Study design: think 'scientific value' not 'p-values'.

Statistically based experimental designs have been available for over a century. However, many preclinical researchers are completely unaware of these methods, and the success of experiments is usually equated only with 'p < 0.05'. By contrast, a well-thought-out experimental design strategy provides data with evidentiary and scientific value. A value-based strategy requires implementation of statistical design principles coupled with basic project management techniques. This article outlines the three phases of a value-based design strategy: proper framing of the research question, statistically based operationalisation through careful selection and structuring of appropriate inputs, and incorporation of methods that minimise bias and process variation. Appropriate study design increases study validity and the evidentiary strength of the results, reduces animal numbers, and reduces waste from noninformative experiments. Statistically based experimental design is thus a key component of the 'Reduction' pillar of the 3R (Replacement, Reduction, Refinement) principles for ethical animal research.

PICO™ (Closed-Incision Negative-Pressure Wound Therapy) Dressing Use as Postoperative Prophylaxis for Preventing Surgical Site Infections in Spinal Surgery: A Retrospective Single-Centre Study.

Introduction Surgical site infections (SSIs) are one of the dreaded complications of spinal surgery. These typically develop within the first 30 days following surgery. The overall pooled incidence of SSIs is reported at 3.1%. Negative pressure wound therapy (NPWT) has been employed for the management of open wounds and soft tissue injury. There has been a recent trend towards the use of closed incision NPWT (ciNPT), such as PICO. There are only a few studies evaluating the prophylactic use of ciNPT in spinal surgery. The aim of this study was to evaluate whether prophylactic use of PICO dressings can reduce SSI incidence and complications in spinal surgery. Methods Data were collected retrospectively for patients undergoing spinal surgery, with a PICO dressing used for closed surgical incisions, from February 2021 to October 2022. Each patient was followed up for 30 days. The results were compared with local hospital infection control statistics for previous years. Results A total of 50 patients underwent spinal surgery and had PICO dressings post-operatively. None of the patients developed a seroma. Two out of 50 (4.0%) patients developed wound dehiscence and then subsequent SSI (1 superficial, 1 deep). These were managed conservatively with the use of antibiotics and prolonged ciNPT. None of these patients returned to the theatre. The average SSI incidence from previous years was 9.27 ± 4.14 per annum (1.15%), but with an average of 77.3% of these requiring a return to theatres. Conclusion Our study reflects that there is no difference in the incidence rates for SSIs for patients who have PICO dressings versus those having standard occlusive dressings as post-operative closed surgical incision site wound closure following spinal surgery. For those who do develop SSIs, there was no difference in the rates of return to theatres among the two patient populations.

Exploring plantar pressure distribution in patients with newly diagnosed diabetes: Implications for foot ulcer prevention in an overweight Mexican population.

INTRODUCTION: Elevated plantar pressure (PP) constitutes a risk factor for developing foot ulcers. Once present, elevated PP increases morbidity and mortality in patients with diabetes. Given the high prevalence of overweight and obesity in the Mexican population, this study aimed to describe the magnitudes and the distribution of the PP observed in a sample of newly diagnosed patients with diabetes, adjusting for body mass index (BMI) groups (normal weight, overweight, grade I obesity, and grade II and III obesity). MATERIALS AND METHODS: A total of 250 volunteers attending a comprehensive care program for the management of type 2 diabetes received foot assessments that included vascular and neurological evaluation, the identification of musculoskeletal changes, and measurements of PP. RESULTS: Diabetic neuropathy and peripheral arterial disease were present in 21.6% and 11.2% of all participants. Musculoskeletal alterations were present in 70.8% of participants. A positive and significant correlation (p<0.001) was observed between BMI and the peak PP of all anatomical regions assessed. After adjusting for BMI, significant differences (p<0.001) were seen between groups. The metatarsal region, particularly under the third metatarsal head, denoted the highest magnitudes across all BMI. CONCLUSIONS: Periodic PP assessment is recommended to identify the distribution of high-pressure points along the plantar surface. However, as a preventive measure, it is suggested to encourage patients with diabetes and overweight or obesity to wear appropriate footwear and pressure-relief insoles to relieve high-pressure areas - often seen in these populations - to help prevent foot complications.

