These results provide clues regarding where to target PN interventions and the importance of recognizing predictors of TTR according to clinic type .


To compare the application of Coopdech bronchial blocker and double lumen bronchial tube during one lung ventilation in children .


Forty children undergoing one lung ventilation for thoracic surgery at Shantou Central Hospital from January 2012 to June 2013 , approved by hospital ethics committee , were randomized into Coopdech bronchial blocker group ( group A ) and double-lumen tube group ( group B ) .


Anesthetic management and lung isolation were performed according to a standardized protocol .


Two groups of children with the intubation time , intubation success rate , collapse score , the frequency of postoperative hoarseness were recorded .


Before and after one lung ventilation in patients of the two groups of PaCO , PaO and airway pressure ( PAW ) changes were recorded .


The intubation time in A was longer than those of group B ( ( 224 72 ) vs ( 165 46 ) s , P < 0.05 ) , the success rate of intubation ( 100 % vs 85 % , P < 0.05 ) , collapse score in A group was higher than in group B ( 95 % vs 75 % , P < 0.05 ) , Sore throat hoarseness occurred after operation in A group was lower than in B group ( 10 % vs 35 % , P < 0.05 ) , PaO was higher in group A after one lung ventilation for 30 min ( ( 206 58 ) vs ( 148 63 ) mmHg , P < 0.05 ) , PaCO and PAW were lower than group B ( ( 36 4 ) vs ( 45 7 ) mmHg ; ( 21.6 3.2 ) vs ( 29.3 5.5 ) cm HO , P < 0.05 ) .


The Coodech bronchial blocker provided effective surgical exposure with less throat injuries , higher intubation success rate , lower airway pressure in children during video-assisted thoracoscopic surgery .


To test the hypothesis that adding obesity gene feedback ( FTO ) to simple weight control advice at a life stage with raised risk of weight gain ( university ) increases readiness to control weight .


Individually randomized controlled trial comparing the effect of : ( i ) simple weight control advice plus FTO feedback ( FA ) and ( ii ) simple weight control advice only ( AO ) on readiness to engage with weight control .


Differences in stage of change by genotype and differential weight control behaviors were secondary outcomes .


Of 1,016 participants randomized , only 279 completed follow-up , yielding 90 % power to detect a small effect for readiness to control weight .


As predicted , FA participants were more likely to be in the contemplation stage than AO participants ( P = 0.023 ) .


Participants receiving higher-risk genetic results were at a higher stage of change than controls ( P = 0.003 ) , with a trend toward a higher stage of change than those getting lower-risk results ( P = 0.051 ) .


Lower-risk results did not decrease weight control intentions compared with controls ( P = 0.55 ) .


There were no group differences in adherence to recommended weight control behaviors ( P = 0.87 ) .


Adding FTO feedback to weight control advice enhanced readiness to control weight , without evidence for genetic determinism , but had no more effect on behavior than weight control advice alone .


The NOURISHED study : Nice OUtcomes for Referrals with Impulsivity , Self Harm and Eating Disorders.Eating Disorders ( ED ) and Borderline Personality Disorder ( BPD ) are both difficult to treat and the combination presents particular challenges .


Both are associated with vulnerability to loss of mentalization ( awareness of one 's own and others ' emotional state ) .


In BPD , Mentalization Based therapy ( MBT ) has been found effective in reducing symptoms .


In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders ( Mentalization Based Therapy for Eating Disorders ( MBT-ED ) ) compared to a standard comparison treatment , Specialist Supportive Clinical Management ( SSCM-ED ) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months .


We will complete a multi-site single-blind randomized controlled trial ( RCT ) of MBT-ED vs SSCM-ED .


Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London .


Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year .


In addition , participants in both groups will have access to up to 5 hours of dietetic advice .


The primary outcome measure is the global score on the Eating Disorders Examination .


Secondary outcome measures include total score on the Zanarini BPD scale , the Object Relations Inventory , the Depression Anxiety Stress Scales , quality of life and cost-effectiveness .


Measures are taken at recruitment and at 6 month intervals up to 18 months .


This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients .


During MBT-ED mentalization is encouraged , while in SSCM-ED it is not overtly addressed .


This study will help elucidate mechanisms of change in the two therapies and analysis of therapy and interview transcripts will provide qualitative information about the conduct of therapy and changes in mentalization and object relations .


ISRCTN51304415 .


Current guidelines recommend coronary artery bypass graft surgery ( CABG ) when treating significant de novo left main coronary artery ( LM ) stenosis ; however , percutaneous coronary intervention ( PCI ) has a class IIa indication for unprotected LM disease in selected patients .


This analysis compares 5-year clinical outcomes in PCI - and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery ( SYNTAX ) trial , the largest trial in this group to date .


The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI ( with TAXUS Express paclitaxel-eluting stents ) or CABG .


The unprotected LM cohort ( N = 705 ) was predefined and powered .


Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9 % in PCI patients and 31.0 % in CABG patients ( hazard ratio , 1.23 [ 95 % confidence interval , 0.95-1 .59 ] ; P = 0.12 ) .


Mortality rate was 12.8 % and 14.6 % in PCI and CABG patients , respectively ( hazard ratio , 0.88 [ 95 % confidence interval , 0.58-1 .32 ] ; P = 0.53 ) .


Stroke was significantly increased in the CABG group ( PCI 1.5 % versus CABG 4.3 % ; hazard ratio , 0.33 [ 95 % confidence interval , 0.12-0 .92 ] ; P = 0.03 ) and repeat revascularization in the PCI arm ( 26.7 % versus 15.5 % ; hazard ratio , 1.82 [ 95 % confidence interval , 1.28-2 .57 ] ; P < 0.01 ) .


Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores ( 33 ) .


At 5 years , no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups .


PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG .


These results suggest that both treatments are valid options for LM patients .


The extent of disease should accounted for when choosing between surgery and PCI , because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles .


http://www.clinicaltrials.gov .


Unique identifier : NCT00114972 .


To analyze the efficacy of intrarectal ice application as an anesthetic method prior to transrectal ultrasound ( TRUS ) guided prostate biopsy .


A total of 120 consecutive men were included into the study prospectively .


Patients were equally randomized as group 1 and 2 with 60 patients each .


Ice was applied as an anesthetic method 5 minutes before procedure to the patients in group 1 .


Patients in group 2 were applied 10 mL of 2 % lidocaine gel 10 minutes before procedure .


Twelve core biopsy procedure was performed for all patients .


The pain level was evaluated using a visual analogue scale ( VAS ) .


Median pain score was 3.5 ( 1-8 ) in group 1 and 5 ( 1-8 ) in group 2 .


There is significantly difference between groups regarding the mean sense of pain level during the procedure .


( p = 0.007 ) There was also no difference in complications between two groups about presence and duration of macroscopic hematuria and rectal bleeding .


Intrarectal ice application prior to TRUS prostate biopsy has an effect on reducing pain .


Development of new techniques about cold effect or ice can make this method more useful and decrease complication rates .


About six percent of pregnant women suffer from severe fear of childbirth .


These women are at increased risk of obstetric labour and delivery interventions and pre - and postpartum complications , e.g. , preterm delivery , emergency caesarean section , caesarean section at maternal request , severe postpartum fear of childbirth and trauma anxiety .


During the last decade , there is increasing clinical evidence suggesting that haptotherapy might be an effective intervention to reduce fear of childbirth in pregnant women .


The present study has been designed to evaluate the effects of such intervention .


Included are singleton pregnant women with severe fear of childbirth , age 18 year , randomised into three arms : ( 1 ) treatment with haptotherapy , ( 2 ) internet psycho-education or ( 3 ) care as usual .


The main study outcome is fear of childbirth .


Measurements are taken at baseline in gestation week 20-24 , directly after the intervention is completed in gestation week 36 , six weeks postpartum and six months postpartum .


Secondary study outcomes are distress , general anxiety , depression , somatization , social support , mother-child bonding , pregnancy and delivery complications , traumatic anxiety symptoms , duration of delivery , birth weight , and care satisfaction .


The treatment , a standard haptotherapeutical treatment for pregnant women with severe fear of childbirth , implies teaching a combination of skills in eight one hour sessions .


The internet group follows an eight-week internet course containing information about pregnancy and childbirth comparable to childbirth classes .


The control group has care as usual according to the standards of the Royal Dutch Organisation of Midwives and the Dutch Organization of Obstetrics and Gynaecology .


This trial was entered in the Dutch Trial Register and registered under number NTR3339 on March 4th , 2012 .


Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis ( BV ) .


The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence .


This randomized , placebo-controlled , double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic ( clinicaltrials.gov registration NCT01450462 ) .


All participants received 500 mg of oral metronidazole twice daily for 7 days .


Intervention participants ( n = 59 ) also received 9 doses of 50,000 IU of cholecalciferol ( vitamin D3 ) over 24 weeks ; control women ( n = 59 ) received matching placebo .


Recurrent BV was assessed via Nugent scoring after 4 , 12 , and 24 weeks .


We assessed the effect of the intervention using an intention-to-treat approach , fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period .


Most participants ( 74 % ) were black , with a median age of 26 years .


Median presupplementation serum 25-hydroxyvitamin D [ 25 ( OH ) D ] was similar across randomization arms : 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm .


At trial completion , median 25 ( OH ) D among women receiving vitamin D was 30.5 ng/mL , vs 17.8 ng/mL in control women ; 16 % of women receiving vitamin D and 57 % receiving placebo remained vitamin D deficient ( < 20 ng/mL ) .


BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4 - and 12-week visits , but by the 24-week visit , BV prevalence was 65 % among women in the vitamin D arm and 48 % among control women .


BV recurrence was not reduced by vitamin D supplementation ( intention-to-treat hazard ratio , 1.11 ; 95 % confidence interval , 0.68-1 .81 ) .


Among women experiencing recurrent BV , median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm .


Women receiving vitamin D experienced significant increases in serum 25 ( OH ) D , but this increase was not associated with decreased BV recurrence in this high-risk sexually transmitted disease clinic population .


To compare the treatment outcomes of women with high-grade squamous intraepithelial lesions ( HSIL ) who underwent immediate loop electrosurgical excision procedure ( LEEP ) and those who had directed biopsies prior to subsequent LEEP .


Women who were referred for HSIL to 2 centers in southeast Nigeria were examined via colposcopy .


Those with positive colposcopic findings were randomized to receive either immediate LEEP ( see-and-treat group ) or directed biopsies ( 3-step group ) .


Women with directed biopsy-confirmed results underwent follow-up LEEP .


