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Age and Ageing Advance Access published online on May 20, 2008
Age and Ageing, doi:10.1093/ageing/afn112
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Copyright © The Author 2008. Published by Oxford University Press on behalf of the British Geriatrics Society.

The effect of bedrails on falls and injury: a systematic review of clinical studies

Frances Healey1, David Oliver2, Alisoun Milne3 and James B. Connelly4

1 National Patient Safety Agency, 4-8 Maple St. London W1 T 5HD UK
2 Department of Geriatric Medicine, Royal Berks Hospital, Reading, UK
3 Social Gerontology, University of Kent, Canterbury, UK
4 Brent Teaching Primary Care Trust, Wembley, UK

Address correspondence to: Frances Healey. Tel: 020 7927 9500. Email: frances.healey{at}npsa.nhs.uk


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusion
 Key points
 References
 
Background: around one-fourth of all falls in healthcare settings are falls from bed. The role of bedrails in falls prevention is controversial, with a prevailing orthodoxy that bedrails are harmful and ineffective.

Objective: to summarise and critically evaluate evidence on the effect of bedrails on falls and injury

Design: systematic literature review using the principles of QuoRoM guidance.

Setting and Subjects: adult healthcare settings

Review Methods: using the keyword, bedrail, and synonyms, databases were searched from 1980 to June 2007 for direct injury from bedrails or where falls, injury from falls, or any other effects were related to bedrail use.

Results: 472 papers were located; 24 met the criteria. Three bedrail reduction studies identified significant increases in falls or multiple falls, and one found that despite a significant decrease in falls in the discontinue-bedrails group, this group remained significantly more likely to fall than the continue-bedrails group; one case-control study found patients who had their bedrails raised significantly less likely to fall; one retrospective survey identified a significantly lower rate of injury and head injury in falls with bedrails up. Twelve papers described direct injury from bedrails.

Discussion: it is difficult to perform conventional clinical trials of an intervention already embedded in practice, and all included studies had methodological limitations. However, this review concludes that serious direct injury from bedrails is usually related to use of outmoded designs and incorrect assembly rather than being inherent, and bedrails do not appear to increase the risk of falls or injury from falls.

Keywords: accidental fall, injury, restraint, rail, bedrail, cot-side, elderly


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Conclusion
 Key points
 References
 
Bedrails are marketed as safety devices to reduce patients' risk of falling from bed. Their use is common internationally, with reported prevalence in hospitals ranging from 8 to 64% [1–5], and in nursing homes from 9 to 71% [6–13]. The commonest reason given by staff for bedrail use is falls prevention [1, 4, 6, 14].

Fall rates of 4–14 per 1,000 bed days have been reported from hospitals [14–24], and around 50% of care home residents fall at least once a year [16, 18, 24]. Such falls are associated with injury, fear of falling, functional impairment, prolonged length of stay, institutionalisation, complaints, litigation and excess costs [15, 22, 25]. Approximately one-fourth of these falls are from bed [4, 14, 18, 19].

The use of restraint is controversial; some papers on bedrails have automatically categorised bedrails as restraint, describing their use as unethical and thereby making any discussion of their effectiveness immaterial. Restraint may be defined as ‘the intentional restriction of a person's voluntary movement or behaviour’ [16] and therefore bedrails used to stop a patient purposefully leaving their bed may be restraint, but used to prevent an accidental fall from bed, may not be restraint.

Although reviews of the wider literature on institutional falls or restraints [6, 15–19, 26–31] have included bedrails, the tendency is to group them with studies of belt, vest, cuff or chair restraints, and existing reviews specific to bedrails [32, 33] are not systematic or recent. Current practice is thus uninformed by a comprehensive and current critique of the empirical evidence on bedrails, but is strongly influenced by a body of published literature with an overwhelmingly negative emphasis. The three main arguments used against bedrails are that their use is morally impermissible; that they are ineffective in preventing falls; or that they are inherently dangerous (either through direct injury, or through increasing the risk of falls and injury). Statements to the effect that bedrails are ‘dangerous and possibly unethical’; [34] cause ‘humiliation’ [35] and constitute ‘a type of physical abuse’ [36] are commonplace. This complicates the existing clinical challenge staff face in balancing patient safety with the promotion of independence and rehabilitation [5, 13, 29, 37, 38]. Whilst such emotive presentation renders objective analysis of the evidence difficult, it is precisely this challenge that this paper seeks to address.

