Consensus conference

协商一致会议
  • 文章类型: Journal Article
    目的:国际泌尿外科协会(IUGA)将积极从事学术和教育活动的高级和初级成员召集在一起,召开一次共识会议,重点是制定可持续培训下一代女性骨盆医学机制研究人员的策略。
    方法:在为期半天的虚拟共识会议中探索了四个先验确定的主要焦点。与会者包括来自不同国家和学科的代表,背景不同-临床医生,医生-科学家,以及泌尿妇科领域的基础科学家,生物力学工程,和分子生物学。在主题演讲之后,每个重点领域首先由一个专门的突破小组解决,由最相关的IUGA委员会主席领导。在分组讨论之后,所有与会者进行了反复讨论,以确定缓解策略,以解决女性骨盆医学领域机械学研究人员的短缺问题。
    结果:主要重点领域包括:IUGA基础科学学者计划的研究重点;可持续基础科学指导的可行策略;基础科学培训的核心能力;以及在资源匮乏的国家进行复杂机械实验的挑战。确定了应纳入研究金/研究生培训的知识和核心能力方面的关键差距,并讨论了现有的培训方式。提出了务实的方法,以增加受训者对学习工具的接触,从而能够对全世界女性骨盆医学的下一代基础科学研究人员进行可持续培训。
    结论:与会者提出了多种观点,以就培训后代机械研究人员的关键领域达成共识。使用IUGA作为平台制定了可持续基础科学学者计划的建议。该计划的首要目标是确保在泌尿外科和盆腔重建手术中成功的从台到床的前后回路,通过科学合理有效的预防和治疗干预措施,最终改善全球数百万妇女的生活。
    OBJECTIVE: The International Urogynecological Association (IUGA) brought together senior and junior members actively engaged in scholarly and educational activities for a consensus conference centered on developing a strategy for sustainable training of the next generation of mechanistic researchers in female pelvic medicine.
    METHODS: Four a priori identified major foci were explored in a half-day virtual consensus conference. Participants included representatives from various countries and disciplines with diverse backgrounds-clinicians, physician-scientists, and basic scientists in the fields of urogynecology, biomechanical engineering, and molecular biology. Following a keynote address, each focus area was first tackled by a dedicated breakout group, led by the Chair(s) of the most relevant IUGA committees. The break-out sessions were followed by an iterative discussion among all attendees to identify mitigating strategies to address the shortage of mechanistic researchers in the field of female pelvic medicine.
    RESULTS: The major focus areas included: research priorities for IUGA basic science scholar program; viable strategies for sustainable basic science mentorship; core competencies in basic science training; and the challenges of conducting complex mechanistic experiments in low-resource countries. Key gaps in knowledge and core competencies that should be incorporated into fellowship/graduate training were identified, and existing training modalities were discussed. Recommendations were made for pragmatic approaches to increasing the exposure of trainees to learning tools to enable sustainable training of the next generation of basic science researchers in female pelvic medicine worldwide.
    CONCLUSIONS: The attendees presented multiple perspectives to gain consensus regarding critical areas of need for training future generations of mechanistic researchers. Recommendations for a sustainable Basic Science Scholar Program were developed using IUGA as a platform. The overarching goal of such a program is to ensure a successful bench-to-bedside-and-back circuit in Urogynecology and Pelvic Reconstructive Surgery, ultimately improving lives of millions of women worldwide through scientifically rational effective preventative and therapeutic interventions.
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  • 文章类型: English Abstract
    Until now, there has not been organized consensus for standardization in bariatric surgery In Russia. We present the results of the first Bariatric Surgery Consensus Conference conducted in Barnaul (March, 2023). A list of questions was proposed within 6 blocks: 1) general issues of bariatric surgery, 2) sleeve gastrectomy, 3) one-anastomosis gastric bypass («mini-gastric bypass»), 4) Roux-en-Y Gastric Bypass, 5) Single Anastomosis Duodenal Switch and other options for biliopancreatic bypass, 6) rare procedures. Consensus (>70% agreement) was reached for 51 out of 96 statements. Stratification by the level of expertise was carried out, and responses of the expert group were compared with responses of all participants.
