CT and MRI measurements of tibial tubercle-trochlear groove distances are not equivalent in patients with patellar instability . BACKGROUND Tibial tubercle-trochlear groove distance ( TT-TG ) is a commonly used measurement for surgical decision making in patients with patellofemoral malalignment and instability . This measurement has historically been performed utilizing axial computed tomography ( CT ) . More recently , magnetic resonance imaging ( MRI ) has been proposed as an equivalent method , but this has not yet been fully validated . PURPOSE To determine the reliability of TT-TG distance measurements on both MRI and CT and to determine whether the measurements are interchangeable with one another . STUDY DESIGN Cohort study ( diagnosis ) ; Level of evidence , 2 . METHODS All patients with patellar instability who underwent both CT and MRI of the knee from 2003 to 2011 were included ( n = 59 knees in 54 patients ) . Two fellowship-trained musculoskeletal radiologists measured the TT-TG distances for each patient by CT and MRI in a randomized , blinded fashion . Interobserver reliability was calculated between radiologists for both imaging modalities , and intermethod reliability was calculated between the 2 imaging modalities . The results are reported using intraclass correlation coefficients ( ICCs ) and Bland-Altman analysis . RESULTS The 59 knees had a mean TT-TG distance of 16.9 mm ( range , 8.3-25.8 mm ) by CT and 14.7 mm ( range , 1.5-25.1 mm ) by MRI . Interobserver reliability between the radiologists was considered excellent for both CT and MRI ( ICC = 0.777 and 0.843 , respectively ) . When comparing CT to MRI , the ICC was considered only fair for each of the raters ( 0.532 and 0.539 ) . Eleven patients ( 19 % ) had a TT-TG distance of ≥20 mm on CT preoperatively and underwent distal realignment by tibial tubercle osteotomy . In this surgical subgroup , the mean TT-TG distance was 22.5 mm ( range , 19.8-25.8 mm ) by CT and only 18.7 mm ( range , 14.4-22.8 mm ) by MRI for a mean difference of 3.80 mm ( P < .001 ) . CONCLUSION The TT-TG distance can be measured with excellent interrater reliability on both MRI and CT ; however , the values derived from these 2 tests may not be interchangeable . This observation should be taken into consideration when MRI is used for surgical planning because MRI may underestimate the TT-TG distance when compared with CT .

CT

MRI

CT

MRI

CT

MRI

TT-TG distance measurements

TT-TG distances

Interobserver reliability

intermethod reliability

TT-TG distance

Interobserver reliability

ICC

TT-TG distance

patellar instability

patellar instability


Singing can facilitate foreign language learning . This study presents the first experimental evidence that singing can facilitate short-term paired-associate phrase learning in an unfamiliar language ( Hungarian ) . Sixty adult participants were randomly assigned to one of three " listen-and-repeat " learning conditions : speaking , rhythmic speaking , or singing . Participants in the singing condition showed superior overall performance on a collection of Hungarian language tests after a 15-min learning period , as compared with participants in the speaking and rhythmic speaking conditions . This superior performance was statistically significant ( p < .05 ) for the two tests that required participants to recall and produce spoken Hungarian phrases . The differences in performance were not explained by potentially influencing factors such as age , gender , mood , phonological working memory ability , or musical ability and training . These results suggest that a " listen-and-sing " learning method can facilitate verbatim memory for spoken foreign language phrases .

Singing

singing

speaking , rhythmic speaking

singing .

speaking

rhythmic speaking conditions .

" listen-and-sing " learning method


[ Therapeutic efficacy of compound Xuanju capsule on type III prostatitis ] . OBJECTIVE To evaluate the therapeutic effect of Compound Xuanju Capsule on type III prostatitis . METHODS A total of 242 patients with type III prostatitis diagnosed by the NIH criteria were randomly divided into an experimental and a control group of equal number , the former treated with Compound Xuanju Capsule + Tamsulosin Hydrochloride , and the latter with Quinolinone antibiotics + Tamsulosin and Hydrochloride , both for 6 months . After treatment , we assessed the therapeutic effects based on the NIH-CPSI scores and the improvement of relevant complications . RESULTS All the 242 patients completed the treatment . The total effectiveness rate was 77.69 % ( 94/121 ) in the experimental group , 71.56 % ( 78/109 ) in those with complications . In comparison , it was only 47.10 % ( 57/121 ) in the control group , 31.78 % ( 34/107 ) in those with complications . Both the NIH-CPSI scores and the improvement of complications were significantly higher in the experimental than in the control group ( P < 0.05 ) . CONCLUSION Compound Xuanju Capsule has a good therapeutic effect on type III prostatitis .

compound Xuanju

Compound Xuanju

Compound Xuanju

improvement of relevant complications

total effectiveness rate

NIH-CPSI scores

improvement of complications

type III prostatitis ]

242 patients

type III prostatitis

242 patients


Unexpected random urinary protein : creatinine ratio results-limitations of the pyrocatechol violet-dye method . BACKGROUND For clinicians , it is important to rely on accurate laboratory results for patient care and optimal use of health care resources . We sought to explore our observations that urine protein : creatinine ratios ( PrCr ) ≥30 mg/mmol are seen not infrequently associated with normal pregnancy outcome . METHODS Urine samples were collected prospectively from 160 pregnant women attending high-risk maternity clinics at a tertiary care facility . Urinary protein was measured using a pyrocatechol violet assay and urinary creatinine by an enzymatic method on Vitros analysers . Maternal/perinatal outcomes were abstracted from hospital records . RESULTS 91/233 ( 39.1 % ) samples had a PrCr ≥30 mg/mmol , especially when urinary creatinine concentration was < 3 mM ( 94.1 % ) vs. ≥3 mM ( 16.4 % ) ( p < 0.001 ) . When using the last sample before delivery , 47/160 ( 29.4 % ) had a PrCr ≥30 mg/mmol in diluted urine vs. only 17/160 ( 15.4 % ) in more concentrated urine ( p < 0.001 ) ; PrCr positive results were also more frequent among the 32 ( 20.0 % ) women with known normal pregnancy outcome ( 90.9 % vs. 0 ) ( p < 0.001 ) . Using the same analyser , 0.12 g/L urinary protein was 'detected ' in deionised water . Re-analysis of data from two cohorts revealed substantially less inflation of PrCr in dilute urine using a pyrogallol red assay . CONCLUSIONS Random urinary PrCr was overestimated in dilute urine when tested using a common pyrocatechol violet dye-based method . This effect was reduced in cohorts when pyrogallol red assays were used . False positive results can impact on diagnosis and patient care . This highlights the need for both clinical and laboratory quality improvement projects and standardization of laboratory protein measurement .

pyrocatechol violet-dye method

women

high-risk maternity


Intravenous adenosine activates diffuse nociceptive inhibitory controls in humans . Experimentally induced pain can be attenuated by concomitant heterotopic nociceptive stimuli ( counterirritation ) . Animal data indicate that this stems from supraspinal " diffuse noxious inhibitory controls " ( DNICs ) triggered by C and Aδ fibers . In humans , only noxious stimuli induce counterirritation . This points at C fibers , but the effects of pharmacologically stimulating C fibers have not been studied . Intravenous adenosine activates pulmonary C fibers and induces dyspnea . This study tests the hypothesis that putative activation of pulmonary C fibers by adenosine would trigger DNICs in humans and induce counterirritation . Twelve healthy volunteers were included ( with valid results available in 9 ) and studied according to a double-blind , randomized , cross-over design ( intravenous adenosine , 140 μg·kg ( -1 ) ·min ( -1 ) , during 5 min vs. placebo ) . We measured ventilatory variables and end-tidal CO2 tension , dyspnea intensity by visual analog scale , and the intensity of putative chest pain . The primary outcome was the amplitude of the RIII component of the nociceptive flexor reflex recorded by biceps femoris electromyogram in response to painful electrical sural nerve stimulation ( RIII ) , taken as a substitute for pain perception . Placebo did not induce any significant effect . Adenosine induced dyspnea , hyperpnea , tachycardia , and significant RIII inhibition ( 24 ± 8 % at the 4th min , P < 0.0001 ) . The temporal dynamics of adenosine-induced dyspnea and RIII inhibition differed ( immediate onset followed by a slow decrease for dyspnea , slower onset for RIII inhibition ) . Intravenous adenosine in normal humans induces counterirritation , fueling the notion that C-fiber stimulation trigger DNICs in humans . The temporal dissociation between adenosine-induced dyspnea and RIII inhibition suggests that C fibers other than pulmonary ones might be involved .

adenosine

intravenous adenosine

placebo

Placebo

Adenosine


The influence of fidelity of implementation on teacher-student interaction quality in the context of a randomized controlled trial of the Responsive Classroom approach . This study examined the direct and indirect effects between training in the Responsive Classroom® ( RC ) approach , teachers ' uptake of RC practices , and teacher-student interaction quality , using a structural equation modeling framework . A total of 24 schools were randomly assigned to experimental or control conditions . Third- and fourth-grade teachers in treatment schools ( n=132 ) received training in the RC approach , whereas teachers in control schools ( n=107 ) continued " business as usual . " Observers rated teachers ' fidelity of implementation ( FOI ) of RC practices 5 times throughout the year using the Classroom Practices Observation Measure . In addition , teachers completed self-report measures of FOI , the Classroom Practices Teacher Survey and Classroom Practices Frequency Survey , at the end of the school year . Teacher-student interactions were rated during classroom observations using the Classroom Assessment Scoring System . Controlling for teachers ' grade level and teacher-student interaction quality at pretest , RC training was expected to predict posttest teacher-student interaction quality directly and indirectly through FOI . Results supported only a significant indirect effect , β=0.85 , p=.002 . Specifically , RC teachers had higher levels of FOI of RC practices , β=1.62 , p < .001 , R2=.69 . In turn , FOI related to greater improvement in teacher-student interaction quality , β=0.52 , p=.001 , R2=.32 . Discussion highlights factors contributing to variability in FOI and school administrators roles in supporting FOI .

