guideline implementation

准则实施
  • 文章类型: Journal Article
    外周动脉疾病(PAD)的全球负担一直在增加。PAD指南建议使用循证医学治疗(EBMT)来降低心血管事件和死亡的风险,但其实施存在很大差异。本研究旨在了解当前有关PAD患者EBMT处方的实践以及实施PAD指南的主要障碍和促进者。
    于2021年12月至2023年3月在新加坡最大的三级医院进行了定性研究。参与者包括参与PAD患者护理的医疗保健专业人员和住院药剂师,以及接受过下肢血管成形术血运重建手术的PAD患者。通过深入收集数据,由训练有素的研究助理面对面或远程进行的个人半结构化访谈。采访是录音的,使用数据管理软件NVivo12.0进行转录和系统编码。为慢性病量身定制的实施(TICD)框架用于指导访谈和分析。
    12名医疗保健专业人员(4名初级顾问,7名高级顾问,和1名高级住院药剂师)和4名患者被招募。出现了7个领域的9个主题。只有一小部分医生知道相关的指引,指南对复杂疾病患者的普适性是医生们最关心的问题。其他障碍包括成本,频繁的转介,缺乏专业合作,不是病人的长期护理提供者,咨询时间短,患者用药知识有限。
    这项研究的结果可能会为提高医疗保健专业人员“对指南的依从性和患者的用药依从性”的策略提供参考。
    UNASSIGNED: The global burden of peripheral artery disease (PAD) has been increasing. Guidelines for PAD recommend evidence-based medical therapy (EBMT) to reduce the risks of cardiovascular events and death but the implementation of this is highly variable. This study aimed to understand the current practices regarding EBMT prescription in PAD patients and the key barriers and facilitators for implementing PAD guidelines.
    UNASSIGNED: A qualitative study was conducted in the largest tertiary hospital in Singapore from December 2021 to March 2023. The participants included healthcare professionals and in-patient pharmacists involved in the care of PAD patients, as well as patients with PAD who had undergone a lower limb angioplasty revascularisation procedure. Data were collected through in-depth, individual semi-structured interviews conducted face-to-face or remotely by a trained research assistant. Interviews were audio-recorded, transcribed and systematically coded using data management software NVivo 12.0. The Tailored Implementation for Chronic Diseases (TICD) framework was used to guide the interviews and analysis.
    UNASSIGNED: Twelve healthcare professionals (4 junior consultants, 7 senior consultants, and 1 senior in-patient pharmacist) and 4 patients were recruited. Nine themes in 7 domains emerged. Only a small proportion of doctors were aware of the relevant guidelines, and the generalisability of guidelines to patients with complicated conditions was the doctors\' main concern. Other barriers included cost, frequent referrals, lack of interprofessional collaboration, not being the patients\' long-term care providers, short consultation time and patients\' limited medication knowledge.
    UNASSIGNED: Findings from this study may inform strategies for improving healthcare professionals\' adherence to guidelines and patients\' medication adherence.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    背景:2013年ACC/AHA指南是脂质管理的范式转变,并确定了四个他汀类药物获益组。许多人研究了该指南的潜在影响,但很少有人调查它对MACE的潜在长期影响。此外,大多数研究也忽略了2011年12月阿托伐他汀较早释放的混杂效应.
    方法:为了评估2013年11月在美国发布的2013年ACC/AHA指南的潜在(长期)影响,我们调查了2013年ACC/AHA指南与5年MACE生存率和其他三个他汀类药物相关结局趋势变化的相关性(他汀类药物使用,最佳使用他汀类药物,和他汀类药物依从性),同时使用中断时间序列分析控制通用阿托伐他汀的可用性,称之为周氏测试。具体来说,我们进行了一项回顾性研究,使用美国全国范围内的去识别索赔和OptumLabs数据库仓库(OLDW)的电子健康记录,追踪2013年ACC/AHA指南中确定的4个他汀类药物获益组的5年MACE生存率和他汀类药物相关结局的趋势.然后,Chow检验用于辨别通用阿托伐他汀可用性和指南潜在影响之间的趋势变化。
    结果:纳入197,021例患者(ASCVD:19,060;高LDL:33,907;糖尿病:138,159;高ASCVD风险:5,895)。准则发布后,糖尿病组5年MACE生存率的长期趋势(斜率)显著改善(P=0.002).ASCVD组的最佳他汀类药物使用也显示出释放后的立即改善(截距)和长期积极变化(斜率)(P<0.001)。在所有他汀类药物获益组中,他汀类药物的使用没有显著的趋势变化,他汀类药物的依从性保持不变。尽管没有发现其他统计上显著的趋势变化,2013年ACC/AHA指南发布后,观察到总体正趋势变化或无变化.
