The 6-PACK programme to decrease falls and fall-related injuries in acute hospitals : protocol for an economic evaluation alongside a cluster randomised controlled trial

Background Falls are a common hospital occurrence complicating the care of patients. From an economic perspective, the impact of in-hospital falls and related injuries is substantial. However, few studies have examined the economic implications of falls prevention interventions in an acute care setting. The 6-PACK programme is a targeted nurse delivered falls prevention programme designed specifically for acute hospital wards. It includes a risk assessment tool and six simple strategies that nurses apply to patients classified as high-risk by the tool.
Objective To examine the incremental cost-effectiveness of the 6-PACK programme for the prevention of falls and fall-related injuries, compared with usual care practice, from an acute hospital perspective.
Methods and design The 6-PACK project is a multicentre cluster randomised controlled trial (RCT) that includes 24 acute medical and surgical wards from six hospitals in Australia to investigate the efficacy of the 6-PACK programme. This economic evaluation will be conducted alongside the 6-PACK cluster RCT. Outcome and hospitalisation cost data will be prospectively collected on approximately 16 000 patients admitted to the participating wards during the 12-month trial period. The results of the economic evaluation will be expressed as ‘cost or saving per fall prevented’ and ‘cost or saving per fall-related injury prevented’ calculated from differences in mean costs and effects in the intervention and control groups, to generate an incremental cost-effectiveness ratio (ICER).
Discussion This economic evaluation will provide an opportunity to explore the cost-effectiveness of a targeted nurse delivered falls prevention programme for reducing in-hospital falls and fall-related injuries. This protocol provides a detailed statement of a planned economic evaluation conducted alongside a cluster RCT to investigate the efficacy of the 6-PACK programme to prevent falls and fall-related injuries.

Osteopaenia - a marker of low bone mass and fracture risk

Areal bone mineral density is commonly categorised into normal bone mineral density, osteopaenia and osteoporosis on the basis of nominal thresholds recommended by the World Health Organization. However, bone mineral density is a continuous variable and there is a strong association between lower bone mineral density and greater risk for fracture. Fracture risk is not negligible in persons with moderate deficits in bone mineral density. Although absolute fracture risk is greatest for individuals with osteoporosis, more than half of the fractures arise from those with osteopaenia, and even normal bone mineral density, a probable consequence of greater numbers of individuals at risk in these categories. However, areal bone mineral density measurements used commonly in clinical practice do not detect differences in bone tissue properties, geometry and microarchitecture, which contribute to bone strength. Newer technologies such as high-resolution peripheral computed tomography have the advantage of assessing trabecular and cortical components of bone separately, in addition to geometric characteristics of the skeleton. Quantifying these parameters and considering clinical risk factors that affect fracture risk independent of bone quantity and quality, may better discriminate between high- and low-risk individuals. This would improve the decision-making for targeting appropriate interventions, either lifestyle or medication, to reduce thepublic health burden of fractures.

Personal and psychosocial impacts of clinical fracture in men

Background : Little is known about the personal burden of fracture across the age spectrum, particularly in men. This study aimed to document the impact of clinical fracture on men's participation in employment, sports and outdoor recreation, mobility, handiwork, activities of daily living, home modification, and utilisation of community and health services.

Methods : This prospective study followed 196 men with incident fracture identified from radiology reports at the Geelong Hospital during the period July 2006 to December 2007 and examined personal and psychosocial impacts 12 months post-fracture, using a self-report questionnaire.

Results : Of all men identified with fracture, 40% took time off work. All fractures, except those to the upper limbs, had considerable impact on mobility. Inability to drive was associated with all fractures, but was most common with ankle fractures and most prolonged with hip fractures. Loss of confidence was reported by over one-third of all fracture cases, even 12 months after the fracture event. All fractures affected activities of daily living, and this was generally most prolonged for fractures of the hip. Similarly, all men with fracture utilised community and health services, even for the relatively minor fractures of the finger/thumb.

Conclusions : This study supports previous reports of the personal impact of hip fracture, and presents data about the consequences of upper and lower limb fractures and the generally poorly described sequelae of fractures of the finger/thumb and foot/toe. These observations have important implications for post-fracture care and rehabilitation in men.

In-hospital falls and fall-related injuries: a protocol for a cost of fall study

Background:
In-hospital falls are common and pose significant economic burden on the healthcare system. To date, few studies have quantified the additional cost of hospitalisation associated with an in-hospital fall or fall-related injury. The aim of this study is to determine  the additional length of stay and hospitalisation costs associated with in-hospital falls and fall-related injuries, from the acute hospital perspective.

Methods and design: 
A multisite prospective study will be conducted as part of a larger falls-prevention clinical trial—the 6-PACK project. This study will involve 12 acute medical and surgical wards from six hospitals across Australia. Patient and admission characteristics, outcome and hospitalisation cost data will be prospectively collected on approximately 15 000 patients during the 15-month study period. A review of all inhospital fall events will be conducted using a multimodal method (medical record review and daily verbal report from the nurse unit manager, triangulated with falls recorded in the hospital incident reporting and administrative database), to ensure complete case ascertainment. Hospital clinical costing data will be used to calculate patient-level hospitalisation costs incurred by a patient during their inpatient stay. Additional hospital and hospital resource utilisation costs attributable to inhospital falls and fall-related injuries will be calculated using linear regression modelling, adjusting for a prioridefined potential confounding factors.

