Objective To assess whether supplementation with calcium and cholecaliferol (vitamin D 3 ) reduces the risk of fracture in women with one or more risk factors for fracture of the hip. Design Pragmatic open randomised controlled trial. Setting Practice nurse led clinics in primary care. Participants 3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight ( < 58 kg), smoker, family history of hip fracture, or fair or poor self reported health. Intervention Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group). Main outcome measures Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12). Results 69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups. Conclusion We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.

Objective To compare the clinical effectiveness of larval therapy with a standard debridement technique (hydrogel) for sloughy or necrotic leg ulcers.Design Pragmatic, three armed randomised controlled trial.Setting Community nurse led services, hospital wards, and hospital outpatient leg ulcer clinics in urban and rural settings, United Kingdom.Participants 267 patients with at least one venous or mixed venous and arterial ulcer with at least 25% coverage of slough or necrotic tissue, and an ankle brachial pressure index of 0.6 or more.Interventions Loose larvae, bagged larvae, and hydrogel.Main outcome measures The primary outcome was time to healing of the largest eligible ulcer. Secondary outcomes were time to debridement, health related quality of life (SF-12), bacterial load, presence of meticillin resistant Staphylococcus aureus, adverse events, and ulcer related pain (visual analogue scale, from 0 mm for no pain to 150 mm for worst pain imaginable).Results Time to healing was not significantly different between the loose or bagged larvae group and the hydrogel group (hazard ratio for healing using larvae v hydrogel 1.13, 95% confidence interval 0.76 to 1.68; P=0.54). Larval therapy significantly reduced the time to debridement (2.31, 1.65 to 3.2; P<0.001). Health related quality of life and change in bacterial load over time were not significantly different between the groups. 6.7% of participants had MRSA at baseline. No difference was found between larval therapy and hydrogel in their ability to eradicate MRSA by the end of the debridement phase (75% (9/12) v 50% (3/6); P=0.34), although this comparison was underpowered. Mean ulcer related pain scores were higher in either larvae group compared with hydrogel (mean difference in pain score: loose larvae v hydrogel 46.74 (95% confidence interval 32.44 to 61.04), P<0.001; bagged larvae v hydrogel 38.58 (23.46 to 53.70), P<0.001).Conclusions Larval therapy did not improve the rate of healing of sloughy or necrotic leg ulcers or reduce bacterial load compared with hydrogel but did significantly reduce the time to debridement and increase ulcer pain.Trial registration Current Controlled Trials ISRCTN55114812 and National Research Register N0484123692.

( 2 0 0 7 ) ( 2 0 0 7 ) Pressure ulcers and their treatment and effects on quality of life: hospital inpatient perspectives. Journal of Advanced Nursing 57(5), 494-504 doi: 10.1111/j. 1365-2648.2006.04140.x Abstract Title. Pressure ulcers and their treatment and effects on quality of life: hospital inpatient perspectives Aim. This paper reports a study exploring patients' perceptions and experiences of the impact of a pressure ulcer and its treatment on their health and quality of life. Background. Pressure ulcers are a significant health problem, and their prevention and management in primary and secondary care is high on the clinical and policy agenda. However, patients' perspectives and experiences of the impact of pressure ulcers on health and quality of life is not understood. Method. Qualitative semi-structured interviews were carried out from 2002 to 2004 with a purposive sample of 23 hospital inpatients (five men, 18 women: aged 33-92 years) with a pressure ulcer (graded 2-5) at various anatomical sites and with varied reasons for hospital admission. Data were analysed thematically. Findings. The majority of participants (91%; n ¼ 21) indicated that the pressure ulcer and its treatment affected their lives emotionally, mentally, physically and socially. They presented their perspectives on the causes of their pressure ulcer and descriptions of pain (experienced by 91%), appearance, smell and fluid leakage. Patients described amounts and quality of care they received, including levels of comfort of dressings and pressure relieving equipment and the timing of interventions. They were largely dependent on others to treat, manage and care for their ulcer, but indicated that the pain, discomfort and distress of pressure ulcers was not acknowledged by nursing staff. The pressure ulcers could be pivotal in preventing full recovery, were perceived to increase hospital stays and resulted in ongoing treatments. Conclusion. Healthcare professionals can learn from these patients' experiences about the management of dressings, providing information (in particular about realistic time expectations for healing), providing preventative interventions and understanding the importance of comfort and positioning for patients. The study highlights the complexities of evaluating the impact of pressure ulceration.

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We can use decision models to estimate cost effectiveness, quantify uncertainty regarding the adoption decision and provide estimates of the value of further research. In many cases, the existence of only limited data with which to populate a decision model can mean that a cost-effectiveness analysis either does not proceed or may misrepresent the degree of uncertainty associated with model inputs. An example is the case of negative pressure wound therapy (NPWT) used to treat severe pressure ulceration, for which the evidence base is limited and sparse. There is, however, substantial practical experience of using this treatment and its comparators. We can capture this knowledge quantitatively to inform a cost-effectiveness model by eliciting beliefs from experts. This paper describes the design and conduct of an elicitation exercise to generate estimates of multiple uncertain model inputs and validate analytical assumptions for a decision model on the use of NPWT. In designing the exercise, the primary focus was the use of elicitation to inform decision models (multistate models), where representations of uncertain beliefs need to be probabilistically coherent. This paper demonstrates that it is feasible to collect formally elicited evidence to inform decision models.