WITHDRAWN: Pharmacological interventions for treating acute heterotopic ossification.

BACKGROUND: Heterotopic ossification (HO) is the formation of mature lamellar bone in soft tissue sites outside the skeleton. HO frequently complicates burns, arthroplasty, fractures, and spinal cord and brain injuries. It can impair joint function. OBJECTIVES: To determine the efficacy of medications to treat acute HO on radiological, symptomatic, functional impairment, and disability outcomes. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group specialised register, the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2004), MEDLINE (1966 to August 2004), EMBASE (1980 to August 2004), CINAHL (1982 to August 2004), other databases, reference lists of articles, and contacted trialists and drug companies. No language restrictions were applied. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials that assessed the efficacy of any medication for treating acute HO (confirmed by bone scintigraphy, radiography, ultrasonography, or biopsy) and which used radiography to grade post-treatment HO severity. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the study quality and extracted data. We analysed two dichotomous outcomes: no progression in HO grade (versus progression) and improvement in HO grade (versus no improvement). MAIN RESULTS: Two randomised trials comparing disodium etidronate versus placebo were included (Ono 1988; Stover 1976), from which ninety-two participants with spinal cord injury had radiographically-proven HO at baseline. At the completion of the 12 week intervention, the Ono study but not the Stover study, suggested that disodium etidronate was associated with a significantly greater likelihood of successfully preventing the progression of radiographic HO grade, (relative risk (RR) 1.50; 95% confidence interval (CI) I 1.16 to 1.93; and RR 1.48; 95% CI 0.78 to 2.84 respectively) and a significantly greater likelihood of improvement in HO grade (RR 2.78; 95% CI 1.66 to 4.66; and RR 0.71; 95% CI 0.20 to 2.53 respectively). There was evidence of statistical heterogeneity for the latter outcome. Longer term radiographic, clinical or side effect outcomes were unavailable. Data was not pooled due to this heterogeneity and the inadequate duration of follow up. AUTHORS' CONCLUSIONS: Given the absence of long term radiographic outcomes in the included studies, there is insufficient evidence to recommend the use of disodium etidronate or other pharmacological agents for the treatment of acute HO. It has been previously suggested that disodium etidronate acts by delaying, rather than preventing, the mineralization of HO, and that mineralization may occur after treatment cessation in many cases, thereby negating the benefit of disodium etidronate on eventual HO grade. Further studies are required to assess all pharmacological treatments for acute HO with sufficient follow-up duration.

Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial.

BACKGROUND: Recent research has shown that wearing multifocal glasses increases the risk of trips and falls in older people. The aim of this study is to determine whether the provision of single-lens distance glasses to older multifocal glasses wearers, with recommendations for wearing them for walking and outdoor activities, can prevent falls. We will also measure the effect of the intervention on health status, lifestyle activities and fear of falling, as well as the extent of adherence to the program. METHODS/DESIGN: Approximately 580 older people who are regular wearers of multifocal glasses people will be recruited. Participants will be randomly allocated to either an intervention group (provision of single lens glasses, with counselling and advice about appropriate use) or a control group (usual care). The primary outcome measure will be falls (measured with 13 monthly calendars). Secondary measures will be quality of life, falls efficacy, physical activity levels and adverse events. DISCUSSIONS: The study will determine the impact of providing single-lens glasses, with advice about appropriate use, on preventing falls in older regular wearers of multifocal glasses. This pragmatic intervention, if found to be effective, will guide practitioners with regard to recommending appropriate glasses for minimising the risk of falls in older people. TRIAL REGISTRATION: The protocol for this study was registered with the Clinical Trials.gov Protocol Registration System on June 7th 2006 (#350855).

Validity, responsiveness, and minimal important difference for the SF-6D health utility scale in a spinal cord injured population.

