Journal of Clinical Epidemiology最新文献_第6页

Guideline organizations’ guidance documents paper 10: developing recommendations about diagnostic tests and strategies 指导组织的指导文件文件10：制定关于诊断测试和策略的建议。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112068

Vanessa Helou , Lynn Basbous , Reem A. Mustafa , Joanne Khabsa , Elie A. Akl

Background and Objectives

Diagnostic tests are central to clinical decision-making, but the rigor and consistency of guidelines that inform their use remain unclear. This study aimed to describe processes for developing recommendations about diagnostic tests and strategies as outlined in guidance documents of guideline-producing organizations.

Methods

We conducted a descriptive summary of guidance documents from guideline-producing organizations. We first compiled a list of eligible organizations using different sources and retrieved their guidance documents on practice guideline development. Two authors screened organizations and their documents in duplicate and independently. We abstracted information on whether organizations provided guidance on developing recommendations about diagnostic tests and strategies for each of the Guideline International Network McMaster Guideline Development Checklist topics and their corresponding details.

Results

Out of 133 guideline-producing organizations identified, 44 (33%) described processes for developing recommendations about diagnostic tests and strategies in their guidance documents. The majority of these organizations were professional (52%) and were at the national level (80%). The median number of topics for which guidance specific to diagnostic tests and strategies was provided was 1 (range = 1–5). The topics most frequently addressed were “judging the quality, strength, or certainty of evidence” (55%) and “question generation” (32%). Topics not addressed by any organization were “establishing guideline group processes,” “identifying target audience and topic selection,” “consumer and stakeholder involvement, ” “conflict of interest considerations,” “dissemination and implementation,” and “updating.”

Conclusion

A minority of guideline-producing organizations’ guidance documents mentioned specific processes for developing recommendations for diagnostic tests and strategies. Further refinement of guidance tailored to diagnostic tests is needed to improve practice guideline development processes.

背景：诊断测试是临床决策的核心，但指导其使用的指南的严谨性和一致性仍不清楚。本研究旨在描述制定指南组织的指导文件中所述的诊断测试和战略建议的制定过程。方法：我们对来自指南制定组织的指导文件进行了描述性总结。我们首先编制了一份使用不同来源的合资格组织的名单，并检索了他们在实践指南制定方面的指导文件。两位作者分头独立地筛选了各组织及其文件。我们提取了有关各组织是否为指南国际网络(GIN)-麦克马斯特指南制定清单主题及其相应细节提供了关于制定诊断测试建议和策略的指导的信息。结果：在确定的133个准则制定组织中，44个（33%）在其指导文件中描述了制定诊断测试和战略建议的过程。这些组织大多数是专业的（52%）和国家级的（80%）。针对诊断测试和策略提供指导的主题中位数为1（范围=1-5）。最常被提及的主题是“判断证据的质量、强度或确定性”（55%）和“问题生成”（32%）。没有任何组织涉及的主题是“建立指导小组流程”、“确定目标受众和主题选择”、“消费者和利益相关者的参与”、“利益冲突考虑”、“传播和实施”和“更新”。讨论：少数准则制定组织的指导文件提到了制定诊断测试和战略建议的具体程序。需要进一步完善针对诊断测试的指南，以改进实践指南的制定过程。

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引用次数: 0

Guideline organizations' guidance documents paper 9: co-operative approaches 指南组织方法手册文件9：合作方法。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112066

Lili Zeidan , Maria Abou Mansour , Holger J. Schünemann , Murad Alam , Joanne Khabsa , Elie A. Akl

