clinical trials

临床试验
  • 文章类型: Journal Article
    目的:青少年和年轻成人(AYA)肿瘤患者的预后改善落后于其他特定年龄的癌症人群。研究表明,临床试验的可用性低,这个年龄组的生物学差异,和一些心理社会因素,包括较高的情绪困扰影响结果。为了提高这些患者的护理和生存率,医院已经实施了AYA肿瘤学计划。目前的研究评估了在一个学术医学中心的AYA计划中的护理文件,该计划基于国家综合癌症网络的AYA肿瘤学临床实践指南中强调的三个领域:临床试验注册,生育力,和心理社会护理。方法:对AYA肿瘤学项目开始前治疗的45例患者和项目开始后治疗的45例患者进行回顾性图表回顾。包括诊断为恶性肿瘤的15-39岁患者。评估的变量包括临床试验登记的文件,生育能力保护和性健康考虑,和行为健康推荐。结果:大多数临床试验和生育变量的文档从计划前到计划后都没有显着改善,尽管更多的患者在项目后记录了这些变量.行为健康推荐从计划前的52.8%显着增加到计划后的95.4%。结论:获得行为保健改善了我们AYA计划的最以下实施,这可能是因为该计划开始时,AYAs的专门心理学家的整合。通过指定的行为健康提供者和更系统的文档流程,可以更好地评估和改进针对该人群的基于指南的护理实践。
    Purpose: Improvements in outcomes for adolescent and young adult (AYA) oncology patients have lagged behind those of other age-specific cancer populations. Research has indicated that low availability of clinical trials, biological differences of this age-group, and several psychosocial factors including higher emotional distress impact outcomes. To improve care and survival rates for these patients, hospitals have implemented AYA oncology programs. The current study evaluated documentation of care in an AYA program housed in an academic medical center based on three areas emphasized in the National Comprehensive Cancer Network\'s Clinical Practice Guidelines in Oncology for AYAs: clinical trial enrollment, fertility, and psychosocial care. Methods: Retrospective chart reviews were conducted for 45 patients treated before the start of the AYA oncology program and 45 patients treated after program initiation. Patients aged 15-39 years with a diagnosis of a malignant tumor were included. Variables evaluated included documentation of clinical trial enrollment, fertility preservation and sexual health considerations, and behavioral health referrals. Results: Documentation of most clinical trial and fertility variables did not significantly improve from pre- to post-program, although a higher number of patients had these variables documented post-program. Behavioral health referrals increased significantly from 52.8% pre-program to 95.4% post-program. Conclusion: Access to behavioral health care improved the most following implementation of our AYA program, which is likely because of the integration of a dedicated psychologist for AYAs when the program began. The practice of guideline-based care for this population can be better assessed and improved with designated behavioral health providers and more systematic documentation processes.
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  • 文章类型: Journal Article
    目的:描述兽医复苏再评估运动(RECOVER)用于重新评估与小型和大型动物CPR相关的科学证据的方法,新生儿复苏,并制定各自的基于共识的临床指南。
    方法:本报告描述了RECOVER采用的基于建议评估等级的指南证据流程,发展,和评估(等级)方法,包括信息专家驱动的系统文献检索,由200多名兽医专业人员进行的证据评估,并在准备和预防领域提供临床指南,基本生命支持,高级生命支持,心脏骤停后护理,新生儿复苏,急救,大型动物CPR
    方法:跨学科,学术界的国际合作,转介实践,和一般实践。
    结果:对于RECOVER2012CPR指南的此更新,我们回答了135人口,干预,比较器,和结果(PICO)问题在一个领域主席团队的帮助下,信息专家,和200多名证据评估员。大多数主要贡献者是兽医专家或兽医技师专家。RECOVER2024指南代表了GRADE方法在临床指南开发中的首次兽医应用。我们采用了一个迭代过程,该过程遵循预定义的步骤序列,旨在减少证据评估者的偏见,并提高证据评估质量和最终治疗建议的可重复性。该过程还使许多重要的知识空白出现,从而为优先考虑兽医复苏科学的研究工作奠定了基础。
    结论:大型协作,以志愿者为基础的证据和共识为基础的临床指南的制定具有挑战性和复杂性,但可行.获得的经验将有助于完善未来兽医指南计划的流程。
    OBJECTIVE: To describe the methodology used by the Reassessment Campaign on Veterinary Resuscitation (RECOVER) to re-evaluate the scientific evidence relevant to CPR in small and large animals, to newborn resuscitation, and to first aid and to formulate the respective consensus-based clinical guidelines.