Design and experimentation of a simple fuzzy pi-based ac chopper electronic load controller for pico hydropower system.

The use of electronic load controllers (ELCrs) is widely adopted in pico hydropower systems to maintain output power supplied to the consumer load, regardless of changes in consumer demand. This is due to the absence of moving mechanical parts, affordability, prevention of the hammer effect in pipes, and being more efficient than the governor systems. However, implementing existing ELCrs in a pico hydropower system can pose challenges related to power quality, efficiency, or costs. In this paper, a fuzzy PI-based single-switch bidirectional AC chopper electronic load controller (FP-SSBAC ELCr) is proposed. This configuration reduces the number of insulated gate bipolar transistors (IGBTs) from two, typically found in the conventional bidirectional AC choppers, to one per phase, resulting in cost reduction. A hybrid controller, comprising fuzzy and PI controllers, is designed to quickly maintain a constant output voltage and frequency when consumer load abruptly changes. The gains of the PI controller are updated by the fuzzy logic controller based on the voltage error and its derivative. The proposed model is simulated in MATLAB/Simulink and validated experimentally under sudden changes in consumer load. The results achieved with the FP-SSBAC ELCr demonstrate improved dynamic performance without overshoot compared to PI-based ELCrs. The highest recorded voltage and current total harmonic distortions (THDs) are 2.8 % and 2.1 %, respectively, meeting the IEEE 519 standard. Therefore, the proposed model has the potential to enhance performance and efficiency and can be implemented cost-effectively in pico hydropower systems.

The use of PICO™ single-use negative pressure wound therapy in the community settings.

The prevalence and incidence of wounds is predicted to rise due to an ageing population, that is also likely to have an increasing number of comorbidities (Dowsett et al, 2017). This trend will invariably result in increased costs to the NHS. The estimated annual cost of wound management in 2017/2018 was £8.3 billion. The cost of managing 70% of wounds which healed was £2.7 billion while it cost £5.6 billion managing only 30% of unhealed wounds (Guest et al, 2020). In view of these figures, it is important that health professionals (HPs) recognise wounds that are not progressing to healing at an early stage and implement all available treatment modalities to ensure that the wound does not become non-healing or stalled. Therefore, this article defines non-healing wounds, how to identify wounds at risk of becoming non-healing and the timely implementation of advanced treatment modalities, such as single use negative pressure wound therapy (sNPWT).

Molecular diversity and seasonal dynamics of Ostreococcus (Mamiellophyceae, Chlorophyta) in typical mariculture bays based on metabarcoding analysis.

Ostreococcus (Mamiellophyceae, Chlorophyta) is a cosmopolitan genus of marine pico-phytoplankton and the smallest free-living photosynthetic eukaryotes with cell size of 1-2 µm. To understand the diversity and spatio-temporal distribution of Ostreococcus in the Rongcheng coastal regions in northern China, metabarcoding analysis based on the 18S rDNA V4 molecular marker was applied to study the molecular diversity and seasonal dynamics of Ostreococcus in three typical mariculture bays (Rongcheng Bay, Lidao Bay and Sanggou Bay). A total of 103 amplicon sequence variants (ASVs) annotated as Ostreococcus were detected in these three typical mariculture bays throughout the year. The top five ASVs in terms of abundance were ASV4, ASV9, ASV14, ASV28 and ASV109, totally occupying 99.1% of Ostreococcus reads. Phylogenetic analysis showed that these five dominant ASVs represented two Ostreococcus ecotypes (OI and OII) and were grouped into four Ostreococcus clades including Ostreococcus lucimarinus (ASV9) and Ostreococcus tauri (ASV28 and ASV109) in OI, and Ostreococcus sp. RC1 (ASV4) and Ostreococcus sp. RC2 (ASV14) in OII, which provided direct evidence to support the co-existence of two ecotypes in the Rongcheng coastal regions. Five dominant ASVs in OI and OII exhibited two distinct seasonal distribution patterns. Three dominant ASVs (ASV9, ASV28 and ASV109) in OI could be detected in all four seasons of the year, exhibiting native distribution properties, while two ASVs (ASV4 and ASV14) in OII decreased sharply in winter and could not be detected in spring, exhibiting characteristics of alien inputs. The composition, succession and association of Ostreococcus community were mainly driven by water temperature in these mariculture bays. This study helps us systematically understand the molecular diversity and distribution patterns of Ostreococcus in typical mariculture bays in northern China, laying the foundation for understanding and revealing the ecological functions of pico-phytoplankton.

