guideline development

指导方针发展
  • 文章类型: Review
    生活评论是一种越来越受欢迎的研究范式。“生活”方法的目的是允许快速整理,对一个重要研究课题的不断发展的证据进行评估和综合,能够及时影响患者护理和公共卫生政策。然而,生活评论是时间和资源密集型的。新证据的积累和评论研究主题中发展的可能性可能会给活的评论工作流程带来独特的挑战。为了调查软件工具的潜力,以支持生活系统或快速审查,我们通过系统审查工具箱网站上包含的工具进行了叙述性审查。我们确定了11种具有相关功能的工具,并讨论了这些工具在实时审查工作流程的不同步骤中的重要功能。四个工具(NestedKnowledge,SWIFT-ActiveScreener,DistillerSR,EPPI-审阅者)涵盖了多个,审查过程的连续步骤,其余工具涉及工作流程的特定组件,包括范围界定和方案制定,参考文献检索,自动数据提取,数据的写入和传播。我们确定了几种可以使生活评论更有效和实用的方法。其中大多数侧重于一般的工作流管理,或者通过人工智能和机器学习实现自动化,在筛选过程中。自动化的更复杂的使用主要针对生活快速审查,以提高生产速度或证据地图,以扩大地图的范围。我们使用案例研究来强调将工具纳入实时审查工作流程和流程的一些障碍和挑战。这些包括增加的工作量,组织的需要,确保与开发定制自动化工具相关的及时传播和挑战,以促进审查过程。我们描述了当前的最终用户工具如何应对这些挑战,以及哪些知识差距仍然存在,可以通过未来的工具开发来解决。专门的网络存在,用于自动传播正在进行的证据更新,而不是仅仅依靠同行评审的期刊出版物,帮助使一个活生生的证据合成的努力值得。尽管提供了基本的生活审查功能,可以进一步开发现有的最终用户工具,以与其他工具互操作,以无缝支持多个工作流程步骤,为了解决从更多来源进行更广泛的自动证据检索的问题,并改善审查更新之间的证据传播。
    Living reviews are an increasingly popular research paradigm. The purpose of a \'living\' approach is to allow rapid collation, appraisal and synthesis of evolving evidence on an important research topic, enabling timely influence on patient care and public health policy. However, living reviews are time- and resource-intensive. The accumulation of new evidence and the possibility of developments within the review\'s research topic can introduce unique challenges into the living review workflow. To investigate the potential of software tools to support living systematic or rapid reviews, we present a narrative review informed by an examination of tools contained on the Systematic Review Toolbox website. We identified 11 tools with relevant functionalities and discuss the important features of these tools with respect to different steps of the living review workflow. Four tools (NestedKnowledge, SWIFT-ActiveScreener, DistillerSR, EPPI-Reviewer) covered multiple, successive steps of the review process, and the remaining tools addressed specific components of the workflow, including scoping and protocol formulation, reference retrieval, automated data extraction, write-up and dissemination of data. We identify several ways in which living reviews can be made more efficient and practical. Most of these focus on general workflow management, or automation through artificial intelligence and machine-learning, in the screening process. More sophisticated uses of automation mostly target living rapid reviews to increase the speed of production or evidence maps to broaden the scope of the map. We use a case study to highlight some of the barriers and challenges to incorporating tools into the living review workflow and processes. These include increased workload, the need for organisation, ensuring timely dissemination and challenges related to the development of bespoke automation tools to facilitate the review process. We describe how current end-user tools address these challenges, and which knowledge gaps remain that could be addressed by future tool development. Dedicated web presences for automatic dissemination of in-progress evidence updates, rather than solely relying on peer-reviewed journal publications, help to make the effort of a living evidence synthesis worthwhile. Despite offering basic living review functionalities, existing end-user tools could be further developed to be interoperable with other tools to support multiple workflow steps seamlessly, to address broader automatic evidence retrieval from a larger variety of sources, and to improve dissemination of evidence between review updates.
