The effect of institutional experience on overall survival ( OS ) in patients with stage III or IV HNC was investigated within a randomized trial of the Radiation Therapy Oncology Group ( RTOG 0129 ) , which compared cisplatin concurrent with standard versus accelerated fractionation radiotherapy .


As a surrogate for experience , institutions were classified as historically low - ( HLACs ) or high-accruing centers ( HHACs ) based on accrual to 21 RTOG HNC trials ( 1997 to 2002 ) .


The effect of accrual volume on OS was estimated by Cox proportional hazards models .


Median RTOG accrual ( 1997 to 2002 ) at HLACs was four versus 65 patients at HHACs .


Analysis included 471 patients in RTOG 0129 ( 2002 to 2005 ) with known human papillomavirus and smoking status .


Patients at HLACs versus HHACs had better performance status ( 0 : 62 % v 52 % ; P = .04 ) and lower T stage ( T4 : 26.5 % v 35.3 % ; P = .002 ) but were otherwise similar .


Radiotherapy protocol deviations were higher at HLACs versus HHACs ( 18 % v 6 % ; P < .001 ) .


When compared with HHACs , patients at HLACs had worse OS ( 5 years : 51.0 % v 69.1 % ; P = .002 ) .


Treatment at HLACs was associated with increased death risk of 91 % ( hazard ratio [ HR ] , 1.91 ; 95 % CI , 1.37 to 2.65 ) after adjustment for prognostic factors and 72 % ( HR , 1.72 ; 95 % CI , 1.23 to 2.40 ) after radiotherapy compliance adjustment .


OS is worse for patients with HNC treated at HLACs versus HHACs to cooperative group trials after accounting for radiotherapy protocol deviations .


Institutional experience substantially influences survival in locally advanced HNC .


Serial C-reactive protein ( CRP ) values may be useful for decision-making regarding duration of antibiotics in neonates .


However , established standard of practice for its use in preterm very low birth weight ( < 1500 g , VLBW ) infants are lacking .


Evaluate compliance with a CRP-guided computerized decision support ( CDS ) algorithm and compare characteristics and outcomes of compliant versus non-compliant cases .


Measure correlation between CRPs and white blood count ( WBC ) indices .


We examined 3 populations : 1 ) all preterm VLBW infants born at Vanderbilt 2006-2011 - we assessed provider compliance with CDS algorithm and measured relevant outcomes ; 2 ) all patients with positive blood culture results admitted to the Vanderbilt NICU 2006-2012 - we tested the correlation between CRP and WBC results within 7 days of blood culture phlebotomy ; 3 ) 1,000 randomly selected patients out of the 7,062 patients admitted to the NICU 2006-2012 - we correlated time-associated CRP values and absolute neutrophil counts .


Of 636 VLBW infants in cohort 1 ) , 569 ( 89 % ) received empiric antibiotics for suspected early-onset sepsis .


In 409 infants ( 72 % ) the CDS algorithm was followed ; antibiotics were discontinued 48 hours in 311 ( 55 % ) with normal serial CRPs and continued in 98 ( 17 % ) with positive CRPs , resulting in significant reduction in antibiotic exposure ( p < 0.001 ) without increase in complications or subsequent infections .


One hundred sixty ( 28 % ) were considered non-compliant because antibiotics were continued beyond 48 hours despite negative serial CRPs and blood cultures .


Serial CRPs remained negative in 38 ( 12 % ) of 308 blood culture-positive infants from cohort 2 , but only 4 patients had clinically probable sepsis with single organisms and no immunodeficiency besides extreme prematurity .


Leukopenia of any cell type was not linked with CRPs in cohorts 2 and 3 .


CDS/CRP-guided antibiotic use is safe and effective in culture-negative VLBW infants .


CRP results are not affected by low WBC indices .


To assess the efficacy of neoadjuvant systemic therapy ( NST ) at increasing the rate of successful breast-conserving therapy ( BCT ) in triple negative breast cancer .


Inducing tumor regression to permit BCT is often cited to support administration of NST .


To quantify this benefit , we conducted a surgical companion study to CALGB40603 , a randomized phase II , 22 factorial trial of neoadjuvant paclitaxel carboplatin bevacizumab ( B ) followed by doxorubicin plus cyclophosphamide B in stage II-III triple negative breast cancer .


Before and after NST , treating surgeons evaluated BCT candidacy by clinico-radiographic criteria ; surgery performed was at surgeon and patient discretion .


We measured ( 1 ) conversion rates from BCT-ineligible to BCT-eligible , ( 2 ) surgical choices in BCT candidates , and ( 3 ) rates of successful BCT with tumor-free margins .


Four hundred four patients were assessable for surgical outcomes .


Two hundred nineteen ( 54 % ) were BCT candidates before NST .


One hundred ninety-seven ( 90 % ) remained BCT candidates after NST , of whom 138 ( 70 % ) chose BCT , which was successful in 130 ( 94 % ) .


Of 185 ( 46 % ) who were not BCT candidates before NST , 78 ( 42 % ) converted to candidates with NST .


Of these , 53 ( 68 % ) chose BCT with a 91 % ( 48/53 ) success rate .


The overall BCT-eligibility rate rose from 54 % to 68 % ( 275/404 ) with NST .


Addition of carboplatin , B , or both increased conversion rates .


This is the first study to document prospectively a 42 % conversion rate from BCT-ineligible to BCT-eligible , resulting in a 14 % absolute increase in BCT eligibility .


BCT was successful in 93 % of patients who opted for it , but 31 % of BCT-eligible patients still chose mastectomy .


To investigate the role of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction .


This was a double-blinded , single-center , prospective , randomized , placebo-controlled trial .


After a 2-week phosphodiesterase type5 inhibitor washout period , patients were assessed with Sexual Health Inventory for Men , International Index of Erectile Function-ED domain scores and Erection Hardness Score .


Randomization into either the low-intensity extracorporeal shockwave therapy group or the sham group took place .


After the 9-week treatment period , patients were followed up 4 weeks later .


Follow-up assessment was in the form of International Index of Erectile Function-ED domain score and Erection Hardness Score .


A total of 70 patients were recruited into the study , 58 patients completed the study .


A total of 28 patients were randomized into the sham therapy arm , and 30 patients were randomized into the low-intensity extracorporeal shockwave therapy arm .


There was no significant difference between these two groups in baseline International Index of Erectile Function-ED domain score and Erection Hardness Score .


The mean International Index of Erectile Function-ED domain score of the low-intensity extracorporeal shockwave therapy arm and sham arm in week 13 were 17.84.8 and 15.86.1 , respectively ( P = 0.156 ) .


The mean Erection Hardness Scores in week13 were 2.70.5 and 2.40.9 , respectively ( P = 0.163 ) .


When patients were stratified into different baseline Sexual Health Inventory for Men subgroups , the pre-intervention and post-intervention difference in low-intensity extracorporeal shockwave therapy was found to be significant in the subgroup with severe erectile dysfunction ( low-intensity extracorporeal shockwave therapy International Index of Erectile Function-ED domain improvement : 10.14.1 vs sham therapy International Index of Erectile Function-ED domain improvement : 3.23.3 ; P = 0.003 ) .


The present trial shows the tolerability and clinical efficacy of low-intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction .


Cochlear implantation requires acclimatization to the electrical input .


Usually , cochlear implant ( CI ) listeners undergo an auditory rehabilitation program that includes auditory training sessions .


Recently , it was shown that a phoneme-based training may improve speech perception abilities even in experienced CI listeners .


The current study focuses on whether the effect of an auditory training program depends on the age of CI listeners .


Fifteen CI listeners took part in an auditory phoneme-based computer training program .


Before and after training , speech recognition tests in moderate and difficult noise ( +5 dB SNR and 0 dB SNR , respectively ) were administered .


Additionally , speech recognition was tested 6 months after the training ( follow-up ) .


A control group consisting of 12 subjects underwent audiometric testing without any auditory training .


Speech perception in moderate noise improved significantly during the training as revealed by comparing pre - and posttraining scores evaluated in the moderate noise condition .


No significant change was observed for the difficult noise situation at 0 dB SNR .


The speech perception measures of the control group remained unchanged .


No significant effect of age on the training effect was observed .


Speech recognition can be improved even in experienced CI listeners .


When motivated to participate , senior CI users with long-term CI experience may benefit in a similar way from an auditory , phoneme-based computer training program as younger CI users .


The aim of this study was to directly compare the effects of aerobic training ( AT ) with progressive resistance training ( RT ) after stroke to determine whether AT-induced fitness gains or RT-induced strength gains translate into improved ambulation across a 12-wk intervention and whether gains are retained 1 yr after cessation of formal training .


This study is a randomized controlled 12-wk intervention trial with a 1-yr follow-up .


Forty-three community-dwelling independent walkers with a chronic ischemic hemiparetic stroke were allocated to AT using a cycle ergometer ( n = 13 ) , RT using training machines ( n = 14 ) , or low-intensity sham training of the arms ( n = 16 ) .


The main outcome measures were 6-min walk distance and fast 10-m walking speed .


Comparisons between AT , RT , and sham training revealed no clinically relevant effects on walking velocity or walking distance .


Muscle strength improved after RT ( P < 0.0001 ) and was preserved at 1-yr follow-up ( P < 0.001 ) .


Aerobic capacity increased after AT ( P < 0.001 ) but was lost during the follow-up observation period .


Improvement of muscle strength or aerobic capacity using non-task-specific training methods does not result in improved ambulation in patients with chronic stroke .


Muscle strength gains were maintained at follow-up , whereas all improvements of aerobic capacity were lost , indicating a long-lasting effect of intensive RT even without maintenance training .


New designs of female condom have been developed to reduce costs and improve acceptability .


To secure regulatory approvals , clinical studies are needed to verify performance .


We aimed to assess the functional performance and safety of three new condom types-the Woman 's Condom , the VA worn-of-women ( wow ) Condom Feminine , and the Cupid female condom-against the existing second-generation female condom ( FC2 ) .


We did a randomised controlled , non-inferiority , four-period crossover trial at three sites in Shanghai , China , and one site in Durban , South Africa , between May 1 , 2011 , and Jan 31 , 2012 .


Participants aged 18-45 years who were sexually active , monogamous , not pregnant , and not sex workers , were eligible for inclusion if they were literate , had no known allergies to the study products ; used a reliable , non-barrier method of contraception , and had no visible or reported sexually transmitted infections .


We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients ( 1:1:1:1 ) to the FC2 control device , or the Woman 's , VA wow , or Cupid condoms , with 12 potential allocations .


Randomisation was stratified by site .


Participants were not masked to condom type , but allocation was concealed from study investigators .


The primary non-inferiority endpoints were total clinical failure and total female condom failure , with a non-inferiority margin of 3 % .


Women were asked to use five of each condom type and were interviewed after use of each type .


We also assessed safety data for each type .


We did both per-protocol and intention-to-treat analyses .