Aims
We aimed to systematically identify and evaluate the empirical evidence for the use or removal of bedrails, and their effect on physical injury or falls, or any other effect, including appraising the capacity of the evidence to support the strong opinions frequently expressed in the literature. We intended the review to provide a resource to inform clinical practice and to identify gaps for future research.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusion
 Key points
 References
 
Overall methodological approach and justification
The methods employed conformed to the principles set out in Quality of Reporting of Meta-analyses guidance [39]. The criteria for inclusion were deliberately broad, including studies of various design type (not restricted to randomised controlled trials) so that studies often cited in the debate over bedrail use could be set out and appraised. Meta-analysis was not attempted, as a recent meta-analysis on falls prevention in institutions identified very few papers where standardised outcome data could be extracted [15].

Search strategy and selection criteria
A search was made for articles published between 1 January 1980 and 30 June 2007 using the MeSH terms: restraint, restraint-physical, bedrail, side rail, cot -side, safety rail and protective device. An additional search was made on the websites of patient safety agencies. Full search strategies, including the databases, websites and the full list of studies rejected (with rationale) are available in appendix 1 (see supplementary data on the Journal's website http://www.ageing.oxfordjournals.org).

This review aimed to locate in adult healthcare settings studies of the following:

(i) The effect of bedrails on falls and injury, including studies of bedrail reduction
(ii) Direct injury apparently from bedrails
(iii) Any other effect of bedrail use

We included combined studies of bedrail and non-bedrail restraints only where bedrail data could be separated. Studies were included if, as a minimum, the numbers of falls or injuries were provided. Multi-faceted falls reduction studies including a bedrail component were included only if changes in bedrail use were described.

Abstraction of data and outcomes and quality scoring
Trials were grouped by design type [40–42] and assessed independently for quality criteria by three reviewers using a well established quality criteria tool designed for appraising evidence from disparate study designs [43, 44]. Retrospective surveys, case series, and case studies were not individually assessed since their design equates to a null score. Falls rates were standardised from the data presented as falls per 1,000 occupied bed days.

Statistical methods
No additional tests of statistical significance were carried out, but tests of statistical significance within original papers or in previously published meta-analysis were abstracted for inclusion.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Conclusion
 Key points
 References
 
Overall characteristics and design of included studies
Of the 472 abstracts retrieved in the initial search, 24 papers [7, 13, 14, 45–65] were identified as meeting the inclusion criteria (Figure 1). Nine studies took place in hospitals [14, 47, 49, 52, 54, 55, 60, 63, 65], nine in nursing homes [7, 13, 45, 46, 48, 50, 57, 58] and six used reports from both settings [53, 56, 59, 61, 62, 64]. Details of quality criteria met by individual studies are presented in appendix 2 (see supplementary data on the Journal's website http://www.ageing.oxfordjournals.org).


Figure 1
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  		Figure 1. QuoRoM Flow diagram for selection and inclusion of studies

 
Prospective before-and-after studies of bedrail reduction (Table 1)
Five such studies were identified; [7, 45–48] all succeeded in reducing bedrail use. Two studies met eight of a possible total of ten quality criteria [46, 48] two met seven quality criteria [7, 47] and one met five quality criteria [45]. One study described a non-significant decrease in falls [7], two described a significant increase in falls [45, 47], one described a significant increase in multiple fallers [48] and one described a significant decrease in falls rates in the patients who had bilateral bedrails removed, although falls remained significantly less likely to occur in the patients who continued to use bilateral bedrails [46]. Subsets of visually impaired patients [45] and patients with a history of stroke [48] experienced significantly increased rates of falls. One study described an apparently significant reduction in serious injuries [47] but only if minor or suspected head injuries, where nurses checked neurological observations, were defined as serious injuries. None of the studies found any significant changes to overall injuries, fractures or subdural haematoma.

