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Brachytherapy is a specific form of radiotherapy consisting of the precise placement of radioactive sources directly into or next to the tumor. This technique is indicated for patients affected by various types of cancers. It is an optimal tool for delivering very high doses to the tumor focally while minimizing the probability of normal tissue complications. Physicians from a wide range of specialties may be involved in either the referral to or the placement of brachytherapy. Many patients require brachytherapy as either primary treatment or as part of their oncologic care. On the basis of high-level evidence from randomized controlled trials, brachytherapy is mainly indicated: 1) as standard in combination with chemoradiation in patients with locally advanced cervical cancer; 2) in surgically treated patients with uterine endometrial cancer for decreasing the risk of vaginal vault recurrence; 3) in patients with high-risk prostate cancer to perform dose escalation and improve progression-free survival; and 4) in patients with breast cancer as adjuvant, accelerated partial breast irradiation or to boost the tumor bed. In this review, the authors discuss the clinical relevance of brachytherapy with a focus on indications, levels of evidence, and results in the overall context of radiation use for patients with cancer.
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Braquiterapia/métodos , Quimiorradioterapia/métodos , Medicina Baseada em Evidências/métodos , Terapia Neoadjuvante/métodos , Neoplasias/terapia , Antineoplásicos/uso terapêutico , Progressão da Doença , Fracionamento da Dose de Radiação , Educação Médica Continuada , Humanos , Neoplasias/complicações , Neoplasias/mortalidade , Seleção de Pacientes , Médicos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. METHODS: COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. RESULTS: Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). CONCLUSIONS: The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03936660.
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Diabetes Mellitus Tipo 2 , Humanos , Feminino , Masculino , Diabetes Mellitus Tipo 2/etnologia , Diabetes Mellitus Tipo 2/terapia , Idoso , Pessoa de Meia-Idade , Doenças Cardiovasculares/etnologia , Fatores Sexuais , Etnicidade , Medicina Baseada em Evidências , Resultado do Tratamento , Estados Unidos/epidemiologia , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêuticoRESUMO
Systematic reviews represent a fundamental study design, providing the highest level of evidence across diverse research inquiries, encompassing both public health and clinical research and practice. However, for healthcare professionals, the process of selecting, synthesizing, and interpreting evidence can be challenging, and requires specialized skills. Therefore, it is imperative to explore innovative solutions aimed at simplifying and making the traditional systematic review process more accessible while ensuring the validity and reliability of results. In this perspective, our research objective is to develop a systematic review framework that, while maintaining a rigorous methodological approach, streamlines the process for healthcare professionals. This study describes such approach in every phase, from the collection of evidence to the writing of the text, creating a guide for the healthcare professional who approaches this type of research. The qualitative and organizational analysis tools are also described, providing useful information for the use of non-paid programs. This systematic review aims to develop a framework with a rigorous methodological approach that allows simplify the process for clinicians and healthcare professionals. The implementation of this methodology in clinical practice offers new perspectives to ensure a thoughtful consideration and application of scientific evidence and opens the way to innovative and easily accessible solutions to facilitate the conduct of systematic reviews in the clinical care setting.
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Pessoal de Saúde , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Humanos , Revisões Sistemáticas como Assunto/métodos , Reprodutibilidade dos TestesRESUMO
Translating evidence-based practice (EBP) into real-world clinical settings often takes a considerable amount of time and resources. In allergy and immunology, the dissemination and implementation (D&I) sciences facilitate the study of how variations in knowledge, resources, patient populations, and staffing models lead to differences in the clinical care of asthma, allergic disease, and primary immunodeficiency. Despite the need for validated approaches to study how to best apply EBP in the real world, the D&I sciences are underutilized. To address this gap, an American Academy of Allergy, Asthma & Immunology (AAAAI) work group was convened to provide an overview for the role of the D&I sciences in clinical care and future research within the field. For the D&I sciences to be leveraged effectively, teams should be multidisciplinary and inclusive of community and clinical partners, and multimethods approaches to data collection and analyses should be used. Used appropriately, the D&I sciences provide important tools to promote EBP and health equity as well as optimization of clinical practice in allergy and immunology.
