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1.
Gastroenterology ; 166(3): 409-434, 2024 03.
Artigo em Inglês | MEDLINE | ID: mdl-38395525

RESUMO

BACKGROUND & AIMS: Fecal microbiota-based therapies include conventional fecal microbiota transplant and US Food and Drug Administration-approved therapies, fecal microbiota live-jslm and fecal microbiota spores live-brpk. The American Gastroenterological Association (AGA) developed this guideline to provide recommendations on the use of fecal microbiota-based therapies in adults with recurrent Clostridioides difficile infection; severe to fulminant C difficile infection; inflammatory bowel diseases, including pouchitis; and irritable bowel syndrome. METHODS: The guideline was developed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of fecal microbiota-based therapies in the specified gastrointestinal conditions and provided implementation considerations for clinical practice. RESULTS: The guideline panel made 7 recommendations. In immunocompetent adults with recurrent C difficile infection, the AGA suggests select use of fecal microbiota-based therapies on completion of standard of care antibiotics to prevent recurrence. In mildly or moderately immunocompromised adults with recurrent C difficile infection, the AGA suggests select use of conventional fecal microbiota transplant. In severely immunocompromised adults, the AGA suggests against the use of any fecal microbiota-based therapies to prevent recurrent C difficile. In adults hospitalized with severe or fulminant C difficile not responding to standard of care antibiotics, the AGA suggests select use of conventional fecal microbiota transplant. The AGA suggests against the use of conventional fecal microbiota transplant as treatment for inflammatory bowel diseases or irritable bowel syndrome, except in the context of clinical trials. CONCLUSIONS: Fecal microbiota-based therapies are effective therapy to prevent recurrent C difficile in select patients. Conventional fecal microbiota transplant is an adjuvant treatment for select adults hospitalized with severe or fulminant C difficile infection not responding to standard of care antibiotics. Fecal microbiota transplant cannot yet be recommended in other gastrointestinal conditions.


Assuntos
Clostridioides difficile , Infecções por Clostridium , Gastroenteropatias , Doenças Inflamatórias Intestinais , Síndrome do Intestino Irritável , Microbiota , Adulto , Humanos , Síndrome do Intestino Irritável/tratamento farmacológico , Resultado do Tratamento , Gastroenteropatias/terapia , Gastroenteropatias/tratamento farmacológico , Transplante de Microbiota Fecal/efeitos adversos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infecções por Clostridium/terapia , Infecções por Clostridium/tratamento farmacológico , Antibacterianos/uso terapêutico , Recidiva
2.
MMWR Recomm Rep ; 73(2): 1-8, 2024 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-38833414

RESUMO

No vaccines and few chemoprophylaxis options exist for the prevention of bacterial sexually transmitted infections (STIs) (specifically syphilis, chlamydia, and gonorrhea). These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW). In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by >70% and gonococcal infections by approximately 50%. This report outlines CDC's recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population. CDC recommends that MSM and TGW who have had a bacterial STI (specifically syphilis, chlamydia, or gonorrhea) diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections. Following shared decision-making with their provider, CDC recommends that providers offer persons in this group a prescription for doxy PEP to be self-administered within 72 hours after having oral, vaginal, or anal sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.Doxy PEP, when offered, should be implemented in the context of a comprehensive sexual health approach, including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care, or other services as appropriate. Persons who are prescribed doxy PEP should undergo bacterial STI testing at anatomic sites of exposure at baseline and every 3-6 months thereafter. Ongoing need for doxy PEP should be assessed every 3-6 months as well. HIV screening should be performed for HIV-negative MSM and TGW according to current recommendations.


Assuntos
Centers for Disease Control and Prevention, U.S. , Doxiciclina , Profilaxia Pós-Exposição , Doenças Bacterianas Sexualmente Transmissíveis , Humanos , Doxiciclina/uso terapêutico , Estados Unidos , Masculino , Feminino , Doenças Bacterianas Sexualmente Transmissíveis/prevenção & controle , Antibacterianos/uso terapêutico , Minorias Sexuais e de Gênero
3.
Ann Surg ; 279(3): 394-401, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-37991188

RESUMO

OBJECTIVE: To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. BACKGROUND: Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. METHODS: Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012-2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes before, during, and after the LOGICA RCT. RESULTS: Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift toward a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction in overall [adjusted odds ratio (aOR):0.62; 95% CI: 0.46-0.82], severe (aOR: 0.64; 95% CI: 0.46-0.90) and cardiac complications (aOR: 0.51; 95% CI: 0.30-0.89) after the LOGICA trial. CONCLUSIONS: The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.


