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The aim of the present study was to investigate eye temperature modifications after road transport in athletic horses habituated to travel. Eight adult Italian saddle horses traveled 100 km and, two weeks later, 300 km. Eye temperature (ET), rectal temperature (RT) and serum cortisol concentration were assessed before (T1), after (T2) and 60 min (T3) after the road transport. ET was evaluated with infrared thermography (IRT) in three regions of interest: EL1 (medial canthus), EL2 (central cornea) and EL3 (lateral canthus). Two-way analysis of variance (ANOVA) for repeated measures showed statistically higher values at T2 and T3 for EL1 (p < 0.01), EL2 (p < 0.01) and EL3 (p < 0.01) following the 100 km journey. RT (p < 0.01) showed higher values at T2 and T3 after the 100 km journey and higher values at T2 (p < 0.01) following the 300 km journey. ET values were positively correlated with RT at T1, T2 and T3 following the 100 km journey and at T2 following the 300 km journey and positively correlated with serum cortisol concentration at T1, T2 and T3 following the 100 km journey and at T2 and T3 following the 300 km journey. Eye temperature monitoring with IRT allows quick and practical strategies to monitor an animal's physiological state and welfare during daily activities.
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The aim of this study was to assess the changes of pro-inflammatory interleukins in 10 horses subjected to road transport practices (distance of 150 km) from the training site (Messina, Sicily) to the competition centre in Syracuse (Sicily). Blood sampling and interleukins analysis were performed during a round trip transportation (transport 1 and transport 2). In particular, blood samples were collected before the transport took place (Pre), five minutes later (Post) and one hour later (Post 1 h), for each transport, in order to assess the serum concentration of IL-1α, IL-1ß, IL-2 and IL-6. The results showed that the serum concentration of IL-1α decreased at Post and Post 1 h compared to the values obtained at rest condition (P < 0.05). The other interleukins analysed (i.e. IL-1ß, IL-2 and IL-6) showed increased levels at Post than Rest and Post 1 h in transport 1 (P < 0.05). In transport 2 the analysed parameters showed no change throughout the analysed time points (P > 0.05); however, higher levels of IL-1α at Pre and higher IL-1ß, IL-2 and IL-6 values at Post were found in transport 1 than transport 2 (P < 0.05). The increase in pro-inflammatory cytokines after transport 1 suggests the triggering of the inflammatory event and this may show that, although horses are animals accustomed to transport, this is a stressful event that could activate the well-orchestrated inflammation cascade, albeit physiological and temporary, as highlighted by the lower serum concentrations of the investigated interleukins found in transport 1 than transport 2 and by the lack of significant differences in the serum concentrations of the investigated interleukins among the time points of transport 2. It must be taken into account that enrolled animals are well-trained and healthy athletic horses participating to a jumper competition, thus, such inflammation did not occur thanks to a good balance between pro-inflammatory and anti-inflammatory cytokines which allowed a prompt restoration of homeostasis eventually impaired by the stressful event.
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A recent evidence gaps assessment of the clinical, health-related quality of life, and economic burden associated with α-thalassemia is lacking. We conducted a systematic literature review (SLR) following the methodological and reporting requirements of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and the Cochrane Handbook for Systematic Reviews, using available literature over the past decade. This SLR identified a considerable evidence gap with regard to understanding the current burden of α-thalassemia as evident from paucity of studies published in the past 10 years. The limited data available still indicate that patients with α-thalassemia experience substantial morbidity and quality of life/economic burden that is generally comparable to patients with ß-thalassemia.
