Phys Ther. 2001 Oct;81(10):1629-40.
A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back, neck, knee, and shoulder pain.
Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analyses were conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies.
An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established.
A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%.
Eight positive recommendations of clinical benefit were developed. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 75% agreement). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation, mechanical traction), there was a lack of evidence regarding efficacy.
This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing EBCPGs that incorporates clinicians' feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions where evidence was insufficient to make recommendations.
我们制定了一种结构化且严谨的方法来制定循证临床实践指南(EBCPGs),并将其用于制定针对下背部、颈部、膝盖和肩部疼痛管理的特定康复干预措施的 EBCPGs。
使用Cochrane协作网定义的方法识别和综合来自随机对照试验(RCTs)和观察性研究的证据,该方法通过采用系统的文献检索、研究选择、数据提取和数据合成方法来尽量减少偏倚。尽可能进行荟萃分析。证据强度被评为RCTs的I级或非随机研究的II级。
通过邀请利益相关者专业组织提名代表组成了一个专家小组。该小组制定了一套用于对证据和建议的强度进行分级的标准。该小组决定,对于一项建议,需要在对患者重要的结局方面有临床重要益处的证据(根据小组专业知识和实证结果,定义为相对于对照组高15%)。还需要统计学显著性,但仅靠它是不够的。经共识确定,对患者重要的结局为疼痛、功能、患者总体评估、生活质量和重返工作,前提是这些结局是使用已确立测量可靠性和有效性的量表进行评估的。
向来自6个专业组织的324名从业者发送了一份反馈调查问卷。回复率为51%。
制定了8项关于临床益处的积极建议。这些建议主要与先前的EBCPGs一致,尽管有些未被其他EBCPGs涵盖。从业者对这些建议广泛认同(认同率超过75%)。对于几种干预措施和适应症(如热疗、治疗性超声、按摩、电刺激、机械牵引),缺乏疗效证据。
这种制定EBCPGs的方法提供了一种结构化的方法来评估文献并制定EBCPGs,该方法纳入了临床医生的反馈,并且被执业临床医生广泛接受。对于几种证据不足以提出建议的干预措施,有必要进行进一步设计良好的RCTs。