Case–control and cohort studies of the relationship between falls and bedrail use
The single case–control study [49] (five quality criteria met) found that having one or more bedrails raised was associated with a significantly reduced risk of falling (Table 2). One retrospective cohort study [13] (five quality criteria met) found that, once adjustments were made for differences in dependency and cognitive impairment, there was no significant difference in falls or injury. A further unadjusted prospective cohort study [50] (four quality criteria met) also found no significanct differences.

Retrospective surveys, case series and case reports
Sixteen such studies [14, 51–65] were included. Five described injury rates in falls from bed with and without bedrails [14, 52, 54, 63, 65] but only the multi-hospital study [14] found significant differences, with falls from bed with bedrails raised significantly less likely to result in injuries, particularly head injuries (see Appendix 3 in the supplementary data on the journal's website http://www.ageing.oxfordjournals.org). One retrospective survey of legal claims after falls from bed [60] found that bedrails were raised in only 2.6% of cases. Twelve studies described direct injury from bedrails or injury in falls after bedrail failure, ranging from fatal entrapment to minor injuries [14, 51–53, 55–59, 61, 62, 64]. Four of these [53, 56, 59, 64] drew from the same dataset (Figure 2) and found that ‘half-rails’ (an outmoded inverted triangle design) were significantly more likely to be associated with death, full rails with non-fatal injury, and spilt rails with near misses (where a patient was entrapped but released without injury) [56].


Figure 2
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  		Figure 2. How bedrails can cause death and injury

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusion
 Key points
 References
 
What this review adds
This article describes the most comprehensive systematic review and synthesis of published evidence of the effect of bedrails on falls and injury to date and examines the quality and limitations of existing research. By extending its focus beyond RCTs and the few studies where standardised outcomes can be calculated to include observational or quasi-experimental studies, it provides an inclusive analysis which allows users to see the range and the limitations of evidence often used by those advocating strongly against bedrail use. It also offers direction for future research.

Methodological limitations and interpretation of findings
We did not identify any RCT, so the level of evidence is far less robust than in a Cochrane review or meta-analysis [40]. Even the eight better-designed studies [7, 13, 45–50] met only between four and eight quality criteria out of a maximum of ten. The very nature of bedrail use as a ‘low-tech’ intervention already routinely embedded in practice, the high prevalence of frailty and cognitive impairment in potential study populations, and the fact that both bedrail use or removal can be seen as interventions, may make the lack of high-quality evidence inevitable [41, 43, 66]. Additionally, most studies were based on reports from frontline staff, a method limited by incomplete data and under-reporting [14, 19–21]. However, it can be argued that the role of systematic reviews ‘is not to let the desire for "best" evidence stand in the way of using the best available evidence.’ [43]


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  		Table 1. Prospective before-and-after studies of bedrail reduction

 


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  		Table 2. Case-control and cohort studies of the relationship between falls and bedrail use

 
The best evidence we located were four of the five before-and-after studies of bedrail reduction which met seven to eight quality criteria [7, 46–48], whilst one before-and-after study was of lower quality [45]. However, even well designed before-and-after studies can be confounded by concurrent changes in staffing, treatment and patient case-mix [48]. Two of these studies [45, 46] tracked individual nursing home residents, whose deteriorating health and mobility over one [45] or two years [46] potentially confounded the findings. Most bedrail reduction studies concurrently introduced additional interventions, including hip protectors, [7] movement alarms, [7, 46, 48] toileting regimes [47] and crash mats [7, 46]. Although unlikely to account for the observed increases in falls from bed in three studies [45, 47, 48] their introduction may have created a ‘Hawthorne effect’ [42], increasing reporting of falls. One bedrail reduction study [46] found significant baseline differences in mobility, falls history, independence and medication between the patients selected to continue using bedrails and the patients selected for bedrail reduction likely to confound the results. None of these studies showed significant differences in overall injury or fracture rates but were likely to be underpowered to detect these, and the single significant finding that neurological observations were less likely to be recorded after bedrail reduction [47] may be a measure of nurses' beliefs rather than of seriousness of injury. Although overall, the before-and-after studies suggest that unselective reductions in bedrail use may contribute to an increase in patient falls, particularly in patients with stroke or visual impairment, the methodological issues mean this cannot be a firm conclusion.