Assuntos
Laparoscopia , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirurgia , Laparoscopia/métodos , Gastrectomia/métodos , Países Baixos , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento
4.
Gastroenterology ; 164(7): 1329-1335.e1, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37086247

RESUMO

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding cognitive, procedural, and post-procedural aspects of performing gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are advanced endoscopists with expertise in treating patients by performing third-space endoscopy and gastric peroral endoscopic myotomy.


Assuntos
Acalasia Esofágica , Gastroparesia , Miotomia , Humanos , Gastroparesia/cirurgia , Resultado do Tratamento , Esfíncter Esofágico Inferior , Endoscopia Gastrointestinal
5.
Eur Respir J ; 63(6)2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38719772

RESUMO

Respiratory symptoms are ubiquitous and impair health-related quality of life in people with respiratory disease. This European Respiratory Society (ERS) task force aimed to provide recommendations for symptomatic treatment in people with serious respiratory illness. The ERS task force comprised 16 members, including representatives of people with serious respiratory illness and informal caregivers. Seven questions were formulated, six in the PICO (Population, Intervention, Comparison, Outcome) format, which were addressed with full systematic reviews and evidence assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation). One question was addressed narratively. An "evidence-to-decision" framework was used to formulate recommendations. To treat symptoms in people with serious respiratory illness, the task force suggests the use of graded exercise therapy (conditional recommendation, low certainty of evidence); and suggests the use of a multicomponent services, handheld fan and breathing techniques (conditional recommendations, very low certainty of evidence). The task force suggests not to use opioids (conditional recommendation, very low certainty of evidence); and suggests either administering or not administering supplemental oxygen therapy (conditional recommendation, low certainty of evidence). The task force suggests that needs assessment tools may be used as part of a comprehensive needs assessment, but do not replace patient-centred care and shared decision making (conditional recommendation, low certainty of evidence). The low certainty of evidence, modest impact of interventions on patient-centred outcomes, and absence of effective strategies to ameliorate cough highlight the need for new approaches to reduce symptoms and enhance wellbeing for individuals who live with serious respiratory illness.


Assuntos
Qualidade de Vida , Humanos , Europa (Continente) , Adulto , Sociedades Médicas , Oxigenoterapia , Terapia por Exercício , Analgésicos Opioides/uso terapêutico , Medicina Baseada em Evidências , Pneumologia/normas , Assistência Centrada no Paciente , Avaliação das Necessidades
6.
BMC Med ; 22(1): 126, 2024 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-38532468

RESUMO

BACKGROUND: Temporary doctors, known as locums, are a key component of the medical workforce in the NHS but evidence on differences in quality and safety between locum and permanent doctors is limited. We aimed to examine differences in the clinical practice, and prescribing safety for locum and permanent doctors working in primary care in England. METHODS: We accessed electronic health care records (EHRs) for 3.5 million patients from the CPRD GOLD database with linkage to Hospital Episode Statistics from 1st April 2010 to 31st March 2022. We used multi-level mixed effects logistic regression to compare consultations with locum and permanent GPs for several patient outcomes including general practice revisits; prescribing of antibiotics; strong opioids; hypnotics; A&E visits; emergency hospital admissions; admissions for ambulatory care sensitive conditions; test ordering; referrals; and prescribing safety indicators while controlling for patient and practice characteristics. RESULTS: Consultations with locum GPs were 22% more likely to involve a prescription for an antibiotic (OR = 1.22 (1.21 to 1.22)), 8% more likely to involve a prescription for a strong opioid (OR = 1.08 (1.06 to 1.09)), 4% more likely to be followed by an A&E visit on the same day (OR = 1.04 (1.01 to 1.08)) and 5% more likely to be followed by an A&E visit within 1 to 7 days (OR = 1.05 (1.02 to 1.08)). Consultations with a locum were 12% less likely to lead to a practice revisit within 7 days (OR = 0.88 (0.87 to 0.88)), 4% less likely to involve a prescription for a hypnotic (OR = 0.96 (0.94 to 0.98)), 15% less likely to involve a referral (OR = 0.85 (0.84 to 0.86)) and 19% less likely to involve a test (OR = 0.81 (0.80 to 0.82)). We found no evidence that emergency admissions, ACSC admissions and eight out of the eleven prescribing safety indicators were different if patients were seen by a locum or a permanent GP. CONCLUSIONS: Despite existing concerns, the clinical practice and performance of locum GPs did not appear to be systematically different from that of permanent GPs. The practice and performance of both locum and permanent GPs is likely shaped by the organisational setting and systems within which they work.


