RESUMO
Several recent studies have investigated the validity of precautionary practices for lymphedema risk reduction after breast cancer treatment, such as avoidance of blood pressure measurements, skin puncture, blood draws, and use of prophylactic compression during air travel. Other studies have elucidated risk factors for breast cancer-related lymphedema, such as axillary lymph node dissection and skin infection (cellulitis). Combining the current evidence base with the consensus opinion of lymphatic experts assembled at the American Cancer Society/Lymphology Association of North America Summit in October 2023, updated evidence-based risk reduction recommendations are presented for those with or at risk of breast cancer-related lymphedema. Recommendation topics include prospective surveillance, patient education, individual risk factors, exercise, blood pressure, skin care and hygiene, skin puncture and blood draws, surgical procedures, prophylactic compression, air travel, and hot climate and sauna. These recommendations will help inform education and medical choices for individuals treated for breast cancer who are at risk of or diagnosed with breast cancer-related lymphedema. More high-quality evidence is required to allow the development of risk reduction recommendations for other cancer types such as gynecological, melanoma, and head and neck. It is recommended that clinicians and organizations serving people at risk of or with lymphedema align risk reduction guidelines with the evidence-based recommendations provided within this consensus document and companion manuscripts from the American Cancer Society/Lymphology Association of North America Lymphedema Summit: Forward Momentum: Future Steps in Lymphedema Management.
Assuntos
Linfedema Relacionado a Câncer de Mama , Consenso , Comportamento de Redução do Risco , Humanos , Feminino , Linfedema Relacionado a Câncer de Mama/prevenção & controle , Linfedema Relacionado a Câncer de Mama/terapia , Linfedema Relacionado a Câncer de Mama/etiologia , Medicina Baseada em Evidências , Neoplasias da Mama/complicações , Fatores de Risco , Linfedema/prevenção & controle , Linfedema/etiologia , Linfedema/terapia , Guias de Prática Clínica como Assunto/normasRESUMO
This article is an abridged version of the updated AWMF mould guideline "Medical clinical diagnostics in case of indoor mould exposure - Update 2023", presented in July 2023 by the German Society of Hygiene, Environmental Medicine and Preventive Medicine (Gesellschaft für Hygiene, Umweltmedizin und Präventivmedizin, GHUP), in collaboration with German and Austrian scientific medical societies, and experts. Indoor mould growth is a potential health risk, even if a quantitative and/or causal relationship between the occurrence of individual mould species and health problems has yet to be established. There is no evidence for a causal relationship between moisture/mould damage and human diseases, mainly because of the ubiquitous presence of fungi and hitherto inadequate diagnostic methods. Sufficient evidence for an association between moisture/mould damage and the following health effects has been established for: allergic respiratory diseases, allergic rhinitis, allergic rhino-conjunctivitis, allergic bronchopulmonary aspergillosis (ABPA), other allergic bronchopulmonary mycosis (ABPM), aspergilloma, Aspergillus bronchitis, asthma (manifestation, progression, exacerbation), bronchitis (acute, chronic), community-acquired Aspergillus pneumonia, hypersensitivity pneumonitis (HP; extrinsic allergic alveolitis (EEA)), invasive Aspergillosis, mycoses, organic dust toxic syndrome (ODTS) [workplace exposure], promotion of respiratory infections, pulmonary aspergillosis (subacute, chronic), and rhinosinusitis (acute, chronically invasive, or granulomatous, allergic). In this context the sensitizing potential of moulds is obviously low compared to other environmental allergens. Recent studies show a comparatively low sensitization prevalence of 3-22,5â% in the general population across Europe. Limited or suspected evidence for an association exist with respect to atopic eczema (atopic dermatitis, neurodermatitis; manifestation), chronic obstructive pulmonary disease (COPD), mood disorders, mucous membrane irritation (MMI), odor effects, and sarcoidosis. (iv) Inadequate or insufficient evidence for an association exist for acute idiopathic pulmonary hemorrhage in infants, airborne transmitted mycotoxicosis, arthritis, autoimmune diseases, cancer, chronic fatigue syndrome (CFS), endocrinopathies, gastrointestinal effects, multiple chemical sensitivity (MCS), multiple sclerosis, neuropsychological effects, neurotoxic effects, renal