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Deimplementation is the discontinuation or abandonment of medical practices that are ineffective or of unclear effectiveness, ranging from simply unhelpful to harmful. With epidemiology expanding to include more translational sciences, epidemiologists can contribute to deimplementation through defining evidence, establishing causality, and advising on study design. An estimated 10-30% of healthcare practices have minimal to no benefit to patients and should be targeted for deimplementation. The steps in deimplementation are: 1) identify low-value clinical practices, 2) facilitate the deimplementation process, 3) evaluate deimplementation outcomes, and 4) sustain deimplementation, each of which is a complex project. Deimplementation science involves researchers, healthcare and clinical stakeholders, and patient and community partners affected by the medical practice. Increasing collaboration between epidemiologists and implementation scientists is important to optimizing health care delivery.
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BACKGROUND: Reducing overweight and obesity has been a longstanding focus of public health messaging and physician-patient interactions. Clinical guidelines by major public health organizations describe both overweight and obesity as risk factors for mortality and other health conditions. Accordingly, a majority of primary care physicians believe that overweight BMI (even without obesity) strongly increases mortality risk. MAIN POINTS: The current evidence base suggests that although both obese BMI and underweight BMI are consistently associated with increased all-cause mortality, overweight BMI (without obesity) is not meaningfully associated with increased mortality. In fact, a number of studies suggest modest protective, rather than detrimental, associations of overweight BMI with all-cause mortality. Given this current evidence base, clinical guidelines and physician perceptions substantially overstate all-cause mortality risks associated with the range of BMIs classified as "overweight" but not "obese." Discrepancies between evidence and communication regarding mortality raise the question of whether similar discrepancies exist for other health outcomes. CONCLUSIONS: Health communication that inaccurately conveys current evidence may do more harm than good; this applies to communication from health authorities to health practitioners as well as to communication from health practitioners to individual patients. We give three recommendations to better align health communication with the current evidence. First, recommendations to the public and health practitioners should distinguish overweight from obese BMI and at this time should not describe overweight BMI as a risk factor for all-cause mortality. Second, primary care physicians' widespread misconceptions about overweight BMI should be rectified. Third, the evidence basis for other potential risks or benefits of overweight BMI should be rigorously examined and incorporated appropriately into health communication.
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Índice de Massa Corporal , Sobrepeso , Humanos , Comunicação , Medicina Baseada em Evidências , Obesidade/mortalidade , Obesidade/complicações , Sobrepeso/mortalidade , Fatores de RiscoRESUMO
BACKGROUND: In the context of expanding digital health tools, the health system is ready for Learning Health System (LHS) models. These models, with proper governance and stakeholder engagement, enable the integration of digital infrastructure to provide feedback to all relevant parties including clinicians and consumers on performance against best practice standards, as well as fostering innovation and aligning healthcare with patient needs. The LHS literature primarily includes opinion or consensus-based frameworks and lacks validation or evidence of benefit. Our aim was to outline a rigorously codesigned, evidence-based LHS framework and present a national case study of an LHS-aligned national stroke program that has delivered clinical benefit. MAIN TEXT: Current core components of a LHS involve capturing evidence from communities and stakeholders (quadrant 1), integrating evidence from research findings (quadrant 2), leveraging evidence from data and practice (quadrant 3), and generating evidence from implementation (quadrant 4) for iterative system-level improvement. The Australian Stroke program was selected as the case study as it provides an exemplar of how an iterative LHS works in practice at a national level encompassing and integrating evidence from all four LHS quadrants. Using this case study, we demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare improvement. We emphasize the transition from research as an endpoint, to research as an enabler and a solution for impact in healthcare improvement. CONCLUSIONS: The Australian Stroke program has nationally improved stroke care since 2007, showcasing the value of integrated LHS-aligned approaches for tangible impact on outcomes. This LHS case study is a practical example for other health conditions and settings to follow suit.
