]>AGG997S0167-4943(99)00048-510.1016/S0167-4943(99)00048-5Elsevier Science Ireland LtdFig. 1(a) The structure of the hip protector. (b) The appearance of the patient with hip protector.Fig. 2Profile of fall (orientation and time).Table 1Summary table of falls and fractures dataControlTreatmentCombinedFracture groupFalls10119129232Residents3140718aAverage falls per resident3.264.784.114Fractures639aOne resident had two fractures (one on each side).Effectiveness and acceptability of a newly designed hip protector: a pilot studyDaniel KChana*d.chan@unsw.edu.auGaryHillierbMichelleCoorebRosemaryCookebRebeccaMonkbJanetteMillscWai THungdaDepartment of Geriatric Medicine, Prince of Wales Hospital, High Street, Randwick 2031, NSW, AustraliabAged Care Assessment Team, Community Health Services, Orange, NSW, AustraliacDepartment of Orthopaedics, Prince of Wales Hospital, High St., Randwick 2031, NSW, AustraliadFAR, School of Mathematical Sciences, University of Technology, Broadway 2007, NSW, Australia*Corresponding author. Tel.: +61-2-93824242; fax: +61-2-93824241AbstractHip fracture has a significant economic and personal cost, involving hospital admission and functional impairment for elderly people. To assess the benefit of using a newly designed hip protector (new material and new design) to prevent fracture in a realistic setting, a randomised intervention-control design was used to trial the effectiveness of pads worn by high falls risk residents (n=71) in nursing home for 9 months. 40 residents were in the intervention group and 31 were in the control group. A profile of falls, including time of day, and orientation was obtained to demonstrate the potential effectiveness of the protectors for injury prevention. Acceptance of the hip protector was also surveyed amongst nursing home staff and residents. One hundred and one falls and six fractures occurred in the control group. In contrast, one hundred and ninety one falls and three fractures occurred in the hip protector (pads) group. The three fractures in the protector wearing group occurred when pads were not in place. This was extrapolated as 1 in every 16.8 falls and 1 in every 63.7 falls resulting in fracture in the two groups, respectively. The relative risk of fracture was 0.264 (95% CI=0.073–0.959) when the fracture incidence rate in the intervention group (three fractures per 191 falls) was compared to the control group (six fractures per 101 falls). This is a statistically significant result and implies that this newly designed hip protector is effective in preventing hip fracture. The majority of falls occurred during the day, which was when protectors were worn in this study, but the data on orientation was incomplete, with direction unknown in 74% of falls. Compliance was an issue, which was interpreted as only 50.3% of falls recorded with protectors in place. Dementia was identified as the explanation for this as the pads were often removed by these residents who comprised the majority of participants. Perception of low risk was the primary barrier to residents accepting the intervention. Comfort of protectors was not a significant concern for staff or residents, and only staff described appearance as an issue. In conclusion, the newly designed hip protector is protective against fractures in a realistic setting. Compliance and acceptance of the protectors will ultimately determine the viability of this prophylaxis.KeywordsNovel hip protectorHip fractureDementia1IntroductionFracture of the hip has been recognised as a significant problem in the elderly population from both an economic perspective, and in terms of the personal impact on the individual experiencing the injury. The impairment in function associated with the fracture, and surgical intervention alters the lives of individuals, increasing the likelihood of permanent institutionalisation five times for previously community dwelling elderly (Cumming et al., 1996). Pre-fracture levels of physical functioning are not regained by more than half the injured patients, and fractured neck of femur increases mortality in the elderly significantly (Butler et al., 1996; Fox et al., 1996).In the majority (60–90%) of fractures direct trauma is the aetiology (Cummings and Nevitt, 1989), which indicates the importance of addressing falls in the elderly. However, this is a complex issue as most falls are multifactorial in cause, including, lower limb weakness, gait instability, vision, cognitive and functional impairments as well as the effects of medication (Rubenstein et al., 1994). External factors have been found to be unreliable determinants of risk, as multiple hazards have been implicated in fractures (Clemson et al., 1996). Therefore, the value of a secondary prophylaxis is suggested as a fracture prevention, to mediate the impact of the fall, when it inevitably occurs.Hip fracture risk is known