effects, reproductive disorders, rheumatism, sick building syndrome (SBS), sudden infant death syndrome, teratogenicity, thyroid diseases, and urticaria.The risk of infection posed by moulds regularly occurring indoors is low for healthy persons; most species are in risk group 1 and a few in risk group 2 (Aspergillus fumigatus, A. flavus) of the German Biological Agents Act (Biostoffverordnung). Only moulds that are potentially able to form toxins can be triggers of toxic reactions. Whether or not toxin formation occurs in individual cases is determined by environmental and growth conditions, water activity, temperature and above all the growth substrates.In case of indoor moisture/mould damage, everyone can be affected by odor effects and/or mood disorders.However, this is not an acute health hazard. Predisposing factors for odor effects can include genetic and hormonal influences, imprinting, context and adaptation effects. Predisposing factors for mood disorders may include environmental concerns, anxiety, condition, and attribution, as well as various diseases. Risk groups to be protected particularly regarding infection risk are immunocompromised persons according to the classification of the German Commission for Hospital Hygiene and Infection Prevention (Kommission für Krankenhaushygiene und Infektionsprävention, KRINKO) at the Robert Koch-Institute (RKI), persons suffering from severe influenza, persons suffering from severe COVID-19, and persons with cystic fibrosis (mucoviscidosis); with regard to allergic risk, persons with cystic fibrosis (mucoviscidosis) and patients with bronchial asthma must be protected. The rational diagnostics include the medical history, physical examination, and conventional allergy diagnostics including provocation tests if necessary; sometimes cellular test systems are indicated. In the case of mould infections, the reader is referred to the specific guidelines. Regarding mycotoxins, there are currently no useful and validated test procedures for clinical diagnostics. From a preventive medical point of view, it is important that indoor mould infestation in relevant magnitudes cannot be tolerated for precautionary reasons.For evaluation of mould damage in the indoor environment and appropriate remedial procedures, the reader is referred to the mould guideline issued by the German Federal Environment Agency (Umweltbundesamt, UBA).
Assuntos
Poluição do Ar em Ambientes Fechados , Fungos , Humanos , Poluição do Ar em Ambientes Fechados/efeitos adversos , Alemanha , Medicina Baseada em Evidências , Guias de Prática Clínica como Assunto , Exposição Ambiental/efeitos adversos , Micoses/diagnóstico , Pneumologia/normasRESUMO
The 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) updated the indications for metabolic and bariatric surgery (MBS), replacing the previous guidelines established by the National Institutes of Health (NIH) over 30 years ago. The evidence supporting these updated guidelines has been strengthened to assist metabolic and bariatric surgeons, nutritionists, and other members of multidisciplinary teams (MDTs), as well as patients. This study aims to assess the level of evidence and the strength of recommendations compared to the previously published criteria.
Assuntos
Cirurgia Bariátrica , Guias de Prática Clínica como Assunto , Humanos , Cirurgia Bariátrica/normas , Obesidade Mórbida/cirurgia , Medicina Baseada em Evidências , Estados Unidos , Obesidade/cirurgiaRESUMO
Scoliosis is a complex three-dimensional deformity of the spine that affects the growth of the spine in adolescent, leading to a heavy burden on families and society. According to the guidelines for the treatment of scoliosis, most adolescent idiopathic scoliosis (AIS) requires rehabilitative intervention. So far there has been a lack of scientific, evidence-based, and standardized rehabilitation assessment and treatment for AIS in China. Therefore, in order to promote the standardization of rehabilitation assessment and treatment for AIS, Chinese Society of Physical Medicine and Rehabilitation organized the domestic experts in multiple disciplines such as rehabilitation medicine, orthopedics, pediatric surgery, radiology, evidence-based medicine, etc., who has conformed to the principles of scientificity, safety, efficacy and advancement to propose the 19 recommendations of 8 categories using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and Reporting Items for Practice Guidelines in Healthcare (RIGHT). Through the steps of literature search, evaluation, and establishment of direction and intensity of recommendation opinions, 19 recommendations were formed, involving AIS screening, assessment and treatment.