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Sistema de Aprendizagem em Saúde , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/terapia , Austrália , Medicina Baseada em Evidências , Prática Clínica Baseada em Evidências/métodosRESUMO
Evidence-based medicine (EBM) can be an unfamiliar territory for those working in tumor pathology research, and there is a great deal of uncertainty about how to undertake an EBM approach to planning and reporting histopathology-based studies. In this article, reviewed and endorsed by the Word Health Organization International Agency for Research on Cancer's International Collaboration for Cancer Classification and Research, we aim to help pathologists and researchers understand the basics of planning an evidence-based tumor pathology research study, as well as our recommendations on how to report the findings from these. We introduce some basic EBM concepts, a framework for research questions, and thoughts on study design and emphasize the concept of reporting standards. There are many study-specific reporting guidelines available, and we provide an overview of these. However, existing reporting guidelines perhaps do not always fit tumor pathology research papers, and hence, here, we collate the key reporting data set together into one generic checklist that we think will simplify the task for pathologists. The article aims to complement our recent hierarchy of evidence for tumor pathology and glossary of evidence (study) types in tumor pathology. Together, these articles should help any researcher get to grips with the basics of EBM for planning and publishing research in tumor pathology, as well as encourage an improved standard of the reports available to us all in the literature.
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Medicina Baseada em Evidências , Neoplasias , Organização Mundial da Saúde , Humanos , Neoplasias/patologia , Neoplasias/classificação , Patologistas , Pesquisa Biomédica , Projetos de Pesquisa/normas , Patologia/normas , Lacunas de EvidênciasRESUMO
PURPOSE: Rare genetic neurodevelopmental disorders associated with intellectual disability require lifelong multidisciplinary care. Clinical practice guidelines may support healthcare professionals in their daily practice, but guideline development for rare conditions can be challenging. In this systematic review, the characteristics and methodological quality of internationally published recommendations for this population are described to provide an overview of current guidelines and inform future efforts of European Reference Network ITHACA (Intellectual disability, TeleHealth, Autism, and Congenital Anomalies). METHODS: MEDLINE, Embase, and Orphanet were systematically searched to identify guidelines for conditions classified as "rare genetic intellectual disability" (ORPHA:183757). Methodological quality was assessed using the Appraisal of Guidelines, Research, and Evaluation II tool. RESULTS: Seventy internationally published guidelines, addressing the diagnosis and/or management of 28 conditions, were included. The methodological rigor of development was highly variable with limited reporting of literature searches and consensus methods. Stakeholder involvement and editorial independence varied as well. Implementation was rarely addressed. CONCLUSION: Comprehensive, high-quality guidelines are lacking for many rare genetic neurodevelopmental disorders. Use and transparent reporting of sound development methodologies, active involvement of affected individuals and families, robust conflict of interest procedures, and attention to implementation are vital for enhancing the impact of clinical practice recommendations.
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Deficiência Intelectual , Transtornos do Neurodesenvolvimento , Guias de Prática Clínica como Assunto , Doenças Raras , Humanos , Transtornos do Neurodesenvolvimento/genética , Transtornos do Neurodesenvolvimento/terapia , Transtornos do Neurodesenvolvimento/diagnóstico , Guias de Prática Clínica como Assunto/normas , Doenças Raras/genética , Doenças Raras/terapia , Doenças Raras/diagnóstico , Deficiência Intelectual/genética , Deficiência Intelectual/terapiaRESUMO
PURPOSE: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals. MATERIALS AND METHODS: Randomized controlled trials published in The Journal of Urology®, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group. RESULTS: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P = .01). Methods criteria demonstrating the greatest improvements included item #3 "which harms were assessed," item #4a "when harm information was collected," and item #4b "methods to attribute harm to intervention." Results sections with the most improvement in reporting include item #6 "reasons for patient withdrawal," item #8a "effect size for harms," and item #8b "stratified serious + minor harms." CONCLUSIONS: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteria-an increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible.