Responsive Classroom approach

fidelity of implementation

teacher-student interaction quality

direct and indirect effects

teacher-student interaction


Can a questionnaire predict vitamin D status in postmenopausal women ? OBJECTIVE Our objective was to determine whether a questionnaire can identify individuals with vitamin D insufficiency ( VDI ) . DESIGN Women completed the Vitamin D & Sun ( VIDSUN ) questionnaire and we measured their serum 25-hydrocyvitamin D ( 25 ( OH ) D ) levels . We assessed the sensitivity and specificity of the questionnaire to identify VDI ( 25 ( OH ) D level < 50 nmol/l ) . SETTING Clinical Research Unit , University of Wisconsin-Madison . SUBJECTS Postmenopausal women . RESULTS We recruited 609 postmenopausal women with a mean age of 61 ( sd 6 years ) , of whom 113 ( 19 % ) had VDI . Women with VDI were more likely to be black ( 17 % v. 2 % , P < 0.001 ) , heavier ( BMI 33.0 ( sd 7 ) kg/m2 v. 29.0 ( sd 7 ) kg/m2 , P < 0.001 ) and less likely to tan in the past year ( 49 % v. 72 % , P < 0.001 ) , use sunscreen ( 57 % v. 72 % , P < 0.001 ) or report sun exposure in the last 3 months . They consumed less vitamin D from supplements ( 2.15 ( sd 5.24 ) μg/d ( 86 ( sd 210 ) IU/d ) v. 4.55 ( sd 8.48 ) μg/d ( 188 ( sd 344 ) IU/d ) , P = 0.003 ) . In logistic regression models , black race , BMI , suntan within the past year , sun exposure in the past 3 months , sunscreen use and supplemental vitamin D intake were the most useful questions to identify VDI . From these six items , a composite score of ≤ 2.25 demonstrated ≥89 % sensitivity but ≤35 % specificity for VDI . CONCLUSIONS The VIDSUN questionnaire provides an initial tool to identify postmenopausal women at high or low risk of VDI . Existing studies suggest that inclusion of physical activity and TAG levels might improve the performance of the VIDSUN questionnaire .

questionnaire

questionnaire

D status

vitamin D insufficiency

sensitivity and specificity

identify VDI ( 25 ( OH ) D level

VDI

black

BMI

likely to tan in the past year

sunscreen

vitamin D from supplements

postmenopausal women

vitamin D insufficiency ( VDI ) .


A randomised controlled trial of ranibizumab with and without ketorolac eyedrops for exudative age-related macular degeneration . AIMS To evaluate whether ketorolac eyedrops and ranibizumab intravitreal injections would provide additional benefit over ranibizumab alone in the treatment of choroidal neovascularisation ( CNV ) . METHODS This was a pilot study of eyes with new-onset CNV . A total of 56 patients were enrolled consecutively and randomised in a 1:1 ratio to receive combination treatment with intravitreal ranibizumab and topical ketorolac ( group 1 ) or ranibizumab alone ( group 2 ) . All patients received monthly 0.5-mg ranibizumab intravitreal injections for 3 months , after which monthly injections were administered in accordance with the standard of care . Group 1 patients also self-administered one drop of ketorolac three times a day for 6 months . All patients were followed up for 6 months . RESULTS At 6 months , both groups showed a significant improvement in best-corrected visual acuity ( both , p < 0.001 ) . The two treatments did not show significant differences in terms of the number of ranibizumab injections required . However , the mean 6-month change in central macular thickness ( CMT ) in the combination group was -124 µm ( -29.7 % ; p < 0.001 ) , while in the ranibizumab-only group , the change was -86.9 µm ( -19.5 % ; p=0.001 ) ; thus , the combination treatment resulted in a greater reduction ( p=0.003 ) . The combination treatment had no adverse effects . CONCLUSIONS This pilot study is the first to prospectively investigate the efficacy and safety of a combination of 0.45 % ketorolac eyedrops three times a day and intravitreal ranibizumab injections in patients with CNV , and suggests that topical ketorolac supplements the activity of intravitreal ranibizumab in reducing CMT in CNV .

ketorolac eyedrops

ranibizumab intravitreal injections

ranibizumab

ranibizumab alone

ranibizumab intravitreal injections

ketorolac

ranibizumab

ketorolac

ranibizumab

best-corrected visual acuity


A chinese mind-body exercise improves self-control of children with autism : a randomized controlled trial . Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors , in children with autism spectrum disorders ( ASD ) , which often contributes to learning difficulties and caregiver burden . The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise , Nei Yang Gong , with that of the conventional Progressive Muscle Relaxation ( PMR ) technique in enhancing the self-control of children with ASD . Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong ( experimental group ) or PMR ( control group ) twice per week for four weeks . The participants ' self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires , and the underlying neural mechanism was assessed by the participants ' brain EEG activity during an inhibitory-control task before and after intervention . The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group , which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors . In addition , the experimental group showed enhanced EEG activity in the anterior cingulate cortex , a region that mediates self-control , whereas the PMR group did not . The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems . Chinese Clinical Trial Registry ; Registration No . : ChiCTR-TRC-12002561 ; URL : www.chictr.org .

Nei Yang Gong ( experimental group )

PMR ( control group )

Chan-based mind-body exercises

self-control

Self-control

neuropsychological tests

improvement in self-control

autistic symptoms

control of temper and behaviors

enhanced EEG activity

children

autism

children

autism spectrum disorders ( ASD )

children

ASD

Forty-six

ASD

children

self-control problems


Components of working memory and visual selective attention . Load theory ( Lavie , N. , Hirst , A. , De Fockert , J. W. , & Viding , E. [ 2004 ] . Load theory of selective attention and cognitive control . Journal of Experimental Psychology : General , 133 , 339-354 . ) proposes that control of attention depends on the amount and type of load that is imposed by current processing . Specifically , perceptual load should lead to efficient distractor rejection , whereas working memory load ( dual-task coordination ) should hinder distractor rejection . Studies support load theory 's prediction that working memory load will lead to larger distractor effects ; however , these studies used secondary tasks that required only verbal working memory and the central executive . The present study examined which other working memory components ( visual , spatial , and phonological ) influence visual selective attention . Subjects completed an attentional capture task alone ( single-task ) or while engaged in a working memory task ( dual-task ) . Results showed that along with the central executive , visual and spatial working memory influenced selective attention , but phonological working memory did not . Specifically , attentional capture was larger when visual or spatial working memory was loaded , but phonological working memory load did not affect attentional capture . The results are consistent with load theory and suggest specific components of working memory influence visual selective attention .

working memory task ( dual-task )

control of attention

amount and type of load

distractor rejection .

distractor effects ;

visual selective attention .

attentional capture task

selective attention

attentional capture

attentional capture

visual selective attention

visual selective attention


A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders : study protocol for a randomized controlled trial . BACKGROUND Adults with high-functioning autism spectrum disorders ( ASD ) have difficulties in social communication ; thus , these individuals have trouble understanding the mental states of others . Recent research also suggests that adults with ASD are unable to understand their own mental states , which could lead to difficulties in emotion-regulation . Some studies have reported the efficacy of cognitive-behavioral therapy ( CBT ) in improving emotion-regulation among children with ASD . The current study will investigate the efficacy of group-based CBT for adults with ASD . METHODS/DESIGN The study is a randomized , waitlist controlled , single-blinded trial . The participants will be 60 adults with ASD ; 30 will be assigned to a CBT group and 30 to a waitlist control group . Primary outcome measures are the 20-item Toronto Alexithymia Scale , the Coping Inventory for Stressful Situations , the Motion Picture Mind-Reading task , and an ASD questionnaire . The secondary outcome measures are the Center for Epidemiological Studies Depression Scale , the World Health Organization Quality of Life Scale 26-item version , the Global Assessment of Functioning , State-trait Anxiety Inventory , Social Phobia and Anxiety Inventory , and Liebowitz Social Anxiety Scale . All will be administered during the pre- and post-intervention , and 12 week follow-up periods . The CBT group will receive group therapy over an 8 week period ( one session per week ) with each session lasting approximately 100 minutes . Group therapy will consist of four or five adults with ASD and two psychologists . We will be using visual materials for this program , mainly the Cognitive Affective Training kit . DISCUSSION This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD . TRIAL REGISTRATION This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No . UMIN000006236 .

cognitive-behavioral intervention

cognitive-behavioral therapy ( CBT )

CBT

waitlist control group

adults

Adults

adults

ASD

children

ASD

adults

ASD

60 adults

ASD

30 will be assigned to a CBT group

30 to a waitlist control group


A randomized double blind placebo controlled clinical trial of N-Acetylcysteine added to risperidone for treating autistic disorders . BACKGROUND This study examined the efficacy and safety of N-acetylcysteine ( NAC ) augmentation for treating irritability in children and adolescents with autism spectrum disorders ( ASD ) . METHOD Forty children and adolescents met diagnostic criteria for ASD according to DSM-IV . They were randomly allocated into one of the two groups of NAC ( 1200 mg/day ) +risperidone or placebo+risperidone . NAC and placebo were administered in the form of effervescent and in two divided doses for 8 weeks . Irritability subscale score of Aberrant Behavior Checklist ( ABC ) was considered as the main outcome measure . Adverse effects were also checked . RESULTS The mean score of irritability in the NAC+risperidone and placebo+risperidone groups at baseline was 13.2 ( 5.3 ) and 16.7 ( 7.8 ) , respectively . The scores after 8 weeks were 9.7 ( 4.1 ) and 15.1 ( 7.8 ) , respectively . Repeated measures of ANOVA showed that there was a significant difference between the two groups after 8 weeks . The most common adverse effects in the NAC+risperidone group were constipation ( 16.1 % ) , increased appetite ( 16.1 % ) , fatigue ( 12.9 % ) , nervousness ( 12.9 % ) , and daytime drowsiness ( 12.9 % ) . There was no fatal adverse effect . CONCLUSIONS Risperidone plus NAC more than risperidone plus placebo decreased irritability in children and adolescents with ASD . Meanwhile , it did not change the core symptoms of autism . Adverse effects were not common and NAC was generally tolerated well . TRIAL REGISTRATION This trial was registered at http : //www.irct.ir . The registration number of this trial was IRCT201106103930N6 .

placebo

N-Acetylcysteine

risperidone

N-acetylcysteine ( NAC )

Adverse effects

mean score of irritability

constipation

increased appetite

fatigue

nervousness

daytime drowsiness

no fatal adverse effect

core symptoms of autism

autistic

autism

Forty children and adolescents

ASD

ASD


Nasal oxytocin for social deficits in childhood autism : a randomized controlled trial . The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans . Preliminary evidence suggests oxytocin may have potential as an intervention for autism . We evaluated a 5-day 'live-in ' intervention using a double-blind randomized control trial . 38 male youths ( 7-16 years old ) with autism spectrum disorders were administered 24 or 12 international units ( depending on weight ) intranasal placebo or oxytocin once daily over four consecutive days . The oxytocin or placebo was administered during parent-child interaction training sessions . Parent and child behaviours were assessed using parent reports , clinician ratings , and independent observations , at multiple time points to measure side-effects ; social interaction skills ; repetitive behaviours ; emotion recognition and diagnostic status . Compared to placebo , intranasal oxytocin did not significantly improve emotion recognition , social interaction skills , or general behavioral adjustment in male youths with autism spectrum disorders . The results show that the benefits of nasal oxytocin for young individuals with autism spectrum disorders may be more circumscribed than suggested by previous studies , and suggest caution in recommending it as an intervention that is broadly effective .

oxytocin

intranasal placebo

oxytocin

measure

side-effects

childhood

autism :

male youths ( 7-16 years old )

autism spectrum disorders

young

autism spectrum disorders


Effects of Positive Action on the emotional health of urban youth : a cluster-randomized trial . PURPOSE We examined the effects of Positive Action ( PA ) , a school-based social-emotional learning and health promotion program , on the emotional health of predominately low-income and ethnic minority urban youth . METHODS The study was a matched-pair , cluster-randomized controlled trial involving 14 Chicago public schools . Outcomes were assessed over a 6-year period of program implementation for a cohort of youth in each school , followed from grades 3 to 8 . Youth reported on their emotional health ( positive affect , life satisfaction , depression , anxiety ) and social-emotional and character development . Growth-curve and structural-equation modeling analyses assessed overall program effects on the emotional health outcomes as well as mediation of these effects via the program 's impact on youths ' social-emotional and character development . RESULTS Students in PA schools , compared with those in control schools , had more favorable change over the course of the study in positive affect ( standardized mean difference effect size [ ES ] = .17 ) and life satisfaction ( ES = .13 ) as well as significantly lower depression ( ES = -.14 ) and anxiety ( ES = -.26 ) at study end point . Program effects for positive affect , depression , and anxiety were mediated by more favorable change over time in social-emotional and character development for students in PA schools . CONCLUSIONS Results suggest that universal , school-based programs can benefit the emotional health of youth in low-income , urban settings . The modest magnitude of effects over an extended period of program implementation , however , reflects the challenges of both mounting interventions and offsetting formidable risks for mental health problems in such environments .