Overtreatment rate , cost , default rate , and cytology-treatment interval were compared between the 2 groups .


In total , 314 women were included in the study .


The overtreatment rate was similar between the groups .


Treatment cost and cytology-treatment interval were significantly higher in the 3-step group ( P = 0.0001 ) .


The default rate was significantly lower in the see-and-treat group ( P = 0.0001 ) .


Most ( 219 [ 69.7 % ] ) participants preferred the see-and-treat approach .


Immediate see-and-treat LEEP for women with HSIL in southeast Nigeria is cheaper , less time-consuming , and associated with better patient compliance than the 3-step management procedure .


Furthermore , it does not lead to significantly higher overtreatment .


The immediate see-and-treat approach may be ideal for the management of women with HSIL in low-resource countries .


To investigate the cost effectiveness of ticagrelor versus clopidogrel in patients with acute coronary syndromes ( ACS ) in the Platelet Inhibition and Patient Outcomes ( PLATO ) study who were scheduled for non-invasive management .


A previously developed cost effectiveness model was used to estimate long-term costs and outcomes for patients scheduled for non-invasive management .


Healthcare costs , event rates and health-related quality of life under treatment with either ticagrelor or clopidogrel over 12months were estimated from the PLATO study .


Long-term costs and health outcomes were estimated based on data from PLATO and published literature sources .


To investigate the importance of different healthcare cost structures and life expectancy for the results , the analysis was carried out from the perspectives of the Swedish , UK , German and Brazilian public healthcare systems .


Ticagrelor was associated with lifetime quality-adjusted life-year ( QALY ) gains of 0.17 in Sweden , 0.16 in the UK , 0.17 in Germany and 0.13 in Brazil compared with generic clopidogrel , with increased healthcare costs of 467 , 551 , 739 and 574 , respectively .


The cost per QALY gained with ticagrelor was 2747 , 3395 , 4419 and 4471 from a Swedish , UK , German and Brazilian public healthcare system perspective , respectively .


Probabilistic sensitivity analyses indicated that the cost per QALY gained with ticagrelor was below conventional threshold values of cost effectiveness with a high probability .


Treatment of patients with ACS scheduled for 12months ' non-invasive management with ticagrelor is associated with a cost per QALY gained below conventional threshold values of cost effectiveness compared with generic clopidogrel .


NCT000391872 .


Ceftriaxone is the foundation of currently recommended gonorrhea treatment .


There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin-resistant Neisseria gonorrhoeae .


We evaluated the efficacy and tolerability of 2 combinations of existing noncephalosporin antimicrobials for treatment of patients with urogenital gonorrhea .


We conducted a randomized , multisite , open-label , noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama , California , Maryland , and Pennsylvania .


Patients aged 15-60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally , or gemifloxacin 320 mg orally plus azithromycin 2 g orally .


The primary outcome was microbiological cure of urogenital infections ( negative follow-up culture ) at 10-17 days after treatment among 401 participants in the per protocol population .


Microbiological cure was achieved by 100 % ( lower 1-sided exact 95 % confidence interval [ CI ] bound , 98.5 % ) of 202 evaluable participants receiving gentamicin/azithromycin , and 99.5 % ( lower 1-sided exact 95 % CI bound , 97.6 % ) of 199 evaluable participants receiving gemifloxacin/azithromycin .


Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection ; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections .


Gastrointestinal adverse events were common in both arms .


Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea .


Gastrointestinal adverse events may limit routine use .


These non-cephalosporin-based regimens may be useful alternative options for patients who can not be treated with cephalosporin antimicrobials .


Additional treatment options for gonorrhea are needed .


Clinical Trials Registration .


NCT00926796 .


Targeted temperature management is recommended after out-of-hospital cardiac arrest .


Whether advanced internal cooling is superior to basic external cooling remains unknown .


The aim of this multicenter , controlled trial was to evaluate the benefit of endovascular versus basic surface cooling .


Inclusion criteria were the following : age of 18 to 79 years , out-of-hospital cardiac arrest related to a presumed cardiac cause , time to return of spontaneous circulation < 60 minutes , delay between return of spontaneous circulation and inclusion < 240 minutes , and unconscious patient after return of spontaneous circulation and before the start of cooling .


Exclusion criteria were terminal disease , pregnancy , known coagulopathy , uncontrolled bleeding , temperature on admission < 30C , in-hospital cardiac arrest , immediate need for extracorporeal life support or hemodialysis .


Patients were randomized between 2 cooling strategies : endovascular femoral devices ( Icy catheter , Coolgard , Zoll , formerly Alsius ; n = 203 ) or basic external cooling using fans , a homemade tent , and ice packs ( n = 197 ) .


The primary end point , that is , favorable outcome evaluated by survival without major neurological damage ( Cerebral Performance Categories 1-2 ) at day 28 , was not significantly different between groups ( odds ratio , 1.41 ; 95 % confidence interval , 0.93-2 .16 ; P = 0.107 ) .


Improvement in favorable outcome at day 90 in favor of the endovascular group did not reach significance ( odds ratio , 1.51 ; 95 % confidence interval , 0.96-2 .35 ; P = 0.07 ) .


Time to target temperature ( 33C ) was significantly shorter and target hypothermia was more strictly maintained in the endovascular than in the surface group ( P < 0.001 ) .


Minor side effects directly related to the cooling method were observed more frequently in the endovascular group ( P = 0.009 ) .


Despite better hypothermia induction and maintenance , endovascular cooling was not significantly superior to basic external cooling in terms of favorable outcome .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00392639 .


Cognitive comorbidity at epilepsy onset reflects disease severity and provides a baseline estimate of reserve capacities with regard to the effects of epilepsy and its treatment .


Given the high incidence of epilepsy at an older age , this study analyzed objective and subjective cognition as well as quality of life in elderly patients with new-onset focal epilepsy before initiation of anti-epileptic treatment .


A total of 257 untreated patients ( 60-95 years of age ) with new-onset epilepsy underwent objective assessment of executive function ( EpiTrack ) and performed subjective ratings of cognition ( Portland Neurotoxicity Scale ) and quality of life ( QoL ; QOLIE-31 ) .


According to age-corrected norms , 58 % of patients ( N = 257 ) demonstrated deficits in executive function ; major determinants were cerebrovascular etiology , neurological comorbidity , and higher body mass index .


Subjective ratings indicated deficits in up to 27 % of patients .


Self-perceived deficits were associated with neurological , cardiovascular , and/or psychiatric comorbidity , whereas poorer QoL was related to neurological comorbidity and female gender .


Objectively assessed executive functions correlated with subjective social functioning , energy , motor function , and vigilance .


We found a relatively high QoL , a low rate of subjective impairment , but a high incidence of objective executive deficits in untreated elderly patients with new-onset epilepsy .


Neurological status and body mass index , rather than seizure frequency or severity , were risk factors for cognitive impairment .


Given the relevance of cognition in the course of epilepsy and its treatment , routine screening before treatment initiation is highly recommended .


The potential interest of antifungal treatment of non-immunocompromized patients with sepsis , extra-digestive Candida colonization and multiple organ failure is unknown .


It represents three-quarters of antifungals prescribed in Intensive Care Units .


It may allow early treatment of invasive fungal infection in the incubation phase but expose patients to unnecessary antifungal treatments with subsequent cost and fungal selection pressure .


As early diagnostic tests for invasive candidiasis are still considered to be insufficient , the potential interest in this strategy needs to be demonstrated .


This prospective multicenter , double blind , randomized-controlled trial is conducted in 23 French Intensive Care Units .


All adult patients , mechanically ventilated for more than four days with sepsis of unknown origin and with at least one extradigestive fungal colonization site and multiple organ failure are eligible for randomization .


Patients with proven invasive candidiasis are not included .


After a complete mycological screening , patients are allocated to receive micafungin 100 mg intravenously once a day or placebo for 14 days .


We plan to enroll 260 patients .


The main objective is to demonstrate that micafungin increases survival of patients without invasive candidiasis at day 28 as compared to placebo .


Other outcomes include day 28 and 90 survival and organ failure evolution .


Additionally , pharmacokinetics of micafungin in enrolled patients will be measured and evolution of fungal biomarkers and susceptibility profiles of infecting fungi will also be followed .


This study will help to provide guidelines for treating non-immunocompromized patients with fungal colonization multiple organ failure and sepsis of unknown origin .


Clinicaltrials.gov number NCT01773876 .


We evaluated the efficacy and safety of the aromatase inhibitor exemestane in patients with advanced , persistent or recurrent endometrial carcinoma .


We performed an open-label one-arm , two-stage , phase II study of 25 mg of oral exemestane in 51 patients with advanced ( FIGO stage III-IV ) or relapsed endometrioid endometrial cancer .


Patients were stratified into subsets of estrogen receptor ( ER ) positive and ER negative patients .


Recruitment to the ER negative group was stopped prematurely after 12 patients due to slow accrual .


In the ER positive patients , we observed an overall response rate of 10 % , and a lack of progression after 6 months in 35 % of the patients .


No responses were registered in the ER negative patients , and all had progressive disease within 6 months .


For the total group of patients , the median progression free survival ( PFS ) was 3.1 months ( 95 % CI : 2.0-4 .1 ) .


In the ER positive patients the median PFS was 3.8 months ( 95 % CI : 0.7-6 .9 ) and in the ER negative patients it was 2.6 months ( 95 % CI : 2.1-3-1 ) .


In the ER positive patients the median overall survival ( OS ) time was 13.3 months ( 95 % CI : 7.7-18 .9 ) , in the ER negative patients the corresponding numbers were 6.1 months ( 95 % CI : 4.1-8 .2 ) .


Treatment with exemestane was well tolerated .


Treatment of estrogen positive advanced or recurrent endometrial cancer with exemestane , an aromatase inhibitor , resulted in a response rate of 10 % and lack of progression after 6 months in 35 % of the patients .


Trial identification number ( Clinical Trials.gov ) : NCT01965080.Nordic Society of Gynecological Oncology : NSGO-EC-0302 .


EudraCT number : 2004-001103-35 .


Severe angulation or shortening can be a surgical indication for fifth metacarpal neck fracture .


In a previous meta-analysis , antegrade intramedullary pinning was shown to produce better hand function outcomes than percutaneous transverse pinning or miniplate fixation for treatment of fifth metacarpal neck fractures .


However , the outcomes of retrograde intramedullary pinning , to our knowledge , have not been compared with those of antegrade intramedullary pinning .