Assuntos
Escoliose , Escoliose/reabilitação , Escoliose/terapia , Humanos , Adolescente , China , Medicina Baseada em EvidênciasRESUMO
PURPOSE: To retrieve, evaluate, and summarize the best available evidence regarding the safe use of pneumatic tourniquet in patients undergoing Limb surgery, providing guidance for preoperative assessment, operation methods and precautions, complication prevention and treatment in clinical practice. METHODS: Using the PIPOST tool, we formulated an evidence-based question, conducted searches in relevant Chinese and international databases and websites for clinical decisions, guidelines, evidence summaries, systematic reviews, and expert consensus on the use of limb surgical tourniquets. The search was limited to literature published until September 30, 2023. Quality assessment and evidence extraction were performed on eligible documents. RESULTS: This study included a total of 13 articles, including 2 clinical decision-making articles, 3 guidelines, 5 expert consensus articles, 1 standard and 2 systematic reviews. A total of 34 best pieces of evidence recommendations were summarized across 10 aspects, including indications and contraindications for the use of pneumatic tourniquets, preoperative evaluation of operators, selection and placement of tourniquet cuffs, tourniquet inflation, monitoring during inflation, tourniquet deflation, common complications and prevention, equipment safety, documentation, and training and education. CONCLUSION: The best evidence summarized in this study can provide reference for clinical medical staff to safely use pneumatic tourniquets, but in clinical practice, targeted selection and application of evidence should be combined with specific situations to improve the safety and hemostatic effect of pneumatic tourniquet use.
Assuntos
Extremidades , Torniquetes , Humanos , Perda Sanguínea Cirúrgica/prevenção & controle , Medicina Baseada em Evidências , Extremidades/irrigação sanguínea , Extremidades/cirurgia , Torniquetes/efeitos adversosRESUMO
Suicide is a leading cause of death in youth. Evidence highlights the importance of identifying youth at risk for suicide in pediatric primary care, and suggests this is a crucial setting for improving youth mental health. The American Academy of Pediatrics recommends primary care providers not only screen and assess for suicide risk, but also become educated on how to better manage certain mental health conditions. This article discusses the epidemiology of youth suicide in the United States and describes evidence-based strategies and innovative practices for suicide prevention in pediatric primary care including suicide risk screening, assessment, intervention, and follow-up care.
Assuntos
Atenção Primária à Saúde , Prevenção do Suicídio , Humanos , Adolescente , Criança , Estados Unidos/epidemiologia , Pediatria/métodos , Suicídio/estatística & dados numéricos , Suicídio/psicologia , Medicina Baseada em Evidências , Medição de Risco , Programas de Rastreamento/métodos , Fatores de RiscoRESUMO
Background: Dupuytren's disease (DD) is a chronic and progressive fibroproliferative disease consisting of the progressive pathological fibrosis of the palmar fascia leading to permanent flexion and deficit of extension, with marked deformity and severe disability. Among treatment options, conservative and infiltrative therapies, physiotherapy, or surgery, with less invasive surgical options, are reported. The therapeutic planning, shared with the patient, must consider the severity of the disease, surgical risks, the functional, aesthetic, and occupational consequences, and the risk of recurrence. Case report: We describe a complicated clinical case that led her to a claim for compensation under presumed medical professional liability profiles. A female patient, 32-years-old, suffering from early symptomatic DD in the left non-dominant hand, underwent to palmar fasciotomy complicated by severe paraesthesia. In the re-surgery, vascular and nerve injury was found, leading to permanent disabling sequelae. Discussion: The early stage of DD, although symptomatic, without previous medical or infiltrative therapy, in a young subject with insulin-dependent diabetes and a high risk of recurrence contraindicated the surgical approach, especially palmar fasciotomy, according to the best evidence. The vascular-nervous lesion in the hand palm indicated a censurable surgical execution technique. The technical consultation ascertained the causal relationship between impairments and surgical malpractice, followed by compensation. Conclusion: The analysis of this case highlights the value of informed clinical practice to provide optimal care and mitigate the risks associated with the management of DD. The choice of possible treatment options must be tailored to the patient in accordance with the best evidence.