Positive Action

Positive Action ( PA )

PA

control

life satisfaction

depression

anxiety

depression

anxiety

urban youth :


Competitive employment for youth with autism spectrum disorders : early results from a randomized clinical trial . For most youth with autism spectrum disorders ( ASD ) , employment upon graduation from high school or college is elusive . Employment rates are reported in many studies to be very low despite many years of intensive special education services . This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD Supports on the employment outcomes for youth with ASD between the ages of 18-21 years of age . This model provides very promising results in that the employment outcomes for youth in the treatment group were much higher in non-traditional jobs with higher than minimum wage incomes than for youth in the control condition . Specifically , 21 out of 24 ( 87.5 % ) treatment group participants acquired employment while 1 of 16 ( 6.25 % ) of control group participants acquired employment .

Project SEARCH plus ASD Supports

control

employment outcomes

non-traditional jobs

acquired employment

youth

autism spectrum disorders

youth

autism spectrum disorders ( ASD )

youth

ASD


A replication and extension of the PEERS intervention : examining effects on social skills and social anxiety in adolescents with autism spectrum disorders . This study aimed to evaluate the Program for the Education and Enrichment of Relational Skills ( PEERS : Laugeson et al . in J Autism Dev Disord 39 ( 4 ) :596-606 , 2009 ) . PEERS focuses on improving friendship quality and social skills among adolescents with higher-functioning ASD . 58 participants aged 11-16 years-old were randomly assigned to either an immediate treatment or waitlist comparison group . Results revealed , in comparison to the waitlist group , that the experimental treatment group significantly improved their knowledge of PEERS concepts and friendship skills , increased in their amount of get-togethers , and decreased in their levels of social anxiety , core autistic symptoms , and problem behaviors from pre-to post-PEERS . This study provides the first independent replication and extension of the empirically-supported PEERS social skills intervention for adolescents with ASD .

PEERS intervention :

PEERS

immediate treatment

waitlist comparison group

waitlist

experimental treatment

PEERS

PEERS social skills intervention

social skills

social anxiety

friendship quality

social skills

amount of get-togethers

levels of social anxiety

core autistic symptoms

social skills

adolescents with ASD .


Randomised trial comparing the recording ability of a novel , electronic emergency documentation system with the AHA paper cardiac arrest record . OBJECTIVE To evaluate the ability of an electronic system created at the University of Washington to accurately document prerecorded VF and pulseless electrical activity ( PEA ) cardiac arrest scenarios compared with the American Heart Association paper cardiac arrest record . METHODS 16 anaesthesiology residents were randomly assigned to view one of two prerecorded , simulated VF and PEA scenarios and asked to document the event with either the paper or electronic system . Each subject then repeated the process with the other video and documentation method . Five types of documentation errors were defined : ( 1 ) omission , ( 2 ) specification , ( 3 ) timing , ( 4 ) commission and ( 5 ) noise . The mean difference in errors between the paper and electronic methods was analysed using a single factor repeated measures ANOVA model . RESULTS Compared with paper records , the electronic system omitted 6.3 fewer events ( 95 % CI -10.1 to -2.5 , p=0.003 ) , which represents a 28 % reduction in omission errors . Users recorded 2.9 fewer noise items ( 95 % CI -5.3 to -0.6 , p=0.003 ) when compared with paper , representing a 36 % decrease in redundant or irrelevant information . The rate of timing ( Δ=-3.2 , 95 % CI -9.3 to 3.0 , p=0.286 ) and commission ( Δ=-4.4 , 95 % CI -9.4 to 0.5 , p=0.075 ) errors were similar between the electronic system and paper , while the rate of specification errors were about a third lower for the electronic system when compared with the paper record ( Δ=-3.2 , 95 % CI -6.3 to -0.2 , p=0.037 ) . CONCLUSIONS Compared with paper documentation , documentation with the electronic system captured 24 % more critical information during a simulated medical emergency without loss in data quality .

AHA paper cardiac arrest record .

electronic system

paper

electronic system

paper

electronic methods

paper

evaluate the ability

repeated measures ANOVA model

rate of timing

and commission


Determinants of exclusive breastfeeding in an urban population of primiparas in Lebanon : a cross-sectional study . BACKGROUND The proportion of mothers who exclusively breastfeed their babies up to 6 months remains low . Determinants of breastfeeding practices have been largely documented in high-income countries . Little evidence exists on possible predictors of breastfeeding behaviors in the Middle East . Our aim was to assess the prevalence of breastfeeding in Beirut and determine the factors that impact breastfeeding behavior in this population . METHODS Data for this longitudinal study is nested within a randomized controlled trial ( RCT ) assessing the impact of a 24-hour hotline and postpartum support film on postpartum stress . Healthy first-time mothers delivering in the capital Beirut between March and July 2009 , were interviewed at 1-3 days and 8-12 weeks post delivery . A multiple logistic regression analysis was used to determine the factors associated with exclusive breastfeeding at 8-12 weeks postpartum . RESULTS The overall breastfeeding rate at 8-12 weeks postpartum was 67 % . The exclusive breastfeeding rate was 27.4 % . Factors associated with exclusive breastfeeding included maternal work ( OR=3.92 ; p-value < 0.001 ) , planned pregnancy ( OR=2.42 , p-value=0.010 ) , intention to breastfeed ( OR=3.28 ; p-value=0.043 ) , source of maternal emotional support ( OR=1.87 , p-value=0.039 ) and the use the postpartum support video , the hotline service or both ( OR=2.55 , p-value=0.044 ; OR=3.87 , p-value=0.004 and OR=4.13 , p-value=0.003 ) . CONCLUSIONS The proportion of healthy first-time mothers who exclusively breastfeed in Beirut is extremely low . Factors associated with breastfeeding behavior are diverse . Future research and interventions should target different levels of the maternal-child pair 's ecosystem . TRIAL REGISTRATION ClinicalTrials.gov , NCT00857051 .

exclusive breastfeeding

exclusively breastfeed

breastfeeding

breastfeeding

overall breastfeeding rate

exclusive breastfeeding rate

maternal work

planned pregnancy

intention to breastfeed

source of maternal emotional support

use the postpartum support video


[ Treating rheumatoid arthritis patients of Shen deficiency and cold invading syndrome by bushen quhan zhiwang decoction combined methotrexate : an evaluation of clinical efficacy and safety ] . OBJECTIVE To evaluate the clinical efficacy and safety of bushen quhan zhiwang decoction ( BQZD ) combined methotrexate ( MTX ) in treating rheumatoid arthritis ( RA ) . METHODS A prospective , randomized controlled study was carried out . RA patients of Shen deficiency and cold invading syndrome in the treatment group ( 120 cases ) were treated with BQZD and MTX ( 10 mg/week ) , while those in the control group ( 120 cases ) were treated with MTX ( 10 mg/week ) alone . The therapeutic course for all was 24 weeks . The efficacy and safety indices were evaluated at the baseline and 24 weeks after treatment , including clinical signs and symptoms , condition assessment , Health Assessment Questionnaire ( HAQ ) , disease activity index 28 ( DAS28 ) , laboratory parameters of erythrocyte sedimentation rate ( ESR ) and C-reactive protein ( CRP ) , safety indicators , and Chinese medical syndrome integrals . RESULTS The total effective rate was 80 . 0 % in the treatment group , better than that of the control group ( 66.7 % ) , showing statistical difference ( P < 0.01 ) . In the two groups significant improvement of clinical signs and symptoms , ESR , CRP , visual analogue scale ( VAS ) by both physicians and patients , HAQ , DAS28 , and Chinese medical syndrome integrals after treatment were shown ( P < 0.01 ) . Better effects were obtained in the treatment group in lessening tender joint numbers and swollen joint numbers , VAS by both physicians and patients , DAS28 , and Chinese medical syndrome integrals ( P < 0.05 ) . Besides , adverse reactions occurred less in the treatment group than in the control group ( P < 0.05 ) . CONCLUSIONS BQZD had roles in relieving symptoms , improving joint functions , signs , ESR , and CRP . It was an effective herb for RA patients of Shen deficiency and cold invading syndrome . It could enhance the efficacy and reduce adverse reactions of MTX through synergistic effects with MTX .

BQZD and MTX ( 10 mg/week )

treated with MTX ( 10 mg/week ) alone

BQZD

clinical signs and symptoms

condition assessment

Health Assessment Questionnaire ( HAQ )

disease activity index 28 ( DAS28 )

C-reactive protein ( CRP )

safety indicators

Chinese medical syndrome integrals

clinical signs and symptoms

ESR

CRP

visual analogue scale ( VAS )

HAQ

tender joint numbers

and

swollen joint numbers


Low protein provision during the first year of life , but not during foetal life , affects metabolic traits , organ mass development and growth in male mink ( Neovison vison ) . Low protein provision in utero and post-partum may induce metabolic disorders in adulthood . Studies in mink have mainly focused on short-term consequences of low protein provision in utero whereas the long-term responses to low protein ( LP ) provision in metabolically programmed mink are unknown . We investigated whether low protein provision in utero affects the long-term response to adequate ( AP ) or LP provision after weaning in male mink . Eighty-six male mink were exposed to low ( 19 % of ME from CP ; crude protein ) or adequate ( 31 % of ME from CP ) protein provision in utero , and to LP ( ~20 % of ME from CP ) or AP ( 30-42 % of ME from CP ) provision post-weaning . Being metabolically programmed by low protein provision in utero did not affect the response to post-weaning diets . Dietary protein content in the LP feed after weaning was below requirements ; evidenced by lower nitrogen retention ( p < 0.001 ) preventing LP mink from attaining their growth potential ( p < 0.02 ) . LP mink had a lower liver , pancreas and kidney weight ( p < 0.05 ) as well as lower plasma IGF-1 concentrations at 8 and 25 ( p < 0.05 ) weeks , and a higher incidence of hepatic lipidosis at 25 weeks ( p < 0.05 ) . Furthermore , LP mink had a higher body fat ( p < 0.05 ) and lower body CP content ( p < 0.05 ) at 50 weeks of age . It is concluded that some effects of low protein provision in utero can be alleviated by an adequate nutrient supply post-partum . However , long-term exposure to low protein provision in mink reduces their growth potential and induces transient hepatic lipidosis and modified body composition .

