***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: Background : We report on the responsiveness of a previously vali date d quality -of-life scale , the Quality of Life in Late-Stage Dementia scale ( QUALID ) , as an outcome measure in a clinical trial of two psychotropic medications . Methods : Secondary analyses were conducted comparing outcome measures used in a r and omized double-blind trial of two antipsychotics ( olanzapine and risperidone ) for the treatment of dementia-related behavioral symptoms . The QUALID was completed for 31 of the patients in addition to several measures of behavior-related dementia symptoms including the Neuropsychiatric Inventory , the Withdrawn Behavior subscale of the Multidimensional Observation Scale for Elderly Subjects , the Mini-Mental State Examination , and the Clinical Global Impression . Measures of safety and adverse effects included the Simpson-Angus Scale and records of specific adverse events . Results : A significant positive relationship was found between QUALID score and improvement in behavioral symptoms , and a negative association was found with adverse medication effects . Conclusions : The QUALID was sensitive to both the treatment effects and the adverse effects of medication in this sample of patients Background the prevalence of individuals with cognitive decline is increasing since the number of elderly adults is growing considerably . The literature provides promising results on the beneficial effect of exercise and vitamin supplementation on cognitive function both in cognitively healthy as well as in the demented elderly . Methods / Design the design is a two-by-two factorial r and omised controlled trial . The study population consists of independently living elderly , between 70 and 80 years old , with mild cognitive impairment ( MCI ) . In the RCT the effect of two interventions , a walking program and vitamin supplementation , is examined . The walking program ( WP ) is a group-based program aim ed at improving cardiovascular endurance ; frequency two lessons a week ; lesson duration one hour ; program duration one year . Non-walking groups receive a placebo activity program ( PAP ) ( i.e. low intensive non-aerobic group exercises , like stretching ) with the same frequency , lesson and program duration . Vitamin supplementation consists of a single daily vitamin supplement containing 50 mg B6 , 5 mg folic acid and 0,4 mg B12 for one year . Subjects not receiving vitamin supplements are daily taking an identically looking placebo pill , also for a year . Participants are r and omised to four groups 1 ) WP and vitamin supplements ; 2 ) WP and placebo supplements ; 3 ) PAP and vitamin supplements ; 4 ) PAP and placebo supplements . Primary outcome measures are measures of cognitive function . Secondary outcomes include psychosocial wellbeing , physical activity , cardiovascular endurance and blood vitamin levels . Discussion no large intervention study has been conducted yet on the effect of physical activity and vitamin supplementation in a population -based sample of adults with MCI . The objective of the present article is to describe the design of a r and omised controlled trial examining the effect of a walking program and vitamin B supplementation on the rate of cognitive decline in older adults with MCI CONTEXT Laboratory evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer disease ( AD ) , along with epidemiological evidence , suggests that nonsteroidal anti-inflammatory drugs ( NSAIDs ) may favorably influence the course of the disease . OBJECTIVE To determine whether treatment with a selective cyclooxygenase ( COX ) -2 inhibitor ( rofecoxib ) or a traditional nonselective NSAID ( naproxen ) slows cognitive decline in patients with mild-to-moderate AD . DESIGN Multicenter , r and omized , double-blind , placebo-controlled , parallel group trial , with 1-year exposure to study medications . SETTING Forty ambulatory treatment centers affiliated with the Alzheimer 's Disease Cooperative Study consortium . PARTICIPANTS Participants with mild-to-moderate AD ( Mini-Mental State Examination score of 13 - 26 ) were recruited from December 1999 to November 2000 using clinic population s , referrals from community physicians , and local advertising . Stable use of cholinesterase inhibitors , estrogen , low-dose aspirin , and vitamin E was allowed . Participants with inflammatory diseases that might respond to the study medications were excluded . Of 474 participants screened , 351 were enrolled . INTERVENTIONS Once-daily rofecoxib , 25 mg , or twice-daily naproxen sodium , 220 mg , or placebo . MAIN OUTCOME MEASURES The primary outcome measure was the 1-year change in the Alzheimer Disease Assessment Scale-Cognitive ( ADAS-Cog ) subscale score . Secondary outcome measures included the Clinical Dementia Rating scale sum-of-boxes , the Neuropsychiatric Inventory , the Quality of Life-AD , and the time to attainment of significant end points ( 4-point decline from baseline ADAS-Cog score , 1-step worsening on the