    METHODS: This report describes the evidence-to-guidelines process employed by RECOVER that is based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and includes Information Specialist-driven systematic literature search, evidence evaluation conducted by more than 200 veterinary professionals, and provision of clinical guidelines in the domains of Preparedness and Prevention, Basic Life Support, Advanced Life Support, Post-cardiac Arrest Care, Newborn Resuscitation, First Aid, and Large Animal CPR.
    METHODS: Transdisciplinary, international collaboration in academia, referral practice, and general practice.
    RESULTS: For this update to the RECOVER 2012 CPR guidelines, we answered 135 Population, Intervention, Comparator, and Outcome (PICO) questions with the help of a team of Domain Chairs, Information Specialists, and more than 200 Evidence Evaluators. Most primary contributors were veterinary specialists or veterinary technician specialists. The RECOVER 2024 Guidelines represent the first veterinary application of the GRADE approach to clinical guideline development. We employed an iterative process that follows a predefined sequence of steps designed to reduce bias of Evidence Evaluators and to increase the repeatability of the quality of evidence assessments and ultimately the treatment recommendations. The process also allowed numerous important knowledge gaps to emerge that form the foundation for prioritizing research efforts in veterinary resuscitation science.
    CONCLUSIONS: Large collaborative, volunteer-based development of evidence- and consensus-based clinical guidelines is challenging and complex but feasible. The experience gained will help refine the process for future veterinary guidelines initiatives.
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  • 文章类型: Journal Article
    目的:系统地审查证据并制定关于犬和猫的高级生命支持(ALS)的临床建议,并确定关键的知识差距。
    方法:标准化,在建议分级后,对与ALS相关的文献进行系统评估,评估,发展,和评估(等级)方法。优先考虑的问题均由证据评估人员进行审查,ALS领域主席和兽医复苏再评估运动(RECOVER)联合主席对调查结果进行了协调,以得出与证据质量相称的治疗建议,风险:利益关系,和临床可行性。此过程是使用证据概况工作表对每个问题实施的,其中包括介绍,关于科学的共识,治疗建议,这些建议的理由,和重要的知识差距。在定稿之前,这些工作表的草稿已分发给兽医专业人员以征求意见4周。
    方法:跨学科,大学国际合作,专业,应急实践。
    结果:关于血管通路的十七个问题,在可电击和不可电击节律中的血管加压药,抗胆碱能药,除颤,抗心律失常药,对辅助药物治疗以及开胸CPR进行了回顾。在制定的33项治疗建议中,6项建议解决了对具有不可电击的停搏节律的患者的管理,10个已解决的可电击节奏,6提供了开胸心肺复苏的指导。我们建议即使在长时间的心肺复苏后也不要使用大剂量肾上腺素,并建议阿托品,当指示时,只使用一次。在具有可电击节律的动物中,初始除颤不成功,我们建议将除颤器剂量加倍一次,并建议使用血管加压素(如果没有血管加压素,则使用肾上腺素),艾司洛尔,利多卡因在狗,和/或猫的胺碘酮。
    结论:这些更新的RECOVERALS指南阐明了治疗难治性可电击节律和延长CPR的方法。由于缺乏狗和猫的临床数据,证据质量非常低,这继续损害了可以提出建议的确定性。
    OBJECTIVE: To systematically review the evidence and devise clinical recommendations on advanced life support (ALS) in dogs and cats and to identify critical knowledge gaps.
    METHODS: Standardized, systematic evaluation of literature pertinent to ALS following Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Prioritized questions were each reviewed by Evidence Evaluators, and findings were reconciled by ALS Domain Chairs and Reassessment Campaign on Veterinary Resuscitation (RECOVER) Co-Chairs to arrive at treatment recommendations commensurate to quality of evidence, risk:benefit relationship, and clinical feasibility. This process was implemented using an Evidence Profile Worksheet for each question that included an introduction, consensus on science, treatment recommendations, justification for these recommendations, and important knowledge gaps. A draft of these worksheets was distributed to veterinary professionals for comment for 4 weeks prior to finalization.
    METHODS: Transdisciplinary, international collaboration in university, specialty, and emergency practice.