    结论:2013年ACA/AHA指南的发布与糖尿病组的长期MACE生存率和ASCVD组的最佳他汀类药物使用的趋势改善有关。这些显著关联可能表明2013年ACA/AHA指南对一级预防组更好的健康结果具有潜在的积极长期影响,并对高风险组的他汀类药物处方行为具有直接的潜在影响。然而,需要进一步调查以确认2013年ACA/AHA指南的因果效应.
    BACKGROUND: The 2013 ACC/AHA Guideline was a paradigm shift in lipid management and identified the four statin-benefit groups. Many have studied the guideline\'s potential impact, but few have investigated its potential long-term impact on MACE. Furthermore, most studies also ignored the confounding effect from the earlier release of generic atorvastatin in Dec 2011.
    METHODS: To evaluate the potential (long-term) impact of the 2013 ACC/AHA Guideline release in Nov 2013 in the U.S., we investigated the association of the 2013 ACC/AHA Guideline with the trend changes in 5-Year MACE survival and three other statin-related outcomes (statin use, optimal statin use, and statin adherence) while controlling for generic atorvastatin availability using interrupted time series analysis, called the Chow\'s test. Specifically, we conducted a retrospective study using U.S. nationwide de-identified claims and electronic health records from Optum Labs Database Warehouse (OLDW) to follow the trends of 5-Year MACE survival and statin-related outcomes among four statin-benefit groups that were identified in the 2013 ACC/AHA Guideline. Then, Chow\'s test was used to discern trend changes between generic atorvastatin availability and guideline potential impact.
    RESULTS: 197,021 patients were included (ASCVD: 19,060; High-LDL: 33,907; Diabetes: 138,159; High-ASCVD-Risk: 5,895). After the guideline release, the long-term trend (slope) of 5-Year MACE Survival for the Diabetes group improved significantly (P = 0.002). Optimal statin use for the ASCVD group also showed immediate improvement (intercept) and long-term positive changes (slope) after the release (P < 0.001). Statin uses did not have significant trend changes and statin adherence remained unchanged in all statin-benefit groups. Although no other statistically significant trend changes were found, overall positive trend change or no changes were observed after the 2013 ACC/AHA Guideline release.
    CONCLUSIONS: The 2013 ACA/AHA Guideline release is associated with trend improvements in the long-term MACE Survival for Diabetes group and optimal statin use for ASCVD group. These significant associations might indicate a potential positive long-term impact of the 2013 ACA/AHA Guideline on better health outcomes for primary prevention groups and an immediate potential impact on statin prescribing behaviors in higher-at-risk groups. However, further investigation is required to confirm the causal effect of the 2013 ACA/AHA Guideline.
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  • 文章类型: Journal Article
    与2型糖尿病(T2D)相关的慢性肾脏病(CKD)管理的临床实践指南旨在通过提供筛查建议来协助医疗保健专业人员进行临床决策。检测,管理,以及这些疾病的治疗。然而,初级保健从业人员(PCP)在临床实践中常规制定CKD和T2D指南建议时,可能存在临床惰性.指南开发人员发布了一系列资源,旨在促进更容易获得指南建议,以支持PCP临床实践的有效和一致实施。在提供策略以减少在初级保健中应用指南建议的惯性方面仍然存在挑战。在这次审查中,我们探讨了对T2D和CKD患者的最佳管理的已发表的循证护理方法的知晓率低和吸收不足的原因.最后,我们就改善初级保健指南指导建议的实施策略提出建议.