to be reduced by a larger body mass index as increased soft tissue appears to absorb the impact of a fall and protect the femur (Hayes et al., 1991; Robinovitch et al., 1995). Even in a direct fall onto the hip in the elderly, research has shown that natural padding is insufficient to attenuate the force, and other mechanisms such as reflex contraction of the quadriceps protect the hip fracture (Robinovitch et al., 1995).As a solution to the prevention of fracture, several clinical trials have demonstrated that external hip protector is effective in protecting the hip, as no fractures occurred in subjects while wearing the appliances (Lauritzen et al., 1993; Tracey et al., 1998). However, the compliance rate is only about 50% (Lauritzen et al., 1993; Tracey et al., 1998) and it drops to about 30% (Tracey et al., 1998) in the long term. The design of these hip protectors are such that they have to be worn with underpants to cover a small area over the greater trochanter. Any movement of the protector may mean that the covering position may be shifted. Therefore, the hip protectors are quite tightly fitted and this may explain a significant proportion of people feeling the discomfort (Tracey et al., 1998). Furthermore, the polypropylene material used is quite hard which may add to the discomfort.We therefore designed a new hip protector using softer material, which is fitted to the inner surfaces of trousers or tracksuit pants. The hip protectors also cover the greater trochanters but have the propensity to allow for some movement, and hence may cause less discomfort. Our aims are to find out both the effectiveness and acceptability of this newly designed hip protector.2Patient and method2.1ParticipantsSubjects were drawn from nine nursing homes and the criteria for inclusion was that the nursing home staff identified the residents as high falls risk. This was not on the basis of particular diagnosis, or any formal evaluation of falls risk, but the perception of the staff themselves. The subjects or the person responsible was then asked to sign consent to participate. Therefore, the purposes of the study were clear to participants and/or the guardians, and involvement was voluntary. Random assignment of subjects was achieved in most nursing homes with some participants designated as control and some to wear the protectors. The current results are based on 71 participants (control=31, treatment=40) on whom data has been collected after 9 months.2.2Hip protectorThe hip protectors were designed to absorb the impact in the upper femur, hip region, in particular to cover the greater trochanter in a fall. They are made of pads as shown in Fig. 1. The pads are worn in pockets sewn into the inner surfaces of tracksuit pants or trousers. Pads are 2×3 rows of cube shapes with dimensions 6 (width)×7 (length)×2.5 (depth) cm in each cube. The material is made from EVA foam. This material is waterproof and the shock absorbency is demonstrated through the successful use in Tai Kwan Do matting. The mould used is also jointed allowing flexibility and comfort. Therefore, this new hip protector is different from that by Lauritzen (Lauritzen et al., 1993) in both material and design.2.3Measurement2.3.1Effectiveness of protectorsA simple form was designed for inclusion in residents files which staff were asked to complete for every fall. Important information, which would indicate the effectiveness of the protector, was injuries, orientation of the fall, and the time of day, as protectors were not worn at night in bed in this current study.2.3.2Acceptance of protectorsCompliance was extrapolated from the percentage of falls recorded for which protectors were worn.Separate surveys were designed for staff and residents, with closed responses to enhance acceptability to nursing staff in terms of time constraints. However, the survey was administered verbally and response options were not designed to quantify responses, but facilitate those actually using the protectors to articulate their opinion of their acceptability.2.4Data analysisThe calculation of the fracture incidence rate ratio (or relative risk) was as follows:three fractures per 191 falls (hip pad group)/six fractures per 101 falls (control group).This is based on the test-based method by Sahai and Khurshid (Sahai and Khurshid, 1996).3Results3.1Effectiveness of protectorsFifty of the 71 subjects had fallen with a total 292 falls recorded. Nine fractures occurred with none of the eight residents wearing protectors at the time of injury (one resident fractured both hips 1 month apart). 