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Animal welfare has become an increasingly important concern regarding equids working as carriage animals. In the present study, the changes in the markers of stress and inflammatory responses as a result of the work performed by tourism carriage horses under real working conditions in Sicily (Italy) were investigated. Twenty-two Standardbreds performed a normal working day in the carriage tourism business during the months of May, June and July 2022, consisting of one day of work for each month. Blood samples were collected in the stables at rest before the tour route (Pre; 07.00 AM) and within 10 min after the end of the workday (Post; 05.00 PM). Haematological parameters, serum concentration of cortisol, total proteins together with the globulin fractions were investigated before and after the carriage work. Environmental temperature, relative humidity and temperature humidity index (THI) were also assessed. The direct erythrocyte indices increased after work compared to rest condition (P < 0.05). The values of cortisol, total proteins and globulins were not affected by carriage work (P > 0.05), while, higher cortisol, total proteins, α1- and α2-globulins values were observed in July compared to May and June (P < 0.05). These changes are probably due to the increase in THI values which showed mild stress in June and high stress in July. This study suggests that the tourism carriage horses herein investigated have adapted to their work activity, however, avoiding working horses during the hottest hours of the day in the summer months is advocated.
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Estresse Fisiológico , Animais , Cavalos/sangue , Sicília , Bem-Estar do Animal , Masculino , Feminino , Hidrocortisona/sangue , Viagem , Estações do Ano , Condições de TrabalhoRESUMO
Introduction: During the first years of the pandemic, COVID-19 forced governments worldwide to take drastic measures to reduce the spread of the virus. Some of these measures included mandatory confinements, constant use of masks, and social distancing. Despite these measures being mandatory in many countries and the abundance of evidence on their effectiveness at slowing the spread of the virus, many people failed to comply with them. Methods: This research explored the role of cognitive factors in predicting compliance with COVID-19 safety measures across two separate studies. Building on earlier work demonstrating the relevance of cognitive processes in health behaviour, this study aimed to identify key predictors of adherence to safety guidelines during the pandemic. Utilising hierarchical regression models, we investigated the influence of age, sex, cognitive control, cognitive flexibility (Study 1), working memory, psychological health, and beliefs about COVID-19 (Study 2) on compliance to biosafety measures. Results: Demographic variables and cognitive control were significant predictors of compliance in both studies. However, cognitive flexibility and working memory did not improve the models' predictive capacities. In Study 2, integrating measures of psychological health and beliefs regarding COVID-19 severity significantly improved the model. Further, interaction effects between age and other variables also enhanced the predictive value. Discussion: The findings emphasise the significant role cognitive control, age, psychological health, and perceptions about COVID-19 play in shaping compliance behaviour, highlighting avenues for targeted interventions to improve public health outcomes during a pandemic.
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This study aimed to evaluate changes in body temperature in athletic horses during two different road transport distances. Six Italian Saddle horses were subjected to a 100 and 300 km transport during different times of day (am and pm). Rectal and cutaneous temperatures were recorded before (T0), immediately (following 5 min- T1) and 1 hour (T2) after transport by means of a rectal digital thermometer and a thermal infrared camera (FLIR T440) respectively, for the evaluation of left and right side of four body regions: jugular, shoulder, croup and inner thigh. There were no differences between left and right sides, inner thigh or rectal temperatures when comparing the transport distance, time points or time of day. At T0, jugular (P < 0.0001), shoulder (P < 0.01) and croup (P < 0.01) average temperatures were higher in the pm compared to those in the am in both journeys. At T1, jugular (P < 0.01) and croup (P < 0.01) temperatures were lower in the pm compared to am following the 300 km journey. Jugular temperature (P < 0.0001) was higher following the 300 km compared to the 100 km journey at each time point (T1 and T2) at both times of day (am and pm). Shoulder (P < 0.0001) and croup temperatures (P < 0.0001) were higher at T2 after the 300 km journey than at T2 after the 100 km journey). The current results suggested a difference between the two distances and the time of day appeared to have as great effect on ocular temperature as road transport distance.