    Clinical practice guidelines for the management of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) are designed to assist healthcare professionals with clinical decision making by providing recommendations on the screening, detection, management, and treatment of these conditions. However, primary care practitioners (PCPs) may have clinical inertia when it comes to routinely enacting CKD and T2D guideline recommendations in their clinical practices. Guideline developers have published a range of resources with the aim of facilitating easier access to guideline recommendations to support efficient and consistent implementation into clinical practice of PCPs. Challenges remain in providing strategies to reduce inertia in the application of guideline recommendations in primary care. In this review, we explore reasons behind the low level of awareness and poor uptake of published evidence-based care approaches to the optimal management of patients with T2D and CKD. Finally, we present suggestions on strategies to improve the implementation of guideline-directed recommendations in primary care.
    Clinical practice guidelines for managing chronic kidney disease (CKD) for people who also have type 2 diabetes (T2D) provide healthcare providers with recommendations on how to identify, diagnose, and treat CKD. Although treatments cannot cure CKD, they can help to reduce the risk of CKD getting worse. The recommendations are based on results of clinical trials that tested how safe and how well a medication works among many people with CKD and T2D. If these clinical trials show that the medicine is beneficial for people with CKD and T2D, then it may be included in guideline recommendations. Most people living with T2D and early-stage CKD are treated by their primary care practitioner (PCP). If PCPs are not fully aware of guideline recommendations, then their patients may lose the opportunity to receive medications that can benefit them. PCPs have said that barriers to implementing guideline recommendations in their clinical practices include too many guidelines and that the guidelines are difficult to understand and use in their offices. Guideline developers have thought of ways to make the guidelines easier to access and use. This includes putting the guidelines onto mobile apps, providing online resources, making versions more relevant to PCPs, and combining multiple guidelines. These approaches are helpful, but more work is needed. This review article talks about the reasons why PCPs are not always aware of the most up-to-date guideline recommendations for CKD and T2D, how guideline developers have found different ways of sharing the guideline recommendations, and what more can be done.
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  • 文章类型: Journal Article
    健康从业者经常插入和维护中心静脉接入装置(CVAD)作为癌症护理的一部分。四分之一的CVAD过早失败,这与死亡率增加有关,发病率和对生活质量的负面影响。为了支持实施更新的准则,eviQ教育开发了一个全面的,同行评审,基于证据的CVAD在线学习包。一项评估表明,电子学习支持临床医生的实践,并增加了CVAD插入和管理方面的知识和临床能力。
    Health practitioners often insert and maintain central venous access devices (CVADs) as part of cancer care. One in four CVADs prematurely fail, which is associated with increased mortality, morbidity and a negative impact on quality of life. To support implementation of updated guidelines, eviQ Education developed a comprehensive, peer-reviewed, evidence-based CVADs eLearning package. An evaluation indicated that the eLearning supported clinicians\' practice and increased knowledge and clinical competency in CVAD insertion and management.
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  • 文章类型: Journal Article
    目的:我们的目的是确定荷兰的所有晕厥单位(SU),并评估这些SUs满足欧洲心律协会和欧洲心脏病学会晕厥指南的共识声明中概述的基本要求的程度。为此,我们开发了SU-19的分数,一种新颖的基于指南的最佳实践验证工具。
    方法:所有心脏病门诊部,对荷兰的神经病学和内科进行了筛查,检查是否存在任何形式的结构化专业晕厥治疗.如果存在,这些作为SUs纳入,并被要求填写一份有关晕厥护理的问卷.我们使用SU-19得分评估了所有SU的结构(3分),可用测试(12分)和初步评估(4分)。
    结果:在荷兰确定了20个SUs,学术(5/20)和非学术医院(15/20),17/20报告了初步评价期间多学科的参与。在19/20神经科,心脏病学,或者两者都负责晕厥的管理。非医师参与进行抬头倾斜测试(44%)和初始评估(40%)。SU-19的平均得分为18,0±1.1,45%的最高得分为19分。在主动站立试验的方案中观察到了变化,颈动脉窦按摩和抬头倾斜试验。
    结论:荷兰有一个由20个SU组成的网络。45%的人完全达到SU-19评分(平均18,0±1.1)。自主功能测试的方案略有不同。神经内科和心脏病学主要参与晕厥治疗。非医师在晕厥护理中起着重要作用。
    OBJECTIVE: We aimed to identify all syncope units (SUs) in the Netherlands and assess the extent to which these SUs fulfil the essential requirements outlined by the consensus statements of the European Heart Rhythm Association and the European Society of Cardiology syncope guidelines. For this, we developed the SU-19 score, a novel guideline based validation tool for best practice.