Three further studies met at least four quality criteria. The single case–control study [49] showed a significantly lower rate of falls in patients with bedrails raised, which needs to be interpreted with caution as only length of stay was controlled for, and other uncontrolled differences between the groups might account for the reduced rate of falling. The two cohort studies [13, 50] found no significant difference in falls rates with or without bedrails, but are likely to be confounded by differences between patients who have or have not been provided with bedrails; [1, 4, 13] even when some differences are adjusted for [13] others will remain.

The design of retrospective surveys, case series, and case studies means they inherently fail to meet quality criteria, but may still provide useful circumstantial information. The five retrospective surveys of falls from bed can only provide information on the likelihood of injury once a fall has occurred, but none supported the current orthodoxy that injury is more likely in falls with bedrails because patients will climb over them and fall from a greater height. Some patients may do so [14, 65] but the largest study found injury, particularly head injury, appeared significantly less likely in falls from bed with bedrails, with most falls from beds with bedrails raised appearing to be feet-first towards the bed end rather than through climbing over bedrails [14]. The study based on legal cases [60] relied on an inherently biased sample but suggests relatives view failure to raise bedrails as negligent. The studies of injury or death from bedrail entrapment or failure describe incidents generally linked to problems with maintenance, assembly or outmoded equipment design rather than to bedrail use itself. Inevitably, these studies cannot provide information on the injuries which might have occurred if the devices had not been used, and few provide data to assess how frequently such injuries occur; one UK study [14] suggests deaths linked to bedrail entrapment in hospitals have been reported at the rate of around one per 20 million admissions, with minor direct injuries from bedrails estimated at 1,250 per 10 million admissions. The US studies [53, 56, 59, 64] suggest an annual average of around 20 deaths through bedrail failure or entrapment across hospital, nursing home and domestic settings.

Our search found no studies describing any effects of raised bedrails other than those on falls and injury described above. Of these, only two included data on any other potential effects of bedrail use and these noted only marginal increases [47] or decreases [48] in length of stay despite substantial decreases in bedrail use. Because a perceived risk of falls is the nurses' main rationale for providing bedrails [1, 4, 5], it is unsurprising to find that patients provided with bedrails are older, less mobile, more cognitively impaired and more likely to be incontinent than patients who are not provided with bedrails [1, 2, 13, 67–69]. Where bedrails have been described as causing incontinence, confusion or reduced mobility [5, 55, 63, 70], this appears to arise from mistaking correlation for causation.

Why is there a mismatch between the evidence and orthodoxy?
Despite the weak methodological quality of many of the studies, the evidence presented in this review does not support the prevailing orthodoxy that bedrails increase the likelihood of falls and injury, or that bedrails result in an inherent risk of fatal entrapment. So why the current negative view of bedrail use? There appear to be a number of interlocking issues that influence practitioners and policy makers.

Evidence-based practice requires critical appraisal, rather than partial citation. Despite the old dictum that ‘absence of evidence is not the same as evidence of absence of effect’ [41] commentators have stated that bedrails should not be used to prevent falls from bed on the basis of no significant findings in inadequately powered arms of studies [7, 35, 36] or because no RCTs have been carried out [34, 71].

Negative opinion may relate to an assumption that patients dislike bedrails. We identified only three studies of patients' views on bedrails: a small study of 17 patients [72] identified one patient distressed by bedrails, whilst in a larger study bedrails were thought acceptable by 89.5% of inpatients surveyed [73, 74], and former patients believed bedrails could be useful, but the term ‘ cot -side’ was demeaning [4]. Additionally, some bedrail reduction studies found patients reluctant to stop using bedrails [7, 48, 75]. Perhaps due to papers that group bedrails with vest, belt, cuff or chair restraint devices, bedrails became ‘guilty by association’ as the use of these other devices is associated with considerable distress and harm [6, 30, 31, 38].