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Temperatura Corporal , Termografia , Animais , Cavalos/fisiologia , Termografia/métodos , Termografia/instrumentação , Temperatura Corporal/fisiologia , Raios Infravermelhos , Meios de Transporte , Masculino , Homeostase/fisiologia , Condicionamento Físico Animal/fisiologia , FemininoRESUMO
BACKGROUND: the present study aimed to investigate the immunological response to common vector-borne pathogens and to evaluate their impact on haematochemical parameters in owned dogs. METHODS: Blood samples were collected from 400 clinically healthy dogs living in an endemic area (Sardinia Island, Italy). All dogs were serologically tested for VBDs and divided into groups based on their negative (Neg) or positive response towards Ehrlichia (Ehrl), Rickettsia (Rick), Leishmania (Leish), Borrelia (Borr), Anaplasma (Anapl), and Bartonella (Barto). A Kruskall-Wallis's test, followed by Dunn's post hoc comparison test, was applied to determine the statistical effect of negativity and single or multiple positivity on the studied parameters. RESULTS: the group of dogs simultaneously presenting antibodies towards Leishmania, Ehrlichia, and Rickettsia showed higher values of total proteins, globulins, creatine phosphokinase, aspartate aminotransferase, alanine aminotransferase, and amylase than dogs that tested negative or dogs with antibodies toward a single pathogen investigated herein. CONCLUSIONS: Our results seem to suggest that exposure to more vector-borne pathogens could lead to greater liver function impairment and a greater inflammatory state. Further investigations are needed in order to better clarify how co-infections affect haematochemical patterns in dogs living in endemic areas of VBDs.
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BACKGROUND: The gold standard treatment for periprosthetic joint infections is the two-stage revision that includes the spacer placement before definitive reimplantation. The management of PJI affects patients' joint function and, subsequently, their mental health. Even though significant advances have been achieved, little to no attention has been paid to the psychological implications. So, based on standardized patient-reported outcome measures (PROMs), this study aimed to clarify the effect of spacer treatment of infected hip and knee arthroplasties on patients' mental health. METHODS: We performed research on the literature on PJIs in the English language using the MEDLINE database with the search strings "spacer" OR "spacers" AND "hip" OR "knee" AND "SF-12" OR "SF-36" OR "EQ-5" OR "mental" OR "depression" OR "anxiety." The reference lists of selected articles were also hand-searched for any additional articles. RESULTS: A total of 973 published papers were extracted, and 9 papers were finally included. A total of 384 patients who underwent spacer placement for PJI were identified. Of these 384 patients, 54% were female. The mean age ranged from 62 to 78.2 years. Of the11 papers identified for this review, 4 analyzed only hip spacers, including 119 patients; 4 only knee spacers, evaluating 153 patients; while a single study included 112 patients for both joints. CONCLUSIONS: Patients with the spacer are living in a state of mental upset, albeit better than the preoperative state. Clinical improvement with the review is not assured. The alteration of mental state turns out not to be transient for all the patients.
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In this study, the expression and implication of acid-sensing ion channels 2 and 4 (ASIC2 and ASIC4) in the gonadal sex differentiation of Dicentrarchus labrax (D. labrax), subjected to increasing water temperatures during gonadal development, were evaluated. Two groups were selected: a control group (CG), in which the average water temperature was maintained at 15 °C and increased to 20 °C in 20 days until weaning; and an experimental group (EG), in which the water temperature was retained at 15 °C for 60 days; thereafter, the temperature was increased daily by 0.5 °C until it reached 20 °C up to the weaning time. Ten fish from the CG and 13 fish from the EG were sampled randomly on the 335th day after hatching (dph). A higher percentage of gonad differentiation in ovaries rather than in testes was observed in the EG compared to the CG (p = 0.01). ASIC2 and ASIC4 were detected for the first time in D. labrax ovaries by indirect immunofluorescence. Both ASIC2 and ASIC4 were expressed in previtellogenic oocytes of ovaries and in scattered cells within some testes, and were most likely intratesticular previtellogenic oocytes in both the CG and EG groups. The CG group showed a higher expression of ASIC4 than the EG cohort (p < 0.05). The results gathered in this study revealed the capacity of water temperature to influence both gonadal differentiation and growth in this gonochoristic fish species, and suggests the possible role of ASIC2 and ASIC4 in gonad differentiation and gamete development in D. labrax.