    RESULTS: All outpatient clinics of cardiology, neurology, and internal medicine in the Netherlands were screened for presence of any form of structured specialized syncope care. If present, these were included as SUs and requested to complete a questionnaire regarding syncope care. We assessed all SUs using the SU-19 score regarding structure (3 points), available tests (12 points), and initial evaluation (4 points). Twenty SUs were identified in the Netherlands, both academic (5/20) and non-academic hospitals (15/20), 17/20 reported multidisciplinary involvement during initial evaluation. In 19/20, neurology, cardiology, or both were responsible for the syncope management. Non-physicians were involved performing the head-up tilt test (44%) and initial evaluation (40%). The mean SU-19 score was 18.0 ± 1.1, 45% achieved the maximum score of 19 points. Variations were observed in protocols for active standing test, carotid sinus massage, and head-up tilt test.
    CONCLUSIONS: There is a network of 20 SUs in the Netherlands. Forty-five per cent fully met the SU-19 score (mean 18.0 ± 1.1). Slight variety existed in protocols for autonomic function tests. Neurology and cardiology were mostly involved in syncope management. Non-physicians play an important role in syncope care.
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  • 文章类型: Journal Article
    国家哮喘教育和预防计划指南强调环境控制是哮喘管理的一个组成部分;然而,关于临床医生如何实施环境控制建议的国家级数据有限。
    我们分析了临床医生自我报告使用推荐的环境控制实践的数据,这些数据是在具有全国代表性的初级保健医生样本(n=1645)中,哮喘专家,和来自全国哮喘医师调查的高级实践提供者,2012年全国门诊医疗调查的补充问卷。
    我们检查了临床医生和实践特征以及临床医生关于环境触发因素评估和跨提供者组环境控制的决策和策略。回归模型用于确定与指南建议实施相关的临床医生和实践特征。
    在家中评估哮喘诱因的专家比例更高,学校,和/或工作比初级保健或高级实践提供者(几乎总是:53.6%vs29.4%和23.7%,分别,P<.001)。几乎所有的临床医生(>93%)建议避免二手烟,而关于烹饪用具的建议(例如,适当的通风)很少。尽管临床医师组之间的评估和推荐实践有所不同,建模结果显示,报告几乎总是评估哮喘控制的临床医师评估环境哮喘触发因素的可能性高出5~6倍.哮喘行动计划的使用也与环境控制建议的实施密切相关。
    哮喘护理提供者对患者的环境评估和建议各不相同。高度遵守其他关键指南组件,比如评估哮喘控制,与环境评估和环境控制建议实践有关。
    UNASSIGNED: The National Asthma Education and Prevention Program guidelines emphasize environmental control as an integral part of asthma management; however, limited national-level data exist on how clinicians implement environmental control recommendations.
    UNASSIGNED: We analyzed data on clinicians\' self-reported use of recommended environmental control practices in a nationally representative sample (n = 1645) of primary care physicians, asthma specialists, and advanced practice providers from the National Asthma Survey of Physicians, a supplemental questionnaire to the 2012 National Ambulatory Medical Care Survey.
    UNASSIGNED: We examined clinician and practice characteristics as well as clinicians\' decisions and strategies regarding environmental trigger assessment and environmental control across provider groups. Regression modeling was used to identify clinician and practice characteristics associated with implementation of guideline recommendations.
    UNASSIGNED: A higher percentage of specialists assessed asthma triggers at home, school, and/or work than primary care or advanced practice providers (almost always: 53.6% vs 29.4% and 23.7%, respectively, P < .001). Almost all clinicians (>93%) recommended avoidance of secondhand tobacco smoke, whereas recommendations regarding cooking appliances (eg, proper ventilation) were infrequent. Although assessment and recommendation practices differed between clinician groups, modeling results showed that clinicians who reported almost always assessing asthma control were 5- to 6-fold more likely to assess environmental asthma triggers. Use of asthma action plans was also strongly associated with implementation of environmental control recommendations.
    UNASSIGNED: Environmental assessment and recommendations to patients varied among asthma care providers. High adherence to other key guideline components, such as assessing asthma control, was associated with environmental assessment and recommendation practices on environmental control.
