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: Objective . To evaluate the quality of life ( QOL ) of untreated children with newly diagnosed attention-deficit/hyperactivity disorder ( ADHD ) , compared with asthmatic and healthy children . Methods . This prospect i ve , case-control study included a group of 120 children , 6 to 12 years of age , with newly diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition . Subjects were matched according to age , gender , and health care area with 2 control groups , ie , 93 asthmatic children and 120 healthy children . Sociodemographic characteristics and Child Health Question naire scores were collected . Results . The QOL of children with ADHD was rated worse than that of asthmatic or healthy children for most Child Health Question naire domains . The greatest differences were found in behavior , social limitations attributable to physical problems , emotional impact on parents , and family activities . Almost every psychosocial domain was more affected in comparison with asthmatic children and both psychosocial and physical domains in comparison with healthy children . Conclusions . ADHD interferes with the daily lives of children , parents , and families even more than asthma , primarily in areas related to psychosocial functioning , although evidence of impaired physical functioning also emerged . Delays in recognition , assessment , and management of ADHD may affect negatively the QOL of those children OBJECTIVE To investigate the effect of melatonin treatment on sleep , behavior , cognition , and quality of life in children with attention-deficit/hyperactivity disorder ( ADHD ) and chronic sleep onset insomnia . METHOD A total of 105 medication-free children , ages 6 to 12 years , with rigorously diagnosed ADHD and chronic sleep onset insomnia participated in a r and omized , double-blind , placebo-controlled trial using 3 or 6 mg melatonin ( depending on body weight ) , or placebo for 4 weeks . Primary outcome parameters were actigraphy-derived sleep onset , total time asleep , and salivary dim light melatonin onset . RESULTS Sleep onset advanced by 26.9 + /- 47.8 minutes with melatonin and delayed by 10.5 + /- 37.4 minutes with placebo ( p < .0001 ) . There was an advance in dim light melatonin onset of 44.4 + /- 67.9 minutes in melatonin and a delay of 12.8 + /- 60.0 minutes in placebo ( p < .0001 ) . Total time asleep increased with melatonin ( 19.8 + /- 61.9 minutes ) as compared to placebo ( -13.6 + /- 50.6 minutes ; p = .01 ) . There was no significant effect on behavior , cognition , and quality of life , and significant adverse events did not occur . CONCLUSION Melatonin advanced circadian rhythms of sleep-wake and endogenous melatonin and enhanced total time asleep in children with ADHD and chronic sleep onset insomnia ; however , no effect was found on problem behavior , cognitive performance , or quality of life PURPOSE We determined the effects of a 3-month low-moderate-intensity strength training program ( 2 sessions/week ) on functional capacity , muscular strength , body composition , and quality of life ( QOL ) in 22 young ( 12 - 16 yrs ) anorexic out patients . METHODS Patients were r and omly assigned to a training or control group  ( n=11 [ 10 females ] each ) . Training sessions were of low intensity ( loads for large muscle groups ranging between 20%-30 % and 50%-60 % of six repetitions maximum [ 6RM ] at the end of the program ) . We measured functional capacity by the time up and go and the timed up and down stairs tests . Muscular strength was assessed by 6RM measures for seated bench and leg presses . We estimated percent body fat and muscle mass . We assessed patients ' QOL with the Short Form-36 items . RESULTS The intervention was well tolerated and did not have any deleterious effect on patients ' health , and did not induce significant losses in their body mass . The only studied variable for which a significant interaction ( group x time ) effect was found ( p=.009 ) was the 6RM seated lateral row test . CONCLUSIONS Low-moderate-intensity strength training does not seem to add major benefits to conventional psychotherapy and refeeding treatments in young anorexic patients Background : Separation anxiety disorder ( SAD ) is one of the earliest and most common mental disorders in childhood , and a strong predictor of