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BACKGROUND: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, with up to 32% of patients with NSCLC harboring an epidermal growth factor receptor (EGFR) mutation. NSCLC harboring an EGFR mutation has a dedicated treatment pathway, with EGFR tyrosine kinase inhibitors and platinum-based chemotherapy often being the therapy of choice. OBJECTIVE: The aim of this study was to systemically review and summarize economic models of first-line treatments used for locally advanced or metastatic NSCLC harboring EGFR mutations, as well as to identify areas for improvement for future models. METHODS: Literature searches were conducted via Ovid in PubMed, MEDLINE, MEDLINE In-Process, Embase, Evidence-Based Medicine Reviews: Health Technology Assessment, Evidence-Based Medicine Reviews: National Health Service Economic Evaluation Database, and EconLit. An initial search was conducted on 19 December 2022 and updated on 11 April 2023. Studies were selected according to predefined criteria using the Population, Intervention, Comparator, Outcome and Study design (PICOS) framework. RESULTS: Sixty-seven articles were included in the review, representing 59 unique studies. The majority of included models were cost-utility analyses (n = 52), with the remaining studies being cost-effectiveness analyses (n = 4) and a cost-minimization analysis (n = 1). Two studies incorporated both a cost-utility and cost-minimization analysis. Although the model structure across studies was consistently reported, justification for this choice was often lacking. CONCLUSIONS: Although the reporting of economic models in NSCLC harboring EGFR mutations is generally good, many of these studies lacked sufficient reporting of justification for structural choices, performing extensive sensitivity analyses and validation in economic evaluations. In resolving such gaps, the validity of future models can be increased to guide healthcare decision making in rare indications.
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Carcinoma Pulmonar de Células não Pequenas , Análise Custo-Benefício , Receptores ErbB , Neoplasias Pulmonares , Modelos Econômicos , Humanos , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/economia , Receptores ErbB/genética , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/genética , Mutação , Inibidores de Proteínas Quinases/economia , Inibidores de Proteínas Quinases/uso terapêuticoRESUMO
Introduction: Dimethyl sulfoxide (DMSO) is widely used as a diluent and/or solvent for pharmacological compounds. Furthermore, DMSO crosses the blood-brain barrier acting on the nervous system. The natural compounds phenylamides and lignanamides (LnHS) have protective effects on neuronal health, being promising neuroprotective candidates. In this scenario, we evaluated the impact of DMSO and/or LnHS on SH-SY5Y and U-87 cells, taken as in vitro model of neurons and glia. Methods: Cells were treated with DMSO and/or LnHS at different doses and proliferation (MTT and trypan blue counting, colony forming ability, autophagy, oxidative stress (NO, ROS determination) and inflammatory (IL8, IL6, TNFα mRNA expression) response was evaluated. Results: We found that DMSO reduces both neuronal and glial cell viability, while LnHS does not affect viability of SH-SY5Y cells but reduces that of U-87 cells. Therefore, we focused on SHSY5Y cells and investigated whether LnHS could counteract DMSO toxicity. LnHS partially attenuates the inhibitory effects of DMSO on cell viability and restores the colony-forming ability of SH-SY5Y cells exposed to DMSO. Furthermore, we found that co-administration of LnHS modulates the expression of SIRT3 and SOD2 enzymes, reduces nitrite release and ROS generation increasing IL-8 levels. Interestingly, co-administration of LnHS counteracts the DMSO-induced production of IL-6, while no modification in TNF-α was found. Discussion: Our study indicates LnHS as a potential feasible compound to support neuronal health as it counteracts DMSO induced cytotoxic effects by improving SH-SY5Y cells survival. Further studies are needed to clarify the molecular mechanisms underlying the LnHS biological activities.