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  • 文章类型: Journal Article
    目的:临床指南已将非酒精性脂肪性肝病(NAFLD)筛查的适应症扩大到2型糖尿病和肥胖症,在城市接受护理的人群中常见的情况,安全网设置。本研究旨在评估安全网初级保健和内分泌临床医生对NAFLD的知识,确定筛选的障碍和促进者,并研究使用电子健康记录工具进行风险评估的观点。
    方法:使用调查和对初级保健进行定性访谈的顺序解释性混合方法,初级保健亚专科,城市的内分泌临床医生,安全网医疗系统。
    结果:共有109名参与者完成了调查(应答率为36.5%),13人参加了面试。大多数受访者低估或不知道NAFLD患病率(68%),没有使用推荐的非侵入性测试进行风险分层(65%),很少有人对筛查(27%)或管理(17%)NAFLD感到满意。内分泌科医生对危险因素有更多的了解,但较低的舒适度和更多的人认为筛查不是他们的责任。定性主题包括:缺乏关于筛查的知识,对NAFLD诊断不足的担忧,严重程度的感知会影响筛查的信念,筛查应该在初级保健中进行,但不是规范的做法,存在对利益的担忧,与复杂人群的竞争需求阻碍了筛查,以及需要更简单的方法将筛查整合到实践中。
    结论:知识差距可能会阻碍城市初级保健和内分泌诊所对NAFLD筛查新指南的采纳,安全网系统。实施策略侧重于培训和教育临床医生,并了解行为经济学可能会增加筛查。
    OBJECTIVE: Clinical guidelines have expanded the indications for nonalcoholic fatty liver disease (NAFLD) screening to type 2 diabetes mellitus and obesity, which are conditions common in populations who receive care in urban safety-net settings. This study aimed to evaluate safety-net primary care and endocrinology clinicians\' knowledge of NAFLD, determine barriers and facilitators to screening, and examine perspectives on the use of electronic health record tools for risk assessment.
    METHODS: Sequential explanatory mixed methods using survey and qualitative interviews with primary care, primary care subspecialty, and endocrinology clinicians in an urban safety-net health care system.
    RESULTS: A total of 109 participants completed the survey (36.5% response rate), and 13 participated in interviews. Most respondents underestimated or did not know the prevalence of NAFLD (68%), did not use the recommended noninvasive tests for risk stratification (65%), and few were comfortable with screening for (27%) or managing (17%) NAFLD. Endocrinologists had greater knowledge of risk factors but lower rates of comfort and more often felt that screening was not their responsibility. The qualitative themes included the following: (1) lack of knowledge about screening, (2) concern for underdiagnosing NAFLD, (3) perception of severity impacts beliefs about screening, (4) screening should occur in primary care but is not normative practice, (5) concerns exist about benefit, (6) competing demands with a complex population hinder screening, and (7) a need for easier ways to integrate screening into practice.
    CONCLUSIONS: Knowledge gaps may hamper uptake of new guidelines for NAFLD screening in primary care and endocrinology clinics in an urban safety-net health care system. Implementation strategies focused on training and educating clinicians and informed by behavioral economics may increase screening.
