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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    根据循证实践制定中国常见癌症诊断和治疗指南,诊断和治疗产品的可用性,而精准医学的最新进展是中国临床肿瘤学会乳腺癌(CSCOBC)委员会的基本任务之一。
    具有高证据水平和良好可用性的协议被用作I级建议;具有相对高证据水平但专家共识略低或可用性差的协议被用作II级建议;临床适用但证据水平低的协议被视为III级建议。根据国内外临床研究的结果和CSCOBC专家的意见,CSCOBC指南确定了临床应用的推荐水平.
    对于人类表皮生长因子受体2(HER2)阳性乳腺癌,曲妥珠单抗和帕妥珠单抗联合方案被推荐为新辅助和一线转移性乳腺癌的I级推荐方案.根据在中国进行的最新研究,在一线和二线治疗中,吡替尼也被推荐为I级推荐。抗体药物缀合物也被推荐用于曲妥珠单抗进展的患者。对于三阴性乳腺癌,早期和转移性乳腺癌的免疫治疗在本版指南中得到了强调,并被列为新章节.对于激素受体(HR)阳性乳腺癌,细胞周期蛋白依赖性激酶4/6(CDK4/6)在不同阶段被推荐,尤其是辅助治疗。通过HR状态分层的低HER2乳腺癌也有了新的一章。
    我们坚信,可用性方面,和基于共识的指南在中国和其他有类似情况的国家的临床实践中更可行。
    UNASSIGNED: Developing guidelines for the diagnosis and treatment of common cancers in China based on the evidence-based practice, the availability of diagnosis and treatment products, and the up-to-date advances in precision medicine is one of the basic tasks of the Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) Committee.
    UNASSIGNED: Protocols with high evidence level and good availability are used as the Level I recommendations; protocols with relatively high evidence level but slightly lower expert consensus or with poor availability are used as the Level II recommendations; and protocols that are clinically applicable but with low evidence level are regarded as the Level III recommendations. Based on the findings of clinical research at home and abroad and the opinions of CSCO BC experts, the CSCO BC guidelines determine the levels of recommendations for clinical application.
    UNASSIGNED: For human epidermal growth factor receptor 2 (HER2)-positive breast cancer, a combination of trastuzumab and pertuzumab regimen were recommended as Level I recommendation for neoadjuvant and first line metastatic breast cancer. Pyrotinib is also recommended as Level I recommendation in first line and second line therapy according to the latest studies conducted in China. Antibody drug conjugates was also recommended for patients with trastuzumab progression. For triple negative breast cancer, immunotherapy in early and metastatic breast cancer was highlighted and listed as new chapters in this version of guideline. For hormone receptor (HR)-positive breast cancer, cyclin dependent kinase 4/6 (CDK4/6) was recommended in different stages, especially in adjuvant therapy. There was also a new chapter for HER2-low breast cancer stratified by HR status.
    UNASSIGNED: We firmly believe that evidence-based, availability-concerned, and consensus-based guidelines will be more feasible for clinical practice in China and in other countries with similar situations.
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  • 文章类型: Journal Article
    特应性皮炎通常始于婴儿期,并伴随着长期的恶化和缓解。病因学复杂,涉及许多导致皮肤屏障缺陷和炎症的因素。在中东,特应性皮炎的负担研究不足。特定于海湾地区的流行病学数据很少,但在阿拉伯联合酋长国的患病率高达约40%。特定地区的因素,比如气候和近亲结婚的频率,可能会影响特应性皮炎的发病率,患病率,随着时间的推移和进化。主要来自阿拉伯联合酋长国的专家小组分析了已发布指南的证据,并考虑专家指导和当地治疗实践,为阿拉伯联合酋长国特应性皮炎的管理制定明确的建议。他们鼓励系统的诊断和治疗方法,使用疾病严重程度评分和生活质量测量工具。治疗建议考虑到既定的治疗方法和批准的全身生物制剂dupilumab和tralokinumab。和Janus激酶抑制剂baricitinib,upadacitinib,和abrocitinib.
    Atopic dermatitis often begins in infancy and follows a chronic course of exacerbations and remissions. The etiology is complex and involves numerous factors that contribute to skin barrier defect and inflammation. In the Middle East, the burden of atopic dermatitis is understudied. Epidemiological data specific to the Gulf region are scarce but reveal a prevalence of up to about 40% in the United Arab Emirates. Region-specific factors, such as the climate and the frequency of consanguineous marriages, may affect atopic dermatitis incidence, prevalence, and evolution over time. A panel of experts predominantly from the United Arab Emirates analyzed the evidence from published guidelines, and considered expert guidance and local treatment practices to develop clear recommendations for the management of atopic dermatitis in the United Arab Emirates. They encourage a systematic approach for the diagnosis and treatment, using disease severity scores and quality-of-life measurement tools. Treatment recommendations take into consideration both established therapies and the approved systemic biologics dupilumab and tralokinumab, and the Janus kinase inhibitors baricitinib, upadacitinib, and abrocitinib.