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Publicações Periódicas como Assunto , Urologia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Padrões de Referência , Projetos de PesquisaRESUMO
OBJECTIVE: To examine sex in human vascular surgery research by quantifying the inclusion and analysis of sex-based data in high-impact vascular surgery journals. METHODS: A bibliographic review of original articles published in the European Journal of Vascular and Endovascular Surgery, Journal of Vascular Surgery, JVS: Venous and Lymphatic Disorders, Journal of Endovascular Therapy, and Annals of Vascular Surgery from January 1, 2018, to December 31, 2020, and from January 1, 2023, to December 31, 2023, was conducted. Abstracted data included sex-based data analysis, inclusion of sex as a variable in multivariable analysis, inclusion of sex as an independent variable, and a discussion of sex-based results. RESULTS: Of the 3762 articles that included human, animal, or cell subjects, 249 (6.6%) did not state sex. Of those 249 articles, 183 included human subjects, 55 included animal subjects, and 11 used cell lines as the subjects. These were removed from analysis as well as the remaining 68 articles with animal subjects. In addition, 23 researched a sex-specific pathology and were removed from analysis. Of the remaining 3422 articles included in our study, 42.3% analyzed sex, 46.9% included sex in multivariable analysis, 4.8% included sex as an independent variable, and 26.6% included a discussion of sex. There were no significant differences in all four sex variables between 2018, 2019, and 2020. Between 2018-2020 and 2023, there were significant increases in all four sex variables. Multicenter studies had significantly higher rates of independent analysis of sex over single-center studies (7.4% vs 3.3%, P < .001). There was no significant difference in independent analysis of sex between U.S.-based and non-U.S.-based studies. Only 191 articles (5.6%) had 90% or greater matching of men and women in their study. CONCLUSIONS: Equitable inclusion and analysis of sex is rare in vascular surgery research. Less than 5% of articles included an independent analysis of data by sex, and few studies included males and females equally. Clinical research is the basis for evidence-based medicine; therefore, it is important to strive for equitable inclusion, analysis, and reporting of data to foster generalizability of clinical research to men and women.
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Randomized controlled trials are considered the "gold standard" for therapeutic interventions, and it is not uncommon for sweeping changes in medical practice to follow positive results from such trials. However, randomized controlled trials are not without their limitations. Physicians frequently view randomized controlled trials as infallible, whereas they tend to dismiss evidence derived from sources other than randomized controlled trials as less credible or reliable. In several situations in obstetrics and gynecology, there are no randomized controlled trials to help guide the clinician. In these circumstances, it is important to evaluate the entire body of evidence including observational studies, rather than dismiss interventions altogether simply because no randomized controlled trials exist. Randomized controlled trials and observational studies should be viewed as complementary rather than at odds with each other. Some reversals in widely adopted clinical practice have recently been implemented following subsequent studies that contradicted the outcomes of major randomized controlled trials. The most notable of these was the withdrawal from the market of 17-hydroxyprogesterone caproate for preterm birth prevention. Such reversals could potentially have been averted if the inherent limitations of randomized controlled trials were carefully considered before implementing these universal practice changes. This Clinical Opinion underscores the limitations of an exclusive reliance on randomized controlled trials while disregarding other evidence in determining how best to care for patients. Solutions are proposed that advocate that clinicians adopt a more balanced perspective that considers the entirety of the available medical evidence and the individual patient characteristics, needs, and wishes.
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Ginecologia , Obstetrícia , Nascimento Prematuro , Feminino , Recém-Nascido , Humanos , Nascimento Prematuro/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVES: To comprehensively compare quality-of-life (QoL) outcomes between open partial nephrectomy (OPN) and robot-assisted PN (RAPN) from the randomised ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial, as QoL data comparing OPN and RAPN are virtually non-existent, especially not from randomised controlled trials (RCTs). PATIENTS AND METHODS: The ROBOCOP II was a single-centre, open-label RCT between OPN and RAPN. The pre-planned analyses of QoL outcomes are presented. Data were analysed descriptively in a modified intention-to-treat population. RESULTS: A total of 50 patients underwent surgery. At postoperative Day 90 (POD90), there was no significant difference for the Kidney Disease Quality of Life-Short Form questionnaire score (mean [sd] OPN 72 [20] vs RAPN 76 [15], P = 0.850), while there were advantages for RAPN in the subdomains of 'Pain' (P = 0.006) and 'Physical functioning' (P = 0.011) immediately after surgery. For the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core there were overall advantages directly after surgery (mean [sd] score OPN 63 [20] vs RAPN 75 [17], P = 0.031), as well as for the subdomains 'Fatigue' (P = 0.026), 'Pain' (P = 0.002) and 'Constipation' (P = 0.045) but no differences at POD90. There were no differences for the EuroQoL five Dimensions five Levels questionnaire at POD90 (mean [sd] score OPN 70 [22] vs RAPN 72 [17], P = 1.0) or at any other time point. Finally, no significant differences were found for the overall Convalescence and Recovery Evaluation questionnaire score at POD90 (mean [sd] OPN 84 [13] vs RAPN 86 [10], P = 0.818) but less pain in the RAPN group (P = 0.017) directly after surgery. CONCLUSIONS: Pain and physical functioning as subdomains of QoL are improved after RAPN compared to OPN in the early postoperative course, while there are no differences anymore after 3 months.