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Forest biomass is an essential resource in relation to the green transition and its assessment is key for the sustainable management of forest resources. Here, we present a forest biomass dataset for Europe based on the best available inventory and satellite data, with a higher level of harmonisation and spatial resolution than other existing data. This database provides statistics and maps of the forest area, biomass stock and their share available for wood supply in the year 2020, and statistics on gross and net volume increment in 2010-2020, for 38 European countries. The statistics of most countries are available at a sub-national scale and are derived from National Forest Inventory data, harmonised using common reference definitions and estimation methodology, and updated to a common year using a modelling approach. For those counties without harmonised statistics, data were derived from the State of Europe's Forest 2020 Report at the national scale. The maps are coherent with the statistics and depict the spatial distribution of the forest variables at 100 m resolution.
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Florestas , Madeira , Biomassa , Bases de Dados Factuais , Europa (Continente)RESUMO
Maca is a traditional Andean crop used as a nutraceutical for the fertility-enhancing properties that are linked with antioxidant activity. The aim of this study was to evaluate, for the first time, the potential beneficial effects of oral Maca (Lepidium meyenii or Lepidium peruvianum) supplementation in improving reproductive performance in male dogs. Forty-eight male dogs of different breeds were enrolled in the study, fed the same maintenance diet, and exposed to the same environmental conditions. The subjects were divided into four groups of 12 dogs each: Subfertile treatment group, Subfertile control group, Normofertile treatment group, and Normofertile control group. The dogs in the treatment groups received Lepidium meyenii in their diet in a capsule formulation [75 mg/kg Maca extract 10:1, thickening agent (hydroxypropyl methylcellulose), ground rice], while the control groups received placebo capsule (starch). For each subject included in the study, the spermiogram was analyzed at three time points of the sperm cycle: at day 0 (T0), day 31 (T31), and day 62 (T62). Dietary supplementation with Maca in subfertile subjects resulted in a significant increase in ejaculate volume and total sperm count compared to the control group. This increase was also observed in normofertile subjects in the treatment group. In addition, total and progressive motility as well as sperm morphology were significantly improved in the groups treated with Maca compared to the control groups. The results thus highlight, for the first time, the potential efficacy of supplementation with 75 mg/kg of Maca extract daily in improving semen quality in dogs.
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This study aimed to investigate the common social and communicative behaviors of the Fonni's Dog under different outdoor conditions. For this study, 70 adult dogs (3-7 years; 32 intact males, 38 intact females) belonging to the Fonni's breed were used. A total of 35 dogs were kept in kennels and 35 were free-ranging dogs in their sheep/goat livestock units. A behavioral repertoire was adapted from the literature and an ethogram was filled in for each dog. All dogs were evaluated in the presence of the owner. Fisher's exact test, following Bonferroni's correction, was used to test possible differences in the categorical variables (presence or absence of the behavior) between free-ranging dogs and dogs kept in kennels. The study revealed that several categories of the dogs' body language were associated with the management condition. However, the breed motivations (guarding and defense of the territory) were satisfied both in kennel and in the animals who were free in the property. The current study suggests a good behavioral balance of the Fonni's Dogs which could be attributed to correct communication between dogs and owners.
