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INTRODUCTION: Hypoxic-ischaemic encephalopathy is a clinical syndrome of neurological dysfunction that occurs immediately after birth following an episode of perinatal asphyxia. We conducted a scoping review to assess the methodological quality of clinical practice guidelines that address this condition. METHODOLOGY: We conducted the evaluation using the AGREE II tool. High methodological quality was defined as a score greater than 70% in every domain. RESULTS: The analysis included three clinical practice guidelines; the highest scores were in the scope and purpose domain (84.26%; SD, 14.25%) and the clarity of presentation domain (84.26%; SD, 17.86%), while the lowest score corresponded to the applicability domain (62.50%; SD, 36.62%). Two guidelines were classified as high quality and one guideline as low-quality. CONCLUSIONS: Two of the assessed guidelines were classified as being of high quality; however, the analysis identified shortcomings in the applicability domain, in addition to methodological variation between guidelines developed in middle- or low-income countries versus high-income countries. Efforts are needed to make high-quality guidelines available to approach the management of hypoxic-ischaemic encephalopathy in newborns.
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Hipóxia-Isquemia Encefálica , Guias de Prática Clínica como Assunto , Humanos , Hipóxia-Isquemia Encefálica/diagnóstico , Hipóxia-Isquemia Encefálica/terapia , Recém-Nascido , Asfixia Neonatal/diagnóstico , Asfixia Neonatal/terapia , Asfixia Neonatal/complicaçõesRESUMO
OBJECTIVES: The aim of this study was to identify methodological variations leading to varied recommendations between the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) valvular heart disease guidelines and to suggest foundational steps towards standardizing guideline development. METHODS: An in-depth analysis was conducted to evaluate the methodologies used in developing the transatlantic guidelines for managing valvular heart disease. The evaluation was benchmarked against the standards proposed by the Institute of Medicine. RESULTS: Substantial discrepancies were noted in the methodologies utilized in development processes, including Writing Committee composition, evidence evaluation, conflict of interest management and voting processes. Furthermore, despite their mutual differences, both methodologies demonstrate notable deviations from the Institute of Medicine standards in several essential areas, including literature review and evidence grading. These dual variances likely influenced divergent treatment recommendations. For example, the ESC/EACTS recommends transcatheter edge-to-edge repair for patients with chronic severe mitral regurgitation ineligible for mitral valve surgery, while the ACC/AHA recommends transcatheter edge-to-edge repair based on anatomy, regardless of surgical risk. ESC/EACTS guidelines recommend a mechanical aortic prosthesis for patients under 60, while ACC/AHA guidelines recommend it for patients under 50. Notably, the ACC/AHA and ESC/EACTS guidelines have differing age cut-offs for surgical over transcatheter aortic valve replacement (<65 and <75 years, respectively). CONCLUSIONS: Variations in methodologies for developing clinical practice guidelines have resulted in different treatment recommendations that may significantly impact global practice patterns. Standardization of essential processes is vital to increase the uniformity and credibility of clinical practice guidelines, ultimately improving healthcare quality, reducing variability and enhancing trust in modern medicine.
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Doenças das Valvas Cardíacas , Guias de Prática Clínica como Assunto , Humanos , Doenças das Valvas Cardíacas/cirurgia , Doenças das Valvas Cardíacas/terapia , Guias de Prática Clínica como Assunto/normas , Medicina Baseada em Evidências/normas , Europa (Continente) , Sociedades Médicas/normas , Estados Unidos , Cardiologia/normasRESUMO
Chronic heart failure continues to be one of the main causes of impairment in the functioning and quality of life of people who suffer from it, as well as one of the main causes of mortality in our country and around the world. Mexico has a high prevalence of risk factors for developing heart failure, such as high blood pressure, diabetes, and obesity, which makes it essential to have an evidence-based document that provides recommendations to health professionals involved in the diagnosis and treatment of these patients. This document establishes the clinical practice guide (CPG) prepared at the initiative of the Mexican Society of Cardiology (SMC) in collaboration with the Iberic American Agency for the Development and Evaluation of Health Technologies, with the purpose of establishing recommendations based on the best available evidence and agreed upon by an interdisciplinary group of experts. This document complies with international quality standards, such as those described by the US Institute of Medicine (IOM), the National Institute of Clinical Excellence (NICE), the Intercollegiate Network for Scottish Guideline Development (SIGN) and the Guidelines International Network (G-I-N). The Guideline Development Group was integrated in a multi-collaborative and interdisciplinary manner with the support of methodologists with experience in systematic literature reviews and the development of CPG. A modified Delphi panel methodology was developed and conducted to achieve an adequate level of consensus in each of the recommendations contained in this CPG. We hope that this document contributes to better clinical decision making and becomes a reference point for clinicians who manage patients with chronic heart failure in all their clinical stages and in this way, we improve the quality of clinical care, improve their quality of life and reducing its complications.