101 of the falls and six of the fractures were recorded in the control group. This may be interpreted as a risk of 1 in every 16.8 falls resulting in a hip fracture. The protector group in comparison accounted for three of the fractures and 191 of the falls with an extrapolated fracture risk of one in every 63.7 falls. The relative risk of fractures in the hip protector group as compared with the control group was 0.264 (95% CI=0.073–0.959). The average falls for control, protector, total and fracture groups is shown in Table 1.The orientation of falls for those resulting in fractures was that three were unknown, one was backwards, and five were sideways. All occurred during the day.In the total study group 81.8% of falls occurred during the day (6:00–22:00 h) and 9.6% were sideways. As 74% of falls were of unknown orientation, it is possible that the protectors may have been more useful in mediating impact than indicated. A profile of falls (orientation and time) is shown in Fig. 2.3.2Acceptance of protectors3.2.1ComplianceIn this study, compliance was defined as the percentage of falls recorded for which hip protectors were worn in the treatment group. The compliance of the participants was 50.3%.In the staff survey dementia was indicated as the reason for non-compliance. 64.8% of the total 71 participants have been identified as having dementia.3.2.2Perceptions of protectorsThe surveys were administered to seven staff and four residents. As most participants were diagnosed with dementia this limits the reliable resident sample. Three of the residents surveyed had been nominated as suitable for the study, but declined to participate. Comments from staff and residents noted informally have also been documented.3.2.3ComfortOnly one staff member noted concern about the comfort suggesting the seams on adapted underwear had rubbed. Also only one resident had serious concerns regarding the protectors highlighting the bulkiness and awkwardness, especially when continence pads are already worn. The tracksuit pants were also an issue for hot weather, so alternative clothing fitted with the protectors was preferred.3.2.4CostSince a pair of protectors cost only $10.00 AUD ($30 with tracksuit pants), no one was unable to afford it.3.2.5AppearanceFifty seven percent of staff described this as concern. However, no residents indicated it was an issue. The obvious bulkiness of the protectors was noted, and one staff member commented public dignity was compromised, such as at a doctors appointment.3.2.6Barriers to acceptanceTwo of the staff indicated they would have serious concerns regarding the use of protectors in resident management. The reasons suggested included, hygiene and the inconvenience of putting them on, especially when resident non-compliance was an issue. Enthusiasm for the protectors appeared to have a direct relationship with perceived effectiveness, as one staff member was sufficiently convinced by their own observation of the protectors, that they would like to continue their use beyond the study. Another respondent indicated that implementation of the protectors would ultimately depend on resident feelings.Residents explanations for not using the protectors centred on a perceived lack of personal risk. This included the belief in the two respondents already post fracture, simply that as they had experienced one fractured hip, they were now safe, and an indication from the doctor that the first fracture was pathological, therefore the resident felt external protection would be of no benefit in preventing fracture. Another resident noted that she had ridden horses for years, and would have needed them more then, as would other people in higher risk occupations, than simply being in danger of falling. Independence to manage their own risk was also an issue as one resident felt she was now too old to care, and another asserted the right to refuse intervention and experience the consequences of their own decision. The one resident surveyed who was wearing the protectors queried the position of the protectors for effectiveness, but was otherwise satisfied with the intervention. His daughter actually commented on the peace of mind provided by knowing he was wearing the protectors.4DiscussionUltimately the aim of this study was to implement protectors in a realistic setting and record data as to their effectiveness. This data has supported the value of pads worn to prevent fracture of the hip as no fractures occurred while they were in place. Furthermore, the reduction of relative risk of hip fracture in this new hip protector (RR=0.264) is comparable or marginally better than the old design (RR=0.44) by Lauritzen (Lauritzen et al., 1993). As most falls occurred during the day, this suggested that current wearing regime should be sufficient, it is the actual compliance with wearing the protectors that is problemsome. 