We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model .


This study is registered , number DOH-27-0113-4271 .


616 women were assessed for eligibility , of whom 600 were randomly assigned to condom-type order ( 30 , 120 , and 150 women in the three sites in China , and 300 women in the site in South Africa ) .


572 women completed follow-up , with at least one condom of each type .


Total female condom failure was 343 % for FC2 , 385 % for the Woman 's Condom ( difference 042 % , 90 % CI -142 to 226 ) , 302 % for VA wow ( -042 % , -186 to 132 ) , and 452 % for Cupid ( 109 % , -060 to 278 ) ; total clinical failure was 288 % , 305 % ( 017 % , -148 to 181 ) , 249 % ( -025 % , -175 to 126 ) , and 387 % ( 099 % , -055 to 252 ) , respectively .


Only two ( < 1 % ) participants , in South Africa , reported serious adverse events , unrelated to use of the study products .


Non-inferiority was shown for all condom failure events for the three new devices versus the FC2 , within the predefined margin .


Universal Access to Female Condoms ( UAFC ) .


To investigate whether vaginal Group B Streptococcus ( GBS ) colonisation or other baseline characteristics of women with preterm premature rupture of membranes ( PPROM ) can help in identifying subgroups of women who would benefit from immediate delivery .


Secondary analysis of the PPROMEXIL trials .


Sixty hospitals in the Netherlands .


Women with PPROM between 34 and 37 weeks of gestation .


Random assignment of 723 women to immediate delivery or expectant management .


Early onset neonatal sepsis .


Vaginal GBS colonisation status was the only marker which was significantly associated with the benefit of immediate delivery ( P for interaction : 0.04 ) .


GBS colonisation was observed in 14 % of women .


The risk of early onset neonatal sepsis in GBS-positive women was high ( 15.2 % ) when they were managed expectantly but this risk was reduced to 1.8 % with immediate delivery .


The early onset neonatal sepsis risk was much lower in neonates of GBS-negative women : 2.6 % after expectant management and 2.9 % with immediate delivery .


We estimated that by inducing labour only in GBS-positive women , there would be a 10.4 % increase in term delivery rate , while keeping neonatal sepsis and caesarean delivery rates comparable to a strategy of labour induction for all .


Our post hoc findings suggest that women with PROM between 34 and 37 weeks might benefit from immediate delivery if they have GBS vaginal colonisation , while in GBS-negative women labour induction could be delayed until 37 weeks .


Depletion of B lymphocytes is associated with suppression of inflammatory activity in multiple sclerosis .


We aimed to assess the safety and efficacy of atacicept , a recombinant fusion protein that suppresses B-cell function and antibody production .


In this placebo-controlled , double-blind , 36-week , phase 2 trial ( ATAMS ) in Australia , Canada , Europe , and the USA , patients aged 18-60 years with relapsing multiple sclerosis were randomly assigned via an interactive voice response system in a 1:1:1:1 ratio , stratified by geographical region , to receive weekly subcutaneous injections with atacicept ( 25 , 75 , or 150 mg ) or placebo .


Both patients and study personnel were masked to treatment assignment .


The primary endpoint was the change in mean number of gadolinium-enhancing lesions on T1-weighted MRI per patient per scan between weeks 12 and 36 .


Efficacy endpoints were analysed in the intention-to-treat population .


Patients who completed week 36 were eligible to participate in a long-term extension study ( ATAMS EXT ) , consisting of a double-blind phase followed by an open-label phase , for a total study time of up to 5 years .


The study was terminated early after the independent data and safety monitoring board noted an increased annualised relapse rate with atacicept .


The protocol was subsequently amended to include a 60-week safety follow-up , to allow treatment with approved multiple sclerosis drugs , and to change the primary endpoint to gadolinium-enhancing T1 lesions per scan during the entire double-blind period of ATAMS .


Both the trial and the extension are registered with ClinicalTrials.gov , numbers NCT00642902 ( ATAMS ) and NCT00853762 ( ATAMS EXT ) .


Between April 23 , 2008 , and early study termination on Sept 11 , 2009 , 255 patients were randomly assigned : 63 to placebo , 63 to atacicept 25 mg , 64 to 75 mg , and 65 to 150 mg .


90 ( 35 % ) patients completed the week 36 treatment visit , 26 ( 10 % ) discontinued before study termination ( including one who dropped out before receiving study treatment ) , and 139 ( 55 % ) discontinued because of study termination .


During the double-blind period of ATAMS , annualised relapse rates were higher in the atacicept groups than in the placebo group ( atacicept 25 mg , 086 , 95 % CI 043-174 ; 75 mg , 079 , 040-158 ; 150 mg , 098 , 052-181 ; placebo , 038 , 017-087 ) .


Mean numbers of gadolinium-enhancing T1 lesions per scan were similar in all groups ( 25 mg , 226 , 097-527 ; 75 mg , 230 , 108-492 ; 150 mg , 249 , 118-527 ; placebo , 307 , 140-677 ) .


Seven patients ( one taking placebo and six atacicept ) discontinued treatment because of adverse events .


One death occurred in the placebo group .


During the safety follow-up , immunoglobulin concentrations and B-cell counts returned towards predose values and annualised relapse rates in the atacicept groups decreased until they were similar to that of the placebo group


Increased clinical disease activity associated with atacicept suggests that the role of B cells and humoral immunity in multiple sclerosis is complex .


For studies that explore therapeutic immunomodulation in multiple sclerosis , rigorous monitoring for negative effects on clinical and MRI outcomes is warranted .


Merck Serono ( Merck KGaA ) and EMD Serono ( Merck KGaA ) .


This study evaluated the effectiveness of using trained volunteer staff in reducing 30-day readmissions of congestive heart failure ( CHF ) patients .


From June 2010 to December 2010 , 137 patients ( mean age 73 years ) hospitalized for CHF were randomly assigned to either : an interventional arm ( arm A ) receiving dietary and pharmacologic education by a trained volunteer , follow-up telephone calls within 48 hours , and a month of weekly calls ; or a control arm ( arm B ) receiving standard care .


Primary outcomes were 30-day readmission rates for CHF and worsening New York Heart Association ( NYHA ) functional classification ; composite and all-cause mortality were secondary outcomes .


Arm A patients had decreased 30-day readmissions ( 7 % vs 19 % ; P < .05 ) with a relative risk reduction ( RRR ) of 63 % and an absolute risk reduction ( ARR ) of 12 % .


The composite outcome of 30-day readmission , worsening NYHA functional class , and death was decreased in the arm A ( 24 % vs 49 % ; P < .05 ; RRR 51 % , ARR 25 % ) .


Standard-care treatment and hypertension , age 65 years and hypertension , and cigarette smoking were predictors of increased risk for readmissions , worsening NYHA functional class , and all-cause mortality , respectively , in the multivariable analysis .


Utilizing trained volunteer staff to improve patient education and engagement might be an efficient and low-cost intervention to reduce CHF readmissions .


To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia ( IXT ) in children .


Multicenter , randomized clinical trial .


Three hundred fifty-eight children 3 to < 11 years of age with previously untreated ( except for refractive correction ) IXT and near stereoacuity of 400 seconds of arc or better were enrolled .


Intermittent exotropia met the following criteria : ( 1 ) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near ; ( 2 ) exodeviation ( tropia or phoria ) of at least 15 prism diopters ( PD ) at distance or near by prism and alternate cover test ( PACT ) ; and ( 3 ) exodeviation of at least 10 PD at distance by PACT .


Participants were assigned randomly either to observation ( no treatment for 6 months ) or to patching for 3 hours daily for 5 months , with a 1-month washout period of no patching before the 6-month primary outcome examination .


The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit , defined as : ( 1 ) constant exotropia measuring at least 10 PD at distance and near by simultaneous prism and cover test , and/or ( 2 ) near stereoacuity decreased by at least 2 octaves from baseline , both assessed by a masked examiner and confirmed by a retest .


Participants who were prescribed any nonrandomized treatment without first meeting either deterioration criteria also were counted as having deteriorated .


Of the 324 participants ( 91 % ) completing the 6-month primary outcome examination , deterioration occurred in 10 of the 165 participants ( 6.1 % ) in the observation group ( 3 of these 10 started treatment without meeting deterioration criteria ) and in 1 of the 159 participants ( 0.6 % ) in the part-time patching group ( difference , 5.4 % ; lower limit of 1-sided exact 95 % confidence interval , 2.0 % ; P = 0.004 , 1-sided hypothesis test ) .


Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment .


Although there is a slightly lower deterioration rate with patching , both management approaches are reasonable for treating children 3 to 10 years of age with IXT .


Panitumumab is a fully human monoclonal antibody that targets EGFR .


We aimed to compare chemoradiotherapy plus panitumumab with chemoradiotherapy alone in patients with unresected , locally advanced squamous-cell carcinoma of the head and neck .


In this international , open-label , randomised , controlled , phase 2 trial , we recruited patients with locally advanced squamous-cell carcinoma of the head and neck from 41 sites in nine countries worldwide .


Patients aged 18 years and older with stage III , IVa , or IVb , previously untreated , measurable ( 10 mm for at least one dimension ) , locally advanced squamous-cell carcinoma of the head and neck ( non-nasopharygeal ) and an Eastern Cooperative Oncology Group performance status of 0-1 were randomly assigned ( 2:3 ) by an independent vendor to open-label chemoradiotherapy ( three cycles of cisplatin 100 mg/m ( 2 ) ) or panitumumab plus chemoradiotherapy ( three cycles of intravenous panitumumab 9.0 mg/kg every 3 weeks plus cisplatin 75 mg/m ( 2 ) ) using stratified randomisation with a block size of five .


All patients received 70 Gy to gross tumour and 50 Gy to areas at risk for subclinical disease with standard fractionation .


The primary endpoint was local-regional control at 2 years , analysed in all randomised patients who received at least one dose of their assigned protocol-specific treatment ( chemotherapy , radiation , or panitumumab ) .


The trial is closed and this is the final analysis .


This trial is registered with ClinicalTrials.gov , number NCT00500760 .


Between Oct 26 , 2007 , and March 26 , 2009 , 153 patients were enrolled and 150 received treatment ( 63 in the chemoradiotherapy group and 87 in the panitumumab plus chemoradiotherapy group ) .


Local-regional control at 2 years was 68 % ( 95 % CI 54-78 ) in the chemoradiotherapy group and 61 % ( 50-71 ) in the panitumumab plus chemoradiotherapy group .


The most frequent grade 3-4 adverse events were dysphagia ( 17 [ 27 % ] of 63 patients in the chemoradiotherapy group vs 35 [ 40 % ] of 87 in the panitumumab plus chemoradiotherapy group ) , mucosal inflammation ( 15 [ 24 % ] vs 48 [ 55 % ] ) , and radiation skin injury ( eight [ 13 % ] vs 27 [ 31 % ] ) .