La insuficiencia cardiaca crónica sigue siendo unas de las principales causas de afectación en el funcionamiento y en la calidad de vida de las personas que la presentan, así como una de las primeras causas de mortalidad en nuestro país y en todo el mundo. México tiene una alta prevalencia de factores de riesgo para desarrollar insuficiencia cardiaca, tales como hipertensión arterial, diabetes y obesidad, lo que hace imprescindible contar con un documento basado en la evidencia que brinde recomendaciones a los profesionales de la salud involucrados en el diagnóstico y el tratamiento de estos pacientes. Este documento establece la guía de práctica clínica (GPC) elaborada por iniciativa de la Sociedad Mexicana de Cardiología (SMC) en colaboración con la Agencia Iberoamericana de Desarrollo y Evaluación de Tecnologías en Salud, con la finalidad de establecer recomendaciones basadas en la mejor evidencia disponible y consensuadas por un grupo interdisciplinario y multicolaborativo de expertos. Cumple con estándares internacionales de calidad, como los descritos por el Institute of Medicine de los Estados Unidos de América (IOM), el National Institute of Clinical Excellence (NICE) del Reino Unido, la Intercollegiate Network for Scottish Guideline Development (SIGN) de Escocia y la Guidelines International Network (G-I-N). El grupo de desarrollo de la guía se integró de manera interdisciplinaria con el apoyo de metodólogos con experiencia en revisiones sistemáticas de la literatura y en el desarrollo de GPC. Se llevó a cabo y se condujo metodología de panel Delphi modificado para lograr un nivel de consenso adecuado en cada una de las recomendaciones contenidas en esta GPC. Esperamos que este documento contribuya para la mejor toma de decisiones clínicas y se convierta en un punto de referencia para los clínicos que manejan pacientes con insuficiencia cardiaca crónica en todas sus etapas clínicas, y de esta manera logremos mejorar la calidad en la atención clínica, aumentar la calidad de vida de los pacientes y disminuir las complicaciones de la enfermedad.
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Insuficiência Cardíaca , Humanos , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/diagnóstico , Doença Crônica , MéxicoRESUMO
BACKGROUND: Preterm birth is a leading cause of perinatal morbidity and mortality and a defining event for pregnant people, infants, and whanau (extended families). Recommendations have been made for a national preterm birth prevention initiative focusing on equity in Aotearoa New Zealand, including the development of a national best practice guide. An understanding of the number and quality of guidelines, and consideration of their suitability and impact on equity is required. METHODS: Guidelines were identified through a systematic literature search, search of professional bodies websites, and invitation to regional health services in Aotearoa New Zealand. Obstetric and midwifery clinical directors were invited to report on guideline use. Identified guidelines were appraised by a 23-member trans-disciplinary Review Panel; quantitatively using the AGREE-II instrument and qualitatively using modified ADAPTE questions. The quality of guidelines available but not in use was compared against those in current use, and by health services by level of maternity and neonatal care. Major themes affecting implementation and impact on equity were identified using Braun and Clarke methodology. RESULTS: A total of 235 guidelines were included for appraisal. Guidelines available but not in use by regional health services scored higher in quality than guidelines in current use (median domain score Rigour and Development 47.5 versus 18.8, p < 0.001, median domain score Overall Assessment 62.5 versus 44.4, p < 0.001). Guidelines in use by regional health services with tertiary maternity and neonatal services had higher median AGREE II scores in several domains, than those with secondary level services (median domain score Overall Assessment 50.0 versus 37.5, p < 0.001). Groups identified by the Review Panel as experiencing the greatest constraints and limitations to guideline implementation were rural, provincial, low socioeconomic, Maori, and Pacific populations. Identified themes to improve equity included a targeted approach to groups experiencing the least advantage; a culturally considered approach; nationally consistent guidance; and improved funding to support implementation of guideline recommendations. CONCLUSIONS: We have systematically identified and assessed guidelines on preterm birth. High-quality guidelines will inform a national best practice guide for use in Taonga Tuku Iho, a knowledge translation project for equity in preterm birth care and outcomes in Aotearoa.
