The health-related quality of life and cost implications of falls in elderly women.

SUMMARY: Fractures and falls are serious cause of morbidity and cost to society. Our results suggest that the main burden to morbidity, measured as impact on health-related quality of life, is due to fear of falling rather than falls or their sequelae, such as fractures. INTRODUCTION: Fractures and falls are serious cause of morbidity and cost to society. We investigated the impact on health-related quality of life (HRQoL) associated with falls, fractures and fear of falling and falls and fractures cost. METHODS: Three datasets providing longitudinal data on fear of falling, HRQoL and a common set of baseline risk factors for fracture (smoking status, weight and age) were analysed. Multilevel random effects models were used to estimate the long-term impact on HRQoL associated with falls, fractures and fear of falling. Healthcare resource use primary data were collected to estimate falls and fractures cost. RESULTS: Older, low weight and smoking women reported lower HRQoL. The impact on HRQoL of a fracture was at least twice as large as that associated with falls. The largest negative effect on HRQoL was associated with self-reported fear of falling. The cost of falls was 1088 pounds. Similarly, the cost of falls leading to a fracture was 15,133 pounds, 2,753 pounds, 1,863 pounds, 1,331 pounds and 3,498 pounds for hip, wrist, arm, vertebral and other fractures, respectively. DISCUSSION: The main burden to morbidity is due to fear of falling. Interventions aimed at reducing fear of falling may produce larger gains in HRQoL.

Patient acceptability of larval therapy for leg ulcer treatment: a randomised survey to inform the sample size calculation of a randomised trial.

BACKGROUND: A trial was commissioned to evaluate the effectiveness of larval therapy to debride and heal sloughy and necrotic venous leg ulcers. Larval therapy in the trial was to be delivered in either loose or bagged form. Researchers were concerned that resistance to larval therapy may threaten the feasibility of the trial. Additionally there was concern that the use of larval therapy may require a larger effect size in time to healing than originally proposed by the investigators. METHODS: To formally evaluate patient preferences a survey using two randomly allocated, nurse administered questionnaires was undertaken. Patients were randomised to receive one of the two following questionnaires (i) preferences between loose larvae and standard treatment (hydrogel) or (ii) patient preferences between bagged larvae and standard therapy (hydrogel). The study was undertaken in a Vascular Clinic, in an Outpatients Department of a large teaching hospital in the North of England. The sample consisted of 35 people aged 18 years and above with at least one leg ulcer of venous or mixed (venous and arterial) aetiology. RESULTS: Approximately 25% of participants would not consider the use of larval therapy as an acceptable treatment option for leg ulcers, regardless of the method of containment. For the patients that would consider the use of larval therapy, different preferences in healing times required to use the therapy were observed depending upon the method of containment. The median response of those participants questioned about bagged larvae found that they would be willing to use this therapy even if they were equally able to achieve healing with the use of hydrogel by 20 weeks. For those participants questioned about the use of loose larvae complete healing would have to have taken place over 17 weeks for them to choose larvae as their preferred option rather than hydrogel. This difference was not significant (p = 0.075). CONCLUSION: We found no evidence of widespread resistance to the utilisation of larval therapy from patients regardless of the method of larval therapy containment. These methods have the potential to inform sample size calculations where there are concerns of patient acceptability.

Pressure relieving support surfaces: a randomised evaluation.