Serious adverse events were reported in 20 ( 32 % ) of 63 patients in the chemoradiotherapy group and in 37 ( 43 % ) of 87 patients in the panitumumab plus chemoradiotherapy group .


In patients with locally advanced squamous-cell carcinoma of the head and neck , the addition of panitumumab to standard fractionation radiotherapy and cisplatin did not confer any benefit , and the role of EGFR inhibition in these patients needs to be reassessed .


Amgen .


Changes in IL-6 , TNF - , and TNF - receptors - sTNFRI and sTNFRII - were evaluated in a group of professional cyclists treated with immunomodulator AM3 ( Inmunofern ) for 6 months of training and competition .


Sixteen male professional cyclists with a similar training program participated in the study which was designed as a randomized , placebo-controlled , double-blind clinical trial .


Venous blood samples were collected in basal conditions , before beginning the supplementation program , and after 90 and 180 days of training and competition season .


No significant differences in biochemical parameters or in IL-6 were evidenced between placebo and AM3-treated groups throughout the study .


Plasma TNF - levels significantly decreased ( P < 0.05 ) after 90 days of training in the AM3 treated group .


TNF - receptors increased during training season in both placebo and AM3 treated groups , although the increase was significantly higher ( P < 0.05 ) in the AM3 group with respect to the placebo group .


The changes produced by regular training and competition were modified throughout the season by AM3 treatment which could reduce the inflammatory response to excessive exercise .


Text messaging has successfully supported smoking cessation .


This study compares a mobile application with text messaging to support smoking cessation .


Young adult smokers 18-30 years old ( n = 102 ) participated in a randomized pretest-posttest trial .


Smokers received a smartphone application ( REQ-Mobile ) with short messages and interactive tools or a text messaging system ( onQ ) , managed by an expert system .


Self-reported usability of REQ-Mobile and quitting behavior ( quit attempts , point-prevalence , 30-day point-prevalence , and continued abstinence ) were assessed in posttests .


Overall , 60 % of smokers used mobile services ( REQ-Mobile , 61 % , mean of 128.5 messages received ; onQ , 59 % , mean of 107.8 messages ) , and 75 % evaluated REQ-Mobile as user-friendly .


A majority of smokers reported being abstinent at posttest ( 6 weeks , 53 % of completers ; 12 weeks , 66 % of completers [ 44 % of all cases ] ) .


Also , 37 % ( 25 % of all cases ) reported 30-day point-prevalence abstinence , and 32 % ( 22 % of all cases ) reported continuous abstinence at 12 weeks .


OnQ produced more abstinence ( p < 0.05 ) than REQ-Mobile .


Use of both services predicted increased 30-day abstinence at 12 weeks ( used , 47 % ; not used , 20 % ; p = 0.03 ) .


REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging .


Text messaging may work better because it is simple , well known , and delivered to a primary inbox .


These advantages may disappear as smokers become more experienced with new handsets .


Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging .


Collaborative care programmes lead to better outcomes in the management of depression .


A programme of this nature has demonstrated its effectiveness in primary care in Spain .


Our objective was to evaluate the cost-effectiveness of this programme compared to usual care .


A bottom-up cost-effectiveness analysis was conducted within a randomized controlled trial ( 2007-2010 ) .


The intervention consisted of a collaborative care programme with clinical , educational and organizational procedures .


Outcomes were monitored over a 12 months period .


Primary outcomes were incremental cost-effectiveness ratios ( ICER ) : mean differences in costs divided by quality-adjusted life years ( QALY ) and mean differences in costs divided by depression-free days ( DFD ) .


Analyses were performed from a healthcare system perspective ( considering healthcare costs ) and from a society perspective ( including healthcare costs plus loss of productivity costs ) .


Three hundred and thirty-eight adult patients with major depression were assessed at baseline .


Only patients with complete data were included in the primary analysis ( 166 in the intervention group and 126 in the control group ) .


From a healthcare perspective , the average incremental cost of the programme compared to usual care was 182.53 ( p < 0.001 ) .


Incremental effectiveness was 0.045 QALY ( p = 0.017 ) and 40.09 DFD ( p = 0.011 ) .


ICERs were 4,056 / QALY and 4.55 / DFD .


These estimates and their uncertainty are graphically represented in the cost-effectiveness plane .


The amount of 13.6 % of patients with incomplete data may have introduced a bias .


Available data about non-healthcare costs were limited , although they may represent most of the total cost of depression .


The intervention yields better outcomes than usual care with a modest increase in costs , resulting in favourable ICERs .


This supports the recommendation for its implementation .


To investigate the effects of intravenous administration of dexamethasone on early postoperative cognitive dysfunction ( POCD ) .


In this prospective randomized trial , 1000 patients with facial spasm undergoing microvascular decompression ( MVD ) were randomly assigned to receive normal sodium ( Dex-0 group , n = 333 ) , dexamethasone 0.1 mg/kg ( Dex-1 group , n = 333 ) , or dexamethasone 0.2 mg/kg ( Dex-2 group , n = 334 ) .


Exclusion criteria included : a history of neurologic or mental disease , renal failure , active liver disease , cardiac or pulmonary dysfunction , endocrine , metabolic , or peptic ulcer disease , a history of past surgery , < 6 years of schooling , inability to complete neuropsychological testing , visual dysfunction , and auditory dysfunction .


Patients were also excluded at any point if additional steroid was required .


Propofol and sufentanil were administered for anesthetic induction , whereas propofol and remifentanil were given for maintenance of anesthesia .


A battery of 9 neuropsychological tests was administered preoperatively and the on day 5 postoperatively .


A postoperative deficit was defined as a postoperative decrement to preoperative score of > 1SD on any test .


Patients who experienced > 2 deficits were considered to have experienced early POCD .


Nine hundred and fifty-four patients completed both preoperative and postoperative neuropsychological testing .


Within the 3 groups : Dex-0 group , n = 319 ; Dex-1 group , n = 320 and Dex-2 , n = 315 .


POCD occurred in 71 patients ( 22.3 % ) in the Dex-0 group , in 66 patients ( 20.6 % ) in the Dex-1 group , and 99 patients ( 31.4 % ) in the Dex-2 group .


POCD was significant among the 3 groups ( P = 0.003 ) .


Partitions of method was applied for multiple comparisons showing that Dex-2 group was significantly different from Dex-1 and Dex-0 groups .


Administration of higher dose of dexamethasone ( 0.2 mg/kg ) increases the incidence of POCD in the early postoperative period after microvascular decompression under general anesthesia .


Irisin , a recently discovered myokine , has been shown to induce browning of white adipose tissue , enhancing energy expenditure and mediating some of the beneficial effects of exercise .


We aimed to estimate the time frame of changes in irisin levels after acute exercise and the effect of different exercise workloads and intensities on circulating irisin levels immediately post-exercise .


In a pilot study , four healthy subjects ( 22.51.7 years ) underwent maximal workload exercise ( maximal oxygen consumption , VO2 max ) and blood was drawn at prespecified intervals to define the time frame of pre - and post-exercise irisin changes over a 24-h period .


In the main study , 35 healthy , non-smoking ( 23.03.3 years ) men and women ( n = 20/15 ) underwent three exercise protocols 48-h apart , in random order : i ) maximal workload ( VO2 max ) ; ii ) relative workload ( 70 % of VO2 max/10min ) ; and iii ) absolute workload ( 75W/10min ) .


Blood was drawn immediately pre-exercise and 3min post-exercise .


In the pilot study , irisin levels increased by 35 % 3min post-exercise , then dropped and remained relatively constant .


In the main study , irisin levels post-exercise were significantly higher than those of pre-exercise after all workloads ( all , P < 0.001 ) .


Post-to-pre-exercise differences in irisin levels were significantly different between workloads ( P = 0.001 ) , with the greatest increase by 34 % following maximal workload ( P = 0.004 vs relative and absolute ) .


Circulating irisin levels were acutely elevated in response to exercise , with a greater increase after maximal workload .


These findings suggest that irisin release could be a function of muscle energy demand .


Future studies need to determine the underlying mechanisms of irisin release and explore irisin 's therapeutic potential .


Benzodiazepines are extensively used in primary care , but their long-term use is associated with adverse health outcomes and dependence .


To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use .


A multicentre three-arm cluster randomised controlled trial was conducted , with randomisation at general practitioner level ( trial registration ISRCTN13024375 ) .


A total of 532 patients taking benzodiazepines for at least 6 months participated .


After all patients were included , general practitioners were randomly allocated ( 1:1:1 ) to usual care , a structured intervention with follow-up visits ( SIF ) or a structured intervention with written instructions ( SIW ) .


The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months .


At 12 months , 76 of 168 ( 45 % ) patients in the SIW group and 86 of 191 ( 45 % ) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 ( 15 % ) in the control group .


After adjusting by cluster , the relative risks for benzodiazepine discontinuation were 3.01 ( 95 % CI 2.03-4 .46 , P < 0.0001 ) in the SIW and 3.00 ( 95 % CI 2.04-4 .40 , P < 0.0001 ) in the SIF group .


The most frequently reported withdrawal symptoms were insomnia , anxiety and irritability .


Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity .


A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits .


Memantine , an uncompetitive antagonist of N-methyl-d-aspartate receptors , may have a role in managing symptoms associated with dementia in Parkinson 's disease ( PDD ) , although its role in improving patient-reported outcomes ( PROs ) has not been extensively investigated .


PROs may be more sensitive than standard psychometric measures for detecting change in complex conditions such as PDD .


The aim of this study was to examine the effect of memantine on PROs : individually determined goals and health-related quality of life .


We also examined memantine 's effect on caregiver burden .


This 22-week double-blind randomised controlled trial evaluated participants with PDD on 20mg of memantine or placebo .


Outcome measures were Goal Attainment Scaling ( GAS ) , the Parkinson 's Disease Questionnaire-8 and the Zarit Burden Inventory .


A significantly greater proportion of participants on memantine ( 64 % ) had better than expected GAS outcomes compared with those on placebo ( 7 % ) ( p = 0.007 ) .


Furthermore , the improvement in mean GAS score , as well as mean caregiver burden score , from baseline to drug discontinuation was significantly greater in those on memantine compared with those on placebo ( p = 0.03 and 0.04 , respectively ) .


Significant differences in quality of life were not seen .


In this study , memantine improved individually set goals and caregiver burden in PDD .


This suggests that clinimetric measures such as GAS may be more sensitive than conventional psychometric measures in detecting improvements in people with PDD .


Fatigue is a common yet difficult to treat condition in primary care .


The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy ( CBT ) based fatigue self-management ( FSM ) intervention as compared to usual care among patients with chronic fatigue in primary care .


An economic evaluation alongside of a parallel randomized controlled study design was used .


Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments .


Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook , New York .


The FSM group ( n = 37 ) received two sessions of a nurse-delivered , fatigue self-management protocol and a self-help book and the usual care group ( n = 36 ) received regular medical care .


The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up .