Assuntos
Contratura de Dupuytren , Fasciotomia , Contratura de Dupuytren/cirurgia , Humanos , Feminino , Adulto , Medicina Baseada em Evidências , Imperícia/legislação & jurisprudênciaRESUMO
PURPOSE: This research aims to use a data-driven analytical method to compare the effectiveness of High-Intensity Focused Ultrasound (HIFU) partial gland ablation with Robot-Assisted Radical Prostatectomy (RARP) for treating localized prostate cancer, evaluating variations in treatment results. METHODS: We performed a systematic review of the literature, covering key databases including the Cochrane Library, PubMed, EMBASE, Web of Science, and Google Scholar, with the latest information updated until August 2024. We utilized Stata 18 for data analysis, computing weighted mean differences (WMDs) for continuous data and odds ratios (ORs) for categorical data, with all results reported alongside 95% confidence intervals (CIs). Additionally, the studies included were evaluated using the Newcastle-Ottawa Scale (NOS). RESULTS: This meta-analysis incorporated data from three paired studies, encompassing a total of 1,503 patients. Patients treated with HIFU experienced a shorter hospital stay (WMD = -2.78, 95%CI -5.14,-0.43; p = 0.02) compared to those who received RARP. Additionally, evaluations at 3 and 12 months post-surgery revealed that the HIFU group exhibited better recovery in urinary continence and sexual function than the RARP group. However, there were no notable disparities in complication rates (OR = 1.48, 95%CI 0.92,2.40; p = 0.110) and the requirement for salvage therapy (OR = 2.92, 95%CI 0.60,14.33; p = 0.186) between the two treatment methods. CONCLUSION: In conclusion, this meta-analysis appears to suggest potential benefits of HIFU partial gland ablation in possibly reducing the length of hospital stays and seems to indicate that it might be associated with improved recovery in terms of urinary incontinence and sexual function, particularly during the early to mid-term postoperative period. Although the differences in complication rates and the requirement for salvage therapy between the two surgical methods were not statistically significant, the findings provided by this analysis are instrumental in guiding clinical decision-making.
Assuntos
Ablação por Ultrassom Focalizado de Alta Intensidade , Prostatectomia , Neoplasias da Próstata , Procedimentos Cirúrgicos Robóticos , Humanos , Masculino , Medicina Baseada em Evidências , Ablação por Ultrassom Focalizado de Alta Intensidade/métodos , Tempo de Internação/estatística & dados numéricos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Próstata/cirurgia , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Resultado do Tratamento , Incontinência Urinária/etiologiaRESUMO
BACKGROUND: Social media is a powerful platform for disseminating health information, yet it is often riddled with misinformation. Further, few guidelines exist for producing reliable, peer-reviewed content. This study describes a framework for creating and disseminating evidence-based videos on polycystic ovary syndrome (PCOS) and thyroid conditions to improve health literacy and tackle misinformation. OBJECTIVE: The study aims to evaluate the creation, dissemination, and impact of evidence-based, peer-reviewed short videos on PCOS and thyroid disorders across social media. It also explores the experiences of content creators and assesses audience engagement. METHODS: This mixed methods prospective study was conducted between December 2022 and May 2023 and comprised five phases: (1) script generation, (2) video creation, (3) cross-platform publication, (4) process evaluation, and (5) impact evaluation. The SIMBA-CoMICs (Simulation via Instant Messaging for Bedside Application-Combined Medical Information Cines) initiative provides a structured process where medical concepts are simplified and converted to visually engaging videos. The initiative recruited medical students interested in making visually appealing and scientifically accurate videos for social media. The students