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Equidade em Saúde , Guias de Prática Clínica como Assunto , Nascimento Prematuro , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez , Povo Maori , Nova Zelândia , Nascimento Prematuro/prevenção & controle , Cuidado Pré-NatalRESUMO
OBJECTIVE: Successful implementation of stroke rehabilitation guidelines demands high-quality practice standards tailored to targeted sociodemographic contexts. The primary objective is to determine the quality differences in post-stroke rehabilitation practice guidelines (PGs), when comparing high-income countries (HIC) and low or middle-income countries (LMIC). STUDY DESIGN AND SETTING: We conducted a scoping review of PGs in English or Spanish, published between 2012 and 2021, and providing recommendations on post-stroke rehabilitation. We used Search engines, databases, guideline libraries, gray literature, and references from previous reviews on post-stroke rehabilitation as sources of evidence. Quality assessment of PGs was performed using 6P's, ELSE, IOM, and AGREE II instruments. We evaluated each item using a scale between 0 to 3, based on the confidence of adherence to the standard. For AGREE II, we followed the instruction manual for scoring. At least two reviewers were independently involved in every step of the process. A cloud-based spreadsheet was used to chart data. We compared the results of PGs originating from HIC with those from LMIC. RESULTS: The inclusion criteria were met by 35 documents, which were subjected to evaluation. The study included 21 documents from HIC and 14 from middle-income countries (MIC). No manuscripts from low-income countries were available for inclusion in the study. The quality of PGs from MIC was found to be lower, in terms of methodological rigor and adherence to international recommendations for guidelines development. PGs from both groups of countries failed to include all target audiences and stakeholders (according to the 6P's criteria) and integration of ethical, legal, social, and economic considerations. CONCLUSION: There are gaps in the quality and availability of stroke rehabilitation guidelines worldwide, especially in LMIC. Designing and providing financial support for the implementation of high-quality guidelines will contribute to more effective implementation strategies in stroke rehabilitation programs and lead to improved patient outcomes.
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Países Desenvolvidos , Países em Desenvolvimento , Reabilitação do Acidente Vascular Cerebral , Humanos , Reabilitação do Acidente Vascular Cerebral/estatística & dados numéricos , Reabilitação do Acidente Vascular Cerebral/normas , Reabilitação do Acidente Vascular Cerebral/métodos , Guias de Prática Clínica como Assunto/normas , Saúde Global , Renda/estatística & dados numéricos , Acidente Vascular CerebralRESUMO
Cluster headache (International Classification of Headache Disorders third edition, ICHD-3 3.1) is a primary headache disorder affecting around 0.12% of individuals. It is characterized by severe headache attacks causing significant negative impact on the lives of patients. While administration of 100% oxygen is considered to be the first-choice acute treatment, undertreatment also exists. Reasons for undertreatment may entail problems with the correct prescription of oxygen, reimbursement issues or the practical implementation of home oxygen therapy. The aim of this manuscript is to review the scientific evidence on oxygen therapy for cluster headache and provide a practical guidance for both physicians and patients to optimize its use in an acute setting. The current evidence of the administration of 100% oxygen as a safe and effective treatment for cluster headache is strong. Based on several clinical trials and surveys, the recommended flow rates range between 12 and 15 L/min via a non-rebreathing mask, for at least fifteen minutes. The frequency of cluster headache attacks and thus the need for acute treatment can be very high. Fortunately, the Belgian social security system provides a full and lifetime reimbursement of oxygen therapy for cluster headache if the diagnosis and the need for this therapy has been certified by a neurologist, neurosurgeon or neuropsychiatrist.
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Cefaleia Histamínica , Oxigenoterapia , Cefaleia Histamínica/terapia , Humanos , Oxigenoterapia/métodos , Oxigênio/administração & dosagemRESUMO
OBJECTIVES: A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in specific areas of health or health care. A COS is developed through a consensus process to ensure health care outcomes to be measured are relevant to decision-makers, including patients and health-care professionals. Use of COS in guideline development is likely to increase the relevance of the guideline to those decision-makers. Previous work has looked at the uptake of COS in trials, systematic reviews, health technology assessments and regulatory guidance but to date there has been no evaluation of the use of COS in practice guideline development. The objective of this study was to investigate the representation of core outcomes in a set of international practice guidelines. STUDY DESIGN AND SETTING: We searched for clinical guidelines relevant to ten high-quality COS (with focus on the United Kingdom, Germany, China, India, Canada, Denmark, United States and World Health Organisation). We matched scope between COS and guideline in terms of condition, population and outcome. We calculated the proportion of guidelines mentioning or referencing COS and the proportion of COS domains specifically, or generally, matching to outcomes specified in each guideline populations, interventions, comparators and outcome (PICO) statement. RESULTS: We found 38 guidelines that contained 170 PICO statements matching the scope of the ten COS and of sufficient quality to allow data extraction. None of the guidelines reviewed explicitly mentioned or referenced the relevant COS. The median (range) of the proportion of core outcomes covered either specifically or generally by the guideline PICO was 30% (0%-100%). CONCLUSION: There is no evidence that COS are being used routinely to inform the guideline development process, and concordance between outcomes in published guidelines and those in COS is limited. Further work is warranted to explore barriers and facilitators in the use of COS when developing clinical guidelines.