A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios ( ICERs ) and net monetary benefit ( NMB ) were calculated as measures of cost-effectiveness .


The ICER for FSM was - $ $ 2358 , indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care .


Complete case analysis yielded smaller ICER ( - $ 1199 ) with greater uncertainties .


Net monetary benefit analysis showed that FSM has a probability of 0.833 ( 95 % CI : 0.819 , 0.847 ) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs .


This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months .


The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care .


Additional research is needed to examine the reproducibility and generalizability of these findings .


ClinicalTrials.gov ( NCT00997451 , March 28 , 2009 ) .


The purpose of this study was to evaluate the effect of a physical activity telemonitoring program on daily physical activity level , oxygen uptake capacity ( VO ( 2peak ) ) , and cardiovascular risk profile in coronary artery disease ( CAD ) patients who completed phase II cardiac rehabilitation ( CR ) .


Eighty CAD patients who completed phase II CR were randomly assigned to an additional telemonitoring intervention or standard CR .


The patients in the intervention group ( n = 40 ) wore a motion sensor continuously for 18 weeks .


Each week these patients received a step count goal , with the aim to gradually increase the patients ' physical activity level .


In the control group ( n = 40 ) , the patients wore an unreadable motion sensor for seven days for measurement purposes only ( at start of follow-up , and after six and 18 weeks ) .


At start of follow-up and after 18 weeks blood lipid profile , glycemic control , waist circumference and body mass index was assessed .


VO ( 2peak ) was assessed at start of follow-up , and after six and 18 weeks .


Re-hospitalisation rate was followed during this timeframe .


In the intervention group , VO ( 2peak ) increased significantly during follow-up ( P = 0.001 ) , in the control group it did not ( P = 0.273 ) .


A significant correlation was found between daily aerobic step count and improvement in VO ( 2peak ) ( P = 0.030 , r = 0.47 ) .


Kaplan-Meier curve analysis showed a trend towards fewer re-hospitalisations for patients in the telemonitoring group ( P = 0.09 ) .


The study showed that , to maintain exercise tolerance and lower re-hospitalisation rate after hospital-based CR in CAD patients , a physical activity telemonitoring program might be an effective intervention .


To compare the effects of different levels of positive end-expiratory pressure on respiratory mechanics and oxygenation indexes in the immediate postoperative period of coronary artery bypass grafting .


Randomized clinical trial in which 136 patients underwent coronary artery bypass grafting between January 2011 and March 2012 were divided into three groups and admitted to mechanical ventilation with different positive end-expiratory pressure levels : Group A , 5 cmH2O ( n = 44 ) , Group B , 8 cmH2O ( n = 47 ) and Group C , 10 cmH2O ( n = 45 ) .


Data about respiratory mechanics were obtained from mechanical ventilator monitor and oxygenation indexes from arterial blood gas samples , collected twenty minutes after intensive care unit admission .


Patients with chronic obstructive pulmonary disease and patients submitted to off-pump , emergency or combined operations were not included .


For statistical analysis , we used Kruskal-Wallis , G and Chi-square tests , considering results significant when P < 0.05 .


Groups were homogeneous in terms of demographic , clinical and surgical variables .


Patients ventilated with positive end-expiratory pressure of 10 cmH2O ( Group C ) had best compliance ( P = 0.04 ) and airway resistance values , this , however , without statistical significance .


They also had best oxygenation indexes , with statistical difference in all analyzed variables , and lower frequency of hypoxemia ( P = 0.03 ) .


Higher levels of positive end-expiratory pressure in immediate postoperative period of coronary artery bypass grafting improved pulmonary compliance values and increased oxygenation indexes , resulting in lower frequency of hypoxemia .


Delirium is a common complication after cardiac surgery and may be as a result of inadequate cerebral perfusion .


We studied delirium after cardiac surgery in relation to intraoperative hypotension ( IOH ) .


This observational single-centre , cohort study was nested in a randomized trial , on a single intraoperative dose of dexamethasone vs placebo during cardiac surgery .


During the first four postoperative days , patients were screened for delirium based on the Confusion Assessment Method ( CAM ) for Intensive Care Unit on the intensive care unit , CAM on the ward , and by inspection of medical records .


To combine depth and duration of IOH , we computed the area under the curve for four blood pressure thresholds .


Logistic regression analyses were performed to investigate the association between IOH and the occurrence of postoperative delirium , adjusting for confounding and using a 99 % confidence interval to correct for multiple testing .


Of the 734 included patients , 99 patients ( 13 % ) developed postoperative delirium .


The adjusted Odds Ratio for the Mean Arterial Pressure < 60 mm Hg threshold was 1.04 ( 99 % confidence interval : 0.99-1 .10 ) for each 1000 mm Hg ( 2 ) min ( 2 ) AUC ( 2 ) increase .


IOH , as defined according to the other three definitions , was not associated with postoperative delirium either .


Deep and prolonged IOH seemed to increase the risk of delirium , but this was not statistically significant .


Independent of the applied definition , IOH was not associated with the occurrence of delirium after cardiac surgery .


This study sought to determine the most effective technique for Valsalva Manoeuvre ( VM ) and Human Dive Reflex Manoeuvre ( HDR ) generation of vagal tone .


We conducted a repeated-measures trial of healthy adult volunteers from a university campus , aged 18-56years , in sinus rhythm .


Participants were randomised to VM ( in supine or Trendelenberg postures ) and HDR ( supine or sitting postures ) sequentially .


Participants performed three trials of each technique , in random order , with a continuous ECG recording .


Single-blinded analysis of ECG data was conducted .


Mean differences between premanoeuvre and postmanoeuvre R-R intervals and heart rates were calculated for each posture within and between vagal manoeuvres .


Seventy-two participants were enrolled .


The difference between VM ( supine ) and VM ( Trendelenberg ) was not significant at 0.008 s ( -0.023 to 0.038 ) .


The difference in mean R-R intervals for HDR ( supine ) was greater than HDR ( sitting ) 0.062 ( 0.031 to 0.093 ) , although this significance was not reflected in a heart-rate change of -0.87 ( -3.00 to 1.26 ) .


VM supine generated greatest overall mean R-R interval difference , while HDR ( sitting ) provided the smallest change in R-R interval .


The VM ( supine ) provided a significant maximum effectiveness over the HDR ( supine ) of 0.102 s ( 0.071 to 0.132 ) .


This study demonstrates that VM ( supine ) generates the greatest vagal tone producing the largest transient heart rate decrease in healthy volunteers .


No advantage was identified in Trendelenberg posturing for the VM in this study .


These results may assist in the standardisation of vagal manoeuvre technique for the range of therapeutic and diagnostic applications .


Traditional Chinese Medicine ( TCM ) possesses several advantages for treating patients with hepatocellular carcinoma ( HCC ) .


The theory of ` Jianpi Huayu Therapy ' rooted from ` Jin Kui Yao Lue ' is one of the most important therapies in this respect .


This study was conducted to investigate the clinical effect and safety of hepatectomy combining with ` Jianpi Huayu Therapy ' in the treatment of HCC .


One hundred and twenty patients with HCC were randomized allocated into hepatectomy combined with ` Jianpi Huayu Therapy ' group ( treatment group , n = 60 ) and hepatectomy alone group ( control group , n = 60 ) .


Disease-free survival ( DFS ) and overall survival ( OS ) were the primary end-points .


Liver function at the end of one week after surgery , complications , average days of hospitalization as well as performance status ( PS ) at the end of one month post operation were also compared .


No significant differences existed between two groups on baseline analysis ( p > 0.05 ) .


No treatment related mortality occurred in either group .


Post-operative complications were detected among 14 patients ( 23.3 % ) in the treatment group , and 12 ( 20.0 % ) in the control group ( p = 0.658 ) .


Alanine aminotransferase ( ALT ) at the end of one week after operation was lower in the treatment than control groups ( p = 0.042 ) .


No significant differences in other indexes of liver function were discovered between two groups .


Average days of hospitalization reduced by 0.9 day in treatment group than in control ( p = 0.034 ) .


During follow-up , 104 patients ( 86.6 % ) developed recurrence .


The rates of 1 - , 3 - , and 5-year DFS and median DFS for all patients were 77.4 % , 26.3 % , 9.0 % and 25.6 months ( range , 6.0 ~ 68.0 ) , respectively ( 78.2 % , 29.2 % , 14.3 % and 28.7 months for the 48 patients in the treatment group and 75.0 % , 23.3 % , 6.4 % , and 22.6 months for the 56 patients in the control group ( p = 0.045 ) ) .


101 patients had died at the time of censor , with 1 - , 3 - , and 5-year overall survival rates and median survival for all patients of 97.5 % , 76.4 % , 40.5 % and 51.2 months ( range , 10.0 ~ 72.0 ) , respectively ( 98.3 % , 78.0 % , 43.6 % and 52.6 months , for treatment and 96.7 % , 74.7 % , 37.4 % , and 49.8 months , for controls , respectively ( p = 0.048 ) ) .


Hepatectomy combined with ` Jianpi Huayu therapy ' was effective in the treatment of HCC , and reduced post-operative recurrence and metastasis and improved DFS and OS of HCC patients .


The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events .


We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up .


This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents .


Primary end point was combined all-cause death , any recurrent myocardial infarction , and any revascularization .


All end points were analyzed according to sex at 2-year follow-up .


Of 1498 patients included in the trial , 254 ( 17.0 % ) were women .


Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men .


In contrast with men , stent diameter was smaller in women .


After multivariate analysis , the primary end point was similar between women and men ( hazard ratio = 0.95 ; 95 % confidence interval , 0.66-1 .37 ) , and among women , between those treated with bare-metal vs everolimus-eluting stents ( hazard ratio = 2.48 ; 95 % confidence interval , 0.95-6 .46 ) .


Women showed a lower rate of repeat revascularization than men ( hazard ratio = 0.55 ; 95 % confidence interval , 0.32-0 .95 ) despite worse baseline characteristics .


This difference was driven by better performance of the everolimus-eluting stent in women .


Despite poorer baseline clinical characteristics , women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men .


The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men .


Emerging cellular markers of endothelial damage and repair include endothelial microparticles ( EMPs ) and endothelial progenitor cells ( EPCs ) , respectively .


Effects of long-chain ( LC ) n-3 ( omega-3 ) polyunsaturated fatty acids ( PUFAs ) and the influence of genetic background on these markers are not known .


We investigated effects of fish-oil supplementation on both classical and novel markers of endothelial function in subjects prospectively genotyped for the Asp298 endothelial nitric oxide synthase ( eNOS ) polymorphism and at moderate risk of cardiovascular disease ( CVD ) .


A total of 84 subjects with moderate risk of CVD ( GG : n = 40 ; GT/TT : n = 44 ) completed a randomized , double-blind , placebo-controlled , 8-wk crossover trial of fish-oil supplementation that provided 1.5 g LC n-3 PUFAs/d .


