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1.
Rev Esp Salud Publica ; 982024 May 13.
Article in Spanish | MEDLINE | ID: mdl-38738501

ABSTRACT

OBJECTIVE: Social media allows individuals to access a vast amount of health-related information immediately and anonymously, a fact that is turning these platforms into one of the primary sources of reference in this area, especially for younger generations. Given this reality, the objective of determining the impact of social media on digital health literacy in the general Spanish population was proposed. METHODS: A cross-sectional descriptive study was carried out in 2023. Using a non-probabilistic sampling, the population residing in Spain, over eighteen years old, and users of social networks were included, obtaining a sample of 1,307 participants. An adaptation of the validated eHEALS questionnaire on digital health literacy was used. This questionnaire, created in Microsoft Forms, was disseminated through an anonymous link via the research team's social networks and collaborators. A descriptive and inferential statistical analysis was performed using SPSS 22.0, assuming a significance level with a value of p<0.05. RESULTS: All participants affirmed having consumed health information through social networks, but 72.1% stated they had actively used these platforms to search for this health information. Regarding digital health literacy, a median score of 24 out of 40 points was obtained on the questionnaire, being significantly higher among those who claimed to use social networks as a source of health information (p=0.0001). CONCLUSIONS: Actively employing social media as a source of health information is associated with a higher level of digital health literacy.


OBJECTIVE: Las redes sociales permiten a las personas acceder de manera inmediata y anónima a una cantidad ingente de información sobre aspectos de salud, hecho que está provocando que se estén convirtiendo en una de las fuentes de referencia en este ámbito, sobre todo para las generaciones más jóvenes. Atendiendo a esta realidad se planteó el objetivo de determinar el impacto de las redes sociales en la alfabetización digital en salud en la población general española. METHODS: Se realizó un estudio descriptivo transversal en el año 2023. Mediante un muestreo no probabilístico, se incluyó población residente en España, mayor de dieciocho años y usuaria de redes sociales, obteniendo una muestra de 1.307 participantes. Se utilizó una adaptación del cuestionario validado eHEALS sobre alfabetización digital en salud. Dicho cuestionario, elaborado en Microsoft Forms, fue difundido mediante un enlace anónimo a través de las redes sociales del equipo investigador y colaboradores. Se realizó un análisis estadístico descriptivo e inferencial mediante SPSS 22.0, asumiendo un nivel de significación con un valor de p<0,05. RESULTS: La totalidad de los participantes afirmaron haber consumido información sobre salud a través de redes sociales, pero fue el 72,1% el que afirmó haber usado estas plataformas activamente para buscar esta información sobre salud. Con respecto a la alfabetización digital en salud, se obtuvo una puntuación mediana en el cuestionario de 24 sobre 40 puntos, siendo significativamente mayor entre los que afirmaron usar las redes sociales como fuente de información sobre salud (p=0,0001). CONCLUSIONS: Emplear de manera activa las redes sociales como fuente de información sobre salud parece tener relación con un mayor nivel de alfabetización digital en salud.


Subject(s)
Health Literacy , Social Media , Humans , Spain , Cross-Sectional Studies , Male , Female , Adult , Middle Aged , Social Media/statistics & numerical data , Young Adult , Aged , Adolescent , Consumer Health Information/methods , Surveys and Questionnaires , Social Networking , Information Sources
2.
J Clin Med ; 13(9)2024 May 01.
Article in English | MEDLINE | ID: mdl-38731186