global Clinical Dementia Rating scale , 15-point decline on the ADCS activities of daily living inventory , institutionalization , or death ) . RESULTS The 1-year mean ( SD ) change in ADAS-Cog scores in participants treated with naproxen ( 5.8 [ 8.0 ] ) or rofecoxib ( 7.6 [ 7.7 ] ) was not significantly different from the change in participants treated with placebo ( 5.7 [ 8.2 ] ) . Results of secondary analyses showed no consistent benefit of either treatment . Fatigue , dizziness , and hypertension were more commonly reported in the active drug groups , and more serious adverse events were found in the active treatment group than in the placebo group . CONCLUSION The results of this study indicate that rofecoxib or low-dose naproxen does not slow cognitive decline in patients with mild-to-moderate AD PURPOSE We investigated whether community consultants could be trained to teach family caregivers a systematic behavioral approach for reducing mood and behavior problems in persons with Alzheimer 's disease . DESIGN AND METHODS This study consisted of a r and omized controlled trial ; we r and omly assigned 95 family caregivers and care recipients with Alzheimer 's disease to STAR-caregivers ( STAR-C ) or control groups . Masked interviewers conducted assessment s at baseline , after treatment , and after 6 months . Consultants were master's-level health care professionals who were currently practicing in community setting s serving older adults . We assessed the extent to which consultants were able to learn and adhere to the treatment protocol , and the relationship between adherence and measures of caregiver mood , burden , and care recipient mood and behavior . RESULTS Community consultants were able to learn and adhere to the behavioral treatment protocol . Caregivers receiving STAR-C training showed significant improvements in depression , burden , and reactivity to behavior problems in the care recipient . There were also significant reductions in the frequency and severity of care recipient behavior problems , and improved quality of life . Results were maintained at 6-month follow-up . IMPLICATION S Community-based consultants successfully implemented a behavioral intervention with family caregivers of persons with Alzheimer 's disease . Consequently , STAR-C seems to be a practicable and reasonable evidence d-based approach to caregiver training in actual clinical setting Quality of life ( QoL ) is now seen as a key outcome in many aspects of dementia care . In a recent r and omized controlled trial of Cognitive Stimulation Therapy ( CST ) groups , significant improvements in self-reported QoL were identified as well as changes in cognitive function . This further analysis of results from the trial examines whether the changes in these two domains occurred independently , perhaps for different reasons , or whether the effect of treatment on QoL was mediated by the changes in cognition . In all , 201 people with dementia living in residential homes or attending day centres were assessed using the  Quality of Life-Alzheimer 's Disease ( QOL-AD ) scale and a range of measures of cognition , dementia level , mood , dependency and communication .  Participants were r and omized to receive an intervention programme of CST or to receive treatment as usual .  The QoL-AD and other measures were repeated eight weeks later . At baseline , higher QoL in dementia was significantly correlated with lower levels of dependency and depression , but not with cognitive function or dementia severity . Improvement in quality of life was associated with being female , low quality of life at baseline , reduced depression and increased cognitive function . Changes in cognitive function mediated the effects of treatment in improving QoL. These results suggest that whilst QoL in dementia appears to be independent of level of cognitive function , interventions aim ed at improving cognitive function can , nonetheless , have a direct effect on CONTEXT There is a compelling need for therapies that prevent , defer the onset , slow the progression , or improve the symptoms of Alzheimer disease ( AD ) . OBJECTIVE To evaluate the effects of testosterone therapy on cognition , neuropsychiatric symptoms , and quality of life in male patients with mild AD and healthy elderly men . DESIGN Twenty-four-week , r and omized , double-blind , placebo-controlled , parallel-group study . SETTING Memory disorders clinics as well as general neurology and medicine clinics from University of California medical centers at Los Angeles , San Francisco , and Irvine . PATIENTS OR OTHER PARTICIPANTS Sixteen male patients with AD and 22 healthy male control subjects . Healthy elderly control men were recruited from the community through advertisements as well as through the university-based clinics . INTERVENTION Testosterone and placebo , in the form of hydroalcoholic gel ( 75 mg ) , were applied daily to the skin of the participants . MAIN OUTCOME MEASURES Instruments assessing cognitive functioning ( Alzheimer 's Disease Assessment