<div><h3>Background and Objectives</h3><div>Collaboration allows participants to share and leverage their strengths, mitigating resource limitations and duplication of efforts. Guideline-producing organizations interested in collaboration have developed policies to engage in collaborative effort. Our objective was to describe co-operative approaches to practice guideline development used by guideline-producing organizations as described in their guidance documents.</div></div><div><h3>Methods</h3><div>We conducted a systematic search to identify publicly available guidance documents from guideline-producing organizations. Two authors assessed eligibility and abstracted data on the organizations' characteristics and their policies for co-operative approaches in guideline development. Regarding key concepts in guideline development, co-operative approaches refer to collaborative efforts among different guideline-producing organizations to ensure the production of comprehensive practice guidelines. Collaboration involves a co-operative and co-ordinated effort between guideline-producing organizations, wherein multiple entities contribute to and engage in guideline development. Endorsement refers to the formal approval of practice guidelines by external entities, indicating their agreement or validation of the proposed guidelines. We distinguished between two perspectives of endorsement: i) Endorser: Organization X endorses guidelines established by an external organization. ii) Endorsee: External organizations endorse guidelines established by Organization X. We prespecified a list of co-operation components based on findings from a systematic review on health research collaboration by academic entities. Additionally, we accommodated any emerging components identified from the data. Subsequently, we abstracted data related to these components. Our study excludes intraorganizational or interteam co-operation. We analyzed categorical variables using frequencies and percentages and summarized the findings in textual, graphical, and tabular formats.</div></div><div><h3>Results</h3><div>Of the 133 identified guideline-producing organizations that described their methods in a publicly available guidance document, 73 (55%) organizations described at least one co-operative approach (<em>N</em> = 59), classified as “collaboration” and (<em>N</em> = 41) as “endorsement.” The most frequently addressed components for collaboration include dissemination plan (50%), team structure and governance (48%), conditions for co-operation and authority for decision to co-operate (42%), and conflict of interest policy (32%). The least addressed components include division of labor (2%), communication plan (2%), and writing (2%). Many components, such as sharing resources, shared benefits, and protocol development plan, were not addressed at all. Components of the endorsement approach varied depending on whether the perspective was an endorser or an endorsee organization.</

简介：协作允许参与者分享和利用他们的优势，减轻资源限制和重复工作。对协作感兴趣的指导方针制定组织已经制定了参与协作工作的政策。我们的目标是描述指导文件中所描述的指导方针生产组织所使用的实践指导方针开发的合作方法。方法：我们进行了系统的搜索，以确定来自指南制定组织的公开可用的指导文件。两名审稿人评估了资格，并提取了组织特征及其政策方面的数据，以便在指南制定中采用合作方法。对于指南制定中的关键概念，合作方法是指不同指南制定组织之间的协作努力，以确保制定全面的实践指南。协作涉及指南制定组织之间的合作和协调努力，其中多个实体为指南制定做出贡献并参与其中。背书是指外部实体对实践指南的正式批准，表明他们同意或确认建议的指南。我们区分了背书的两种观点：i)背书者：组织X认可由外部组织制定的指导方针。ii)被认可方：外部组织认可x组织制定的准则。我们根据学术实体对卫生研究合作的系统审查结果预先指定了一份合作组成部分清单。此外，我们还容纳了从数据中识别的任何新出现的组件。随后，我们抽象了与这些组件相关的数据。我们的研究排除了组织内或团队间的合作。我们使用频率和百分比分析分类变量，并以文本、图形和表格格式总结研究结果。结果：在133个确定的在公开指导文件中描述其方法的指导方针生产组织中，73个（55%）组织描述了至少一种合作方法，（N=59）被归类为“合作”，（N=41）被归类为“认可”。最常被提及的合作要素包括传播计划（50%）、团队结构和治理（48%）、合作条件和合作决策的权威（42%）以及利益冲突政策（32%）。最少被提及的部分包括劳动分工（2%）、沟通计划（2%）和写作（2%）。许多组件，如共享资源、共享利益和协议开发计划，根本没有得到解决。背书方法的组成部分根据视角是背书者还是被背书的组织而有所不同。讨论：最常见的合作组成部分是传播计划。在核可方面，最经常提到的是合作条件。许多重要的组成部分要么不够充分，要么没有包括在内。

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引用次数: 0

User experiences of qualitative evidence in the GRADE evidence-to-decision framework: findings from Malawi, Nigeria, and South Africa GRADE从证据到决策框架中定性证据的用户体验——来自马拉维、尼日利亚和南非的调查结果。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112060

Elodie Besnier , Dachi Arikpo , Emmanuel Effa , Idriss I. Kallon , Moriam Chibuzor , Simon Lewin , Nyanyiwe Mbeye , Susan Munabi-Babigumira , Sara Cooper , Claire Glenton

Objectives

Qualitative evidence can provide valuable insights to guideline development groups (GDGs) on the acceptability, feasibility, equity and implementation considerations of an intervention. However, there is inadequate guidance on how to present qualitative evidence that informs these questions. In the Global Evidence, Local Adaptation (GELA) project, we explored GDG members' experiences of the qualitative evidence that informed the acceptability, feasibility, and equity criteria of the GRADE Evidence-to-Decision framework (EtD-F), in the context of guideline development in three sub-Saharan African countries.

Study Design and Setting

We carried out user tests of the GRADE EtD-F developed during GELA. We conducted a total of 12 interviews with GDG members in Malawi, Nigeria, and South Africa. We reviewed the interview transcripts to identify and prioritize problems, positive feedback, and suggestions. We also carried out a thematic analysis informed by Rosenbaum's adaptation of the Honeycomb Model, which defines seven domains of user experience (accessibility, findability, usability, understandability, credibility, desirability, and affiliation).

