Institute of Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
Institute of Applied Nursing Science, Eastern Switzerland University of Applied Sciences (formerly FHS St. Gallen), St. Gallen, Switzerland.
Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD012476. doi: 10.1002/14651858.CD012476.pub2.
Physical restraints, such as bedrails, belts in chairs or beds, and fixed tables, are commonly used for older people in general hospital settings. Reasons given for using physical restraints are to prevent falls and fall-related injuries, to control challenging behavior (such as agitation or wandering), and to ensure the delivery of medical treatments. Clear evidence of their effectiveness is lacking, and potential harms are recognised, including injuries associated with the use of physical restraints and a negative impact on people's well-being. There are widespread recommendations that their use should be reduced or eliminated.
To assess the best evidence for the effects and safety of interventions aimed at preventing and reducing the use of physical restraint of older people in general hospital settings. To describe the content, components and processes of these interventions.
We searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register the International Clinical Trials Registry Portal on 20 April 2022.
We included randomised controlled trials and controlled clinical trials that investigated the effects of interventions that aimed to prevent or reduce the use of physical restraints in general hospital settings. Eligible settings were acute care and rehabilitation wards. We excluded emergency departments, intensive care and psychiatric units, as well as the use of restrictive measures for penal reasons (e.g. prisoners in general medical wards). We included studies with a mean age of study participants of at least 65 years. Control groups received usual care or active control interventions that were ineligible for inclusion as experimental interventions.
Two review authors independently selected the articles for inclusion, extracted data, and assessed the risk of bias of all included studies. Data were unsuitable for meta-analysis, and we reported results narratively. We used GRADE methods to describe our certainty in the results.
We included four studies: two randomised controlled trials (one individually-randomised, parallel-group trial and one clustered, stepped-wedge trial) and two controlled clinical trials (both with a clustered design). One study was conducted in general medical wards in Canada and three studies were conducted in rehabilitation hospitals in Hong Kong. A total of 1709 participants were included in three studies; in the fourth study the number of participants was not reported. The mean age ranged from 67 years to 84 years. The duration of follow-up covered the period of patients' hospitalisation in one study (21 days average length of stay) and ranged from 4 to 11 months in the other studies. The definition of physical restraints differed slightly, and one study did not include bedrails. Three studies investigated organisational interventions aimed at implementing a least-restraint policy to reduce physical restraints. The theoretical approach of the interventions and the content of the educational components was comparable across studies. The fourth study investigated the use of pressure sensors for participants with an increased falls risk, which gave an alarm if the participant left the bed or chair. Control groups in all studies received usual care. Three studies were at high risk of selection bias and risk of detection bias was unclear in all studies. Because of very low-certainty evidence, we are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on our primary efficacy outcome: the use of physical restraints in general hospital settings. One study found an increase in the number of participants with at least one physical restraint in the intervention and control groups, one study found a small reduction in both groups, and in the third study (the stepped-wedge study), the number of participants with at least one physical restraint decreased in all clusters after implementation of the intervention but no detailed information was reported. For the use of bed or chair pressure sensor alarms for people with an increased fall risk, we found moderate-certainty evidence of little to no effect of the intervention on the number of participants with at least one physical restraint compared with usual care. None of the studies systematically assessed adverse events related to use of physical restraint use, e.g. direct injuries, or reported such events. We are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on the number of participants with at least one fall (very low-certainty evidence), and there was no evidence that organisational interventions or the use of bed or chair pressure sensor alarms for people with an increased fall risk reduce the number of falls (low-certainty evidence from one study each). None of the studies reported fall-related injuries. We found low-certainty evidence that organisational interventions may result in little to no difference in functioning (including mobility), and moderate-certainty evidence that the use of bed or chair pressure sensor alarms has little to no effect on mobility. We are uncertain about the effect of organisational interventions on the use of psychotropic medication; one study found no difference in the prescription of psychotropic medication. We are uncertain about the effect of organisational interventions on nurses' attitudes and knowledge about the use of physical restraints (very low-certainty evidence).
AUTHORS' CONCLUSIONS: We are uncertain whether organisational interventions aimed at implementing a least-restraint policy can reduce physical restraints in general hospital settings. The use of pressure sensor alarms in beds or chairs for people with an increased fall risk has probably little to no effect on the use of physical restraints. Because of the small number of studies and the study limitations, the results should be interpreted with caution. Further research on effective strategies to implement a least-restraint policy and to overcome barriers to physical restraint reduction in general hospital settings is needed.