ABSTRACT

Background: Shortened femoral stems aim to mimic the biomechanical performance of traditional stems while preserving more bone and minimizing soft tissue damage. Our objective is to assess the outcomes of patients treated with a shortened stem (Furlong Evolution, JRI Orthopaedics, Sheffield, UK) to analyze the implant's efficacy and survivorship. Methods: This retrospective observational study included all patients aged 18 to 70 undergoing uncemented shortened stem total hip replacement at Hospital del Mar between 2010 and 2018. Hip function and pain were assessed with the Merle d'Aubigné-Postel scale and visual analog scale, respectively. A radiographic analysis measured stem and cup orientation, leg length discrepancy, stem subsidence, and radiolucencies around the cup. Perioperative complications, prosthetic failures, and reoperations were documented. Results: A total of 109 patients (74 male, 35 female) of a mean age of 51.8 ± 8.8 years were included. The average follow-up was 91 ± 17.4 months. Radiographically, 71 (65.1%) of the stems had been inserted at the appropriate angulation (±3°), and 102 (93.6%) of the cups had been placed in the Lewinnek safety zone. Leg length discrepancy was observed in 19 (17.4%) cases. The mean Merle d'Aubigné-Postel score improved from 13.1 ± 1.39 preoperatively to 17.8 ± 0.49 at 6 months postoperatively (p < 0.001). Merle d'Aubigné-Postel subscales also reflected a statistically significant improvement (p < 0.001). The mean pain score 12 months postoperatively was 0.52 ± 1.22, with 95.4% of patients declaring themselves satisfied or highly satisfied. The expected 13-year survival according to a Kaplan-Meier analysis was 100% in the absence of infection and 91.3% if revision for any cause is taken as a survival endpoint. Conclusions: The shortened stem under analysis provides excellent functional results and long-term survival rates.

3.
J Chem Phys ; 160(16)2024 Apr 28.
Article in English | MEDLINE | ID: mdl-38651804

ABSTRACT

The sinking of alkali cations in superfluid 4He nanodroplets is investigated theoretically using liquid 4He time-dependent density functional theory at zero temperature. The simulations illustrate the dynamics of the buildup of the first solvation shell around the ions. The number of helium atoms in this shell is found to linearly increase with time during the first stages of the dynamics. This points to a Poissonian capture process, as concluded in the work of Albrechtsen et al. on the primary steps of Na+ solvation in helium droplets [Albrechtsen et al., Nature 623, 319 (2023)]. The energy dissipation rate by helium atom ejection is found to be quite similar between all alkalis, the main difference being a larger energy dissipated per atom for the lighter alkalis at the beginning of the dynamics. In addition, the number of helium atoms in the first solvation shell is found to be lower at the end of the dynamics than at equilibrium for both Li+ and Na+, pointing to a kinetic rather than thermodynamical control of the snowball size for small and strongly attractive ions.

4.
Clin Transl Oncol ; 2024 Apr 20.
Article in English | MEDLINE | ID: mdl-38642257

ABSTRACT

PURPOSE: RAS (KRAS/NRAS) mutational status on a tumor biopsy is mandatory to guide the best treatment in metastatic colorectal cancer (mCRC). Determining the RAS mutational status by tumor-tissue biopsy is essential in guiding the optimal treatment decision for mCRC. RAS mutations are negative predictive factors for the use of EGFR monoclonal antibodies. Cell-free DNA (cfDNA) analysis enables minimally invasive monitoring of tumor evolution. METHODS/PATIENTS: PERSEIDA was an observational, prospective study assessing cfDNA RAS, BRAF and EGFR mutations (using Idylla™) in first-line mCRC, RAS wild-type (baseline tumor-tissue biopsy) patients (cohort 2). Plasma samples were collected before first-line treatment, after 20 ± 2 weeks, and at disease progression. RESULTS: 117 patients were included (103 received panitumumab + chemotherapy as first-line treatment). At baseline, 7 (6.8%) patients had RAS mutations, 4 (3.9%) BRAF mutations and no EGFR mutations were detected (cfDNA, panitumumab + chemotherapy subpopulation [panitumumab + Ch]). The baseline RAS mutational status concordance between tissue and liquid biopsies was 94.0% (93.2%, panitumumab + Ch). At 20 weeks, only one patient in the study (included in the panitumumab + Ch) had an emerging cfDNA RAS mutation. No emerging BRAF or EGFR mutations were reported. At disease progression, 6 patients had emergent mutations not present at baseline (RAS conversion rate: 13.3% [6/45]; 15.0% [6/40], panitumumab + Ch). CONCLUSIONS: The concordance rate between liquid and solid biopsies at baseline was very high, as previously reported, while our results suggest a considerable emergence of RAS mutations during disease progression. Thus, the dynamics of the genomic landscape in ctDNA may provide relevant information for the management of mCRC patients.