Results

Overall, users experienced the GRADE Evidence-to-Decision document as credible and understandable and identified with the content related to the acceptability, feasibility, and equity criteria. Users disagreed on how summarized information presenting qualitative evidence should be. Given the text-heavy nature of qualitative evidence, the design and layout of this information in the document helped make the qualitative evidence more desirable, understandable, and relatable to users. However, some GDG members had difficulties in navigating the document, understanding certain framework components, or defining its purpose; highlighting their need for orientation and further guidance to efficiently make use of the acceptability, feasibility, and equity information presented.

Conclusion

How qualitative evidence is presented contributes to guideline panels' ability to understand, identify with, and use this evidence when making decisions. However, further research is needed on how to optimize user experiences of different types of evidence in the GRADE EtD-F.

定性证据可以为指南制定小组（gdg）提供有关干预措施的可接受性、可行性、公平性和实施考虑因素的有价值的见解。然而，关于如何提供定性证据来说明这些问题的指导并不充分。在全球证据，地方适应（GELA）项目中，我们在三个撒哈拉以南非洲国家制定指南的背景下，探讨了GDG成员在定性证据方面的经验，这些定性证据为GRADE证据到决策框架（EtD-F）的可接受性、可行性和公平性标准提供了依据。研究设计和设置我们对GELA期间开发的GRADE EtD-F进行了用户测试。我们对马拉维、尼日利亚和南非的gg成员进行了总共12次采访。我们回顾了面试记录，以确定问题、积极反馈和建议的优先级。我们还根据Rosenbaum对蜂巢模型的改编进行了专题分析，该模型定义了用户体验的七个领域（可访问性、可查找性、可用性、可理解性、可信度、可取性和从属关系）。结果总体而言，用户认为GRADE从证据到决策的文件是可信的、可理解的，并认同与可接受性、可行性和公平性标准相关的内容。用户对如何总结提供定性证据的信息持不同意见。考虑到定性证据的大量文本性质，文档中这些信息的设计和布局有助于使定性证据更可取、更容易理解，并与用户产生关联。然而，一些GDG成员在浏览文件、理解某些框架组件或定义其目的方面存在困难；强调他们需要指导和进一步的指导，以有效地利用所提供的可接受性、可行性和公平性信息。结论如何提供定性证据有助于指南小组在决策时理解、认同和使用这些证据的能力。然而，如何在GRADE EtD-F中优化不同类型证据的用户体验还需要进一步的研究。

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引用次数: 0

Guideline organizations’ guidance documents paper 7: updating practice guidelines 指引机构指引文件第7号文件：更新实务指引

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112062

Rachad Ghazal , Joanne Khabsa , Jessica Mroueh , Omar Ezzedin , Vanessa Mroueh , Elie A. Akl

Background and Objectives

Practice guidelines play a crucial role in patient care and policymaking, making it essential that they remain current and reflect the latest evidence. This study describes the processes used by guideline-producing organizations to update practice guidelines as described in their guidance documents.

Methods

We conducted a descriptive summary of guideline-producing organizations’ publicly available guidance documents on guideline development addressing guideline updates (eg, guideline handbooks). We assessed eligibility and abstracted data independently and in duplicate. We synthesized data in textual and tabular formats.

Results

Of 133 identified guideline-producing organizations with guidance documents on guideline development, 107 (80%) had guidance covering at least one aspect of the updating process. The most common trigger for updating was a change in evidence (75%), and most organizations revisited their previous search strategy for the updating process (65%). The updated guidelines were primarily published electronically (84%), with only a small proportion specifying methods for highlighting changes (12%) or notifying users (5%). A small proportion of organizations used a prespecified frequency for expiring guidelines (12%).

Conclusion

This research provides new insights into the updating process of practice guidelines and highlights the need for improved methods, particularly for communicating to users the occurrence of updates and any changes to the recommendations.