An interventional study to assess the impact of behavior modification therapy on motivation level for tobacco cessation among adult tobacco users in a resettlement colony of South Delhi.

BACKGROUND: Tobacco use remains a significant global health challenge, contributing to 8 million annual deaths and potentially reaching 1 billion deaths in the 21st century. Despite taking efforts like India's National Tobacco Control Program, the country faces a persistent 39% tobacco use prevalence, particularly in low-income communities like those from Madanpur Khadar, Delhi. This study explores the effectiveness of behavior modification therapy in addressing this challenge. MATERIALS AND METHODS: In a community-based trial, 400 adult tobacco users from Madanpur Khadar were enrolled and randomization and allocation concealment were done (CTRI no.: CTRI/2021/06/034298). Participants were randomly assigned to intervention and control groups during the study period of 18 months. Data on sociodemographic characteristics, smoking behaviors, and motivation levels were collected. The intervention included behavior modification therapy, while the control group received brief advice. Motivation levels were assessed using the contemplation ladder, and carbon monoxide levels were measured with piCO + Smokerlyzer. The study adhered to ethical considerations and obtained approval from Jamia Hamdard's Institutional Ethical Committee. RESULTS: Sociodemographic characteristics revealed a predominantly male (88%) population, aged above 30 years (68.5%), with lower middle class representation (51%). The intervention group exhibited a 7% smoking cessation rate, which is significantly higher than the control group (1%). piCO+ Smokerlyzer confirmed a 41.7% reduction in carbon monoxide levels among participants in the intervention group. High motivation levels correlated with successful quitting, with a 6.5 times higher odds ratio for highly motivated individuals compared to low or moderately motivated ones. CONCLUSIONS: The study highlights the cost-effective impact of behavior modification therapy in promoting tobacco cessation, particularly in resource-constrained settings. The significant association between motivation levels and quitting underscores the importance of tailored interventions in public health initiatives aimed at reducing tobacco use.

What evidence exists relating the impact of different grassland management practices to soil carbon in livestock systems? A systematic map protocol.

Background: Grasslands are essential for providing vital resources in the livestock sector and delivering invaluable ecosystem services such as biodiversity and soil carbon (C) sequestration. Despite their critical importance, these ecosystems face escalating threats from human disturbances, human degradation, and climate change, compromising their ability to effectively stock C. Restoring degraded grasslands emerges as a pragmatic and cost-effective approach to tackling climate change. However, the successful implementation of grassland management toward this goal, faces significant challenges. A systematic mapping approach will help to compile a comprehensive global inventory of studies investigating the impact of differing grassland management practices on soil carbon. In addition, the potential for trade-offs with other greenhouse gas emissions further underlines the value of a systematic assessment. This approach aims to identify knowledge clusters (i.e., well-represented subtopics that are amenable to full synthesis) for potential systematic reviews and pinpoint knowledge gaps requiring further primary research efforts, all contributing to a better understanding of the evidence surrounding this topic. Methods: Following systematic evidence synthesis standards, we developed the question to address in the systematic map protocol using the PICO framework. We established a preliminary search string by combining search terms for the Population (Grasslands), Intervention (management) and Outcome (soil carbon) categories, as well as with one additional group (Study types-to focus on farm and field experiments). We will conduct a comprehensive literature search of relevant peer-reviewed and grey literature using Web of Science, Scopus, CABI platforms, Google Scholar, and specialised websites (e.g., Agrotrop). Searches will be conducted in the English, Spanish, Portuguese, French, German, and Mongolian languages, as per the linguistic capabilities of the research team. The comprehensiveness of the search will be assessed by comparing the literature collected to a test-list of forty relevant articles. The repeatability of the literature screening process will be ensured by a list of inclusion/exclusion criteria and inter-reviewer consistency statistical tests. Data extraction will be organised into four complementary sections (article information, PICO categories, study characteristics, measurable parameters), on which we will perform queries to produce the tables, figures and evidence maps that will compose the systematic map. The results will identify and describe knowledge gaps and clusters. Supplementary Information: The online version contains supplementary material available at 10.1186/s13750-024-00345-2.

