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1.
BMC Geriatr ; 24(1): 3, 2024 01 02.
Artigo em Inglês | MEDLINE | ID: mdl-38166670

RESUMO

BACKGROUND: The contribution of the postoperative process to developing or worsening urinary incontinence (UI) after hip fracture surgery (HFS) remains unclear. We aimed to evaluate UI incidence and worsening among older patients undergoing HFS, and explore associated risk factors. METHODS: This prospective cohort study included patients ≥ 75 years admitted between October 2019 and October 2021 to the Traumatology Service of three hospitals in the Consorci Sanitari de Alt-Penedès i Garraf (Barcelona, Spain) with hip fracture requiring surgical treatment. UI was assessed using the first two questions of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) at baseline and at days 30 (± 3 days) and 90 (± 3 days) after HFS. Surgery-related data and post-surgical complications were recorded. RESULTS: A total of 248 patients with a mean (SD) age of 85.8 (6.78) years were included; 77.8% were female and 154 (62.1%) had UI at baseline. After HFS, 3.24% experienced urinary tract infections (UTIs), 3.64%, acute urinary retention (AUR), 8.57%, constipation, and 53.9%, prolonged catheterization (> 24 h). Fifty-eight patients without baseline UI developed UI at 30 days, resulting in a UI incidence of 61.7% (95% CI 51.1-71.54) between days 0 and 30. Of the 248 patients, 146 (59.1%) experienced worsening of UI. AUR and UTIs were identified as risk factors for UI development and worsening after HFS, respectively. CONCLUSION: The incidence of UI in older patients after HFS is significant. Patient management protocols should consider AUR and UTIs to reduce or eliminate the incidence of UI in older patients undergoing HFS.


Assuntos
Fraturas do Quadril , Incontinência Urinária , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Estudos Prospectivos , Incidência , Incontinência Urinária/diagnóstico , Incontinência Urinária/epidemiologia , Incontinência Urinária/etiologia , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/cirurgia , Fatores de Risco , Inquéritos e Questionários , Qualidade de Vida
2.
Phys Chem Chem Phys ; 25(12): 8574-8582, 2023 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-36883855

RESUMO

The electrochemical conversion of CO2 into value-added chemicals is an important approach to recycling CO2. In this work, we have combined the most efficient metal catalysts for this reaction, namely Cu, Ag, and Au, as single-atom particles dispersed on a two-dimensional carbon nitride support, with the aim of exploring their performance in the CO2 reduction reaction. Here, we report density functional theory computations showing the effect of single metal-atom particles on the support. We found that bare carbon nitride needed a high overpotential to overcome the energy barrier for the first proton-electron transfer, while the second transfer was exergonic. The deposition of single metal atoms enhances the catalytic activity of the system as the first proton-electron transfer is favored in terms of energy, although strong binding energies were found for CO adsorption on Cu and Au single atoms. Our theoretical interpretations are consistent with the experimental evidence that the competitive H2 generation is favored due to the strong CO binding energies. Our computational study paves the road to finding suitable metals that catalyze the first proton-electron transfer in the carbon dioxide reduction reaction and produce reaction intermediates with moderate binding energies, promoting a spillover to the carbon nitride support and thereby serving as bifunctional electrocatalysts.

3.
Emerg Infect Dis ; 27(12): 3073-3081, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34808091

RESUMO

Zika virus (ZIKV) is a member of the Flaviviridae family, which includes other clinically notable viruses such as the 4 dengue virus serotypes (DENV-1-4). Distinguishing DENVs from ZIKV using the established serologic assays widely used for monitoring DENV transmission is difficult because of antibody cross-reactivity between these closely related flaviviruses. We describe a modified and improved recombinant envelope domain III-based serologic assay for detecting ZIKV type-specific antibodies in regions with endemic DENV transmission. When the assay was used to measure ZIKV seroprevalence in 2017 among children 9-14 years of age living in a region of the Philippines with endemic DENV transmission, we observed a ZIKV seroprevalence of 18%. Investigators should consider using the ZIKV envelope domain III-based assay, which is simple and readily adaptable for use in standard clinical and public health laboratories, to assess ZIKV seroprevalence in areas with endemic DENV transmission.