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Avaliação de Resultados em Cuidados de Saúde , Guias de Prática Clínica como Assunto , Humanos , Guias de Prática Clínica como Assunto/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , ConsensoRESUMO
We conducted this study to systematically review and assess the current clinical practice guidelines (CPGs) related to the diagnosis and treatment of Helicobacter pylori (H. pylori) infection. The aim was to evaluate the quality of these included CPGs and provide clinicians with a convenient and comprehensive reference for updating their own CPGs. We searched four databases to identify eligible CPGs focusing on H. pylori diagnosis and treatment recommendations. The results were presented using evidence mappings. Quality and clinical applicability were assessed comprehensively using AGREE-II and AGREE-REX. Statistical tests, specifically Bonferroni tests, were employed to compare the quality between evidence-based guidelines and consensus. A total of 30 eligible CPGs were included, comprising 17 consensuses and 13 guidelines. The quality showed no statistical significance between consensuses and guidelines, mainly within the moderate to low range. Notably, recommendations across CPGs exhibited inconsistency. Nevertheless, concerning diagnosis, the urea breath test emerged as the most frequently recommended method for testing H. pylori. Regarding treatment, bismuth quadruple therapy stood out as the predominantly recommended eradication strategy, with high-dose dual therapy being a newly recommended option. Our findings suggest the need for specific organizations to update their CPGs on H. pylori or refer to recently published CPGs. Specifically, CPGs for pediatric cases require improvement and updating, while a notable absence of CPGs for the elderly was observed. Furthermore, there is a pressing need to improve the overall quality of CPGs related to H. pylori. Regarding recommendations, additional evidence is essential to elucidate the relationship between H. pylori infection and other diseases and refine test indications. Clinicians are encouraged to consider bismuth quadruple or high-dose dual therapy, incorporating locally sensitive antibiotics, as empirical radical therapy. .
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Infecções por Helicobacter , Helicobacter pylori , Guias de Prática Clínica como Assunto , Infecções por Helicobacter/tratamento farmacológico , Infecções por Helicobacter/diagnóstico , Humanos , Testes Respiratórios , Antibacterianos/uso terapêutico , Bismuto/uso terapêutico , Quimioterapia CombinadaRESUMO
BACKGROUND: Transfer of severely injured patients to trauma centers, either directly from the field or after evaluation at non-trauma centers, reduces preventable morbidity and mortality. Failure to transfer these patients appropriately (i.e., under-triage) remains common, and occurs in part because physicians at non-trauma centers make diagnostic errors when evaluating the severity of patients' injuries. We developed Night Shift, a theory-based adventure video game, to recalibrate physician heuristics (intuitive judgments) in trauma triage and established its efficacy in the laboratory. We plan a type 1 hybrid effectiveness-implementation trial to determine whether the game changes physician triage decisions in real-life and hypothesize that it will reduce the proportion of patients under-triaged. METHODS: We will recruit 800 physicians who work in the emergency departments (EDs) of non-trauma centers in the US and will randomize them to the game (intervention) or to usual education and training (control). We will ask those in the intervention group to play Night Shift for 2 h within 2 weeks of enrollment and again for 20 min at quarterly intervals. Those in the control group will receive only usual education (i.e., nothing supplemental). We will then assess physicians' triage practices for older, severely injured adults in the 1-year following enrollment, using Medicare claims, and will compare under-triage (primary outcome), 30-day mortality and re-admissions, functional independence, and over-triage between the two groups. We will evaluate contextual factors influencing reach, adoption, implementation, and maintenance with interviews of a subset of trial participants (n = 20) and of other key decision makers (e.g., patients, first responders, administrators [n = 100]). DISCUSSION: The results of the trial will inform future efforts to improve the implementation of clinical practice guidelines in trauma triage and will provide deeper understanding of effective strategies to reduce diagnostic errors during time-sensitive decision making. TRIAL REGISTRATION: ClinicalTrials.gov; NCT06063434 . Registered 26 September 2023.