We asked whether the clinical and radiographic outcomes of antegrade intramedullary pinning are different from those of percutaneous retrograde intramedullary pinning for treating patients with displaced fifth metacarpal neck fractures .


Forty-six patients with displaced fifth metacarpal neck fractures with an apex dorsal angulation greater than 30 were enrolled in our prospective study .


Subjects were treated randomly by antegrade intramedullary pinning ( antegrade group ) or by percutaneous retrograde intramedullary pinning ( retrograde group ) .


Clinical evaluations , which included active ROM of the fifth metacarpophalangeal joint , VAS for pain , grip strength , and DASH score , were performed at 3 months and 6 months postoperatively .


Radiographic evaluations of apex dorsal angulation and axial shortening were performed preoperatively and 6 months postoperatively .


Patients in the antegrade group achieved better outcomes than patients in the retrograde group for all clinical parameters at 3 months postoperatively ( ROM : antegrade median 80 [ range , 57-90 ] versus retrograde 69 [ range , 45-90 ] , difference of medians 11 , p < 0.001 ; VAS : antegrade median of 2 [ range , 0-5 ] versus retrograde 4 [ range , 0-7 ] , difference of medians 2 , p < 0.001 ; grip strength : antegrade median 81 % [ range , 60 % -100 % ] versus retrograde 71 % [ range , 49 % -98 % ] , differences of medians 10 % , p < 0.001 ; DASH : antegrade median 4.3 [ range , 0-15 .8 ] versus retrograde 10.3 [ range , 0-28 .4 ] , difference of medians 6 , p < 0.001 ) , but these differences , with the numbers available , were not observed at 6 months postoperatively for any clinical parameters ( ROM : antegrade median 88 [ range , 81-90 ] versus retrograde 87 [ range , 80-90 ] , difference of medians 1 , p = 0.35 ; VAS : antegrade median 1 [ range , 0-2 ] versus retrograde 1 [ range , 0-3 ] , difference of medians 0 , p = 0.67 ; grip strength : antegrade median 93 % [ range , 78 % -104 % ] versus retrograde 91 % [ range , 76 % -101 % ] , difference of medians 2 % , p = 0.41 ; DASH : antegrade median 3 [ range , 0-12 .5 ] versus retrograde of 4.3 [ range , 0-15 .8 ] , difference of medians 1.3 , p = 0.48 ) .


At 6 months postoperatively , there also were no differences , with the numbers available , in radiographic parameters between the antegrade and retrograde fixation groups .


Residual angulation was not different ( antegrade median : 7 [ range , 2-11 ] , retrograde : 9 [ range , 3-13 ] , difference of medians 2 , p = 0.56 ) .


Shortening between the two groups also was not different ( antegrade median : 1 mm [ range , 0 mm-2 mm ] , retrograde median : 1 mm [ range , 0 mm-2 mm ] , difference of medians 0 , p = 0.78 ) .


Our study findings suggest antegrade intramedullary pinning has some clinical advantages during the early recovery period over percutaneous retrograde intramedullary pinning for treatment of displaced fifth metacarpal neck fractures , but the advantages are not evident at 6 months postoperatively .


In addition , our study showed no differences in radiographic outcomes between antegrade and retrograde techniques .


For patients who require an early return of hand function , such as athletes , antegrade intramedullary pinning can be recommended .


Otherwise , treatment could be decided according to the surgeon 's preference and patient status , and based on consideration of the need for an accessory procedure for pin removal after antegrade intramedullary pinning .


Level I , therapeutic study .


Bedside sonography has become a popular method of assessment of critically ill patients with shock and dyspnea .


This study evaluated the usefulness of integrated cardiopulmonary sonography for assessment of acute pulmonary edema .


A total of 128 intensive care unit ( ICU ) patients with acute pulmonary edema were randomly divided into 2 groups : a sonography group , which received standard treatment as well as cardiopulmonary sonography , and a control group , which received standard treatment only .


All patients were treated according to the same therapeutic strategies and underwent chest radiography and central venous catheter placement .


Serum myocardial injury marker levels and central venous/arterial blood gas parameters were measured 0 , 24 , and 72 hours after enrollment .


The cumulative fluid infusion volume at 6 , 12 , 24 , and 72 hours , the time to diagnosis of the pulmonary edema etiology by the attending physician , the lengths of ICU and hospital stays , and ICU mortality were recorded .


The sonography group had a shorter time to diagnosis and received a smaller fluid infusion volume than the control group .


There were no significant differences in ICU mortality and lengths of ICU and hospital stays between the sonography and control groups .


In patients with cardiogenic pulmonary edema , the sonography group had a significantly shorter ICU stay and a faster return to normal myocardial injury marker levels and perfusion parameters than the control group ( P < .05 ) .


Integrated cardiopulmonary sonography resulted in faster and better-informed clinical decision making , shortened the time to diagnosis of the pulmonary edema etiology , and decreased fluid use .


However , the impact of this examination on prognoses requires further study .


We propose that integrated cardiopulmonary sonography may be a useful bedside tool for treatment of ICU patients with acute pulmonary edema .


Biotin functions as a cofactor for several carboxylase enzymes with key roles in metabolism .


At present , the dietary requirement for biotin is unknown and intake recommendations are provided as Adequate Intakes ( AIs ) .


The biotin AI for adults and pregnant women is 30 g/d , whereas 35 g/d is recommended for lactating women .


However , pregnant and lactating women may require more biotin to meet the demands of these reproductive states .


The current study sought to quantify the impact of reproductive state on biotin status response to a known dietary intake of biotin .


To achieve this aim , we measured a panel of biotin biomarkers among pregnant ( gestational week 27 at study entry ; n = 26 ) , lactating ( postnatal week 5 at study entry ; n = 28 ) , and control ( n = 21 ) women who participated in a 10 - to 12-wk feeding study providing 57 g of dietary biotin/d as part of a mixed diet .


Over the course of the study , pregnant women excreted 69 % more ( vs. control ; P < 0.001 ) 3-hydroxyisovaleric acid ( 3-HIA ) , a metabolite that accumulates during the catabolism of leucine when the activity of biotin-dependent methylcrotonyl-coenzyme A carboxylase is impaired .


Interestingly , urinary excretion of 3-hydroxyisovaleryl-carnitine ( 3-HIA-carnitine ) , a downstream metabolite of 3-HIA , was 27 % lower ( P = 0.05 ) among pregnant ( vs. control ) women , a finding that may arise from carnitine inadequacy during gestation .


No differences ( P > 0.05 ) were detected in plasma biotin , urinary biotin , or urinary bisnorbiotin between pregnant and control women .


Lactating women excreted 76 % more ( vs. control ; P = 0.001 ) of the biotin catabolite bisnorbiotin , indicating that lactation accelerates biotin turnover and loss .


Notably , with respect to control women , lactating women excreted 23 % less ( P = 0.04 ) urinary 3-HIA and 26 % less ( P = 0.05 ) urinary 3-HIA-carnitine , suggesting that lactation reduces leucine catabolism and that these metabolites may not be useful indicators of biotin status during lactation .


Overall , these data demonstrate significant alterations in markers of biotin metabolism during pregnancy and lactation and suggest that biotin intakes exceeding current recommendations are needed to meet the demands of these reproductive states .


This trial was registered at clinicaltrials.gov as NCT01127022 .


Although platelet-rich plasma ( PRP ) has been used in rotator cuff repair , most authors have been unable to report the advantages of this method in clinical trials .


The use of PRP promotes better functional and structural results in arthroscopic rotator cuff repair .


Randomized controlled trial ; Level of evidence , 1 .


This was a prospective , randomized , double-blind study with 2 groups of 27 patients each ( PRP group and control group ) .


Complete supraspinatus tears with retraction of less than 3 cm were subjected to arthroscopic single-row repair ; at the end of the surgical procedure , liquid PRP prepared by apheresis was given to the patients in the PRP group with autologous thrombin .


The outcomes were assessed by the University of California at Los Angeles ( UCLA ) and Constant scales , visual analog scale ( VAS ) for pain , and magnetic resonance imaging ( MRI ) before and 3 , 6 , 12 , and 24 months after surgery .


The significance level was 5 % .


The 2 groups of patients exhibited significant clinical improvement ( P < .001 ) .


Between the preoperative assessment and 24-month follow-up , the mean UCLA score increased from 13.63 3.639 to 32.70 3.635 and from 13.93 4.649 to 32.44 4.318 in the control and PRP groups , respectively ( P = .916 ) .


The mean Constant score increased from 47.37 11.088 to 85.15 9.879 in the control group and from 46.96 11.937 to 84.78 14.048 in the PRP group ( P = .498 ) .


The mean VAS score varied from 7.00 1.939 and 6.67 1.617 before surgery to 1.15 1.916 and 0.96 2.244 at the 24-month assessment in the control and PRP groups , respectively ( P = .418 ) .


The only difference was in the mean UCLA score at 12 months , with 30.04 4.528 in the control group and 32.30 3.506 in the PRP group ( P = .046 ) .


The control group exhibited 1 case of a complete retear and 4 partial retears , and the PRP group exhibited 2 cases of partial retears ( P = .42 ) .


Platelet-rich plasma prepared by apheresis and applied in the liquid state with thrombin did not promote better clinical results at 24-month follow-up .


Given the numbers available for analysis , the retear rate also did not change .


Effective interventions are needed to reduce neurobehavioral impairments in children due to maternal alcohol use during pregnancy .


Currently , health-counseling interventions have shown inconsistent results to reduce prenatal alcohol use .


Thus , more research using health counseling is needed to gain more knowledge about the effectiveness of this type of intervention on reducing alcohol use during pregnancy .


An alternative and promising strategy is computer tailoring .


However , to date , no study has shown the effectiveness of this intervention mode .


The aim was to test the effectiveness of health counseling and computer tailoring on stopping and reducing maternal alcohol use during pregnancy in a Dutch sample of pregnant women using alcohol .


A total of 60 Dutch midwifery practices , randomly assigned to 1 of 3 conditions , recruited 135 health counseling , 116 computer tailoring , and 142 usual care respondents from February to September 2011 .


Health-counseling respondents received counseling from their midwife according to a health-counseling protocol , which consisted of 7 steps addressed in 3 feedback sessions .


Computer-tailoring respondents received usual care from their midwife and 3 computer-tailored feedback letters via the Internet .


Usual care respondents received routine alcohol care from their midwife .


After 3 and 6 months , we assessed the effect of the interventions on alcohol use .


