human
***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 assess whether implementation of a stepwise multicomponent intervention ( STA OP ! ) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia . DESIGN Cluster r and omized controlled trial . SETTING Twenty-one clusters ( single independent nursing home units ) in 12 nursing homes within the Netherl and s. PARTICIPANTS Residents with advanced dementia ( N = 288 ) . INTERVENTION Staff working on intervention units received comprehensive stepwise multidisciplinary training ; the control condition received training on general nursing skills , dementia management and pain without the stepwise component . MEASUREMENTS The primary outcome was agitation ( Cohen-Mansfield Agitation Inventory ( CMAI ) ) . Secondary outcomes included psychotropic medication use , neuropsychiatric symptoms ( Neuropsychiatric Inventory-Nursing Home version ( NPI-NH ) ) , and symptoms of depression ( Cornell Scale for Depression in Dementia ( CSDD ) , Minimum Data set Depression Rating Scale ( MDS-DRS ) ) . Measurements were made at baseline and 3 and 6 months after the intervention . Multilevel analysis and logistical generalized estimating equations were used to test treatment and time effects . Analysis was on an intention-to-treat basis . RESULTS Multilevel modeling revealed an overall effect of the intervention on challenging behavior and depression ; CMAI ( mean difference -4.07 points , 95 % confidence interval = ( CI ) = -7.90 to -0.24 , P = .02 ) , NPI-NH ( mean difference -3.57 points , 95 % CI = -6.30 to -0.84 , P = .005 ) , CSDD ( mean difference -1.59 points , 95 % CI = -2.49 to -0.69 , P < .001 ) , and MDS-DRS ( mean difference -0.96 points , 95 % CI = -1.40 to -0.52 , P < .001 ) scores were significantly lower in the intervention condition than the control condition . There was a significant reduction of antidepressants ( N06A ) ( OR = 0.32 ) ; nonsignificant reductions of antipsychotics ( N05A ) , anxiolytics ( N05B ) , and hypnotic-sedatives ( N05C ) ( odds ratios = 0.69 to 0.90 ) . CONCLUSION For nursing home residents with advanced dementia and challenging behavior , providing staff with comprehensive training in behavioral management , result ed in improved behavior and less psychotropic medication use OBJECTIVES To test the efficacy of an individualized social activity intervention ( ISAI ) on decreasing daytime sleep , improving nighttime sleep , and lowering the day/night sleep ratio and to determine its cost . DESIGN Pretest/posttest r and omized with an experimental and control group . SETTING Seven nursing homes . PARTICIPANTS One hundred forty-seven residents with dementia . INTERVENTION One to 2 hours of individualized social activities for 21 consecutive days . MEASUREMENTS Twenty-four-hour sleep/wake patterns using an Actigraph . RESULTS The ISAI group had significantly less daytime sleep ( P=.001 ) and a lower day/night sleep ratio ( P=.03 ) than the control group , after adjusting for baseline values . Because 40 % of the sample slept 7 or more hours at night , a secondary analysis was conducted . When only those residents with a sleep efficiency of less than 50 % ( n=50 ) were included , the ISAI group ( n=20 ) had less daytime sleep ( P=.005 ) , a lower day/night sleep ratio ( P=.02 ) , fell asleep faster ( P=.03 ) , and were awake less at night ( P=.04 ) than the control group ( n=30 ) , after adjusting for baseline values . The weekly cost of the ISAI was roughly $ 70 per participant . Initial training and supply costs were $ 1,944 . CONCLUSION The ISAI provides an alternative to medications , without side effects Objective To compare the clinical effectiveness of a programme of physiotherapy and occupational therapy with st and ard care in care home residents who have mobility limitations and are dependent in performing activities of daily living . Design Cluster r and omised controlled trial , with r and om allocation at the level of care home . Setting Care homes within the NHS South Birmingham primary care trust and the NHS Birmingham East and North primary care trust that had more than five beds and provided for people in the care categories “ physical disability ” and “ older people . ” Participants Care home residents with mobility limitations , limitations in activities of daily living ( as screened by the Barthel index ) , and not receiving end of life care were eligible to take part in the study . Intervention A targeted three month occupational therapy and physiotherapy programme . Main outcome measures Scores on the Barthel