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  • 文章类型: Journal Article
    背景:肺炎支原体(M.肺炎)是儿童社区获得性肺炎的重要原因。自1968年以来,日本最初报道了对大环内酯类抗生素耐药的肺炎支原体菌株,大环内酯耐药肺炎支原体(MRMP)已在世界许多国家被证明,发病率不同。MRMP感染导致对大环内酯类抗生素的反应不佳,经常导致长时间的发烧,延长抗生素治疗,住院率增加,重症监护室入院,接受糖皮质激素或二线抗生素的患者比例明显更高。自2000年以来,MRMP的全球发病率逐渐上升,尤其是在东亚,对儿童肺炎支原体感染的治疗提出了严峻的挑战,引起了儿科医生的广泛关注。然而,关于儿童MRMP的诊断和治疗仍未达成全球共识.
    方法:我们组织了29名中国儿科肺病学和流行病学专家,撰写了世界上第一个关于小儿MRMP肺炎诊断和治疗的共识,基于证据收集。使用电子数据库进行证据搜索和审查,包括PubMed,Embase,WebofScience,CNKI,Medline,还有Cochrane图书馆.我们在术语“大环内酯抗性”中使用了变体,“肺炎支原体”,\"MP\",\"M.肺炎\“,\"肺炎\",\"MRMP\",“下呼吸道感染”,“肺炎支原体感染”,\"children\",和“儿科”。
    结果:流行病学,发病机制,临床表现,早期识别,实验室检查,抗生素使用原则,糖皮质激素和静脉注射免疫球蛋白的应用,并强调支气管镜检查的注意事项。现在,通过呼吸道标本中的聚合酶链反应和荧光探针技术,可以早期快速鉴定与MRMP相关的基因突变。尽管对大环内酯的耐药率仍然很高,幸运的是,肺炎支原体仍然对四环素和喹诺酮类药物等二线抗生素保持良好的体外敏感性,使它们成为由大环内酯类抗生素引起的初始治疗失败的患者的有效治疗选择。
    结论:这一共识,基于国际和国家科学证据,为儿童MRMP的诊断和治疗提供科学指导。迫切需要对儿童四环素和喹诺酮类药物进行进一步研究,以评估其对生长发育的影响。此外,制定抗生素轮换治疗策略对于降低MRMP菌株的患病率是必要的.
    BACKGROUND: Mycoplasma pneumoniae (M. pneumoniae) is a significant contributor to community-acquired pneumonia among children. Since 1968, when a strain of M. pneumoniae resistant to macrolide antibiotics was initially reported in Japan, macrolide-resistant M. pneumoniae (MRMP) has been documented in many countries worldwide, with varying incidence rates. MRMP infections lead to a poor response to macrolide antibiotics, frequently resulting in prolonged fever, extended antibiotic treatment, increased hospitalization, intensive care unit admissions, and a significantly higher proportion of patients receiving glucocorticoids or second-line antibiotics. Since 2000, the global incidence of MRMP has gradually increased, especially in East Asia, which has posed a serious challenge to the treatment of M. pneumoniae infections in children and attracted widespread attention from pediatricians. However, there is still no global consensus on the diagnosis and treatment of MRMP in children.
    METHODS: We organized 29 Chinese experts majoring in pediatric pulmonology and epidemiology to write the world\'s first consensus on the diagnosis and treatment of pediatric MRMP pneumonia, based on evidence collection. The evidence searches and reviews were conducted using electronic databases, including PubMed, Embase, Web of Science, CNKI, Medline, and the Cochrane Library. We used variations in terms for \"macrolide-resistant\", \"Mycoplasma pneumoniae\", \"MP\", \"M. pneumoniae\", \"pneumonia\", \"MRMP\", \"lower respiratory tract infection\", \"Mycoplasma pneumoniae infection\", \"children\", and \"pediatric\".
    RESULTS: Epidemiology, pathogenesis, clinical manifestations, early identification, laboratory examination, principles of antibiotic use, application of glucocorticoids and intravenous immunoglobulin, and precautions for bronchoscopy are highlighted. Early and rapid identification of gene mutations associated with MRMP is now available by polymerase chain reaction and fluorescent probe techniques in respiratory specimens. Although the resistance rate to macrolide remains high, it is fortunate that M. pneumoniae still maintains good in vitro sensitivity to second-line antibiotics such as tetracyclines and quinolones, making them an effective treatment option for patients with initial treatment failure caused by macrolide antibiotics.