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Médicos , Jogos de Vídeo , Idoso , Humanos , Serviço Hospitalar de Emergência , Medicare , Triagem/métodos , Estados Unidos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
With the increasing prevalence of obesity placing additional demands on healthcare systems, many jurisdictions and professional bodies have developed clinical practice guidelines to support practitioners in the management of people with overweight and obesity. This scoping review aimed to identify key features of contemporary guidelines for the clinical management of overweight and obesity. Searches of MEDLINE, Guidelines International Network's international guidelines library, and other grey literature sources identified 38 guidelines of 18 countries and one region published since 2010. Guidelines were developed by committees (n = 36, 95%) that comprised knowledgeable experts (n = 36, 95%) and were multidisciplinary (n = 33, 87%), with limited consumer representation (n = 11, 29%). Guideline documentation incorporated review questions (n = 23, 61%), systematic reviews (n = 25, 66%), evidence grading systems (n = 33, 87%), processes for reaching consensus (n = 19, 50%), and guideline review details (n = 28, 74%). Treatment approaches included in most guidelines were nutrition and physical activity (n = 38, 100%), psychology (n = 37, 97%), pharmacotherapy (n = 32, 84%), and bariatric surgery (n = 31, 82%). Most guidelines targeted populations based on age (n = 30, 79%). Guidelines contained recommendations for pregnancy (n = 12, 32%), older adults (n = 9, 24%), and people with eating disorders (n = 8, 21%). Future guidelines would benefit from involvement of consumers including groups known to be at increased risk of overweight and obesity, targeted guidance for at risk groups, and consideration of weight bias and stigma.
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Cirurgia Bariátrica , Sobrepeso , Guias de Prática Clínica como Assunto , Idoso , Feminino , Humanos , Gravidez , Atenção à Saúde , Obesidade/terapia , Sobrepeso/terapia , Fatores de RiscoRESUMO
As opioid fatalities rise in North America, the need to improve the supports available to those who are dependent on opioids and pregnant has become more urgent. This paper discusses the social organisation of drug treatment supports for those who are pregnant, using Canadian clinical practice guidelines (CPGs) for methadone maintenance treatment (MMT) as a case study. Pregnant patients are a priority population for MMT, both in Canada and internationally; the regulatory bodies that oversee MMT in Canada are the provincial Colleges of Physician and Surgeons and Health Canada. The paper analyses MMT CPGs published by these agencies, comparing their general recommendations to those specific to pregnant patients. We demonstrate that the guidelines address few treatment considerations for pregnant patients, other than improved birth outcomes and child welfare, despite acknowledging their more complex needs. Drawing on social science studies of gender and drugs, we argue that MMT CPGs therefore perpetuate the intensified surveillance and foetal prioritisation that have long generated barriers to care for opiate-dependent pregnant patients. We also discuss how and why the CPGs ultimately only reinforced these current limitations in the drug treatment sector.
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Metadona , Transtornos Relacionados ao Uso de Opioides , Feminino , Humanos , Gravidez , Analgésicos Opioides/uso terapêutico , Canadá , Metadona/uso terapêutico , Tratamento de Substituição de Opiáceos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/reabilitação , Recém-Nascido , Guias de Prática Clínica como AssuntoRESUMO
BACKGROUND: Current methods for developing clinical practice guidelines have several limitations: they are characterised by the "black box" operation-a process with defined inputs and outputs but an incomplete understanding of its internal workings; they have "the integration problem"-a lack of framework for explicitly integrating factors such as patient preferences and trade-offs between benefits and harms; they generate one recommendation at a time that typically are not connected in a coherent analytical framework; and they apply to "average" patients, while clinicians and their patients seek advice tailored to individual circumstances. METHODS: We propose augmenting the current guideline development method by converting evidence-based pathways into fast-and-frugal decision trees (FFTs) and integrating them with generalised decision curve analysis to formulate clear, individualised management recommendations. RESULTS: We illustrate the process by developing recommendations for the management of heparin-induced thrombocytopenia (HIT). We converted evidence-based pathways for HIT, developed by the American Society of Hematology, into an FFT. Here, we consider only thrombotic complications and major bleeding. We leveraged the predictive potential of FFTs to compare the effects of argatroban, bivalirudin, fondaparinux, and direct oral anticoagulants (DOACs) using generalised decision curve analysis. We found that DOACs were superior to other treatments if the FFT-predicted probability of HIT exceeded 3%. CONCLUSIONS: The proposed analytical framework connects guidelines, pathways, FFTs, and decision analysis, offering risk-tailored personalised recommendations and addressing current guideline development critiques.