Discussion:
This protocol provides the detailed statement of the planned analysis. The results from this study will be used to support healthcare planning, policy making and allocation of funding relating to falls prevention within acute hospitals.

Fixed-angle locking proximal humerus plate: an evaluation of functional results and implant-related outcomes

Background
Displaced and unstable proximal humeral fractures are challenging injuries to treat. Proximal humeral locking plates are a recent development for the treatment of these complex fractures.

Methods
Retrospective analysis of 23 patients with 23 proximal humeral fractures treated with the Synthes locking proximal humerus plate. These were Neer two-, three- and four-part fractures. Follow-up was at a mean of 22 months and included clinical assessment using the Constant score (CS) and the Short Form-12 health questionnaire. Radiographic assessment was performed to assess implant-related complication in relation to the initial fracture pattern and the presence of adequate medial support.

Results
The mean CS for all patients was 60.4 (range, 29–85). The mean adjusted CS was 82% (range, 30–117), active forward flexion 127 degrees and the active abduction 115 degrees. Initial fracture pattern, the presence or absence of adequate medial support and age did not significantly influence the clinical scores. Complications included one infection, two cases of avascular necrosis, two cases of varus collapse with screw penetration and one non-union. The overall reoperation rate was 26%. There was an increased rate of complications in those with inadequate medial support (P = 0.0183) and a trend to higher complication rates in four-part fractures.

Conclusion
Using the locking proximal humerus plate for the treatment of proximal humeral fractures is an acceptable procedure with comparable outcomes with historical controls, but with a complication rate of 30%. More important than implant selection, however, is the ability to achieve a stable reduction with calcar support.

Polyalanine repeat polymorphism in RUNX2 is associated with site-specific fracture in post-menopausal femals

Runt related transcription factor 2 (RUNX2) is a key regulator of osteoblast differentiation. Several variations within the RUNX2 gene have been found to be associated with significant changes in BMD, which is a major risk factor for fracture. In this study we report that an 18 bp deletion within the polyalanine tract (17A>11A) of RUNX2 is significantly associated with fracture. Carriers of the 11A allele were found to be nearly twice as likely to have sustained fracture. Within the fracture category, there was a significant tendency of 11A carriers to present with fractures of distal radius and bones of intramembranous origin compared to bones of endochondral origin (p = 0.0001). In a population of random subjects, the 11A allele was associated with decreased levels of serum collagen cross links (CTx, p = 0.01), suggesting decreased bone turnover. The transactivation function of the 11A allele showed a minor quantitative decrease. Interestingly, we found no effect of the 11A allele on BMD at multiple skeletal sites. These findings suggest that the 11A allele is a biologically relevant polymorphism that influences serum CTx and confers enhanced fracture risk in a site-selective manner related to intramembranous bone ossification.

Direct comparison of eight national FRAX® tools for fracture prediction and treatment qualification in Canadian women

The authors compared the calibration of FRAX tools from Canada, the US (white), UK, Sweden, France, Australia, New Zealand, and China when used to assess fracture risk in 36,730 Canadian women. Their data underscores the importance of applying country-specific FRAX tools that are based upon high-quality national fracture epidemiology.

Rheumatoid arthritis and incident fracture in women: a case-control study

Background:
To examine fracture incidence in women with rheumatoid arthritis (RA) for an entire geographical region of south-eastern Australia.

Methods:
Women aged 35 years and older, resident in the Barwon Statistical Division (BSD) and clinically diagnosed with RA 1994–2001 were eligible for inclusion as cases (n =1,008). The control population (n = 172,422) comprised the entire female BSD population aged 35 years and older, excluding those individuals identified as cases. Incident fractures were extracted from the prospective Geelong Osteoporosis Study Fracture Grid. We calculated rate ratios (RR) and 95% confidence intervals (CI) to compare the age- adjusted rate of fracture between the RA and non-RA populations, and used a chi-square test to compare proportions of fractures between women with and without RA, and a two-sided Mann–Whitney U-test to examine age-differences.

Results:
Among 1,008 women with RA, 19 (1.9%) sustained a fracture, compared to 1,981 fractures sustained by the 172,422 women without RA (1.2%). Fracture rates showed a trend for being greater among women diagnosed with RA (age-adjusted RR 1.43, 95%CI 0.98-2.09, p= 0.08). Women with RA sustained vertebral fractures at twice the expected frequency, whereas hip fractures were underrepresented in the RA population (p< 0.001). RA status was not associated with the likelihood of sustaining a fracture at sites adjacent to joints most commonly affected by RA (p= 0.22).

Conclusion:
Given that women with RA have a greater risk of fracture compared to women without RA, these patients may be a suitable target population for anti-resorptive agents; however, larger studies are warranted.

FRAX provides robust fracture prediction regardless of socioeconomic status

The authors investigated the fracture risk assessment tool (FRAX) Canada calibration and discrimination according to income quintile in 51,327 Canadian women, with and without a competing mortality framework. The data shows that, under a competing mortality framework, FRAX provides robust fracture prediction and calibration regardless of socioeconomic status (SES).