Low protein provision

Low protein

low protein provision

low protein ( LP ) provision

low protein

low protein provision in

low protein provision

metabolic traits

organ mass development and growth

metabolic disorders

post-weaning diets

Dietary protein content

liver , pancreas and kidney weight

plasma IGF-1 concentrations

hepatic lipidosis

higher body fat

lower body CP content

low protein provision

nutrient supply post-partum

growth potential


[ Risk factors for atherosclerotic disease from the Japanese Elderly Diabetes Intervention Trial ( J-EDIT ) ] .

Elderly Diabetes Intervention

Japanese

Elderly

Diabetes


Anemia and associated clinical outcomes in patients with heart failure due to reduced left ventricular systolic function . BACKGROUND Anemia is associated with decreased functional capacity , reduced quality of life , and worsened outcomes among patients with heart failure ( HF ) due to reduced left ventricular ejection fraction ( HFREF ) . We sought to evaluate the independent effect of anemia on clinical outcomes among those with HFREF . HYPOTHESIS Anemia is associated with cardiovascular events in patients with heart failure . METHODS The HF-ACTION trial was a prospective , randomized trial of exercise therapy vs usual care in 2331 patients with HFREF . Patients with New York Heart Association class II to IV HF and left ventricular ejection fractions of ≤ 35 % were recruited . Hemoglobin ( Hb ) was measured up to 1 year prior to entry and was stratified by quintile . Anemia was defined as baseline Hb < 13 g/dL and < 12 g/dL in men and women , respectively . Hemoglobin was assessed in 2 models : a global prediction model that had been previously developed , and a modified model including variables associated with anemia and the studied outcomes . RESULTS Hemoglobin was available at baseline in 1763 subjects ( 76 % of total study population ) ; their median age was 59.0 years , 73 % were male , and 62 % were Caucasian . The prevalence of anemia was 515/1763 ( 29 % ) . Older age , female sex , African American race , diabetes , hypertension , and lower estimated glomerular filtration rates were all more frequent in lower Hb quintiles . Over a median follow-up of 30 months , the primary outcome of all-cause mortality or all-cause hospitalization occurred in 78 % of those with anemia and 64 % in those without ( P < 0.001 ) . The secondary outcomes of all-cause mortality alone , cardiovascular ( CV ) mortality or CV hospitalization , and CV mortality or HF hospitalization occurred in 23 % vs 15 % , 67 % vs 54 % , and 44 vs 29 % , respectively ( P < 0.001 ) . Heart failure hospitalizations occurred in 36 % vs 22 % , and urgent outpatient visits for HF exacerbations occurred in 67 % and 55 % , respectively ( P < 0.001 ) . For the global model , there was an association observed for anemia and all-cause mortality or hospitalization ( adjusted hazard ratio [ HR ] : 1.15 , 95 % confidence interval [ CI ] : 1.01-1.32 , P = 0.04 ) , but other outcomes were not significant at P < 0.05 . In the modified model , the adjusted HR for anemia and the primary outcome of all-cause mortality or all-cause hospitalization was 1.25 ( 95 % CI : 1.10-1.42 , P < 0.001 ) . There were independent associations between anemia and all-cause death ( HR : 1.11 , 95 % CI : 0.87-1.42 , P = 0.38 ) , CV death or CV hospitalization ( HR : 1.16 , 95 % CI : 1.01-1.33 , P = 0.035 ) , and CV death and HF hospitalization ( HR : 1.27 , 95 % CI : 1.06-1.51 , P = 0.008 ) . CONCLUSIONS Anemia modestly is associated with increased rates of death , hospitalization , and HF exacerbation in patients with chronic HFREF . After adjusting for other important covariates , anemia is independently associated with an excess hazard for all-cause mortality and all-cause hospitalization . Anemia is also associated with combinations of CV death and CV/HF hospitalizations as composite endpoints .

exercise therapy vs usual care

recruited

Hemoglobin ( Hb )

quintile

Anemia

Hemoglobin

RESULTS Hemoglobin

of all-cause mortality alone

cardiovascular ( CV ) mortality

CV hospitalization

CV mortality

HF hospitalization

Heart failure hospitalizations

urgent outpatient visits

HF exacerbations

all-cause mortality or hospitalization

adjusted HR

0.38 )

CV death

CV hospitalization

HF hospitalization

HFREF

patients with heart failure

2331 patients

HFREF

men

women

their median age was 59.0 years ,

male

in patients with chronic HFREF


Ilioinguinal-iliohypogastric nerve block within travenous dexketoprofen improves postoperative analgesia in abdominal hysterectomies . BACKGROUND AND OBJECTIVE In this study , our aim was to evaluate the effects of intravenous dexketoprofen trometamol with ilioinguinal and iliohypogastric nerve block on analgesic quality and morphine consumption after total abdominal hysterectomy operations . METHODS We conducted this randomized controlled clinical study on 61 patients . The study was conducted in the operation room , post-anesthesia care unit , and inpatient clinic . We randomly grouped the 61 patients into control group ( group C ) , block group ( group B ) and dexketoprofen-block group ( group DB ) . Before the skin incision performed after anesthesia induction , we performed ilioinguinal iliohypogastric block ( group C given saline and group P and DB given levobupivacaine ) . In contrast to group C and B , group DB was given dexketoprofen . We administered morphine analgesia to all patients by patient-controlled analgesia ( PCA ) during the postoperative 24 hours . We recorded Visual Analogue Scale ( VAS ) , satisfaction scores , morphine consumption and side effects during postoperative 24 hours . RESULTS We found the DB group ’ s VAS scores to be lower than the control group and block group ’ s ( p < 0.05 ) values at postoperative 1st , 2nd , 6th and 12th hours . VAS scores of group C were higher than of group B at postoperative fi rst 2 hours . Time to fi rst PCA demand was longer , morphine consumption values were lower and satisfaction scores were higher in group DB than in the other two groups ( p < 0.05 ) . CONCLUSIONS Ilioinguinal-iliohypogastric nerve block with IV dexketoprofen increases patient satisfaction by decreasing opioid consumption , increasing patient satisfaction , which suggests that dexketoprofen trometamol is an effective non-steroidal anti-inflammatory analgesic in postoperative analgesia .

dexketoprofen

dexketoprofen trometamol

control group

block group

dexketoprofen-block group

ilioinguinal iliohypogastric block

saline

DB

levobupivacaine

dexketoprofen

morphine analgesia

Visual Analogue Scale ( VAS )

satisfaction scores

morphine consumption

side effects

VAS scores

morphine consumption

abdominal hysterectomies

abdominal hysterectomy


EULAR Sjogren 's Syndrome Disease Activity Index ( ESSDAI ) is sensitive to show efficacy of rituximab treatment in a randomised controlled trial .

rituximab treatment

efficacy


Tissue microarray in a subset of South African patients with DLBCL . Tissue samples from 93 de novo diffuse large B-cell lymphoma patients seen between 1995 and 2009 randomly receiving either standard combination chemotherapy ( CHOP , n=48 ) or the identical program with rituximab ( n=45 ) were subtyped using an investigational immunohistochemical ( IHC ) based tissue microarray ( TMA ) and contrasted to the approximately corresponding categories as defined either by Hans and associates using a three marker panel into germinal or non-germinal centre subtypes or by Choi and colleagues with two additional antibodies into germinal centre ( GCB ) or activated B-cells ( ABC ) . Each of these primary subdivisions was further evaluated for expression of BCL2 and LMO2 both of which are recognised to predicate response . The addition of rituximab to the uniform drug regimen did not show any significant improvement in 5 years overall ( 63 % versus 59 % , p 0.68 ) or event-free survival ( 42 % versus 39 % , p 0.94 ) , for CHOP versus R-CHOP comparisons . Similarly no differences were evident in subtype analysis . Interestingly however , when segregated on the Choi criteria , cytotoxic drugs alone showed a non-significant trend in improved survival ( 74 % versus 55 % , p 0.32 ) as well as event-free survival ( 44 % versus 40 % , p 0.42 ) for the germinal centre as opposed to the activated B-cell subtype . Nevertheless not even a small difference could be demonstrated in the presence of the anti CD 20 monoclonal antibody . According to Choi , both regimens ( chemotherapy or immunotherapy antibody ) revealed similar results to the Hans algorithm on 5 years OS as well as 3 year EFS when comparing GCB versus ABC or non-GCB subgroups . BCL2 and LMO2 marker expression of the respective immunohistochemical ( IHC ) subtype , despite small sample size , revealed the following . Analysis by Choi criteria on survival for BCL2 , no matter for which subsets ( GCB or ABC ) or treatment modality ( chemotherapy with or without the addition of rituximab ) showed no difference in 5 years OS or EFS . In contrast , a significant difference for better EFS ( p=0.0015 ) in the BCL2 positive group of the ABC subgroups subtypes treated with rituximab containing chemotherapy . For LMO2 similar results on survival outcome were seen thus showing no difference in 5 years OS or EFS - regardless of subtype or treatment modality . Also here , this was contrasted by better EFS ( p=0.039 ) in the LMO2 positive group of ABC subtypes when treated with the rituximab containing regimen . The use of the IHC based TMA methodology has shown to be a simple , cost effective and a robust alternative to gene expression profiling ( GEP ) which is currently regarded as the gold standard for the classification in lymphomas . It provides a useful prognostic tool in stratifying DLBCL or other entities in future , even when frozen tissue samples are not available for GEP analysis . With the current budgetary limitations in South African public hospitals chemotherapy protocols for lymphoproliferative disorders exclude agents such as rituximab . Local therapeutic drug committees consider the approximately 15 % overall survival benefit seen at 5 years for DLBCL when rituximab is added to combination chemotherapy as too marginal for justifying the arising additional expenses . Accordingly , demonstration that a specific molecular subtype accounts for superior outcome , when using these regimens , is needed . Such an option would provide convincing evidence for the use of immunochemotherapy in a resource constrained setting .