    CONCLUSIONS: This consensus, based on international and national scientific evidence, provides scientific guidance for the diagnosis and treatment of MRMP in children. Further studies on tetracycline and quinolone drugs in children are urgently needed to evaluate their effects on the growth and development. Additionally, developing an antibiotic rotation treatment strategy is necessary to reduce the prevalence of MRMP strains.
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  • 文章类型: Journal Article
    背景:最近的出版物强调需要更新的建议,以解决<2厘米肿瘤的根治性手术,诱导化疗,或局部晚期宫颈癌的免疫疗法,以及复发或转移性宫颈癌的全身治疗。目的:总结目前诊断的证据,治疗,和宫颈癌的随访并提供循证临床实践建议。方法:根据AGREEII标准开发,该指南根据卫生技术评估和关税系统标准对科学证据进行分类。建议根据发展小组的证据强度和共识水平进行分级。主要结果:(1)早期癌症:基质浸润和淋巴血管间隙受累(LVSI)从预处理活检确定候选手术,特别是简单的子宫切除术。(2)手术方式:不建议进行微创手术,除了T1A,LVSI阴性肿瘤,由于预期寿命的减少。(3)局部晚期癌症:同步放化疗(CCRT),然后进行近距离放射治疗(BRT)是基础治疗。低风险患者(少于两个转移淋巴结或FIGOIB2-II)可以在7天后考虑诱导化疗(ICT),然后进行CCRT和BRT。高风险患者(两个或更多转移性淋巴结或FIGOIIIA,IIIB,和IVA)受益于pembrolizumab与CCRT和维持治疗。(4)转移,持久性,和复发癌症:来自预处理活检的PD-L1状态可识别Pembrolizumab与可用的全身治疗的候选者,而三联疗法(阿替珠单抗/贝伐单抗/化疗)成为PD-L1非依赖性选择。结论:这些循证指南旨在通过基于个体风险因素的精确治疗策略来改善临床结果。预测因子,和疾病阶段。
    Background: Recent publications underscore the need for updated recommendations addressing less radical surgery for <2 cm tumors, induction chemotherapy, or immunotherapy for locally advanced stages of cervical cancer, as well as for the systemic therapy for recurrent or metastatic cervical cancer. Aim: To summarize the current evidence for the diagnosis, treatment, and follow-up of cervical cancer and provide evidence-based clinical practice recommendations. Methods: Developed according to AGREE II standards, the guidelines classify scientific evidence based on the Agency for Health Technology Assessment and Tariff System criteria. Recommendations are graded by evidence strength and consensus level from the development group. Key Results: (1) Early-Stage Cancer: Stromal invasion and lymphovascular space involvement (LVSI) from pretreatment biopsy identify candidates for surgery, particularly for simple hysterectomy. (2) Surgical Approach: Minimally invasive surgery is not recommended, except for T1A, LVSI-negative tumors, due to a reduction in life expectancy. (3) Locally Advanced Cancer: concurrent chemoradiation (CCRT) followed by brachytherapy (BRT) is the cornerstone treatment. Low-risk patients (fewer than two metastatic nodes or FIGO IB2-II) may consider induction chemotherapy (ICT) followed by CCRT and BRT after 7 days. High-risk patients (two or more metastatic nodes or FIGO IIIA, IIIB, and IVA) benefit from pembrolizumab with CCRT and maintenance therapy. (4) Metastatic, Persistent, and Recurrent Cancer: A PD-L1 status from pretreatment biopsy identifies candidates for Pembrolizumab with available systemic treatment, while triplet therapy (Atezolizumab/Bevacizumab/chemotherapy) becomes a PD-L1-independent option. Conclusions: These evidence-based guidelines aim to improve clinical outcomes through precise treatment strategies based on individual risk factors, predictors, and disease stages.