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BACKGROUND AND OBJECTIVES: The Writing Committee of American Society for Apheresis released the ninth edition of guidelines for therapeutic apheresis in 2023. Categories have been a part of the guidelines since the first edition, and the grading system was introduced in the fifth edition, with updates in every new edition. In this study, we investigated the category and grade change trends through the latest five editions, focusing on therapeutic plasma exchange, to suggest future directions as part of evidence-based medicine. MATERIALS AND METHODS: Categories and grades for therapeutic plasma exchange (TPE) were collected and analysed from the fifth through ninth editions. We aligned classification changes to the ninth edition's clinical context and compared its categories and grades with those introduced in the guideline. RESULTS: Among 166 total indications in the ninth edition, 118 included TPE procedure, either as a sole treatment or as one of the therapeutic apheresis techniques. The total number of indications changed, but Category III remained predominant throughout the editions. Similarly, Grade 2C consistently emerged as the most prevalent grade. Notably, 24 cases had grade changes. Of the 16 cases with evidence quality changes, the quality weakened in six and improved in 10. Evidence levels were not improved throughout the study period for 102 clinical conditions. CONCLUSION: To address gaps in evidence quality, international collaboration is imperative to establish comprehensive large-scale studies or randomized controlled trials. This will refine the use of therapeutic apheresis, including TPE, to foster evidence-based advancements in clinical practice.
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Remoção de Componentes Sanguíneos , Medicina Baseada em Evidências , Troca Plasmática , Humanos , Troca Plasmática/métodos , Remoção de Componentes Sanguíneos/métodos , Guias de Prática Clínica como Assunto , Sociedades Médicas , Estados Unidos , Feminino , MasculinoRESUMO
AIMS: To investigate perioperative opioid requirements in patients on methadone or buprenorphine as medication for opioid-use disorder (MOUD) who attended a transitional pain clinic (Personalized Pain Program, PPP). METHODS: This retrospective cohort study assessed adults on MOUD with surgery and attendance at the Johns Hopkins PPP between 2017 and 2022. Daily non-MOUD opioid use over 6 time-points was evaluated with regression models controlling for days since surgery. The time to complete non-MOUD opioid taper was analysed by accelerated failure time and Kaplan-Meier models. RESULTS: Fifty patients (28 on methadone, 22 on buprenorphine) were included with a median age of 44.3 years, 54% male, 62% Caucasian and 54% unemployed. MOUD inpatient administration occurred in 92.8% of patients on preoperative methadone but only in 36.3% of patients on preoperative buprenorphine. Non-MOUD opioid use decreased over time postoperatively (ß = -0.54, P < .001) with a median decrease of 90 mg morphine equivalents (MME) between the first and last PPP visit, resulting in 46% tapered off by PPP completion. Older age and duration in PPP were associated with lower MME, while mental health conditions, longer hospital stays and higher discharge opioid prescriptions were associated with higher MME. The average time to non-MOUD opioid taper was 1.79× longer in patients on buprenorphine (P = .026), 2.75× in males (P = .023), 4.66× with mental health conditions (P < .001), 2.37× with chronic pain (P = .031) and 3.51× if on preoperative non-MOUD opioids; however, higher initial MOUD level decreased time to taper (P = .001). CONCLUSIONS: Postoperative opioid tapering utilizing a transitional pain service is possible in patients on MOUD.