adult psychopathology . Despite significant progress in psychotherapy research on childhood anxiety disorders , no r and omized controlled trial has been conducted with a disorder-specific treatment program for young children suffering from SAD . Methods : Forty-three children ( ages 5–7 ) with SAD and their parents were assigned to either a 16-session disorder-specific SAD treatment program including parent training and classical cognitive-behavioral therapy ( CBT ) components , or to a 12-week waiting list group . Categorical and /or continuous data for anxiety , impairment/distress and quality of life were collected at baseline , after treatment/waiting list condition , and at a 4-week follow-up . Results : Intention-to-treat analyses indicate that 76.19 % of children allocated to the treatment group definitively no longer fulfilled DSM-IV criteria for SAD at follow-up , compared to 13.64 % in the waiting list group . Between 91 and 100 % of children rated themselves or were rated by their father , mother or therapist as very much or much improved on the global success rating immediately after treatment . Results indicated large time by treatment condition interaction effect sizes ( d = 0.98–1.41 ) across informants for reduction of distress/avoidance in separation situations after the test for the treatment condition . Further , parents reported significant improvements in impairment/distress in the child ’s major life domains and the child ’s quality of life . Treatment gains were maintained at the 4-week follow-up assessment . Conclusions : Results indicate the short-term efficacy of a disorder-specific treatment approach for SAD , and are among the first to indicate that CBT programs work with young children BACKGROUND Although cognitive-behavioral therapy ( CBT ) is established as a first line treatment for anxiety disorders in children and adolescents , there is little evidence about the effectiveness of CBT protocol s in cases identified in the community in low and middle income countries ( LaMICs ) . AIMS To evaluate the effectiveness of group CBT protocol for youths with anxiety disorders identified in a community sample in LaMICs . METHOD A total of 14 sessions of group CBT for youths and 2 concurrent sessions for parents based on Kendall 's Coping Cat program were offered . Participants were selected from a cross-sectional community study ; 45 subjects fulfilled inclusion criteria and 28 agreed to participate in the open clinical trial .  Treatment effectiveness was evaluated with st and ard clinical , self- and parent-rated measures of anxiety , depression , externalizing symptoms and quality of life ( QoL ) . RESULTS Twenty youths completed the protocol . All scales showed an improvement of anxiety and reduction in externalizing symptoms over time , with a moderate to large effect size ( d = 0.59 to 2.06 ; p < .05 ) , but not in depressive symptoms or QoL. CONCLUSIONS Consistent with previous evidence , group CBT is effective in treating anxiety disorders in youths . Results encourage further r and omized clinical trials using CBT protocol s adapted and developed to be used in LaMICs The current study was design ed to investigate the changes that occur in depression , anxiety , obsessive — compulsive symptoms and health-related quality of life during methylpheni date ( MPH ) treatment in children with attention-deficit hyperactivity disorder ( ADHD ) . Forty-five treatment naive children with ADHD , aged 8—14 , were assessed based on self , parent and teacher reports at the baseline and at the end of the first and third month of MPH treatment regarding changes in inattention , hyperactivity , impulsivity , depression , anxiety and obsessive — compulsive symptoms . Changes in the quality of life were also noted . Repeated measures of analysis of variance ( ANOVA ) tests with Bonferroni corrections were conducted in order to evaluate the data . Symptoms of inattention , hyperactivity and impulsivity were significantly reduced ( p < 0.017 ) following a three-month MPH treatment . There were significant decreases in depression ( p = 0.004 ) , trait anxiety ( p = 0.000 ) and checking compulsion symptom scores ( p = 0.001 ) . Moreover , parents reported significant improvements in psychosocial ( p = 0.001 ) and total scores ( p = 0.009 ) of quality of life , despite no change in physical health scores ( p > 0.05 ) . Children ’s ratings of quality of life measures showed no significant changes in physical health and psychosocial scores ( p > 0.05 ) , while total scores significantly improved ( p = 0.001 ) after the treatment . Over a three-month MPH treatment , depression , trait anxiety and checking compulsion symptoms decreased and quality of life seemed to improve along with those of inattention , hyperactivity and impulsivity BACKGROUND There are limited published data on the impact of treatment on the health-related quality of life ( HRQOL ) in individuals with autistic disorder . OBJECTIVE The aim of this study was to evaluate the impact of aripiprazole on HRQOL in the treatment of irritability in pediatric patients ( aged 6 - 17 years ) with autistic disorder . METHODS This post hoc analysis assessed data from two 8-week , double-blind , r and omized , placebo-controlled studies that compared the efficacy of aripiprazole ( fixed-dose study , 5 , 10 , and 15 mg/d ; flexible-dose study , 2 - 15 mg/d ) with placebo in the treatment of irritability associated with autistic disorder . HRQOL was assessed at baseline and week 8 using 3 Pediatric Quality of Life Inventory ( PedsQL ™ ) scales . Clinical ly relevant improvement in HRQOL was determined using an accepted distribution-based criterion-1 st and ard error of measurement . RESULTS In total , 316 patients were r and omly assigned to receive treatment with aripiprazole ( fixed-dose study , 166 ; flexible-dose study , 47 ) or placebo ( fixed-dose study , 52 ; flexible-dose study , 51 ) . Aripiprazole was associated with significantly greater improvement  than placebo in PedsQL combined-scales total score ( difference , 7.8 ; 95 % CI , 3.8 - 11.8 ; P < 0.001 ) and in 3 PedsQL scale scores ( differences [ 95 % CI ] : Emotional Functioning , 7.8 [ 3.4 - 12.2 ] ; Social Functioning , 6.2 [ 0.7 - 11.8 ] ; Cognitive Functioning , 9.3 [ 3.8 - 14.9 ] ; all , P < 0.05 ) . Patients who received aripiprazole were significantly more likely than those who received placebo to have a clinical ly meaningful improvement on the combined-scales total score ( odds ratio [ OR ] = 1.9 ; 95 % CI , 1.0 - 3.3 ; P < 0.05 ) , Emotional Functioning scale ( OR = 2.2 ; 95 % CI , 1.2 - 4.0 ; P < 0.05 ) and Social Functioning scale ( OR = 2.2 ; 95 % CI , 1.2 - 4.1 ; P < 0.05 ) , and were significantly less likely to experience deterioration ( OR : 0.3 , 95 % CI : 0.1 - 0.8 ; P < 0.05 ) when " Stable " was used as the reference group . CONCLUSIONS The findings from the present post hoc analysis suggest that aripiprazole was associated with improved HRQOL , as assessed using 3 PedsQL scales , in pediatric patients with irritability associated with autistic disorder OBJECTIVE Information on psychostimulant treatment in long-term studies for attention-deficit/hyperactivity disorder ( ADHD ) in adolescents is limited . This study aim ed to assess the safety and effectiveness of lisdexamfetamine dimesylate ( LDX ) over 52 weeks in adolescents with ADHD . METHODS This open-label multicenter study enrolled eligible participants after their participation in a r and omized , double-blind , placebo-controlled 4 week trial in adolescents with ADHD . Following a 4 week dose-optimization phase , participants were maintained on treatment for up to ∼48 weeks on an optimal dose . Safety assessment s included treatment-emergent adverse events ( TEAEs ) , vital signs , laboratory findings , and electrocardiograms . Effectiveness measures included the ADHD Rating Scale IV ( ADHD-RS-IV ; primary ) and Clinical Global Impressions-Improvement ( CGI-I ) . The Youth Quality of Life- Research Version ( YQOL-R ) was also included in this study ; raw scores are transformed to a 0 - 100 point scale . RESULTS Of 269 enrolled ( from the antecedent study ) , 265 ( 98.5 % ) were in the safety population and effectiveness population . Common TEAEs ( ≥5 % ) with LDX included upper respiratory tract infection ( 21.9 % ) , decreased appetite ( 21.1 % ) , headache ( 20.8 % ) , decreased weight ( 16.2 % ) , irritability ( 12.5 % ) , insomnia ( 12.1 % ) , nasopharyngitis ( 7.2 % ) , influenza ( 6 
    Output:
    
agent
The systematic review revealed widespread utilization of developmentally appropriate QL instruments but less frequent use of both self and proxy reports and an inconsistent approach to age group specificities .