Effects of genotype and fish-oil supplementation on the blood lipid profile , inflammatory markers , vascular function ( by using peripheral artery tonometry ) , and numbers of circulating EPCs and EMPs ( by using flow cytometry ) were assessed .


There was no significant effect of fish-oil supplementation on blood pressure , plasma lipids , or plasma glucose , although there was a trend ( P = 0.069 ) toward a decrease in the plasma triglyceride concentration after fish-oil supplementation compared with placebo treatment .


GT/TT subjects tended to have higher concentrations of total cholesterol and low-density lipoprotein cholesterol , but vascular function was not affected by either treatment or eNOS genotype .


Biochemical markers of endothelial function were also unaffected by treatment and eNOS genotype .


In contrast , there was a significant effect of fish-oil supplementation on cellular markers of endothelial function .


Fish-oil supplementation increased numbers of EPCs and reduced numbers of EMPs relative to those with placebo treatment , which potentially favored the maintenance of endothelial integrity .


There was no influence of genotype for any cellular markers of endothelial function , which indicated that effects of fish-oil supplementation were independent of eNOS genotype .


Emerging cellular markers of endothelial damage , integrity , and repair appear to be sensitive to potentially beneficial modification by dietary n-3 PUFAs .


This trial was registered at www.controlled-trials.com/isrctn as ISRCTN76272133 .


Data are limited on effects of household or community support persons ( `` care buddies '' ) on enrollment into and adherence to pre-antiretroviral HIV care .


We assessed the impact of care buddies on adherence to HIV clinic appointments , HIV progression , and conduct of daily life among pre-antiretroviral therapy ( pre-ART ) HIV-infected individuals in Rakai , Uganda .


A total of 1209 HIV-infected pre-ART patients aged 15 years were randomized to standard of care ( SOC ) ( n = 604 ) or patient-selected care buddy ( PSCB ) ( n = 605 ) and followed at 6 and 12 months .


Outcomes were adherence to clinic visits , HIV disease progression , and self-reported conduct of daily life .


Incidence and prevalence rate ratios and 95 % confidence intervals ( CIs ) were used to assess outcomes in the intent-to-treat and as-treated analyses .


Baseline characteristics were comparable .


In the intent to treat analysis , both arms were comparable with respect to adherence to CD4 monitoring visits [ adjusted prevalence risk ratio ( adjPRR ) , 0.98 ; 95 % CI : 0.93 to 1.04 ; P = 0.529 ] , and ART eligibility ( adjPRR , 1.00 ; 95 % CI : 0.77 to 1.31 ; P = 0.946 ) .


Good conduct of daily life was significantly higher in the PSCB than the SOC arm ( adjPRR , 1.08 ; 95 % CI : 1.03 to 1.13 ; P = 0.001 ) .


More men ( 61 % ) compared with women ( 30 % ) selected spouses/partners as buddies ( P < 0.0001 ) .


Twenty-two percent of PSCB arm participants discontinued use of buddies .


In pre-ART persons , having care buddies improved the conduct of daily life of the HIV-infected patients but had no effect on HIV disease progression and only limited effect on clinic appointment adherence .


Reproductive health and sexually transmitted diseases ( STD ) account for a high proportion of health problems in the rural-to-urban young female migrant workers in China .


Improving these conditions remains highly challenging .


To developed an educational programme to advance the reproductive health of the female workers .


An intervention study was conducted between July 2010 and April 2011 in Shenzhen .


Two commune factories were selected to participate and provided a control cluster receiving routine local government health services and a second cluster receiving an educational intervention in addition to the routine services .


The intervention included distribution and free access to educational study materials .


The factory workers ' knowledge , attitudes and behaviour in the area of reproductive health and STD were the main study outcomes .


Compared with the control cluster , at the 6-month follow-up assessment , the intervention cluster had a significantly higher proportion of correct answers to queries about human immunodeficiency virus/acquired immunodeficiency syndrome ( HIV/AIDS ) ( standardised coefficients of multiple linear regression ( B ) 0.047 ; P = 0.020 ) and awareness of places providing free contraceptives ( odds ratio [ OR ] 2.011 , 95 % confidence interval [ CI ] 1.635-2 .472 ; P < 0.001 ) , and a significantly lower proportion accepting premarital sex ( OR 0.492 , 95 % CI 0.416-0 .582 ; P < 0.001 ) , practising premarital sex ( OR 0.539 , 95 % CI 0.478-0 .608 ; P < 0.001 ) or suffering from gynaecological disorders ( OR 0.801 , 95 % CI 0.697-0 .921 ; P = 0.002 ) .


A community-based educational intervention targeting unmarried female migrant workers appears to be effective in substantially improving their knowledge of reproductive health and their attitudes and behaviour towards health , and in reducing prevalence of STD .


Antifibrinolytics can reduce intraoperative blood loss .


The primary aim of this study was to determine the efficacy of intraoperative tranexamic acid , epsilon-aminocaproic acid , and placebo at reducing perioperative blood loss and the transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal arthrodesis .


This is a prospective , randomized , double-blind comparison of tranexamic acid , epsilon-aminocaproic acid , and placebo used intraoperatively in patients with adolescent idiopathic scoliosis .


One hundred and twenty-five patients with adolescent idiopathic scoliosis were randomly assigned to the tranexamic acid , epsilon-aminocaproic acid , or control groups .


Parameters recorded included estimated blood loss , hematocrit , blood product usage , drain output , and total blood losses .


The primary outcomes were intraoperative blood loss and postoperative drainage .


Secondary outcomes were transfusion requirements and hematocrit changes both intraoperatively and postoperatively .


One hundred and twenty-five patients ( ninety-seven female and twenty-eight male , with a mean age of fifteen years ) were randomized to receive tranexamic acid ( thirty-six patients ) , epsilon-aminocaproic acid ( forty-two patients ) , or saline solution ( forty-seven patients ) .


The groups were similar at baseline , with one exception : the saline solution group had a higher estimated blood volume at baseline than the tranexamic acid group .


Both tranexamic acid and epsilon-aminocaproic acid reduced the estimated blood loss per degree and estimated blood loss per pedicle screw .


Epsilon-aminocaproic acid , but not tranexamic acid , reduced estimated blood loss and estimated blood loss per level .


Tranexamic acid also reduced total blood losses compared with epsilon-aminocaproic acid or saline solution .


In an analysis controlling for level , degree , and number of anchors , tranexamic acid reduced drain output and total blood losses .


Tranexamic acid or epsilon-aminocaproic acid had a smaller decrease in hematocrit postoperatively .


In an analysis controlling for the mean arterial pressure during surgical exposure , tranexamic acid reduced estimated blood loss and total blood losses .


Overall , antifibrinolytics ( tranexamic acid or epsilon-aminocaproic acid ) reduced estimated blood loss , total blood losses , and the decline in hematocrit postoperatively compared with saline solution .


There was no difference among the groups with respect to the transfusion rate , duration of surgery , levels fused , or pedicle screws placed .


Tranexamic acid and epsilon-aminocaproic acid reduced operative blood loss but not transfusion rate .


Tranexamic acid is more effective at reducing postoperative drainage and total blood losses compared with epsilon-aminocaproic acid .


Maintenance of the mean arterial pressure at < 75 mm Hg during surgical exposure appears to be critical for maximizing antifibrinolytic benefit .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Randomized clinical trials show higher 30-day risk of stroke or death after carotid artery stenting compared with surgery .


We examined whether operator experience is associated with 30-day risk of stroke or death in the Carotid Stenting Trialists ' Collaboration database .


The Carotid Stenting Trialists ' Collaboration is a pooled individual patient database including all patients recruited in 3 randomized trials of stenting versus endarterectomy for symptomatic carotid stenosis ( Endarterectomy Versus Angioplasty in patients with Symptomatic Severe Carotid Stenosis trial , Stent-Protected Angioplasty versus Carotid Endarterectomy trial , and International Carotid Stenting Study ) .


Lifetime carotid artery stenting experience , lifetime experience in stenting procedures excluding the carotid , and annual number of procedures performed within the trial ( in-trial volume ) , divided into tertiles , were used to measure operator experience .


The outcome event was the occurrence of any stroke or death within 30 days of the procedure .


The analysis was done per protocol .


Among 1546 patients who underwent carotid artery stenting , 120 ( 7.8 % ) had a stroke or death within 30 days of the procedure .


The 30-day risk of stroke or death did not differ according to operator lifetime carotid artery stenting experience ( P = 0.8 ) or operator lifetime stenting experience excluding the carotid ( P = 0.7 ) .


In contrast , the 30-day risk of stroke or death was significantly higher in patients treated by operators with low ( mean 3.2 procedures/y ; risk 10.1 % ; adjusted risk ratio = 2.30 [ 1.36-3 .87 ] ) and intermediate annual in-trial volumes ( 3.2-5 .6 procedures/y ; 8.4 % ; adjusted risk ratio = 1.93 [ 1.14-3 .27 ] ) compared with patients treated by high annual in-trial volume operators ( > 5.6 procedures/y ; 5.1 % ) .


Carotid stenting should only be performed by operators with annual procedure volume 6 cases per year .


The aim of this study was to evaluate occlusion rates of great saphenous veins ( GSV ) with a diameter between 5-10 mm that received a pre-treatment size reduction via perivenous tumescent application ( TA ) followed by catheter-directed foam sclerotherapy ( CDFS ) .


A prospective blinded randomized clinical trial comparing the occlusion rates of GSV at 1 - , 6 - , and 12-month follow-up .


Fifty patients were included and randomized into two groups .


CDFS was performed accessing the GSV at knee level and applying 8 mL of 2 % polidocanol-foam ( EasyFoam ) while the catheter was withdrawn .


Strictly perivenous TA was performed in group 1 before applying the sclerosant agent .


Occlusion rates and clinical scores were assessed by blinded examiners .


After 12 months in group 1 full occlusion was achieved in 73.9 % , partial occlusion in 8.7 % , and 17.4 % were classified as treatment failure .


In group 2 , 75 % of the targeted GSV were fully occluded , 20 % were partially occluded , and 5 % were diagnosed as treatment failure .


Both groups showed a significant reduction of the vein diameter .


Patient 's tolerance and satisfaction with the treatment was high in both groups .


No benefit could be found using additional TA to reduce the vein diameter before the treatment .


Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity .


We sought to determine whether single-agent paclitaxel ( T ) was inferior to doxorubicin and cyclophosphamide ( AC ) , when each was administered for four or six cycles of therapy , and whether it offered less toxicity .


Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC , defined as the one-sided 95 % upper-bound CI ( UCB ) of hazard ratio ( HR ) of T versus AC less than 1.30 for the primary end point of relapse-free survival ( RFS ) .


As a 2 2 factorial design , duration of therapy was also addressed and was previously reported .


With 3,871 patients enrolled onto the trial , a median follow-up period of 6.1 years , and 437 RFS events , we achieved an HR of 1.26 ( one sided 95 % UCB , 1.48 ; favoring AC does not allow a conclusion of noninferiority of T with AC ; UCB > 1.3 ) .