index and the Rivermead mobility index . Results 24 of 77 nursing and residential homes that catered for residents with mobility limitations and dependency for activities of daily living were selected for study : 12 were r and omly allocated to the intervention arm ( 128 residents , mean age 86 years ) and 12 to the control arm ( 121 residents , mean age 84 years ) . Participants were evaluated by independent assessors blind to study arm allocation before r and omisation ( 0 months ) , three months after r and omisation ( at the end of the treatment period for patients who received the intervention ) , and again at six months after r and omisation . After adjusting for home effect and baseline characteristics , no significant differences were found in mean Barthel index scores at six months post-r and omisation between treatment arms ( mean effect 0.08 , 95 % confidence interval −1.14 to 1.30 ; P=0.90 ) , across assessment s ( −0.01 , −0.63 to 0.60 ; P=0.96 ) , or in the interaction between assessment and intervention ( 0.42 , −0.48 to 1.32 ; P=0.36 ) . Similarly , no significant differences were found in the mean Rivermead mobility index scores between treatment arms ( 0.62 , −0.51 to 1.76 ; P=0.28 ) , across assessment s ( −0.15 , −0.65 to 0.35 ; P=0.55 ) , or interaction ( 0.71 , −0.02 to 1.44 ; P=0.06 ) . Conclusions The three month occupational therapy and physiotherapy programme had no significant effect on mobility and independence . On the other h and , the variation in residents ’ functional ability , the prevalence of cognitive impairment , and the prevalence of depression were considerably higher in this sample than expected on the basis of previous work . Further research to clarify the efficacy of occupational therapy and physiotherapy is required if access to therapy services is to be recommended in this population . Trial registration IS RCT OBJECTIVE To test the effect of a complex guideline -based intervention on agitation and psychotropic prescriptions . DESIGN , SETTING , PARTICIPANTS Cluster r and omized controlled trial ( VIDEANT ) with blinded assessment of outcome in 18 nursing homes in Berlin , Germany , comprising 304 dementia patients . INTERVENTION Training , support , and activity therapy intervention , delivered at the level of each nursing home , focusing on the management of agitation in dementia . Control group nursing homes  received treatment as usual . MEASUREMENTS Levels of agitated and disruptive behavior ( Cohen-Mansfield agitation inventory [ CMAI ] ) as the primary outcome . Number of neuroleptics , antidepressants , and cholinesterase inhibitors ( ChEIs ) prescribed in defined daily dosages ( DDDs ) . RESULTS Of 326 patients screened , 304 ( 93.3 % ) were eligible and cluster-r and omized to 9 intervention ( n = 163 ) and 9 control ( n = 141 ) nursing homes . Data were collected from 287 ( 94.4 % ) patients at 10 months . At 10 months , compared with controls , nursing home residents with dementia in the intervention group exhibited significantly less agitation as measured with the CMAI ( adjusted mean difference , 6.24 ; 95 % CI 2.03 - 14.14 ; P = .009 ; Cohen 's d = 0.43 ) , received fewer neuroleptics ( P < .05 ) , more  ChEIs  ( P < .05 ) , and more antidepressants ( P < .05 ) . CONCLUSION Complex guideline -based interventions are effective in reducing agitated and disruptive behavior in nursing home residents with dementia . At the same time , increased prescription of ChEIs and antidepressants together with decreased neuroleptic prescription suggests an effect toward guideline -based pharmacotherapy Background Previous research highlights the importance of staff involvement in psychosocial interventions targeting neuropsychiatric symptoms of dementia . Music therapy has shown potential effects , but it is not clear how this intervention can be programmed to involve care staff within the delivery of patients ’ care . This study reports initial feasibility and outcomes from a five month music therapy programme including weekly individual active music therapy for people with dementia and weekly post-therapy video presentations for their carers in care homes . Methods 17 care home residents and 10 care staff were r and omised to the  music therapy intervention group or st and ard care control group . The cluster r and omised , controlled trial included baseline , 3-month , 5-month and post-intervention 7-month measures of residents ’ symptoms and well-being . Carer-resident interactions were also assessed . Feasibility was based on carers ’ feedback through