Assuntos
Vírus da Dengue , Dengue , Infecção por Zika virus , Zika virus , Anticorpos Antivirais , Criança , Reações Cruzadas , Dengue/diagnóstico , Dengue/epidemiologia , Vírus da Dengue/genética , Humanos , Filipinas/epidemiologia , Estudos Soroepidemiológicos , Zika virus/genética , Infecção por Zika virus/diagnóstico , Infecção por Zika virus/epidemiologia
4.
Pain Pract ; 21(8): 984-990, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-33934501

RESUMO

BACKGROUND: Fluoroscopic-guided lumbar procedures have increased in daily pain practice because the lumbar spine is one of the most common sources of pain. Interventional pain fellows must develop a minimum number of skills during their training in order to achieve the competences without neglecting radiological safety. However, medical training in fluoroscopic-guided interventions is being affected by the current coronavirus disease 2019 (COVID-19) situation. METHODS: The objective of this study was to evaluate the use of a phantom model for lumbar injection as a training strategy during the COVID-19 pandemic in fellows of interventional pain. The study was divided into theoretical and practical modules. The hands-on practice was performed in a lumbar model phantom where fellows were evaluated in four fluoroscopically guided approaches: intra-articular facet block (IAFB), medial branch block (MBB), transforaminal block (TFB), and interlaminar block (ILB) divided in 5 sessions. The aim was to make as many punctures as possible in every session. We measured total procedural performance (TPP), total needle hand time (TNH), and total radiation dose generated by the fluoroscopic machine (TRD) during each procedure. Additionally, a survey was applied to evaluate confidence and satisfaction before and after training. RESULTS: A total of 320 lumbar punctures were completed. The results were statistically significant in all approaches attempted (p < 0.01). The fellow's survey for satisfaction and confidence demonstrated a significant difference between pre and post-test (p < 0.01). CONCLUSIONS: The results of this study highlight the importance of adaptations and adoption of new educational models. The use of the phantom model for simulation could be a strategy for other emerging situations, like the COVID-19 pandemic. Including this practice in the interventional pain programs could lead to better results for the patient and operator radiology safety.


Assuntos
COVID-19 , Pandemias , Fluoroscopia , Humanos , Dor , SARS-CoV-2
5.
Int J Mol Sci ; 21(10)2020 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-32438732

RESUMO

Diabetes prevalence is constantly increasing and, nowadays, it affects more than 350 million people worldwide. Therefore, the prevalence of diabetic nephropathy (DN) has also increased, becoming the main cause of end-stage renal disease (ESRD) in the developed world. DN is characterized by albuminuria, a decline in glomerular filtration rate (GFR), hypertension, mesangial matrix expansion, glomerular basement membrane thickening, and tubulointerstitial fibrosis. The therapeutic advances in the last years have been able to modify and delay the natural course of diabetic kidney disease (DKD). Nevertheless, there is still an urgent need to characterize the pathways that are involved in DN, identify risk biomarkers and prevent kidney failure in diabetic patients. Rodent models provide valuable information regarding how DN is set and its progression through time. Despite the utility of these models, kidney disease progression depends on the diabetes induction method and susceptibility to diabetes of each experimental strain. The classical DN murine models (Streptozotocin-induced, Akita, or obese type 2 models) do not develop all of the typical DN features. For this reason, many models have been crossed to a susceptible genetic background. Knockout and transgenic strains have also been created to generate more robust models. In this review, we will focus on the description of the new DN rodent models and, additionally, we will provide an overview of the available methods for renal phenotyping.