Multilevel multiple logistic regression analyses showed that computer-tailoring respondents stopped using alcohol more often compared to usual care respondents 6 months after baseline ( 53/68 , 78 % vs 51/93 , 55 % ; P = .04 ) .


Multilevel multiple linear regression analyses showed that computer-tailoring respondents ( mean 0.35 , SD 0.31 units per week ) with average ( P = .007 ) or lower ( P < .001 ) alcohol use before pregnancy or with average ( P = .03 ) or lower ( P = .002 ) social support more strongly reduced their alcohol use 6 months after baseline compared to usual care respondents ( mean 0.48 , SD 0.54 units per week ) .


Six months after baseline , 72 % ( 62/86 ) of the health-counseling respondents had stopped using alcohol .


This 17 % difference with the usual care group was not significant .


This is the first study showing that computer tailoring can be effective to reduce alcohol use during pregnancy ; health counseling did not effectively reduce alcohol use .


Future researchers developing a health-counseling intervention to reduce alcohol use during pregnancy are recommended to invest more in recruitment of pregnant women and implementation by health care providers .


Because pregnant women are reluctant to disclose their alcohol use to health professionals and computer tailoring preserves a person 's anonymity , this effective computer-tailoring intervention is recommended as an attractive intervention for pregnant women using alcohol .


Dutch Trial Register NTR 2058 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2058 ( Archived by WebCite at http://www.webcitation.org/6NpT1oHol ) .


The purpose of this study was to investigate the effect of active vs passive scapular correction on pain and pressure pain threshold at the most symptomatic cervical segment in patients with chronic neck pain .


Twenty-three volunteers with chronic , idiopathic neck pain were recruited ( age , 38.9 14.4 years ; sex [ man/woman ] , 3/20 ; Neck Disability Index , 28.1 % 9.9 % ) .


Subjects were randomly allocated to 2 groups : active scapular correction or passive scapular correction .


Pressure pain threshold and pain intensity rated on a numerical rating scale during a posteroanterior glide over the most symptomatic cervical segment were measured before and immediately after the active or passive scapular intervention .


Only the active scapular correction produced a reduction in pain ( pre , 6.3 1.2 ; post , 3.7 2.4 ; P < .05 ) and increase in pressure pain threshold ( pre , 8.7 4.2 kg/cm ( 2 ) ; post , 10.1 3.8 kg/cm ( 2 ) ; P < .05 ) at the most painful cervical segment .


An active scapular correction exercise resulted in an immediate reduction of pain and pressure pain sensitivity in patients with chronic neck pain and scapular dysfunction .


Ginger-salt-indirect moxibustion is widely applied to treat urge urinary incontinence after stroke , which is a common complication in stroke survivors .


Moxa cone moxibustion and moxa box moxibustion are the main techniques of ginger-salt-indirect moxibustion .


Our previous study had shown that ginger-salt-indirect moxibustion using moxa cones was feasible and effective for urination disorders post-stroke .


This pilot study aims to assess the feasibility of conducting research to evaluate the efficacy and safety of ginger-salt-indirect moxibustion for patients with post-stroke urge urinary incontinence .


This is a multicentre , prospective , single-blinded , pilot randomised controlled trial .


120 eligible patients will be randomly allocated to three groups .


Treatment group A ( n = 40 ) will receive moxa cone moxibustion and routine care ; treatment group B ( n = 40 ) will receive moxa box moxibustion and routine care ; control group ( n = 40 ) will only receive routine care for stroke recovery .


The entire moxibustion treatment will consist of a total of 28 sessions during the course of 4weeks .


The primary outcome measure will be the increase in mean volume per void assessed at week 4 from the first moxibustion session ( baseline ) .


Secondary outcome measures will include mean frequency of urination per day and quality of life assessments measured by completion of the Incontinence Quality of Life Questionnaire and Barthel Index .


All outcome measures will be assessed at baseline and at 4 and 16weeks from baseline .


Adverse events in the three groups will be recorded to assess the safety of moxibustion .


Research ethics was approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University ( ref : 2013BL-094 ) .


Written informed consent will be obtained from all participants .


Study results will be published in peer reviewed journals .


ISRCTN 44706974 .


As public discourse surrounding obesity highlights the societal costs of obesity and individual 's own responsibility for their weight , being overweight is often framed as immoral .


Such ` moralizing ' messages about being overweight may be a psychological threat for those with high body mass .


Attempting to counter-moralise the public discourse ( i.e. actively arguing that there is nothing ` immoral ' about being overweight ) may relieve this threat , inducing people , especially those with higher ( perceived ) weight , to engage in healthier behaviours .


Two experiments were performed among Dutch and US participants .


( Counter - ) moralisation was manipulated .


Body mass and weight-related self-perceptions were measured .


The dependent variable was healthy vs. unhealthy snack choice .


( Counter - ) moralisation and ( perceived ) overweight jointly predicted snack choice : counter-moralising messages induced healthy snacking , but only among those who regarded themselves to have a high body mass .


The effects of moralising vs. counter-moralising obesity depended on one 's ( perceived ) overweight .


This suggests that , for people with relatively high weight , the current moralising public discourse on obesity works in counterproductive ways .


Campaigns that ` counter-moralize ' obesity ( i.e. that refute moralising messages ) are more productive , although they should be tailored to those who see themselves as being overweight .


Whether initial treatment for Parkinson 's disease should consist of levodopa , dopamine agonists , or monoamine oxidase type B inhibitors ( MAOBI ) is uncertain .


We aimed to establish which of these three classes of drug , as initial treatment , provides the most effective long-term control of symptoms and best quality of life for people with early Parkinson 's disease .


In this pragmatic , open-label randomised trial , patients newly diagnosed with Parkinson 's disease were randomly assigned ( by telephone call to a central office ; 1:1:1 ) between levodopa-sparing therapy ( dopamine agonists or MAOBI ) and levodopa alone .


Patients and investigators were not masked to group assignment .


Primary outcomes were the mobility dimension on the 39-item patient-rated Parkinson 's disease questionnaire ( PDQ-39 ) quality-of-life scale ( range 0-100 with six points defined as the minimally important difference ) and cost-effectiveness .


Analysis was intention to treat .


This trial is registered , number ISRCTN69812316 .


Between Nov 9 , 2000 , and Dec 22 , 2009 , 1620 patients were assigned to study groups ( 528 to levodopa , 632 to dopamine agonist , 460 to MAOBI ) .


With 3-year median follow-up , PDQ-39 mobility scores averaged 18 points ( 95 % CI 05-30 , p = 0005 ) better in patients randomly assigned to levodopa than those assigned to levodopa-sparing therapy , with no increase or attrition of benefit during 7 years ' observation .


PDQ-39 mobility scores were 14 points ( 95 % CI 00-29 , p = 005 ) better in patients allocated MAOBI than in those allocated dopamine agonists .


EQ-5D utility scores averaged 003 ( 95 % CI 001-005 ; p = 00002 ) better with levodopa than with levodopa-sparing therapy ; rates of dementia ( hazard ratio [ HR ] 081 , 95 % CI 061-108 , p = 014 ) , admissions to institutions ( 086 , 063-118 ; p = 04 ) , and death ( 085 , 069-106 , p = 017 ) were not significantly different , but the upper CIs precluded any substantial increase with levodopa compared with levodopa-sparing therapy .


179 ( 28 % ) of 632 patients allocated dopamine agonists and 104 ( 23 % ) of 460 patients allocated MAOBI discontinued allocated treatment because of side-effects compared with 11 ( 2 % ) of 528 patients allocated levodopa ( p < 00001 ) .


Very small but persistent benefits are shown for patient-rated mobility scores when treatment is initiated with levodopa compared with levodopa-sparing therapy .


MAOBI as initial levodopa-sparing therapy was at least as effective as dopamine agonists .


UK National Institute for Health Research Health Technology Assessment Programme and UK Department of Health .


Observational studies suggest that moderate intakes of retinol and increased circulating retinol levels may increase fracture risk .


Easy access to supplements , combined with an aging population , makes this a potentially important association .


The aim of this study was to investigate plasma retinol and total carotene concentrations in relation to fracture risk after long-term supplementation with retinol and/or beta-carotene in 998 adults between 1990 and 2007 .


Participants were 663 men and 335 women in a cancer prevention program who were initially randomized to a retinol ( 7.5 mg RE/d ) or beta-carotene ( 30 mg/d ) supplement between 1990 and 1996 .


After 1996 , all participants received the retinol supplement only .


Plasma retinol and total carotene , medication use and various lifestyle factors were measured at annual clinic visits .


Fractures were identified by self-report in 2007 .


The risk for any fracture or osteoporotic fracture was modeled using Cox proportional hazard models .


Over a median follow-up of 7.8 y , 123 participants with plasma samples reported an incident fracture .


Although plasma retinol concentrations were markedly higher than those reported in observational studies , no association was observed between plasma retinol and risk for any fracture ( hazard ratio [ HR ] , 0.86 mol/L ; 95 % confidence interval [ CI ] , 0.65-1 .14 ) or osteoporotic fracture ( HR , 0.97 mol/L ; 95 % CI , 0.66-1 .43 ) .


A lower risk for any fracture was suggested with increasing plasma total carotenes ( HR , 0.85 mol/L ; 95 % CI , 0.71-1 .01 ) .


This study does not support earlier reports of an increased fracture risk associated with increased plasma retinol concentration .


The potential for carotenes to prevent fractures deserves further investigation .


To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ( ` LNG-IUS ' ) and usual medical treatment for women with menorrhagia in primary care ; and compare the cost-effectiveness findings using two alternative measures of quality of life .


571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009 .


Women were randomised to having a LNG-IUS fitted , or usual medical treatment , after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment .


The treatment was specified prior to randomisation .


For the economic evaluation we developed a state transition ( Markov ) model with a 24 month follow-up .


The model structure was informed by the trial women 's pathway and clinical experts .


The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year ( QALY ) estimated using both EQ-5D and SF-6D .


Using EQ-5D , LNG-IUS was the most cost-effective treatment for menorrhagia .


LNG-IUS costs 100 more than usual medical treatment but generated 0.07 more QALYs .


The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was 1600 per additional QALY .


Using SF-6D , usual medical treatment was the most cost-effective treatment .


Usual medical treatment was both less costly ( 100 ) and generated 0.002 more QALYs .


Impact on quality of life is the primary indicator of treatment success in menorrhagia .


However , the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY .


Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia .


This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial .


Hyperuricemia is a recognized risk factor for cardiovascular diseases .


Soy foods contain a moderate amount of purine and may predispose to raised serum uric acid ( UA ) .