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  • 文章类型: Review
    背景:在过去的十年中,围绕医疗保健行业的临床实践指南(CPG)开发,这增加了准则生产组织加快发展CPG的压力。这些旨在提高提供给患者的护理质量,同时控制医疗保健成本并减少临床实践中的变异性。然而,这无意中导致了卫生组织之间CPG建议的差异,也挑战医疗保健提供者依赖这些决策和告知临床护理。从全球角度来看,尽管一些国家已经启动了关于发展的国家议定书,评估和实施高质量的CPG,在CPG生产的任何方面都没有标准化的方法。
    方法:根据JoannaBrigg研究所的范围审查方法对文献和文献分析进行范围审查。这包括两种定性方法:对文献的全面回顾(使用CINAHL,Scopus和PubMeD)以及对所有国家和国际指南制定过程的文件分析(手动搜索与健康相关的网站,国家/国际组织卫生政策和文件)。
    结果:确定了一套明确的原则和流程对CPG开发至关重要,通知规划,建议的执行和传播。从根本上说,报告了两个共同目标:提高临床实践(患者护理)的质量和一致性,以及减少低等级CPG的重复或批准.
    结论:CPG工作组之间的协商和沟通,包括广泛的代表(包括专业组织,区域和地方办事处,和相关国家机构)至关重要。需要进一步研究以确定标准化方法和传播建议的可行性。
    BACKGROUND: Over the past decade, an industry has emerged around Clinical Practice Guideline (CPG) development in healthcare, which has increased pressure on guideline-producing organisations to develop CPGs at an accelerated rate. These are intended to improve the quality of care provided to patients while containing healthcare costs and reducing variability in clinical practice. However, this has inadvertently led to discrepancies in CPG recommendations between health organisations, also challenging healthcare providers who rely on these for decision-making and to inform clinical care. From a global perspective, although some countries have initiated national protocols regarding developing, appraising and implementing high-quality CPGs, there remains no standardised approach to any aspect of CPG production.
    METHODS: A scoping review of the literature and document analysis were conducted according to Joanna Brigg\'s Institute methodology for scoping reviews. This comprised two qualitative methods: a comprehensive review of the literature (using CINAHL, Scopus and PubMeD) and a document analysis of all national and international guideline development processes (manual search of health-related websites, national/international organisational health policies and documents).
    RESULTS: A set of clear principles and processes were identified as crucial to CPG development, informing the planning, implementation and dissemination of recommendations. Fundamentally, two common goals were reported: to improve the quality and consistency of clinical practice (patient care) and to reduce the duplication or ratification of low-grade CPGs.
    CONCLUSIONS: Consultation and communication between CPG working parties, including a wide range of representatives (including professional organisations, regional and local offices, and relevant national bodies) is essential. Further research is required to establish the feasibility of standardising the approach and disseminating the recommendations.
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  • 文章类型: Journal Article
    BACKGROUND: Evidence-to-decision (EtD) frameworks provide a structured and transparent approach for groups of experts to use when formulating recommendations or making decisions. While extensively used for clinical and public health recommendations, EtD frameworks are not in widespread use in environmental health. This review sought to identify, compare and contrast key EtD frameworks for decisions on interventions used in clinical medicine, public health or environmental health. This information can be used to develop an EtD framework suitable for formulating recommendations for interventions in environmental health.
    METHODS: We identified a convenience sample of EtD frameworks used by a range of organizations. We searched Medline for systematic reviews of frameworks. We summarized the decision criteria in the selected frameworks and reviews in a qualitative manner.
    RESULTS: Fourteen organizations provided 18 EtD frameworks; most frameworks focused on clinical medicine or public health interventions; four focused on environmental health and three on economic considerations. Harms of interventions were examined in all frameworks and benefits in all but one. Other criteria included certainty of the body of evidence (15 frameworks), resource considerations (15), feasibility (13), equity (12), values (11), acceptability (11), and human rights (2). There was variation in how specific criteria were defined. The five identified systematic reviews reported a similar spectrum of EtD criteria.
    CONCLUSIONS: The EtD frameworks examined encompassed similar criteria, with tailoring to specific audience needs. Existing frameworks are a useful starting point for development of one tailored to decision-making in environmental health.
    UNASSIGNED: JPB Foundation.