Assuntos
Nefropatias Diabéticas/patologia , Animais , Nefropatias Diabéticas/genética , Nefropatias Diabéticas/fisiopatologia , Modelos Animais de Doenças , Taxa de Filtração Glomerular , Humanos , Rim/patologia , Rim/fisiopatologia , Podócitos/patologia
7.
Eur J Cancer Care (Engl) ; 28(4): e13070, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31050081

RESUMO

Women with gynaecological cancer (GC) experience significant morbidity with associated needs for support, not all of which are currently met by the current system. Types and levels of unmet needs vary across age and the care continuum. This study aimed to identify the shared and unique supportive care needs of younger and older GC patients and survivors to inform improved supportive care. Nineteen younger and ten older women, 3 months to 5 years post a GC diagnosis, were purposively recruited during active treatment, and at early and extended survivorship. Audiotaped and transcribed semi-structured interviews were thematically analysed to establish areas of needs. GC patients reported nine shared needs relating to support, isolation, uncertainty, information, asking questions, escape from illness, advocacy, loss and finding meaning. Younger patients reported unique needs related to the impact of treatment-induced menopause. There is a need for a systematic screening process to identify women who require and want additional help, to ensure appropriate and timely assistance or referrals are provided. Identification of needs will allow health professionals to provide relevant and timely information and support services, resulting in improved quality of life for women affected by GC.


Assuntos
Sobreviventes de Câncer/psicologia , Neoplasias dos Genitais Femininos/terapia , Apoio Social , Atividades Cotidianas , Adaptação Psicológica , Adolescente , Adulto , Fatores Etários , Idoso , Compreensão , Aconselhamento , Feminino , Preservação da Fertilidade/psicologia , Neoplasias dos Genitais Femininos/psicologia , Humanos , Infertilidade Feminina/psicologia , Relações Interpessoais , Pessoa de Meia-Idade , Avaliação das Necessidades , Defesa do Paciente , Educação de Pacientes como Assunto , Relações Profissional-Paciente , Qualidade de Vida , Autoimagem , Grupos de Autoajuda , Disfunções Sexuais Fisiológicas/psicologia , Parceiros Sexuais , Isolamento Social , Estigma Social , Estresse Psicológico/etiologia , Adulto Jovem
9.
Clin Infect Dis ; 66(12): 1960-1971, 2018 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-29177437

RESUMO

In addition to improved water supply and sanitation, the 2-dose killed oral cholera vaccine (OCV) is an important tool for the prevention and control of cholera. We aimed to document the immunogenicity and protection (efficacy and effectiveness) conferred by a single OCV dose against cholera. The metaanalysis showed that an estimated 73% and 77% of individuals seroconverted to the Ogawa and Inaba serotypes, respectively, after an OCV first dose. The estimates of single-dose vaccine protection from available studies are 87% at 2 months decreasing to 33% at 2 years. Current immunologic and clinical data suggest that protection conferred by a single dose of killed OCV may be sufficient to reduce short-term risk in outbreaks or other high-risk settings, which may be especially useful when vaccine supply is limited. However, until more data suggest otherwise, a second dose should be given as soon as circumstances allow to ensure robust protection.


Assuntos
Vacinas contra Cólera/imunologia , Cólera/prevenção & controle , Imunogenicidade da Vacina , Vacinas de Produtos Inativados/imunologia , Administração Oral , Vacinas contra Cólera/administração & dosagem , Surtos de Doenças/prevenção & controle , Humanos , Esquemas de Imunização , Soroconversão , Sorogrupo , Vacinação/métodos , Potência de Vacina , Vacinas de Produtos Inativados/administração & dosagem , Vibrio cholerae/imunologia
10.
Eur J Pediatr ; 177(9): 1377-1381, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29374831

RESUMO

Normal procalcitonin (PCT) levels have been reported in adult pulmonary tuberculosis (TB) but have not been previously investigated in children. We aimed to assess PCT levels at diagnosis of TB in young children in a low-burden setting. In a cross-sectional observational study in a referral pediatric center in Barcelona (Spain), we assessed the value of PCT and other inflammatory markers (leucocyte counts, C-reactive protein, and erythrocyte sedimentation rate) in the diagnosis of TB in pre-school children (< 6 years at diagnosis, n = 45), as compared with two control groups (pneumococcal pneumonia, n = 25; and healthy controls, n = 49). Normal PCT levels were observed at diagnosis of TB in most cases, while C-reactive protein values and leucocyte counts were slightly elevated when compared to healthy controls. All three inflammatory biomarkers were significantly higher in children with pneumococcal pneumonia. CONCLUSIONS: In our study, PCT was not a useful diagnostic test for TB in young children. In a low-burden TB setting, PCT may be of some value in distinguishing pulmonary TB from pneumococcal pneumonia. What is Known: • Diagnosis of pediatric tuberculosis on clinical evidence is difficult, particularly in infants and small children. • Studies in adults with tuberculosis have mostly reported normal procalcitonin levels at diagnosis. What is New: • In pre-scholars with tuberculosis, erythrocyte sedimentation rate and white blood cell counts were higher than in healthy controls, but procalcitonin was not. • Procalcitonin may be useful in the differential diagnosis of intrathoracic tuberculosis and pneumococcal pneumonia.