    До настоящего времени в России не проводилось согласования относительно проблем стандартизации в бариатрической хирургии. В данной публикации представлены результаты первой Консенсус-конференции по бариатрической хирургии. Был предложен перечень вопросов в рамках 6 блоков: 1) общие вопросы бариатрической хирургии; 2) продольная резекция желудка; 3) одноанастомозное желудочное («минижелудочное») шунтирование; 4) шунтирование по Ру; 5) SADI и другие варианты билиопанкреатического шунтирования; 6) редко выполняемые бариатрические операции. Консенсус считался достигнутым при наличии 70% голосов. Консенсус был достигнут по 51 из 96 вопросам. Проведена стратификация по уровню экспертности и осуществлено сравнение ответов группы экспертов с ответами всех участников голосования.
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  • 文章类型: English Abstract
    目的:乳腺癌手术标准共识会议旨在通过解决临床实践中与乳腺癌手术相关的争议和手术问题,建立行业技术标准并改善乳腺癌手术实践。会议由广东省医疗工业协会(GMIA)乳腺肿瘤及重建分会牵头,85名具有乳腺癌保存专业知识的乳腺外科医师参加,致癌塑料,重建手术.通过3次会议达成了共识。第一次会议提出了感兴趣的话题,并提交了证据摘要供第二次会议辩论;举行了第三次会议,以就选定的主题达成共识建议。预定义的共识标准要求只有在超过70%的小组成员就该主题达成共识时才达成共识。在准备投票的57个问题中,11个手术标准被推荐为首选,一个被推荐为考虑。首选手术标准包括保乳手术的手术细节,乳房切除术,重建手术,叶状肿瘤的手术治疗。还讨论了小组成员之间未达成共识的选定主题。这些首选的手术标准可以帮助指导常规患者护理中的临床手术实践。
    OBJECTIVE: The Breast Cancer Surgery Operative Standards Consensus Conference aimed to establish industry technical standards and improve breast cancer surgery practices by addressing controversial and operative breast cancer surgery-related issues in clinical practice.The conference was led by the Breast Oncoplastic and Reconstruction Branch of Guangdong Medical Industry Association (GMIA) and involved 85 breast surgeons with expertise in breast cancer conserving, oncoplastic, and reconstructive surgery.Consensus was reached through 3 meetings.The first meeting brought up the topics of interest, and evidence summaries were presented for debate during the second meeting; the third meeting was held to reach consensus recommendation for selected topics.Pre-defined consensus criteria required that the consensus was reached only when more than 70% of the panelists agreed on the topic.Out of the 57 questions set for voting, 11 operative standards were recommended as Preferred, and one was recommended as Considered.Preferred operative standards included surgical details in breast conserving surgery, mastectomy, reconstructive surgery, surgical treatment of phyllodes tumor.Selected topics that did not reach consensus among the panelists were also discussed.These Preferred operative standards could help guide clinical surgical practice in routine patient care.
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  • 文章类型: Journal Article
    UNASSIGNED: To date, there is a lack of published information on the utilization of the Deliberative dialogue methodology and the right to a dignified death in minors under 18 years of age in Colombia and Latin America.
    UNASSIGNED: To examine the issue of children and adolescents\' entitlement to a dignified death, including the criteria for exclusion, and to formulate a comprehensive plan for pediatric palliative care. A public policy document will be created with the aim of supporting the implementation of Resolution 825/2018.
    UNASSIGNED: Participatory Action Research utilizing a Deliberative dialogue methods that has been adapted based on feminist epistemological principles.
    UNASSIGNED: The outcome of the exercise was the production of a document containing Public Policy recommendations regarding euthanasia in minors and its submission to the Ministry of Health and Social Protection of Colombia a few days prior to the release of the Resolution regulating the right to a dignified death for this population. Additionally, the conclusions of this event enabled the creation of a guide for the implementation of (Cabildos Ciudadanos) Citizen Council, in which girls, boys, and adolescents are included, trans-disciplinarity is encouraged, and feminist epistemological foundations are explored.
    UNASSIGNED: The deliberative dialogue method may serve as a cost-efficient alternative to replace or complement participatory approaches utilized in the development of public health guidelines and policies.
    UNASSIGNED: En Colombia y Latinoamérica no se cuenta con registros publicados de temas abordados desde los metodos del diálogo deliberativo frente a temas de salud sobre la población pediátrica.
    UNASSIGNED: El diálogo deliberativo fue utilizado para deliberar sobre el derecho a la muerte digna en niñas, niños y adolescentes, sus criterios de exclusión, y el marco de acción de los cuidados paliativos pediátricos.
    UNASSIGNED: Investigación acción participativa recurriendo a la metodología Deliberative Poll.