Assuntos
Medicina de Família e Comunidade , Médicos de Família , Humanos , Inglaterra , Encaminhamento e Consulta , Antibacterianos/uso terapêutico , Atenção Primária à Saúde
7.
J Cardiovasc Electrophysiol ; 35(3): 469-477, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38282257

RESUMO

INTRODUCTION: The optimized ablation index (AI) value for catheter ablation of atrial fibrillation (AF) remains to be defined. We aimed to compare the efficacy and safety of CLOSE protocol and lower AI protocol in paroxysmal AF. METHODS AND RESULTS: Patients with symptomatic, drug-resistant paroxysmal AF for first ablation were prospectively enrolled from September 2020 to January 2022. The patients were randomly divided into CLOSE group (AI ≥ 550 for anterior/roof segments and ≥400 for posterior/inferior segments) and lower AI group (AI ≥ 450 for anterior/roof segments and ≥350 for posterior/inferior segments). First-pass isolation, acute pulmonary vein (PV) reconnections, 1-year arrhythmia recurrence, and major complications were assessed. Of the 270 enrolled patients, 238 completed 1-year follow-up (118 in CLOSE group and 120 in lower AI group). First-pass isolation in left PVs was higher in CLOSE group (71.2% vs. 53.3%, p = .005). Acute PV reconnections were comparable between groups (9.3% vs. 14.2%, p = .246). At 1 year, 86.4% in CLOSE group versus 81.7% in lower AI group were free from atrial arrhythmia (log rank p = .334). The proportion difference was -4.8% (95% CI: -14.1% to 4.6%), and p = .475 for noninferiority. Stroke occurred in four patients of lower AI group, and no cardiac tamponade, atrioesophageal fistula, major bleeding or death occurred post procedure. CONCLUSION: For patients with paroxysmal AF and treated by AI-guided PV ablation, lower AI is not noninferior to CLOSE protocol.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Resultado do Tratamento , Protocolos Clínicos
8.
Am J Obstet Gynecol ; 231(1): B9-B11, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38599477

RESUMO

Position: The Society for Maternal-Fetal Medicine acknowledges gun violence as a public health crisis in the United States, with a substantial impact on pregnant and postpartum people. We recognize the urgent need for a robust, equitable, data-driven approach to mitigate the impact of access to firearms and accompanying violence on pregnant and postpartum individuals and communities. As such, the Society for Maternal-Fetal Medicine endorses the following policy principles.


Assuntos
Violência com Arma de Fogo , Sociedades Médicas , Humanos , Feminino , Gravidez , Estados Unidos , Violência com Arma de Fogo/prevenção & controle , Obstetrícia , Armas de Fogo/legislação & jurisprudência
9.
Lupus ; 33(5): 481-489, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38446533