standard combination chemotherapy

identical program with rituximab

overall

or event-free survival

5 years OS or EFS

survival benefit

DLBCL


Impact of a leptin single nucleotide polymorphism and zilpaterol hydrochloride on growth and carcass characteristics in finishing steers . A total of 4,178 steers ( mean initial BW = 403.9 ± 16.04 kg ) were used to test the interactive effects , if any , of leptin R25C genotypes ( CC , CT , or TT ) and zilpaterol hydrochloride ( ZH ) feeding duration on growth performance and carcass traits . Steers were blocked by arrival at the feed yard , genotyped for the leptin SNP , allotted to genotype-specific pens ( 90 steers/pen ) , and assigned randomly within genotype and block to 0 or 21 d of dietary ZH . All pens within a block were slaughtered on the same day ( 132.1 ± 10.9 d on feed ) . Final BW of steers fed ZH was 6.0 kg heavier ( P = 0.008 ) , and ZH-fed steers had greater ( P = 0.003 ) ADG than steers not fed ZH . Feeding ZH decreased DMI in steers with increased frequency of the T allele ( 9.67 , 9.53 , and 9.28 kg/d for CC , CT , and TT , respectively ) , but DMI increased with the frequency of the T allele ( 9.68 , 9.90 , and 10.1 kg for CC , CT , and TT , respectively ) when ZH was not fed ( leptin genotype × ZH , P = 0.011 ) . At the conclusion of the study , ultrasonic fat was greatest for TT steers ( 11.4 ± 0.28 mm ) and least ( P = 0.003 ) for CC steers ( 11.0 ± 0.25 mm ) . Regardless of ZH-feeding duration , TT steers produced a greater ( P = 0.006 ) percentage of USDA yield grade ( YG ) 4 or higher carcasses ( 5.4 vs. 2.7 % ) and a lesser ( P = 0.006 ) percentage of YG 1 carcasses ( 17.7 vs. 26.8 % ) than CC steers . In addition , ZH-fed steers produced a greater ( P < 0.001 ) percentage of USDA YG 1 carcasses ( 25.9 vs. 16.2 % ) and a lesser ( P < 0.001 ) percentage of YG 4 or higher carcasses ( 1.6 vs. 6.0 % ) than steers fed the control diet . Marbling scores and the percentage of carcasses grading USDA Choice and Prime were greater in TT than CC steers when fed diets devoid of ZH , but both marbling and quality grades did not differ among leptin genotypes when fed ZH for 21 d ( leptin genotype × ZH , P ≤ 0.03 ) . The amount of HCW gain tended to be less ( P = 0.095 ) for steers of the TT genotype ( 12.7 kg ) than either CC ( 16.3 kg ) or CT ( 17.0 kg ) genotypes . Results indicated that leptin R25C genotype impacted most traits associated with fatness whereas feeding ZH for 21 d affected HCW and ADG positively but impacted feed intake , marbling , and USDA quality grades negatively .

zilpaterol hydrochloride

ultrasonic fat

finishing steers .


Bedside ultrasound-guided celiac plexus neurolysis in upper abdominal cancer patients : a randomized , prospective study for comparison of percutaneous bilateral paramedian vs. unilateral paramedian needle-insertion technique . INTRODUCTION Percutaneous anterior abdominal ultrasound guidance for performing celiac plexus neurolysis is a relatively new but more economical , less time-consuming , more comfortable bedside technique for interventional pain management . Paucity of studies evaluating the efficacy of single-site vs. double-site injections at celiac trunk for ultrasound-guided celiac plexus neurolysis ( USCPN ) prompted us to conduct a prospective , randomized , single-blind clinical trial to compare USCPN using bilateral paramedian ( double needle ) technique with unilateral paramedian ( single needle ) technique . METHODS Sixty patients aged 18 years or older with unresectable upper abdominal cancers were randomized into two groups to receive USCPN . A 20-mL mixture of 50 % ethanol with 0.25 % bupivacaine was injected either unilaterally ( 20 mL×1 site ) or bilaterally ( 10 mL×2 sites ) depending on the randomization group . Subjects were assessed for the pain relief using Numerical rating scale ( NRS ) to assess their pain relief . RESULTS Baseline parameters being comparable ( P > 0.05 ) , the site of drug injections ( single or double needle ) had no bearing on the onset of pain relief and patient satisfaction scores ( P > 0.05 ) . Pain relief during follow-up visits was comparable between the two groups ( P > 0.05 ) . The discomfort score correlated well with the pain relief scoring without any significant difference between the two groups except in the last visit ( at 3 month ) . Incidences of the complications were comparable in the two groups ( P > 0.05 ) . CONCLUSION Ultrasound-guided celiac plexus neurolysis using unilateral paramedian ( single needle ) needle-insertion technique is comparable with bilateral paramedian ( double needle ) needle-insertion technique with regard to pain relief and side effects .

bilateral paramedian

USCPN

ethanol

bupivacaine

pain relief

patient satisfaction scores

pain relief

side effects

upper abdominal cancer

Sixty

18 years or older

upper abdominal cancers


A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis . Abstract Tirasemtiv is a fast skeletal muscle activator that increases the sensitivity of the sarcomere to calcium , increasing the efficiency of muscle contraction when the muscle is stimulated at submaximal contraction frequencies . A previous study showed single doses of tirasemtiv to be well tolerated and associated with potentially important improvements in a variety of functional outcomes . This study determined safety of tirasemtiv when given at doses up to 500 mg daily for three weeks . Tirasemtiv was given as a single daily dose up to 375 mg for two weeks , with and without concomitant riluzole . In a separate cohort , an ascending dose protocol evaluated a total dose of 500 mg daily given in two divided doses . Safety and tolerability were assessed , as well as measures of function , muscle strength and endurance . Results showed that tirasemtiv was well tolerated , with dizziness the most common adverse event . Tirasemtiv approximately doubled the serum concentration of riluzole . Trends were noted for improvement in ALSFRS-R , Maximum Minute Ventilation , and Nasal Inspiratory Pressure . In conclusion , tirasemtiv is well tolerated and can be given safely with a reduced dose of riluzole . Positive trends in multiple exploratory outcome measures support the further study of this agent in ALS .

tirasemtiv

Abstract Tirasemtiv

tirasemtiv

Tirasemtiv

safety

tolerability

safety

Safety and tolerability

tolerated

dizziness

serum concentration of riluzole

safely

amyotrophic lateral sclerosis

ALS


Community-based treatment for opioid dependent offenders : a pilot study . BACKGROUND Primary care opioid substitution treatment ( OST ) has not been compared to program-based OST for community-supervised offenders . OBJECTIVE The purpose of this project was to compare primary care to specialist supervised OST for opioid dependent offenders in terms of substance use and HIV risk outcomes . METHODS This project randomly assigned 15 jail diversion participants to either : ( i ) primary care buprenorphine OST , ( ii ) specialist facility buprenorphine OST , or ( iii ) specialist facility methadone OST . Participation lasted 13.5 months ( 12-month active treatment plus a post-participation visit ) . RESULTS All subjects endorsed 0 days of opioid use in the previous 14 at follow-up . Specialty care reduced HIV risk ( Risk Assessment Battery composite score ) over 6 months ( -.24 ± .17 ) compared to primary care ( .02 ± .14 ; p = .032 ) . CONCLUSION Findings support primary care OST feasibility for a community-supervised offender sample . Specialist care may facilitate improvements in secondary outcomes , such as HIV risk behaviors . SCIENTIFIC SIGNIFICANCE Further research is needed to clarify ( i ) the role of primary care in addicted offender management , and ( ii ) the matching of offenders , based upon history and co-morbidity , to care coordination conditions .

Community-based treatment

primary care

buprenorphine

OST

specialist facility

buprenorphine

OST

specialist facility

methadone

OST

substance use

HIV risk outcomes .

such as HIV risk behaviors

opioid dependent offenders

community-supervised offenders

jail diversion participants


Successful production of piglets derived from expanded blastocysts vitrified using a micro volume air cooling method without direct exposure to liquid nitrogen . This study was conducted to clarify the feasibility of newly developed vitrification techniques for porcine embryos using the micro volume air cooling ( MVAC ) method without direct contact with liquid nitrogen ( LN₂ ) . Expanded blastocysts were vitrified in a solution containing 6 M ethylene glycol , 0.6 M trehalose and 2 % ( wt/vol ) polyethylene glycol in 10 % HEPES-buffered PZM-5 . The blastocysts were collected from gilts and vitrified using the new device ( MVAC ) or a Cryotop ( CT ) . Blastocysts were stored in LN₂ for at least 1 month . After warming , cryoprotective agents were removed using a single step . Survival of the embryos was assessed by in vitro culture ( Experiment 1 ) and by embryo transfer to recipients ( Experiment 2 ) . In Experiment 1 , the embryos vitrified by the MVAC or CT and fresh embryos without vitrification ( Control ) were used . The survival rates of embryos in the MVAC , CT and Control groups were 88.9 % ( 32/36 ) , 91.7 % ( 33/36 ) and 100 % ( 34/34 ) , respectively , after 48 h culture , and the hatching rates of embryos after 48 h incubation were 69.4 % ( 25/36 ) , 63.9 % ( 23/36 ) and 94.1 % ( 32/34 ) , respectively . In Experiment 2 , 64 vitrified embryos were transferred to 5 recipient gilts , and 8 healthy piglets were produced from 3 recipients in the MVAC group . Similarly , 66 vitrified embryos were transferred to 5 recipient gilts , and 9 healthy piglets were produced from 2 recipients in the CT group . These results indicated that porcine expanded blastocysts can be cryopreserved using the MVAC method without potential pathogen contamination from LN₂ .

micro volume air cooling method

micro volume air cooling ( MVAC )

production

piglets


Infant distress and development of functional gastrointestinal disorders in childhood : is there a connection ?