However , no study has examined the long-term effect of soy intake on UA levels .


We examined whether consumption of soy foods and isoflavone extracts for 6 months altered serum UA .


The analysis included two randomized controlled trials ( soy protein trial and whole soy trial ) among total 450 postmenopausal women with either prehypertension or prediabetes .


We conducted a pooled analysis by combining participants from both the soy flour and soy protein groups ( combined soy foods group ) , participants from both the isoflavone and daidzein groups ( combined isoflavone group ) and participants from both milk placebo groups .


Fasting venous samples were obtained at baseline and the end of the trial for serum UA analysis .


In the pooled data , 417 subjects completed the study according to protocol .


The baseline serum UA levels were comparable among the three combined groups .


There was a lower decrease in UA levels among women in the combined soy foods group compared with women in the other two groups ( p = 0.028 and 0.026 ) .


The net decrease and % decrease in UA were 14.5 mol/L ( 95 % CI 1.93-25 .6 , p = 0.023 ) or 4.9 % ( 95 % CI 1.3-8 .5 % , p = 0.023 ) between the combined soy foods group and placebo group .


Among Chinese postmenopausal women with either prehypertension or prediabetes , soy intake did not increase urate levels .


Surgical site infections are the most common hospital-acquired infections among surgical patients .


The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections .


The optimal timing of this procedure is still a matter of debate .


While most studies suggest that it should be given as close to the incision time as possible , others conclude that this may be too late for optimal prevention of surgical site infections .


A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30minutes before surgery .


The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis .


In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland , we plan to include 5,000 patients undergoing general , oncologic , vascular and orthopedic trauma procedures .


Patients are randomized in a 1:1 ratio into two groups : one receiving surgical antimicrobial prophylaxis in the anesthesia room ( 75 to 30minutes before incision ) and the other receiving surgical antimicrobial prophylaxis in the operating room ( less than 30minutes before incision ) .


We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30minutes before the scheduled incision .


The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period ( one year with an implant in place ) .


When assuming a 5 % surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room , the planned sample size has an 80 % power to detect a relative risk reduction for surgical site infections of 33 % when administering surgical antimicrobial prophylaxis in the anesthesia room ( with a two-sided type I error of 5 % ) .


We expect the study to be completed within three years .


The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital .


Moreover , the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics .


This trial is registered on ClinicalTrials.gov under the identifier NCT01790529 .


Depression and anxiety are prevalent in patients with chronic pain and adversely affect pain , quality of life , and treatment response .


The purpose of this psychometric study was to determine the reliability and validity of the four-item Patient Reported Outcomes Measurement Information System ( PROMIS ) depression and anxiety scales in patients with chronic pain .


Secondary analysis of data from the Stepped Care to Optimize Pain care Effectiveness study , a randomized clinical trial of optimized analgesic therapy .


Five primary care clinics at the Roudebush VA Medical Center ( RVAMC ) in Indianapolis , Indiana .


Two hundred forty-four primary care patients with chronic musculoskeletal pain .


All patients completed the four-item depression and anxiety scales from the PROMIS 29-item profile , as well as several other validated psychological measures .


The minimally important difference ( MID ) using the standard error of measurement ( SEM ) was calculated for each scale , and convergent validity was assessed by interscale correlations at baseline and 3 months .


Operating characteristics of the PROMIS measures for detecting patients who had probable major depression or were anxiety-disorder screen-positive were calculated .


The PROMIS scales had good internal reliability , and the MID ( as represented by two SEMs ) was 2 points for the depression scale and 2.5 points for the anxiety scale .


Convergent validity was supported by strong interscale correlations .


The optimal screening cutpoint on the 4 - to 20-point PROMIS scales appeared to be 8 for both the depression and anxiety scales .


The PROMIS four-item depression and anxiety scales are reasonable options as ultra-brief measures for screening in patients with chronic pain .


To investigate the association of radiographic progression defined by Prostate Cancer Working Group ( PCWG ) -2 guidelines and overall survival ( OS ) in men with metastatic castration-resistant prostate cancer ( mCRPC ) .


Two trials that used PCWG-2 guidelines to define progression were analysed : a randomized phase II trial ( n = 221 ) comparing first-line docetaxel-prednisone plus AT-101 or placebo , and a phase III trial ( n = 873 ) comparing prednisone plus sunitinib or placebo after docetaxel-based chemotherapy .


Cox proportional hazards regression models were used to estimate the association of radiographic progression with OS .


Landmark analyses compared progressing patients with those who had not progressed .


Sub-analyses compared patients removed from trial for progression vs other reasons .


An increased risk of death was seen for radiographic progression at landmark times from 6 to 12 months with docetaxel-based therapy ( hazard ratio [ HR ] > 1.7 at all time-points ) .


An increased risk of death was also seen with post-docetaxel prednisone alone or with sunitinib for progression at landmark times from 2 to 8 months ( HR > 2.7 at all time-points ) .


Kendall 's was 0.50 ( P < 0.001 ) in the setting of docetaxel-based therapy and 0.34 ( P < 0.001 ) in the post-docetaxel setting for association between radiographic progression and death amongst patients with both events .


Removal from study due to radiographic progression was associated with a significantly lower OS compared with removal for other reasons in both trials .


Limitations of a retrospective analysis apply and there was no central radiology review .


Radiographic progression by PCWG-2 criteria was significantly associated with OS in patients with mCRPC receiving first-line docetaxel-based chemotherapy or post-docetaxel therapy .


With external validation as a surrogate endpoint in trials showing survival benefits , the use of radiographic progression-free survival may expedite drug development in mCRPC , which has been hampered by the lack of intermediate endpoints .


This study aimed to develop a system for predicting work-related musculoskeletal disorders ( WMSD ) among dental students .


The system comprised 2 accelerometer sensors to register neck and upper back postures and movements , and software developed to collect and process the data .


Hidden Markov models ( HMMs ) were used to predict the likelihood of WMSD in dental students by comparing their neck and upper back movement patterns with WMSD and non-WMSD HMMs learned from previous data .


To evaluate the performance of the system , 16 participants were randomly assigned into a 2 2 crossover trial scheduled for each sequence of working : receiving feedback or no-feedback from the system .


The primary outcome measure was the extension of the neck and upper back , before ( pre-test ) and after ( posttest ) receiving feedback or no-feedback from the system .


The secondary outcome measure was the log likelihood of classifying the movements as WMSD .


The results showed that in the group that received feedback , the extension of the neck in the y axis and of the upper back in the y axis decreased significantly ( t test , p < .05 ) on the post-test .


The system for predicting and preventing WMSD aids the correction of the extension of the neck and upper back in the y axis .


This exploratory study investigated whether integration of the Client Self-Care Commitment Model ( CSCCM ) Instructional Module in a dental hygiene curriculum , as an additional educational experience , would further enhance students ' client-centred knowledge , values and actions .


Subjects ( n = 26 ) were second-year students enrolled in a BS entry-level dental hygiene programme with random assignments to two groups .


The experimental group participated in a 2-h didactic session , an 8-h preclinical session , an 8-h clinical session and a 1-h question and answer period .


An online pretest-post-test survey administered at three time intervals ( baseline , 3 and 6 weeks ) was used to measure differences between the groups on three subscales ( knowledge , values and actions ) .


Cronbach 's for each subscale across time was above 0.90 .


A repeated-measures anova determined that there were no statistically significant interactions between Time and Group ( experimental or control group ) for the knowledge and values variables ; however , there was a significant interaction between Time ( P = 0.003 ) and Group ( P = 0.033 ) for the actions variable .


A content analysis of participants ' responses to three open-ended questions reflected both positive and negative comments and revealed that students ' primary barrier to implementing the model in client care was lack of time .


Significant differences in the actions variable between the groups suggested that implementation of the CSCCM Instructional Module enhanced students ' client-centred actions during client care .


To evaluate health related quality of life ( HRQOL ) in TEACH , a phase III randomized placebo controlled trial of 12 months of adjuvant lapatinib in HER2 positive ( HER2 + ) early breast cancer which demonstrated marginal benefit in disease-free survival .


Women on TEACH completed the Short Form 36-item health survey ( version2 ; SF-36v2 ) at the baseline , six and 12 months after therapy initiation and six monthly thereafter .


Mean changes were compared between treatment groups for two summary measures ( Physical and Mental Component Summary scores ; PCS and MCS ) and eight domain measures ( physical functioning , role physical , bodily pain , general health , vitality , social functioning , role emotional and mental health ) , and in patients discontinuing therapy .


A five-point change was deemed a Minimally Clinically Important Difference ( MCID ) .


Response analysis compared the proportion of patients demonstrating a MCID in HRQOL , and a regression analysis identified predictors of worsening HRQOL .


3074 ( 97 % ) subjects completed baseline SF-36v2 .


During the initial 12 months , summary SF-36v2 scores decreased in both arms but did not reach Minimally Clinically Important Difference ( MCID ) despite significant incidences of diarrhoea and rash in lapatinib treated patients .


At six months , women receiving lapatinib had more significant reductions ( p < 0.01 versus placebo ) in social functioning .


Early treatment discontinuations were more frequent on lapatinib ( 32 % versus 18 % ) , and were associated with more substantial decrements of HRQOL in both arms .


For those discontinuing primarily due to adverse events , decrements in HRQOL reached MCID in Mental Summary scores ( MCS ) only .


Lower baseline HRQOL was a significant predictor of worsening HRQOL ( p < 0.05 ) .


Despite frequent but usually mild toxicities , adjuvant lapatinib is not associated with clinically significant decreases in overall HRQOL .


These placebo-controlled results may also help to inform physicians and patients using lapatinib in metastatic HER2 positive breast cancer .


GlaxoSmithKline .


The AVON Foundation NY supported PEG , DF and BM and The Friends of the Mater Foundation supported FB .


Cerebrovascular anomalies resulting from the persistence of unfused embryonic twig-like vessels are associated with intracranial aneurysms .


All records of patients with ruptured intracranial aneurysms who were treated at our institution were retrospectively reviewed for the presence of aneurysm-associated , unfused , twig-like vessels in the middle cerebral artery ( MCA ) .


Such vessels were recorded as twig-like MCA ( T-MCA ) or twig-like networks of an anomalous collateral artery ( T-NACA ) .


Additionally , we sought to characterize vulnerable intracranial aneurysms associated with those vascular anomalies .


A total of 442 ruptured aneurysms were treated from June 2006 to November 2013 ; of these , 4 ruptured aneurysms exhibited the presence of ipsilateral , unfused , twig-like vessels .