    UNASSIGNED: Redacción de un documento de recomendaciones de Política Pública en torno a la eutanasia en población pediátrica y entrega del mismo al Ministerio de Salud y Protección Social de Colombia días previos a la expedición de la Resolución que reglamentó el derecho a morir con dignidad para esta población; así mismo, las conclusiones de este ejercicio posibilitaron la estructuración de una guía metodológica para la realización de Cabildos Ciudadanos en donde se integra a niñas, niños y adolescentes.
    UNASSIGNED: el diálogo deliberativo puede constituirse en una alternativa costo-eficiente para reemplazar o complementar metodologías de participación empleadas en la construcción de lineamientos y políticas públicas en salud.
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  • 文章类型: Review
    背景:机器人辅助手术(RAS)的健康技术评估(HTAs)在评估机器人手术平台的价值方面面临着一些挑战。由于采用了不同的评估方法,以前的HTAs在评估RAS时得出了不同的结论。虽然可用的系统和外科手术的数量正在快速增长,评估MedTech的现有框架提供了一个起点,但RAS的HTA需要具体考虑,以确保一致的结果。这项工作旨在讨论不同的方法,并为评估RAS提供指导。
    方法:采用共识会议研究方法。由14名专家组成的小组具有国际经验,代表相关利益相关者:临床医生,健康经济学家,HTA从业者,政策制定者,和工业。对以前的HTA进行了回顾,并从文献中提取了七个关键主题以供考虑。在五次会议上,小组讨论了关键主题,并制定了共识声明。
    结果:总共从25个国家中确定了98个以前的HTA。七个关键主题是证据纳入和排除,患者和临床医生报告的结果,学习曲线,成本分配,适当的时间范围,经济分析方法,和机器人生态系统/更广泛的好处。
    结论:机器人手术平台是工具,不是疗法。它们的价值因情况而异,应在治疗领域和利益相关者之间予以考虑。本文提出的原则应有助于各级HTA机构评估RAS。这项工作可以作为MedTech中需要特别考虑HTAs的快速发展领域的案例研究。
    BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS.
    METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements.
    RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits.
    CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.
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  • 文章类型: Journal Article
    目的:缺乏一致报告的结果限制了循证种植牙科和护理质量的进展。该计划的目的是开发一个核心结果集(COS)和植入物牙科临床试验(ID-COSM)的测量。
    方法:这项在有效性试验(COMET)注册的国际核心结果措施包括24个月内的六个步骤:(i)对过去10年报告的结果进行系统回顾;(ii)国际患者焦点小组;(iii)与广泛的利益相关者(护理提供者,临床研究人员,方法学家,患者和行业代表);(iv)专家组讨论使用理论框架组织领域的结果并确定COSs;(v)确定有效的测量系统以捕获不同领域,以及(vi)最终共识和正式批准,涉及专家和患者。根据类风湿关节炎临床试验中的结果测量和COMET手册,从最佳实践方法对方法进行了修改。
    结果:系统评价和患者焦点组确定了754项(分别为665+89项)相关结局指标。在消除冗余和重复之后,111在Delphi项目中进行了正式评估。通过应用预先指定的过滤器,德尔菲过程确定了22个基本结果。在汇总相同特征的替代评估后,这些减少到13。专家委员会将其分为四个核心成果领域:(i)病理生理学,(ii)植入物/假体寿命,(iii)对生命的影响和(iv)获得护理的机会。在每个领域,确定了核心结局以反映治疗的益处和危害.强制性结果领域包括手术发病率和并发症的评估,种植体周围组织健康状况,干预相关不良事件,无并发症生存率和患者总体满意度和舒适度。在特定情况下被视为强制性的结果包括功能(咀嚼,演讲,美学和假牙固位),生活质量,治疗和维护的努力和成本效益。确定了专门的COSs用于骨骼和软组织增强程序。测量仪器的有效性从国际共识(种植体周围组织健康状况)到早期识别重要结果(由焦点小组确定的患者报告结果)。
    结论:ID-COSM计划就植入牙科和/或软组织/骨增强的临床试验的一组核心强制性结果达成共识。在未来的协议中采用并通过目前正在进行的试验报告各自领域将有助于改善循证植入物牙科和护理质量。
    OBJECTIVE: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM).
    METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals.
    RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups).
    CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.