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  • 文章类型: Journal Article
    西班牙风湿病学会(SER)汇集了大多数西班牙风湿病学家,在它为会员提供的众多服务中,有一个研究单位(RU)。该部门为SER成员提供临床和流行病学研究的方法学支持,协调和开展研究项目,设计和维护大型患者数据库,开发定性研究项目,并制作循证医学(EBM)文件。通过这最后的活动,SER的RU制定符合最苛刻方法学标准的风湿病学相关主题的临床实践指南和建议文件.本文的目的是描述SERUI遵循的管理流程和方法,以确定其EBM文档的主题以及如何执行和制定其指南和建议。
    The Spanish Society of Rheumatology (SER) brings together the majority of Spain\'s rheumatologists and, among the many services it offers its members, has a Research Unit (RU). This unit provides methodological support to SER members in clinical and epidemiological research, coordinates and carries out research projects, designs and maintains large patient databases, develops qualitative research projects and produces evidence-based medicine (EBM) documents. Through this last activity, the RU of the SER produces clinical practice guidelines and recommendation documents on topics relevant to rheumatology that meet the most demanding methodological standards. The aim of this article is to describe the management process and methodology followed by the UI of the SER to identify the topics of its EBM documents and how it executes and develops its guidelines and recommendations.
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  • 文章类型: Journal Article
    基于循证实践,制定中国常见癌症诊断和治疗指南,诊断和治疗产品的可用性,精准医学的最新进展是中国临床肿瘤学会(CSCO)的基本任务之一。近年来,医疗资源的可用性已成为临床指南中的主要关注点,这对发展中国家或社会经济多样化的国家和地区尤为重要。中国是世界上最大的发展中国家,幅员辽阔,经济和学术发展不平衡。CSCO准则必须考虑到地区发展的差异,药物和诊断方法的可用性,以及癌症治疗的社会价值。因此,对于CSCO指南中的每个临床问题和干预,证据等级应根据现有证据和专家共识进行分级,建议的等级应基于产品的可用性和成本效益。具有高证据水平和良好可用性的协议被用作I级建议;具有相对较高的证据水平但略低的专家共识或具有较差可用性的协议被用作II级建议;临床适用但证据水平低的协议被视为III级建议。根据国内外临床研究的结果和CSCO专家的意见,CSCO指南确定了临床应用的推荐水平.CSCO指导工作组坚信,以证据为基础,可用性方面,以共识为基础的指南将更适合临床实践。再一次,我们的读者的任何意见都非常感谢,并将在这些指南的更新中考虑,为了保持准确性,公平,以及CSCO指南的及时性。
    Developing guidelines for the diagnosis and treatment of common cancers in China based on the evidence-based practice, the availability of diagnosis and treatment products, and the up-to-date advances in precision medicine is one of the basic tasks of the Chinese Society of Clinical Oncology (CSCO). In recent years, the availability of medical resources has become a major concern in clinical guidelines, which is particularly important for developing countries or socioeconomically diverse countries and territories. China is the world\'s largest developing country, with a large territory and uneven economic and academic developments. The CSCO guidelines must take into account the differences in regional development, the availability of medicines and diagnostic methods, and the social value of cancer treatment. Therefore, for each clinical problem and intervention in the CSCO guidelines, the levels of evidence should be graded according to the currently available evidences and expert consensuses, and the grades of recommendations should be based on the availability and cost-effectiveness of the products. Protocols with high evidence level and good availability are used as the Level I recommendations; protocols with relatively high evidence level but slightly lower expert consensus or with poor availability are used as the Level II recommendations; and protocols that are clinically applicable but with low evidence level are regarded as the Level III recommendations. Based on the findings of clinical research at home and abroad and the opinions of CSCO experts, the CSCO guidelines determine the levels of recommendations for clinical application. The CSCO Guidance Working Group firmly believes that evidence-based, availability-concerned, and consensus-based guidelines will be more feasible for clinical practice. Again, any comments from our readers are greatly appreciated and will be considered in updates of these guidelines, so as to maintain the accuracy, fairness, and timeliness of the CSCO guidelines.
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  • 文章类型: Journal Article
    世界卫生组织(WHO)最近的指南旨在提供基于证据的建议,以补充喂养(CF)健康的足月婴儿和幼儿6-23个月生活在低,middle-,和高收入国家,包括母乳喂养和非母乳喂养的儿童。就像谁,我们的组织旨在促进最佳的婴幼儿营养和健康,重点是促进母乳喂养以及适当和及时的CF。在本文中,我们对指导方针的各个方面都有同样的担忧,其中一些可能会对婴幼儿造成意外伤害,并提出替代或修改的建议。
    The recent World Health Organization (WHO) guideline aims to provide evidence-based recommendations on complementary feeding (CF) of healthy term infants and young children 6-23 months living in low-, middle-, and high-income countries, including both breastfed and non-breastfed children. Like WHO, our organizations aim to promote optimal infant and young child nutrition and health, with a focus on promoting breastfeeding as well as appropriate and timely CF. In this paper, we share our concerns about aspects of the guideline, some of which may have the potential to cause unintended harm in infants and young children and suggest alternative or modified proposals.