    RESULTS: Seventeen questions pertaining to vascular access, vasopressors in shockable and nonshockable rhythms, anticholinergics, defibrillation, antiarrhythmics, and adjunct drug therapy as well as open-chest CPR were reviewed. Of the 33 treatment recommendations formulated, 6 recommendations addressed the management of patients with nonshockable arrest rhythms, 10 addressed shockable rhythms, and 6 provided guidance on open-chest CPR. We recommend against high-dose epinephrine even after prolonged CPR and suggest that atropine, when indicated, is used only once. In animals with a shockable rhythm in which initial defibrillation was unsuccessful, we recommend doubling the defibrillator dose once and suggest vasopressin (or epinephrine if vasopressin is not available), esmolol, lidocaine in dogs, and/or amiodarone in cats.
    CONCLUSIONS: These updated RECOVER ALS guidelines clarify the approach to refractory shockable rhythms and prolonged CPR. Very low quality of evidence due to absence of clinical data in dogs and cats continues to compromise the certainty with which recommendations can be made.
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  • 文章类型: Journal Article
    目的:在2012年兽医复苏(RECOVER)CPR指南重新评估运动之后,这是基于证据的基本生命支持(BLS)共识指南的更新,高级生命支持(ALS),和持久监控。
    方法:这些复苏CPR指南是使用建议分级的修改版本生成的,评估,发展,和评估(等级)系统,用于评估证据并将其转化为清晰可行的临床指导。人口中优先考虑的临床问题,干预,比较器,和结果(PICO)格式被用作信息专家进行系统的文献检索的基础,从相关出版物中提取信息,为了评估这些证据的质量,最后将研究结果转化为治疗建议。这些建议由RECOVER写作小组审查,并由兽医专业人员开放4周征求意见。
    方法:跨学科,大学国际合作,专业,应急实践。
    结果:总共准备了40个工作表,以评估BLS的3个领域的问题,ALS和监测,产生了90个单独的治疗建议。不再推荐使用大剂量肾上腺素,还有阿托品,如果使用,只管理一次。在未插管的动物中,袋式面罩通气优先于口鼻通气。此外,一种用于初始评估的算法,更新的心肺复苏算法,一个节律诊断工具,和更新的药物剂量表提供。
    结论:虽然大多数BLS和ALS建议保持不变,由于过去10年出现的新证据,人们做出了一些值得注意的变化。证据的间接性仍然是指南制定确定性的最大障碍,并强调迫切需要对狗和猫的目标物种进行更多研究。
    OBJECTIVE: After the 2012 Reassessment Campaign on Veterinary Resuscitation (RECOVER) CPR Guidelines, this is an update of evidence-based consensus guidelines for Basic Life Support (BLS), advanced life support (ALS), and periarrest monitoring.
    METHODS: These RECOVER CPR Guidelines were generated using a modified version of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system for evidence evaluation and translation of this evidence into clear and actionable clinical instructions. Prioritized clinical questions in the Population, Intervention, Comparator, and Outcome (PICO) format were used as the basis to conduct systematic literature searches by information specialists, to extract information from relevant publications, to assess this evidence for quality, and finally to translate the findings into treatment recommendations. These recommendations were reviewed by the RECOVER writing group and opened for comment by veterinary professionals for 4 weeks.
    METHODS: Transdisciplinary, international collaboration in university, specialty, and emergency practice.
    RESULTS: A total of 40 worksheets were prepared to evaluate questions across the 3 domains of BLS, ALS and Monitoring, resulting in 90 individual treatment recommendations. High-dose epinephrine is no longer recommended, and atropine, if used, is only administered once. Bag-mask ventilation is prioritized over mouth-to-nose ventilation in nonintubated animals. In addition, an algorithm for initial assessment, an updated CPR algorithm, a rhythm diagnosis tool, and an updated drug dosing table are provided.
    CONCLUSIONS: While the majority of the BLS and ALS recommendations remain unchanged, some noteworthy changes were made due to new evidence that emerged over the past 10 years. Indirectness of evidence remains the largest impediment to the certainty of guidelines formulation and underscores an urgent need for more studies in the target species of dogs and cats.