semi-structured interviews , programme evaluations and track records of the study . Results The music therapy programme appeared to be a practicable and acceptable intervention for care home residents and staff in managing dementia symptoms . Recruitment and retention data indicated feasibility but also challenges . Preliminary outcomes indicated differences in symptoms ( 13.42 , 95 % CI : [ 4.78 to 22.07 ; p = 0.006 ] ) and in levels of wellbeing ( −0.74 , 95 % CI : [ −1.15 to −0.33 ; p = 0.003 ] ) between the two groups , indicating that residents receiving music therapy improved . Staff in the intervention group reported enhanced caregiving techniques as a result of the programme . Conclusion The data supports the value of developing a music therapy programme involving weekly active individual music therapy sessions and music therapist-carer communication . The intervention is feasible with modifications in a more rigorous evaluation of a larger sample size . Trial registration Clinical trials.gov , number NCT01744600 Background / Aims : Numerous studies have indicated the value of music therapy in the management of patients with Alzheimer ’s disease . A recent pilot study demonstrated the feasibility and usefulness of a new music therapy technique . The aim of this controlled , r and omised study was to assess the effects of this new music therapy technique on anxiety and depression in patients with mild to moderate Alzheimer-type dementia . Methods : This was a single-centre , comparative , controlled , r and omised study , with blinded assessment of its results . The duration of follow-up was 24 weeks . The treated group ( n = 15 ) participated in weekly sessions of individual , receptive music therapy . The musical style of the session was chosen by the patient . The vali date d ‘ U ’ technique was employed . The control group ( n = 15 ) participated under the same conditions in reading sessions . The principal endpoint , measured at weeks 1 , 4 , 8 , 16 and 24 , was the level of anxiety ( Hamilton Scale ) . Changes in the depression score ( Geriatric Depression Scale ) were also analyzed as a secondary endpoint . Results : Significant improvements in anxiety ( p < 0.01 ) and depression ( p < 0.01 ) were observed in the music therapy group as from week 4 and until week 16 . The effect of music therapy was sustained for up to 8 weeks after the discontinuation of sessions between weeks 16 and 24 ( p < 0.01 ) . Conclusion : These results confirm the valuable effect of music therapy on  anxiety and depression  in patients with mild to moderate Alzheimer ’s disease . This new music therapy technique is simple to implement and can easily be integrated in a multidisciplinary programme for the management of Alzheimer ’s disease Background Process evaluations are recommended to open the ‘ black box ’ of complex interventions evaluated in trials , but there is limited guidance to help research ers design process evaluations . Much current literature on process evaluations of complex interventions focuses on qualitative methods , with less attention paid to quantitative methods . This discrepancy led us to develop our own framework for design ing process evaluations of cluster-r and omised controlled trials . Methods We review ed recent theoretical and method ological literature and selected published process evaluations ; these publications identified a need for structure to help design process evaluations . We drew upon this literature to develop a framework through iterative exchanges , and tested this against published evaluations . Results The developed framework presents a range of c and i date approaches to underst and ing trial delivery , intervention implementation and the responses of targeted participants . We believe this framework will be useful to others design ing process evaluations of complex intervention trials . We also propose key information that  process evaluations could report to facilitate their identification and enhance their usefulness . Conclusion There is no single best way to design and carry out a process evaluation . Research ers will be faced with choices about what questions to focus on and which methods to use . The most appropriate design depends on the purpose of the process evaluation ; the framework aims to help research ers make explicit their choices of research questions and methods .Trial registration Clinical trials.gov BACKGROUND A r and omized , placebo-controlled clinical trial was undertaken to determine the efficacy of nonpharmacolog 
    Output:
    