5.
Clin Transl Oncol ; 2024 Apr 05.
Article in English | MEDLINE | ID: mdl-38578537

ABSTRACT

BACKGROUND: Retrospective data suggest an association between bevacizumab efficacy and the incidence of arterial hypertension (AHT). Additionally, epigenetic mechanisms have been related to AHT. METHODS: This prospective observational study conducted by GEICAM Spanish Breast Cancer Research Group included metastatic breast (MBC) or colorectal (mCRC) cancer patients treated with bevacizumab-containing chemotherapy as first-line treatment. Blood pressure (BP) levels were measured (conventional and 24-h Holter monitoring) at baseline and up to cycle 3. Primary endpoint assessed BP levels increase as predictive factor for progression-free survival (PFS). Germline DNA methylation profile was explored in pre-treatment blood samples; principal component analysis was used to define an epigenetic predictive score for increased BP levels. RESULTS: From Oct-2012 to Jul-2016, 143 (78 MBC and 65 mCRC) patients were included. The incidence of AHT according to guidelines was neither predictive of PFS nor of best overall tumor response (BOR). No statistically significant association was observed with systolic BP nor diastolic BP increment for PFS or BOR. Grade 3 and 4 adverse events were observed in 37 and 5% of patients, respectively. We identified 27 sites which baseline methylation status was significantly associated to BP levels increase secondary to bevacizumab-containing chemotherapy. CONCLUSIONS: Neither the frequency of AHT nor the increase of BP levels were predictive of efficacy in MBC and mCRC patients treated with bevacizumab-containing chemotherapy. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov Identifier: NCT01733628.

7.
Chemosphere ; 357: 142075, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38648985

ABSTRACT

Pesticides are considered one of the main sources of contamination of surface waters, especially in rural areas highly influenced by traditional agricultural practices. The objective of this work was to evaluate the impact caused by pesticides and their transformation products (TPs) related to olive groves in surface waters with strong agricultural pressure. 11 streams were monitored during four sampling campaigns over 2 years. A solid-phase extraction, followed by ultra-high-performance liquid chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS) analysis was used in the quantitative target approach, with more than 70 validated compounds. Target method was combined with a suspect screening strategy involving more than 500 pesticides and TPs, using ultra-high-performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS) to identify additional pesticides and TPs out of the scope of analysis. A total of 43 different compounds were detected with the target method. The herbicide MCPA was present in all samples and at the highest concentration (1260 ng L-1), followed by the fungicide carbendazim (1110 ng L-1), and the herbicide chlorotoluron (706 ng L-1). The suspect screening strategy revealed the presence of 7 compounds out of the target analysis (1 pesticide and 6 TPs). 6 analytes were confirmed with the analytical standards. Semi-quantification results revealed that TPs exhibited higher concentrations than their corresponding parent compounds, indicating higher persistency. Some small streams showed a comparable number of pesticides and concentrations to the most polluted large river. The determined pesticide and TPs concentrations represented an estimated environmental hazard in almost all sampling sites under study. This work underscores the importance of including pesticide TPs and small streams impacted by extensive agricultural activities in water quality monitoring programs.


Subject(s)
Agriculture , Environmental Monitoring , Olea , Pesticides , Rivers , Tandem Mass Spectrometry , Water Pollutants, Chemical , Rivers/chemistry , Water Pollutants, Chemical/analysis , Pesticides/analysis , Risk Assessment , Olea/chemistry , Solid Phase Extraction , Carbamates/analysis , Chromatography, High Pressure Liquid , Herbicides/analysis , Benzimidazoles/analysis , Phenylurea Compounds
8.
Environ Res ; 252(Pt 1): 118712, 2024 Mar 26.
Article in English | MEDLINE | ID: mdl-38548255