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  • 文章类型: Journal Article
    目的:系统地审查证据并设计狗和猫的基本生命支持(BLS)的治疗建议,并确定关键的知识差距。
    方法:标准化,在对建议进行分级后,对与BLS相关的文献进行系统评估,评估,发展,和评估(等级)方法。优先考虑的问题分别由2名证据评估员进行审查,BLS领域主席和兽医复苏再评估运动(RECOVER)联合主席对调查结果进行了协调,以达成与证据质量相称的治疗建议,风险与利益的关系,和临床可行性。此过程是使用证据概况工作表对每个问题实施的,其中包括介绍,关于科学的共识,治疗建议,这些建议的理由,和重要的知识差距。在定稿之前,这些工作表的草稿已分发给兽医专业人员以征求意见4周。
    方法:跨学科,大学国际合作,专业,应急实践。
    结果:关于动物位置的二十个问题,胸部按压点和技术,通风策略,以及CPR周期和胸部按压暂停的持续时间进行了检查,并制定了32项治疗建议。在这些中,在CPR期间进行25次胸部按压和7次知情通气。这些建议主要基于非常低质量的证据和专家意见。这些新的治疗建议继续强调高质量的关键重要性,不间断的胸部按压,建议对宽胸犬的胸部按压技术进行修改。当无法插管时,建议使用带有氧气补充的紧身面罩进行袋面罩通气,而不是口鼻通气。
    结论:这些更新的RECOVERBLS治疗建议强调持续的胸部按压,特定构象的胸部按压技术,和所有动物的通风。由于缺乏狗和猫的临床数据,证据质量非常低,始终损害了建议的确定性。强调需要在这一领域进行更多的兽医研究。
    OBJECTIVE: To systematically review evidence and devise treatment recommendations for basic life support (BLS) in dogs and cats and to identify critical knowledge gaps.
    METHODS: Standardized, systematic evaluation of literature pertinent to BLS following Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Prioritized questions were each reviewed by 2 Evidence Evaluators, and findings were reconciled by BLS Domain Chairs and Reassessment Campaign on Veterinary Resuscitation (RECOVER) Co-Chairs to arrive at treatment recommendations commensurate to quality of evidence, risk to benefit relationship, and clinical feasibility. This process was implemented using an Evidence Profile Worksheet for each question that included an introduction, consensus on science, treatment recommendations, justification for these recommendations, and important knowledge gaps. A draft of these worksheets was distributed to veterinary professionals for comment for 4 weeks prior to finalization.
    METHODS: Transdisciplinary, international collaboration in university, specialty, and emergency practice.
    RESULTS: Twenty questions regarding animal position, chest compression point and technique, ventilation strategies, as well as the duration of CPR cycles and chest compression pauses were examined, and 32 treatment recommendations were formulated. Out of these, 25 addressed chest compressions and 7 informed ventilation during CPR. The recommendations were founded predominantly on very low quality of evidence and expert opinion. These new treatment recommendations continue to emphasize the critical importance of high-quality, uninterrupted chest compressions, with a modification suggested for the chest compression technique in wide-chested dogs. When intubation is not possible, bag-mask ventilation using a tight-fitting facemask with oxygen supplementation is recommended rather than mouth-to-nose ventilation.
    CONCLUSIONS: These updated RECOVER BLS treatment recommendations emphasize continuous chest compressions, conformation-specific chest compression techniques, and ventilation for all animals. Very low quality of evidence due to absence of clinical data in dogs and cats consistently compromised the certainty of recommendations, emphasizing the need for more veterinary research in this area.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    在本概述中,我们试图评估最近研究THC的实验和观察性研究及其在各种医学疾病中作为辅助治疗的潜在作用.最近的临床试验表明THC具有多种药理潜力,但样本量较小,研究持续时间短,未能解决宽容问题,剂量变化很小,不明确的结果衡量标准,以及未能识别和/或评估混淆,所有这些都可能对大多数试验的有效性构成重大威胁.然而,现有的工作强调了THC的潜在治疗价值,同时,呼吁人们注意迫切需要更好设计的方案,以充分探索和证明安全性和有效性。在最普遍的意义上,本简要综述阐明了一些关于THC的有趣发现,以及支持这些发现的研究有效性的基本威胁。目的是突出现有随机对照试验文献中现有的一般性弱点,最重要的是,为改进临床研究提供指导。
    In this overview, we seek to appraise recent experimental and observational studies investigating THC and its potential role as adjunctive therapy in various medical illnesses. Recent clinical trials are suggestive of the diverse pharmacologic potentials for THC but suffer from small sample sizes, short study duration, failure to address tolerance, little dose variation, ill-defined outcome measures, and failure to identify and/or evaluate confounds, all of which may constitute significant threats to the validity of most trials. However, the existing work underscores the potential therapeutic value of THC and, at the same time, calls attention to the critical need for better-designed protocols to fully explore and demonstrate safety and efficacy. In the most general sense, the present brief review illuminates some intriguing findings about THC, along with the basic threats to the validity of the research that supports those findings. The intent is to highlight existing generic weaknesses in the existing randomized controlled trial literature and, most importantly, provide guidance for improved clinical research.
