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Objectives Since 1987, the Harstad community in Norway has run an injury prevention program according to the Safe Community approach. The effectiveness of this approach in reducing injury rates is poorly documented. The aim of this study was to evaluate the impact of the Harstad program on the incidence of injuries. Methods We used data from the National Injury register of Norway and compared age-adjusted incidence rates and standardized rate ratios of injuries in Harstad and three control communities for the period 1992-1997. Results Harstad had the second highest rates for both all injuries and fractures. No reduction in the incidence of injuries in Harstad was observed from 1992-1997. The injury rates in 1992-1997 were similar to the rates recorded in 1985/86. Conclusions The injury prevention program in Harstad has not reduced overall injury rates. The Safe Community concept is an organizational strategy, but implementation of proven and targeted risk reduction measures will be needed if community-bas...

PROBLEM Numerous activities to promote bicycle safety have been implemented in Norway. The overall effect of these activities has not been evaluated. method Information about cases of bicycle-related injuries occurring in 1990-1993 was obtained from prospective registration of all injuries treated by hospitals and emergency clinics in four urban centers in NORWAY. Incidence was calculated per number of cyclists, based on data obtained from the 1992 National Bicycle Survey. Temporal changes in injury severity and in age-specific incidence (per bicycle riders) of all injuries, upper-head injuries, other injuries, injuries due to bicycle-motor vehicle collision, and injuries leading to inpatient treatment were analyzed by logistic regression analysis. RESULTS 3,893 injuries occurred in the study population in 1990-1993. The average annual incidence was 33.1 per 10,000 population aged 4 years and higher, or 47.9 per 10,000 bicyclists. No significant secular trends were found for any of the analyzed p...

Fred Burbank,1 Mark J Buchfuhrer,2 Branko Kopjar31Salt Creek International Women’s Health Foundation, San Clemente, CA, USA; 2Stanford University Center for Sleep Sciences, Downey, CA, USA; 3Department of Health Services, University of Washington, Seattle, WA, USAPurpose: Pooled data from two randomized, double-blind, prospective clinical trials were analyzed (i) to determine if vibratory stimulation can safely treat patients with moderately severe restless legs syndrome and (ii) to compare two types of shams.Patients and methods: One hundred and fifty-eight patients with at least moderately severe primary restless legs syndrome (a score of 15 or greater on the International Restless Legs Syndrome Study Group rating scale) were enrolled at five investigational sites, between April 20, 2009 and February 12, 2010. Patients were randomly assigned to treatment with a vibrating pad or control (sound-producing or light-emitting sham pad). Patients and investigators were blinded to pad assignment type (treatment pad or sham pad). Efficacy was measured as a change in score from baseline to week 4, on the Medical Outcomes Study Sleep Problems Index II, the Johns Hopkins Restless Legs Syndrome Quality of Life summary scale, and the International Restless Legs Syndrome Study Group rating scale. Clinicians were asked to evaluate the effectiveness of the pad assignment and to guess whether treatment or sham therapy had been assigned. Adverse events related to vibrating pad assignment were tabulated.Results: The Medical Outcomes Study Sleep Problems Index II scores improved significantly more for patients receiving a vibrating pad over those receiving a sham pad (P ≤ 0.02) even when corrected for multiplicity (P ≤ 0.04). Clinician evaluation favored patients assigned vibrating pads, and neither patients nor clinicians accurately guessed which pad was assigned. No significant difference in adverse event rates was observed between the vibrating and sham pad groups. Sound and light sham pads performed comparably with respect to safety and efficacy.Conclusion: Four weeks of treatment with vibrating pads safely improved sleep in patients with restless legs syndrome and both shams functioned comparably.Keywords: restless legs syndrome, vibration therapy, sham-controlled, double-blind, randomized clinical trial

Correspondence: Fred Burbank Salt Creek International Women’s Health Foundation, 1235 Puerta del Sol, Suite 700, San Clemente, CA, 92673, USA Tel +1 949 496 0026 Fax +1 949 492 0650 Email fburbank@cox.net Background: Vibratory stimulation pads have been shown to improve sleep in patients with restless legs syndrome (RLS) to a greater extent than sham therapy. The current gold standard of treatment is drugs approved by the US Food and Drug Administration (FDA) for use in RLS. The aim of this meta-analysis was to compare the efficacy and safety of vibratory stimulation pads, sham pads, and drugs approved by the FDA for use in RLS. Methods: We searched the PubMed, Embase, and clinical trial websites to identify the relevant randomized, double-blind, and placebo-controlled or sham-controlled studies. Fifteen studies including a combined total of 3455 patients with at least moderately severe primary RLS met our search criteria. Efficacy was defined as the standardized mean difference in sleep improvement between treatment and controls. Safety was assessed by comparing the odds ratios of any adverse events and adverse events leading to study withdrawal between treatment and control subjects. Results: Improvement in Medical Outcomes Study (MOS) sleep inventory scores from baseline was significantly greater in patients treated with vibratory stimulation pads than in those receiving sham pads (Hedges’s g, standardized mean difference −0.39, P # 0.02). There was no difference in improvement in sleep scores between patients treated with vibratory stimulation pads (−0.39) and those receiving an approved RLS drug (−0.44, P . 0.70). The risk of any adverse event or withdrawal because of an adverse event was not significantly different between patients treated with vibratory stimulation pads and those assigned to sham pads (Mantel-Haenszel odds ratio 2.16 [P . 0.14] and 1.39 [P . 0.80], respectively). The odds ratios for patients reporting any adverse events and adverse events leading to withdrawal were not significantly different between patients treated with vibratory stimulation pads (2.16 and 1.39, respectively) and those who received approved RLS drugs (2.11 [P . 0.89] and 2.07 [P . 0.82], respectively, mixed-effects model). Conclusion: For patients with moderately severe RLS, vibratory stimulation pads were more effective than sham pads for improving sleep, as effective as FDA-approved RLS drugs, and as safe as both sham pads and FDA-approved RLS drugs.