RESUMO

BACKGROUND: In 2017, belimumab (BEL) was approved in subcutaneous (SQ) administration. The effectiveness after switching from intravenous (IV) to SQ and patient satisfaction in daily clinical practice has not been studied. During the pandemic, patient follow-up and treatment were significantly affected, and some patients need a change from IV to SQ. Our aim was to evaluate daily clinical practice satisfaction to SQ BEL therapy in patients previously treated IV BEL. We hypothesized that SQ BEL in SLE patients previously treated with IV BEL was similar in effectiveness and conferred higher satisfaction. METHODS: Observational, multicenter study, conducted in 7 reference centers in Catalonia. We included stable SLE patients (EULAR/ACR 2019) on treatment with SQ BEL and previous use of IV BEL (at least 3 months on IV BEL before switching). Since there are no well-validated tools for SQ BEL treatment satisfaction, we used RASQ-SQ, validated in patients with lymphoma who switched from IV Rituximab to SQ treatment, and modified for BEL treatment. RESULTS: Twenty-seven patients were included. The more prevalent clinical manifestations observed were related to the skin and joints and the patients had a mean baseline SLEDAI of 2.96 (SD 2.4) and SLICC score of 0.67 (SD 0.88). The median time from treatment with IV BEL before switching to SQ was 21 months (range). 84% of patients reported confidence in SQ BEL. 85.2% felt that treatment with SQ BEL was convenient or very convenient. 85% felt they had gained time with the change. 89% would recommend the SQ injection to other patients. Disease activity (mean SLEDAI) and remission rates remain stable after switching. No major new adverse effects were reported. CONCLUSIONS: Overall satisfaction, satisfaction with via of administration, and satisfaction with the time taken to receive BEL were higher for SQ BEL treatment. A switching SQ strategy is a reasonable alternative for BEL patients.


Assuntos
Anticorpos Monoclonais Humanizados , Imunossupressores , Lúpus Eritematoso Sistêmico , Humanos , Imunossupressores/uso terapêutico , Resultado do Tratamento , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Satisfação Pessoal
10.
Diabetes Obes Metab ; 2024 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-38899425

RESUMO

Diabetic nephropathy, also known as diabetic kidney disease (DKD), remains a challenge in clinical practice as this is the major cause of kidney failure worldwide. Clinical trials do not answer all the questions raised in clinical practice and real-world evidence provides complementary insights from randomized controlled trials. Real-life longitudinal data highlight the need for improved screening and management of diabetic nephropathy in primary care. Adherence to the recommended guidelines for comprehensive care appears to be suboptimal in clinical practice in patients with DKD. Barriers to the initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with DKD persist in clinical practice, in particular for the elderly. Attainment of blood pressure targets often remains an issue. Initiation of glucagon-like peptide-1 receptor agonists (GLP-1RAs) in routine clinical practice is associated with a reduced risk of albuminuria progression and a possible beneficial effect on kidney function. Real-world evidence confirms a beneficial effect of SGLT2 inhibitors on the decline of glomerular filtration, even in the absence of albuminuria, with a lower risk of acute kidney injury events compared to GLP-1RA use. In addition, SGLT2 inhibitors confer a lower risk of hyperkalaemia after initiation compared with dipeptidyl peptidase-4 inhibitors in patients with DKD. Data from a large population indicate that diuretic treatment increases the risk of a significant decline in glomerular filtration rate in the first few weeks of treatment after SGLT2 inhibitor initiation. The perspective for a global approach targeting multifaceted criteria for diabetic individuals with DKD is emerging based on real-world evidence but there is still a long way to go to achieve this goal.

11.
Cerebrovasc Dis ; 53(1): 46-53, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37263235

RESUMO

INTRODUCTION: The aim of this study was to determine the safety and efficacy of intravenous (IV) alteplase at 0.6 mg/kg for patients with acute wake-up or unclear-onset strokes in clinical practice. METHODS: This multicenter observational study enrolled acute ischemic stroke patients with last-known-well time >4.5 h who had mismatch between DWI and FLAIR and were treated with IV alteplase. The safety outcomes were symptomatic intracranial hemorrhage (sICH) after thrombolysis, all-cause deaths, and all adverse events. The efficacy outcomes were favorable outcome defined as an mRS score of 0-1 or recovery to the same mRS score as the premorbid score, complete independence defined as an mRS score of 0-1 at 90 days, and change in NIHSS at 24 h from baseline. RESULTS: Sixty-six patients (35 females; mean age, 74 ± 11 years; premorbid complete independence, 54 [82%]; median NIHSS on admission, 11) were enrolled at 15 hospitals. Two patients (3%) had sICH. Median NIHSS changed from 11 (IQR, 6.75-16.25) at baseline to 5 (3-12.25) at 24 h after alteplase initiation (change, -4.8 ± 8.1). At discharge, 31 patients (47%) had favorable outcome and 29 (44%) had complete independence. None died within 90 days. Twenty-three (35%) also underwent mechanical thrombectomy (no sICH, NIHSS change of -8.5 ± 7.3), of whom 11 (48%) were completely independent at discharge. CONCLUSIONS: In real-world clinical practice, IV alteplase for unclear-onset stroke patients with DWI-FLAIR mismatch provided safe and efficacious outcomes comparable to those in previous trials. Additional mechanical thrombectomy was performed safely in them.