were then guided to create video scripts based on frequently searched PCOS- and thyroid-related topics. Once experts confirmed the accuracy of the scripts, the medical students produced the videos. The videos were checked by clinical experts and experts with lived experience to ensure clarity and engagement. The SIMBA-CoMICs team then guided the students in editing these videos to fit platform requirements before posting them on TikTok, Instagram, YouTube, and Twitter. Engagement metrics were tracked over 2 months. Content creators were interviewed, and thematic analysis was performed to explore their experiences. RESULTS: The 20 videos received 718 likes, 120 shares, and 54,686 views across all platforms, with TikTok (19,458 views) and Twitter (19,678 views) being the most popular. Engagement increased significantly, with follower growth ranging from 5% on Twitter to 89% on TikTok. Thematic analysis of interviews with 8 out of 38 participants revealed 4 key themes: views on social media, advice for using social media, reasons for participating, and reflections on the project. Content creators highlighted the advantages of social media, such as large outreach (12 references), convenience (10 references), and accessibility to opportunities (7 references). Participants appreciated the nonrestrictive participation criteria, convenience (8 references), and the ability to record from home using prewritten scripts (6 references). Further recommendations to improve the content creation experience included awareness of audience demographics (9 references), sharing content on multiple platforms (5 references), and collaborating with organizations (3 references). CONCLUSIONS: This study demonstrates the effectiveness of the SIMBA CoMICs initiative in training medical students to create accurate medical information on PCOS and thyroid disorders for social media dissemination. The model offers a scalable solution to combat misinformation and improve health literacy.
Assuntos
Disseminação de Informação , Síndrome do Ovário Policístico , Mídias Sociais , Gravação em Vídeo , Humanos , Estudos Prospectivos , Feminino , Disseminação de Informação/métodos , Doenças da Glândula Tireoide , Medicina Baseada em Evidências , Revisão por Pares/métodos , Letramento em Saúde/métodosRESUMO
BACKGROUND: Knee arthroplasty is an established surgical treatment for advanced osteoarthritis of the knee. In view of the rising number of surgical procedures, increasing costs in the healthcare system with a parallel increase in patient age and comorbidities, an evidence-based perioperative management is gaining importance. Fast Recovery concepts comprise a range of evidence-based strategies for optimizing the perioperative course. By reducing perioperative risks and optimizing pre-, peri- and postoperative processes, complications can be reduced, as well as perioperative morbidity, while comprising faster convalescence. MATERIAL AND METHODS: This review is based on a systematic literature search in the PubMed, Cochrane Library and Web of Science databases on the topic of perioperative optimization and evidence for Fast Recovery programs in knee resurfacing. RESULTS: In knee arthroplasty, Fast Recovery protocols lead to a significant reduction in the length of stay in hospital without an increase in complication rates. Patients also benefit from a faster return to mobility and a reduced level of postoperative pain. The involvement of multidisciplinary teams, the optimization of pain therapy, the minimization of blood loss and early mobilization are key elements of these protocols. The implementation of Fast Recovery protocols in the perioperative care of patients is an effective strategy to improve surgical outcomes. Essential for the success of such programs is individualized multidisciplinary patient care with preoperative risk assessment, optimized pain management and early physiotherapeutic mobilization. Future research should focus on the long-term effects of these approaches and their adaptation to different patient populations.