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Dogs are the common pets adopted by humans, and their circadian behavior and physiology are influenced by human habits. In many families, there is a change of lifestyle with respect to the natural daylight (NDL) cycle. Exposure to constant light disrupts some central and peripheral circadian rhythms. The aim of the present study was to improve the knowledge about the circadian changes of clock components in the peripheral blood in dogs housed under NDL and constant light (LL) conditions. Blood samples were collected on five female Beagle dogs (2 years old, 14 ± 0.5 kg) every 4 hours for a 24-hour period during an NDL (Sunrise 05:05 h - Sunset 20:55 h) and 24-hour period of constant light (LL). Blood samples were stored in a PAX gene Blood RNA Tube, real-time RT-quantitative polymerase chain reaction was performed to determine Clock, Per1-3, and Cry1-2 gene expression. During the NDL, all genes investigated showed robust diurnal daily rhythmicity. During the constant light, only Clock maintained its daily rhythmicity. Clock acrophase was observed close to sunrise (ZT 0) and was statistically different from the other clock genes except for Per3. Per3 daily oscillations were not statistically significant. No differences were observed among the clock genes tested in the amplitude and robustness values. Our results can be considered preliminary data to provide new insights into the adaptation mechanism of the canine peripheral circadian clock. The persistence of Clock gene expression during the LL indicated the presence of an endogenously generated signal in blood. Because peripheral blood is an easily accessible sample in dogs, the analysis of clock gene expression in this tissue could be useful to investigate the adaptive capacity of this species housed in different environmental conditions linked to the owner's lifestyle.
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Relógios Circadianos , Fotoperíodo , Cães , Animais , Feminino , Humanos , Pré-Escolar , Ritmo Circadiano/genética , Relógios Circadianos/genética , RNA Mensageiro/metabolismo , Expressão GênicaRESUMO
Data about biosimilar Peg-filgrastim (bioPEG) in autologous stem cell transplant (ASCT) are still scarce. The aim of this study has been to assess efficacy and safety of bioPEG among lymphoma and myeloma patients undergoing ASCT, comparing these data with historical controls receiving other G-CSFs. Furthermore, an economic evaluation has been included to estimate the savings by using bioPEG. This is a prospective cohort study comparing lymphoma and myeloma patients undergoing ASCT and receiving bioPEG (n = 73) with three historical consecutive cohorts collected retrospectively who received other G-CSFs (Lenograstim - Leno - n = 101, biosimilar Filgrastim - bioFIL n = 392, and originator Peg-filgrastim - oriPEG n = 60). We observed a significantly shorter time to neutrophils and platelet engraftment (p < 0.001) in patients treated with bioPEG and oriPEG. Moreover, patients who received bioPEG showed a shorter hospitalization time (p < 0.001) and a lower transfusion need (p < 0.001). We did not observe any significant difference in terms of transplant-related mortality, mucositis, and diarrhea among the four groups. No serious adverse events were associated with bioPEG. Similar data were obtained after running a stratified analysis for lymphomas and myeloma separately conducted by using a propensity score matching. The average total cost per patient of bioPEG was 18218.9 compared to 23707.8, 20677.3 and 19754.9 of Leno, oriPEG, and bioFIL, respectively. In conclusion, bioPEG seems to be as effective as the originator and more effective than short-acting G-CSFs in terms of post-transplant engraftment in myeloma and lymphoma patients undergoing ASCT. Moreover, bioPEG was cost-effective when compared with the other G-CSFs.