导言：实践指南在患者护理和政策制定中发挥着至关重要的作用，使其保持最新并反映最新证据至关重要。本研究描述了制定指南的组织更新其指南文件中所描述的实践指南所使用的过程。方法：我们对制定指南的组织的公开可用的指南文件进行了描述性总结，这些文件涉及指南的更新（例如，指南手册）。我们评估了合格性，并独立提取了两份数据。我们以文本和表格格式合成数据。结果：分析了107家指南编制机构的更新过程。最常见的更新触发器是证据的变化（75%），大多数组织在更新过程中重新审视了他们以前的搜索策略（65%）。更新后的指南主要以电子方式发布（84%），只有一小部分指定了突出显示更改的方法（12%）或通知用户（5%）。一小部分组织使用预先指定的指南过期频率（12%）。讨论：这项研究为实践指南的更新过程提供了新的见解，并强调了改进方法的必要性，特别是与用户沟通更新的发生和建议的任何更改。

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引用次数: 0

Guideline organizations’ guidance documents paper 6: adaptation of practice guidelines 指引机构指引文件第6号文件：实务指引的改编

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112064

Rayane El-Khoury , Mariam Nour Eldine , Walid Abboud , Joanne Khabsa , Holger J. Schünemann , Elie A. Akl

Background and Objectives

Developing high-quality practice guidelines is resource-intensive, leading many guideline-producing organizations to adapt existing recommendations. The objective of this paper is to describe processes for adapting practice guidelines of guideline-producing organizations as described in their guidance documents on guideline development.

Methods

We conducted a descriptive summary. Using multiple sources, we compiled a list of guideline-producing organizations and then searched for their publicly available guidance documents on guideline development (eg, handbooks). We included organizations addressing adaptation in their guidance documents. Teams of two authors assessed eligibility and abstracted data in duplicate and independently. We synthesized data in both textual and tabular formats.

Results

Of 133 identified guideline-producing organizations with guidance documents on guideline development, 23 (17%) addressed adaptation. The most frequently addressed aspects of the adaptation process were (1) developing an adaptation plan (91%); (2) the factors considered for modifying source recommendations (91%), including acceptability of the intervention (52%), resource considerations (48%), values and preferences (43%), and applicability of the intervention (40%); (3) assessing the source guidelines (83%), with the three main criteria used being quality (65%), currency (65%), and relevance (39%); and (4) using source recommendations (78%). None of the organizations described a detailed approach for how to explain discordance of recommendations between different source guidelines, and which one to use.

Conclusion

Although this study provides insight into different aspects of the adaptation process, most organizations do not address these aspects in a comprehensive or detailed way. Clearer guidance and checklists are needed to support organizations in conducting efficient and context-specific adaptation efforts.

背景：开发高质量的实践指南是资源密集型的，导致许多指南生产组织适应现有的建议。本文的目的是描述在指南制定的指导文件中描述的指南生产组织的适应实践指南的过程。方法：进行描述性总结。使用多种来源，我们编制了一个指南生产组织的列表，然后搜索他们关于指南开发的公开可用的指导文件（例如，手册）。我们将处理适应问题的组织纳入其指导文件。由两名审稿人组成的小组评估合格性，并独立地提取两份数据。我们以文本和表格两种格式合成数据。结果：在133个具有指南制定指导文件的确定指南制定组织中，23个（17%）涉及适应问题。适应过程中最常被提及的方面是：(1)制定适应计划（91%）；(2)修改来源建议时考虑的因素（91%），包括干预的可接受性（52%）、资源考虑（48%）、价值观和偏好（43%）以及干预的适用性（40%）；(3)评估来源指南（83%），使用的三个主要标准是质量（65%），货币（65%）和相关性（39%）；(4)使用源推荐（78%）。没有一个组织详细描述了如何解释不同来源指南之间建议的不一致，以及使用哪一个。讨论：虽然这项研究提供了对适应过程的不同方面的见解，但大多数组织并没有以全面或详细的方式解决这些方面。需要更清晰的指导和清单，以支持各组织开展有效和具体情况的适应工作。

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引用次数: 0

Guideline organizations' guidance documents paper 2: priority setting 指导组织的指导文件文件2：优先级设置。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112070

May Mohamad , Joanne Khabsa , Mariam Nour Eldine , Sally Yaacoub , Fatimah Chamseddine , Zeina Itani , Rayane El-Khoury , Elie A. Akl

Background and Objectives

In the development of practice guidelines, priority setting of topics, questions, and outcomes ensures relevance and resource efficiency. The objective of this study was to describe priority setting processes as described in guidance documents by guideline-producing organizations.

Methods

We conducted a descriptive summary of guideline-producing organizations' publicly available guidance documents on practice guideline development (eg, guideline handbooks). We screened guideline-producing organizations' documents and abstracted data in duplicate and independently. We abstracted data on the elements of the priority setting process, including generation of initial list, method or tool used in the priority setting process, use of priority setting criteria, and refinement.

