement in model predictions of the accumulation of these faecal bacteria on grasslands. Results from this study suggest that the use of first-order kinetic equations for determining land-based reservoirs of faecal bacteria should be approached with caution and greater emphasis placed on accounting for actual survival patterns observed under field relevant conditions.

Spatial variability of soil phosphorus in relation to the topographic index and critical source areas: sampling for assessing risk to water quality.

A measure of soil P status in agricultural soils is generally required for assisting with prediction of potential P loss from agricultural catchments and assessing risk for water quality. The objectives of this paper are twofold: (i) investigating the soil P status, distribution, and variability, both spatially and with soil depth, of two different first-order catchments; and (ii) determining variation in soil P concentration in relation to catchment topography (quantified as the "topographic index") and critical source areas (CSAs). The soil P measurements showed large spatial variability, not only between fields and land uses, but also within individual fields and in part was thought to be strongly influenced by areas where cattle tended to congregate and areas where manure was most commonly spread. Topographic index alone was not related to the distribution of soil P, and does not seem to provide an adequate indicator for CSAs in the study catchments. However, CSAs may be used in conjunction with soil P data for help in determining a more "effective" catchment soil P status. The difficulties in defining CSAs a priori, particularly for modeling and prediction purposes, however, suggest that other more "integrated" measures of catchment soil P status, such as baseflow P concentrations or streambed sediment P concentrations, might be more useful. Since observed soil P distribution is variable and is also difficult to relate to nationally available soil P data, any assessment of soil P status for determining risk of P loss is uncertain and problematic, given other catchment physicochemical characteristics and the sampling strategy employed.