Computed tomography ( CT ) scans , three-dimensional CT angiography , and digital subtraction angiography ( DSA ) were performed immediately after the initial ictus .


Data analysis included age , sex , Hunt and Hess grade ( HHG ) , Fisher grade ( FG ) , medical risk factors , angiographic architecture , operative methods and findings , radiologic outcomes , and Glasgow outcome scale ( GOS ) .


The average follow-up period was 26 months .


Patient ages ranged from 26 to 49 years with a mean age of 41 ; there were two females and two males .


All four patients showed FG IV , and three patients had unfavorable HHG ( IV in 2 and V in one ) at admission .


An M1 segmental occlusion and an adjacent small aneurysmal pouch were detected with three-dimensional CT angiography in three patients .


Hypertension was recorded in all patients .


The initial DSA revealed T-MCA in one patient and T-NACA in three patients .


Six aneurysms in all , including two unruptured aneurysms , were found ; three ruptured aneurysms existed inside of the twigs .


All but one patient required diverse treatment modalities , and four of the five aneurysms were completely occluded after treatment .


The remaining aneurysm , treated only with gluing , disappeared during follow-up .


In two of the three patients with T-NACA , atresia of the M1 segment was confirmed intraoperatively .


The GOS during follow-up was recorded as favorable ( good recovery ) in two patients and unfavorable ( severe disability and permanent vegetative state ) in two patients .


These unique vascular anomalies , T-MCA and T-NACA , which are caused by heterogeneous maldevelopment of the primitive cerebral vessels , are not benign because of their frequent association with flow-related aneurysms , which are vulnerable to rupture .


Microsurgical or endovascular treatments for this type of flow-related aneurysm associated with twigs are mandatory to prevent fatal rebleeding , and more attention has to be given when physicians encounter steno-occlusive MCA lesions in patients with subarachnoid hemorrhage to detect any vulnerable aneurysms associated with twig-like vessels .


To evaluate the efficacy of memantine on metabolite levels in different areas of the brain and to determine whether changes in metabolite levels correlate with clinical variables in Fibromyalgia ( FM ) patients .


Doubled-blind parallel randomized controlled trial .


Twenty-five patients diagnosed with FM were enrolled in the study .


Patients were administered questionnaires on pain , anxiety , depression , quality of life , and cognitive impairment , and single-voxel MRS of the brain was performed .


All assessments were performed at baseline and after 6months of treatment with memantine or placebo .


Patients treated with memantine exhibited a significant increase in the glutamate ( P = 0.010 ) , glutamate/creatine ratio ( P = 0.013 ) , combined glutamate + glutamine ( P = 0.016 ) and total N-acetyl-aspartate ( NAA+NAAG ) ( P = 0.034 ) in the posterior cingulate cortex compared with those on placebo .


Furthermore , the memantine group exhibited increases in creatine ( P = 0.013 ) and choline ( Cho ) ( P = 0.025 ) in the right posterior insula and also a correlation between choline and the Fibromyalgia Impact Questionnaire ( FIQ ) in the posterior insula ( P = 0.050 ) was observed .


Memantine treatment resulted in an increase in cerebral metabolism in FM patients , suggesting its utility for the treatment of the illness .


The objective of this study was to evaluate the effect of vaginal packing following pelvic floor surgery with regard to post-operative pain , bleeding and infection .


This was a double-blind randomised study of women undergoing vaginal hysterectomy and/or pelvic floor repair at a tertiary urogynaecology unit .


The primary outcome of day 1 post-operative pain was assessed using the short-form McGill Pain score .


Secondary outcomes were haematological and infective morbidity , evaluated using changes in full blood count , and cultures of midstream urine and high vaginal swabs .


A transvaginal ultrasound scan to exclude pelvic haematoma was performed at 6 weeks in all women who underwent vaginal hysterectomy with or without a pelvic floor repair .


In total , 190 women were recruited : mean age 58.3 years ( 27-91 years ) , mean body mass index 27.4 kg/m ( 2 ) and median parity 3 .


Women were randomised into the ` pack ' ( n = 86 ) and ` no pack ' ( n = 87 ) arms with no demographic differences between the groups .


No statistically significant differences in the post-operative pain scores or secondary outcome measures were demonstrated .


Incidence of haematoma formation ( 14.8 % no pack , 7.3 % pack , p = 0.204 ) was not statistically significant .


There were three clinically significant complications in the no pack group and none in the pack group .


This is the first study to examine pain in association with post-operative vaginal packing .


There is no evidence to suggest that packing increases pain scores or post-operative morbidity .


A trend towards increased haematoma and significant complications was seen in the no pack group .


As vaginal packing does no harm and may be of some benefit it may be argued that packing should be recommended as routine clinical practice .


Cognitive remediation ( CR ) aims primarily to improve cognition and functional outcomes .


However , a limited number of studies reported a positive effect on symptoms .


This limited effect may be because the symptom clusters considered are too broad and heterogeneous .


This study explores , for the first time , the effect of CR on five empirically defined symptom dimensions of schizophrenia .


Participants were patients with schizophrenia taking part in a randomised controlled trial comparing CR plus treatment as usual ( CR , N = 43 ) to treatment as usual ( TAU , N = 42 ) .


All participants were assessed at baseline and 14-weeks ( i.e. at the conclusion of treatment for the CR group ) with the Positive and Negative Symptoms Scale ( PANSS ) .


Five symptom dimensions were derived from the PANSS scores : Positive ( POS ) , Negative ( NEG ) , Disorganised ( DIS ) , Excited ( EXC ) and Emotional Distressed ( EMD ) .


After CR , the therapy group had a significant reduction in DIS and NEG symptom dimensions compared to the TAU group .


The traditional PANSS factors showed no effect of CR on symptoms .


CR can have not only a positive effect on disorganisation but also on negative symptoms .


Using detailed symptom dimensions can characterise more accurately the effect of CR on symptom of schizophrenia .


To increase access to early second-trimester surgical abortion by determining noninferiority of same-day synthetic osmotic dilators compared with overnight Laminaria for cervical preparation before early second-trimester dilation and evacuation .


We enrolled women between 14 and 18 weeks of gestation and randomized them to same-day synthetic osmotic dilators or overnight Laminaria .


Study participants and clinicians were blinded to group assignment .


The primary outcome was procedure duration .


The trial was powered to assess noninferiority of synthetic osmotic dilators to exclude a mean difference of 5 minutes or longer .


We enrolled 72 patients : 36 were randomized to same-day synthetic osmotic dilators and 36 to overnight Laminaria .


Mean procedure duration was 8.1 and 5.9 minutes , respectively , with a mean difference of 2.1 minutes ( 97.5 % confidence interval -0.3 to 4.5 ) .


Same-day synthetic osmotic dilators resulted in less initial cervical dilation than overnight Laminaria ( mean circumference 48 compared with 60 mm Pratt , P < .001 ) and required more mechanical dilation ( 69 % compared with 27 % , P = .001 ) .


There was no difference in complications , all of which were minor , or in the median procedural difficulty score rated by physicians .


Most patients in both groups would choose a same-day procedure if necessary in the future .


Despite less initial cervical dilation and a greater need for mechanical dilation , same-day synthetic osmotic dilators are not inferior to overnight Laminaria with respect to procedure duration .


Same-day osmotic dilation is preferred by patients and may be a reasonable alternative to overnight Laminaria for cervical preparation before early second-trimester dilation and evacuation .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00775983 .


I.


Obstructive sleep apnea ( OSA ) , common in Parkinson disease ( PD ) , contributes to sleep disturbances and daytime sleepiness .


We assessed the effect of continuous positive airway pressure ( CPAP ) on OSA , sleep , and daytime sleepiness in patients with PD .


This was a randomized placebo-controlled , crossover design .


Patients with PD and OSA were randomized into 6 w of therapeutic treatment or 3 w of placebo followed by 3 w of therapeutic treatment .


Patients were evaluated by polysomnography ( PSG ) and multiple sleep latency test ( MSLT ) pretreatment ( baseline ) , after 3 w , and after 6 w of CPAP treatment .


Analyses included mixed models , paired analysis , and within-group analyses comparing 3 w to 6 w of treatment .


Sleep laboratory .


Thirty-eight patients with PD ( mean age = 67.2 9.2 y ; 12 females ) .


Continuous positive airway pressure .


PSG OUTCOME MEASURES : sleep efficiency , % sleep stages ( N1 , N2 , N3 , R ) , arousal index , apnea-hypopnea index ( AHI ) , and % time oxygen saturation < 90 % ( % time SaO2 < 90 % ) .


MSLT outcome measures : mean sleep-onset latency ( MSL ) .


There were significant group-by-time interactions for AHI ( P < 0.001 ) , % time SaO2 < 90 % ( P = 0.02 ) , % N2 ( P = 0.015 ) and % N3 ( P = 0.014 ) .


Subjects receiving therapeutic CPAP showed significant decrease in AHI , % time SaO2 < 90 % , % N2 , and significant increase in % N3 indicating effectiveness of CPAP in the treatment of OSA , improvement in nighttime oxygenation , and in deepening sleep .


The paired sample analyses revealed that 3 w of therapeutic treatment resulted in significant decreases in arousal index ( t = 3.4 , P = 0.002 ) .


All improvements after 3 w were maintained at 6 w. Finally , 3 w of therapeutic CPAP also resulted in overall decreases in daytime sleepiness ( P = 0.011 ) .


Therapeutic continuous positive airway pressure versus placebo was effective in reducing apnea events , improving oxygen saturation , and deepening sleep in patients with Parkinson disease and obstructive sleep apnea .


Additionally , arousal index was reduced and effects were maintained at 6 weeks .


Finally , 3 weeks of continuous positive airway pressure treatment resulted in reduced daytime sleepiness measured by multiple sleep latency test .


These results emphasize the importance of identifying and treating obstructive sleep apnea in patients with Parkinson disease .


Simple aeration of food matrices with gas has previously been shown to generate immediate suppression of appetite , though duration of effects has not been shown .


This research tested whether liquids aerated with nitrous oxide ( N2 O ) to achieve high in-body stability could produce enhanced and sustained effects on eating motivations .


In two randomized cross-over studies , appetite ratings were collected for 240 min .


In Study 1 , 24 volunteers consumed a full portion liquid ( 325 ml , 190 kcal ) or aerated ( 1,000 ml , 190 kcal ) drink at 0 min , or half portions of liquid ( 162 ml , 95 kcal ) or aerated ( 500 ml , 95 kcal ) drink at 0 and 120 min .