ABSTRACT

Lead ammunition stands out as one of the most pervasive pollutants affecting wildlife. Its impact on bird populations have spurred efforts for the phase-out of leaded gunshot in several countries, although with varying scopes and applications. Ongoing and future policy changes require data to assess the effectiveness of adopted measures, particularly in the current context of biodiversity loss. Here, we assessed the long-term changes in blood lead (Pb) levels of Egyptian vultures from the Canary Islands, Spain, which have been severely affected by Pb poisoning over the past two decades. During this period, the reduction in hunting pressure and changes in legislation regarding firearms usage for small game hunting likely contributed to a decrease in environmental Pb availability. As anticipated, our results show a reduction in Pb levels, especially after the ban on wild rabbit hunting with shotgun since 2010. This effect was stronger in the preadult fraction of the vulture population. However, we still observed elevated blood Pb levels above the background and clinical thresholds in 5.6% and 1.5% of individuals, respectively. Our results highlight the positive impact of reducing the availability of Pb from ammunition sources on individual health. Nonetheless, the continued use of Pb gunshot remains an important source of poisoning, even lethal, mainly affecting adult individuals. This poses a particular concern for long-lived birds, compounding by potential chronic effects associated with Pb bioaccumulation. Our findings align with recent studies indicating insufficient reductions in Pb levels among European birds of prey, attributed to limited policy changes and their uneven implementation. We anticipated further reductions in Pb levels among Egyptian vultures with expanded restrictions on hunting practices, including a blanket ban on Pb shot usage across all small game species.

9.
Clin Transl Oncol ; 2024 Feb 27.
Article in English | MEDLINE | ID: mdl-38411748

ABSTRACT

PURPOSE: The optimal drug regimen and sequence are still unknown for patients with metastatic colorectal cancer (mCRC) who are candidates for third-line (3L) or subsequent treatment. The aim of this study is to know the opinion of experts on the most appropriate treatment options for mCRC in 3L and to clarify certain clinical decisions in Spain. METHODS: Using a modified Delphi method, a group of experts discussed the treatment in 3L of patients with mCRC and developed a questionnaire with 21 items divided into 5 sections. RESULTS: After 2 rounds, the 67 panelists consulted agreed on 17 items (81%). They considered that the main objective of 3L is to equally increase survival and improve patients' quality of life (QoL), but preferably the QoL. It was agreed that patients with mCRC in 3L prefer to receive active versus symptomatic treatment. Panelists considered trifluridine/tipiracil (FTD/TPI) to be the best oral treatment available to them in 3L. In patients with MSI-H or dMMR and BRAF V600E, the panelists mostly prefer targeted treatments. Panelists agreed the use of a therapeutic sequence that not only increases outcomes but also allows patients to be treated later. Finally, it was agreed that FTD/TPI has a mechanism of action that allows it to be used in patients refractory to previous treatment with 5-fluorouracil. CONCLUSION: The experts agreed with most of the proposed items on 3L treatment of mCRC, prioritizing therapeutic options that increase survival and preserve QoL, while facilitating the possibility that patients can continue to be treated later.

10.
TH Open ; 8(1): e1-e8, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38197015

ABSTRACT

Background In acute pulmonary embolism (PE), echocardiographic identification of right ventricular (RV) dysfunction will inform prognostication and clinical decision-making. Registro Informatizado Enfermedad TromboEmbolica (RIETE) is the world's largest registry of patients with objectively confirmed PE. The reliability of site-reported RV echocardiographic measurements is unknown. We aimed to validate site-reported key RV echocardiographic measurements in the RIETE registry. Methods Fifty-one randomly chosen patients in RIETE who had transthoracic echocardiogram (TTE) performed for acute PE were included. TTEs were de-identified and analyzed by a core laboratory of two independent observers blinded to site-reported data. To investigate reliability, intraclass correlation coefficients (ICCs) and Bland-Altman plots between the two observers, and between an average of the two observers and the RIETE site-reported data were obtained. Results Core laboratory interobserver variations were very limited with correlation coefficients >0.8 for all TTE parameters. Agreement was substantial between core laboratory observers and site-reported data for key parameters including tricuspid annular plane systolic excursion (ICC 0.728; 95% confidence interval [CI], 0.594-0.862) and pulmonary arterial systolic pressure (ICC 0.726; 95% CI, 0.601-0.852). Agreement on right-to-left ventricular diameter ratio (ICC 0.739; 95% CI, 0.443-1.000) was validated, although missing data limited the precision of the estimates. Bland-Altman plots showed differences close to zero. Conclusion We showed substantial reliability of key RV site-reported measurements in the RIETE registry. Ascertaining the validity of such data adds confidence and reliability for subsequent investigations.