Assuntos
Artroplastia do Joelho , Assistência Perioperatória , Artroplastia do Joelho/métodos , Artroplastia do Joelho/efeitos adversos , Humanos , Assistência Perioperatória/métodos , Osteoartrite do Joelho/cirurgia , Tempo de Internação , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Recuperação Pós-Cirúrgica Melhorada , Resultado do Tratamento , Medicina Baseada em EvidênciasRESUMO
The introduction of cancer screening programs requires solid evidence of a proper balance between health benefits, harms and resources needed. The primary outcome measure in most randomized cancer screening trails so far has been cancer-related mortality. Collecting data on this outcome requires large study groups and adequate follow-up. Alternative primary outcome measures have been proposed, such as a stage shift, which has been selected in the ongoing UK NHS-Galleri trial. Recent commentaries have discussed the limitations of such alternative outcome measures in cancer screening trials.
Assuntos
Detecção Precoce de Câncer , Programas de Rastreamento , Neoplasias , Humanos , Programas de Rastreamento/métodos , Detecção Precoce de Câncer/métodos , Neoplasias/diagnóstico , Medicina Baseada em Evidências , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Cardiovascular diseases represent a major burden worldwide, and clinical trials are critical to define treatment improvements. Since various conflicts of interest (COIs) may influence trials at multiple levels, cardiovascular research represents a paradigmatic example to analyze their effects and manage them effectively to re-establish the centrality of evidence-based medicine.Despite the manifest role of industry, COIs may differently affect both sponsored and non-sponsored studies in many ways. COIs influence may start from the research question, data collection and adjudication, up to result reporting, including the spin phenomenon. Outcomes and endpoints (especially composite) choice and definitions also represent potential sources for COIs interference. Since large randomized controlled trials significantly influence international guidelines, thus impacting also clinical practice, their critical assessment for COIs is mandatory. Despite specific protocols aimed to mitigate COI influence, even scientific societies and guideline panels may not be totally free from COIs, negatively affecting their accountability and trustworthiness.Shared rules, awareness of COI mechanisms and transparency with external data access may help promoting evidence-based research and mitigate COIs impact. Managing COIs effectively should preserve public trust in the cardiovascular profession without compromising the positive relationships between investigators and industry.
Assuntos
Doenças Cardiovasculares , Conflito de Interesses , Humanos , Doenças Cardiovasculares/terapia , Cardiologia/ética , Pesquisa Biomédica/ética , Medicina Baseada em Evidências , Apoio à Pesquisa como Assunto/éticaRESUMO
INTRODUCTION: The Australian-led 2023 International evidence-based guideline for the assessment and management of polycystic ovary syndrome was based on best available evidence, clinical expertise and consumer preference. It followed best practice, involved extensive evidence synthesis and applied relevant frameworks across evidence quality, feasibility, acceptability, cost and implementation. Thirty-nine societies and organisations covering 71 countries were engaged. The evidence in the assessment and management of polycystic ovary syndrome (PCOS) has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report, 52 systematic reviews and analyses (approximately 6000 pages) underpin 77 evidence-based and 54 consensus recommendations, with 123 practice points. MAIN RECOMMENDATIONS: Changes include: refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone levels as an alternative to ultrasound in adults only, and differentiation of adolescent and adult criteria; strengthening the recognition of broad features of PCOS including metabolic effects, cardiovascular disease, dermatological symptoms, sleep apnoea, a high prevalence of psychological features and a high risk of adverse pregnancy outcomes; emphasising the poorly recognised, diverse burden of disease, the vital need for greater health professional education, evidence-based patient information, improved models of care, shared decision making and research efforts to improve patient experience; maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and emphasising evidence-based medical therapy and cheaper and safer fertility management. CHANGES IN MANAGEMENT AS A RESULT OF THIS GUIDELINE: The 2023 guideline is approved by the National Health and Medical Research Council and provides clinicians and patients with clear advice on best practice in a common and neglected condition, based on the best available evidence, expert multidisciplinary input and consumer preferences. It provides vital, extensive patient and provider resources to enhance evidence-based care. The full guideline is available at www.monash.edu/medicine/mchri/pcos/guideline.
