***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: Summary A  quality of life scale was developed to measure the subjective fear of falling  in nursing home residents . We assessed the dimensions fear of falling , daily living and social life within a r and omized controlled trial of hip protector use . The Nottingham Health Profile ( NHP ) was used for validation . Statistical analysis covered factor analysis , internal consistency of subscales , construct and discriminant validity . Factor analysis revealed three reliable components ( Cronbach ’s Alpha ) : fear of falling ( 0.92 ) , social restriction due to limited mobility ( 0.74 ) and restriction by clothes due to the hip protector ( 0.72 ) . The subscales fear of falling and social restriction were significantly intercorrelated with all subscales of the NHP . The new tool is a reliable and valid measure of fear of falling in nursing home residents . However , generalizability and applicability are limited by the small proportion of subjects able to complete the tests . ZusammenfassungEs wurde ein Instrument zur Erhebung der subjektiven gesundheitsbezogenen Lebensqualität in Bezug auf Sturzangst bei Alten- und Pflegeheimbewohnern entwickelt . Erfasst wurden die Dimensionen Sturzangst , tägliches Leben und soziales Leben innerhalb einer r and omisiert-kontrollierten Studie zur Prävention von Hüftfrakturen durch Hüftprotektion . Zur Validierung wurde das Nottingham Health Profile ( NHP ) herangezogen . Die statistische Analyse umfasste die faktorielle Validität und Reliabilität sowie die konvergente und diskriminante Validität . Die Faktorenanalyse ergab drei Komponenten mit hoher Reliabilität ( Cronbach ’s Alpha ) : Sturzangst ( 0,92 ) , soziale Einschränkungen durch limitierte Mobilität ( 0,74 ) und Einschränkungen durch die Bekleidung in Bezug auf Hüftprotektion ( 0,72 ) . Insgesamt waren für die Subskalen Sturzangst und soziale Einschränkungen alle Korrelationen mit den Skalen des NHP statistisch signifikant . Für das neu entwickelte Instrument zur Messung der Sturzangst bei Altenheimbewohnern konnte eine angemessene Validität und Reliabilität nachgewiesen werden . Generalisierbarkeit und Übertragbarkeit sind jedoch limitiert auf Grund der geringen Anzahl der Personen , die in der Lage waren , den Fragebogen zu beantworten 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 The aim of this cluster r and omised controlled trial was to test the impact of an infection control education and training programme on meticillin-resistant Staphylococcus aureus ( MRSA )  prevalence in nursing homes . Nursing homes were r and omised to intervention ( infection control education and training programme ; N=16 ) or control ( usual practice continued ; N=16 ) . Staff in intervention homes were educated and trained ( 0 , 3 and 6 months ) in the principles and implementation of good infection control practice with infection control audits conducted in all sites ( 0 , 3 , 6 and 12 months ) to assess compliance with good practice . Audit scores were fed back to nursing home managers in intervention homes , together with a written report indicating where practice could be improved . Nasal swabs were taken from all consenting residents and staff at 0 , 3 , 6 and 12 months . The primary outcome was MRSA prevalence in residents and staff , and the secondary outcome was a change in infection control audit scores . In all , 793 residents and 338 staff were recruited at baseline . MRSA prevalence did not change during the study in residents or staff . The relative risk of a resident being colonised with MRSA in an intervention home compared with a control home at 12 months was 0.99 ( 95 % confidence interval : 0.69 , 1.42 ) after adjustment for clustering . Mean infection control audit scores were significantly higher in the intervention homes ( 82 % ) compared with the control homes ( 64 % ) at 12 months ( P<0.0001 ) . Consideration should be given to other approaches which may help to reduce MRSA in this setting Objectives : To evaluate the effects of a high-intensity functional exercise programme on depressive symptoms and psychological well-being among older people dependent in activities of daily living ( ADL ) and living in residential care facilities . Method : Cluster-r and omized controlled study . Participants were 191 older people , aged 65–100 , dependent in ADL and with Mini Mental State Examination scores between 10 and 30 . One-hundred ( 52 % ) of the participants had a diagnosed dementia disorder . A high-intensity functional weight-bearing exercise programme and a control activity were performed in groups . Sessions were held five times over each two week period for three months , a total of 29 times . The outcome measures , Geriatric Depression Scale ( GDS-15 ) and Philadelphia Geriatric Center Morale Scale ( PGCMS ) were blindly assessed at baseline , three and six months . Results : At baseline , mean ± SD ( range ) for GDS was 4.4 ± 3.2 ( 0–14 ) , and for PGCMS 11.0 ± 3.5 ( 2–17 ) . There were no significant differences in GDS or PGCMS between the exercise and the control group at the three and six month follow-ups in the total sample . Among people with dementia , there was a between-group difference at three months in PGCMS scores in favour of the exercise group . Conclusion : A high-intensity functional exercise programme seems generally not to influence depressive symptoms or psychological well-being among older people dependent in ADL and living in residential care facilities . An individualized and multifactorial intervention may be needed in this group . However , an exercise programme as a single intervention may have a short-term effect on well-being among people with dementia CONTEXT Cognitive decline , mood , behavioral and sleep disturbances , and limitations of activities of daily living commonly burden elderly patients with dementia and their caregivers . Circadian rhythm disturbances have been associated with these symptoms . OBJECTIVE To determine whether the progression of cognitive and noncognitive symptoms may be ameliorated by individual or combined long-term application of the 2 major synchronizers of the circadian timing system : bright light and melatonin . DESIGN , SETTING , AND PARTICIPANTS A long-term , double-blind , placebo-controlled , 2 x 2 factorial r and omized