***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 
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    ***EXAMPLES*** 
    Input: Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement OBJECTIVE To evaluate the efficacy of a dementia care program to reduce behavior disorders in nursing home patients with dementia . DESIGN R and omized controlled clinical trial with 6-month follow-up . SETTING A 250-bed community nursing home . PATIENTS The nursing home was screened to identify patients with dementia and behavior disorders . A total of 118 patients were eligible for r and omization . Of these , 89 ( 75.4 % ) were r and omized , and 81 of these ( 91.0 % ) completed the trial . INTERVENTION The A.G.E. dementia care program consisted of Activities , Guidelines for psychotropic medications , and Educational rounds . The control treatment was usual nursing home care . MEASUREMENTS Behavior disorders , antipsychotic drug and physical restraint use , patient activity levels , and cognitive and functional status . RESULTS After 6 months , 12 of 42 ( 28.6 % ) intervention patients exhibited behavior disorders compared with 20 of 39 ( 51.3 % ) controls ( OR = 0.38 ; 95 % CI [ 0.15 , 0.95 ] ; P = .037 ) . Controls were more than twice as likely to receive antipsychotics ( OR = 2.55 , 95 % CI [ 0.96 , 6.76 ] ; P < .056 ) , to be restrained during activity times ( OR = 2.98 , 95 % CI [ 1.10 , 8.04 ] ; P < .028 ) , and to be restrained on nursing units ( OR = 2.14 , 95 % CI [ 0.9 , 5.3 ] ; P < .10 ) . Intervention patients were much more likely to participate in activities ( OR = 13.71 ; 95 % CI [ 4.51 , 41.73 ] ; P = .001 ) . CONCLUSIONS The A.G.E. program reduces the prevalence of behavior disorders and the use of antipsychotic drugs and restraints . It is practical , feasible , and appears to improve the lives of patients with dementia in nursing homes 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 This paper shows patients ' enactment of choice in mixed methods , multidisciplinary study on the use of bedrails as restraints . APPROACH Under the pressure of the implementation of impending legislation , patients from a Canadian elderly care rehabilitation unit were recruited to be part of this study and assigned to either a study or control group . Study group patients were exposed to a new facility policy on restraints  in which bedrails were not to be used on a patient 's bed except under specified conditions . Patients in the control group continued to have bedrails on a routine basis according to the facility 's old policy . Following group assignments , patients could choose to crossover to either the control or study group based on their opinions about bedrails . FINDINGS After patients crossed over into either the study or control group , findings for the new groups differed significantly . Participants in the rails-up group had lower admission Functional Independence Measure scores ( p = .001 ) and higher admission Cumulative Illness Rating scores ( p = .000 ) compared to those in the rails-down group . CONCLUSIONS Patients have specific concerns related to the use of bedrails that might affect implementing bedrail minimization policies . Additionally , the authors conclude that patients ' input into research design may increase patients ' support of the protocol and help maintain study integrity Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods . Therefore , reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important . The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents . Methods A cluster r and omized trial was applied to 5 psycho-geriatric nursing home wards ( n = 167 residents with dementia ) . The wards were assigned at r and om to either educational intervention ( 3 wards ) or control status ( 2 wards ) . The restraint status was observed and residents ' characteristics , such as cognitive status , were determined by using the Minimum Data Set ( MDS ) at baseline and 1 month after intervention . Results Restraint use did not change significantly over time in the experimental group ( 55%–56 % ) , compared to a significant increased use ( P < 0.05 ) in the control group ( 56%–70 % ) . The mean restraint intensity and mean multiple restraint use in residents increased in the control group but no changes were shown in the experimental group . Logistic regression analysis showed that residents in the control group were more likely to experience increased restraint use than residents in the experimental group . Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term . However , the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group . Whether the intervention will reduce restraint use in the long term could not be inferred from these results . Further research is necessary to gain insight into the long-term effects of this educational intervention OBJECTIVES To investigate the effects of an educational intervention on the use of physical restraints with psychogeriatric nursing home residents . DESIGN Cluster-r and omized trial . SETTING Fifteen psychogeriatric nursing home wards in the Netherl and s. PARTICIPANTS In total , 432 psychogeriatric nursing home residents from 15 psychogeriatric nursing home wards in seven nursing homes were selected for participation ; 404 consented , and 371 of these were available at baseline . Two hundred forty-one from 14 wards had complete data and were included in the data analyses . INTERVENTION The nursing home wards were assigned at r and om to educational intervention or control status . The educational intervention consisted of an educational program for nursing staff combined with consultation with a nurse specialist ( registered nurse ( RN ) level ) . MEASUREMENTS Data were collected at baseline and 1 , 4 , and 8 months postintervention . At each measurement , the use of physical restraints was measured using observations of blinded , trained observers on four separate occasions over a 24-hour period . Other resident characteristics , such as cognitive status , were determined using the Minimum Data Set . RESULTS Logistic and linear regression analyses showed no treatment effect on restraint status , restraint intensity , or multiple restraint use in any of the three postintervention measurements . Furthermore , only small changes occurred in the types of restraints used with residents in the experimental group . CONCLUSION An educational program for nursing staff combined with consultation with a nurse specialist ( RN level ) had no effect on the use of physical restraints with psychogeriatric nursing home residents . In addition to restraint education and consultation , new measures to reduce the use of physical restraints with psychogeriatric nursing home residents should be developed 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 
    Output:
    
There is insufficient evidence supporting the effectiveness of educational interventions targeting nursing staff for preventing or reducing the use of physical restraints in geriatric long-term care