Assuntos
Calcitonina/sangue , Tuberculose Pulmonar/diagnóstico , Biomarcadores/sangue , Proteína C-Reativa , Pré-Escolar , Estudos Transversais , Diagnóstico Diferencial , Feminino , Humanos , Lactente , Contagem de Leucócitos , Masculino , Espanha
11.
Eur J Cancer Care (Engl) ; 27(5): e12893, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30016004

RESUMO

Prevalence of clinical anxiety among patients with cancer is higher than the general population. Clinical anxiety in people with other medical conditions is associated with greater healthcare resource use and costs. This scoping review describes the evidence relating to costs associated with clinical anxiety in cancer populations. We conducted searches of online databases Medline, Embase, Cinahl, National Health Service Economic Evaluation Database (NHS-EED) and Cochrane Library of systematic reviews to identify studies published between 2006 and 2017 that included healthcare cost in terms of monetary or health service utilisation variables. Of 411 records screened, six studies met inclusion criteria. Only one study used formal diagnostic criteria to identify clinical anxiety. The healthcare system perspective was most common, with direct costs such as medications, hospital visits, type of therapy and use of mental health services reported. All studies found anxiety was related to increased costs/resource use; however, methodological differences mean specific costs and potential impact of interventions on resource use remain relatively unquantified. Despite the prevalence of clinical anxiety, there is little data on the economic impact on health service costs and utilisation. Future studies quantifying the true cost are urgently needed to inform healthcare service planning and delivery, and quality improvement initiatives.


Assuntos
Transtornos de Ansiedade/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Serviços de Saúde Mental/economia , Neoplasias/psicologia , Transtornos de Ansiedade/etiologia , Humanos , Neoplasias/economia
13.
J Vasc Surg ; 63(4): 1091-8, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27016858

RESUMO

BACKGROUND: Clinical practice guidelines (CPGs) provide recommendations to assist health professionals and patients in the process of making decisions for specific clinical conditions to improve the quality of the patient care. However, there are concerns about the quality of some CPGs. The aim of this study was to review the quality of CPGs in pharmacologic management of peripheral artery disease (PAD). METHODS: A systematic review of CPGs for the pharmacologic treatment of PAD was performed. CPGs published between 2003 and January 2015 in English, Spanish, or French were retrieved using PubMed, Cochrane, and TRIP databases; guideline developer organization Web sites, and European and American scientific societies related to PAD Web sites. One reviewer performed the search and guideline selection, which was validated by a second reviewer. Three appraisers independently assessed the quality of CPGs using the Appraisal of Guidelines, REsearch and Evaluation II (AGREE II) instrument. RESULTS: A total of seven CPGs, published between 2006 and 2012, were included. All except one were written in English. Average AGREE II guidelines scores varied from 45% to 72%. There was considerable variation in the quality of the CPGs across the AGREE II domain scores (ranging from 4% to 85%). The highest scored domains were 'clarity of presentation' and 'editorial independence' and the lowest scored domain was 'applicability.' The reviewers consider that six CPGs could be recommended with modifications for use and one without modification. CONCLUSIONS: There is great variability in the quality of the CPGs on pharmacologic treatment in PAD. All of the assessed guidelines could be recommended; however, there is considerable scope to improve their quality by highlighting aspects of applicability, the involvement of the stakeholder, as well as the rigor of development.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Fidelidade a Diretrizes/normas , Doença Arterial Periférica/tratamento farmacológico , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Fármacos Cardiovasculares/efeitos adversos , Humanos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Melhoria de Qualidade/normas , Resultado do Tratamento
14.
Enferm Infecc Microbiol Clin ; 34(7): 409-14, 2016.
Artigo em Espanhol | MEDLINE | ID: mdl-26589755