在综合医院环境中,通常会使用身体约束物,如床栏、椅子或床上的安全带以及固定桌子,来约束老年人。使用身体约束物的原因是防止跌倒和跌倒相关伤害,控制挑战性行为(如躁动或徘徊),并确保医疗治疗的实施。缺乏对其有效性的明确证据,并且已经认识到潜在的危害,包括与使用身体约束物相关的伤害以及对人们福祉的负面影响。因此,广泛建议减少或消除身体约束物的使用。
评估旨在预防和减少综合医院环境中老年人身体约束的使用的干预措施的最佳证据,描述这些干预措施的内容、组成部分和流程。
我们于 2022 年 4 月 20 日在 Cochrane 痴呆症和认知改善组登记册、MEDLINE(Ovid SP)、Embase(Ovid SP)、PsycINFO(Ovid SP)、CINAHL(EBSCOhost)、Web of Science 核心合集(Clarivate)、LILACS(BIREME)、ClinicalTrials.gov 和世界卫生组织的国际临床试验注册门户的元注册中进行了检索。
我们纳入了旨在预防或减少综合医院环境中身体约束使用的干预措施的随机对照试验和对照临床试验。合格的设置为急性护理和康复病房。我们排除了急诊科、重症监护病房和精神病病房,以及因刑事原因(例如普通病房中的囚犯)使用限制措施。我们纳入了研究参与者平均年龄至少为 65 岁的研究。对照组接受了常规护理或不符合纳入标准的积极对照干预措施。
两位综述作者独立选择纳入的文章,提取数据,并评估所有纳入研究的偏倚风险。数据不适合进行荟萃分析,我们以叙述性方式报告结果。我们使用 GRADE 方法来描述我们对结果的确信程度。
我们纳入了四项研究:两项随机对照试验(一项个体随机、平行组试验和一项聚类、阶梯式试验)和两项对照临床试验(均采用聚类设计)。一项研究在加拿大的普通内科病房进行,三项研究在香港的康复医院进行。三项研究中有 1709 名参与者,在第四项研究中未报告参与者人数。平均年龄范围从 67 岁到 84 岁。随访时间涵盖了一项研究中患者住院期间的时间(平均住院时间为 21 天),而在其他三项研究中,随访时间从 4 到 11 个月不等。身体约束的定义略有不同,一项研究未包括床栏。三项研究调查了旨在实施最低约束政策以减少身体约束的组织干预措施。干预措施的理论方法和教育组成部分的内容在研究之间具有可比性。第四项研究调查了使用压力传感器对跌倒风险增加的参与者的使用,如果参与者离开床或椅子,传感器会发出警报。所有研究的对照组均接受常规护理。三项研究存在选择偏倚风险高的问题,并且所有研究的检测偏倚风险均不明确。由于证据确定性极低,我们不确定旨在实施最低约束政策的组织干预措施对我们的主要疗效结局(综合医院环境中身体约束的使用)是否有效。一项研究发现干预组和对照组的参与者至少有一个身体约束的人数增加,一项研究发现两组的人数都有所减少,而在第三项(阶梯式试验)中,在实施干预措施后,所有集群中的参与者至少有一个身体约束的人数减少,但没有详细信息报告。对于使用压力传感器对跌倒风险增加的人发出床或椅子警报,我们发现干预措施对参与者至少有一个身体约束的人数的影响较小或没有影响,与常规护理相比,证据确定性为中等。没有研究系统地评估与使用身体约束相关的不良事件,例如直接伤害,或报告此类事件。我们不确定旨在实施最低约束政策的组织干预措施对至少有一次跌倒的人数(极低确定性证据)的影响,并且没有证据表明组织干预措施或使用压力传感器对跌倒风险增加的人发出床或椅子警报可以减少跌倒次数(来自一项研究的低确定性证据)。没有研究报告跌倒相关伤害。我们发现低确定性证据表明,组织干预措施可能对功能(包括移动能力)几乎没有影响,而中度确定性证据表明,使用床或椅子压力传感器警报对移动能力几乎没有影响。我们对组织干预措施对使用精神药物的影响不确定;一项研究发现精神药物的处方没有差异。我们对组织干预措施对护士使用身体约束的态度和知识的影响不确定(极低确定性证据)。
我们不确定旨在实施最低约束政策的组织干预措施是否可以减少综合医院环境中的身体约束。对跌倒风险增加的人使用压力传感器发出床或椅子警报可能对身体约束的使用影响较小或没有影响。由于研究数量较少且研究存在局限性,应谨慎解释结果。需要进一步研究在综合医院环境中实施最低约束政策和克服减少身体约束障碍的有效策略。