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  • 文章类型: Journal Article
    人工智能(AI)在医疗保健中的使用正在改变许多医疗领域,包括肾脏病学.各种AI技术在肾病学中的集成有助于早期检测的预测,诊断,预后,和肾脏疾病的治疗。然而,最近的报告表明,大多数已发表的临床人工智能研究缺乏统一的人工智能报告标准,这给口译带来了巨大的挑战,复制,并将研究转化为常规临床应用。针对这些问题,全球倡议制定了发布AI相关研究的指南,概述了研究人员应包含的最少必要信息。通过遵循标准化报告框架,研究人员和临床医生可以确保可重复性,可靠性,以及人工智能模型的道德使用。这将最终导致更好的研究成果,加强临床决策,更好的病人管理这篇综述文章强调了在医学研究中坚持人工智能报告指南的重要性,专注于肾脏病学和泌尿科,和临床实践,以推进该领域和优化患者护理。
    The use of artificial intelligence (AI) in healthcare is transforming a number of medical fields, including nephrology. The integration of various AI techniques in nephrology facilitates the prediction of the early detection, diagnosis, prognosis, and treatment of kidney disease. Nevertheless, recent reports have demonstrated that the majority of published clinical AI studies lack uniform AI reporting standards, which poses significant challenges in interpreting, replicating, and translating the studies into routine clinical use. In response to these issues, worldwide initiatives have created guidelines for publishing AI-related studies that outline the minimal necessary information that researchers should include. By following standardized reporting frameworks, researchers and clinicians can ensure the reproducibility, reliability, and ethical use of AI models. This will ultimately lead to improved research outcomes, enhanced clinical decision-making, and better patient management. This review article highlights the importance of adhering to AI reporting guidelines in medical research, with a focus on nephrology and urology, and clinical practice for advancing the field and optimizing patient care.
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  • 文章类型: Journal Article
    JAK抑制剂是目前治疗骨髓纤维化的标准,但许多人没有解决,可能会加剧贫血;因此,传统上,在关键的临床试验中,贫血相关的反应被忽略为疗效终点,导致他们的报告缺乏一致性和分析细节。在这里,我们将我们的经验应用于莫美罗替尼的III期试验,JAK1/JAK2/ACVR1抑制剂和美国FDA指定的用于贫血的骨髓纤维化患者的第一种疗法,强调不同标准的应用如何影响骨髓纤维化任何潜在治疗方法的贫血相关获益。我们主张建立一个新的专家共识小组,以使骨髓纤维化中贫血相关反应的定义具有一致性和透明度。
    这个观点是关于什么的?贫血(健康红细胞过少)在骨髓纤维化患者中很常见。虽然在临床试验中测量与骨髓纤维化的潜在治疗相关的贫血益处变得越来越普遍,有不同的贫血获益定义.本观点回顾了这些定义,他们之间的差异,以及为什么测量贫血益处的一致性和清晰度很重要。莫美罗替尼临床试验中使用的定义,对骨髓纤维化和贫血患者的治疗,还解释了如果使用不同的定义,这些试验中观察到的贫血益处可能会发生变化。贫血获益的定义可能包括患者接受的红细胞输血次数,血液中血红蛋白(一种红细胞蛋白)的含量,或其组合。时间等考虑因素,包括患者的类型,和其他因素在定义之间并不一致,也不总是清楚地报告。当在莫美罗替尼临床试验中遵循贫血益处的不同定义时,结果表明,治疗观察到的益处量根据使用的定义而变化。从这个角度可以得出什么结论?骨髓纤维化临床试验中贫血益处的定义需要更多的一致性和清晰度,建议一个新的专家小组应该聚在一起讨论这个话题。
    JAK inhibitors are the current standard of care in myelofibrosis, but many do not address and may worsen anemia; thus, anemia-related responses have traditionally been overlooked as efficacy end points in pivotal clinical trials, leading to a lack of consistency and analytic detail in their reporting. Here we apply our experiences in the phase III trials of momelotinib, a JAK1/JAK2/ACVR1 inhibitor and the first therapy indicated by the US FDA for myelofibrosis patients with anemia, to highlight how application of different criteria impacts the anemia-related benefits reported for any potential treatment in myelofibrosis. We advocate for a convention of a new expert consensus panel to bring consistency and transparency to the definition of anemia-related response in myelofibrosis.