Results

Of the 133 identified organizations with publicly available guidance documents, 94 (71%) reported on a priority setting process for guideline development, with 16 also reporting on a priority setting process for guideline updating (12%). Most of the organizations addressed, in their guidance documents, topic priority setting (94%), whereas a minority addressed priority setting of questions (36%), outcomes (29%), implementation (12%), quality measures (15%), and future research (5%). In the guidance documents, generation of the initial list was the most addressed element for topics (88%), questions (65%) and outcomes (59%), followed by the use of criteria for topics (89%) and questions (59%), and refinement for outcomes (52%). A minority of organizations provided guidance to a published priority setting method or tool, which was only for topics (24%). The top used criteria for priority setting of topics were the impact of intervention on health outcomes (74%), variation/gaps in practice (69%), availability of evidence (69%), and disease health burden (68%); whereas for questions, top criteria were availability of evidence (60%), followed by interest at health professional/organization level (50%), uncertainty or controversy about best practice (40%), and variation/gaps in practice (40%).

Conclusion

This analysis of guideline-producing organizations revealed that a majority reported a priority-setting process, which primarily focused on topic selection and less on aspects like questions and outcomes. Although generating an initial list and using priority-setting criteria are common, few organizations report in their guidance documents using formal priority-setting tools, addressing refinement, or providing guidance for guideline updating or adaptation. A standardized priority setting process for all aspects of guideline development is needed.

导言：在实践指南的制定中，主题、问题和结果的优先设置确保了相关性和资源效率。本研究的目的是描述指导方针编制组织在指导文件中所描述的优先事项确定过程。方法：我们对制定指南的组织在实践指南发展方面公开可用的指导文件（例如，指南手册）进行了描述性总结。我们筛选了制定指南的组织的文件，并独立地提取了两份数据。我们提取了优先级设置过程要素的数据，包括初始列表的生成、优先级设置过程中使用的方法或工具、优先级设置标准的使用以及细化。结果：在133个拥有公开指导文件的确定组织中，94个（71%）报告了指南制定的优先级设置过程，16个还报告了指南更新的优先级设置过程（12%）。大多数组织在其指导文件中解决了主题优先级设置（94%），而少数组织解决了问题优先级设置（36%），结果（29%），实施（12%），质量措施（14%）和未来研究（5%）。在指导文件中，生成初始列表是主题（88%）、问题（65%）和结果（59%）的最重要元素，其次是使用主题（89%）和问题（59%）的标准，以及结果的细化（52%）。少数组织为发布的优先级设置方法或工具提供指导，这仅针对主题（24%）。优先确定主题的最常用标准是干预对健康结果的影响（74%）、实践中的差异/差距（69%）、证据的可获得性（69%）和疾病健康负担（68%）；而对于问题，最高标准是证据的可获得性（60%），其次是卫生专业人员/组织层面的兴趣（50%），最佳实践的不确定性或争议（40%）以及实践中的差异/差距（40%）。讨论：对制定指导方针的组织的分析表明，大多数组织报告了优先级设置过程，主要关注主题选择，较少关注问题和结果等方面。虽然生成初始列表和使用优先级设置标准是常见的，但很少有组织在其指导文件中使用正式的优先级设置工具，解决改进问题，或为指南更新或适应提供指导。需要为指南制定的各个方面制定标准化的优先顺序。

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引用次数: 0

Guideline organizations' guidance documents paper 5: conflict of interest and funding 指导组织的指导文件文件5：利益冲突和资金。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-19 DOI: 10.1016/j.jclinepi.2025.112061

Joanne Khabsa , Zeina Itani , Hussein A. Noureldine , Francesco Nonino , Mohamed M. Khamis , Jose F. Meneses-Echavez , Joseph Bejjani , Sally Yaacoub , Holger J. Schünemann , Elie A. Akl

Background and Objectives

Bias in the development process of practice guidelines can be introduced through contributors' conflicts of interest (COIs) and the funding sources. The objective of this study was to describe policies of guideline-producing organizations on COIs of contributors and funding of practice guideline projects.

Methods

We conducted a descriptive summary of publicly available guidance documents of guideline-producing organizations. Two authors assessed eligibility and abstracted data on the organizations' characteristics, COI policies (declaration, verification, assessment of whether an interest qualifies as a COI, management, and reporting), and funding policies.

Results

Out of 133 identified guideline-producing organizations, 110 reported a COI and/or a funding policy. Most COI policies required the declaration of relevant interests only (60%). A minority of policies described a process to verify declarations (10%). Most policies mentioned the assessment of whether an interest qualifies as a COI (55%), but few provided specific criteria. Policies mostly specified discussions (43%) and voting (43%) as parts of the process from which conflicted individuals should be excluded. A minority of policies reported on the process by which COIs were evaluated and managed (25%). Most organizations accept external funding (70%), either any external funding (44%) or any external funding except for industry funding (26%), with 72% mentioning mitigation strategies.