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BACKGROUND AND OBJECTIVES: Clinical Practice Guidelines (CPGs) are crucial tools for clinicians seeking to deliver evidence-based patient care. We utilized the Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist to assess the reporting quality of CPGs addressing the management of rectal cancer. METHODS: Four multidisciplinary rectal cancer CPGs published 2017-2022 were evaluated: American Society of Colon and Rectal Surgeons (ASCRS), European Society for Medical Oncology (ESMO), National Comprehensive Cancer Network (NCCN), and National Institute for Health and Care Excellence (NICE). We quantitatively assessed each CPG using the RIGHT checklist and qualitative analysis was performed to generate common themes. RESULTS: RIGHT checklist items fulfilled by each CPG ranged from 12 to 17 (out of 22). Each guideline demonstrated unique categories of weakness: ASCRS in Basic Information (1 of 4 items), ESMO in Evidence (1 of 3), NCCN in Recommendations (1 of 3), and NICE in Review and Quality Assurance (0 of 2). Common themes that emerged included sprase discussion on the financial aspects of rectal cancer management and lack of transparency in formulating recommendations. CONCLUSIONS: Despite their variability, each of the 22 checklist elements are present in contemporary CPGs. Utilizing the RIGHT checklist would allow experts to create guidelines adhering to high-quality reporting standards.
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Lista de Checagem , Guias de Prática Clínica como Assunto , Neoplasias Retais , Humanos , Neoplasias Retais/terapia , Guias de Prática Clínica como Assunto/normasRESUMO
OBJECTIVE: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair. METHODS: Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting. RESULTS: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth. CONCLUSION: Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed.
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A primary care pediatrician casts a skeptical eye at the American Academy of Pediatrics Obesity Guideline. Using back-of-the-envelope calculations, she explains that meeting the guidelines would swamp her office, hospital, and the country's clinicians in a manner that is unrealistic. Warning against the alienation that boots-on-the-ground clinicians experience when guidelines are too theoretical to be practical, she suggests alternative avenues for addressing this public health issue.
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Emoções , Saúde Pública , Criança , Feminino , Estados Unidos , Humanos , Obesidade , Fidelidade a DiretrizesRESUMO
PURPOSE OF REVIEW: This document critically examines the role of cannabinoids in cancer care during an era marked by rapid advancements in oncology and changing perceptions on cannabis. It traces the historical context of cannabis in medicinal use, navigating its journey from widespread acceptance, subsequent criminalization, to its resurgence in modern therapeutic applications, particularly within the framework of Evidence-Based Medicine (EBM). RECENT FINDINGS: Anchored in EBM principles, this study synthesizes current research from clinical trials, systematic reviews, and meta-analyses to evaluate the efficacy and safety of cannabinoids in oncology. The focus is on their palliative effects, considering the nuances of effectiveness, risk assessment, and challenges inherent in translating these findings into clinical guidelines. The study seeks to bridge the gap between scientific research and clinical practice, offering insights to inform future oncological therapies and symptom management strategies involving cannabinoids. The potential benefits and risks of cannabinoid use in cancer treatment are assessed to guide clinicians and researchers in developing comprehensive, evidence-based approaches to patient care.
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OBJECTIVE: To review published clinical trial data related to efficacy and safety of administering denosumab at extended dosing intervals for prevention of skeletal-related events (SREs) in cancer patients. DATA SOURCES: A literature search of PubMed was performed (January 2006 to February 2023) using the following search terms: denosumab, bone metastasis, bone lesions, and lytic lesions. Abstracts from conferences, article bibliographies, and product monographs were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Relevant English-language studies were considered. DATA SYNTHESIS: Early phase II denosumab trials included treatment arms that utilized extended-interval denosumab, and various retrospective reviews, meta-analyses, and prospective trials have included extended-interval regimens. Most recently, the ongoing randomized REDUSE trial is comparing the efficacy and safety of extended-interval denosumab to standard dosing. At this time, the best available data are restricted to small, randomized trials not designed to compare efficacy and safety of extended-interval denosumab to conventional dosing and did not use consistent endpoints. Furthermore, primary endpoints of available trials largely consisted of surrogate markers of efficacy that may not be reflective of clinical outcomes. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Historically, denosumab has been dosed at 4-week intervals for prevention of SREs. If efficacy is maintained, extending the dosing interval could potentially reduce toxicity, drug cost, and clinic visits compared to every 4-week dosing. CONCLUSIONS: At this time, data demonstrating efficacy and safety of extended-interval denosumab remain limited, and the results of the REDUSE trial are eagerly anticipated to help answer remaining questions.