With 266 patient deaths , the HR for overall survival ( OS ) was 1.27 favoring AC ( UCB , 1.56 ) .


The estimated absolute advantage of AC at 5 years is 3 % for RFS ( 91 v 88 % ) and 1 % for OS ( 95 v 94 % ) .


All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS .


Hematologic toxicity was more common in patients treated with AC , and neuropathy was more common in patients treated with T.


This trial did not show noninferiority of T to AC , a conclusion that is unlikely to change with additional events and follow-up .


T was less toxic than AC .


Adenotonsillectomy for obstructive sleep apnea syndrome ( OSAS ) may lead to weight gain , which can have deleterious health effects when leading to obesity .


However , previous data have been from nonrandomized uncontrolled studies , limiting inferences .


This study examined the anthropometric changes over a 7-month interval in a randomized controlled trial of adenotonsillectomy for OSAS , the Childhood Adenotonsillectomy Trial .


A total of 464 children who had OSAS ( average apnea/hypopnea index [ AHI ] 5.1 / hour ) , aged 5 to 9.9 years , were randomized to Early Adenotonsillectomy ( eAT ) or Watchful Waiting and Supportive Care ( WWSC ) .


Polysomnography and anthropometry were performed at baseline and 7-month follow-up .


Multivariable regression modeling was used to predict the change in weight and growth indices .


Interval increases in the BMI z score ( 0.13 vs. 0.31 ) was observed in both the WWSC and eAT intervention arms , respectively , but were greater with eAT ( P < .0001 ) .


Statistical modeling showed that BMI z score increased significantly more in association with eAT after considering the influences of baseline weight and AHI .


A greater proportion of overweight children randomized to eAT compared with WWSC developed obesity over the 7-month interval ( 52 % vs. 21 % ; P < .05 ) .


Race , gender , and follow-up AHI were not significantly associated with BMI z score change .


eAT for OSAS in children results in clinically significant greater than expected weight gain , even in children overweight at baseline .


The increase in adiposity in overweight children places them at further risk for OSAS and the adverse consequences of obesity .


Monitoring weight , nutritional counseling , and encouragement of physical activity should be considered after eAT for OSAS .


Vulvar lichen sclerosus is a chronic condition usually responsive to topical corticosteroids .


We sought to evaluate the efficacy ( reduction of signs and symptoms ) and safety of clobetasol propionate 0.05 % and tacrolimus 0.1 % in the treatment of vulvar lichen sclerosus .


This double-blind , randomized study comparing 2 treatments over a 3-month period , enrolled 58 female patients with newly diagnosed vulvar lichen sclerosus or untreated vulvar lichen sclerosus for at least 1 month .


In all , 55 patients were included in the statistical analysis .


A total of 28 patients were assigned to the tacrolimus group and 27 patients to the clobetasol group .


Both groups showed a significant difference in the decrease of symptoms and signs of lichen sclerosus .


At the end of the study , 28 participants ( 19tacrolimus and 9 clobetasol ) still had some clinical signs of lichen sclerosus ( ( 2 ) = 6.56 , P = .015 ) .


However , a significantly higher number of patients in the clobetasol group ( n = 15 ) had absence of signs and symptoms of lichen sclerosus ( ( 2 ) = 10.35 , P = .002 ; ( 2 ) = 10.35 , P = .002 ) .


No adverse events were reported .


Short length of trial and recruitment through our vulvar disease referral center are limitations .


This study showed that topical clobetasol propionate was significantly more effective in treating vulvar lichen sclerosus than topical tacrolimus .


Combining cisplatin or cetuximab with radiation improves overall survival ( OS ) of patients with stage III or IV head and neck carcinoma ( HNC ) .


Cetuximab plus platinum regimens also increase OS in metastatic HNC .


The Radiation Therapy Oncology Group launched a phase III trial to test the hypothesis that adding cetuximab to the radiation-cisplatin platform improves progression-free survival ( PFS ) .


Eligible patients with stage III or IV HNC were randomly assigned to receive radiation and cisplatin without ( arm A ) or with ( arm B ) cetuximab .


Acute and late reactions were scored using Common Terminology Criteria for Adverse Events ( version 3 ) .


Outcomes were correlated with patient and tumor features and markers .


Of 891 analyzed patients , 630 were alive at analysis ( median follow-up , 3.8 years ) .


Cetuximab plus cisplatin-radiation , versus cisplatin-radiation alone , resulted in more frequent interruptions in radiation therapy ( 26.9 % v. 15.1 % , respectively ) ; similar cisplatin delivery ( mean , 185.7 mg/m2 v. 191.1 mg/m2 , respectively ) ; and more grade 3 to 4 radiation mucositis ( 43.2 % v. 33.3 % , respectively ) , rash , fatigue , anorexia , and hypokalemia , but not more late toxicity .


No differences were found between arms A and B in 30-day mortality ( 1.8 % v. 2.0 % , respectively ; P = .81 ) , 3-year PFS ( 61.2 % v. 58.9 % , respectively ; P = .76 ) , 3-year OS ( 72.9 % v. 75.8 % , respectively ; P = .32 ) , locoregional failure ( 19.9 % v. 25.9 % , respectively ; P = .97 ) , or distant metastasis ( 13.0 % v. 9.7 % , respectively ; P = .08 ) .


Patients with p16-positive oropharyngeal carcinoma ( OPC ) , compared with patients with p16-negative OPC , had better 3-year probability of PFS ( 72.8 % v. 49.2 % , respectively ; P < .001 ) and OS ( 85.6 % v. 60.1 % , respectively ; P < .001 ) , but tumor epidermal growth factor receptor ( EGFR ) expression did not distinguish outcome .


Adding cetuximab to radiation-cisplatin did not improve outcome and hence should not be prescribed routinely .


PFS and OS were higher in patients with p16-positive OPC , but outcomes did not differ by EGFR expression .


Oncogenic mutations are powerful predictive biomarkers for molecularly targeted cancer therapies .


For mutation detection patients have to undergo invasive tumor biopsies .


Alternatively , archival samples are used which may no longer reflect the actual tumor status .


Circulating tumor cells ( CTC ) could serve as an alternative platform to detect somatic mutations in cancer patients .


We sought to develop a sensitive and specific assay to detect mutations in the EGFR gene in CTC from lung cancer patients .


We developed a novel assay based on real-time polymerase chain reaction ( PCR ) and melting curve analysis to detect activating EGFR mutations in blood cell fractions enriched in CTC .


Non-small-cell lung cancer ( NSCLC ) was chosen as disease model with reportedly very low CTC counts .


The assay was prospectively validated in samples from patients with EGFR-mutant and EGFR-wild type NSCLC treated within a randomized clinical trial .


Sequential analyses were conducted to monitor CTC signals during therapy and correlate mutation detection in CTC with treatment outcome .


Assay sensitivity was optimized to enable detection of a single EGFR-mutant CTC/mL peripheral blood .


CTC were detected in pretreatment blood samples from all 8 EGFR-mutant lung cancer patients studied .


Loss of EGFR-mutant CTC signals correlated with treatment response , and its reoccurrence preceded relapse .


Despite low abundance of CTC in NSCLC oncogenic mutations can be reproducibly detected by applying an unbiased CTC enrichment strategy and highly sensitive PCR and melting curve analysis .


This strategy may enable non-invasive , specific biomarker diagnostics and monitoring in patients undergoing targeted cancer therapies .


We defined the theoretical oxygen tension behind modern scleral contact lenses ( CLs ) made of different rigid gas permeable ( RGP ) materials , assuming different thickness of the tear layer behind the lens .


A second goal was to show clinically the effect of the postlens tear film on corneal swelling .


We simulated the partial pressure of oxygen across the cornea behind scleral CLs made of different lens materials ( oxygen permeability Dk , 75-200 barrer ) and different thickness ( Tav , 100-300 m ) .


Postlens tear film thicknesses ( Tpost-tear ) ranging from 150 to 350 m were considered .


Eight healthy subjects were fitted randomly with a scleral lens with a thin and a thick postlens tear layer in two different sessions for a period of 3 hours under open-eye conditions .


The CLs with less than 125 barrer of Dk and a thickness over 200 m depleted the oxygen availability at the lens-cornea interface below 55 mm Hg for a postlens tear film of 150 m. For a postlens tear film thickness of 350 m , no combination of material or lens thickness will meet the criteria of 55 mm Hg .


Our clinical measures of corneal edema showed that this was significantly higher ( P < 0.001 , Wilcoxon signed ranks test ) with the thicker compared to the thinner Tpost-tear ( mean SD , 1.66 1.12 vs. 4.27 1.19 % ) .


Scleral RGP CLs must be comprised of at least 125 barrer of oxygen permeability and up to 200 m thick to avoid hypoxic effects even under open eye conditions .


Postlens tear film layer should be below 150 m to avoid clinically significant edema .


To determine the influence of socio-demographic , clinical parameters and obstetric complications on postpartum health-related quality of life ( HRQoL ) .


We used data of three randomized controlled trials to investigate HRQoL determinants in women after an obstetric complication .


The DIGITAT and HYPITAT trials compared induction of labor and expectant management in women with intra-uterine growth restriction ( IUGR ) and hypertensive disorders .


The WOMB trial randomized anemic women after postpartum hemorrhage to red blood cell transfusion or expectant management .


The HRQoL-measure Short-Form36 was completed at six weeks postpartum .


Multivariable analyses were used to identify which parameters affected the Short-Form36 physical component score ( PCS ) and mental component score ( MCS ) .


HRQoL analyses included 1391 women ( 60 % ) of the 2310 trial participants .


HYPITAT and DIGITAT participants had significantly lower MCS than WOMB participants .


In multivariable analysis , PCS after elective and emergency cesarean section was 5-6 points lower than after vaginal delivery .


Gestational hypertension , neonatal admission and delivery in an academic hospital had a small negative effect on PCS .


No effect was found for randomization status , maternal age , BMI , country of birth , education , parity , induction of labor , analgesics , birth weight , perineal laceration , delivery of placenta , postpartum hemorrhage , congenital anomaly , urinary tract infection , thromboembolic event or endometritis .


MCS was influenced only mildly by these parameters .


IUGR and hypertensive disorders lead to lower HRQoL scores postpartum than PPH .


In a heterogeneous obstetric population , only mode of delivery by cesarean section has a profound , negative impact , on physical HRQoL ( PCS ) .


No profound impacts on MCS were detected .


The effects of hypnosis on physiological ( gastrointestinal ) functions are incompletely understood , and it is unknown whether they are hypnosis-specific and gut-specific , or simply unspecific effects of relaxation .


Sixty-two healthy female volunteers were randomly assigned to either a single session of hypnotic suggestion of ingesting an appetizing meal and an unappetizing meal , or to relax and concentrate on having an appetizing or unappetizing meal , while the electrogastrogram ( EGG ) was recorded .