11.
J Neurol ; 271(3): 1224-1234, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38197947

ABSTRACT

BACKGROUND: In the different published studies, there is no consensus on the efficacy of virtual reality as an adjuvant treatment of mood states. AIM: The aim of this study is to evaluate the impact of no immersive virtual reality with the Nintendo Switch device in rehabilitation treatment on mood, anxiety and depression in stroke patients admitted to neurorehabilitation units. METHODS: Fifty-eight patients admitted to neurorehabilitation units underwent a 1:3 multicentre randomised clinical trial. The intervention group consisted of 17 patients and the control group of 41 patients. The intervention group performed 6 virtual reality sessions together with the conventional treatment, and the control group performed only the conventional rehabilitation sessions. Primary and secondary clinical outcomes were measured before and six weeks after the intervention. RESULTS: Comparing the intervention group and control group, the anxiety levels of the intervention group decreased compared to the results observed in the control group (p = 0.01), as did the dependence of the intervention group (0.015). On the other hand, the results obtained after the intervention by the control group for anxiety (0.479) and depression (0.292) were not statistically significant. CONCLUSION: Rehabilitation VR used as an adjuvant treatment to conventional treatment has a beneficial impact on the neurological status and state of anxiety of stroke patients admitted to neurorehabilitation units. TRIAL REGISTRATION: Registered in the https://clinicaltrials.gov/ repository (NTC NCT05143385). Protocol registration date 7 October 2021, retrospectively registered.


Subject(s)
Stroke Rehabilitation , Stroke , Video Games , Humans , Stroke Rehabilitation/methods , Depression/etiology , Depression/therapy , Stroke/complications , Stroke/therapy , Anxiety/etiology , Anxiety/therapy
12.
Eur J Clin Microbiol Infect Dis ; 43(3): 533-540, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38236366

ABSTRACT

PURPOSE: To describe a cohort with a high risk of recurrence who received bezlotoxumab during the first episode of Clostridioides difficile infection (CDI) and to compare this cohort with patients with similar characteristics who did not receive the monoclonal antibody. METHODS: A prospective and multicentre study of patients with a high risk of recurrence (expected recurrence rate>35%) who were treated with bezlotoxumab during their first episode of CDI was conducted. A propensity score-matched model 1:2 was used to compare both cohorts that were weighed according to basal characteristics (hospital-acquisition, creatinine value, and fidaxomicin as a CDI treatment). RESULTS: Sixty patients (mean age:72 years) were prospectively treated with bezlotoxumab plus anti-Clostridioides antibiotic therapy. Vancomycin (48 patients) and fidaxomicin (12 patients) were prescribed for CDI treatment, and bezlotoxumab was administered at a mean of 4.2 (SD:2.1) days from the beginning of therapy. Recurrence occurred in nine out of 54 (16.7%) evaluable patients at 8 weeks. Forty bezlotoxumab-treated patients were matched with 69 non-bezlotoxumab-treated patients. Recurrence rates at 12 weeks were 15.0% (6/40) in bezlotoxumab-treated patients vs. 23.2% (16/69) in non-bezlotoxumab-treated patients (OR:0.58 [0.20-1.65]). No adverse effects were observed related to bezlotoxumab infusion. Only one of 9 patients with previous heart failure developed heart failure. CONCLUSION: We observed that patients treated with bezlotoxumab in a real-world setting during a first episode of CDI having high risk of recurrence, presented low rate of recurrence. However, a significant difference in recurrence could not be proved in comparison to the controls. We did not detect any other safety concerns.