OBJECTIVES: To determine differences between alternating pressure overlays and alternating pressure replacement mattresses with respect to the development of new pressure ulcers, healing of existing pressure ulcers, patient acceptability and cost-effectiveness of the different pressure-relieving surfaces. Also to investigate the specific additional impact of pressure ulcers on patients' well-being. DESIGN: A multicentre, randomised, controlled, open, fixed sample, parallel-group trial with equal randomisation was undertaken. The trial used remote, concealed allocation and intention-to-treat (ITT) analysis. The main trial design was supplemented with a qualitative study involving a purposive sample of 20-30 patients who developed pressure ulcers, to assess the impact of the pressure ulcers on their well-being. In addition, a focus group interview was carried out with clinical research nurses, who participated in the PRESSURE (Pressure RElieving Support SUrfaces: a Randomised Evaluation) Trial, to explore the experiences of their role and observations of pressure area care. SETTING: The study took place in 11 hospital-based research centres within six NHS trusts in England. PARTICIPANTS: Acute and elective patients aged 55 years or older and admitted to vascular, orthopaedic, medical or care of the elderly wards in the previous 24 hours were investigated. INTERVENTIONS: Patients were randomised to either an alternating pressure overlay or an alternating pressure mattress replacement, with mattress specifications clearly defined to enable the inclusion of centres using products from different manufacturers, and to exclude hybrid mattress systems (which either combine foam or constant low pressure with alternating pressure in one mattress, or can be used as either an overlay or a replacement mattress). MAIN OUTCOME MEASURES: Development of a new pressure ulcer (grade < or =2, i.e. partial-thickness wound involving epidermis/dermis only) on any skin site. Also healing of existing pressures ulcers, patient acceptability and cost-effectiveness. RESULTS: In total, 6155 patients were assessed for eligibility to the trial and 1972 were randomised: 990 to the alternating pressure overlay (989 after one postrandomisation exclusion) and 982 to the alternating pressure mattress replacement. ITT analysis found no statistically significant difference in the proportions of patients developing a new pressure ulcer of grade 2 or above [10.7% overlay patients, 10.3% mattress replacement patients, a difference of 0.4%, 95% confidence interval (CI) -2.3 to 3.1%, p = 0.75]. When logistic regression analysis was used to adjust for minimisation factors and prespecified baseline covariates, there was no difference between the mattresses with respect to the odds of ulceration (odds ratio 0.94, 95% CI 0.68 to 1.29). There was no evidence of a difference between the mattress groups with respect to time to healing (p = 0.86). The Kaplan-Meier estimate of the median time to healing was 20 days for each intervention. More patients allocated overlays requested mattress changes due to dissatisfaction (23.3%) than mattress replacement patients (18.9%, p = 0.02) and more than one-third of patients reporting difficulties associated with movement in bed and getting into or out of bed. There is a higher probability (64%) that alternating mattress replacements are cost-saving; they were associated with lower overall costs (74.50 pounds sterling per patient on average, mainly due to reduced length of stay) and greater benefits (a delay in time to ulceration of 10.64 days on average). Patients' accounts highlighted that the development of a pressure ulcer could be pivotal in the trajectory from illness to recovery, by preventing full recovery or causing varied impacts on their quality of life. CONCLUSIONS: There is no difference between alternating pressure mattress replacements and overlays in terms of the proportion of patients developing new pressure ulcers; however, alternating pressure mattress replacements are more likely to be cost-saving. The results suggest that when renewing alternating pressure surfaces or ordering equipment within a rental contract, mattress replacements should be specified; however, overlays are acceptable if no replacement mattress is available. Similarly, patient preferences can be supported, without any great increase in risk, if individual patients request an overlay rather than a replacement mattress. Further research could include a randomised controlled trial comparing alternating pressure mattress replacements and high-specification foam mattresses in patients at moderate to high risk; an accurate costing study to understand better how much pressure ulcers cost health and social services in the UK; and trials in higher risk groups of patients. Also future trials should measure time to ulceration as the primary end-point, since this is more informative economically and possibly also from a patient and clinical perspective.

Economic analysis of VenUS I, a randomized trial of two bandages for treating venous leg ulcers.

BACKGROUND: The study investigated the cost-effectiveness of four-layer and short-stretch compression bandages for treating venous leg ulcers. METHODS: Cost-effectiveness and cost-utility analyses were performed using patient-level data collected alongside the VenUS I leg ulcer study. The perspective for the economic analysis was that of the UK National Health Service (NHS) and Personal Social Service. The time horizon for the analysis was 1 year after recruitment. Health benefit was measured as differences in ulcer-free days and quality-adjusted life years (QALYs). RESULTS: The mean healing time for ulcers treated with four-layer bandages was 10.9 (95 per cent confidence interval (c.i.) -6.8 to 29.1) days less than that for ulcers treated with short-stretch bandages. Mean average difference in QALYs between compression systems was -0.02 (95 per cent c.i. -0.08 to 0.04). The four-layer bandage cost a mean of pound 227.32 (95 per cent c.i. pound 16.53 to pound 448 .30) less per patient per year than the short-stretch bandage. CONCLUSION: On average, four-layer bandaging was associated with greater health benefits and lower costs than short-stretch bandaging.

Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers (VenUS I).

