***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: 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 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 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 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 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 OBJECTIVES To examine predictors of continued restraint use in nursing home residents following efforts aim ed at  restraint reduction . DESIGN Secondary analysis of data from a clinical trial using a one-group , pre-test post-test design . SETTING Three nonprofit , religion-affiliated nursing homes in a metropolitan area . PARTICIPANTS The sample consisted of 201 physically restrained nursing home residents . Following restraint reduction efforts , 135 of the sample were still restrained . Mean age of participants was 83.9 years . MEASUREMENTS Physical restraint use was measured by observation and included any chest/vest , wrist , mitt , belt , crotch , suit , or harness restraint plus any sheet used as restraint or a geriatric chair with fixed tray table . Nursing home residents were subjected to any one of three conditions aim ed at restraint reduction , including adherence to the m and ate of the Omnibus Budget Reconciliation Act of 1987 ( OBRA ' 87 ) , staff education , and education with consultation from a gerontological clinical nurse specialist . Resident characteristics including dependency , health status , mental status , depression , behavior , fall risk ; presence of treatment devices and institutional factors were determined . RESULTS Physical dependency , lower cognitive status , behavior , presence of treatment devices , presence of psychiatric disorders , fall risk , and fall risk as staff rationale for restraint were associated ( P < .10 ) with continued restraint use . Nursing hours , staff mix , prevalence of restraint use by unit , and site were also associated ( P < .10 ) with continued use of physical restraints . Following bivariate analysis , associated resident characteristics were subjected to logistic regression . Lower cognitive status ( OR = 2.4 ( for every 7-point decrease in MMSE ) , 95 % CI , 1.7 , 3.3 ) and fall risk as staff rationale for restraint ( OR = 3.5 , 95 % CI . , 1.5 , 8.0 ) were predictive of continued restraint use . Adding nursing hours , staff mix , and prevalence of restraint use by unit to the logistic regression model was not statistically significant ( partial chi-square = 2.79 , df = 6 , P = .834 ) . Nursing home site was added to the model without changing the significance ( P < .05 ) of cognitive status or fall risk as a staff rationale for restraint use . CONCLUSION Continued restraint use in nursing home residents in this study most often occurred with severe cognitive impairment and /or when fall risk was considered by staff as a rationale for restraint . Efforts to reduce or eliminate physical restraint use with these groups will require greater efforts to educate staff in the assessment and analysis of fall risk , along with targeted interventions , particularly when cognition is also impaired OBJECTIVES To evaluate the effects of a restraint minimization education program on staff knowledge and attitudes and use of physical restraints . DESIGN Cluster-r and omized controlled trial with nursing units as the basis for r and omization . SETTING Forty group dwelling units for people with dementia . PARTICIPANTS At baseline , there were 184 staff and 191 residents in the intervention group and 162 staff and 162 residents in the control group . At the 6-month follow-up , there were 156 staff and 185 residents ( 36 newly admitted ) in the intervention group and 133 staff and 165 residents ( 26 
    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 .
Relevance to clinical practice .
Our findings indicate that educational programmes targeting nursing staff might not be effective in reducing the use of physical restraints in geriatric long-term care .
It remains unclear which components should be included in educational programmes aim ing to reduce physical restraints