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Medicamentos Biossimilares , Linfoma , Mieloma Múltiplo , Humanos , Filgrastim/efeitos adversos , Lenograstim , Mieloma Múltiplo/tratamento farmacológico , Medicamentos Biossimilares/efeitos adversos , Estudos Retrospectivos , Estudos Prospectivos , Linfoma/tratamento farmacológico , Fator Estimulador de Colônias de Granulócitos , Transplante de Células-Tronco , Proteínas Recombinantes , Mobilização de Células-Tronco HematopoéticasRESUMO
Background: The drive to expedite patient access for diseases with high unmet treatment needs has come with an increasing use of single-arm trials (SATs), especially in oncology. However, the lack of control arms in such trials creates challenges to assess and demonstrate comparative efficacy. External control (EC) arms can be used to bridge this gap, with various types of sources available to obtain relevant data. Objective: To examine the source of ECs in single-arm oncology health technology assessment (HTA) submissions to the National Institute for Health and Care Excellence (NICE) and the Pharmaceutical Benefits Advisory Committee (PBAC) and how this selection was justified by manufacturers and assessed by the respective HTA body. Methods: Single-arm oncology HTA submission reports published by NICE (England) and PBAC (Australia) from January 2011 to August 2021 were reviewed, with data qualitatively synthesized to identify themes. Results: Forty-eight oncology submissions using EC arms between 2011 and 2021 were identified, with most submissions encompassing blood and bone marrow cancers (52%). In HTA submissions to NICE and PBAC, the EC arm was typically constructed from a combination of data sources, with the company's justification in data source selection infrequently provided (PBAC [2 out of 19]; NICE [6 out of 29]), although this lack of justification was not heavily criticized by either HTA body. Conclusion: Although HTA bodies such as NICE and PBAC encourage that EC source justification should be provided in submissions, this review found that this is not typically implemented in practice. Guidance is needed to establish best practices as to how EC selection should be documented in HTA submissions.
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Comitês Consultivos , Tecnologia Biomédica , Humanos , Inglaterra , Austrália , Avaliação da Tecnologia Biomédica , Análise Custo-BenefícioRESUMO
There is an urgent need for expedited approval and access for new health technologies targeting rare and very rare diseases, some of which are associated with high unmet treatment needs. Once a new technology achieves regulatory approval, the technology needs to be assessed by health technology assessment (HTA) bodies to inform coverage and reimbursement decisions. This assessment quantitatively examines the clinical effectiveness, safety and/or economic impact of the new technology relative to standard of care (SoC) in a specific market. However, in rare and very rare diseases, the patient populations are small and there is often no established treatment pathway available to define 'SoC'. In these situations, several challenges arise to assess the added benefit of a new technology - both clinically and economically - due to lack of established SoC to guide an appropriate comparator selection. These challenges include: How should 'SoC' be defined and characterized in HTA submissions for new technologies aiming to establish new treatment standards? What is usual care without an established clinical pathway? How should the evidence for the comparator 'SoC' (i.e., usual care) arm be collected in situations with low patient representation and, sometimes, limited disease-specific clinical knowledge in certain geographies? This commentary outlines the evidence generation challenges in designing clinical comparative effectiveness for a new technology when there is a lack of established SoC. The commentary also proposes considerations to facilitate the reliable integration of real-world evidence into HTA and decision-making based on the collective experience of the authors.
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Doenças Raras , Avaliação da Tecnologia Biomédica , Humanos , Padrão de Cuidado , Resultado do TratamentoRESUMO
In this study, we introduce novel microporous poly(D,L-lactide) acid-carbon nanodot (PLA-CD) nanocomposite scaffolds tailored for potential applications in image-guided bone regeneration. Our primary objective was to investigate concentration-dependent structural variations and their relevance to cell growth, crucial aspects in bone regeneration. The methods employed included comprehensive characterization techniques such as DSC/TGA, FTIR, rheological, and degradation assessments, providing insights into the scaffolds' thermoplastic behavior, microstructure, and stability over time. Notably, the PLA-CD scaffolds exhibited distinct self-fluorescence, which persisted after 21 days of incubation, allowing detailed visualization in various multicolor modalities. Biocompatibility assessments were conducted by analyzing human adipose-derived stem cell (hADSC) growth on PLA-CD scaffolds, with results substantiated through cell viability and morphological analyses. hADSCs reached a cell viability of 125% and penetrated throughout the scaffold after 21 days of incubation. These findings underscore the scaffolds' potential in bone regeneration and fluorescence imaging. The multifunctional nature of the PLA-CD nanocomposite, integrating diagnostic capabilities with tunable properties, positions it as a promising candidate for advancing bone tissue engineering. Our study not only highlights key aspects of the investigation but also underscores the scaffolds' specific application in bone regeneration, providing a foundation for further research and optimization in this critical biomedical field.