BACKGROUND: A randomized clinical trial was undertaken to determine the relative effectiveness of four-layer and short-stretch bandaging for venous ulceration. METHODS: A total of 387 adults with a venous ulcer, who were receiving leg ulcer treatment either in primary care or as a hospital outpatient, were recruited to this parallel-group open study and randomized to either four-layer or short-stretch bandages. Follow-up continued until the patient's reference leg was ulcer free or for a minimum of 12 months. The primary endpoint was time to complete healing of all ulcers on the reference leg. Secondary outcomes included proportion of ulcers healed, health-related quality of life, withdrawals and adverse events. Analysis was by intention to treat. RESULTS: Unadjusted analysis identified no statistically significant difference in median time to healing: 92 days for four-layer and 126 days for short-stretch bandages. However, when prognostic factors were included in a Cox proportional hazards regression model, ulcers treated with the short-stretch bandage had a lower probability of healing than those treated with the four-layer bandage: hazard ratio 0.72 (95 per cent confidence interval 0.57 to 0.91). More adverse events and withdrawals were reported with the short-stretch bandage. CONCLUSION: Venous leg ulcers treated using a four-layer bandage healed more quickly than those treated with a short-stretch bandage.

The cost utility of bisphosphonate treatment in established osteoporosis.

BACKGROUND: Hip fracture is an important and costly problem. Bisphosphonate therapy prevents hip and other fractures among women with established osteoporosis, but there are few published economic evaluations of this treatment. AIM: To assess the cost-effectiveness of risedronate, a recently launched bisphosphonate for the prevention of fractures among women with established osteoporosis. METHODS: A state transition Markov model of established post-menopausal osteoporosis based upon randomized clinical trial data was developed. Uncertainty underlying model parameters and outcomes was dealt with using traditional sensitivity analysis and stochastic sensitivity analysis to produce quasi-95%CIs. We focussed on patients aged approximately 75 years, since this population most closely matches the randomized controlled trial, and is typical of osteoporosis patients in the UK. RESULTS: The baseline model of treating a cohort of 1000 75-year-old women for 3 years with risedronate and then modelling the costs and benefits over their expected lifetimes, produced net savings of pound sterling 786 000 for the treatment group per 1000 treated women, (95%CI pound sterling 1.55m savings to pound sterling 47000 extra costs). Restricting the horizon of the analysis to only three years led to a small net cost of pound sterling 138 000 per 1000 treated women (95%CI pound sterling 196 000 savings to pound sterling 477 000 extra costs) with a net increment in Quality Adjusted Life years (QALYs) of 16 per 1000 treated women. This resulted in a cost per QALY of pound sterling 8625 per treated woman. CONCLUSIONS: In this example, the use of risedronate therapy in 75-year-old women at high risk of hip fracture leads to an improvement in quality of life with possible cost savings. Restricting the analysis to a time horizon of only three years leads to a QALY gain at a modest net cost.

Improving the measurement of quality of life in older people: the York SF-12.

To assess whether changing the layout of the SF-12 affected item response rates, we tested two SF-12 formats in a quasi-randomized trial of women aged >or=70 years in two general practices in North Yorkshire. The modified version of the SF-12 ('York SF-12') converted the 'stem and leaf' format of some questions to individual items. We assessed the effect of the two types of questionnaires on item response rates. The difference in overall response rates to the two questionnaires (York SF-12 26.8%; SF-12 29.5%) was not statistically significant (95%CI -1.88% to 7.22%). However, the modified SF-12 had a statistically significantly lower item non-response rate of 8.5%, compared with the 26.6% of the SF-12 (95%CI 11.1%-25.1%). Chronbach's alpha reliability scores for the York SF-12 were also slightly better than for the older version. The York version of the SF-12 is an improvement on the original questionnaire. We recommend that the York SF-12 be used in preference to the SF-12 when surveying an older population.

Prevalence of hip fracture risk factors in women aged 70 years and over.

We estimated the prevalence of common risk factors for hip fracture and the numbers needed to treat (NNT) to prevent a hip fracture in various high-risk population groups, using a postal risk factor survey of women aged 70 years and above from General Practices in Grampian and Yorkshire. Recorded risk factors included prior fracture of any type; low body weight; smoking; and family history of fracture. The prevalence rates of hip fracture risk factors were 34%, 7% and 11% for previous fracture, maternal hip fracture and smoking, respectively for the Grampian practices (low body weight being defined as falling in the lowest quartile) and 34%, 7% and 7% for a single practice in the York area. Applying previously published estimates of risk, NNT analysis produced a value of about 300 for women with no risk factors, whilst for women with three risk factors it was between 32 and 71, depending on which risk factors were present and assuming intervention reduced fracture rates by 30% or 50%. Groups of women at high risk of hip fracture can easily be identified in primary care and offered treatment, with realistic prospects of hip fracture prevention.