***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: Objective . To evaluate the quality of life ( QOL ) of untreated children with newly diagnosed attention-deficit/hyperactivity disorder ( ADHD ) , compared with asthmatic and healthy children . Methods . This prospect i ve , case-control study included a group of 120 children , 6 to 12 years of age , with newly diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition . Subjects were matched according to age , gender , and health care area with 2 control groups , ie , 93 asthmatic children and 120 healthy children . Sociodemographic characteristics and Child Health Question naire scores were collected . Results . The QOL of children with ADHD was rated worse than that of asthmatic or healthy children for most Child Health Question naire domains . The greatest differences were found in behavior , social limitations attributable to physical problems , emotional impact on parents , and family activities . Almost every psychosocial domain was more affected in comparison with asthmatic children and both psychosocial and physical domains in comparison with healthy children . Conclusions . ADHD interferes with the daily lives of children , parents , and families even more than asthma , primarily in areas related to psychosocial functioning , although evidence of impaired physical functioning also emerged . Delays in recognition , assessment , and management of ADHD may affect negatively the QOL of those children OBJECTIVE To investigate the effect of melatonin treatment on sleep , behavior , cognition , and quality of life in children with attention-deficit/hyperactivity disorder ( ADHD ) and chronic sleep onset insomnia . METHOD A total of 105 medication-free children , ages 6 to 12 years , with rigorously diagnosed ADHD and chronic sleep onset insomnia participated in a r and omized , double-blind , placebo-controlled trial using 3 or 6 mg melatonin ( depending on body weight ) , or placebo for 4 weeks . Primary outcome parameters were actigraphy-derived sleep onset , total time asleep , and salivary dim light melatonin onset . RESULTS Sleep onset advanced by 26.9 + /- 47.8 minutes with melatonin and delayed by 10.5 + /- 37.4 minutes with placebo ( p < .0001 ) . There was an advance in dim light melatonin onset of 44.4 + /- 67.9 minutes in melatonin and a delay of 12.8 + /- 60.0 minutes in placebo ( p < .0001 ) . Total time asleep increased with melatonin ( 19.8 + /- 61.9 minutes ) as compared to placebo ( -13.6 + /- 50.6 minutes ; p = .01 ) . There was no significant effect on behavior , cognition , and quality of life , and significant adverse events did not occur . CONCLUSION Melatonin advanced circadian rhythms of sleep-wake and endogenous melatonin and enhanced total time asleep in children with ADHD and chronic sleep onset insomnia ; however , no effect was found on problem behavior , cognitive performance , or quality of life PURPOSE We determined the effects of a 3-month low-moderate-intensity strength training program ( 2 sessions/week ) on functional capacity , muscular strength , body composition , and quality of life ( QOL ) in 22 young ( 12 - 16 yrs ) anorexic out patients . METHODS Patients were r and omly assigned to a training or control group  ( n=11 [ 10 females ] each ) . Training sessions were of low intensity ( loads for large muscle groups ranging between 20%-30 % and 50%-60 % of six repetitions maximum [ 6RM ] at the end of the program ) . We measured functional capacity by the time up and go and the timed up and down stairs tests . Muscular strength was assessed by 6RM measures for seated bench and leg presses . We estimated percent body fat and muscle mass . We assessed patients ' QOL with the Short Form-36 items . RESULTS The intervention was well tolerated and did not have any deleterious effect on patients ' health , and did not induce significant losses in their body mass . The only studied variable for which a significant interaction ( group x time ) effect was found ( p=.009 ) was the 6RM seated lateral row test . CONCLUSIONS Low-moderate-intensity strength training does not seem to add major benefits to conventional psychotherapy and refeeding treatments in young anorexic patients Background : Separation anxiety disorder ( SAD ) is one of the earliest and