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  • 文章类型: Journal Article
    目的:从多个利益相关者那里获得投入,并使用Delphi方法就植入物牙科的基本结果达成共识,并将其纳入定义核心结果集的国际共识中。
    方法:种植牙科的候选结果来自通过5项委托进行的系统评价的科学证据,以及通过4个国际焦点小组的有牙科种植经验的人(PWLE)。一个指导委员会确定了牙科专业人员代表中的利益相关者,行业相关专家和PWLE。参与者使用多方利益相关者方法进行了三轮Delphi调查;他们评估了第一轮Delphi中确定的候选结果和其他结果。该过程遵循COMET方法。
    结果:从系统评价中确定的665个潜在结果和PWLE焦点组中的89个潜在结果,指导委员会选择了100个,并将其分为13个类别,纳入第一轮问卷作为候选结果。共有99位牙科专家,7名牙科行业相关专家和17名PWLE参加了第一轮比赛,第二轮又增加了11项结果.第一轮和第二轮之间没有减员,其中61例(54.9%)结局超过了预先设定的协议阈值.PWLE和专家参加了应用“先验”标准过滤器来提取候选基本结果列表的第三轮。
    结论:这项德尔菲研究采用了标准化的方法,透明和包容性的方法,并初步验证了分为四个核心领域的13项基本成果。这些结果为ID-COSM共识的最后阶段提供了信息。
    OBJECTIVE: To obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry using the Delphi methodology and incorporate them into an international consensus defining a core outcome set.
    METHODS: Candidate outcomes in implant dentistry were generated from scientific evidence through five commissioned systematic reviews and from people with lived experience in dental implants (PWLE) through four international focus groups. A steering committee identified stakeholders among representatives from dental professionals, industry-related experts and PWLE. Participants underwent a three-round Delphi survey using a multi-stakeholder approach; they assessed candidate outcomes and additional outcomes identified in the first Delphi round. The process followed the COMET methodology.
    RESULTS: From the 665 potential outcomes identified in the systematic reviews and 89 in the PWLE focus group, the steering committee selected 100 and organized them into 13 categories, to be included in the first-round questionnaire as candidate outcomes. A total of 99 dental experts, 7 dental-industry-related experts and 17 PWLE participated in the first round, and 11 additional outcomes were added to the second round. There was no attrition between the first and second rounds, where 61 (54.9%) outcomes exceeded the pre-established threshold of agreement. PWLE and experts participated in the third round that applied \"a priori\" standard filters to distil a list of candidate essential outcomes.
    CONCLUSIONS: This Delphi study utilized a standardized, transparent and inclusive methodology and preliminarily validated 13 essential outcomes organized into four core areas. These results informed the final stage of the ID-COSM consensus.
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  • 文章类型: Journal Article
    目的:从多个利益相关者那里获得投入,并使用Delphi方法就植入物牙科的基本结果达成共识,并将其纳入定义核心结果集的国际共识中。
    方法:种植牙科的候选结果来自通过5项委托进行的系统评价的科学证据,以及通过4个国际焦点小组的有牙科种植经验的人(PWLE)。一个指导委员会确定了牙科专业人员代表中的利益相关者,行业相关专家和PWLE。参与者使用多方利益相关者方法进行了三轮Delphi调查;他们评估了第一轮Delphi中确定的候选结果和其他结果。该过程遵循COMET方法。
    结果:从系统评价中确定的665个潜在结果和PWLE焦点组中的89个潜在结果,指导委员会选择了100个,并将其分为13个类别,纳入第一轮问卷作为候选结果。共有99位牙科专家,7名牙科行业相关专家和17名PWLE参加了第一轮比赛,第二轮又增加了11项结果.第一轮和第二轮之间没有减员,其中61例(54.9%)结局超过了预先设定的协议阈值.PWLE和专家参加了应用“先验”标准过滤器来提取候选基本结果列表的第三轮。
    结论:这项德尔菲研究采用了标准化的方法,透明和包容性的方法,并初步验证了分为四个核心领域的13项基本成果。这些结果为ID-COSM共识的最后阶段提供了信息。
    To obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry using the Delphi methodology and incorporate them into an international consensus defining a core outcome set.
    Candidate outcomes in implant dentistry were generated from scientific evidence through five commissioned systematic reviews and from people with lived experience in dental implants (PWLE) through four international focus groups. A steering committee identified stakeholders among representatives from dental professionals, industry-related experts and PWLE. Participants underwent a three-round Delphi survey using a multi-stakeholder approach; they assessed candidate outcomes and additional outcomes identified in the first Delphi round. The process followed the COMET methodology.