Removal of black tattoos by Picosecond Q-switched Nd-YAG laser in the middle eastern skin type IV: prospective study.

Tattoo removal is considered a challenging field in cosmetic dermatology. Picosecond Q-switched Nd-YAG lasers targeting unique chromophores effectively manage this condition without serious complications. To evaluate the efficacy and safety of Picosecond Q-switched Nd-YAG laser in the treatment of black tattoos in the skin of middle eastern mostly skin type IV. The study was carried out on 20 patients with skin type IV the most common in middle eastern area with professional black tattoos. They were treated by Picosecond Nd-YAG laser (2 sessions 8 weeks apart). The percentage of improvement ranged from 20.0 to 95.0 (with a mean of 61 ± 24.6). 8 patients (40%) showed excellent improvement, 4 patients (20%) showed marked improvement, 4 patients (20%) showed moderate improvement, and 4 patients (20%) showed mild improvement. No severe side effects were detected. Picosecond Nd-YAG laser was an effective and safe technique in the treatment of professional black tattoos; with only 2 sessions most patients reached excellent to moderate response with minimal side effects.

What happened to my Index Medicus?

From its first printing in 1879 to when publication ceased in 2004, the Index Medicus had proved invaluable for persons wishing to conduct healthcare-related research. With the loss of this resource and the rapid expansion of alternative, online sources, it is vital that persons understand how to appropriately search for and use this information. The purpose of this review is to outline the information sources available, discuss how to use current search technology to best obtain relevant information while minimizing nonproductive references, and give the author's opinion on the reliability of the various informational sources available. Topics to be discussed will include Medical Subject Headings and PICO searches and sources ranging from the National Library of Medicine and Cochrane Reviews to Wikipedia and other sites, such as associations and commercial interest sites.

Clinical research text summarization method based on fusion of domain knowledge.

OBJECTIVE: The objective of this study is to integrate PICO knowledge into the clinical research text summarization process, aiming to enhance the model's comprehension of biomedical texts while capturing crucial content from the perspective of summary readers, ultimately improving the quality of summaries. METHODS: We propose a clinical research text summarization method called DKGE-PEGASUS (Domain-Knowledge and Graph Convolutional Enhanced PEGASUS), which is based on integrating domain knowledge. The model mainly consists of three components: a PICO label prediction module, a text information re-mining unit based on Graph Convolutional Neural Networks (GCN), and a pre-trained summarization model. First, the PICO label prediction module is used to identify PICO elements in clinical research texts while obtaining word embeddings enriched with PICO knowledge. Then, we use GCN to reinforce the encoder of the pre-trained summarization model to achieve deeper text information mining while explicitly injecting PICO knowledge. Finally, the outputs of the PICO label prediction module, the GCN text information re-mining unit, and the encoder of the pre-trained model are fused to produce the final coding results, which are then decoded by the decoder to generate summaries. RESULTS: Experiments conducted on two datasets, PubMed and CDSR, demonstrated the effectiveness of our method. The Rouge-1 scores achieved were 42.64 and 38.57, respectively. Furthermore, the quality of our summarization results was found to significantly outperform the baseline model in comparisons of summarization results for a segment of biomedical text. CONCLUSION: The method proposed in this paper is better equipped to identify critical elements in clinical research texts and produce a higher-quality summary.

Quasi-steady aerodynamic modeling and dynamic stability of mosquito-inspired flapping wing pico aerial vehicle.