RESUMO

INTRODUCTION: VINCat is a nosocomial infection surveillance program in hospitals in Catalonia. The aim of the study was to determine the surveillance and control measures of methicillin-resistant Staphylococcus aureus (MRSA) in these centres. METHODS: An e-mail survey was carried out from January to March 2013 with questions related to the characteristics of the hospitals and their control measures for MRSA. RESULTS: A response was received from 53 hospitals (>500 beds: 7; 200-500 beds: 14;<200 beds: 32; had ICU: 29). Computer alert of readmissions was available in 63%. There was active surveillance of patients admitted from another hospital (46.2%) or a long-term-care centre (55.8%), both being significantly more common measures in hospitals with a rate of MRSA≤22% (global median). Compliance with hand hygiene was observed in 77.4% of the centres, and was greater than 50% in 69.7% of them. All hospitals had contact precautions, although 62.3% did not have exclusive frequently used clinical material in bedrooms. The room cleaning was performed more frequently in 54.7% of hospitals, and 67.9% of them had programs for the appropriate use of antibiotics. CONCLUSIONS: This study provides information on the implementation of measures to prevent MRSA in hospitals participating in the VINCat program. Most of the centres have an MRSA protocol, however compliance with it should be improved, especially in areas such as active detection on admission in patients at risk, hand hygiene adherence, cleaning frequency and optimising the use of antibiotics.


Assuntos
Infecção Hospitalar/prevenção & controle , Controle de Infecções/métodos , Staphylococcus aureus Resistente à Meticilina , Infecções Estafilocócicas/prevenção & controle , Infecção Hospitalar/microbiologia , Hospitais , Humanos , Meticilina , Resistência a Meticilina , Infecções Estafilocócicas/microbiologia , Inquéritos e Questionários
15.
Bull World Health Organ ; 92(12): 881-93, 2014 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-25552772

RESUMO

OBJECTIVE: To describe and analyse the characteristics of oral cholera vaccination campaigns; including location, target population, logistics, vaccine coverage and delivery costs. METHODS: We searched PubMed, the World Health Organization (WHO) website and the Cochrane database with no date or language restrictions. We contacted public health personnel, experts in the field and in ministries of health and did targeted web searches. FINDINGS: A total of 33 documents were included in the analysis. One country, Viet Nam, incorporates oral cholera vaccination into its public health programme and has administered approximately 10.9 million vaccine doses between 1997 and 2012. In addition, over 3 million doses of the two WHO pre-qualified oral cholera vaccines have been administered in more than 16 campaigns around the world between 1997 and 2014. These campaigns have either been pre-emptive or reactive and have taken place under diverse conditions, such as in refugee camps or natural disasters. Estimated two-dose coverage ranged from 46 to 88% of the target population. Approximate delivery cost per fully immunized person ranged from 0.11-3.99 United States dollars. CONCLUSION: Experience with oral cholera vaccination campaigns continues to increase. Public health officials may draw on this experience and conduct oral cholera vaccination campaigns more frequently.


Assuntos
Vacinas contra Cólera/administração & dosagem , Cólera/prevenção & controle , Programas de Imunização , Administração Oral , Vacinas contra Cólera/economia , Saúde Global , Humanos , Programas de Imunização/economia , Prática de Saúde Pública , Vietnã , Organização Mundial da Saúde
16.
Eur J Anaesthesiol ; 31(3): 143-52, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24247414