Assuntos
Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Feminino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Ativador de Plasminogênio Tecidual/efeitos adversos , AVC Isquêmico/tratamento farmacológico , Imagem de Difusão por Ressonância Magnética , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/tratamento farmacológico , Terapia Trombolítica/efeitos adversos , Fibrinolíticos/efeitos adversos , Isquemia Encefálica/tratamento farmacológico
12.
J Vasc Interv Radiol ; 35(6): 818-824, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38789204

RESUMO

Hepatocellular carcinoma, historically, has had a poor prognosis with very few systemic options. Furthermore, most patients at diagnosis are not surgical candidates. Therefore, locoregional therapy (LRT) has been widely used, with strong data supporting its use. Over the last 15 years, there has been progress in the available systemic agents. This has led to the updated Barcelona Clinic Liver Cancer (BCLC) algorithm's inclusion of these new systemic agents, with advocacy of earlier usage in those who progress on LRT or have tumor characteristics that make them less likely to benefit from LRT. However, neither the adjunct of LRT nor the specific sequencing of combination therapies is addressed directly. This Research Consensus Panel sought to highlight research priorities pertaining to the combination and optimal sequencing of LRT and systemic therapy, assessing the greatest needs across BCLC stages.


Assuntos
Pesquisa Biomédica , Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/patologia , Quimioembolização Terapêutica/normas , Consenso , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/patologia , Neoplasias Hepáticas/diagnóstico por imagem , Estadiamento de Neoplasias , Resultado do Tratamento
13.
BMC Med Res Methodol ; 24(1): 109, 2024 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-38704520

RESUMO

BACKGROUND: During the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies. OBJECTIVE: To describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring. METHODS: REVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022. RESULTS: The Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted. CONCLUSION: Protocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted.


Assuntos
COVID-19 , Humanos , COVID-19/prevenção & controle , COVID-19/epidemiologia , Pantoprazol/uso terapêutico , SARS-CoV-2 , Unidades de Terapia Intensiva/estatística & dados numéricos , Pandemias/prevenção & controle , Feminino , Respiração Artificial/estatística & dados numéricos , Masculino , Protocolos Clínicos , Pessoa de Meia-Idade , Hemorragia Gastrointestinal/prevenção & controle , Antiulcerosos/uso terapêutico , Antiulcerosos/administração & dosagem
14.
Ann Allergy Asthma Immunol ; 132(2): 124-176, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38108678

RESUMO

This practice parameter update focuses on 7 areas in which there are new evidence and new recommendations. Diagnostic criteria for anaphylaxis have been revised, and patterns of anaphylaxis are defined. Measurement of serum tryptase is important for diagnosis of anaphylaxis and to identify underlying mast cell disorders. In infants and toddlers, age-specific symptoms may differ from older children and adults, patient age is not correlated with reaction severity, and anaphylaxis is unlikely to be the initial reaction to an allergen on first exposure. Different community settings for anaphylaxis require specific measures for prevention and treatment of anaphylaxis. Optimal prescribing and use of epinephrine autoinjector devices require specific counseling and training of patients and caregivers, including when and how to administer the epinephrine autoinjector and whether and when to call 911. If epinephrine is used promptly, immediate activation of emergency medical services may not be required if the patient experiences a prompt, complete, and durable response. For most medical indications, the risk of stopping or changing beta-blocker or angiotensin-converting enzyme inhibitor medication may exceed the risk of more severe anaphylaxis if the medication is continued, especially in patients with insect sting anaphylaxis. Evaluation for mastocytosis, including a bone marrow biopsy, should be considered for adult patients with severe insect sting anaphylaxis or recurrent idiopathic anaphylaxis. After perioperative anaphylaxis, repeat anesthesia may proceed in the context of shared decision-making and based on the history and results of diagnostic evaluation with skin tests or in vitro tests when available, and supervised challenge when necessary.