    From the 665 potential outcomes identified in the systematic reviews and 89 in the PWLE focus group, the steering committee selected 100 and organized them into 13 categories, to be included in the first-round questionnaire as candidate outcomes. A total of 99 dental experts, 7 dental-industry-related experts and 17 PWLE participated in the first round, and 11 additional outcomes were added to the second round. There was no attrition between the first and second rounds, where 61 (54.9%) outcomes exceeded the pre-established threshold of agreement. PWLE and experts participated in the third round that applied \"a priori\" standard filters to distil a list of candidate essential outcomes.
    This Delphi study utilized a standardized, transparent and inclusive methodology and preliminarily validated 13 essential outcomes organized into four core areas. These results informed the final stage of the ID-COSM consensus.
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  • 文章类型: Journal Article
    目的:缺乏一致报告的结果限制了循证种植牙科和护理质量的进展。该计划的目的是开发一个核心结果集(COS)和植入物牙科临床试验(ID-COSM)的测量。
    方法:这项在有效性试验(COMET)注册的国际核心结果措施包括24个月内的六个步骤:(i)对过去10年报告的结果进行系统回顾;(ii)国际患者焦点小组;(iii)与广泛的利益相关者(护理提供者,临床研究人员,方法学家,患者和行业代表);(iv)专家组讨论使用理论框架组织领域的结果并确定COSs;(v)确定有效的测量系统以捕获不同领域,以及(vi)最终共识和正式批准,涉及专家和患者。根据类风湿关节炎临床试验中的结果测量和COMET手册,从最佳实践方法对方法进行了修改。
    结果:系统评价和患者焦点组确定了754项(分别为665+89项)相关结局指标。在消除冗余和重复之后,111在Delphi项目中进行了正式评估。通过应用预先指定的过滤器,德尔菲过程确定了22个基本结果。在汇总相同特征的替代评估后,这些减少到13。专家委员会将其分为四个核心成果领域:(i)病理生理学,(ii)植入物/假体寿命,(iii)对生命的影响和(iv)获得护理的机会。在每个领域,确定了核心结局以反映治疗的益处和危害.强制性结果领域包括手术发病率和并发症的评估,种植体周围组织健康状况,干预相关不良事件,无并发症生存率和患者总体满意度和舒适度。在特定情况下被视为强制性的结果包括功能(咀嚼,演讲,美学和假牙固位),生活质量,治疗和维护的努力和成本效益。确定了专门的COSs用于骨骼和软组织增强程序。测量仪器的有效性从国际共识(种植体周围组织健康状况)到早期识别重要结果(由焦点小组确定的患者报告结果)。
    结论:ID-COSM计划就植入牙科和/或软组织/骨增强的临床试验的一组核心强制性结果达成共识。在未来的协议中采用并通过目前正在进行的试验报告各自领域将有助于改善循证植入物牙科和护理质量。
    Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM).
    This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals.
    The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups).
    The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.
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  • 文章类型: Journal Article
    就一套有效和全面的结果达成共识,以充分了解植入牙科干预措施的益处和危害,这是朝着更好的临床指南和政策取得进展的关键。在这个领域,结果研究仍然支离破碎,使用了太多不同的结果。他们仍然无法涵盖正确评估收益所需的全部广度,危害和成本。医学的最佳实践示例启发了植入物牙科核心结果集和测量(ID-COSM)计划,该计划确定了4个核心结果领域(病理生理学,植入物/假体寿命,生活影响,和获得护理的机会)和所有试验都必须的5项基本结果,在特定情况下必须的6项。创新的多步骤方法结合了科学证据的投入,来自多个国家的患者,方法学家和行业代表。这是重要的一步。ID-COSM共识希望有助于在试验中更好地采用相关和有效的结果,并能够将其结果结合到高质量的荟萃分析中,以支持更好的知情护理和政策。本文受版权保护。保留所有权利。
    Consensus on a valid and comprehensive set of outcomes to capture the full benefits and harms of implant dentistry interventions is key for progress towards better clinical guidelines and policy. In this field, outcome research remains fragmented and uses too many different outcomes. Accordingly, such efforts are still unable to cover the full breadth necessary to properly evaluate benefits, harms, and costs. Best practice examples from medicine have inspired the Implant Dentistry Core Outcome Set and Measurements (ID-COSM) initiative that identified four core outcome domain areas (pathophysiology, implant/prosthesis lifespan, life impact, and access to care) and five essential outcomes mandatory for all trials, plus six others that are mandatory in specific circumstances. The innovative multistep approach has combined input from scientific evidence, patients from multiple countries, methodologists, and industry representatives. It is an important step. The ID-COSM consensus aspires to contribute to better adoption of relevant and valid outcomes in trials and enable combining their results in high-quality meta-analyses to support better informed care and policy.
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