Subject(s)
Broadly Neutralizing Antibodies , Clostridium Infections , Heart Failure , Humans , Aged , Fidaxomicin/therapeutic use , Prospective Studies , Recurrence , Anti-Bacterial Agents/adverse effects , Antibodies, Monoclonal/adverse effects , Clostridium Infections/microbiology , Heart Failure/chemically induced , Heart Failure/drug therapy
13.
Oper Neurosurg (Hagerstown) ; 26(1): 86-91, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-37707418

ABSTRACT

BACKGROUND AND IMPORTANCE: Traumatic lateral spondyloptosis, or lateraloptosis, is the complete lateral dislocation of the spine. Reduction in these dislocations presents unique challenges, especially in cases of preserved neurological function. Open techniques carry significant risks of cerebrospinal fluid leak and neurological injury. For traditional spondyloptosis, off-table closed techniques have been described but may result in loss of the reduction when the patient is transferred to the operative table. An on-table closed reduction technique has potential advantages over previously described open reduction or off-table techniques for the treatment of lateraloptosis. CLINICAL PRESENTATION: The authors describe an on-table closed reduction technique for lateraloptosis, presenting an illustrative case in which the technique was applied. This technique is compared with alternative open and off-table reduction techniques described in the literature. The patient had good mechanical and neurological outcomes. At 14 months postoperatively, she is neurologically intact, back to work involving heavy lifting, and has only moderate back pain. CONCLUSION: On-table closed reduction before open fixation should be considered in cases of lateraloptosis, particularly when there is preserved neurological function.


Subject(s)
Joint Dislocations , Spinal Fractures , Spondylolisthesis , Female , Humans , Spinal Fractures/surgery , Spine , Joint Dislocations/surgery , Spondylolisthesis/surgery , Back Pain
14.
Pediatr Dev Pathol ; 27(2): 187-192, 2024.
Article in English | MEDLINE | ID: mdl-37818649

ABSTRACT

The differential diagnosis for neonatal primary lung masses includes developmental anomalies and congenital lung tumors. Fetal lung interstitial tumor (FLIT) is a rare benign mesenchymal lesion which presents either antenatally or within the first 3 months of age. FLIT is a circumscribed solid-cystic mass which histologically resembles the fetal lung during the canalicular stage at 20-24 weeks of gestation. It is composed of immature mesenchymal cells expanding the interstitium and irregular airspace-like structures. Of all published cases, only 1 identified an α2-macroglobulin (A2M)::anaplastic lymphoma kinase (ALK) fusion and all cases underwent surgical resection in the neonatal or infancy period. We present the second case of FLIT with an A2M::ALK fusion diagnosed postnatally in a neonate which partially regressed spontaneously during conservative management with interim resection at 39 months of age, and provide a review of the literature.


Subject(s)
Lung Neoplasms , Pregnancy-Associated alpha 2-Macroglobulins , Infant, Newborn , Pregnancy , Female , Humans , Anaplastic Lymphoma Kinase/genetics , Lung Neoplasms/diagnosis , Lung Neoplasms/genetics , Lung Neoplasms/congenital , Lung/pathology , alpha-Macroglobulins
15.
Clin. transl. oncol. (Print) ; 25(12): 3378-3394, dec. 2023.
Article in English | IBECS | ID: ibc-227284

ABSTRACT

Peritoneal metastases (PM) occur when cancer cells spread inside the abdominal cavity and entail an advanced stage of colorectal cancer (CRC). Prognosis, which is poor, correlates highly with tumour burden, as measured by the peritoneal cancer index (PCI). Cytoreductive surgery (CRS) in specialized centres should be offered especially to patients with a low to moderate PCI when complete resection is expected. The presence of resectable metastatic disease in other organs is not a contraindication in well-selected patients. Although several retrospective and small prospective studies have suggested a survival benefit of adding hyperthermic intraperitoneal chemotherapy (HIPEC) to CRS, the recently published phase III studies PRODIGE-7 in CRC patients with PM, and COLOPEC and PROPHYLOCHIP in resected CRC with high-risk of PM, failed to show any survival advantage of this strategy using oxaliplatin in a 30-min perfusion. Final results from ongoing randomized phase III trials testing CRS plus HIPEC based on mitomycin C (MMC) are awaited with interest. In this article, a group of experts selected by the Spanish Group for the Treatment of Digestive Tumours (TTD) and the Spanish Group of Peritoneal Oncologic Surgery (GECOP), which is part of the Spanish Society of Surgical Oncology (SEOQ), reviewed the role of HIPEC plus CRS in CRC patients with PM. As a result, a series of recommendations to optimize the management of these patients is proposed (AU)