Recent exploration in insect-inspired robotics has generated considerable interest. Among insects navigating at low Reynolds numbers, mosquitoes exhibit distinct flight characteristics, including higher wingbeat frequencies, reduced stroke amplitudes, and slender wings. This leads to unique aerodynamic traits such as trailing edge vortices via wake capture, diminished reliance on leading vortices, and rotational drag. This paper shows the energetic analysis of a mosquito-inspired flapping-wing Pico aerial vehicle during hovering, contributing insights to its future design and fabrication. The investigation relies on kinematic and quasi-steady aerodynamic modeling of a symmetric flapping-wing model with a wingspan of approximately 26 mm, considering translational, rotational, and wake capture force components. The control strategy adapts existing bird flapping wing approaches to accommodate insect wing kinematics and aerodynamic features. Flight controller design is grounded in understanding the impact of kinematics on wing forces. Additionally, a thorough analysis of the dynamic stability of the mosquito-inspired PAV model is conducted, revealing favorable controller response and maneuverability at a small scale. The modified model, incorporating rigid body dynamics and non-averaged aerodynamics, exhibits weak stability without a controller or sufficient power density. However, the controller effectively stabilizes the PAV model, addressing attitude and maneuverability. These preliminary findings offer valuable insights for the mechanical design, aerodynamics, and fabrication of RoboMos, an insect-inspired flapping wing pico aerial vehicle developed at UPM Malaysia.

EU HTA Regulation and Joint Clinical Assessment-Threat or Opportunity?

The vision of a unified European HTA is by no means a new endeavor. At its core are the publicly declared ambitions to harmonize assessments of clinical data within the EU and avoid the duplication of efforts. Not surprisingly, these ambitions are publicly announced to be motivating the new 2022 EU HTA regulation. However, industry experts typically see more of a risk for additional bureaucracy resulting in delays, further scrutiny, and one additional EU (clinical) dossier to submit on top of all national HTA dossiers, which could be considered a duplication of effort and therefore counterproductive. Regardless of how the details of the process will be defined and how the entire process will work in practice, we can be sure that EU officials will refer to the EU HTA and Joint Clinical Assessment (JCA) in particular as a learning system. The purpose of this article is to take a closer look at the new EU HTA regulation and analyze threats and opportunities for manufacturers and what the resulting opportunities and threats will be at the affiliate level throughout the EU.

Comparing generative and extractive approaches to information extraction from abstracts describing randomized clinical trials.

BACKGROUND: Systematic reviews of Randomized Controlled Trials (RCTs) are an important part of the evidence-based medicine paradigm. However, the creation of such systematic reviews by clinical experts is costly as well as time-consuming, and results can get quickly outdated after publication. Most RCTs are structured based on the Patient, Intervention, Comparison, Outcomes (PICO) framework and there exist many approaches which aim to extract PICO elements automatically. The automatic extraction of PICO information from RCTs has the potential to significantly speed up the creation process of systematic reviews and this way also benefit the field of evidence-based medicine. RESULTS: Previous work has addressed the extraction of PICO elements as the task of identifying relevant text spans or sentences, but without populating a structured representation of a trial. In contrast, in this work, we treat PICO elements as structured templates with slots to do justice to the complex nature of the information they represent. We present two different approaches to extract this structured information from the abstracts of RCTs. The first approach is an extractive approach based on our previous work that is extended to capture full document representations as well as by a clustering step to infer the number of instances of each template type. The second approach is a generative approach based on a seq2seq model that encodes the abstract describing the RCT and uses a decoder to infer a structured representation of a trial including its arms, treatments, endpoints and outcomes. Both approaches are evaluated with different base models on a manually annotated dataset consisting of RCT abstracts on an existing dataset comprising 211 annotated clinical trial abstracts for Type 2 Diabetes and Glaucoma. For both diseases, the extractive approach (with flan-t5-base) reached the best F 1 score, i.e. 0.547 ( ± 0.006 ) for type 2 diabetes and 0.636 ( ± 0.006 ) for glaucoma. Generally, the F 1 scores were higher for glaucoma than for type 2 diabetes and the standard deviation was higher for the generative approach. CONCLUSION: In our experiments, both approaches show promising performance extracting structured PICO information from RCTs, especially considering that most related work focuses on the far easier task of predicting less structured objects. In our experimental results, the extractive approach performs best in both cases, although the lead is greater for glaucoma than for type 2 diabetes. For future work, it remains to be investigated how the base model size affects the performance of both approaches in comparison. Although the extractive approach currently leaves more room for direct improvements, the generative approach might benefit from larger models.