Assuntos
Medicina Baseada em Evidências , Síndrome do Ovário Policístico , Guias de Prática Clínica como Assunto , Humanos , Síndrome do Ovário Policístico/terapia , Síndrome do Ovário Policístico/diagnóstico , Feminino , Austrália , AdultoRESUMO
Background: Folic acid (FA), which in its chemical form is pteroylglutamic acid, is the fully oxidised, water-soluble, monoglutamic form of vitamin B9. This compound is part of the folate group but with higher bioavailability, and it is found in vitamin supplements and fortified foods and drugs. Folate metabolism is complex and associated with various metabolic pathways, all of which confer protection on the cell and allow its survival. Methods: We conducted a non-systematic search of articles published in English and Spanish including controlled trials, cohort studies, systematic re-views, and meta-analyses were included, as well as key studies in animal models related to pharmacokinetic studies. Search terms encompassed: "folic acid", "folates", "5-metyltetrahydrofolate", "5-MTHF", "neural tube defects", "supplementation", "fortification", AND "homocysteine" Results: A crucial role demonstrated for FA is to help prevent neural tube defects (NTDs). However, more studies are definitely still needed to establish 5-MTHF as a safe and effective therapeutic approach comparable with FA. Moreover, there is a lack of clinical studies that evaluate the efficacy of 5-MTHF supplementation in the prevention of NTDs. The present evidence-based narrative review discusses differences between FA and 5-MTHF in terms of structure, metabolism, bioavailability, clinical efficacy, and safety. Conclusions: Despite the potential value of 5-MTHF as an alternative to FA, clinical studies would be urgently needed to support the efficacy, dosage, timing, and/or safety of its use as a supplement.
Assuntos
Suplementos Nutricionais , Ácido Fólico , Defeitos do Tubo Neural , Tetra-Hidrofolatos , Ácido Fólico/administração & dosagem , Humanos , Defeitos do Tubo Neural/prevenção & controle , Tetra-Hidrofolatos/administração & dosagem , Animais , Feminino , Gravidez , Medicina Baseada em EvidênciasRESUMO
PURPOSE: The primary results of phase III oncology trials may be challenging to interpret, given that results are generally based on P value thresholds. The probability of whether a treatment is beneficial, although more intuitive, is not usually provided. Here, we developed and released a user-friendly tool that calculates the probability of treatment benefit using trial summary statistics. METHODS: We curated 415 phase III randomized trials enrolling 338,600 patients published between 2004 and 2020. A phase III prior probability distribution for the treatment effect was developed on the basis of a three-component zero-mean mixture distribution of the observed z-scores. Using this prior, we computed the probability of clinically meaningful benefit (hazard ratio [HR] <0.8). The distribution of signal-to-noise ratios and power of phase III oncology trials were compared with that of 23,551 randomized trials from the Cochrane Database. RESULTS: The signal-to-noise ratios of phase III oncology trials tended to be much larger than randomized trials from the Cochrane Database. Still, the median power of phase III oncology trials was only 49% (IQR, 14%-95%), and the power was <80% in 65% of trials. Using the phase III oncology-specific prior, only 53% of trials claiming superiority (114 of 216) had a ≥90% probability of clinically meaningful benefits. Conversely, the probability that the experimental arm was superior to the control arm (HR <1) exceeded 90% in 17% of trials interpreted as having no benefit (34 of 199). CONCLUSION: By enabling computation of contextual probabilities for the treatment effect from summary statistics, our robust, highly practical tool, now posted on a user-friendly webpage, can aid the wider oncology community in the interpretation of phase III trials.