agent
***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 assess whether implementation of a stepwise multicomponent intervention ( STA OP ! ) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia . DESIGN Cluster r and omized controlled trial . SETTING Twenty-one clusters ( single independent nursing home units ) in 12 nursing homes within the Netherl and s. PARTICIPANTS Residents with advanced dementia ( N = 288 ) . INTERVENTION Staff working on intervention units received comprehensive stepwise multidisciplinary training ; the control condition received training on general nursing skills , dementia management and pain without the stepwise component . MEASUREMENTS The primary outcome was agitation ( Cohen-Mansfield Agitation Inventory ( CMAI ) ) . Secondary outcomes included psychotropic medication use , neuropsychiatric symptoms ( Neuropsychiatric Inventory-Nursing Home version ( NPI-NH ) ) , and symptoms of depression ( Cornell Scale for Depression in Dementia ( CSDD ) , Minimum Data set Depression Rating Scale ( MDS-DRS ) ) . Measurements were made at baseline and 3 and 6 months after the intervention . Multilevel analysis and logistical generalized estimating equations were used to test treatment and time effects . Analysis was on an intention-to-treat basis . RESULTS Multilevel modeling revealed an overall effect of the intervention on challenging behavior and depression ; CMAI ( mean difference -4.07 points , 95 % confidence interval = ( CI ) = -7.90 to -0.24 , P = .02 ) , NPI-NH ( mean difference -3.57 points , 95 % CI = -6.30 to -0.84 , P = .005 ) , CSDD ( mean difference -1.59 points , 95 % CI = -2.49 to -0.69 , P < .001 ) , and MDS-DRS ( mean difference -0.96 points , 95 % CI = -1.40 to -0.52 , P < .001 ) scores were significantly lower in the intervention condition than the control condition . There was a significant reduction of antidepressants ( N06A ) ( OR = 0.32 ) ; nonsignificant reductions of antipsychotics ( N05A ) , anxiolytics ( N05B ) , and hypnotic-sedatives ( N05C ) ( odds ratios = 0.69 to 0.90 ) . CONCLUSION For nursing home residents with advanced dementia and challenging behavior , providing staff with comprehensive training in behavioral management , result ed in improved behavior and less psychotropic medication use OBJECTIVES To test the efficacy of an individualized social activity intervention ( ISAI ) on decreasing daytime sleep , improving nighttime sleep , and lowering the day/night sleep ratio and to determine its cost . DESIGN Pretest/posttest r and omized with an experimental and control group . SETTING Seven nursing homes . PARTICIPANTS One hundred forty-seven residents with dementia . INTERVENTION One to 2 hours of individualized social activities for 21 consecutive days . MEASUREMENTS Twenty-four-hour sleep/wake patterns using an Actigraph . RESULTS The ISAI group had significantly less daytime sleep ( P=.001 ) and a lower day/night sleep ratio ( P=.03 ) than the control group , after adjusting for baseline values . Because 40 % of the sample slept 7 or more hours at night , a secondary analysis was conducted . When only those residents with a sleep efficiency of less than 50 % ( n=50 ) were included , the ISAI group ( n=20 ) had less daytime sleep ( P=.005 ) , a lower day/night sleep ratio ( P=.02 ) , fell asleep faster ( P=.03 ) , and were awake less at night ( P=.04 ) than the control group ( n=30 ) , after adjusting for baseline values . The weekly cost of the ISAI was roughly $ 70 per participant . Initial training and supply costs were $ 1,944 . CONCLUSION The ISAI provides an alternative to medications , without side effects Objective To compare the clinical effectiveness of a programme of physiotherapy and occupational therapy with st and ard care in care home residents who have mobility limitations and are dependent in performing activities of daily living . Design Cluster r and omised controlled trial , with r and om allocation at the level of care home . Setting Care homes within the NHS South Birmingham primary care trust and the NHS Birmingham East and North primary care trust that had more than five beds and provided for people in the care categories “ physical disability ” and “ older people . ” Participants Care home residents with mobility limitations , limitations in activities of daily living ( as screened by the Barthel index ) , and not receiving end of life care were eligible to take part in the study . Intervention A targeted three month occupational therapy and physiotherapy programme . Main outcome measures Scores on the Barthel