AlpaPICO: Extraction of PICO frames from clinical trial documents using LLMs.

In recent years, there has been a surge in the publication of clinical trial reports, making it challenging to conduct systematic reviews. Automatically extracting Population, Intervention, Comparator, and Outcome (PICO) from clinical trial studies can alleviate the traditionally time-consuming process of manually scrutinizing systematic reviews. Existing approaches of PICO frame extraction involves supervised approach that relies on the existence of manually annotated data points in the form of BIO label tagging. Recent approaches, such as In-Context Learning (ICL), which has been shown to be effective for a number of downstream NLP tasks, require the use of labeled examples. In this work, we adopt ICL strategy by employing the pretrained knowledge of Large Language Models (LLMs), gathered during the pretraining phase of an LLM, to automatically extract the PICO-related terminologies from clinical trial documents in unsupervised set up to bypass the availability of large number of annotated data instances. Additionally, to showcase the highest effectiveness of LLM in oracle scenario where large number of annotated samples are available, we adopt the instruction tuning strategy by employing Low Rank Adaptation (LORA) to conduct the training of gigantic model in low resource environment for the PICO frame extraction task. More specifically, both of the proposed frameworks utilize AlpaCare as base LLM which employs both few-shot in-context learning and instruction tuning techniques to extract PICO-related terms from the clinical trial reports. We applied these approaches to the widely used coarse-grained datasets such as EBM-NLP, EBM-COMET and fine-grained datasets such as EBM-NLPrev and EBM-NLPh. Our empirical results show that our proposed ICL-based framework produces comparable results on all the version of EBM-NLP datasets and the proposed instruction tuned version of our framework produces state-of-the-art results on all the different EBM-NLP datasets. Our project is available at https://github.com/shrimonmuke0202/AlpaPICO.git.

PICO questions and DELPHI methodology for improving the management of patients with acute hepatic porphyria.

BACKGROUND: Acute hepatic porphyrias (AHPs) are a group of rare diseases that encompasses acute intermittent porphyria, variegate porphyria, hereditary coproporphyria, and 5-aminolaevulinic acid dehydratase deficiency porphyria. Symptoms of AHP are nonspecific which, together with its low prevalence, difficult the diagnosis and follow-up of these patients. MATERIAL AND METHODS: This project used DELPHI methodology to answer PICO questions related to management of patients with AHPs. The objective was to reach a consensus among multidisciplinary porhyria experts providing answers to those PICO questions for improving diagnosis and follow-up of patients with AHP. RESULTS: Ten PICO questions were defined and grouped in four domains: 1. Biochemical diagnosis of patients with AHP. 2. Molecular tests for patients with AHP. 3. Follow-up of patients with AHP. 4. Screening for long-term complications of patients with AHP. CONCLUSIONS: PICO questions and DELPHI methodology have provided a consensus on relevant and controversial issues for improving the management of patients with AHP.

Cardiorespiratory fitness and mortality risk in patients receiving hemodialysis: a prospective cohort / Aptidão cardiorrespiratória e risco de mortalidade em pacientes em hemodiálise: uma coorte prospectiva