Conclusion

Some, but not all, aspects of COI and funding were commonly addressed by policies of guideline-producing organizations. There were also inconsistencies across policies.

导言：在实践指南的制定过程中，通过贡献者的利益冲突和资金来源，可以引入偏见。本研究的目的是描述指南制定组织在贡献者利益冲突和实践指南项目资助方面的政策。方法：我们对指导方针制定组织的公开可用的指导文件进行了描述性总结。两位作者评估了资格，并提取了有关组织特征、利益冲突政策（声明、验证、利益是否符合利益冲突的评估、管理和报告）和资助政策的数据。结果：在133个指南制定组织中，110个报告了利益冲突和/或资助政策。大多数利益冲突政策只要求申报相关利益（60%）。少数政策描述了验证声明的过程（10%）。大多数政策提到了对利益是否符合利益冲突的评估（55%），但很少提供具体标准。政策大多指定讨论（43%）和投票（43%）作为过程的一部分，冲突的个人应该被排除在外。少数政策报告了评估和管理利益冲突的过程（25%）。大多数组织接受外部资助（70%），要么接受任何外部资助（44%），要么接受除行业资助以外的任何外部资助（26%）；72%的人提到了缓解策略。讨论：制定指导方针的组织的政策通常处理利益冲突和资金的某些方面，但不是所有方面。政策之间也存在不一致之处。

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引用次数: 0

Methods for developing diagnostic criteria for conditions without objective tests, biomarkers, or reference standards: a scoping review 无客观试验、生物标记物或参考标准的病症诊断标准的制定方法：范围综述

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-18 DOI: 10.1016/j.jclinepi.2025.112052

Samuel J. White , Timothy H. Barker , Tracy Merlin , Grace Holland , Sharon Sanders , Aoife O'Mahony , Thanya Pathirana , Rebecca Theiss , Danielle Pollock , Natasha Reid , Zachary Munn

<div><h3>Background and Objectives</h3><div>Diagnostic criteria play an important role in informing clinical decision-making, particularly for conditions lacking objective tests, biomarkers, or reference standards. Despite their importance, there is no established methodological guidance for developing diagnostic criteria. This scoping review aimed to identify and describe the methodological approaches used to develop diagnostic criteria in the absence of objective tests, biomarkers, or reference standards.</div></div><div><h3>Study Design and Setting</h3><div>We conducted a scoping review in accordance with JBI methodology and the PRISMA-ScR reporting guideline. Studies published between 2000 and 2024 that described methods used to develop diagnostic criteria for conditions without objective tests, biomarkers, or reference standards were included. A comprehensive search was performed across multiple databases and supplemented with gray literature searches and expert consultation. Data were extracted independently by two reviewers and synthesized using descriptive statistics and qualitative content analysis.</div></div><div><h3>Results</h3><div>We included 139 studies. Suboptimal reporting of methodology was a barrier to assessment of methodological credibility. Authors used one or more of three main approaches to develop diagnostic criteria: consensus-based, literature-based, and/or primary study–based. Consensus methods were used in 98/139 (71%) of studies, with Delphi or modified Delphi approaches being the most commonly adopted. The role of evidence in diagnostic criteria development was not described in 36/139 (26%) of the included studies. In studies using consensus methodology to develop diagnostic criteria, prospective approaches to ensuring appropriate diversity among the diagnostic criteria development panel were employed in only 5/98 (5%) of studies and patient/advocate consultation was performed in 18/98 (18%) of studies.</div></div><div><h3>Conclusion</h3><div>Methodological approaches to developing diagnostic criteria for conditions without objective tests or standards are variable, inconsistently reported and often lack a clear evidence base. This could be aided by development of specific methodological guidance.</div></div><div><h3>Plain Language Summary</h3><div>When lab tests or scans are not available to confirm a diagnosis, doctors may use diagnostic criteria to help them decide what condition a patient may have. There is currently no clear way to create these criteria, which can lead to inconsistency and confusion. We looked at why this matters—because diagnostic criteria developed without transparency or methodological rigor may lead to incorrect diagnosis, patient harm or inequitable access to care—and explored how researchers develop diagnostic criteria when an objective test does not exist. Most studies relied on expert meetings, but many did not explain how they chose experts, gathered evidence or involved diverse perspe