index and the Rivermead mobility index . Results 24 of 77 nursing and residential homes that catered for residents with mobility limitations and dependency for activities of daily living were selected for study : 12 were r and omly allocated to the intervention arm ( 128 residents , mean age 86 years ) and 12 to the control arm ( 121 residents , mean age 84 years ) . Participants were evaluated by independent assessors blind to study arm allocation before r and omisation ( 0 months ) , three months after r and omisation ( at the end of the treatment period for patients who received the intervention ) , and again at six months after r and omisation . After adjusting for home effect and baseline characteristics , no significant differences were found in mean Barthel index scores at six months post-r and omisation between treatment arms ( mean effect 0.08 , 95 % confidence interval −1.14 to 1.30 ; P=0.90 ) , across assessment s ( −0.01 , −0.63 to 0.60 ; P=0.96 ) , or in the interaction between assessment and intervention ( 0.42 , −0.48 to 1.32 ; P=0.36 ) . Similarly , no significant differences were found in the mean Rivermead mobility index scores between treatment arms ( 0.62 , −0.51 to 1.76 ; P=0.28 ) , across assessment s ( −0.15 , −0.65 to 0.35 ; P=0.55 ) , or interaction ( 0.71 , −0.02 to 1.44 ; P=0.06 ) . Conclusions The three month occupational therapy and physiotherapy programme had no significant effect on mobility and independence . On the other h and , the variation in residents ’ functional ability , the prevalence of cognitive impairment , and the prevalence of depression were considerably higher in this sample than expected on the basis of previous work . Further research to clarify the efficacy of occupational therapy and physiotherapy is required if access to therapy services is to be recommended in this population . Trial registration IS RCT OBJECTIVE To test the effect of a complex guideline -based intervention on agitation and psychotropic prescriptions . DESIGN , SETTING , PARTICIPANTS Cluster r and omized controlled trial ( VIDEANT ) with blinded assessment of outcome in 18 nursing homes in Berlin , Germany , comprising 304 dementia patients . INTERVENTION Training , support , and activity therapy intervention , delivered at the level of each nursing home , focusing on the management of agitation in dementia . Control group nursing homes  received treatment as usual . MEASUREMENTS Levels of agitated and disruptive behavior ( Cohen-Mansfield agitation inventory [ CMAI ] ) as the primary outcome . Number of neuroleptics , antidepressants , and cholinesterase inhibitors ( ChEIs ) prescribed in defined daily dosages ( DDDs ) . RESULTS Of 326 patients screened , 304 ( 93.3 % ) were eligible and cluster-r and omized to 9 intervention ( n = 163 ) and 9 control ( n = 141 ) nursing homes . Data were collected from 287 ( 94.4 % ) patients at 10 months . At 10 months , compared with controls , nursing home residents with dementia in the intervention group exhibited significantly less agitation as measured with the CMAI ( adjusted mean difference , 6.24 ; 95 % CI 2.03 - 14.14 ; P = .009 ; Cohen 's d = 0.43 ) , received fewer neuroleptics ( P < .05 ) , more  ChEIs  ( P < .05 ) , and more antidepressants ( P < .05 ) . CONCLUSION Complex guideline -based interventions are effective in reducing agitated and disruptive behavior in nursing home residents with dementia . At the same time , increased prescription of ChEIs and antidepressants together with decreased neuroleptic prescription suggests an effect toward guideline -based pharmacotherapy Background Previous research highlights the importance of staff involvement in psychosocial interventions targeting neuropsychiatric symptoms of dementia . Music therapy has shown potential effects , but it is not clear how this intervention can be programmed to involve care staff within the delivery of patients ’ care . This study reports initial feasibility and outcomes from a five month music therapy programme including weekly individual active music therapy for people with dementia and weekly post-therapy video presentations for their carers in care homes . Methods 17 care home residents and 10 care staff were r and omised to the  music therapy intervention group or st and ard care control group . The cluster r and omised , controlled trial included baseline , 3-month , 5-month and post-intervention 7-month measures of residents ’ symptoms and well-being . Carer-resident interactions were also assessed . Feasibility was based on carers ’ feedback through