Efficacy and safety of diclofenac diethylamine 1.16 % gel in acute neck pain : a randomized , double-blind , placebo-controlled study . BACKGROUND Neck pain ( NP ) is a common musculoskeletal disorder in primary care that frequently causes discomfort . Non-steroidal anti-inflammatory drugs ( NSAIDs ) may be used to reduce neck pain and associated inflammation and facilitate earlier recovery . Topical diclofenac diethylamine ( DDEA ) 1.16 % gel is clinically proven to be effective and well tolerated in acute and chronic musculoskeletal conditions , but until now no clinical data existed for its use in acute NP . The aim of this study was to assess the efficacy and safety of DDEA 1.16 % gel compared with placebo gel in acute NP . METHODS In a randomized , double-blind , placebo-controlled study , patients with acute NP ( n = 72 ) were treated with DDEA 1.16 % gel ( 2 g , 4x/day , for 5 days ) or placebo . Efficacy assessments included pain-on-movement ( POM ) , pain-at-rest ( PAR ) , functional neck disability index ( NDI ) and response to treatment ( decrease in POM by 50 % after 48 h ) . Adverse events ( AEs ) were recorded throughout the study . RESULTS The primary outcome , POM at 48 h , was statistically significantly lower with DDEA gel ( 19.5 mm ) vs. placebo ( 56.9 mm ) ( p < 0.0001 ) , representing a clinically relevant decrease from baseline ( 75 % vs. 23 % , respectively ) . All POM scores were significantly lower with DDEA gel vs. placebo from 1 h , as were PAR and NDI scores from first assessment ( 24 h ) onwards ( all p < 0.0001 ) . Response to treatment was significantly higher with DDEA gel ( 94.4 % ) vs. placebo ( 8.3 % ) ( p < 0.0001 ) . There were no AEs with DDEA gel . CONCLUSIONS DDEA 1.16 % gel , which is available over-the-counter , was effective and well tolerated in the treatment of acute neck pain . The tools used to assess efficacy suggest that it quickly reduced neck pain and improved neck function . However , questions remain regarding the comparability and validity of such tools . Further studies will help ascertain whether DDEA 1.16 % gel offers an alternative treatment option in this common , often debilitating condition . TRIAL REGISTRATION ClinicalTrials.gov identifier : NCT01335724 .

diclofenac diethylamine

placebo gel

acute neck pain

acute NP


Assessment of global functioning in adolescents with autism spectrum disorders : utility of the Developmental Disability-Child Global Assessment Scale . Assessment of global functioning is an important consideration in treatment outcome research ; yet , there is little guidance on its evidence-based assessment for children with autism spectrum disorders . This study investigated the utility and validity of clinician-rated global functioning using the Developmental Disability-Child Global Assessment Scale in a sample of higher functioning adolescents with autism spectrum disorders and comorbid anxiety disorders enrolled in a randomized controlled trial ( n = 30 ) . Pretreatment Developmental Disability-Child Global Assessment Scale scores correlated with severity of autism spectrum disorders core symptoms ( r = -.388 , p = .034 ) , pragmatic communication ( r = .407 , p = .032 ) , and verbal ability ( r = .449 , p = .013 ) and did not correlate with severity of anxiety symptoms or with parent-reported adaptive behavior . Change in Developmental Disability-Child Global Assessment Scale scores during treatment was associated with autism spectrum disorders symptomatic improvement ( r = .414 , p = .040 ) and with improved general communication ( r = .499 , p = .013 ) . Results support the importance of assessing global functioning in addition to symptom change and treatment response in clinical trials .

controlled

global functioning

global functioning

global functioning

anxiety symptoms

general communication

global functioning

symptom change

adolescents

autism spectrum disorders

children with autism spectrum disorders


Use of EORTC target definition guidelines for dose-intensified salvage radiation therapy for recurrent prostate cancer : results of the quality assurance program of the randomized trial SAKK 09/10 . PURPOSE Different international target volume delineation guidelines exist and different treatment techniques are available for salvage radiation therapy ( RT ) for recurrent prostate cancer , but less is known regarding their respective applicability in clinical practice . METHODS AND MATERIALS A randomized phase III trial testing 64 Gy vs 70 Gy salvage RT was accompanied by an intense quality assurance program including a site-specific and study-specific questionnaire and a dummy run ( DR ) . Target volume delineation was performed according to the European Organisation for the Research and Treatment of Cancer guidelines , and a DR-based treatment plan was established for 70 Gy . Major and minor protocol deviations were noted , interobserver agreement of delineated target contours was assessed , and dose-volume histogram ( DVH ) parameters of different treatment techniques were compared . RESULTS Thirty European centers participated , 43 % of which were using 3-dimensional conformal RT ( 3D-CRT ) , with the remaining centers using intensity modulated RT ( IMRT ) or volumetric modulated arc technique ( VMAT ) . The first submitted version of the DR contained major deviations in 21 of 30 ( 70 % ) centers , mostly caused by inappropriately defined or lack of prostate bed ( PB ) . All but 5 centers completed the DR successfully with their second submitted version . The interobserver agreement of the PB was moderate and was improved by the DR review , as indicated by an increased κ value ( 0.59 vs 0.55 ) , mean sensitivity ( 0.64 vs 0.58 ) , volume of total agreement ( 3.9 vs 3.3 cm ( 3 ) ) , and decrease in the union volume ( 79.3 vs 84.2 cm ( 3 ) ) . Rectal and bladder wall DVH parameters of IMRT and VMAT vs 3D-CRT plans were not significantly different . CONCLUSIONS The interobserver agreement of PB delineation was moderate but was improved by the DR. Major deviations could be identified for the majority of centers . The DR has improved the acquaintance of the participating centers with the trial protocol .

64 Gy vs 70 Gy salvage RT

intense quality assurance program

dummy run ( DR )

3-dimensional conformal RT ( 3D-CRT )

intensity modulated RT ( IMRT )

Thirty


Increase in 2-long terminal repeat circles and decrease in D-dimer after raltegravir intensification in patients with treated HIV infection : a randomized , placebo-controlled trial . BACKGROUND The degree to which human immunodeficiency virus ( HIV ) continues to replicate during antiretroviral therapy ( ART ) is controversial . We conducted a randomized , double-blind , placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication , as defined by an increase in the level of 2-long terminal repeat ( 2-LTR ) circles . METHODS Thirty-one subjects with an ART-suppressed plasma HIV RNA level of < 40 copies/mL and a CD4 ( + ) T-cell count of ≥350 cells/mm ( 3 ) for ≥1 year were randomly assigned to receive raltegravir 400 mg twice daily or placebo for 24 weeks . 2-LTR circles were analyzed by droplet digital polymerase chain reaction at weeks 0 , 1 , 2 , and 8 . RESULTS The median duration of ART suppression was 3.8 years . The raltegravir group had a significant increase in the level of 2-LTR circles , compared to the placebo group . The week 1 to 0 ratio was 8.8-fold higher ( P = .0025 ) and the week 2 to 0 ratio was 5.7-fold higher ( P = .023 ) in the raltegravir vs. placebo group . Intensification also led to a statistically significant decrease in the D-dimer level , compared to placebo ( P = .045 ) . CONCLUSIONS Raltegravir intensification resulted in a rapid increase in the level of 2-LTR circles in a proportion of subjects , indicating that low-level viral replication persists in some individuals even after long-term ART . Intensification also reduced the D-dimer level , a coagulation biomarker that is predictive of morbidity and mortality among patients receiving treatment for HIV infection .

low-level viral replication

2-long terminal repeat

HIV infection


Gefitinib versus placebo in completely resected non-small-cell lung cancer : results of the NCIC CTG BR19 study . PURPOSE Survival of patients with completely resected non-small-cell lung cancer ( NSCLC ) is unsatisfactory , and in 2002 , the benefit of adjuvant chemotherapy was not established . This phase III study assessed the impact of postoperative adjuvant gefitinib on overall survival ( OS ) . PATIENTS AND METHODS Patients with completely resected ( stage IB , II , or IIIA ) NSCLC stratified by stage , histology , sex , postoperative radiotherapy , and chemotherapy were randomly assigned ( 1:1 ) to receive gefitinib 250 mg per day or placebo for 2 years . Study end points were OS , disease-free survival ( DFS ) , and toxicity . RESULTS As a result of early closure , 503 of 1,242 planned patients were randomly assigned ( 251 to gefitinib and 252 to placebo ) . Baseline factors were balanced between the arms . With a median of 4.7 years of follow-up ( range , 0.1 to 6.3 years ) , there was no difference in OS ( hazard ratio [ HR ] , 1.24 ; 95 % CI , 0.94 to 1.64 ; P = .14 ) or DFS ( HR , 1.22 ; 95 % CI , 0.93 to 1.61 ; P = .15 ) between the arms . Exploratory analyses demonstrated no DFS ( HR , 1.28 ; 95 % CI , 0.92 to 1.76 ; P = .14 ) or OS benefit ( HR , 1.24 ; 95 % CI , 0.90 to 1.71 ; P = .18 ) from gefitinib for 344 patients with epidermal growth factor receptor ( EGFR ) wild-type tumors . Similarly , there was no DFS ( HR , 1.84 ; 95 % CI , 0.44 to 7.73 ; P = .395 ) or OS benefit ( HR , 3.16 ; 95 % CI , 0.61 to 16.45 ; P = .15 ) from gefitinib for the 15 patients with EGFR mutation-positive tumors . Adverse events were those expected with an EGFR inhibitor . Serious adverse events occurred in ≤ 5 % of patients , except infection , fatigue , and pain . One patient in each arm had fatal pneumonitis . CONCLUSION Although the trial closed prematurely and definitive statements regarding the efficacy of adjuvant gefitinib can not be made , these results indicate that it is unlikely to be of benefit .

Gefitinib

placebo

gefitinib

gefitinib 250 mg per day or placebo

gefitinib

placebo

gefitinib

gefitinib

overall survival ( OS ) .

OS

disease-free survival ( DFS )

toxicity

OS

DFS

DFS

OS benefit

DFS

OS

Adverse events

Serious adverse events

503 of 1,242

344 patients


Aftermath of a clinical trial : evaluating the sustainability of a medical device intervention in Ghana . A randomized controlled trial recently demonstrated that continuous positive airway pressure ( CPAP ) effectively decreases respiratory rate in children presenting to Ghanaian district hospitals with respiratory distress . A follow-up study 16 months later evaluated the extent to which the skills and equipment necessary for CPAP use have been maintained . Seven of eight CPAP machines were functional , but five of eight oxygen concentrators and three of four electric generators were non-functional . Nurses trained by US study personnel ( first-generation ) and nurses trained by Ghanaian nurses after the study ( second-generation ) were evaluated on CPAP knowledge and skills . Twenty-eight nurses participated in the study , 9 first-generation and 19 second-generation . First-generation trainees scored significantly higher than second-generation trainees on both skills and knowledge assessments ( p = 0.003 ) . Appropriate technical support and training must be ensured to address equipment maintenance . Protocolization of the training program , in conjunction with skills and knowledge assessment , may improve acquisition and retention among second- and future-generation trainees .

medical device intervention

continuous positive airway pressure

respiratory rate

skills and knowledge assessments

acquisition and retention

children

respiratory distress

Twenty-eight


Negative emotional experiences during navigation enhance parahippocampal activity during recall of place information . It is known that the parahippocampal cortex is involved in object-place associations in spatial learning , but it remains unknown whether activity within this region is modulated by affective signals during navigation . Here we used fMRI to measure the neural consequences of emotional experiences on place memory during navigation . A day before scanning , participants undertook an active object location memory task within a virtual house in which each room was associated with a different schedule of task-irrelevant emotional events . The events varied in valence ( positive , negative , or neutral ) and in their rate of occurrence ( intermittent vs. constant ) . On a subsequent day , we measured neural activity while participants were shown static images of the previously learned virtual environment , now in the absence of any affective stimuli . Our results showed that parahippocampal activity was significantly enhanced bilaterally when participants viewed images of a room in which they had previously encountered negatively arousing events . We conclude that such automatic enhancement of place representations by aversive emotional events serves as an important adaptive mechanism for avoiding future threats .

