Gillespie Brigid M, Walker Rachel M, Latimer Sharon L, Thalib Lukman, Whitty Jennifer A, McInnes Elizabeth, Chaboyer Wendy P
School of Nursing and Midwifery, Griffith University, Brisbane, Australia.
Gold Coast University Hospital, Gold Coast Health, Gold Coast, Australia.
Cochrane Database Syst Rev. 2020 Jun 2;6(6):CD009958. doi: 10.1002/14651858.CD009958.pub3.
A pressure injury (PI), also referred to as a 'pressure ulcer', or 'bedsore', is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.
To assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.
We searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.
Randomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.
Three review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. We assessed the certainty of the evidence using GRADE.
We identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage. Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials. Primary outcomes: proportion of new PI of any stage Repositioning frequencies: three trials compared different repositioning frequencies We pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision. One of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision. In one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence). The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision. Positioning regimens: four trials compared different tilt positions We pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision. One trial involving 120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence. Secondary outcomes No studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction. Cost analysis Two included trials also performed economic analyses. A cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time. The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed. A second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR -46.50, 95% CI EUR -1.25 to EUR -74.60).
AUTHORS' CONCLUSIONS: Despite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base. Given the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus "usual care" (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.
压力性损伤(PI),也被称为“压疮”或“褥疮”,是身体任何部位因压力、摩擦或剪切力未得到缓解而导致的局部组织损伤区域。活动受限是一个主要风险因素,手动重新摆放体位是一种常见的预防策略。这是对2014年首次发表的一篇综述的更新。
评估重新摆放体位方案(即重新摆放时间表和患者体位)在预防任何环境下成人PI方面的临床和成本效益,无论其风险如何。
我们于2019年2月12日检索了Cochrane伤口专业注册库、Cochrane对照试验中央注册库(CENTRAL)、Ovid MEDLINE、Ovid Embase和EBSCO CINAHL Plus。我们还检索了临床试验注册库以查找正在进行和未发表的研究,并浏览了纳入研究以及综述、荟萃分析和卫生技术报告的参考文献列表以识别其他研究。在语言、出版日期或研究环境方面没有限制。
随机对照试验(RCT),包括整群随机试验(c-RCT),无论是否发表,评估任何重新摆放时间表或不同患者体位的效果,并测量任何环境下成人的PI发生率。
三位综述作者独立进行研究选择、“偏倚风险”评估和数据提取。我们使用GRADE评估证据的确定性。
在本次更新中,我们又识别出五项试验和一项经济子研究,因此该综述共纳入八项试验,涉及来自急性和长期护理机构的3941名参与者以及两项经济子研究。六项研究报告了发生任何阶段PI的参与者比例。八项试验中的两项报告了试验内成本评估。随访期较短(24小时至21天)。所有研究的偏倚风险都很高。五项试验报告了资金来源。主要结局:任何阶段新PI的比例 重新摆放频率:三项试验比较了不同的重新摆放频率 我们汇总了三项试验(1074名参与者)的数据,比较了每2小时和每4小时重新摆放频率(固定效应;I² = 45%;汇总风险比(RR)1.06,95%置信区间(CI)0.80至1.41)。与每4小时重新摆放并结合任何支撑面相比,每2小时重新摆放是否会增加或降低PI的发生率尚不确定。由于偏倚风险高,证据确定性被下调两次,因不精确性下调一次。其中一项试验有三个组(967名参与者),比较了在高密度床垫上每2小时、每3小时和每4小时的重新摆放方案;一项比较的数据纳入了汇总分析。另一项比较基于每2小时与每3小时重新摆放。PI发生率的RR为4.06(95% CI 0.87至18.98)。第三项研究比较基于每3小时与每4小时重新摆放(RR 0.20,95% CI 0.04至0.92)。由于偏倚风险和不精确性,证据确定性较低。在一项c-RCT中,32个病房群组中的262名参与者被随机分配在标准床垫上每2小时和每3小时重新摆放,以及在粘弹性床垫上每4小时和每6小时重新摆放。与在标准床垫上每3小时重新摆放相比,每2小时重新摆放的PI的RR不精确(RR 0.90,95% CI 0.69至1.16;极低确定性证据)。对于在粘弹性泡沫上每4小时和每6小时重新摆放的比较,PI的CI既包括大幅降低也包括无差异(RR 0.73,95% CI 0.53至1.02)。证据确定性极低,因偏倚风险高被下调两次,因不精确性下调一次。体位摆放方案:四项试验比较了不同的倾斜体位 我们汇总了两项试验(252名参与者)的数据,比较了30°倾斜与90°倾斜(随机效应;I² = 69%)。1期或2期PI的发生率没有明显差异。倾斜的效果不确定,因为证据确定性极低(汇总RR 0.62,95% CI 0.10至3.97),因严重的设计局限性和非常严重的不精确性被下调。一项涉及120名参与者的试验比较了30°倾斜和45°倾斜与“常规护理”,并报告未发生PI事件(低确定性证据)。另一项涉及116名ICU患者的试验比较了俯卧位与常规仰卧位预防PI的情况。报告不完整,这是低确定性证据。次要结局 没有研究报告与健康相关的生活质量效用评分、操作疼痛或患者满意度。成本分析两项纳入试验还进行了经济分析。一项成本最小化分析比较了养老院居民中每3小时和每4小时重新摆放与每2小时重新摆放时间表的成本。与每2小时重新摆放方案相比,每3小时或每4小时重新摆放方案估计每位居民每天的重新摆放成本分别低11.05加元和16.74加元。经济效益估计主要由节省的护理时间价值驱动。该分析假设每2小时、每3小时或每4小时重新摆放与PI发生率相似,因为未观察到发生率有差异。第二项研究比较了养老院居民中使用30°倾斜每3小时重新摆放与标准护理(每6小时90°侧旋重新摆放)的护理时间成本。据报告,与标准护理相比,该干预措施节省成本(每位患者的护理时间成本为206.60欧元对253.10欧元,增量差异为-46.50欧元,95% CI为-1.25欧元至-74.60欧元)。
尽管增加了五项试验,但本次更新的结果与我们早期的综述一致,证据被判定为低或极低确定性。对于预防PI的重新摆放频率和体位摆放,仍然缺乏有力的评估,其有效性也存在不确定性。由于所有比较的样本量都不足,证据基础存在高度不确定性。鉴于经济评估的数据有限,相对于护理时间而言,每三小时使用30°倾斜重新摆放与“常规护理”(90°倾斜)相比,或者每3至4小时与每2小时重新摆放相比,成本是否更低仍不清楚。