most common mental disorders in childhood , and a strong predictor of adult psychopathology . Despite significant progress in psychotherapy research on childhood anxiety disorders , no r and omized controlled trial has been conducted with a disorder-specific treatment program for young children suffering from SAD . Methods : Forty-three children ( ages 5–7 ) with SAD and their parents were assigned to either a 16-session disorder-specific SAD treatment program including parent training and classical cognitive-behavioral therapy ( CBT ) components , or to a 12-week waiting list group . Categorical and /or continuous data for anxiety , impairment/distress and quality of life were collected at baseline , after treatment/waiting list condition , and at a 4-week follow-up . Results : Intention-to-treat analyses indicate that 76.19 % of children allocated to the treatment group definitively no longer fulfilled DSM-IV criteria for SAD at follow-up , compared to 13.64 % in the waiting list group . Between 91 and 100 % of children rated themselves or were rated by their father , mother or therapist as very much or much improved on the global success rating immediately after treatment . Results indicated large time by treatment condition interaction effect sizes ( d = 0.98–1.41 ) across informants for reduction of distress/avoidance in separation situations after the test for the treatment condition . Further , parents reported significant improvements in impairment/distress in the child ’s major life domains and the child ’s quality of life . Treatment gains were maintained at the 4-week follow-up assessment . Conclusions : Results indicate the short-term efficacy of a disorder-specific treatment approach for SAD , and are among the first to indicate that CBT programs work with young children BACKGROUND Although cognitive-behavioral therapy ( CBT ) is established as a first line treatment for anxiety disorders in children and adolescents , there is little evidence about the effectiveness of CBT protocol s in cases identified in the community in low and middle income countries ( LaMICs ) . AIMS To evaluate the effectiveness of group CBT protocol for youths with anxiety disorders identified in a community sample in LaMICs . METHOD A total of 14 sessions of group CBT for youths and 2 concurrent sessions for parents based on Kendall 's Coping Cat program were offered . Participants were selected from a cross-sectional community study ; 45 subjects fulfilled inclusion criteria and 28 agreed to participate in the open clinical trial .  Treatment effectiveness was evaluated with st and ard clinical , self- and parent-rated measures of anxiety , depression , externalizing symptoms and quality of life ( QoL ) . RESULTS Twenty youths completed the protocol . All scales showed an improvement of anxiety and reduction in externalizing symptoms over time , with a moderate to large effect size ( d = 0.59 to 2.06 ; p < .05 ) , but not in depressive symptoms or QoL. CONCLUSIONS Consistent with previous evidence , group CBT is effective in treating anxiety disorders in youths . Results encourage further r and omized clinical trials using CBT protocol s adapted and developed to be used in LaMICs The current study was design ed to investigate the changes that occur in depression , anxiety , obsessive — compulsive symptoms and health-related quality of life during methylpheni date ( MPH ) treatment in children with attention-deficit hyperactivity disorder ( ADHD ) . Forty-five treatment naive children with ADHD , aged 8—14 , were assessed based on self , parent and teacher reports at the baseline and at the end of the first and third month of MPH treatment regarding changes in inattention , hyperactivity , impulsivity , depression , anxiety and obsessive — compulsive symptoms . Changes in the quality of life were also noted . Repeated measures of analysis of variance ( ANOVA ) tests with Bonferroni corrections were conducted in order to evaluate the data . Symptoms of inattention , hyperactivity and impulsivity were significantly reduced ( p < 0.017 ) following a three-month MPH treatment . There were significant decreases in depression ( p = 0.004 ) , trait anxiety ( p = 0.000 ) and checking compulsion symptom scores ( p = 0.001 ) . Moreover , parents reported significant