RESUMO

BACKGROUND: Airway assessment and management are cornerstones of anaesthesia, yet airway complications remain an important source of morbidity. OBJECTIVE: We performed a before-and-after evaluation of a collaborative intervention to improve adherence to airway assessment and management guidelines in patients scheduled for surgery under general anaesthesia. DESIGN: A prospective, multicentre before-and-after evaluation of a collaborative intervention. SETTING: Collaborative intervention to improve adherence to airway assessment and management guidelines in patients scheduled for surgery under general anaesthesia. Data were collected on 21 consecutive days before and after the intervention. PARTICIPANTS: Anaesthetists with staff or residency positions at 22 hospitals. Patients aged 18 years or older undergoing nonemergency surgery were recruited. INTERVENTION: Establishing a learning network that included local leaders, meetings to share experiences and knowledge, interactive sessions and provision of printed materials on airway assessment and management. Clinical airway management for general anaesthesia was provided by the anaesthetists participating in the study. MAIN OUTCOME MEASURES: Outcomes were the completion of airway assessment at the preanaesthetic visit, rates of unanticipated difficult airway, algorithm adherence and related airway complications. RESULTS: The study included 3753 patients (1947 preintervention and 1806 postintervention). The percentage of patients with a complete airway assessment increased from 25.1% preintervention to 48.4% postintervention (P <0.001). The incidences of unanticipated difficult airway were 4.1% before the intervention and 3% after it (P = 0.433). Rates of adherence to the algorithms for anticipated and unanticipated difficult airway management were similar in the two periods. The incidences of related adverse events were also similar. CONCLUSION: The collaborative intervention was effective in improving airway assessment but not in changing difficult airway management practices.


Assuntos
Manuseio das Vias Aéreas/métodos , Anestesia Geral/métodos , Anestesiologia/métodos , Guias de Prática Clínica como Assunto , Adulto , Idoso , Algoritmos , Anestesia Geral/efeitos adversos , Comportamento Cooperativo , Feminino , Fidelidade a Diretrizes , Humanos , Internato e Residência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
17.
Cir Esp (Engl Ed) ; 2024 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-38908513

RESUMO

AIM: To evaluate the clinical outcome of early closure of a protective ileostomy and preoperative stimulation of the efferent limb in a cohort of patients with rectal cancer treated surgically, primarily using the laparoscopic approach. METHODS: We performed an observational retrospective cohort study in a prospectively recorded series of patients with rectal cancer who underwent laparoscopic surgery with a protective loop ileostomy between 2017 and 2022. Ileostomy closure was programmed for within 3 months after surgery. All patients underwent stimulation of the efferent limb. Primary outcomes were morbidity and mortality, length of stay (LOS), and re-admission. RESULTS: Between 2017 and 2022, 108 patients underwent resection for rectal cancer and protective ileostomy. The laparoscopic approach was performed in 84.3% of patients (n = 91). Permanent ileostomy was performed in 5 patients (4.6%). Ileostomy closure was thus performed in 95.4% of patients (n = 103). Median time to closure was 74.5 days (range 57-113). In 63.1% (n = 65) of patients, reconstructive surgery was performed within 90 days. Prior to closure, efferent limb stimulation was performed in 77.8% (n = 84) of patients. Global morbidity was 26.2% (n = 27) (85.19%, n = 23 Clavien-Dindo I and 7.41%, n = 2 Clavien-Dindo II). The main causes of morbidity were postoperative ileus (10.7%, n = 11) and rectal bleeding (8.7%, n = 9). Anastomosis leakage occurred in 2 patients. Median hospital stay was 6 days (5-7). Readmission was needed in 6.8% (n = 7) of patients. CONCLUSION: A previous laparoscopic approach, early closure and stimulation of the efferent limb could be a useful strategy to reduce the morbidity and mortality of temporary ileostomy closure.

18.
Healthcare (Basel) ; 12(11)2024 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-38891132

RESUMO

Digital health technologies (DHTs) at the intersection of health, medical informatics, and business aim to enhance patient care through personalised digital approaches. Ensuring the efficacy and reliability of these innovations demands rigorous clinical validation. A PubMed literature review (January 2006 to July 2023) identified 1250 papers, highlighting growing academic interest. A focused narrative review (January 2018 to July 2023) delved into challenges, highlighting issues such as diverse regulatory landscapes, adoption issues in complex healthcare systems, and a plethora of evaluation frameworks lacking pragmatic guidance. Existing frameworks often omit crucial criteria, neglect empirical evidence, and clinical effectiveness is rarely included as a criterion for DHT quality. The paper underscores the urgency of addressing challenges in accreditation, adoption, business models, and integration to safeguard the quality, efficacy, and safety of DHTs. A pivotal illustration of collaborative efforts to address these challenges is exemplified by the Digital Health Validation Center, dedicated to generating clinical evidence of innovative healthcare technologies and facilitating seamless technology transfer. In conclusion, it is necessary to harmonise evaluation approaches and frameworks, improve regulatory clarity, and commit to collaboration to integrate rigorous clinical validation and empirical evidence throughout the DHT life cycle.