semi-structured interviews , programme evaluations and track records of the study . Results The music therapy programme appeared to be a practicable and acceptable intervention for care home residents and staff in managing dementia symptoms . Recruitment and retention data indicated feasibility but also challenges . Preliminary outcomes indicated differences in symptoms ( 13.42 , 95 % CI : [ 4.78 to 22.07 ; p = 0.006 ] ) and in levels of wellbeing ( −0.74 , 95 % CI : [ −1.15 to −0.33 ; p = 0.003 ] ) between the two groups , indicating that residents receiving music therapy improved . Staff in the intervention group reported enhanced caregiving techniques as a result of the programme . Conclusion The data supports the value of developing a music therapy programme involving weekly active individual music therapy sessions and music therapist-carer communication . The intervention is feasible with modifications in a more rigorous evaluation of a larger sample size . Trial registration Clinical trials.gov , number NCT01744600 Background / Aims : Numerous studies have indicated the value of music therapy in the management of patients with Alzheimer ’s disease . A recent pilot study demonstrated the feasibility and usefulness of a new music therapy technique . The aim of this controlled , r and omised study was to assess the effects of this new music therapy technique on anxiety and depression in patients with mild to moderate Alzheimer-type dementia . Methods : This was a single-centre , comparative , controlled , r and omised study , with blinded assessment of its results . The duration of follow-up was 24 weeks . The treated group ( n = 15 ) participated in weekly sessions of individual , receptive music therapy . The musical style of the session was chosen by the patient . The vali date d ‘ U ’ technique was employed . The control group ( n = 15 ) participated under the same conditions in reading sessions . The principal endpoint , measured at weeks 1 , 4 , 8 , 16 and 24 , was the level of anxiety ( Hamilton Scale ) . Changes in the depression score ( Geriatric Depression Scale ) were also analyzed as a secondary endpoint . Results : Significant improvements in anxiety ( p < 0.01 ) and depression ( p < 0.01 ) were observed in the music therapy group as from week 4 and until week 16 . The effect of music therapy was sustained for up to 8 weeks after the discontinuation of sessions between weeks 16 and 24 ( p < 0.01 ) . Conclusion : These results confirm the valuable effect of music therapy on  anxiety and depression  in patients with mild to moderate Alzheimer ’s disease . This new music therapy technique is simple to implement and can easily be integrated in a multidisciplinary programme for the management of Alzheimer ’s disease Background Process evaluations are recommended to open the ‘ black box ’ of complex interventions evaluated in trials , but there is limited guidance to help research ers design process evaluations . Much current literature on process evaluations of complex interventions focuses on qualitative methods , with less attention paid to quantitative methods . This discrepancy led us to develop our own framework for design ing process evaluations of cluster-r and omised controlled trials . Methods We review ed recent theoretical and method ological literature and selected published process evaluations ; these publications identified a need for structure to help design process evaluations . We drew upon this literature to develop a framework through iterative exchanges , and tested this against published evaluations . Results The developed framework presents a range of c and i date approaches to underst and ing trial delivery , intervention implementation and the responses of targeted participants . We believe this framework will be useful to others design ing process evaluations of complex intervention trials . We also propose key information that  process evaluations could report to facilitate their identification and enhance their usefulness . Conclusion There is no single best way to design and carry out a process evaluation . Research ers will be faced with choices about what questions to focus on and which methods to use . The most appropriate design depends on the purpose of the process evaluation ; the framework aims to help research ers make explicit their choices of research questions and methods .Trial registration Clinical trials.gov BACKGROUND A r and omized , placebo-controlled clinical trial was undertaken to determine the efficacy of nonpharmacolog 
    Output:
    