目的：诊断标准在告知临床决策方面发挥重要作用，特别是在缺乏客观检测、生物标志物或参考标准的情况下。尽管它们很重要，但尚无制定诊断标准的既定方法学指导。本综述旨在确定和描述在缺乏客观检测、生物标志物或参考标准的情况下用于制定诊断标准的方法学方法。研究设计和设置：我们按照JBI方法和PRISMA-ScR报告指南进行了范围审查。2000年至2024年间发表的研究，描述了在没有客观测试、生物标志物或参考标准的情况下制定诊断标准的方法。在多个数据库中进行了全面的搜索，并辅以灰色文献搜索和专家咨询。数据由两位审稿人独立提取，并使用描述性统计和定性内容分析进行综合。结果：我们纳入了139项研究。不理想的方法学报告是评估方法学可信性的障碍。作者使用三种主要方法中的一种或多种来制定诊断标准：基于共识、基于文献和/或基于初步研究。98/139（71%）的研究采用了共识法，其中德尔菲法或修正德尔菲法是最常用的方法。纳入的研究中有36/139（26%）没有描述证据在诊断标准制定中的作用。在使用共识方法制定诊断标准的研究中，只有5/98（5%）的研究采用前瞻性方法来确保诊断标准制定小组之间的适当多样性，18/98（18%）的研究进行了患者/倡导者咨询。结论：在没有客观测试或标准的情况下制定诊断标准的方法学方法是可变的，报告不一致，往往缺乏明确的证据基础。这可以通过制定具体的方法指导得到帮助。简单的语言总结：当实验室测试或扫描无法确认诊断时，医生可能会使用诊断标准来帮助他们确定患者可能患有的疾病。目前还没有明确的方法来创建这些标准，这可能导致不一致和混乱。我们研究了为什么这很重要——因为在没有透明度或方法严密性的情况下制定的诊断标准可能导致错误的诊断、对患者的伤害或获得护理的不公平机会——并探讨了在没有客观测试的情况下，研究人员如何制定诊断标准。大多数研究依赖于专家会议，但许多研究没有解释他们如何选择专家、收集证据或涉及不同的观点，如病人的声音。我们的研究表明，目前的做法往往没有得到很好的解释，可能存在偏见或不完整。通过了解哪些是缺失的，哪些是可行的，我们希望这项研究能鼓励更好、更透明的方法，这样未来的诊断标准对患者和医疗保健提供者来说都更清晰、更公平、更值得信赖。

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引用次数: 0

Guideline organizations' guidance documents paper 11: quality assurance and improvement in guideline development 指南组织的指导文件文件11：指南制定的质量保证和改进。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-17 DOI: 10.1016/j.jclinepi.2025.112069

Lili Zeidan , Ahmad Najia , Elena Parmelli , Miranda Langendam , Joanne Khabsa , Elie A. Akl

Background and Objectives

The integration of quality assurance and improvement (QAI) into all steps of guideline development can promote the measurability and relevance of guidelines to real-world practice. Our objective was to describe QAI processes as described in guidance documents of guideline-producing organizations.

Methods

We conducted a comprehensive search in 2021, and updated it in 2024, to identify guidance documents publicly available by guideline-producing organizations. We abstracted data based on the items of the Guidelines International Network (GIN)-McMaster Checklist Extension for Quality Assurance and Quality Improvement (published in 2022) as well as any additional items that emerged from our data. Two authors independently assessed the eligibility of identified organizations and abstracted data on the organization's characteristics, QAI processes in guideline development, and on terminology used to refer to QAI elements (eg, quality indicators, performance measures). We analyzed categorical variables using frequencies and percentages and summarized the findings in textual and tabular formats.

Results

Sixty-nine of 133 guideline-producing organizations (about half) addressed QAI either as a brief mention (57%), a section in a document (33%), or a dedicated document (10%). Guideline-producing organizations used inconsistent terminology when referring to QAI elements. The most frequently addressed QAI items were predefining the process to select final quality measures (26%), the need for project subgroups to work on QAI (25%), and identifying the individuals of the subgroups (23%). The least addressed items were considering institutional conflicts of interest (1%), providing clarity on accountability to making the changes in quality indicators (3%), and developing/adopting a standardized reporting format (4%). Some QAI items were not addressed at all, including determining the QAI scheme scope, perspective, and pilot-testing of indicators with target users.

Conclusion

The coverage of the items of the GIN-McMaster GDC QAI extension varies across the guidance documents of guideline-producing organizations. Also, the organizations used inconsistent terminology when referring to QAI elements.