At the end of the session , participants drank water until they felt full , in order to detect EGG-signal changes after ingestion of a true gastric load .


During both conditions participants reported their subjective well-being , hunger and disgust at several time points .


Imagining eating food induced subjective feelings of hunger and disgust as well as changes in the EGG similar to , but more pronounced than those seen with a real gastric water load during both hypnosis and relaxation conditions .


These effects were more pronounced when imagining an appetizing meal than with an unappetizing meal .


There was no significant difference between the hypnosis and relaxation conditions .


Imagination with and without hypnosis exhibits similar changes in subjective and objective measures in response to imagining an appetizing and an unappetizing food , indicating high sensitivity but low specificity .


To investigate the effects of two different rehabilitation programs in acute central vestibulopathy secondary to posterior circulation stroke .


A prospective randomized controlled study was conducted on 25 patients with posterior circulation stroke .


Patients were instructed in routine balance and mobility exercises during the acute hospitalization period .


At discharge , patients were assigned to either a rehabilitation or home exercise group .


The home exercise group was instructed to perform the same exercise program provided in the course of hospitalization period .


The rehabilitation group was randomized into the visual feedback posturography training or vestibular rehabilitation group .


The balance and gait performance were assessed with clinical and objective measurements before and after 6 weeks of training .


The balance and gait scores were significantly improved in both rehabilitation groups and in the home exercise group ( p < 0.05 ) , but no significant difference was found between the groups in terms of post-treatment values ( p > 0.05 ) .


The improvements of balance and gait function in rehabilitation groups did not differ from the home exercise group .


Rehabilitation programs were equally effective to improve the recovery in acute central vestibulopathy .


To compare the suitability of CO2 laser with steel instruments for margin excision in transoral laser microsurgery .


Prospective randomized blinded study .


Patients with glottic cancer undergoing laser resection were randomized to margin excision by either steel instruments or CO2 laser .


Margins were analyzed for size , interpretability and degree of artifact by a pathologist who was blinded to technique .


45 patients were enrolled in the study with 226 total margins taken .


39 margins taken by laser had marked artifact and 0 were uninterpretable .


20 margins taken by steel instruments had marked artifact , and 2 were uninterpretable .


Controlling for margin size , the laser technique was associated with increasing degrees of margin artifact ( p = 0.210 ) , but there was no difference in crude rates of uninterpretability ( p = 0.24 ) .


Laser margin excision is associated with a greater degree of artifact than steel instrument excision , but was not associated with higher rate of uninterpretability .


Less than half of patients with chronic hepatitis C genotype 3 ( G3 ) and high viral load ( HVL ) without a rapid virological response ( RVR ) achieve a sustained virological response ( SVR ) when treated with peginterferon plus ribavirin ( RBV ) .


To assess the impact of high doses of RBV on SVR in patients with G3 and HVL .


Ninety-seven patients were randomized to receive peginterferon -2 a + RBV 800 mg/day ( A ; n = 42 ) or peginterferon -2 a + RBV 1600 mg/day + epoetin 400 IU/kg/week SC ( B ; n = 55 ) .


Patients allocated to group B who achieved RVR continued on RBV ( 800mg/day ) for a further 20 weeks ( B1 ; n = 42 ) while non-RVR patients received a higher dose of RBV ( 1600 mg/day ) + epoetin ( B2 ; n = 13 ) .


RVR was observed in 64.3 % of patients in A and in 76.4 % in B ( p = 0.259 ) .


Intention-to-treat ( ITT ) analysis showed SVR rates of 64.3 % ( A ) and 61.8 % ( B ) , with a reduction of -2.5 % ( -21.8 % to 16.9 % ) ( p = 0.835 ) .


The SVR rate was 61.9 % in arm B1 and 61.5 % in arm B2 .


No serious adverse events were reported , and the rate of moderate adverse events was < 5 % .


G3 patients with high viral load without RVR did not obtain a benefit from a higher dose of RBV .


Higher doses of RBV plus epoetin were safe and well tolerated ( Clin Trials Gov NCT00830609 ) .


A limited number of nondigestible oligosaccharides are available for use in infant formula .


This study evaluated growth and safety in infants fed formula supplemented with a mixture of bovine milk-derived oligosaccharides ( BMOS ) .


This mixture , which was generated from whey permeate , contains galactooligosaccharides and other oligosaccharides from bovine milk , such as 3 ' - and 6 ' - sialyllactose .


We hypothesized that growth in infants fed BMOS-supplemented formula would be noninferior to that in infants fed standard formula .


Healthy term infants 14days old were randomly assigned to standard formula ( control ; n = 84 ) ; standard formula with BMOS ( IF-BMOS ; n = 99 ) ; or standard formula with BMOS and probiotics ( Bifidobacterium longum , Lactobacillus rhamnosus ) ( IF-BMOS + Pro ; n = 98 ) .


A breastfed reference group was also enrolled ( n = 30 ) .


The primary outcome was mean weight gain/day from enrollment to age 4months ( noninferiority margin : -3.0 g/day ) .


189 ( 67.3 % ) formula-fed infants were included in the primary analysis .


Mean differences in weight gain between the control and IF-BMOS and IF-BMOS + Pro groups were < 1g/day , with 97.5 % confidence intervals above -3.0 g/day , indicating noninferior weight gain in the BMOS formula groups .


Compared with control , infants in the BMOS groups had more frequent ( p < 0.0001 ) and less hard ( p = 0.0003 ) stools .


No significant differences were observed between the control and BMOS groups in caregivers ' reports of flatulence , vomiting , spitting up , crying , fussing , and colic .


When based on clinical evaluation by the investigator , the incidence of colic was higher ( p = 0.01 ) in IF-BMOS than in control ; the incidence of investigator-diagnosed colic was not significantly different in control and IF-BMOS + Pro ( p = 0.15 ) .


Stool bifidobacteria and lactobacilli counts were higher with IF-BMOS + Pro compared with control ( p < 0.05 ) , whereas Clostridia counts were lower ( p < 0.05 ) in both BMOS groups compared with control .


Infant formula containing BMOS either with or without probiotics provides adequate nutrition for normal growth in healthy term infants .


Further studies are needed to fully explore the digestive tolerance of BMOS formula .


ClinicalTrials.gov NCT01886898 .


Registered 24 June 2013 .


Frailty is a risk factor for adverse events after surgery .


Residents ' ability to recognize frailty is underdeveloped .


We assessed the influence of a frailty education module on surgical residents ' estimates of lobectomy risk .


Traditional track cardiothoracic surgery residents were randomly allocated to take an online short course on frailty ( experimental group ) or to receive no training ( control group ) .


Residents read a clinical vignette , made an initial risk estimate of major complications for lobectomy , and rated clinical factors on their importance to their estimates .


They viewed a video of a standardized patient portraying the patient in the vignette , randomly selected to exhibit either vigorous or frail behavior , and provided a final risk estimate .


After rating five vignettes , they completed a test on their frailty knowledge .


Forty-one residents participated ( 20 in the experimental group ) .


Initial risk estimates were similar between the groups .


The experimental group rated clinical factors as `` very important '' in their initial risk estimates more often than did the control group ( 47.6 % versus 38.5 % ; p < 0.001 ) .


Viewing videos resulted in a significant change from initial to final risk estimates ( frail 50 % 75 % increase , p = 0.008 ; vigorous 14 % 32 % decrease , p = 0.043 ) .


The magnitude of change in risk estimates was greater for the experimental group ( 10.0 8.1 versus 5.1 7.7 ; p < 0.001 ) .


The experimental group answered more frailty test questions correctly ( 93.7 % versus 75.2 % ; p < 0.001 ) .


A frailty education module improved resident knowledge of frailty and influenced surgical risk estimates .


Training in frailty may help educate residents in frailty recognition and surgical risk assessment .


Type 1 diabetes results from autoimmune destruction of pancreatic cells .


Findings from preclinical studies suggest that dipeptidyl peptidase-4 inhibitors and proton-pump inhibitors might enhance - cell survival and regeneration .


We postulated that sitagliptin and lansoprazole would preserve - cell function in patients with recent-onset type 1 diabetes .


We did a double-blind , placebo-controlled , phase 2 trial ( REPAIR-T1D ) .


Participants aged 11-36 years , diagnosed with type 1 diabetes within the past 6 months were recruited from Sanford Health Systems ( Sioux Falls , SD , USA ; Fargo , ND , USA ) , Children 's Hospitals and Clinics of Minnesota ( St Paul , MN , USA ) , and Rady Children 's Hospital ( San Diego , CA , USA ) .


Participants were randomly assigned ( 2:1 ) to receive oral sitagliptin ( 100 mg for participants 18 years , 50 mg for those < 18 years ) and lansoprazole ( 60 mg for participants 18 years , 30 mg for those < 18 years ) or matched placebo for 12 months .


Randomisation was done by a blocked randomisation process ( blocks of three and six ) , with separate streams for younger ( < 18 years ) and older ( 18 years ) participants , and males and females .


All participants and personnel remained masked until after the completion of the final 12 month visit , at which time data were unmasked to the analysis team .


The primary endpoint was C-peptide response to a mixed meal challenge at 12 months measured as 2 h area under curve .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT01155284 .


Between Sept 21 , 2010 , and May 29 , 2012 , 46 participants were randomly assigned to the treatment group and 22 to the placebo group ; of whom 40 participants in the treatment group and 18 in the placebo group completed the 12-month treatment .


At 12 months , the mean change in C-peptide area under curve was -229 pmol/L ( 95 % CI -316 to -142 ) for the treatment group and -253 pmol/L ( -383 to -123 ) for the placebo group ; this difference was not significant ( p = 077 ) .


No adverse or serious adverse events were probably or definitely related to the study treatment .


Although the expected change in the primary endpoint was not achieved , not all participants had increases in glucagon-like peptide-1 and gastrin concentrations that were expected with treatment .


Although participants did not have adverse events related to study drugs , the study is not powered to address safety definitively .


Further trials including these drugs might be warranted , but should be designed to ensure appropriate selection of participants and increases in these intermediary hormones .


Sanford Research and JDRF .


In the TARGET I randomized controlled trial , the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions .


This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population ( including patients with small vessels , long lesions and multi-vessels ) , and at validating the ability of the SYNTAX score ( SS ) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent .


TARGET II was a prospective , multicenter , single-arm study with primary outcome of 12-month target lesion failure ( TLF ) , including cardiac death , target vessel myocardial infarction ( TV-MI ) and ischemia-driven target lesion revascularization ( TLR ) .


Stent thrombosis was defined according to the Academic Research Consortium ( ARC ) definition .


Patients were grouped by tertiles of SS ( 6 , > 6 to 12 , and > 12 ) .


All patients were exclusively treated with the FIREHAWK stent and were followed up at 1 , 6 , and 12 months , and annually thereafter up to five years .


A total of 730 patients were included in this registry study .