19.
Lancet Infect Dis ; 24(7): 737-745, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38527474

RESUMO

BACKGROUND: A three-dose dengue vaccine (CYD-TDV) was licensed for use in children aged 9 years and older starting in 2015 in several dengue-endemic countries. In 2016, the Philippine Department of Health implemented a dengue vaccination programme, which was discontinued because of safety concerns. We assessed the relative risk of developing virologically confirmed dengue among children who did or did not receive a single dose of CYD-TDV by previous dengue virus (DENV) infections at baseline classified as none, one, and two or more infections. METHODS: In this longitudinal, prospective, population-based cohort study, we enrolled healthy children (aged 9-14 years) residing in Bogo or Balamban, Cebu, Philippines, between May 2, and June 2, 2017, before a mass dengue vaccination campaign, via the Rural Health Unit in Bogo and three Rural Health Units in Balamban. We collected demographic information and sera for baseline DENV serostatus and conducted active surveillance for acute febrile illness. Children who developed acute febrile illness were identified, clinical data were collected, and blood was drawn for confirmation of dengue by RT-PCR. The primary outcome was the relative risk of developing virologically confirmed dengue among children who received or did not receive a single dose of CYD-TDV by DENV serostatus at baseline. FINDINGS: A single dose of CYD-TDV did not confer protection against virologically confirmed dengue in children who had none or one previous DENV infection at baseline. One dose conferred significant protection against hospital admission for virologically confirmed dengue among participants who had two or more previous DENV infections at baseline during the first 3 years (70%, 95% CI 20-88; p=0·017) and the entire follow-up period (67%, 19-87; p=0·016). INTERPRETATION: The risk of developing virologically confirmed dengue after a single dose of CYD-TDV varied by baseline DENV serostatus. Since the study assessed the effect of only a single dose, the findings cannot inform decisions on vaccination by public health officers. However, the findings have implications for children who receive an incomplete vaccination regimen and these results should prompt more detailed analyses in future trials on dengue vaccines. FUNDING: The Philippine Department of Health, Hanako Foundation, WHO, Swedish International Development Cooperation Agency, International Vaccine Institute, University of North Carolina, and US National Institute of Allergy and Infectious Diseases.


Assuntos
Vacinas contra Dengue , Dengue , Vacinas Atenuadas , Humanos , Filipinas/epidemiologia , Criança , Dengue/prevenção & controle , Dengue/epidemiologia , Vacinas contra Dengue/administração & dosagem , Vacinas contra Dengue/imunologia , Estudos Prospectivos , Feminino , Masculino , Adolescente , Estudos Longitudinais , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/imunologia , Vírus da Dengue/imunologia , Vacinação
20.
Int J Dermatol ; 2024 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-38736107

RESUMO

BACKGROUND: Certolizumab is an Fc-free PEGylated tumor necrosis factor-alpha (TNFα) inhibitor recently approved for the treatment of moderate-to-severe plaque psoriasis, although there is limited real-world evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab. The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate-to-severe plaque psoriasis under real-world conditions. METHODS: This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting. RESULTS: A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under-response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI [hazard ratio (HR): 1.12 (1.02-1.23); P = 0.023] and a more significant reduction in PASI at Week 12 [HR: 1.16 (1.07-1.27); P < 0.001] and Week 52 [HR: 1.47 (1.11-1.96); P = 0.007] was shown to be significantly related with better survival for the entire follow-up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn. CONCLUSIONS: Certolizumab consistently showed high effectiveness and drug survival rates in this real-life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.

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