导言：将质量保证和改进（QAI）整合到指南制定的所有步骤中，可以促进指南与现实世界实践的可测量性和相关性。我们的目标是按照制定指导方针的组织的指导文件描述质量质量评价过程。方法：我们于2021年进行了全面检索，并于2024年进行了更新，以确定指南制定组织公开提供的指导文件。我们根据GIN-McMaster质量保证和质量改进扩展清单（2022年出版）的项目以及从我们的数据中出现的任何其他项目提取数据。两位作者独立地评估了确定的组织的资格，并对组织的特征、指南制定中的质量评价过程以及用于参考质量评价要素（例如，质量指标、绩效度量）的术语提取了数据。我们使用频率和百分比分析分类变量，并以文本和表格格式总结研究结果。结果：133个制定指南的组织中有68个（约一半）将QAI作为简短的提及（57%），文档中的一个部分（34%）或专门的文档（9%）。制定指南的组织在提及QAI元素时使用了不一致的术语。最常提到的QAI项目是预先定义选择最终质量度量的过程（25%），项目子组在QAI上工作的需要（22%），以及确定子组的个体（22%）。涉及最少的项目是考虑机构利益冲突（1%），制定/采用标准化报告格式（3%），以及为质量指标的变化提供明确的责任（3%）。一些质量评价项目根本没有得到解决，包括确定质量评价方案的范围、观点和目标用户指标的试点测试。讨论：GIN-McMaster指南开发清单QAI扩展项目的覆盖范围在指南制作组织的指导文件中有所不同。此外，组织在引用QAI元素时使用了不一致的术语。

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引用次数: 0

Guideline organizations' guidance documents paper 8: considering equity 指引组织的指引文件第8号文件：考虑公平。

IF 5.2 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology

Pub Date : 2025-11-17 DOI: 10.1016/j.jclinepi.2025.112067

Jana Khawandi , Noha El Yaman , Omar Dewidar , Tracy Faddoul , Lynn Lteif , Reem A. Mustafa , Elie A. Akl , Joanne Khabsa

Background and Objectives

To ensure practice guidelines contribute to improving equity, guideline developers need to consciously consider populations experiencing inequities throughout the process. Our aim was to describe whether and how guideline-producing organizations consider equity in the guideline development process as described in their guidance documents on guideline development.

Methods

We conducted a descriptive summary of guideline-producing organizations using different sources and retrieved their publicly available guidance documents on guideline development (eg, handbooks). We screened guidance documents and abstracted information about equity consideration within topics of the GIN-McMaster guideline development checklist.

Results

Of 133 identified guideline-producing organizations with guidance documents on guideline development, 52% considered equity in their guidance documents in at least one of the 18 topics of the GIN-McMaster checklist. Most organizations were professional (55%) and national (77%). The median number of topics considered per organization was 2 (IQR = 1–4), with the World Health Organization (WHO) considering the highest number of topics. The topic in which equity was considered the most was “guideline group membership” (57%), while the topic in which equity was considered the least was “conflict of interest considerations” (1%). In addition, some of the terms related to equity and populations experiencing inequities used were “inequitable or equality” and “minority or disadvantaged”, respectively.

Conclusion

More than half of guideline-producing organizations consider equity in guideline development, with considerations limited to a few groups of populations and a few topics of the guideline development process.

背景：为了确保实践指南有助于提高公平性，指南的制定者需要有意识地考虑在整个过程中经历不公平的人群。我们的目的是描述指南制定组织是否以及如何在指南制定过程中考虑其指南制定指导文件中所描述的公平性。方法：我们使用不同的资源对制定指南的组织进行了描述性总结，并检索了他们关于指南制定的公开指导文件（例如手册）。我们筛选了指导文件，并从GIN-McMaster指南制定清单的主题中提取了有关公平考虑的信息。结果：在133个确定的指导方针制定组织中，52%的组织在其指导文件中考虑了GIN-McMaster清单中18个主题中至少一个主题的公平性。大多数组织是专业的（55%）和全国性的（77%）。每个组织审议的主题数中位数为2 (IQR=1-4)，其中世界卫生组织（世卫组织）审议的主题数最多。公平性被考虑最多的主题是“指南小组成员”（57%），而公平性被考虑最少的主题是“利益冲突考虑”（1%）。此外，所使用的与公平和遭受不平等的人口有关的一些用语分别是：“不公平或平等”和“少数或处境不利”。讨论：超过一半的制定指南的组织在制定指南时考虑到公平，只考虑指南制定过程中的少数人群和少数主题。

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引用次数: 0