The 12-month incidence of TLF was 4.4 % and the incidence of TLF components were , cardiac death 0.5 % , TV-MI 3.2 % , and TLR 2.2 % .


One definite/probable stent thrombosis was observed at 12-month follow-up .


Mean SS was 10.876.87 .


Patients in the SS > 12 tertile had significantly higher TLF ( P = 0.02 ) and TLR ( P < 0.01 ) rates than those in lower SS groups .


In COX proportional-hazards regression analyses , TLF incidence was strongly related to lesion length ( long lesion vs. non-long lesion patients ; HR 3.416 , 95 % CI , 1.622-7 .195 ) , but unrelated to diabetic , small vessel , and multivessel subgroups .


The low TLF incidence in this study indicates that FIREHAWK is safe and effective in the treatment of moderately complex coronary disease .


SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients .


To determine the efficacy of 4 g/day fish oil to lower triglycerides and impact lipoprotein particles , inflammation , insulin resistance , coagulation , and thrombosis .


Participants ( n = 42 , age 14 2 years ) with hypertriglyceridemia and low-density lipoprotein ( LDL ) cholesterol < 160 mg/dL were enrolled in a randomized , double-blind , crossover trial comparing 4 g of fish oil daily with placebo .


Treatment interval was 8 weeks with a 4-week washout .


Lipid profile , lipoprotein particle distribution and size , glucose , insulin , high-sensitivity C-reactive protein , interleukin-6 , fibrinogen , plasminogen activator inhibitor-1 , and thrombin generation were measured .


Baseline lipid profile was total cholesterol 194 ( 5.4 ) mg/dL ( mean [ SE ] ) , triglycerides 272 ( 21 ) mg/dL , high-density lipoprotein cholesterol 39 ( 1 ) mg/dL , and LDL cholesterol 112 ( 3.7 ) mg/dl .


LDL particle number was 1614 ( 60 ) nmol/L , LDL size was 19.9 ( 1.4 ) nm , and large very low-density lipoprotein/chylomicron particle number was 9.6 ( 1.4 ) nmol/L .


Triglycerides decreased on fish oil treatment but the difference was not significant compared with placebo ( -52 16 mg/dL vs -16 16 mg/dL ) .


Large very low-density lipoprotein particle number was reduced ( -5.83 1.29 nmol/L vs -0.96 1.31 nmol/L ; P < .0001 ) .


There was no change in LDL particle number or size .


There was a trend towards a lower prothrombotic state ( lower fibrinogen and plasminogen activator inhibitor-1 ; .10 > P > .05 ) ; no other group differences were seen .


In children , fish oil ( 4 g/day ) lowers triglycerides slightly and may have an antithrombotic effect but has no effect on LDL particles .


Examine the effect of weekday exposure over 6 months to different lunch sizes on energy intake and body weight in a free-living sample of working adults .


Adults ( n = 233 ) were randomly assigned to one of three lunch size groups ( 400 kcal , 800 kcal , and 1,600 kcal ) or to a no-free lunch control group for 6 months .


Weight and energy intake were measured at baseline , and months 1 , 3 , and 6 .


Lunch energy was significantly higher in the 800 and 1,600 kcal groups compared with the 400 kcal group ( P < 0.0001 ) .


Total energy was significantly higher for the 1,600 kcal group compared with the 400 and 800 kcal groups ( P = 0.02 ) .


Body weight change at 6 months did not significantly differ at the 5 % level by experimental group ( 1,600 kcal group : +1.1 kg ( SD = 0.44 ) ; 800 kcal group : -0.1 kg ( SD = 0.42 ) ; 400 kcal group : -0.1 kg ( SD = 0.43 ) ; control group : 1.1 ( SD = 0.42 ) ; P = 0.07 ) .


Weight gain over time was significant in the 1,600 kcal box lunch group ( P < 0.05 ) .


Weekday exposure for 6 months to a 1,600 kcal lunch caused significant increases in total energy intake and weight gain .


Environmental enteropathy ( EE ) is subclinical , diffuse villous atrophy characterized by T cell infiltration of the small intestinal mucosa associated with nutrient malabsorption and stunting .


EE is assessed by the lactulose : mannitol ( L : M ) test , whereby nonmetabolized sugars are ingested and quantified in the urine .


Multiple micronutrient ( MN ) deficiency morphologically mimics EE , and -3 ( n-3 ) polyunsaturated fatty acids reduce mucosal inflammation in Crohn disease .


We tested the hypothesis that supplementary MNs , with or without fish oil ( FO ) , would improve L : M in rural Malawian children aged 1-3 y compared with a control ( C ) group receiving a placebo .


The MNs and FO provided the Recommended Dietary Intake for 26 vitamins , minerals , eicosapentaenoic acid , and docosahexaenoic acid .


This was a 3-arm , randomized , double-blind , placebo-controlled clinical trial , with the primary outcomes being the change in L : M ( L : M ) after 12 and 24 wk of supplementation .


Comparisons were made for L : M after 12 and 24 wk within each group by using a Wilcoxon matched pairs signed rank test , because the data are not normally distributed .


A total of 230 children had specimens adequate for analysis ; all had an abnormal baseline L : M , defined as > 0.10 .


After 12 wk , children who received MNs + FO had a L : M [ mean ( 95 % CI ) ] of -0.10 ( -0.04 , -0.15 ; P = 0.001 ) , and children receiving only MNs had L : M of -0.12 ( -0.03 , -0.21 ; P = 0.002 ) .


After 24 wk , children who received MNs + FO had a L : M of -0.09 ( -0.03 , -0.15 ; P = 0.001 ) ; children receiving only MNs had a L : M of -0.11 ( -0.02 , -0.20 ; P = 0.001 ) , and the C group had L : M of -0.07 ( 0.02 , -0.16 ) ; P = 0.002 ) .


Linear growth was similar in all groups , 4.3 cm over 24 wk .


Although the effect was modest , these data suggest MNs can transiently ameliorate EE in rural African children .


The trial was registered at clinicaltrials.gov as NCT01593033 .


To investigate the impact of hyperglycemia during inductive treatment on the prognosis of acute lymphocytic leukemia ( ALL ) in children .


Clinical data of 159 ALL childhood cases were reviewed .


The patients were divided into the hyperglycemia group ( fasting glucose126 mg/dl and/or random blood glucose200 mg/dl ) and the euglycemia group according to the blood glucose values .


The ?


2 test was performed to compare the complete remission rates of the two groups , and Kaplan-Meier and log-rank tests were performed to compare the 5-year overall and relapse-free survival .


The incidence of hyperglycemia in the age10-year-old group was higher than the younger-age group ( P = 0.009 ) .


Values in the interim - and high-risk groups were higher than the standard-risk group ( P = 0.028 ) , while there was no significant difference between genders ( P = 0.056 ) .


The complete remission rates of the 2 groups demonstrated no significant difference ( P = 0.134 ) , while the 5-year OS of the hyperglycemia group was lower than in the euglycemia group ( 83.86.0 % vs 94.92.4 % , P = 0.014 ) .


The 5 - year RFS was significantly lower than the euglycemia group ( 62.98.7 % ) vs 80.29.1 % , P < 0.001 ) .


Children with age10 years old , and in the middle - and high-risk groups appear prone to complicating hyperglycemia during inductive chemotherapy , associated with lower 5-year OS and RFS .


Breathlessness is a common and distressing symptom , which increases in many diseases as they progress and is difficult to manage .


We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness .


In this single-blind randomised trial , we enrolled consecutive adults with refractory breathlessness and advanced disease from three large teaching hospitals and via general practitioners in South London .


We randomly allocated ( 1:1 ) patients to receive either a breathlessness support service or usual care .


Randomisation was computer generated centrally by the independent Clinical Trials Unit in a 1:1 ratio , by minimisation to balance four potential confounders : cancer versus non-cancer , breathlessness severity , presence of an informal caregiver , and ethnicity .


The breathlessness support service was a short-term , single point of access service integrating palliative care , respiratory medicine , physiotherapy , and occupational therapy .


Research interviewers were masked as to which patients were in the treatment group .


Our primary outcome was patient-reported breathlessness mastery , a quality of life domain in the Chronic Respiratory Disease Questionnaire , at 6 weeks .


All analyses were by intention to treat .


Survival was a safety endpoint .


This trial is registered with ClinicalTrials.gov , number NCT01165034 .


Between Oct 22 , 2010 and Sept 28 , 2012 , 105 consenting patients were randomly assigned ( 53 to breathlessness support service and 52 to usual care ) .


83 of 105 ( 78 % ) patients completed the assessment at week 6 .


Mastery in the breathlessness support service group improved compared with the control ( mean difference 058 , 95 % CI 001-115 , p = 0048 ; effect size 044 ) .


Sensitivity analysis found similar results .


Survival rate from randomisation to 6 months was better in the breathlessness support service group than in the control group ( 50 of 53 [ 94 % ] vs 39 of 52 [ 75 % ] ) and in overall survival ( generalised Wilcoxon 390 , p = 0048 ) .


Survival differences were significant for patients with chronic obstructive pulmonary disease and interstitial lung disease but not cancer .


The breathlessness support service improved breathlessness mastery .


Our findings provide robust evidence to support the early integration of palliative care for patients with diseases other than cancer and breathlessness as well as those with cancer .


The improvement in survival requires further investigation .


UK National Institute for Health Research ( NIHR ) and Cicely Saunders International .


To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers .


Multicenter , randomized , double-blind , placebo-controlled trial with random assignment to 12 weeks of varenicline 1mg twice daily ( n = 57 ) or matched placebo ( n = 55 ) , with in-person and telephone counseling .


Urban methadone programs in the Bronx , New York City , New York , USA .


Methadone maintenance patients , smoking 5 cigarettes/day , interested in quitting , stable in methadone treatment , without current Axis I psychiatric disorders , suicidal ideation or recent suicide attempts .


Seven-day point prevalence abstinence verified by expired carbon monoxide ( CO ) < 8 parts per million at week 12 ( primary outcome ) ; carbon monoxide ( CO ) - verified abstinence , cigarettes/day , incident Axis I psychiatric illness , suicidal ideation or serious adverse events ( SAEs ) at weeks 2 , 4 , 8 , 12 or 24 ( secondary outcomes ) .


Baseline demographic , smoking and clinical factors were similar between groups .


Retention at 24 weeks was 90 % .


Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence ( 10.5 versus 0 % , P = 0.03 ; effect size 10.5 % , 95 % confidence interval ( CI ) = 4.4-19 .3 % ) and to reduce smoking ( median five versus two cigarettes/day , P < 0.001 ) at 12 weeks .


These effects were not maintained after drug treatment ceased .


Incident psychiatric illness ( OR = 0.84 , 95 % CI = 0.16 , 4.4 ) and suicidality [ odds ratio ( OR ) = 0.88 , 95 % CI 0.2 , 3.9 ] were not different between groups .


There were no psychiatric or cardiac SAEs .