Subject(s)
Humans , Colorectal Neoplasms/pathology , Hyperthermia, Induced/methods , Peritoneal Neoplasms/secondary , Neoplasm Metastasis , Physical Therapy Modalities , Retrospective Studies , Prospective Studies , Survival Rate
17.
Cancers (Basel) ; 15(18)2023 Sep 15.
Article in English | MEDLINE | ID: mdl-37760559

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the long-term oncological progression pattern of locally advanced rectal cancer patients with post-neoadjuvant nodal metastatic disease (ypN+) and correlate potential prognostic features associated with proven radiochemoresistant nodal biology. METHODS: Individual patient data (100 variables) from a 20-year consecutive single-institution multidisciplinary experience (1995-2015), delivering multimodal therapy to rectal cancer patient candidates for radical treatment, including a neoadjuvant component and surgical resection with or without intraoperative radiotherapy followed by optional adjuvant chemotherapy. The ypN+ disease data was registered in the context of initial staging categories post-neoadjuvant T status (ypT). RESULTS: Data on 487 patients showed histologically confirmed diagnoses of metastatic nodal disease in 108 specimens (ypN+, 22.1). There was a significant age difference (p = 0.009) between the ypN groups: age ≥ 65 was 57.6% in pN0 and 43.5% in ypN+ and patients aged < 65 constituted 42.4% of pN0 and 56.5% of ypN+. According to the clinical stage there were statistically significant differences (p = 0.001) in the categories' distribution: ypN+ patients 10.8% were stage II and 89.2% were stage III. Univariant analysis on outcome variables showed statistically significant differences in overall survival at 7 years (63.8% vs. 55.7%, p = 0.016) disease-free survival (DFS) (78% vs. 53.8%, p = 0.000) and local recurrence-free survival (LRFS) (93.6% vs. 84%, p = 0.002). CONCLUSIONS: The presence of nodal metastases (ypN+) after neoadjuvant therapy containing long-course pelvic irradiation severely impacts the long-term outcome for patients with locally advanced rectal cancer and correlates with multiple clinical and therapeutic variable metrics. Implementation of local and systemic therapies should be adapted and intensified in relation to the finding of ypN+ category in surgical specimens.

18.
Front Pharmacol ; 14: 1188368, 2023.
Article in English | MEDLINE | ID: mdl-37693908

ABSTRACT

Background: Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability. Methods: The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council. Biosimilar policies were identified and their sustainability was assessed based on country-specific reviews of the scientific and grey literature, validation by industry experts and 23 international and local non-industry experts, and two advisory board meetings with these non-industry experts. Results: Given that European countries tend to have more experience with biosimilars and more developed policy frameworks, they generally have higher sustainability scores than the other selected countries. Existing approaches to biosimilar manufacturing and R&D, policies guaranteeing safe and high-quality biosimilars, exemption from the requirement to apply health technology assessment to biosimilars, and initiatives counteracting biosimilar misconceptions are considered sustainable. However, biosimilar contracting approaches, biosimilar education and understanding can be ameliorated in all selected countries. Also, similar policies are sometimes perceived to be sustainable in some markets, but not in others. More generally, the sustainability of the biosimilar landscape depends on the nature of the healthcare system and existing pharmaceutical market access policies, the experience with biosimilar use and policies. This suggests that a general biosimilar policy toolkit that ensures sustainability does not exist, but varies from country to country. Conclusion: This study proposes a set of elements that should underpin sustainable biosimilar policy development over time in a country. At first, biosimilar policies should guarantee the safety and quality of biosimilars, healthy levels of supply and a level of cost savings. As a country gains experience with biosimilars, policies need to optimise uptake and combat any misconceptions about biosimilars. Finally, a country should implement biosimilar policies that foster competition, expand treatment options and ensure a sustainable market environment.

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