trial performed from 1999 to 2004 with 189 residents of 12 group care facilities in the Netherl and s ; mean ( SD ) age , 85.8 ( 5.5 ) years ; 90 % were female and 87 % had dementia . INTERVENTIONS R and om assignment by facility to long-term daily treatment with whole-day bright ( + /- 1000 lux ) or dim ( + /- 300 lux ) light and by participant to evening melatonin ( 2.5 mg ) or placebo for a mean ( SD ) of 15 ( 12 ) months ( maximum period of 3.5 years ) . MAIN OUTCOME MEASURES St and ardized scales for cognitive and noncognitive symptoms , limitations of activities of daily living , and adverse effects assessed every 6 months . RESULTS Light attenuated cognitive deterioration by a mean of 0.9 points ( 95 % confidence interval [ CI ] , 0.04 - 1.71 ) on the Mini-Mental State Examination or a relative 5 % . Light also ameliorated depressive symptoms by 1.5 points ( 95 % CI , 0.24 - 2.70 ) on the Cornell Scale for Depression in Dementia or a relative 19 % , and attenuated the increase in functional limitations over time by 1.8 points per year ( 95 % CI , 0.61 - 2.92 ) on the nurse-informant activities of daily living scale or a relative 53 % difference . Melatonin  shortened sleep onset latency by 8.2 minutes ( 95 % CI , 1.08 - 15.38 ) or 19 % and increased sleep duration by 27 minutes ( 95 % CI , 9 - 46 ) or 6 % . However , melatonin adversely affected scores on the Philadelphia Geriatric Centre Affect Rating Scale , both for positive affect ( -0.5 points ; 95 % CI , -0.10 to -1.00 ) and negative affect ( 0.8 points ; 95 % CI , 0.20 - 1.44 ) . Melatonin also increased withdrawn behavior by 1.02 points ( 95 % CI , 0.18 - 1.86 ) on the Multi Observational Scale for Elderly Subjects scale , although this effect was not seen if given in combination with light . Combined treatment also attenuated aggressive behavior by 3.9 points ( 95 % CI , 0.88 - 6.92 ) on the Cohen-Mansfield Agitation Index or 9 % , increased sleep efficiency by 3.5 % ( 95 % CI , 0.8%-6.1 % ) , and improved nocturnal restlessness by 1.00 minute per hour each year ( 95 % CI , 0.26 - 1.78 ) or 9 % ( treatment x time effect ) . CONCLUSIONS Light has a modest benefit in improving some cognitive and noncognitive symptoms of dementia . To counteract the adverse effect of melatonin on mood , it is recommended only in combination with light . TRIAL REGISTRATION controlled-trials.com/is rct n Identifier : IS RCT N93133646 It is now well known that st and ard statistical procedures become invali date d when applied to cluster r and omized trials in which the unit of inference is the individual . A result ing consequence is that research ers conducting such trials are faced with a multitude of design choices , including selection of the primary unit of inference , the degree to which clusters should be matched or stratified by prognostic factors at baseline , and decisions related to cluster subsampling . Moreover , application of ethical principles developed for individually r and omized trials may also require modification . We discuss several topics related to these issues , with emphasis on the choices that must be made in the planning stages of a trial and on some potential pitfalls to be avoided Background Several review s of published cluster r and omised trials have reported that about half did not take clustering into account in the analysis , which was thus incorrect and potentially misleading . In this paper I ask whether cluster r and omised trials are increasing in both number and quality of reporting . Methods Computer search for papers on cluster r and omised trials  since 1980 , h and search of trial reports published in selected volumes of the British Medical Journal over 20 years . Results There has been a large increase in the numbers of method ological papers and of trial reports using the term ' cluster r and om ' in recent years , with about equal numbers of each type of paper . The British Medical Journal contained more such reports than any other journal . In this journal there was a corresponding increase over time in the number of trials where subjects were r and omised in clusters . In 2003 all reports showed awareness of the need to allow for clustering in the analysis . In 1993 and before clustering was ignored in most such trials . Conclusion Cluster trials are becoming more frequent and reporting is of higher quality . Perhaps statistician pressure works OBJECTIVE To test the effectiveness of using a full-time project nurse to assist residential aged care facilities in using evidence -based approaches to falls injury prevention . DESIGN , SETTING AND PARTICIPANTS Cluster r and omised controlled trial involving 5391 residents in 88 aged care facilities in the Hunter and Lower Mid North Coast areas of New South Wales . Residents were followed for 545 days or until death or discharge . Data were collected from July 2005 to June 2007 . INTERVENTION Employment of a project nurse to encourage best- practice falls injury prevention strategies during the 17-month intervention period . MAIN OUTCOME MEASURES Monthly data about falls , falls injury and falls injury prevention programs ; audit of hospitalisation for fractured neck of femur . RESULTS Despite significant increases in the provision of hip protectors and use of vitamin D supplementation in both intervention and control facilities , there was no difference in the number of falls or falls injuries between the intervention and control groups , nor a reduction in falls overall . There was also no difference between the 7-month pre-intervention period and the intervention period in the number of falls or falls injuries . Factors related to residents having an increased risk of falls with fractured neck of femur included being ambulant , having dementia , increasing age , and having a high falls risk assessment score . CONCLUSION It is difficult 
    Output:
    
Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials .
Journal endorsement of the CONSORT statement was not associated with trial quality .
Conclusions Despite international attempts to improve methods in cluster r and omised trials , important quality limitations remain amongst these trials in residential facilities .
Statistician involvement on trial teams may be more effective in promoting quality than further journal endorsement of the CONSORT statement .