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  • 文章类型: Journal Article
    背景:在COVID-19大流行的高峰期,泰国几乎耗尽了重症监护资源,特别是重症监护病房(ICU)的病床和呼吸机。这促使有必要制定国家资源分配准则。本文介绍了COVID-19大流行期间泰国关键资源分配国家指南的制定过程。
    方法:指南制定过程包括三个步骤:(1)快速审查现有的配给指南和文献;(2)采访在照顾COVID-19病例方面经验丰富的泰国临床医生;(3)多方利益相关者协商。在步骤1和2,使用主题和内容分析方法对数据进行了综合和分类,这指导了准则草案的制定。在第3步中,在进入决策阶段之前,对泰国重症监护分配指南草案进行了辩论并最终确定。
    结果:三阶优先标准,包括(1)使用四种工具的临床预后(Charlson合并症指数,序贯器官失效评估,虚弱评估和认知障碍评估),(2)研究小组根据文献综述和访谈提出了保存生命年数和(3)社会有用性。在协商中,由于潜在的年龄和性别歧视,利益相关者拒绝使用生命年作为标准,以及社会效用,因为担心它会助长公众的不信任,因为这个判断可以是任意的。商定,主治医师必须是泰国医学法律背景下的决策者,而患者审查委员会将发挥咨询作用。分配决策要记录在案,以提高透明度,没有上诉机制。只有在尽最大努力调动激增能力后,需求超过供应时,才会触发该准则。一旦实施,它适用于所有患者,COVID-19和非COVID-19,在入住ICU之前和入住ICU期间需要重症监护资源。
    结论:在泰国COVID-19爆发的背景下,重症监护资源分配的指南制定过程是有科学证据的,医学法律背景,考虑到问题的敏感性和指导原则的道德困境,现有的规范和社会价值观可以减少公众不信任的风险,尽管它以创纪录的速度进行。我们的经验教训可以为制定类似的优先级指南提供见解,特别是在其他低收入和中等收入国家。
    BACKGROUND: At the height of the COVID-19 pandemic, Thailand had almost depleted its critical care resources, particularly intensive care unit (ICU) beds and ventilators. This prompted the necessity to develop a national guideline for resource allocation. This paper describes the development process of a national guideline for critical resource allocation in Thailand during the COVID-19 pandemic.
    METHODS: The guideline development process consisted of three steps: (1) rapid review of existing rationing guidelines and literature; (2) interviews of Thai clinicians experienced in caring for COVID-19 cases; and (3) multi-stakeholder consultations. At steps 1 and 2, data was synthesized and categorized using a thematic and content analysis approach, and this guided the formulation of the draft guideline. Within step 3, the draft Thai critical care allocation guideline was debated and finalized before entering the policy-decision stage.
    RESULTS: Three-order prioritization criteria consisting of (1) clinical prognosis using four tools (Charlson Comorbidity Index, Sequential Organ Failure Assessment, frailty assessment and cognitive impairment assessment), (2) number of life-years saved and (3) social usefulness were proposed by the research team based on literature reviews and interviews. At consultations, stakeholders rejected using life-years as a criterion due to potential age and gender discrimination, as well as social utility due to a concern it would foster public distrust, as this judgement can be arbitrary. It was agreed that the attending physician is required to be the decision-maker in the Thai medico-legal context, while a patient review committee would play an advisory role. Allocation decisions are to be documented for transparency, and no appealing mechanism is to be applied. This guideline will be triggered only when demand exceeds supply after the utmost efforts to mobilize surge capacity. Once implemented, it is applicable to all patients, COVID-19 and non-COVID-19, requiring critical care resources prior to ICU admission and during ICU stay.
    CONCLUSIONS: The guideline development process for the allocation of critical care resources in the context of the COVID-19 outbreak in Thailand was informed by scientific evidence, medico-legal context, existing norms and societal values to reduce risk of public distrust given the sensitive nature of the issue and ethical dilemmas of the guiding principle, though it was conducted at record speed. Our lessons can provide an insight for the development of similar prioritization guidelines, especially in other low- and middle-income countries.
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  • 文章类型: Journal Article
    UNASSIGNED: Clinical trials are essential for the advancement of cancer treatments; however, participation by patients is suboptimal. Currently, there is a lack of synthesized qualitative review evidence on the patient experience of trial entry from which to further develop decision support. The aim of this review is to synthesise literature reporting experiences of participants when deciding to enrol in a cancer clinical trial in order to inform practice.
    UNASSIGNED: A systematic review and meta-synthesis of qualitative studies were conducted to describe the experiences of adult cancer patients who decided to enrol in a clinical trial of an anti-cancer treatment.
    UNASSIGNED: Forty studies met eligibility criteria for inclusion. Three themes were identified representing the overarching domains of experience when deciding to enrol in a cancer trial: 1) need for trial information; (2) trepidation towards participation; and (3) justifying the decision. The process of deciding to enrol in a clinical trial is one marked by uncertainty, emotional distress and driven by the search for a cure.