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Trombocitopenia , Humanos , Trombocitopenia/induzido quimicamente , Técnicas de Apoio para a Decisão , Assistência ao PacienteRESUMO
AIMS: The aim of this study was to describe the methodological features of the randomized controlled trials (RCTs) cited in American and European clinical practice guidelines (CPGs) for ST elevation myocardial infarction (STEMI) and non-ST elevation acute coronary syndrome (NSTE-ACS). METHODS AND RESULTS: Out of 2128 non-duplicated references cited in the 2013 and 2014 American College of Cardiology/American Heart Association and 2017 and 2020 European Society of Cardiology CPGs for STEMI and NSTE-ACS, we extracted data for 407 RCTs (19.1% of total references). The majority were multicenter studies (81.8%), evaluated pharmacological interventions (63.1%), had a 2-arm (82.6%), and superiority (90.4%) design. Most RCTs (60.2%) had an active comparator, and 46.2% were funded by industry. The median observed sample size was 1001 patients (84.2% of RCTs achieved ≥80% of the intended sample size). Most RCTs had a single primary outcome (90.9%), which was a composite in just over half (51.9%). Among the RCTs testing for superiority, 44.0% reported a P-value of ≥0.05 for the primary outcome and 61.9% observed a risk reduction of >15%. The observed treatment effect was lower-than-expected in 67.6% of RCTs, with 34.4% having at least a 20% lower-than-expected treatment effect. The calculated post hoc statistical power was ≥80% for 33.9% of cited RCTs. CONCLUSIONS: This analysis demonstrates that RCTs cited by CPGs can still have significant methodological issues and limitations, highlighting that a better understanding of the methodological aspects of RCTs is crucial in order to formulate recommendations relevant to clinical practice.
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Síndrome Coronariana Aguda , Cardiologia , Infarto do Miocárdio com Supradesnível do Segmento ST , Estados Unidos , Humanos , Síndrome Coronariana Aguda/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , American Heart AssociationRESUMO
Background: Clinical practice guidelines (CPGs) are used to guide decision-making, especially regarding complementary and alternative medicine (CAM) therapies that are unfamiliar to orthodox healthcare providers. This systematic review aimed to critically review and summarise CAM recommendations associated with anxiety management included in the existing CPGs. Methods: Seven databases, websites of six international guidelines developing institutions, and the National Centre for Complementary and Integrative Health website were systematically searched. Their reporting and methodological quality were evaluated using the Reporting Items for practice Guidelines in Healthcare checklist and the Appraisal of Guidelines for Research and Evaluation (2nd version) instrument, respectively. Results: Ten CPGs were included, with reporting rates between 51.4 and 88.6%. Seven of these were of moderate to high methodological quality. Seventeen CAM modalities were implicated, involving phytotherapeutics, mind-body practice, art therapy, and homeopathy. Applied relaxation was included in 70% CPGs, which varied in degree of support for its use in the treatment of generalised anxiety disorder. There were few recommendations for other therapies/products. Light therapy was not recommended for use in generalised anxiety disorder, and St John's wort and mindfulness were not recommended for use in social anxiety disorder in individual guidelines. Recommendations for the applicability of other therapies/products for treating a specific anxiety disorder were commonly graded as "unclear, unambiguous, or uncertain". No CAM recommendations were provided for separation anxiety disorder, specific phobia or selective mutism. Conclusion: Available guidelines are limited in providing logically explained graded CAM recommendations for anxiety treatment and care. A lack of high-quality evidence and multidisciplinary consultation during the guideline development are two major reasons. High quality and reliable clinical evidence and the engagement of a range of interdisciplinary stakeholders are needed for future CPG development and updating. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022373694, identifier CRD42022373694.
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BACKGROUND: Guideline adaptation is an emerging field to provide more appropriate recommendations for local clinical practice quality and to promote global health equity. However, its utilization status, adaptation procedures, and related materials remain to be studied. METHODS: This study developed a quality improvement protocol for a study as the Development, Evaluation, and impLemenTation for guideline Adaptation (DELTA) study. Current adapted clinical practice guidelines (CPGs) will be systematically searched. Their characteristics, utilization status, and adaptation procedures will be extracted, compared, and analyzed. Whether these adapted CPGs rigorously followed the instruments and steps of adaptation frameworks will also be appraised. In addition, the advantages and limitations of current adaptation methods and their suitable application situations will be analyzed. In addition, future perspectives as DELTA series and DELTA system, aiming for comprehensively evaluating current needs for guideline adaptation and developing a unified framework and related materials were proposed to improve the acceptability, applicability, and implementation of guideline adaptation in clinical practice. The DELTA series are divided into four phases: phase I in analyzing status, characteristics, and procedures and completeness of adapted CPGs; phase II in analyzing differences, heterogeneity, and implementation between adapted and original CPGs; and phase III in collecting, analyzing, and comparing all available adaptation materials. With these research bases, an international working group will be established in phase IV and will develop unified guideline adaptation materials after Delphi consensus, including adaptation frameworks, appraisal tools and checklists, registries, and databases. DISCUSSION: Guideline adaptation has been advanced as an efficient way to guide local clinical practice. However, it still faces several major challenges. The proposed DELTA study, series, and system will further contribute to this emerging topic. TRIAL REGISTRATION: This study has been registered by the PROSPERO international database. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=400170 .