ABSTRACT Background: Kidney failure reduces life expectancy by one-third compared with the general population, and cardiovascular complications and poor cardiorespiratory fitness (CRF) are the main causes. We aimed to evaluate the association between severely low CRF and all-cause mortality risk in HD patients. Methods: This observational prospective cohort study followed-up patients receiving HD from August 2015 until March 2022. Cardiorespiratory fitness was evaluated through the cardiopulmonary exercise test, and the peak oxygen uptake (VO2peak) value was used to determine severely low CRF (< 15 mL∙kg−1∙min−1). Cox regression and univariate Kaplan-Meier analysis were used to evaluate the association of severely low CRF with mortality risk and survival rate. Results: Forty-eight patients were followed-up for a median of 33.0 [14.3 - 49.3] months. A total of 26 patients had severely low CRF. During the follow-up period, 11 patients (22.92%) died from all causes. From these, eight (30.8%) had severely low CRF. Even so, severely low CRF was not associated with crude death rates for patients stratified by CRF levels (p = 0.189), neither in unadjusted (HR 2.18; CI 95% 0.58−8.23) nor in adjusted (HR 1.32; CI 95% 0.31−5.59) Cox proportional hazard models. As a continuous variable, VO2peak was not associated with mortality risk (HR 1.01; CI 95% 0.84−1.21). Univariate Kaplan-Meier analysis showed that patients with severely low CRF did not have significantly worse survival rates than those with mild-moderate CRF (p = 0.186). Conclusion: Our findings indicated that severely low CRF was not associated with all-cause mortality in patients on HD. Despite severely low CRF being prevalent, larger cohort studies are needed to establish strong conclusions on its association with all-cause mortality.

RESUMO Introdução A insuficiência renal reduz a expectativa de vida em um terço comparada à população em geral. Complicações cardiovasculares e baixa aptidão cardiorrespiratória (ACR) são as principais causas. Avaliamos a associação entre ACR muito baixa e risco de mortalidade por todas as causas em pacientes em HD. Métodos Este estudo de coorte prospectivo observacional acompanhou pacientes em HD de agosto/2015 a março/2022. Avaliou-se a aptidão cardiorrespiratória pelo teste de exercício cardiopulmonar, e o valor do pico do consumo de oxigênio (VO2pico) foi usado para determinar ACR muito baixa (< 15 mL∙kg−1∙min−1). Utilizamos regressão de Cox e análise univariada de Kaplan-Meier para avaliar associação da ACR muito baixa com o risco de mortalidade e taxa de sobrevida. Resultados Acompanhamos 48 pacientes por uma média de 33,0 [14,3 - 49,3] meses. Um total de 26 pacientes apresentaram ACR muito baixa. No período de acompanhamento, 11 pacientes (22,92%) foram a óbito por todas as causas. Destes, oito (30,8%) apresentavam ACR muito baixa. Mesmo assim, ACR muito baixa não foi associada a taxas brutas de mortalidade para pacientes estratificados por níveis de ACR (p = 0,189), nem em modelos de risco proporcional de Cox não ajustados (HR 2,18; IC 95% 0,58-8,23) ou ajustados (HR 1,32; IC 95% 0,31-5,59). Como variável contínua, VO2pico não foi associado ao risco de mortalidade (HR 1,01; IC 95% 0,84-1,21). A análise univariada de Kaplan-Meier mostrou que pacientes com ACR muito baixa não apresentaram taxas de sobrevida significativamente piores do que aqueles com ACR leve-moderada (p = 0,186). Conclusão Nossos achados indicaram que a ACR muito baixa não foi associada à mortalidade por todas as causas em pacientes em HD. Apesar de ACR muito baixa ser prevalente, são necessários estudos de coorte maiores para estabelecer conclusões sólidas sobre sua associação com mortalidade por todas as causas.

Quality Control Assessment of Human Adipose-Derived Hydrogels.

Decellularized human-adipose tissue (hDAT) can serve as an alternative to two-dimensional monolayer culture and current ECM hydrogels due to its unlimited availability and cytocompatibility. A major hurdle in the clinical translation and integration of hDAT and other hydrogels into current in vitro culture processes is adherence to current good manufacturing practices (cGMP). Transferring of innovative technologies, including hydrogels, requires the establishing standardized protocols for quality assurance and quality control (QA/QC) of the material.Integration of basic characterization techniques, including physiochemical characterization, structural/morphological characterization, thermal and mechanical characterization, and biological characterization, in addition to the reduction of batch-to-batch variability and establishment of proper sterilization, storage, and fabrication processes verifies the integrity of the hydrogel. Obatala Sciences has established a characterization protocol that involves a series of assays including the evaluation of gelation properties, protein content, glycosaminoglycan content, soluble collagen content, and DNA content of hDAT.