Scale-Cognitive Subscale , California Verbal Learning Test , Block Design Subtest , Judgment of Line Orientation , Developmental Test of Visual-Motor Integration ) , neuropsychiatric symptoms ( Neuropsychiatric Inventory ) , global functioning ( Clinician 's Interview-Based Impression of Change ) , and quality of life ( Quality of Life-Alzheimer Disease Scale ) . RESULTS For the patients with AD , the testosterone-treated group had significantly greater improvements in the scores on the caregiver version of the quality -of-life scale ( P = .01 ) . No significant treatment group differences were detected in the cognitive scores at end of study , although numerically greater improvement or less decline on measures of visuospatial functions was demonstrated with testosterone treatment compared with placebo . In the healthy control group , a nonsignificant trend toward greater improvement in self-rated quality of life was observed in the testosterone-treated group ( P = .09 ) compared with placebo treatment . No difference between the treatment groups was detected in the remaining outcome measures . Testosterone treatment was well tolerated with few adverse effects relative to placebo . CONCLUSIONS Results suggest that testosterone replacement therapy improved overall quality of life in patients with AD .  Testosterone had minimal effects on cognition Before being introduced to wide use , health status instruments should be evaluated for reliability and validity . Increasingly , they are also tested for responsiveness to important clinical changes . Although st and ards exist for assessing these properties , confusion and inconsistency arise because multiple statistics are used for the same property ; controversy exists over how to measure responsiveness ; many statistics are unavailable on common software programs ; strategies for measuring these properties vary ; and it is often unclear how to define a clinical ly important change in patient status . Using data from a clinical trial of therapy for back pain , we demonstrate the calculation of several statistics for measuring reproducibility and responsiveness , and demonstrate relationships among them . Simple computational guides for several statistics are provided . We conclude that reproducibility should generally be quantified with the intraclass correlation coefficient rather than the more common Pearson r. Assessing reproducibility by retest at one-to-two week intervals ( rather than a shorter interval ) may result in more realistic estimates of the variability to be observed among control subjects in a longitudinal study . Instrument responsiveness should be quantified using indicators of effect size , a modified effect size statistic proposed by Guyatt , or the use of receiver operating characteristic ( ROC ) curves to describe how well various score changes can distinguish improved from unimproved patients Background : Although cholinesterase inhibitors have produced statistically significant treatment effects , their clinical meaningfulness in Alzheimer 's disease is disputed . An important aspect of clinical meaningfulness is the extent to which an intervention meets the goals of treatment . Methods : In this r and omized controlled trial , patients with mild to moderate Alzheimer 's disease were treated with either galantamine or placebo for 4 months , followed by a 4-month open-label extension during which all patients received galantamine . The primary outcome measures were Goal Attainment Scaling ( GAS ) scores from assessment s by clinicians and by patients or caregivers of treatment goals set before treatment and evaluated every 2 months . Secondary outcome measures included the cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog ) , the Clinician 's Interview-based Impression of Change plus Caregiver Input ( CIBIC-plus ) , the Disability Assessment for Dementia ( DAD ) and the Caregiving Burden Scale ( CBS ) . To evaluate treatment effect , we calculated effect sizes ( as st and ardized response means [ SRMs ] ) and p values . Results : Of 159 patients screened , 130 ( mean age 77 [ st and ard deviation ( SD ) 7.7 ] ; 63 % women ) were enrolled in the study ( 64 in the galantamine group and 66 in the placebo group ) ; 128 were included in the analysis because they had at least one post-baseline evaluation . In the intention-to-treat analysis , the clinician- 
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Altogether QoL was assessed in only 10 ( 4.4 % ) of these RCTs , of which 2 reported on responsiveness of QoL. This review provides evidence that QoL-instruments are seldom used as outcome measures in RCTs in dementia and Mild Cognitive Impairment , and that information on responsiveness is scarce .
QoL- measures should be applied more often in clinical trials , as currently no disease modifying drugs are available , although there are valid and reliable QoL- measures for dementia that reflect the aims of palliative care and provide transparent information about patient 's and caregiver 's treatment benefits .