***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVES To evaluate the effectiveness of a multifactorial intervention to reduce the use of physical restraints in residents of nursing homes . DESIGN Cluster-r and omized controlled trial . SETTING Forty-five nursing homes in Germany . PARTICIPANTS Three hundred thirty-three residents who were being restrained at the start of the intervention . INTERVENTION Persons responsible for the intervention in the nursing homes attended a 6-hour training course that included education about the reasons restraints are used , the adverse effects , and alternatives to their use . Technical aids , such as hip protectors and sensor mats , were provided . The training was design ed to give the change agents tools for problem-solving to prevent behavioral symptoms and injuries from falls without using physical restraints . MEASUREMENTS The main outcome was the complete cessation of physical restraint use on 3 consecutive days 3 months after the start of the intervention . Secondary outcomes were partial reductions in restraint use , percentage of fallers , number of psychoactive drugs , and occurrence of behavioral symptoms . RESULTS The probability of being unrestrained in the intervention group ( IG ) was more than twice that in the control group ( CG ) at the end of the study ( odds ratio=2.16 , 95 % confidence interval=1.05 - 4.46 ) . A partial reduction of restraint use was also about twice as often achieved in the IG as in the CG . No negative effect was observed regarding medication or behavioral symptoms . The percentage of fallers was higher in the IG . CONCLUSION The intervention reduced restraint use without a significant increase in falling , behavioral symptoms , or medication At present , observational studies and expert opinion are the best evidence for the use of physical restraints . Large regional and national disparities are described in acute and long-term care . Epidemiological data demonstrate a prevalence of 3 - 5 % body-fixed or near body restraint devices . The hip fracture rate in Germany are approximately 50 per 1000 resident years . Between 40 - 50 % of the residents in nursing homes are treated with psycho-tropic medication potentially limiting their physical mobility . The presented study protocol was design ed to test the effectiveness of a multifactorial intervention to reduce physical restraints in long-term care ( LTC ) residents particularly with cognitive impairment . The intervention consists of an educational and an organizational part to empower staff members to improve their skills and practice in using restraints . Technical devices to reduce fall related injuries are additionally offered to the LTC facilities . The study population includes 200 LTC residents in 54 facilities in three states in Germany . The sample size calculation was based upon a 5 % prevalence rate in the control group and an expected reduction of 50 % in the intervention group . The protocol is a waiting-list control design . All waiting facilities will be offered to participate after their waiting period . Primary endpoints are the number of restrained residents and resident time ( hours ) of being restrained . The use of psychotropics , falls , fall-related injuries and the incidence of residents newly being restrained is being monitored . The study starts with a baseline documentation of all facilities followed by r and omization and a three month intervention . Change agents will be responsible for the intervention . Technical devices will include a newly developed soft hip protector and sensor mats which notice the intent of leaving the bed . The aim of the study is to develop an evidence -based model for a knowledge transfer project to implement minimum restraint environments in LTC Background Physical restraints are regularly applied in German nursing homes . Their frequency varies substantially between centres . Beneficial effects of physical restraints have not been proven , however , observational studies and case reports suggest various adverse effects . We developed an evidence -based guidance on this topic . The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aim ed to reduce physical restraints and minimise centre variations . Methods / Design Cluster-r and omised controlled trial with nursing homes r and omised either to the  intervention  group or to the control group with st and ard information . The intervention comprises a structured information programme for nursing staff , information material s for legal guardians and residents ' relatives and a one-day training workshop for nominated nurses .  A total of 36 nursing home clusters including approximately 3000 residents will be recruited . Each cluster has to fulfil the inclusion criteria of at least 20 % prevalence of physical restraints at baseline . The primary endpoint is the number of residents with at least one physical restraint at six months . Secondary outcome measures are the number of falls and fall-related fractures . Discussion If successful , the intervention should be implemented throughout Germany . In case the intervention does not succeed , a three-month pre-post- study with an optimised intervention programme within the control group will follow the r and omised trial . Trial registration IS RCT The prevention of injury associated with falls in older people  is a public health target in many countries around the world . Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls , the effect on serious injury rates is unclear . Historically , trials have not been adequately powered to detect injury endpoints , and variations in case definition across trials have hindered meta- analysis . It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in population s who are at a higher risk of injury . Further research is required to determine whether fall-prevention interventions can reduce serious injuries . Prevention of Falls Network Europe ( ProFaNE ) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice ( www.profane.eu.org ) . The European Commission funds the network , which links clinicians , members of the public , and research ers worldwide . The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity , including clinical trials , comparative research , and prospect i ve meta- analysis . Work is being undertaken in a 4-year program . As a first step , the development of a common set of outcome definitions and measures for future trials or meta- analysis was considered 
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In our view , bedrails should not be excluded from PR , even if this is in accordance with other studies in the field .
In conclusion , we would have expected the authors to adhere to the study protocol even if this would have led to a nonsignificant result .
Rather than ‘ ‘ fishing for P-values , ’ ’ analyses of strengths and weaknesses of the program would have been of great significance even if not ‘ ‘ statistically significant . ’ ’