Assuntos
Anafilaxia , Mordeduras e Picadas de Insetos , Mastocitose , Adulto , Humanos , Criança , Adolescente , Anafilaxia/diagnóstico , Anafilaxia/tratamento farmacológico , Anafilaxia/prevenção & controle , Mordeduras e Picadas de Insetos/tratamento farmacológico , Epinefrina/uso terapêutico , Mastocitose/diagnóstico , Alérgenos
15.
Ann Allergy Asthma Immunol ; 132(3): 274-312, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38108679

RESUMO

BACKGROUND: Guidance addressing atopic dermatitis (AD) management, last issued in 2012 by the American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force, requires updating as a result of new treatments and improved guideline and evidence synthesis methodology. OBJECTIVE: To produce evidence-based guidelines that support patients, clinicians, and other decision-makers in the optimal treatment of AD. METHODS: A multidisciplinary guideline panel consisting of patients and caregivers, AD experts (dermatology and allergy/immunology), primary care practitioners (family medicine, pediatrics, internal medicine), and allied health professionals (psychology, pharmacy, nursing) convened, prioritized equity, diversity, and inclusiveness, and implemented management strategies to minimize influence of conflicts of interest. The Evidence in Allergy Group supported guideline development by performing systematic evidence reviews, facilitating guideline processes, and holding focus groups with patient and family partners. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach informed rating the certainty of evidence and strength of recommendations. Evidence-to-decision frameworks, subjected to public comment, translated evidence to recommendations using trustworthy guideline principles. RESULTS: The panel agreed on 25 recommendations to gain and maintain control of AD for patients with mild, moderate, and severe AD. The eAppendix provides practical information and implementation considerations in 1-2 page patient-friendly handouts. CONCLUSION: These evidence-based recommendations address optimal use of (1) topical treatments (barrier moisturization devices, corticosteroids, calcineurin inhibitors, PDE4 inhibitors [crisaborole], topical JAK inhibitors, occlusive [wet wrap] therapy, adjunctive antimicrobials, application frequency, maintenance therapy), (2) dilute bleach baths, (3) dietary avoidance/elimination, (4) allergen immunotherapy, and (5) systemic treatments (biologics/monoclonal antibodies, small molecule immunosuppressants [cyclosporine, methotrexate, azathioprine, mycophenolate, JAK inhibitors], and systemic corticosteroids) and UV phototherapy (light therapy).


Assuntos
Asma , Dermatite Atópica , Eczema , Hipersensibilidade , Inibidores de Janus Quinases , Criança , Humanos , Estados Unidos , Dermatite Atópica/tratamento farmacológico , National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division , Corticosteroides , Imunossupressores
16.
BJOG ; 2024 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-38646667

RESUMO

OBJECTIVE: To examine long-term complications in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP), with and without surgical mesh implants. DESIGN: Longitudinal open cohort study from 1 April 2006 (or 1 April 2012) to 30 November 2018. SETTING: The Clinical Practice Research Datalink (CPRD) Gold database, which is linked to Hospital Episodes Statistics (HES) inpatient data, the HES Diagnostic Imaging Dataset (DID), Office for National Statistics mortality data and Index of Multiple Deprivation socio-economic status data. SAMPLE: Women aged ≥18 years with a diagnostic SUI/POP Read code. METHODS: Rates are estimated using negative binomial regression. MAIN OUTCOME MEASURES: Rates of referrals for: psychological and pain services; urinalysis, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) testing; and pelvic ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) scans. RESULTS: A cohort of 220 544 women were eligible for inclusion; 74% (n = 162 687) had SUI, 37% (n = 82 123) had POP and 11% (n = 24 266) had both. Rates of psychological referrals and CT scans were lower in women with SUI mesh surgery, but this was offset by higher rates of CRP testing in women with SUI or POP mesh, MRI scans in women with SUI mesh, and urinalysis testing and referrals to pain clinics for women with POP mesh. CONCLUSIONS: Our results suggest a higher burden of morbidity in women with SUI/POP mesh surgery, and that these women may require ongoing follow-up in the primary care setting.