fMRI

neural activity

parahippocampal activity

object location memory task


Outcomes and biochemical parameters following cardiac surgery : effects of transfusion of residual blood using centrifugation and multiple-pass hemoconcentration . OBJECTIVES To determine whether or not there was a significant difference between the methods of centrifugation ( CF ) and multiple-pass hemoconcentration ( MPH ) of the residual cardiopulmonary-bypass volume in relation to biochemical measurements and patient outcomes . DESIGN Prospective , randomized , and controlled . SETTING Conducted at a western Canadian tertiary care hospital . PARTICIPANTS Consisted of 61 consecutive male and female patients from ages 40 to 80 who were scheduled for cardiac surgery with cardiopulmonary bypass . INTERVENTIONS Either the centrifugation or multiple-pass hemoconcentration method was used to process the residual blood from the cardiopulmonary bypass circuit . RESULTS The 12-hour postoperative levels of serum hemoglobin were not significantly different in the centrifugation group as compared to the multiple-pass hemoconcentration group . However , the serum levels of total protein and albumin were significantly higher in the multiple-pass hemoconcentration group as compared to the centrifugation group . Additionally , after 12-hours postoperatively , the serum fibrinogen and platelet counts were significantly higher in the multiple-pass hemoconcentration group as compared to those of the centrifugation group . The allogeneic product transfusion index and the chest-tube blood drainage indices were lower in the multiple-pass hemoconcentration group as compared to the centrifugation group . CONCLUSION Although the CF method provided a product in a shorter turnaround time , with consistent clearance of heparin , the MPH method trended towards enhanced biochemical and clinical patient outcomes over the 12-hour postoperative period .

cardiac surgery :

transfusion of residual blood

cardiac surgery

cardiopulmonary bypass .

centrifugation

multiple-pass hemoconcentration

multiple-pass hemoconcentration

centrifugation

multiple-pass hemoconcentration

centrifugation

multiple-pass hemoconcentration

centrifugation

CF method

MPH method

serum fibrinogen

platelet counts

allogeneic product transfusion index

chest-tube blood drainage indices

cardiac surgery

male

female

ages 40 to 80


A comparison of Villalta-Prandoni scale and venous clinical severity score in the assessment of post thrombotic syndrome . BACKGROUND Post-thrombotic syndrome ( PTS ) is the most important late complication of acute deep venous thrombosis ( DVT ) , with as many as two-thirds of patients developing symptoms of pain , edema , hyperpigmentation , or ulceration . Although several instruments are available for evaluation of the severity of PTS , including the Villalta-Prandoni scale ( VPS ) and Venous Clinical Severity Score ( VCSS ) , no studies have yet compared the 2 instruments . The purpose of this study is to compare the 2 instruments as part of a larger randomized controlled study that assessed the impact of graduated compressive stockings in the prevention of PTS . METHODS Sixty-nine consecutive patients with acute DVT documented by duplex ultrasonography were randomized to treatment with 30-40 mm Hg graduated compressive stockings ( GCS ) or no stockings . Patients were followed clinically at months 1 , 3 , 6 , 12 , 18 , and 24 after the diagnosis of DVT . PTS as defined by the VPS and VCSS were assessed at these follow-up visits . Based upon the VPS , PTS was scored as absent ( score < 3 or 3 without objective criteria ) , mild to moderate ( score ≥3 with 1 objective criteria ) , or severe ( score ≥4 ) . For the VCSS , PTS was considered to be absent ( score ≤3 ) , mild to moderate ( score 4-7 ) , or severe ( score ≥8 ) . The 2 instruments were compared for mild to moderate and severe disease using the Pearson chi-squared test and gamma statistic . RESULTS Good correlation was detected in the ability of VPS and VCSS instruments to detect mild to moderate disease ( gamma statistic = 0.71-0.98 ; P < 0.05 ) . For severe disease , a statistically significant correlation was not found in the ability of the 2 instruments to detect disease ( gamma statistic = 0.5-0.98 ; P > 0.05 ) , especially at 12 and 24 months . CONCLUSION Both VPS and the VCSS scoring systems are important tools in the identification and follow-up of PTS . There exists agreement between the 2 instruments for detecting mild to moderate disease . For severe disease however , VCSS may possibly be a more sensitive instrument .

Villalta-Prandoni scale

venous clinical severity score

Villalta-Prandoni scale ( VPS )

Venous Clinical Severity Score ( VCSS )

graduated compressive stockings

no stockings

post thrombotic syndrome

pain

edema

hyperpigmentation

ulceration

Villalta-Prandoni scale ( VPS )

Venous Clinical Severity Score ( VCSS )


Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder : a pilot trial . OBJECTIVES A large percentage of children with autism spectrum disorders ( ASD ) have bedtime and sleep disturbances . However , the treatment of these disturbances has been understudied . The purpose of our study was to develop a manualized behavioral parent training ( BPT ) program for parents of young children with ASD and sleep disturbances and to test the feasibility , fidelity , and initial efficacy of the treatment in a small randomized controlled trial ( RCT ) . PARTICIPANTS AND METHODS Parents of a sample of 40 young children diagnosed with ASD with an average age of 3.5years were enrolled in our study . Participants were randomized to either the BPT program group or a comparison group who were given nonsleep-related parent education . Each participant was individually administered a 5-session program delivered over the 8-week study . Outcome measures of feasibility , fidelity , and efficacy were collected at weeks 4 and 8 after the baseline time point . Children 's sleep was assessed by parent report and objectively by actigraphy . RESULTS Of the 20 participants in each group , data were available for 15 participants randomized to BPT and 18 participants randomized to the comparison condition . Results supported the feasibility of the manualized parent training program and the comparison program . Treatment fidelity was high for both groups . The BPT program group significantly improved more than the comparison group based on the primary sleep outcome of parent report . There were no objective changes in sleep detected by actigraphy . CONCLUSIONS Our study is one of few RCTs of a BPT program to specifically target sleep disturbances in a well-characterized sample of young children with ASD and to demonstrate the feasibility of the approach . Initial efficacy favored the BPT program over the comparison group and suggested that this manualized parent training approach is worthy of further examination of the efficacy within a larger RCT .

Behavioral parent training

manualized behavioral parent training

BPT program

nonsleep-related parent education

sleep disturbances

bedtime

sleep disturbances .

sleep disturbances

sleep

feasibility

fidelity

primary sleep outcome

changes in sleep

sleep disturbances

feasibility

Initial efficacy

young children

autism spectrum disorder

spectrum disorders ( ASD )

ASD

ASD


Incremental cost-effectiveness of pharmacotherapy and two brief cognitive-behavioral therapies compared with usual care for panic disorder and noncardiac chest pain . The aim of this study was to assess the incremental cost-effectiveness ratios ( ICERs ) of two brief cognitive-behavioral therapy ( CBT ) -based interventions and a pharmacological treatment , compared with usual care , initiated in the emergency department ( ED ) for individuals with panic disorder ( PD ) with a chief complaint of noncardiac chest pain . A total of 69 patients were followed up to 6 months . The primary outcome variables were direct and indirect costs of treatment and PD severity . Panic management ( PM ) had an ICER of $ 124.05 , per the Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , severity score change ( 95 % confidence interval [ CI ] , $ 54.63- $ 314.57 ) , compared with pharmacotherapy ( paroxetine ) , with an ICER of $ 213.90 ( 95 % CI , $ 133.51- $ 394.94 ) , and brief CBT , with an ICER of $ 309.31 ( 95 % CI , $ 151.27- $ 548.28 ) . The pharmacological and CBT interventions were associated with a greater clinical improvement compared with usual care at posttest . PM presented a superior ICER , suggesting that it may be a promising treatment option to implement in EDs .

pharmacotherapy

cognitive-behavioral therapies

pharmacological treatment

usual care

cost-effectiveness

panic disorder

cost-effectiveness ratios

panic disorder

ICER

ICER

ICER

clinical improvement

ICER

69 patients


A randomized controlled trial to improve colon cancer screening in rural family medicine : an Iowa Research Network ( IRENE ) study . BACKGROUND Many adults have not been screened for colon cancer , a potentially preventable cause of death . METHODS This was a randomized controlled trial conducted between December 2008 and April 2011 to improve CRC screening in 16 rural family physician offices . Subjects due for CRC screening were randomized within each practice to 1 of 4 groups : ( 1 ) usual care ; ( 2 ) physician chart reminder ; ( 3 ) physician chart reminder , mailed education , CRC reminder magnet , and fecal immunochemical test ( FIT ) ( mailed education/FIT ) ; or ( 4 ) all the preceding plus a structured telephone call to the patient from project staff to provide education , assess interest in screening , explain the screening tests , and address barriers ( mailed education/FIT plus phone call ) . The main outcome was completion of any CRC screening . RESULTS This study enrolled 743 patients . CRC screening was completed by 17.8 % in the usual care group , 20.5 % in the chart reminder group , 56.5 % in the mailed education/FIT group , and 57.2 % in the mailed education/FIT plus phone call group . We found no effect from the chart reminder compared with usual care ( odds ratio [ OR ] , 1.2 ; 95 % confidence interval [ CI ] , 0.7-2.0 ) ; and a beneficial effect from the mailed education/FIT ( OR , 6.0 ; 95 % CI , 3.7-9.6 ) and the mailed education/FIT plus phone call ( OR , 6.2 ; 95 % CI , 3.8-9.9 ) . Both FIT and colonoscopy rates increased significantly in both mailed education groups . CONCLUSION CRC screening rates increased significantly among patients who were overdue for screening after they received mailed educational materials and a FIT . The addition of a phone call did not further increase screening rates .

colon cancer screening

usual care

( 2 ) physician chart reminder

( 3 ) physician chart reminder

mailed education

CRC reminder magnet

completion of any CRC screening .

completed

beneficial effect

FIT and colonoscopy rates increased

CRC screening rates

rural family

CRC screening


Intravesical seeding of upper urinary tract urothelial carcinoma cells during nephroureterectomy : an exploratory analysis from the THPMG trial . OBJECTIVE The Pirarubicin Monotherapy Study Group trial was a randomized Phase II study that evaluated the efficacy of intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma . This study conducted further analysis of the Pirarubicin Monotherapy Study Group cohort , focusing on intravesical seeding of cancer cells . METHODS Using the data from the Pirarubicin Monotherapy Study Group trial , bladder recurrence-free survival rates and factors associated with bladder recurrence in the control group were analyzed . RESULTS Of 36 patients in the control group , 14 with positive urine cytology had more frequent recurrence when compared with the 22 patients with negative cytology ( P = 0.004 ) . Based on the multivariate analysis in the control group , voided urine cytology was an independent predictive factor of bladder recurrence ( hazard ratio , 5.54 ; 95 % confidence interval 1.12-27.5 ; P = 0.036 ) . Of 72 patients in the Pirarubicin Monotherapy Study Group trial , 31 had positive urine cytology . Among the 31 patients , 17 patients who received pirarubicin instillation had fewer recurrences when compared with 14 patients who received control treatment ( P = 0.0001 ) . On multivariate analysis , pirarubicin instillation was an independent predictor of better recurrence-free survival rates in the patients with positive urine cytology ( hazard ratio , 0.02 ; 95 % confidence interval , 0.00-0.53 ; P = 0.018 ) . Of 21 patients with bladder recurrence , 17 had recurrent tumor around cystotomy or in the bladder neck compromised by the urethral catheter , supporting the notion that tumor cells seeded in the injured urothelium . CONCLUSIONS Intravesical instillation of pirarubicin immediately after nephroureterectomy significantly reduced the bladder recurrence rate in patients with positive voided urine cytology . The results suggest that intravesical seeding of upper urinary tract urothelial carcinoma occurs during nephroureterectomy .