OBJECTIVE: To determine the feasibility, acceptability, discriminative validity, responsiveness, and minimal important difference (MID) of the SF-6D for people with spinal cord injury (SCI). METHODS: A total of 305 people with SCI completed the SF-36 health status questionnaire at baseline and at subsequent occurrence of a urinary tract infection (UTI) or 6-month follow-up. Normative SF-36 data were obtained from the Australian Bureau of Statistics. SF-36 scores were transformed to SF-6D utility values using Brazier's algorithm. We used UTI as the external criterion of clinically important change to determine responsiveness and two categories of the SF-36 transition question ("somewhat worse" and "somewhat better") as the external criterion to determine the MID. Derived SF-12 responsiveness was also assessed. RESULTS: The mean SF-6D values were: 0.68 (SD 0.21, n = 305) all patients; 0.66 (SD 0.19, n = 167) tetraplegia; 0.72 (SD 0.26, n = 138) paraplegia; 0.57 (SD 0.15, n = 138) with UTI. The Australian normative SF-6D mean value was 0.80 (SD 0.14, n = 18,005). The SF-6D was able to discriminate between SCI and the Australian normative sample (effect size [ES] = 0.86), tetraplegia-paraplegia (ES = 0.23), and it was responsive to UTI (ES = 0.86 SF-36 variant, ES = 0.92 SF-12 variant). The MID for respondents who reported being somewhat worse or somewhat better at follow-up was 0.03 (SD 0.17, n = 108/305), while the MID for only those who were somewhat worse was 0.10 (SD 0.14, n = 58). CONCLUSIONS: The content of the SF-6D is more appropriate than that of the SF-36 for this physically impaired population. The SF-6D has discriminative power and is responsive to clinically important change because of UTI. The MID is consistent with published estimates for other disease groups.

Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial.

OBJECTIVE: To determine whether the provision of single lens distance glasses to older wearers of multifocal glasses reduces falls. DESIGN: Parallel randomised controlled trial stratified by recruitment site and source of referral, with 13 months' follow-up and outcome assessors blinded to group allocation. SETTING: Community recruitment and treatment room assessments in Sydney and Illawarra regions of NSW, Australia. PARTICIPANTS: 606 regular wearers of multifocal glasses (mean age 80 (SD 7) years). Inclusion criteria included increased risk of falls (fall in previous year or timed up and go test >15 seconds) and outdoor use of multifocal glasses at least three times a week. INTERVENTIONS: Provision of single lens distance glasses with recommendations for wearing them for walking and outdoor activities compared with usual care. MAIN OUTCOME MEASURES: Number of falls and injuries resulting from falls during follow-up. RESULTS: Single lens glasses were provided to 275 (90%) of the 305 intervention group participants within two months; 162 (54%) of the intervention group reported satisfactory use of distance glasses for walking and outdoor activities for at least 7/12 months after dispensing. In the 299 intervention and 298 control participants available to follow-up, the intervention resulted in an 8% reduction in falls (incidence rate ratio 0.92, 95% confidence interval 0.73 to 1.16). Pre-planned sub-group analyses showed that the intervention was effective in significantly reducing all falls (incidence rate ratio 0.60, 0.42 to 0.87), outside falls, and injurious falls in people who regularly took part in outside activities. A significant increase in outside falls occurred in people in the intervention group who took part in little outside activity. CONCLUSIONS: With appropriate counselling, provision of single lens glasses for older wearers of multifocal glasses who take part in regular outdoor activities is an effective falls prevention strategy. The intervention may be harmful, however, in multifocal glasses wearers with low levels of outdoor activity. TRIAL REGISTRATION: Clinical trials NCT00350389.

Health status rated with the Medical Outcomes Study 36-Item Short-Form Health Survey after spinal cord injury.

OBJECTIVE: To describe the health status of Australians with spinal cord injury (SCI). DESIGN: Survey. SETTING: Australian population-based sample. PARTICIPANTS: Participants (N=305) with SCI at recruitment to a randomized trial. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) health questionnaire. RESULTS: Compared with the general population, our sample reported significantly lower scores in 6 SF-36 domains (physical function, role-physical, bodily pain, general health, social function, vitality) and the physical component summary (PCS) score, but unexpectedly higher mental component summary (MCS) scores (difference in mean MCS scores, 4.6; 95% confidence interval [CI], 2.4-6.8). Compared with people with tetraplegia, those with paraplegia had better physical function and PCS scores (difference, 21; 95% CI, 17-24; difference, 3; 95% CI, 1-5, respectively), and worse bodily pain scores (difference, 9; 95% CI, 2-15). Recent urinary infections were associated with worse general health, vitality, mental health, and MCS scores. Receiving family or external physical care was associated with worse physical function and PCS scores, but better mental health and MCS scores. Older age at injury was associated with lower bodily pain and PCS scores. CONCLUSIONS: Using the SF-36, Australians with SCI rate their physical (not mental) health status as worse than the general population.