17.
Med J Aust ; 220(11): 582-591, 2024 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-38763516

RESUMO

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) affect up to 10% of all pregnancies annually and are associated with an increased risk of maternal and fetal morbidity and mortality. This guideline represents an update of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines for the management of hypertensive disorders of pregnancy 2014 and has been approved by the National Health and Medical Research Council (NHMRC) under section 14A of the National Health and Medical Research Council Act 1992. In approving the guideline recommendations, NHMRC considers that the guideline meets NHMRC's standard for clinical practice guidelines. MAIN RECOMMENDATIONS: A total of 39 recommendations on screening, preventing, diagnosing and managing HDP, especially preeclampsia, are presented in this guideline. Recommendations are presented as either evidence-based recommendations or practice points. Evidence-based recommendations are presented with the strength of recommendation and quality of evidence. Practice points were generated where there was inadequate evidence to develop specific recommendations and are based on the expertise of the working group. CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINE: This version of the SOMANZ guideline was developed in an academically robust and rigorous manner and includes recommendations on the use of combined first trimester screening to identify women at risk of developing preeclampsia, 14 pharmacological and two non-pharmacological preventive interventions, clinical use of angiogenic biomarkers and the long term care of women who experience HDP. The guideline also includes six multilingual patient infographics which can be accessed through the main website of the guideline. All measures were taken to ensure that this guideline is applicable and relevant to clinicians and multicultural women in regional and metropolitan settings in Australia and New Zealand.


Assuntos
Hipertensão Induzida pela Gravidez , Humanos , Gravidez , Feminino , Austrália , Nova Zelândia , Hipertensão Induzida pela Gravidez/diagnóstico , Hipertensão Induzida pela Gravidez/terapia , Hipertensão Induzida pela Gravidez/prevenção & controle , Pré-Eclâmpsia/diagnóstico , Pré-Eclâmpsia/prevenção & controle , Pré-Eclâmpsia/terapia , Sociedades Médicas , Obstetrícia/normas , Anti-Hipertensivos/uso terapêutico , Guias de Prática Clínica como Assunto
18.
Pediatr Transplant ; 28(5): e14781, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38808744

RESUMO

The International Pediatric Transplant Association convened an expert consensus conference to assess current evidence and develop recommendations for various aspects of care relating to post-transplant lymphoproliferative disorders (PTLD) after pediatric solid organ transplantation. This report addresses the outcomes of deliberations by the PTLD Management Working Group. A strong recommendation was made for reduction in immunosuppression as the first step in management. Similarly, strong recommendations were made for the use of the anti-CD20 monoclonal antibody (rituximab) as was the case for chemotherapy in selected scenarios. In some scenarios, there is uncoupling of the strength of the recommendations from the available evidence in situations where such evidence is lacking but collective clinical experiences drive decision-making. Of note, there are no large, randomized phase III trials of any treatment for PTLD in the pediatric age group. Current gaps and future research priorities are highlighted.


Assuntos
Transtornos Linfoproliferativos , Transplante de Órgãos , Complicações Pós-Operatórias , Rituximab , Humanos , Transtornos Linfoproliferativos/etiologia , Transtornos Linfoproliferativos/diagnóstico , Transtornos Linfoproliferativos/terapia , Criança , Adolescente , Rituximab/uso terapêutico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/diagnóstico , Imunossupressores/uso terapêutico , Pré-Escolar
19.
J Intensive Care Med ; 39(7): 623-627, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38176890

