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Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseases.

机译:底漆:评估非药物治疗慢性风湿病的疗效和安全性。

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摘要

Nonpharmacologic treatments (including surgery, technical operation, rehabilitation, physiotherapy, education or the use of external technical devices) represent a wide range of treatments for chronic rheumatic disease. Randomized, controlled trials (RCTs) are recognized as the best method for avoiding bias in assessing nonpharmacologic treatments. Designs such as nonrandomized studies, cluster-randomized trials, patient-preference trials, modified Zelen-design trials, tracker trials and expertise-based RCTs could, however, be used to assess such treatments. Assessing nonpharmacologic treatments involves methodologic issues linked to difficulties associated with blinding, duration of the study, main outcomes of the study, difficulties associated with standardizing the intervention and the influence of health-care providers. Hence, these treatments cannot be assessed according to the standards used for pharmacologic treatments. As well, specific instruments such as A CheckList to Evaluate A Report of a NonPharmacological Trial (CLEAR NPT) should be used to assess the quality of reports in this field. Important reporting guidelines that take an evidence-based approach to improve the quality of reports from RCTs, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, should be extended to take these issues into account.
机译:非药物治疗(包括手术,技术操作,康复,物理治疗,教育或使用外部技术设备)代表了多种治疗慢性风湿病的方法。公认的随机对照试验(RCT)是避免在评估非药物治疗方面产生偏见的最佳方法。但是,可以使用非随机研究,聚类随机试验,患者偏好试验,改良的Zelen设计试验,跟踪器试验和基于专业知识的RCT等设计来评估此类治疗。评估非药物治疗涉及与盲法相关的困难,研究时间,研究的主要结果,与标准化干预措施有关的困难以及卫生保健提供者的影响等方法学问题。因此,不能根据用于药物治疗的标准评估这些治疗。同样,应使用诸如“评估非药理学试验报告”的检查清单(CLEAR NPT)之类的特定工具来评估该领域报告的质量。重要的报告准则应采用基于证据的方法来提高RCT的报告质量,例如报告合并标准(CONSORT)声明,应予以扩展以考虑这些问题。

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