Unit of Clinical Epidemiology, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
BMJ Open. 2023 Jun 23;13(6):e068134. doi: 10.1136/bmjopen-2022-068134.
Several systematic reviews (SRs) assessing the effectiveness of superficial physical agents have been published, but the evidence about their safety remains controversial.
To identify areas where there is evidence of the safety of physical agents by a scoping review.
Four databases were systematically searched for including English SRs that explored and reported safety in terms of adverse events (AEs) related to the application of physical agents in outpatient and inpatient physical medicine and rehabilitation settings managed by healthcare professionals, published in January 2011-29 September 2021. The severity of AEs was classified according to the Common Terminology Criteria. Then, AE findings were summarised according to the SR syntheses. Finally, the reporting of the certainty of the evidence was mapped.
Overall, 117 SRs were retrieved. Most of the SRs included randomised controlled trials (77%) and patients with musculoskeletal disorders (67%). The most investigated physical agents were extracorporeal shock wave therapy (ESWT) (15%), transcutaneous electrical nerve stimulation (13%) and electrical stimulation (12%). No AE (35%) was reported in one-third of the included primary studies in SRs, whereas few severe AEs occurred in less than 1% of the sample. Among physical agents, ESWT showed an increased risk of experiencing mild AEs compared with the control. Most SRs reported a qualitative AE synthesis (65.8%), and few reported the certainty of the evidence (17.9%), which was mainly low.
We found evidence of safety on several physical agents coming mostly from qualitative synthesis. No significant harms of these interventions were found except for ESWT reporting mild AEs. More attention to the AEs reporting and their classification should be pursued to analyse them and assess the certainty of evidence quantitatively.
已有多项评估浅层物理因子有效性的系统评价(SR)发表,但关于其安全性的证据仍存在争议。
通过范围综述确定物理因子安全性方面的证据所在。
系统检索了 4 个数据库,纳入了在 2011 年 1 月至 2021 年 9 月 29 日期间发表的、评估由医疗保健专业人员在门诊和住院物理医学与康复环境中应用物理因子时安全性的英语 SR,这些 SR 对与应用物理因子相关的不良事件(AE)进行了探讨和报告。AE 的严重程度根据通用术语标准进行分类。然后,根据 SR 综合结果总结 AE 发现。最后,对证据确定性的报告进行了映射。
共检索到 117 项 SR。大多数 SR 纳入了随机对照试验(77%)和肌肉骨骼疾病患者(67%)。最受关注的物理因子是体外冲击波疗法(ESWT)(15%)、经皮神经电刺激(13%)和电刺激(12%)。在 SR 中的纳入研究中,有三分之一的研究未报告任何 AE(35%),而少数严重 AE 发生在不到 1%的样本中。在物理因子中,与对照组相比,ESWT 出现轻度 AE 的风险增加。大多数 SR 报告了定性 AE 综合(65.8%),很少报告证据的确定性(17.9%),主要是低确定性。
我们发现了多项物理因子安全性方面的证据,这些证据主要来自定性综合。除 ESWT 报告轻度 AE 外,这些干预措施没有明显的危害。应更加关注 AE 的报告及其分类,以便对其进行分析,并对证据的确定性进行定量评估。