RESUMO

PURPOSE: Temperature targets in patients with cardiac arrest and return of spontaneous circulation (ROSC) have changed. Changes to higher temperature targets have been associated with higher breakthrough fevers and mortality. A post-ROSC normothermia bundle was developed to improve compliance with temperature targets. METHODS: In August 2021, "ad hoc" normothermia at the discretion of the attending intensivist was initiated. In December 2021, a post-ROSC normothermia protocol was implemented, incorporating a rigorous, stepwise approach to fever prevention (temperature ≥ 37.8). We conducted a before-after cohort study of all adult patients post-ROSC who survived to intensive care unit admission between August 1, 2021, and April 1, 2022. They were divided into "ad hoc" and "protocol" groups. Clinical outcomes compared included fevers, active cooling, and paralytic use. RESULTS: Fifty-eight post-ROSC patients were admitted; 24 in the "ad hoc" and 34 in the "protocol" groups. Patient demographics were similar between groups. The "ad hoc" group had more shockable rhythms (67% vs 24%, P = .001) and cardiac catheterizations (42% vs 15%, P = .03). The "protocol" group were significantly less likely to have a fever at 40 h (6% vs 40%, P < .001) and 72 h (14% vs 65%, P ≤ .001). Patients in the normothermia "protocol" used significantly less neuromuscular blocking agents (24% vs 50%, P = .05). The normothermia "protocol" resulted in similar mortality (56% vs 58%, P = 1.0). CONCLUSION: Use of a normothermia "protocol" resulted in fewer fevers and less neuromuscular blocker administration compared to "ad hoc" management. A protocolized approach for improved quality of care should be considered in institutions adopting normothermia.


Assuntos
Febre , Pacotes de Assistência ao Paciente , Humanos , Masculino , Feminino , Pacotes de Assistência ao Paciente/normas , Pessoa de Meia-Idade , Idoso , Febre/terapia , Melhoria de Qualidade , Temperatura Corporal , Reanimação Cardiopulmonar/normas , Reanimação Cardiopulmonar/métodos , Parada Cardíaca/terapia , Parada Cardíaca/mortalidade , Unidades de Terapia Intensiva , Cuidados Críticos/normas , Cuidados Críticos/métodos , Protocolos Clínicos/normas , Resultado do Tratamento
20.
Colorectal Dis ; 26(1): 145-196, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38050857

RESUMO

AIM: The primary aim of the European Society of Coloproctology (ESCP) Guideline Development Group (GDG) was to produce high-quality, evidence-based guidelines for the management of cryptoglandular anal fistula with input from a multidisciplinary group and using transparent, reproducible methodology. METHODS: Previously published methodology in guideline development by the ESCP has been replicated in this project. The guideline development process followed the requirements of the AGREE-S tool kit. Six phases can be identified in the methodology. Phase one sets the scope of the guideline, which addresses the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula in adult patients presenting to secondary care. The target population for this guideline are healthcare practitioners in secondary care and patients interested in understanding the clinical evidence available for various surgical interventions for anal fistula. Phase two involved formulation of the GDG. The GDG consisted of 21 coloproctologists, three research fellows, a radiologist and a methodologist. Stakeholders were chosen for their clinical and academic involvement in the management of anal fistula as well as being representative of the geographical variation among the ESCP membership. Five patients were recruited from patient groups to review the draft guideline. These patients attended two virtual meetings to discuss the evidence and suggest amendments. In phase three, patient/population, intervention, comparison and outcomes questions were formulated by the GDG. The GDG ratified 250 questions and chose 45 for inclusion in the guideline. In phase four, critical and important outcomes were confirmed for inclusion. Important outcomes were pain and wound healing. Critical outcomes were fistula healing, fistula recurrence and incontinence. These outcomes formed part of the inclusion criteria for the literature search. In phase five, a literature search was performed of MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews by eight teams of the GDG. Data were extracted and submitted for review by the GDG in a draft guideline. The most recent systematic reviews were prioritized for inclusion. Studies published since the most recent systematic review were included in our analysis by conducting a new meta-analysis using Review manager. In phase six, recommendations were formulated, using grading of recommendations, assessment, development, and evaluations, in three virtual meetings of the GDG. RESULTS: In seven sections covering the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula, there are 42 recommendations. CONCLUSION: This is an up-to-date international guideline on the management of cryptoglandular anal fistula using methodology prescribed by the AGREE enterprise.


Assuntos
Doenças do Ânus , Fístula Retal , Adulto , Humanos , Abscesso , Revisões Sistemáticas como Assunto , Fístula Retal/diagnóstico , Fístula Retal/cirurgia , Cicatrização , Resultado do Tratamento
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