In Study 2 , assessing the effect of N2 O itself , 23 volunteers consumed water saturated with N2 O or with CO2 10 min after a mini-drink ( 180 kcal ) .


Appetite was quantified by area-under-the curve ( AUC ) and time-to-return-to-baseline ( TTRTB ) .


Full - and half-size aerated drinks decreased hunger AUC over 4 h by 26 and 50 % ( P < 0.0001 ) versus the respective liquid versions .


Effects were also sustained significantly longer ( TTRTB from 203 to 335 and from 173 to 286 min , respectively ) .


In Study 2 , N2 O and CO2 had similar effects on appetite ratings .


Aeration of foods using appropriate microstructural design has a powerful effect on eating motivations .


Hypo-fractionated external beam radiotherapy with narrow CTV-PTV margins is increasingly applied for prostate cancer .


This demands a precise target definition and knowledge on target location and extension during treatment .


It is unclear how increase in fraction size affects changes in prostate volume during treatment .


Our aim was to study prostate volume changes during extreme hypo-fractionation ( 7 6.1 Gy ) by using sequential MRIs .


Twenty patients treated with extreme hypo-fractionation were recruited from an on-going prospective randomized phase III trial .


An MRI scan was done before start of treatment , at mid treatment and at the end of radiotherapy .


The prostate was delineated at each MRI and the volume and maximum extension in left-right , anterior-posterior and cranial-caudal directions were measured .


There was a significant increase in mean prostate volume ( 14 % ) at mid treatment as compared to baseline .


The prostate volume remained enlarged ( 9 % ) at the end of radiotherapy .


Prostate swelling was most pronounced in the anterior-posterior and cranial-caudal directions .


Extreme hypo-fractionation induced a significant prostate swelling during treatment that was still present at the time of last treatment fraction .


Our results indicate that prostate swelling is an important factor to take into account when applying treatment margins during short extreme hypo-fractionation , and that tight margins should be applied with caution .


This is a randomized , double-blind , placebo-controlled study aimed to evaluate the clinical and biologic effects of letrozole plus lapatinib or placebo as neoadjuvant therapy in hormone receptor ( HR ) - positive/human epidermal growth factor receptor 2 ( HER2 ) - negative operable breast cancer .


Ninety-two postmenopausal women with stage II to IIIA primary breast cancer were randomly assigned to preoperative therapy consisting of 6 months of letrozole 2.5 mg orally daily plus lapatinib 1,500 mg orally daily or placebo .


Surgery was performed within 2 weeks from the last study medication .


Clinical response was assessed by ultrasonography .


Pre - and post-treatment samples were evaluated for selected biomarkers .


Fresh-frozen tissue samples were collected for genomic analyses .


Numerically similar clinical response rates ( partial + complete response ) were observed ( 70 % for letrozole-lapatinib and 63 % for letrozole-placebo ) .


Toxicities were generally mild and manageable .


A significant decrease in Ki-67 and pAKT expression from baseline to surgery was observed in both arms .


Overall , 34 patients ( 37 % ) had a mutation in PIK3CA exon 9 or 20 .


In the letrozole-lapatinib arm , the probability of achieving a clinical response was significantly higher in the presence of PIK3CA mutation ( objective response rate , 93 % v 63 % in PIK3CA wild type ; P = .040 ) .


The combination of letrozole-lapatinib in early breast cancer was feasible , with expected and manageable toxicities .


In unselected estrogen receptor-positive/HER2-negative patients , letrozole-lapatinib and letrozole-placebo resulted in a similar overall clinical response rate and similar effect on Ki-67 and pAKT .


Our secondary end point findings of a significant correlation between PIK3CA mutation and response to letrozole-lapatinib in HR-positive/HER2-negative early breast cancer must now be independently confirmed .


To study the effects of low tidal volume with positive end-expiratory pressure ( PEEP ) on arterial blood gases of patients undergoing laparoscopic urologic surgeries .


Eighty-six laparoscopic urologic patients were enrolled in this study .


Patients were randomized into two groups according to the ventilatory settings .


In the conventional group ( Group C ) ( n = 43 ) , the tidal volume was 10mL/kg , and the PEEP was set at 0cm of H2O .


In the low tidal volume with PEEP group ( Group LP ) , the tidal volume was 6mL/kg , with PEEP of 5cm of H2O .


In both groups total minute volume was 6 L/kg .


Peak and plateau airway pressure ( PPEAK and PPLAT , respectively ) and arterial blood gases were recorded before pneumoperitoneum ( PNP ) ( T1 ) and the first and third hour ( T3 ) after PNP induction and also after extubation in the intensive care unit .


Additionally , heart rate , mean arterial pressure , and peripheral O2 saturation of hemoglobin were recorded .


Heart rate , PPEAK , and PPLAT values were similar in both groups .


Partial arterial O2 pressure values measured postoperatively were significantly higher in Group LP , whereas those measured before PNP induction were similar ( P = .014 and P = .056 , respectively ) .


Compared with the baseline , partial arterial CO2 pressure values measured at T1 and at T3 after PNP induction were significantly higher in Group C than in Group LP ( P < .001 ) .


The pH values of Group C at T1 and at T3 postoperatively were significantly lower than the values of Group LP ( P < .001 ) .


Extubation times were significantly lower in Group LP .


The results of the present study suggest that low tidal volume with PEEP application may be a good alternative for preventing high CO2 levels and yielding better oxygenation and lower extubation times in patients undergoing prolonged laparoscopic urology .


Masitinib is a highly selective tyrosine kinase inhibitor with activity against the main oncogenic drivers of gastrointestinal stromal tumor ( GIST ) .


Masitinib was evaluated in patients with advanced GIST after imatinib failure or intolerance .


Prospective , multicenter , randomized , open-label trial .


Patients with inoperable , advanced imatinib-resistant GIST were randomized ( 1 : 1 ) to receive masitinib ( 12 mg/kg/day ) or sunitinib ( 50 mg/day 4-weeks-on/2-weeks-off ) until progression , intolerance , or refusal .


Primary efficacy analysis was noncomparative , testing whether masitinib attained a median progression-free survival ( PFS ) ( blind centrally reviewed RECIST ) threshold of > 3 months according to the lower bound of the 90 % unilateral confidence interval ( CI ) .


Secondary analyses on overall survival ( OS ) and PFS were comparative with results presented according to a two-sided 95 % CI .


Forty-four patients were randomized to receive masitinib ( n = 23 ) or sunitinib ( n = 21 ) .


Median follow-up was 14 months .


Patients receiving masitinib experienced less toxicity than those receiving sunitinib , with significantly lower occurrence of severe adverse events ( 52 % versus 91 % , respectively , P = 0.008 ) .


Median PFS ( central RECIST ) for the noncomparative primary analysis in the masitinib treatment arm was 3.71 months ( 90 % CI 3.65 ) .


Secondary analyses showed that median OS was significantly longer for patients receiving masitinib followed by post-progression addition of sunitinib when compared against patients treated directly with sunitinib in second-line [ hazard ratio ( HR ) = 0.27 , 95 % CI 0.09-0 .85 , P = 0.016 ] .


This improvement was sustainable as evidenced by 26-month follow-up OS data ( HR = 0.40 , 95 % CI 0.16-0 .96 , P = 0.033 ) ; an additional 12.4 months survival advantage being reported for the masitinib treatment arm .


Risk of progression while under treatment with masitinib was in the same range as for sunitinib ( HR = 1.1 , 95 % CI 0.6-2 .2 , P = 0.833 ) .


Primary efficacy analysis ensured the masitinib treatment arm could satisfy a prespecified PFS threshold .


Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care .


Encouraging median OS and safety data from this well-controlled and appropriately designed randomized trial indicate a positive benefit-risk ratio .


Further development of masitinib in imatinib-resistant/intolerant patients with advanced GIST is warranted .


We evaluated the efficacy and safety of a once monthly oxybutynin vaginal ring in women with overactive bladder .


This randomized , multicenter , double-blind , 12-week phase 2 study compared oxybutynin vaginal ring ( 4 or 6 mg daily ) to a placebo vaginal ring in women with well-defined overactive bladder symptoms .


The primary efficacy variable was the change from baseline to week 12 in the total weekly number of incontinence episodes ( stress and urge ) .


Safety was measured in terms of treatment emergent adverse events , laboratory , physical , gynecologic examinations , electrocardiogram and vital signs .


After a 3-week post-randomization placebo run-in phase ( sample size 720 ) 445 women entered the treatment phase ( safety population ) .


Of these women 323 met all 3 overactive bladder specific baseline characteristics of 10 or more urinary urge incontinence episodes weekly , urinary frequency 8 or more voids per 24 hours and voided volume 3 L or less per 24 hours ) ( analysis population ) .


Women treated with 4 and 6 mg daily oxybutynin vaginal ring had significantly fewer incontinence episodes weekly ( p = 0.036 and p = 0.018 , respectively ) , lower daily urinary frequency ( p = 0.014 , p = 0.002 ) and a higher proportion had no incontinence episodes at week 12 ( p = 0.026 , p = 0.027 ) compared with placebo .


The change in severity of urgency and voided volume was similar for all groups ( p > 0.05 ) .


Except for a higher incidence of dry mouth and urinary tract infections that were not always culture confirmed , the oxybutynin vaginal ring was well tolerated and had a safety profile similar to that of the placebo vaginal ring .


The oxybutynin vaginal ring appears to be an effective and safe once monthly treatment option for women with overactive bladder characterized primarily by urinary urge incontinence that merits further evaluation in a phase 3 study .


The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs , acid suppressive therapy , and antiplatelets .


However , their effectiveness in changing actual practice is unknown .


The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies .


A cost-benefit analysis will also be conducted .


We will carry out a parallel , open , superiority , randomized trial directed to primary care physicians .


Physicians will be recruited and allocated at a cluster-level ( primary care unit ) by minimization .


Data will be analyzed at the physician level .


Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate .


Physicians in intervention units will be offered individual educational outreach visits ( one for each guideline ) at their workplace during a six-month period .


Physicians in the control group will be offered a single unrelated group training session .


Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class , and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention .


Prescription data will be collected from the regional pharmacy claims database .


We estimated a sample size of 110 physicians in each group , corresponding to 19 clusters with a mean size of 6 physicians .


Outcome collection and data analysis will be blinded to allocation , but due to the nature of the intervention , physicians and detailers can not be blinded .


This trial will attempt to address unresolved issues in the literature , namely , long term persistence of effect , the importance of sequential visits in an outreach program , and cost issues .


If successful , this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service .