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  • 文章类型: Guideline
    这是一项基于共识的加拿大指南,其主要目的是在全国范围内标准化和促进慢性移植物抗宿主病(cGvHD)的管理。在加拿大创建统一的医疗保健指南是一个挑战,原因有很多,包括医疗保健机构结构的差异。各省和地区之间的资金和医疗资源的获取,以及地理大小。这些差异可能导致可变和不平等地获得GvHD的有效疗法。本文件将提供全面和实用的指导,可在加拿大各地由医疗保健专业人员照顾cGvHD患者。希望,这一方针,根据全国GvHD治疗机构的意见,将有助于cGvHD护理标准化,并促进获得急需的新疗法。这篇共识论文旨在讨论cGvHD初步评估的最佳方法,审查严重性评分和全球分级系统,讨论全身和局部治疗,以及支持疗法,并提出了一种治疗算法,用于成人和儿科患者的cGvHD治疗的前线和后续线。最后,我们将对cGvHD治疗的未来发展方向提出建议,例如(1)基于作用模式的cGvHD药物选择,根据cGvHD的发病机制,(2)结合新型靶向药物的引入,(3)无类固醇方案,特别是对于cGvHD治疗的一线治疗,和(4)一种先发制人的方法,可以预防注定要发展为严重和高度病态形式的cGvHD的高风险患者的cGvHD进展。
    This is a consensus-based Canadian guideline whose primary purpose is to standardize and facilitate the management of chronic graft-versus-host disease (cGvHD) across the country. Creating uniform healthcare guidance in Canada is a challenge for a number of reasons including the differences in healthcare authority structure, funding and access to healthcare resources between provinces and territories, as well as the geographic size. These differences can lead to variable and unequal access to effective therapies for GvHD. This document will provide comprehensive and practical guidance that can be applied across Canada by healthcare professionals caring for patients with cGvHD. Hopefully, this guideline, based on input from GvHD treaters across the country, will aid in standardizing cGvHD care and facilitate access to much-needed novel therapies. This consensus paper aims to discuss the optimal approach to the initial assessment of cGvHD, review the severity scoring and global grading system, discuss systemic and topical treatments, as well as supportive therapies, and propose a therapeutic algorithm for frontline and subsequent lines of cGvHD treatment in adults and pediatric patients. Finally, we will make suggestions about the future direction of cGvHD treatment development such as (1) a mode-of-action-based cGvHD drug selection, according to the pathogenesis of cGvHD, (2) a combination strategy with the introduction of newer targeted drugs, (3) a steroid-free regimen, particularly for front line therapy for cGvHD treatment, and (4) a pre-emptive approach which can prevent the progression of cGvHD in high-risk patients destined to develop severe and highly morbid forms of cGvHD.
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  • 文章类型: Review
    背景:在过去的几十年里,患者报告结果(PRO)已被用于更好地了解患者的健康状况.因此,已经制定了许多PRO措施(问卷)和准则或指南。然而,从许多可用的指导中选择目标指导并理解所选择的指导是具有挑战性的。这项研究全面收集了现有的PRO临床试验或研究和实践指南,以支持学术界的新手PRO用户,工业,临床实践,以及监管和报销决策。
    方法:对于范围审查,我们搜索了MEDLINE,Embase,谷歌图书,WorldCat,以及2009年至2023年的国家医学图书馆(NLM)书架数据库。资格标准是临床试验的PRO指导,临床实践,或卫生技术评估等应用。这些指南涵盖了生活质量(QOL)、PRO,与健康相关的QOL,健康国家公用事业,心理测量要求,实施方法,分析和解释,或临床实践应用。经过系统的搜索,三名研究人员分别审查了收集的数据,审查的文章和书籍使用相同的标准进行审查。
    结果:我们收集了2009年至2023年之间在文章和书籍中发布的PRO指南。从数据库搜索,确定了1455篇文章和387本书,其中一本书和33篇文章最终被选中。收集的PRO指南被归类为采用PRO措施,使用PRO设计和报告试验或研究,在临床试验或研究或临床实践中实施PRO评估,PROs的分析和解释,和PRO评估的应用。基于这种分类,对于新手,我们建议如下:在选择指南时,新手应该澄清将使用指南的“地点”和“目的”。此外,他们应该知道,与PRO相关的术语以及PRO的范围和期望因“地点”和“目的”而异。
    结论:从对现有PRO指南的范围审查中,我们提供了摘要和警告,以帮助新手选择适合其目的的指南并理解它。
    BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making.
    METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria.
    RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the \"place\" and \"purpose\" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by \"places\" and \"purposes\".
    CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.
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