nephroureterectomy

pirarubicin

intravesical seeding of cancer cells

control

pirarubicin instillation

nephroureterectomy

bladder recurrence-free survival rates

positive urine cytology

recurrence

urine cytology .

recurrences

recurrence-free survival rates

bladder recurrence rate

nephroureterectomy


Network coordination following discharge from psychiatric inpatient treatment : a study protocol . BACKGROUND Inadequate discharge planning following inpatient stays is a major issue in the provision of a high standard of care for patients who receive psychiatric treatment . Studies have shown that half of patients who had no pre-discharge contact with outpatient services do not keep their first outpatient appointment . Additionally , discharged patients who are not well linked to their outpatient care networks are at twice the risk of re-hospitalization . The aim of this study is to investigate if the Post-Discharge Network Coordination Program at ipw has a demonstrably significant impact on the frequency and duration of patient re-hospitalization . Subjects are randomly assigned to either the treatment group or to the control group . The treatment group participates in the Post-Discharge Network Coordination Program . The control group receives treatment as usual with no additional social support . Further outcome variables include : social support , change in psychiatric symptoms , quality of life , and independence in daily functioning . METHODS/DESIGN The study is conducted as a randomized controlled trial . Subjects are randomly assigned to either the control group or to the treatment group . Computer generated block randomization is used to assure both groups have the same number of subjects . Stratified block randomization is used for the psychiatric diagnosis of ICD-10 , F1 . Approximately 160 patients are recruited in two care units at Psychiatrie-Zentrum Hard Embrach and two care units at Klinik Schlosstal Winterthur . DISCUSSION The proposed post-discharge network coordination program intervenes during the critical post-discharge period . It focuses primarily on promoting the integration of the patients into their social networks , and additionally to coordinating outpatient care and addressing concerns of daily life . TRIAL REGISTRATION ISRCTN ISRCTN58280620 .

psychiatric inpatient treatment

psychiatric treatment

treatment as usual

control

treatment

Computer generated block randomization

high standard of care

social support

change in psychiatric symptoms

quality of life

independence in daily functioning

coordinating outpatient care

addressing concerns of daily life

psychiatric inpatient treatment :


Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial . BACKGROUND Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease ( COPD ) to improve exercise capacity , symptoms and quality of life , however only a minority of individuals with COPD are able to participate . Travel and transport are frequently cited as barriers to uptake of centre-based programs . Other models of pulmonary rehabilitation , including home-based programs , have been proposed in order to improve access to this important treatment . Previous studies of home-based pulmonary rehabilitation in COPD have demonstrated improvement in exercise capacity and quality of life , but not all elements of the program were conducted in the home environment . It is uncertain whether a pulmonary rehabilitation program delivered in its entirety at home is cost effective and equally capable of producing benefits in exercise capacity , symptoms and quality of life as a hospital-based program . The aim of this study is to compare the costs and benefits of home-based and hospital-based pulmonary rehabilitation for people with COPD . METHODS/DESIGN This randomised , controlled , equivalence trial conducted at two centres will recruit 166 individuals with spirometrically confirmed COPD . Participants will be randomly allocated to hospital-based or home-based pulmonary rehabilitation . Hospital programs will follow the traditional outpatient model consisting of twice weekly supervised exercise training and education for eight weeks . Home-based programs will involve one home visit followed by seven weekly telephone calls , using a motivational interviewing approach to enhance exercise participation and facilitate self management . The primary outcome is change in 6-minute walk distance immediately following intervention . Measurements of exercise capacity , physical activity , symptoms and quality of life will be taken at baseline , immediately following the intervention and at 12 months , by a blinded assessor . Completion rates will be compared between programs . Direct healthcare costs and indirect ( patient-related ) costs will be measured to compare the cost-effectiveness of each program . DISCUSSION This trial will identify whether home-based pulmonary rehabilitation can deliver equivalent benefits to centre-based pulmonary rehabilitation in a cost effective manner . The results of this study will contribute new knowledge regarding alternative models of pulmonary rehabilitation and will inform pulmonary rehabilitation guidelines for COPD .

home-based pulmonary rehabilitation

Pulmonary rehabilitation

pulmonary rehabilitation

home-based pulmonary rehabilitation

pulmonary rehabilitation program

hospital-based program .

home-based

hospital-based pulmonary rehabilitation

Home-based programs

self management

home-based pulmonary rehabilitation

cost effective

change in 6-minute walk distance

Completion rates

chronic obstructive pulmonary disease

chronic obstructive pulmonary disease

COPD

COPD

COPD


Why does lag affect the durability of memory-based automaticity : loss of memory strength or interference ? In Rickard , Lau , and Pashler 's ( 2008 ) investigation of the lag effect on memory-based automaticity , response times were faster and proportion of trials retrieved was higher at the end of practice for short lag items than for long lag items . However , during testing after a delay , response times were slower and proportion of trials retrieved was lower for short lag items than for long lag items . The current study investigated the extent to which the lag effect on the durability of memory-based automaticity is due to interference or to the loss of memory strength with time . Participants repeatedly practiced alphabet subtraction items in short lag and long lag conditions . After practice , half of the participants were immediately tested and the other half were tested after a 7-day delay . Results indicate that the lag effect on the durability of memory-based automaticity is primarily due to interference . We discuss potential modification of current memory-based processing theories to account for these effects .

lag

trials

practice

testing after a delay

immediately tested

tested after a 7-day delay .

durability of memory-based automaticity

memory-based automaticity

response times

durability of memory-based automaticity

durability of memory-based automaticity

memory-based automaticity :

Participants


A randomized , double-blind comparison of atomoxetine and placebo on response inhibition and interference control in children and adolescents with autism spectrum disorder and comorbid attention-deficit/hyperactivity disorder symptoms .

atomoxetine

placebo

children

adolescents


Novel population pharmacokinetic method compared to the standard noncompartmental approach to assess bioequivalence of iron gluconate formulations . PURPOSE Iron-containing products are atypical in terms of their pharmacokinetic properties because iron is only removed by plasma sampling and is non-linear . This study aims to present a novel way of assessing the relative bioavailability of two sodium ferric gluconate complex ( SFGC ) formulations and compare this approach to a standard previously published noncompartmental approach . METHODS Data were from open-label , randomized , single-dose studies ( Study 1 was parallel whereas Study 2 was crossover ) . Subjects with low but normal iron levels were infused IV SFGC in sucrose by GeneraMedix Inc. and/or Ferrlecit ® Injection ( Watson Laboratories Inc. ) . In Study 1 ( n=240 ) , 125 mg was infused over 10 minutes . In Study 2 ( n=29 ) , 62.5 mg was infused over 30 minutes . Samples were assayed for total iron ( TI ) and transferrin-bound iron ( TBI ) over 36 hours ( Study 1 ) or 72 hours ( Study 2 ) post-dose . Studies 1 and 2 used standard noncompartmental analysis . Study 2 also used population PK ( PPK ) analyses with ADAPT 5® . The final model predicted SFGC area-under-the-curve ( AUCpred ) and maximal concentration ( Cmaxpred ) . Analyses of variance was conducted on ln-transformed PK parameters . Ratios of means and 90 % confidence intervals ( CIs ) were estimated . Bioequivalence was demonstrated if values were within 80-125 % . RESULTS For Study 1 , ratios and 90 % CIs for TI baseline-corrected Cmax and AUC0-36 were 100.4 ( 96.5 - 104.5 ) and 99.7 ( 94.2 - 105.5 ) . For TBI , results for TI baseline-corrected Cmax and AUC0-36 were 86.8 ( 82.7 - 91.1 ) and 92.4 ( 85.6 - 99.7 ) . For Study 2 , a multi-compartmental model simultaneously described the PK of TI , TBI and SFGC . Ratios and 90 % CIs for SFGC Cmaxpred and AUCpred were 89.9 ( 85.9 - 94.0 ) and 89.7 ( 85.7 - 93.9 ) , while ratios and 90 % CI obtained from the noncompartmental analysis of Study 2 did not meet BE criteria because of low power . CONCLUSIONS Both the standard and PPK modeling approach suggested bioequivalence between the iron products . However , with the PPK method , less subjects were required to meet study objectives compared to the standard noncompartmental approach which required considerably more subjects ( 29 vs 240 ) .

IV SFGC in sucrose


The effect of person-centred dementia care to prevent agitation and other neuropsychiatric symptoms and enhance quality of life in nursing home patients : a 10-month randomized controlled trial . AIMS We examined whether Dementia Care Mapping ( DCM ) or the VIPS practice model ( VPM ) is more effective than education of the nursing home staff about dementia ( control group ) in reducing agitation and other neuropsychiatric symptoms as well as in enhancing the quality of life among nursing home patients . METHODS A 10-month three-armed cluster-randomized controlled trial compared DCM and VPM with control . Of 624 nursing home patients with dementia , 446 completed follow-up assessments . The primary outcome was the change on the Brief Agitation Rating Scale ( BARS ) . Secondary outcomes were changes on the 10-item version of the Neuropsychiatric Inventory Questionnaire ( NPI-Q ) , the Cornell Scale for Depression in Dementia ( CSDD ) and the Quality of Life in Late-Stage Dementia ( QUALID ) scale . RESULTS Changes in the BARS score did not differ significantly between the DCM and the control group or between the VPM and the control group after 10 months . Positive differences were found for changes in the secondary outcomes : the NPI-Q sum score as well as the subscales NPI-Q agitation and NPI-Q psychosis were in favour of both interventions versus control , the QUALID score was in favour of DCM versus control and the CSDD score was in favour of VPM versus control . CONCLUSIONS This study failed to find a significant effect of both interventions on the primary outcome . Positive effects on the secondary outcomes indicate that the methods merit further investigation .

person-centred dementia care

Dementia Care Mapping ( DCM )

VIPS practice model ( VPM )

dementia

DCM

VPM

Brief Agitation Rating Scale ( BARS ) .

BARS score

NPI-Q sum score

NPI-Q agitation and NPI-Q psychosis

QUALID score

CSDD score

nursing home patients

dementia