Institute of Bone and Joint Research, Kolling Institute, Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
University of Sydney, Faculty of Health Sciences, Discipline of Physiotherapy, Sydney, New South Wales, Australia.
BMJ Open. 2019 Apr 4;9(4):e024752. doi: 10.1136/bmjopen-2018-024752.
Surgical and invasive procedures are widely used in adults with degenerative lumbar spinal stenosis when conservative treatments fail. However, little is known about the comparative efficacy and safety of these interventions. To address this, we will perform a network meta-analysis (NMA) and systematic review to compare the efficacy and safety of surgical and invasive procedures for adults with degenerative lumbar spinal stenosis.
We will include randomised controlled trials assessing surgical and invasive treatments for adults with degenerative lumbar spinal stenosis. We will search AMED, CINAHL, EMBASE, the Cochrane Library and MEDLINE. Only English studies will be included and no restriction will be set for publication status. For efficacy, our primary outcome will be physical function. Secondary outcomes will include pain intensity, health-related quality of life, global impression of recovery, work absenteeism and mobility. For safety, our primary outcome will be all-cause mortality. Secondary outcomes will include adverse events (number of events or number of people with an event) and treatment withdrawal due to adverse effect. Two reviewers will independently select studies, extract data and assess the risk of bias (Revised Cochrane risk-of-bias tool for randomized trials) of included studies. The quality of the evidence will be evaluated through the Grading of Recommendations Assessment, Development and Evaluation framework. Random-effects NMA will be performed to combine all the evidence under the frequentist framework and the ranking results will be presented through the surface under the cumulative ranking curve and mean rank. All analyses will be performed in Stata and R.
No ethical approval is required. The research will be published in a peer-reviewed journal.
CRD42018094180.
当保守治疗失败时，手术和有创性操作被广泛应用于患有退行性腰椎椎管狭窄的成年人。然而，这些干预措施的相对疗效和安全性知之甚少。为了解决这个问题，我们将进行网络荟萃分析（NMA）和系统评价，以比较退行性腰椎椎管狭窄成年人手术和有创性治疗的疗效和安全性。
我们将纳入评估退行性腰椎椎管狭窄成年人手术和有创性治疗的随机对照试验。我们将检索 AMED、CINAHL、EMBASE、Cochrane 图书馆和 MEDLINE。仅纳入英语研究，对发表状态不设限制。对于疗效，我们的主要结局将是身体功能。次要结局将包括疼痛强度、健康相关生活质量、总体恢复印象、旷工和活动能力。对于安全性，我们的主要结局将是全因死亡率。次要结局将包括不良事件（事件数量或发生事件的人数）和因不良事件而停止治疗。两名评审员将独立选择研究、提取数据并评估纳入研究的偏倚风险（修订后的 Cochrane 随机试验偏倚风险工具）。通过推荐评估、制定和评价框架对证据质量进行评估。将在频率论框架下进行随机效应 NMA 以合并所有证据，通过累积排序曲线下的表面和平均秩呈现排名结果。所有分析都将在 Stata 和 R 中进行。
不需要伦理批准。研究结果将发表在同行评议的期刊上。
PROSPERO 注册号：CRD42018094180。