    What is this Perspective about? Anemia (too few healthy red blood cells) is common in patients with myelofibrosis. While it is becoming more common to measure the anemia benefits associated with potential treatments for myelofibrosis in clinical trials, different definitions of anemia benefit are available. This Perspective reviews these definitions, the differences between them, and why consistency and clarity in measuring anemia benefit matter. The definitions used in clinical trials of momelotinib, a treatment for patients with myelofibrosis and anemia, are also explained to show how the anemia benefit observed in these trials could have changed if different definitions were used. What does this Perspective show? Definitions of anemia benefit may include the number of red blood cell transfusions a patient receives, the amount of hemoglobin (a red blood cell protein) in their blood, or a combination thereof. Considerations such as timing, the types of patients included, and other factors are not consistent across definitions and not always clearly reported. Results when different definitions of anemia benefit were followed in the momelotinib clinical trials show that the amount of benefit observed with treatments changes depending on which definition is used. What conclusions can be drawn from this Perspective? More consistency and clarity in the definitions of anemia benefit in myelofibrosis clinical trials are needed, suggesting that a new panel of experts should come together to discuss this topic.
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  • 文章类型: Journal Article
    背景:临床实践指南(CPGs)中的建议受到随机对照试验(RCTs)结果的严重影响。因此,必须全面报告所有RCT结果,以确保使用准确的信息创建CPG.这里,我们使用CONSORT扩展RCT中的危害来评估危害报告的质量,以支持美国骨科医师学会(AAOS)对老年人CPG中髋关节骨折的管理建议。
    方法:使用CONSORT扩展对老年人CPG髋部骨折AAOS管理中作为建议证据的每个RCT进行评估,以确定危害报告的质量。描述性统计(频率,百分比,95%置信区间)用于总结对CONSORTHarms项目的依从性。线性回归模型用于评估CONSORT危害随时间变化对报告质量的影响。
    结果:在确定的156项RCT中,共有31,848名参与者。大多数RCT在单中心(137;87.8%)和单盲方式(130;83.3%)进行。54个(34.6%)RCT没有提供资金报表。试验充分报告了18个CONSORT扩展中的平均6.65个危害项目(37.0%)。一个RCT充分报告了所有项目,而五个报告零项目。47个RCT(30.1%)报告项目≥50%,73个(46.8%)报告项目≤33.3%。线性回归模型显示平均依从性随时间没有显着增加(调整后的R2=-0.006;p=0.563)。
    结论:我们的研究结果强调了在老年患者CPG髋部骨折的AAOS管理中,RCT的危害报告不足。虽然CONSORT危害扩展旨在加强报告,线性回归模型未显示随时间的显著改善.
    BACKGROUND: Recommendations within clinical practice guidelines (CPGs) are heavily influenced by results from randomized controlled trials (RCTs). Therefore, it is imperative that all RCT outcomes are reported thoroughly to ensure CPGs are created using accurate information. Here, we evaluate the quality of harms reporting using the CONSORT Extension for Harms in RCTs underpinning recommendations in the American Academy of Orthopedic Surgeons (AAOS) Management of Hip Fractures in Older Adults CPG.
    METHODS: Each RCT cited as evidence for recommendations in the AAOS Management of Hip Fractures in Older Adults CPG was evaluated using the CONSORT Extension for Harms to determine the quality of harms reporting. Descriptive statistics (frequencies, percentages, 95 % confidence intervals) were used to summarize adherence to CONSORT Harms items. A linear regression model was used to evaluate the CONSORT Harms influence on the quality of reporting over time.
    RESULTS: Among the 156 RCTs identified, there were a total of 31,848 participants. Most RCTs were conducted at a single center (137; 87.8 %) and in a single-blind manner (130; 83.3 %). Fifty-four (34.6 %) RCTs did not provide funding statements. Trials adequately reported an average of 6.65 out of 18 CONSORT Extension for Harms items (37.0 %). One RCT adequately reported all items, while five reported zero items. Forty-seven RCTs (30.1 %) reported ≥ 50 % of items and 73 (46.8 %) reported ≤ 33.3 % of items. The linear regression model demonstrated no significant increase in mean adherence over time (adjusted R2 = -0.006; p = 0.563).
    CONCLUSIONS: Our results highlight inadequate harms reporting among RCTs in the AAOS Management of Hip Fractures in Older Patients CPG. While the CONSORT Harms Extension was intended to enhance reporting, the linear regression model did not demonstrate significant improvements over time.
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