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Saúde Global , Melhoria de Qualidade , Humanos , Lista de Checagem , Consenso , Bases de Dados Factuais , Guias como AssuntoRESUMO
BACKGROUND AND OBJECTIVE: Clinical practice guidelines (CPGs) are evaluated for quality with the Appraisal of Guidelines for Research and Evaluation (AGREE) tool, and this is increasingly done for different countries and regional groupings. This scoping review aimed to describe, map, and compare these geographical synthesis studies, that assessed CPG quality using the AGREE tool. This allowed a global interpretation of the current landscape of these country-wide or regional synthesis studies, and a closer look at its methodology and results. STUDY DESIGN AND METHODS: A scoping review was conducted searching databases Medline, Embase, Epistemonikos, and grey literature on 5 October 2021 for synthesis studies using the later versions of AGREE (AGREE II, AGREE-REX and AGREE GRS) to evaluate country-wide or regional CPG quality. Country-wide or regional synthesis studies were the units of analysis, and simple descriptive statistics was used to conduct the analysis. AGREE scores were analysed across subgroups into one of the seven Sustainable Development Goal regions, to allow for meaningful interpretation. RESULTS: Fifty-seven studies fulfilled our eligibility criteria, which had included a total of 2918 CPGs. Regions of the Global North, and Eastern and South-Eastern Asia were most represented. Studies were consistent in reporting and presenting their AGREE domain and overall results, but only 18% (n = 10) reported development methods, and 19% (n = 11) reported use of Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Overall scores for domains Rigor of development and Editorial independence were low, notably in middle-income countries. Editorial Independence scores, especially, were low across all regions with a maximum domain score of 46%. There were no studies from low-income countries. CONCLUSION: There is an increasing tendency to appraise country-wide and regionally grouped CPGs, using quality appraisal tools. The AGREE tool, evaluated in this scoping review, was used well and consistently across studies. Findings of low report rates of development of CPGs and of use of GRADE is concerning, as is low domain scores globally for Editorial Independence. Transparent reporting of funding and competing interests, as well as highlighting evidence-to-decision processes, should assist in further improving CPG quality as clinicians are in dire need of high-quality guidelines.
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Bases de Dados Factuais , Guias de Prática Clínica como Assunto , Guias de Prática Clínica como Assunto/normasRESUMO
INTRODUCTION: Physicians must share decisions and choose personalised treatments regarding patients´ beliefs and values. OBJECTIVE: To analyse the quality of the recommendations about shared decision making (SDM) in colorectal (CRC) and anal cancer treatment clinical practice guidelines (CPGs) and consensus statements (CSs). METHODS: Guidelines were systematically reviewed following prospective registration (Prospero: CRD42021286146) without language restrictions searching 15 databases and 59 professional society websites from January 2010 to November 2021. A validated 31-item SDM quality assessment tool was employed to extract data in duplicate. RESULTS: We identified 134 guidelines. Only 46/134 (34.3 %) mentioned SDM. Fifteen (11.1 %) made clear, precise and actionable recommendations, while 9/134 (6.7 %) indicated the strength of the SDM-related recommendations. CPGs underpinned by systematic reviews reported SDM more often than those based on consensus or reviews (35.9 % vs 32.0 %; p = 0.031). Guidelines that reported following quality tools (i.e., AGREE II) more commonly commented about SDM than when it was not reported (75.0 % vs 32.0 %; p = 0.003). CONCLUSION AND PRACTICE IMPLICATIONS: Most of the CRC and anal treatment guidelines did not mention SDM and it was superficial. Guidelines based on systematic reviews and those using quality tools demonstrated better reporting of SDM. Recommendations about SDM in these guidelines merit urgent improvement.