improvements in psychosocial ( p = 0.001 ) and total scores ( p = 0.009 ) of quality of life , despite no change in physical health scores ( p > 0.05 ) . Children ’s ratings of quality of life measures showed no significant changes in physical health and psychosocial scores ( p > 0.05 ) , while total scores significantly improved ( p = 0.001 ) after the treatment . Over a three-month MPH treatment , depression , trait anxiety and checking compulsion symptoms decreased and quality of life seemed to improve along with those of inattention , hyperactivity and impulsivity BACKGROUND There are limited published data on the impact of treatment on the health-related quality of life ( HRQOL ) in individuals with autistic disorder . OBJECTIVE The aim of this study was to evaluate the impact of aripiprazole on HRQOL in the treatment of irritability in pediatric patients ( aged 6 - 17 years ) with autistic disorder . METHODS This post hoc analysis assessed data from two 8-week , double-blind , r and omized , placebo-controlled studies that compared the efficacy of aripiprazole ( fixed-dose study , 5 , 10 , and 15 mg/d ; flexible-dose study , 2 - 15 mg/d ) with placebo in the treatment of irritability associated with autistic disorder . HRQOL was assessed at baseline and week 8 using 3 Pediatric Quality of Life Inventory ( PedsQL ™ ) scales . Clinical ly relevant improvement in HRQOL was determined using an accepted distribution-based criterion-1 st and ard error of measurement . RESULTS In total , 316 patients were r and omly assigned to receive treatment with aripiprazole ( fixed-dose study , 166 ; flexible-dose study , 47 ) or placebo ( fixed-dose study , 52 ; flexible-dose study , 51 ) . Aripiprazole was associated with significantly greater improvement  than placebo in PedsQL combined-scales total score ( difference , 7.8 ; 95 % CI , 3.8 - 11.8 ; P < 0.001 ) and in 3 PedsQL scale scores ( differences [ 95 % CI ] : Emotional Functioning , 7.8 [ 3.4 - 12.2 ] ; Social Functioning , 6.2 [ 0.7 - 11.8 ] ; Cognitive Functioning , 9.3 [ 3.8 - 14.9 ] ; all , P < 0.05 ) . Patients who received aripiprazole were significantly more likely than those who received placebo to have a clinical ly meaningful improvement on the combined-scales total score ( odds ratio [ OR ] = 1.9 ; 95 % CI , 1.0 - 3.3 ; P < 0.05 ) , Emotional Functioning scale ( OR = 2.2 ; 95 % CI , 1.2 - 4.0 ; P < 0.05 ) and Social Functioning scale ( OR = 2.2 ; 95 % CI , 1.2 - 4.1 ; P < 0.05 ) , and were significantly less likely to experience deterioration ( OR : 0.3 , 95 % CI : 0.1 - 0.8 ; P < 0.05 ) when " Stable " was used as the reference group . CONCLUSIONS The findings from the present post hoc analysis suggest that aripiprazole was associated with improved HRQOL , as assessed using 3 PedsQL scales , in pediatric patients with irritability associated with autistic disorder OBJECTIVE Information on psychostimulant treatment in long-term studies for attention-deficit/hyperactivity disorder ( ADHD ) in adolescents is limited . This study aim ed to assess the safety and effectiveness of lisdexamfetamine dimesylate ( LDX ) over 52 weeks in adolescents with ADHD . METHODS This open-label multicenter study enrolled eligible participants after their participation in a r and omized , double-blind , placebo-controlled 4 week trial in adolescents with ADHD . Following a 4 week dose-optimization phase , participants were maintained on treatment for up to ∼48 weeks on an optimal dose . Safety assessment s included treatment-emergent adverse events ( TEAEs ) , vital signs , laboratory findings , and electrocardiograms . Effectiveness measures included the ADHD Rating Scale IV ( ADHD-RS-IV ; primary ) and Clinical Global Impressions-Improvement ( CGI-I ) . The Youth Quality of Life- Research Version ( YQOL-R ) was also included in this study ; raw scores are transformed to a 0 - 100 point scale . RESULTS Of 269 enrolled ( from the antecedent study ) , 265 ( 98.5 % ) were in the safety population and effectiveness population . Common TEAEs ( ≥5 % ) with LDX included upper respiratory tract infection ( 21.9 % ) , decreased appetite ( 21.1 % ) , headache ( 20.8 % ) , decreased weight ( 16.2 % ) , irritability ( 12.5 % ) , insomnia ( 12.1 % ) , nasopharyngitis ( 7.2 % ) , influenza ( 6 
    Output:
    