Assuntos
Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Neoplasias/terapia , Oncologia/métodos , Resultado do Tratamento , Razão Sinal-Ruído , Medicina Baseada em EvidênciasRESUMO
OBJECTIVE: In this systematic review, we aim to propose evidence-based management for perioperative care to improve outcomes at the time of planned cesarean hysterectomy for placenta accreta spectrum, a procedure associated with significant maternal and neonatal morbidity. DATA SOURCES: We conducted a literature search for studies published in MEDLINE (via Ovid), Embase, CINAHL, and Cochrane/CENTRAL up until February 25, 2022. The search included free-text and controlled-vocabulary terms for cesarean section, cesarean delivery, and hysterectomy. STUDY ELIGIBILITY CRITERIA: We included randomized controlled trials, prospective cohort, retrospective cohort, and case-control studies published in English that reported on a perioperative intervention in the performance of a planned CH for PAS. Studies must have included a comparator group. Of the 8,907 studies screened in this systematic review, 79 met the inclusion criteria. STUDY APPRAISAL AND SYNTHESIS METHODS: Articles examining each step or intervention of the CH were grouped together and reviewed qualitatively as a group. Evidence levels and recommendations were made by consensus of all authors according to the terminology of the United States Preventive Services Task Force (USPSTF). We synthesized the results of 79 articles, and provided 28 recommendations. RESULTS: Based on USPSTF criteria, 21.4 % of the recommendations were level B (n = 6), 39.3 % were C (n = 11), 10.7 % were D (n = 3) and 28.6 % were I (n = 8). The interventions with the highest level of recommendation included delivery at a hospital with high cesarean hysterectomy volume, implementation of a standardized hospital protocol, delivery via a planned procedure, neuraxial anesthesia, and transverse skin incision (all level B recommendations by USPSTF criteria). CONCLUSIONS: Development of a standardized hospital protocol, delivery at a center with high CH surgical volume, and utilization of neuraxial anesthesia garnered B evidence levels. Recommendations were limited due to the lack of prospective trials. Further research into the technical aspects of this high-risk procedure is warranted.
Assuntos
Cesárea , Histerectomia , Placenta Acreta , Humanos , Feminino , Placenta Acreta/cirurgia , Cesárea/efeitos adversos , Gravidez , Histerectomia/métodos , Medicina Baseada em EvidênciasRESUMO
BACKGROUND: Dahuang Mudan Decoction is commonly used in China for the treatment of acute pancreatitis. Nevertheless, the therapeutic efficacy of the drug remains a subject of debate, and its active ingredients and potential therapeutic targets remain to be determined. The present study used a network pharmacological approach to investigate the active ingredients and possible targets of the drug, and illustrated the clinical effectiveness of Dahuang Mudan Decoction in the treatment of acute pancreatitis by meta-analysis. METHODS: The present study investigated the active ingredients of the constituent herbs of Dahuang Mudan Decoction using the TCMID database. In order to further identify molecular targets, Swiss Target Prediction, OMIM and Genecards databases was be used. The present study used metascape database for gene ontology function enrichment analysis and Kyoto Genome Encyclopedia pathway enrichment analysis. A gene interaction network diagram was established for predicting the main targets and mechanism of action to Dahuang Mudan Decoction for acute pancreatitis. To further illustrate the validity of the gene targets and the clinical efficacy of the drug, 13 relevant studies were included for meta-analysis and analyzed using the Cochrane Collaboration's Review Manager 5.4 software. RESULT: After a thorough screening process, the present study identified three main components of Dahuang Mudan Decoction: kaempferol, quercetin and eupatin. These three major components have the potential to target 5 important proteins: AKT1, TNF-a, IL-6, TP53, HIF1A. In addition, pathway analyses by the Kyoto Genome Encyclopedia showed that Dahuang Mudan Decoction is active through the Pathways in cancer, AGE-RAGE signaling pathway in diabetic complications, PI3K-Akt signaling pathway, etc signaling pathway to act on acute pancreatitis. The results of meta-analysis showed that compared with the control group, the experimental group had superior performance in terms of overall treatment efficacy, reduction of hospital stays and inflammatory factor levels after treatment. CONCLUSION: In summary, network pharmacological studies have shown that Dahuang Mudan Decoction affects acute pancreatitis through different components, targets, and mechanisms. In addition, the meta-analysis study strongly supported the effectiveness of Dahuang Mudan Decoction in the treatment of acute pancreatitis.