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Neoplasias Colorretais , Tomada de Decisão Compartilhada , Humanos , Tomada de Decisões , Estudos Prospectivos , Participação do Paciente , Neoplasias Colorretais/terapiaRESUMO
Purpose: To assess the proportion of inpatients who received guideline-concordant antibiotics for community-acquired bacterial pneumonia (CABP) in special populations of the All of Us database. Background: CABP contributes significantly to healthcare burden worldwide. The American Thoracic Society and Infectious Disease Society of America jointly published guidelines for the treatment of CABP. Guideline-concordant antibiotics for CABP are associated with better patient and cost outcomes. Methods: This was a retrospective cohort study of patients with pneumonia (n = 1608; SNOMED 233604007) from 10/1/2018 to 1/01/22 in the All of Us database. Cases were excluded for treatment setting other than inpatient, prior (within 90 days) pneumonia, receipt of intravenous antibiotics, respiratory isolation of methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa, and/or other non-community-acquired types of pneumonia. Patients were grouped based on patient age, sex, race, and ethnicity. The proportion of patients on guideline-concordant therapy was compared within groups using chi-square statistics. Significant associations were assessed using multivariate logistic regression models. Results: A total of 1608 cases were included, and 45% of these patients received guideline-concordant antibiotics. Non-Hispanic White (NHW) patients vs. Black patients were associated with a 36% higher likelihood for receiving guideline-concordant antibiotics (adjusted OR, 1.36; 95% CI 1.02-1.81), whereas NHW vs. Hispanic patients were associated with a 34% lower likelihood for receiving guideline-concordant antibiotics (aOR 0.66; 0.48-0.91). Conclusion: Black patients with CABP in the All of Us database were less likely to receive guideline-concordant antibiotics, and Hispanic patients were more likely to receive guideline-concordant antibiotics, than NHW patients.
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Background: There is a need for evidence-informed guidance on the use of complementary and alternative medicine (CAM) for insomnia because of its widespread utilization and a lack of guidance on the balance of benefits and harms. This systematic review aimed to identify and summarize the CAM recommendations associated with insomnia treatment and care from existing comprehensive clinical practice guidelines (CPGs). The quality of the eligible guidelines was appraised to assess the credibility of these recommendations. Methods: Formally published CPGs incorporating CAM recommendations for insomnia management were searched for in seven databases from their inception to January 2023. The NCCIH website and six websites of international guideline developing institutions were also retrieved. The methodological and reporting quality of each included guideline was appraised using the AGREE II instrument and RIGHT statement, respectively. Results: Seventeen eligible GCPs were included, and 14 were judged to be of moderate to high methodological and reporting quality. The reporting rate of eligible CPGs ranged from 42.9 to 97.1%. Twenty-two CAM modalities were implicated, involving nutritional or natural products, physical CAM, psychological CAM, homeopathy, aromatherapy, and mindful movements. Recommendations for these modalities were mostly unclear, unambiguous, uncertain, or conflicting. Logically explained graded recommendations supporting the CAM use in the treatment and/or care of insomnia were scarce, with bibliotherapy, Tai Chi, Yoga, and auriculotherapy positively recommended based on little and weak evidence. The only consensus was that four phytotherapeutics including valerian, chamomile, kava, and aromatherapy were not recommended for insomnia management because of risk profile and/or limited benefits. Conclusions: Existing guidelines are generally limited in providing clear, evidence-informed recommendations for the use of CAM therapies for insomnia management due to a lack of high-quality evidence and multidisciplinary consultation in CPG development. More well-designed studies to provide reliable clinical evidence are therefore urgently needed. Allowing the engagement of a range of interdisciplinary stakeholders in future updates of CPGs is also warranted. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=369155, identifier: CRD42022369155.
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Biblioterapia , Terapias Complementares , Distúrbios do Início e da Manutenção do Sono , Yoga , Humanos , Distúrbios do Início e da Manutenção do Sono/terapia , Guias de Prática Clínica como AssuntoRESUMO
Cytomegalovirus (CMV) infection during pregnancy may result in long-term health problems for children with congenital CMV (cCMV). Currently, no prevention or treatment interventions are approved by the Food and Drug Administration for a cCMV indication. Healthcare provider and public awareness is low, and formal clinical practice guidelines and local practice patterns vary. A pilot study of eight cCMV experts was performed using qualitative semi-structured interviews to better understand clinical practice guidelines and patterns in the United States. Results from participant interviews highlighted the need for better prenatal diagnostic techniques, broader neonatal screening opportunities, and more robust evidence supporting intervention strategies. Healthcare provider and public partnerships are essential for advancing cCMV guidelines and improving care delivery. Our results provide a preliminary knowledge base and framework for developing a consensus cCMV research agenda to address evidence gaps that limit the revision of clinical practice guidelines. The changes in clinical practice patterns that may arise as a result of further research have the potential to reduce risk during pregnancy and improve care for children with cCMV infection.