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  • 文章类型: Journal Article
    肾脏病:改善慢性肾脏病(CKD)糖尿病管理的全球结果(KDIGO)指南于2022年更新,距上次更新仅2年。这种快速更新的需求反映了旨在降低糖尿病患者肾脏和心血管疾病发病率和死亡率的众多临床试验的近期和前所未有的积极结果。肾脏病结果质量倡议(KDOQI)CKD糖尿病工作组,由国家肾脏基金会召集,在此提供了对这些变化的评论,特别是对美国医疗保健的影响。KDIGO指南的变化反映了钠/葡萄糖协同转运蛋白2(SGLT2)抑制剂和胰高血糖素样肽1受体激动剂从纯粹的抗高血糖药物到心肾代谢疗法的演变,SGLT2抑制剂起始的估计肾小球滤过率较低,≥20mL/min/1.73m2。新数据也带来了一流的加入,联邦药物管理局批准的非甾体盐皮质激素受体拮抗剂费内酮作为降低心肾终点的药物。虽然创新取得了重大进展,实施仍然面临严峻挑战,特别是在美国,保险范围的不平等和高成本限制了它们的使用,特别是在弱势群体中,最终扩大医疗保健差距。
    The Kidney Disease: Improving Global Outcomes (KDIGO) guideline for diabetes management in chronic kidney disease (CKD) was updated in 2022, just 2 years after the previous update. The need for this rapid update is reflective of the recent and unprecedented positive results of numerous clinical trials aimed at reducing kidney and cardiovascular morbidity and mortality in people with diabetes. The Kidney Disease Outcomes Quality Initiative (KDOQI) work group for diabetes in CKD, convened by the National Kidney Foundation, provides herein a commentary on these changes, particularly the implications for health care in the United States. Changes to the KDIGO guideline mirror the evolution of sodium/glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists from purely antihyperglycemic agents to cardiorenal-metabolic therapeutics, and the lower estimated glomerular filtration rate of≥20mL/min/1.73m2 for SGLT2 inhibitor initiation. New data have also brought the addition of the first-in-class, Federal Drug Administration-approved nonsteroidal mineralocorticoid receptor antagonist finerenone as an agent to reduce cardiorenal end points. While there has been significant progress in innovation, there remain serious challenges to implementation, particularly in the United States where inequities in insurance coverage and high costs limit their use, particularly in vulnerable populations, ultimately widening health care disparities.
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  • 文章类型: Journal Article
    背景:选择有效的实施策略来支持指南-一致的牙科护理是一个复杂的过程。我们正在利用DISGO研究期间收集的数据,以反映我们在实施审议性参与过程中遇到的障碍,以讨论与该干预措施中针对的循证指南相关的实施策略。目标是确定可能影响协商参与成功的因素,这是一种让医护人员参与确定实施策略优先事项的技术。
    方法:我们借鉴了在DISGO研究期间收集的协商参与论坛的在线聊天记录。每次讨论都会自动生成聊天记录,并捕获所有参与牙科诊所的参与者和主持人之间的书面交流。按照内容分析方法分析了聊天记录。
    结果:我们的研究结果揭示了在DISGO研究背景下成功实施协商参与的障碍。与会者不熟悉为论坛准备的材料,也不熟悉审议主题。与会者也没有分享不同的观点,加强了现有的想法,而不是提出新的想法。
    结论:为了确保本研究中遇到的障碍不再重复,重要的是要仔细考虑工作人员如何有效地为审议做好准备。参与者必须熟悉指南的内容,关于内容和证据的大多数问题应该在审议参与会议之前回答。如果员工对准则的看法是同质的,简报材料应介绍补充工作人员现有观点的观点。还必须创造一个环境,让员工乐于介绍大多数同事可能不会持有的意见。
    背景:该项目在ClinicalTrials.gov注册,ID为NCT04682730。该试验于2020年12月18日首次注册。https://clinicaltrials.gov/ct2/show/NCT04682730.
    BACKGROUND: Selecting effective implementation strategies to support guideline-concordant dental care is a complex process. We are drawing on data collected during the DISGO study to reflect on barriers we encountered in implementing a deliberative engagement process for discussing implementation strategies relevant to the evidence-based guideline targeted in this intervention. The goal is to identify factors that may influence the success of deliberative engagement as a technique to involve healthcare staff in identifying priorities for implementation strategies.
    METHODS: We drew on online chat transcripts from the deliberative engagement forums collected during the DISGO study. The chat transcripts were automatically generated for each discussion and captured the written exchanges between participants and moderators in all participating dental clinics. Chat transcripts were analyzed following a content analysis approach.
    RESULTS: Our findings revealed barriers to the successful implementation of deliberative engagement in the context of the DISGO study. Participants were not familiar with the materials that had been prepared for the forum and lacked familiarity with the topic of deliberation. Participants also did not share divergent viewpoints and reinforced existing ideas rather than introducing new ideas.
    CONCLUSIONS: In order to ensure that obstacles that were encountered in this study are not repeated, it is important to carefully consider how staff can effectively be prepared for the deliberations. Participants must be familiar with the content of the guideline, and most questions about the content and evidence should be answered before the deliberative engagement sessions. If perspectives among staff on a guideline are homogenous, briefing materials should introduce perspectives that complement existing views among staff. It is also necessary to create an environment in which staff are comfortable introducing opinions that may not be held by the majority of colleagues.
    BACKGROUND: This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730 .
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