    UNASSIGNED: Findings from this review show that decision support modelled by shared decision-making and the quality of a shared decision needs to be accompanied by tailored or personalised psychosocial and supportive care. Although the decision process bears similarities to theoretical processes outlined in decision-making frameworks, there are a lack of supportive interventions for cancer patients that are adapted to the clinical trial context. Theory-based interventions are urgently required to support the specific needs of patients deciding whether to participate in cancer trials.
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  • 文章类型: Journal Article
    UNASSIGNED: Prehospital care is integral in addressing sub-Saharan Africa\'s (SSA) high injury and illness burden. Consequently, robust, high-quality prehospital guidance documents are needed to inform care. These guidance documents include, but are not limited to, clinical practice guidelines (CPGs), protocols and algorithms that are contextually appropriate for SSA. However, SSA prehospital guidance mostly originates from the \'Global North,\' with limited guidance for Africa by Africans. To strengthen prehospital clinical practice in SSA, we described and appraised all prehospital SSA guidance documents informing clinical decision making.
    UNASSIGNED: We conducted a scoping review of prehospital-relevant guidance documents, including CPGs, algorithms, protocols and position statements originating from SSA. We performed a comprehensive literature search in various databases (PUBMED and SCOPUS), guideline clearing houses (Scottish Intercollegiate Guidelines Network, Trip, and Guidelines International Network), journals, various forms of grey literature and contacted experts. Guidance document screening and data extraction was done independently, in duplicate and reviewed by a third author. Guidance quality was then determined using the AGREE II tool and data were analysed using simple descriptive statistics.
    UNASSIGNED: We included 51 guidance documents from 13 countries across SSA after screening 2320 potential documents. The majority of guidance documents lacked an evidence foundation, made recommendations based on expert input, and were predominantly end-user presentations such as algorithms or protocols. Overall, reporting quality was poor, specifically for critical domains such as rigour of development; however, clarity of presentation was generally strong. Guidance topics were focused around resuscitation and common diseases (both communicable and non-communicable) with major gaps identified across a variety of topics; such as mental health for example.
    UNASSIGNED: The majority of prehospital clinical guidance from SSA provides clinicians with excellent ready to use end-user material. Conversely, most of the guidance documents lack an appropriate evidence foundation and fail to transparently report the guidance development process, highlighting the need to strengthen and build guideline development capacity to promote the transition from eminence-based to evidence-based guidance for prehospital care in SSA. Guideline developers, professional societies and publishers need to be aware of international and local guidance document development and reporting standards in order to produce guidance we can trust.
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  • 文章类型: Journal Article
    The objective of this narrative review was to identify and evaluate published international guidelines on mandibular third molars (M3M) and to assess their clinical scope and the validity of the recommendations. The search strategy used data obtained from a variety of sources including MEDLINE, national regulatory bodies, national dental and surgical colleges and associations, and military medical departments. Adherence to clinical guideline development was investigated using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation). Sixteen guidelines pertaining to M3M were included in this review. The guidelines produced by the Faculty of Dental Surgery of the Royal College of Surgeons of England (FDS RCS) and Scottish Intercollegiate Guidelines Network (SIGN) were recommended as meeting the criteria for use. Seven other guidelines were recommended but required modifications. The AGREE II instrument provides an excellent framework for guideline assessment. Unfortunately, very few guidelines scored highly across all domains and therefore were not believed to be of high quality. Due to the significant lack of structure and variable standards in guideline development, the conclusions and recommendations of these guidelines are compromised. There is a need for organizations involved in developing M3M guidelines to update guidance periodically in order to ensure that the information available to clinicians and patients is accurate and relevant to clinical practice.
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  • 文章类型: Journal Article
    BACKGROUND: Given the considerable efforts and resources required to develop practice guidelines, developers need to prioritize what topics and questions to address. This study aims to identify and describe prioritization approaches in the development of clinical, public health, or health systems guidelines.
    METHODS: We searched Medline and CINAHL electronic databases in addition to Google Scholar. We included papers describing prioritization approaches in sufficient detail allowing for reproducibility. We synthesized findings in a semi-quantitative way. We followed an iterative process to develop a common framework of prioritization criteria that captures all of the criteria reported by each included study.