Further, there can be little doubt that, in the past, routine and inappropriate bedrail use did occur [5, 6, 33, 76]. It may be that challenging the traditional, and often harmful, use of bedrails has resulted in the adoption of an opposing view; if routine bedrail use is ‘institutional’ and ‘bad practice’ then not using bedrails at all represents up-to-date and enlightened practice.

Implications for policy, practice, and research
Overall, whilst the evidence base is of limited quantity and quality, it does not support the prevailing orthodoxy that bedrail use should be eliminated or strictly curtailed on the basis of bedrail effect on falls, injury in falls or direct injury, and suggests wholesale bedrail reduction may increase the risk of falls. Practical and ethical considerations mean that bedrails are not usually appropriate for a patient who could be independently mobile without them, or for a patient with capacity who does not want them, nor for a patient with severe confusion who is mobile enough to climb over them. But for patients who request bedrails, or who are incapable of leaving their bed without help, bedrails are unlikely to act as restraint, or restrict independence. For patients without decision-making capacity, staff have a duty of care to act in their best interests [77, 78] underpinned by realistic assessment and regular review of the individual risks of bedrail use or non-use [79].

Bedrails should never be a substitute for adequate levels of care and observation [6, 38, 80] or used as a stand-alone method of falls prevention [14, 15, 37]. Crash mats, movement alarms, and ultra-low beds are often suggested as alternatives to bedrails, their effect on reducing injury is unknown [15, 81] whilst we know that recognising and treating delirium, [82, 83] comprehensive geriatric assessment, [84] medication review, [85, 86] or multifaceted falls prevention interventions [15] can reduce falls rates in institutional settings.

Healthcare organisations need to appreciate that fatal bedrail entrapment is neither random nor inevitable but can be prevented by removing outdated equipment, ensuring that all bed, mattress and bedrail combinations are compatible, maintaining equipment, and training staff to fit and use bedrails safely and appropriately [4, 53, 79, 87–89].

Whilst an RCT of bedrail use would present design challenges [90] and for ethical reasons could randomise only individuals without absolute contraindications or indications for bedrail use, the controversy is unlikely to be fully resolved until such a trial is carried out. In addition to effects on falls and injury, any other potential harms or benefits of bedrail use merit investigation, as does the effect of different bedrail designs, partial compared to full bedrails, alternatives to bedrails, and the role of policy or decision tools to support staff in assessing the risks and benefits of bedrail use for individual patients. Given the emotive nature of the bedrail debate, qualitative exploration of the views of patients and staff may also be helpful.


   Conclusion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusion
Key points
 References
 
Careful evaluation of the empirical evidence on the use and non-use of bedrails does not lend adequate support to the widely held and powerful views that bedrails are inherently harmful. This review suggests that healthcare organisations should not aim for the universal reduction of bedrail use, but focus on eliminating outdated equipment and reducing inappropriate bedrail use on a case-by-case basis.


   Conflicts of interest
 
None


   Key points
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusion
 Key points
References
 

  • Bedrails, used to prevent accidental falls from bed, are not defined as restraints, and most patients find their use acceptable
  • No evidence was located that bedrails increase falls from bed or increase fall-related injuries
  • Fatalities from bedrail entrapment are not an inherent risk of bedrail use but usually relate to outmoded design, incorrect assembly and incompatible combinations of equipment
  • Healthcare organisations and practitioners should be encouraged to reduce inappropriate use of bedrails rather than uncritically push for wholesale and universal reduction in use


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusion
 Key points
 References
 

    (Due to the large number of references, only 29 are listed below and are represented by bold type throughout the text. The full list can be found in the supplementary data online, on the journal website http://www.ageing.oxfordjournals.org)
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Received 27 September 2007; accepted in revised form 11 April 2008.


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