50.3% is a low compliance, even allowing for the minority of falls occurring at night when the protectors were not worn (i.e. compliance rate is actually higher if night time falls are excluded from the calculation). However, this compliance rate is consistent with other designs of hip protectors (Lauritzen et al., 1993; Tracey et al., 1998). Dementia is the most significant factor in this study regarding compliance, which is an area that perhaps should be addressed in the design of the pads so they are not able to be removed easily and are less obvious to the person as their presence appears to irritate these residents.Unfortunately the low compliance could also reduce the strength of the fracture risk findings comparing the treatment and control groups. Although compliance was related to dementia in this research, the surveys regarding acceptance have gauged the importance of attitudes to the protectors in actually implementing them as an intervention tool.As for the perception and acceptance survey, the sample used was small, especially of residents. However, the diversity of responses even in this group suggests the difficulty of assessing attitudes and marketing the protectors to the consumer. In terms of staff it is interesting that they accorded more concern regarding the appearance of the protectors than the residents. It is the actual perception and understanding of fracture risk that appears to be the central barrier to acceptance amongst residents. This supports the value of education to the elderly who are high risk, such as frequent fallers or post fracture clients, in understanding the risk not simply of falling, but of fracture (Cameron and Quine, 1994). Therefore, the preferred management of the problem of fractured neck of femur would include not just falls prevention but fracture protection.The findings of this study were limited to a nursing home population where protectors have had been implemented and monitored by staff. Therefore, issues such as ease of use for the client have not been explored which could be a significant difficulty for community living elderly with mobility impairments. A similar study using community living individuals would be appropriate, not to validate the actual effectiveness of protectors but their practicality.In terms of the participant group selected as suitable for the research the variables were not monitored by the researcher, it was based on the subjective opinion of staff. However, the comparison in the average falls per year per bed of 1.5 in institutions to the 4.11 recorded for this group in a 9-month period, suggests that staff are accurate in determining high falls risk residents. Another point of note is the higher rate of fall (4.78 falls per bed per 9 months) in treatment group compared to controls (3.26) may be due to willingness of staff to allow patients to ambulate after they are put on hip protectors (rather than restricting them).The hip fracture per fall rate in the control group is 5.94% (six fractures in 101 falls). This is considerably higher than fracture rates of elderly in the community but is in accord with findings from Butler et al. (Butler et al., 1996) (the risk of hip fracture in institutions is 101.5 times those living in private homes).Since a lot of the fallers are demented people whose rehabilitation and functional outcome after a fracture hip is poor, this raises the ethical question as to their rights to choose or deny wearing the hip protectors. As our study actually includes proxy consent from carers or guardians, this raises the important question as to whether the important information about hip protectors should be focused on carers or guardians, not just elderly fallers.The price of a pair of protectors is only $10.00 AUD, making it possible to be affordable to nearly all pensioners. Cost was a concern in some other protectors (Cameron and Quine, 1994).5ConclusionThe descriptive data about falls and fractures in a realistic trial in nursing homes indicates the viability of protectors as a valid instrument in the prevention of fractured hips as none occurred while the device was in place. However, further information regarding the profile of falls, especially direction of fall, would increase the evidence for the potential effectiveness of this device. Potential barriers to implementation include compliance, and attitudes to perceived risk.AcknowledgementsThe authors express their gratitude and thanks to Calare Nursing Home, Orange; Cudal Memorial Hospital; Eugowra Memorial Hospital; Mater Misericordiae Nursing Home, Forbes; Moyne Eventide Home, Canowindra; Niola Nursing Home, Parkes; Wontama Nursing Home, Orange; Sir Joseph Banks Nursing Home, Botany; Camelot Nursing Home, Maroubra for their co-operation and help.ReferencesButler et al., 1996M.ButlerR.NortonL.TrevorA.ChengA.J.CampbellThe risk of hip fracture in older people from nursing homes and institutionsAge Ageing251996381385Cameron and Quine, 1994I.CameronS.QuineExternal hip protectors: likely non-compliance among high risk elderly people living in the communityArch. Gerentol. 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