    RESULTS: Our search captured 33,339 unique citations out of which we identified 10 papers reporting prioritization approaches for guideline development. All of the identified approaches focused on prioritizing guideline topics but none on prioritizing recommendation questions or outcomes. The two most frequently reported steps of the development process for these approaches were reviewing the grey literature (9 out of 10, 90%) and engaging various stakeholders (9 out of 10, 90%). We derived a common framework of 20 prioritization criteria that can be used when prioritizing guideline topics. The most frequently reported criteria were the health burden of disease which was included in all of the approaches, practice variation (8 out of 10, 80%), and impact on health outcomes (7 out of 10, 70%). Two of the identified approaches stood out as being comprehensive and detailed.
    CONCLUSIONS: We described 10 prioritization approaches in the development of health practice guidelines. There is a need to assess the effectiveness, efficiency and transparency of the identified approaches and to develop standardized and validated priority setting tools.
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  • 文章类型: Journal Article
    As early as 1997, the German Guideline for Guidelines laid down patient participation in guideline development as the cornerstone of good, trustworthy medical guidelines. The German Guideline Assessment Tool (DELBI) published in 2005 requires patients or relatives to be involved in the development of medical guidelines. Ideally, this should be effected through membership in the author group. The Association of the Scientific Medical Societies in Germany (AWMF) recommends this approach for the so-called S3 guidelines (systematically developed guidelines) and S2k guidelines (consensus-based guidelines). The present study addresses the question of whether and to what extent German guideline publishers adhere to these principles of patient orientation.
    For this purpose, a descriptive analysis of the guidelines valid at the beginning of November 2017 was carried out. All guidelines (n=520) of the AWMF member societies were assessed. We evaluated S3- and S2k guidelines only, as these are of particular importance for patient involvement due to the requirement of an interdisciplinary guideline group. Data were reported on the involvement of patients (as co-authors of medical guidelines) and on the existence of guidance documents addressing patients and the public (so-called patient information and patient guidelines).
    Regarding the 105 (165) S3 (S2k) guidelines, we found evidence on patient involvement in guideline development in 99 (134) cases (94 % of S3 / 81 % of S2k guidelines). In 61 (87) guidelines, authors had contributed to the authors group (58 % / 53 %) and 59 (80) guidelines with voting rights (56 % / 48 %). For 50 (15) S3 (S2k) guidelines (48 % / 9 %), the guideline report provided information on the existence or planned development of guidance documents for patients and the public (patient guidelines or patient information). Guidance-related patient information was available on the internet for only 37 (2) S3 (S2k) guidelines (35 % / 2 %).
    A substantial gap remains between patient / public involvement standards for guideline development and practice in Germany, even 12 years after the publication of national guideline standards. This is a missed opportunity since guidelines without adequate participation of those affected by the recommendations have a problem of legitimacy and transparency. Only guidelines where patients were involved in all voting processes during development build and strengthen trust between patients and the medical profession. And only those who present the rationale for medical recommendations in a generally understandable and comprehensible manner let affected individuals make individual decisions.
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  • 文章类型: Journal Article
    The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on five decision-criteria: research evidence; curative/preventive effect size, severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives (i.e. a prioritization group) was assigned the task of ranking condition-intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision making process during the two-year development of national guidelines for methods of preventing disease.
    A qualitative inductive longitudinal case study approach was used to investigate the decision making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis. Conventional and summative qualitative content analysis was used to analyse data.
    The guideline development model was modified ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs. low adoptability of recommendation; insufficient evidence vs. high urgency to act; and incoherence in assessment and prioritization within and between four different lifestyle areas. The formal guideline development model guided the decision-criteria used, but three new or revised criteria were added by the group: \'clinical knowledge and experience\', \'potential guideline consequences\' and \'needs of vulnerable groups\'. The frequency of the use of various criteria in discussions varied over time. Gender, professional status, and interpersonal skills were perceived to affect individuals\' relative influence on group discussions.
    The study shows that guideline development groups make compromises between rigour and pragmatism. The formal guideline development model incorporated multiple aspects, but offered few details on how the different criteria should be handled. The guideline development model devoted little attention to the role of the decision-model and group-related factors. Guideline development models could benefit from clarifying the role of the group-related factors and non-research evidence, such as clinical experience and ethical considerations, in decision-processes during guideline development.
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