ClinicalTrials.gov number NCT01984034 .


Few studies have compared the effect of Web-based eLearning versus small-group learning on medical student outcomes .


Palliative and end-of-life ( PEOL ) education is ideal for this comparison , given uneven access to PEOL experts and content nationally .


In 2010 , the authors enrolled all third-year medical students at the University of California , Davis School of Medicine into a quasi-randomized controlled trial of Web-based interactive education ( eDoctoring ) compared with small-group education ( Doctoring ) on PEOL clinical content over two months .


Students participated in three 3-hour PEOL sessions with similar content .


Outcomes included a 24-item PEOL-specific self-efficacy scale with three domains ( diagnosis/treatment [ Cronbach alpha = 0.92 ; CI : 0.91-0 .93 ] , communication/prognosis [ alpha = 0.95 ; CI : 0.93-0 .96 ] , and social impact/self-care [ alpha = 0.91 ; CI : 0.88-0 .92 ] ) ; 8 knowledge items ; 10 curricular advantage/disadvantages ; and curricular satisfaction ( both students and faculty ) .


Students were randomly assigned to Web-based eDoctoring ( n = 48 ) or small-group Doctoring ( n = 71 ) curricula .


Self-efficacy and knowledge improved equivalently between groups ( e.g. , prognosis self-efficacy , 19 % ; knowledge , 10 % -42 % ) .


Student and faculty ratings of the Web-based eDoctoring curriculum and the small-group Doctoring curriculum were equivalent for most goals , and overall satisfaction was equivalent for each , with a trend toward decreased eDoctoring student satisfaction .


Findings showed equivalent gains in self-efficacy and knowledge between students participating in a Web-based PEOL curriculum in comparison with students learning similar content in a small-group format .


Web-based curricula can standardize content presentation when local teaching expertise is limited , but it may lead to decreased user satisfaction .


We hypothesized that novices would be able to use the McGrath MAC ( Aircraft Medical Ltd , Edinburgh , UK ) equally as well as the GlideScope Ranger ( Verathon , Inc , Bothell , WA ) for intubation in regular simulated airways .


We performed a prospective , randomized crossover study of 39 medical students using the McGrath MAC , GlideScope Ranger , and Macintosh in a manikin with 2 normal airways .


The primary outcome was the intubation time .


Secondary outcomes included the success rates and the overall glottic view of the 3 laryngoscopes .


The mean intubation times for each attempt with the McGrath MAC were 30.8 16.9 seconds or less and did not differ significantly from those obtained with the GlideScope Ranger or the Macintosh in both airway scenarios ( P = .18 ; P = .49 ) .


The mean success rates at each attempt with the McGrath MAC were 82.0 % 38.8 % or more , equal to the Macintosh and the GlideScope Ranger in both scenarios ( P = .026 ; P = .72 ) except during the first intubation attempt in a normal airway ( P = .008 ) .


The median grades of the glottic view visible at each intubation attempt with the McGrath Mac were Cormack-Lehane grade 1 ( scenario 1 : interquartile range , 1-1 ; scenario 2 : interquartile range , 1-2 ) , which was significantly better than the Macintosh laryngoscope in both scenarios .


However , the McGrath Mac did not produce a better glottic view than the GlideScope Ranger with either scenario .


The intubation performance of novices using the McGrath MAC was equal to their performance using the GlideScope Ranger in regular simulated airways .


Complications are a common and accepted risk of surgery .


Failure to optimize the management of patients who suffer postoperative morbidity may result in poorer surgical outcomes .


This study aimed to evaluate a checklist-based tool to improve and standardize care of postoperative complications .


Surgical trainees conducted baseline ward rounds of three patients with common postoperative complications in a high-fidelity simulated ward environment .


Subjects were randomized to intervention or control groups , and final ward rounds were conducted with or without the aid of checklists for management of postoperative complications .


Adherence to critical care processes was assessed , in addition to technical ( Surgical Ward-care Assessment Tool , SWAT ) and non-technical ( Ward NOn-TECHnical Skills ( W-NOTECHS ) scale ) performance .


Subjects completed a feedback questionnaire regarding their perception of the checklists .


Twenty trainees completed 120 patient assessments .


All intervention group subjects opted to use the checklists , resulting in significantly fewer critical errors compared with controls ( median ( i.q.r. ) 0 ( 0-0 ) versus 60 ( 40-73 ) per cent ; P < 0001 ) .


The intervention group demonstrated improved patient management ( SWAT-M ) ( P < 0001 ) and non-technical skills ( P = 0043 ) between baseline and final ward rounds , whereas controls did not ( P = 0571 and P = 0809 respectively ) .


A small learning effect was seen with improvement in patient assessment ( SWAT-A ) in both groups ( P < 0001 ) .


Intervention group subjects found checklists easy and effective to use , and would want them used for their own care if they were to experience postoperative complications .


Checklist use resulted in significantly improved standardization , evidence-based management of postoperative complications , and quality of ward rounds .


Simulation-based piloting aided appropriate use of checklists and staff engagement .


Checklists represent a low-cost intervention to reduce rates of failure to rescue and to improve patient care .


We sought to improve lumbar spine bone mineral density ( LS-BMD ) in long-term survivors of childhood acute lymphoblastic leukemia ( ALL ) using calcium and cholecalciferol supplementation .


This double-blind , placebo-controlled trial randomized 275 participants ( median age , 17 [ 9-36 .1 ] years ) with age - and gender-specific LS-BMD Z-scores < 0 to receive nutritional counseling with supplementation of 1,000 mg/day calcium and 800 International Unit cholecalciferol or placebo for 2 years .


The primary outcome was change in LS-BMD assessed by quantitative computerized tomography ( QCT ) at 24 months .


Linear regression models were employed to identify the baseline risk factors for low LS-BMD and to compare LS-BMD outcomes .


Pre-randomization LS-BMD below the mean was associated with male gender ( P = 0.0024 ) , White race ( P = 0.0003 ) , lower body mass index ( P < 0.0001 ) , and cumulative glucocorticoid doses of 5,000 mg ( P = 0.0012 ) .


One hundred eighty-eight ( 68 % ) participants completed the study ; 77 % adhered to the intervention .


Mean LS-BMD change did not differ between survivors randomized to supplements ( 0.33 0.57 ) or placebo ( 0.28 0.56 ) .


Participants aged 9-13 years and those 22-35 years had the greatest mean increases in LS-BMD ( 0.50 0.66 and 0.37 0.23 , respectively ) .


Vitamin D insufficiency ( serum 25 [ OH ] D < 30 ng/ml ) found in 296 ( 75 % ) , was not associated with LS-BMD outcomes ( P = 0.78 ) .


Cholecalciferol and calcium supplementation provides no added benefit to nutritional counseling for improving LS-BMD among adolescent and young adult survivors of ALL ( 93 % of whom had LS-BMD Z-scores above the mean at study entry ) .


Strategies for oxygen therapy for preterm infants , such as the Vermont-Oxford 's ` Breathsavers ' guidelines , seek to strike a balance between the potential risks of the extremes of hyperoxia and hypoxia in preterm infants .


Using an algorithm based on those guidelines , we aimed to compare the proportion of time spent within the SpO2 target range during algorithm-based management of oxygen delivery compared with routine nursing care .


In a randomised crossover trial , maintenance of SpO2 over a 4-hour period during routine care was compared with algorithm-based control ( administered by a dedicated research nurse ) .


SpO2 target ( 88-92 % ) and alarm limits ( 86-94 % ) were identical in both arms .


Infants < 32 weeks ' gestation were eligible if having > 8 desaturations episodes to < 85 % / 4 h while receiving continuous positive airway pressure/synchronised intermittent mandatory ventilation .


Data was recorded via the Powerlab system from Masimo oximeters and Babylog 8000 + ventilators .


16 infants with a gestation of 26.7 1.3 weeks ( mean SD ) and birth weight 901 193 g were studied at a postmenstrual age of 30.5 2.4 weeks .


The percentage of time spent within target range was 34.6 28.5 % during routine care versus 38.3 29.3 % during algorithm-based care ( p = 0.23 ) .


Compliance with alarm limits was 58.4 21.8 % during routine versus 64.7 22.1 % for algorithm-based care ( p = 0.091 ) .


The frequency of desaturations , episode severity or number of FiO2 adjustments did not differ between the two care strategies .


The observation that algorithm-based control did not improve time spent within the SpO2 target and alarm limits suggests nursing care has reached an optimum in the unit studied .


Our finding indicates that significant modifications to the algorithm are likely to be necessary to improve target range compliance .


After a hip fracture , a catabolic state develops , with increased bone loss during the first year .


The aim of this study was to evaluate the effects of postoperative treatment with calcium , vitamin D , and bisphosphonates ( alone or together ) with nutritional supplementation on total hip and total body bone mineral density ( BMD ) .


Seventy-nine patients ( 56 women ) , with a mean age of 79 years ( range , 61-96 years ) and with a recent hip fracture , who were ambulatory before fracture and without severe cognitive impairment , were included .


Patients were randomized to treatment with bisphosphonates ( risedronate 35 mg weekly ) for 12 months ( B ; n = 28 ) , treatment with bisphosphonates along with nutritional supplementation ( 40 g protein , 600 kcal daily ) for the first 6 months ( BN ; n = 26 ) , or to controls ( C ; n = 25 ) .


All participants received calcium ( 1,000 mg ) and vitamin D3 ( 800 IU ) daily .


Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline , 6 , and 12 months .


Marker of bone resorption C-terminal telopeptide of collagen I and 25-hydroxy vitamin D were analyzed in serum .


Analysis of complete cases ( 70/79 at 6 months and 67/79 at 12 months ) showed an increase in total hip BMD of 0.7 % in the BN group , whereas the B and C groups lost 1.1 % and 2.4 % of BMD , respectively , between baseline and 6 months ( P = 0.071 , between groups ) .


There was no change in total body BMD between baseline and 12 months in the BN group , whereas the B group and C group both lost BMD , with C losing more than B ( P = 0.009 ) .


Intention-to-treat analysis was in concordance with the complete cases analyses .


Protein-and energy-rich supplementation in addition to calcium , vitamin D , and bisphosphonate therapy had additive effects on total body BMD and total hip BMD among elderly hip fracture patients .


Ten percent of the time , peripheral intravenous access ( PIV ) is not obtained in 2 attempts in the emergency department .


Typically , a tourniquet is used to dilate the target vein ; but recent research showed that a blood pressure ( BP ) cuff improves dilation , which may translate to increased PIV success .